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"Devices",63898,"Completed","Baxter Healthcare Corp.","Route 120 And Wilson Rd",,"Round Lake","IL","60073-9799","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including FL, GA, IL, KS, KY, MI, MO, NC, ND, OH, PA, SC, TN, TX, WV, Puerto Rico and Internationally  to Canada.","Z-2687-2016","Class II","Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case;   For the administration of drugs and solutions to a patient's vascular system through a vascular access device.","15,257 units","Some of the individual extension set packages were improperly sealed, compromising the sterility of the product.","08/29/2016",," product code 2N3345, lot number UR12E03108",12/14/2012,"12/14/2012",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",63990,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide)","Z-2055-2016","Class II","Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids  Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.","20,311","Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.","06/27/2016",," 14339017  14339062  14339063  14339066  14339071  14339072  14339076  14339078  14339079  14339084  14339086  14339087  14339089  14339090  14339091  14339095  14339097  14339098  14339099  14339102  14339104  14339105  14339107  14339108  14339111  14339113  14339114  14339115  14339116  14339119  14339121  14339125  14339128  14339130  14339133  14339136  14339138  14339139  14339140  14339141  14339142  14339145  14339146  14339149  14339150  14339152  14339154  14339155  14339158  14339168  14339171  14339172  14339179  14339180  14339185  14339190  14339192  14339194  14339195  14339200  14339201  14339205  14339216  14339228  14339230  14339231  14339233  14339236  14339243  14339246  14339248  14339250  14339251  14339254  14339262  14339271  14339274  14339280  14339283  14339287  14339291  14339293  14339299  14339302  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"Devices",63990,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - USA (nationwide)","Z-2056-2016","Class II","Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids  Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.","15,285","Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.","06/27/2016",," 14589003  14589008  14589009  14589012  14589013  14589014  14589015  14589017  14589020  14589022  14589028  14589030  14589031  14589033  14589034  14589035  14589043  14589046  14589048  14589049  14589050  14589053  14589057  14589060  14589063  14589064  14589066  14589068  14589072  14589078  14589082  14589083  14589086  14589092  14589095  14589100  14589101  14589105  14589108  14589110  14589111  14589116  14589117  14589118  14589121  14589127  14589131  14589133  14589135  14589136  14589137  14589139  14589140  14589141  14589144  14589148  14589149  14589151  14589154  14589159  14589160  14589161  14589162  14589165  14589167  14589169  14589172  14589174  14589175  14589178  14589180  14589188  14589195  14589203  14589204  14589206  14589214  14589215  14589221  14589222  14589225  14589228  14589230  14589231  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"Devices",63993,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution and Canada","Z-0354-2017","Class II","Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027","15,285","Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.","11/03/2016",," Serial Numbers:    14589003  14589008  14589009  14589012  14589013  14589014  14589015  14589017  14589020  14589022  14589028  14589030  14589031  14589033  14589034  14589035  14589043  14589046  14589048  14589049  14589050  14589053  14589057  14589060  14589063  14589064  14589066  14589068  14589072  14589078  14589082  14589083  14589086  14589092  14589095  14589100  14589101  14589105  14589108  14589110  14589111  14589116  14589117  14589118  14589121  14589127  14589131  14589133  14589135  14589136  14589137  14589139  14589140  14589141  14589144  14589148  14589149  14589151  14589154  14589159  14589160  14589161  14589162  14589165  14589167  14589169  14589172  14589174  14589175  14589178  14589180  14589188  14589195  14589203  14589204  14589206  14589214  14589215  14589221  14589222  14589225  14589228  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"Devices",63993,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution and Canada","Z-0353-2017","Class II","Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026","20,311","Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.","11/03/2016",," Serial Numbers:    14339017  14339062  14339063  14339066  14339071  14339072  14339076  14339078  14339079  14339084  14339086  14339087  14339089  14339090  14339091  14339095  14339097  14339098  14339099  14339102  14339104  14339105  14339107  14339108  14339111  14339113  14339114  14339115  14339116  14339119  14339121  14339125  14339128  14339130  14339133  14339136  14339138  14339139  14339140  14339141  14339142  14339145  14339146  14339149  14339150  14339152  14339154  14339155  14339158  14339168  14339171  14339172  14339179  14339180  14339185  14339190  14339192  14339194  14339195  14339200  14339201  14339205  14339216  14339228  14339230  14339231  14339233  14339236  14339243  14339246  14339248  14339250  14339251  14339254  14339262  14339271  14339274  14339280  14339283  14339287  14339291  14339293  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"Devices",63994,"Ongoing","Hospira Inc.","275 N. Field Dr.",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Canada","Z-0305-2017","Class II","Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids    Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.","35,596 devices in total"," button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.","10/24/2016",," 14339017  14339062  14339063  14339066  14339071  14339072  14339076  14339078  14339079  14339084  14339086  14339087  14339089  14339090  14339091  14339095  14339097  14339098  14339099  14339102  14339104  14339105  14339107  14339108  14339111  14339113  14339114  14339115  14339116  14339119  14339121  14339125  14339128  14339130  14339133  14339136  14339138  14339139  14339140  14339141  14339142  14339145  14339146  14339149  14339150  14339152  14339154  14339155  14339158  14339168  14339171  14339172  14339179  14339180  14339185  14339190  14339192  14339194  14339195  14339200  14339201  14339205  14339216  14339228  14339230  14339231  14339233  14339236  14339243  14339246  14339248  14339250  14339251  14339254  14339262  14339271  14339274  14339280  14339283  14339287  14339291  14339293  14339299  14339302  14339304  14339308  14339322  14339327  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"Devices",63994,"Ongoing","Hospira Inc.","275 N. Field Dr.",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and Canada","Z-0306-2017","Class II","Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids  Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.","35,596 devices in total"," button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.","10/24/2016",," 14589003  14589008  14589009  14589012  14589013  14589014  14589015  14589017  14589020  14589022  14589028  14589030  14589031  14589033  14589034  14589035  14589043  14589046  14589048  14589049  14589050  14589053  14589057  14589060  14589063  14589064  14589066  14589068  14589072  14589078  14589082  14589083  14589086  14589092  14589095  14589100  14589101  14589105  14589108  14589110  14589111  14589116  14589117  14589118  14589121  14589127  14589131  14589133  14589135  14589136  14589137  14589139  14589140  14589141  14589144  14589148  14589149  14589151  14589154  14589159  14589160  14589161  14589162  14589165  14589167  14589169  14589172  14589174  14589175  14589178  14589180  14589188  14589195  14589203  14589204  14589206  14589214  14589215  14589221  14589222  14589225  14589228  14589230  14589231  14589232  14589233  14589235  14589237  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"Devices",64005,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Canada","Z-0362-2017","Class II","Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids.  List number 16027.  Note that Hospira retired this pump June 30, 2015.  The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.","10897","May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes.  Delay or interruption of therapy.","11/04/2016",," 14589022  14589046  14589066  14589083  14589108  14589117  14589154  14589165  14589169  14589172  14589232  14589235  14589264  14589276  14589277  14589293  14589321  14589328  14589346  14589382  14589399  14589431  14589451  14589587  14589642  14589692  14589696  14589720  14589721  14589733  14589761  14589779  14589792  14589802  14590003  14590023  14590035  14590117  14590153  14590279  14590287  14590315  14590324  14590409  14590436  14590445  14590469  14590484  14590507  14590526  14590527  14590531  14590542  14590544  14590548  14590568  14590582  14590677  14590687  14590693  14590736  14590796  14590830  14590877  14590905  14590947  14590956  14591038  14591080  14591081  14591182  14591210  14591386  14591406  14591442  14591460  14591473  14591496  14591500  14591518  14591574  14591583  14591599  14591632  14591634  14591672  14591673  14591678  14591696  14591697  14591723  14591741  14591760  14591761  14591762  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14593398  14593428  14593448  14593456  14593488  14593531  14593554  14593561  14593643  1459",3/16/2011,"03/16/2011",11/16/2016,"11/16/2016","4599550  14599551  14599552  14599553  14599554  14599555  14599556  14599557  14599558  14599559  14599560  14599562  14599563  14599564  14599565  14599566  14599567  14599568  14599569  14599570  14599571  14599573  14599574  14599575  14599577  14599580  14599581  14599582  14599583  14599584  14599585  14599586  14599587  14599588  14599589  14599590  14599591  14599592  14599595  14599596  14599597  14599598  14599599  14599600  14599601  14599603  14599604  14599605  14599606  14599607  14599608  14599609  14599610  14599611  14599612  14599613  14599614  14599615  14599616  14599617  14599618  14599619  14599620  14599621  14599622  14599623  14599625  14599626  14599627  14599628  14599629  14599630  14599631  14599632  14599633  14599634  14599635  14599637  14599638  14599639  14599640  14599641  14599642  14599645  14599646  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17327652  17327654  17327657  17327659  17327661  17327664  17327666  17327669  17327671  17327673  17327674  17327676  17327677  17327678  17327679  17327680  17327682  17327683  17327689  17327690  17327691  17327694  17327695  17327696  17327698",,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64005,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Canada","Z-0361-2017","Class II","Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids.  List number 16026.  Note that Hospira retired this pump June 30, 2015.  The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.","10,337","May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes.  Delay or interruption of therapy.","11/04/2016",," 14339017  14339063  14339071  14339076  14339078  14339084  14339086  14339087  14339091  14339095  14339097  14339104  14339105  14339108  14339114  14339115  14339119  14339125  14339130  14339140  14339142  14339145  14339146  14339149  14339158  14339171  14339172  14339192  14339195  14339200  14339271  14339283  14339304  14339308  14339322  14339327  14339328  14339344  14339358  14339359  14339362  14339367  14339369  14339370  14339377  14339380  14339384  14339389  14339391  14339392  14339396  14339407  14339411  14339413  14339414  14339415  14339422  14339424  14339426  14339504  14339517  14339519  14339524  14339529  14339534  14339545  14339569  14339572  14339664  14339669  14339681  14339723  14339789  14339849  14339905  14339921  14339932  14339933  14339985  14339987  14339989  14339990  14340000  14340002  14340004  14340006  14340008  14340017  14340027  14340038  14340039  14340041  14340048  14340053  14340058  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14342619  14342657  14342664  14342668  14342678  14342694  14342752  14342857  14342886  1434",3/16/2011,"03/16/2011",11/16/2016,"11/16/2016","4352109  14352110  14352111  14352114  14352115  14352116  14352117  14352118  14352120  14352121  14352122  14352123  14352124  14352125  14352126  14352127  14352128  14352129  14352130  14352131  14352132  14352133  14352135  14352136  14352138  14352139  14352141  14352142  14352143  14352144  14352145  14352146  14352147  14352148  14352149  14352150  14352151  14352152  14352153  14352154  14352155  14352158  14352159  14352161  14352162  14352164  14352165  14352166  14352167  14352168  14352169  14352170  14352171  14352172  14352173  14352174  14352175  14352177  14352179  14352181  14352182  14352183  14352185  14352187  14352188  14352189  14352190  14352191  14352194  14352196  14352197  14352198  14352199  14352201  14352202  14352203  14352204  14352205  14352206  14352210  14352214  14352217  14352218  14352222  14352223  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"Devices",64230,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.","Z-2874-2016","Class II","LifeCare PCA 3, PCA Serial List Number 12384    Allows for clinician administration or self-administration of analgesic medications. ","69","Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops. ","09/22/2016",," Serial Number  12921204	  12922976	  12924008	  12925861	  12925924	  12925998	  12928528	  12928807	  12929016	  12929126	  12920432	  12920820	  12920856	  12920915	  12921404	  12921413	  12922304	  12922976	  12925861	  12925998	  12927215	  12929016	  12931044	  12931141	  12931155	  12931192	  12931244	  12931342	  12931361	  12931413	  12931610	  12931639	  12931649	  12931911	  12921480	  12921487	  12923723	  12924326	  12924350	  12924546	  12925259	  12925447	  12926315	  12927938	  12928075	  12928614	  12930418	  12930709	  12930890	  12931441	  12931760	  12931911	  12932487	  12932717	  12920754	  12920791	  12920897	  12921063	  12921613	  12922062	  12923441	  12924161	  12926859	  12927756	  12928775	  12929346	  12929438	  12931942	  12920112	  ",3/8/2013,"03/08/2013",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64230,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.","Z-2873-2016","Class II","LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709    Allows for clinician administration or self-administration of analgesic medications. ","8,794  ","Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops. ","09/22/2016",," Serial Number  15553367,   16224548,   16224939,   16225091,   16225646,   16225851,   16226006,   16226095,   16226117,   16226159,   16226360,   16226383,   16226435,   16226460,   16226680,   16226707,   16226726,   16226730,   16226756,   16226763,   16226891,   16226895,   16226898,   16226910,   16226917,   16226918,   16226919,   16226920,   16226921,   16226922,   16226923,   16226924,   16226925,   16226926,   16226927,   16226928,   16226929,   16226930,   16226931,   16226932,   16226933,   16226934,   16226935,   16226936,   16226937,   16226938,   16226939,   16226940,   16226941,   16226943,   16226944,   16226945,   16226946,   16226947,   16226948,   16226949,   16226950,   16226951,   16226952,   16226953,   16226954,   16226955,   16226956,   16226957,   16226958,   16226959,   16226960,   16226961,   16226962,   16226963,   16226964,   16226965,   16226966,   16226967,   16226968,   16226969,   16226970,   16226971,   16226972,   16226973,   16226974,   16226975,   16226976,   16226977,   16226978,   16226979,   16226980,   16226981,   16226982,   16226983,   16226984,   16226985,   16226986,   16226987,   16226988,   16226989,   16226990,   16226991,   16226992,   16226993,   16226994,   16226995,   16226996,   16226997,   16226998,   16226999,   16227000,   16227001,   16227002,   16227003,   16227004,   16227005,   16227006,   16227007,   16227008,   16227009,   16227010,   16227011,   16227012,   16227013,   16227014,   16227015,   16227016,   16227017,   16227018,   16227019,   16227020,   16227021,   16227022,   16227023,   16227024,   16227026,   16227027,   16227028,   16227029,   16227030,   16227031,   16227032,   16227033,   16227035,   16227036,   16227038,   16227039,   16227040,   16227041,   16227042,   16227043,   16227044,   16227045,   16227046,   16227047,   16227048,   16227049,   16227050,   16227051,   16227052,   16227053,   16227054,   16227055,   16227056,   16227057,   16227058,   16227059,   16227061,   16227062,   16227063,   16227064,   16227065,   16227066,   1",3/8/2013,"03/08/2013",9/28/2016,"09/28/2016",",   19352807,   19352808,   19352809,   19352810,   19352811,   19352812,   19352813,   19352814,   19352815,   19352816,   19352817,   19352818,   19352819,   19352820,   19352821,   19352822,   19352823,   19352824,   19352825,   19352826,   19352827,   19352828,   19352829,   19352830,   19352831,   19352832,   19352833,   19352834,   19352835,   19352836,   19352837,   19352838,   19352839,   19352840,   19352841,   19352842,   19352843,   19352844,   19352845,   19352846,   19352847,   19352848,   19352849,   19352850,   19352851,   19352852,   19352853,   19352854,   19352855,   19352856,   19352857,   19352858,   19352859,   19352860,   19352861,   19352862,   19352863,   19352864,   19352865,   19352866,   19352867,   19352868,   19352869,   19352870,   19352871,   19352872,   19352873,   19352874,   19352875,   19352876,   19352877,   19352878,   19352879,   19352880,   19352881,   19352882,   19352883,   19352884,   19352885,   19352886,   19352887,   19352888,   19352889,   19352890,   19352891,   19352892,   19352893,   19352894,   19352895,   19352896,   19352897,   19352898,   19352899,   19352900,   19352901,   19352902,   19352903,   19352904,   19352905,   19352906,   19352907,   19352908,   19352909,   19352910,   19352911,   19352912,   19352913,   19352914,   19352915,   19352916,   19352917,   19352918,   19352919,   19352920,   19352921,   19352922,   19352923,   19352924,   19352925,   19352926,   19352927,   19352928,   19352929,   19352930,   19352931,   19352932,   19352933,   19352934,   19352935,   19352936,   19352937,   19352938,   19352939,   19352940,   19352941,   19352942,   19352943,   19352944,   19352945,   19352946,   19352947,   19352948,   19352949,   19352950,   19352951,   19352953,   19352954,   19352955,   19352956,   19352957,   19352958,   19352959,   19352960,   19352961,   19352962,   19352963,   19352964,   19352965,   19352966,   19352967,   19352968,   19352969,   19352970,   19352971,   19352972,   19352973,   19352974,   19352975,   19352976,   19352977,   1",",   19355686,   19355687,   19355688,   19355689,   19355691,   19355692,   19355693,   19355694,   19355695,   19355696,   19355697,   19355698,   19355699,   19355700,   19355702,   19355703,   19355704,   19355705,   19355706,   19355707,   19355708,   19355709,   19355710,   19355711,   19355712,   19355713,   19355714,   19355715,   19355716,   19355717,   19355718,   19355719,   19355720,   19355721,   19355722,   19355724,   19355725,   19355727,   19355728,   19355729,   19355730,   19355731,   19355732,   19355733,   19355734,   19355735,   19355736,   19355737,   19355739,   19355740,   19355741,   19355743,   19355744,   19355745,   19355748,   19355749,   19355750,   19355751,   19355752,   19355753,   19355754,   19355755,   19355756,   19355757,   19355758,   19355759,   19355761,   19355762,   19355763,   19355764,   19355765,   19355766,   19355767,   19355770,   19355771,   19355772,   19355773,   19355774,   19355775,   19355776,   19355777,   19355778,   19355779,   19355780,   19355782,   19355783,   19355784,   19355785,   19355786,   19355787,   19355789,   19355790,   19355791,   19355792,   19355793,   19355794,   19355795,   19355796,   19355797,   19355798,   19355799,   19355800,   19355801,   19355802,   19355803,   19355804,   19355805,   19355806,   19355808,   19355810,   19355811,   19355812,   19355814,   19355816,   19355817,   19355822,   19355828,   19355830,   19355831,   19355832,   19355834,   19355835,   19355836,   19355837,   19355838,   19355839,   19355840,   19355841,   19355842,   19355843,   19355844,   19355845,   19355846,   19355847,   19355848,   19355849,   19355850,   19355851,   19355852,   19355853,   19355854,   19355855,   19355856,   19355857,   19355858,   19355859,   19355860,   19355861,   19355862,   19355863,   19355864,   19355865,   19355866,   19355867,   19355868,   19355869,   19355870,   19355871,   19355872,   19355873,   19355874,   19355875,   19355876,   19355877,   19355878,   19355879,   19355880,   19355881,   19355882,   19355884,   1",",   19358852,   19358853,   19358854,   19358855,   19358856,   19358857,   19358858,   19358859,   19358860,   19358861,   19358862,   19358864,   19358865,   19358866,   19358868,   19358869,   19358870,   19358871,   19358872,   19358873,   19358874,   19358875,   19358878,   19358879,   19358882,   19358884,   19358885,   19358889,   19358890,   19358891,   19358892,   19358893,   19358894,   19358895,   19358896,   19358897,   19358898,   19358899,   19358900,   19358901,   19358902,   19358903,   19358904,   19358905,   19358906,   19358907,   19358908,   19358909,   19358910,   19358911,   19358912,   19358913,   19358915,   19358916,   19358917,   19358918,   19358919,   19358920,   19358921,   19358922,   19358923,   19358924,   19358925,   19358926,   19358927,   19358928,   19358929,   19358930,   19358931,   19358932,   19358933,   19358934,   19358935,   19358936,   19358937,   19358938,   19358940,   19358941,   19358942,   19358943,   19358944,   19358945,   19358946,   19358947,   19358948,   19358950,   19358951,   19358952,   19358953,   19358954,   19358955,   19358956,   19358957,   19358958,   19358959,   19358960,   19358961,   19358962,   19358963,   19358964,   19358965,   19358966,   19358967,   19358968,   19358969,   19358970,   19358971,   19358972,   19358973,   19358975,   19358976,   19358977,   19358978,   19358979,   19358980,   19358981,   19358982,   19358983,   19358984,   19358985,   19358986,   19358987,   19358988,   19358989,   19358990,   19358992,   19358993,   19358994,   19358996,   19358997,   19358998,   19358999,   19359000,   19359001,   19359002,   19359003,   19359004,   19359005,   19359006,   19359007,   19359008,   19359009,   19359011,   19359012,   19359013,   19359014,   19359015,   19359016,   19359017,   19359018,   19359019,   19359020,   19359021,   19359022,   19359024,   19359025,   19359026,   19359027,   19359031,   19359032,   19359033,   19359034,   19359035,   19359036,   19359037,   19359038,   19359039,   19359041,   19359042,   19359043,   1",,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64261,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.","Z-2722-2016","Class II","Plum A+ Hyperbaric Infusion Pump.  List Number 11005.  The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.","357,778 total","The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.","09/06/2016",," List Number 11005.  Serial numbers:  16792201,   16792202,   16792205,   16792206,   16792208,   16792209,   16792210,   16792211,   16792213,   16792216,   16792217,   16792219,   16792220,   16792222,   16792223,   16792224,   16792225,   16792226,   16792227,   16792228,   16792230,   16792232,   16792233,   16792234,   16792235,   16792236,   16792238,   16792239,   16792240,   16792241,   16792242,   16792244,   16792245,   16792246,   16792248,   16792249,   16792250,   16792251,   16792252,   16792253,   16792254,   16792255,   16792256,   16792257,   16792258,   16792259,   16792260,   16792261,   16792263,   16792264,   16792265,   16792266,   16792268,   16792269,   16792271,   16792272,   16792273,   18807402,   18807405,   18807406,   18807407,   18807408,   18807409,   18807410,   18807413,   18807414,   18807417,   18807418,   18807420,   18807421,   18807423,   18807427,   18807428,   18807429,   18807430,   18807431,   18807432,   18807433,   18807434,   18807439,   18807443,   18807444,   18807446,   18807449,   18807452,   18807453,   18807455,   18807456,   18807459,   18807463,   18807466,   18807472,   18807474,   18807478,   18807484,   18807485,   18807486,   18807490,   18807491,   18807494,   18807496,   18807499,   18807500,   18807501,   18807506,   18807509,   18807510,   18807511,   18807513,   18807514,   18807518,   18807523,   18807524,   18807529,   18807535,   18807536,   18807539,   18807540,   18807541,   18807542,   18807543,   18807545,   18807546,   18807556,   18807557,   18807568,   18807574,   18807575,   18807576,   18807578,   18807581,   18807584,   18807585,   18807586,   18807588,   18807589,   18807590,   18807591,   18807596,   18807597,   18807598,   18807599,   18807600,   18807601,   18807602,   18807604,   18807605,   18807607,   18807608,   18807609,   18807610,   18807611,   18807612,   18807613,   18807614,   18807617,   18807618,   18807619,   18807620,   18807623,   18807625,   18807626,   18807627,   18807628,   18807630,   18807631,   18807632,   188",2/6/2013,"02/06/2013",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64261,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.","Z-2728-2016","Class II","Plum A+3 Infusion Pump System.  List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.","357,778 total","The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.","09/06/2016",," List number 12348,  Serial Numbers:   13740156, 13740256, 13740266, 13740351, 13740380, 13740451, 13740508, 13740612, 13740632, 13740731, 13740732, 13740733, 13740734, 13740735, 13740736, 13740737, 13740738, 13740739, 13740740, 13740741, 13740742, 13740743, 13740744, 13740745, 13740746, 13740747, 13740748, 13740749, 13740750, 13740751, 13740752, 13740753, 13740754, 13740755, 13740756, 13740757, 13740758, 13740759, 13740760, 13740761, 13740762, 13740763, 13740764, 13740765, 13740766, 13740767, 13740768, 13740769, 13740770, 13740771, 13740772, 13740773, 13740774, 13740775, 13740776, 13740777, 13740778, 13740779, 13740780, 13740781, 13740782, 13740783, 13740784, 13740785, 13740786, 13740787, 13740788, 13740789, 13740790, 13740791, 13740792, 13740793, 13740794, 13740795, 13740796, 13740797, 13740798, 13740799, 13740800, 13740801, 13740802, 13740803, 13740804, 13740805, 13740806, 13740807, 13740808, 13740809, 13740810, 13740811, 13740812, 13740813, 13740814, 13740815, 13740816, 13740818, 13740819, 13740820, 13740821, 13740822, 13740823, 13740824, 13740825, 13740826, 13740827, 13740828, 13740829, 13740830, 13740831, 13740832, 13740833, 13740834, 13740835, 13740836, 13740837, 13740838, 13740839, 13740840, 13740841, 13740842, 13740843, 13740844, 13740845, 13740846, 13740847, 13740848, 13740849, 13740850, 13740851, 13740852, 13740853, 13740854, 13740855, 13740856, 13740857, 13740858, 13740859, 13740860, 13740861, 13740862, 13740863, 13740864, 13740865, 13740866, 13740867, 13740868, 13740869, 13740870, 13740871, 13740872, 13740873, 13740874, 13740875, 13740876, 13740877, 13740878, 13740879, 13740880, 13740881, 13740882, 13740883, 13740884, 13740885, 13740886, 13740887, 13740888, 13740889, 13740890, 13740891, 13740892, 13740893, 13740894, 13740895, 13740896, 13740897, 13740898, 13740899, 13740900, 13740901, 13740902, 13740903, 13740904, 13740905, 13740906, 13740907, 13740908, 13740909, 13740910, 13740911, 13740912, 13740913, 13740914, 13740915, 13740916, 13740917, 13740918, 13740919, 13740920, 13740921, 13740922, 137409",2/6/2013,"02/06/2013",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64261,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.","Z-2724-2016","Class II","Plum A+ Infusion Pump.  List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.","357,778 total","The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.","09/06/2016",," List Number 11973.  Serial numbers:  12570148,   12570150,   12570154,   12570163,   12570170,   12570177,   12570204,   12570211,   12570212,   12570255,   12570270,   12570319,   12570359,   12570385,   12570413,   12570425,   12570455,   12570487,   12570662,   12570695,   12570854,   12570915,   12571080,   12571243,   12571437,   12571631,   12571692,   12571776,   12571826,   12571835,   12571837,   12571842,   12571877,   12571880,   12571886,   12572317,   12572369,   12572586,   12572909,   12573547,   12573567,   12573837,   12573990,   12574424,   12574501,   12574524,   12574556,   12574599,   12574619,   12574731,   12574749,   12574853,   12574858,   12574860,   12574865,   12574961,   12575626,   12575698,   12575886,   12576125,   12576443,   12576485,   12576518,   12576593,   12576609,   12576710,   12576722,   12577271,   12577685,   12578856,   12579183.     ",2/6/2013,"02/06/2013",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64261,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.","Z-2730-2016","Class II","Plum A+3 Infusion Pump with Hospira MedNet Software.  List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.","357,778 total","The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.","09/06/2016",," List number 20678.  Serial numbers:  15541001, 15541011, 15541021, 15541031, 15541041, 15541051, 15541061, 15541071, 15541081, 15541091, 15541101, 15541111, 15541121, 15541131, 15541141, 15541151, 15541161, 15541171, 15541181, 15541191, 15541201, 15541211, 15541231, 15541241, 15541261, 15541271, 15541281, 15541291, 15541301, 15541311, 15541321, 15541331, 15541341, 15541351, 15541361, 15541371, 15541381, 15541391, 15541401, 15541411, 15541421, 15541431, 15541441, 15541451, 15541461, 15541471, 15541481, 15541491, 15541501, 15541511, 15541521, 15541531, 15541541, 15541551, 15541561, 15541571, 15541581, 15541591, 15541601, 15541611, 15541621, 15541631, 15541641, 15541651, 15541661, 15541671, 15541681, 15541691, 15541701, 15541711, 15541721, 15541731, 15541741, 15541751, 15541761, 15541771, 15541781, 15541791, 15541801, 15541811, 15541821, 15541831, 15541841, 15541851, 15541861, 15541871, 15541881, 15541891, 15541901, 15541911, 15541921, 15541931, 15541941, 15541951, 15541961, 15541971, 15541981, 15541991, 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"Devices",64261,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.","Z-2725-2016","Class II","Plum A+3 Infusion Pump.  List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.","357,778 total","The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.","09/06/2016",," List Number 12391.  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"Devices",64261,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.","Z-2726-2016","Class II","Plum A+ Infusion Pump with Hospira MedNet Software.  List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.","357,778 total","The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.","09/06/2016",," List Number 20679.  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"Devices",64261,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.","Z-2723-2016","Class II","Plum A+ Infusion Pump.  List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.","357,778 total","The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.","09/06/2016",," List Number 11971.  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"Devices",64261,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.","Z-2729-2016","Class II","Plum A+3 Infusion Pump.  List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.","357,778 total","The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.","09/06/2016",," list number 12618.  serial numbers: 14040001, 14040002, 14040003, 14040004, 14040005, 14040006, 14040008, 14040009, 14040010, 14040011, 14040012, 14040014, 14040015, 14040016, 14040017, 14040018, 14040019, 14040020, 14040021, 14040022, 14040023, 14040024, 14040025, 14040026, 14040027, 14040027, 14040027, 14040028, 14040028, 14040028, 14040029, 14040030, 14040031, 14040033, 14040034, 14040034, 14040034, 14040035, 14040036, 14040037, 14040038, 14040039, 14040040, 14040041, 14040042, 14040043, 14040044, 14040045, 14040047, 14040048, 14040049, 14040050, 14040051, 14040052, 14040053, 14040054, 14040056, 14040059, 14040061, 14040062, 14040063, 14040064, 14040065, 14040066, 14040067, 14040068, 14040069, 14040070, 14040071, 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"Devices",64261,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States nationwide distribution including PR, and USVI.  Costa Rica, Turks and Caicos, and Dominican Republic.","Z-2727-2016","Class II","Plum A+ Infusion Pump with Hospira MedNet Software.  List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.","357,778 total","The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of  therapy.","09/06/2016",," List Number 20792.  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16342046,   16342047,   16342048,   16342049,   16342050,   16342051,   16342052,   16342053,   16342054,   16342055,   16342056,   16342057,   16342058,   16342059,   16342060,   16342061,   16342062,   16342063,   16342064,   16342065,   16342066,   16342067,   16342068,   16342069,   16342070,   16342072,   16342074,   16342075,   16342076,   16342077,   16342078,   16342079,   16342080,   16342081,   16342083,   16342084,   16342085,   16342086,   16342087,   16342088,   16342089,   16342090,   16342091,   16342092,   16342093,   16342094,   16342095,   16342096,   16342097,   16342098,   16342099,   16342100,   16342102,   16342103,   16342104,   16342105,   16342106,   16342107,   16342108,   16342109,   16342110,   16342111,   16342112,   16342113,   16342114,   16342115,   16342116,   16342117,   16342118,   16342119,   16342120,   16342121,   16342122,   16342123,   16342124,   16342125,   16342126,   16342127,   16342128,   16342130,   16342131,   16342132,   16342133,   16342134,   16342135,   16342136,   16342137,   16342138,   16342139,   16342140,   16342141,   16342142,   16342143,   16342144,   16342145,   16342146,   16342147,   16342148,   16342149,   16342150,   16342151,   163 42152,   16342153,   16342154,   16342155,   16342156,   16342157,   16342158,   16342159,   16342160,   16342161,   16342162,   16342163,   16342164,   16342165,   16342166,   16342167,   16342168,   16342169,   16342170,   16342171,   16342172,  ",,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-163-2016","Class I","Innova Senior Plus Dog Food, 11+ Years, packaged 4-oz. (UPC 751485153100), 6-lb. (UPC 751485123288), 15-lb. (UPC 751485123271), and 30-lb. (751485123264) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","140,038 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-153-2016","Class I","Innova Senior Cat Food, packaged in 4-oz. (UPC 751485159980),  2.2-lb. (UPC 751485416038), 6-lb. (UPC 751485416083), and 15-lb. (UPC 751485416076) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","117,859 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-130-2016","Class I","EVO Turkey & Chicken Formula Cat & Kitten Food, packaged in 4-oz. (UPC 751485152509), 2.2- lb. (UPC 751485414027), 6.6-lb. (UPC 751485414010), and 15.4-lb. (UPC 751485414003)  bags.   Manufactured by: Natura Pet Products, Inc., Fremont, NE.","658,903 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014.  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-155-2016","Class I","Innova Prime Grain Free Beef & Lamb Meat Formula Adult Dog Food, packaged 4-oz. (UPC 751485153148),   5-lb. (UPC 751485127323), 12-lb. (UPC 751485127316), and 25-lb. (751485127309) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","84,251 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-184-2016","Class I","California Natural Grain Free Venison Meal Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158983), 5-lb. (UPC 751485393728), 15-lb. (UPC 751485393711), 30-lb. (UPC 751485393704), and 30-lb. bilingual (UPC 751485125626) bags.  The firm name on the label is Natura Pet Products, Davis, CA.","201,510 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-156-2016","Class I","Innova Prime Grain Free Chicken & Turkey Formula Adult Dog Food, packaged 4-oz. (UPC 751485153124),   5-lb. (UPC 751485127262), 12-lb. (UPC 751485127255), and 25-lb. (UPC 751485127248) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","119,822 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-188-2016","Class I","California Natural Chicken Meal & Rice Formula Puppy Food, packaged in 4-oz. (UPC 751485158884), 5-lb. (UPC 751485823805), and 15-lb. (UPC 751485823539), and 30-lb. (UPC 751485823522) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","79,350 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-152-2016","Class I","Innova Weight Management Adult Cat Food, packaged in 4-oz. (UPC 751485159881),  2.2-lb. (UPC 751485413914), 6-lb. (UPC 751485413907), and 15-lb. (UPC 751485413891) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","192,331 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-168-2016","Class I","Innova Large Breed Puppy Food, packaged 4-oz. (UPC 751485153025), 2.2-lb. (UPC 751485127231),  6-lb. (UPC 751485127422), 15-lb. (UPC 751485127415),  30-lb. (UPC 751485127408), and 30-lb. bilingual (UPC 751485125534)  bags.   Manufactured by Natura Pet Products, Inc., Fremont, NE.","161,038 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-149-2016","Class I","HealthWise Chicken Meal & Brown Rice Formula Natural Premium Puppy Food, packaged in 4-oz. (UPC 751485154435),  5-lb. (UPC 751485707327), 17.5-lb. (UPC 751485707310), and 35-lb. (UPC 751485707303) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","42,388 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-161-2016","Class I","Innova Large Breed Senior Dog Food, 6+ Years - 60+ lbs., packaged 4-oz. (UPC 751485153018), 15-lb. (UPC 751485127156), and 30-lb. (751485127149) bags.   Manufactured by Natura Pet Products, Inc., Fremont, NE.","43,243 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-185-2016","Class I","California Natural Lamb Meal & Rice Formula Large Bites Adult Dog Food, packaged in 4-oz. (UPC 751485158806), 5-lb. (UPC 751485393230), 15-lb. (UPC 751485393513), 30-lb. (UPC 751485393506), and 30-lb. bilingual (UPC 751485125619) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","387,344 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-174-2016","Class I","California Natural Chicken Meal & Rice Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158839), 5-lb. (UPC 751485823775), 15-lb. (UPC 751485823515), 30-lb. (UPC 751485823508), and 30-lb. bilingual (UPC 751485125596) bags.  The firm name on the label is Natura Pet Products, Fremont, NE.","355,214 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-137-2016","Class I","EVO Red Meat Formula Dog Food, packaged in 4-oz. (UPC 751485152042), 6.6-lb. (UPC 751485126777), 13.2-lb (UPC 751485126760), and 28.6-lb. (UPC 751485126753) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","196,659 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-175-2016","Class I","California Natural Rice & Chicken Meal Formula Low Fat Adult Dog Food, packaged in 4-oz. (UPC 751485158891), 5-lb. (UPC 751485823621), 15-lb. (UPC 751485823553), and 30-lb. (UPC 751485823546) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","94,611 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-164-2016","Class I","Innova Adult Dog Food-Small Bites, packaged 4-oz. (UPC 751485159898), 2.2-lb. (UPC 751485123738), 6-lb. (UPC 751485123363), 6-lb. bilingual (UPC 751485125510), 15-lb. (UPC 751485123356), and 30-lb. (751485123677) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","454,716 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-178-2016","Class I","California Natural Grain Free Kangaroo & Red Lentils Formula Adult Dog Food, packaged in 4-oz. (UPC 751485159874), 5-lb. (UPC 751485399423), 15-lb. (UPC 751485399416), 30-lb. (UPC 751485399409), and 30-lb. bilingual (UPC 751485125640) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","191,083 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-170-2016","Class I","Innova Adult Dog Food-Red Meat-Small Bites, packaged 4-oz. (UPC 751485153049), 2.2-lb. (UPC 751485123592),  6-lb. (UPC 751485123585), 15-lb. (UPC 751485123578),  and 30-lb. (UPC 751485123561) bags.   Manufactured by Natura Pet Products, Santa Clara, CA.","54,560 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-147-2016","Class I","HealthWise Chicken Meal & Oatmeal Formula Weight Control Natural Premium Adult Dog Food, packaged in 4-oz. (UPC 751485154428),  5-lb. (UPC 751485707228), 17.5-lb. (UPC 751485707211), and 35-lb. (UPC 751485707204) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","39,018 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-146-2016","Class I","HealthWise Chicken Meal & Oatmeal Formula Adult Dog Food for Active Adult Dogs, packaged in 4-oz. (UPC 751485154404),  5-lb. (UPC 751485707020), 17.5-lb. (UPC 751485707013), and 35-lb. (UPC 751485707006) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","21,014 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-167-2016","Class I","Innova Puppy Food, packaged 4-oz. (UPC 751485159942), 2.2-lb. (UPC 751485123837),  6-lb. (UPC 751485123349), 15-lb. (UPC 751485123332), 15-lb. bilingual (UPC 751485125503), and 30-lb. (UPC 751485123325) bags.   Manufactured by Natura Pet Products, Inc., Fremont, NE.","204,999 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-165-2016","Class I","Innova Weight Management Adult Dog Food, packaged 4-oz. (UPC 751485153117), 6-lb. (UPC 751485123318), 15-lb. (UPC 751485123301), 30-lb. (751485123295), and 30-lb. bilingual (UPC 751485125565) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","204,518 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-134-2016","Class I","EVO Wild Cravings Turkey & Chicken Formula Savory Treats for Cats, packaged in 3-oz. bags, UPC 751485414706.  The firm name on the label is Natura Pet Products, Davis, CA.","65,124 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014.  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-182-2016","Class I","California Natural Grain Free Chicken Meal Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158969), 5-lb. (UPC 751485393629), 15-lb. (UPC 751485393612), and 30-lb. (UPC 751485393605) bags.  The firm name on the label is Natura Pet Products, Davis, CA.","183,360 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-159-2016","Class I","Innova Adult Dog Food-Large Bites, packaged 4-oz. (UPC 751485159904),  2.2-lb. (UPC 751485123769), 6-lb. (UPC 751485123226), 15-lb. (UPC 751485123219), 30-lb. (751485123202), and 30-lb. bilingual (UPC 751485125527) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","500,364 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-160-2016","Class I","Innova Large Breed Adult Dog Food, packaged 4-oz. (UPC 751485153001), 15-lb. (UPC 751485127057), 30-lb. (751485127040), and 30-lb. bilingual (UPC 751485125541) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","199,541 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-145-2016","Class I","HealthWise Chicken Meal & Oatmeal Formula Adult Dog Food, packaged in 4-oz. (UPC 7514815154411), 5-lb. (UPC 751485707129), 17.5-lb. (UPC 751485707112), 35-lb. (UPC 751485707105), and 38.5-lb. (UPC 751485707044) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","146,361 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-180-2016","Class I","California Natural Grain Free Salmon Meal & Peas Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158778), 5-lb. (UPC 751485393803), 15-lb. (UPC 751485393797), 30-lb. (UPC 751485393780), and 30-lb. bilingual (UPC 751485125657) bags.   Manufactured by Natura Pet Products, Inc., Fremont, NE.","141,567 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-151-2016","Class I","Innova Cat Food, packaged in 4-oz. (UPC 751485159959),  2.2-lb. (UPC 751485413877), 6-lb. (UPC 751485413938), 6-lb. bilingual (UPC 751485125831) and 15-lb. (UPC 751485413921) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","318,838 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-133-2016","Class I","EVO Wild Cravings Herring & Salmon Formula Savory Treats for Cats, packaged in 3-oz. bags, UPC 751485414805.  The firm name on the label is Natura Pet Products, Davis, CA.","97,308 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014.  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-187-2016","Class I","California Natural Lamb Meal & Rice Formula Puppy Food, packaged in 4-oz. (UPC 751485158815), 5-lb. (UPC 751485393261), and 15-lb. (UPC 751485393537), and 30-lb. (UPC 751485393520) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","78,012 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-142-2016","Class I","EVO Senior Formula Dog Food, packaged in 4-oz. (UPC 751485152554); 6.6-lb. (UPC 751485126876), 13.2-lb (UPC 751485126869), and 28.6-lb. (UPC 751485126852) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","41,542 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-139-2016","Class I","EVO Turkey & Chicken Formula Dog Food, packaged in 4-oz. (UPC 751485152011); 6.6-lb. (UPC 751485126074), 13.2-lb (UPC 751485126067), and 28.6-lb. (UPC 751485126050) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","226,495 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-135-2016","Class I","EVO Wild Cravings Weight Management Savory Treats for Cats, packaged in 3-oz. bags, UPC 751485414751.   The firm name on the label is Natura Pet Products, Davis, CA.","24,372 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014.  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-143-2016","Class I","EVO Ferret Food, packaged in 6.6-lb. bags, UPC 751485421018.  The firm name on the label is Natura Pet Products, Davis, CA.","24,670 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-162-2016","Class I","Innova Senior Dog Food, 8+ Years, packaged 4-oz. (UPC 751485159928), 6-lb. (UPC 751485123257), 15-lb. (UPC 751485123240), and 30-lb. (751485123233), and 30-lb. bilingual (UPC 751485125558) bags.   Manufactured by Natura Pet Products, Inc., Fremont, NE.","108,914 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-172-2016","Class I","California Natural Chicken & Brown Rice Formula Cat & Kitten Food, packaged in 4-oz. (UPC 751485158853), 5-lb. (UPC 751485823874), 5-lb. bilingual (UPC 751485125572), 15-lb. (UPC 751485823560), and 15-lb. bilingual (UPC 751485125589) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","319,290 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-157-2016","Class I","Innova Prime Grain Free Salmon & Herring Formula Adult Dog Food, packaged 4-oz. (UPC 751485153131),  5-lb. (UPC 751485127293), 12-lb. (UPC 751485127286), and 25-lb. (751485127279) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","86,936 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-144-2016","Class I","HealthWise Chicken Meal & Rice Formula Food for Adult Cats & Kittens, packaged in 4-oz. (UPC 75148154459), 5-lb. (UPC 751485707754), 16.5-lb. (UPC 751485707709), and 18.5-lb. (UPC 751485707808) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","154,230 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-140-2016","Class I","EVO Turkey & Chicken Formula Small Bites Dog Food, packaged in 4-oz. (UPC 751485152004); 2.2-lb. (UPC 751485126043), 6.6-lb. (UPC 751485126036), 13.2-lb (UPC 751485126012), and 28.6-lb. (UPC 751485126005) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","419,737 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-176-2016","Class I","California Natural Senior Dog-6+ years, Chicken Meal & Brown Rice Formula Senior Dog Food, packaged in 4-oz. (UPC 751485158990), 5-lb. (UPC 751485393773), 15-lb. (UPC 751485393766), and 30-lb. (UPC 751485393759) bags.  The firm name on the label is Natura Pet Products, Fremont, NE.","40,296 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-186-2016","Class I","California Natural Lamb Meal & Rice Formula Small Bites Adult Dog Food, packaged in 4-oz. (UPC 751485158945), 5-lb. (UPC 751485393292), and 15-lb. (UPC 751485393568) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","237,412 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-166-2016","Class I","Innova Kitten Food, packaged 4-oz. (UPC 751485153162), 2.2-lb. (UPC 751485413723),  and 6-lb. (UPC 751485413716) bags.   Manufactured by Natura Pet Products, Inc., Fremont, NE.","64,532 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-179-2016","Class I","California Natural Rice & Lamb Meal Formula Low Fat Adult Dog Food, packaged in 4-oz. (UPC 751485158822), 5-lb. (UPC 751485393353), 15-lb. (UPC 751485393551), and 30-lb. (UPC 751485393544) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","163,639 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-169-2016","Class I","Innova Adult Dog Food-Red Meat-Large Bites, packaged 4-oz. (UPC 751485153032), 2.2-lb. (UPC 751485123554),  6-lb. (UPC 751485123547), 15-lb. (UPC 751485123530),  and 30-lb. (UPC 751485123523) bags.   Manufactured by Natura Pet Products, Santa Clara, CA.","39,863 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-131-2016","Class I","EVO Herring & Salmon Formula Cat & Kitten Food, packaged in 4-oz. (UPC 751485152516), 2.2- lb. (UPC 751485414126), 6.6-lb. (UPC 751485414119), and 15.4-lb. (UPC 751485414102)  bags.   Manufactured by: Natura Pet Products, Inc., Fremont, NE.","217,690 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014.  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-138-2016","Class I","EVO Red Meat Formula Small Bites Dog Food, packaged in 4-oz. (UPC 751485152028), 2.2-lb. (UPC 751485126746); 6.6-lb. (UPC 751485126722), 13.2-lb (UPC 751485126715), and 28.6-lb. (UPC 751485126708) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","257,002 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014    ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-158-2016","Class I","Innova Salmon & Herring Formula Adult Dog Food, packaged 4-oz. (UPC 751485123653),  5-lb. (UPC 751485123646), 12-lb. (UPC 751485123639), and 25-lb. (751485123622) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","49,203 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-183-2016","Class I","California Natural Grain Free Lamb Meal Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158976), 5-lb. (UPC 751485393674), 15-lb. (UPC 751485393667), 30-lb. (UPC 751485393650), and 30-lb. bilingual (UPC 751485125633) bags.  The firm name on the label is Natura Pet Products, Davis, CA.","142,515 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-150-2016","Class I","Innova Prime Grain Free Chicken & Turkey Formula Adult Cat Food, packaged in 4-oz. (UPC 751485153155),  2-lb. (UPC 751485414041), 5-lb. (UPC 751485413990), and 12-lb. (UPC 751485413983) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","114,170 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-177-2016","Class I","California Natural Herring & Sweet Potato Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158905), 5-lb. (UPC 751485397030), 15-lb. (UPC 751485397054), 30-lb. (UPC 751485397047), and 30-lb. bilingual (UPC 751485125602) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","280,785 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-136-2016","Class I","EVO Herring & Salmon Formula Adult Dog Food, packaged in 4-oz. (UPC 751485152066), 6.6-lb. (UPC 751485126821), 13.2-lb (UPC 751485126814), and 28.6-lb. (UPC 751485126807) bags, Manufactured by Natura Pet Products, Inc., Fremont, NE.","188,581 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-173-2016","Class I","California Natural Herring & Sweet Potato Formula Adult Cat Food, packaged in 4-oz. (UPC 751485158915), 5-lb. (UPC 751485823911), and 15-lb. (UPC 751485823577) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","118,658 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-132-2016","Class I","EVO Weight Management Adult Cat Food, packaged in 4-oz. (UPC 751485152523), 2.2- lb. (UPC 751485414072), 6.6-lb. (UPC 751485414065), and 15.4-lb. (UPC 751485414058)  bags.   Manufactured by: Natura Pet Products, Inc., Fremont, NE.","172,729 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014.  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-154-2016","Class I","Innova Cat Treats, packaged in 3-oz. bags, UPC 751485413013.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","70,128 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-181-2016","Class I","California Natural Grain Free Chicken Formula Cat and Kitten Food, packaged in 4-oz. (UPC 751485158792), 5-lb. (UPC 751485829265), and 15-lb. (UPC 751485829258) bags.  The firm name on the label is Natura Pet Products, Fremont, NE.","142,231 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-148-2016","Class I","HealthWise Lamb Meal & Oatmeal Formula Natural Premium Adult Dog Food, packaged in 4-oz. (UPC 751485154442),  5-lb. (UPC 751485707426), 17.5-lb. (UPC 751485707419), and 35-lb. (UPC 751485707402) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","42,936 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-171-2016","Class I","Karma Organic Food for Dogs, packaged in 4-oz. (UPC 751485150017) and 7-lb. (UPC 751485601021) bags.  Manufactured in Fremont, NE, Natura Pet Products.","44,530 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",64642,"Terminated","Natura Manufacturing, Inc.","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was nationwide.  Foreign distribution was made to Canada, Hong Kong, Korea, Japan, Malaysia, and Costa Rica.","V-141-2016","Class I","EVO Weight Management Adult Dog Food, packaged in 4-oz. (UPC 751485152059); 6.6-lb. (UPC 751485126180), 13.2-lb (UPC 751485126173), and 28.6-lb. (UPC 751485126166) bags.  Manufactured by Natura Pet Products, Inc., Fremont, NE.","146,564 bags","Product is potentially contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including March 24, 2014  ",3/18/2013,"03/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64758,"Ongoing","Ge Healthcare It","540 W Northwest Hwy",,"Barrington","IL","60010-3051","United States","Voluntary: FDA Requested","Letter","US Nationwide Distribution.","Z-2300-2016","Class II","Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18  Product Usage:  is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA. ","13","A software defect was discovered that causes images to be out of context with clinical information. ","07/28/2016",," Imagecast  PACS  3.5.69,  3.5.86,  3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.",2/18/2013,"02/18/2013",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64761,"Completed","Ge Healthcare It","540 W Northwest Hwy",,"Barrington","IL","60010-3051","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2739-2016","Class II","Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction other systems have with the Centricity Enterprise Archive. Centricity Enterprise Archive is not intended for use in patient vicinity. The intended users for Centricity Enterprise Users service personnel and System administrators, and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-I profiles (published by IHE).","1,379 units","There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.","09/06/2016",," Version: 3.0.x",11/16/2012,"11/16/2012",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64785,"Ongoing","GE Healthcare It","540 W Northwest Hwy",,"Barrington","IL","60010-3051","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.","Z-2579-2016","Class II","GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x   Picture Archiving and Communication System    Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure. ","498 units","While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager.   When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.","08/17/2016",," Centricity PACS versions 3.1.1.x through 3.2.1.x  ",11/15/2012,"11/15/2012",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",64796,"Ongoing","GE Healthcare It","540 W Northwest Hwy",,"Barrington","IL","60010-3051","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally  to India, Australia, Canada, England, Qatar, and Scotland.","Z-2671-2016","Class II","Centricity Laboratory Core Lab System 4.1    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. ","17","The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the  corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.","08/26/2016",," Versions 4.1, 4.0, 3.3.2 & 3.3Almp",11/20/2012,"11/20/2012",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-243-2016","Class I","Innova Large Breed Puppy Food, packaged 4-oz. (UPC 751485153025), 2.2-lb. (UPC 751485127231), 6-lb. (UPC 751485127422), 15-lb. (UPC 751485127415), 30-lb. (UPC 751485127408), and 30-lb. bilingual (UPC 751485125534)  bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","56,174 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-219-2016","Class I","EVO Turkey & Chicken Formula Small Bites Dog Food, packaged in 4-oz. (UPC 751485152004); 2.2-lb. (UPC 751485126043), 6.6-lb. (UPC 751485126036), 13.2-lb (UPC 751485126012), and 28.6-lb. (UPC 751485126005) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","114,450 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-261-2016","Class I","Mother Nature, Moose's Munchies Small Biscuits, Dog Treats, packaged in 4-lb. (UPC 751485701530) and 20-lb. (UPC 751485702537) bags. Manufactured by Natura Pet Products, Davis, CA.","102 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-198-2016","Class I","California Natural Lamb Meal & Rice Formula Puppy Food, packaged in 4-oz. (UPC 751485158815), 5-lb. (UPC 751485393261), and 15-lb. (UPC 751485393537), and 30-lb. (UPC 751485393520) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.",,"The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-203-2016","Class I","California Natural Grain Free Venison Meal Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158983), 5-lb. (UPC 751485393728), 15-lb. (UPC 751485393711), 30-lb. (UPC 751485393704), and 30-lb. bilingual (UPC 751485125626) bags. The firm name on the label is Natura Pet Products, Davis, CA.","44,873 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-234-2016","Class I","Innova Kitten Food, packaged 4-oz. (UPC 751485153162), 2.2-lb. (UPC 751485413723), and 6-lb. (UPC 751485413716) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","26,598 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-215-2016","Class I","EVO Wild Cravings Weight Management Savory Treats for Cats, packaged in 3-oz. bags, UPC 751485414751. The firm name on the label is Natura Pet Products, Davis, CA.","7,572 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-228-2016","Class I","HealthWise Chicken Meal & Oatmeal Formula Adult Dog Food, packaged in 4-oz. (UPC 7514815154411), 5-lb. (UPC 751485707129), 17.5-lb. (UPC 751485707112) and 35-lb. (UPC 751485707105) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","32,664 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-239-2016","Class I","Innova Weight Management Adult Cat Food, packaged in 4-oz. (UPC 751485159881), 2.2-lb. (UPC 751485413914), 6-lb. (UPC 751485413907), and 15-lb. (UPC 751485413891) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","68,298 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-256-2016","Class I","Mother Nature, Beef Stew Recipe, Dog Biscuits, packaged in 4-lb. (UPC 751485701066), 20-lb (UPC 751485702063) and 20-oz. (UPC 751485700069) bags. Manufactured in Fremont, NE, Natura Pet Products.","992 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-242-2016","Class I","Innova Large Breed Senior Dog Food, 6+ Years - 60+ lbs., packaged 4-oz. (UPC 751485153018), 15-lb. (UPC 751485127156), and 30-lb. (751485127149) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","18,319 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-257-2016","Class I","Mother Nature, Buffalo Stew Recipe, Dog Biscuits, packaged in 4-lb. (UPC 751485701097), 20-lb (UPC 751485702094) and 20-oz. (UPC 751485700090) bags. Manufactured in Fremont, NE, Natura Pet Products.","1,252 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-240-2016","Class I","Innova Salmon & Herring Formula Adult Dog Food, packaged 4-oz. (UPC 751485123653), 5-lb. (UPC 751485123646), 12-lb. (UPC 751485123639) and 25-lb. (751485123622) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","39,224 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-248-2016","Class I","Innova Puppy Food, packaged 4-oz. (UPC 751485159942), 2.2-lb. (UPC 751485123837), 6-lb. (UPC 751485123349), 15-lb. (UPC 751485123332), 15-lb. bilingual (UPC 751485125503), and 30-lb. (UPC 751485123325) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","62,142 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-230-2016","Class I","HealthWise Lamb Meal & Oatmeal Formula Natural Premium Adult Dog Food, packaged in 4-oz. (UPC 751485154442), 5-lb. (UPC 751485707426), 17.5-lb. (UPC 751485707419), and 35-lb. (UPC 751485707402) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","13,518 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-196-2016","Class I","California Natural Grain Free Chicken Meal Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158969), 5-lb. (UPC 751485393629), 15-lb. (UPC 751485393612), and 30-lb. (UPC 751485393605) bags. The firm name on the label is Natura Pet Products, Davis, CA.","26,998 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-217-2016","Class I","EVO Wild Cravings, Herring Formula, treats for dogs, packaged in 10-oz bags, UPC 751485126609, Manufactured by Natura Pet Products, Davis, CA.","9390 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-252-2016","Class I","Innova HealthBar-Baked Dog Treats, Large Bars, packaged in 4-lb (UPC 751485123912), 26-oz (UPC 751485123943), 10-lb (UPC 751485123967) and 26-oz (UPC 751485413051) bags. Manufactured by: Natura Pet Products, Inc., Fremont, NE.","4,576 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-207-2016","Class I","California Natural Rice & Chicken Meal Formula Low Fat Adult Dog Food, packaged in 4-oz. (UPC 751485158891), 5-lb. (UPC 751485823621), 15-lb. (UPC 751485823553), and 30-lb. (UPC 751485823546) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","25,964 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-213-2016","Class I","EVO Wild Cravings Turkey & Chicken Formula Savory Treats for Cats, packaged in 3-oz. bags, UPC 751485414706. The firm name on the label is Natura Pet Products, Davis, CA.","14,016 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-194-2016","Class I","California Natural Chicken Meal & Rice Formula Puppy Food, packaged in 4-oz. (UPC 751485158884), 5-lb. (UPC 751485823805), and 15-lb. (UPC 751485823539), and 30-lb. (UPC 751485823522) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.",,"The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-199-2016","Class I","California Natural Lamb Meal & Rice Formula Small Bites Adult Dog Food, packaged in 4-oz. (UPC 751485158945), 5-lb. (UPC 751485393292), and 15-lb. (UPC 751485393568) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","56,043 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-227-2016","Class I","HealthWise Chicken Meal & Oatmeal Formula Adult Dog Food for Active Adult Dogs, packaged in 4-oz. (UPC 751485154404), 5-lb. (UPC 751485707020), 17.5-lb. (UPC 751485707013), and 35-lb. (UPC 751485707006) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","9,432 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-235-2016","Class I","Innova Cat Food, packaged in 4-oz. (UPC 751485159959), 2.2-lb. (UPC 751485413877), 6-lb. (UPC 751485413938), 6-lb. bilingual (UPC 751485125831) and 15-lb. (UPC 751485413921) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","99,583 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-223-2016","Class I","EVO Wild Cravings Red Meat Formula Dog Treats, packaged in 20-oz. bags UPC 751485126500.  Manufactured by Natura Pet Products, Davis, CA.","16,992 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-210-2016","Class I","EVO Herring & Salmon Formula Cat & Kitten Food, packaged in 4-oz. (UPC 751485152516), 2.2- lb. (UPC 751485414126), 6.6-lb. (UPC 751485414119), and 15.4-lb. (UPC 751485414102) bags. Manufactured by: Natura Pet Products, Inc., Fremont, NE.","55,413 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-241-2016","Class I","Innova Large Breed Adult Dog Food, packaged 4-oz. (UPC 751485153001), 15-lb. (UPC 751485127057), 30-lb. (751485127040), and 30-lb. bilingual (UPC 751485125541) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","59,170 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-262-2016","Class I","Mother Nature, Scooter & Friends Mini Biscuits, Dog Biscuits, packaged in 4-lb. (UPC 751485701547), 20-lb. (UPC 751485702544) and  20-oz. (UPC 751485700540) bags. Manufactured by Natura Pet Products, Fremont, NE.","3,139 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-209-2016","Class I","EVO Ferret Food, packaged in 6.6-lb. bags, UPC 751485421018. The firm name on the label is Natura Pet Products, Davis, CA.","5385 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-200-2016","Class I","California Natural Grain Free Kangaroo & Red Lentils Formula Adult Dog Food, packaged in 4-oz. (UPC 751485159874), 5-lb. (UPC 751485399423), 15-lb. (UPC 751485399416), 30-lb. (UPC 751485399409), and 30-lb. bilingual (UPC 751485125640) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","11,732 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-229-2016","Class I","HealthWise Chicken Meal & Brown Rice Formula Natural Premium Puppy Food, packaged in 4-oz. (UPC 751485154435), 5-lb. (UPC 751485707327), 17.5-lb. (UPC 751485707310), and 35-lb. (UPC 751485707303) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","10,555 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-214-2016","Class I","EVO Weight Management Adult Cat Food, packaged in 4-oz. (UPC 751485152523), 2.2- lb. (UPC 751485414072), 6.6-lb. (UPC 751485414065), and 15.4-lb. (UPC 751485414058) bags. Manufactured by: Natura Pet Products, Inc., Fremont, NE.","47,358 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-212-2016","Class I","EVO Turkey & Chicken Formula Cat & Kitten Food, packaged in 4-oz. (UPC 751485152509), 2.2- lb. (UPC 751485414027), 6.6-lb. (UPC 751485414010), and 15.4-lb. (UPC 751485414003) bags. Manufactured by: Natura Pet Products, Inc., Fremont, NE.","153,202 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-222-2016","Class I","EVO Red Meat Formula Dog Food, packaged in 4-oz. (UPC 751485152042), 6.6-lb. (UPC 751485126777), 13.2-lb (UPC 751485126760), and 28.6-lb. (UPC 751485126753) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","49,606 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-259-2016","Class I","Mother Nature, Dott's Delights Large Dog Biscuits, packaged in 4-lb. (UPC 751485701523) and 17-lb. (UPC 751485702520) bags. Manufactured in Fremont, NE, Natura Pet Products.","235 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-225-2016","Class I","EVO Weight Management Adult Dog Food, packaged in 4-oz. (UPC 751485152059); 10-oz. (UPC 751485126555), 6.6-lb. (UPC 751485126180), 13.2-lb (UPC 751485126173), and 28.6-lb. (UPC 751485126166) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE","44,516 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-220-2016","Class I","EVO Senior Formula Dog Food, packaged in 4-oz. (UPC 751485152554); 6.6-lb. (UPC 751485126876), 13.2-lb (UPC 751485126869), and 28.6-lb. (UPC 751485126852) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","14,977 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-237-2016","Class I","Innova Cat Treats, packaged in 3-oz. bags, UPC 751485413013. Manufactured by Natura Pet Products, Inc., Fremont, NE.","30,228 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-255-2016","Class I","Karma Organic Food for Dogs, packaged in 4-oz. (UPC 751485150017) and 7-lb. (UPC 751485601021) bags. Manufactured in Fremont, NE, Natura Pet Products.","10,830 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-208-2016","Class I","California Natural Rice & Lamb Meal Formula Low Fat Adult Dog Food, packaged in 4-oz. (UPC 751485158822), 5-lb. (UPC 751485393353), 15-lb. (UPC 751485393551), and 30-lb. (UPC 751485393544) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","46,701 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-236-2016","Class I","Innova Senior Cat Food, packaged in 4-oz. (UPC 751485159980), 2.2-lb. (UPC 751485416038), 6-lb. (UPC 751485416083), and 15-lb. (UPC 751485416076) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","41,225 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-245-2016","Class I","Innova Adult Dog Food-Small Bites, packaged 4-oz. (UPC 751485159898), 2.2-lb. (UPC 751485123738), 6-lb. (UPC 751485123363), 6-lb. bilingual (UPC 751485125510), 15-lb. (UPC 751485123356), and 30-lb. (751485123677) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","134,915 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-251-2016","Class I","Innova Prime Grain Free Chicken & Turkey Formula Adult Dog Food, packaged 4-oz. (UPC 751485153124), 5-lb. (UPC 751485127262), 12-lb. (UPC 751485127255), and 25-lb. (UPC 751485127248) bags. Manufactured by Natura Pet Products, Inc., Fremont, ","54,336 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-224-2016","Class I","EVO Red Meat Formula Small Bites Dog Food, packaged in 4-oz. (UPC 751485152028), 2.2-lb. (UPC 751485126746); 6.6-lb. (UPC 751485126722), 13.2-lb (UPC 751485126715), and 28.6-lb. (UPC 751485126708) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","66,155 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-238-2016","Class I","Innova Prime Grain Free Chicken & Turkey Formula Adult Cat Food, packaged in 4-oz. (UPC 751485153155), 2-lb. (UPC 751485414041), 5-lb. (UPC 751485413990), and 12-lb. (UPC 751485413983) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","46,554 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-190-2016","Class I","California Natural Chicken & Brown Rice Formula Cat & Kitten Food, packaged in 4-oz. (UPC 751485158853), 5-lb. (UPC 751485823874), 5-lb. bilingual (UPC 751485125572), 15-lb. (UPC 751485823560), and 15-lb. bilingual (UPC 751485125589) bags.  The firm name on the label is Natura Pet Products, Santa Clara, CA.","73,007 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-193-2016","Class I","California Natural Chicken Meal & Rice Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158839),  5-lb. (UPC 751485823775), 15-lb. (UPC 751485823515), 30-lb. (UPC 751485823508), and 30-lb. bilingual (UPC 751485125596) bags. The firm name on the label is Natura Pet Products, Fremont, NE.",,"The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-233-2016","Class I","HealthWise Chicken Meal & Oatmeal Formula Adult Dog Food, packaged in 38.5-lb. (UPC 751485707044) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","5,377 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-211-2016","Class I","EVO Wild Cravings Herring & Salmon Formula Savory Treats for Cats, packaged in 3-oz. bags, UPC 751485414805. The firm name on the label is Natura Pet Products, Davis, CA.","15,972 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-189-2016","Class I","California Natural Lamb Meal & Rice Formula Large Bites Adult Dog Food, packaged in 4-oz. (UPC 751485158808), 5-lb. (UPC 751485393230), 15-lb. (UPC 751485393513), 30-lb. (UPC 751485393506), and 30-lb. bilingual (UPC 751485125619) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","102,410 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-218-2016","Class I","EVO Turkey & Chicken Formula Dog Food, packaged in 4-oz. (UPC 751485152011); 6.6-lb. (UPC 751485126074), 13.2-lb (UPC 751485126067), and 28.6-lb. (UPC 751485126050) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","59,069 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-231-2016","Class I","HealthWise Chicken Meal & Oatmeal Formula Weight Control Natural Premium Adult Dog Food, packaged in 4-oz. (UPC 751485154428), 5-lb. (UPC 751485707228), 17.5-lb. (UPC 751485707211), and 35-lb. (UPC 751485707204) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","11,426 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-202-2016","Class I","California Natural Grain Free Salmon Meal & Peas Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158778), 5-lb. (UPC 751485393803), 15-lb. (UPC 751485393797), 30-lb. (UPC 751485393780), and 30-lb. bilingual (UPC 751485125657) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","38,937 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-244-2016","Class I","Innova Adult Dog Food-Large Bites, packaged 4-oz. (UPC 751485159904), 2.2-lb. (UPC 751485123769), 6-lb. (UPC 751485123226), 15-lb. (UPC 751485123219), 30-lb. (751485123202), and 30-lb. bilingual (UPC 751485125527) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE","124,803 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-253-2016","Class I","Innova HealthBar-Baked Dog Treats, Small Bars, packaged in 4-lb (UPC 751485123929), 26-oz (UPC 751485123950), 10-lb (UPC 751485123974) and 26-oz (UPC 751485413105) bags. Manufactured by: Natura Pet Products, Inc., Fremont, NE.","8,972 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-206-2016","Class I","California Natural Salmon Meal Formula HealthBars for dogs, packaged in 10-oz. (UPC 751485394107) bags. The firm name on the label is Natura Pet Products, Davis, CA.","2,000 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-197-2016","Class I","California Natural Herring & Sweet Potato Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158905), 5-lb. (UPC 751485397030), 15-lb. (UPC 751485397054), 30-lb. (UPC 751485397047), and 30-lb. bilingual (UPC 751485125602) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.",,"The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-205-2016","Class I","California Natural Lamb Meal & Rice Formula HealthBars-Small Bars for dogs, packaged in 4-lb. (UPC 751485393926), 26-oz. (UPC 751485393957), and 10-lb. (UPC 751485393971) bags. The firm name on the label is Natura Pet Products, Fremont, NE.","3990 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-258-2016","Class I","Mother Nature, Carrot Cake Recipe, Dog Treats, packaged in 4-lb. (UPC 751485701028), 20-lb (UPC 751485702025) and 20-oz. (UPC 751485700021) bags. Manufactured in Fremont, NE, Natura Pet Products.","3,807 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-247-2016","Class I","Innova Senior Plus Dog Food, 11+ Years, packaged 4-oz. (UPC 751485153100), 6-lb. (UPC 751485123288), 15-lb. (UPC 751485123271), and 30-lb. (751485123264) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","46,975 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-226-2016","Class I","HealthWise Chicken Meal & Rice Formula Food for Adult Cats & Kittens, packaged in 4-oz. (UPC 75148154459), 5-lb. (UPC 751485707754) and 16.5-lb. (UPC 751485707709) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","35,172 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-246-2016","Class I","Innova Senior Dog Food, 8+ Years, packaged 4-oz. (UPC 751485159928), 6-lb. (UPC 751485123257), 15-lb. (UPC 751485123240), and 30-lb. (751485123233), and 30-lb. bilingual (UPC 751485125558) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","27,756 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-204-2016","Class I","California Natural Lamb Meal & Rice Formula HealthBars-Large Bars for dogs, packaged in 4-lb. (UPC 751485393919), 26-oz. (UPC 751485393940), and 10-lb. (UPC 751485393964) bags. The firm name on the label is Natura Pet Products, Fremont, NE.","3354 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-254-2016","Class I","Innova Weight Management Adult Dog Food, packaged 4-oz. (UPC 751485153117), 6-lb. (UPC 751485123318), 15-lb. (UPC 751485123301), 30-lb. (751485123295), and 30-lb. bilingual (UPC 751485125565) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","68,063 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-221-2016","Class I","EVO Wild Cravings, Turkey & Chicken Formula, treats for dogs, packaged in 20-oz bags, UPC 751485126203 bags. Manufactured by Natura Pet Products, Davis, CA.","23,351 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-192-2016","Class I","California Natural Grain Free Chicken Formula Cat and Kitten Food, packaged in 4-oz. (UPC 751485158792), 5-lb. (UPC 751485829265), and 15-lb. (UPC 751485829258) bags. The firm name on the label is Natura Pet Products, Fremont, NE.",,"The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-249-2016","Class I","Innova Prime Grain Free Beef & Lamb Meat Formula Adult Dog Food, packaged 4-oz. (UPC 751485153148), 5-lb. (UPC 751485127323), 12-lb. (UPC 751485127316), and 25-lb. (751485127309) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","29,769 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-201-2016","Class I","California Natural Grain Free Lamb Meal Formula Adult Dog Food, packaged in 4-oz. (UPC 751485158976), 5-lb. (UPC 751485393674), 15-lb. (UPC 751485393667), 30-lb. (UPC 751485393650), and 30-lb. bilingual (UPC 751485125633) bags. The firm name on the label is Natura Pet Products, Davis, CA.","36,231 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-195-2016","Class I","California Natural Senior Dog-6+ years, Chicken Meal & Brown Rice Formula Senior Dog Food, packaged in 4-oz. (UPC 751485158990), 5-lb. (UPC 751485393773), 15-lb. (UPC 751485393766), and 30-lb. (UPC 751485393759) bags. The firm name on the label is Natura Pet Products, Fremont, NE.","6,862 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-232-2016","Class I","HealthWise Chicken Meal & Rice Formula Food for Adult Cats & Kittens, packaged in 18.5-lb. (UPC 751485707808) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","1,860 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-216-2016","Class I","EVO Herring & Salmon Formula Adult Dog Food, packaged in 4-oz. (UPC 751485152066), 6.6-lb. (UPC 751485126821), 13.2-lb (UPC 751485126814), and 28.6-lb. (UPC 751485126807) bags, Manufactured by Natura Pet Products, Inc., Fremont, NE.","34,860 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-250-2016","Class I","Innova Prime Grain Free Salmon & Herring Formula Adult Dog Food, packaged 4-oz. (UPC 751485153131), 5-lb. (UPC 751485127293), 12-lb. (UPC 751485127286), and 25-lb. (751485127279) bags. Manufactured by Natura Pet Products, Inc., Fremont, NE.","29,729 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-260-2016","Class I","Mother Nature, Honey Glazed Chicken Recipe, Dog Treats, packaged in 4-lb. (UPC 751485701073), 20-lb. (UPC 751485702070) and 20-oz. (UPC 751485700076) bags. Manufactured by Natura Pet Products, Davis, CA.","3,299 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-191-2016","Class I","California Natural Herring & Sweet Potato Formula Adult Cat Food, packaged in 4-oz. (UPC 751485158914), 5-lb. (UPC 751485823911), and 15-lb. (UPC 751485823577) bags. The firm name on the label is Natura Pet Products, Santa Clara, CA.","41,485 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",65475,"Terminated","Natura Pet Products","2779 Rademakers Way",".","Fremont","NE","68025-8044","United States","Voluntary: Firm Initiated","Press Release","Distribution was made to AZ, CA, CO, FL, GA, ID, IL, MI, MN, MT, NC, NJ, NV, NY, OH, PA, RI, TX, VT, and WA.","V-263-2016","Class I","Mother Nature, Chicken & Turkey recipe, Dog Biscuits, packaged in 4-lb. (UPC 751485701042, 751485701059, 751485701080), 20-lb. (UPC 751485702049, 751485702056, 751485702087) and  20-oz. (UPC 751485700045, 751485700052, 751485700083) bags. Manufactured by Natura Pet Products, Fremont, NE.","8,439 bags","The product may be contaminated with Salmonella.","01/21/2016","01/28/2016"," All expiration dates prior to and including June 9, 2014.",6/18/2013,"06/18/2013",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",66278,"Completed","Schafer Fisheries","21985 WALLER RD",,"FULTON","IL","61252-9780","United States","Voluntary: Firm Initiated","Telephone","US: IL, NY, CA","F-0041-2017","Class II","Label reads in part: TWIN FIN DELI; Gefilte Fish; Kosher Fish Products Inc., Fulton, IL. FDA# 1481764; Net WT. 24 OZ (680G)","250 cases (12 units per case)","Lack of adequate HACCP records.","10/07/2016",," Bar Code Number: 4278600076;   Lot Number: 12478, 11945, 12694, 12390, 12395r, 12750, 12819, 12367, 12339Revise, 12366, 12670, 12815, 12394.; Manufacture date: 7/2/2013, 7/10/2013, 8/13/2013. ",8/22/2013,"08/22/2013",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",66278,"Completed","Schafer Fisheries","21985 WALLER RD",,"FULTON","IL","61252-9780","United States","Voluntary: Firm Initiated","Telephone","US: IL, NY, CA","F-0040-2017","Class II","Label reads in part: TWIN FIN DELI; Salami; Net WT. 1lb (453g); P.O. Box 399 Thomson IL, FDA# 1481764 Thomason","398 cases (12 units per case)","Lack of adequate HACCP records.","10/07/2016",," Bar Code Number:  4278600054;   Lot Number: 14278, 11945, 12562, 12509, 12304, 12429, 12395r, 12489, 12750, 12773, 12394, 12380, 11944, 12312, 12002, 12172, 12763.; Manufacture date: 7/2/2013, 7/23/2013. ",8/22/2013,"08/22/2013",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",66278,"Completed","Schafer Fisheries","21985 WALLER RD",,"FULTON","IL","61252-9780","United States","Voluntary: Firm Initiated","Telephone","US: IL, NY, CA","F-0039-2017","Class II","*** 1) Fish hot dogs total 1 lb in weight vacuum packaged in plastic bags; Label reads in part: TWIN FIN DELI; Franks; Net WT. 1lb (453g); Kosher Fish Products Inc. Fulton, IL FDA# 1481764;   *** 2) Fish hot dogs total 15 lbs in weight packaged 120 x box with a poly liner",,"Lack of adequate HACCP records.","10/07/2016",," *** 1) Bar Code Number: 4278600053; Lot Number: 12509, 12650, 12651, 12489, 12534, 12750, 12773, 12763, 12762; Manufacture date: 7/23/2013, 7/29/2013, 8/13/2013.   *** 2) Bar Code Number: ",8/22/2013,"08/22/2013",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66372,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US (Nationwide) Distribution","Z-2060-2016","Class II","*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product  Usage:  The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.  ","3,920,932 units in total","Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.","06/29/2016",," ***** CANADA DISTRIBUTION *****     *** 1) List Number 14220-28-01",9/9/2013,"09/09/2013",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66372,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US (Nationwide) Distribution","Z-2059-2016","Class II","*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML;   *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML;    *** 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; ***   4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP;   *** 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; *** 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 110 IN (279 CM); PRIMING VOLUME: 21.4 ML;   *** 7) Product labeled in part: 19671-28; LIFESHIELD; CONVERTIBLE PP LIFECARE 5000 CASSETTE W/CLAVE MICRODRIP SOLUSET 150 X 60 DPM, CLAVE INJECTION SITE, NON DEHP; NOMINAL LENGTH: 124 IN (315 CM); PRIMING VOLUME: 13 ML;   *** 8) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML;   *** 9) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; USA;   *** 10) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 ","1) 65,904 units; 2) 270,321 units; 3) 32,088 units; 4) 4,944 units; 5) 14,064 units; 6) 503,328 units; 7) 7,560 units","Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.","06/29/2016",," ***** US DISTRIBUTION *****   *** 1) List Number: 14952-04-01; Lot Numbers:  681775H	,  711485H	,  750515H	,  770115H	,  782335H	,  800765H	,  840515H	,  880315H	,  962345H	,  052015H	,  061965H	,  121605H	,  210165H	,  231625H	,  231835H	,  281085H	,  281155H	;   *** 2) List Number: 14954-04-28; Lot Numbers:   662045H	,  712055H	,  051935H	,  132675H	,  151615H	,  231375H	,  260465H	,  260485H	;   *** 3) List Number: 19553-04-12; Lot Number:   751145H;   *** 4) List Number: 19556-04-28; Lot Numbers:   750295H	,  801115H	,  900585H	,  040145H	,  143175H	,  210195H	,  281095H	;   *** 5) List Number: 19557-04-28; Lot Numbers:   962435H	,  040155H	,  070705H	,  071735H	,  082165H	,  091245H	,  091255H	,  091365H	,  102515H	,  200795H	,  200945H	,  210835H	,  241705H	,  280465H	,  280475H	,  240135H	;   *** 6) List Number: 19671-04-28; Lot Numbers:   701785H	,  730805H	,  811605H	,  861435H	,  880255H	;   *** 7) List Number: 19683-04-28; Lot Numbers:   782315H	,  042125H	,  211065H	,  231825H	;   *** 8) List Number: 19685-04-28; Lot Numbers:   682285H	,  791285H	,  850175H	;   *** 9) List Number: 19720-04-28; Lot Numbers:   962305H	,  092585H	,  121635H	,  180645H	,  221715H	,  260525H	;   *** 10) List Number: 19721-04-28; Lot Numbers:   962315H,   132735H;   *** 11) List Number: 19729-04-28; Lot Numbers:   032195H	,  082285H	,  121645H	,  170415H	,  200235H	;   *** 12) List Number: 19734-04-28; Lot Number:   133265H;     ***** CANADA DISTRIBUTION *****     *** 13) List Number: 14951-04-48; Lot Numbers:   761875H	,  761905H	,  821525H	,  830335H	,  870625H	,  870635H	,  880125H	,  051955H	,  092565H	,  142995H	,  211715H	,  231355H	,  271495H	,  281105H	;   *** 14) List Number: 14952-04-01; Lot Numbers:  681775H	,  711485H	,  750515H	,  770115H	,  782335H	,  800765H	,  840515H	,  880315H	,  962345H	,  052015H	,  061965H	,  121605H	,  210165H	,  231625H	,  231835H	,  281085H	,  281155H	;   *** 15) List Number: 14954-04-28; Lot Numbers:   662045H	,  712055H	,  051935H	,  132675H	,  151615H	,  231375H	,  260465H	,  ",9/9/2013,"09/09/2013",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66372,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US (Nationwide) Distribution","Z-2058-2016","Class II","*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP;   *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 Inch, Non-DEHP;   Product  Usage:  The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.  ","1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units","Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.","06/29/2016",," ***** US DISTRIBUTION *****     *** 1) List Number: 14212-04-28; Lot Numbers:   962235H	,  030565H	,  030575H	,  081425H	,  090515H	,  100905H	,  100915H	,  102255H	,  102265H	,  122515H	,  122525H	,  143405H	,  152655H	,  152665H	,  152675H	,  161375H	,  161385H	,  161395H	,  170955H	,  172025H	,  172035H	,  172045H	,  143415H	,  241805H	,  251735H	,  251745H	,  250845H	;   *** 2) List Number: 14254-08-28; Lot Number:   072055H;   *** 3) List Number: 14687-04-28; Lot Numbers:   650935H	,  710435H	,  720925H	,  721925H	,  721895H	,  721325H	,  721905H	,  730175H	,  761965H	,  771895H	,  772175H	,  780725H	,  781395H	,  780715H	,  800135H	,  800145H	,  810185H	,  851685H	,  840795H	,  861775H	,  861785H	,  810155H	,  880695H	,  901065H	,  901055H	,  901095H	,  921945H	,  020765H	,  020775H	,  020785H	,  020795H	,  030185H	,  030195H	,  042005H	,  052335H	,  052755H	,  052345H	,  061035H	,  070625H	,  080325H	,  080335H	,  091085H	,  092935H	,  132125H	,  142805H	,  153285H	,  153495H	,  171435H	,  180405H	,  211275H	,  201225H	,  201235H	;      ***** FOREIGN DISTRIBUTION *****     *** 4) List Number: 12193-83-24; Lot Numbers:   662095H	,  712345H	,  741615H	,  880705H	,  890735H	,  920595H	,  952665H	,  020485H	;   *** 5) List Number: 12193-92-28; Lot Numbers:   063285H	,  071115H	,  071475H	,  133335H	,  140205H	,  171535H	,  180045H	,  250515H	,  281895H	;   *** 6) List Number: 19194-83-24; Lot Numbers:   662115H	,  702305H	,  721795H	,  721805H	,  732055H	,  732035H	,  732045H	,  732065H	;   *** 7) List Number: 19194-84-24; Lot Numbers:   881945H,   950975H;   *** 8) List Number: 12194-92-28; Lot Numbers:   071105H	,  140085H	,  151445H	,  180055H	;   *** 9) List Number: 12195-83-24; Lot Numbers:   662105H	,  712355H	,  821545H	,  880715H	,  890745H	,  910745H	;   *** 10) List Number: 12195-84-24; Lot Numbers:   681645H	,  681655H	,  702295H	,  721695H	,  721785H	,  741635H	,  741355H	,  761495H	,  771395H	,  782265H	,  782275H	,  791315H	,  890755H	,  900455H	,  940615H	,  951325H	,  010725H	,  011475H	,  ",9/9/2013,"09/09/2013",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66372,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US (Nationwide) Distribution","Z-2061-2016","Class II","*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML;  Product  Usage:  The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.  ","3,920,932 units in total","Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.","06/29/2016",," ***** US DISTRIBUTION *****   *** 1) List Number: 19734-04-28; Lot Number:   133265H;     ***** CANADA DISTRIBUTION *****     *** 1) List Number: 19732-04-28; Lot Numbers:   114405H	,  143545H	,  170385H	,  170425H	,  170395H	,  210225H	,  201655H	,  260535H	,  291595H",9/9/2013,"09/09/2013",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66372,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US (Nationwide) Distribution","Z-2062-2016","Class II","*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML;   *** 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML;    *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML;  *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML:   *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML;   *** 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML;     Product Usage:  The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.  ","3,920,932 units in total","Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.","06/29/2016",," X",9/9/2013,"09/09/2013",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",66393,"Completed","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","1718 Northrock Ct",,"Rockford","IL","61103-1201","United States","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Guam","D-1468-2016","Class II","Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL  61103.","a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.","08/23/2016",," Lot #: a) 3039795, 3042896, Exp 04/14; b) 3039793, 3042892, Exp 04/14; c) 2120054, Exp 02/14; 2120090, Exp 05/14",9/17/2013,"09/17/2013",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",66393,"Completed","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","1718 Northrock Ct",,"Rockford","IL","61103-1201","United States","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Guam","D-1466-2016","Class II","Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL  61103.","a) 9,156 cartons; b) 521,310 cartons","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.","08/23/2016",," Lot #: a) 3039792, Exp 04/14; 3037880, Exp 01/14; 3043938, Exp 07/14; b) 3036811, Exp 10/13; 3037514, Exp 01/14; 3039975, Exp 04/14; 3042583, Exp 07/14   ",9/17/2013,"09/17/2013",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",66393,"Completed","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","1718 Northrock Ct",,"Rockford","IL","61103-1201","United States","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Guam","D-1467-2016","Class II","Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d) 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL  61103.","a) 42,733 cartons; b) 3,267 cartons; c) 10,303 cartons; d) 4,262,856 cartons","CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.","08/23/2016",," Lot #: a) 3038339, Exp 02/14; 3043618, Exp 06/14; b) 3041862, Exp 05/14; 3044258, Exp 06/14; c) 2120031, Exp 01/14; 2120067, Exp 06/14; d) 3035787, 3035834, 3035835, Exp 10/13; 3037125, 3037126, 3037127, 3037511, 3037512, 3037513, Exp 01/14; 3038113, 3038114, 3038115, 3038116, 3039641, 3039642, 3039643, 3039974, Exp 02/14; 3040567, 3040977, Exp 04/14; 3041253, 3041800, 3041801, Exp 05/14; 3042446, 3042624, 3043015, Exp 06/14; 3043401, 3043466, Exp 08/14; 3044590, Exp 09/14; 3044591, Exp 10/14; 3045063, 3045064, Exp 11/14",9/17/2013,"09/17/2013",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66448,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, Singapore, South Africa","Z-2593-2016","Class II","Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL)  Canister, ATS, 2000, with Valve     1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT FILL 900 ABOVE LINE  2) List Numbers 43423-01 and 43423-21; LIST NO. 43423; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; 1400.   3) List Numbers 43445-01 and 43445-11; LIST NO. 43445; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; DO NOT FILL 1900 ABOVE THIS LINE.  4) List Number 43496-01.","67,410,861 liners and 67,410,861 lids/canisters in total","Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.","08/18/2016",," 43423-04-01  43423-04-11  43423-04-21  43445-04-01  43445-04-11  43449-04-01  43449-04-11  43496-04-01    ",9/10/2013,"09/10/2013",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66448,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, Singapore, South Africa","Z-2594-2016","Class II","Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL)    1) List Number 43056-01;   2) List Number 43023-01;   3) List Number 43025-01;   4) List Number 43025-11;   5) List Number 43025-21;   6) List Number 43025-25;   7) List Number 43038-05;   8) List Number 43043-01;   9) List Number 43044-01;   10) List Number 43044-11;   11) List Number 43046-01;   12) List Number 43047-01;   13) List Number 43041-01;   14) List Number 43024-01;   15) List Number 43027-01;   16) List Number 43027-14;   17) List Number 43001-01;   18) List Number 43064-01;   19) List Number 43046-05;   20) List Number 43042-11;   21) List Number 43042-01;   22) List Number 43044-05;   23) List Number 43044-15","67,410,861 liners and 67,410,861 lids/canisters in total","Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.","08/18/2016",," 43001-04-01  43023-04-01  43024-04-01  43024-04-62  43025-04-01  43025-04-11  43025-04-21  43025-04-25  43027-04-01  43027-04-05  43027-04-11  43027-04-14  43027-04-17  43031-04-02  43032-04-05  43034-04-06  43036-04-04  43037-04-02  43038-04-04  43038-04-05  43041-04-01  43042-04-01  43042-04-11  43043-04-01  43044-04-01  43044-04-05  43044-04-11  43044-04-15  43044-04-51  43046-04-01  43046-04-05  43047-04-01  43056-04-01  43061-04-01  43062-04-01  43063-04-01  43064-04-01  0L212-01  0L213-01  ",9/10/2013,"09/10/2013",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66544,"Completed","Siemens Medical Solutions USA, Inc.","2501 Barrington Rd",,"Hoffman Estates","IL","60195-2061","United States","Voluntary: Firm Initiated","Other","Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, Netherlands, United Kingdom, Brazil, South Africa, Kuwait, Belgium, Russia, Taiwan, Australia, Bangladesh, Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, Hong Kong, Croatia, Hungary, Indonesia, Iran, Israel, India, South Korea, Kuwait, Kazakhstan, Lithuania, Latvia, Morocco, Mexico, Norway, New Zealand, Peru, Phillipines, Pakistan, Portugal, Qatar, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Taiwan, Venezuela, and Vietnam.","Z-0061-2017","Class II","Symbia S,    Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy.    .","732 units","The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.","10/07/2016",," Material Number 8717741, Serial Numbers: 1001 ,  1002 ,  1003 ,  1005 ,  1006 ,  1007 ,  1008 ,  1009 ,  1010 ,  1011 ,  1012 ,  1013 ,  1014 ,  1015 ,  1016 ,  1017 ,  1018 ,  1019 ,  1020 ,  1021 ,  1022 ,  1023 ,  1024 ,  1025 ,  1027 ,  1028 ,  1029 ,  1030 ,  1031 ,  1032 ,  1033 ,  1034 ,  1035 ,  1036 ,  1037 ,  1038 ,  1039 ,  1040 ,  1041 ,  1042 ,  1043 ,  1044 ,  1045 ,  1046 ,  1047 ,  1048 ,  1049 ,  1050 ,  1051 ,  1052 ,  1053 ,  1054 ,  1055 ,  1056 ,  1057 ,  1058 ,  1059 ,  1060 ,  1061 ,  1062 ,  1063 ,  1064 ,  1065 ,  1066 ,  1067 ,  1068 ,  1069 ,  1070 ,  1071 ,  1072 ,  1073 ,  1074 ,  1075 ,  1076 ,  1077 ,  1078 ,  1079 ,  1080 ,  1081 ,  1082 ,  1083 ,  1084 ,  1085 ,  1086 ,  1087 ,  1088 ,  1089 ,  1090 ,  1091 ,  1092 ,  1093 ,  1094 ,  1095 ,  1096 ,  1097 ,  1098 ,  1099 ,  1100 ,  1101 ,  1102 ,  1103 ,  1104 ,  1105 ,  1106 ,  1107 ,  1108 ,  1109 ,  1110 ,  1111 ,  1112 ,  1113 ,  1114 ,  1115 ,  1116 ,  1117 ,  1118 ,  1119 ,  1120 ,  1121 ,  1122 ,  1123 ,  1124 ,  1125 ,  1126 ,  1127 ,  1128 ,  1129 ,  1130 ,  1131 ,  1132 ,  1133 ,  1134 ,  1135 ,  1136 ,  1137 ,  1138 ,  1139 ,  1140 ,  1141 ,  1142 ,  1143 ,  1144 ,  1145 ,  1146 ,  1147 ,  1148 ,  1149 ,  1150 ,  1151 ,  1152 ,  1153 ,  1154 ,  1155 ,  1156 ,  1157 ,  1158 ,  1159 ,  1160 ,  1161 ,  1162 ,  1163 ,  1164 ,  1165 ,  1166 ,  1167 ,  1168 ,  1169 ,  1170 ,  1171 ,  1172 ,  1173 ,  1174 ,  1175 ,  1176 ,  1177 ,  1178 ,  1179 ,  1180 ,  1181 ,  1182 ,  1183 ,  1184 ,  1185 ,  1186 ,  1187 ,  1188 ,  1189 ,  1190 ,  1191 ,  1192 ,  1193 ,  1194 ,  1195 ,  1196 ,  1197 ,  1198 ,  1199 ,  1200 ,  1201 ,  1202 ,  1203 ,  1204 ,  1205 ,  1206 ,  1207 ,  1208 ,  1209 ,  1210 ,  1211 ,  1212 ,  1213 ,  1214 ,  1215 ,  1216 ,  1217 ,  1218 ,  1219 ,  1220 ,  1221 ,  1222 ,  1223 ,  1224 ,  1225 ,  1226 ,  1227 ,  1228 ,  1229 ,  1230 ,  1231 ,  1232 ,  1233 ,  1234 ,  1235 ,  1236 ,  1237 ,  1238 ,  1239 ,  1240 ,  1241 ,  1242 ,  1243 ,  1244 ,  1245 ,  1246 ,  1247 ,  1248 ,  1249 ,  1250 ,  1251 ,  1252 ,  125",8/16/2013,"08/16/2013",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66544,"Completed","Siemens Medical Solutions USA, Inc.","2501 Barrington Rd",,"Hoffman Estates","IL","60195-2061","United States","Voluntary: Firm Initiated","Other","Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, Netherlands, United Kingdom, Brazil, South Africa, Kuwait, Belgium, Russia, Taiwan, Australia, Bangladesh, Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, Hong Kong, Croatia, Hungary, Indonesia, Iran, Israel, India, South Korea, Kuwait, Kazakhstan, Lithuania, Latvia, Morocco, Mexico, Norway, New Zealand, Peru, Phillipines, Pakistan, Portugal, Qatar, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Taiwan, Venezuela, and Vietnam.","Z-0062-2017","Class II","Symbia T Series SPECT + CT     Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy.    ","1109 units","The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.","10/07/2016",," Material Number 10275007, Serial Numbers 1001 ,  1006 ,  1007 ,  1032 ,  1053 ,  1104 ,  1134 ,  1012 ,  1226 ,  1014 ,  1015 ,  1284 ,  1024 ,  1034 ,  1055 ,  1060 ,  1064 ,  1038 ,  1039 ,  1065 ,  1041 ,  1071 ,  1043 ,  1044 ,  1076 ,  1098 ,  1108 ,  1109 ,  1110 ,  1050 ,  1051 ,  1111 ,  1112 ,  1113 ,  1117 ,  1056 ,  1057 ,  1119 ,  1131 ,  1137 ,  1145 ,  1146 ,  1147 ,  1160 ,  1170 ,  1066 ,  1180 ,  1181 ,  1183 ,  1189 ,  1191 ,  1199 ,  1204 ,  1074 ,  1213 ,  1215 ,  1231 ,  1232 ,  1249 ,  1252 ,  1269 ,  1287 ,  1292 ,  1318 ,  1324 ,  1086 ,  1087 ,  1325 ,  1326 ,  1090 ,  1091 ,  1327 ,  1099 ,  1101 ,  1102 ,  1116 ,  1130 ,  1042 ,  1096 ,  1097 ,  1115 ,  1173 ,  1162 ,  1235 ,  1259 ,  1309 ,  1171 ,  1175 ,  1176 ,  1178 ,  1179 ,  1185 ,  1186 ,  1036 ,  1200 ,  1202 ,  1206 ,  1209 ,  1210 ,  1211 ,  1018 ,  1026 ,  1045 ,  1216 ,  1217 ,  1058 ,  1114 ,  1128 ,  1192 ,  1193 ,  1194 ,  1195 ,  1246 ,  1257 ,  1258 ,  1291 ,  1229 ,  1307 ,  1315 ,  1234 ,  1236 ,  1242 ,  1253 ,  1262 ,  1266 ,  1267 ,  1273 ,  1276 ,  1278 ,  1282 ,  1290 ,  1295 ,  1296 ,  1310 ,  1317 ,  1319 ,  1321 ,  1322 ,  1100 ,  1208 ,  1281 ,  1062 ,  1078 ,  1009 ,  1122 ,  1132 ,  1011 ,  1017 ,  1019 ,  1077 ,  1094 ,  1106 ,  1149 ,  1168 ,  1172 ,  1221 ,  1225 ,  1251 ,  1268 ,  1305 ,  1142 ,  1254 ,  1320 ,  1247 ,  1264 ,  1285 ,  1299 ,  1125 ,  1143 ,  1190 ,  1277 ,  1005 ,  1008 ,  1021 ,  1047 ,  1049 ,  1070 ,  1073 ,  1075 ,  1105 ,  1107 ,  1124 ,  1144 ,  1150 ,  1158 ,  1163 ,  1164 ,  1165 ,  1177 ,  1182 ,  1184 ,  1188 ,  1196 ,  1197 ,  1203 ,  1214 ,  1218 ,  1219 ,  1239 ,  1244 ,  1250 ,  1263 ,  1265 ,  1271 ,  1279 ,  1288 ,  1303 ,  1306 ,  1312 ,  1313 ,  1029 ,  1030 ,  1035 ,  1046 ,  1079 ,  1085 ,  1156 ,  1159 ,  1207 ,  1224 ,  1261 ,  1272 ,  1283 ,  1151 ,  1152 ,  1153 ,  1154 ,  1169 ,  1227 ,  1311 ,  1088 ,  1135 ,  1166 ,  1238 ,  1297 ,  1010 ,  1031 ,  1120 ,  1121 ,  1123 ,  1013 ,  1061 ,  1069 ,  1083 ,  1103 ,  1167 ,  1187 ,  1223 ,  1294 ,  1016 ,  102",8/16/2013,"08/16/2013",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",66606,"Completed","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide including Puerto Rico;  Australia, Canada, New Zealand, and Japan","Z-2609-2016","Class II","1) The HomeChoice automated peritoneal dialysis system.  Dataplate located on the device is labeled in part: Baxter.     2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter.    The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.","*** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units","In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP).  This can cause serious problems in patients with unrelated a co-morbid condition of ascites.","08/22/2016",," *** 1) HomeChoice automated peritoneal dialysis system:   Product Codes: 5C4471 and 5C4471R;   Serial Numbers: All serial numbers;     *** 2) HomeChoice Pro automated peritoneal dialysis system:   Product Codes: 5C8310 and 5C8310R;   Serial Numbers: All serial numbers",10/7/2013,"10/07/2013",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",67531,"Terminated","Medisca Inc","661 State Route 3 ","Unit C","Plattsburgh","NY","12901-6531","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Australia","D-0674-2016","Class I","CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg).","25 g: 15 bottles, 100 g: 153 bottles; 500 g: 18 bottles, 1 kg: 24 bottles","Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.","02/17/2016","02/17/2016"," Lot #s: 95482/A, 95482/B, 95482/C, 95482/D, 96453/A, 96453/B, 96453/C, and 96453/D, Exp. 10/31/2014 ",2/14/2014,"02/14/2014",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",67583,"Completed","Pro Pet LLC","1400 McKinley Rd",".","Saint Marys","OH","45885","United States","Voluntary: Firm Initiated","Press Release","Product was shipped to the following states: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MT, NC, ND, NE, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI and WV.","V-127-2016","Class I","Hubbard Life Maintenance Dog Food, Complete and balanced nutrition for all life stages, Natural fiber for healthy digestive system.  NET WT 40 lb/18.14 KG Hubbard Feeds, Inc. P.O. Box 8500 Mankato, MN 56001-8500 www.hubbardlife.com","750/40 lb bags","During an internal investigation, the firm discovered five additional products that were packaged on the same finishing line as a previous product which tested positive for Salmonella contamination.","01/21/2016",," Lot Number: 096 13 SM L2 2A",2/4/2014,"02/04/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",67583,"Completed","Pro Pet LLC","1400 McKinley Rd",".","Saint Marys","OH","45885","United States","Voluntary: Firm Initiated","Press Release","Product was shipped to the following states: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MT, NC, ND, NE, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI and WV.","V-128-2016","Class I","Joy Combo Cat Stars Cat Food MEAT, FISH & MILK FLAVOR NET WT. 15 LBS. (6.8 KG) & 40 LBS. (18.18 KG) paper bags. JOY PET FOODS PINCKNEYVILLE, IL 62274 800-245-4125 www.joypetfood.com","450/15lb. Bags + 560/40lb. Bags","During an internal investigation, the firm discovered five additional products that were packaged on the same finishing line as a previous product which tested positive for Salmonella contamination.","01/21/2016",," Lot Number: 096 13 SM L2 2A and 096 13 SM L2 1A",2/4/2014,"02/04/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",67583,"Completed","Pro Pet LLC","1400 McKinley Rd",".","Saint Marys","OH","45885","United States","Voluntary: Firm Initiated","Press Release","Product was shipped to the following states: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MT, NC, ND, NE, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI and WV.","V-126-2016","Class I","Hubbard Life Cat Stars Cat Food, Complete and balanced nutrition for all life stages, NET WT 15 lb/8.18 KG Hubbard Feeds, Inc. P.O. Box 8500 Mankato, MN 56001-8500 www.hubbardlife.com","1,350/15 lb bags","During an internal investigation, the firm discovered five additional products that were packaged on the same finishing line as a previous product which tested positive for Salmonella contamination.","01/21/2016",," Lot Number: 096 13 SM L2 1A",2/4/2014,"02/04/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",67583,"Completed","Pro Pet LLC","1400 McKinley Rd",".","Saint Marys","OH","45885","United States","Voluntary: Firm Initiated","Press Release","Product was shipped to the following states: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MT, NC, ND, NE, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI and WV.","V-125-2016","Class I","Hubbard Life Happy Hound 27/15 Dog Food, Complete and balanced nutrition for all life stages, NET WT 40 lb/18.14 KG Hubbard Feeds, Inc. P.O. Box 8500 Mankato, MN 56001-8500 www.hubbardlife.com","1,100/40 lb bags","During an internal investigation, the firm discovered five additional products that were packaged on the same finishing line as a previous product which tested positive for Salmonella contamination.","01/21/2016",," Lot Number: 096 13 SM L2 2A and 096 13 SM L2 1A",2/4/2014,"02/04/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",67583,"Completed","Pro Pet LLC","1400 McKinley Rd",".","Saint Marys","OH","45885","United States","Voluntary: Firm Initiated","Press Release","Product was shipped to the following states: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MT, NC, ND, NE, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI and WV.","V-129-2016","Class I","Quality Care Plus QC+ Adult 26/15 Real Chicken and Brown Rice Formula Dog Food ALIMENT FOUR CHIEN NET WT. 20 LBS (9.06 KG) & 40 LBS. (18.12 KG) paper bags. Distributed by: Quality Care Plus QC+ P. O. Box 369, St. Marys, OH 45885 USA 1-800-780-0874 www.QCPlus.com","377/20lb. Bags + 544/40 lb. Bags ","During an internal investigation, the firm discovered five additional products that were packaged on the same finishing line as a previous product which tested positive for Salmonella contamination.","01/21/2016",," Lot Number: 097 13 SM L2 2A and 097 13 SM L2 1A",2/4/2014,"02/04/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",67969,"Terminated","The Robert Abady Dog & Cat Food Co  / Nutra-Vet Research Co","201 Smith St",,"Poughkeepsie","NY","12601-2110","United States","Voluntary: Firm Initiated","Press Release","Distributed in 6 states: CT, MA, MI, NJ, NY, RI","V-276-2016","Class I"," packed in a cardboard retail box with white label with color printing attached to the exterior of the box.  Lot code is stamped on the box.    Product was provided in 3 pack sizes:  NET WT. 2 lbs. (0.9 kgs.)***PRODUCT No. 201-02.    NET WT. 5 lbs (2.27 kgs.)***PRODUCT No. 201-05.  NET WT. 15 lbs (6.81 kgs.)***PRODUCT No. 201-15.","8x2lb boxes, 21x5lb boxes, 6x15lb boxes"," because they have the potential to be contaminated with Salmonella.","01/22/2016","02/05/2016"," 14029/21",4/8/2014,"04/08/2014",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",68318,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:","Z-2141-2016","Class II","LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a wide range of clinical settings that includes but is not limited to the following: medical, laboratory/delivery/post-partum, burn unit, surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), pediatrics.","38,878 infusion pump systems","Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.","07/08/2016",," List No. 20709; Serial Numbers: 15551001	;  15551002	;  15551003	;  15551004	;  15551005	;  15551007	;  15551009	;  15551010	;  15551011	;  15551012	;  15551013	;  15551014	;  15551015	;  15551016	;  15551017	;  15551018	;  15551019	;  15551020	;  15551021	;  15551022	;  15551023	;  15551024	;  15551025	;  15551026	;  15551028	;  15551029	;  15551030	;  15551031	;  15551032	;  15551033	;  15551034	;  15551035	;  15551036	;  15551037	;  15551038	;  15551039	;  15551040	;  15551041	;  15551043	;  15551044	;  15551045	;  15551046	;  15551047	;  15551048	;  15551049	;  15551050	;  15551051	;  15551052	;  15551053	;  15551054	;  15551055	;  15551056	;  15551057	;  15551058	;  15551059	;  15551060	;  15551061	;  15551062	;  15551063	;  15551064	;  15551065	; 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"Devices",68318,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:","Z-2140-2016","Class II","The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum,  burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 infusion pump allows clinicians to administer or patients to self-administer analgesia safely and effectively within clinician programmed limits. The epidural route can be used to provide anesthesia or analgesia.","8,216 infusion pump systems","Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.","07/08/2016",," List No. 12384; Serial Numbers: 12920041	;  12920048	;  12920052	;  12920056	;  12920066	;  12920069	;  12920079	;  12920082	;  12920101	;  12920102	;  12920104	;  12920105	;  12920106	;  12920107	;  12920117	;  12920121	;  12920122	;  12920152	;  12920158	;  12920159	;  12920160	;  12920174	;  12920246	;  12920248	;  12920251	;  12920252	;  12920255	;  12920257	;  12920264	;  12920265	;  12920268	;  12920270	;  12920275	;  12920276	;  12920277	;  12920278	;  12920282	;  12920287	;  12920289	;  12920291	;  12920294	;  12920304	;  12920305	;  12920311	;  12920312	;  12920320	;  12920328	;  12920330	;  12920332	;  12920340	;  12920343	;  12920346	;  12920347	;  12920352	;  12920353	;  12920357	;  12920358	;  12920359	;  12920360	;  12920362	;  12920364	; 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"Devices",68318,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:","Z-2139-2016","Class II","The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.","53,151 infusion pump systems","Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.","07/08/2016",," List No. 1950; Serial Numbers: 5815	;  10002	;  10015	;  10057	;  10067	;  10087	;  10095	;  10096	;  10099	;  10101	;  10107	;  10109	;  10111	;  10112	;  10118	;  10122	;  10123	;  10125	;  10128	;  10129	;  10130	;  10131	;  10132	;  10134	;  10136	;  10137	;  10142	;  10143	;  10146	;  10148	;  10149	;  10151	;  10154	;  10162	;  10163	;  10164	;  10165	;  10167	;  10168	;  10169	;  10170	;  10171	;  10172	;  10174	;  10176	;  10178	;  10179	;  10180	;  10181	;  10182	;  10183	;  10185	;  10186	;  10187	;  10188	;  10189	;  10190	;  10192	;  10193	;  10194	;  10195	;  10196	;  10199	;  10200	;  10202	;  10203	;  10204	;  10205	;  10206	;  10207	;  10208	;  10209	;  10210	;  10211	;  10212	;  10214	;  10216	;  10217	;  10220	;  10221	;  10222	;  10223	; 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"Devices",68318,"Completed","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:","Z-2142-2016","Class II","The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.","6,268 infusion pump systems","Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.","07/08/2016",," List No. 0F782; Serial Numbers: 100	;  101	;  102	;  105	;  105	;  106	;  106	;  107	;  108	;  108	;  109	;  111	;  112	;  114	;  116	;  117	;  119	;  120	;  121	;  122	;  123	;  124	;  125	;  125	;  126	;  126	;  127	;  127	;  128	;  128	;  129	;  129	;  130	;  130	;  131	;  131	;  132	;  132	;  133	;  133	;  134	;  134	;  135	;  135	;  136	;  136	;  137	;  137	;  138	;  138	;  139	;  140	;  141	;  142	;  142	;  143	;  143	;  144	;  144	;  145	;  146	;  147	;  147	;  148	;  148	;  149	;  150	;  150	;  151	;  152	;  153	;  154	;  154	;  155	;  155	;  156	;  157	;  158	;  158	;  159	;  160	;  161	;  162	;  162	;  163	;  164	;  164	;  165	;  165	;  166	;  166	;  167	;  167	;  168	;  169	;  170	;  171	;  172	;  172	;  173	;  173	;  174	;  174	;  175	;  175	;  176	;  176	;  177	;  177	;  178	;  178	;  179	;  180	;  181	;  182	;  183	;  183	;  184	;  184	;  185	;  186	;  186	;  187	;  188	;  188	;  189	;  189	;  190	;  191	;  192	;  193	;  194	;  195	;  196	;  197	;  198	;  199	;  200	;  200	;  201	;  201	;  202	;  202	;  203	;  203	;  204	;  204	;  205	;  205	;  206	;  206	;  207	;  207	;  208	;  208	;  209	;  209	;  210	;  210	;  211	;  212	;  212	;  213	;  213	;  214	;  214	;  215	;  216	;  216	;  217	;  217	;  218	;  218	;  219	;  220	;  221	;  222	;  223	;  224	;  224	;  225	;  225	;  226	;  226	;  227	;  227	;  228	;  229	;  229	;  230	;  231	;  232	;  233	;  234	;  235	;  236	;  237	;  238	;  239	;  240	;  241	;  241	;  242	;  242	;  243	;  243	;  244	;  245	;  245	;  246	;  246	;  247	;  247	;  248	;  248	;  249	;  250	;  250	;  251	;  251	;  252	;  252	;  253	;  253	;  254	;  255	;  256	;  256	;  257	;  258	;  259	;  259	;  260	;  260	;  261	;  262	;  263	;  263	;  264	;  265	;  265	;  266	;  266	;  267	;  267	;  268	;  269	;  269	;  270	;  270	;  271	;  271	;  272	;  273	;  273	;  274	;  274	;  275	;  275	;  276	;  277	;  277	;  278	;  279	;  279	;  280	;  280	;  281	;  281	;  282	;  283	;  283	;  284	;  284	;  285	;  286	;  287	;  288	;  288	;  289	;  290	;  290	;  291	;  291	;  292	;  292	;  293	;  293",3/8/2013,"03/08/2013",7/20/2016,"07/20/2016","0388	;  95590389	;  95590390	;  95590391	;  95590392	;  95590393	;  95590394	;  95590395	;  95590396	;  95590397	;  95590398	;  95590399	;  95590400	;  95590401	;  95590402	;  95590403	;  95590404	;  95590405	;  95590406	;  95590407	;  95590408	;  95590409	;  95590410	;  95590411	;  95590412	;  95590413	;  95590414	;  95590415	;  95590416	;  95590417	;  95590418	;  95590419	;  95590420	;  95590421	;  95590422	;  95590423	;  95590424	;  95590425	;  95590426	;  95590427	;  95590428	;  95590429	;  95590430	;  95590431	;  95590432	;  95590433	;  95590434	;  95590435	;  95590436	;  95590437	;  95590438	;  95590439	;  95590440	;  95590441	;  95590442	;  95590443	;  95590444	;  95590445	;  95590446	;  95590447	;  95590448	;  95590449	;  95590450	;  95590451	;  95590452	;  95590453	;  95590454	;  95590455	;  95590456	;  95590457	;  95590458	;  95590459	;  95590460	;  95590461	;  95590462	;  95590463	;  95590464	;  95590465	;  95590466	;  95590467	;  95590468	;  95590469	;  95590470	;  95590471	;  95590472	;  95590473	;  95590474	;  95590475	;  95590476	;  95590477	;  95590478	;  95590479	;  95590480	;  95590481	;  95590482	;  95590483	;  95590484	;  95590485	;  95590486	;  95590487	;  95590488	;  95590489	;  95590490	;  95590491	;  95590492	;  95590493	;  95590494	;  95590495	;  95590496	;  95590497	;  95590498	;  95590499	;  95590500	;  95590501	;  95590502	;  95590503	;  95590504	;  95590505	;  95590506	;  95590507	;  95590508	;  95590509	;  95590510	;  95590511	;  95590512	;  95590513	;  95590514	;  95590515	;  95590516	;  95590517	;  95590518	;  95590519	;  95590520	;  95590521	;  95590522	;  95590523	;  95590524	;  95590525	;  95590526	;  95590527	;  95590528	;  95590529	;  95590530	;  95590531	;  95590532	;  95590533	;  95590534	;  95590535	;  95590536	;  95590537	;  95590538	;  95590539	;  95590540	;  95590541	;  95590542	;  95590543	;  95590544	;  95590545	;  95590546	;  95590547	;  95590548	;  95590549	;  95590550	;  95590551	;  95590552	;  95590553	;  95590554	;  95590555	;  95590556	;  95590557	;  95590558	",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",68873,"Completed","Hi-Tech Pharmacal Co., Inc.","369 Bayview Ave",,"Amityville","NY","11701-2801","United States","Voluntary: Firm Initiated","Letter","CA, FL, ID, IL, LA, MI, MN, NC, ND, NJ, NY, OH, PA, SC, VT and Puerto Rico","F-0817-2017","Class III","Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701","22,872 bottles","Out-of-specification results for pH.","12/20/2016",," Lot 618283 (Exp. 01/2015), Lot 620151 (Exp. 03/2015), Lot 623407 (Exp. 09/2015) --- EXTENSION: Lots 620915 (Expiry 04/2015), 622298 (Exp. 07/2015), 624881 (Exp. 12/2015), 625981 (Exp. 02/2016), 626967 (Exp. 04/2016), 627676 (Exp. 05/2016).  ",7/28/2014,"07/28/2014",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69095,"Completed","Hi-Tech Pharmacal Co., Inc.","369 Bayview Ave",,"Amityville","NY","11701-2801","United States","Voluntary: Firm Initiated","Letter","CA, FL, ID, IL, LA, MI, NC, NJ, NY, OH, PA, VT, and Puerto Rico","F-0820-2017","Class III","Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701","7692 bottles","The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.","12/21/2016",," Lot 619618 (Exp. 01/2015)",8/25/2014,"08/25/2014",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69205,"Completed","Sietsema Farms Feeds Llc","19117 Lake Montcalm Rd",,"Howard City","MI","49329-8732","United States","Voluntary: Firm Initiated","Telephone","These feeds were shipped within Michigan.","V-461-2016","Class I","Bulk turkey feed with designation: T116","566.2 tons total (of all designations)","Reported turkey deaths suspected to have resulted after the turkeys consumed feeds containing high levels of the drug Lasalocid sodium.","07/25/2016",," Product code: T116",8/11/2014,"08/11/2014",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69205,"Completed","Sietsema Farms Feeds Llc","19117 Lake Montcalm Rd",,"Howard City","MI","49329-8732","United States","Voluntary: Firm Initiated","Telephone","These feeds were shipped within Michigan.","V-459-2016","Class I","Bulk turkey feed with designation: T113; a blend of designations T105 and T116","566.2 tons total (of all designations)","Reported turkey deaths suspected to have resulted after the turkeys consumed feeds containing high levels of the drug Lasalocid sodium.","07/25/2016",," Product code: T113",8/11/2014,"08/11/2014",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69205,"Completed","Sietsema Farms Feeds Llc","19117 Lake Montcalm Rd",,"Howard City","MI","49329-8732","United States","Voluntary: Firm Initiated","Telephone","These feeds were shipped within Michigan.","V-460-2016","Class I","Bulk turkey feed with designation: T114; a blend of designations T105 and T116","566.2 tons total (of all designations)","Reported turkey deaths suspected to have resulted after the turkeys consumed feeds containing high levels of the drug Lasalocid sodium.","07/25/2016",," Product code: T114",8/11/2014,"08/11/2014",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69205,"Completed","Sietsema Farms Feeds Llc","19117 Lake Montcalm Rd",,"Howard City","MI","49329-8732","United States","Voluntary: Firm Initiated","Telephone","These feeds were shipped within Michigan.","V-456-2016","Class I","Bulk turkey feed with designation: T105","566.2 tons total (of all designations)","Reported turkey deaths suspected to have resulted after the turkeys consumed feeds containing high levels of the drug Lasalocid sodium.","07/25/2016",," Product code: T105",8/11/2014,"08/11/2014",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69205,"Completed","Sietsema Farms Feeds Llc","19117 Lake Montcalm Rd",,"Howard City","MI","49329-8732","United States","Voluntary: Firm Initiated","Telephone","These feeds were shipped within Michigan.","V-458-2016","Class I","Bulk turkey feed with designation: T110; a blend of designations T105 and T116","566.2 tons total (of all designations)","Reported turkey deaths suspected to have resulted after the turkeys consumed feeds containing high levels of the drug Lasalocid sodium.","07/25/2016",," Product code: T110",8/11/2014,"08/11/2014",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69205,"Completed","Sietsema Farms Feeds Llc","19117 Lake Montcalm Rd",,"Howard City","MI","49329-8732","United States","Voluntary: Firm Initiated","Telephone","These feeds were shipped within Michigan.","V-457-2016","Class I","Bulk turkey feed with designation: T106; a blend of designations T105 and T116","566.2 tons total (of all designations)","Reported turkey deaths suspected to have resulted after the turkeys consumed feeds containing high levels of the drug Lasalocid sodium.","07/25/2016",," Product code: T106",8/11/2014,"08/11/2014",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0094-2017","Class III","Joint Optima Rebuilds, Lubricates and Soothes Joints, Triple Strength, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305.  Made in USA.","1500 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," Lot  #: all, Best use before 09/2016",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0108-2017","Class III","CardioAdvance","528 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0104-2017","Class III","Maca","3,000 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0092-2017","Class III","RISHI MUSHROOM SPORE, 60 count. 24 PER BOX","unable to determine","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," Lot  #: 1222412",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0098-2017","Class III","Lecithin Reishi Complex soft gels","1,390 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0105-2017","Class III","Lecithin soft gels","714 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0107-2017","Class III","Collagen","192 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0090-2017","Class III","Byron J. Richards Wellness resources Hyaluronic Acid Dietary Supplement, 60 Capsules, Distributed by Wellness Resources, Inc. 7155 Amundson Avenue, Minneapolis, MN 55439 800-717-WELL.","unable to determine","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0103-2017","Class III","Placenta","227 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0095-2017","Class III","Joint Lubrica Rebuilds, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305.  Made in USA.","4000 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," Lot  #: 43913, Best use before 09/2016",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0102-2017","Class III","Premium Reishi King","1,151 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0100-2017","Class III","Swiss Placenta","1,200 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0101-2017","Class III","Super Fish Oil Complex soft gels","2,290 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0093-2017","Class III","Premium Protein III, NET WT 16 OZ. (454g) www.greenwoodbiotech.com","unable to determine","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," Lot  #: 21713, Best use before 06/2016",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0089-2017","Class III","Premium Protein III Nutritional Supplement, NET WT 16 OZ. (454g), Manufactured for Celwa Biotech Brooklyn, NY 11219.  Made in USA","unable to determine ","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0097-2017","Class III","Super Lecithin Complex soft gels","1,450 bottles ","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0106-2017","Class III","Eagle Lecithin soft gels","1,008 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0099-2017","Class III","Super Fish Oil soft gels","2,004 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0088-2017","Class III","PREMIUM PROTEIN III For kids Nutritional Supplement, NET WT 16 OZ (454g), Manufactured for Celwa Biotech Brooklyn, NY 11219.  Made in USA","693 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," all lot numbers, all expiration dates",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0096-2017","Class III","DIETARY SUPPLEMENT BLUE ROCK HOLISTICS SUPER SHIELD, 90 Vegetable Capsules, Distributed by: Holistic Blends, Inc. 925 State Fair Blvd Syracuse, NY 13209 USA.","21,825 bottles","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," Lot  #: 120067, Best use before 04/2014",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69241,"Ongoing","Triceutical Inc./Zhang","164 Milbar Blvd",,"Farmingdale","NY","11735-1425","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","*Domestic* - FL, NY, PA, *International*- China","F-0091-2017","Class III","Super Natural Children's Growth Formula Dietary Supplement, 90 Tablets, Manufactured for GW Biotech Greenwood Biotech, LLC New York.  Made in USA.","unable to determine","Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices.  ","10/14/2016",," Lot 415712, Exp Date: 09/2015",10/10/2014,"10/10/2014",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",69339,"Ongoing","Philips Medical Systems, Inc.","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to:  CZECH REPUBLIC  ALBANIA  ALGERIA  ARGENTINA  AUSTRALIA  AUSTRIA  AZARBAIJAN  BAHAMAS  BANGLADESH  BELGIUM  BRAZIL  BULGARIA  CAYMAN ISLANDS  CHILE  CHINA  COLUMBIA  COSTA RICA  CROATIA  CUBA  CZECHOSLOVAKIA  DENMARK  DOMINICAN REPUB  ECUADOR  EGYPT  ESTONIA  FINLAND  FRANCE  GABON  GERMANY  GREECE  HONG KONG  HUNGARY  ICELAND  INDIA  INDONESIA  IRAN  IRAQ  IRELAND  ISRAEL  ITALY  JAPAN  JORDAN  KAZAKHSTAN  KENYA  KOREA SOUTH  KUWAIT  LATVIA  LEBANON  LIBYA  LITHUANIA  MACEDONIA  MALAYSIA  MAURITIUS  MEXICO  MOLDAVIA  MONGOLIA  MOROCCO  NEPAL  NETHERLANDS  NETHERLANDS ANT  NEW ZEALAND  NORWAY  OMAN  PAKISTAN  PALESTINE  PANAMA  Papua New Guinea  PARAGUAY  PERU  PHILIPPINES  POLAND  PORTUGAL  PUORTO RICO  QATAR  REUNION  ROMANIA  RUSSIAN FEDERAT  SAUDI ARABIA  SERBIA  SINGAPORE  SLOVENIA  SOUTH AFRICA  SPAIN  SUDAN  SWEDEN  SWITZERLAND  SYRIA  TAIWAN  TANZANIA  THAILAND  TUNISIA  TURKEY  UKRAINE  UNITED ARAB EMI  United Arab Emirates  UNITED KINGDOM  URUGUAY  USA  UZBEKISTAN  VENEZUELA  VIETNAM  YEMEN  GUADELOUPE  SYRIAN ARAB REPUBLIC","Z-1279-2016","Class II","Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038  This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Reproductive system, Respiratory system, Circulatory system, Various:Arthrograms, Myelograms, Facet joint injections, Discography, Sialography","168","Loss of key image functionality due to a bent pedal of the Footswitch.","03/31/2016",," Foot Switches:  452270000141 Footswitch CV 3p 4m; 452270000151 Footswitch MD 3p 6m;  452270000142 Footswitch CV 3p 4m; 452270000381 Footswitch CV 3p 8m; 452270000382 Footswitch CV 3p 8m; 459800076001 Footswitch CV 4p+2 4m; 459800076021 Footswitch CV 4p+2 8m; 459800415571 Wireless Footswitch 4p+2; 459800415581 Wireless footswitch set 4p+2;  459800415531 Wireless Footswitch 3P;  459800415561 Wireless footswitch set 3P.",9/24/2014,"09/24/2014",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",69339,"Ongoing","Philips Medical Systems, Inc.","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to:  CZECH REPUBLIC  ALBANIA  ALGERIA  ARGENTINA  AUSTRALIA  AUSTRIA  AZARBAIJAN  BAHAMAS  BANGLADESH  BELGIUM  BRAZIL  BULGARIA  CAYMAN ISLANDS  CHILE  CHINA  COLUMBIA  COSTA RICA  CROATIA  CUBA  CZECHOSLOVAKIA  DENMARK  DOMINICAN REPUB  ECUADOR  EGYPT  ESTONIA  FINLAND  FRANCE  GABON  GERMANY  GREECE  HONG KONG  HUNGARY  ICELAND  INDIA  INDONESIA  IRAN  IRAQ  IRELAND  ISRAEL  ITALY  JAPAN  JORDAN  KAZAKHSTAN  KENYA  KOREA SOUTH  KUWAIT  LATVIA  LEBANON  LIBYA  LITHUANIA  MACEDONIA  MALAYSIA  MAURITIUS  MEXICO  MOLDAVIA  MONGOLIA  MOROCCO  NEPAL  NETHERLANDS  NETHERLANDS ANT  NEW ZEALAND  NORWAY  OMAN  PAKISTAN  PALESTINE  PANAMA  Papua New Guinea  PARAGUAY  PERU  PHILIPPINES  POLAND  PORTUGAL  PUORTO RICO  QATAR  REUNION  ROMANIA  RUSSIAN FEDERAT  SAUDI ARABIA  SERBIA  SINGAPORE  SLOVENIA  SOUTH AFRICA  SPAIN  SUDAN  SWEDEN  SWITZERLAND  SYRIA  TAIWAN  TANZANIA  THAILAND  TUNISIA  TURKEY  UKRAINE  UNITED ARAB EMI  United Arab Emirates  UNITED KINGDOM  URUGUAY  USA  UZBEKISTAN  VENEZUELA  VIETNAM  YEMEN  GUADELOUPE  SYRIAN ARAB REPUBLIC","Z-1280-2016","Class II","Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xper FD1O/10, 722012 Allura Xper FD2O, 722013 Allura XPER FD2O BIPLANE, 722014 Allura Xper FD1O OR Table, 722015 Allura Xper FD2O OR Table, 722019 Allura Xper FD1O/10 OR Table, 722020 Allura Xper FD2O Biplane OR Table, 722022 Allura Xper FD1O OR Table, 722023 Allura Xper FD2O OR Table, 722024 Allura Xper FD1O/10 OR Table, 722025 Allura Xper FD2O Biplane OR Table, 722026 Allura Xper FD1O, 722027 Allura Xper FD1O/10, 722028 Allura Xper FD2O, 722029 Allura Xper FD2O/10, 722031 Allura CV2O, 722033 Allura Xper FD1O OR Table, 722034 Allura Xper FD1O/10 OR Table, 722035 Allura Xper FD2O OR Table, 722036 Allura Xper FD2O/10 OR Table, 722038 Allura Xper FD2O/20, 722039 Allura Xper FD2O/20 OR Table, 722058 Allura Xper FD20115, 722059 Allura Xper FD2O/15 OR Table, 722123 Field extensions Xper cardio systems, 722124 Field extensions Xper vascular systems, 722126 SmartPath to AlluraClarity cardio, 722127 SmartPath to AlluraClarity vascular, 722133 Field ext. Xper cardio systems R7.6, 722134 Field ext. Xper vascular systems R7.6, 722400 Cardio Vascular-Allura Centron, 889006 Diamond Select Allura Xper FD1 0  The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Tis included, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Addition","4180 devices","Loss of key image functionality due to a bent pedal of the Footswitch.","03/31/2016",," Foot Switches:  452270000141 Footswitch CV 3p 4m; 452270000151 Footswitch MD 3p 6m;  452270000142 Footswitch CV 3p 4m; 452270000381 Footswitch CV 3p 8m; 452270000382 Footswitch CV 3p 8m; 459800076001 Footswitch CV 4p+2 4m; 459800076021 Footswitch CV 4p+2 8m; 459800415571 Wireless Footswitch 4p+2; 459800415581 Wireless footswitch set 4p+2;  459800415531 Wireless Footswitch 3P;  459800415561 Wireless footswitch set 3P.",9/24/2014,"09/24/2014",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69353,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide.","V-291-2016","Class I","Premium Turkey Formula BRAVO Balance RAW DIET  Product Number: 31-405; Size: 5 lb. (80 OZ) 2.3KG plastic tubes - UPC: 829546314057, Keep Frozen",,"Product has the potential to be contaminated with Salmonella.","01/22/2016",," Best used by date: 11-05-15  ",9/25/2014,"09/25/2014",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69353,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide.","V-289-2016","Class I","BRAVO! Raw Food Diet TURKEY BLEND FOR DOGS AND CATS; Product Number: 31-102; Size: 2 lb. (32 OZ) plastic tubes, UPC: 829546311025; Keep Frozen",,"Product has the potential to be contaminated with Salmonella.","01/22/2016",," Best used by date: 11-05-15",9/25/2014,"09/25/2014",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69353,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide.","V-290-2016","Class I","Bravo! Blends All Natural Chicken Blend diet for dogs & cats; Product Number: 21-102; Size: 2 lb. (32 OZ) plastic tubes - UPC: 829546211028  and Product Number: 21-105 Size: 5 lb. (80 OZ) 2.3KG plastic tubes - UPC: 829546211059; Keep Frozen. ",,"Product has the potential to be contaminated with Salmonella.","01/22/2016",," Best used by date: 08-11-16 ",9/25/2014,"09/25/2014",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69399,"Terminated","Restaurant Recycling Services LLC","616 Industrial Dr",,"Fremont","MI","49412-1868","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MI, IN, OH and IL","V-453-2016","Class I","Animal Feed Fat","1,870,150 lbs.","Restaurant Recycling Services, LLC decided to initiate this voluntary recall out of an abundance of caution due to information received from the FDA and Michigan Department of Agriculture regarding possible lasalocid contamination.","07/13/2016","07/14/2016"," All tanker loads distributed: July 1, 2014 through September 24, 2014",9/30/2014,"09/30/2014",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69517,"Ongoing","Shur-Green Farms","9159 State Route 118",,"Ansonia","OH","45303","United States","Voluntary: Firm Initiated","Telephone","Direct US customers:  IN and OH.  NO foreign.","V-411-2016","Class I"," causing misuse and feed contamination.  No labeling, all products in tanker trucks.","unknown by firm"," causing misuse and contamination in animal feed.","05/11/2016",," No codes",10/16/2014,"10/16/2014",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69640,"Ongoing","GA Wintzer & Son Co","12279 S Dixie Hwy",,"Wapakoneta","OH","45895","United States","Voluntary: Firm Initiated","Telephone","Product was distributed in Ohio and Indiana.","V-415-2016","Class I","True Energy Formula A - Bulk - No labeling, all products in tanker trucks","Approximately 1 million pounds","Feed raw material was manufactured using oil that was contaminated with Lascadoil. ","06/10/2016",," - Batches 4179, 4180, and 4181. ",10/10/2014,"10/10/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69672,"Terminated","Co-Alliance LLP","219 Howard St.","P.O. Box 357","La Crosse","IN","46348-0357","United States","Voluntary: Firm Initiated","Letter","Domestic only: IN, MI, IL","V-410-2016","Class I","bulk custom ordered animal feed for swine ","LaCrosse, IN up to 13,644 ton; Reynolds, IN up to 8,383 ton; Flora, IN up to 8,553 ton ","Co-Alliance is voluntarily recalling the feed manufactured at the LaCrosse facility between July 1, 2014-September 19, 2014 due to an ongoing Class I recall of the grease that was used in manufacturing the animal feed. The grease is an industrial waste by-product from the manufacturing process for Lasalocid, which is not approved for swine feed.","05/11/2016","05/18/2016"," bulk  custom feed produced and distrbuted between July 1, 2014-September 19, 2014",10/20/2014,"10/20/2014",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69690,"Terminated","House Of Spices (india) Inc.","127-40 Willets Point Blvd.",,"Flushing","NY","11368-1506","United States","Voluntary: Firm Initiated","Press Release","FL, IL, NY, NJ, PA via retail stores","F-1974-2016","Class I","LAXMI NUTKHHAT Golden Raisins, Net Wt. 200g (7 oz), Product of USA -- Distributed by House of Spice Flushing, NY","115 cases ","The product contained undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets ","08/24/2016","08/24/2016"," Lot number: ABA20A2014",11/3/2014,"11/03/2014",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69702,"Terminated","Wholesome Soy Products","1150 W 40th St",,"Chicago","IL","60609-2505","United States","Voluntary: Firm Initiated","Telephone","US: IL","F-0615-2016","Class I","Mung bean sprouts packaged in 10 lb., 15 lb., and 30 lb. plastic bags.","110,000 lbs. of mung bean sprouts","Listeria monocytogenes was found in the mung bean sprouts and the area where the sprouts are produced.","02/17/2016","04/13/2016"," There are no product or production codes associated with these products.",8/29/2014,"08/29/2014",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-430-2016","Class I","725 HEN TURKEY BREEDER DIET 102. The product is made and transported in bulk. "," 19 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch numbers 44178 and 44179",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-439-2016","Class I","Swine feed Ration #31007. The product is made and transported in bulk. ","12 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch numbers 43659 and 43977",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-437-2016","Class I","Swine feed Ration #407. The product is made and transported in bulk. ","24 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch numbers 43557, 43696, and 43698",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-431-2016","Class I","830 10% TOM BREEDER + Methionine (Experimental). The product is made and transported in bulk. ","44.5 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch numbers 43575, 43576, 43671, 43782, 43869, 43968, 44050, and 44083",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-436-2016","Class I","725-55 HEN TURKEY BREEDER DIET. The product is made and transported in bulk. ","124.5 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch numbers 43577, 43665, 43666, 43779, 43780, 43867, 43967, 43970, 44076, 44078, and 44079",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-435-2016","Class I","906 TURKEY BREEDER HOLDING 1. The product is made and transported in bulk. ","18 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch numbers 44048 and 44168",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-434-2016","Class I","905 TURKEY BREEDER REPLACEMENT 5 w/AVATEC. The product is made and transported in bulk. ","39 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch numbers 43792, 43876, 44005, 44049, and 44096",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-433-2016","Class I","903 TURKEY BREEDER REPLACEMENT 3 w/ HISTOSTAT. The product is made and transported in bulk. ","23 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch numbers 43741, 43742, 43793, 43879, and 44097",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-432-2016","Class I","902 TURKEY BREEDER REPLACEMENT 2 w/ HISTOSTAT. The product is made and transported in bulk. ","21 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch number 43626",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69705,"Ongoing","Cooper Hatchery Inc","Rr 1",,"Oakwood","OH","45873","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in OH","V-438-2016","Class I","Swine feed Ration #3407. The product is made and transported in bulk. ","60 tons","Contaminated oil was used as a raw material to make finished animal feed. ","06/10/2016",," Batch numbers 43673, 43769, 43807, 43878, 43899, 43911, 44085, and 44120",10/31/2014,"10/31/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69721,"Ongoing","Cooper Farms Inc","2321 State Route 49",,"Fort Recovery","OH","45846-9501","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected product was distributed in Ohio and Kentucky.","V-413-2016","Class I","All poultry and swine animal feeds, medicated and non-medicated, which were manufactured using the contaminated lascadoil. The product is made and transported in bulk with no labeling.","Approximately 11,000 tons of feed","Various animal feeds were manufactured using a contaminated oil as a raw material. ","05/23/2016",," The firm does not assign lot or batch codes to product. ",10/31/2014,"10/31/2014",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69794,"Terminated","Wholesome Soy Products","1150 W 40th St",".","Chicago","IL","60609-2505","United States","Voluntary: Firm Initiated","Telephone","US: IL","F-1019-2016","Class I","Mung bean sprouts are packaged 1 lb., 5 lbs., 10 lbs., 15 lbs., or 30 lbs. per plastic bag.","4,800 bags","Environmental sampling conducted by the FDA found contamination with Listeria monocytogenes.","04/06/2016","04/13/2016"," 10302014CS; 10312014CS; 11012014CS; 11032014CS; 11042014CS; 11052014CS; 11062014CS; 11072014CS",11/7/2014,"11/07/2014",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",69828,"Completed","Flying Cow Creamery","11717 Independence Rd",,"Rochester","WA","98579","United States","Voluntary: Firm Initiated","Telephone","distributed in Washington","F-1844-2016","Class II",".","117  jars total","Flying Cow Creamery whole milk yogurt is recalled because the milk may not have been adequately pasteurized.","07/28/2016",," Batch #70   Best Before 12/3;    Milk from 11/3/14 was used to manufacturer Batch #70 with Best Before date of 12/3",11/20/2014,"11/20/2014",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69843,"Terminated","Mars Petcare USA","315 Cool Springs Blvd",,"Franklin","TN","37067-1632","United States","Voluntary: Firm Initiated","Telephone","Product was distributed to distributors in CA, GA, MI, MN, NV, PA, TX, and VT as well as British Columbia, Canada.","V-288-2016","Class I","EVO Grain Free Turkey  & Chicken Formula Ferret Food, packaged in 6.6 lbs. paper bags, UPC 5148 542101, Manufactured by Natura  Pet Products, Inc., Fremont, NE;","875 bags","Batches of cat and ferret food were manufactured with no added vitamins and double the specified minerals.","01/22/2016","02/05/2016"," Lots 4300A700D3 and 4307A700D3;",11/20/2014,"11/20/2014",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69843,"Terminated","Mars Petcare USA","315 Cool Springs Blvd",,"Franklin","TN","37067-1632","United States","Voluntary: Firm Initiated","Telephone","Product was distributed to distributors in CA, GA, MI, MN, NV, PA, TX, and VT as well as British Columbia, Canada.","V-286-2016","Class I","EVO Grain Free Turkey & Chicken Formula Cat & Kitten Food, packaged in 15.4 lbs. paper bags, UPC 5148 541400, Manufactured by Natura Pet Products, Inc., Fremont, NE;","2128 units","Batches of cat and ferret food were manufactured with no added vitamins and double the specified minerals.","01/22/2016","02/05/2016"," (1) Lot 4300A700D2;  (2) Lots 4301A700A4, 4301A700B4, and 4301A700C4;  (3) Lot 4300A700D3;",11/20/2014,"11/20/2014",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69843,"Terminated","Mars Petcare USA","315 Cool Springs Blvd",,"Franklin","TN","37067-1632","United States","Voluntary: Firm Initiated","Telephone","Product was distributed to distributors in CA, GA, MI, MN, NV, PA, TX, and VT as well as British Columbia, Canada.","V-287-2016","Class I","California Natural Herring & Sweet Potato Formula, Adult Cat Food, packaged in 15 lbs paper boxes, UPC 5148 582357, Manufactured by Natura Pet Products, Inc., Fremont, NE.","126 units","Batches of cat and ferret food were manufactured with no added vitamins and double the specified minerals.","01/22/2016","02/05/2016"," Lot 4307A700D2;",11/20/2014,"11/20/2014",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69865,"Ongoing","Gerber & Sons Inc","100 South Ray St",,"Baltic","OH","43804","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected product was distributed to Ohio and Pennsylvania.","V-417-2016","Class I","All Livestock, Poultry, and Deer feeds, medicated and non-medicated, which were manufactured using the contaminated lascadoil. The product is made and transported in bulk with no labeling. ","An estimated hundreds of tons of feed. ","Contaminated ingredient oil [TEFA] from supplier was used as an ingredient in animal feeds. ","06/10/2016",," The firm does not assign batch or lot codes to the products. ",11/20/2014,"11/20/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69914,"Ongoing","Burkmann Feeds Llc","1111 Perryville Rd",,"Danville","KY","40422-1306","United States","Voluntary: Firm Initiated","Visit","The affected product was distributed to four firms in KY.     The affected product was not distributed to any foreign or government consignees..","V-514-2016","Class I","Burkmann Feeds Layer Ration 20% Pellet  656, Feed for chickens, packaged paper bags, 50 lbs per bag","360 bags","Burkemann Feeds conducted a recall in response to monensin found in chicken feed 656.","09/13/2016",," Lot # 2090341",10/14/2014,"10/14/2014",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69929,"Ongoing","Lakeland Animal Nutrition, Inc.","2725 S Combee Rd",,"Lakeland","FL","33803-7386","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FLORIDA","V-309-2016","Class I","Signature brand FEP-862S Q STATUS PELLET FORMULA Pelleted Maintenance & Light Exercise Ration 50 lb bag (paper bags, poly-lined, sewn at both ends) ","89 bags of  50 lbs. each","Products may contain monensin.","02/11/2016",," Lot Number 14-280 Manufacture Date: October 7 ",10/22/2014,"10/22/2014",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-420-2016","Class I","12% Beef Grain packaged in 50 lb. bags, 100 lb. bags, and in bulk","92,000 lbs.","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-423-2016","Class I","26% Calf Pellets packaged in 50 lb. bags, 100 lb. bags, and in bulk","16,000 lbs.","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-421-2016","Class I","32% Calf Supplement Pellet packaged in 50 lb. bags, 100 lb. bags, and in bulk","89,000 lbs","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-426-2016","Class I","Premium Deer Feed packaged in 50 lb. bags, 100 lb. bags, and in bulk","26,000 lbs.","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-427-2016","Class I","Custom cattle feeds packaged in 50 lb. bags, 100 lb. bags, and in bulk","64,100 lbs.","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-428-2016","Class I","Custom horse feeds packaged in 50 lb. bags, 100 lb. bags, and in bulk","6,000 lbs.","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-429-2016","Class I","Custom deer feed packaged in 50 lb. bags, 100 lb. bags, and in bulk","4,000 lbs.","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-418-2016","Class I","18% Calf Starter packaged in 50 lb. bags, 100 lb. bags, and in bulk","105,000 lbs.","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-419-2016","Class I","Calf Grower with Bovatec packaged in 50 lb. bags, 100 lb. bags, and in bulk","103,000 lbs.","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-422-2016","Class I","LM Calf Grower packaged in 50 lb. bags, 100 lb. bags, and in bulk","4,750 lbs.","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-424-2016","Class I","Rumensin Calf Grower packaged in 50 lb. bags, 100 lb. bags, and in bulk","36,000 lbs","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",69975,"Ongoing","Gerber Feed Service Inc.","3094 Moser Road",,"Dalton","OH","44618-9743","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.","V-425-2016","Class I","Horse Feed packaged in 50 lb. bags, 100 lb. bags, and in bulk","44,000 lbs","Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.","06/10/2016",," The firm does not assign lot or batch codes to product. ",12/9/2014,"12/09/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",70054,"Completed","Sysmex Corporation","1 5 1 Wakinohamakaigandoori","CHUO-KU","Kobe-shi",,,"Japan","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam.    THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.","Z-1945-2016","Class II","The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.","1,137 units (US) 54 units (Canada) 9 inventory","There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.","06/10/2016",," 1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484;     2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.",12/18/2014,"12/18/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70092,"Ongoing","New Bedford Feed & Supply LLC","33906 State Route 643",,"Baltic","OH","43804-9501","United States","Voluntary: Firm Initiated","Other","The affected products were distributed inside the state of Ohio.","V-445-2016","Class I","Fifty pound bags and bulk shipment of 10% Horse Feed","7 tons","Feed was manufactured with an ingredient that had been manufactured with contaminated oil.  The oil was a non-food use oil that was blended into a feed grade oil by the oil supplier.","06/11/2016",," No codes or lot numbers.",12/8/2014,"12/08/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70092,"Ongoing","New Bedford Feed & Supply LLC","33906 State Route 643",,"Baltic","OH","43804-9501","United States","Voluntary: Firm Initiated","Other","The affected products were distributed inside the state of Ohio.","V-446-2016","Class I","Fifty pound bags and bulk shipment of 17% Deer Feed","7 tons","Feed was manufactured with an ingredient that had been manufactured with contaminated oil.  The oil was a non-food use oil that was blended into a feed grade oil by the oil supplier.","06/11/2016",," No codes or lot numbers.",12/8/2014,"12/08/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70092,"Ongoing","New Bedford Feed & Supply LLC","33906 State Route 643",,"Baltic","OH","43804-9501","United States","Voluntary: Firm Initiated","Other","The affected products were distributed inside the state of Ohio.","V-443-2016","Class I","Fifty pound bags and bulk shipment of 12% Hi Oats Horse Feed","16 Tons","Feed was manufactured with an ingredient that had been manufactured with contaminated oil.  The oil was a non-food use oil that was blended into a feed grade oil by the oil supplier.","06/11/2016",," No codes or lot numbers.",12/8/2014,"12/08/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70092,"Ongoing","New Bedford Feed & Supply LLC","33906 State Route 643",,"Baltic","OH","43804-9501","United States","Voluntary: Firm Initiated","Other","The affected products were distributed inside the state of Ohio.","V-444-2016","Class I","Fifty pound bags and bulk shipment of 11% Beef Feed","11 tons","Feed was manufactured with an ingredient that had been manufactured with contaminated oil.  The oil was a non-food use oil that was blended into a feed grade oil by the oil supplier.","06/11/2016",," No codes or lot numbers.",12/8/2014,"12/08/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70099,"Ongoing","Witmers Feed & Grain Inc","3770 Renkenberger Road",,"Columbiana","OH","44408-9733","United States","Voluntary: Firm Initiated","Letter","The affected product was distributed to the following states:  OH, PA, AR, and NY.","V-416-2016","Class I","Various custom livestock feeds, packaged in 50 lb. paper bags and in bulk","526.81 tons","Feed was manufactured with an ingredient that had been manufactured with contaminated oil.  ","06/10/2016",," The firm does not use codes.",12/17/2014,"12/17/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",70112,"Ongoing","Valeant Pharmaceuticals North America LLC ","400 Somerset Corporate Blvd",,"Bridgewater","NJ","08807-2867","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1035-2016","Class III","Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada;  Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ  08807, NDC 68682-409-10.","564,454 bottles","Failed Impurities/Degradation Specifications","06/16/2016",," Lot #: 13G005P, 13G010P, Exp 06/16; 3H029P, 13J048P, 13J049P, 13J050P, Exp 08/17; 14B047P, 14B048P, 14B049P,14C043P, 14C048P, 14C049P,  Exp 01/18; 14D048P, 14D053P, 14D054P, Exp 03/18; 14G042P, 14G047P, 14G049P, Exp 5/18; 14J005P, 14J006P, 14J007P, Exp 07/18; 14K114P, 14K115P, 14K116P, Exp 09/18; 15B008P, 158013P, 15B021P, 15C058P, 15C059P, 15C064P, Exp 01/19; 15E037P, 15E038P, Exp 04/19",4/18/2015,"04/18/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",70112,"Ongoing","Valeant Pharmaceuticals North America LLC ","400 Somerset Corporate Blvd",,"Bridgewater","NJ","08807-2867","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1034-2016","Class III","Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada;  Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.","6,321 bottles","Failed Impurities/Degradation Specifications","06/16/2016",," Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19",4/18/2015,"04/18/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70145,"Terminated","TDBBS","5701 Eastport Blvd",,"Richmond","VA","23231-4450","United States","Voluntary: Firm Initiated","E-Mail","The company  identified 17 customers who are either pet store owners or distribution centers that may have received the affected lot. They are instructing our customers to return the product for accountability. They do not have any foreign or US government accounts.","V-277-2016","Class I","Brand name: Barkworthies All Natural Chicken Vittles (Chicken neck)","65 Cases were manufactured from 152kg (335 lbs) on 5/5/14. Distribution began on 5/6/14. All of the 65 cases have been distributed. ","Feed Sample Report from the Colorado Department of Agriculture found Salmonella detected in Barkworthies All Natural Chicken Vittles (Lot 1254T1). ","01/22/2016","01/28/2016"," UPC: 8-16807-01151-0     SKU: BARK-ChicVit1lbc6    BEST BY: 05/2016    LOT: 1254T1    Net weight: 16oz. per bag, 6 bags per case",12/22/2014,"12/22/2014",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70196,"Ongoing","Jump Your Bones, Inc.","6839 Town Harbour Blvd","Bldg 16, Unit 1615","Boca Raton","FL","33433-4315","United States","Voluntary: Firm Initiated","Press Release","Distributors in  WA, CA and NY - product sold Nationwide and via internet sales at  Pet Stores, Pet Boutiques, Groomers and Veterinarian Offices.","V-293-2016","Class I","Jump Your Bones Roo Bites (Cubes) - Packaged in 80g/2.82 oz. including samples of .32 oz.plastic bags in a re-sealable container","1,339 kilograms (to make 80 grams bags) ","The Colorado Department of Agriculture collected a sample and found that it was positive for Salmonella. They submitted the Salmonella isolate to the FDA for further identification.","02/04/2016",," No codes/lots #'s or Best By or Expiration date on the packages only UPC 63633010041",12/31/2014,"12/31/2014",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0444-2017","Class I","SAUER'S BARBEQJ E SPICE, 3 oz. ","32 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.      ","11/15/2016","11/15/2016"," PRODUCT ID 00504    LOT # 14230R",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0445-2017","Class I","SAUER'S CHILl POWDER, 2.25 oz. ","60 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein. ","11/15/2016","11/15/2016"," PRODUCT ID 00518, Lots 14279R, 14280R, 14282R, 14289R, 14293R, 14294R  ",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0446-2017","Class I","SAUER'S HOT CHILl POWDER, 2.25oz.","84 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.    ","11/15/2016","11/15/2016"," PRODUCT ID 00519, Lot 14227R  ",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0449-2017","Class I","MARCUM CHILl POWDER, 2.25 oz.","9337 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.    ","11/15/2016","11/15/2016"," PRODUCT ID 09153    LOT #     14258R  14270R  14286R  14288R  ",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0453-2017","Class I","GOLD MEDAL CHILl POWDER,5.5 lbs  RESTAURANT PRIDE DEPENDABLE CHILl POWDER, 5.5 lbs ","230 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.    ","11/15/2016","11/15/2016"," PRODUCT ID 02203    LOT #     14231R    ",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0451-2017","Class I","SAUER'S GROUND CUMIN,5lbs . CHEF'S MAGIC GROUND CUMIN, 5 lbs. CODE GROUND CUMIN, 5 lbs.  JAKE'S GROUND CUMIN,5 lbs.  PREMIUM RECIPE GROUND CUMIN,5 lbs  RESTAURANT  PRIDE GROUND CUMIN,5 lbs. ","80 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.    ","11/15/2016","11/15/2016"," PRODUCT ID 01107     LOT #     14273R    ",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0450-2017","Class I","POLLOTROPICAL TUMBLE MARINADE, 21.25 lbs. ","1867 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.    ","11/15/2016","11/15/2016"," PRODUCT ID 09089     LOT #     14226R  14230R    ",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0447-2017","Class I","SAUER'S CHILl POWDER, 5.5 lbs.    BLUE MOUNTAIN VALLEY CHILl POWDER, 5.5 lbs.     CHEF'S MAGIC CHILl POWDER, 5.5 lbs.    CODE CHILl POWDER, 5.5 lbs.    IFH CHILI POWDER,5.5 lbs.     NUGGET CHILl POWDER,5.5 lbs.    POCAHONTAS CHILl POWDER, 5.5 lbs.    PREMIUM RECIPE CHILl POWDER, 5.5 lbs.    RESTAURANT PRIDE PREFERRED CHILI POWDER,5.5 lbs.     ULF CHILl POWDER,5.5 lbs.    WENDLING CHILI POWDER, 5.5 lbs.    JAKES CHILI POWDER, 5.5 lbs.","392 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.    ","11/15/2016","11/15/2016"," PRODUCT ID 01047    LOT # 14231R",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0452-2017","Class I","SAUER'S REDUCED SODIUM TACO SEASONING,14oz.","719 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.    ","11/15/2016","11/15/2016"," PRODUCT ID 09273    LOT #     14230R     ",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",70292,"Terminated","C.F. Sauer Company","2000 W Broad St",,"Richmond","VA","23220-2006","United States","Voluntary: Firm Initiated","Telephone","The product was distributed thru out the United States .","F-0448-2017","Class I","MARCUM GROUND CUMIN, 2.25 o z.","4603 Cases","The firm was notified that a specific lot of Ground Cumin Seed (lot # 2686E) they purchased had tested and found to be positive for peanut protein.    ","11/15/2016","11/15/2016"," PRODUCT ID 09114     LOT #     14164R  14 212R  14272R  14287R  ",12/24/2014,"12/24/2014",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70319,"Terminated","J.J. Fuds, Inc.","316 N 400 E",,"Valparaiso","IN","46383-9704","United States","Voluntary: Firm Initiated","Telephone","Domestic: IN, IL, MI, MN    Foreign: None","V-122-2016","Class I","Chicken Tender Chunks  5 lb bag, 6- 5 lb bags/case, and 10 lb bag","6000 lbs. in the form of 200 x 5lb. bags and 500 x 10 lb. bags combined product","Listeria monocytogenes was found in retail surveillance sample collected by the State of Michigan.  The firm was notified and initiated a recall and contacted customers via telephone, press release and letters to be issued.","01/12/2016","05/13/2016"," All UPC Package Codes; Manufacture Date: 05/06/2014 to 01/7/2015  ",1/13/2015,"01/13/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70319,"Terminated","J.J. Fuds, Inc.","316 N 400 E",,"Valparaiso","IN","46383-9704","United States","Voluntary: Firm Initiated","Telephone","Domestic: IN, IL, MI, MN    Foreign: None","V-123-2016","Class I","Beef Tender Chunks  5 lb bag, 6- 5 lb bags/case, and 10 lb bag","6000 lbs. in the form of 200 x 5lb. bags and 500 x 10 lb. bags combined product","Listeria monocytogenes and Salmonella was found in retail surveillance sample collected by the State of Michigan.  The firm was notified and initiated a recall and contacted customers via telephone, press release and letters starting on 1/13/2015.","01/12/2016","05/13/2016"," All UPC Package Codes; Manufacture Date: 05/06/2014 to 01/7/2015  ",1/13/2015,"01/13/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70319,"Terminated","J.J. Fuds, Inc.","316 N 400 E",,"Valparaiso","IN","46383-9704","United States","Voluntary: Firm Initiated","Telephone","Domestic: IN, IL, MI, MN    Foreign: None","V-124-2016","Class I","Duckling Tender Chunks  5 lb bag, 6- 5 lb bags/case, and 10 lb bag","6000 lbs. in the form of 200 x 5lb. bags and 500 x 10 lb. bags combined product","The product may be contaminated with Listeria monocytogenes and Salmonella.  L. mono and Salmonella were detected in other varieties processed at the firm in retail surveillance samples collected by the State of Michigan.  The firm was notified and initiated a recall and contacted customers via telephone, press release and letters starting on 1/13/2015.","01/12/2016","05/13/2016"," All UPC Package Codes; Manufacture Date: 05/06/2014 to 01/7/2015  ",1/13/2015,"01/13/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70406,"Terminated","Grill-Phoria LLC","1082 Denver Ave",,"Loveland","CO","80537-5165","United States","Voluntary: Firm Initiated","Press Release","Big Bark All Natural Beef Jerky Treats for Dogs was distributed primarily in Colorado, with some product distributed in Wyoming, Utah, Oklahoma, and Arizona through Nor-Sky Pet Supply LLC to independent pet stores.","V-296-2016","Class I","Big Bark All Natural Beef Jerky Treat for Dogs, Guaranteed Analysis, Crude Protein 65%, Crude Fat 8.0%, Crude Fiber 2.0%, Moisture 10.0%, Ingredients: Dehydrated Beef Heart Made in USA Grill-Phoria LLC 1082 North Denver Ave, Loveland, Colorado 80537, Item #NS01701, 3.5 oz (99 g), 8 17894 01701 0","221 x 3.5 oz bags","Grill-Phoria of Loveland, Colorado is recalling certain Big Bark All Natural Beef Jerky Treats for Dogs due to potential contamination with Salmonella.","02/04/2016","06/14/2016"," No lot codes are listed on the product.  Product is packed in 3.5 oz resealable plastic pouches.  It was manufactured and distributed from 9/20/14 through 1/02/15.",1/30/2015,"01/30/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70504,"Terminated","Tuffy's Pet Food, Inc","145 1st Ave N","P.O. Box 190","Perham","MN","56573-0190","United States","Voluntary: Firm Initiated","Letter","Product distributed to distributors in CA and IL","V-297-2016","Class I","Nutrisca Chicken and Chick Pea Recipe Dry Dog Food, Net Wt. 4 lbs.","17,376 units","Specific lots of Nutrisca Chicken and Chick Pea Recipe Dry Dog Food have the potential to be contaminated with Salmonella.","02/04/2016","04/07/2016"," First five digits of Lot Codes:  4G29P, 4G31P, 4H01P, 4H04P, 4H05P, 4H06P.  Best By Dates:  Jul28 16, Jul 30 16, Jul 31 16, Aug 03 16, Aug 04 16, Aug 05 16.",2/11/2015,"02/11/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70508,"Ongoing","Pet International Inc.","8600 NW 30th Ter",,"Doral","FL","33122-1909","United States","Voluntary: Firm Initiated","Other","Colorado","V-307-2016","Class I"," Beef Trachea, 12 pack in plastic pouch","1500 units","Samples collected by the Colorado Department of Agriculture and tested in FDA laboratory tested positive for Salmonella","02/09/2016",," Lot #54, 8501450; UPC #8501450",1/12/2015,"01/12/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70575,"Terminated","Cargill Feed and Nutrition","1088 E Main St",,"Mount Joy","PA","17552-9332","United States","Voluntary: Firm Initiated","Telephone","PA","V-278-2016","Class I","Bulk SP06193 Covance Rabbit 16 Feed","15 tons","A single lot of custom-produced, bulk rabbit feed was delivered by truck to a single customer. Flaked corn was inadvertently mixed with the rabbit feed. The sudden change in starch in the rabbit feed caused the death of less than 0.3% of population","01/22/2016","04/27/2016"," Product Code: 207052",1/13/2015,"01/13/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70582,"Terminated","Purina Animal Nutrition LLC","1700 Industries Rd",,"Richmond","IN","47374-1375","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: Duke University   Durham, NC  27708  Contact:  Francis Sun  Tel  919-684-2341      Foreign: None","V-313-2016","Class I","Mod LabDiet 5058 w/150 ppm Fenbendazole  Plastic sealed bag in a box; 1 - 480 kg package","1 - 480 kg package","A manufacturing error resulting in Ivermectin used in place of Fenbendazole in custom research diet for mice resulted in mice mortality.","02/25/2016","05/18/2016"," Product Code:  57T7; Manufactured 01/26/2015",2/23/2015,"02/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70612,"Terminated","Land O Lakes Purina LLC","1080 County Road F W",,"Shoreview","MN","55126-2910","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","V-264-2016","Class I","DuMor Sheep Formula Net WT 50 lb (22.67kg)","120 bags.","Potential Copper Toxicity in the sheep feed lot.","01/22/2016","03/30/2016"," Item # 0047317; Formula No.: 55 ea; Lot Number 4NOV28LCK1. 50 lb bag' 40 paper bags/pallet.",2/20/2015,"02/20/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70646,"Ongoing","Eastern Colorado Recycling dba Triple A Brand Meat Co.","43465 US Highway 24",,"Burlington","CO","80807-9402","United States","Voluntary: Firm Initiated","Telephone","Nevada, Minnesota, and Louisiana.  No foreign/govt/VA/military consignees.","V-292-2016","Class I","Eastern Colorado Recycling CO. 43465 Highway 24, Burlington, CO 80807, 25 pound cardboard boxes, 5 packages per case, frozen","33 cases","Triple A Brand Meat Company is recalling Horse Chunk due to potential contamination with barbiturates. ","02/04/2016",," Lot number indicates the date of production: OCT 22 2014, OCT 27 2014, NOV 15 2014",2/27/2015,"02/27/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70734,"Terminated","Primal Pet Foods Inc.","2405 Mckinnon Ave",,"San Francisco","CA","94124","United States","Voluntary: Firm Initiated","Press Release","MO, PA, MN, FL, NY, OH, CA,  HI.","V-300-2016","Class I","Primal Formula for Cats; Turkey - 93% Turkey, 7% produce and supplements.  1 oz. nuggets - Keep Frozen:  Net wt. 3 lbs. (1.35 kg)  Feline Turkey Formula    Ingredients: Turkey, Turkey Necks, Turkey Hearts, Turkey Livers, Organic Collard Greens, Organic Squash, Organic Celery, Cranberries, Blueberries, Organic Pumpkin Seeds, Organic Sunflower Seeds, Minerals (Zinc Sulfate, Copper Carbonate, Selenium), Almonds, Organic Apple Cider Vinegar, Sardine Oil, Taurine, Organic Quinoa Sprout Powder, Dried Organic Kelp, Organic Cilantro, Organic Coconut Oil, Cod Liver Oil, Organic Ginger, Natural Vitamin E.    Primal Pet Foods Inc.","52 cases (8 x 3 lb. bags per case) (1248 lbs.","One lot of Feline Turkey Raw Frozen Formula 3 pound bag tested FDA was found to be low in Thiamine.","02/09/2016","02/16/2016"," Best By date 060815 B22  UPC 8 50334-00414 0.",3/13/2015,"03/13/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",70765,"Ongoing","Midmark  Corp dba Progeny Inc","675 Heathrow Dr",,"Lincolnshire","IL","60069-4206","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AL, AR, AZ, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI; and Internationally to Australia, Belgium, Canada, Czech Republic, France, Hungary, Lithuania, New Zealand, Poland, Russia, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Vietnam.","Z-0651-2016","Class II","Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging    The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evalu","832 systems","Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.","01/25/2016",," Model Number: 60-A0001;   ZA05002	,  ZA05003	,  ZA05004	,  ZA05005	,  ZA05006	,  ZA05007	,  ZA05008	,  ZA05009	,  ZA05010	,  ZA05011	,  ZA05012	,  ZA05013	,  ZA05014	,  ZA05015	,  ZA05016	,  ZA05017	,  ZA05018	,  ZA05019	,  ZA05020	,  ZA05021	,  ZA05022	,  ZA05023	,  ZB51001	,  ZB51002	,  ZB51003	,  ZB51004	,  ZB51007	,  ZB51008	,  ZB51009	,  ZB51010	,  ZB51011	,  ZB51012	,  ZB51013	,  ZB51014	,  ZB51015	,  ZB51016	,  ZB51017	,  ZB51018	,  ZB51019	,  ZB51021	,  ZB51023	,  ZB51024	,  ZB51025	,  ZB51026	,  ZB51027	,  ZB51028	,  ZB51029	,  ZB51030	,  ZB51031	,  ZB51032	,  ZB51034	,  ZB51035	,  ZB51036	,  ZB52001	,  ZB52002	,  ZB52003	,  ZB52004	,  ZB52005	,  ZB52006	,  ZB52007	,  ZB52008	,  ZB52009	,  ZB52010	,  ZB52011	,  ZB52012	,  ZB52013	,  ZB52014	,  ZB52015	,  ZB52016	,  ZB52017	,  ZB52018	,  ZB52019	,  ZB52020	,  ZB52021	,  ZB52022	,  ZB52023	,  ZB92002	,  ZB92003	,  ZB92004	,  ZB92005	,  ZB92006	,  ZB92007	,  ZB92008	,  ZB92009	,  ZB92011	,  ZC38001	,  ZC38002	,  ZC38003	,  ZC38004	,  ZC38005	,  ZC38007	,  ZC38008	,  ZC38009	,  ZC38010	,  ZC38011	,  ZC38013	,  ZC38015	,  ZC38016	,  ZC38017	,  ZC38018	,  ZC38019	,  ZC38020	,  ZC38021	,  ZC38022	,  ZC39001	,  ZC39002	,  ZE09001	,  ZE09002	,  ZE09003	,  ZE09004	,  ZE09006	,  ZE09007	,  ZE09008	,  ZE09009	,  ZE09010	,  ZE09011	,  ZE09012	,  ZE09014	,  ZE09015	,  ZE09016	,  ZE09017	,  ZE09018	,  ZE09019	,  ZE09020	,  ZE47001	,  ZE47002	,  ZE47003	,  ZE47004	,  ZE47005	,  ZE47006	,  ZE47007	,  ZE47008	,  ZE47009	,  ZE47010	,  ZE47011	,  ZE47012	,  ZE47013	,  ZE47014	,  ZE47015	,  ZE47016	,  ZE47017	,  ZE47018	,  ZE47019	,  ZE47020	,  ZE47021	,  ZE77001	,  ZE77002	,  ZE77003	,  ZE77004	,  ZE77005	,  ZE77006	,  ZE77007	,  ZE77008	,  ZE77009	,  ZE77010	,  ZF41001	,  ZF41002	,  ZF41003	,  ZF41004	,  ZF41005	,  ZF41006	,  ZF41007	,  ZF41008	,  ZF41009	,  ZF41010	,  ZF41011	,  ZF41012	,  ZF41013	,  ZF41014	,  ZF41015	,  ZF41016	,  ZF41017	,  ZF41018	,  ZF41019	,  ZF41020	,  ZF41021	,  ZF41022	,  ZF41023	,  ZF41024	,  ZF95001	,  ZF95002	,  ZF95003	,  ZF95004	,  ZF950",9/4/2014,"09/04/2014",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70877,"Terminated","5Cs Drying LLC","9960 Rosedale Rd",,"Hicksville","OH","43526-9248","United States","Voluntary: Firm Initiated","Letter","All product was shipped to IL.","V-280-2016","Class I","5C's DRYING LLC Cranberry Pomace, 1700 lbs plastic bag, Manufactured by 5C's Drying, LLC 09960 Rosedale Rd. Hicksville, Ohio 43526",,"The firm was notified by their customer that the product test positive for Salmonella.","01/22/2016","02/04/2016"," Lot #66",3/24/2015,"03/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",70996,"Terminated","TFH Publications, Inc./Nylabone Products","120 3rd Ave Ste 1",,"Neptune","NJ","07753-8214","United States","Voluntary: Firm Initiated","Telephone","Nationwide","V-279-2016","Class I","Nylabone Puppy Starter Kit Net Wt. 1.69 oz (48 g)Nylabone Products, PO Box 427 Neptune, NJ 07754-0427   UPC 0-1821481291-3","2,513 eaches ","Nylabone Puppy Starter Kit may be contaminated with Salmonella.","01/22/2016","03/30/2016"," Lot #21935",4/10/2015,"04/10/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71008,"Completed","Verathon, Inc.","20001 N Creek Pkwy",,"Bothell","WA","98011-8218","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-0811-2016","Class II","GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5).    GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor.    AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System.  The difference between systems is that the AVL has a digital platform and the GVL an analog platform.","total 9088 units ( 5786 units in the US and 3302 units International)","Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated  use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.","02/17/2016",," Affected GVL Reusable Blades Serial Numbers, by Part Number    GVL 3- 0574-0007: MD131859- MD151622;  GVL 4- 0574-0001: LG131994- LG151773;  GVL 5- 0574-0030: XL131577-  XL151524.    Affected AVL Reusable Blades Serial Numbers, by Part Numbers:    AVL 2- 0574-0118: AC131852- AC151510;  AVL 3- 0574-0115: AD131589- AD151506;   AVL 4- 0574-0116: AE131586- AE151558;  AVL 5- 0574-0117: AF131503- AF151500.    ",4/13/2015,"04/13/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71136,"Terminated","Kent Nutrtion Group Inc","2905 N Highway 61",,"Muscatine","IA","52761-5809","United States","Voluntary: Firm Initiated","Telephone","Nebraska and Oregon.","V-281-2016","Class I","Blue Seal Home Fresh Starter Amp Medicated, 0.0125% Amprolium (113.5 g/ton), Manufactured by Kent Nutrition Group, Inc. General Offices Muscatine, Iowa 52761","103 50 lb bags and 40 25 lb bags","A batch of poultry feed was assayed at 3.5% salt (above specification).","01/22/2016","02/05/2016"," Lot: 1015072",4/17/2015,"04/17/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71148,"Completed","CMP Industries, Llc","413 N Pearl St",,"Albany","NY","12207-1311","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX;  and, the country of Canada.","Z-1089-2016","Class II","IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748.     Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.","246 units","During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district.","03/09/2016",," Lot Number 103113 ",11/18/2013,"11/18/2013",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1149-2016","Class I","XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health ",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1140-2016","Class I","EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida, 33062 WWW.BEEEXTREMELYAMAZED.COM",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1139-2016","Class I","Asset extreme+PLUS Capsules,  500 mg, 30-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com  www.allnaturalbeelievers.com",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1144-2016","Class I","Oasis Capsules,  500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043","581 bottles","Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1138-2016","Class I","Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com ",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1150-2016","Class I","XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1147-2016","Class I","SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1145-2016","Class I","Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203","1,104 bottles","Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1142-2016","Class I","Jenesis Capsules, 350 mg,  60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104","79 bottles","Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1151-2016","Class I","ZI XIU TANG BEAUTY FACE & FIGURE Capsules,  250 mg,  60-count bottles",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1146-2016","Class I","SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceuticals Ltd. MUMBAI-400-030 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCUL, Selaqui, Dehradun, 248 197 ",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1143-2016","Class I","La' Trim Plus Capsules, 350 mg,  60-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando, FL 32801 (407) 930-4043",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1141-2016","Class I","Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition ",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71187,"Ongoing","Bee Extremely Amazed LLC","85205 Sportsmans Club Rd",,"Jewett","OH","43986-9794","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1148-2016","Class I","Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang Success, LLC Trexlertown, PA 18087, USA www.zixiutangsuccess.com ",,"Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.","07/06/2016","."," All lots",12/15/2015,"12/15/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71258,"Ongoing","oc Raw Dog","30052 Aventura Ste A",,"Rancho Santa Margarita","CA","92688-2042","United States","Voluntary: Firm Initiated","E-Mail","U.S. distribution to the following; MN, MO, CO, and PA.  No foreign distribution.","V-285-2016","Class I","OC Raw Dog  Turkey & Produce  Raw Frozen Formulation  6.5 lbs./2.95 Kg and bulk bags    Product is raw and frozen, and packaged in plastic bags.","2055 lbs (58 cases)","OC Raw Dog, LLC is initiating a recall of OC Raw Dog Turkey & Produce in 6.5 lb and bulk bags due to potential Salmonella contamination.","01/22/2016",," lot 1511  USE BY 100815",5/13/2015,"05/13/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71372,"Ongoing","Ethicon, Inc.","US Highway 22 West",,"Somerville","NJ","08876","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1996-2016","Class II","EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel.    Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.","228 units"," were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the valid expiration date (2016-12-28).","06/15/2016",," Product Code #EVT5024, Lot #U01F012A",4/11/2016,"04/11/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71401,"Ongoing","Centro Naturista","14211 Coit Rd","Ste H","Dallas","TX","75254-2862","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0877-2016","Class I","Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011","Unknown","Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.","05/26/2016",," All lots",6/3/2015,"06/03/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71401,"Ongoing","Centro Naturista","14211 Coit Rd","Ste H","Dallas","TX","75254-2862","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0878-2016","Class I","Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle,  Distributed by: SmartLipo365, Arlington, TX 76011","Unknown","Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.","05/26/2016",," All lots",6/3/2015,"06/03/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71520,"Terminated","Boulder Dog Food Company, L.L.C.","3026 Valmont Rd",,"Boulder","CO","80301-2115","United States","Voluntary: Firm Initiated","Telephone","Distributed to Colorado, Washington, Maryland, Virginia, Florida, California  No foreign or VA/govt/military consignees.","V-283-2016","Class I","Boulder Dog Food Company,Gourmet Dog Treats Turkey Sprinkles Food Enhancer, Net Wt. 3 oz (85G), 100% Turkey","24 bags","Boulder Dog Food Company is recalling Chicken Sprinkles with Best by Date of 05/04/2016 and Turkey Sprinkles with Best by Date of 5/30/2016 because of the potential for Salmonella contamination.","01/22/2016","07/12/2016"," Best By date of 05/18/16, 05/28/2016 and 05/30/2016, a Lot Number of 743, and a UPC Code of 899883001224",6/4/2015,"06/04/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71520,"Terminated","Boulder Dog Food Company, L.L.C.","3026 Valmont Rd",,"Boulder","CO","80301-2115","United States","Voluntary: Firm Initiated","Telephone","Distributed to Colorado, Washington, Maryland, Virginia, Florida, California  No foreign or VA/govt/military consignees.","V-282-2016","Class I","Boulder Dog Food Company, L.L.C. Chicken Sprinkles, 3 Ounces, Single packages, with each package 8 x 5.","10","Boulder Dog Food Company is recalling Chicken Sprinkles with Best by Date of 05/04/2016 because it tested positive for Salmonella.","01/22/2016","07/12/2016"," Lot # 998, Best By 05/04/16",6/4/2015,"06/04/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71547,"Completed","Syfrett Feed Company, Inc.","3079 NW 8th St",,"Okeechobee","FL","34972-7621","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US- Florida","V-414-2016","Class I","Syfrett Horse Pellets, also known as Syfrett All Purpose Pellets, a non-medicated pellet feed. Item # 4-1200 (This feed was not bagged but was sent to a customer tank where individuals can drive up and fill their bulk bins or bags with the feed.)","2,749 pounds","Customer complaints that the feed was causing horses to fall ill or die","06/10/2016",," Item # 4-1200 Batch # 31749",4/17/2014,"04/17/2014",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71607,"Ongoing","Carnivore Meat Company, LLC","2878 Ontario Rd",,"Green Bay","WI","54311-6877","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: RI, MA, VT, PA, OH, GA, FL, TX, IL, CO, CA NM.","V-294-2016","Class I","Vital Essentials Frozen Beef Tripe Patties, 6 lb package (heat sealed bag), 4 per case, product code #3809, UPC 33211 00809.  Vital Essentials Frozen Tripe Treat Nibblets, 3 lb package (heat sealed bag), 6 per case, product code #3904, UPC 33211 00904.","4848 lbs.","Carnivore Meat Company LLC is recalling Frozen Beef Tripe Patties (Lot Number 10930) and Frozen Beef Tripe Nibblets (Lot Number 10719) because of the presence of Listeria monocytogenes in the product.  ","02/04/2016",," Tripe Patties - lot# 10930, product code# 3809, Best by date 20160210.  Tripe Nibblets lot# 10719, Product code# 3904, Best by date 12022015.  ",6/19/2015,"06/19/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71647,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of : Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Panama, PERU, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom and Viet Nam.","Z-0810-2016","Class II","Actuator for angiographic x-ray monitor ceiling suspension system.  Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001  Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010 Allura Xper FD10; 722011 Allura Xper FD10/10; 722012 Allura Xper FD20; 722013 Allura XPER FD20 BIPLANE; 722015 Allura Xper FD20 OR Table; 722020 Allura Xper FD20 Biplane OR Table; 722022 Allura Xper FD10 OR Table; 722023 Allura Xper FD20 OR Table; 722025 Allura Xper FD20 Biplane OR Table; 722026 Allura Xper FD10; 722027 Allura Xper FD10/10; 722028 Allura Xper FD20; 722029 Allura Xper FD20/10; 722035 Allura Xper FD20 OR Table; 722038 Allura Xper FD20/20; 722039 Allura Xper FD20/20 OR Table; 722058 Allura Xper FD20/15; 722123 Field extensions Xper cardio R7.6; 722124 Field extensions Xper vascular R7.6; 722133 Field ext. Xper cardio systems R7.6; 722134 Field ext. Xper vascular systems R7.6; 72249 INTEGRIS BV5000; 722043 INTEGRIS Allura 15-12 (mono); 722121 Field extensions INTEGRIS cardio systems ","3158 devices","The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.","02/16/2016",," Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122",7/6/2015,"07/06/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71648,"Ongoing","Stella & Chewy's, LLC","2842 S 5th Ct",,"Milwaukee","WI","53207-1472","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: AZ, CA, CO, FL GA, IL, KS, MD, MN, NY, NC, PA, RI, TX, VI, VA, WI,WA.","V-477-2016","Class I","Stella & Chewy's Freeze-Dried Tummy Ticklin' Turkey Dinner for Cats, 12 oz, UPC 186011000663.","Total for all product : 5045 cases and 12 pieces","Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #111-15.  As a precautionary measure the company is recalling  all products from lot # 111-15 including products that could have come into contact with the affected lot.  ","08/02/2016",," Lot 114-¿15, Use By 5/4/2016.  Lot 115-15, Use By 5/4/2016.  ",7/3/2015,"07/03/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71648,"Ongoing","Stella & Chewy's, LLC","2842 S 5th Ct",,"Milwaukee","WI","53207-1472","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: AZ, CA, CO, FL GA, IL, KS, MD, MN, NY, NC, PA, RI, TX, VI, VA, WI,WA.","V-474-2016","Class I","Stella & Chewy's Carnivore Crunch Turkey Recipe, 3.25 oz, UPC 186011001103.","Total for all product : 5045 cases and 12 pieces","Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #111-15.  As a precautionary measure the company is recalling all products from lot # 111-15 including products that could have come into contact with the affected lot.  ","08/02/2016",," Lot 111-¿15, Use By 5/3/2016 and 5/4/2016.",7/3/2015,"07/03/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71648,"Ongoing","Stella & Chewy's, LLC","2842 S 5th Ct",,"Milwaukee","WI","53207-1472","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: AZ, CA, CO, FL GA, IL, KS, MD, MN, NY, NC, PA, RI, TX, VI, VA, WI,WA.","V-476-2016","Class I","Stella & Chewy's Freeze-Dried Chick, Chick, Chicken Dinner for Cats, 12 oz, UPC 186011000434.","Total for all product : 5045 cases and 12 pieces","Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #11115. As a precautionary measure the company is recalling all products from lot # 111-15 including products that could have come into contact with the affected lot.  ","08/02/2016",," Lot 111-¿15, Use By 4/29/2016 and 5/3/2016.  Lot 104-15, Use By 4/23/2016.  Lot 109-15, Use By 4/29/2016.",7/3/2015,"07/03/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71648,"Ongoing","Stella & Chewy's, LLC","2842 S 5th Ct",,"Milwaukee","WI","53207-1472","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: AZ, CA, CO, FL GA, IL, KS, MD, MN, NY, NC, PA, RI, TX, VI, VA, WI,WA.","V-473-2016","Class I","Stella & Chewy's Freeze-¿Dried Chewy's Chicken Dinner for Dogs, 15 oz., UPC 186011000045.     Frozen Chewy's Chicken Dinner Morsels for Dogs, 4 lb, UPC 186011001387.    Frozen Chewy's Chicken Dinner Patties for Dogs, 6 lb, UPC 186011000120.    Frozen Chewy's Chicken Dinner Patties for Dogs, 3 lb, UPC 186011000038.    Carnivore Crunch Chicken Recipe, 3.25 oz, UPC 186011001080.","Total for all product : 5045 cases and 12 pieces","Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #111-15.  As a precautionary measure the company is recalling all products from lot # 111-15 including products that could have come into contact with the affected lot.  ","08/02/2016",," Lot 111-¿15, Use By 4/21/2016, 4/23/2016 and 4/26/2016.  Lot 110-15, Use by 5/3/2016.  Lot 114-15, Use By 4/26/2016.",7/3/2015,"07/03/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71648,"Ongoing","Stella & Chewy's, LLC","2842 S 5th Ct",,"Milwaukee","WI","53207-1472","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: AZ, CA, CO, FL GA, IL, KS, MD, MN, NY, NC, PA, RI, TX, VI, VA, WI,WA.","V-480-2016","Class I","Stella & Chewy's  Freeze-Dried Tantalizing Turkey Meal Mixers, 18 oz, UPC 186011000229.  Freeze-Dried Tantalizing Turkey Meal Mixers, 9 oz, UPC 186011000205. ","Total for all product : 5045 cases and 12 pieces","Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #111-15.  As a precautionary measure the company is recalling all products from lot # 111-15 including products that could have come into contact with the affected lot.  ","08/02/2016",," Lot 105-¿15, Use By 5/3/2016.  Lot 113-¿15, Use By 5/3/2016.",7/3/2015,"07/03/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71648,"Ongoing","Stella & Chewy's, LLC","2842 S 5th Ct",,"Milwaukee","WI","53207-1472","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: AZ, CA, CO, FL GA, IL, KS, MD, MN, NY, NC, PA, RI, TX, VI, VA, WI,WA.","V-478-2016","Class I","Stella & Chewy's Freeze-Dried Salmon & Chicken Dinner for Cats, 12 oz, UPC 186011000403.","Total for all product: 5045 cases and 12 pieces","Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #111-15.  As a precautionary measure the company is recalling all products from lot # 111-15 including products that could have come into contact with the affected lot. ","08/02/2016",,"  Lot 107-¿15, Use By 4/23/2016. ",7/3/2015,"07/03/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71648,"Ongoing","Stella & Chewy's, LLC","2842 S 5th Ct",,"Milwaukee","WI","53207-1472","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: AZ, CA, CO, FL GA, IL, KS, MD, MN, NY, NC, PA, RI, TX, VI, VA, WI,WA.","V-479-2016","Class I","Stella & Chewy's Frozen Surf'N Turf Dinner Patties for Dogs, 6 lb, UPC 186011000533.","Total for all product : 5045 cases and 12 pieces","Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #111-15.  As a precautionary measure the company is recalling all products from lot # 111-15 including products that could have come into contact with the affected lot.  ","08/02/2016",,"  Lot 111-¿15, Use By 4/21/2016.",7/3/2015,"07/03/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71648,"Ongoing","Stella & Chewy's, LLC","2842 S 5th Ct",,"Milwaukee","WI","53207-1472","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: AZ, CA, CO, FL GA, IL, KS, MD, MN, NY, NC, PA, RI, TX, VI, VA, WI,WA.","V-475-2016","Class I","Stella & Chewy's Frozen Duck Duck Goose Dinner Morsels for Dogs, 4 lb, UPC 186011001394.","Total for all product: 5045 cases and 12 pieces","Stella & Chewy's is voluntarily recalling some of its products due to concerns of a possible presence of Listeria monocytogenes. The recall was prompted by a positive test confirming Listeria monocytogenes in Chewy's Chicken Freeze-Dried Dinner Patties for Dogs, 15 ounce, Lot #111-15.  As a precautionary measure the company is recalling all products from lot # 111-15 including products that could have come into contact with the affected lot.  ","08/02/2016",,"  Lot 111-¿15, Use By 4/21/2016.  ",7/3/2015,"07/03/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71667,"Ongoing","Stryker Medical Division of Stryker Corporation","3800 E Centre Ave",,"Portage","MI","49002-5826","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : AL, AZ, FL, GA, HI, IA, IL, KS, LA, MI, MN, MO, NE, NJ, OH, PA, SC, TN and TX., and Internationally to the countries of : Canada and UK.","Z-1555-2016","Class II","Spirit One A-C Powered Hospital Bed","143 total","Customer complaints associated with faulty brake system","04/22/2016",," MDL#: E341062; Serial Numbers: B5A00-029643  029644  029537  029538  029539  029412  029413  029092  029093  029430  029431  029432  029433  029411  029479  029480  029463  029658  029461  029462  027773  029536  029420  029421  029423  029424  029094  029095  029096  029097  029098  029458  029459  027772  028853  028854  029563  029564  029639  029640  028835  030097  030099  028845  028846  028847  028848  029416  028003  029177  029418  029427  029428  029558  029559  029560  028834  029419  029429  029416  028840  028842  028843  028844  028836  028837  028838  028839  028849  028850  028851  028852  028841  028957  028958  028959  029460  029466  029467  029468  029415  029648  029460  029466  029645  029649  029650  029652  029654  029655  029657  029659  030096  030098  029467  029468  029656  029417  030154  030157  030158  030159  030161  030223  030225  030226  030354  030100  030152  030439; B5F00-029179  028654  028655  028656  028659  028660  028661  028663  028664  028793  028657  029540  029541  029646  029642  028788  029176  029175  029414  029178  029561  028216  029464  030151; B5C00-029182  029183  029184  029185  029186  029187  029188  029189                                    ",7/2/2015,"07/02/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71733,"Ongoing","Life and More LLC","5771 NW 112th Ave Apt 112",,"Doral","FL","33178-4161","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Colombia, South America","D-0664-2016","Class I","Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida  ","783 bottles","Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.","02/12/2016",," Lot # 000815004400; Exp 12/17",7/13/2015,"07/13/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71736,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Press Release","CT, MA, NH, NY, WI, OH, TX, AZ, MO, MN, MI, CA, CO, OR, NM, IN, FL, SC, PA, WA, RI, IL, MD","V-304-2016","Class I","Bravo Blend Chicken diet for dogs & cats, Patties, Item Number: 21¿508, 5 lb. (80 oz.) bag, UPC: 829546215088","124 cases","Product did not test positive for Salmonella, but is being voluntarily recalled out of an abundance of caution because it was manufactured in the same manufacturing facility on the same day as the product that tested positive for Salmonella spp. Poly A. ","02/09/2016",," 12-05-16",7/23/2015,"07/23/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71736,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Press Release","CT, MA, NH, NY, WI, OH, TX, AZ, MO, MN, MI, CA, CO, OR, NM, IN, FL, SC, PA, WA, RI, IL, MD","V-301-2016","Class I","Bravo Blends All Natural Chicken Blend diet for dogs & cats, Item #: 21¿-102, 2 lb (32 oz.) chub; UPC: 829546211028","105 cases","Product tested positive for Salmonella spp. Poly A","02/09/2016",," 12-05-16",7/23/2015,"07/23/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71736,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Press Release","CT, MA, NH, NY, WI, OH, TX, AZ, MO, MN, MI, CA, CO, OR, NM, IN, FL, SC, PA, WA, RI, IL, MD","V-302-2016","Class I","Bravo Balance Chicken Dinner for dogs, Patties, Item #: 21¿401; 3 lb (48 oz.) bag UPC: 829546214012","42 cases","Product did not test positive for Salmonella, but is being voluntarily recalled out of an abundance of caution because it was manufactured in the same manufacturing facility on the same day as the product that tested positive for Salmonella spp. Poly A. ","02/09/2016",," 12-05-16",7/23/2015,"07/23/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71736,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Press Release","CT, MA, NH, NY, WI, OH, TX, AZ, MO, MN, MI, CA, CO, OR, NM, IN, FL, SC, PA, WA, RI, IL, MD","V-303-2016","Class I","Bravo Balance Chicken Dinner for dogs, Chub, Item Code: 21¿402, 2 lb., (32 oz.) UPC: 829546214029","48 cases","Product did not test positive for Salmonella, but is being voluntarily recalled out of an abundance of caution because it was manufactured in the same manufacturing facility on the same day as the product that tested positive for Salmonella spp. Poly A. ","02/09/2016",," 12-05-16",7/23/2015,"07/23/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71764,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and  TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland.","Z-0766-2016","Class II","Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.","399 distributed, 262 are subject to this event","If arm is not fastened securely it could fall down.    ","02/05/2016",," All TraumaDiagnost products that were delivered before the week of July 2, 2007. ",7/22/2015,"07/22/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71789,"Ongoing","Nature's Variety","Suite 200","55 West Port Plaza Drive","Saint Louis","MO","63146","United States","Voluntary: Firm Initiated","Press Release","Nationwide distribution.  Product was also distributed to Canada.  No military or government distribution was reported.","V-267-2016","Class I","Nature's Variety Instinct Raw Chicken Formula Bites Nutrition for Dogs, packaged  in 4 lb. plastic bags Net Wt. 4.0 LB (1.8 kg), UPC 7 6994961143 1, 6 (4 lb. bags) per case (UPC 7 69949 71143 8)  and 7 lb. plastic bags Net Wt. 7.0 LB (3.2 kg), UPC 7 69949 61144 8, 4 (7 lb. bags) per case (UPC 7 69949 71144 5) .  The responsible firm name on the label is Nature's Variety, Saint Louis, MO 63146.","3,978 - 4 lb. bags and 2,040 - 7 lb. bags","Product tested positive for Salmonella","01/22/2016",," Best By 04/27/16",7/24/2015,"07/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71789,"Ongoing","Nature's Variety","Suite 200","55 West Port Plaza Drive","Saint Louis","MO","63146","United States","Voluntary: Firm Initiated","Press Release","Nationwide distribution.  Product was also distributed to Canada.  No military or government distribution was reported.","V-268-2016","Class I","Nature's Variety Instinct Raw Chicken Formula Patties Nutrition for Dogs, packaged  in 6 lb. plastic bags Net Wt. 6.0 LB (2.7 kg), UPC 7 6994961148 6, 6 (6 lb. bags) per case (UPC 7 69949 71148 3).  The responsible firm name on the label is Nature's Variety, Saint Louis, MO 63146.","3,018 - 6 lb. bags","Product tested positive for Salmonella","01/22/2016",," Best By 04/27/16",7/24/2015,"07/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71810,"Completed","Tribe Mediterranean Foods Inc.","110 Prince Henry Drive",,"Taunton","MA","02780-7385","United States","Voluntary: Firm Initiated","Telephone","GA, IL, MA, PA","F-0085-2017","Class II","Trader Joes Freshly Made Original Hummus Dip (Tahini Free),  packaged in 16 oz. clear plastic cups  SKU: 00299091","2388 cases (12/case)","Product may contain sesame (allergen)","10/12/2016",," Best used by date of Aug. 6, 2015",7/23/2015,"07/23/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71871,"Terminated","Spring Creek Milling Co-op Inc.","74219 Highway 1054",,"Kentwood","LA","70444-4953","United States","Voluntary: Firm Initiated","Telephone","LA & MS","V-274-2016","Class I","Custom blended goat feed, packaged in bulk","1,000 lbs","Various feeds including horse feed were found to be contaminated with monensin","01/22/2016","01/28/2016"," None",7/24/2015,"07/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71871,"Terminated","Spring Creek Milling Co-op Inc.","74219 Highway 1054",,"Kentwood","LA","70444-4953","United States","Voluntary: Firm Initiated","Telephone","LA & MS","V-273-2016","Class I","Custom blended goat feed, medicated, packaged in bulk","8,000 lbs","Various feeds including horse feed were found to be contaminated with monensin","01/22/2016","01/28/2016"," None",7/24/2015,"07/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71871,"Terminated","Spring Creek Milling Co-op Inc.","74219 Highway 1054",,"Kentwood","LA","70444-4953","United States","Voluntary: Firm Initiated","Telephone","LA & MS","V-270-2016","Class I","Custom blended dairy feed, packaged in bulk","254,984 lbs","Various feeds including horse feed were found to be contaminated with monensin","01/22/2016","01/28/2016"," None",7/24/2015,"07/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71871,"Terminated","Spring Creek Milling Co-op Inc.","74219 Highway 1054",,"Kentwood","LA","70444-4953","United States","Voluntary: Firm Initiated","Telephone","LA & MS","V-269-2016","Class I","Custom blended horse feed, packaged in 50 lb bags and in bulk","8,000 lbs","Various feeds including horse feed were found to be contaminated with monensin","01/22/2016","01/28/2016"," None",7/24/2015,"07/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71871,"Terminated","Spring Creek Milling Co-op Inc.","74219 Highway 1054",,"Kentwood","LA","70444-4953","United States","Voluntary: Firm Initiated","Telephone","LA & MS","V-275-2016","Class I","Corn, packaged in bulk","1,000 lbs","Various feeds including horse feed were found to be contaminated with monensin","01/22/2016","01/28/2016"," None",7/24/2015,"07/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71871,"Terminated","Spring Creek Milling Co-op Inc.","74219 Highway 1054",,"Kentwood","LA","70444-4953","United States","Voluntary: Firm Initiated","Telephone","LA & MS","V-272-2016","Class I","Custom blended beef cattle feed, medicated, packaged in bulk","46,066 lbs","Various feeds including horse feed were found to be contaminated with monensin","01/22/2016","01/28/2016"," None",7/24/2015,"07/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71871,"Terminated","Spring Creek Milling Co-op Inc.","74219 Highway 1054",,"Kentwood","LA","70444-4953","United States","Voluntary: Firm Initiated","Telephone","LA & MS","V-271-2016","Class I","Custom blended beef cattle feed, packaged in bulk","31,999 lbs","Various feeds including horse feed were found to be contaminated with monensin","01/22/2016","01/28/2016"," None",7/24/2015,"07/24/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71874,"Ongoing","Whole Foods Market","1821 30th St",,"Boulder","CO","80301-1074","United States","Voluntary: Firm Initiated","Press Release","Nationwide to CO, UT, ID, NM, and KS. No foreign/VA/gov/military.","F-2040-2016","Class I","Whole Foods Market, CC & FP HSH Coconut Curry Cauliflower Salad, SOLD BY THE POUND, CLEAR PLASTIC CONTAINERS.","250 pounds","Whole Foods Market is recalling CC & FP HSH Coconut Curry Cauliflower Salad because an undeclared allergen, almonds, was mistakenly included in the salad kit.","09/16/2016",," PLU 27436000000  PLU 27436100000  ALL AFFECTED PRODUCT HAD A USE BY DATE OF 8/1/15  ",7/30/2015,"07/30/2015",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71875,"Terminated","Natural Dog Company, Inc.","7350 Greendale Rd",,"Windsor","CO","80550-8004","United States","Voluntary: Firm Initiated","Press Release","Nationwide to CO, FL, IL, MO, MN, MT, NC, OH, UT and WA.  No foreign/ military/ VA/ govt.","V-284-2016","Class I","The Natural Dog Company, 12 Tremenda Sticks, 12oz, Resealable plastic bags","560 bags","The Natural Dog Company is recalling 12 Tremenda Sticks due to potential Salmonella.","01/22/2016","06/14/2016"," All products not containing a lot number.",7/20/2015,"07/20/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71879,"Ongoing","Samuel Adams Brewery Co","1625 Central Pkwy",,"Cincinnati","OH","45214-2423","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","No international firms.  Wholesalers in the following states:  SC, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, NE, LA, AR, TX, CO, NM,","F-0832-2017","Class II","Apple Orchard Crisp Apple Hard Cider  Three packages sizes:  ¿ Loose case = 24  12 oz bottles  ¿ 12 pack = 12  12 oz bottles, shipped as 2  12 packs per case  ¿ 4  6 pack = 6  12 oz bottles per pack, shipped as 4  6 packs per case","17492 packages","Due to concerns of re-fermentation, bottles may burst under increased pressure.","12/21/2016",," June 2016 1665C & June 2016  1805C",7/22/2015,"07/22/2015",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71908,"Terminated","Red Diamond, Inc.","400 Park Ave",,"Moody","AL","35004-3330","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Alabama, Arkansas, Illinois, Minnesota, Ohio, and Texas","F-0619-2016","Class II","RED DIAMOND, European Roast, COFFEE CONCENTRATE, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL;  Item # 111590 ","22 units","Elevated pH levels in an acidified product","02/18/2016","02/24/2016"," ALL CODES",8/5/2015,"08/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71908,"Terminated","Red Diamond, Inc.","400 Park Ave",,"Moody","AL","35004-3330","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Alabama, Arkansas, Illinois, Minnesota, Ohio, and Texas","F-0620-2016","Class II","RED DIAMOND, COLOMBIAN, NATURALLY DECAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL;  Item # 111591 ","136 units","Elevated pH levels in an acidified product","02/18/2016","02/24/2016"," ALL CODES",8/5/2015,"08/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71908,"Terminated","Red Diamond, Inc.","400 Park Ave",,"Moody","AL","35004-3330","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Alabama, Arkansas, Illinois, Minnesota, Ohio, and Texas","F-0618-2016","Class II","RED DIAMOND, COLOMBIAN, NATURALLY CAFFEINATED, Coffee Concentrate, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL;  Item # 111589","302 units","Elevated pH levels in an acidified product","02/18/2016","02/24/2016"," ALL CODES",8/5/2015,"08/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71924,"Ongoing","Brainlab AG","Kapellenstrasse 12",".","Feldkirchen",,,"Germany","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.","Z-0598-2016","Class I","Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments.    The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. ","1,430 units","Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.","01/19/2016",," 1) Model	22035	,	VVC NAVIGATION SOFTWARE CRANIAL 5.0	,	Serial Numbers: 22035-103911-004	,  22035-103953-001	,  22035-103977-001	,  22035-103982-002	,  22035-103987-001	,  22035-103988-001	,  22035-104566-001	;   2) Model	22040	,	VV NAVIGATION SOFTWARE CRANIAL 4.0	,	Serial Numbers:   22040/18820	,  22040/21370	,  22040/26909	,  22040/36997	,  22040-103675-006	,  22040-103687-009	,  22040-103710-001	,  22040-103942-008	,  22040-103974-011	,  22040-104067-001	,  22040-104072-001	,  22040-104114-001	,  22040-104148-001	,  22040-104151-001	,  22040-104505-001	,  22040-104542-001	,  22040-104545-001	,  22040-104614-005	,  22040-123772-001	;   3) Model	22040-02	,	VV NAV SW CRANIAL 7.8.1 (ANY PLATFORM)	,	Serial Number: 	000000002600509001	;   4) Model	22040-11	,	UPDATE VV NAV SW CRANIAL 7.9.1 FROM 7.9	,	Serial Numbers:   000000007665811001	,  000000007801111004	,  000000007801111005	,  000000007801111006	,  000000007801111007	,  000000007801111008	,  000000007801111009	,  000000007808711004	,  000000007808711007	,  000000007808711008	,  000000007837611010	,  000000007847411007	,  000000007865211004	,  000000007865211005	,  000000007942211004	,  000000007942211008	,  000000007942211010	,  000000007950411001	,  000000007950411004	,  000000007950411007	,  000000007950411010	,  000000007956611005	,  000000007956611010	,  000000007956611017	,  000000007965011001	,  000000007965011006	,  000000007965011007	,  000000007980111001	,  000000007980111002	,  000000007980111003	,  000000007980111004	,  000000007980111005	,  000000007980111006	,  000000007980111007	,  000000008000111003	,  000000008000111006	,  000000008000111007	,  000000008012411001	,  000000008012411003	,  000000008012411008	,  000000008026011002	,  000000008026011003	,  000000008036811002	,  000000008036811006	,  000000008036811007	,  000000008036811008	,  000000008036911002	,  000000008036911004	,  000000008036911005	,  000000008046111002	,  000000008046111005	,  000000008073511003	,  000000008073511007	,  000000008086811001	,  000000008106711001	,  000000008",4/22/2013,"04/22/2013",1/27/2016,"01/27/2016","	,  000000006044113001	,  000000006044213001	,  000000006395013001	,  000000006395113001	,  000000006501913001	,  000000006643113001	,  000000006738213001	,  000000006878013001	,  000000007095113001	,  000000007095213001	,  000000007223613001	,  000000007248815001	,  000000007377813001	,  000000007487813001	,  000000007641214001	,  000000007641314001	,  000000007819514001	,  000000007844914001	,  000000007931414001	,  000000008021914001	,  000000008260014001	,  000000008296214001	,  000000008319314001	,  000000008454614001	,  000000008500114001	,  000000008795614001	,  000000008860614001	,  000000008860714001	,  000000008878214001	,  000000009480014001	;   55) Model	71096	,	UPG TO CRAN 2.x CURVE FROM CRAN UNL 1.0	,	Serial Numbers: 	000000000239112001	,   000000000239212001	,  000000000239312001	,  000000000330112001	,  000000000789212001	,  000000000789312001	,  000000000998012001	,  000000001081912001	,  000000001186712001	,  000000001231712001	,  000000001352512001	,  000000001620512001	,  000000001706812001	,  000000001749112001	,  000000001895012001	,  000000002056312001	,  000000002098912001	,  000000002235012001	,  000000002235112001	,  000000002360412001	,  000000002696813001	,  000000002777313001	,  000000002777413001	,  000000002878213001	,  000000003057013001	,  000000003261813001	,  000000003314513001	,  000000003450613001	,  000000003450713001	,  000000003450813001	,  000000003602013001	,  000000003609213001	,  000000003609313001	,  000000003609413001	,  000000003666113001	,  000000009232212001	,  000000009389912001	,  000000009530112001	,  000000009764012001	;   54) Model	71096A	,	UPG TO CRAN 2.x CURVE FROM CRAN UNL 1.0	,	Serial Numbers: 	000000001634614001	, 000000002290314001	,  000000003924813001	,  000000003960613001	,  000000003960713001	,  000000004303913001	,  000000004533313001	,  000000005397113001	,  000000005503813001	,  000000005535413001	,  000000006656213001	,  000000006894413001	,  000000006894513001	,  000000006941613001	,  000000007196713001	,  000000007365713001	,  00000000759591",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",71927,"Terminated","Northwest Farm Food Cooperative","1370 S Anacortes St",,"Burlington","WA","98233-3038","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in OR and WA","V-295-2016","Class I",".","total about 4200 lbs. (700 lbs. of 50 blocks and 3000 lbs. of 10 lbs. chubs)"," is recalled due to contamination with Salmonella.  ","02/04/2016","03/01/2016"," Jul12015B.    The code is interpreted as manufacture date (07/01/15) and shift (B)",8/10/2015,"08/10/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71942,"Terminated","Heartland Products Inc.","5016 Park Avenue",,"Des Moines","IA","50321","United States","Voluntary: Firm Initiated","Letter","Product was distributed in IA and IL.  No foreign, military, or federal goverment distribution.","F-1076-2016","Class III","ILL RIVER #14 Bread Base, 050102, packaged in 28-lb. poly-lined cardboard boxes, Distributed by T.S. Products, Inc.","4,366 - 28 lb. boxes","Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.","04/13/2016","04/14/2016"," F1001-F1010, F1101-F1105, G1301-G1315, G1501-G1503, G2101-G2110, G2211-G2220, and G2401-G2409",8/27/2015,"08/27/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71942,"Terminated","Heartland Products Inc.","5016 Park Avenue",,"Des Moines","IA","50321","United States","Voluntary: Firm Initiated","Letter","Product was distributed in IA and IL.  No foreign, military, or federal goverment distribution.","F-1077-2016","Class III","Heartland Products, Inc. Roma's Italian Base, 120116, packaged in 50-lb. poly-lined cardboard boxes, Manufactured by Heartland Products, Inc., Des Moines, IA.","36 - 50 lb. boxes","Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.","04/13/2016","04/14/2016"," G0602",8/27/2015,"08/27/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71942,"Terminated","Heartland Products Inc.","5016 Park Avenue",,"Des Moines","IA","50321","United States","Voluntary: Firm Initiated","Letter","Product was distributed in IA and IL.  No foreign, military, or federal goverment distribution.","F-1080-2016","Class III","Waveland Pancake and Waffle Mix, 030608, packaged in 25-lb. poly-lined cardboard boxes, Manufactured Heartland Products, Inc. Des Moines, IA 50321.","48 - 25 lb. boxes","Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.","04/13/2016","04/14/2016"," No lot number given; date of manufacture was 6/4/2015",8/27/2015,"08/27/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71942,"Terminated","Heartland Products Inc.","5016 Park Avenue",,"Des Moines","IA","50321","United States","Voluntary: Firm Initiated","Letter","Product was distributed in IA and IL.  No foreign, military, or federal goverment distribution.","F-1075-2016","Class III","Dough base/premix packaged in 30-lb. poly-lined cardboard boxes, manufactured under the following labels:    (1) Heartland Products, Inc. Fancy Breads Italian Base, 090108.   Manufactured by Heartland Products, Inc., Des Moines, IA; and    (2) Northern Lights Pizza, 090108, Manufactured by Heartland Products, Inc., Des Moines, IA.","(1) 24 - 30 lb. boxes and (2) 24- 30 lb. boxes","Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.","04/13/2016","04/14/2016"," (1) G0601 and (2) G0301",8/27/2015,"08/27/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71942,"Terminated","Heartland Products Inc.","5016 Park Avenue",,"Des Moines","IA","50321","United States","Voluntary: Firm Initiated","Letter","Product was distributed in IA and IL.  No foreign, military, or federal goverment distribution.","F-1078-2016","Class III","ILL RIVER Sweet Dough Base, 050107, packaged in 50-lb. poly-lined cardboard boxes, Distributed by T.S. Products, Inc.","100- 50 lb. boxes","Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.","04/13/2016","04/14/2016"," G1501-G1503",8/27/2015,"08/27/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71942,"Terminated","Heartland Products Inc.","5016 Park Avenue",,"Des Moines","IA","50321","United States","Voluntary: Firm Initiated","Letter","Product was distributed in IA and IL.  No foreign, military, or federal goverment distribution.","F-1079-2016","Class III","Turano Knead Dough Base, 70101, packaged in 42-lb. poly-lined cardboard boxes, Manufactured for Turano Baking Co., Bolingbrook, IL.","480 - 42 lb. boxes","Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.","04/13/2016","04/14/2016"," G3101, G3102, H0501-H0508",8/27/2015,"08/27/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0479-2016","Class II","Cleveland Pickle Original Garlic Dill 16 oz (454 g) Ingredients: Cucumbers, Water***Manufactured For: CLEVELAND PICKLE 850 EUCLID AVE. CLEVELAND OH 44114 216-575-1111 UPC 8 67051 00001 0 ","146 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot # 48875",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0476-2016","Class II","BINO'S ITALIAN HOT PEPPERS Ingredients: Hungarian hot peppers w/seeds, onions, vinegar, garlic, sugar, Bell peppers, tomato sauce, tomato puree, salt and olive oil. NET WT 16 oz UPC 8 67752 00013 5  NET WT 32 oz UPC 8 67752 00011 1 ","108 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," 16 oz Lot # 263245 32 oz Lot # 253255",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0494-2016","Class II","PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Mom's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot and Sweet Peppers, Garlic, Canola Oil, Vinegar, Salt, Oregano. pattspeppers.com UPC 7 48252 07478 2","254 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot #'s: 39855, 393255 & 394105.",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0493-2016","Class II","Kiem's Garden Harvest sweet & tangy citrus salsa 1 PT (14 oz 397g) Ingredients:tomatoes, onions***lemon juice concentrate, lime juice concentrate***Manufactured by: Keim's Garden Harvest (937) 515-4518 2232 Honeysuckle Lane Wellston, OH 45692 UPC 6 09722 32346 8","80 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," All Lots",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0492-2016","Class II","Kiem's Garden Harvest corn relish 1 PT (14 oz 397g) Ingredients: corn, peppers, celery***Manufactured by: Keim's Garden Harvest (937) 515-4518 Honeysuckle Lane Wellston, OH 45692 Mild UPC 6 09722 32335 2 Hot UPC 6 09722 32349 9","40 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot #14715, Lot # 13715",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0496-2016","Class II","RJ's DIAVOLO SAUCE WITH PEPPERS 25 oz INGREDIENTS: ground unpeeled vine-ripened tomatoes, tomato puree, tomato past, Hungarian hot wax peppers, Cubanelle peppers, fresh sweet onions, fresh garlic,***Manufactured for: RJ's Pepper Pantry Warren, OH 44484 Phone 330-765-2863 Mild UPC 8 53827 00403 0, Medium Hot UPC 8 5327 00404 7, Hot UPC 8 53827 00405 4","12 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," All Lots.",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0488-2016","Class II","Keim's Garden Harvest pickled red beet eggs Ingredients: eggs, water, vinegar, sugar, salt***beet juice, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83455 7, 32 oz 6 09788 83457 4 ","86 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot# 2465",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0490-2016","Class II","Keim's Garden Harvest pickled zesty mustard eggs Ingredients: eggs, water, vinegar, sugar, salt***yellow #5, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83464 9, 32 oz 6 09788 83459 5","44 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," All Codes",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0483-2016","Class II","HERBERT'S chow-chow Mild New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6 ","1","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot #'s 75225, 76815",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0471-2016","Class II","A BIT OF A BITE SALSA MELISSA MEDIUM NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS, FRESH HABANERO PEPPERS. A Bit of  Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95416 7","45 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",,"  Lot# 253255",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0477-2016","Class II","BINO'S ITALIAN SWEET PEPPERS Ingredients: Bell peppers, onions, vinegar, garlic, sugar, tomato sauce, tomato puree, salt and olive oil. NET WT  16 oz UPC 8 67752 00012 8 NET WT 32 oz UPC 8 67752 00010 4","115 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," 16 oz Lot # 253255, 32 oz Lot # 253255",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0498-2016","Class II","ROASTED MEDITERRANEAN PEPPER RELISH 16 Fl Oz (355 ml) MANUFACTURED FOR RUST BELT PEPPER CO P.O. BOX 36014 CANTON, OHIO 44718 330.323-4735 INGREDIENTS: Imported Roasted Red Peppers***UPC 8 11975 01109 6","153 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",,"  Lot# 576235, 57885",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0474-2016","Class II","Abruzzi's Hot Peppers in oil 15 Fl Oz (444 ml) Manufactured For: Abruzzis Hot Peppers, LLC, 371 Marwood Drive, S.E. Warren, Ohio 44484  (330) 883-7933 UPC 8 51071 00500 1 ","1143 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot #377205, 377285 &377295.",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0501-2016","Class II","Keim's Garden Harvest pickled spicy jalapeno eggs Ingredients: eggs, water, vinegar, sugar, salt, spices, peppers, pepper oil, yellow #5, red #40*** Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83460 1, 1 QT (32 oz 946 ML) 6 09788 83458 8","16 oz - 41 cases, 32 oz - 20 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," All codes",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0500-2016","Class II","SEASONAL SELECTIONS SUGAR & SPICE GOURMET BEETS NET WT 16 OZ (1 lb) 453g INGREDIENTS: Beets, Vinegar, Sugar, Whole Allspice, Salt, Cinnamon Sticks SEASONAL SELECTIONS P.O. BOX 251 Waynesville, OH 45060 UPC 8 57596 00308 9","50 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," All codes",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0470-2016","Class II","A BIT OF A BITE SALSA HEINEY HOT SALSA NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of  Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95415 0","26 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot# 24325",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0473-2016","Class II","A BIT OF A BITE SALSA THREE SISTERS NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, ORGANIC BLACK BEANS, FRESH CORN***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of  Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95418 1","52 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot# 27315",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0475-2016","Class II","Barney's Hot Peppers 16 oz (443 ml) Ingredients: Hot Peppers, Canola Oil, Garlic, Oregano, Salt, Acidic Calcium Sulfate Distributed by: Barney's Hot Peppers 2061 Elm Road Warren, Ohio 44483 330-964-2922 UPC # 7 01807 99994 7 ","106 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot # 437305, 43835 & 433315.",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0485-2016","Class II","House MADE Sriracha Sauce NET WT. 8 oz (237 mL) INGREDIENTS: THAI CHILIES, DISTILLED VINEGAR, SUGARS, GARLIC, MOLASSES, KOSHER SALT. www.housemadesriracha.com UPC 6 12524 99999 1","129 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot# 52485",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0487-2016","Class II","Keim's Garden Harvest pickled beets Ingredients: red beets, water, sugar, vinegar, spices, salt. Manufactured by: Keim's Garden Harvest  (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 14 oz UPC 6 09722 32336 9, 32 oz UPC 6 09722 32339 0","127 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot # 56295-5625",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0480-2016","Class II","Cleveland Pickle Spicy Garlic Dill 16 oz (454 g) Ingredients: Cucumbers, Water***Habanero Peppers***Manufactured For: CLEVELAND PICKLE 850 EUCLID AVE. CLEVELAND OH 44114 216-575-1111 UPC 8 67051 00001 0","160 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot # 48875",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0495-2016","Class II","PATTY'S PEPPERS HUNGARIAN HOT & SWEET PEPPERS Uncle Joe's Original Recipe NET WT 16 oz & 32 oz Ingredients: Hungarian Hot Wax Peppers, Garlic, Vinegar, All Natural Ketchup, Sugar, Canola Oil, pattyspeppers.com UPC 7 48252 07486 7 ","266 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot# 40855, 404105, 403255 & 406295.",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0499-2016","Class II","ROASTED MEDITERRANEAN SPICY PEPPER RELISH 16 Fl Oz (355 ml) MANUFACTURED FOR RUST BELT PEPPER CO P.O. BOX 36014 CANTON, OHIO 44718 330.323-4735 INGREDIENTS: Imported Roasted Red Peppers***Habanero Pepper. UPC 8 63131 00011 6","143 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot# 58885, 586235 & 58495,",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0484-2016","Class II","HERBERT'S chow-chow Original New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6","1","The firm was manufacturing acidified foods without a license.","01/14/2016",," All codes",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0482-2016","Class II","HERBERT'S chow-chow Hot New Weight 12.8 oz (363g) Ingredients: Cabbage***Manufactured for: The All-American Relish Company. North Canton OH 44720 330-842-0168 UPC 8 57025 00270 6 ","156 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot # 66295",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0478-2016","Class II","Cafe 422 HOT PEPPERS in oil INGREDIENTS Hungarian Hot Peppers***Manufactured & Hand Packed by: Caf¿ 422 4422 Youngstown Rd SE Warren, Ohio 44484 330.369.2422 16 oz UPC 8 60557 00010 2 & 32 oz UPC 8 60557 00011 9","136 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot # 467285",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0472-2016","Class II","A BIT OF A BITE SALSA SARAH SWEET NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS. A Bit of  Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95417 4","64 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot # 263245",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0489-2016","Class II","Keim's Garden Harvest pickled white eggs Ingredients: eggs, water, vinegar, sugar, salt. Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 1 PT (17 oz 502 ML) UPC 6 09788 83461 8, 32 oz 6 09788 83456 4","50 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Lot# 16815",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0491-2016","Class II","Kiem's Garden Harvest black bean salsa 1 PT (14 oz 397g) Ingredients: beans, corn, tomato***Manufactured by: Keim's Garden Harvest (937) 515-4518 Honeysuckle Lane Wellston, OH UPC 6 09722 32347 5","41 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," All Codes",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0486-2016","Class II","Keim's Garden Harvest tomato salsa 1 PT (14 oz 397g) Ingredients: tomatoes, onions, peppers, herbs***Manufactured by: Keim's Garden Harvest (937) 515.4518 2232 Honeysuckle Lane Wellston OH 45692 mild UPC 6 09722 32345 1 medium UPC 6 09722 32343 7, hot UPC 6 09722 32344 4","81 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," Mild Lot # 106295, Medium All Codes, Hot Lot #: 86305",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0497-2016","Class II","RJ's PEPPERS IN OIL 12 OZ. (340G) INGREDIENTS: PEPPERS, CANOLA OIL***Manufactured for: RJ's Pepper Pantry Warren, OH 4484 Phone: 330-766-2863 Mild UPC 8 53827 00401 6, Medium Hot UPC 8 53827 00402 3, Hot UPC 8 53827 00400 9  ","265 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",," All Lots.",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",71962,"Ongoing","Garden Harvest","62969 US Highway 50",,"Mc Arthur","OH","45651-8410","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: OH, FL, WV","F-0481-2016","Class II","DUTCH COUNTRY KETTLES HOMEMADE Pickled Beets  Ingredients: Beets, Water, Vinegar, Sugar, Salt. Dutch Country Kettles 6732 Pavey Road. Leesburg, OH 45135 1-937-780-6718 1 Pint (1 lb. 3oz) 538g UPC 6 98241 12224 9 & 1 Quart (32 oz) 907g UPC 6 98241 14444 9","211 cases","The firm was manufacturing acidified foods without a license.","01/14/2016",,"  Lot # 633305 & 635285",8/12/2015,"08/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0215-2017","Class II","Lap Band Pack, Kit number AMS1785(A    convenience custom kits used for general surgery in hospital operating room  ","390 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    58289 10/17/2014  60644 2/19/2015  65363 2/28/2015  61474 7/23/2015  65877 11/1/2015  64537 11/30/2015  66998 1/31/2016  68952 1/31/2016  67661 2/29/2016  71625 2/29/2016  70410 4/30/2016  71947 5/31/2016  72877 5/31/2016  57137 6/7/2016  77238 6/30/2016  78143 6/30/2016  73985 8/31/2016  74752 8/31/2016  74973 8/31/2016  76523 8/31/2016      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0200-2017","Class II","GYN Lap Pack, Kit number PSS2194(B  convenience custom kits used for general surgery in hospital operating room","20 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    73774 2/6/2016  73292 2/21/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0259-2017","Class II","Peri GYN, Kit number PSS2193(A    convenience custom kits used for general surgery in hospital operating room                            ","430 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    58336 3/5/2014  61990 8/20/2014  61732 9/10/2014  63878 2/9/2015  65773 2/25/2015  64610 3/27/2015  68071 8/5/2015  69931 10/26/2015  71918 2/15/2016  73291 2/22/2016  74558 6/14/2016  77064 7/14/2016  78767 9/5/2016  78000 9/8/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0253-2017","Class II","Ortho Kit, Kit number PSS1039(A and PSS1039(B    convenience custom kits used for general surgery in hospital operating room                ","145 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    70753 10/4/2014  68086 10/10/2014  68499 10/12/2014  70327 10/13/2014  71916 10/19/2014  71132 10/26/2014  69921 10/30/2014  74311 12/17/2016  76481 12/20/2016  72346 1/16/2017  73050 3/15/2017              ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0251-2017","Class II","Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A    convenience custom kits used for general surgery in hospital operating room              ","120 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    76053 11/18/2016  75386 1/18/2017  79443 8/17/2017  77581 9/28/2017      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0234-2017","Class II","Major Lithotomy Pack, kit number 002641-5 and 002641-6    convenience custom kits used for general surgery in hospital operating room","156 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    60743 1/13/2014  66029 1/31/2014  66769 1/31/2014  64456 9/28/2014  65289 9/30/2014  68942 9/9/2015  70848 9/11/2015  58030 7/11/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0201-2017","Class II","GYN Pack, Kit number PSS2643  convenience custom kits used for general surgery in hospital operating room","48 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/Expiration Date:    58662 4/6/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0276-2017","Class II","Total Joint Pack, Kit number 006358-5 and 006358-6    convenience custom kits used for general surgery in hospital operating room                                                                                ","58 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    58057 5/6/2014  58493 5/30/2014  61598 7/28/2014  59008 8/21/2014  60647 8/31/2014  62544 1/16/2015  63813 2/28/2015  66309 4/13/2015  67352 11/1/2015  73747 3/1/2016  77176 6/17/2016  56393 7/3/2016  79087 8/31/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0255-2017","Class II","Ortho Pack, Kit number PSS3466 and PSS3466(A    convenience custom kits used for general surgery in hospital operating room                      ","92 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    74829 5/25/2017  78510 8/8/2017  79116 11/5/2017  79279 1/18/2018                      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0211-2017","Class II","Knee Arthroscopy Pack	AMS2610, AMS2610(A, AMS3236,  PSS2188(A, and PSS2208(A  convenience custom kits used for general surgery in hospital operating room    ",,"The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    63879 1/23/2014  58286 3/18/2014  58810 6/21/2014  62512 10/18/2014  63024 12/13/2014  65774 2/25/2015  68072 4/17/2015  68548 4/25/2015  70982 11/26/2015  73402 3/14/2016  74837 3/22/2016  75198 4/20/2016  67703 7/1/2016  78551 7/30/2016  78600 7/30/2016  68823 9/11/2016  68713 9/20/2016  71080 12/26/2016  72020 1/10/2017  73647 1/28/2017  73205 3/9/2017  73034 3/23/2017  77621 7/21/2017  79992 8/1/2017  77815 8/11/2017  80859 8/31/2017  77783 10/10/2017  75744 10/21/2017  79326 1/13/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0163-2017","Class II","Custom Arterial Pack, kit number RMS1712(F    convenience custom kits used for general surgery in hospital operating room","102 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/Expiration Date:    59045 8/18/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0189-2017","Class II","Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327  convenience custom kits used for general surgery in hospital operating room      ","111 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    61285 3/28/2014  66414 11/5/2015  64644 11/9/2015  67019 12/10/2015  68565 12/20/2015  71659 4/20/2016  69369 5/8/2016  72748 8/23/2016      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0288-2017","Class II","Port Access Kit, Kit number PSS1505(C  convenience custom kits used for general surgery in hospital operating room                                                                                                          ","227 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    63411 7/26/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0178-2017","Class II","Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C  convenience custom kits used for general surgery in hospital operating room      ","2048 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    59444 7/10/2014  60056 8/8/2014  60425 8/20/2014  60967 11/3/2014  59000 1/13/2015  63464 2/9/2015  64533 2/25/2015  61267 2/27/2015  63798 3/30/2015  65629 7/30/2015  66813 10/21/2015  69765 11/2/2015  69528 11/18/2015  67138 11/19/2015  67399 1/2/2016  67989 2/6/2016  70374 3/17/2016  69766 3/30/2016  71447 4/18/2016  72241 5/15/2016  57208 7/24/2016  75250 8/7/2016  58621 8/10/2016  73977 8/11/2016  73190 8/12/2016  73277 8/23/2016  74340 8/26/2016  78679 10/24/2016  79046 10/25/2016  75603 1/26/2017  76940 2/11/2017  76159 2/14/2017  78015 6/16/2017  76568 6/26/2017  79824 7/25/2017  81121 8/13/2017  68922   ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0265-2017","Class II","Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422  convenience custom kits used for general surgery in hospital operating room                                                  ","3142 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    61268 4/17/2014  58664 4/10/2015  59825 8/30/2015  61858 11/9/2015  64825 11/10/2015  64826 11/15/2015  66761 11/20/2015  64827 11/21/2015  63483 11/23/2015  59800 11/24/2015  63482 12/6/2015  62873 12/18/2015  65631 12/30/2015  64536 1/5/2016  63481 1/6/2016  63800 1/7/2016  66762 2/5/2016  66763 3/1/2016  67345 6/17/2016  75666 6/25/2016  68684 6/26/2016  66755 7/5/2016  78206 7/30/2016  67334 8/9/2016  60594 8/19/2016  68146 9/15/2016  69196 9/16/2016  70378 9/27/2016  70812 10/17/2016  71784 10/19/2016  71471 11/6/2016  72148 12/3/2016  71157 12/20/2016  71970 12/21/2016  74621 1/14/2017  72889 1/21/2017  73855 1/30/2017  73854 2/5/2017  72495 2/8/2017  72725 3/5/2017  75398 4/19/2017  74872 4/24/2017  76184 4/27/2017  75108 4/29/2017  74121 5/9/2017  75399 5/16/2017  77316 7/12/2017  77104 7/28/2017  77416 8/3/2017  77417 8/9/2017  77407 8/24/2017  77408 8/24/2017  77775 9/2/2017  78643 10/3/2017  76478 10/25/2017  80532 12/6/2017  79831 12/18/2017  79347 1/16/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0273-2017","Class II","Surgical Pack, Kit number PSS3540 and PSS3540(A    convenience custom kits used for general surgery in hospital operating room                                                                        ","64 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    75513 6/25/2016  79705 1/26/2018  79982 2/14/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0159-2017","Class II","C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449  convenience custom kits used for general surgery in hospital operating room    ","268 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    58207 8/31/2013  61591 1/2/2014  59228 1/19/2014  66522 1/31/2014  61763 3/5/2014  62929 9/10/2014  67485 9/19/2014  67664 9/21/2014  63835 9/22/2014  65290 9/30/2014  56956 6/18/2016  57666 6/23/2016  71060 10/13/2016  68943 10/26/2016  79065 11/9/2017  79842 1/25/2018  80908 2/15/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0184-2017","Class II","Extremity Pack-N Brunswick, kit number PSS1866(A    convenience custom kits used for general surgery in hospital operating room","290 units","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    65973 11/5/2015  61941 11/16/2015  65778 11/16/2015  63876 1/22/2016  57229 6/20/2016  68500 8/11/2016  67599 8/14/2016  69803 8/15/2016  74672 5/14/2017  74836 5/23/2017  74529 5/25/2017  77056 11/10/2017  77056 11/10/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0248-2017","Class II","Nasal Pack, Kit number PSS2186    convenience custom kits used for general surgery in hospital operating room        ","16 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    57967 11/11/2015  67251 7/10/2016            ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0269-2017","Class II","Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B.  convenience custom kits used for general surgery in hospital operating room                                                                    ","1124 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    59007 8/27/2013  57610 8/31/2013  60128 12/15/2013  62099 12/21/2013  61297 2/9/2014  62189 2/12/2014  57522 4/30/2014  60028 5/12/2014  60303 5/19/2014  61416 8/17/2014  63836 9/7/2014  66799 9/19/2014  61924 12/3/2014  63333 12/8/2014  65167 12/31/2014  67369 2/4/2015  68073 4/17/2015  70983 9/6/2015  70169 9/21/2015  71061 10/10/2015  65331 11/5/2015  62082 11/7/2015  66580 11/20/2015  64544 1/29/2016  68947 2/19/2016  74854 3/23/2016  75534 4/25/2016  69610 5/7/2016  71352 6/17/2016  66677 7/5/2016  67866 7/6/2016  67702 7/30/2016  77629 7/30/2016  78550 7/30/2016  68712 9/13/2016  68215 9/17/2016  79701 10/11/2016  70494 10/17/2016  75648 12/1/2016  71381 12/12/2016  76128 1/22/2017  72479 3/15/2017  72951 3/24/2017  73131 4/15/2017  74758 5/5/2017  73849 5/7/2017  73192 5/30/2017  76672 7/17/2017  80956 8/8/2017  78024 8/23/2017  77684 10/24/2017  79660 1/9/2018  78944 1/16/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0283-2017","Class II","Vein Kit - No Introducer	TVS4027-NI(A    convenience custom kits used for general surgery in hospital operating room                                                                                            ","360 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    60996 8/3/2015  59383 8/20/2015  63706 11/11/2015  65733 11/30/2015  65404 12/26/2015  58253 7/23/2016  58476 8/30/2016  70957 11/6/2016  71370 12/11/2016  72254 1/8/2017  76639 11/19/2017    ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0206-2017","Class II","Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A.  convenience custom kits used for general surgery in hospital operating room    ","2004 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    62890 3/28/2014  61286 5/28/2014  61286 5/28/2014  59473 4/20/2015  59560 7/3/2015  60355 7/17/2015  60356 7/22/2015  60357 7/23/2015  60452 8/29/2015  61629 9/3/2015  60755 10/3/2015  61443 10/19/2015  65058 11/1/2015  64558 11/6/2015  65918 11/13/2015  66516 11/15/2015  65281 11/16/2015  61558 11/17/2015  62751 11/21/2015  64660 11/21/2015  62752 11/25/2015  61971 11/29/2015  64624 11/30/2015  72235 12/3/2015  67959 12/12/2015  69436 12/16/2015  68587 12/21/2015  69183 12/21/2015  71969 12/21/2015  65701 12/23/2015  67341 12/26/2015  70809 12/26/2015  62944 1/8/2016  72839 5/8/2016  57471 6/5/2016  57615 6/26/2016  68222 7/5/2016  58757 8/9/2016  67888 8/10/2016  59028 8/15/2016  68864 9/19/2016  69701 10/6/2016  69063 10/10/2016  69678 10/23/2016  69679 10/26/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0266-2017","Class II","Robotic Pack, Kit number AMS4389    convenience custom kits used for general surgery in hospital operating room                                                  ","33 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    79062 9/16/2017  79998 1/27/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0235-2017","Class II","Major Ortho Pack, kit number 002647-12 and 002647-13    convenience custom kits used for general surgery in hospital operating room    ","1200 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59180 8/13/2013  58144 11/7/2013  63191 12/3/2013  62098 12/6/2013  61064 12/13/2013  61592 12/16/2013  63809 12/17/2013  62398 12/19/2013  60127 12/20/2013  59454 1/25/2014  66802 1/31/2014  67030 1/31/2014  59839 2/16/2014  61296 2/21/2014  65291 2/28/2014  68567 9/5/2014  62930 9/20/2014  67877 9/21/2014  64458 9/30/2014  71056 10/11/2015  68946 10/26/2015  69206 5/10/2016  69631 5/23/2016  70482 5/29/2016  71057 6/4/2016  57292 6/11/2016  57780 6/23/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0169-2017","Class II","D & C Kit, Kit number CMP1466 and CMP1466(A  convenience custom kits used for general surgery in hospital operating room","592 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    63769 11/20/2015  63004 1/7/2016  64664 1/18/2016  57354 6/27/2016  58304 8/14/2016  70196 12/13/2016  74082 5/15/2017  76454 7/14/2017  74810 7/17/2017  77337 11/3/2017  69835 1/15/2018  79554 1/19/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0271-2017","Class II","Spine Pack, Kit number AMS3753 and AMS3783(A    convenience custom kits used for general surgery in hospital operating room                                                                    ","86 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    75946 6/22/2016  76964 6/30/2016  76134 7/23/2016  76981 8/12/2016  77637 10/31/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0221-2017","Class II","Laparotomy Kit, Kit number PSS1036(A and PSS1036(B    convenience custom kits used for general surgery in hospital operating room                  ","230 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    57846 11/27/2014  58334 11/16/2014  60660 7/21/2015  61766 7/22/2015  62797 10/20/2015  63414 1/30/2016  66908 11/26/2015  67932 4/9/2016  68546 6/11/2016  71757 9/7/2016  72106 9/2/2016  72622 8/25/2016  73283 8/5/2016  73423 8/13/2016  73765 8/2/2016  74067 8/16/2016  74310 12/8/2016  75360 2/4/2017        ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0182-2017","Class II","ENT Tray, Kit number AMS1195(A    convenience custom kits used for general surgery in hospital operating room","1795 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59841 7/3/2015  59998 7/22/2015  60492 9/12/2015  61308 9/24/2015  64554 10/19/2015  65916 11/1/2015  65449 11/2/2015  62451 11/6/2015  65563 11/9/2015  63498 11/11/2015  66317 11/12/2015  66528 11/27/2015  62114 11/30/2015  64157 1/7/2016  63818 1/24/2016  68366 7/12/2016  67034 7/15/2016  57296 7/25/2016  78780 7/30/2016  66529 8/26/2016  59011 8/28/2016  69786 9/7/2016  70822 9/13/2016  69209 10/10/2016  71824 12/10/2016  72548 1/17/2017  72194 1/31/2017  73166 3/7/2017  73705 4/2/2017  74465 5/7/2017  74906 5/30/2017  75575 7/3/2017  75725 7/8/2017  76499 7/21/2017  75890 7/29/2017  79088 9/27/2017  76846 10/5/2017                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0254-2017","Class II","Ortho Minor Pack, Kit number AMS3710    convenience custom kits used for general surgery in hospital operating room                  ","160 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    78883 2/28/2017  76448 7/14/2017  78558 9/30/2017  79282 11/5/2017  80449 1/3/2018  79729 1/25/2018                    ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0170-2017","Class II","D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B  convenience custom kits used for general surgery in hospital operating room","615 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    75712 3/11/2016  69832 3/14/2016  74687 3/16/2016  71295 3/21/2016  74077 3/23/2016  70789 3/25/2016  74537 3/25/2016  75697 3/25/2016  79345 3/26/2016  73305 3/28/2016  75819 3/30/2016  78202 3/30/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0153-2017","Class II","Bleph Pack, Kit part number AMS3325  convenience custom kits used for general surgery in hospital operating room  ","10 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/Expiration Date:  71657 3/14/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0202-2017","Class II","GYN-Laparoscopy Tray	AMS1196(A  convenience custom kits used for general surgery in hospital operating room","88 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates    63499 1/5/2016  67887 9/2/2016  58066 9/17/2016  79234 11/2/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0176-2017","Class II","Dr. Fetters Hand Pack, Kit number AMS3690    convenience custom kits used for general surgery in hospital operating room","40 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/Expiration Date:    75188 12/2/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0237-2017","Class II","Mammoplasty Pack, Kit number AMS2535    convenience custom kits used for general surgery in hospital operating room        ","140 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    62891 3/18/2014  61287 3/30/2014  65893 11/1/2015  64645 11/6/2015  68632 12/20/2015  69437 12/28/2015  73352 5/12/2016  72482 5/14/2016  72942 5/25/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0199-2017","Class II","GLBSC Minor Pack, Kit number PSS2644  convenience custom kits used for general surgery in hospital operating room","60 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    58663 4/6/2015  62629 11/19/2015  61998 11/27/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0154-2017","Class II","Body Contour Pack, Kit part number PSS1749    convenience custom kits used for general surgery in hospital operating room","288 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    57223 2/26/2015  58307 4/10/2015  60261 7/17/2015  63765 11/15/2015  64007 7/5/2015  64597 1/6/2016  65800 11/5/2015  70762 10/25/2016  72336 12/9/2016  72759 1/24/2017  73439 1/27/2017  74083 4/25/2017  75079 6/25/2016  77743 9/17/2017  80762 8/2/2017      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0284-2017","Class II","Virginia Custom Pack, Kit number RMS1744    convenience custom kits used for general surgery in hospital operating room                                                                                            ","5388 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59798 9/26/2014  59796 7/5/2015  59797 7/5/2015  61329 7/5/2015  60411 8/5/2015  61222 9/1/2015  60758 9/9/2015  66544 11/5/2015  66261 11/7/2015  64654 11/8/2015  61679 11/9/2015  63209 11/13/2015  62471 11/17/2015  61678 11/27/2015  65932 11/30/2015  62470 12/9/2015  63208 12/18/2015  63927 1/5/2016  64653 1/7/2016  64307 1/18/2016  63926 1/20/2016  68195 7/5/2016  68638 7/7/2016  67670 7/16/2016  66545 7/23/2016  69868 9/15/2016  69907 9/17/2016  68874 9/25/2016  70705 10/25/2016  69039 10/27/2016  70945 12/5/2016  70704 1/4/2017  71513 1/27/2017  71688 3/6/2017  71840 3/6/2017  73729 4/17/2017  73177 4/20/2017  73393 4/21/2017  73731 5/16/2017  74648 5/30/2017  75024 7/3/2017  75160 7/11/2017  75975 7/21/2017  76242 8/3/2017  76441 8/18/2017  77269 8/22/2017  78308 9/26/2017  77268 10/8/2017  78593 11/4/2017  79038 11/20/2017  79881 1/7/2018  79039 2/28/2018    ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0281-2017","Class II","Upper Torso Tray, Kit number PSS1554(B    convenience custom kits used for general surgery in hospital operating room                                                                                          ","546 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    58440 12/26/2014  57416 2/5/2015  56848 2/23/2015  59052 5/17/2015  58812 5/28/2015  63227 7/20/2015  61936 8/28/2015  59666 10/14/2015  65111 10/20/2015  64230 11/10/2015  65410 12/11/2015  66232 5/19/2016  67772 7/9/2016  57871 7/12/2016  68610 9/20/2016  78517 9/30/2016  70880 10/28/2016  71119 12/14/2016  74426 12/24/2016  73427 1/22/2017  72781 1/30/2017  73810 3/18/2017  78127 8/18/2017  79916 9/20/2017      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0222-2017","Class II","Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A.   convenience custom kits used for general surgery in hospital operating room                                ","1528 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    57968 3/10/2014  58335 3/26/2014  57096 3/30/2014  59915 6/16/2014  58966 6/19/2014  61731 8/7/2014  63240 8/21/2014  61024 9/17/2014  61499 9/22/2014  63588 2/11/2015  65772 2/25/2015  65779 2/26/2015  64225 2/28/2015  65239 3/20/2015  66645 7/20/2015  68070 8/4/2015  58830 8/5/2015  68893 8/12/2015  68265 8/17/2015  59541 8/30/2015  60650 9/1/2015  69806 10/6/2015  59840 11/9/2015  63811 1/18/2016  73766 2/2/2016  72807 2/7/2016  71917 2/9/2016  73424 2/15/2016  72515 2/15/2016  73401 2/15/2016  72806 2/28/2016  74679 4/11/2016  74853 5/15/2016  71892 6/1/2016  74680 6/1/2016  71726 6/11/2016  72656 6/16/2016  57461 6/23/2016  57174 7/11/2016  58034 7/11/2016  76085 8/4/2016  58492 8/8/2016  58502 8/13/2016  76923 8/24/2016  78168 9/5/2016  79609 9/9/2016  78573 9/27/2016  70930 9/28/2016  71324 10/19/2016  73071 1/29/2017  74331 5/1/2017  75004 5/4/2017  75545 7/16/2017  77174 7/20/2017  79653 8/7/2017  78409 8/12/2017  79636 1/9/2019  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0152-2017","Class II","Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2    convenience custom kits used for general surgery in hospital operating room","312 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot NumbersExpiration Dates:    58626 10/25/2014  61076 5/14/2015  62460 6/4/2015  63884 6/6/2015  63742 6/11/2015  65028 6/12/2015  63220 6/18/2015  66436 11/27/2015  65659 11/30/2015  57175 5/16/2016  67267 5/17/2016  72357 5/25/2016  72480 7/21/2016  78609 1/17/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0261-2017","Class II","Plastic General Pack, Kit number AMS4215    convenience custom kits used for general surgery in hospital operating room                                ","15 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:  77336 7/20/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0224-2017","Class II","Lipo Pack, Kit number AMS4420    convenience custom kits used for general surgery in hospital operating room                      ","40 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot number/Expiration date:    79639 1/9/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0164-2017","Class II","Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D  convenience custom kits used for general surgery in hospital operating room       ","546 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    62743 8/18/2013  57375 9/5/2013  58352 9/13/2013  58985 1/28/2014  62106 7/14/2014  61743 7/21/2014  63397 12/21/2014  63273 12/26/2014  64371 3/13/2015  64329 3/21/2015  66935 4/22/2015  67471 5/11/2015  68296 9/19/2015  68614 9/27/2015  68614 9/27/2015  70876 10/12/2015  69816 10/14/2015  70681 10/20/2015  71211 10/21/2015  71695 10/26/2015  73064 12/20/2015  72359 12/24/2015  77377 1/19/2016  76155 1/25/2016  81170 7/8/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0161-2017","Class II","Cardiac Cath Pack, kit number AMS2707  convenience custom kits used for general surgery in hospital operating room  ","138 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    67078 11/16/2015  66903 11/26/2015  64343 12/24/2015  68965 9/10/2016  68647 9/18/2016  68147 9/28/2016  70233 10/30/2016  71064 12/7/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0185-2017","Class II","Extremity Tray, Kit number AMS1200(B and AMS1200(C    convenience custom kits used for general surgery in hospital operating room","816 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    59843 3/1/2015  60753 8/17/2015  59894 9/6/2015  65996 11/13/2015  61600 11/28/2015  62117 12/12/2015  64160 1/3/2016  69211 5/5/2016  56959 6/8/2016  57789 7/1/2016  67355 7/5/2016  58586 8/27/2016  69588 10/8/2016  70509 1/6/2017  72551 1/10/2017  76068 7/17/2017  77502 7/17/2017  78140 9/19/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0157-2017","Class II","Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C.  convenience custom kits used for general surgery in hospital operating room                                     ","288 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates    58933 7/15/2015  57079 7/29/2015  58462 7/31/2015  63011 11/2/2015  64381 11/15/2015  65577 11/30/2015  64599 1/20/2016  70562 9/27/2016  67303 10/26/2016  71405 1/5/2017  72164 1/27/2017  71900 3/19/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0192-2017","Class II","General Male Pack, Kit number AMS1580  convenience custom kits used for general surgery in hospital operating room","26 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    67438 11/5/2015  67649 8/22/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0155-2017","Class II","Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430.  convenience custom kits used for general surgery in hospital operating room            ","1498 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    59278 10/2/2013  58407 10/14/2013  62436 12/4/2013  62922 12/18/2013  60740 5/20/2014  63467 6/2/2014  62067 6/7/2014  64703 6/10/2014  61619 6/14/2014  64110 6/14/2014  63539 6/29/2014  65271 7/8/2014  65364 7/11/2014  65837 7/31/2014  70246 9/3/2014  70351 9/4/2014  69850 9/7/2014  67400 9/11/2014  69434 9/18/2014  71639 9/18/2014  68310 9/30/2014  72944 10/1/2014  71948 10/9/2014  71949 10/22/2014  65894 2/7/2015  68624 3/12/2015  77600 8/12/2015  76292 8/14/2015  72862 10/5/2015  73989 10/7/2015  67704 12/5/2015  73680 1/3/2016  74974 1/7/2016  76004 1/9/2016  75570 1/17/2016  73628 1/24/2016  73982 2/3/2016  74027 2/24/2016  74377 3/26/2016  75655 3/29/2016  79047 4/5/2016  78542 4/14/2016  78888 4/27/2016  77381 4/30/2016  57192 5/30/2016  57138 6/4/2016  78207 6/20/2016  71656 8/3/2016  75175 8/19/2016  77224 8/23/2016  74582 9/9/2016  78973 10/28/2016  79324 11/16/2016  79137 11/25/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0141-2017","Class II","Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A  convenience custom kits used for general surgery in hospital operating room  	  ","93 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers; Expiration Dates:    62090 11/18/2015  64503 11/20/2015  65165 11/9/2015  66042 7/15/2016  68496 9/18/2016  75702 7/4/2017  76407 2/4/2017  78060 2/23/2017  78683 9/8/2017  79143 11/3/2017        ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0210-2017","Class II","Hystero Pack, Kit number PSS3535  convenience custom kits used for general surgery in hospital operating room","40 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    74708 4/23/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0239-2017","Class II","Minor Lap Pack, Kit number AMS2624    convenience custom kits used for general surgery in hospital operating room            ","130 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    65441 11/2/2015  61136 11/8/2015  63732 1/6/2016  67075 7/4/2016  67779 9/25/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0204-2017","Class II","Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073.  convenience custom kits used for general surgery in hospital operating room              ","8132 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot codes/Expiration dates:    65013 3/1/2014  58261 3/20/2014  58964 3/27/2014  61857 4/10/2014  60968 4/20/2014  57095 4/25/2014  59002 5/2/2014  60388 5/5/2014  60299 6/30/2014  62798 8/21/2014  62654 10/25/2014  64447 12/5/2014  63072 12/9/2014  64328 12/13/2014  64679 12/18/2014  63368 12/20/2014  63799 1/13/2015  66644 2/2/2015  66509 2/14/2015  65777 2/25/2015  65573 2/25/2015  65718 2/28/2015  65875 3/6/2015  65572 3/15/2015  59027 3/26/2015  58692 4/5/2015  68613 4/12/2015  67175 4/14/2015  57249 4/20/2015  68069 4/28/2015  59297 7/3/2015  59538 7/4/2015  59157 7/13/2015  59846 8/2/2015  60663 8/4/2015  60131 8/5/2015  60113 8/6/2015  60132 8/6/2015  70171 8/13/2015  61311 8/18/2015  61435 8/20/2015  59514 8/24/2015  59845 8/31/2015  60605 9/7/2015  60754 9/7/2015  61006 9/7/2015  60722 9/11/2015  61164 9/14/2015  60662 9/20/2015  61479 9/21/2015  68892 9/29/2015  61310 10/16/2015  65295 11/2/2015  71133 11/2/2015  62199 11/5/2015  62600 11/5/2015  62349 11/6/2015  61601 11/6/2015  64476 11/6/2015  66318 11/6/2015  61521 11/7/2015  66319 11/8/2015  65296 11/10/2015  64850 11/11/2015  64477 11/11/2015  62200 11/13/2015  62943 11/13/2015  70754 11/13/2015  62903 11/14/2015  63199 11/15/2015  61602 11/23/2015  61642 11/26/2015  62425 11/27/2015  62546 11/27/2015  66795 11/27/2015  61603 11/29/2015  65598 11/30/2015  65700 11/30/2015  72347 12/4/2015  72783 12/15/2015  72804 12/21/2015  65699 12/23/2015  65294 12/26/2015  65195 12/27/2015  64632 1/2/2016  73047 1/6/2016  64291 1/7/2016  64349 1/8/2016  63430 1/9/2016  65019 1/12/2016  64475 1/16/2016  63200 1/18/2016  63711 1/22/2016  63948 1/25/2016  64042 1/30/2016  63984 1/30/2016  67589 2/5/2016  69258 2/5/2016  69459 2/5/2016  71210 2/11/2016  66794 2/14/2016  68862 2/14/2016  69603 2/20/2016  69604 2/20/2016  67588 2/24/2016  74530 2/25/2016  73860 3/6/2016  74555 3/10/2016  68572 3/13/2016  68863 3/22/2016  69062 3/26/2016  66552 4/4/2016  70511 4/6/2016  71878 4/8/2016  70512 4/10/2016  70267 4/14/2016  70268 4/16/2016  74731 4/18/2016  69605 4/2",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0219-2017","Class II","Laparoscopic Pack, Kit number AMS2499    convenience custom kits used for general surgery in hospital operating room          ","1290 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    62086 11/7/2015  65280 11/8/2015  62087 11/17/2015  65736 11/30/2015  64547 1/6/2016  67957 7/7/2016  67016 7/16/2016  67697 8/9/2016  69435 9/18/2016  70253 9/23/2016  70497 10/18/2016  70156 10/31/2016  70808 12/13/2016  71959 1/14/2017  73320 3/5/2017  72888 3/24/2017  73333 5/7/2017  75288 5/11/2017  76049 7/20/2017  78640 8/12/2017  78151 8/18/2017  76946 8/31/2017  77686 10/8/2017  77310 10/24/2017  69018 12/10/2017  78978 1/20/2018        ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0270-2017","Class II","Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A,   convenience custom kits used for general surgery in hospital operating room                                                                            ","3104 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    61069 1/5/2015  57470 1/15/2015  64162 1/20/2015  66792 1/31/2015  61312 2/27/2015  66392 2/27/2015  59327 4/24/2015  60099 7/15/2015  61872 7/26/2015  60277 8/24/2015  60278 8/24/2015  61393 9/7/2015  63201 9/15/2015  61394 10/14/2015  62762 11/3/2015  61940 11/17/2015  62155 11/23/2015  64557 11/27/2015  61280 11/27/2015  61279 11/28/2015  61392 11/30/2015  66184 12/24/2015  65278 12/27/2015  63178 1/3/2016  63994 1/13/2016  64601 1/13/2016  64643 1/17/2016  63782 1/23/2016  63783 1/23/2016  73045 1/29/2016  69613 2/19/2016  69677 4/9/2016  70513 4/11/2016  76391 4/13/2016  74109 4/24/2016  57074 5/25/2016  76644 5/30/2016  57513 6/20/2016  71983 7/15/2016  67297 7/20/2016  67764 7/20/2016  58232 7/24/2016  58465 7/25/2016  77327 7/26/2016  77744 7/30/2016  78161 7/30/2016  65887 8/1/2016  67940 8/23/2016  68760 9/22/2016  70301 9/22/2016  70693 10/7/2016  69712 10/26/2016  68631 10/31/2016  71525 12/18/2016  71460 1/3/2017  72471 1/10/2017  72320 1/15/2017  70770 1/21/2017  72628 1/21/2017  73287 1/23/2017  72147 1/24/2017  72387 1/26/2017  72082 1/26/2017  72859 3/9/2017  72963 3/28/2017  73114 3/28/2017  76279 4/24/2017  76886 4/24/2017  74673 5/22/2017  75245 6/21/2017  76449 7/14/2017  77055 7/19/2017  77333 8/11/2017  78762 9/19/2017  78747 9/20/2017  79341 11/19/2017  79919 1/23/2018  73790 (no date was provided)    ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0218-2017","Class II","Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A  convenience custom kits used for general surgery in hospital operating room          ","258 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    68014 8/28/2016  70788 1/4/2017  72355 1/21/2017  72522 1/23/2017  76700 7/16/2017  69491 12/17/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0260-2017","Class II","Peri Kit, Kit number PSS1037    convenience custom kits used for general surgery in hospital operating room                              ","115 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    57953 7/20/2016  58914 9/12/2015  61492 11/7/2015  62258 11/20/2015  63415 1/22/2016  63988 11/22/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0252-2017","Class II","Open Procedure Pack II, Kit number RMS1740(A    convenience custom kits used for general surgery in hospital operating room            ","145 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59942 4/3/2015  59692 4/19/2015  59858 11/25/2015  65398 11/30/2015  66543 7/4/2016  67496 9/14/2016  70943 1/31/2017  70944 8/11/2017  79014 9/17/2017  79771 1/10/2018            ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0196-2017","Class II","General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B.  convenience custom kits used for general surgery in hospital operating room    ","1378 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    66206 2/25/2015  61424 8/18/2015  63370 11/2/2015  58543 11/8/2015  65418 11/9/2015  63596 11/11/2015  61749 11/22/2015  63420 1/4/2016  64414 1/9/2016  64968 1/13/2016  56888 5/22/2016  56889 5/23/2016  57341 6/8/2016  68248 7/11/2016  58351 7/14/2016  67619 7/16/2016  67417 8/9/2016  57586 8/14/2016  70741 9/5/2016  70742 9/5/2016  68659 9/21/2016  69502 9/23/2016  70631 9/24/2016  69732 9/26/2016  69073 9/27/2016  68295 9/28/2016  68059 9/29/2016  70630 10/23/2016  71024 12/10/2016  71126 12/17/2016  72093 1/7/2017  70999 1/18/2017  73785 1/27/2017  73806 4/5/2017  73807 4/9/2017  74111 4/10/2017  73618 4/20/2017  76130 7/15/2017  81087 1/9/2018      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0267-2017","Class II","Set Up Pack, Kit number PSS3574(A    convenience custom kits used for general surgery in hospital operating room                                                    ","16 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    80547 8/8/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0240-2017","Class II","Minor Lithotomy Pack, Kit number 002650-7    convenience custom kits used for general surgery in hospital operating room              ","114 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    66523 1/31/2014  61660 2/2/2014  61505 2/24/2014  60540 3/30/2014  67197 9/10/2014  65055 9/30/2014  58208 7/5/2016  68949 9/12/2016  71055 12/27/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0144-2017","Class II","Basic Extended Pack, kit part number AMS4421.    convenience custom kits used for general surgery in hospital operating room","20 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/Expiration Date:    79640 1/10/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0140-2017","Class II","Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A.    convenience custom kits used for general surgery in hospital operating room","192 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    62789 11/7/2015  61201 11/8/2015  63413 11/9/2015  67096 11/9/2015  64598 1/29/2016  74803 6/26/2016  57510 6/27/2016  67607 8/21/2016  69801 9/15/2016  71002 10/6/2016  68446 10/9/2016  71403 12/24/2016  72095 1/14/2017  78759 11/5/2017  81077 2/13/2018    ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0228-2017","Class II","Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669.  convenience custom kits used for general surgery in hospital operating room                                    ","582 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    62895 3/16/2014  61290 3/30/2014  57472 4/2/2014  59889 8/8/2014  61313 8/27/2014  62201 10/18/2014  63202 12/12/2014  64163 12/17/2014  65489 3/8/2015  68367 4/13/2015  66793 4/30/2015  69272 9/14/2015  70920 9/30/2015  71438 11/4/2015  66044 11/8/2015  64134 11/10/2015  65690 11/17/2015  71985 11/30/2015  65282 12/1/2015  68490 12/21/2015  69186 12/21/2015  71052 12/25/2015  67699 12/27/2015  67960 12/30/2015  72484 5/28/2016  69442 9/21/2016  80467 10/31/2016              ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0172-2017","Class II","DND Pack, Kit number AMS3846  convenience custom kits used for general surgery in hospital operating room  ","108 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    76409 5/10/2016  77844 9/6/2016  77330 9/24/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0207-2017","Class II","Head Pack, Item number PSS1934(B  convenience custom kits used for general surgery in hospital operating room","70 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    64983 1/1/2016  70780 9/27/2016  70972 1/7/2017  75249 8/15/2017  78954 11/4/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0249-2017","Class II","Newport Coast Basic Pack, Kit number 007484-1    convenience custom kits used for general surgery in hospital operating room          ","280 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59310 7/9/2015  63339 11/11/2015  61486 11/27/2015  65400 11/30/2015  65399 12/26/2015  67044 4/5/2016  67905 5/13/2016  75637 6/25/2016  74959 8/5/2016  71107 8/11/2016  71635 8/29/2016  74764 1/15/2017  78706 9/26/2017              ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0188-2017","Class II","Face Pack, Kit number AMS3641    convenience custom kits used for general surgery in hospital operating room","27 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    73462 4/16/2017  74265 5/25/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0181-2017","Class II","ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214.    convenience custom kits used for general surgery in hospital operating room","123 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    63064 11/3/2015  64818 1/4/2016  71870 12/17/2016  72451 1/7/2017  73240 3/8/2017  72702 3/30/2017  77335 8/10/2017  81025 1/3/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0242-2017","Class II","Minor Pack	AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A.  convenience custom kits used for general surgery in hospital operating room      ","1025 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    59360 4/4/2015  60180 7/22/2015  60972 8/20/2015  60716 9/20/2015  61627 10/15/2015  65729 11/15/2015  65371 11/18/2015  62925 11/26/2015  64759 12/26/2015  63807 1/14/2016  64511 1/16/2016  65907 7/11/2016  57777 7/16/2016  67561 8/26/2016  69460 9/11/2016  69554 11/9/2016  72302 1/5/2017  71984 1/27/2017  73801 4/2/2017  74579 4/23/2017  78211 4/26/2017  74831 5/23/2017  74685 5/24/2017  74462 5/25/2017  74578 5/26/2017  75514 7/2/2017  77373 7/19/2017  78511 8/6/2017  75602 9/19/2017  79095 11/4/2017  79588 11/20/2017  79682 1/17/2018  79251 1/26/2018  81260 2/13/2018  80649 2/27/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0193-2017","Class II","General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A.  convenience custom kits used for general surgery in hospital operating room","1596 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    64285 3/3/2014  61278 3/4/2014  62888 3/28/2014  67339 11/27/2014  64287 10/26/2015  65277 11/1/2015  64286 11/4/2015  65531 11/15/2015  65566 11/20/2015  65215 11/26/2015  70153 12/5/2015  67953 12/7/2015  71459 12/12/2015  69644 12/14/2015  69127 12/16/2015  70377 12/19/2015  67952 12/24/2015  64642 12/26/2015  68630 12/26/2015  71458 12/27/2015  64656 1/5/2016  71965 5/7/2016  72838 5/8/2016  73354 5/12/2016  71966 5/15/2016  68316 9/18/2016  71083 10/28/2016  69577 11/16/2016  71499 12/27/2016  72690 1/14/2017  72222 1/25/2017  73248 3/5/2017  73815 4/30/2017  75445 5/13/2017  75892 7/8/2017  76336 7/17/2017  78746 8/6/2017  80739 8/7/2017  76447 8/7/2017  78102 8/15/2017  78417 9/30/2017  77353 10/1/2017  78847 11/9/2017  78648 1/9/2018  78946 1/25/2018  80448 2/28/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0146-2017","Class II","Basic Kit, Part numbers BP1110(C and CMP1109(A.  convenience custom kits used for general surgery in hospital operating room      ","53 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    57495 7/3/2016  57946 6/29/2016  59013 8/22/2016  59014 3/28/2015  60496 9/1/2015  61879 11/6/2015  62950 11/28/2015  64294 1/7/2016  65396 11/3/2015  65981 11/1/2015  67215 7/16/2016  68373 9/4/2016  70215 9/15/2016  71010 10/17/2016  72059 3/21/2017  73446 3/7/2017  73960 4/5/2017  74662 5/9/2017  75137 5/5/2017  75760 7/13/2017  77133 7/17/2017  77727 8/16/2017  78449 9/15/2017  79367 1/25/2018  79939 1/17/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0171-2017","Class II","D&C/GYN/Hysteroscopy Pack, Kit number PSS3341  convenience custom kits used for general surgery in hospital operating room","56 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    69510 9/4/2014  74078 12/12/2015  74315 12/25/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0162-2017","Class II","Cath Pack, kit number AMS4283    convenience custom kits used for general surgery in hospital operating room","246 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    77875 7/30/2016  78282 7/30/2016  78570 9/28/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0180-2017","Class II","Endoscopy Pack, Kit number PSS1646    convenience custom kits used for general surgery in hospital operating room","304 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    59053 3/28/2015  77459 9/11/2015  65230 10/26/2015  60259 10/27/2015  61170 11/14/2015  66914 11/26/2015  64387 1/11/2016  63883 1/25/2016  57221 6/19/2016  57956 7/20/2016  77460 7/30/2016  69800 9/6/2016  70560 12/3/2016  72104 1/1/2017  72585 4/19/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0216-2017","Class II","Lap Gallbladder Pack, Kit number AMS3707    convenience custom kits used for general surgery in hospital operating room    ","85 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    76445 8/7/2017  79281 8/15/2017  78556 9/20/2017      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0274-2017","Class II","Taymour GYN Pack, Kit number  PSS2642    convenience custom kits used for general surgery in hospital operating room                                                                          ","15 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:  58661 4/12/2015  61997 11/30/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0236-2017","Class II","Major Pack, Kit Number	PSS3516 and PSS3516(A    convenience custom kits used for general surgery in hospital operating room        ","64 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    74830 5/31/2017  79119 11/11/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0194-2017","Class II","General Pack I, Kit number CMP1811(B  convenience custom kits used for general surgery in hospital operating room","1596 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    59313 4/12/2015  59483 7/22/2015  59876 9/13/2015  61092 9/13/2015  60552 10/29/2015  65936 11/2/2015  61362 11/7/2015  62976 11/8/2015  65432 11/8/2015  66398 11/10/2015  61093 11/15/2015  62301 11/18/2015  62676 12/14/2015  64312 1/6/2016  64793 1/12/2016  64183 1/14/2016  63524 1/17/2016  57212 6/16/2016  57213 7/5/2016  67910 7/15/2016  67594 7/27/2016  58074 8/7/2016  58649 8/30/2016  70167 9/15/2016  67911 9/18/2016  68879 10/9/2016  69319 10/31/2016    ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0208-2017","Class II","Hernia Pack, Kit number AMS1519  convenience custom kits used for general surgery in hospital operating room","765 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    62455 8/19/2013  61070 9/10/2013  58150 1/30/2014  59474 1/31/2014  63203 9/11/2014  64165 9/14/2014  65059 9/27/2014  67591 9/29/2014  68544 5/7/2015  68386 5/24/2015  68720 9/14/2015  70550 10/8/2015  69342 10/17/2015  74095 12/2/2015  73780 12/23/2015  76033 2/22/2016  76082 2/22/2016  72977 2/25/2016  76032 2/27/2016  56835 5/29/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0212-2017","Class II","Knee Pack, Kit number AMS4211  convenience custom kits used for general surgery in hospital operating room","30 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    77332 8/10/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0139-2017","Class II","Abdominoplasty Pack, Kit number AMS3326  convenience custom kits used for general surgery in hospital operating room                                                                      ","15 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    71658 8/3/2016  73140 8/12/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0233-2017","Class II","Major Laparotomy Pack - NS, kit number AMS4347  convenience custom kits used for general surgery in hospital operating room","12 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    78422 11/9/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0217-2017","Class II","Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A    convenience custom kits used for general surgery in hospital operating room      ","117 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    66043 11/6/2015  64648 11/9/2015  68489 12/13/2015  69185 12/17/2015  71154 12/24/2015  71783 5/12/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0278-2017","Class II","Transvaginal Pack, Kit number CMP1767    convenience custom kits used for general surgery in hospital operating room                                                                                  ","1780 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    59178 4/13/2015  59934 7/12/2015  65288 11/2/2015  62926 11/10/2015  61866 11/11/2015  66049 11/15/2015  62393 11/28/2015  65692 12/22/2015  63808 1/6/2016  64452 1/17/2016  57606 6/7/2016  66520 7/23/2016  57779 8/10/2016  69057 9/3/2016  59004 9/11/2016  67872 9/30/2016  60067 12/27/2016  69452 1/3/2017  72635 1/9/2017  72687 1/17/2017  72841 3/9/2017  72688 3/22/2017  73048 5/21/2017  74873 5/24/2017  74988 7/16/2017  76993 8/14/2017  77250 9/11/2017  80477 1/9/2018  77808 1/16/2018  67027 (no date was provided)    ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0230-2017","Class II","Major Breast Pack, Kit number AMS3409  convenience custom kits used for general surgery in hospital operating room","20 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    71660 8/3/2016  73216 8/17/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0243-2017","Class II","Minor Tray	AMS2685  convenience custom kits used for general surgery in hospital operating room","600 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    64509 1/4/2016  63184 1/24/2016  68824 9/2/2016  69550 9/5/2016  71960 1/2/2017  72952 3/12/2017  73688 4/5/2017  73599 4/20/2017  74550 5/7/2017  74782 5/22/2017  75650 7/29/2017  80441 8/9/2017  78329 9/23/2017  76679 10/4/2017  78742 1/4/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0280-2017","Class II","Upper Extremity Pack, Kit number AMS2536 and AMS2536(A    convenience custom kits used for general surgery in hospital operating room                                                                                        ","108 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    62892 3/18/2014  61288 3/30/2014  66302 11/8/2015  64646 11/30/2015  68734 12/19/2015  68513 12/31/2015      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0209-2017","Class II","HSG Pack, Kit number PSS3287  convenience custom kits used for general surgery in hospital operating room","360 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    67433 8/1/2016  71250 9/12/2016  69748 9/20/2016  71417 1/3/2017  72802 4/23/2017  74796 7/14/2017  78203 8/5/2017  76919 8/16/2017  79432 2/25/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0225-2017","Class II","Liposuction Pack, Kit number AMS3323    convenience custom kits used for general surgery in hospital operating room                        ","20 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    71655 3/14/2016  72609 8/23/2016  73694 8/30/2016      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0247-2017","Class II","Morris Lap Pack, Kit number PSS3199 and PSS3199(A    convenience custom kits used for general surgery in hospital operating room        ","80 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    65960 11/17/2015  69490 10/8/2016  71746 1/7/2017  76351 7/24/2017  80571 2/28/2018          ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0245-2017","Class II","Mok Eye Pack, Kit number PSS2640      convenience custom kits used for general surgery in hospital operating room","28 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    58659 3/6/2014  59684 6/13/2014    ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0231-2017","Class II","Major General Pack, Kit number 002645-11 and 002645-12    convenience custom kits used for general surgery in hospital operating room","852 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers Expiration Dates  58579 8/20/2013  62097 12/4/2013  61593 12/15/2013  59838 12/30/2013  64762 12/31/2013  60645 1/13/2014  59179 1/14/2014  67196 1/31/2014  65990 2/28/2014  63190 9/15/2014  62540 9/20/2014  67875 9/28/2014  65484 9/30/2014  69395 5/2/2016  56674 5/29/2016  71054 6/3/2016  57460 6/14/2016  68944 6/20/2016  70475 8/10/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0174-2017","Class II","Dr Mullins Kit, kit number PSS1861(A    convenience custom kits used for general surgery in hospital operating room","648 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    65805 2/24/2015  59138 8/31/2015  61015 9/17/2015  65118 10/20/2015  65413 11/3/2015  66234 11/8/2015  66921 11/29/2015  57959 8/15/2016  69802 9/27/2016  68607 10/5/2016  71901 10/19/2016  71111 12/26/2016  72510 3/14/2017  76252 4/14/2017  76892 4/23/2017  74517 5/15/2017  73799 5/24/2017  75239 7/15/2017  77363 8/25/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0142-2017","Class II","Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A.  convenience custom kits used for general surgery in hospital operating room  ","5723 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    66444 2/5/2015    73046 1/1/2016  74702 3/18/2016  73595 4/17/2016  78038 7/30/2016  76691 9/1/2016  78555 9/11/2016  78554 10/19/2016    56085 6/6/2016  59697 8/1/2015  67248 7/16/2016  68753 9/12/2016  69101 9/3/2016  78129 8/23/2017  80761 2/1/2018    60666 10/19/2014  59667 7/19/2015  60265 7/19/2015  60266 7/22/2015  60267 7/24/2015  61386 8/20/2015  60268 8/25/2015  60269 8/26/2015  61384 9/17/2015  61385 9/27/2015  61388 10/13/2015  61389 10/15/2015  65208 10/19/2015  61387 11/7/2015  63013 11/14/2015  65740 11/15/2015  65803 11/17/2015  64600 11/20/2015  61979 11/21/2015  61980 11/22/2015  63012 12/9/2015  63014 12/18/2015  63231 12/19/2015  65902 12/24/2015  63993 1/16/2016  57069 5/21/2016  57629 6/24/2016  58257 7/20/2016  58321 7/24/2016  67609 7/24/2016  58463 7/25/2016  77994 7/30/2016  58936 8/21/2016  58938 8/22/2016  59058 8/23/2016  68288 9/3/2016  69711 9/18/2016  68756 9/22/2016  70300 9/23/2016  70300 9/23/2016  68287 9/24/2016  70569 9/24/2016  68757 9/25/2016  70769 9/28/2016  70299 10/22/2016  71130 12/17/2016  72509 1/15/2017  72796 1/16/2017  72081 1/21/2017  72319 1/21/2017  73779 1/23/2017  73412 3/21/2017  72961 3/22/2017  73089 3/23/2017  73549 4/15/2017  74273 4/19/2017  74274 4/20/2017  74275 4/23/2017  74276 4/23/2017  74410 4/24/2017  76487 4/24/2017  76884 4/24/2017  74823 5/23/2017  74824 5/23/2017  75046 5/24/2017  75205 5/24/2017  75352 6/21/2017  75675 6/21/2017  76278 7/19/2017  76277 7/24/2017  76885 7/24/2017  78352 9/14/2017  78133 9/29/2017  78952 11/21/2017  80544 1/18/2018  79605 1/23/2018  70570 1/24/2018  81269 2/14/2018    60229 5/18/2014  61713 8/5/2014  62412 10/12/2014  62622 12/4/2014    63424 12/3/2014  63758 1/18/2015  64012 12/11/2014  66920 2/21/2015  67462 4/4/2015  68759 4/5/2015  69468 9/28/2015  70973 11/20/2015  72097 12/24/2015  73763 3/9/2016  74313 4/25/2016  75999 5/24/2016  77194 11/30/2016  79795 2/26/2017          ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0183-2017","Class II","Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A  PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706    convenience custom kits used for general surgery in hospital operating room      ","3829 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    59926 5/26/2014  60668 8/14/2014  70310 1/17/2015  68666 1/20/2015  62745 1/29/2015  69836 2/9/2015  66661 4/25/2015  59586 7/22/2015  60264 7/23/2015  59204 8/5/2015  61382 8/20/2015  63063 9/4/2015  61012 9/11/2015  61013 9/14/2015  64817 10/10/2015  61618 10/15/2015  61383 10/18/2015  64593 10/19/2015  64969 11/3/2015  65776 11/5/2015  64394 11/14/2015  63778 11/15/2015  65580 11/16/2015  61938 11/17/2015  62567 11/18/2015  61626 11/20/2015  66917 11/21/2015  61343 11/22/2015  66393 11/23/2015  62154 11/23/2015  66584 11/26/2015  63230 12/18/2015  66183 12/24/2015  64380 1/4/2016  63989 1/7/2016  63404 1/9/2016  78771 1/9/2016  63992 1/11/2016  64696 1/13/2016  64395 1/14/2016  63779 1/18/2016  73914 3/2/2016  73298 3/16/2016  73714 3/23/2016  56866 5/22/2016  57094 5/23/2016  57068 5/24/2016  77013 6/4/2016  70913 6/6/2016  74518 6/8/2016  57067 6/10/2016  71703 6/14/2016  57216 6/19/2016  76121 6/21/2016  57511 6/22/2016  67763 7/1/2016  69284 7/16/2016  70977 7/17/2016  72321 7/17/2016  58092 7/20/2016  67097 7/23/2016  58319 7/25/2016  77988 7/30/2016  77053 7/30/2016  78132 7/30/2016  77721 7/30/2016  58935 8/21/2016  59057 8/22/2016  57588 8/23/2016  72894 8/25/2016  68286 8/25/2016  59210 8/28/2016  70323 9/11/2016  68755 9/22/2016  69925 9/22/2016  70567 9/24/2016  68888 9/26/2016  70568 9/28/2016  77749 10/21/2016  70298 10/23/2016  69708 10/24/2016  71084 10/28/2016  69471 10/31/2016  69083 11/24/2016  71424 12/11/2016  72789 1/10/2017  72318 1/10/2017  70981 1/21/2017  72960 1/21/2017  73548 1/22/2017  73097 3/13/2017  73917 4/18/2017  74272 4/24/2017  74822 5/14/2017  75045 5/24/2017  74474 5/25/2017  75351 6/20/2017  77597 7/19/2017  75822 7/23/2017  76486 7/27/2017  74084 8/4/2017  76956 8/7/2017  79077 9/10/2017  78131 9/19/2017  77601 10/9/2017  77531 10/10/2017  78761 11/5/2017  78757 11/9/2017  79263 11/23/2017  78470 1/5/2018  79339 1/16/2018  80751 1/23/2018  79337 1/25/2018  79604 2/25/2018  80517 2/25/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0191-2017","Class II","Foot Pack, Kit number AMS3637  convenience custom kits used for general surgery in hospital operating room","85 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    73044 1/27/2016  74133 4/16/2016  76510 10/9/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0244-2017","Class II","Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B  convenience custom kits used for general surgery in hospital operating room  ","360 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    75820 6/11/2016  75698 6/25/2016  75713 6/25/2016  68016 9/28/2016  70207 9/28/2016  69484 10/9/2016  71296 12/4/2016  72356 3/14/2017  73927 5/24/2017  76051 7/13/2017  74538 6/25/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0167-2017","Class II","Custom Tray, Kit numbers: PSS1836 and PSS1836(A  convenience custom kits used for general surgery in hospital operating room","56 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59060 11/3/2015  57225 5/21/2016  57696 7/9/2016  72681 1/11/2017  77152 7/13/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0285-2017","Class II","Dr. Fritsch Pack, Kit number AMS2696    convenience custom kits used for general surgery in hospital operating room                                                                                              ","224 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    63188 1/4/2015  63187 1/28/2015  63186 1/29/2015  65285 6/7/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0250-2017","Class II","OB/GYN Pack, Kit number AMS2038    convenience custom kits used for general surgery in hospital operating room            ","18 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:  58648 4/17/2015    ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0226-2017","Class II","Lithotomy Pack, Kit number AMS2333 and AMS2333(A    convenience custom kits used for general surgery in hospital operating room                          ","630 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    61276 3/4/2014  61277 3/10/2014  62761 11/15/2015  64641 11/30/2015  65276 11/30/2015  69772 12/3/2015  71457 12/3/2015  68312 12/5/2015  69392 12/17/2015  71152 12/17/2015  68629 12/25/2015  64905 12/27/2015        ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0177-2017","Class II","Dr. Harrimans Kit, Kit number PSS3600  convenience custom kits used for general surgery in hospital operating room","120 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    77213 6/5/2017  78414 7/13/2017  79983 10/20/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0241-2017","Class II","Minor Ortho Pack, Kit number 002646-12 and 002646-13    convenience custom kits used for general surgery in hospital operating room                  ","352 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59453 8/2/2013  58726 8/21/2013  62658 12/11/2013  63489 12/17/2013  61162 12/21/2013  60183 12/29/2013  65535 1/31/2014  66430 1/31/2014  66807 1/31/2014  61804 2/7/2014  67876 9/5/2014  64144 9/7/2014  64457 9/30/2014  64909 9/30/2014  69781 5/2/2016  68945 5/10/2016  71058 6/4/2016  57425 6/28/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0173-2017","Class II","Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8  convenience custom kits used for general surgery in hospital operating room  ","360 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    61836 6/30/2013  58821 9/2/2013  60583 11/1/2013  62371 3/8/2014  65618 4/16/2014  64076 4/20/2014  67477 7/11/2014  69351 10/2/2014  69593 12/20/2014  72030 2/2/2016  73144 2/17/2016  72643 2/28/2016  74897 5/31/2016  77971 6/16/2016  76042 6/20/2016  56380 6/25/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0150-2017","Class II","Basin Pack, kit number AMS2497	  convenience custom kits used for general surgery in hospital operating room","1243 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    67015 7/5/2016  67549 8/10/2016  68418 7/7/2016  68820 9/19/2016  68959 9/12/2016  69548 9/20/2016  69852 10/23/2016  70495 10/20/2016  71780 12/11/2016  71957 10/20/2016  71958 1/7/2017  72481 3/15/2017  73643 1/22/2017  73644 4/10/2017  73850 4/23/2017  74062 7/9/2017  76185 7/11/2017  76345 8/31/2017  76673 10/21/2017  77769 10/4/2017  78025 9/22/2017  78741 1/17/2018  80940 8/8/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0277-2017","Class II","Total Knee Pack, Kit number AMS4010(A    convenience custom kits used for general surgery in hospital operating room                                                                                  ","9 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    78940 9/5/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0149-2017","Class II","Basic Tray, Kit part numbers AMS1199(A and PSS1559(A   convenience custom kits used for general surgery in hospital operating room  ","1599 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    56958 5/29/2016  56991 6/4/2016  57637 7/5/2016  57788 7/10/2016  59063 1/22/2016  59363 3/24/2015  60073 10/30/2016  60752 10/29/2015  61309 9/27/2015  62116 11/28/2015  62453 11/14/2015  62727 11/5/2015  63987 1/8/2016  64556 1/6/2016  65214 1/1/2016  65698 11/30/2015  66531 8/9/2016  66620 11/9/2015  68220 9/28/2016  68650 9/13/2016  69059 9/22/2016  69210 5/26/2016  69417 9/7/2016  69787 1/29/2017  70198 11/30/2016  70590 9/21/2016  70993 12/6/2016  71368 12/13/2016  71904 3/30/2017  72550 1/10/2017  72914 3/29/2017  73285 7/21/2017  73824 4/5/2017  74175 5/3/2017  75314 5/11/2017  75728 7/3/2017  76171 7/7/2017  76624 8/4/2017  77162 8/10/2017  77576 10/8/2017  77742 10/2/2017  78128 9/30/2017  78139 9/22/2017  79481 1/23/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0165-2017","Class II","Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070.    convenience custom kits used for general surgery in hospital operating room","6526 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    60238 4/27/2014  63592 5/22/2014  61110 5/31/2014  64981 6/6/2014  64360 6/6/2014  63344 6/17/2014  62792 6/18/2014  63990 6/23/2014  61099 8/21/2014  59122 9/20/2014  65818 11/18/2014  72314 11/25/2014  57135 1/21/2015  65766 2/26/2015  73492 3/31/2015  59151 4/24/2015  57576 5/8/2015  70776 5/13/2015  58841 5/15/2015  57136 5/25/2015  59700 7/8/2015  60764 8/7/2015  61177 8/12/2015  61496 8/15/2015  59482 8/19/2015  60670 9/12/2015  60618 9/15/2015  60619 9/20/2015  61098 9/27/2015  65575 10/17/2015  65113 10/18/2015  60828 10/27/2015  62788 11/2/2015  61930 11/4/2015  61354 11/6/2015  66242 11/7/2015  65407 11/8/2015  62515 11/10/2015  65328 11/10/2015  65380 11/16/2015  62064 11/18/2015  61734 11/22/2015  63294 11/28/2015  63296 11/28/2015  63350 12/9/2015  63743 12/11/2015  62511 12/25/2015  63037 12/25/2015  63371 12/28/2015  63295 12/28/2015  64672 1/13/2016  63423 1/16/2016  63746 1/22/2016  63751 1/23/2016  61978 1/28/2016  75438 5/18/2016  57063 5/22/2016  71254 5/26/2016  56759 5/31/2016  57500 6/20/2016  75530 6/25/2016  56878 7/5/2016  67109 7/5/2016  68691 7/7/2016  66642 7/11/2016  57583 7/12/2016  67283 7/19/2016  57518 7/21/2016  67771 7/29/2016  68690 7/30/2016  58316 8/13/2016  58533 8/16/2016  58916 8/23/2016  58970 8/23/2016  68245 9/3/2016  69838 9/15/2016  69469 9/20/2016  66608 9/21/2016  70428 9/29/2016  70203 10/21/2016  69728 11/2/2016  68983 11/16/2016  70998 12/17/2016  71524 12/17/2016  72094 12/18/2016  72507 1/10/2017  72343 1/15/2017  70557 1/17/2017  72354 1/20/2017  72864 1/21/2017  73491 1/22/2017  73575 1/27/2017  72972 3/5/2017  73284 3/7/2017  72863 3/15/2017  73094 3/24/2017  72768 3/29/2017  73764 4/18/2017  74120 4/19/2017  73432 5/21/2017  74424 5/22/2017  74838 5/23/2017  76477 7/20/2017  75810 7/22/2017  75363 7/23/2017  74113 7/27/2017  75811 7/28/2017  75818 7/29/2017  78094 8/29/2017  77196 8/30/2017  77752 9/2/2017  78208 9/15/2017  77605 9/19/2017  76282 9/30/2017  77372 10/8/2017  76910 10/24/2017  78629 11/3/2017  78209 11/3",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0262-2017","Class II","Plastic Kit, Kit number CMP1084(B    convenience custom kits used for general surgery in hospital operating room                                  ","1164 Kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    58302 3/26/2014  59046 6/9/2014  60228 6/15/2014  60559 6/20/2014  63222 8/14/2014  61004 9/13/2014  61491 9/21/2014  63003 12/11/2014  64005 2/14/2015  63768 2/22/2015  64592 3/18/2015  65494 5/30/2015  67289 6/11/2015  67602 8/14/2015  68438 8/22/2015  68275 8/25/2015  69589 10/22/2015  70504 10/24/2015  71258 12/7/2015  71749 12/19/2015  72506 2/15/2016  72750 2/22/2016  74081 2/24/2016  73436 2/28/2016  56986 5/24/2016  76902 6/20/2016  77188 9/9/2016  77986 9/18/2016  78514 9/19/2016  79246 9/26/2016  80549 10/27/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0275-2017","Class II","Total Hip Pack, Kit number PSS2956    convenience custom kits used for general surgery in hospital operating room                                                                            ","54 Kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    62002 11/6/2015  64669 11/18/2015  64376 11/20/2015  65757 11/26/2015  79509 1/17/2016  79302 1/5/2017  72766 3/1/2017  73547 4/19/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0220-2017","Class II","Laparoscopy Pack, Kit number AMS2537 and AMS2537(A    convenience custom kits used for general surgery in hospital operating room              ","184 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    62091 11/7/2015  62893 1/22/2016  64647 7/14/2016  69438 9/16/2016  69184 9/25/2016  70969 10/20/2016  72483 1/17/2017  73353 3/12/2017      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0205-2017","Class II","Hand Tray	PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D  PSS2365(E,   convenience custom kits used for general surgery in hospital operating room    ","3444 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    62742 2/28/2014  65112 3/23/2014  65816 4/24/2014  56706 5/15/2014  66648 7/21/2014  66649 7/21/2014  66165 7/25/2014  57524 9/1/2014  57338 9/20/2014  57977 9/22/2014  56883 9/24/2014  57057 9/24/2014  57523 9/25/2014  58348 1/3/2015  58349 1/4/2015  59680 1/17/2015  60694 1/24/2015  59678 1/25/2015  59679 1/26/2015  59221 1/28/2015  60104 1/29/2015  61738 4/24/2015  61740 6/11/2015  64688 6/19/2015  63590 6/22/2015  63772 6/22/2015  64002 6/22/2015  61739 6/27/2015  63257 6/28/2015  67941 2/11/2016  69813 3/23/2016  69812 3/26/2016  70306 3/30/2016  70581 3/30/2016  68432 6/1/2016  68433 6/9/2016  68006 6/12/2016  68578 6/13/2016  68008 6/30/2016  68894 6/30/2016  75064 7/30/2016  75200 7/30/2016  75500 7/30/2016  75803 7/30/2016  71902 9/10/2016  70989 9/21/2016  72308 9/24/2016  72754 9/24/2016  71238 9/25/2016  74820 11/9/2016  73337 11/15/2016  73397 11/15/2016  74294 11/24/2016  72983 11/25/2016  73566 11/28/2016  78172 4/16/2017  78171 4/19/2017  77607 4/23/2017  76467 4/24/2017  77068 4/24/2017  78380 4/24/2017  80630 4/24/2017  79474 4/25/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0268-2017","Class II","Set-Up Pack, Kit number PSS1305(B and PSS1305(C    convenience custom kits used for general surgery in hospital operating room                                                        ","2225 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    67723 11/19/2015  61928 11/20/2015  56692 7/19/2016  67757 7/22/2016  58305 8/6/2016  58345 8/14/2016  69798 9/14/2016  69922 9/16/2016  69923 9/29/2016  58346 10/4/2016  70578 10/11/2016  68747 10/12/2016  69280 10/23/2016  70579 12/5/2016  70580 12/26/2016  70988 3/23/2017  73558 4/24/2017  74320 5/24/2017  74472 5/25/2017  75989 7/16/2017  77190 7/21/2017  76466 7/22/2017  74850 7/23/2017  76890 7/23/2017  75368 7/30/2017  76891 8/4/2017  76903 8/10/2017  77517 8/29/2017  77987 9/5/2017  77361 10/10/2017  78110 1/9/2018  78111 2/6/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0264-2017","Class II","Podiatry Kit	PSS1040(A, PSS1040(B, and PSS1040(C    convenience custom kits used for general surgery in hospital operating room                                          ","545 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    63877 2/4/2015  65406 2/26/2015  65972 2/26/2015  64947 10/18/2015  61767 11/13/2015  64379 1/4/2016  63309 1/22/2016  57497 7/1/2016  67411 7/11/2016  58086 7/19/2016  77189 7/30/2016  68577 9/22/2016  69473 10/17/2016  72803 1/16/2017  72989 3/29/2017  73422 4/16/2017  76920 4/23/2017  73577 4/25/2017  74415 5/9/2017  74835 6/18/2017  76482 7/13/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0187-2017","Class II","Eye Tray, Kit number PSS1834 and PSS1939    convenience custom kits used for general surgery in hospital operating room","802 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    76299 8/11/2017  78136 8/14/2017  77537 8/15/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0168-2017","Class II","Custom Venous Kit, TVS4024(C    convenience custom kits used for general surgery in hospital operating room","1584 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers Expiration Dates  57411 5/13/2015  58475 5/14/2015  57820 5/17/2015  60799 8/3/2015  62975 11/14/2015  63103 11/14/2015  62235 11/15/2015  62675 11/25/2015  65935 11/27/2015  60995 11/29/2015  63104 12/14/2015  64487 1/5/2016  63521 1/29/2016  67570 4/30/2016  68694 7/11/2016  69235 7/14/2016  68935 7/18/2016  67788 7/30/2016  70949 9/19/2016  76072 11/2/2016  80515 11/2/2016  74746 11/9/2016  76638 11/25/2016  73892 11/26/2016  75428 11/28/2016  79295 11/30/2016  71620 12/12/2016  70720 1/4/2017  75219 5/31/2017  77663 6/19/2017  78672 8/22/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0175-2017","Class II","Dr. Casey Pack, kit number AMS4313  convenience custom kits used for general surgery in hospital operating room      ","48 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    81302 11/14/2015  78341 11/23/2015  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0279-2017","Class II","Universal Pack, Kit number AMS2036    convenience custom kits used for general surgery in hospital operating room                                                                                    ","99 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    63911 6/1/2014  61913 8/10/2014  71796 9/3/2014  68840 9/12/2014  58646 12/17/2014  74391 6/18/2016  78100 6/30/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0282-2017","Class II","Vaginal Pack, Kit number AMS1722    convenience custom kits used for general surgery in hospital operating room                                                                                            ","12 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    62061 6/14/2014  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0213-2017","Class II","Knee Scope Pack, Kit number AMS2498 and AMS2498(A  convenience custom kits used for general surgery in hospital operating room","272 kits ","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    62085 11/12/2015  64546 1/4/2016  67402 7/13/2016  67696 8/21/2016  68498 9/18/2016  70496 9/23/2016  74549 5/9/2017  76677 7/19/2017  75582 7/22/2017  77685 (no expiration date provided)  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0227-2017","Class II","Local Pack, Kit number AMS1544    convenience custom kits used for general surgery in hospital operating room                            ","190 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    65460 11/11/2015  66427 11/28/2015  63176 12/28/2015  63803 1/12/2016  67585 8/10/2016          ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0195-2017","Class II","General Pack II, Kit number CMP1812(B  convenience custom kits used for general surgery in hospital operating room","135 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    59655 7/11/2015  65453 11/3/2015  66602 11/28/2015  62302 1/7/2016  57319 6/27/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0223-2017","Class II","Laparotomy Tray, Kit number PSS1538    convenience custom kits used for general surgery in hospital operating room                    ","32 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    57508 6/19/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0197-2017","Class II","General Plastics Pack, Kit number 008617-1  convenience custom kits used for general surgery in hospital operating room","985 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    60558 11/6/2014  58503 11/9/2014  58887 11/15/2014  61480 11/21/2014  61881 5/16/2015  62122 5/25/2015  72125 3/12/2016  56859 5/22/2016  57574 6/26/2016  75367 10/18/2016  78105 10/20/2016  72126 10/21/2016  73669 10/23/2016  74705 10/23/2016  72127 10/27/2016  76745 4/2/2017  75824 4/23/2017  79786 8/6/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0190-2017","Class II","Facial Tray, Kit number PSS1558(A    convenience custom kits used for general surgery in hospital operating room","282 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59208 11/3/2015  66913 11/9/2015  64949 1/1/2016  63581 1/4/2016  56990 6/19/2016  58800 8/22/2016  68611 9/11/2016  69745 9/17/2016  73553 1/27/2017  70679 3/22/2017  73768 4/11/2017  74539 6/19/2017  75798 9/19/2017  79480 1/2/2018  80615 2/23/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0272-2017","Class II","Student Pack-NS, Kit number PSS2788    convenience custom kits used for general surgery in hospital operating room                                                                    ","5 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    58594 7/23/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0198-2017","Class II","General Surgery Pack, Kit number PSS1380(A  convenience custom kits used for general surgery in hospital operating room","168 kits ","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    70328 2/3/2015  65789 2/26/2015  65574 11/9/2015  62152 11/13/2015  68748 12/27/2015  63873 1/24/2016  66910 5/30/2016  72335 7/8/2016  72751 7/25/2016  79224 9/10/2017  75804 10/9/2017  79488 1/9/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0147-2017","Class II","Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758,  AMS2758(A, AMS2972,  AMS4264,  AMS4309,  PSS1833, and PSS1848(A.     convenience custom kits used for general surgery in hospital operating room                                 ","6381 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    56104 4/5/2015  56836 6/19/2016  57228 5/22/2016  57473 6/26/2016  58063 8/6/2016  58068 7/11/2016  58357 7/31/2016  58588 4/10/2015  59298 3/11/2015  59847 9/13/2015  60274 11/4/2015  60353 7/18/2015  60354 7/22/2015  60649 10/28/2015  60797 11/5/2015  61071 10/3/2015  61873 11/28/2015  62203 11/7/2015  62456 11/28/2015  62945 11/2/2015  63065 9/3/2015  63204 11/11/2015  63665 1/29/2016  64166 1/6/2016  64470 1/13/2016  64559 1/29/2016  64750 1/18/2016  64819 10/11/2015  64976 1/14/2016  65020 6/27/2017  65048 11/1/2015  65116 1/17/2016  65411 11/1/2015  65442 11/15/2015  65737 2/15/2016  65804 2/25/2015  65879 12/22/2015  66321 11/12/2015  66395 6/27/2015  66696 11/4/2015  67207 11/16/2015  67521 8/21/2015  67551 7/23/2016  67694 5/2/2015  67700 7/26/2016  67701 7/4/2016  67810 8/10/2016  67966 7/15/2016  68145 8/28/2016  68387 7/6/2016  68410 9/21/2016  68413 9/25/2015  68710 9/13/2016  68711 9/22/2016  68721 9/18/2016  68822 9/5/2016  68857 2/21/2015  69056 11/26/2017  69067 9/20/2016  69191 9/16/2016  69343 9/5/2016  69344 9/11/2016  69345 9/14/2016  69549 9/20/2016  69646 12/24/2016  69893 3/29/2017  70157 9/12/2016  70176 12/12/2015  70966 7/11/2016  70970 10/10/2016  71156 12/27/2016  71450 2/13/2015  71634 1/5/2017  71634 1/5/2017  71788 10/20/2016  71945 1/3/2017  71955 2/7/2015  71987 1/21/2017  72112 3/24/2017  72306 1/7/2017  72490 3/21/2017  72616 3/23/2017  72640 3/12/2017  72978 3/1/2017  72978 3/1/2017  73191 8/21/2016  73203 3/8/2017  73204 4/20/2017  73428 4/4/2017  73645 1/22/2017  73646 4/5/2017  73826 7/27/2017  73933 4/13/2017  73933 4/13/2017  73934 5/3/2017  74061 1/16/2017  74442 4/20/2017  74460 5/9/2017  75094 5/4/2017  75255 6/21/2017  75455 6/25/2016  75646 7/16/2017  75745 6/27/2016  75830 7/9/2017  75902 7/11/2017  76026 7/2/2017  76034 7/23/2017  76083 4/23/2017  76141 7/9/2017  76142 4/23/2017  76152 7/30/2016  76161 8/30/2017  76236 7/15/2016  76662 10/25/2017  76680 8/29/2017  76917 8/5/2017  76948 8/30/2017  77315 10/1/2017  77434 8/14/2017",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0256-2017","Class II","Pacemaker Kit, Kit number AMS4281    convenience custom kits used for general surgery in hospital operating room                        ","102 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    77873 7/30/2016  78569 7/30/2016  78933 9/18/2017                      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0287-2017","Class II","Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C  convenience custom kits used for general surgery in hospital operating room                                                                                                          ","340 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    58259 12/20/2013  55829 12/25/2013  59562 5/1/2014  59430 5/3/2014  63233 10/23/2014  60818 10/28/2014  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0286-2017","Class II","Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B    convenience custom kits used for general surgery in hospital operating room                                                                                                  ","50 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    57847 10/1/2014  59048 10/13/2014  62496 10/19/2014  65226 10/26/2014  65787 10/18/2014  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0148-2017","Class II","Basic Setup Pack, kit part number AMS1787(A	  convenience custom kits used for general surgery in hospital operating room                                 ","256 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers Expiration Dates  60480 9/6/2015  61269 9/2/2015  63468 11/10/2015  65272 11/13/2015  68625 9/14/2016  69999 10/2/2016  70654 10/11/2016  71789 12/10/2016  72154 3/8/2017  73836 5/16/2017  75272 7/18/2017  76643 7/1/2017  77304 10/8/2017  78543 8/30/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0229-2017","Class II","Lumbar Laminectomy Pack, Kit number AMS2501    convenience custom kits used for general surgery in hospital operating room                                ","249 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    64906 11/3/2015  66041 11/6/2015  62111 11/12/2015  65892 12/22/2015  66759 7/29/2016  69271 9/19/2016  68960 9/26/2016  67958 9/28/2016  70334 1/29/2017  74063 5/15/2017  75454 7/8/2017  80958 8/8/2017  78464 9/14/2017  77100 10/25/2017  79659 1/17/2018  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0238-2017","Class II","Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15  convenience custom kits used for general surgery in hospital operating room              ","356 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    58414 8/13/2013  62931 12/9/2013  60184 12/29/2013  59455 1/9/2014  61163 1/21/2014  66804 1/31/2014  65169 2/28/2014  67878 9/11/2014  62190 9/26/2014  64342 9/30/2014  68948 5/10/2016  70180 5/16/2016  57028 5/30/2016  71059 6/4/2016  57611 7/2/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0246-2017","Class II","Morris Hysto Pack, Kit number PSS3198 and PSS3198(A    convenience custom kits used for general surgery in hospital operating room    ","186 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    65959 12/25/2015  68013 8/9/2016  69749 11/23/2016  71891 12/18/2016  70206 1/5/2017  72293 1/7/2017  72801 5/24/2017  74795 7/30/2017  79807 8/1/2017  76757 10/25/2017        ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0186-2017","Class II","Eye Plastic Tray, Kit number PSS1931(A    convenience custom kits used for general surgery in hospital operating room","720 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers Expiration Dates  56700 2/25/2014  57515 4/17/2014  62330 8/13/2014  61942 8/29/2014  59216 10/8/2014  63015 1/2/2015  62624 1/6/2015  68055 6/9/2015  66922 6/26/2015  68289 8/28/2015  68448 10/13/2015  72101 11/18/2015  72971 2/28/2016  75676 5/16/2016  76488 9/4/2016  78162 11/13/2016  79264 1/6/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0258-2017","Class II","Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D  convenience custom kits used for general surgery in hospital operating room                              ","1160 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    56901 1/31/2015  57410 5/13/2015  57819 5/25/2015  58770 7/19/2015  59874 8/14/2015  60612 10/10/2015  61900 11/6/2015  62135 11/13/2015  64254 11/16/2015  65934 11/18/2015  63855 1/2/2016  64311 1/5/2016  68002 7/12/2016  73542 1/3/2017  74101 1/9/2017  77040 3/11/2017  75746 3/15/2017  78275 3/23/2017  78671 9/10/2017  80514 11/27/2017                        ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0158-2017","Class II","C-Birth Pack, Kit part number AMS2037 and AMS2037(A  convenience custom kits used for general surgery in hospital operating room                                   ","48 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates    58647 8/18/2013  60158 10/31/2015  66579 11/28/2015  67412 4/30/2016  68841 1/31/2016  73940 8/31/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0166-2017","Class II","Custom Pack - with Introducer Kit,  Kit number TVS4011NI(K and TVS4011NI(L  convenience custom kits used for general surgery in hospital operating room","1470 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:      62733 11/3/2015  62734 11/11/2015  63822 11/15/2015  63851 1/1/2016  64256 1/3/2016  64255 1/13/2016  63852 4/2/2016  69318 7/14/2016  69233 7/18/2016  69910 9/17/2016  70959 12/6/2016  70958 1/3/2017  73965 1/9/2017  73697 1/20/2017  73698 1/23/2017  75426 5/18/2017  73966 5/20/2017  76637 6/11/2017  76070 6/30/2017  78670 8/13/2017  78276 9/30/2017      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0179-2017","Class II","Dr. Newman Surgical Procedure Pack, kit numbers PSS1689  PSS1689(A  convenience custom kits used for general surgery in hospital operating room          ","666 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    58460 7/10/2015  60260 7/18/2015  61708 10/14/2015  65115 11/17/2015  61937 11/29/2015  64687 1/12/2016  68445 3/17/2016  66915 7/5/2016  57957 7/21/2016  67620 9/29/2016  70297 10/26/2016  73096 11/12/2016  72508 11/21/2016  73565 12/20/2016  74851 1/23/2017  75802 4/30/2017  79176 5/5/2017  79475 5/26/2017  79793 6/27/2017      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0145-2017","Class II","Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D.    convenience custom kits used for general surgery in hospital operating room","2266 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    57202 6/5/2016  57594 7/18/2016  58486 8/2/2016  58745 8/27/2016  59099 3/1/2015  59975 7/18/2015  60444 9/13/2015  60705 8/3/2015  61043 8/20/2015  61552 11/27/2015  62834 11/7/2015    63155 11/27/2015  63156 1/2/2016  64068 11/23/2015  64504 11/10/2015    65556 11/9/2015  65855 11/6/2015  66687 11/26/2015  67232 11/18/2015  67233 8/10/2016  67579 8/22/2016  68618 7/11/2016  68940 9/12/2016  69988 9/23/2016  71297 9/12/2016  71430 12/25/2016  71814 12/13/2016  72034 3/13/2017  73741 4/3/2017  74154 4/26/2017  74893 5/4/2017  75440 5/14/2017  75692 7/12/2017  76228 7/3/2017  76544 7/29/2017  76710 8/29/2017  77124 9/23/2017  79188 9/16/2017  79450 1/9/2018  79755 2/28/2018          ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0151-2017","Class II","Bayview Abdominoplasty Pack, Kit part number 009079-1  convenience custom kits used for general surgery in hospital operating room  ","90 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/Expiration Dates:    57718 6/18/2016  60804 5/16/2015  62210 5/7/2015  62802 6/6/2015  66875 11/20/2015  72825 7/29/2016  73912 7/5/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0156-2017","Class II","Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A.    convenience custom kits used for general surgery in hospital operating room                             ","505 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59572 3/1/2015  58932 4/24/2015  57078 7/8/2015  57694 7/14/2015  60620 8/4/2015  61768 11/4/2015  67414 11/16/2015  65034 1/17/2016  75189 4/16/2016  76805 4/17/2016  57372 6/19/2016  57636 6/20/2016  66625 7/29/2016  67295 9/27/2016  71082 9/28/2016  71404 12/21/2016  72826 1/16/2017  72162 1/27/2017  75661 6/18/2017  76889 7/16/2017  77066 7/19/2017  81026 1/13/2018  79638 1/9/2019  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0214-2017","Class II","Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B  convenience custom kits used for general surgery in hospital operating room    ","838 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot numbers/Expiration dates:    75528 5/27/2016  76257 7/24/2016  78137 9/3/2016  79387 9/13/2016  76896 9/18/2016  74939 9/20/2016  79907 10/10/2016      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0203-2017","Class II","Hall SAP, Kit number SRK1031(A  convenience custom kits used for general surgery in hospital operating room","30 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/Expiration Date:    57039 5/21/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0257-2017","Class II","Pelviscopy/Laparoscopy Pack, Kit number PSS3342    convenience custom kits used for general surgery in hospital operating room                          ","28 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    69511 9/5/2014  73546 12/27/2015                      ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0143-2017","Class II","Augmentation Mammoplasty Tray, Kit part number AMS2234.  convenience custom kits used for general surgery in hospital operating room  ","132 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59290 3/26/2015  60125 10/3/2015  61861 11/30/2015  62390 12/11/2015  63343 12/3/2015  63477 1/24/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0160-2017","Class II","C-Tray Pack, Kit number PSS2707and PSS2707(A  convenience custom kits used for general surgery in hospital operating room","186 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers/ Expiration Dates:    59927 1/26/2013  67573 1/15/2014  65388 1/17/2014  66189 1/18/2014  64668 1/25/2014  68256 12/6/2014  72518 7/8/2015  75168 7/16/2015  73464 7/17/2015  77622 1/26/2016  76003 7/3/2016  77246 7/17/2016  76580 7/29/2016  74412 7/31/2016  72288 1/9/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0232-2017","Class II","Major Kit, Kit number PHC1307(A  convenience custom kits used for general surgery in hospital operating room","175 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Numbers Expiration Dates  59849 9/7/2015  65027 10/19/2015  62205 11/5/2015  57300 7/1/2016  77646 7/30/2016  66323 8/27/2016  73020 1/29/2017  70214 1/30/2017  75780 7/8/2017  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",71968,"Completed","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.","Z-0263-2017","Class II","Plastic Pack	, Kit number AMS1833(A    convenience custom kits used for general surgery in hospital operating room                                    ","204 kits","The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.","10/20/2016",," Lot Number/ Expiration Date:    58987 3/10/2014  65124 6/13/2014  63594 6/30/2014  65383 7/3/2014  67936 9/16/2014  68657 9/20/2014  67280 9/27/2014  76180 6/10/2016  57602 6/18/2016  78529 7/30/2016  59242 8/27/2016  80645 11/19/2016  ",4/22/2015,"04/22/2015",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0973-2016","Class I","Xcellerator (product not labeled)",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," unknown",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0961-2016","Class I","Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules.  Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," UPC 853002003025",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0970-2016","Class I","Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," UPC 859613274229",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0967-2016","Class I","TruTrim (product not labeled)",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," unknown",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0965-2016","Class I","Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers.  http://www.secretsofherbs.com.  Made in the USA.",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," unknown",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0971-2016","Class I","Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," UPC 859613252258",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0964-2016","Class I","MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers.  www.metapro360.com 877-778-7509.",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," UPC 637687114593",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0966-2016","Class I","The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049.",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," UPC 020025500095",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0969-2016","Class I","Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers.  TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," UPC 637687019133",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0972-2016","Class I","Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers.  Distributed by Cloma Pharma Laboratories, Samford, CT 06902.",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," UPC 859613638496",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0968-2016","Class I","Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," UPC 637687019003",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0963-2016","Class I","Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules.  Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," unknown",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",71989,"Ongoing","Novacare, LLC","312 W 6100 S",".","Murray","UT","84107-6990","United States","Voluntary: FDA Requested",,"Nationwide","D-0962-2016","Class I","The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers.  Manufactured by TPC, LLC, www.thepeopleschemist.com.",,"Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.","06/06/2016",," UPC 793573902665",8/24/2015,"08/24/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72001,"Ongoing","HeartWare Inc","14400 NW 60th Ave",,"Miami Lakes","FL","33014-2807","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.","Z-0005-2017","Class I","HeartWare Ventricular Assist System Controller     Product Usage:  For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter","8799  Worldwide, 4,564 in US","Loose connector ports in controller body.","10/17/2016",," All Heartware Controllers manufactured after September 2014.  US Model No: 1400, 1401XX, 1403US.   International Model No: 1400, 1401XX, 1407XX. ",6/8/2016,"06/08/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1159-2016","Class II","HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212","352 syringes","Stability Data Does Not Support Expiry","07/06/2016","."," Lot: 150090, exp 12/24/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1158-2016","Class I","fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165","1652 syringes","Subpotent Drug","07/06/2016","."," Lot: 6324, exp 10/11/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1161-2016","Class II","LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033","450 syringes","Subpotent Drug","07/06/2016","."," Lot: 150947, exp 9/5/15; 151087, exp 9/21/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1155-2016","Class I","fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301","235 syringes","Subpotent Drug","07/06/2016","."," Lot: 151142, exp 10/22/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1152-2016","Class I","fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450","884 syringes","Subpotent Drug","07/06/2016","."," Lot: 6234, exp 9/20/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1162-2016","Class II","Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455","3853 syringes","Subpotent Drug","07/06/2016","."," Lot: 6218, exp 9/17/15; 6877, exp 1/24/16",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1156-2016","Class I","fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR","a) 564 syringes and b) 1146 syringes","Subpotent Drug","07/06/2016","."," a) Lots: 148292, exp 11/9/15 and 150610, exp 1/6/16 and b) Lots: 6208, exp 9/16/15 and 6851, exp 1/19/16",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1154-2016","Class I","fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131","42 syringes","Subpotent Drug","07/06/2016","."," Lot: 150125, 12/19/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1164-2016","Class II","MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161","1570 syringes","Subpotent Drug","07/06/2016","."," Lot: 6178, exp, 9/12/15; 6529, exp 11/22/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1153-2016","Class I","Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL),  in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453 ","a) 450 syringes and b) 1250 syringes","Subpotent Drug","07/06/2016","."," a) Lots: 149690, exp 9/14/15 and 151665, exp 11/5/15 and   b) Lots: 149198, exp 9/3/15; 151454, exp 9/14/15; 151668, exp 11/5/15 and 151962, exp 11/11/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1163-2016","Class II","MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721","212 syringes","Subpotent Drug","07/06/2016","."," Lot: 149167, exp 9/2/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1157-2016","Class I","fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR ---  UPC: 9999993491","148 syringes","Subpotent Drug","07/06/2016","."," Lot: 150370, exp 1/2/16",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72028,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1160-2016","Class II","HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163","4170 syringes","Stability Data Does Not Support Expiry","07/06/2016","."," Lot: 6146, exp 9/5/15",8/21/2015,"08/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72077,"Terminated","Provimi North American Inc","943 Schneider St",,"Fremont","NE","68025-6133","United States","Voluntary: Firm Initiated","Telephone","Nebraska","V-305-2016","Class I","START A300 PAC, 2000# tote, Manufactured by Provimi North America, Inc., Brookville, Ohio 45309","6/2000 lbs/totes","Elevated levels of vitamin A can lead to elevated levels of morbidity and mortality in swine.","02/09/2016","02/09/2016"," F0002474302",8/27/2015,"08/27/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1137-2016","Class III","Iowa Select Herbs LLC, Alisma Leaf, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 130601H040, Expires - 02/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1181-2016","Class III"," (Annona muricata), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402","(a) 12 bottles, (b) 5 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 22363, Expires - 09/2020;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1166-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, Cyperus Leaf,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 06305SL12, Expires - 04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1191-2016","Class III","Iowa Select Herbs LLC, Licorice Root (Glycyrrhiza glabra), www.iowaselectherbs.com, (a) 2 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz., Cedar Rapids, IA 52402","(a) 2 bottles (b) 127 bottles (c) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32698, Expires - 02/2020; Lot - 33380, Expires - 02/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1153-2016","Class III","Iowa Select Herbs LLC, Buchu Leaf, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30338, Expires - 07/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1226-2016","Class III","Iowa Select Herbs LLC, Suma Root,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","3 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-21035 Expires-02/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1175-2016","Class III","Iowa Select Herbs LLC, Fenugreek Seed (Trigonella foenum-graecum),  www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz., (c) 16 fl. Oz, (d) 32 fl. Oz., Cedar Rapids, IA 52402","(a) 1 bottle, (b) 33 bottles, (c) 3 bottles, (d) 2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32684, Expires - 11/2019; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1214-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, Raspberry Leaf,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-19183 Expire-04/20",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1142-2016","Class III","Iowa Select Herbs LLC, Atragalus Root (Astragalus Membranaceus), www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 2 fl. Oz., (c) 4 fl. Oz., and (d) 7.5 fl. Oz., Cedar Rapids, IA 52402","(a) 2 bottles, (b) 1 bottle, (c) 10 bottles, (d) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31685, Expires - 05/2019 and Lot - 30900, Expires - 05/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1185-2016","Class III","Iowa Select Herbs LLC, Hibiscus Flowers (Hibiscus sabdariffa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30763, Expires - 03/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1151-2016","Class III","Iowa Select Herbs LLC, Boswellia Serrata, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 108tc13, Expires - 07/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1146-2016","Class III","Iowa Select Herbs LLC, Bilberry Leaf (Vaccinium myrtulli), www.iowaselectherbs.com, (a) 4 fl. Oz. and (b) 1 gallon , Cedar Rapids, IA 52402","(a) 10 bottles and (b) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 19889, Expires - 05/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1224-2016","Class III","Iowa Select Herbs LLC, Solomon Seal,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","3 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-350150980313 Expires-02/2019; Lot-32862 Expires-02/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1209-2016","Class III","Iowa Select Herbs LLC, Propolis (Ligustrum lucidum), 4 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-22386 Exp - 08/2018",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1155-2016","Class III","Iowa Select Herbs LLC, Cascara Root (Rhamnus purshiana), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 17233, Expires - 03/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1202-2016","Class III","Iowa Select Herbs LLC, Oregano Leaf (Origanum vulgare), www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 19976, Expires - 05/2018; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1203-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, Papaya Leaf, www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 12 fl. Oz. (d) 16 fl. Oz. (e) 32 fl. Oz. (f) 128 fl. Oz. (g) unknown size, Cedar Rapids, IA 52402","(a) 5 bottles, (b) 93 bottles, (c) 1 bottle, (d) 23 bottles, (e) 19 bottles (f) 1 bottle (g) 4 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 52972, Expires 04/20",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1184-2016","Class III","Iowa Select Herbs LLC, Hawthorn Berry (Crateagus oxycanthus), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 96483, Expires - 02/2020;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1229-2016","Class III","Iowa Select Herbs LLC, White Peony Root (Paeonia lactiflora),  www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 4 fl. Oz., (c) 16 fl. Oz., (d) 32 fl. Oz., (e) 40 fl. Oz., (f) unknown size, Cedar Rapids, IA 52402","(a) 10 bottles (b) 65 bottles (c) 2 bottles (d) 1 bottle (e) 1 bottle (f) 1 bottle = 80 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-111001H209 Expires-02/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1217-2016","Class III","Iowa Select Herbs LLC, Rhubarb Root (Rhizoma rhei),  www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-30176 Exp-02/2018",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1141-2016","Class III","Iowa Select Herbs LLC, Ashwaganda Root (Withania somnifera), www.iowaselectherbs.com, (a) 1 fl. Oz. and (b) 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402","(a) 2 bottles and (b) 10 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 22349, Expires - 05/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1173-2016","Class III","Iowa Select Herbs LLC, Eleuthero Root (Eleutherococcus senticosus),  www.iowaselectherbs.com,  7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30469, Expires - 12/2019; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1171-2016","Class III","Iowa Select Herbs LLC, Echinacea Purpurea,  www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz. (d) 1 gallon, Cedar Rapids, IA 52402","(a) 2 bottles, (b) 2 bottles, (c) 1 bottle, (d) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32263, Expires - 04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1216-2016","Class III","Iowa Select Herbs LLC, Rhodiola Root,  www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-131101H504 Exp-12/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1144-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, Bayberry Root, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31186, Expires - 04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1148-2016","Class III","Iowa Select Herbs LLC, Black Cohosh Root, www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 19972, Expires - 08/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1201-2016","Class III","Iowa Select Herbs LLC, Olive Leaf (Olea europa), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz., (c) 1 gallon (d) Unknown size. Cedar Rapids, IA 52402","(a) 16 bottles, (b) 1 bottle, (c) 1 bottle, (d) 25 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32772, Expires - 05/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1143-2016","Class III","Iowa Select Herbs LLC,Atractylodes (Atractylodes macrocephala), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402","10 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 45811, Expires - 05/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1189-2016","Class III","Iowa Select Herbs LLC, Kava Kava Root (Piper methysticum), www.iowaselectherbs.com, (a) 2 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz., Cedar Rapids, IA 52402","(a) 1 bottle, (b) 26 bottles, (c) 2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30540, Expires - 02/2020; Lot - 33660, Expires - 02/2020;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1174-2016","Class III","Iowa Select Herbs LLC, Fennel Seed (Foeniculum vulgara),  www.iowaselectherbs.com,  4 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31001, Expires - 04/2020; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1176-2016","Class III","Iowa Select Herbs LLC, Garcinia Fruit (Garcinia cambogia),  www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 4 fl. Oz., Cedar Rapids, IA 52402","(a) 2 bottles, (b) 2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 21484, Expires - 06/2019; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1237-2016","Class III","Iowa Select Herbs LLC,  Yucca Root (Yucca aloifolia) www.iowaselectherbs.com, 1 Gallon., Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31990, Expires - 02/2019; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1156-2016","Class III","Iowa Select Herbs LLC, Cat's Claw (Uncaria tomentosa), www.iowaselectherbs.com, 7.5 Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31487, Expires - 04/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1195-2016","Class III","Iowa Select Herbs LLC, Alcohol Free, Milk Thistle, www.iowaselectherbs.com, 16 fl. Oz., Cedar Rapids, IA 52402","12 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32358, Expires - 04/2020; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1211-2016","Class III","Iowa Select Herbs LLC, Psoralea Seed (Psoralea corylifolia), 1 gallon, www.iowaselectherbs.com, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-49697 Exp - 02/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1177-2016","Class III","Iowa Select Herbs LLC, Ginger Root (Zingiber officinale),  www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 7.5 fl. Oz., (d) 1 gallon, Cedar Rapids, IA 52402","(a) 1 bottle, (b) 1 bottle, (c) 1 bottle, (d) 20 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 33500, Expires - 05/2019; Lot - 31123, Expires - 05/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1161-2016","Class III","Iowa Select Herbs LLC, Cinnamon Bark (Cinnamomum cassia), www.iowaselectherbs.com, (a) 1 fl. Oz..(b) 4 fl. Oz., Cedar Rapids, IA 52402","(a) 2 bottles, (b) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 29792, Expires - 05/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1207-2016","Class III","Iowa Select Herbs LLC, Organic Papaya Leaf (paw paw/papain), 500 mg, 60 Capsules, www.iowaselectherbs.com, Cedar Rapids, IA 52402","36 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Unknown",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1162-2016","Class III","Iowa Select Herbs LLC,Citrus Peel (Uncaria tomentosa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 55756, Expires - 04/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1178-2016","Class III","Iowa Select Herbs LLC, Ginkgo Leave (Ginkgo biloba),  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30520, Expires - 08/2018;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1165-2016","Class III","Iowa Select Herbs LLC, Cudweed,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31796, Expires - 03/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1139-2016","Class III","Iowa Select Herbs LLC, Arnica Flowers, www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402","10 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30599, Expires - 02/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1134-2016","Class III","Iowa Select Herbs LLC, Acerola Berry (Malpighia), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402","10 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32795, Expires 04/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1227-2016","Class III","Iowa Select Herbs LLC, Tumeric,  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-37441 Expires-07/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1180-2016","Class III","Iowa Select Herbs LLC, Grape Seed Leaf (Vitis vinifera), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","3 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32574, Expires - 02/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1200-2016","Class III","Iowa Select Herbs LLC, Oatstraw (Avena sativa), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz., (c) 32 fl. Oz., (d) 128 fl. Oz. Cedar Rapids, IA 52402","(a) 28 bottles, (b) 76 bottles, (c) 3 bottles, (d) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31953, Expires - 092019; Lot - 33183, Expires - 09/2019; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1232-2016","Class III","Iowa Select Herbs LLC, Yarrow Flowers (Achillea millefolium),  www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402","24 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-22396 Expires-07/2018",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1215-2016","Class III","Iowa Select Herbs LLC, Reishi Mushroom (Ganoderma Lucidum),  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-8427 Exp-02/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1230-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, White Willow Bark,  www.iowaselectherbs.com, (a) 16 fl. Oz. (b) 1 gallon, Cedar Rapids, IA 52402","(a) 1 bottle, (b) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-32973 Expires-04/20",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1183-2016","Class III","Iowa Select Herbs LLC, Gymnema Sylvestre (Gymnena sylvestre), www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz., Cedar Rapids, IA 52402","(a) 12 bottles (b) 16 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - m10866, Expires - 02/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1206-2016","Class III","Iowa Select Herbs LLC, Red Ginseng Root (Panax ginseng), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 8958, Expires - 12/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1223-2016","Class III","Iowa Select Herbs LLC, Scullcap (Scutellaria lateriflora),  www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402","3 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-32863 Expires-04/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1187-2016","Class III","Iowa Select Herbs LLC, Jewel Weed, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","4 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 17544800916, Expires - 05/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1160-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, Cilantro Leaf, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32446, Expires - 04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1218-2016","Class III","Iowa Select Herbs LLC, Alcohol-free, Sage Leaf,  www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-32880 Expire-04/20",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1145-2016","Class III","Iowa Select Herbs LLC, Beet Root (Beta vulgaris), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402","10 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 22351, Expires - 08/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1167-2016","Class III","Iowa Select Herbs LLC, Damiana Leaf (Turnera diffusa),  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31265, Expires - 04/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1221-2016","Class III","Iowa Select Herbs LLC, Saw Palmetto Berry (Serenoa repens),  www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz., (c) 32 fl. Oz., (d) unknown size., Cedar Rapids, IA 52402","(a) 10 bottles, (b) 7 bottles, (c) 1 bottle, (d) 2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-32654 Expires-09/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1188-2016","Class III","Iowa Select Herbs LLC, Juniper Berry (Juniperus communis), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 19836, Expires - 05/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1147-2016","Class III","Iowa Select Herbs LLC, Bitter Melon (Momordica charantia, www.iowaselectherbs.com, 32 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 58545F, Expires - 05/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1154-2016","Class III","Iowa Select Herbs LLC, Burdock Root, www.iowaselectherbs.com, 4 fl. Oz.., Cedar Rapids, IA 52402","24 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 20771, Expires - 04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1138-2016","Class III","Iowa Select Herbs LLC, Aloe Vera Juice (Aloe barbaderis mill), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402","10 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - m10752, Expires - 11/2016",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1212-2016","Class III","Iowa Select Herbs LLC, Pygeum Bark,  www.iowaselectherbs.com, (a) 4 fl Oz. (b) unknown size, Cedar Rapids, IA 52402","(a) 38 bottles, (b) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-32407 Exp - 12/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1169-2016","Class III","Iowa Select Herbs LLC, Dandelion Root,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","20 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30902, Expires - 09/2019; Lot - 32945, Expires - 09/2019; Lot - 20792, Expires - 09/2019; Lot - 33154, Expires - 09/2019; Lot - 33583, Expires - 09/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1233-2016","Class III","Iowa Select Herbs LLC, Yohimbe Bark (Pausinystalia Yohimbe),  www.iowaselectherbs.com, (a) 2 fl. Oz., (b) 4 fl. Oz., (c) 1 gallon, Cedar Rapids, IA 52402","(a) 1 bottle, (b) 2 bottles, (c) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-32533 Expires-04/2018",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1192-2016","Class III","Iowa Select Herbs LLC, Lobelia Leaf, (Lobelia inflata) www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31266, Expires - 06/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1219-2016","Class III","Iowa Select Herbs LLC, Sangre De Grado (Rhizoma rhei),  www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-32900 Exp-02/2018",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1163-2016","Class III","Iowa Select Herbs LLC, Cold Be Gone, www.iowaselectherbs.com, (a) 1/2 fl. Oz., (b) 15 ml, (c) 1 fl. Oz., (d) 30 ml (e) unknown size, Cedar Rapids, IA 52402","(a) 108 bottles, (b) 6 bottles, (c) 184 bottles, (d) 1 bottle, (e) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 87366, Expires - 01/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1164-2016","Class III","Iowa Select Herbs LLC, Cranberry,  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 76542, Expires - 03/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1205-2016","Class III","Iowa Select Herbs LLC, Osha Root (Ligusticum porteri), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz. (c) 1 gallon, (d) unknown size, Cedar Rapids, IA 52402","(a) 31 bottles, (b) 1 bottle, (c) 2 bottles, (d) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32303, Expires 03/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1208-2016","Class III","Iowa Select Herbs LLC, Organic Cold-Pressed Pomegranate Oil, 7.5 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-15114217282",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1140-2016","Class III","Iowa Select Herbs LLC, Artichoke Leaf (Cynara Scolymus), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402","10 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 45894, Expires - 05/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1196-2016","Class III","Iowa Select Herbs LLC, Milk Thistle Seed (Carduus marianus), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., (c) 32 fl. Oz., Cedar Rapids, IA 52402","(a) 2 bottles, (d) 97 bottles (c) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32358, Expires - 10/2019; Lot - 32964, Expires - 10/2019; Lot - 631H42200122, Expires - 10/2019; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1193-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, Magnolia Bark  www.iowaselectherbs.com, 1 Gallon., Cedar Rapids, IA 52402","1 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - PAS130828, Expires - 04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1168-2016","Class III","Iowa Select Herbs LLC, Dandelion Leaf (Taraxacum officinale),  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","26 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 324966, Expires - 09/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1179-2016","Class III","Iowa Select Herbs LLC, Goldenseal Root (Hydrastis canadensis),  www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 32 fl. Oz. (c) 1 gallon, Cedar Rapids, IA 52402","(a) 1 bottle, (b) 1 bottle, (c) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32996, Expires - 09/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1157-2016","Class III","Iowa Select Herbs LLC, Chamomile Flowers (Chamomilla recutita), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402","(a) 9 bottles, (b) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31778, Expires - 03/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1231-2016","Class III","Iowa Select Herbs LLC, Wormseed,  www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 1 gallon, Cedar Rapids, IA 52402","(a) 24 bottles (b) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-0415AN01 Expires-07/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1236-2016","Class III","Iowa Select Herbs LLC,  Magnolia Bark  www.iowaselectherbs.com, 1 Gallon., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - PAS130828, Expires - 05/2019; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1136-2016","Class III","Iowa Select Herbs LLC, Alfalfa Leaf (Medicago sativa), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30464, Expires - 02/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1197-2016","Class III","Iowa Select Herbs LLC, Momordica Leaf, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 58545F, Expires - 06/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1199-2016","Class III","Iowa Select Herbs LLC, Nettle Leaf (Urtica dioica), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 7.5 fl. Oz., Cedar Rapids, IA 52402","(a) 4 bottles, (b) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 56598, Expires - 052019; Lot - 20769, Expires - 05/2019; ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1220-2016","Class III","Iowa Select Herbs LLC, Sassparilla Smilax uti lis,  www.iowaselectherbs.com, 7.5 fl. Oz.., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-30709 Expires-07/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1190-2016","Class III","Iowa Select Herbs LLC, Lemon Balm Leaf (Melissa officinalis), www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 4 fl. Oz., (c) 8 fl. Oz., (d) 16 fl. Oz., (e) 32 fl. Oz., Cedar Rapids, IA 52402","(a) 1 bottle, (b) 6 bottles, (c) 1 bottle, (d) 3 bottles, (e) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32700, Expires - 02/2020;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1228-2016","Class III","Iowa Select Herbs LLC, Valerian Root (Valeriana officinalis),  www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402","24 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-30772 Expires-04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1225-2016","Class III","Iowa Select Herbs LLC, St John's Wart,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-19892 Expires-02/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1150-2016","Class III","Iowa Select Herbs LLC, Blood Root (Sanguinaria canadenix), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30746, Expires - 05/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1210-2016","Class III","Iowa Select Herbs LLC, Propolis Resin (Ligustrum lucidum), 2 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-22386 Exp - 08/2018",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1235-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, Dandelion Root,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 20792, Expires - 04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1170-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, Dulse Leaf,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 22356, Expires - 04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1172-2016","Class III","Iowa Select Herbs LLC, Elderberry Fruit (Sambucus nigra),  www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 7.5 fl. Oz., (c) 16 fl. Oz., Cedar Rapids, IA 52402","(a) 1 bottle, (b) 1 bottle, (c) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 33223, Expires - 05/2019; Lot - 19847, Expires 06/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1149-2016","Class III","Iowa Select Herbs LLC, Black Currant (Ribes nigrum), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 64832, Expires - 05/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1234-2016","Class III","Iowa Select Herbs LLC, Ziziphus (Zizyphus jujuba spinosa),  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-0515GF Expires-08/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1158-2016","Class III","Iowa Select Herbs LLC, Chaparral Leaf (Larrea tridentata), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 31467, Expires - 05/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1198-2016","Class III","Iowa Select Herbs LLC, Muira Puama (Ptychopetalum ovata), www.iowaselectherbs.com, (a) 1 fl. Oz. (b) 2 fl. Oz. (c) 4 fl. Oz. (d) 1 gallon, Cedar Rapids, IA 52402","(a) 2 bottles, (b) 1 bottle, (c) 18 bottles, (d) 1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - R11165, Expires - 01/2020;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1222-2016","Class III","Iowa Select Herbs LLC, Schizandra Berry (Fructus schizandrae),  www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-22389 Expires-07/2018",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1159-2016","Class III","Iowa Select Herbs LLC, Alcohol-Free, Chicory Root, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 55426, Expires - 04/2020, Lot - 55910, Expires - 04/2020, ",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1186-2016","Class III","Iowa Select Herbs LLC, Jerusalem Artichoke www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402","24 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 5514, Expires - 05/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1204-2016","Class III","Iowa Select Herbs LLC, Papaya Leaf (Carica papaya), www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 16 fl. Oz. (d) 32 fl. Oz. (e) 32 & 16 fl. Oz. (f) 128 fl. Oz. (g) 164 fl. Oz. (h) unknown size, Cedar Rapids, IA 52402","(a) 10 bottles, (b) 375 bottles, (c) 347 bottles, (d) 65 bottles, (e) 1 bottle, (f) 1 bottle, (g) 1 bottle, (h) 5 bottles ","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - R1380ST, Expires - 04/2020; Lot - 52972, Expires -  04/2020",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1152-2016","Class III","Iowa Select Herbs LLC, Broad Beans, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 15882, Expires - 11/2018",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1135-2016","Class III","Iowa Select Herbs LLC, Acia Berry (Euterpe oleracea), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402","10 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 22345, Expires 05/2017",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1213-2016","Class III","Iowa Select Herbs LLC, Quack Grass,  www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402","2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot-20668 Exp - 12/2019",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1194-2016","Class III","Iowa Select Herbs LLC, Marshmallow Root  (Althaea officinalis), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402","(a) 2 bottle, (b) 2 bottles","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 30933, Expires - 04/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72083,"Ongoing","Iowa Select Herbs LLC","2347 Blairs Ferry Rd NE","Suite 2","Cedar Rapids","IA","52402-1998","United States","FDA Mandated","Press Release","The recalled product was distributed to retail stores in CA, FL, GA, IA, MI, MO, MT, NY, and SC and consumers nationwide and internationally in Denmark, Canada, UK, Australia, and Serbia.","F-1182-2016","Class III","Iowa Select Herbs LLC, Geen Tea Leaf, www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402","1 bottle","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because they are misbranded, unapproved new drugs and adulterated dietary supplements.","05/02/2016",," Lot - 32513, Expires - 02/2019;",9/11/2015,"09/11/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72085,"Ongoing","BIMBO Bakeries USA Inc.","255 Business Center Dr",,"Horsham","PA","19044-3424","United States","Voluntary: Firm Initiated","Visit","AL, FL, GA, KY, NC, OH, SC, TN, VA, WV","F-1088-2016","Class II","Bimbo 100% Whole Wheat Bread, 16oz,  On bag: SEP 01,  UPC: 7432309230    Sara Lee 100% Whole Wheat Bread 16 oz	On bag: SEP 01   UPC: 7294561103;     Sara Lee 100% Whole Wheat Bread  20 oz	On bag: SEP 01    UPC: 7294560134;     Kroger 100% Whole Wheat Round Top Bread, 16 oz, On bag: SEP 01, UPC: 1111000132;    Nature's Harvest Stone ground 100% Whole Wheat Bread, 20oz, On bag: SEP 01, UPC: 7870080162;     Great Value 100% Whole Wheat Roundtop Bread, 16oz, On bag: SEP 01, UPC: 7874207448;     Great Value 100% Whole Wheat Bread,  20oz, On bag: SEP 01, UPC: 7874236690  ","17,974 units","Certain bread products under multiple brands, including supermarket brands, recalled due to possible glass contamination.","04/15/2016",," On bread bag -Sep 01",8/26/2015,"08/26/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72085,"Ongoing","BIMBO Bakeries USA Inc.","255 Business Center Dr",,"Horsham","PA","19044-3424","United States","Voluntary: Firm Initiated","Visit","AL, FL, GA, KY, NC, OH, SC, TN, VA, WV","F-1086-2016","Class II","Sara Lee Delightful 100% Whole Wheat made with Real Honey Bread  20oz  On bag: AUG 29 UPC: 7294571589;     	  Sara Lee Honey Wheat Bread; 20 oz; On bag: SEP 01   UPC: 7294560136;   Sara Lee Honey Wheat Bread Twin pack 2 lbs 8oz  On bag: SEP 01	 UPC: 7294561159;  ","12,576 units","Certain bread products under multiple brands, including supermarket brands, recalled due to possible glass contamination.","04/15/2016",," On bread bag - Aug 29 or Sep 01",8/26/2015,"08/26/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72085,"Ongoing","BIMBO Bakeries USA Inc.","255 Business Center Dr",,"Horsham","PA","19044-3424","United States","Voluntary: Firm Initiated","Visit","AL, FL, GA, KY, NC, OH, SC, TN, VA, WV","F-1087-2016","Class II","Sara Lee Delightful Healthy Multi-Grain Bread Twin pack, 2 lbs 8 oz, On bag: AUG 29, UPC:  7294561169;   Sara Lee Delightful Healthy Multi-Grain Bread,  20 oz, On bag: SEP 01, UPC: 7294571588  ","3934 bags","Certain bread products under multiple brands, including supermarket brands, recalled due to possible glass contamination.","04/15/2016",," On bread bag - Aug 29 or Sep 01",8/26/2015,"08/26/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72085,"Ongoing","BIMBO Bakeries USA Inc.","255 Business Center Dr",,"Horsham","PA","19044-3424","United States","Voluntary: Firm Initiated","Visit","AL, FL, GA, KY, NC, OH, SC, TN, VA, WV","F-1089-2016","Class II","Fit & Active Multigrain Bread,  20 oz, On bag: AUG 31, UPC: 4149821093","2080 bags","Certain bread products under multiple brands, including supermarket brands, recalled due to possible glass contamination.","04/15/2016",," On bread bag -Aug 31",8/26/2015,"08/26/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72092,"Completed","Boesl Packing Company, Inc.","2322 Belair Rd",,"Baltimore","MD","21213-1222","United States","Voluntary: Firm Initiated","E-Mail","The product was distributed in Maryland to two Direct accounts and one Distributor","V-451-2016","Class I","Chicken and Vegetable, K-9, Dog Food, Frozen Raw Dog Food Patties. ","182 Cases","Chicken and Vegetable, K-9, Dog Food (sample  # 912272 ) tested positive for Listeria monocytogenes and Salmonella.    Chicken and Vegetable, K-9, Dog Food is manufactured by the Boesl Packing Company, Inc., 2322 Belair Rd, Baltimore, Maryland.          ","06/11/2016",," No Code Information availible",8/31/2015,"08/31/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72105,"Completed","Barilla America NY, Inc.","100 Horseshoe Boulevard",".","Avon","NY","14414","United States","Voluntary: Firm Initiated","E-Mail","FLA, MA, MD, MI, NJ, NY & PA","F-0460-2016","Class II","Barilla Packaged Specifically for FoodService, PENNE RIGATE, 160 OZ (10 LBS) (4.54 kg), GTIN 1007680839242, packed as two bags per case.","6,178 cases","Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments","12/30/2015",," Lot Code: 5755U05, 5765U05",7/2/2015,"07/02/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72105,"Completed","Barilla America NY, Inc.","100 Horseshoe Boulevard",".","Avon","NY","14414","United States","Voluntary: Firm Initiated","E-Mail","FLA, MA, MD, MI, NJ, NY & PA","F-0458-2016","Class II","Barilla MEDIUM SHELLS, 1 LB (454 g), GTIN 00076808002881, packed as twelve boxes in 1 case","43 cases","Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments","12/30/2015",," Lot Code 5745U05",7/2/2015,"07/02/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72105,"Completed","Barilla America NY, Inc.","100 Horseshoe Boulevard",".","Avon","NY","14414","United States","Voluntary: Firm Initiated","E-Mail","FLA, MA, MD, MI, NJ, NY & PA","F-0461-2016","Class II","Barilla  PENNE, 8 X 1 LB (454 g) BOXES, [NET WT. 8 LB (3.63 kg)], GTIN 10076808034360, packed as a Multi-unit box, 8 units per case for sale at club stores.","9,360 cases","Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments","12/30/2015",," Lot Code: 5755U05, 5765U05",7/2/2015,"07/02/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72105,"Completed","Barilla America NY, Inc.","100 Horseshoe Boulevard",".","Avon","NY","14414","United States","Voluntary: Firm Initiated","E-Mail","FLA, MA, MD, MI, NJ, NY & PA","F-0459-2016","Class II","Barilla Pronto PENNE, 12 OZ (340 g), GTIN number 10076808005605, packed as 16 boxes per case, sold as individual units at retailer. ","82 cases","Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments","12/30/2015",," Lot Codes: 5745U05 & 5755U05",7/2/2015,"07/02/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72116,"Ongoing","The Kraft Heinz Company","3 Lakes Dr",,"Northfield","IL","60093-2753","United States","Voluntary: Firm Initiated","Telephone","Approximately 335,000 additional cases of the recalled product were shipped by Kraft Heinz to retailers in the U.S. and Puerto Rico, Anguilla, Bahamas, Belize, Bermuda, Cayman Islands Grand Cayman, Netherland Antilles, Saint Kitts and Nevis, South Korea, St. Lucia, and British Virgin Islands.","F-0374-2016","Class II","Kraft Singles American packaged in a blue box with white lettering. ","6, 3 lb. cartons. 36, 1 lb. cartons. 12, 3 lb. cartons. 8, 4 lb. cartons.","Kraft Singes wrapped American slices due to the possibility that a thin strip of the individual packaging film may remain adhered to the slice after the wrapper has been removed. If the film sticks to the slice and is not removed, it could potentially cause a choking hazard. ","02/09/2016",," Best When Used By date between 13 DEC 15 and 18 FEB 16, Best When Used By date between 09 DEC 15 and 19 FEB 16, Best When Used By date between 24 JAN 16 and 6 FEB 16.",9/3/2015,"09/03/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72116,"Ongoing","The Kraft Heinz Company","3 Lakes Dr",,"Northfield","IL","60093-2753","United States","Voluntary: Firm Initiated","Telephone","Approximately 335,000 additional cases of the recalled product were shipped by Kraft Heinz to retailers in the U.S. and Puerto Rico, Anguilla, Bahamas, Belize, Bermuda, Cayman Islands Grand Cayman, Netherland Antilles, Saint Kitts and Nevis, South Korea, St. Lucia, and British Virgin Islands.","F-0376-2016","Class II","Kraft Singles Deli Deluxe American Slices packaged in a blue box with white lettering. ","6, 3 lb. cartons. ","Kraft Singes wrapped American slices due to the possibility that a thin strip of the individual packaging film may remain adhered to the slice after the wrapper has been removed. If the film sticks to the slice and is not removed, it could potentially cause a choking hazard. ","02/09/2016",," Best When Used By date between 21 JAN 16 and 02 MAR 16",9/3/2015,"09/03/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72116,"Ongoing","The Kraft Heinz Company","3 Lakes Dr",,"Northfield","IL","60093-2753","United States","Voluntary: Firm Initiated","Telephone","Approximately 335,000 additional cases of the recalled product were shipped by Kraft Heinz to retailers in the U.S. and Puerto Rico, Anguilla, Bahamas, Belize, Bermuda, Cayman Islands Grand Cayman, Netherland Antilles, Saint Kitts and Nevis, South Korea, St. Lucia, and British Virgin Islands.","F-0375-2016","Class II","Kraft Singles White American singles packaged in a blue box with white lettering. ","12, 3 lb. cartons, 8, 4 lb. cartons, 12, 1 lb. cartons. ","Kraft Singes wrapped American slices due to the possibility that a thin strip of the individual packaging film may remain adhered to the slice after the wrapper has been removed. If the film sticks to the slice and is not removed, it could potentially cause a choking hazard. ","02/09/2016",," Best When Used By date between 12 DEC 15 and 13 FEB 16, Best When Used By date of 12 JAN 16, Best When Used By date of 11 JAN 16",9/3/2015,"09/03/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72147,"Terminated","Frontier Cooperative Co","2175 14th Ave",,"Columbus","NE","68601","United States","Voluntary: Firm Initiated","Visit","NE","V-310-2016","Class I"," goat pellets (16.5 lbs rumensin per ton) packaged into 50 lb. bags.  Manufactured by Frontier Cooperative Columbus, NE","40 - 50 lb. bags","Product contained elevated levels of monensin which resulted in animal death.","02/22/2016","04/13/2016"," 237.15.1 manufactured on or about 8/27/2015",9/2/2015,"09/02/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72162,"Terminated","Ridley USA, Inc","424 N Riverfront Dr",,"Mankato","MN","56001-3447","United States","Voluntary: Firm Initiated","Telephone","Kansas","V-306-2016","Class I","CORDEL GF5 DDG 20 C-M, Swine Grower/Finisher, Complete to Increase the Digestibility of Phytin-Bound Phosphorus in Swine Diets  ","31,780 lbs","Excessive magnesium in pig feed","02/09/2016","02/09/2016"," B00923811",9/8/2015,"09/08/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72164,"Terminated","Kassik Milling Co Inc","309 Main St","PO Box 128","Milligan","NE","68406-3949","United States","Voluntary: Firm Initiated","Telephone","NE","V-311-2016","Class I","Bulk Prestart 550 non-medicated nursery swine feed manufactured with Start 300 Vitamin Pac.  The responsible firm is Kassik Milling, Milligan, NE.","38250.5 pounds","Product is superpotent for Vitamin A.","02/23/2016","03/09/2016"," lots:  15040912,15041403, 15042102, 15050107, 15040922, 15042222, 15043014, 15043013, 15041017, and 15042215  ",8/25/2015,"08/25/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72164,"Terminated","Kassik Milling Co Inc","309 Main St","PO Box 128","Milligan","NE","68406-3949","United States","Voluntary: Firm Initiated","Telephone","NE","V-312-2016","Class I","Bulk Start 300 non-medicated nursery swine feed manufactured with Start 300 Vitamin Pac.  The responsible firm is Kassik Milling, Milligan, NE.","80071.2 pounds","Product is superpotent for Vitamin A.","02/23/2016","03/09/2016"," lots:  15040913, 15041404, 15042101, 15050108, 15042016, 15042223, 15043015, 15041627, and 15043007  ",8/25/2015,"08/25/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72173,"Terminated","Del Monte Fresh Produce N A Inc","6311 Deramus Ave",".","Kansas City","MO","64120-1358","United States","Voluntary: Firm Initiated","Telephone","Texas, Oklahoma, Arkansas, Kansas","F-0436-2016","Class I","Cross Valley Farms cucumbers, 24 count corrugated carton","2356 cases","Possible contamination with Salmonella.","12/28/2015","04/12/2016"," 7563200",9/10/2015,"09/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0608-2016","Class II","Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.",,"Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0595-2016","Class II","Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","665","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0597-2016","Class II","Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","475","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0601-2016","Class II","Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","525","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0591-2016","Class II","Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","5875","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0603-2016","Class II","Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","5000","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0594-2016","Class II","Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.","4100","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0605-2016","Class II","Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.","378","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0602-2016","Class II","Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","250","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0609-2016","Class II","Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.",,"Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0599-2016","Class II","Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","1530","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0606-2016","Class II","Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.",,"Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0588-2016","Class II","Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","4123","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0596-2016","Class II","Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","7100","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0598-2016","Class II","Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","8000","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0593-2016","Class II","Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","210","Subpotent drug. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0607-2016","Class II","Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.",,"Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0600-2016","Class II","Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","600","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0590-2016","Class II","Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.",,"Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0589-2016","Class II","Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","1150","Subpotent drug. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0604-2016","Class II","Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","400","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72177,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0592-2016","Class II","Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.","2750","Stability data does not support expiry. ","01/27/2016",," All lots with expiration dates up to 11/17/2015",8/19/2015,"08/19/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-346-2016","Class II","Diclofenac Sodium Ointment (0.1%) in 4 gm metal tube; For Topical Ophthalmic Use, Rx.","18 tubes","Lack of sterility assurance.","03/03/2016",," Lot: 06292015@84 BUD: 9/27/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-343-2016","Class II","Desmopressin Acetate, Ophthalmic (0.1 mg/mL (10 mcg/0.1 mL) in 10 mL dropper bottle; For Topical Ophthalmic Use, Rx.    ","2 bottles","Lack of sterility assurance.","03/03/2016",," Lot: 07162015@86 BUD: 10/14/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-381-2016","Class II","Stanozolol 10 mL Vial (50 mg/mL) in glass vials; Stanozolol 30 mL Vial (50 mg/mL) in glass vials; For IM Injection Only, Rx.","126 vials","Lack of sterility assurance.","03/03/2016",," Lot: : 07072015@35 BUD: 1/3/2016, 06162015@51 BUD: 12/13/2015, 07072015@66 BUD: 1/3/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-327-2016","Class II","Bethanechol (5 mg/mL) in 100 mL amber glass vials; For IM or IV Use, Rx.","4 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03262015@19 BUD: 9/22/2015, 05072015@21 BUD: 11/3/2015, 06152015@71 BUD: 12/12/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-342-2016","Class II","Deslorelin Kit 10 mL Vial (15 mg) in amber glass vials; For IM Use Only, Rx.    ","62 vials","Lack of sterility assurance.","03/03/2016",," Lot: 05042015@7 BUD: 10/31/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-390-2016","Class II","Voriconazole Ophthalmic (1% (10 mg/mL)) in 15 mL dropper bottles; For Topical Ophthalmic Use, Rx.","2 bottles","Lack of sterility assurance.","03/03/2016",," Lot: : 08312015@43 BUD: 9/14/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-340-2016","Class II","Cyclosporine Ointment 4 gm tube (2%) in metal tube, Cyclosporine Ointment 4 gm tube (1%) in metal tube; For Topical Ophthalmic Use, Rx.    ","30 tubes","Lack of sterility assurance.","03/03/2016",," Lot: 06152015@54 BUD: 9/13/2015, 07152015@87 BUD: 10/13/2015, 07282015@123 BUD: 10/26/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-349-2016","Class II","Estradiol Cypionate Sterile 100 mL vial (2 mg/mL) in glass vials, Estradiol Cypionate Sterile 30 mL vial (5 mg/mL) in glass vials, Estradiol Cypionate Sterile 50 mL vial (2 mg/mL) (5 mg/mL) (10 mg/mL) in glass vials in glass vials; For IM Use Only, Rx.","110 vials","Lack of sterility assurance.","03/03/2016",," Lot: 06022015@83 BUD: 11/29/2015, 06052015@22 BUD: 12/2/2015,  08312015@57 BUD: 2/27/2016, 04152015@17 BUD: 10/12/2015,  04202015@63 BUD: 10/17/2015, 04212015@51 BUD: 10/18/2015,  06042015@20 BUD: 12/1/2015, 06192015@14 BUD: 12/16/2015,  07212015@70 BUD: 1/17/2016, 07272015@38 BUD: 12/2/2015,  07302015@20 BUD: 12/2/2015, 09042015@10 BUD: 2/28/2016,  09042015@26 BUD: 2/28/2016,",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-366-2016","Class II","Miconazole Ointment 4 gm tube (1%) in metal tubes; For Topical Ophthalmic Use, Rx.","98 tubes","Lack of sterility assurance.","03/03/2016",," Lot: 03302015@21 BUD: 9/16/2015, 05132015@47 BUD: 9/16/2015, 05192015@72 BUD: 9/16/2015, 06012015@50 BUD: 9/16/2015, 06042015@89 BUD: 12/1/2015, 06182015@55 BUD: 12/1/2015, 08102015@60 BUD: 12/1/2015, 09032015@43 BUD: 12/1/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-333-2016","Class II","CACODYLATE Cmpd (w/ Strych 0.00348%) Sterile (6.4/1/0.2 mg/mL) in 100 mL amber glass vials; For IV or IM Use Only, Rx.    ","111 vials","Lack of sterility assurance.","03/03/2016",," Lot: 05062015@18 BUD: 10/5/2015, 05182015@32 BUD: 10/5/2015, 05202015@63 BUD: 10/5/2015, 06022015@64 BUD: 10/5/2015, 06052015@28 BUD: 10/5/2015, 06232015@24 BUD: 10/5/2015, 07212015@45 BUD: 10/5/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-335-2016","Class II","Chloral Hydrate Inj. Solution (1 gm/mL)  in 20 mL glass vials; For IM Use Only, Rx.    ","2 vials","Lack of sterility assurance.","03/03/2016",," Lot: 08072015@36 BUD: 11/5/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-341-2016","Class II","Deslorelin & HCG Kit 10 mL Vial (15 mg/20,000 units) in amber glass vials; Deslorelin & HCG Kit 1 mL Vial (1.5 mg/2,000 units) in amber glass vials; Deslorelin & HCG Kit 2 mL Vial (1.5 mg/2,000 units) in amber glass vials; For IM Use Only, Rx.    ","566 vials","Lack of sterility assurance.","03/03/2016",," Lot: 06082015@45 BUD: 12/5/2015, 04062015@10 BUD: 10/3/2015, 04062015@10 BUD: 10/3/2015, 06222015@2 BUD: 12/19/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-352-2016","Class II","Fluoxetine HCl*Sterile (32 mg/mL) in 50 mL glass vials; For Injection, Rx","2 vials","Lack of sterility assurance.","03/03/2016",," Lot: 07062015@57 BUD: 10/4/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-374-2016","Class II","Pluronic 30% Gel Sterile (30%) in 20 mL Syringe; For Wound Care, Rx.","3 syringes","Lack of sterility assurance.","03/03/2016",," Lot: 07202015@8 BUD: 1/16/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-368-2016","Class II","Naloxone (0.5 mg/mL) in 10 mL glass vial; For IM and IV Use, Rx. ","40 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04062015@43 BUD: 9/20/2015, 04222015@61 BUD: 9/30/2015, 05012015@20 BUD: 9/30/2015, 07082015@21 BUD: 1/3/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-373-2016","Class II","Pentosan 100 mL Vial (250 mg/mL) in amber glass vials; Pentosan 50 mL Vial (250 mg/mL) in amber glass vials; Pentosan 6 mL in 10 mL Vial (250 mg/mL) in amber glass vials; For IM Use Only, Rx.","1124 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04292015@49 BUD: 10/26/2015, 06242015@49 BUD: 12/21/2015, 06242015@78 BUD: 12/21/2015, 07152015@81 BUD: 1/11/2016, 03182015@34 BUD: 9/14/2015, 05122015@77 BUD: 11/7/2015, 06232015@5 BUD: 12/19/2015, 04202015@4 BUD: 10/17/2015, 04272015@44 BUD: 10/24/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-391-2016","Class II","Xylazine HCl Preservative Free Sterile (333 mg/mL) in 20 mL glass vials; Xylazine Preservative Free (300 mg/mL) in 100 mL glass vials; For IM or IV Use.","7 vials","Lack of sterility assurance.","03/03/2016",," Lot: : 04032015@21 BUD: 9/30/2015, 07152015@88 BUD: 1/11/2016, 05212015@5 BUD: 11/17/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-321-2016","Class II","Aspirin (100 mg/mL) in glass vials; For IV Use, Rx.","16 vials.","Lack of sterility assurance.","03/03/2016",," Lot: 03242015@38 BUD: 9/20/2015, 05202015@66 BUD: 11/16/2015, 08032015@18 BUD: 1/30/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-360-2016","Class II","Magnesium Sulfate 100 mL vial (500 mg/mL (4 meq/mL) in amber glass vial; Magnesium Sulfate 250 mL (500 mg/mL (4 meq/mL) in amber glass vial;   Magnesium Sulfate 500 mL (500 mg/mL (4 meq/mL) in amber glass vial; For IV or IM Injection, Rx.","275 vials/bottes","Lack of sterility assurance.","03/03/2016",," Lot: 05132015@12 BUD: 11/9/2015, 06102015@95 BUD: 12/7/2015, 04072015@7 BUD: 10/4/2015, 06292015@30 BUD: 12/26/2015, 04072015@9 BUD: 10/4/2015, 06092015@66 BUD: 12/6/2015, 06292015@53 BUD: 12/26/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-329-2016","Class II","Buprenorphine HCl Sterile 100 mL Vial (0.6 mg/mL) in amber glass vials; Buprenorphine Sterile 10 mL (0.6 mg/mL) in glass vials; Buprenorphine Sterile 20 mL vial (0.6 mg/mL) in glass vials; Buprenorphine Sterile 30 mL Vial (0.6 mg/mL) in glass vials; Buprenorphine Sterile 50 mL Vial (0.6 mg/mL) in glass vials; Buprenorphine Sterile 5 mL Vial (0.6 mg/mL) in glass vials; Buprenorphine HCL Sterile 30 mL Vial (0.9 mg/mL) in glass vials; Buprenorphine Sterile 60 mL in 100 mL Vial (0.6 mg/mL) in glass vials; For IV or IM Use Only, Rx.    ","457 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03232015@51 BUD: 9/19/2015, 04102015@20 BUD:10/7/2015, 04212015@53 BUD: 10/18/2015, 04102015@11 BUD: 10/7/2015, 05082015@24 BUD: 11/4/2015, 05212015@20 BUD: 11/17/2015,  06012015@26 BUD: 11/28/2015, 06222015@20 BUD: 12/6/2015,  07302015@35 BUD: 1/1/2016, 08062015@64 BUD: 1/1/2016,  04212015@20 BUD: 10/18/2015, 06112015@39 BUD: 12/8/2015,  08032015@24 BUD: 1/1/2016, 03302015@8 BUD: 9/26/2015,  04232015@21 BUD: 10/18/2015, 04242015@50 BUD: 10/21/2015, 04212015@53 BUD: 10/18/2015,  05212015@21 BUD: 11/17/2015,  06012015@10 BUD: 11/28/2015, 06092015@35 BUD: 12/6/2015,  07132015@4 BUD: 1/9/2016, 08052015@26 BUD: 1/1/2016,  05082015@24 BUD: 11/4/2015, 05212015@20 BUD: 11/17/2015,  06012015@26 BUD: 11/28/2015, 06222015@20 BUD: 12/6/2015,  07302015@35 BUD: 1/1/2016, 08062015@64 BUD: 1/1/2016,  04212015@20 BUD: 10/18/2015, 05132015@21 BUD: 10/7/2015,  05192015@56 BUD: 10/7/2015, 06022015@62 BUD: 11/28/2015,  06112015@19 BUD: 12/6/2015, 06192015@13 BUD: 12/6/2015,  06262015@53 BUD: 12/23/2015, 07212015@52 BUD: 1/1/2016,  08062015@62 BUD: 1/1/2016, 06012015@32 BUD: 11/28/2015,  06122015@43 BUD: 12/6/2015, 06172015@41 BUD: 12/14/2015,  06262015@60 BUD: 12/23/2015, 08072015@16 BUD: 1/1/2016,  06082015@46 BUD: 11/17/2015, 06122015@37 BUD: 12/6/2015,  06172015@42 BUD: 12/14/2015, 07302015@23 BUD: 1/1/2016,  04232015@21 BUD: 10/18/2015, 06032015@54 BUD: 11/30/2015,  06122015@44 BUD: 12/6/2015, 06182015@54 BUD: 12/14/2015,  07172015@69 BUD: 1/1/2016, 04242015@50 BUD: 10/21/2015,  06112015@18 BUD: 12/6/2015, 06172015@43 BUD: 12/14/2015,  08062015@91 BUD: 1/1/2016    ",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-359-2016","Class II","L-Arginine Sterile 100 mL Vial (200 mg/mL) in glass vials; L-Arginine Sterile 100 mL Vial (100 mg/mL) in glass vials; For IV Use, Rx.","22 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03182015@29 BUD: 9/14/2015, 06302015@32 BUD: 12/27/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-336-2016","Class II","Chloramphenicol Ointment 4 gm tube (1%) in metal tubes; For Topical Ophthalmic Use, Rx.    ","9 tubes","Lack of sterility assurance.","03/03/2016",," Lot: 06292015@89 BUD: 9/27/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-357-2016","Class II","Ivermectin (2%) in 100 mL glass vials; For IM Use Only, Rx.","10 vials","Lack of sterility assurance.","03/03/2016",," Lot: 07272015@23 BUD: 10/25/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-338-2016","Class II","Ciprofloxacin Ophthalmic 4 gm tube (0.5%) in metal tubes; For Topical Ophthalmic Use, Rx.    ","19 tubes","Lack of sterility assurance.","03/03/2016",," Lot: 04272015@10 BUD: 9/16/2015, 07012015@71 BUD: 12/1/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-320-2016","Class II","Apomorphine 1 mL Vial (1 mg/mL) in 2 mL amber glass vial; Apomorphine 1 mL Vial (10 mg/mL) in 2 mL amber glass vial; Apomorphine 10 mL Vial (1 mg/mL) in 10 mL glass vial; Apomorphine 10 mL Vial (3 mg/mL) in 10 mL glass vial; Apomorphine 1 mL Vial (3 mg/mL) in 2 mL amber glass vial; Apomorphine Sterile 30 mL Vial (1 mg/mL) in 30 mL glass vials, For IV or IM Injection/For SC or IV Use, Rx.","356 vials","Lack of sterility assurance.","03/03/2016",," Lot:06192015@38 BUD: 9/17/2015, 08042015@32 BUD: 11/2/2015, 08102015@63 BUD: 11/8/2015, 09022015@66 BUD: 12/1/2015, 07082015@10 BUD: 10/6/2015, 07092015@30 BUD: 10/7/2015, 07202015@44 BUD: 10/18/2015, 06222015@53 BUD: 9/20/2015, 06302015@44 BUD: 9/28/2015, 07082015@19 BUD: 10/6/2015, 07202015@36 BUD: 10/18/2015, 07202015@37 BUD: 10/18/2015, 07272015@15 BUD: 10/25/2015, 07312015@26 BUD: 10/29/2015, 08072015@24 BUD: 11/5/2015, 08072015@35 BUD: 11/5/2015, 08312015@49 BUD: 11/29/2015, 09022015@19 BUD: 12/1/2015, 06222015@24 BUD: 9/20/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-362-2016","Class II","Meloxicam (10 mg/mL) in 10 mL glass vials; Meloxicam (2.5 mg/mL) in 10 mL glass vials; Meloxicam Sterile 50 ml vial (5 mg/mL) in glass vials; For IV or SC Use, Rx.","93 vials","Lack of sterility assurance.","03/03/2016",," Lot: 07152015@35 BUD: 10/13/2015, 09012015@22 BUD: 11/30/2015, 09012015@47 BUD: 11/30/2015, 07172015@65 BUD: 10/15/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-325-2016","Class II"," B12/B2/B6/B3/B5/Cu Gluc/CACO/Dex Sterile 250 mL Bottle (0.3 mg/10.75 mg/10 mg/100 mg/15 mg/0.2 mg/6.4 mg/1 mg/mL) in plastic bottles; For IV Use After Dilution, Rx.","10 bottles","Lack of sterility assurance.","03/03/2016",," Lot: 03172015@18 BUD: 9/13/2015, 04292015@13 BUD: 10/26/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-344-2016","Class II","Detomidine HCl/Xylazine HCl Sterile 50 mL vial (10 mg/10 mg/mL) in glass vials; Detomidine HCl/Xylazine HCl Sterile 50 mL vial (20 mg/10 mg/mL) in amber glass vials; For IM or IV Use, Rx.    ","59 vials","Lack of sterility assurance.","03/03/2016",," Lot: 062602015@28 BUD: 9/24/2015, 062602015@50 BUD: 9/24/2015, 07292015@44 BUD: 10/3/2015, 07312015@22 BUD: 10/29/2015, 08102015@48 BUD: 11/8/2015, 09012015@87 BUD: 11/30/2015, 062602015@28 BUD: 9/24/2015, 062602015@50 BUD: 9/24/2015, 07292015@44 BUD: 10/27/2015, 07312015@22 BUD: 10/29/2015, 08102015@48 BUD: 11/8/2015, 09012015@87 BUD: 11/30/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-389-2016","Class II","Voriconazole Ointment (1% (10 mg/mL)) in 4 gm metal tubes; For Topical Ophthalmic Use, Rx.","3 tubes","Lack of sterility assurance.","03/03/2016",," Lot: : 08312015@43 BUD: 9/14/2015, 09092015@54 BUD: 9/23/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-355-2016","Class II","Guanabenz Acetate (2 mg/mL) in 50 mL glass vials; For IM Use Only, Rx.","35 vials","Lack of sterility assurance.","03/03/2016",," Lot: 05192015@77 BUD: 11/15/2015, 06022015@63 BUD: 11/15/2015, 07202015@31 BUD: 1/16/2016, 07292015@35 BUD: 1/25/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-339-2016","Class II","Cyclosporine (A) in oil 10 mL dropper (2%) in 15 mL dropper bottle, Cyclosporine (A) in oil 10 mL in 15 mL dropper (1%), Cyclosporine (A) in Oil 15 mL dropper (1%), Cyclosporine (A) in Oil 15 mL dropper (2%), Cyclosporine (A) in Oil 8 mL in 10 mL dropper (2%), Cyclosporine (A) in Oil in 8 mL in 10 mL dropper (1%), Cyclosporine (A) in Oil in 8 mL in 15 mL dropper (2%), Cyclosporine (A) in Oil in 8 mL in 15 mL dropper (1%); For Topical Ophthalmic Use, Rx.    ","844 bottles","Lack of sterility assurance.","03/03/2016",," Lot: 05052015@57 BUD: 11/1/2015, 05052015@57 BUD: 11/1/2015,  06082015@52 BUD: 12/5/2015, 03192015@12 BUD: 9/15/2015,  04062015@12 BUD: 10/3/2015, 06162015@30 BUD: 12/13/2015,  03192015@20 BUD: 9/15/2015, 05052015@54 BUD: 11/1/2015,  05112015@24 BUD: 11/7/2015, 05052015@57 BUD: 11/1/2015,  05112015@24 BUD: 11/7/2015, 06152015@13 BUD: 12/12/2015,  06232015@76 BUD: 12/20/2015, 07072015@56 BUD: 1/3/2016  ",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-363-2016","Class II","Methionine/Inositol/Choline Chloride/B12 Sterile 100 mL Vial (25 mg/50 mg/50 mg/0.2 mg/mL) in amber glass vials; For IM Use Only, Rx.","94 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04292015@5 BUD: 10/19/2015, 06012015@68 BUD: 10/19/2015, 06012015@69 BUD: 10/19/2015, 07272015@39 BUD: 1/23/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-384-2016","Class II","Triamcinolone Diacetate 100 mL Vial (2 mg/mL) in amber glass vials; For IM & Regional Injection, Rx.","72 vials","Lack of sterility assurance.","03/03/2016",," Lot: : 04152015@12 BUD: 10/12/2015, 06242015@62 BUD: 12/21/2015, 07062015@45 BUD: 1/2/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-370-2016","Class II","Neomycin/Bacitracin/Polymyxin-B Ophthalmic 4 gm Tube (3.5 mg/400 IU/10000 U/gm) in metal tubes; For Topical Ophthalmic Use, Rx.","7 tubes","Lack of sterility assurance.","03/03/2016",," Lot: 04232015@58 BUD: 9/16/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-331-2016","Class II","CACO CMPD 100 mL Vial (6.4 mg/1 mg/0.2 mg/mL) in amber glass vials; For IV or IM Use Only, Rx.    ","910 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03182015@31 BUD: 9/14/2015, 04102015@21 BUD: 10/7/2015, 05122015@95 BUD: 11/8/2015, 06042015@76 BUD: 12/1/2015, 06152015@82 BUD: 12/12/2015, 06222015@31 BUD: 12/19/2015, 07012015@28 BUD: 12/28/2015, 07152015@12 BUD: 1/11/2016  ",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-345-2016","Class II","Dexamethasone Sodium Phosphate 50 mL Vial (480 mg/mL) in amber glass vials; For IM or IV Use, Rx. ","3 vials","Lack of sterility assurance.","03/03/2016",," Lot: 08032015@45 BUD: 1/30/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-324-2016","Class II","B12/B2/B6/B3/B5/Cu Gluc/CACO Sterile 250 mL bottle (0.3mg/14.7/10 mg/100 mg/15 mg/0.2 mg/6.4 mg/mL) in plastic bottles; For IM Use Only, Rx.","134 bottles","Lack of sterility assurance.","03/03/2016",," Lot: 03232015@7 BUD: 9/19/2015, 04012015@11 BUD: 9/28/2015, 04292015@33 BUD: 10/26/2015, 07012015@87 BUD: 12/28/2015, 07062015@43 BUD: 1/2/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-385-2016","Class II","Triamcinolone Diacetate 5 mL in 10 mL (6 mg/mL) amber glass vials; For IM & Regional Use Only, Rx.","13 vials","Lack of sterility assurance.","03/03/2016",," Lot: : 07062015@52 BUD: 1/2/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-392-2016","Class II","Yohimbine-Compound Sterile (5 mg/mL (0.5%)) in 100 mL glass vials; Yohimbine HCl-Compound Sterile (5 mg/mL (0.5%)) in 100 mL glass vials; For IM Use Only, Rx.","43 vials","Lack of sterility assurance.","03/03/2016",," Lot: : 05072015@34 BUD: 11/3/2015, 06152015@33 BUD: 11/16/2015, 06252015@55 BUD: 11/16/2015, 07092015@18 BUD: 11/3/2015, 07102015@12 BUD: 1/3/2016, 08042015@91 BUD: 1/31/2016, 09042015@4 BUD: 2/6/2016, 04202015@44 BUD: 9/20/2015, 04302015@43 BUD: 10/19/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-337-2016","Class II","Cimetidine (150 mg/mL) in 100 mL glass vials; For IM Use Only, Rx.    ","8 vials","Lack of sterility assurance.","03/03/2016",," Lot: 07202015@24 BUD: 10/18/2015, 07282015@67 BUD: 10/26/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-323-2016","Class II","Atropine/Phenylpropanolamine/Chlorpheniramine 10 mL Vial (0.2 mg/12.5 mg/5 mg/mL) in glass vials; For IM Use Only, Rx.","40 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03242015@20 BUD: 9/20/2015, 04302015@33 BUD: 10/27/2015, 06252015@12 BUD: 12/22/2015, 07202015@47 BUD: 1/16/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-371-2016","Class II","Pen-G/Dexameth./Chlorphenir/Gentamicin (200,000U/0.5/5/20 mg/mL) in 100 mL glass vials; For IM Use Only, Rx.","13 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04232015@30 BUD: 10/20/2015, 07092015@37 BUD: 1/5/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-379-2016","Class II","Sesame Oil, Sterile 10 mL Vial (100% oil) in glass vials; For IM Use Only, Rx.","1 vial","Lack of sterility assurance.","03/03/2016",," Lot: : 04152015@35 BUD: 10/12/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-377-2016","Class II","Progesterone in Sesame Oil Sterile 100 mL Vial (150 mg/mL) in glass vials; Progesterone in Sesame Oil Sterile 100 mL Vial (100 mg/mL) in glass vials","30 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04222015@6 BUD: 10/19/2015, 06042015@24 BUD: 12/1/2015, 06042015@29 BUD: 12/1/2015, 07142015@48 BUD: 1/10/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-326-2016","Class II","Betamethasone Combo 5 mL in 10 mL Vial (7 mg/mL) in amber glass vials; For IM & Regional Injection, Rx.","308 vials","Lack of sterility assurance.","03/03/2016",," Lot: 06032015@60 BUD: 11/29/2015, 07092015@65 BUD: 1/4/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-350-2016","Class II","Estrone AQ 100 mL Vial (5 mg/mL) in amber glass vials; Estrone AQ 30 mL Vial (5 mg/mL) in amber glass vials; For IM Use Only, Rx.","523 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04292015@44 BUD: 10/26/2015, 06112015@10 BUD: 12/8/2015, 07092015@60 BUD: 1/5/2016, 07232015@43 BUD: 1/19/2016, 04292015@29 BUD: 10/26/2015, 06012015@49 BUD: 11/28/2015, 07132015@6 BUD: 1/9/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-382-2016","Class II","Tolazoline Sterile 100 mL Vial (10%(100 mg/mL)) in amber glass vials; For IV Use, Rx.","62 vials","Lack of sterility assurance.","03/03/2016",," Lot: : 05062015@23 BUD: 10/18/2015, 05072015@14 BUD: 10/18/2015, 05192015@45 BUD: 11/15/2015, 08102015@34 BUD: 2/3/2016, 09042015@30 BUD: 3/2/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-383-2016","Class II","Tranexamic Acid (100 mg/mL) in 100 mL glass vials; For IV Use, Rx.","1 vial","Lack of sterility assurance.","03/03/2016",," Lot: : 08072015@28 BUD: 11/5/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-328-2016","Class II","Budesonide/Gentamicin (3 mg/120 mg/25 mL) in 250 mL glass vials; For IM Use Only, Rx.","8 vials","Lack of sterility assurance.","03/03/2016",," Lot: 09032015@33 BUD: 11/2/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-375-2016","Class II","Praziquantel/Lidocaine Injection (VET) (56.8/5 mg/mL) in 50 mL glass vials; For IM Use Only, Rx.","3 vials","Lack of sterility assurance.","03/03/2016",," Lot: 07152015@55 BUD: 10/13/2015, 09022015@28 BUD: 12/1/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-330-2016","Class II","Buprenorphine PF 1 mL Syringe (0.3 mg/mL) in 3 mL syringes; For IV or IM Use Only, Rx.    ","1047 syringes","Lack of sterility assurance.","03/03/2016",," Lot: 04232015@2 BUD: 10/20/2015, 05212015@10 BUD: 11/17/2015, 06292015@4 BUD: 12/26/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-318-2016","Class II","Ammonium Chloride Sterile 10 mL Vial (5%) in glass vials; For IV Use After Dilution, Rx.","250 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03182015@23 BUD: 9/14/2015, 04142015@7 BUD: 10/11/2015, 05072015@17 BUD: 11/3/2015, 06012015@60 BUD: 11/28/2015, 06162015@7 BUD: 12/13/2015, 06242015@64 BUD: 12/21/2015, 07132015@19 BUD: 1/9/2016, 07282015@125 BUD: 1/24/2016, 09012015@81 BUD: 2/28/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-388-2016","Class II","Tryptophan (L) 100 mL Vial (100 mg/mL) in amber glass vials; For IM Use Only, Rx.","34 vials","Lack of sterility assurance.","03/03/2016",," Lot: : 05112015@11 BUD: 11/7/2015, 05142015@20 BUD: 11/10/2015, 06022015@35 BUD: 11/29/2015, 07152015@91 BUD: 1/11/2016, 07282015@99 BUD: 1/24/2016, 08312015@85 BUD: 1/25/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-365-2016","Class II","Metronidazole (VET) Sterile 100 mL vial (100 mg/mL) in glass vials; For IM Use Only, Rx.","60 vials","Lack of sterility assurance.","03/03/2016",," Lot: 05182015@77 BUD: 9/13/2015, 06292015@127 BUD: 9/13/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-334-2016","Class II","Camphor in Olive Oil (20%) in 100 mL glass vials; For IM Use Only, Rx.    ","30 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03262015@32 BUD: 9/22/2015, 06042015@74 BUD: 12/1/2015, 07172015@30 BUD: 1/13/2016, 09032015@44 BUD: 3/1/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-378-2016","Class II","Pyrilamine Maleate Sterile 100 mL Vial (20 mg/mL) in amber glass vials; Pyrilamine Maleate Sterile 100 mL Vial (100 mg/mL) in glass vials; For IV Use, Rx.","38 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04172015@12 BUD: 10/14/2015, 04272015@26 BUD: 10/24/2015, 05212015@6 BUD: 11/17/2015, 06022015@48 BUD: 11/29/2015, 0812205@29 BUD: 2/8/2016, 09012015@4 BUD: 2/28/2016, 09032015@75 BUD: 3/1/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-380-2016","Class II","Progesterone in Sesame Oil Sterile 100 mL Vial (150 mg/mL) in glass vials; Progesterone in Sesame Oil Sterile 100 mL Vial (100 mg/mL) in glass vials; For IM Use Only, Rx.","30 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04222015@6 BUD: 10/19/2015, 06042015@24 BUD: 12/1/2015, 06042015@29 BUD: 12/1/2015, 07142015@48 BUD: 1/10/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-319-2016","Class II","Ammonium Sulfate Sterile 100 mL Vial (0.75%) and (10%) in amber glass vials; For IV Use After Dilution, Rx.","161 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03262015@26 BUD: 9/22/2015, 04032015@18 BUD: 9/30/2015, 04062015@28 BUD: 10/3/2015, 04302015@22 BUD: 10/27/2015, 05052015@15 BUD: 11/1/2015, 06102015@95 BUD: 12/7/2015, 06112015@28 BUD: 12/8/2015, 06162015@9 BUD: 12/13/2015, 07152015@27 BUD: 1/11/2016, 07222015@62 BUD: 1/18/2016, 08042015@74 BUD: 1/31/2016, 09012015@84 BUD: 2/28/2016, 09032015@17 BUD: 3/1/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-317-2016","Class II","Amikacin PF 2 mL (250 mg/mL) in glass vials; For Intra-Articular, IM, or IV Use Only, Rx.","1856 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04032015@11 BUD: 9/30/2015, 05192015@7 BUD: 11/15/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-367-2016","Class II","Na Acet./KCl/CaCl/MgCl/Dextrose Sterile 100 mL Vial (100/0.7/0.3/0.2/50 mg/mL) in amber glass vials: For IV injection After Dilution, Rx.","174 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03162015@30 BUD: 9/12/2015, 03312015@43 BUD: 9/27/2015, 04272015@29 BUD: 10/24/2015, 05062015@38 BUD: 11/2/2015, 06112015@25 BUD: 12/8/2015, 07082015@6 BUD: 1/4/2016, 07092015@41 BUD: 1/7/2016, 08112015@18 BUD: 2/7/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-347-2016","Class II","Diclofenac Sodium Solution (0.1%) in 10 mL dropper bottles; For Topical Ophthalmic Use, Rx.","3 bottles","Lack of sterility assurance.","03/03/2016",," Lot: 07212015@25 BUD: 1/17/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-361-2016","Class II","Medroxyprogesterone 100 mL Vial (200 mg/mL) in amber glass vials; Medroxyprogesterone 100 mL Vial (100 mg/mL) in amber glass vials;  Medroxyprogesterone 30 mL Vial (200 mg/mL) in amber glass vials;  Medroxyprogesterone 30 mL Vial (100 mg/mL) in amber glass vials; For IM Use Only, Rx.","476 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04162015@32 BUD: 10/13/2015, 05182015@85 BUD: 11/14/2015, 06022015@96 BUD: 11/29/2015, 06152015@65 BUD: 12/12/2015, 06152015@84 BUD: 12/12/2015, 04162015@28 BUD: 10/13/2015, 05072015@6 BUD: 11/1/2015, 06022015@82 BUD: 11/29/2015, 07152015@10 BUD: 1/10/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-376-2016","Class II","Progest./Estradiol-17B, Sesame Oil Sterile 100 mL Vial (50 mg/3.33 mg/mL) in glass vials; For IM Use Only, Rx.","2 vials","Lack of sterility assurance.","03/03/2016",," Lot: 06242015@46 BUD: 12/21/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-348-2016","Class II","Estradiol 17B (10 mg/mL) in 10 mL glass vials; For IM Use Only, Rx.","14 vials","Lack of sterility assurance.","03/03/2016",," Lot: 07012015@55 BUD: 9/29/2015, 07062015@49 BUD: 10/4/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-316-2016","Class II","Adenosine Monophosphate (200 mg/mL) in 100 mL amber glass vials; For IM Use Only, Rx.","9 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04152015@69 BUD: 10/12/2015, 05182015@45 BUD: 11/7/2015, 07172015@23 BUD: 1/13/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-315-2016","Class II","Acth. Gel*R* (80 units/mL) and (40 units/mL) in 10 mL amber glass vials and 10 mL glass vials; For IM Use Only, Rx.","57 vials","Lack of sterility assurance.","03/03/2016",," Lot: 06162015@54 BUD: 9/14/2015, 06182015@39 BUD: 9/16/2015, 08062015@28 BUD: 11/4/2015, 09032015@2 BUD: 12/2/2015, 09082015@7 BUD: 12/7/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-369-2016","Class II","N-Butyl Alcohol Sterile 100 mL vial (7%) in glass vials; For IM Use Only, Rx.","91 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03172015@9 BUD: 9/13/2015, 03182015@14 BUD: 9/14/2015, 03262015@11 BUD: 9/22/2015, 04032015@23 BUD: 9/30/2015, 04282015@9 BUD: 10/25/2015, 06182015@61 BUD: 12/15/2015, 06232015@37 BUD: 12/20/2015, 07012015@13 BUD: 12/28/2015, 07132015@70 BUD: 1/9/2016, 08112015@38 BUD: 1/31/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-353-2016","Class II","Folic Acid (15 mg/mL) in 100 mL glass vials; Folic Acid Sterile 100 mL vial (10 mg) in glass vials; For IM or IV use, Rx.","138 vials","Lack of sterility assurance.","03/03/2016",," Lot: 05192015@38 BUD: 11/15/2015, 04222015@43 BUD: 10/19/2015, 05202015@62 BUD: 11/16/2015, 06022015@75 BUD: 11/29/2015, 06172015@23 BUD: 12/14/2015, 07142015@30 BUD: 1/10/2015, 09012015@1 BUD: 2/27/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-322-2016","Class II","ATP/B12/NA Selenite/Potassium ASP/Magnesium ASP (2/1/2/20/30 mg per mL) in 100 mL glass vials; For IV or IM Use Only, Rx.","5 vials","Lack of sterility assurance.","03/03/2016",," Lot: 08122015@15 BUD: 11/10/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-364-2016","Class II","Methocarbamol 100 mL Vial (100 mg/mL) in clear glass vials; For IV or IM Injection, Rx.","232 vials","Lack of sterility assurance.","03/03/2016",," Lot: 06122015@2 BUD: 10/9/2015, 07212015@11 BUD: 11/17/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-314-2016","Class II","Acetyl-D-Glucosamine 100 mL Vial (20%) in amber glass vials; For IM Injection Only, Rx.","189 vials","Lack of sterility assurance.","03/03/2016",," Lot: 04132015@41 BUD: 10/10/2015, 04222015@63 BUD: 10/19/2015, 07272015@62 BUD: 1/23/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-356-2016","Class II","Idoxuridine Solution (0.1%) in 5 mL dropper bottle; For Topical Ophthalmic Use, Rx.","11 bottles","Lack of sterility assurance.","03/03/2016",," Lot: 06252015@43 BUD: 9/23/2015, 08042015@58 BUD: 11/2/2015, 08122015@41 BUD: 11/10/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-358-2016","Class II","Ketoprofen 100 mL (10%) in amber glass vials; For IV or IM Injection, Rx.","659 vials","Lack of sterility assurance.","03/03/2016",," Lot: 05062015@52 BUD: 11/2/2015, 05202015@59 BUD: 11/16/2015, 06082015@47 BUD: 12/5/2015, 06242015@44 BUD: 12/21/2015, 07172015@33 BUD: 1/12/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-351-2016","Class II","FENH/B2/B6/B3/B5/Co Gluc./GU Gluc./Choline/CHL/Inositol/Methionine/Lysine/HCl/Glycine/Cyanocobalamin/Biotin (1.5 gm/1.075 gm/1 gm/10 gm/1.5 gm/0.07 gm) in 250 mL brown bottle; For IM or SC Injection, Rx.","71 bottles","Lack of sterility assurance.","03/03/2016",," Lot: 03162015@4 BUD: 9/12/2015, 06092015@4 BUD: 12/6/2015, 07202015@10 BUD: 1/16/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-354-2016","Class II","Guaifenesin 1000 mL Bag (5%(50 mg/mL)) in 1000 mL IV Bags; Guaifenesin 500 mL bag (5%(50 mg/mL)); For IV Infusion or IV Injection, Rx.","304 bags","Lack of sterility assurance.","03/03/2016",," Lot: 03192015@37 BUD: 9/15/2015, 04152015@52 BUD: 10/12/2015, 05212015@63 BUD: 11/17/2015, 06042015@54 BUD: 12/1/2015, 06232015@91 BUD: 12/20/2015, 07222015@99 BUD: 1/18/2015, 04232015@28 BUD: 10/20/2015, 06292015@119 BUD: 12/26/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-372-2016","Class II","Pen-G/Dexameth./Chlorpheniramine (200,000U/0.5 mg/5 mg/mL) in 100 mL glass vials; For IM Use Only, Rx.","2 vials","Lack of sterility assurance.","03/03/2016",," Lot: 06022015@47 BUD: 11/29/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-387-2016","Class II","Tripelennamine HCL injection (20 mg/mL) in 100 mL amber glass vials; For IV or IM Use Only, Rx","159 vials","Lack of sterility assurance.","03/03/2016",," Lot: : 03262015@13 BUD: 9/22/2015, 04092015@18 BUD: 10/6/2015, 05182015@13 BUD: 11/14/2015, 05182015@74 BUD: 11/14/2015, 05222015@43 BUD: 11/14/2015, 06012015 BUD: 11/28/2015, 06012015@35 BUD: 11/28/2015, 06102015@72 BUD: 12/7/2015, 06102015@72 BUD: 12/7/2015, 07172015@41 BUD: 11/14/2015, 07282015@116 BUD: 1/17/2016, 08052015@15 BUD: 1/17/2016, 09012015@42 BUD: 2/28/2016, 09032015@74 BUD: 2/28/2016",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-332-2016","Class II","CACO/Ferric Cl/Cu Gluc./Strychnine Sterile 100 m: (6.4 mg/1 mg/0.2 mg/mL) in 100 mL amber glass vials; For IV or IM Use Only, Rx.    ","162 vials","Lack of sterility assurance.","03/03/2016",," Lot: 03162015@10 BUD: 9/12/2015, 04142015@27 BUD: 10/11/2015, 05182015@28 BUD: 11/14/2015, 05202015@3 BUD: 11/15/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72180,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-386-2016","Class II","Triamcinolone Diacetate PF 2 mL vial (6 mg/mL) in amber glass vials; For IM & Regional Injection, Rx.","130 vials","Lack of sterility assurance.","03/03/2016",," Lot: : 06182015@38 BUD: 12/15/2015",9/12/2015,"09/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0663-2016","Class II","Accusorb MRI   MAC7001  Part Number: MRI-01  MRI-Large Blanket Various Sizes    Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","49 units","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0665-2016","Class II","Accusorb MRI   MAC7004  Part Number: MRI-04  MRI-Poncho    Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","one unit","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0670-2016","Class II","Accusorb MRI    MAC7006  Part Number: MRI-06  MRI-Large Torso Wrap  Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","5 units","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0671-2016","Class II","Accusorb MRI  MAC7009   Part Number: MRI-09  MRI- Leg Wrap Blanket Various Sizes    Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","47 units","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0664-2016","Class II","Accusorb MRI   MAC7002  Part Number: MRI-02  MRI-Arm Sleeve  Various Sizes    Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","31 units","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0669-2016","Class II","Accusorb MRI   MAC7005  Part Number: MRI-05 Leg Wrap    Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","18 units","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0672-2016","Class II","Accusorb MRI     MAC7010    Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","1 units","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0668-2016","Class II","Accusorb MRI   MAC7003  Part Number: MRI-03 U (Upper) and MRI-03 L (Lower)  Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","14 units","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0666-2016","Class II","Accusorb MRI   MAC7007  Part Number: MRI-07  MRI-Breast Shield    Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","6 units","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0667-2016","Class II","Accusorb MRI   MAC7008  Part Number: MRI-08  MRI-Boot    Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","15 units","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72202,"Ongoing","MWT Materials, Inc.","90 Dayton Ave Ste 6E Building 21",".","Passaic","NJ","07055-7014","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of NY and  MA.","Z-0673-2016","Class II","Accusorb MRI     MAC7030    Product Usage:  Radio frequency shielding blankets and body-part covers for the MRI environment.  ","1 unit","When not used correctly, Accusorb MRI products may overheat and lead to patient injury. ","01/20/2016",," All",10/6/2014,"10/06/2014",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72210,"Ongoing","Mevion Medical Systems, Inc.","300 Foster Street",,"Littleton","MA","01460-2017","United States","Voluntary: Firm Initiated","Letter","US nationwide distribution including FL, NJ, OK, and MO.","Z-0767-2016","Class II","MEVION S250 Radiation therapy system","4","The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.","02/08/2016",," Manufacturing Lot or Serial Number: S250-0004",11/18/2015,"11/18/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72226,"Ongoing","I and Love and You - NatPets LLC","2108 55th St Unit 100",,"Boulder","CO","80301-2827","United States","Voluntary: Firm Initiated","Letter","Nationwide to Ohio, Rhode Island, Washington and Florida.  No foreign/VA/Govt/military","V-515-2016","Class I","Natpet, LLC dba I and Love and You cow-boom! strips-beef gullet, 2.0 oz poly bags with zipper, 5 beef gullet strips per bag, 6 bags per case.  ","8430 cases (6 bags per case)","Natpet, LLC dba I and Love and You conducts a recall of cow-boom! strips-beef gullet pet treats due to contaminaton with Salmonella.","09/13/2016",," lot numbers ending in 4T1 or 5T1, a best-by-year of 2016 or 2017 and UPC number 818336011344",7/10/2015,"07/10/2015",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72227,"Ongoing","XTREME Z DISTRIBUTORS INC","3300 NE 191st St Apt 813",,"Aventura","FL","33180-2444","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1165-2016","Class I","Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180","70,350 capsules","Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.","07/06/2016","."," Lot 1220062085, Exp. 09/16",7/2/2015,"07/02/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72250,"Ongoing","Zarbee's Naturals Inc.","11650 S State St Ste 101",,"Draper","UT","84020-7144","United States","Voluntary: FDA Requested","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide to MN, IL, NJ and MI, further distributed nationwide.  No foreign/VA/govt/military.","F-1618-2016","Class III","Baby Vitamin D Dietary supplement (in liquid form), 15 ml and 14 ml in glass bottle with dropper dispenser.","59,418 units","Some units of each lot may contain contaminants (elevated aerobic plate count) and do not meet acceptable visual appearance standards for the product.","07/06/2016","."," Lot# 15042013283, expiry 05/2016  Lot# 15049013283, expiry 05/2016  Lot# 15100013283, expiry 07/2016  Lot# 15113013283, expiry 07/2016  Lot# 15118013283, expiry 07/2016  Lot# 15119013283, expiry 07/2016  Lot# 1517301283, expiry 07/2016  Lot# 1517401283, expiry 09/2016",9/21/2015,"09/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72250,"Ongoing","Zarbee's Naturals Inc.","11650 S State St Ste 101",,"Draper","UT","84020-7144","United States","Voluntary: FDA Requested","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide to MN, IL, NJ and MI, further distributed nationwide.  No foreign/VA/govt/military.","F-1617-2016","Class III","Baby Omega 3 Dietary supplement (in liquid form), 15 ml and 14 ml in glass bottle with dropper dispenser.","41,565 units","Some units of each lot may contain contaminants (elevated aerobic plate count) and do not meet acceptable visual appearance standards for the product.","07/06/2016","."," Lot# 15043013284, expiry 05/2016  Lot# 15100013284, expiry 07/2016  Lot# 15114013284, expiry 07/2016  Lot# 1516901284, expiry 09/2016  Lot# 1517001284, expiry 09/2016",9/21/2015,"09/21/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72252,"Ongoing","Praxair Inc.","39 Old Ridgebury Road",,"Danbury","CT","06817-0001","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0782-2016","Class III","UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.","127 cylinders","CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.","03/28/2016",," Lot #  P411517501, P411517601, P411517701, P411518001, P411518101, P411518201, P411518202, P411518301, P411518701, P411518801, P411518901, P411519101, P411519401, P411519601, P411519602, P411519701, P411520101, P411520301, P411520401, P411520901, P411521001, P411521002, P411521101, P411521201, P411521501, P411521601, P411521701, P411521801, P411521901, P411522201, P411522401, P411522501, P411522901, P411523001, P411523101, P411523201, P411523301, P411523601, P411523701, P411523801, P411523901, P411524001, P411524301, ",9/16/2015,"09/16/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72252,"Ongoing","Praxair Inc.","39 Old Ridgebury Road",,"Danbury","CT","06817-0001","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0783-2016","Class III","UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,","382 cylinders ","CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.","03/28/2016",," Lot #  K411517501, K411517601, K411517701, K411518001, K411518101, K411518201, K411518202, K411518301, K411518302, K411518701, K411518801, K411518901, K411518902, K411519001, K411519101, K411519401, K411519501, K411519601, K411519602, K411519701, K411519801, K411520101, K411520201, K411520301, K411520302, K411520401, K411520901, K411521001, K411521002, K411521101, K411521102, K411521201, K411521501, K411521601, K411521602, K411521701, K411521702, K411521801, K411521901, K411522201, K411522301, K411522401, K411522501, K411523001, K411523101, K411523201, K411523202, K411523301, K411523601, K411523701, K411523801, K411523901, K411523902, K411524001, K411524301, K411524302, K411524401, K411522601, K411522901, ",9/16/2015,"09/16/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72259,"Ongoing","Picnic Gourmet Spreads LLC","8011 Old Georgetown Rd",,"Bethesda","MD","20814-2426","United States","Voluntary: Firm Initiated","Telephone","Product is distributed by Euro USA Food Distributor","F-0728-2016","Class I","Picnic Gourmet Spreads ( Tandoori Garlic Cheese Spread) 8 oz containers .12 Containers per case",,"Maryland Department of Health and Mental Hygiene (DHMH) collected a sample collected a sample of Red Pepper Feta Cheese Spread that came up positive for L. Monocytogenes.     The analysis was done by the DHMH Laboratories Administration and revealed the presence of Listeria Monocytogenes in the product.    The product is made by Picnic Gourmet Spreads, Potomac , MD 20854","03/07/2016",," 10696 54148",9/17/2015,"09/17/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72259,"Ongoing","Picnic Gourmet Spreads LLC","8011 Old Georgetown Rd",,"Bethesda","MD","20814-2426","United States","Voluntary: Firm Initiated","Telephone","Product is distributed by Euro USA Food Distributor","F-0729-2016","Class I","Picnic Gourmet Spreads ( Parmesan Cheese Spread) 8 oz containers .12 Containers per case",,"Maryland Department of Health and Mental Hygiene (DHMH) collected a sample collected a sample of Red Pepper Feta Cheese Spread that came up positive for L. Monocytogenes.     The analysis was done by the DHMH Laboratories Administration and revealed the presence of Listeria Monocytogenes in the product.    The product is made by Picnic Gourmet Spreads, Potomac , MD 20854","03/07/2016",," 10696 54145",9/17/2015,"09/17/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72259,"Ongoing","Picnic Gourmet Spreads LLC","8011 Old Georgetown Rd",,"Bethesda","MD","20814-2426","United States","Voluntary: Firm Initiated","Telephone","Product is distributed by Euro USA Food Distributor","F-0731-2016","Class I","Picnic Gourmet Spreads ( Moroccan Cilantro Cheese Spread) 8 oz containers .12 Containers per case",,"Maryland Department of Health and Mental Hygiene (DHMH) collected a sample collected a sample of Red Pepper Feta Cheese Spread that came up positive for L. Monocytogenes.     The analysis was done by the DHMH Laboratories Administration and revealed the presence of Listeria Monocytogenes in the product.    The product is made by Picnic Gourmet Spreads, Potomac , MD 20854","03/07/2016",," 10696 54153",9/17/2015,"09/17/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72259,"Ongoing","Picnic Gourmet Spreads LLC","8011 Old Georgetown Rd",,"Bethesda","MD","20814-2426","United States","Voluntary: Firm Initiated","Telephone","Product is distributed by Euro USA Food Distributor","F-0730-2016","Class I","Picnic Gourmet Spreads ( Herbed Goat Cheese Spread) 8 oz containers .12 Containers per case",,"Maryland Department of Health and Mental Hygiene (DHMH) collected a sample collected a sample of Red Pepper Feta Cheese Spread that came up positive for L. Monocytogenes.     The analysis was done by the DHMH Laboratories Administration and revealed the presence of Listeria Monocytogenes in the product.    The product is made by Picnic Gourmet Spreads, Potomac , MD 20854","03/07/2016",," none",9/17/2015,"09/17/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72259,"Ongoing","Picnic Gourmet Spreads LLC","8011 Old Georgetown Rd",,"Bethesda","MD","20814-2426","United States","Voluntary: Firm Initiated","Telephone","Product is distributed by Euro USA Food Distributor","F-0727-2016","Class I","Picnic Gourmet Spreads ( Red Pepper Feta Cheese Spread) 8 oz containers .12 Containers per case","To be provided by firm","Maryland Department of Health and Mental Hygiene (DHMH) collected a sample collected a sample of Red Pepper Feta Cheese Spread that came up positive for L. Monocytogenes.     The analysis was done by the DHMH Laboratories Administration and revealed the presence of Listeria Monocytogenes in the product.    The product is made by Picnic Gourmet Spreads, Potomac , MD 20854","03/07/2016",," 10696 54154",9/17/2015,"09/17/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72269,"Ongoing","Lucy's Weight Loss (dba. Waisted With Lucy)","813 Oram St",,"Arlington","TX","76010-2837","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0880-2016","Class I","Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010","Unknown","Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.","05/26/2016",," All lots",9/23/2015,"09/23/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72269,"Ongoing","Lucy's Weight Loss (dba. Waisted With Lucy)","813 Oram St",,"Arlington","TX","76010-2837","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0881-2016","Class I","Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010",,"Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.","05/26/2016",," All lots",9/23/2015,"09/23/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72269,"Ongoing","Lucy's Weight Loss (dba. Waisted With Lucy)","813 Oram St",,"Arlington","TX","76010-2837","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0879-2016","Class I","Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010","Unknown","Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.","05/26/2016",," All lots",9/23/2015,"09/23/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72270,"Ongoing","Western Milling, LLC.","31120 West Street",,"Goshen","CA","93227","United States","Voluntary: Firm Initiated","Telephone","CA, AZ","V-412-2016","Class I","Kruse's Perfection - Western Blend Horse Feed; Promise  Formula K66505, Lot 5251, 50 lb. bag packages (22.68 kg)    UPC 000005251    Manufactured by:  O.H. Kruse Grain and Milling, Goshen, CA","708 x 50 lb. bags, 5.77 tons bulk","One lot of Western Forage Blend for horses is being recalled due to positive results for monensin quick test and three horse deaths.","05/19/2016",," Formula K66505, Lot 5251  ",9/23/2015,"09/23/2015",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72283,"Completed","MFA Inc","201 Ray Young Dr",,"Columbia","MO","65201","United States","Voluntary: Firm Initiated","Telephone","KS","V-299-2016","Class III","DQ Goat Grower 15% RU-27 Medicated - A Feed for Goats, Monensin Sodium 27 g/ton, packaged as bulk in 1000 lb. plastic totes.  The responsible firm is MFA Incorporated, Columbia, MO 65201.","4 -1000 lb totes","Product contains monensin.","02/05/2016",," lot 197180",9/24/2015,"09/24/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72283,"Completed","MFA Inc","201 Ray Young Dr",,"Columbia","MO","65201","United States","Voluntary: Firm Initiated","Telephone","KS","V-298-2016","Class III","DQ Goat Grower 15% RU-27 Medicated - A Feed for Goats, Monensin Sodium 27 g/ton, packaged as bulk in 1000 lb. plastic totes.  The responsible firm is MFA Incorporated, Columbia, MO 65201.","2 - 1000lb totes","Product contains monensin and excess copper.","02/05/2016",," lot 194632",9/24/2015,"09/24/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72287,"Ongoing","Murphy Hay Farm","359 W Dyking Rd",,"Louisburg","NC","27549-7313","United States","Voluntary: Firm Initiated","Telephone","NC and VA","V-409-2016","Class I","Alfalfa Hay,  Square-baled, Bound with reddish-orange twine, weighing approximately 70 lbs.  ","843 bales (70 lbs per bale)","Product was found to be contaminated with blister beetles which can be deadly to horses. ","05/11/2016",," Product distributed on or after August 11, 2015",9/18/2015,"09/18/2015",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72294,"Ongoing","Tf Supplements","6666 Gulf Fwy",,"Houston","TX","77087-1416","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0771-2016","Class I","RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA","350 Bottles","Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.","03/09/2016",," All lots",9/25/2015,"09/25/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72294,"Ongoing","Tf Supplements","6666 Gulf Fwy",,"Houston","TX","77087-1416","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0772-2016","Class I","Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748      ","128 Blister Packs","Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.","03/09/2016",," All lots",9/25/2015,"09/25/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72299,"Ongoing","Amcane Sugar Llc","21010 Trolley Industrial Dr",".","Taylor","MI","48180-1841","United States","Voluntary: Firm Initiated","Telephone","IL, GA, WI, KY","F-0438-2016","Class II","Bulk refined sugar.  CON AAA in 2200 poly super totes  ","169,400 lbs","Foreign material in product, small pieces of brass less than 7mm.  ","12/28/2015",," Manufacturing Pans 6510 and 6511.  Customer specific lot numbers as idenified in individual recall notices:  6510-5204;  6522-5210;  6513-5211;  6518-5217;  6546-5224;  6547-5225;  6572-5233.",9/4/2015,"09/04/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72299,"Ongoing","Amcane Sugar Llc","21010 Trolley Industrial Dr",".","Taylor","MI","48180-1841","United States","Voluntary: Firm Initiated","Telephone","IL, GA, WI, KY","F-0439-2016","Class II","Bulk refined sugar.  Sanding in 50 lb paper bags  ","196,500 lbs","Foreign material in product, small pieces of brass less than 7mm.  ","12/28/2015",," Manufacturing Pans 6510 and 6511.  Customer specific lot numbers as idenified in individual recall notices:  6525-5211;  6352-5218;  6546-5226;  6515-5225;  6544-5230.",9/4/2015,"09/04/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72299,"Ongoing","Amcane Sugar Llc","21010 Trolley Industrial Dr",".","Taylor","MI","48180-1841","United States","Voluntary: Firm Initiated","Telephone","IL, GA, WI, KY","F-0437-2016","Class II","Bulk refined sugar.  CON AA in 50lb paper bags, 2000 and 2200 poly super totes  "," 526,000 lbs","Foreign material in product, small pieces of brass less than 7mm.  ","12/28/2015",," Manufacturing Pans 6510 and 6511.  Customer specific lot numbers as idenified in individual recall notices:  6260-5219;  6394-5227;  6518-5227;  6260-5233;  6394-5233;  6515-5210;  6544-5225;  6547-5230;  6570-5233;  6511-5209;  6513-5210;  6509-5204;  6509-5209;  6515-5213;  6524-5222;  6518-5224.  ",9/4/2015,"09/04/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72300,"Ongoing","oc Raw Dog","30052 Aventura Ste A",,"Rancho Santa Margarita","CA","92688-2042","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; VT, CO, PA.  No foreign distribution.","V-308-2016","Class I","OC Raw Dog Chicken, Fish & Produce Raw Frozen Canine Formulation   3lb Meat Rox  UPC Code: 022099069171    4lb Sliders  UPC Code: 095225852640    6.5lb Doggie Dozen Patty Bags  UPC Code: 022099069225","640 lbs.","OC Raw Dog, LLC is recalling OC Raw Dog Chicken, Fish & Produce Raw Frozen Canine Formulation due to potential Salmonella contamination.","02/10/2016",," Lot #1819  Use by Date 050516",9/27/2015,"09/27/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72306,"Completed","Cooperative Milling, Inc.","1892 York Rd",,"Gettysburg","PA","17325-8205","United States","Voluntary: Firm Initiated","Visit","MD","V-442-2016","Class I","Sold in Bulk truck  Southern States  SSC-25-249707  Commercial   28% Gamebird Starter   Lot G5252    Per customer request: feed contains added Amprolium 1.4 lbs/ton (159g/Ton)","13,700 lbs","Particle size for Commercial 28% Gamebird Starter was larger than intended resulting in starve out of quail.","06/11/2016",," Tag - Lot G5252",9/22/2015,"09/22/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72310,"Ongoing","United Pet Group, Inc.","3001 Commerce St",,"Blacksburg","VA","24060-6671","United States","Voluntary: Firm Initiated","Press Release","Nationwide distribution to AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MO, MS, NC, NY, OH, OK, PA, SC, TX, UT, VA, and WA.  There was not foreign, government, or military distribution.","V-452-2016","Class I","Good 'n' Fun Beefhide Chicken Sticks Chicken Jerky, Item No. 82247, packaged in cases of 24 bags.  Each bag contains 10 sticks - Net Wt. 2.8 oz. (80g), UPC 0 91093 82247 1.  Made in Colombia.  Distributed by Salix Animal Health, LLC, Deerfield, FL 33442.","465,777 bags","Product may be contaminated with Salmonella.","06/11/2016",," Multiple lots:  AO15007, AO15009, AO15010, AO15015, AO15020, and AO15030  All product with expiration dates:  02/2018, 03/2018, 04/2018, 05/2018, 06/2018, and 07/2018.",9/30/2015,"09/30/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72323,"Terminated","Medline Industries Inc","1 Medline Pl",,"Mundelein","IL","60060-4485","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0663-2016","Class I","ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.",,"Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.","02/12/2016","06/29/2016"," lot # 45810; Exp. 05/18",9/25/2015,"09/25/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72323,"Terminated","Medline Industries Inc","1 Medline Pl",,"Mundelein","IL","60060-4485","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0662-2016","Class I","ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.","7,372 HDPE Bottles","Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.","02/12/2016","06/29/2016"," lot # 45810; Exp. 05/18",9/25/2015,"09/25/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72325,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US Nationwide in the states of : AK, AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, UT, WI, WV and the country of Canada.","Z-1066-2016","Class II","Philips X-Ray Systems, Allura Xper with R8.2.16    Product Usage:  The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for:  Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.","196 devices","Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.","03/07/2016",," Product Codes: 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059 systems with release R8.2.16",10/1/2015,"10/01/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72339,"Terminated","The Dough Shop Pizza Dough Shop, Inc.","12257 Nicollet Ave",".","Burnsville","MN","55337-1650","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI","F-0457-2016","Class II","CPT05 5 Ounce Pizza Dough Ball, 112 - 5 Ounce Dough Balls, Net Weight 35.0 Pounds, UPC 1 081267 0012644 4.. ","18 cases","The Dough Shop is recalling one lot of pizza dough because a piece of vinyl glove was found in the product.","12/29/2015","03/09/2016"," 09022015-2",10/1/2015,"10/01/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72349,"Ongoing","Pure Source, Inc.","9750 Nw 17th St",".","Doral","FL","33172-2753","United States","Voluntary: Firm Initiated","Letter","Pure Source, Inc manufactured the recalled product for Baker's Best Health Products, Inc.  They sold all of the the products to Baker's Best Health Products, Inc. in Wixom, MI who then distributed the products to their customers via catalog sales and internet sales.    Baker's Best Health Products, Inc. distributed product throughout the U.S.","F-0456-2016","Class II","Baker's Best Maximum Mind & Memory Formula, 60 capsules, Vitamin B6 75 mg.  Distributed by Baker's Best Health Products, Inc. Wixom, MI","2,185 bottles","Vitamin B6 level below percent declared on label","12/29/2015",," Lot #080115, Exp 01/2018",9/25/2015,"09/25/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72350,"Ongoing","Hummingbird Med","20371 Lake Forest Dr Ste A6",,"Lake Forest","CA","92630-8106","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, KY, MD, GA, and  IL.","Z-1636-2016","Class I","ABG-HM-1 Hummi Micro Draw Blood Transfer Device    Product Usage:  It is used for blood transfer and collection from Peripheral Arterial Line Catheters.  ","11500 units"," Y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.","05/20/2016",," Lot 15180, 15286, 15287, 15300, 15305",10/1/2015,"10/01/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72375,"Terminated","Ducktrap River of Maine LLC","57 Little River Dr",,"Belfast","ME","04915-6035","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide.","F-1529-2016","Class II","Ducktrap Smoked Scallops in both 6oz and 16oz Tubs",,"Environmental sampling detected Listeria in the environment. ","06/16/2016","06/16/2016"," Lot Numbers: 535003 to 538004.    Explanation of coding:  The lot # coding is (538003 for example)  - 5  year (2015), 38 week, 00 batch during the day if more than one batch produced, 3 day of the week, 1 is Sunday so 3 would be Tuesday.                           ",10/6/2015,"10/06/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72375,"Terminated","Ducktrap River of Maine LLC","57 Little River Dr",,"Belfast","ME","04915-6035","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide.","F-1530-2016","Class II","Ducktrap Smoked Shrimp in both 6oz and 16oz Tubs",,"Environmental sampling detected Listeria in the environment. ","06/16/2016","06/16/2016"," Lot Numbers: 533004 to 537005.     Explanation of coding:  The lot # coding is (538003 for example)  - 5  year (2015), 38 week, 00 batch during the day if more than one batch produced, 3 day of the week, 1 is Sunday so 3 would be Tuesday.   ",10/6/2015,"10/06/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72375,"Terminated","Ducktrap River of Maine LLC","57 Little River Dr",,"Belfast","ME","04915-6035","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide.","F-1528-2016","Class II","Ducktrap Smoked Mussels in both 6oz and 16oz Tubs",,"Environmental sampling detected Listeria in the environment. ","06/16/2016","06/16/2016"," Lot Numbers: 533006 to 538003    Explanation of coding:  The lot # coding is (538003 for example)  - 5  year (2015), 38 week, 00 batch during the day if more than one batch produced, 3 day of the week, 1 is Sunday so 3 would be Tuesday.   ",10/6/2015,"10/06/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72380,"Terminated","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","Telephone","Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.","D-723-2016","Class I","fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3479, PharMEDium.","180 syringes","Subpotent Drug","02/18/2016","02/22/2016"," Lot #: 15002077M, Exp 04-02-2015",1/13/2015,"01/13/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72380,"Terminated","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","Telephone","Nine specific hospital pharmacies in VA, IA, WI, CO, CA, PA, and OK.","D-724-2016","Class I","fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride, 1 mL Total Volume For IV Use, packaged in a 3 mL syringe, code 2R3174, PharMEDium","500 syringes","Subpotent Drug","02/18/2016","02/22/2016"," Lot #: 15002250M, Exp 04-02-2015",1/13/2015,"01/13/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72382,"Ongoing","Mutual Pharmaceutical Company,  Inc.","1100 Orthodox St",".","Philadelphia","PA","19124-3168","United States","Voluntary: Firm Initiated","Letter","MS","D-0572-2016","Class II","Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01","9526","Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.","01/19/2016",," Lot # 6727001 Exp 01/18",10/9/2015,"10/09/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72387,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey,  Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-0798-2016","Class I","Shuttle Select Slip-Cath Catheter. Angiographic catheter.     For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over  an appropriately sized wire guide.","9519","Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. Recall expanded 10/07/2015 to include additional catheters.","02/24/2016",," All lot numbers of the following  Product numbers:   SCBR4.5-35-135-P-NS-ANG-SHTL,  SCBR4.5-35-135-P-NS-ANG-SHTL-JP,  SCBR4.5-35-150-P-NS-0-SHTL,  SCBR4.5-35-150-P-NS-ANG-SHTL,  SCBR4.5-35-75-P-NS-ANGSHTL   ",10/7/2015,"10/07/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72391,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) in states of: AZ, CA, MA, NY, TX & WA, and to countries of: Bahrain, Egypt, Slovakia, France, Spain, Italy, Norway, Singapore, New Zealand, Germany, Australia, Republic Korea, Netherlands, Denmark, Finland & United Kingdom.","Z-0755-2016","Class II","ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538    Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.","87 units","Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) communication/Laboratory Automation (LAS) issue, Printer Driver Resets, ISE Calibration Ranges are too conservative for Urine Sodium, Archiving and deletion may fail and Workstation services may restart.","02/04/2016",," Software Version 1.0.3",10/7/2015,"10/07/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72405,"Completed","Bedford Pharmacy","209 Route 101",,"Bedford","NH","03110-5440","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NH","V-393-2016","Class II","Desmopressin 0.01% Ophtalmic Solution Sterile, For Dogs.  Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919","3 units","Lack of assurance of sterility","03/03/2016",," LoT # 08042015@14, BUD 09/14/2015",9/22/2015,"09/22/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72417,"Ongoing","The Kroger Co","1014 Vine St",,"Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states:: AL, AR, GA, IL, IN, KS, KY, LA, MI, MO, MS, NE, OH, SC, TN, TX, VA & WV.","F-1320-2016","Class I","Kroger Raw #4 Macadamia Nuts. UPC 2 04192 51053 2 Dist. by the Kroger Company Cincinnati, Ohio 45202","28, 675 lbs in 25 lb packages","Positive Salmonella sample results in Kroger brand raw Macadamia nuts","05/05/2016",," SELL BY 10 14 15 #54192",10/16/2015,"10/16/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72428,"Terminated","BPL Plasma, Inc.","2631 Dunn Ave",,"Jacksonville","FL","32218-4656","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California, Massachusetts, Florida and the United Kingdom","B-0157-2017","Class II","Source Plasma","844 units","Source Plasma, collected from ineligible donors, were distributed. ","11/17/2016","11/17/2016"," JV0237956, JV0239268, JV0246064, JV0254782, JV0255262, JV0257134, JV0260256, JV0236084, JV0274026, JV0274590, JV0276017, JV0276750, JV0264131, JV0266191, JV0266821, JV0268725, JV0270484, JV0271922, JV0272506, JV0274012, JV0274473, JV0276032, JV0276487, JV0227425, JV0228056, JV0229749, JV0230766, JV0272271, JV0252381, JV0254354, JV0255336, JV0256136, JV0257237, JV0257930, JV0258964, JV0259794, JV0245308, JV0247968, JV0249587, JV0250275, JV0251941, JV0252877, JV0253997, JV0274222, JV0246739, JV0252281, JV0246766, JV0247774, JV0248899, JV0249958, JV0252217, JV0253693, JV0254274, JV0255833, JV0256582, JV0257607, JV0261030, JV0259994, JV0261288, JV0261831, JV0263027, JV0264265, JV0264785, JV0266076, JV0266659, JV0268178, JV0268597, JV0269963, JV0270452, JV0272921, JV0276000, JV0276696, JV0236530, JV0237183, JV0239634, JV0240288, JV0242017, JV0242441, JV0243736, JV0263377, JV0263876, JV0265178, JV0265622, JV0268989, JV0269462, JV0276943, JV0247996, JV0248801, JV0251773, JV0252456, JV0253854, JV0254418, JV0256248, JV0257317, JV0257848, JV0240993, JV0241686, JV0248788, JV0271421, JV0234973, JV0235828, JV0237014, JV0237931, JV0239813, JV0240268, JV0242038, JV0242512, JV0244325, JV0245077, JV0246463, JV0247134, JV0248522, JV0249694, JV0251272, JV0253528, JV0254067, JV0255378, JV0255921, JV0257073, JV0259002, JV0259231, JV0261156, JV0261693, JV0262886, JV0263408, JV0264540, JV0265022, JV0266501, JV0267143, JV0268442, JV0268825, JV0270347, JV0270707, JV0272302, JV0272923, JV0274278, JV0274882, JV0276337, JV0276822, JV0263806, JV0273529, JV0274090, JV0235682, JV0239052, JV0240089, JV0241565, JV0243567, JV0243875, JV0246680, JV0247638, JV0248887, JV0249933, JV0251214, JV0252213, JV0253428, JV0254264, JV0255311, JV0256111, JV0257131, JV0257882, JV0259243, JV0259703, JV0260871, JV0261670, JV0262572, JV0263453, JV0264341, JV0265270, JV0266112, JV0264021, JV0265919, JV0266827, JV0273827, JV0266778, JV0267716, JV0268663, JV0271563, JV0272279, JV0273505, JV0274653, JV0275459, JV0277734, JV0275050, JV0277123, JV0238756, JV0239254",5/18/2015,"05/18/2015",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72428,"Terminated","BPL Plasma, Inc.","2631 Dunn Ave",,"Jacksonville","FL","32218-4656","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California, Massachusetts, Florida and the United Kingdom","B-0158-2017","Class III","Source Plasma","109 units","Source Plasma, collected from ineligible donors, were distributed. ","11/17/2016","11/17/2016"," JV0270934, JV0277659, JV0240182, JV0241791, JV0242961, JV0244173, JV0239324, JV0240904, JV0242828, JV0239508, JV0240115, JV0241644, JV0242043, JV0243618, JV0245092, JV0245641, JV0249256, JV0250009, JV0252761, JV0253308, JV0254621, JV0255180, JV0256509, JV0256975, JV0268728, JV0270630, JV0272048, JV0272627, JV0273934, JV0274571, JV0276013, JV0276676, JV0243297, JV0244646, JV0247322, JV0243515, JV0243702, JV0245159, JV0245982, JV0247235, JV0248263, JV0249476, JV0250521, JV0251862, JV0253394, JV0253883, JV0255459, JV0256310, JV0257523, JV0258060, JV0259307, JV0259858, JV0260969, JV0261493, JV0264030, JV0264451, JV0245555, JV0247693, JV0249916, JV0250964, JV0255834, JV0245882, JV0247544, JV0249996, JV0251734, JV0255080, JV0255820, JV0248651, JV0250159, JV0251825, JV0252537, JV0253932, JV0255033, JV0256313, JV0263715, JV0264125, JV0262615, JV0264606, JV0265132, JV0266453, JV0267115, JV0274830, JV0275663, JV0264367, JV0265432, JV0266434, JV0267855, JV0268660, JV0269751, JV0270574, JV0271640, JV0272981, JV0274035, JV0275081, JV0276334, JV0277231, JV0266771, JV0267799, JV0268783, JV0269682, JV0270467, JV0272170, JV0273125, JV0274163, JV0275073, JV0276569, JV0277225, JV0275332, JV0277869",5/18/2015,"05/18/2015",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72429,"Completed","Innovative Blood Resources","737 Pelham Blvd",,"Saint Paul","MN","55114-1739","United States","Voluntary: Firm Initiated","Letter","MN, ND, WI. NJ, TN FL, OH, MI, CA, TX, LA, NC, SC, NE, NY, PA, IL.","B-0478-16","Class II","Red Blood Cells, Leukocytes Reduced Irradiated","35 units","Blood products, lacking assurance of sterility, were distributed.","04/22/2016",," W051514110095  W051514163819  W051515031018  W051514088641  W051514106549  W051514090200  W051514109764  W051514111719  W051514109919  W051514109925  W051514090331  W051514120081  W051514110234  W051514110236  W051514122176  W051514122268  W051514110311  W051514110352  W051514123301  W051514123402  W051514145643  W051514145644  W051514145913  W051514153436  W051514163817  W051515005416  W051515020425  W051515020430  W051515031909  W051515037880  W051515045603  W051514163721  W051514163800  W051514163860  W051514163875  ",6/17/2015,"06/17/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72429,"Completed","Innovative Blood Resources","737 Pelham Blvd",,"Saint Paul","MN","55114-1739","United States","Voluntary: Firm Initiated","Letter","MN, ND, WI. NJ, TN FL, OH, MI, CA, TX, LA, NC, SC, NE, NY, PA, IL.","B-0477-16","Class II","Fresh Frozen Plasma","137 units","Blood products, lacking assurance of sterility, were distributed.","04/22/2016",," W051514110265  W051514123294  W051514090242  W051515031711  W051514089790  W051514089795  W051514089800  W051514089801  W051514088629  W051514088641  W051514087032  W051514087884  W051514090010  W051514090061  W051514109643  W051514090200  W051514115216  W051514090252  W051514090268  W051514115061  W051514110084  W051514110093  W051514120940  W051514124044  W051514110260  W051514110298  W051514137384  W051514141085  W051514141121  W051514123392  W051514139329  W051514123465  W051514123490  W051514139469  W051514123528  W051514145719  W051514145722  W051514136429  W051514136440  W051514136570  W051514136711  W051514163817  W051514159239  W051514163880  W051515005226  W051515005237  W051515005240  W051515005279  W051515005406  W051515005462  W051515005799  W051515005883  W051515005962  W051515005984  W051515031729  W051515014709  W051515014724  W051515014765  W051515014799  W051515031995  W051515030865  W051515037749  W051515030945  W051515031051  W051514089745  W051514089750  W051514087900  W051514104441  W051514090196  W051514115051  W051514110269  W051514132860  W051514139476  W051514136419  W051514136577  W051515005276  W051515005597  W051515020427  W051515020776  W051515031904  W051515031908  W051515031909  W051515046508  W051514110155  W051514122080  W051514122090  W051514122095  W051514124045  W051514132850  W051514136675  W051514153532  W051514136774  W051514136777  W051515005641  W051515005802  W051515014821  W051515014969  W051515030803  W051515030869  W051514090066  W051514122087  W051514132845  W051514110398  W051514123271  W051514123279  W051514133104  W051514141107  W051514141112  W051514123398  W051514123472  W051514123474  W051514139459  W051514123531  W051514145725  W051514136433  W051514149676  W051514145976  W051514145980  W051514136574  W051514165127  W051514163819  W051514163865  W051515005655  W051515005656  W051515005688  W051515005725  W051515005729  W051515012046  W051515014813  W051515005937  W051515031718  W051514123395  W051515014662  W051515037997  W051515031054  W051515031058  W051",6/17/2015,"06/17/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72429,"Completed","Innovative Blood Resources","737 Pelham Blvd",,"Saint Paul","MN","55114-1739","United States","Voluntary: Firm Initiated","Letter","MN, ND, WI. NJ, TN FL, OH, MI, CA, TX, LA, NC, SC, NE, NY, PA, IL.","B-0476-16","Class II","Red Blood Cells, Leukocytes Reduced","858 units","Blood products, lacking assurance of sterility, were distributed.","04/22/2016",," W051514107278  W051514106615  W051514110122  W051514123310  W051514133159  W051514123432  W051514139579  W051514149692  W051514136650  W051514153417  W051514153438  W051514136685  W051514153526  W051515005656  W051515005794  W051515005827  W051515005597  W051515005951  W051515014472  W051515014709  W051515031904  W051515031998  W051515037803  W051515037806  W051515031015  W051515031024  W051515031026  W051515037974  W051515037988  W051515037990  W051515046525  W051515046530  W051515046539  W051514086777  W051514086779  W051514086785  W051514086790  W051514086792  W051514089790  W051514089801  W051514089803  W051514089807  W051514088639  W051514087900  W051514090007  W051514104527  W051514104539  W051514104541  W051514106548  W051514090090  W051514090098  W051514104674  W051514104682  W051514104684  W051514090161  W051514109643  W051514109740  W051514090242  W051514090245  W051514109885  W051514109887  W051514109899  W051514111963  W051514111966  W051514111995  W051514120940  W051514110167  W051514122080  W051514122090  W051514124022  W051514122129  W051514110227  W051514110271  W051514122252  W051514122258  W051514122271  W051514110287  W051514110301  W051514132833  W051514132835  W051514132850  W051514132929  W051514137384  W051514137394  W051514133073  W051514139641  W051514123351  W051514123353  W051514133164  W051514141085  W051514123465  W051514139376  W051514123493  W051514139471  W051514139473  W051514123525  W051514123531  W051514123534  W051514145646  W051514145716  W051514145769  W051514136460  W051514145864  W051514145892  W051514145899  W051514145905  W051514149695  W051514136637  W051514136688  W051514153482  W051514153490  W051514165120  W051514163722  W051514159202  W051514159270  W051515005234  W051515005655  W051515005661  W051515005376  W051515005729  W051515005403  W051515012024  W051515005489  W051515005492  W051515005501  W051515005796  W051515005802  W051515014803  W051515014854  W051515014858  W051515005928  W051515005937  W051515005962  W051515005963  W051515015053  W051515014412  W051",6/17/2015,"06/17/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72446,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",".","Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.","Z-0592-2016","Class II","BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455     BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.","30,111 devices. ","Inadequate biocompatibility testing.","01/05/2016",," Model Number:  PAK4140, Lot Numbers:  977597, 981669, 984020, 987879, 989549, 995908, 1001595, 1004140, 1008710, 1010960, 1014334, 1015290, 1040122, 1040123, 1041414, 1045559, 1051854, 1052717, 1057786, 1062286, 1062287, 1062316, 1062317, 1065506, 1069146, 1069147,  1069996, 1075432, 1077541, 1077695, 1079484, 1087552, 1092512, 1095127, 1101673, 1108857, 1116020, 1124781, 1126602, 1133466,  1138040, 1142164, 1142165, 1142166,1142167, 1146388, 1146389, 1146390, 1154210, 1155762, 1161343, 1165414, 1166599, 1169299, 1170515, 1171394,1172306,1172307,1173594,1177247, 1177864, 1180531, 1180696, 1182190, 1182794, 1184132,  1184574, 1184575;     Model Number:  PAK4155, Lot Numbers:  1093011, 1109345, 1124776,  1130228, 1147152, 1165412, 1173301, 1179689, 1179946, 1181748, 1182412, 1183051, 1183632;    Model Number:  PAK4240,  Lot Numbers:  976863,  984016, 989553, 1002872, 1008694, 1014133, 1040125, 1040126, 1053095, 1053272, 1054998, 1057787, 1059216, 1062288, 1062289, 1062315, 1063247,  1065954, 1069997, 1075433, 1077542, 1078854, 1100721, 108854, 1115057, 1118381,  1130245, 1133478,1142170, 1142171, 1145306, 1145307,  147153,  1154213,  1161339,  1165350, 1166597, 1166982, 171069, 1171551,  1172742, 1173592, 1174352, 1175517,  1177865, 1179604, 1183052, 1184133, 1184577, 1184578;    Model Number:  PAK4255, Lot Numbers:  1101674, 1101932, 1145936,  1165798, 1172302, 1182694;    Model Number:  PAK4340, Lot Numbers:  984895, 996687, 1040764, 1054537, 1062290, 1063244, 1063585, 1071105, 1076277, 1139560, 145302,1150519, 1166596,1174356, 1184854;    Model Number:  PAK4355, Lot Numbers:  1076102, 1095125, 1124758, 1178454;    Model Number:  PAK4440, Lot Numbers:  990071, 1040763, 1062307, 1062314, 1165408, 1173300, 1175589;    Model Number:  PAK4455, Lot Numbers:  1143174, 1166992;     Model Number:  PAK5140, Lot Numbers:  987881,  992597,  993051, 1008713, 1016816, 1027348, 1030633, 1040152, 1053291, 1053292,  1055001,  1057776, 1059419, 1060681, 1060683, 1064187, 1068777, 1074334, 1075711, 1077697, 1090897, 1095824, 1",9/21/2015,"09/21/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72446,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",".","Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.","Z-0591-2016","Class II","BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655    BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations. ","30,111 devices ","Inadequate biocompatibility testing.","01/05/2016",," Model Number: PPC484, Lot Numbers: 970773, 977566, 987984, 1003033, 1038519, 1038520, 1045556, 1046268, 1054540, 1059416, 1059512, 1065495, 1065497, 1071762, 1071763, 1073161, 1073163, 1108328, 1128077, 1139601, 1141281, 1141282, 1150838, 1153463, 1165800, 1167709, 1171489, 1172858, 1173629, 1179005,  1183068, 1184510.    Model Number: PPC485, Lot Numbers: 1071764, 1071765, 1118826, 1143159, 1171487, 1178795, 1179690.     Model Number PPC654, Lot Numbers: 977565, 987983, 1004138, 1009002, 1032456, 1033485, 1034852, 1035364, 1053562, 1053563, 1053564, 1053860, 1054512, 1065507, 1069998, 1069999, 1071165 , 1071167,  1088473, 1088475, 1104109,  1104110,  1121837,  1128074, 1128623, 1150839, 1153465,  1161360, 1165775, 1168905, 1168906, 1171488,  1173628, 1175898, 1177389, 1177390, 1181586, 1181587, 1184511, 1185509, 1185511.     Model Number PPC655, Lot Numbers: 1032473, 1057790, 1086562, 1088470, 1166995, 1176293.    ",9/21/2015,"09/21/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72446,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",".","Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.","Z-0593-2016","Class II","BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H    BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.","30,111 devices.","Inadequate biocompatibility testing.","01/05/2016",," Model Number:  PIC484, Lot Numbers:   942680,  950198, 950706, 957203, 963249, 973436, 977567, 993384, 1004520, 1015298, 1024240, 1034518, 1048991, 1057119, 1095480, 1105770, 1131300, 1133485,  1158650, 1165796, 1169295, 1172741, 1175519, 1178568, 1181589, 1184490;   Model Number:  PIC484H, Lot Numbers:   952664, 1023220, 1034517, 1057121, 1084058, 1085156, 1086404, 1115750, 1169297, 1174217,  1182906, 1187568;    Model Number:  PIC485, Lot Numbers:  1137568, 1137603, 1176653,  1184855;    Model Number:  PIC485H, Lot Numbers: 1113005, 1170171, 1181580;  Model Number:  PIC654, Lot Numbers:  934480, 950196, 954781, 957204, 961452, 977568, 988996, 1016258, 1024427, 1034516, 048990, 1060550, 1073328, 1073329, 1092256, 1105771, 1115811, 1115812, 1115813, 1115815, 1115816, 1116774;  Model Number:  PIC654H, Lot Numbers:  970700, 988995, 989022, 1015301, 1043973, 1069114, 1073325, 1073327, 1074848, 1147383, 1166591, 1174216, 1184508, 1184509;   Model Number:  PIC655, Lot Numbers:   1040760, 1044047, 1048195, 1115778;  Model Number:  PIC655H, Lot Numbers:   1031581, 1079916,  973403-S1.         ",9/21/2015,"09/21/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72446,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",".","Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.","Z-0594-2016","Class II","BIOMET 3i, PROVIDE IMPRESSION COPING KITS,  Catalog # PRK484, PRK485, PRK654, and PRK655    BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.","30,111 devices. ","Inadequate biocompatibility testing.","01/05/2016",," Model Number:  PRK484, Lot Numbers:  929282 , 948311, 949496, 949497, 949668, 950083, 952452, 954303, 957220, 957368, 960733, 963052, 963054, 971802, 975153, 977973, 979767, 984897, 987880, 989210, 992599, 996689, 1001596, 1004143, 1008573, 1012089, 1013629, 1015576, 1023526, 1030628, 1033053, 1036120, 1041405,1044169,1046263, 1055914, 1055916, 1062672,1062819,1063241, 1064625,1065949, 1069639, 1071532, 1073172, 1075436, 1079918, 1083264, 1086406, 1089300, 1095122, 1098706, 1100723,1104907,1108327,1113200, 1119709, 1124780, 1128073, 1130255, 1131856, 1145310, 1147645, 1153461, 1161337, 1162496, 1166592, 1166593, 1166987, 1170183, 1171068, 1172744, 174130, 1176170, 1176650, 1177487, 1179602, 1181083, 1182414, 1183058, 1184585, 184586,  1185984;     Model Number:  PRK485, Lot Numbers:   1117971, 1127401, 1148502,  1165797, 1170173, 1174218, 1181185, 1184583;    Model Number:  PRK654, Lot Numbers:   929284, 948045, 952097, 952481, 952482, 957221, 957222, 957369, 961075, 961076, 966055, 971292, 976372, 978223, 979359, 984019, 987878, 991534, 996579, 1001594, 1004519, 1008716, 1013056, 1013628, 1016826, 1029923, 1031579, 1033052, 1036122, 1041538, 1051466, 1051616, 1053274, 1063078, 1063080, 1063531, 1064519, 1065947, 1069154, 1070308, 1070323, 1071531,  1072663, 1075435, 1077545, 1079499, 1080408, 1082647, 1087546, 1088471, 1091356, 1095135, 1101665,1105924,1108322, 1111753, 1122177, 1124967, 1127403, 1143157, 1146493, 1149132 , 1161341, 1165349, 1165799, 1170181, 1170182, 1170956, 1172743, 1176568, 1178724, 1179004, 1179951, 1181463, 1184279, 1184572, 1184573, 1186937;    Model Number:  PRK655, Lot Numbers:  977274,  992602, 1005231, 1027142, 1031582, 1036123, 1049035, 1049035, 1055858, 1055858, 1059763, 1059763, 1060690, 1060690, 1063239, 1063239, 1071325, 1071325, 1086079, 1104105, 1104105,1128070, 1151635,  166984, 1166984, 1181738, 1181738.           ",9/21/2015,"09/21/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1959-2016","Class II","Oregon Sardines -  Spicy Tomato-NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1962-2016","Class II","Wild Northwest Razor Clams - Custom Smoked-NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1956-2016","Class II","Wild Steelhead Salmon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1965-2016","Class II","Oregon Sardines - Custom Smoked-NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1957-2016","Class II","Wild Steelhead Salmon - Custom Packed-NW Wild Products, 6.5 oz. metal cans.  No UPC","will be provided","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1954-2016","Class II","Columbia River Chinook Salmon -Custom Smoked, NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1960-2016","Class II","Wild Columbia River Sturgeon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1953-2016","Class II","Wild Columbia River Coho Salmon- Custom Packed, NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1961-2016","Class II","Pacific White Albacore Tuna - Custom Smoked -NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1963-2016","Class II","Wild Northwest Razor Clams - Custom Packed-NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1964-2016","Class II","Pacific Black Cod- Custom Smoked -NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1958-2016","Class II","Oregon Sardines - Mustard-NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1955-2016","Class II","Columbia River Chinook Salmon -Custom Packed, NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1952-2016","Class II","Wild Columbia River Coho Salmon- Custom Smoked, NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1951-2016","Class II","Pacific Black Cod, NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72460,"Terminated","Northwest Wild Products","354 Industry Street",,"Astoria","OR","97103-6306","United States","Voluntary: Firm Initiated","Press Release","distributed in Oregon and sold to consumers through mail orders.  The firm did not keep records regarding who the product was sold to.","F-1966-2016","Class II","Pacific White Albacore Tuna - Custom Packed -NW Wild Products, 6.5 oz. metal cans.  No UPC","cannot be determined","All canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and Razor clams with any codes starting with OC because it has the potential to be contaminated with Clostridium botulinum.","08/19/2016","08/19/2016"," any codes starting with OC and it can be found on top or bottom of a can.  Last date of distribution was September 2015.",10/19/2015,"10/19/2015",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72461,"Ongoing","Cargill, Inc         Corporate Headquarters","15407 Mcginty Rd W",,"Wayzata","MN","55391-2365","United States","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AL, CA, CO, CT, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WI & WV.","F-0744-2017","Class II","refyne Artificially Flavored BUTTER FLAVORED OIL, NET CONTENTS 1 GAL (3.79 L) INGREDIENTS; SOYBEAN OIL, HYDROGENATED SOYBEAN OIL,***TBHQ--- Dimethylpolysiloxane***CONTAINS: SOY., UPC 0 41560 13659 4","654cs/3/1 gallon bottles","Products contain an excessive amount of TBHQ (tert-Butylhydroquinone) and DMPS (dimethyl polysiloxane). ","12/15/2016",," Item # 100087373, Batch # 3000519677, Code Date S24015, Best By 5/24/2016",10/19/2015,"10/19/2015",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72461,"Ongoing","Cargill, Inc         Corporate Headquarters","15407 Mcginty Rd W",,"Wayzata","MN","55391-2365","United States","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AL, CA, CO, CT, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WI & WV.","F-0743-2017","Class II","Crisco PROFESSIONAL Liquid Butter Alternative,  SALTED FOR ADDED FLAVOR, NET/NETO 1 GAL (3.79 L) INGREDIENTS; Corn Oil, Soybean Oil, Sunflower Oil, Hydrogenated Soybean Oil, Salt, Soy Lecithin***TBHQ  ***Dimethylpolysiloxane***CONTAINS: SOY.  UPC 7 81525 64775 7","1,544cs/3/1 gallon bottles","Products contain an excessive amount of TBHQ (tert-Butylhydroquinone) and DMPS (dimethyl polysiloxane). ","12/15/2016",," Item # 100087427, Batch # 3000524439, Code Date S24615, Best By 3/1/2016",10/19/2015,"10/19/2015",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72461,"Ongoing","Cargill, Inc         Corporate Headquarters","15407 Mcginty Rd W",,"Wayzata","MN","55391-2365","United States","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AL, CA, CO, CT, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WI & WV.","F-0742-2017","Class II","Beyond PREMIUM LIQUID BUTTER ALTERNATIVE ,ARTIFICIALLY FLAVORED SODIUM FREE, NET/NETO 1 GAL (3.79 L) INGREDIENTS; SOYBEAN OIL, HYDROGENATED SOYBEAN OIL ***TBHQ***DIMETHYLPOLYSILOXANE ***CONTAINS: SOY.  UPC 7 58108 08439 1","1,928cs/6/1 gallon bottles","Products contain an excessive amount of TBHQ (tert-Butylhydroquinone) and DMPS (dimethyl polysiloxane). ","12/15/2016",," Item # 100087598, Batch # 3000485116, Code Date S19815, Best By 4/12/2016",10/19/2015,"10/19/2015",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72461,"Ongoing","Cargill, Inc         Corporate Headquarters","15407 Mcginty Rd W",,"Wayzata","MN","55391-2365","United States","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AL, CA, CO, CT, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WI & WV.","F-0740-2017","Class II","QUALI FRY PREMIUM BUTTERY PAN AND GRILL, ARTIFICIALLY FLAVORED OIL, NET/NETO 1 GAL (3.79 L)  INGREDIENTS: SOYBEAN OIL, HYDROGENATED SOYBEAN OIL***TBHQ***DIMETHYLPOLYSILOXANE***CONTAINS: SOY, UPC 7 58108 45416 3","1.312 cs/6/1 gallon bottles","Products contain an excessive amount of TBHQ (tert-Butylhydroquinone) and DMPS (dimethyl polysiloxane). ","12/15/2016",," Item # 100087586:  Batch # 3000532083, Code Date S25615, Best By 6/9/2016; Batch # 3000550665, Code Date S28215, Best By 7/5/2016",10/19/2015,"10/19/2015",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72461,"Ongoing","Cargill, Inc         Corporate Headquarters","15407 Mcginty Rd W",,"Wayzata","MN","55391-2365","United States","Voluntary: Firm Initiated","Telephone","Product was shipped to the following states: AL, CA, CO, CT, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WI & WV.","F-0741-2017","Class II","MONARCH LIQUID BUTTER ALTERNATIVE, ARTIFICIALLY FLAVORED ,NET/NETO 1 GAL (3.79 L) INGREDIENTS; SOYBEAN OIL, HYDROGENATED SOYBEAN OIL WITH SALT***TBHQ***DIMETHYLPOLYSILOXANE***CONTAINS: SOY.  UPC 7 58108 38874 1","18,359cs/3/1 gallon bottles","Products contain an excessive amount of TBHQ (tert-Butylhydroquinone) and DMPS (dimethyl polysiloxane). ","12/15/2016",," Item # 100087374: Batch # 3000474230, Code Date S18415, Best By 3/29/2016; Batch # 3000509515, Code Date S22815, Best By 5/12/2016; Batch # 3000515241 Code Date S234515, Best By 5/18/2016; Batch # 3000532385 Code Date S25615 Best By 6/9/2016; Batch # 3000532572, Code Date S25715, Best By 6/10/2016; Batch # 3000542939, Code Date S27115, Best By 6/24/2016 & Batch # 3000548381, Code Date S27815, Best By 7/1/2016.",10/19/2015,"10/19/2015",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72467,"Terminated","Centinela Pet Supplies","2727 Maricopa St",,"Torrance","CA","90503-5145","United States","Voluntary: Firm Initiated","E-Mail","CA","V-402-2016","Class III","Welcome Home Duck Jerky, Item No. 10204, 10206, Sku No. 318384, 318385, Bag Wt. 14oz, 30 oz","661 cases","Centinela Feed & Pet Supplies is recalling Home Duck Jerky & Duck Treats because they may contain trace amounts of antibiotics.","03/04/2016","03/04/2016"," UPC 784815102042",10/16/2015,"10/16/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72467,"Terminated","Centinela Pet Supplies","2727 Maricopa St",,"Torrance","CA","90503-5145","United States","Voluntary: Firm Initiated","E-Mail","CA","V-404-2016","Class III","Welcome Home Jerky Duck, Item No. 15104, 15106, Sku No. 328408, 328409, Bag Wt. 12oz, 25.5oz","310 cases","Centinela Feed & Pet Supplies is recalling Home Duck Jerky & Duck Treats because they may contain trace amounts of antibiotics.","03/04/2016","03/04/2016"," UPC 784815104954, 784815104961",10/16/2015,"10/16/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72467,"Terminated","Centinela Pet Supplies","2727 Maricopa St",,"Torrance","CA","90503-5145","United States","Voluntary: Firm Initiated","E-Mail","CA","V-403-2016","Class III","Welcome Home Duck Sticks, Item No. 102012, 10214, Sku No. 318388, 318389, Bag Wt. 14oz, 42oz","208 cases","Centinela Feed & Pet Supplies is recalling Home Duck Jerky & Duck Treats because they may contain trace amounts of antibiotics.","03/04/2016","03/04/2016"," UPC 784815102127",10/16/2015,"10/16/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72470,"Ongoing","DesignPac Gifts Inc LLC","2457 W North Ave",,"Melrose Park","IL","60160-1120","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed to 27 Costco stores. There were no foreign consignees.","F-2639-2016","Class II","Elegant sophistication gift basket containing apple cidar in glass bottles. The label on the back of the gift basket is white with black lettering. ","560 units (gift baskets)","According to the recall notification from S. Martinelli, there is a possibility of small glass chips at the top of the bottles occurring when opening the bottle, which could potentially enter the beverage which could result in consumers potentially being cut or injured if a chip occurs. ","09/30/2016",," Gift # where Martinelli 8.4 FL. oz. Sparkling Cider was used F159765-CO   Gift Basket Name Elegant Sophistication  Item # FOD 0110  ",10/15/2015,"10/15/2015",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72474,"Ongoing","Liquid Coffee Inc","3540 Agricultural Center Dr",,"St Augustine","FL","32092-0926","United States","Voluntary: Firm Initiated","E-Mail","Distributed nationwide to AL, AZ, CA, FL, KY, MI, OH, OR, PA, TX, WA","F-1125-2016","Class II","Concentrated coffee packed in 1/2 gallon or 1 gallon hermetically sealed Scholle or Liquibag.","642 gallons","The pH level in coffee product was elevated above 4.6.","04/26/2016",," Production date used to track product.  ",8/3/2015,"08/03/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72478,"Terminated","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","Telephone","WI","D-0658-2016","Class I","Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.","19 Syringes","Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.","02/10/2016","02/18/2016"," Lot #:151370066M, Exp. 08/15/2015",5/22/2015,"05/22/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0302-2016","Class I","Mendiant Orange apricot & carmelized hazelnut packaged in a clear plastic bag with brown label with white lettering. ","120 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: MDOACH Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0310-2016","Class I","Inclusion bar-scorpion pepper, bourbon, smoked sea salt, and caramel pecans. ","708 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1029 Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0307-2016","Class I","Inclusion bar-cherries, cocoa nibs, cayenne.","228 bars ","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1026 Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0319-2016","Class I","Meltaways- 3 piece Blood Orange meltaways. ","40 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," SKU: ML1033 Expiration date range: 10/21/2015- 1/15/2016.",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0316-2016","Class I","Meltaways- 3 piece peppermint meltaways. ","20 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: ML1031 Expiration date range: 10/21/2015 - 1/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0306-2016","Class I","Inclusion bar-strawberries, rose petals, and pink peppercorns.","528 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1024 Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0317-2016","Class I","Meltaways- 3 piece Vanilla Sea Salt meltaways. ","60 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: ML1032Expiration date range: 10/21/2015 - 1/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0308-2016","Class I","Inclusion bar-strawberries, mangoes, and chiles.","444 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1027 Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0309-2016","Class I","Inclusion bar-expresso, cherries, and hazelnuts. ","444 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1028 Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0320-2016","Class I","Meltaways- 3 piece meltaways assorted.","130 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," SKU: ML1035 Expiration date range: 10/21/2015- 1/15/2016.",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0305-2016","Class I","Inclusion bar-strawberries, rose petals, and pink peppercorns.","372 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1024 Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0314-2016","Class I","Meltaway bar- Blood Orange & Vanilla bean. ","348 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: MB1023 Expiration date range: 10/21/2015 - 1/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0301-2016","Class I","Inclusion chocolate bar 66% Cacao topped with pistachios, cranberries & Sea Salt  in a white and green wrapping with white and gray lettering. ","636 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1022 expiration date range of 10/21/2015 to 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0312-2016","Class I","Meltaway bar-black cherry lemonade. ","216 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: MB1021 Expiration date range: 10/21/2015 - 1/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0318-2016","Class I","Meltaways- 3 piece Tahitian Vanilla Lemon Meltaways. ","30 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," SKU: ML1034 Expiration date range: 10/21/2015- 1/15/2016.",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0304-2016","Class I","Inclusion bar-candied ginger, candied orange peel, and coriander. ","312 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1023 Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0303-2016","Class I","Inclusion bar-macadamia nuts, raspberries, and kaffir lime","600 bars ","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1021 Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0321-2016","Class I","Meltaway bar- French Vanilla & salted Almond. ","348 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," SKU: MB1024 Expiration date range: 10/21/2015- 1/15/2016.",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0315-2016","Class I","Mendiant- Pistachio, Rose Petal & Candied Ginger. ","180 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: MDPRC Expiration date range: 10/21/2015 - 1/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0313-2016","Class I","Meltaway bar- Sweet basil & Cherry blossom. ","264 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: MB1022 Expiration date range: 10/21/2015 - 1/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72481,"Ongoing","E3 Artisan","113 S Benton St",,"Woodstock","IL","60098-3205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm distributed the product to 86 domestic firms. The spread sheet is attached.","F-0311-2016","Class I","Inclusion bar-Cocao Nibs, caramel almonds, and sea salt. ","720 bars","Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk. ","02/09/2016",," Sku: CB1030 Expiration date range: 10/21/2015 - 4/15/2016",10/21/2015,"10/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72486,"Ongoing","Verathon, Inc.","20001 N Creek Pkwy",,"Bothell","WA","98011-8218","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and to the countries of : Guam,  United Arab Emirates, Australia, Belgium, Canada , China, Czech Republic,  France, Germany, Luxembourg, Netherlands, Norway, Saudi Arabia, Sweden , Taiwan, and United Kingdom","Z-1091-2016","Class II","BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451.    AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.","2524 units total (1441 units of BVI 9600 and 820 units of AMI 9700 in US; 209 units of BVI 9600 and 54 units of AMI 9700 OUTSIDE the US","The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices.  The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).","03/10/2016",," SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA ****************    A7001001, A7001002, A7001005, A7001007, A7001011, A7001022, A7001024, A7001031, A7001034, A7001036, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001060, A7001062, A7001065, A7001067, A7001068, A7001079, A7001080, A7001086, A7001088, A7001093, A7001094, A7001098, A7001101, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001126, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001138, A7001139, A7001140, A7001141, A7001143, A7001144, A7001146, A7001147, A7001148, A7001150, A7001151, A7001152, A7001153, A7001155, A7001156, A7001157, A7001158, A7001161, A7001162, A7001163, A7001164, A7001165, A7001168, A7001169, A7001170, A7001171, A7001172, A7001173, A7001174, A7001175, A7001176, A7001177, A7001178, A7001179, A7001180, A7001181, A7001182, A7001183, A7001184, A7001185, A7001186, A7001187, A7001188, A7001189, A7001190, A7001191, A7001192, A7001194, A7001195, A7001196, A7001197, A7001198, A7001199, A7001201, A7001202, A7001204, A7001205, A7001206, A7001207, A7001209, A7001210, A7001211, A7001212, A7001216, A7001217, A7001218, A7001219, A7001220, A7001221, A7001222, A7001223, A7001224, A7001226, A7001227, A7001228, A7001229, A7001231, A7001232, A7001233, A7001234, A7001235, A7001236, A7001237, A7001238, A7001239, A7001240, A7001241, A7001242, A7001243, A7001244, A7001246, A7001247, A7001248, A7001249, A7001250, A7001251, A7001252, A7001253, A7001254, A7001255, A7001256, A7001257, A7001258, A7001260, A7001261, A7001262, A7001264, A7001265, A7001266, A7001268, A7001269, A7001270, A7001271, A7001272, A7001273, A7001275, A7001276, A7001277, A7001278, A7001279, A7001281, A7001283, A7001284, A7001285, A7001286, A7001287, A7001288, A7001289, A7001290, A7001291, A7001292, A7001293, A7001294, A7001295, A7001296, A7001297, A7001298, A7001299, A7001300, A7001301, A700130",11/30/2015,"11/30/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72496,"Ongoing","ConAgra Foods Inc","1 Conagra Dr",".","Omaha","NE","68102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide in the United States.  Foreign distribution to Hong Kong and Mexico.  Product was distributed to military bases in Georgia; no other government distribution.","F-0420-2016","Class I","David Trail Mix Sweet & Salty individual plastic bags net wt. 5 oz. (142 g) UPC 00 26200 23885 2 shipped in the following configurations:    1) cases of eight (8) with UPC 20-0-26200-23885-6;    2) 36-count multi-pack shipper case UPC 00-0-26200-23890-6 which contains 16 individual 5.25 oz. bags of Classic flavor and 20 individual 5 oz. bags Sweet & Salty flavor UPC 00 26200 23885 2; and    3) 24-count snack rack case UPC 27000-82339 store display which contains individual 5 oz. bags Sweet & Salty flavor UPC 00 26200 23885 2.","UPC 26200-23885 - 299,776 cases; UPC 26200-23890 - 2,803 cases; and UPC 27000-82339 - 200 cases","Product contains undeclared milk.","01/04/2016",," All lots distributed since 11/14/2012.",10/24/2015,"10/24/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72501,"Ongoing","Kalman Health & Wellness, Inc. dba Essential Wellness Pharma","4625 N University St",,"Peoria","IL","61614-5828","United States","Voluntary: Firm Initiated","Letter","US: IL and IA","V-395-2016","Class II","Cyclosporin 1% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614","130 mL","Lack of sterility assurance:  Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry.  The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.","03/04/2016",," Lot # 061515, Exp. Date 09/15/2015;  Lot # 062615, Exp. Date 09/26/2015;  Lot # 072415, Exp. Date 10/24/2015;  Lot # 072715, Exp. Date 10/27/2015;  Lot # 073115, Exp. Date 10/31/2015;  Lot # 081015, Exp. Date 11/10/2015; and  Lot # 081215, Exp. Date 11/12/2015  ",9/3/2015,"09/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72501,"Ongoing","Kalman Health & Wellness, Inc. dba Essential Wellness Pharma","4625 N University St",,"Peoria","IL","61614-5828","United States","Voluntary: Firm Initiated","Letter","US: IL and IA","V-394-2016","Class II","Cyclosporin 0.2% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614","80 mL","Lack of sterility assurance:  Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry.  The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.","03/04/2016",," Lot # 060515, Exp. Date 09/05/2015;  Lot # 061215, Exp. Date 09/12/2015;  Lot # 062615, Exp. Date 09/26/2015;  Lot # 070215, Exp. Date 10/02/2015;  Lot # 070615, Exp. Date 10/06/2015;  Lot # 072415, Exp. Date 10/24/2015;  Lot # 072715, Exp. Date 10/27/2015; and  Lot # 081315, Exp. Date 11/13/2015  ",9/3/2015,"09/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72501,"Ongoing","Kalman Health & Wellness, Inc. dba Essential Wellness Pharma","4625 N University St",,"Peoria","IL","61614-5828","United States","Voluntary: Firm Initiated","Letter","US: IL and IA","V-399-2016","Class II","Tacrolimus 0.02% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614","170 mL","Lack of sterility assurance:  Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry.  The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.","03/04/2016",," Lot # 071415, Exp. Date 09/14/2015;  Lot # 071515, Exp. Date 09/15/2015;  Lot # 072015, Exp. Date 09/20/2015;  Lot # 072315, Exp. Date 09/23/2015;  Lot # 080515, Exp. Date 10/05/2015; and  Lot # 081215, Exp. Date 10/12/2015  ",9/3/2015,"09/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72501,"Ongoing","Kalman Health & Wellness, Inc. dba Essential Wellness Pharma","4625 N University St",,"Peoria","IL","61614-5828","United States","Voluntary: Firm Initiated","Letter","US: IL and IA","V-396-2016","Class II","Cyclosporin 2% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614","40 mL","Lack of sterility assurance:  Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry.  The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.","03/04/2016",," Lot # 060815, Exp. Date 09/08/2015;  Lot # 070315, Exp. Date 10/03/2015;  Lot # 072915, Exp. Date 10/29/2015; and  Lot # 080715, Exp. Date 11/07/2015    ",9/3/2015,"09/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72501,"Ongoing","Kalman Health & Wellness, Inc. dba Essential Wellness Pharma","4625 N University St",,"Peoria","IL","61614-5828","United States","Voluntary: Firm Initiated","Letter","US: IL and IA","V-397-2016","Class II","Desmopressin (Desmopressin Acetate) 0.01% Ophthalmic solution, packaged in 2.5 mL and 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614","25 mL","Lack of sterility assurance:  Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry.  The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.","03/04/2016",," Lot # 062015, Exp. Date 09/20/2015;  Lot # 070615, Exp. Date 10/06/2015;  Lot # 072315, Exp. Date 10/23/2015; and  Lot # 080315, Exp. Date 11/03/2015    ",9/3/2015,"09/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72501,"Ongoing","Kalman Health & Wellness, Inc. dba Essential Wellness Pharma","4625 N University St",,"Peoria","IL","61614-5828","United States","Voluntary: Firm Initiated","Letter","US: IL and IA","V-398-2016","Class II","Methocarbamol 100mg/mL Injection, packaged in 50 mL sterile glass vials, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614","100 mL","Lack of sterility assurance:  Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry.  The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.","03/04/2016",," Lot # 060915, Exp. Date 09/09/2015    ",9/3/2015,"09/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72501,"Ongoing","Kalman Health & Wellness, Inc. dba Essential Wellness Pharma","4625 N University St",,"Peoria","IL","61614-5828","United States","Voluntary: Firm Initiated","Letter","US: IL and IA","V-400-2016","Class II","Tacrolimus 0.03% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614","90 mL","Lack of sterility assurance:  Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry.  The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.","03/04/2016",," Lot # 070315, Exp. Date 09/13/2015;  Lot # 071715, Exp. Date 09/15/2015;  Lot # 072815, Exp. Date 09/28/2015;  Lot # 073115, Exp. Date 09/31/2015;  Lot # 080515, Exp. Date 10/05/2015;  Lot # 081215, Exp. Date 10/12/2015; and  Lot # 081415, Exp. Date 10/14/2015    ",9/3/2015,"09/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72508,"Ongoing","Skinny Latina LLC","521 Gerona Ave",".","Coral Gables","FL","33146-2714","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to distribution centers and retail stores nationwide.    Distributed to KeHe distribution centers which distribute product to Target stores and WholeFood stores nationwide.  Skinny Latina, LLC directly ships to Fresh Market stores in Florida.","F-0464-2016","Class I","Skinny Latina Million Dollar Marinade, 12 oz, shelf stable, dry storage. ","18,822 bottles","Undeclared soy","01/05/2016",," UPC #8-55329-00400-6; Lots 12/02/15A, 12/02/15B, 10/21/15A, 10/21/15B, 10/22/15A, 10/22/15B, 10/23/15A, 10/23/15B, 10/24/15A, 10/24/15B, 10/28/15A, 10/28/15B, 10/27/15A, 10/27/15B, 10/29/15A, 10/29/15B",10/3/2015,"10/03/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72512,"Ongoing","MSNV, Inc dba National Video Supply","21100 Centre Pointe Pkwy",,"Santa Clarita","CA","91350-2978","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0671-2016","Class I","Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA","460 Blister Packs","Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.","02/16/2016",," All Lots",10/1/2015,"10/01/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72512,"Ongoing","MSNV, Inc dba National Video Supply","21100 Centre Pointe Pkwy",,"Santa Clarita","CA","91350-2978","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0670-2016","Class I","Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA. ","868 Bottles","Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.","02/16/2016",," All Lots",10/1/2015,"10/01/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72515,"Ongoing","Regulatory Insight, Inc","33 Golden Eagle Ln",,"Littleton","CO","80127-5745","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.","Z-0753-2016","Class II","GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. ","43","It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.","02/24/2016",," NRT no.: 02980000",7/1/2008,"07/01/2008",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0442-2016","Class I","Helados La Tapatia Creamy Fruit Bars;  Strawberry Cream flavor; Net Wt. 3 FL oz;    UPC 6 34242 20001 2;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO  AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80,  CARRAGEENAN), STABILIZER (XANTHAN GUM, GUAR GUM, STANDARDIZED  WITH DEXTROSE) WATER, STRAWBERRIES, SUGAR, AND RED #40 (WATER,  YELLOW 5 AND BLUE 1, CITRIC ACID AND SODIUM BENZOATE (A  PRESERVATIVE)).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, FD&C YELLOW NO.5    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","326 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.","12/29/2015",," UPC 6 34242 20001 2;   Distributed 10-8 to 10-16-2015.   lot number ¿282 15 01;   lot number ¿285 15 02¿  ¿  ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0448-2016","Class I"," Cream; Net Wt. 3 FL oz;   UPC 6 34242 20010 4;  INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80, CARRAGEENAN}, CHOCOLATE COOKIES (ENRICHED FLOUR (WHEAT FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE (VITAMIN B1 RIBOFLAVIN (VITAMIN 82), FOLIC AOD), SOYBEAN AND PALM OIL WITH TBHQ FOR FRESHNESS, COCOA PROCESSED WITH ALKALI, INVERT SUGAR CONTAINS TWO PERCENT OF LESS OF DEGERMINATED YELLOW CORN FLOUR, CORNSTARCH, CHOCOLATE, SALT, LEAVENING BAKING SODA, MONOCALCIUM PHOSPHATE) ARTIFICIAL FLAVOR, SOY LECITHIN, WHEY), SUGAR AND STABILIZER (XANTHAN GUM, GUAR GUM,STANDARDIZED WITH DEXTROSE).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, WHEAT AND SOY      Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","0 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..","12/29/2015",," UPC 6 34242 20010 4;   Distributed 10-8 to10-16-2015.   lot number ¿282 15 03¿¿,  lot number ¿288 15 02¿  ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0446-2016","Class I","Helados La Tapatia Creamy Fruit Bars;  Banana Platano; Net Wt. 3 FL oz;   UPC 6 34242 20004 3;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP,  MONO AND DIGLYCERIDES,CELLULOSE GUM,GUAR GUM, POLYSORBATE  80, CARRAGEENAN), WATER, FRESH BANANAS, SUGAR, STABILIZER  (XANTHAN GUM, GUAR GUM, STANDARDIZED WITH DEXTROSE),  YELLOW 5 (WATER, YELLOW 5 AND BLUE 1, CITRIC ACID AND SODIUM  BENZOATE (A PRESERVATIVE)) AND RED 40 (WATER, FD&C YELLOW #5,  FD&C RED #40, CITRIC ACID AND SODIUM BENZOATE (PRESERVATIVE)).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, FD&C YELLOW #5    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","0 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..","12/29/2015",," UPC 6 34242 20004 3;  no lot codes  Distributed 10-8 to10-16-2015.   lot number ¿281 15 04¿  ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0443-2016","Class I","Helados La Tapatia Creamy Fruit Bars;  Natural Creamy All Natural Coconut Coco; Net Wt. 3 FL oz; (85g)    UPC 6 34242 20002 9;    INGREDIENTS: ICE CREAM MIX MILK, FRESH CONDENSED  SKIM MILK, SUCROSE, CORN SYRUP, DESSERT SOLIDS (WHEY, REDUCED  LACTOSE WHEY AND. NON FAT DRIED MILK) AND STABILIZER (GUAR  GUM, MONO AND DIGLYCERIDES), CALCIUM SORBATE, POLYSORBATE  40, CELLULOSE GUM AND CARRAGENAN), WATER, FRESH COCONUT,  SUGAR AND COCONUT FLAVOR.  Manufactured in a facility that produces products with almonds,  peanuts, cashews, hazel nuts, pecans and/or walnuts.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","3,248 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.","12/29/2015",," UPC 6 34242 20002 9;   Distributed 10-8 to 10-16-2015.   lot number ¿282 15 02¿   lot number ¿285 15 03¿   lot number ¿288 15 03¿¿    ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0454-2016","Class I","Helados La Tapatia ;  Granola; Net Wt. 4 oz, (113g)  UPC 6 34242 60012 6;  INGREDIENTS FOR ICE MILK BARS:  ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED SKIM  MILK, SUCROSE, CORN SYRUP. DESSERT SOLIDS (WHEY,  REDUCED LACTOSE, WHEY AND NON FAT DRIED MILK) AND  STABILIZER ( GUAR GUM, MONO, AND DIGLYCERIDES),  CAI.,CIUM SORBATE, POLYSORBATE 40, CEllUlOSE GUM  AND CARRAGENAN), WATER, WHOLE ROASTED OAT FlAKES,  RAISINS, COCONUT FlAKES, SUGAR.  MAY CONTAIN ALMONDS, PEANUTS, CASHEWS,  HAZELNUTS, PECANS AND/OR WALNUTS.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","1,104 units","Product has undeclared allergens:  soy and almonds.","12/29/2015",," UPC 6 34242 60012 6;  lot numbers 286 15 06 and 286 15 07  .",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0452-2016","Class I","Helados La Tapatia Creamy Fruit Bars;  All Natural Rice Arroz; Net Wt. 3 FL oz;   UPC 6 34242 20008 1;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED  SKIM MILK, SUCROSE, CORN SYRUP, DESSERT SOLIDS  (WHEY, REDUCED LACTOSE, WHEY AND NON FAT  DRIED MILK) AND STABILIZER {GUAR GUM, MONO, AND  DIGLYCERIDES), CALCIUM SORBATE, POLYSORBATE 40,  CELLULOSE GUM AND CARRAGENAN), WATER, RICE,  SUGAR, CINNAMON, AND RAISINS.  PROCESSED IN A FACILITY THAT PROCESSES NUTS.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","0 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.","12/29/2015",," UPC 6 34242 20008 1;   Distributed 10-8 to10-16-2015.   lot number ¿285 15 01¿¿  ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0449-2016","Class I","STANDARDIZED WITH DEXTROSE), CORN OIL, PEANUTS AND YELLOW COLOR (WATER, FD&C YELLOW 5, FD&C RED 40, CITRIC ACID, SODIUM BENZOATE AS A PRESERVATIVE).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, PEANUTS AND FD&C YELLOW 5 AND SOY.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","0 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.","12/29/2015",," UPC 6 34242 20012 8;   Distributed 10-8 to10-16-2015.   lot number ¿289 15 04¿¿  ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0455-2016","Class I","Helados La Tapatia ;  Cafe Coffee; Net Wt. 3 fl. oz.  UPC 6 34242 60013 5;  INGREDIENTS FOR ICE MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80, CARRAGEENAN), WATER, SUGAR, GROUND COFFEE AND STABILIZER (XANTHAN GUM, GUAR GUM, STANDARDIZED WITH DEXTROSE).   PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS MILK.           .    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","0 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.","12/29/2015",," UPC 6 34242 20013 5;  lot numbers 281 15 02 and 289 15 03  .",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0447-2016","Class I","Helados La Tapatia Creamy Fruit Bars;  Vanilla vainilla; Net Wt. 3 FL oz;   UPC 6 34242 20005 0;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO  AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80  CARRAGEENAN), WATER, SUGAR, STABILIZER (XANTHAN GUM, GUAR GUM,  STANDARDIZED WITH DEXTROSE), YELLOW 5 (WATER, FD&C YELLOW #5, FD&C RED #40,CITRIC ACID AND SODIUM BENZOATE (PRESERVATIVE)) ,AND RED 40 (WATER, YELLOW 5 AND BLUE 1, CITRIC ACID, AND SODIUM BENZOATE (A PRESERVATIVE)), NATURAL VANILLA AND RAISINS.  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, FD&C YELLOW #5      Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","0 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.","12/29/2015",," UPC 6 34242 20005 0;   Distributed 10-8 to10-16-2015.   lot number ¿287 15 03¿¿  ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0445-2016","Class I","Helados La Tapatia Creamy Fruit Bars;  Chocolate; Net Wt. 3 FL oz;   UPC 6 34242 20003 6;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK. SUGAR, CORN SYRUP. MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM,POLYSORBATE 80 CARRAGEENAN), WATER, SUGAR,CHOCOLATE (HIGH FRUCTOSE CORN SYRUP. CORN SYRUP. WATER, COCOA, SUGAR, CONTAINS 2% OR LESS OF: POTASSIUM SORBATE (PRESERVATIVE), SALT, MONO AND DIGLYCERIDES, XANTHAN GUM, POLYSORBATE 60, VANILLIN AND ARTIFICIAL FLAVOR) AND STABILIZER (XANTHAN GUM, GUAR GUM, STANDARDIZED WITH DEXTROSE).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK  Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","0 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..","12/29/2015",," UPC 6 34242 20003 6;  no lot codes  Distributed 10-8 to10-16-2015.   lot number ¿281 15 03¿  ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0450-2016","Class I","Helados La Tapatia Creamy Fruit Bars;  Pina Colada; Net Wt. 3 FL oz;   UPC 6 34242 20014 2;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX  (MILK  FAT AND  NON FAT MILK, SUGAR,CORN SYRUP. MONO AND DIGLYCERIDES, CELLULOSE GUM,GUAR GUM,POLYSORBATE 80 CARRAGEENAN),WATER,SUGAR,FRESH COCONUT, FRESH PINEAPPLE. COCONUT  FLAVOR (WATER,SUCROSE,VEGETABLE OIL (COCONUT), MODIFIED CORNSTARCH,ARTIFICIAL FLAVORINGS,BROMINATED VEGETABLE OIL 0.03% ANHYDROUS CITRIC ACID, SODIUM   BENZOATE   (PRESERVATIVE), PROPYLENE  GLYCOL,  AND  ANTIFOAM), PINEAPPLE FLAVOR (PROPYLENE GLYCOL  AND ETHANOL),CHERRIES,STABILIZER (XANTHAN GUM,GUAR GUM, STANDARDIZED WITH DEXTROSE),YELLOW 5 (WATER,FD&C YELLOW #5,FD&C RED #40,CITRIC ACID, AND SODIUM BENZOATE (PRESERVATIVE)),AND RED 40   (WATER,YEllOW 5 AND BLUE l,CITRIC ACID AND SODIUM BENZOATE (PRESERVATIVE)).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS CONTAINING PEANUTS,TREE NUTS,SOY,WHEAT AND MILK.   CONTAINS:MILK AND FD&C YELLOW #5        Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","0 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.","12/29/2015",," UPC 6 34242 20014 2;   Distributed 10-8 to10-16-2015.   lot number ¿288 15 01¿¿  ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0453-2016","Class I","Helados La Tapatia ;  Cookies 'n' Cream Biscuits au Chocolat; Net Wt. 4 oz, (113g)  UPC 6 34242 60007 2;    INGREDIENTS FOR ICE FRUIT BARS:  ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED SKIM  MILK, SUCROSE, CORN SYRUP. DESSERT SOLIDS (WHEY,  REDUCED LACTOSE, WHEY AND NON FAT DRIED MILK) AND  STABILIZER (GUAR GUM, MONO, AND DIGLYCERIDESJ,  CALCIUM SORBATE, POLYSORBATE 40, CELLULOSE GUM  AND CARRAGENAN),WATER, CHOCOLATE COOKIES AND SUGAR.  MAY CONTAIN ALMONDS, PEANUTS, CASHEWS,HAZELNUTS, PECANS AND/OR WALNUTS.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","1,104 units","Product has undeclared allergens: soy and wheat. .","12/29/2015",," UPC 6 34242 60007 2;   lot number ¿286 15 15¿   lot number ¿286 15 16¿    .",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72519,"Ongoing","Helados La Tapatia, Inc.","4495 W Shaw Ave",".","Fresno","CA","93722-6206","United States","Voluntary: Firm Initiated","Press Release","CA, NV, WA and AZ","F-0451-2016","Class I","Helados La Tapatia Creamy Fruit Bars;  Pecan Nuez; Net Wt. 3 FL oz;   UPC 6 34242 20007 4;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN  SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM,  POLYSORBATE 80 CARRAGEENAN), WATER, SUGAR, MAPLE BUTTER  FLAVOR (PROPYLENE GLYCOL, WATER AND GLYCERIN), STABILIZER  (XANTHAN GUM, GUAR GUM, STANDARDIZED WITH DEXTROSE),  CARAMEL COLOR AND NATURAL FRESH PECANS.  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, PECANS      Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F","0 units","Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..","12/29/2015",," UPC 6 34242 20007 4;   Distributed 10-8 to10-16-2015.   lot number ¿287 15 01¿  ",10/27/2015,"10/27/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72521,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS","Z-0650-2016","Class II","Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo),  9mm, 11mm, 13mm, 15mm, and 17mm","21","PMMA is listed as a material on the label but the product does not contain PMMA.","01/13/2016",," Part #11-162709   9mm  Lots: 329750, 404380, 487400, 767120, 951680  Part # 11-162711  11mm  Lots: 329760, 505030, 505050  Part # 11-162713  13mm  Lots: 837750, 977460  Part # 11-162715  15mm  772410, 837780, 897070, 951810  Part # 11-162717  17mm  Lots: 311410, 410500, 535530, 712800, 728080, 829580",11/17/2015,"11/17/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72522,"Ongoing","Premiere Sales Group","21446 Golden Triangle Rd",,"Santa Clarita","CA","91350-2911","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0672-2016","Class I","Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA  ","337 bottles","Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.","02/16/2016",," All lots",9/30/2015,"09/30/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72522,"Ongoing","Premiere Sales Group","21446 Golden Triangle Rd",,"Santa Clarita","CA","91350-2911","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0673-2016","Class I","Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA  ",,"Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.","02/16/2016",," All lots",9/30/2015,"09/30/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72527,"Ongoing","Sanofi-Aventis U.S. LLC","55 Corporate Dr",,"Bridgewater","NJ","08807-1265","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0873-2016","Class I","Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ  08807 A Sanofi Company ","159,000 prefilled injectors","Defective Delivery System; potential to have inaccurate dosage delivery","05/25/2016",," a) 2144144, exp 10/2015;  2469674, exp 04/2016;  2506492, 2546978, 2546979, exp 05/2016;  2654817, 2654818, exp 06/2016;   2692143, 2692144, exp 07/2016;  2719838, exp 08/2016;  2824845, 2891021, 2857530, exp 09/2016;  2883631, 2883632, exp 10/2016;  2883633, 2945429, 3028243, exp 11/2016;  3037230, 2966680, 2974276, 2974280, exp 12/2016; and   b) 2525474, exp 05/2016  ",10/28/2015,"10/28/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72527,"Ongoing","Sanofi-Aventis U.S. LLC","55 Corporate Dr",,"Bridgewater","NJ","08807-1265","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0872-2016","Class I","Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ  08807 A Sanofi Company ","383,900 prefilled syringes","Defective Delivery System; potential to have inaccurate dosage delivery","05/25/2016",," a) 2081278, 2113841, 2113842, 2144138, exp 10/2015;  	  2440675, exp 04/2016;    2506456, 2506460, 2546946, 2546947, exp 05/2016;    2620206, 2620207, 2659534, exp 06/2016;    2692111, 2692112, exp 07/2016;    2716517, 2719817, 2734079, 2734080, 2734081, 2778035, 2800128, exp 08/2016;    2800130, 2824828, 2824829, 2857516, 2867928, 2870928, 2867929, 2867930, 2883616, 2883617, exp 09/2016;    2883618, 2883619, 2974267, 2883620, 2945419, 2974269, exp 10/2016;    3026968, 3026969, exp 11/2016;    3026970, 3028227, 3032005, 3037217, 3037218, 3037219, exp 12/2016;    b) 2299596, 03/2016  ",10/28/2015,"10/28/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72536,"Terminated","CSFPDX, LLC","500 S Biak Ave",,"Garibaldi","OR","97118-1306","United States","Voluntary: Firm Initiated","Press Release","Their own retail store and 3 restaurants in Oregon","F-0624-2016","Class II","    Label is black ink on an off white label.    No UPC","142 cans","This voluntary recall was initiated after the manufacturing firm notified the recalling firm that products were possibly under- processed. Under-processed seafood could lead to contamination with Clostridium botulinum.","02/23/2016","02/25/2016"," OCK 16AAPR2017",10/28/2015,"10/28/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72540,"Ongoing","Mercury Enterprises, Inc. dba Mercury Medical","11300 49th St N",,"Clearwater","FL","33762-4807","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Guam, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirate, and United Kingdom..","Z-0639-2016","Class II","Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit.  The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices","753,245 devices ","Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient. ","01/12/2016",," Neo-Tee Resuscitator:  Part # 1050800 Unique Device ID # 10641043508004 Lot #s less than 1528850800; Part # 1050801 Unique Device ID # 10641043508015 Lot #s less than 1528850801;Part # 1050802 Unique Device ID # 10641043508022 Lot #s less than 1528850802; Part # 1050803 Unique Device ID # 10641043508039 Lot #s less than 1528850803; Part # 1050804 Unique Device ID # 10641043508046 Lot #s less than 1528850804; Part # 1050805 Unique Device ID # 10641043508053 Lot #s less than 1528850805; Part # 1050806 Unique Device ID # 10641043508060 Lot #s less than 1528850806;  Part # 1050807 Unique Device ID # 10641043508077 Lot #s less than 1528850807; Part # 1050808 Unique Device ID # 10641043508084 Lot #s less than 1528850808;  Part # 1050809 Unique Device ID # 10641043508091 Lot #s less than 1528850809; Part # 1050810 Unique Device ID # 10641043508107 Lot #s less than 1528850810;  Part # 1050811 Unique Device ID # 10641043508114 Lot #s less than 1528850811;  Part # 1050812 Unique Device ID # 10641043508121 Lot #s less than 1528850813;  Part # 10508138 Unique Device ID # 10641043508004 Lot #s less than 1528850813;  Part # 1050814 Unique Device ID # 106410435081454 Lot #s less than 1528850814;  Part # 1050815 Unique Device ID # 10641043508152 Lot #s less than 1528850815;  Part # 1050816 Unique Device ID # 10641043508169 Lot #s less than 1528850816;  Part # 1050817 Unique Device ID # 10641043508176 Lot #s less than 1528850817;  Part # 1050818 Unique Device ID # 10641043508183 Lot #s less than 1528850818;  Part # 1050819 Unique Device ID # 10641043508190 Lot #s less than 1528850819;  Part # 1050820 Unique Device ID # 10641043508206 Lot #s less than 1528850820;  Part # 1050821 Unique Device ID # 10641043508213 Lot #s less than 1528850821;  Part # 1050822 Unique Device ID # 10641043508220 Lot #s less than 1528850822; Part # 1050823 Unique Device ID # 10641043508237 Lot #s less than 1528850823;  Part # 1050824 Unique Device ID # 10641043508244 Lot #s less than 1528850824;  Part # 1050825 Unique Device ID # 10641043508251 Lot #",10/22/2015,"10/22/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72542,"Ongoing","Trumpf Medical Systems, Inc.","1046 Legrand Blvd",".","Charleston","SC","29492-7672","United States","Voluntary: Firm Initiated","Letter","USA  (nationwide) Distribution to the states of : AL, AK, AZ, CA,  CO,  CT,  DE,  FL, GA,  ID,  IL, IN, IA, KY, ME, MA,  MN, MO, NE, NV, NJ,  NM, NY,  NC,  ND,  OH, OR,  PA,  SC, TN, TX, UT,  VA,  VT,  WA,  WI and WY., and Internationally to Canada.","Z-0563-2016","Class II","Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5","20,713","The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.","12/31/2015",," 4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM) ",11/2/2015,"11/02/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72565,"Ongoing","Tate's Wholesale, Llc. ","62 Pine St",".","East Moriches","NY","11940-1117","United States","Voluntary: Firm Initiated","Press Release","Nationwide in U.S.","F-0441-2016","Class I","TATE'S BAKE SHOP Cookies GINGER ZINGER GLUTEN FREE, NET WT. 7 OZ (198 G), UPC Code 810291001095, product is packed in plastic which is inserted into a mint green paper wrapper, DISTRIBUTED BY: TATE'S BAKE SHOP 43 NORTH SEA RD. SOUTHAMPTON NY 11968 631-780-6511, WWW.TATEBAKESHOP.COM, MADE IN THE U.S.A.","0","Tate's Bake Shop has recalled Chocolate Chip Cookies and Ginger Zinger Cookies due to the presence of undeclared walnuts.","12/29/2015",," Outer Case Code 15.07.08 - BEST BY JAN 04 2016",11/4/2015,"11/04/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72565,"Ongoing","Tate's Wholesale, Llc. ","62 Pine St",".","East Moriches","NY","11940-1117","United States","Voluntary: Firm Initiated","Press Release","Nationwide in U.S.","F-0440-2016","Class I","TATE'S BAKE SHOP CHOCOLATE CHIP COOKIES, NET WT. 7 OZ (198 G), UPC Code 810291001002, product is packed in plastic which is inserted into green paper wrapping, DISTRIBUTED BY: TATE'S BAKE SHOP 43 NORTH SEA RD. SOUTHAMPTON NY 11968 631-780-6511, WWW.TATEBAKESHOP.COM, MADE IN THE U.S.A.","1065 cases","Tate's Bake Shop has recalled Chocolate Chip Cookies and Ginger Zinger Cookies due to the presence of undeclared walnuts.","12/29/2015",," Outer Case Code 15.09.22 - BEST BY MAR 20 2016",11/4/2015,"11/04/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72569,"Ongoing","St Jude Medical Cardiac Rhythm Management Division","15900 Valley View Ct",".","Sylmar","CA","91342-3577","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.","Z-0660-2016","Class I","Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q.  St. Jude Medical.                     Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).     ","447 units total (281 units in US)","Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.","01/20/2016",," BRE010002  BRE010016  BRE010032  BRE010033  BRE010034  BRE010035  BRE010037  BRE010039  BRE010040  BRE010042  BRE010044  BRE010046  BRE010062  BRE010066  BRE010075  BRE010077  BRE010082  BRE010096  BRE010097  BRE010098  BRE010099  BRE010165  BRE010166  BRE010173  BRE010183  BRE010185  BRE010191  BRE010194  BRE010195  BRE010205  BRE010208  BRE010215  BRE010220  BRE010226  BRE010232  BRE010235  BRE010240  BRE010241  BRE010258  BRE010299  BRE013300  BRE013302  BRG010102  BRG010103  BRG010116  BRG010174  BRG010178  BRG010179  BRG010188  BRG010205  BRG010206  BRG010207  BRG010213  BRG010232  BRG010233  BRG010237  BRG010238  BRG010246  BRG010247  BRG010248  BRG010249  BRG010250  BRG010264  BRG010285  BRG010298  BRG010350  BRG010383  BRG010396  BRG010404  BRG010405  BRG010411  BRG010415  BRG010574  BRG010619  BRG010625  BRG010658  BRG010664  BRG010684  BRG010721  BRG010722  BRG010723  BRG010770  BRG010812  BRG010814  BRG010818  BRG010820  BRG010821  BRG010822  BRG010937  BRG010938  BRG010939  BRG010946  BRG010947  BRG010967  BRG010978  BRG010979  BRG010982  BRG010983  BRG010992  BRG010993  BRG010998  BRG010999  BRG011013  BRG011016  BRG011057  BRG011085  BRG011300  BRG011301  BRG011302  BRG011306  BRG011307  BRG011318  BRG011326  BRG011512  BRH010166  BRH010167  BRH010168  BRH010174  BRH010175  BRH010187  BRH010190  BRH010197  BRH010198  BRH010307  BRH010310  BRH010348  BRH010352  BRH010361  BRH010373  BRH010387  BRH010391  BRH010401  BRH010402  BRH010421  BRH010428  BRH010439  BRH010442  BRH010445  BRH010454  BRH010455  BRH010497  BRH010518  BRH010519  BRH010522  BRH010523  BRH010538  BRH010549  BRH010550  BRH010574  BRH010603  BRH010607  BRH010644  BRH010645  BRH010658  BRH010711  BRH010794  BRH010801  BRH010802  BRH010823  BRH010834  BRH010849  BRH010863  BRH010866  BRH010871  BRH010872  BRH010873  BRH010881  BRH010886  BRH010887  BRH010893  BRH010905  BRH010906  BRH010916  BRH010917  BRH010927  BRH010931  BRH010963  BRH010964  BRH010970  BRH010972  BRH010980  BRH010982  BRH011002  BRH011003  BRH011004  BRH011005",11/3/2015,"11/03/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0609-2016","Class II","Siemens Acute Care  CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma  Catalog Number: CCTNI  SMN: 10445071","5558","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  235151002, 235159002, 235166002, 235173002, 235208002  235215002, 235222002, 235229002, 235236002, 235243002  235250002, 235257002, 235278002, 235285002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0614-2016","Class II"," CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer  Catalog Number: CCCRP  SMN:10445066  ","78","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Number:  425229002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0619-2016","Class II","Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak  Catalog Number: CCKMB-D  SMN: 10445070","146","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  845173002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0611-2016","Class II","Siemens Acute Care DDMR TestPak  Catalog Number: CDDMRE  SMN: 10701511    in vitro diagnostic","2647","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  405131002, 405173002, 405187002, 405208002, 405229002  405278002, 405292002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0613-2016","Class II","Siemens Acute Care CKMB TestPak-  in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma  Catalog Number: CCKMB  SMN:10445068","1051","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  245138002, 245152002, 245215002, 245262002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0616-2016","Class II","Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer  Catalog Number: CCCRP-C  SMN:10445067","65","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  625229002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0617-2016","Class II","Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method  Catalog Number: CBHCG-C  SMN:10445061","196","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  625229002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0618-2016","Class II","Siemens Acute Care MYO DilPak  Catalog Number: CMYO-D  SMN:10445081  in vitro diagnostic","192","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  815131002, 815222002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0615-2016","Class II","Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care  hCG method  Catalog Number: CBHCG  SMN:10445060","590","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  445146002, 445201002, 445243002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0612-2016","Class II"," MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma  Catalog Number: CMYO  SMN:10445079","608","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  515146002, 515201002, 515285002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72570,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",".","Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-0610-2016","Class II","Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma.   Catalog Number: CPBNPM  SMN: 10445086","1157","Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems","01/07/2016",," Lot Numbers:  215166002, 215194002, 215222002, 215271002",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72571,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution.  US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.","Z-0765-2016","Class II","Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.  ","2 subject to correction and removal","Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).","02/05/2016",," Ceiling version only. ",11/3/2015,"11/03/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72571,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution.  US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.","Z-0764-2016","Class II","Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.","15 subject to correction and removal","Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).","02/05/2016",," Ceiling version only. ",11/3/2015,"11/03/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72579,"Ongoing","PERU FOOD IMPORT INC","815 Fairview Ave, Unit  #1",,"Fairview","NJ","07022","United States","Voluntary: Firm Initiated","Letter","NY and CT","F-1092-2016","Class I","Peru Food Mote Corn Maiz Mote Net Wt. 15 oz.   Imported and distributed by: Peru Food Import Inc.PO Box 419 West New York, NJ 07093    UPC 812125009628  ","2664 bags","Mote corn contains undeclared sulfites.","04/19/2016",," Lote 38 16",11/4/2015,"11/04/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0369-2016","Class II","Smoked Spring Chinook, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67402 9, UPC 7 48252 67382 4, UPC 7 48252 67372 5","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0372-2016","Class II","Smoked Walleye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 94504 39610 2","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0355-2016","Class II","Peppered & Smoked Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67282 7 and 7 48252 67302 2.","Unknown13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0354-2016","Class II","Fancy Spring Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67412 8","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0364-2016","Class II","Smoked Jalapeno Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67312 1","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0366-2016","Class II","Smoked Jalapeno Sturgeon, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67272 8","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0363-2016","Class II","Smoked Garlic Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67362 6","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0353-2016","Class II","Fancy Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67292 6","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0368-2016","Class II","Smoked Sockeye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67242 1","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0362-2016","Class II","Smoked Garlic Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67222 3","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0356-2016","Class II","Peppered & Smoked Coho (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67212 4","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0360-2016","Class II","Smoked Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67282 7","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0367-2016","Class II","Smoked Jalapeno Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67352 7","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0361-2016","Class II","Smoked Coho (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67222 3","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0370-2016","Class II","Smoked Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67342 8","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0371-2016","Class II","Smoked Sturgeon, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67262 9","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0357-2016","Class II","Peppered & Smoked Steelhead, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67332 9","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0358-2016","Class II","Peppered & Smoked Sockeye, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67232 2","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0359-2016","Class II","Smoked Catfish, Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67252 0","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72580,"Ongoing","Sockeye Suzys Fish LLC","Simcoe Creed Rd",,"White Swan","WA","98952","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0365-2016","Class II","Smoked Jalapeno Spring Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67392 3","13,281 cans (total)","Product has the potential to be contaminated with Clostridium botulinum.","01/14/2016",," Any production codes starting with OC.  The last date of distribution of recalled products was September 2015.  ",9/27/2015,"09/27/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72582,"Ongoing","Brett Anthony Foods","1350 Greenleaf Ave",,"Elk Grove Village","IL","60007-5521","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Whole Foods Market Midwest Distribution Center  480 West 45th Street Munster, IN 46321","F-0738-2016","Class I","Tofu Curry Cous Cous Salad packaged in a clear plastic 16 oz box with a white and green label with black lettering. ","30 cases, 6 salads per case ","Undeclared Allergens. The Tofu Curry Cous Cous Box salad label does not declare peanuts, soy, and eggs. ","03/09/2016",," lot code: 110715 ",11/4/2015,"11/04/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72593,"Ongoing","CHS INC","815 S 2nd St",,"Harrisburg","OR","97446-9662","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon and Washington","V-468-2016","Class I","    No UPC code    50 lb bags - Yellow label attached to a brown bag.","103 50lb bags plus 3 tons bulk (5 tons bulk was used to produce recalled Kountry ","CHS Inc. discovered high levels of copper during routine analysis of Provider 15% Pellet both for Mature Cattle, Horses, Goats & Sheep.","08/02/2016",," Lot # 85101415-M732580;  Lot #85101415-M734810  ",11/7/2015,"11/07/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72593,"Ongoing","CHS INC","815 S 2nd St",,"Harrisburg","OR","97446-9662","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon and Washington","V-467-2016","Class I","    UPC 7 13757 96142 4    50 lb bags - Salmon colored label attached to a brown bag.","3757 50lb bags","CHS Inc. discovered high levels of copper during routine analysis of Kountry Buffet 14% Text for Mature Cattle, Horses, Goats & Sheep.","08/02/2016",," Lot # 85092415-M702660;  Lot # 85100615-M720130;  Lot # 85101215-M728050;  Lot # 85101515-M734590;  Lot#  85102315-M748470.",11/7/2015,"11/07/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0526-2016","Class II","Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","73 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0538-2016","Class II","Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","19 bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0551-2016","Class II","Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045                 ","7 bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0534-2016","Class II","Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","1 bag","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0539-2016","Class II","Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","46 Minibags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0555-2016","Class II","Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL,  b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 ","9 bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0536-2016","Class II","Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","35 Minibags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0535-2016","Class II","0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","7 bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0531-2016","Class II","L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","14 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0537-2016","Class II","Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","14 Accuflo bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0527-2016","Class II","Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","49 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0530-2016","Class II","Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","52 Minibags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0528-2016","Class II","Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e) 750 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","95 Accuflo bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0544-2016","Class II","Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","30 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0556-2016","Class II","0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 ","43 bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0529-2016","Class II","Piperacillin/Tazobactam (Zosyn)  Accuflo bag, a) 18 g/NS 275 mL  b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","26 Accuflo bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0553-2016","Class II","Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045        ","7 Accuflo bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0542-2016","Class II","Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","23 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0552-2016","Class II","Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045    ","1 bag","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0549-2016","Class II","Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 ","27 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0540-2016","Class II","IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","1 bag","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0543-2016","Class II","Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","23 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0541-2016","Class II","Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","20 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0547-2016","Class II","IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","5 bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0545-2016","Class II","Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","23 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0548-2016","Class II","Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045  ","63 Minibags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0558-2016","Class II","3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 ","87 bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0557-2016","Class II","0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 ","7 bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0546-2016","Class II","Famotidine injection syringe a) 10 mg/1 mL  b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","21 syringes","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0550-2016","Class II","Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL  b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","30 Accuflo bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0554-2016","Class II","Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045     ","26 Minibags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0532-2016","Class II","Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045","40 Minibags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72594,"Ongoing","Walgreens Infusion Services","14220 Northbrook Dr Ste 100B",".","San Antonio","TX","78232-5045","United States","Voluntary: Firm Initiated","Letter","Texas","D-0533-2016","Class II","Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Lack  ","34 Accuflo bags","Lack of Assurance of Sterility","12/30/2015",," All lots within expiry.",11/10/2015,"11/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72597,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and  Venezuela.","Z-0642-2016","Class II","VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD.    Product  Usage:  The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)","Domestic: 157, Foreign: 270","Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.","01/13/2016",," Software Version 3.2 and below; Serial Numbers J46001001 -J4600636",11/3/2015,"11/03/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72597,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and  Venezuela.","Z-0640-2016","Class II","VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD.    Product  Usage:  For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.  ","Domestic: 200, Foreign: 554","Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.","01/13/2016",," Software Version 3.2 and below; Serial Numbers J36000012 - 36000879",11/3/2015,"11/03/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72597,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and  Venezuela.","Z-0643-2016","Class II","VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD.    Product  Usage:  The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.).  ","VITROS 5,1: Domestic - 932, Foreign - 1245; 5,1 Refurbished: Domestic - 63; Foreign - 153","Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.","01/13/2016",," Software Version 2.8 and below;  VITROS 5,1 FS Chemistry System Serial Numbers J34000016 - J34002323;  VITROS 5,1 FS Chemistry System Refurbished Serial Numbers 34000133, 34000193, 34000197, 34000212,   34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451,   34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799, 34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274,   34001297, 34001311, 34001317, 34001345, 34001378, 34001379, 34001389,   34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572,   34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840,   34001850, 34001875, 34001897, 34000123, 34000143, 34000191, 34000215,  34000219, 34000235, 34000251, 34000256, 34000260, 34000261, 34000319,   34000331, 34000380, 34000382, 34000406, 34000408, 34000412, 34000426,  34000431, 34000454, 34000464, 34000473, 34000501, 34000523, 34000530,   34000541, 34000542, 34000546, 34000548, 34000553, 34000558, 34000576,   34000577, 34000584, 34000585, 34000609, 34000612, 34000615, 34000616,  34000617, 34000618, 34000620, 34000625, 34000637, 34000644, 34000672,   34000744, 34000745, 34000755, 34000759, 34000776, 34000793, 34000800, 34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870,   34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938,   34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045,   34001052, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129,   34001154, 34001161, 34001171, 34001182, 34001192, 34001195, 34001201, 34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271,   34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301,   34001302, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367,   34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423,   34001427, 34001429, 34001457, 34001490, 34001518, 3400",11/3/2015,"11/03/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72597,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and  Venezuela.","Z-0641-2016","Class II","VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD.    Product  Usage:  For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.","Domestic: 1083, Foreign: 999","Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.","01/13/2016",," Software Version 3.2 and below; Serial Numbers J56000024 - J56002309",11/3/2015,"11/03/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0723-2016","Class II","INTEGRIS BH5000; Model Number: 72247    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0707-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures	 ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0705-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0718-2016","Class II","INTEGRIS HM3000; Model Number: 72239    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0709-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures 	 ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0710-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.	 	 	 ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0713-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0703-2016","Class II","Allura Xper FD10/10; Model Numbers: 722027 722011 722005    Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).	 ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0726-2016","Class II","INTEGRIS Allura 9 (biplane); Model Number: 722021    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0711-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.	 ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0704-2016","Class II","Allura Xper FD10 OR Table; Model Numbers: 722033 722022    Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0721-2016","Class II","INTEGRIS V3000; Model Number: 72243, 72244, 72245    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0720-2016","Class II","INTEGRIS BH3000; Model Number: 72242    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0730-2016","Class II","INTEGRIS BV3000 MONO; Model Number: 72241    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions  ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers. ",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0722-2016","Class II","INTEGRIS H5000; Model Number: 72246    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0708-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0717-2016","Class II","INTEGRIS H3000; Model Number: 72238    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0712-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.	 ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0724-2016","Class II","INTEGRIS V5000: Model Number: 72248    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0719-2016","Class II","INTEGRIS BN/BV3000; Model Number: 72240    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0729-2016","Class II","INTEGRIS CV; Model Number: 722030    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers. ",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0715-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. 	 ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0706-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0727-2016","Class II","INTEGRIS Allura 15-12 (mono); Model Number: 722043    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0716-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.  ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0702-2016","Class II","Allura Xper FD10, FD10 C, and FD10 F; Model Numbers:  722026 722010 722003 722002 722001    Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers. ",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0725-2016","Class II","INTEGRIS BV5000: Model Number: 72249    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0728-2016","Class II","INTEGRIS Allura 15-12 (biplane); Product Code: 722044    The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers. ",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72599,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0714-2016","Class II"," Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.	 ","13297 in total","The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. ","01/30/2016",," All serial numbers",11/3/2015,"11/03/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72600,"Ongoing","Prinova US LLC","285 E. Fullerton Ave",,"Carol Stream","IL","60188","United States","Voluntary: Firm Initiated","Letter","sent out to vaiours manufactures. A spreadsheet of customers is attached.","F-1571-2016","Class I","Pea protein 85% dry powder in a 20 KG bag. ","Lot# 3700D04019DB15106  -   27,500 KG   Lot# 3700D04019DB15107  -   12,000 KG","Undeclared Soy on label. RFR was generated by a customer who used the Pea Protein in a blended product that claims to be soy free. The Pea Protein tested positive for soy allergen.","06/22/2016",," Lot# 3700D04019DB15106 and Lot# 3700D04019DB15107",10/16/2015,"10/16/2015",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72605,"Terminated","Specialty Commodities, Inc.","1530 47th St NW",,"Fargo","ND","58102-2858","United States","Voluntary: Firm Initiated","Telephone","CA, FL, IL, NJ, NY, and PA","F-0398-2016","Class I","Heartland Flax Meal, Net Wt. 50 lbs.","340 - 50 lb bags","Specialty Commodities, Inc. is recalling a specific lot of Flax Meal that may be contaminated with Salmonella typhimurium.","03/09/2016","04/26/2016"," Manufacturing Lot Code:  2T330-04515-101",11/2/2015,"11/02/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72606,"Ongoing","Brett Anthony Foods","1350 Greenleaf Ave",,"Elk Grove Village","IL","60007-5521","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Whole Foods Market Midwest Distribution Center  480 West 45th Street Munster, IN 46321","F-1090-2016","Class I","Wild Mushroom Soup packaged in a 24 oz clear plastic container with green and white label and green lettering. ","33 cases, 6, 24 oz containers of soup per case. ","The Wild Mushroom soup was MIS-la bled and does not declare chestnuts. ","04/18/2016",," Sell by 11/21/2015 ",11/9/2015,"11/09/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72613,"Ongoing","Halo, Purely for Pets, Inc.","12400 Race Track Rd",,"Tampa","FL","33626-3117","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, CA, CO, DE, GA, ID, IL, IN, MA, MI, MN, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT AND WA  Canada","V-405-2016","Class II","Halo Spot's Stew Wholesome Turkey Recipe Sensitive Formula for Cats (Dry Cat Kibble)","1,080 bags (3 lbs.) and 6,983 bags (6 lbs.)","Reports of mold in the product.","03/07/2016",," 3 lbs. All Lots with Best by Date of 09/04/2016  6 lbs. All Lots with Best by Date of 09/04/2016",10/26/2015,"10/26/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72614,"Terminated","Inaffit, LLC","356 Urban Ave",,"Gaithersburg","MD","20878-4054","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0675-2016","Class I","NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827. ","6000 Bottles","Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.","02/17/2016","03/14/2016"," All lots",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72615,"Ongoing","Yummy Earth Inc","79 N Franklin Tpke Ste 200",".","Ramsey","NJ","07446-2029","United States","Voluntary: Firm Initiated","Letter","MN","F-1022-2016","Class II","YumEarth Organics Gummy Worms Net Wt. 5 oz.  Distributed by YummyEarth Inc., Ramsey, NJ 07446  UPC 810165018259","66,312 units","Gummy Worms and Gummy Bears are labeled incorrectly in that the outer package lists 11 mg carbohydrates and the individual packages lists 18 mg carbohydrates.","04/04/2016",," All lots",11/6/2015,"11/06/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72615,"Ongoing","Yummy Earth Inc","79 N Franklin Tpke Ste 200",".","Ramsey","NJ","07446-2029","United States","Voluntary: Firm Initiated","Letter","MN","F-1023-2016","Class II","YumEarth Organics Gummy Bears and Gummy Worms Net Wt. 15 oz.   Distributed by Yummy Earth, Ramsey, NY 07446  UPC 810165018273","7,308 units","Gummy Worms and Gummy Bears are labeled incorrectly in that the outer package lists 11 mg carbohydrates and the individual packages lists 18 mg carbohydrates.","04/04/2016",," All lots",11/6/2015,"11/06/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72615,"Ongoing","Yummy Earth Inc","79 N Franklin Tpke Ste 200",".","Ramsey","NJ","07446-2029","United States","Voluntary: Firm Initiated","Letter","MN","F-1021-2016","Class II","YumEarth Organics Gummy Bears 5 oz.  Distributed by YummyEarth Inc., Ramsey, NJ 07446  UPC 810165018310","74,088 units","Gummy Worms and Gummy Bears are labeled incorrectly in that the outer package lists 11 mg carbohydrates and the individual packages lists 18 mg carbohydrates.","04/04/2016",," All lots",11/6/2015,"11/06/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72620,"Completed","Homestat Farm Ltd","6065 Frantz Rd Ste 206",,"Dublin","OH","43017-3372","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AK, CA, FL, GA, IL, IN, KS, MD, MI, MN, MS, NC, NH, OH, PA & TX.","F-0344-2016","Class I","ORGANIC HOMESTAT FARM Quick STEEL CUT OATS & CHIA with Flax and Rye Flakes NET WT 42 OZ (2 LB. 10 OZ.) INGREDIENTS:***organic milled flaxseed*** Distributed by Homestat Farm LTD 6065 Frantz Rd. Suite 206, Dublin, OH 43017 UPC 8 35882 00620 4","7,217 trays/5/42 oz boxes","The firm was notified by their supplier that the Flax Meal delivered to them test positive for Salmonella Typhimurium.","03/09/2016",," BEST USE BY DATE: 03/16/17-1, 03/16/18-1, 03/19/17-1, 03/19/17-2, 03/23/17-1, 03/23/17-2, 03/24/17-1, 03/26/17-1, 03/26/17-2, & 04/08/17-2. ",11/5/2015,"11/05/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72625,"Ongoing","Nutritional Resources Inc","5003 Wrightsboro Rd",,"Grovetown","GA","30813-2843","United States","Voluntary: Firm Initiated","E-Mail","Domestic: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MA, MD, MI, MN, MS, MD, MT, NC, NH, NJ, NY, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, Foreign accounts: Aurba, Canada, Santo Domingo.","F-1875-2016","Class II","Healthwise, Protein Chips,  Barbecue Crunch, Net Weight 1.2 ounces (34 grams), Distributed by Nutritional Resources, Inc., Grovetown, GA 30813.","94,080 bags","Foreign matter (plastic) was observed in the product.","08/05/2016",," UPC 03447  02385, Manufacture lot code: Oct 1316F  (stamped on the rear of the bag).",11/9/2015,"11/09/2015",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72627,"Terminated","Blue Buffalo Company","11 River Rd",,"Wilton","CT","06897-6010","United States","Voluntary: Firm Initiated","Press Release","USA: CA  CO  FL  GA  IL  IN  KY  MA  MD  MI  MN  NC  NE  NJ  NV  NY  OH  PA  RI  SC  TX  WA    Canada","V-401-2016","Class II","Blue Kitty Yums Tasty Chicken Recipe, UPC: 859610007820","2070 cases","Product contains propylene glycol.","03/04/2016","04/14/2016"," Best If Used By: April 24, 2016 and July 24, 2016.  ",11/6/2015,"11/06/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72628,"Terminated","Trader Joes Company","800 S Shamrock Ave",,"Monrovia","CA","91016-6346","United States","Voluntary: Firm Initiated","Press Release","Nationwide in US","F-0703-2016","Class I","Butternut Squash Triangoli, Net Wt. 8.8 oz (250g)","62,244 units","Trader Joe's is recalling Trader Giotto's Butternut Squash Triangoli because it may contain undeclared tree nuts.","03/01/2016","03/22/2016"," SKU 94348,  Use or Freeze by codes 04 16 15 through 01 15 16",11/12/2015,"11/12/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72629,"Ongoing","Pine Pharmaceuticals, LLC","100 Colvin Woods Pkwy Suite 300",".","Tonawanda","NY","14150-6974","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0584-2016","Class II"," Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150. ",,"Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.","01/20/2016",," Lot #: 1918@5, exp. 1/26/2016; 1820@5, exp. 1/12/2016; 1773@5, exp. 1/6/2016; 1665@5, exp. 12/22/2015; 1542@5, exp. 12/1/2015; 1544@6, exp. 12/1/2015.",11/4/2015,"11/04/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72629,"Ongoing","Pine Pharmaceuticals, LLC","100 Colvin Woods Pkwy Suite 300",".","Tonawanda","NY","14150-6974","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0582-2016","Class II"," Syringe for intravitreal, Rx --  Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.",,"Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.","01/20/2016",," Lot #: 1648@7, exp. 12/20/2015; 1428@4, exp. 11/17/2015",11/4/2015,"11/04/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72629,"Ongoing","Pine Pharmaceuticals, LLC","100 Colvin Woods Pkwy Suite 300",".","Tonawanda","NY","14150-6974","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0581-2016","Class II"," Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.",,"Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.","01/20/2016",," Lot #: 1956@2, exp. 2/2/2016; 1954@1, exp. 2/2/2016; 1958@3, exp. 2/2/2016; 1943@2, exp. 2/1/2016; 1942@1, exp. 2/1/2016; 1944@3, exp. 2/1/2016; 1938@1, exp. 1/31/2016; 1939@2, exp. 1/31/2016; 1931@1, exp. 1/28/2016; 1932@2, exp. 1/28/2016; 1935@3, exp. 1/28/2016; 1925@1, exp. 1/27/2016; 1927@2, exp. 1/27/2016; 1928@3, exp. 1/27/2016; 1913@3, exp. 1/26/2016; 1917@4, exp. 1/26/2016; 1911@1, exp. 1/26/2016; 1921@6, exp. 1/26/2016; 1906@3, exp. 1/25/2016; 1903@1, exp. 1/25/2016; 1904@2, exp. 1/25/2016; 1899@3, exp. 1/24/2016; 1896@2, exp. 1/24/2016; 1895@1, exp. 1/24/2016; 1886@2, exp. 1/21/2016; 1893@5, exp. 1/21/2016; 1890@4, exp. 1/21/2016; 1885@1, exp. 1/21/2016; 1888@3, exp. 1/21/2016; 1879@5, exp. 1/20/2016; 1872@1, exp. 1/20/2016; 1875@3, exp. 1/20/2016; 1873@2, exp. 1/20/2016; 1867@5, exp. 1/19/2016; 1870@6, exp. 1/19/2016; 1866@4, exp. 1/19/2016; 1854@4, exp. 1/18/2016; 1853@5, exp. 1/18/2016; 1855@6, exp. 1/18/2016; 1839@3, exp. 1/17/2016; 1836@1, exp. 1/17/2016; 1831@2, exp. 1/14/2016; 1813@2, exp. 1/14/2016; 1830@1, exp. 1/14/2016; 1825@1, exp. 1/13/2016; 1818@4, exp. 1/13/2016; 1827@2, exp. 1/13/2016; 1816@3, exp. 1/12/2016; 1812@1, exp. 1/13/2016; 1804@4, exp. 12/31/2015; 1799@6, exp. 1/10/2016; 1797@5, exp. 1/10/2016; 1789@3, exp. 1/7/2016; 1635@5, exp. 12/17/2015; 1490@1, exp. 11/25/2015; 1790@4, exp. 1/7/2016; 1633@4, exp. 12/17/2015; 1492@2, exp. 11/25/2015; 1786@1, exp. 1/7/2016; 1628@2, exp. 12/17/2015; 1497@5, exp. 11/25/2015; 1788@2, exp. 1/7/2016; 1629@3, exp. 12/17/2015; 1486@7, exp. 11/24/2015; 1764@1, exp. 1/6/2016; 1617@1, exp. 12/16/2015; 1476@3, exp. 11/24/2015; 1768@3, exp. 1/6/2016; 1623@4, exp. 12/16/2015; 1474@1, exp. 11/24/2015; 1769@4, exp. 1/6/2016; 1620@3, exp. 12/16/2015; 1466@2, exp. 11/23/2015; 1757@2, exp. 1/5/2016; 1625@5, exp. 12/16/2015; 1473@5, exp. 11/23/2015; 1756@1, exp. 1/5/2016; 1618@2, exp. 12/16/2015; 1465@1, exp. 11/23/2015; 1762@4, exp. 1/5/2016; 1608@2, exp. 12/15/2015; 1460@2, exp. 11/22/2015; 1749@3, exp. 1/4/2016; 1610@3, exp. 12/15/2015; 1458@1, exp. 11/",11/4/2015,"11/04/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72629,"Ongoing","Pine Pharmaceuticals, LLC","100 Colvin Woods Pkwy Suite 300",".","Tonawanda","NY","14150-6974","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0583-2016","Class II"," Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.  ",,"Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.","01/20/2016",," Lot #: 1837@2, exp. 1/17/2016; 1646@6, exp. 12/20/2015",11/4/2015,"11/04/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72630,"Ongoing","Valeant Pharmacueticals International","400 Somerset Corporate Blvd",".","Bridgewater","NJ","08807-2867","United States","Voluntary: Firm Initiated","Letter","USA (nationwide) Distribution and Internationally to Canada and France.","Z-0674-2016","Class II","Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series.  Model No. SPAG-2.  A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol. ","1178","The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available. ","01/21/2016",," SPAG 2 Unit, Product Part Number 6002",9/21/2015,"09/21/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72631,"Terminated","Eastland Food Corporation","8305 Stayton Dr Ste C",,"Jessup","MD","20794-3008","United States","Voluntary: Firm Initiated","E-Mail","The shrimp powder is manufactured in Thailand and imported to the United States by Eastland. Eastland then distributes the shrimp powder nationwide to retail stores.","F-0724-2016","Class II","Maesri Brand Shrimp Powder, 6.oz","945 cases","The New York Department of Agriculture and Markets notified Eastland Food Corp. that they analyzed a sample of the shrimp powder and determined that the product contained FD&C Yellow #6, but the label failed to declare its presence. Yellow #6 can cause an allergic reaction for a small population of individuals. ","03/07/2016","03/10/2016"," Item Code: 210240",10/20/2015,"10/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72634,"Ongoing","Campbell Soup Supply Co., LLC","1 Campbell Pl",,"Camden","NJ","08103-1701","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, AZ, CA, CO, ID, KS, LA, MO, MS, OK, OR, TN, TX, UT, WA","F-2084-2016","Class II","Campbell's SpaghettiOs Original Pasta in Tomato and Cheese Sauce Net Wt. 14.2 ounces in metal cans, NDC: 0-51000-22432-3","14,789 cases","Potential choking hazard posed by pieces of red plastic found in cans.","09/21/2016",," FEB22017 08245 CT 3G LOE XXXX  XXXX is 0752-0322",11/12/2015,"11/12/2015",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72639,"Ongoing","PQ Corporation","340 E Grove St",".","Utica","IL","61373-9001","United States","Voluntary: Firm Initiated","E-Mail","Kentucky","D-0564-2016","Class III","EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.","41,650 lbs. (833 bags)","Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).","01/07/2016",," Lot # U150511; Exp. 05/18 ",10/29/2015,"10/29/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72641,"Ongoing","Frozen Specialties Inc","720 W Barre Rd",,"Archbold","OH","43502-9304","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: NC, NY, PA, SC & VA..","F-0713-2016","Class III","FOOD LION CHEESE microwaveable crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08821 5","5,515cs/16/5.2 oz boxes","The product contains the Kosher symbol on its retail packaging.  This symbol is a trademark of the Orthodox Union representing Kosher status.  None of our products are not Kosher.","03/03/2016",," USE BY: 7/22/16, 7/28/16, 8/6/16, 8/10/16, 8/15/16, 8/19/16, 8/26/16, 8/29/16, 9/25/16, 10/1/16 & 10/23/16.",10/28/2015,"10/28/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72641,"Ongoing","Frozen Specialties Inc","720 W Barre Rd",,"Archbold","OH","43502-9304","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: NC, NY, PA, SC & VA..","F-0711-2016","Class III","Hannaford CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074 UPC 0 41268 19400 1","360 cs/16/5.2 oz boxes","The product contains the Kosher symbol on its retail packaging.  This symbol is a trademark of the Orthodox Union representing Kosher status.  None of our products are not Kosher.","03/03/2016",," USE BY 9/30/16 & 10/26/2016",10/28/2015,"10/28/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72641,"Ongoing","Frozen Specialties Inc","720 W Barre Rd",,"Archbold","OH","43502-9304","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: NC, NY, PA, SC & VA..","F-0712-2016","Class III","FOOD LION CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08815 4","10,980cs/16/5.2 oz boxes","The product contains the Kosher symbol on its retail packaging.  This symbol is a trademark of the Orthodox Union representing Kosher status.  None of our products are not Kosher.","03/03/2016",," USE BY: 8/15/16, 8/18/16, 8/26/16, 8/28/16, 9/1/16, 9/11/16, 9/22/16, 10/1/16, 10/13/16, 10/20/16 & 10/23/16.",10/28/2015,"10/28/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72645,"Ongoing","Bake Rite Rolls Divison of Northeast Foods","2945 Samuel Dr",,"Bensalem","PA","19020-7305","United States","Voluntary: Firm Initiated","Letter","US Distribution:  VA, MD, PA, NJ","F-0598-2016","Class II","100% Whole Grain Hot Dog Rolls","6852","Possible presence of plastic","02/17/2016",," Bakery Code: 09, Julian Code: 304, 305, Fresh Through Code: 11-11, 11-12",11/2/2015,"11/02/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72648,"Ongoing","Dr. Reddy's Laboratories, Inc.","107 College Rd E",,"Princeton","NJ","08540-6623","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0721-2016","Class III","Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30","11,123 bottles","Failed Tablet/Capsule Specifications:  Product recalled due to reports of breakage and leakage of Paricalcitol capsules.","02/18/2016",," Lot #s: C404440, Exp 04/2016; C404946, Exp 05/2016; C505704, Exp 07/2017",11/4/2015,"11/04/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72648,"Ongoing","Dr. Reddy's Laboratories, Inc.","107 College Rd E",,"Princeton","NJ","08540-6623","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0719-2016","Class III","Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-663-30","9,155  bottles","Failed Tablet/Capsule Specifications:  Product recalled due to reports of breakage and leakage of Paricalcitol capsules.","02/18/2016",," Lot #s: C404795, C404796, C404797, Exp 05/2016; C406272, C406273, C406274, C406518, Exp  07/2016; C409586, C409587, Exp 11/2016; C409588, Exp 12/2016;   C501835, C501836 , C501837, Exp 02/2017; C503797, C503798, Exp 05/2017; C505009, Exp 06/2017; C505568, C505569, Exp 07/2017    ",11/4/2015,"11/04/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72648,"Ongoing","Dr. Reddy's Laboratories, Inc.","107 College Rd E",,"Princeton","NJ","08540-6623","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0720-2016","Class III","Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30","4383 bottles","Failed Tablet/Capsule Specifications:  Product recalled due to reports of breakage and leakage of Paricalcitol capsules.","02/18/2016",," Lot #s: C404653, C404654, C404655, Exp 05/2016; C505010, Exp 06/2017    ",11/4/2015,"11/04/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72652,"Ongoing","Maquet Cardiovascular Us Sales, Llc","45 Barbour Pond Drive",".","Wayne","NJ","07470","United States","Voluntary: Firm Initiated","Letter","United States Nationwide Distribution","Z-0589-2016","Class II","Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W    Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less. ","100 Units (distributed in United States)","Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. This can shut down the compressor or the entire HCU 30 Type 2 unit.","01/05/2016",," HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371  HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4642  HCU 30 Base Unit Canadian/US, Model Number 705501/70103.4653  Heater Cooler Unit 30 with Serial Number <93101480    The affected power supply boards have serial numbers less than 107006001.",11/13/2015,"11/13/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72656,"Ongoing","Pioneer Frozen Foods, Inc","627 Big Stone Gap Rd",,"Duncanville","TX","75137-2223","United States","Voluntary: Firm Initiated","E-Mail","Texas, Georgia, Iowa, Kansas, Michigan","F-2134-2016","Class III","McGriddles Hot Cakes 192/1.75 oz packaged in brown cardboard box","3,999 cases","Rain water from the roof and water condensate dripped onto baked product and the conveyor belt in the production areas.  Third party analysis revealed a high APC count.","09/12/2016",," Lot Code: 5296 Use THRU 18 JUL 2016 DT and 5297 Use THRU 19 JUL 2016 ",11/11/2015,"11/11/2015",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72657,"Ongoing","Casey's Bakery, Inc","251 N Main Ave Ste 301",".","Sioux Center","IA","51250-1818","United States","Voluntary: Firm Initiated","Visit","Sioux Center, IA area.","F-0465-2016","Class I","Casey's Bakery, 8X8 Snickers cake, www.caseysbakery.com, Sioux Center, IA","At least 7, but up to 57 more.","Product contains undeclared peanuts","01/05/2016",," All date codes earlier than 696",11/17/2015,"11/17/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72658,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",".","Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii.,  and to the countries of :  Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.","Z-0564-2016","Class II","Radiographic Transparency for Certain and External Connection Tapered Implants.  Images that assist with measurements for dental implants. ","686","Images contained within radiographic transparency ART 1036 are undersized. ","12/31/2015",," Model Number:  ART 1036, Rev. C 03/13; Purchase Order # 184427.",11/16/2015,"11/16/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72661,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",".","Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of IL, NC, and VT.","Z-0555-2016","Class II","Merge Cardio with software version 10.1 LA.","1","The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.","12/28/2015",," Merge Cardio with software version 10.1 LA.    Merge Cardio is intended to allow users to review diagnostic and non-diagnostic quality images.   ",10/26/2015,"10/26/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72661,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",".","Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of IL, NC, and VT.","Z-0554-2016","Class II","Merge Hemo with software versions 10.0 LA.    Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.   ","2","The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.","12/28/2015",," Merge Hemo with software versions 10.0 LA",10/26/2015,"10/26/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72662,"Ongoing","Wegmans Food Markets, Inc.","1500 Brooks Ave",,"Rochester","NY","14624","United States","Voluntary: Firm Initiated","Press Release","NY, NJ, PA VA, MD & MA through Wegmans retail stores","F-0599-2016","Class I","Wegmans ITALIAN CLASSICS BUTTERNUT SQUASH RAVIOLI, NET WT 9 OZ, UPC #77890 36434, KEEP REFRIGERATED, PRODUCT OF ITALY","55,773 units","Wegmans Food Markets, Inc. initiated a recall due to the presence of undeclared tree nuts (Cashews and Almonds)","02/17/2016",," All date codes ",11/17/2015,"11/17/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72664,"Ongoing","Southeastern Grocers Llc","5050 Edgewood Ct",,"Jacksonville","FL","32254-3601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected Harveys stores (56 stores) are located in Florida, Georgia, and South Carolina.  The affected Winn-Dixie Stores (85 stores) are located in Florida and Georgia.","F-0531-2016","Class I","Cookie Platter Containing Oatmeal Rasin Cookies packaged in plastic container, 48-count and 36-count","21,600 total Baked Oatmeal Raisin Cookies","Undeclared walnuts","02/02/2016",," 48-count - UPC 00269736000009, SLU 69736;      36-count - UPC 0020755000003, SLU 7550",10/28/2015,"10/28/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72664,"Ongoing","Southeastern Grocers Llc","5050 Edgewood Ct",,"Jacksonville","FL","32254-3601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected Harveys stores (56 stores) are located in Florida, Georgia, and South Carolina.  The affected Winn-Dixie Stores (85 stores) are located in Florida and Georgia.","F-0530-2016","Class I","Bakery Variety Pack Cookies Containing Oatmeal Rasin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count","21,600 total Baked Oatmeal Raisin Cookies","Undeclared walnuts","02/02/2016",," 12-count - UPC 00209700000000, SLU 9700;      18-count - UPC 00267982000002, SLU 67982;      20-count - UPC 00209701000009, SLU 9701",10/28/2015,"10/28/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72664,"Ongoing","Southeastern Grocers Llc","5050 Edgewood Ct",,"Jacksonville","FL","32254-3601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The affected Harveys stores (56 stores) are located in Florida, Georgia, and South Carolina.  The affected Winn-Dixie Stores (85 stores) are located in Florida and Georgia.","F-0529-2016","Class I","Bakery Oatmeal Raisin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count","21,600 Baked Oatmeal Rasin Cookies","Undeclared walnuts","02/02/2016",," 12-count - UPC 00207995000002, SLU 7995;      18-count - UPC 00267987000007, SLU 67987;      20-count - UPC 00209699000005, SLU 9699",10/28/2015,"10/28/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72665,"Ongoing","Immuno - Dynamics, Inc","1800 Dodge St",".","Fennimore","WI","53809-2301","United States","Voluntary: Firm Initiated","Letter","Nationwide to include Puerto Rico.  Outside the US to include:  Australia, Canada, Finland, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Russian Federation, Singapore, Sri Lanka, Sweden, Thailand, Turkey , United Kingdom (Great Britain).","F-1014-2016","Class III","PerCoBa Colostrum Capsules, Dietary Supplement, Colostrum (bovine) 1g.  120 capsules.  UPC 90576-00011.  Allergen statement:  contains dairy.  Distributed by:  Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimore, WI  53809.","662 units","The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.","04/04/2016",," Lots:  625-20, 638-10.",11/10/2015,"11/10/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72665,"Ongoing","Immuno - Dynamics, Inc","1800 Dodge St",".","Fennimore","WI","53809-2301","United States","Voluntary: Firm Initiated","Letter","Nationwide to include Puerto Rico.  Outside the US to include:  Australia, Canada, Finland, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Russian Federation, Singapore, Sri Lanka, Sweden, Thailand, Turkey , United Kingdom (Great Britain).","F-1016-2016","Class II","PerCoBa 1, Colostral Whey, Dietary Supplement, Colostral Whey Protein 6.4%.  Net Contents:  4 oz.  Immuno-Dynamics, Inc. , PO Box 544 Perry, Iowa  50220","2,815 units","The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.","04/04/2016",," Lots:  477, 479, 481, 484.",11/10/2015,"11/10/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72665,"Ongoing","Immuno - Dynamics, Inc","1800 Dodge St",".","Fennimore","WI","53809-2301","United States","Voluntary: Firm Initiated","Letter","Nationwide to include Puerto Rico.  Outside the US to include:  Australia, Canada, Finland, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Russian Federation, Singapore, Sri Lanka, Sweden, Thailand, Turkey , United Kingdom (Great Britain).","F-1017-2016","Class III","PerCoBa Whey Protein Isolate with Colostrum, Dietary Supplement.  Net Weight:  1 kg (2.2 lbs), Colostrum 3,000 mg.  UPC 90576-00009.  Immuno-Dynamics, Inc., 18000 Dodge Street, Fennimore, WI  53809.","20 units","The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.","04/04/2016",," Lot:  644-35.",11/10/2015,"11/10/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72665,"Ongoing","Immuno - Dynamics, Inc","1800 Dodge St",".","Fennimore","WI","53809-2301","United States","Voluntary: Firm Initiated","Letter","Nationwide to include Puerto Rico.  Outside the US to include:  Australia, Canada, Finland, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Russian Federation, Singapore, Sri Lanka, Sweden, Thailand, Turkey , United Kingdom (Great Britain).","F-1013-2016","Class III","Colostrum Powder, Dietary Supplement, Allergen statement:  contains dairy.  Colostrum (bovine) packaged in the following sizes and brand names:    1.  PerCoBa Extra Edge Net Weight 150 grams, UPC 90576-00099.  3,000 mg Colostrum (bovine) per 2 teaspoons.   Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimore, WI  53809;     2. PerCoBa Extra Edge Net Weight 250 grams, UPC 90576-00001.  3,000 mg Colostrum (bovine) per 2 teaspoons.     Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimore, WI  53809.;     3.  Synertek Balanced Pure, 8.8 ounces, UPC 09408-29292.  1,500 mg Colostrum (bovine) per 1 teaspoon.  Distributed by Synertek Colostrum, Inc., Cheyenne, WY  82009.","250 gram jars -  2,532 units.  150 gram jars - 68 units. 8.8 ounce jars - 11,008 units","The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.","04/04/2016",," 250 gram jar Lots:  627-30, 628-30, 628-31, 630-31, 632-30, 633-30, 633-31, 635-30, 635-35,  636-30, 637-30, 637-31, 638-30, 638-31, 639-30, 639-31, 639-32, 641-30, 642-30, 644-30, 644-31, 646-30.    150 gram Jar Lots:  642-100    8.8 ounce jar Lots:  627-30, 628-30, 628-31, 630-31, 632-30, 633-30, 633-31, 635-30, 635-35,  636-30, 637-30, 637-31, 638-30, 638-31, 639-30, 639-31, 639-32, 641-30, 642-30, 644-30, 644-31, 646-30",11/10/2015,"11/10/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72665,"Ongoing","Immuno - Dynamics, Inc","1800 Dodge St",".","Fennimore","WI","53809-2301","United States","Voluntary: Firm Initiated","Letter","Nationwide to include Puerto Rico.  Outside the US to include:  Australia, Canada, Finland, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Russian Federation, Singapore, Sri Lanka, Sweden, Thailand, Turkey , United Kingdom (Great Britain).","F-1015-2016","Class III","Colostrum Lozenges, Dietary Supplement,  Colostrum (Bovine) 200mg.  Allergen statement:  contains dairy.   Packaged in the following sizes and Brand names:    1.  PerCoBa,  UPC 90576-00006.  100 Lozenges  Distributed by:  Immuno-Dynamics, Inc., Fennimore, WI  53809;     2.  Synertek, UPC 90576-00007.  100 lozenges.  Distributed by:  Synertek Colostrum, Inc., Cheyenne, WY  82009.  ","PerCoBa 3,310 units.  Synertek 9,468 units.","The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.","04/04/2016",," PerCoBa Lots:  627-20, 638-20.    Synertek Lots:  627-20,  638-20.",11/10/2015,"11/10/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72668,"Terminated","Ehrmann Arizona Dairy Llc","1285 W Gila Bend Hwy",".","Casa Grande","AZ","85193-3802","United States","Voluntary: Firm Initiated","E-Mail","Distribution to ALDI distribution centers for their stores only.  U.S. distribution to the following; IL, PA, TX, MD, MN, IN, FL, OH, GA, TN, WI, MO, KS, NC, PA, CT, NY, MI","F-0336-2016","Class II","Friendly Farms   Greek   Peach Parfait  Nonfat Yogurt  net wt. 5.3 oz (150g)    Distributed by ALDI Inc., Batavia, IL 60510  ","237,184 cups","Ehrmann Arizona Dairy, LLC is recalling Friendly Farm Greek Peach Parfait due to the cups displaying gluten free logo when the ingredients state that the granola contains wheat flakes.","12/28/2015","02/19/2016"," Batch #, Best By Date  6047, 11/9/2015  7673, 11/15/2015  9708, 11/23/2015  1093, 11/29/2015  3117, 12/7/2015  4476, 12/13/2015  5679, 12/19/2015  7698, 12/27/2015  9371, 1/3/2016",11/13/2015,"11/13/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72680,"Ongoing","Fritz Industries, Inc","2950 Executive Blvd",,"Mesquite","TX","75149-2802","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, TX, CA, WA, NJ, FL, IN, NY, KY, OH, PA, SC, OK","V-406-2016","Class II","Fritz Aquatics Mardel Coppersafe Provides Relief From Unwelcome Parasites Net 1 Gallon (3.8L)  Treats 3024 Gallons; Fritz Aquatics Mardel Coppersafe Provides Relief From Unwelcome Parasites Net 16 FL OZ (473mL) Treats 378 Gallons; NDC: 53745-013-38; OTC","368 gallons","Incorrect dosage instructions were printed on the labels. Upon use, the incorrect instructions would result in a 217% increase in active ingredient concentration.","03/09/2016",," Lot Number: 2824FID101 Expiration: 10/9/2016 and 3244FID101 Expiration: 11/20/2016",12/15/2014,"12/15/2014",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72685,"Terminated","CHS Nutrition","5325 10th Ave N",,"Great Falls","MT","59405-1089","United States","Voluntary: Firm Initiated","Telephone","One consignee","V-469-2016","Class I",,"120/50lb bags","CHS Nutrition is recalling MSU High Alfalfa Lamb Pellets no salt B 24 due to high copper levels.  The high copper levels were discovered during routine analysis of the feed.","08/02/2016","08/02/2016"," M736460 (10/16/2015)",11/20/2015,"11/20/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72689,"Ongoing","East-West Specialty Sauces, Inc.","950 Vallejo St",,"Denver","CO","80204-3843","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The recall product was distributed in Colorado and Texas","F-0739-2016","Class I","East-West Classic Sweet & Sour Sauce, 12 fl. Oz., Glass bottle, 6/case, Refrigerate after opening, Distributed by East-West Specialty Sauces, Inc. Denver, CO 80204","404","East-West Specialty Sauces is recalling Classic Sweet & Sour Sauce due to mislabeling.  The  Zesty Orange sauce had been mislabeled with Sweet & Sour labels East-West Specialty Sauces is recalling Classic Sweet & Sour Sauce due to mislabeling.  The  Zesty Orange sauce had been mislabeled with Sweet & Sour labels which presents a potential wheat and soy allergen issue.","03/09/2016",," 092315 Best By 9/17 and 102015 Best By 10/17",10/28/2015,"10/28/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72696,"Ongoing","President East Company","3 Galasso Pl",,"Maspeth","NY","11378-2010","United States","Voluntary: Firm Initiated","E-Mail","NY","F-0627-2016","Class III","FROZEN KINGFISH STEAK, QF, IVP, Size: 10/12 OZ, WEIGHT 22 LBS, IMPORTER:PRESIDENT EAST COMPANY, PRODUCT OF TAIWAN, individual pieces are held within clear plastic vacuum-sealed packaging.  ","11 Cartons","Recent FDA analysis determined that the product is decomposed and was also identified as Spanish mackerel.","02/24/2016",," PRODUCTION DATE: 2015/05/19  BEST BEFORE DATE: 2017/05/19",11/19/2015,"11/19/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72697,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","325 Paramount Drive",".","Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.","Z-0658-2016","Class II","FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325    Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. ","115 units","Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.","01/15/2016",," Lot Number: M1505056",11/20/2015,"11/20/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72697,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","325 Paramount Drive",".","Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.","Z-0656-2016","Class II","FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code:  283305    Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. ","50 units","Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.","01/15/2016",," Lot Number: M1505055",11/20/2015,"11/20/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72697,"Ongoing","DePuy Mitek, Inc., a Johnson & Johnson Co.","325 Paramount Drive",".","Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US states of TX, OH, MI, and ME; and the countries of FR, DE, SK, IT, NL, CH, and CZ.","Z-0657-2016","Class II","FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315    Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. ","45 units","Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.","01/15/2016",," Lot Number: M1505053",11/20/2015,"11/20/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72698,"Ongoing","Cyberonics, Inc","100 Cyberonics Blvd",,"Houston","TX","77058-2069","United States","Voluntary: Firm Initiated","Letter","US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.","Z-0645-2016","Class II","Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator Model 106","29 units","Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.","01/13/2016",," Serial numbers 36602, 37019, 39097, 40311, 40465",11/18/2015,"11/18/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72701,"Terminated","Nipro Medical Corporation","3150 Nw 107th Ave",,"Miami","FL","33172","United States","Voluntary: Firm Initiated","Other","US Distribution to states of: TN and NJ.","Z-0624-2016","Class II","NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set     A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines. ","1,484 pieces. ","Blood foaming was found during evaluation of the product. ","01/08/2016","02/04/2016"," Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.   ",3/30/2015,"03/30/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72704,"Ongoing","Land O Lakes Purina LLC","1080 County Road F W",,"Shoreview","MN","55126-2910","United States","Voluntary: Firm Initiated","Telephone","SD only.","V-440-2016","Class I","Dakota Calf Starter 22% R40, Medicated, Type C Medicated Feed.  Product code RHRJ.  Complete feed for dairy starter - 3 days to 3 mons in confinement.  For Prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuemii.  Monensin (as Monensin Sodium) 40.00 g/ton.  Manufactured by Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN  55126-2910. Bulk Net Weight.","6,040 lb.","The Dakota Calf Starter 22% R40 has an elevated level of Monensin.  This may have resulted in calf mortality.","06/10/2016",," 11/10/2015; manufacturing date and lot number are the same",11/19/2015,"11/19/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72705,"Ongoing","Made In Nature, LLC","1708 13th St",".","Boulder","CO","80302-6226","United States","Voluntary: Firm Initiated","Telephone","nationwide.  No foreign, VA/govt","F-0335-2016","Class II","Pacific Superfoods Snack Lava Rock Sriracha Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve,  8 packages per case","8,500 sell units ","Made in Nature is recalling Made In Nature Sriracha Chili Kale Chips and Pacific Superfoods Snack Lava Rock Sriracha Kale Chips due to undeclared soy allergen from Tamari.","01/05/2016",," UPC # 850747004102 ",11/20/2015,"11/20/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72705,"Ongoing","Made In Nature, LLC","1708 13th St",".","Boulder","CO","80302-6226","United States","Voluntary: Firm Initiated","Telephone","nationwide.  No foreign, VA/govt","F-0334-2016","Class II","Made In Nature Sriracha Chili Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve,  8 packages per case","50,176 sell units","Made in Nature is recalling Made In Nature Sriracha Chili Kale Chips and Pacific Superfoods Snack Lava Rock Sriracha Kale Chips due to undeclared soy allergen from Tamari.","01/05/2016",," UPC # 720379585044",11/20/2015,"11/20/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72707,"Completed","Nipro Medical Corporation","3150 Nw 107th Ave",".","Miami","FL","33172","United States","Voluntary: Firm Initiated","Other","US distribution including TN.","Z-0599-2016","Class III","NIPRO SafeTouch II Safety AVF Needle,  17G x 1 ¿ inch.  Item code FS+173230BC.","160,000 pieces.","Device has the potential to have torn wings. ","01/06/2016",," Model No.: FS+173230BC, Lot #14A22 and Lot #14A26.",4/1/2014,"04/01/2014",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72708,"Ongoing","HEB Retail Support Center","4710 N Pan Am Expy",,"San Antonio","TX","78218-5415","United States","Voluntary: Firm Initiated","Press Release","TX","F-0423-2016","Class II","Mi Tienda Tostaditas Botoneras Rojas packaged in bag","14 units","Possible presence of metal fragments.","01/11/2016",," Sell by 11/16/15 and 11/17/15; UPC 22847000000",11/20/2015,"11/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72708,"Ongoing","HEB Retail Support Center","4710 N Pan Am Expy",,"San Antonio","TX","78218-5415","United States","Voluntary: Firm Initiated","Press Release","TX","F-0421-2016","Class II","Mi Tienda Masa Preparada By the Pound packaged in bag","15 units","Possible presence of metal fragments.","01/11/2016",," Sell by 11/16/15; UPC 22854300000",11/20/2015,"11/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72708,"Ongoing","HEB Retail Support Center","4710 N Pan Am Expy",,"San Antonio","TX","78218-5415","United States","Voluntary: Firm Initiated","Press Release","TX","F-0422-2016","Class II","Mi Tienda Tostada Siveria Large Tostada packaged in bag","30 units","Possible presence of metal fragments.","01/11/2016",," Sell by 11/16/15 and 11/17/15; UPC 22859400000",11/20/2015,"11/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72710,"Ongoing","Partners In Medicine Llc","11469 Olive Blvd Ste 127",".","Saint Louis","MO","63141-7108","United States","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including MI and CA.","Z-0572-2016","Class II","CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance.  Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be used for vital sign monitoring of critically ill patients under absence of additional, suitable self-monitoring devices or medical trained personnel. The device measures continuously the subject's hemodynamic parameters without reporting any diagnosis. It is the physician's responsibility to make proper judgment based on these parameters.","28 worldwide 2 monitors distributed in the U.S.","Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure). ","01/04/2016",," Serial numbers:  003040i-2014-161-014-GG-0000,  003040i-2015-101-003-GG-0000,  003040i-2014-161-001-GG-0000,  003040i-2014-161-002-GG-0000,  003040i-2014-161-003-GG-0000,  003040i-2014-161-004-GG-0000,  003040i-2014-161-005-GG-0000,  003040i-2014-161-006-GG-0000,  003040i-2014-161-007-GG-0000,  003040i-2014-161-008-GG-0000,  003040i-2014-161-009-GG-0000,  003040i-2014-161-010-GG-0000,  003040i-2014-161-011-GG-0000,  003040i-2014-161-012-GG-0000,  003040i-2014-161-013-GG-0000,  003040i-2014-161-015-GG-0000,  003040i-2014-161-016-GG-0000,  003040i-2014-161-017-GG-0000,  003040i-2014-161-018-GG-0000,  003040i-2014-161-019-GG-0000,  003040i-2014-161-020-GG-0000,  003040i-2014-161-021-GG-0000,  003040i-2014-161-022-GG-0000,  003040i-2014-161-023-GG-0000,  003040i-2014-161-024-GG-0000,  003040i-2014-161-025-GG-0000,  003040i-2015-101-001-GG-0000, and  003040i-2015-101-002-GG-0000",12/1/2015,"12/01/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72712,"Ongoing","Aesculap, Inc.","3773 Corporate Pkwy",".","Center Valley","PA","18034-8217","United States","Voluntary: Firm Initiated","Letter","US Distribution to state of: NY.","Z-0566-2016","Class II","Valve XS Atrium Retractor  FC429R  52154756    The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.","41","AAG received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an FC424R blade. Investigation revealed that the corrosion was due to incorrect material used in the manufacturing of the disk spring of the ball joint by the supplier","12/31/2015",," Product Information All lots affected  	Product Description  FC424R	Valve XS Atrium Lift Ret. Blade50X35  FC425R	Valve XS Atrium Lift Ret. Blade60X35  FC426R	Valve XS Atrium Lift Ret. Blade70X35  FC428R	Valve XS Atrium Lift Ret. Blade50X45  FC429R	Valve XS Atrium Lift Ret. Blade60X45  FC430R	Valve XS Atrium Lift Ret. Blade70X45  FC431R	Valve XS Atrium Lift Ret. Blade25X20  FC432R	Valve XS Atrium Lift Ret. Blade25X25  FC433R	Valve XS Atrium Lift Ret. Blade40X25  FC434R	Valve XS Atrium Lift Ret. Blade50X25  FC435R	Valve XS Atrium Lift Ret. Blade25X40  FC436R	Valve XS Atrium Lift Ret. Blade25X50  FC420R	Valve XS Atrium Lift Ret. Blade Complete Set  ",11/17/2015,"11/17/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72715,"Completed","Stryker Sustainability Solutions","10232 S 51st St",".","Phoenix","AZ","85044-5205","United States","Voluntary: Firm Initiated","Letter","US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.","Z-0478-2016","Class I","The Fuhrman Pleural/Pneumopericardial Drainage Set    The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.","34 devices","Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient. ","01/04/2016",," Item Number  G03974    Lot Number  295397U  331621U  374044U  394431U  406125U  406131U  410982U  412655U  415094U  422060U  519812U  7718289U  838193U",11/17/2015,"11/17/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72717,"Ongoing","Restaurant Depot/Jetro","1030 W Division St",,"Chicago","IL","60642-4205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All product was distributed in the state of Florida.","F-0579-2016","Class III","Swai Fillets ( 7-9 oz.) packaged in a 15 lb. blue and white box with blue and white lettering. ","1134 cases (A case is 1, 15 lb. box of fillets) Fillets per box vary","Nitrofuran (SCA) was found in the product during routine third party lab testing. ","03/16/2016",,"  Production date: 08/19/2015; Best used by date: 08/19/2017;   PO No: 429-13385  ",11/4/2015,"11/04/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72719,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",".","Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, France, UAE, Austria, Australia, Belgium,  CANADA, Switzerland, Germany, Denmark, Spain, Finland, UK, Hong Kong, ISRAEL, India, Italy, Japan, South Korea, Netherlands, Norway, Poland, PORTUGAL, Sweden, SINGAPORE, Thailand, Turkey, and SOUTH AFRICA.","Z-0584-2016","Class II","BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers:    74121238, MODULAR HEAD 38 MM -8MM  74121242,  MODULAR HEAD 42 MM -8MM  74121246,  MODULAR HEAD 46 MM -8MM  74121250,  MODULAR HEAD 50 MM -8MM  74121254,  MODULAR HEAD 54 MM -8MM  74121258,  MODULAR HEAD 58 MM -8MM  74121338,  MODULAR HEAD 3 8MM -4 (SHORT)  74121342,  MODULAR HEAD 42 MM -4 (SHORT)  74121346,  MODULAR HEAD 46 MM -4 (SHORT)  74121350,  MODULAR HEAD 50 MM -4 (SHORT)  74121354,  MODULAR HEAD 54 MM -4 (SHORT)  74121358,  MODULAR HEAD 58 MM -4 (SHORT)  74121438,  MODULAR HEAD 38 MM +0 (MED)  74121442,  MODULAR HEAD 42 MM +0 (MED)  74121446,  MODULAR HEAD 46 MM +0 (MED)  74121450,  MODULAR HEAD 50 MM +0 (MED)  74121454,  MODULAR HEAD 54 MM +0 (MED)  74121458,  MODULAR HEAD 58 MM +0 (MED)  74121538,  MODULAR HEAD 38 MM +4 (LONG)  74121542,  MODULAR HEAD 42 MM +4 (LONG)  74121546,  MODULAR HEAD 46 MM +4 (LONG)  74121550,  MODULAR HEAD 50 MM +4 (LONG)  74121554,  MODULAR HEAD 54 MM +4 (LONG)  74121558,  MODULAR HEAD 58 MM +4 (LONG)","16 units in US","The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US.  The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use.","01/04/2016",," All codes",11/16/2015,"11/16/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72720,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of  Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.","Z-0856-2016","Class II","Philips Healthcare IntelliVue Info Center iX, A.0 866023  ","5671 units","Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.","02/23/2016",," Software A.0.X",11/25/2015,"11/25/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72720,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of  Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.","Z-0858-2016","Class II","Philips Healthcare IntelliVue Info Center iX, B.0,  866389   Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)","1880 units","Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.","02/23/2016",," Software Versions: B.0.X",11/25/2015,"11/25/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72720,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of  Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.","Z-0857-2016","Class II","Philips Healthcare PIIC Classic Upgrade, 866117   Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)","5569 units","Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.","02/23/2016",," Software B.O",11/25/2015,"11/25/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72722,"Terminated","Jensens Old Fashioned Smokehouse Inc","10520 Greenwood Ave N",".","Seattle","WA","98133-8721","United States","Voluntary: Firm Initiated","Telephone","distributed in Washington only","F-1018-2016","Class II","Teriyaki hot smoked Atlantic salmon,   Teriyaki hot smoked King salmon,    Teriyaki hot smoked Sockeye salmon,   Teriyaki hot smoked salmon (no species listed).    Product was packed in bulk cases, 10 lbs. each, sold in bulk bin. There are no retail packages and NO UPC.","distributed 1533.89 lbs. to consignee and sold 138.91 lbs. on site","Teriyaki hot smoked Atlantic salmon, Teriyaki hot smoked King salmon,  Teriyaki hot smoked Sockeye salmon, and Teriyaki hot smoked salmon (no species listed)  are recalled due to undeclared wheat and soy sauce.","04/04/2016","04/06/2016"," Lot codes of products distributed to consignee between June 29, 2015 and October 13, 2015 are:     517301, 519102, 519801, 520402, 520802, 520806, 521314, 522202, 523906, 524014, 524306, 524514, 524714, 525814, 526114, 526406, and 526814.    *******LOT CODES OF TERIYAKI SMOKED KING SALMON SOLD ONSITE AT JENSEN's between December 26, 2014 and November 19, 2015 are********  517001, 519101, and 522301.      The code breaks down as:    1st digit: corresponds to the last digit of the year the fish was received at Jensens;  2nd, 3rd, 4th digits:  represent the Julian date the fish was received;  5th and 6th digits:  represent the species of the fish",11/19/2015,"11/19/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72727,"Ongoing","Corflex","669 E Ind Park Dr",".","Manchester","NH","03109-5625","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.","Z-0575-2016","Class II","CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE	  Model: 75-7500-011    Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.  Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.","6 units","Knee  brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,","01/04/2016",," (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range:  Braces manufactured between September 1, 2015 and November 6, 2015",11/12/2015,"11/12/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72727,"Ongoing","Corflex","669 E Ind Park Dr",".","Manchester","NH","03109-5625","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.","Z-0578-2016","Class II","BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE  Model: 75-7500-087    Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.","10 units","Knee  brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,","01/04/2016",," (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range:  Braces manufactured between September 1, 2015 and November 6, 2015",11/12/2015,"11/12/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72727,"Ongoing","Corflex","669 E Ind Park Dr",".","Manchester","NH","03109-5625","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.","Z-0579-2016","Class II","ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE  Model: 75-7500-231  Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.","9 units","Knee  brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,","01/04/2016",," (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range:  Braces manufactured between September 1, 2015 and November 6, 2015",11/12/2015,"11/12/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72727,"Ongoing","Corflex","669 E Ind Park Dr",".","Manchester","NH","03109-5625","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.","Z-0576-2016","Class II","HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE  Model : 75-7500-038  Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.	  	  ","4 units","Knee  brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,","01/04/2016",," (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range:  Braces manufactured between September 1, 2015 and November 6, 2015",11/12/2015,"11/12/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72727,"Ongoing","Corflex","669 E Ind Park Dr",".","Manchester","NH","03109-5625","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.","Z-0580-2016","Class II","CONTENDER POST-OP-KNEE BRACE FULL FOAM  Model: 75-7550-000  Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.","80 units","Knee  brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,","01/04/2016",," (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range:  Braces manufactured between September 1, 2015 and November 6, 2015",11/12/2015,"11/12/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72727,"Ongoing","Corflex","669 E Ind Park Dr",".","Manchester","NH","03109-5625","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.","Z-0574-2016","Class II","Corflex Contender Post-Op Knee Brace Lite  Model: 75-7500-000  Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.","1,406 units","Knee  brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,","01/04/2016",," (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range:  Braces manufactured between September 1, 2015 and November 6, 2015",11/12/2015,"11/12/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72727,"Ongoing","Corflex","669 E Ind Park Dr",".","Manchester","NH","03109-5625","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.","Z-0577-2016","Class II","ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE  Model: 75-7500-075  Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.  	","42 units","Knee  brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,","01/04/2016",," (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range:  Braces manufactured between September 1, 2015 and November 6, 2015",11/12/2015,"11/12/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72728,"Terminated","Raley's","500 W Capitol Ave",".","Broderick","CA","95605-2624","United States","Voluntary: Firm Initiated","E-Mail","CA and NV","F-0444-2016","Class I","Raley's Sweet Pumpkin Ravioli;  Fresh egg pasta with a pumpkin & Amaretti Biscuits filling.  Net Wt. 10 oz. (284 g);  Ingredients: Filling- pumpkin, bread crumbs (wheat flour, natural yeast, salt), Butter Amaretti Biscuits (sugar, apricot kernels, egg whites, lactose, milk protein, leavening- sodium hydrogen carbonate(, salt..  Pasta - soft wheat flour, pasteurized eggs, durum wheat seminola:  Contains eggs, milk, wheat, gluten;    Proudly distributed by Raley's West Sacramento, CA  Product of Italy.","305 cases","Raley's was notified by the manufacturer that their Pumpkin Ravioli may contain undeclared cashew and almond.","12/29/2015","12/29/2015"," UPC  046567021218; All lots  ",11/17/2015,"11/17/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72730,"Terminated","Northwest Mothers Milk Bank","417 SW 117th Ave Ste 105",,"Portland","OR","97225-5924","United States","Voluntary: Firm Initiated","Telephone","distributed in Oregon","F-0468-2016","Class II","Pasteurized Donor Human Milk, Frozen then thawed. Product is packaged in 4 oz. glass bottle with metal lid and plastic seal.     A bar code is present on each label but there is NO UPC codes.","51 bottles (4 oz. each)","Report by recipient hospital found a foreign particle in a single bottle of mother's milk once thawed and opened.  Finder reported the particle was a fruit fly or sugar ant. ","01/11/2016","01/25/2016"," Batch number 001757-1.  Expiration date: 04/04/2016    The number reflects the pool of donor milk created (001757) and the single batch created from the pool(001757-1) ",11/10/2015,"11/10/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72732,"Terminated","B & D Seafoods Inc","8361 Westminster Blvd Ste 320",,"Westminster","CA","92683-8323","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, FL.  No foreign distribution.","F-0581-2016","Class III","Pacific Surf Swai Fillets  IQF 2 lbs x 5/ctn, 5 lbs x 6/ctn (size 7-9)  Farm Raised  Product of Vietnam  Packed for:  PAFCO Global Seafood Services    IQF well trimmed, boneless, skinless, belly off, fat off, red meat off    Products are packaged in cardboard boxes.","2113 cases","B&D Seafoods, Inc. is recalling frozen swai fillets due to the presence of nitrofurans.","02/12/2016","02/24/2016"," Lot Numbers: 257699, 4850",11/25/2015,"11/25/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72732,"Terminated","B & D Seafoods Inc","8361 Westminster Blvd Ste 320",,"Westminster","CA","92683-8323","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, FL.  No foreign distribution.","F-0582-2016","Class III","Happy Fish  Swai Fillet  Farm Raised  Product of Vietnam   Net Weight: 22 lbs    IQF well trimmed, boneless, skinless, belly off, fat off, red meat off    Products are packaged in cardboard boxes.","1818 cases","B&D Seafoods, Inc. is recalling frozen swai fillets due to the presence of nitrofurans.","02/12/2016","02/24/2016"," Production Date: 08/19/2015  Best By: 08/19/2017",11/25/2015,"11/25/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72732,"Terminated","B & D Seafoods Inc","8361 Westminster Blvd Ste 320",,"Westminster","CA","92683-8323","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, FL.  No foreign distribution.","F-0580-2016","Class III","B&D Seafoods   Basa Choice  Swai Fillets  IQF 15 lbs x 1/case (size 5-7, 7-9, 9-11), 11 lbs 2/case (size 6-8)  Farm Raised  Distributed by B&D Seafoods, Inc.  Product of Vietnam    IQF well trimmed, boneless, skinless, belly off, fat off, red meat off    Products are packaged in cardboard boxes.","7072 cases","B&D Seafoods, Inc. is recalling frozen swai fillets due to the presence of nitrofurans.","02/12/2016","02/24/2016"," Lot Numbers: 429-13385, 429-13388  Production Date: June 26, 2015",11/25/2015,"11/25/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72734,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","1001 N Lincoln Blvd",".","Oklahoma City","OK","73104-3299","United States","Voluntary: Firm Initiated","FAX","Oklahoma","B-0171-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Leukoreduced blood products, not tested for residual WBC count, were distributed. ","01/05/2016","01/05/2016"," W091015269516 (double collection)",10/8/2015,"10/08/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72736,"Terminated","Smith's Country Cheese, Inc.","20 Otter River Rd",,"Winchendon","MA","01475-2040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA. NH, MA","F-0698-2016","Class III","Smith's Country Cheese-Gouda with Horseradish Spread  packaged in  8 oz. plastic container    ",,"Contaminated with non pathogenic E. Coli","02/29/2016","03/04/2016"," Exp. Date: 2-27-16",11/24/2015,"11/24/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72736,"Terminated","Smith's Country Cheese, Inc.","20 Otter River Rd",,"Winchendon","MA","01475-2040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA. NH, MA","F-0699-2016","Class III","Smith's Country Cheese-Gouda with with Sundried Tomato & Basil  Spread  packaged in  8 oz. plastic container    ",,"Contaminated with non pathogenic E. Coli","02/29/2016","03/04/2016"," Exp. Date: 2-27-16",11/24/2015,"11/24/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72736,"Terminated","Smith's Country Cheese, Inc.","20 Otter River Rd",,"Winchendon","MA","01475-2040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA. NH, MA","F-0695-2016","Class III","Smith's Country  Cheese -Gouda Spread Garlic packaged in  8 oz. plastic container    ",,"Contaminated with non pathogenic E. Coli","02/29/2016","03/04/2016"," Exp. Date: 2-27-16",11/24/2015,"11/24/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72736,"Terminated","Smith's Country Cheese, Inc.","20 Otter River Rd",,"Winchendon","MA","01475-2040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA. NH, MA","F-0693-2016","Class III","Smith's Country Cheese -Creamy Gouda Spread packaged in  8 oz. plastic container    ",,"Contaminated with non pathogenic E. Coli","02/29/2016","03/04/2016"," Exp. Date: 2-27-16",11/24/2015,"11/24/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72736,"Terminated","Smith's Country Cheese, Inc.","20 Otter River Rd",,"Winchendon","MA","01475-2040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA. NH, MA","F-0694-2016","Class III","Smith's Country Cheese- Creamy Gouda with Wine Spread packaged in  8 oz. plastic container    ",,"Contaminated with non pathogenic E. Coli","02/29/2016","03/04/2016"," Exp. Date: 2-27-16",11/24/2015,"11/24/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72736,"Terminated","Smith's Country Cheese, Inc.","20 Otter River Rd",,"Winchendon","MA","01475-2040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA. NH, MA","F-0692-2016","Class III","Gouda Cheese packaged under the brand names:  Smith's Farmstead Gouda and Jansal Valley Mountain Gouda,  Packaged in 11 lb. waxed wheel in saran wrap. 5 lb. Half wheels wrapped in shrink pack packaging.","104  wheels","Contaminated with non pathogenic E. Coli","02/29/2016","03/04/2016"," Lot Number: 1469",11/24/2015,"11/24/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72736,"Terminated","Smith's Country Cheese, Inc.","20 Otter River Rd",,"Winchendon","MA","01475-2040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA. NH, MA","F-0697-2016","Class III","Smith's Country Cheese-Gouda with Bacon Spread  packaged in  8 oz. plastic container    ",,"Contaminated with non pathogenic E. Coli","02/29/2016","03/04/2016"," Exp. Date: 2-27-16",11/24/2015,"11/24/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72736,"Terminated","Smith's Country Cheese, Inc.","20 Otter River Rd",,"Winchendon","MA","01475-2040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA. NH, MA","F-0700-2016","Class III","Smith's Country Cheese-Gouda with with Onion and Chive  Spread  packaged in  8 oz. plastic container    ",,"Contaminated with non pathogenic E. Coli","02/29/2016","03/04/2016"," Exp. Date: 2-27-16",11/24/2015,"11/24/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72736,"Terminated","Smith's Country Cheese, Inc.","20 Otter River Rd",,"Winchendon","MA","01475-2040","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA. NH, MA","F-0696-2016","Class III","Smith's Country Cheese-Gouda with Herb Spread  packaged in  8 oz. plastic container    ",,"Contaminated with non pathogenic E. Coli","02/29/2016","03/04/2016"," Exp. Date: 2-27-16",11/24/2015,"11/24/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72737,"Ongoing","Glades Drugs Inc.","109 S Lake Ave",,"Pahokee","FL","33476-1803","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York and Georgia","D-0669-2016","Class I","Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.  ","7800 capsules","Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).","02/16/2016",," AICACABF@3, AICECABF@2, AJBFCABF@4, ABCCABF@4, AICACABF@5, AICECABF@3, AJBHCABF@2, ABCCABF@5, AICBCABF@1, AICECABF@4, AJCBCABF@1, ABGCABF@4, AICBCABF@2, AICECABF@5, JCBCABF@2,  BACDCABF@5, AICBCABF@3, AICICABF@3, BAAGCABF@2, BADACABF@3,  AICBCABF@4, AJADCABF@1, BAAICABF@1, BACCABF@3, AICECABF@1,  AJBECABF@6, BABCCABF@2 and BBAECABF@5, Exp 02/20/2016  ",11/6/2015,"11/06/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72739,"Terminated","Boston Scientific Corporation","4100 Hamline Ave N",".","Saint Paul","MN","55112-5700","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, and Thailand.","Z-0588-2016","Class II","Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr.  Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119.      The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature.  The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket.  The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer .","900 units","Potential for separation of the proximal handle from the shaft.","01/05/2016","04/08/2016"," Model 8104, Lots:  18279548, 18279734, 18324877, 18329863, 18330946, 18348755, 18351569, 18353214, 18426640, 18461104, 18461521.      Model 8105, Lots:  18281110, 18315176, 18322343, 18323156, 18323651, 18324468, 18327210, 18327359, 18345738, 18346540, 18346668, 18347522, 18352159, 18354329, 18379847, 18380498, 18393785, 18394034, 18395315, 18408497, 18408902, 18410018, 18428314, 18435809, 18437015, 18437680, 18439474, 18440388, 18444811, 18445630, 18446236, 18462103, 18462459, 18463154, 18466449, 18478544.      Model 8106, Lots:  18286550, 18410783.      Model 8107, Lots:  18285401, 18285605, 18312411, 18312981, 18313754, 18337534, 18338037, 18354248, 18411116, 18413022, 18413155, 18413834.      Model 8108, Lots:  18273724, 18284294, 18338159, 18414856.      Model 8109, Lots:  18285220, 18293137, 18294062, 18313856, 18314250, 18332118, 18337848, 18353117, 18415202, 18415923, 18416945, 18418278, 18419899.      Model 8110, Lots:  18421013, 18473202.       Model 8111, Lots:  18285930, 18351033, 18353540, 18420652, 18468909 .      Model 8112, Lots:  18291473, 18336768, 18355225, 18421690, 18427953.      Model 8113, Lots:  18324876, 18324963, 18332278, 18352696, 18358192, 18371973, 18372577, 18440783, 18441697, 18467134, 18468171, 18471598, 18472178, 18478892, 18479477.       Model 8114, Lots:  18282143, 18284604, 18335173, 18345117, 18441212, 18442550, 18442887.       Model 8115, Lots:  18288704, 18328790, 18329233, 18356691, 18357371, 18357372, 18372837, 18373201, 18377504, 18378867, 18446665, 18447045, 18451382, 18451950, 18452785, 18453099, 18464410, 18473932, 18477470, 18483223, 18483940.       Model 8116, Lots:  18281865, 18473055.      Model 8117, Lots:  18333920, 18334332, 18466601.       Model 8118, Lots:  18316161, 18336837, 18348081.       Model 8119, Lots:  18286265, 18291252, 18332911, 18336838, 18347898, 18480844, 18483020, 18471580.     ",11/25/2015,"11/25/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72743,"Terminated","Blue Buffalo Company","11 River Rd",,"Wilton","CT","06897-6010","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PetSmart Stores in:  California, Nevada, Utah, Kansas, Washington, Montana, Minnesota, Oregon, Michigan","V-441-2016","Class I","Blue Wilderness Wild Chews - Cub Size Wilderness Wild Chews Bones, UPC: 840243110087","1440 bones were shipped to two PetSmart distribution centers, 240 bones were shipped to PetSmart stores. 11 bones were sold to customers","Cub Size Wilderness Wild Chews Bones may be contaminated with Salmonella. ","06/10/2016","06/13/2016"," on a sticker affixed to the product",11/25/2015,"11/25/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72744,"Ongoing","Cosmos Corp","103 Enterprise Dr",,"Wentzville","MO","63385-5543","United States","Voluntary: Firm Initiated","Telephone","Product was distributed to distribution centers in AL, AZ, CA, CO, GA, IA, IL, IN, KS, MI, MN, NC, NY, OH, OR, PA, SC, TX, VA, and WI. Further distribution to retail stores was likely to more states.","V-407-2016","Class III","Naturel Promise, Fresh Dental, Healthy Dental Chews For Dogs, Hip & Joint, Fortified with Glucosamine & Chondroitin, NET WT. 8 OZ (227 g), 28+ Healthy Dental Snacks, Natur¿l Promise, Troy, MO 63379","1,148/12/8 OZ/bags/cases","Some bags of product showed evidence of mold.","03/29/2016",," Lot # 3892907135, best by date July 13, 2017 ",11/25/2015,"11/25/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0634-2016","Class II","Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","9 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 17-Sep-15, 19-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0628-2016","Class II","Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 3 Bags, b) 60 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 22-Sep-15, b) 19-Sep-15, 20-Sep-15, 22-Sep-15, 23-Sep-15, 24-Sep-15, 25-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0644-2016","Class II","MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","10 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 24-Sep-15, 27-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0637-2016","Class II","Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","7 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0620-2016","Class II","Dextrose-NaCl (D5-1/2NS) in NS, Packaged in  a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 1 Bag b) 7 Bags c) 8 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15, c) 28-Sep-15, 1-Oct-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0641-2016","Class II","GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 11 bags, b) 9 Bags, c) 3 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15, c) 24-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0635-2016","Class II","Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","28 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0615-2016","Class II","CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 4 Syringes, b) 49 Syringes, c) 18 Bags, d) 80 Bags, e) 23 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 28-Sep-15, 29-Sep-15, c) 30-Sep-15 d) 28-Sep-15, 1-Oct-15 e) 25-Sep-15, 28-Sep-15, 29-Sep-15, 30-Sep-15,1-Oct-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0643-2016","Class II","Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","7 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 28-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0623-2016","Class II","VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 12 Bags, b) 36 Bags, c) 8 Bags, d) 65 Bags, e) 18 Bags, f) 36 Bags g) 21 Bags, h) 7 Bags, i) 3 Bags, j) 3 Bags, k) 2 Bags, l) 6 Bags, m) 3 Bags ","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15, 30-Sep-15, b) 25-Sep-15, 29-Sep-15, c) 25-Sep-15 d) 25-Sep-15, 26-Sep-15, 29-Sep-15, e) 25-Sep-15, 1-Oct-15, f) 28-Sep-15, 29-Sep-15, 1-Oct-15, g) 25-Sep-15, h) 25-Sep-15, 27-Sep-15, 29-Sep-15, i) 29-Sep-15, j) 25-Sep-15, 26-Sep-15, k) 29-Sep-15, l) 25-Sep-15, 27-Sep-15, 30-Sep-15, m) 1-Oct-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0633-2016","Class II","FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","7 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 25-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0632-2016","Class II","PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a)1 Bag, b) 4 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 27-Sep-15, b) 28-Sep-15, 30-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0627-2016","Class II","ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","7 Syringes","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0640-2016","Class II","Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","9 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 28-Sep-15, 30-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0630-2016","Class II","ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 56 Bags b) 28 Bags c) 4 Bags, d) 10 Bags e) 2 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15 b) 28-Sep-15 c) 25-Sep-15, 29-Sep-15, d) 26-Sep-15, 29-Sep-15 e) 1-Oct-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0612-2016","Class II","CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML Homepumps, j) 650MG in 13ML Syringes, k) 800MG in 40ML Homepumps, l) 950MG in 19 mL Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 7 Syr, b) 11 Syr, c) 5 Syr, d) 8 Syr, e) 6 Syr, f) 9 Syr, g) 4 Syr, h) 7 Bags, i) 7 Bags, j) 6 Syr, k) 3 Bags l) 4 Syr","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 24-Sep-15, b) 24-Sep-15, 27-Sep-15, c) 26-Sep-15, d) 24-Sep-15, e) 27-Sep-15, f) 26-Sep-15, 27-Sept-15, g) 24-Sep-15, h) 26-Sep-15, i) 27-Sep-15, j) 26-Sep-15, k) 21-Sep-15 l) 24-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0642-2016","Class II","Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","1 Bag","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0613-2016","Class II","SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 2 Bags, b) 1 Bags, c) 2 Bags, d) 4 Bags, e) 7 Bags f) 3 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15, 1-Oct-15, b) 22-Sep-15, c) 30-Sep-15 d) 29-Sep-15, e) 25-Sep-15, f) 28-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0616-2016","Class II","Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps, j) 144MG in 180ML Homepumps, k) 152MG in 190ML Homepumps, l) 160MG in 200ML Homepumps, m) 172MG in 215ML Homepumps, n) 176MG in 220ML Homepumps, and o) 200MG in 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 7, b) 4, c) 8, d) 8, e) 3, f) 4, g) 4, h) 3, i) 4, j) 4, k) 3, l) 3, m) 9, n) 6, o) 3 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 29-Sep-15, c) 25-Sep-15, 30-Sep-15, d) 25-Sep-15, e) 1-Oct-15, f) 29-Sep-15, g) 26-Sep-15, h) 1-Oct-15, i) 29-Sep-15, j) 25-Sep-15, k) 1-Oct-15, l) 25-Sep-15, m) 27-Sep-15, 1-Oct-15, n) 24-Sep-15, 30-Sep-15, o) 25-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0611-2016","Class II","MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 159 Bags b) 33 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 18-Sep-15, 20-Sep-15, 21-Sep-15, 22-Sep-15, 23-Sep-15, 24-Sep-15 b) 16-Sep-15, 19-Sep-15, 21-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0619-2016","Class II","POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 7 Bags, b) 2 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 30-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0639-2016","Class II","CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","6 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0621-2016","Class II","CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 8 Bags, b) 70 Bags c) 4 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15, 27-Sep-15, b) 21-Sep-15, 24-Sep-15, 25-Sep-15, 26-Sep-15, 27-Sep-15, c) 25-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0617-2016","Class II","SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","7 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 22-Sep-15, 23-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0618-2016","Class II","INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 7 Bags, b) 1 Bag, c) 7 Bags, d) 6 Bags e) 7 Bags,  f) 7 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15,  b) 20-Sep-15, c) 24-Sep-15, d) 20-Sep-15, e) 24-Sep-15, f) 26-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0636-2016","Class II","Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 4 Bags b) 3 Bags c) 6 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15 b) 14-Sept-15 c) 1-Oct-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0631-2016","Class II","MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 5 Bags, b) 4 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0638-2016","Class II","AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","12 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0629-2016","Class II","CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 21 Bags, b) 26 Bags c) 3 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 30-Sep-15, 1-Oct-15, c) 28-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0625-2016","Class II","HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps,  Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 42 Syringes, b) 6 Bags, c) 4 Bags, d) 4 Bags, e) 1 Bag","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15 b) 30-Sep-15 c) 1-Oct-15, d) 30-Sep-15, e) 30-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0626-2016","Class II","GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 22 Bags, b) 3 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, 1-Oct-15, b) 28-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0622-2016","Class II","DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 7 Bags, b) 4 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0624-2016","Class II","ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","77 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 25-Sep-15, 28-Sep-15, 29-Sep-15, 1-Oct-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72746,"Ongoing","Sentara Enterprises","535 Independence Pkwy Ste 300",,"Chesapeake","VA","23320-5176","United States","Voluntary: Firm Initiated","E-Mail","U.S. Including: VA, NC","D-0614-2016","Class II","Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.","a) 7, b) 7, c) 6, d) 7, e) 4,  f) 13, g) 2,  h) 4,  i) 7,  j) 5,  k) 10,  l) 11, m) 11, n) 11, o) 7, p) 7, q) 7 Bags","Lack of Assurance of Sterility: Product sterility cannot be guaranteed.","01/28/2016",," All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15, b) 16-Sep-15 c) 25-Sep-15, d) 25-Sep-15 e) 20-Sep-15, 26-Sep-15, f) 20-Sep-15, 24-Sep-15, g) 20-Sep-15, 26-Sep-15, h) 20-Sep-15, i) 15-Sep-15, j) 26-Sep-15, k) 25-Sep-15, 26-Sep-15, l) 20-Sep-15, 23-Sep-15, m) 20-Sept-15, 24-Sep-15, 26-Sep-15, n) 23-Sep-15, o) 20-Sep-15, p) 26-Sep-15, q) 20-Sep-15",9/18/2015,"09/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72749,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.","Z-0822-2016","Class II","Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles    Product Usage:  The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.  ","2711 kits","Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use","02/18/2016",," Kit Lot numbers:  00B0203  00Z1924  00Z1992  00Z1993  00Z2030  00Z2062  00Z2063  00Z2072  00Z2081  00Z2090  00Z2098  00Z2117  00Z2119  00Z2121  00Z2122  00Z2123  00Z2124  00Z2129  00Z2130  00Z2133  00Z2138  00Z2139  00Z2143  00Z2145  00Z2146  00Z2147  00Z2148  00Z2150  00Z2151  00Z2152  00Z2153  00Z2154  00Z2155  00Z2159  00Z2160  00Z2161  00Z2163  00Z2164  00Z2166  00Z2167  00Z2171  00Z2172  00Z2174  00Z2175  00Z2176  00Z2177  00Z2179  00Z2181  00Z2182  00Z2183  00Z2184  00Z2187  00Z2190  00Z2191  00Z2192  00Z2193  00Z2194  00Z2198  00Z2199  00Z2200  00Z2201  00Z2208  00Z2209  00Z2211  00Z2212  00Z2213  00Z2216  00Z2217  00Z2220  00Z2221  00Z2222  00Z2223  00Z2224  00Z2225  00Z2233  00Z2234  00Z2237  00Z2243  00Z2244  00Z2245  00Z2249  00Z2252  00Z2254  00Z2255  00Z2265  00Z2268  00Z2272  00Z2273  00Z2287  00Z2289  00Z2304  00Z2305  00Z2306  00Z2312  00Z2315  00Z2321  00Z2322  00Z2323  00Z2325  00Z2326  00Z2327  00Z2328  00Z2351  00Z2352  00Z2353  00Z2367  00Z2391  00Z2392  00Z2396  00Z2432  00Z5001  00Z5001A  BARIATRICRR1  BARIATRICRR5  BARIATRICRR7  ENDOBARIATRICR  ENDOBARIATRICS  ENDOTHORACICL  ENDOTHORACICS  ENDOTHORACICW  THORACICRR1  00Z2363  00Z2364  00Z2387  ",12/2/2015,"12/02/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72749,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.","Z-0821-2016","Class II","Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle  Ref: EGIAUXL    Product Usage:  The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.  ","327,797 units","Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use","02/18/2016",," Lot numbers within each range are affected:  Lot # starting with P3C through P5B0454X, P5B0468X, P5C0152X through P5E0450X.    Individual Lot Number: P5B0468X, P5E0523X, P5E0273X",12/2/2015,"12/02/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72749,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.","Z-0820-2016","Class II","Covidien Endo GIA Ultra Universal Standard Stapler Handle  Ref: EGIAUSTND    Product Usage:  The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.      ","1,102,166 units","Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use","02/18/2016",," RANGES OF LOT NUMBERS  (all lot numbers within each range are affected)  Lot # starting with P3C through P5B0521X P5D0410X through P5D0411X P5D0823X through P5D0829X   P5E0080X through P5E0082X   P5E0317X through P5E0320X   P5E0322X through P5E0324X   P5F0001X through P5F0002X    INDIVIDUAL LOT NUMBERS  (in addition to ranges)  P5C0239X, P5C0241X, P5C0508X, P5C0510X,  P5C0512X,  P5C0597X P5C0599X, P5C0601X, P5C0603X, P5C0684X, P5C0803X, P5C0805X, P5C0807X. P5E0527X, P5E0529X      P5D0067X, P5D0069X , P5D0073X, P5D0170X,  P5D0413X,  P5D0415X ,P5D0417X, P5D0419X, P5D0447X, P5D0623X, P5D0624X ,P5D0626X, P5D0628X	    P5D0630X, P5E0525X,  P5F0004X, P5F0006X,  P5F0008X, P5F0010X, P5F0014X, P5F0017X, P5F0019X, P5F0021X, P5F0213X, P5F0217X		    	    	  ",12/2/2015,"12/02/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72749,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.","Z-0819-2016","Class II","Covidien Endo GIA Ultra Universal  12 mm Short Stapler Handle  Ref: EGIAUSHORT    Product Usage:  The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.  ","364,768 units","Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use","02/18/2016",," RANGES OF LOT NUMBERS  (all lot numbers within each range are affected)  Lot # starting with P3C through P5B0289X   P5C0196X through P5C0197X   P5C0304X through P5C0307X   P5C0796X through P5C0798X   P5D0049X through P5D0051X   P5D0146X through P5D0148X   P5E0261X through P5E0262X   P5F0158X through P5F0161X    INDIVIDUAL LOT NUMBERS  (in addition to ranges)  N3F0260RX                  N3F0266RX                  N3F0267RX  P5C0201X  P5D0538X   P5E0680X   P5E0682X   P5E0686X  P5E0760X  P5E0762X                    P5E0765X  ",12/2/2015,"12/02/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72750,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",".","Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.","Z-0590-2016","Class II","NexGEN System REF 5980-37-01 Tibial Component  Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component  Option CR/PS/LPS Size Stemmed 3.   Tibial component of implanted knee prosthesis.","384 distribution events; 1 unit was returned leaving 383 units  .","A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3.","01/05/2016",," lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)",12/3/2015,"12/03/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72751,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",".","Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including:  AL, AZ, CA, CO, FL, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NC, NY, OH, OK, PA, SC, TN, TX, VA, and WI.","Z-0597-2016","Class II","Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.  ","73 units"," on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2x2 layout, the 4D tabcard will show an incorrect, too small length measurement. This could result in selecting a device of the wrong size, which then needs to be exchanged.","01/06/2016",," Software Version: SW VD-10E",11/18/2015,"11/18/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72753,"Ongoing","KCI USA, INC.","12930 W Interstate 10",".","San Antonio","TX","78249-2248","United States","Voluntary: Firm Initiated","Letter","Japan and Australia","Z-0600-2016","Class II","ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.","12,728 units","There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.","01/06/2016",," Models M8275058-JP/5 and M8275059/5.  manufactured between October 5, 2014 and May 29, 2015.  Labeled with a 23 month shelf life from the date of manufacture. ",11/25/2015,"11/25/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72756,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution-DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI. IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.","Z-0760-2016","Class II","Arctic Sun 5000 and Arctic Sun 2000;  Intended for monitoring and controlling patient temperatures.","1,539","Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.","02/05/2016",," All lots/serial numbers sold prior to August 2014.",11/10/2015,"11/10/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72760,"Terminated","Biomerieux Inc","595 Anglum Rd",".","Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.","Z-0556-2016","Class II","Granada Biphasic Broth    The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.","24 cartons","FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.","12/29/2015","02/24/2016"," REF 42722 - Lot Numbers 896, 897 & 899",11/23/2015,"11/23/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72761,"Ongoing","Bertagni 1882","viale Sant'Agostino, 12/13",,"Arcugnano",,,"Italy","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Bertagni product was distributed directly in CA, IL, MI, MN, NY, OH, and OR between 5/11/15 and 11/12/15.    Meijer product was distributed in IL, IN, KY, MI, OH, and WI between 6/12/15 to 10/26/15.","F-1043-2016","Class I","Bertagni fresh Sweet Butternut Squash Ravioli, packaged in a paper tray inside a plastic bag and wrapped around with paper band, net weight 8.8 oz., UPC 8001020110139.","4839 cases","Bertagni fresh Sweet Butternut Squash Ravioli is recalled because the products may contain undeclared cashew and almond.  ","05/11/2016",," Expiration dates from 8/3/16 to 1/29/17.  Lot codes: 506B, 508C, 511D, 512C, 513B, 516B, 520A, 522B, 522F, 523B, 523C, 529C, 530F, 531F, 535C, and 536A.    The lot code is interpreted as below:   Example 506B: 5=2015;  06= week 6 of the year; B= second day of the week (Tuesday)",11/17/2015,"11/17/2015",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72761,"Ongoing","Bertagni 1882","viale Sant'Agostino, 12/13",,"Arcugnano",,,"Italy","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Bertagni product was distributed directly in CA, IL, MI, MN, NY, OH, and OR between 5/11/15 and 11/12/15.    Meijer product was distributed in IL, IN, KY, MI, OH, and WI between 6/12/15 to 10/26/15.","F-1044-2016","Class I","Meijer frozen Butternut Squash Ravioli, product is packaged in a paper box, net weight 12 oz., UPC 760236398479","1080 cases","Meijer frozen Butternut Squash Ravioli is recalled because  product may contain undeclared cashew and almond.  ","05/11/2016",," Expiration date: 11/5/2016  Lot code: 519 E    ",11/17/2015,"11/17/2015",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72763,"Ongoing","Natus Neurology DBA Excel Tech., Ltd. (XLTEK)","2568 Bristol Cir",".","Oakville",,,"Canada","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Distribution including states of: AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX and UT; and countries of: INDIA, KOREA, SPAIN, SWITZERLAND, THAILAND, UNITED KINGDOM, and CANADA.    .","Z-0581-2016","Class II","Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.    The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. ","56 (43 US, 13 OUS)","During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.","01/04/2016",," Serial Number  013926020008  013926020009  013926020006  013926020016  013926020014  013926030024  013926030031  013926020001  013926020004  013926030059  013926030060  013926030074  013926030075  013926030052  013926030017  013926030018  013926030021  013926030053  013926030101  013926030058  013926030019  013926030038  013926030039  013926030044  013926020015  013926030097  013926020013  013926030055  013926030056  013926030081  013926030096  013926030078  013926030048  013926030057  013926030064  013926030047  013926030027  013926030025  013926030042  013926030023  013926030030  013926030036  013926030026  013926030050  013926030080  013926030099  013926030035  013926030046  013926030049  013926030073  013926030020  013926030092  013926030040  013926030041  013926030061  013926030062  ",11/11/2015,"11/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72764,"Terminated","Community Blood Center of the Ozarks","220 W Plainview Rd",".","Springfield","MO","65810-2619","United States","Voluntary: Firm Initiated","Telephone","MO; AR","B-0225-16","Class II","Red Blood Cells, Leukocytes Reduced","13 units","Blood products, possibly contaminated with air, were distributed.","01/07/2016","01/07/2016"," W045115149859; W045115149897; W045115148686; W045115149856; W045115152267; W045115143105; W045115143671; W045115145972; W045115149880; W045115139004; W045115153016; W045115153019; W045115153030",10/20/2015,"10/20/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72765,"Terminated","Carter BloodCare","2205 Highway 121",".","Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","FAX","TX","B-0226-16","Class II","Platelets","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed","01/07/2016","01/07/2016"," W035215263152Y",11/16/2015,"11/16/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72766,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",".","Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","PA","B-0229-16","Class II","Plasma Frozen","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","01/07/2016","01/07/2016"," W270115521421",10/27/2015,"10/27/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72766,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",".","Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","PA","B-0230-16","Class II","Pooled Platelets, Leukocytes Reduced","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","01/07/2016","01/07/2016"," W270115520076",10/27/2015,"10/27/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72766,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",".","Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","PA","B-0228-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","01/07/2016","01/07/2016"," W270115521421 ",10/27/2015,"10/27/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72771,"Terminated","Bay Valley Foods","2021 Spring Rd Ste 500",".","Oak Brook","IL","60523-1859","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","F-1024-2016","Class I","Crispers Honey Lime Dressing, 1 GL, Distributed by Bay Valley Foods, LLC, Oak Brook, IL 60523","36 cases (4 X 1 GL) ","Undeclared allergen: Egg.","04/04/2016","04/11/2016"," Best By: 03/04/16    /81E11055",12/2/2015,"12/02/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72772,"Terminated","Roundys Supermarkets, Inc.","1111 E Delafield Rd","PO Box 473","Oconomowoc","WI","53066-8673","United States","Voluntary: Firm Initiated","E-Mail","IL and WI only","F-0633-2016","Class I","Simply Roundy's Natural Authentic Italian Butternut Squash Ravioli, Net Wt. 9 oz (255g).  Packaged in a paper tray inside a plastic bag and wrapped around with paper band.   Made in Italy.  UPC 11150-50750","1542 cases","Roundy's is recalling Simply Roundy's Natural Authentic Italian Sweet Butternut Squash Ravioli because the product may contain undeclared cashew and almond.  This product was manufactured and recalled by Bertagni 1882 SpA of Arcugnano, Italy due to undeclared cashews and almonds.","02/25/2016","04/11/2016"," Lot Numbers:  506B, 508C, 511D, 512C, 513B, 516B, 520A, 522B, 522F, 523B, 523C, 529C, 530F, 531F, 535C, and 536A",11/18/2015,"11/18/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72774,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US nationwide distibution.","Z-0585-2016","Class II","SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.","65","The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.","01/04/2016",," Part number: 352.135;   Lot number: F-17180",12/1/2015,"12/01/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72776,"Terminated","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain,  Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.    .","Z-0652-2016","Class II","0 deg, 8mm Endoscope, IS4000:  Model numbers: 470026-34, 470026-40, 470026-41.    General and Plastic Surgery:  The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.","2624 total all models","This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments.  It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.","01/14/2016","04/05/2016"," Model numbers: 470026-34, 470026-40, 470026-41.  All lots.",11/23/2015,"11/23/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72776,"Terminated","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain,  Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.    .","Z-0653-2016","Class II","30 deg, 8mm Endoscope, IS4000:  Model numbers: 470027-34, 470027-40, 470027-41.    General and Plastic Surgery:  The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.","2624 total all models","This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments.  It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.","01/14/2016","04/05/2016"," Model numbers: 470027-34, 470027-40, 470027-41.  All lots.",11/23/2015,"11/23/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72777,"Ongoing","Jem Raw Chocolate, LLC ","910 SE Wilson Ave Ste C3",,"Bend","OR","97702-4401","United States","Voluntary: Firm Initiated","Press Release","Products are distributed nationwide in the US and in Canada, Japan, and Germany","F-0708-2016","Class I",".","the firm did not provide","Superberry Maqui Camu - Sprouted Almond Spread is recalled because it has the potential to be contaminated with Salmonella","03/02/2016",," Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016).      The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. ",12/2/2015,"12/02/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72777,"Ongoing","Jem Raw Chocolate, LLC ","910 SE Wilson Ave Ste C3",,"Bend","OR","97702-4401","United States","Voluntary: Firm Initiated","Press Release","Products are distributed nationwide in the US and in Canada, Japan, and Germany","F-0707-2016","Class I",".","the firm did not provide","Hazelnut Raw Cacao - Sprouted Hazelnut Spread is recalled because it has the potential to be contaminated with Salmonella","03/02/2016",," Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016).      The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. ",12/2/2015,"12/02/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72777,"Ongoing","Jem Raw Chocolate, LLC ","910 SE Wilson Ave Ste C3",,"Bend","OR","97702-4401","United States","Voluntary: Firm Initiated","Press Release","Products are distributed nationwide in the US and in Canada, Japan, and Germany","F-0706-2016","Class I",".","the firm did not provide","Cinnamon Red Maca - Sprouted Almond Spread is recalled because it has the potential to be contaminated with Salmonella","03/02/2016",," Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016).      The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. ",12/2/2015,"12/02/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72777,"Ongoing","Jem Raw Chocolate, LLC ","910 SE Wilson Ave Ste C3",,"Bend","OR","97702-4401","United States","Voluntary: Firm Initiated","Press Release","Products are distributed nationwide in the US and in Canada, Japan, and Germany","F-0705-2016","Class I",".","the firm did not provide","Cashew Cardamom - Sprouted Cashew Almond Spread is recalled because it has the potential to be contaminated with Salmonella","03/02/2016",," Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016).      The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. ",12/2/2015,"12/02/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72777,"Ongoing","Jem Raw Chocolate, LLC ","910 SE Wilson Ave Ste C3",,"Bend","OR","97702-4401","United States","Voluntary: Firm Initiated","Press Release","Products are distributed nationwide in the US and in Canada, Japan, and Germany","F-0709-2016","Class I",".    ***THIS ITEM BEING PHASED OUT AND DISCONTINUED.  THE FIRM RECALLED IT AFTER THE PRESS RELEASE ISSUED ON 12/2/15 SO THIS ITEM IS NOT LISTED IN THE PRESS RELEASE.","the firm did not provide","Coconut Cardamom- Sprouted Almond Spread is recalled because it has the potential to be contaminated with Salmonella","03/02/2016",," Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016).      The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning. ",12/2/2015,"12/02/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72778,"Ongoing","Land O Lakes Purina LLC","1080 County Road F W",,"Shoreview","MN","55126-2910","United States","Voluntary: Firm Initiated","Letter","ND and SD","V-455-2016","Class II","Purina Steakmaker Co-Product Balancer R700, Medicated, Type B Medicated Feed.  Supplement Feed for Grower-Finisher Feedlot cattle.  For improved feed efficiency in cattle fed in confinement for slaughter.  Monensin (as Monensin Sodium) 700.00 g/ton.  Manufactured by Purina Animal Nutrition, LLC, 1080 County Road F West, Shoreview, MN  55126.Bulk Net Weight.  Formula No. L386, Item No. 1720041.","190 bags","Purina is retrieving all bags of Steakmaker Co-Product Balancer R700, Lot 5NOV10SXF1 due to the product being deficient in Rumensin.","07/21/2016",," Lot Code:  5NOV10SXF1",11/25/2015,"11/25/2015",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72779,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.","Z-0561-2016","Class II","MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.","751 units total (701 units in US)","Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.","12/30/2015",," 2016-04-30  Part No. B1017-202",12/1/2015,"12/01/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72779,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.","Z-0558-2016","Class II","MicroScan Pos Combo Panel Type 21, Part No. B1017-201    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.","284 units total (96 units in US)","Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.","12/30/2015",," 2016-05-05  Part No. B1017-201  ",12/1/2015,"12/01/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72779,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.","Z-0559-2016","Class II","MicroScan Pos Combo Panel Type 33, Part No. B1017-211    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.","2,706 units total (1,276 units in US)","Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.","12/30/2015",," 2016-04-29  2016-05-04  Part No. B1017-211  ",12/1/2015,"12/01/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72779,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.","Z-0562-2016","Class II","MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.","715 units total (616 units in US)","Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.","12/30/2015",," 2016-05-06  Part No. B1017-206  ",12/1/2015,"12/01/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72779,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.","Z-0560-2016","Class II","MicroScan Pos Combo Panel Type 34, Part No. B1017-214    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.","1,324 units total (1,215 units in US)","Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.","12/30/2015",," 2016-04-29  2016-05-06  Part No. B1017-214  ",12/1/2015,"12/01/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72780,"Ongoing","3M Company - Health Care Business","3m Center 2510 Conway Ave , B# 275-5-W-6",".","Saint Paul","MN","55144-0001","United States","Voluntary: Firm Initiated","Letter","US nationwide distribution.","Z-0601-2016","Class II","3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.","167 cases (30 rolls/case)","Product mislabeled as latex free.  Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to  users with sensitivity or allergic reaction to latex, which could range from mild to severe.","01/06/2016",," Catalog# 1581, lot # 2020-10AN  Catalog# 2081, lot # 2018-AM (shipper carton)",12/1/2015,"12/01/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72781,"Ongoing","Bimeda, Inc.","291 Forest Prairie Rd",,"Le Sueur","MN","56058-4520","United States","Voluntary: Firm Initiated","E-Mail","US: CO, FL, ID, IL IA, MN, MO, PA, WI.    OUS: Mexico","V-408-2016","Class II","Dexium (dexamethasone) Solution. Bimeda (1DEX022) and VetOne (1DEX032), NADA 200-312, 2mg/mL, packaged in 100 mL glass amber vial, Sterile. ANDA 200-312.    Each-ml. contains 2mg dexamethasone, 500 mg polyethylene glyco 400, 9 mg  benzyl alcohol, 1.8 mg methylparaben and 0.2 mg propylparaben as preservatives, 4.75% alcohol, HCI to adjust pH to approximately 4.9, water  for injection q.s.  For intravenous or Intramuscular injection.  USUAL DOSE:  Bovine- 5 to 20 mg  equine- 2.5 to 5 mg","18,341 vials","Bimeda Dexium (dexamethasone) Solution, Item# 1DEX022 and VetOne Dexamethasone Solution, Item# 1DEX032 are being recalled by Bimeda, Inc due that the product might contain particles that appear to be crystals.","03/30/2016",," 4M022",11/23/2015,"11/23/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72782,"Ongoing","Lipo Escultura Corp.","888 Wyckoff Ave",,"Brooklyn","NY","11237-6116","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0860-2016","Class I","LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com","unknown","Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.","05/23/2016",," All lots",12/3/2015,"12/03/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72783,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",".","Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","PA","B-0224-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.","01/07/2016","01/07/2016"," W270115514365",11/16/2015,"11/16/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72787,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",".","Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution and the country of Canada","Z-0605-2016","Class II","  (18 cm), 1C8433,    Product Usage:  C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.  ","9264 units","Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.","01/06/2016",," Lot Numbers: GR323998, GR325035, GR326082, and GR327965",11/30/2015,"11/30/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72787,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",".","Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution and the country of Canada","Z-0607-2016","Class II","Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687,     Product Usage:  C8687: An accessory to transfer a medicinal product from one container to another container.  ","77,136 units","Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.","01/06/2016",," Lot Numbers:  GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534",11/30/2015,"11/30/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72787,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",".","Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution and the country of Canada","Z-0606-2016","Class II","Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s,    Product Usage:  C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device.  .   ","9600 units","Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.","01/06/2016",," Lot Numbers:  GR324012, GR325322, GR326769, and GF328518",11/30/2015,"11/30/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",72788,"Terminated","Santee Cosmetics","13202 Estrella Ave",".","Gardena","CA","90248-1520","United States","Voluntary: Firm Initiated","Letter","US: CA, FL.    Worldwide: Mexico","F-0425-2016","Class II","SANTEE Diamond Color Mascara, Item No. ST081, Net Wt. 10g    Product Measurements: 5.5 x 1 x 1","1,466 dozens (30.5 cases)","Santee Cosmetics is recalling Santee Diamond Color Mascara because it has the potential to be contaminated with mold, Bacillus lentus, Pseudomonas putida, and Achromobacter xylosoxidans.","12/29/2015","03/18/2016"," UPC 849609004381",12/4/2015,"12/04/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72789,"Ongoing","ArthroCare Corporation","7000 W William Cannon Dr",,"Austin","TX","78735-8509","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide including OH, MO, AZ, AL, CA, FL, SC, GA, and PA; Spain, France, United Kingdom, Germany, Switzerland, Singapore, Russia, Turkey, and Ecuador.","Z-0623-2016","Class II","Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.","262 units","There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier.","01/08/2016",," Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328",10/26/2015,"10/26/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72793,"Terminated","Whole Foods Market","5980 Horton St Ste 200",,"Emeryville","CA","94608-2057","United States","Voluntary: Firm Initiated","Other","One retail location in CA","F-0719-2016","Class II","Whole Foods Market Crazy for Cream cheese Brownie;   Sold as single (4 oz.) and 4-pack (15 oz.)    Ingredients: unbleached wheat flour, cocoa, vanilla, sugar, butter (pasteurized cream, salt), eggs, cream cheese (pasteurized milk and cream cheese culture, salt, xanthan and or carob bean stabilizer) sugar, butter (cream, salt) baking soda and sea salt, non-stick spray (soy, soy lecithin). Contains wheat, milk, soy, eggs.     Whole Foods, Emeryville, CA.    UPC -  single: 0024044800000, 0024369200000,   UPC - 4-pack: 00243693000000; 0024369400000.","19 single, 166 4 pack","Metal shavings were found around the perimeter of brownies purchased by customer. ","03/04/2016","03/11/2016"," Best by date of  before 12/7/15.",12/3/2015,"12/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72793,"Terminated","Whole Foods Market","5980 Horton St Ste 200",,"Emeryville","CA","94608-2057","United States","Voluntary: Firm Initiated","Other","One retail location in CA","F-0716-2016","Class II","Whole Foods Market Raspberry Brownie;   sold as a single item (2. oz.) or a 4 pack (15 oz.);    Ingredients: Unbleached wheat flour, sugar, butter (pasteurized cream, salt), eggs, cocoa, vanilla, raspberry preserves (raspberries, sugar, fruit pectin, citric acid), baking soda and seal salt, non-stick spray (soy, soy lecithin) Contains: wheat, milk, soy, eggs.    Whole Foods, Emeryville, CA.    UPC - single:  0022241800000  UPC 4-pack:  0024374200000, 0024374800000","5 single brownies, 51- 4-packs","Metal shavings were found around the perimeter of brownies purchased by customer. ","03/04/2016","03/11/2016"," Best by date of  before 12/7/15.",12/3/2015,"12/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72793,"Terminated","Whole Foods Market","5980 Horton St Ste 200",,"Emeryville","CA","94608-2057","United States","Voluntary: Firm Initiated","Other","One retail location in CA","F-0718-2016","Class II","Whole Foods Market Peanut Butter & Yah Brownie;  Sold as Single- 3. oz and 4 pack  15 oz;.     Ingredients: Ingredients: Cane sugar, cage free eggs, expeller pressed canola oil, unbleached wheat flour (wheat flour, malted barley, flour, niacin, iron, folic acid) cocoa powder (processed with Alkali) semi-sweet chocolate (unsweetened chocolate, sugar, anhydrous dextrose, soy lecithin, vanilla), butter (milk, salt) pure vanilla, peanut butter (peanuts, salt). Contains wheat, eggs, milk, soy, peanuts.    Whole Foods, Emeryville, CA.    UPC - single: 0023426200000;  UPC - 4-pack: 0024374000000;","10 single,  129 4-packs","Metal shavings were found around the perimeter of brownies purchased by customer. ","03/04/2016","03/11/2016"," Best by date of  before 12/7/15.",12/3/2015,"12/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72793,"Terminated","Whole Foods Market","5980 Horton St Ste 200",,"Emeryville","CA","94608-2057","United States","Voluntary: Firm Initiated","Other","One retail location in CA","F-0720-2016","Class II","Whole Foods Market Brownie Double Trouble;   Sold as single (2 oz.) and 4-pack (15 oz.)    Ingredients: unbleached wheat flour,  sugar, butter (pasteurized cream, salt), cream, eggs, cocoa, vanilla, baking soda and seal salt. Non-stick spray (soy, soy lecithin). Contains wheat, milk, soy, eggs.     Whole Foods, Emeryville, CA.    UPC -  single: 0024370300000; 0024829300000  UPC - 4-pack: 0024370000000; ","31 single,  237 4-pack","Metal shavings were found around the perimeter of brownies purchased by customer. ","03/04/2016","03/11/2016"," Best by date of  before 12/7/15.",12/3/2015,"12/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72793,"Terminated","Whole Foods Market","5980 Horton St Ste 200",,"Emeryville","CA","94608-2057","United States","Voluntary: Firm Initiated","Other","One retail location in CA","F-0721-2016","Class II","Whole Foods Market Brownie Choc Full O' Nuts;   Sold as single (2 oz.) and 4-pack (15 oz.)    Ingredients: unbleached wheat flour,  sugar, butter (pasteurized cream, salt), cream, eggs, cocoa, vanilla, non GMO corn syrup, walnuts, baking soda and seal salt. Non-stick spray (soy, soy lecithin). Contains wheat, milk, soy, eggs, treenuts.     Whole Foods, Emeryville, CA.    UPC -  single: 0024373100000; 0024373200000;  UPC - 4-pack: 0024365400000; 0024374300000.","24 single, 196 4-pack","Metal shavings were found around the perimeter of brownies purchased by customer. ","03/04/2016","03/11/2016"," Best by date of  before 12/7/15.",12/3/2015,"12/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72793,"Terminated","Whole Foods Market","5980 Horton St Ste 200",,"Emeryville","CA","94608-2057","United States","Voluntary: Firm Initiated","Other","One retail location in CA","F-0717-2016","Class II","Whole Foods Market Tart Key Lime Square  Net wt 16 oz.     Whole Foods, Emeryville, CA.    UPC - 0022263800000","1","Metal shavings were found around the perimeter of brownies purchased by customer. ","03/04/2016","03/11/2016"," Best by date of  before 12/7/15.",12/3/2015,"12/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72793,"Terminated","Whole Foods Market","5980 Horton St Ste 200",,"Emeryville","CA","94608-2057","United States","Voluntary: Firm Initiated","Other","One retail location in CA","F-0722-2016","Class II","Whole Foods Market Salted Caramel Swirl Brownie;   Sold in 4-pack (15 oz.)    Ingredients: cane sugar, cage free eggs, expeller pressed canola oil, unbleached wheat flour (wheat flour, malted barley, flour, niacin, iron, folic acid) cocoa powder (processed with alkali), semisweet chocolate (unsweetened c chocolate, sugar, anhydrous dextrose, soy lecithin, vanilla) butter (milk, salt),  pure vanilla, salt, caramel (non GMO corn syrup, S,C, whole milk (milk, skim milk, sugar) evaporated milk (milk, dipotassium phosphate carrageenan, Vitamin D3) sugar, water, palm oil, cream monodiglycerides, salt, soy lecithin, disodium phosphate,  natural flavors, salt. Contains  eggs, milk, soy, wheat.     Whole Foods, Emeryville, CA.    UPC - 4-pack: 0024375100000; 0024829300000.","50 4-packs","Metal shavings were found around the perimeter of brownies purchased by customer. ","03/04/2016","03/11/2016"," Best by date of  before 12/7/15.",12/3/2015,"12/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72794,"Ongoing","Vidco, Inc.","6175 Sw 112th Ave",".","Beaverton","OR","97008-4838","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide distribution in the states of  AZ, CA, MD, NM, NJ, and OH.","Z-0582-2016","Class II","Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4.    The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values which as heart rate and systolic, mean and diastolic pressure. This device acts as the Central Monitor Station, it permits from one (1) to sixteen (16) bedside monitor(s) to be connected simultaneously.","59 units","Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap condition, not allowing system to reset and reboot.  Two customers recently complained of the system freezing and it could only be restarted if the user re-applied power.  ","01/04/2016",," Serial numbers: 6533-6537, 6561, 6566-6581, 6539, 6540, 6558-6560, 6562, 6508-6528, 6563-6565, 6529, 6531, 6532, 6541, 6551, 6556, and 6557.",11/8/2015,"11/08/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72795,"Ongoing","Freedom Pharmaceuticals Inc","801 W New Orleans St",,"Broken Arrow","OK","74011-1844","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0567-2016","Class II","Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK  74011.","20 kg","Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.","01/12/2016",," Lot #: F10349, F10349A, F10349B, F10349C, F10349D, F10349E, Exp 01/15; F10829, F10829A, F10829B, F10829C, F10829-2, F10829-2A, F10829-2B, F10829-2D, F10829-2E, F10829-3, F10829-3A, F10829-3B, F10829-3C, F10829-3D, Exp 01/17; F11035, F11035A, F11035B, F11035C, Exp 08/17",3/10/2015,"03/10/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72796,"Ongoing","AGA Gas Inc","6055 Rockside Woods Blvd",,"Independence","OH","44131-2301","United States","Voluntary: Firm Initiated","Letter","Product was delivered to Ohio","D-0779-2016","Class II","Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01","1,500 gallons","cGMP Deviations; trailer may not have met GMP requirements prior to filling","03/18/2016",," Lot# 7931-O-V32-5330-5-1062",11/29/2015,"11/29/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72797,"Terminated","Freedom Pharmaceuticals Inc","801 W New Orleans St",".","Broken Arrow","OK","74011-1844","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0562-2016","Class III","5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm  in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd.  328 Wener Rd, Xihu, Hangzhou, Zhejiang, China","(a) 2 containers, (b) 32 containers, (c) 48 containers","Subpotent Drug","01/06/2016","02/08/2016"," Lot# F11641, Exp 9/17/2016",1/8/2015,"01/08/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72798,"Ongoing","Del Medical, Inc.","241 Covington Dr",,"Bloomingdale","IL","60108-3109","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines.","Z-0762-2016","Class II","VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.","4000","The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.","02/05/2016",," Product #		Serial #  110-5124G1	,	00019-0114  110-5124G1	,	00020-0114  110-5124G1	,	00092-0114  110-5124G1	,	00551-0314  110-5124G1	,	00512-0214  110-5124G1	,	00447-0214  110-5124G1	,	00016-0114  110-5124G1	,	00554-0314  110-5124G1	,	00094-0114  110-5124G1	,	00256-0214  110-5124G1	,	00741-0314  110-5124G1	,	00446-0214  110-5124G1	,	00017-0114  110-5124G1	,	00093-0114  110-5124G1	,	00236-0114  110-5124G1	,	00814-0414  110-5124G1	,	00815-0414  110-5124G1	,	00340-0214  110-5124G3	,	00995-0414  110-5124G1	,	00338-0214  110-5124G1	,	00552-0314  110-5124G1	,	00253-0214  110-5124G1	,	00445-0214  110-5124G1	,	00254-0214  110-5124G1	,	00095-0114  110-5124G1	,	00670-0314  110-5124G1	,	00252-0214  110-5124G1	,	00018-0114  110-5124G1	,	00669-0314  110-5124G1	,	00339-0214  110-5124G1	,	00444-0214  110-5124G1	,	00255-0214  ",12/3/2015,"12/03/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72798,"Ongoing","Del Medical, Inc.","241 Covington Dr",,"Bloomingdale","IL","60108-3109","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines.","Z-0761-2016","Class II","VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.","4000","The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.","02/05/2016",," Product #		Serial #  110-5010G1	,	00504-0214  110-5010G1	,	00855-0414  110-5010G1	,	00182-0114  110-5010G1	,	00108-0114  110-5010G1	,	00479-0214  110-5010G1	,	00014-0114  110-5010G1	,	00251-0214  110-5010G1	,	00854-0414  110-5010G1	,	00505-0214  110-5010G1	,	00342-0214  110-5010G1	,	00477-0214  110-5010G1	,	00184-0114  110-5010G1	,	00248-0214  110-5010G1	,	00588-0314  110-5010G1	,	00852-0414  110-5010G1	,	00107-0114  110-5010G1	,	00183-0114  110-5010G1	,	00480-0214  110-5010G1	,	00503-0214  110-5010G1	,	00443-0214  110-5010G1	,	00853-0414  110-5010G1	,	00941-0414  110-5010G1	,	00013-0114  110-5010G1	,	00343-0214  110-5010G1	,	00478-0214  110-5010G1	,	00249-0214  110-5010G1	,	00185-0114  110-5010G1	,	00442-0214  110-5010G1	,	00632-0314  110-5010G1	,	00475-0214  110-5010G1	,	00507-0214  110-5010G1	,	00015-0114  110-5010G1	,	00631-0314  110-5010G1	,	01008-0514  110-5010G1	,	00635-0314  110-5010G1	,	00011-0114  110-5010G1	,	00012-0114  110-5010G1	,	00345-0214  110-5010G1	,	00590-0314  110-5010G1	,	00440-0214  110-5010G1	,	00591-0314  110-5010G1	,	00506-0214  110-5010G1	,	00106-0114  110-5010G1	,	00774-0314  110-5010G1	,	00508-0214  110-5010G1	,	00476-0214  110-5010G1	,	00186-0114  110-5010G1	,	00587-0314  110-5010G1	,	00441-0214  110-5010G1	,	00589-0314  110-5010G1	,	00250-0214  110-5010G1	,	00247-0214  110-5010G1	,	00773-0314  110-5010G1	,	00344-0214  110-5010G3	,	01090-0514  110-5010G3	,	00709-0314  110-5010G3	,	00988-0414  110-5010G3	,	00010-0114  110-5010G4	,	01080-0514  110-5010G4	,	00047-0114  110-5010G4	,	00925-0414  ",12/3/2015,"12/03/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72799,"Ongoing","The Kroger Co","1014 Vine St",".","Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: AL, GA, ID, IL, IN, KY, LA, MI, MO, MT, NM, NV, OH, SC, TN, TX, UT, WV & WY.","F-0466-2016","Class I","BAKERY FRESH GOODNESS Chocolate Brownie NET WT 16 OZ (1 LB) 453 g CONTAINS: MILK, EGGS, WHEAT, SOY. MAY CONTAIN: ALMONDS, PECANS, WALNUTS, CASHEWS, COCONUT. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 09172 7","1,322 cs/12/16 oz containers","The firm was notified by a consumer of undeclared walnuts in the product.","01/06/2016",," Lot 15307 Sel By 02 Aug 2016",11/16/2015,"11/16/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72801,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",".","Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AK, AZ, AR, CA, CO, CT, DE DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, ,MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WY; and countries of:  Antiqua & Barbuda, Australia, Austria, Bahama, Bahrain, Canada, Czech Republic, Germany, Hungary, Saudi Arabia, Sweden, Turkey, & United Kingdom.","Z-0557-2016","Class II","MOSAIQ Oncology Information System    MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.","399"," and patient weight data item issue.","12/29/2015",," Versions 2.50 and higher",12/9/2015,"12/09/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72802,"Ongoing","Leica Microsystems, Inc.","1700 Leider Ln",,"Buffalo Grove","IL","60089-6622","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan , Netherlands, Romania  Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and UK.","Z-0808-2016","Class II","Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.","3745","The Firm  informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining.","02/12/2016",," Product Code DS9390 with lot numbers 41203, 41407, 41478, 41575, 41619, 41779, 41872, 42027, 42105, 42172, 42181, 42251, 42345, 42397, 42512 and 42594.",11/27/2015,"11/27/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72803,"Ongoing","True North Salmon","874 Main Street",,"Blacks Harbour","New Brunswick",,"Canada","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA,  MD, NJ,  NY, PA,  TX    Foreign: Beijing","F-1011-2016","Class II","True North  Gutted  Farmed Whole Atlantic Salmon, various weights from 8 to more than 16 lbs. packaged in plastic in styrofoam container, 50 lbs/case.  Product of Canada.  Product Code:  DHON 8¿10 50#  DHDN 10¿12 5O#,   DHON 14¿16 50#,   DHON 16+ 5O#  ","21,180.23 lbs","Foreign Object; Cylindrical metal Pit (Passive Integrated Transponder)  tags .","09/16/2016",," Lot Code: 16139",12/7/2015,"12/07/2015",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72804,"Ongoing","Brainlab AG","Kapellenstr. 12",,"Feldkirchen",,,"Germany","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.","Z-0647-2016","Class II","RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms","20 systems","Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.","01/14/2016",," Brain Metastases version 1.0.0    Model/catalogue number       Description  21702-04                     ELEMENTS AUT. BRAIN METASTASES PLAN INST  21703-01                     ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE  21703-02                     ELEMENTS ADAPT HYB SURG ANALYSIS INST  21702                       ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-12                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-36                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-60                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21703                       ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-12                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-36                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-60                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21713                       ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS  21722                       ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-12                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-36                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-60                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21723                       ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-12                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-36                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-60                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21732                       ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M  ",11/5/2015,"11/05/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72804,"Ongoing","Brainlab AG","Kapellenstr. 12",,"Feldkirchen",,,"Germany","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.","Z-0648-2016","Class II","RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms","48  systems","Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0","01/14/2016",," Adaptive Hybrid Surgery Analysis version 1.0.0    Model/catalogue number       Description  21702-04                     ELEMENTS AUT. BRAIN METASTASES PLAN INST  21703-01                     ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE  21703-02                     ELEMENTS ADAPT HYB SURG ANALYSIS INST  21702                       ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-12                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-36                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-60                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21703                       ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-12                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-36                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-60                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21713                       ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS  21722                       ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-12                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-36                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-60                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21723                       ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-12                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-36                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-60                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21732                       ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M  ",11/5/2015,"11/05/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72808,"Ongoing","Perkinelmer","940 Winter Street",,"Waltham","MA","02451","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.","Z-0638-2016","Class II",", 1000 samples.  Product Code: 2480-0010  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples  ","188 units","The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect.  The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed.  If the error is undetected, the Gamma Counter may produce erroneous results.","01/12/2016",," Serial Numbers:  DG12107256  DG04106256  DG08118161  DG03117633  DG09118348  DG06117938  DG04106271  DG03117625  DG11118603  DG03129003  DG11107087  DG09118269  DG09118346  DG09118323  DG09118410  DG10118462  DG12118695  DG03129030  DG05117802  DG04129089  DG11107086  DG03117631  DG10118453  DG01117421  DG04106256_REWORK  DG06106456  DG03106146  DG11118564  DG03129000  DG02106095  DG08106711  DG02128912  DG10106940  DG07118046  DG07118051  DG03117635  DG09118273  DG05117890  DG12118657  DG09118349  DG03117557  DG10118483  DG10118478  DG11107160  DG04129156  DG02106081  DG09118167  DG02128958  DG03129032  DG03117634  DG11118575  DG08118256  DG05106334  DG10106910  DG10106950  DG03117630  DG05106409  DG07106656  DG12107176  DG05106333  DG05117810  DG10106978  DG03106122  DG12107186  DG08106662  DG05117817  DG05117874  DG02128962  DG11118610  DG03129033  DG03129034  DG12118735  DG11107053  DG09118307  DG07118070  DG09118306  DG08118170  DG02128953  DG02128936  DG03129053  DG08118162  DG11118587  DG03129031  DG02128933  DG03129002  DG03129001  DG08118163  DG02128895  DG10118489  DG02117474  DG09118281  DG09118316  DG10106976  DG06117966  DG06106504  DG08118168  DG08118169  DG11118545  DG01128861  DG10118448  DG10118458  DG10118474  DG10118458  DG10118472  DG01128794  DG03129055  DG09118321  DG07118071  DG10118440  DG02128879  DG03117632  DG10118408  DG02128927  DG06106505  DG10118418  DG01128802  DG12118717  DG12118769  DG12118783  DG01106026  DG09106876  DG03129068  DG05106332  DG01105987  DG03106128  DG10118388  DG08118165  DG01128850  DG06117937  DG06117936  DG06117939  DG08118166  DG04117759  DG11118579  DG10118424  DG01128854  DG01128856  DG12107271  DG11118623  DG08118164  DG01128829  DG09118312  DG06117986  DG03106165  DG12118688  DG05117847  DG10118417  DG02128918  DG04106222  DG06106437  DG11118584  DG03117571  DG09118290  DG09106811  DG12107248  DG04106273  DG08106755  DG10106977  DG10106938  DG06117987  DG03106136  DG12118727  DG02128898  DG06106464  DG11107127  DG05106395  DG11107034  DG01128809  DG11",12/8/2015,"12/08/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72808,"Ongoing","Perkinelmer","940 Winter Street",,"Waltham","MA","02451","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.","Z-0635-2016","Class II","Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100.  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples  ","47 units","The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect.  The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed.  If the error is undetected, the Gamma Counter may produce erroneous results.","01/12/2016",," Model Number: 2470-0100  Serial Numbers:  DG06106436  DG08118240  DG02106050  DG06106502  DG11118609  DG01128795  DG02117461  DG12118702  DG09106861  DG05117833  DG05117834  DG10107006  DG06106452  DG09118367  DG03106154  DG04129081  DG06106559  DG06117903  DG07106599  DG09106774  DG05106387  DG06106524  DG10106949  DG09118284  DG05117787  DG04117755  DG09106770  DG03106196  DG04129159  DG08118192  DG06106469  DG08118189  DG04129075  DG12107252  DG12118677  DG06117923  DG08106741  DG03106186  DG12118759  DG01117444  DG02106112  DG12107236  DG11107031  DG12107249  DG11118612  DG05117781  Model: 3470-0100 (1 unit)  Serial Number: DG02128911  ",12/8/2015,"12/08/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72808,"Ongoing","Perkinelmer","940 Winter Street",,"Waltham","MA","02451","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.","Z-0637-2016","Class II","Perkin Elmer WIZARD2 10-detector, 1000 samples.  Product Code: 2470-0200, 3470-0200.  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples  ","22 units","The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect.  The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed.  If the error is undetected, the Gamma Counter may produce erroneous results.","01/12/2016",," Serial Numbes:  DG08118243  DG12118732  DG09106871  DG03117554  DG05106373  DG02117481  DG11107153  DG07118106  DG03128981  DG04106316  DG03117574  DG04106296  DG04117674  DG05106414  DG02117455  DG07106607  DG11107048  DG03106163  DG07106604  DG05117805  DG08106759  DG03129008  ",12/8/2015,"12/08/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72808,"Ongoing","Perkinelmer","940 Winter Street",,"Waltham","MA","02451","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.","Z-0634-2016","Class II","Perkin Elmer ClWIZARD2 5-detector, 550 samples  Product Code: 2470-0050, 3470-0050.  The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.","62 units","The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect.  The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed.  If the error is undetected, the Gamma Counter may produce erroneous results.","01/12/2016",," Model: 2470-0050  Serial Numbers:  DG05106329  DG02117493  DG11107166  DG09106782  DG07118133  DG07118141  DG09106791  DG04117727  DG06118036  DG12107192  DG02106101  DG04106223  DG01128843  DG12107272  DG07118124  DG09106892  DG12118684  DG12118673  DG11107126  DG04117704  DG04117763  DG01117363  DG06106484  DG12107240  DG01128871  DG05117880  DG12118685  DG09118357  DG03106204  DG05106386  DG11107137  DG03106172  DG03106206  DG02106113  DG09106818  DG02106065  DG04106309  DG09106882  DG11118590  DG06106483  DG01117316  DG08118221  DG06117898  DG12107263  DG08118250  DG12118711  DG04117710  DG06106448  DG06106453  DG06106463  DG06117912  DG03106135  DG01117373  DG05117837  DG06106517  DG01128805  DG06117970  DG04106310  DG02117521  DG06106538  Model: 3470-0050 (2 units)  Serial Numbers:  DG12118660  DG10118464  ",12/8/2015,"12/08/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72808,"Ongoing","Perkinelmer","940 Winter Street",,"Waltham","MA","02451","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.","Z-0633-2016","Class II","Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples","60 units","The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect.  The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed.  If the error is undetected, the Gamma Counter may produce erroneous results.","01/12/2016",," Serial Numbers:  DG02117524  DG09118363  DG08118156  DG08118195  DG02128922  DG10118375  DG12107235  DG08118222  DG02117537  DG08118184  DG09106872  DG11107116  DG03117626  DG03117611  DG01117425  DG12107293  DG09118332  DG06106503  DG06118006  DG01128820  DG12118707  DG05106427  DG03106166  DG11118630  DG01117434  DG09106779  DG02117500  DG12118742  DG06106477  DG03106208  DG09106800  DG10106903  DG05117853  DG03117671  DG06106473  DG04117754  DG04117698  DG11118538  DG11118617  DG01117392  DG03117644  DG05117882  DG03117655  DG04117683  DG02106106  DG05106347  DG06118043  DG10118385  DG08106671  DG01128869  DG06118023  DG05106328  DG02117516  DG11107142  DG05106354  DG08118254  DG03106181  DG03106197  DG02117505  DG11107105  ",12/8/2015,"12/08/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72808,"Ongoing","Perkinelmer","940 Winter Street",,"Waltham","MA","02451","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.","Z-0636-2016","Class II","Perkin Elmer WIZARD2 5-detector, 1000 samples  Product Code: 2470-0150, 3470-0150  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples  ","4 units","The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect.  The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed.  If the error is undetected, the Gamma Counter may produce erroneous results.","01/12/2016",," Serial Numbers:  DG04129084  DG12118776  DG04117773  DG05106408  ",12/8/2015,"12/08/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72808,"Ongoing","Perkinelmer","940 Winter Street",,"Waltham","MA","02451","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.","Z-0632-2016","Class II","Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010  The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples","47 units","The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect.  The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed.  If the error is undetected, the Gamma Counter may produce erroneous results.","01/12/2016",," Serial Numbers:  DG06106539  DG12118720  DG07106646  DG12107250  DG12107281  DG03117619  DG11118605  DG01117400  DG12107202  DG01117401  DG06106449  DG03117666  DG05117791  DG06106454  DG03106180  DG11118637  DG07118121  DG07106598  DG11118633  DG06106520  DG03106137  DG07118111  DG02128888  DG08118247  DG06118014  DG01128790  DG12107207  DG07106637  DG01128876  DG04117764  DG01106035  DG12118780  DG05106342  DG01117399  DG06117909  DG06118011  DG09106846  DG11107146  DG12118694  DG08118217  DG02106084  DG04117690  DG05117838  DG09106799  DG04117735  DG03117548  DG01117362  ",12/8/2015,"12/08/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72809,"Terminated","Encore Medical, Lp","9800 Metric Blvd",,"Austin","TX","78758-5445","United States","Voluntary: Firm Initiated","Letter","Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX","Z-0626-2016","Class II","AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046.  Orthopedic surgical instrument for use with Encore Shoulder prosthesis. ","23 units","The trial shell mating feature on the broach is undersized. ","01/09/2016","03/01/2016"," 178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06",12/8/2015,"12/08/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72810,"Terminated","RenovoRx, Inc.","4546 El Camino Real Ste 282",".","Los Altos","CA","94022-1068","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA  and  FL.","Z-0565-2016","Class II","RenovoCath RC 120;  Temporary Intravascular Occluding Catheter  Model number: MMRC120-DB-1111;  Rx only.    Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.","11 units","Incorrect version of Instructions for Use were shipped to two US customers.","12/31/2015","02/29/2016"," Model number: MMRC120-DB-1111;  Lot number: B2456974A; Expiry 2016-07.  Lot B2457150A - all 72 units were either used or returned prior to initiation of recall.",11/25/2015,"11/25/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72813,"Terminated","American National Red Cross, Penn Jersey Region","700 Spring Garden St",".","Philadelphia","PA","19123-3508","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0201-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from donor for whom donor suitability was not adequately dertermined, were distributed.","01/06/2016","01/06/2016"," W202715268938",10/13/2015,"10/13/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72813,"Terminated","American National Red Cross, Penn Jersey Region","700 Spring Garden St",".","Philadelphia","PA","19123-3508","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0202-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from donor for whom donor suitability was not adequately dertermined, were distributed.","01/06/2016","01/06/2016"," W202715920925",10/13/2015,"10/13/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72813,"Terminated","American National Red Cross, Penn Jersey Region","700 Spring Garden St",".","Philadelphia","PA","19123-3508","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0200-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from donor for whom donor suitability was not adequately dertermined, were distributed.","01/06/2016","01/06/2016"," W202715268938",10/13/2015,"10/13/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72814,"Ongoing","Ultradent Products, Inc.","505 W 10200 S",".","South Jordan","UT","84095-3935","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.","Z-0583-2016","Class II","InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012    Product Usage:    InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.  ","157","Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.","01/04/2016",," lot#s BC2GN and BC4L7",12/22/2015,"12/22/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72815,"Terminated","Haemonetics Corporation","400 Wood Rd",,"Braintree","MA","02184-2412","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Arabia  Argentina  Austria  Azerbaijanan  Bahrain  Bangladesh  Belarus  Belgium  Brazil  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  France  Guam  Georgia  Germany  Great Britain  Haiti  Hong Kong  Hungary  India  Iran  Italy  Jordan  Kazakhst  Kurdistan  Latvia  Libya  Lithuania  Luxemburg  Malaysia  Mexico  Netherlands  Norway  Panam¿  Peru  Philippines  Poland  Saudi Arabia  Serbia  Slovakia  Solvenia  Spain  Brazil  Sri Lanka  Sweden  Switzerland  Tuniisia  Ukrain  Uruguay  Venezuela  Virgin Islands","B-0347-16","Class III","Haemonetics MCS+ 8150 Apheresis System-Automated Blood Cell Separator  Catalog number: 08150-110-XX, 08150-220-XX    ","3006 units","Haemonetics' Rotor Cleaning Updated User Manual Addendum was distributed.","03/02/2016","04/15/2016"," All serial numbers",12/4/2015,"12/04/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72815,"Terminated","Haemonetics Corporation","400 Wood Rd",,"Braintree","MA","02184-2412","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Arabia  Argentina  Austria  Azerbaijanan  Bahrain  Bangladesh  Belarus  Belgium  Brazil  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  France  Guam  Georgia  Germany  Great Britain  Haiti  Hong Kong  Hungary  India  Iran  Italy  Jordan  Kazakhst  Kurdistan  Latvia  Libya  Lithuania  Luxemburg  Malaysia  Mexico  Netherlands  Norway  Panam¿  Peru  Philippines  Poland  Saudi Arabia  Serbia  Slovakia  Solvenia  Spain  Brazil  Sri Lanka  Sweden  Switzerland  Tuniisia  Ukrain  Uruguay  Venezuela  Virgin Islands","B-0346-16","Class III","Haemonetics Model 215 Automated Glycerolization/Deglycerolization  System List number: 02215-110-XX, 02215-220-XX","2055 Units","Haemonetics' Rotor Cleaning Updated User Manual Addendum was distributed.","03/02/2016","04/15/2016"," All serial numbers",12/4/2015,"12/04/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72815,"Terminated","Haemonetics Corporation","400 Wood Rd",,"Braintree","MA","02184-2412","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Arabia  Argentina  Austria  Azerbaijanan  Bahrain  Bangladesh  Belarus  Belgium  Brazil  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  France  Guam  Georgia  Germany  Great Britain  Haiti  Hong Kong  Hungary  India  Iran  Italy  Jordan  Kazakhst  Kurdistan  Latvia  Libya  Lithuania  Luxemburg  Malaysia  Mexico  Netherlands  Norway  Panam¿  Peru  Philippines  Poland  Saudi Arabia  Serbia  Slovakia  Solvenia  Spain  Brazil  Sri Lanka  Sweden  Switzerland  Tuniisia  Ukrain  Uruguay  Venezuela  Virgin Islands","B-0349-16","Class III","Haemonetics PCS2 Plasma Collection System-Automated Blood Cell Separator.  Catalog Numbers:06002-CP-110, 06002-CP-220-XX, 06002-CPL-110, 06002-110-XX-XX, 06002-220-XX","40,919 units","Haemonetics' Rotor Cleaning Updated User Manual Addendum was distributed.","03/02/2016","04/15/2016"," All serial numbers",12/4/2015,"12/04/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72815,"Terminated","Haemonetics Corporation","400 Wood Rd",,"Braintree","MA","02184-2412","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Arabia  Argentina  Austria  Azerbaijanan  Bahrain  Bangladesh  Belarus  Belgium  Brazil  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  France  Guam  Georgia  Germany  Great Britain  Haiti  Hong Kong  Hungary  India  Iran  Italy  Jordan  Kazakhst  Kurdistan  Latvia  Libya  Lithuania  Luxemburg  Malaysia  Mexico  Netherlands  Norway  Panam¿  Peru  Philippines  Poland  Saudi Arabia  Serbia  Slovakia  Solvenia  Spain  Brazil  Sri Lanka  Sweden  Switzerland  Tuniisia  Ukrain  Uruguay  Venezuela  Virgin Islands","B-0348-16","Class III","Haemonetics MCS+ 9000 Apheresis System-Automated Cell Separator  Catalog number: 09000-110-XX, 09000-220-XX","10,603 units","Haemonetics' Rotor Cleaning Updated User Manual Addendum was distributed.","03/02/2016","04/15/2016"," All serial numbers",12/4/2015,"12/04/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72816,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",".","Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0957-2016","Class I","0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02","255,852 VIAFLEX Plastic Containers","Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.","06/06/2016",," Lot # C980227; Exp. 11/16",12/15/2015,"12/15/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72816,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",".","Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0958-2016","Class I","Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06","28,080 VIAFLEX Plastic Containers","Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.","06/06/2016",," Lot # C985150; Exp.  07/16",12/15/2015,"12/15/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72817,"Ongoing","Bayer Healthcare","1 Bayer Dr",,"Indianola","PA","15051-9702","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to the states of : AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT and WI.","Z-0627-2016","Class II","Medrad Source Administration Sets, Catalog number INT CSS.  For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.","198,598","The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of  specification and may result in the system failing to position the dose correctly  during extraction, potentially leading to a low measurement of the extracted dose or  to a higher dose being extracted. The occluded SAS tubing may impair the priming  function and prompt an RP prime fail","01/11/2016",," 50856405, 50857510, 50860994,  50866789, 50867921, 50869464, 50869465, 50871131, 50872965,  50878229, 50878230, 50878231, 50878232, 50881328, 50881393,  50881394, 50881395, 50881506, 50881511, 50881512, 50882753,  50886316, 50886467, 50886468, 50886469, 50888285, 50888286,  50888287, 50888288, 50888373, 50890483, 50890484, 50890485,  50892357, 50892358, 50892359, 50892360, 60000321, 60000322,  60000323, 60000692, 60000789, 60000790, 60000833, 60000834,  60000835  ",11/30/2015,"11/30/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72818,"Ongoing","Avantor Performance Materials Inc","3477 Corporate Parkway",".","Center Valley","PA","18034","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the US including: CA, IL & NC; Canada","D-0563-2016","Class III","Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.","265 Drums","Failed Impurities/Degradation Specifications: Out of specifications results for impurities.","01/06/2016",," Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17.",10/30/2015,"10/30/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72819,"Ongoing","Bio-pharm, Inc.","2091 Hartel Ave",".","Levittown","PA","19057-4506","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0809-2016","Class III","Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51","103,664 Bottles","Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.","04/01/2016",," Lot #s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026,  14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15B040, 15B041, Exp. 08/2016; 15E042, Exp. 11/2016; 15F019, 15F021, Exp. 12/2016; 15G038, Exp. 01/2017; 15H004, 15H008, Exp. 02/2017",12/17/2015,"12/17/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72820,"Ongoing","Lucy's Weight Loss (dba. Waisted With Lucy)","813 Oram St",,"Arlington","TX","76010-2837","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0882-2016","Class I","Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010","Unknown","Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.","05/26/2016",," All lots, all colors and all strengths",12/9/2015,"12/09/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72820,"Ongoing","Lucy's Weight Loss (dba. Waisted With Lucy)","813 Oram St",,"Arlington","TX","76010-2837","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0883-2016","Class I","Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010","Unknown","Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.","05/26/2016",," All lots, all colors and all strengths",12/9/2015,"12/09/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72821,"Ongoing","Nestle Waters North America","900 Long Ridge Rd","Building 2","Stamford","CT","06902-1128","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-0503-2016","Class II","Sweet Leaf Organic Half and Half Lemonade Tea, 16 oz glass bottle  UPC: 6-51538-06708-1"," 15,764  cases (12/case)","Product contains glass particles","01/12/2016",," Best By Dates:  6/30/16, 8/31/16, 10/31/16  ",12/9/2015,"12/09/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72821,"Ongoing","Nestle Waters North America","900 Long Ridge Rd","Building 2","Stamford","CT","06902-1128","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-0507-2016","Class II","Sweet Leaf Organic Tea Mint & Honey, 16 oz glass bottle  UPC: 6-51538-06701-2"," 33,916  cases (12/case)","Product contains glass particles","01/12/2016",," Best By Dates:  6/30/16, 8/31/16, 10/31/16  ",12/9/2015,"12/09/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72821,"Ongoing","Nestle Waters North America","900 Long Ridge Rd","Building 2","Stamford","CT","06902-1128","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-0502-2016","Class II","Sweet Leaf Organic Raspberry Iced Tea, 16 oz glass bottle  UPC: 6-51538-06703-6","13,175 cases (12/case)","Product contains glass particles","01/12/2016",," Best By Dates:  6/30/16,  8/31/16, 10/31/16  ",12/9/2015,"12/09/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72821,"Ongoing","Nestle Waters North America","900 Long Ridge Rd","Building 2","Stamford","CT","06902-1128","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-0505-2016","Class II","Sweet Leaf All Natural Citrus Green Tea, 16 oz glass bottle  UPC: 6-51538-06720-3  ",,"Product contains glass particles","01/12/2016",," Best By Dates:  6/30/16, 8/31/16,10/31/16  ",12/9/2015,"12/09/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72821,"Ongoing","Nestle Waters North America","900 Long Ridge Rd","Building 2","Stamford","CT","06902-1128","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-0504-2016","Class II","Sweet Leaf Organic Original Sweet Tea,  16 oz glass bottle  UPC: 6-51538-06700-5"," 35,821  cases (12/case)","Product contains glass particles","01/12/2016",," Best By Dates:  6/30/16, 8/31/16, 10/31/16  ",12/9/2015,"12/09/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72821,"Ongoing","Nestle Waters North America","900 Long Ridge Rd","Building 2","Stamford","CT","06902-1128","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-0506-2016","Class II","Sweet Leaf  All Natural Peach Iced Tea , 16 oz glass bottle  UPC: 6-51538-06704-3"," 22,663  cases (12/case)","Product contains glass particles","01/12/2016",," Best By Dates:  6/30/16, 8/31/16,10/31/16  ",12/9/2015,"12/09/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0824-2016","Class III","HEB Original Seasonal Fish Fry Mix NET WT. 16 OZ (1 LB) CONT. NET 454g and HEB Original Seasonal Fish Fry Mix NET WT. 10 OZ  CONT. NET 284g  packed in paper box","30,404 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0833-2016","Class III","HEB Sweet & Spicy Cornbread Mix NET WT. 13.3 OZ (377g) packed in paper box","14042 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0860-2016","Class III","On The Border Mexican Grill & Cantina Tempura Batter Net Wt 25 LBS (11.34 kg)","8985 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0870-2016","Class III","Morrison's Cornbread Mix NET WT 5 LB (2.27 kg) ","12,437 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0871-2016","Class III","Ben E. Keith Cornbread Mix NET WT 5 lb. (2.27kg)","5911 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0835-2016","Class III","HEB Maple Bacon Flavored Cornbread Mix NET WT. 13.3 OZ (377g) packed in paper box","14280 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0885-2016","Class III","Ben E. Keith Keith's Premium Deluxe Buttermilk Pancake Mix NET WT 5 lb (2.27 kg)","5489 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0879-2016","Class III","Pioneer Mulit-Grain Pancake & Waffle Mix NET WT 5 LBS (2.27 kg)","5834 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0846-2016","Class III","Morrison's Hushpuppy Mix NET WT 5 LB (2.27 kg)","1177 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0830-2016","Class III","Pioneer Brand No Fat Complete Buttermilk Pancake & Waffle Mix Premium Quality NET WT 32 oz. (2 lb) 907g packed in paper box","2664 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0891-2016","Class III","American Blue Ribbon Holdings. LLC Multigrain Pancake Mix NET WT 37.5 LBS (17.01 kg)","3220 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0838-2016","Class III","Morrison's Coarse Ground Yellow Cornbread Mix NET WT 6 OZ (170g) packed in paper box","2764 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0843-2016","Class III","Morrison's Texas Style White Cornbread Mix NET WT 6 OZ (170g) packed in paper box","1335 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0866-2016","Class III","Z Tejas Cornbread Blend 212759 NET WEIGHT 4.5 LBS. (2.04 kg)","424 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0895-2016","Class III","Razzoo's Seasoned Corn Flour NET WT 25 LB (11.33 kg)","33,283 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0862-2016","Class III","Chicken Express Batter Mix 93455 Net Wt. 25 LBS (11.34 kg)","6778 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0832-2016","Class III","HEB Rosemary Olive Oil with Sea Salt Cornbread Mix NET WT. 13.3 OZ (377g) packed in paper box","9774 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0855-2016","Class III","Delgado Relleno Batter Mix Net Wt 1 lb. (453 kg)","158 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0883-2016","Class III","Superior by Farmer Brothers Buttermilk Pancake Mix NET WT 5 LB (2.27 kg)","28,898 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0880-2016","Class III","Pioneer Original Buttermilk Pancake & Waffle Mix NET WT 5 LBS 2.27 kg and Pioneer Original Buttermilk Pancake & Waffle Mix NET WT 25 LBS 11.34 kg ","44,666 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0893-2016","Class III","Braum's Hot Cake Mix NET WT 32 oz (907 g)","6856 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0829-2016","Class III","Pioneer Brand Original Buttermilk Pancake and Waffle Mix Premium Quality NET WT 32 oz. (2 lb) 907g packed in paper box","63,673 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0848-2016","Class III","Champs Chicken Southern Style Fish Breading Net Wt. 25 lbs. (11.33 Kg)","525 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0888-2016","Class III","Morrison's Country Style Buttermilk Pancake Mix Net Wt 5 LB (2.27 kg) ","8009 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0857-2016","Class III","HSRG Cornmeal Breader NET WT 25 LB (11.33 kg)","3609 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0900-2016","Class III","Morrison's Premuim Self-Rising Cornmeal Mix NET WT 25 LB (11.33 kg)","9847 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0856-2016","Class III","Bill Miller BBQ Batter Mix NET WT 48 OZ (3 LB) (1.36 kg)","7552 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0850-2016","Class III","Krispy Krunchy Chicken Fish Fry Net Weight 5 Lbs. (2.27kg)","8625 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0872-2016","Class III","Ben E. Keith Home Style Cornbread Mix NET WT 5 lb. (2.27kg)","6394 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0823-2016","Class III","HEB Lemon Seasonal Fish Fry Mix NET WT. 16 OZ (1 LB) CONT. NET 454g and HEB Lemon Seasonal Fish Fry Mix NET WT. 10 OZ  CONT. NET 284g  packed in paper box","29,350 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0849-2016","Class III","Champs Chicken Batter Mix Net Wt. 25 lbs. (11.33 Kg)","886 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0828-2016","Class III","Pioneer Brand Complete Buttermilk Pancake & Waffle Mix Premium Quality NET WT 32 oz. 2 lb/907g and Pioneer Brand Buttermilk Pancake & Waffle Complete Mix Premium Quality NET WT 6 oz (170g) packed in paper box","33,406 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0839-2016","Class III","Morrison's Corn Kits Prepares Cornbread Mix NET WT 6 OZ (170g) packed in paper box","278,374 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0867-2016","Class III","Pioneer Sweet Corn Muffin Mix NET WT. 5 LBS 2.27 kg","4737 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0859-2016","Class III","Golden Chicken Batter Mix Net Wt. 27 LBS (12.25 kg)","4372 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0876-2016","Class III","Chubby's Foods Cornbread Mix 6/5 LB 7816","125 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0865-2016","Class III","Marie Callender's Low Fat Original Corn Bread Mix NET WT 1 lb (16 oz. ) 454 grams","13,164 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0831-2016","Class III","Pioneer Brand Maple Flavor Pancake & Waffle Complete Mix Premium Quality NET WT 6 oz. (170g) packed in paper box","918 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0820-2016","Class III","Morrison's Premium White Corn Meal Enriched NET WT 5 LB (2.27 kg); Morrison's Premium White Corn Meal Self-Rising Mix Enriched NET WT 5 LB (2.27 kg); Hill Country Fare Enriched White Cornmeal NET WT. 32 OZ (2 LBS); Great Value Self-Rising White Corn Meal Mix Enriched NET WT 5 LB (2.27 kg); Pioneer Enriched White Corn Meal NET WT 5 LB (2.27 kg); Pioneer Enriched White Corn Meal NET WT 2 LB (0.90 kg) - all products packaged in paper bags; Morrison's Premium White Corn Meal NET WT 25 lb (11.34 kg); Premium White Cornmeal Enriched NET WT 25 LB (11.34 kg); Pioneer Enriched White Corn Meal NET WT 25 LB (11.343 kg)","49,597 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0864-2016","Class III","Marie Callender's Low Fat Southwestern Corn Bread Mix NET WT 1 lb (16 oz. ) 454 grams","2473 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0840-2016","Class III","Morrison's Texas Style Honey Sweet Cornbread Mix NET WT 6 OZ (170g) packed in paper box","66610 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0878-2016","Class III","Conestoga Buttermilk Pancake & Waffle Mix NET WT 25 LB (11.34 kg)","1598 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0826-2016","Class III","HEB Fish Coating Mix Black Pepper Parmesan NET WT. 12 OZ (340g) packed in paper box","5,277 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0863-2016","Class III","Marie Callender's Low Fat Honey Butter Corn Bread and Muffin Mix NET WT 1 lb (16 oz. ) 454 grams","8120 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0837-2016","Class III","Parade Cornbread Mix White NET WT/PESO NETO 6 OZ (170g) packed in paper box","847 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0877-2016","Class III","Conestoga Buttermilk Pancake Mix NET WT. 5 LB. (2.27 kg)","22,442 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0853-2016","Class III","CFS Batter/Breader Mix Net Weight 5 Lbs (2.27 KG)","27,495 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0899-2016","Class III","Pioneer Buttermilk Pancake Mix NET WT 5 LBS (2.27 kg)","194,612 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0869-2016","Class III","Morrison's Home Style Cornbread Mix NET WT 5 LB (2.27 kg) ","4234 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0858-2016","Class III","Hartz Krispy Chicken 'N' Rolls Milk Dip Net Wt 20 LBS (9.07 kg)","683 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0890-2016","Class III","Deluxe Buttermilk Pancake Mix NET WT 25 LB (11.33 kg)","2033 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0821-2016","Class III","Parade Enriched All-Purpose Corn Meal Yellow NET WT/PESO NETO 5 LB (2.27 kg); Parade Enriched All-Purpose Corn Meal Yellow NET WT/PESO NETO 32 OZ (2 LB); Hill Country Fare Enriched Yellow Cornmeal NET WT 5 LBS CONT. NET. 2.3 kg; Hill Country Fare Enriched Yellow Cornmeal NET WT 32 OZ (2 LBS); Morrison's Premium Yellow Corn Meal Self-Rising Mix Enriched NET WT 5 LB (2.27 kg); Morrison's Premium Yellow Corn Meal Enriched NET WT 5 LB (2.27 kg) - all packaged in paper bags; Luby's Yellow Corn Meal NET WT 25 LB (11.34 kg); Morrison's Peacemaker Yellow Corn Meal Enriched NET WT 25 LB (11.34 KG); Morrison's Premium Yellow Degermed Corn Meal NET WT 25 LB (11.34 kg); Ben E. Keith Keith's Exclusive Premium Yellow Corn Meal NET WT 25 LB (11.34 kg); Morrison's Premium Yellow Corn Meal NET WT 25 LB (11.33 kg)","297,348 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0852-2016","Class III","FBR Batter Mix NET WT 30 LBS (13.61 kg)","1546 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0822-2016","Class III","HEB Seasonal Shrimp & Oyster Fry Mix NET WT. 10 OZ CONT. NET 284g packed in paper box","9121 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0827-2016","Class III","HEB Fish Coating Mix Mango Habanero NET WT. 12 OZ (340g) packed in paper box","5,469 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0834-2016","Class III","HEB Cheddar Bacon Flavored Cornbread Mix NET WT. 13.3 OZ (377g) packed in paper box","17038 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0881-2016","Class III","Pioneer Original Buttermilk Pancake Mix NET WT 5 LBS 2.27 kg","2377 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0886-2016","Class III","Ben E. Keith Keith's Exclusive Complete Pancake Mix NET WT 5 lb (2.27 kg)","12,152 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0889-2016","Class III","Morrison's Pancake Mix Net Wt 5 LB (2.27 kg) ","15,881 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0847-2016","Class III","Pioneer Hush Puppy Mix  NET WT 5 LB 2.27 kg","1933 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0887-2016","Class III","Morrison's Pancake Mix Complete Net Wt 5 LB (2.27 kg) ","4915 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0897-2016","Class III","Darden Super Breader XL NET WEIGHT 25 LB (11.34 kg)","149,643 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0868-2016","Class III","Morrison's Country Style Corn Bread Mix NET WT 25 LB (11.33 kg) and Morrison's Country Style Cornbread Mix NET WT 5 LB (2.27 kg)","23,676 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0873-2016","Class III","Fletcher's Corny Dog Mix NET WT 25 LB (11.33 kg)","5855 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0894-2016","Class III","Buttermilk Pancake Mix # 1 NET WT 5 LBS (2.27kg)","6774 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0836-2016","Class III","Parade Cornbread Mix Yellow NET WT/PESO NETO 6 OZ (170g) packed in paper box","2767 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0882-2016","Class III","Pioneer Sweet Potato Pancake Mix NET WT/PESO NETO 5 LBS (2.27 kg)","620 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0861-2016","Class III","Cotton Patch Cafe Chicken Fried Steak Batter Mix NET WT 30 LBS (13.63 kg)","6404 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0845-2016","Class III","Razzoo's Hushpuppy Mix NET WT 5 LBS (2.27 kg)","6027 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0892-2016","Class III","Braum's Pancake & Waffle Mix NET WT 24 LBS (10.90kg)","3359 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0884-2016","Class III","Authentic Creations Multigrain Pancake Mix NET WT 37.5 LBS (17.01 kg) ","1286 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0851-2016","Class III","Cotton Patch Cafe Catfish Breader 212562 Net Wt. 25 LBS (11.34 kg)","2490 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0825-2016","Class III","HEB Original Seasonal Catfish Fry Mix NET WT. 10 OZ  CONT. NET 284g  packed in paper box","11,938 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0842-2016","Class III","Morrison's Texas Style Yellow Cornbread Mix NET WT 6 OZ (170g) packed in paper box","83828 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0841-2016","Class III","Morrison's Texas Style Mexican Cornbread Mix NET WT 6 OZ (170g) packed in paper box","2005 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0896-2016","Class III","Morrison's Premium Yellow Corn Flour NET WT 25 LB (11.33 kg)","61,697 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0844-2016","Class III","Fiesta Yellow Cornbread Mix NET WT 6 OZ (170g) packed in paper box","1704 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0875-2016","Class III","Legendary Baking Trans Fat Free 93375 ","1911 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0854-2016","Class III","Original Tempura Batter Mix Net Weight 5 Lbs (2.27 KG)","8321 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0874-2016","Class III","Cotton Patch Cafe Sweet Corn Muffin Mix 93381 NET WT. 6 LBS. (2.72 kg)","6831 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72822,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-0898-2016","Class III","Pioneer Corn Bread Mix NET WT 5 LBS (2.27 kg)","300,179 cases","May contain small metal fragments from wire mesh sifter.","04/11/2016",," All lots",12/7/2015,"12/07/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72823,"Ongoing","ConvaTec, Inc","7900 Triad Center Dr Ste 400",,"Greensboro","NC","27409-9076","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, ME, MA, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TX VA, WA, WI, and countries of: Australia, Belgium, Burma, Canada, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Netherlands, Norway, Russia, Saudi Arabia, Sweden, Switzerland, United Kingdom & Vietnam.","Z-1044-2016","Class II","Nebulizer Masks Opti-Mist and Opti-Mist Clear    Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.","3,605,700 pieces","The Nebulizer mask malfunctions in that there is reduced or no aerosol output.  The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.","03/03/2016",," lot/batch numbers  13-23, 13-24, 13-29, 13-30, 13-31, 13-32, 97750, 97774, 97777, 97870, 97871, 97873, 97874, 97880, 97988, 98030, 98031, 98033, 98034, 98043, 98048, 98058, 98059, 98099, 98103, 98330, 98338, 98380, 98491, 98520, 98546, 98556, 98570, 98571, 98578, 98595, 98635, 98683, 98694, 98721, 98722, 98730, 98733, 98738, 98777, 98779, 98782, 98840, 98841, 98843, 98844, 98853, 98856, 98859, 98867, 98868, 98869, 98870, 98871, 98969, 99078, 99079, 99199, 99206, 99207, 99227, 99230, 99231, 99232, 99297, 99397, 99398, 99447, 99450, 99451, 99466, 99492, 99539, 99577, 99578, 99591, 99606, 99628, 99630, 99631, 99642, 99661, 99673, 99674, 99708, 99709, 99735, 99845, 99852, 99853, 99854, 99919, 99920, 99928, 99932, 99997, 100029, 100065, 100066, 100074, 100077, 100101, 100102, 100114, 100119, 100155, 100167, 100177, 100180, 100205, 100206, 100207, 100238, 100254, 100401, 100402, 100424, 100483, 100506, 100516, 100546, 100549, 100552, 100563, 100599, 100603, 100693, 100697, 100700, 100705, 100752, 100759, 100784, 100809, 100812, 100814, 100871, 100931, 100984, 100985, 101186, 101200, 101201, 101202, 101310, 101312, 101450, 101473, 101474, 101484, 101485, 101527, 101528, 101533, 101537, 101555, 101556, 101557, 101558, 101559, 101625, 101626, 101686, 101704, 101708, 101709, 101721, 101723, 101750, 101751, 101752, 101753, 101759, 101761, 101785, 101889, 109211, 101926, 101949, 101984, 102038, 102046, 102061, 102063, 102076, 102135, 102138, 102141, 102281, 102284, 102330, 102389, 102461, 102468, 102473, 102474, 102476, 102478, 102570, 102571, 102606, 102642, 102671, 102681, 102702, 102703, 102710, 102712, 102720, 102725, 102744, 102745, 102746, 102751, 102796, 102806, 102807, 102861, 102945, 102976, 103021, 103076, 103079, 103116, 103151, 103161, 103166, 103206, 103284, 103301, 103341, 103342, 103348, 103387, 103429, 103431, 103432, 103448, 103449, 103463, 103464, 103465, 103485, 103575, 103580, 103585, 103587, 103607, 103674, 103675, 103693, 103694, 103695, 103746, 103747, 103786, 103790, 103802, 103803, 103825, 103827",11/11/2015,"11/11/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72824,"Ongoing","Cardiac Science Corporation","N7 W22025 Johnson Dr",,"Waukesha","WI","53186-1856","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US all states including PR except ND & RI.  International Distribution to Argentina, Australia, Belgium, Bermuda, Canada, Chile, Colombia, Ecuador, France, Germany, Hong Kong, Iceland, Ireland , Israel, Lebanon, Malaysia, Malta, Norway, Oman, Philippines, Poland, Qatar, Romania, Russian Federation, Singapore, Slovenia, Sweden, Turkey, United Kingdom.","Z-0829-2016","Class II","9131-001 Defibrillation Electrodes, Lot No. 141125-02  Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs  Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.","12,095","Defibrillation electrodes may exhibit higher than expected electrical impedance over time. If electrode impedance becomes too high, your Powerheart G3 Automatic External Defibrillator (AED) will fail the electrode self-test and it will not be Rescue Ready. If the AED fails the self-test, the STATUS INDICATOR on the AED will be RED and the AED will beep. This is normal and correct behavior when the","02/22/2016",," Lot No. 141125-02",1/14/2016,"01/14/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72825,"Ongoing","Steris Corporation","5960 Heisley Rd",".","Mentor","OH","44060-1834","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Bahrain, Canada, China, Colombia, Costa Rica, France, Hong Kong, India, Indonesia, Israel, Kuwait, Lebanon, Mexico, Panama, Peru, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, Viet Nam & Virgin Islands.","Z-0603-2016","Class II","AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation     To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.","2,319 units","The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.  ","01/06/2016",," Serial #'s: 0428014026 - 0432115014",11/20/2015,"11/20/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72826,"Ongoing","Nicomex Inc.","88 1st St",".","Passaic","NJ","07055-6406","United States","Voluntary: Firm Initiated","Letter","NJ and NY.","F-0467-2016","Class II","Nicomex Velitas Candies Candles Net. Wt. 2 oz (56.7 gms) Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055","316 packages (2 ounce units) ","This recall has been initiated because the laboratory analysis indicates that the product contains FD & C Red #3, and Yellow #5 which are not declared on the ingredient statement on the product label.","01/07/2016",," UPC 884678102323",11/23/2015,"11/23/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72827,"Terminated","Azuma Foods International Inc USA","20201 Mack Street",,"Hayward","CA","94545-1015","United States","Voluntary: Firm Initiated","Letter","Three US Customers and One customer in Holland. Second lot bonded and tested in Switzerland but final destination was same customer in Holland. Additional customer in United Kingdom.","F-1068-2016","Class I","Chuka Ika Sansai ECO - International name and Natural Chuka Ika Sansai for US (Seasoned Squid Salad);  Net Wt.: 4.4 lbs. (2 kg) for US customer:  2.2 lbs. (1 kg) for European customer.    Second lot:  Net Wt. 2.2 lbs (8 pkg/1 kg) for European customer  4.4.lbs (2 kg)    Shelf life is 24 months for US, 18 months for EU customer per request.    Perishable/Keep frozen Until Use;  Thaw under refrigeration immediately before use.    Ingredients: Squid (Peru. Wild), Yamakurage (lettuce stem) Kikurage Mushroom, Bamboo Shoot, Seasoned Ginger (ginger, water, cane sugar, salt, distilled white vinegar, citric acid), Sesame Seed, Sugar, Natural Vinegar, White Soy Sauce (water, salt, soybeans, wheat), Sweet Rice Wine, Natural Rice Wine, Sesame Oil, Sorbitol (2 g per 100g serving) Salt, Kelp Extract, Bonito Extract, Red Pepper, Dextrose, Yeast Extract, Xanthan Gum, Annatto, Sodium Phosphate.  Allergen Information: Contains Squid, Fish Extract (Bonito) Sesame See, Soy, Wheat.    Manufactured by: Azuma Foods International Inc., U.S.A.  Hayward, CA 94545  Processed in the U.S. A.","138 cases lot 25-1429 and 124 cases of lot 26-0937: Additional 1179 cases for final recall expansion.","Firm was notified by EU of a positive sample for Listeria Monocytogenes in Squid Salad tested by their customer in the Netherlands. A second customer reported an additional positive finding and an additional lot of Squid Salad was also recalled.","04/12/2016","06/03/2016"," Product number: 825353 in US and 82539KY international:  Lot 25-1429 - US  Lot 25-1429-1 and 25-1429-2 Foreign.    Additional lot - first recall expansion:  26-0937-1 - International  26-0937 - US    Second recall expansion:  US: 25-1424, 25-1540, 25-2388, 25, 2689, 26-0065, 26-0286, 26-0440, 26-0594, 26-0661, 26-0713.     ",12/4/2015,"12/04/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72830,"Terminated","Reesna, Inc","7921 Canoga Ave Ste I",".","Canoga Park","CA","91304-5021","United States","Voluntary: Firm Initiated","Telephone","Nationwide and United Kingdom","D-0959-2016","Class I","FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle  WWW.FUELUPPILLS.COM","26,250 capsules","Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.","06/06/2016","06/09/2016","  Exp. 12/18",12/11/2015,"12/11/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72830,"Terminated","Reesna, Inc","7921 Canoga Ave Ste I",".","Canoga Park","CA","91304-5021","United States","Voluntary: Firm Initiated","Telephone","Nationwide and United Kingdom","D-0960-2016","Class I","FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle  WWW.FUELUPPILLS.COM","7,250 capsules","Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.","06/06/2016","06/09/2016","  Exp. 12/18",12/11/2015,"12/11/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72831,"Ongoing","Pine Valley Foods Inc","131 Frost Commerical Dr",".","West Monroe","LA","71292-2479","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0432-2016","Class I","Crazy about Cookies 2lb DSC Custom Decorated Sugar Cookies Item # 101-2207 thru 101- 2355  UPC Code - None","647 units","Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg.","01/04/2016",," Dates codes:  10/9/15  11/23/15 (Julian Dates - 15282  - 15327)   ",12/10/2015,"12/10/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72831,"Ongoing","Pine Valley Foods Inc","131 Frost Commerical Dr",".","West Monroe","LA","71292-2479","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0429-2016","Class I","Crazy about Cookies 2lb Monster Bash COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4032 UPC Code - 698768034322","3231 units","Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg.","01/04/2016",," Dates codes:  10/9/15  11/23/15 (Julian Dates - 15282  - 15327)   ",12/10/2015,"12/10/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72831,"Ongoing","Pine Valley Foods Inc","131 Frost Commerical Dr",".","West Monroe","LA","71292-2479","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0433-2016","Class I","Crazy about Cookies 2.7lb WALNUT CHUNKY CHOCOLATE CHIP Pre-Portioned cookie dough Item # 25-2008 UPC Code - 698768102168","701 units","Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg.","01/04/2016",," 11/24/15 (Julian Date 15328)",12/10/2015,"12/10/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72831,"Ongoing","Pine Valley Foods Inc","131 Frost Commerical Dr",".","West Monroe","LA","71292-2479","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0430-2016","Class I","Crazy about Cookies 2lb Birthday Celebration COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4033 UPC Code - 698768034339","569 units","Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg.","01/04/2016",," Dates codes:  10/9/15  11/23/15 (Julian Dates - 15282  - 15327)   ",12/10/2015,"12/10/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72831,"Ongoing","Pine Valley Foods Inc","131 Frost Commerical Dr",".","West Monroe","LA","71292-2479","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0426-2016","Class I","Crazy about Cookies 2.7lb Sugar Cookies Pre-Portion Item # 25-2004 UPC Code  - 698768102120","8163 units","Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg.","01/04/2016",," Dates codes:  10/9/15  11/23/15 (Julian Dates - 15282  - 15327)   ",12/10/2015,"12/10/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72831,"Ongoing","Pine Valley Foods Inc","131 Frost Commerical Dr",".","West Monroe","LA","71292-2479","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0428-2016","Class I","Crazy about Cookies 2lb Fairytale Princess COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4031 UPC Code - 698768034315","2273 units","Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg.","01/04/2016",," Dates codes:  10/9/15  11/23/15 (Julian Dates - 15282  - 15327)   ",12/10/2015,"12/10/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72831,"Ongoing","Pine Valley Foods Inc","131 Frost Commerical Dr",".","West Monroe","LA","71292-2479","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0427-2016","Class I","Crazy about Cookies 2lb Holiday Gathering COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4034 UPC Code - 698768034346","8943 units","Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg.","01/04/2016",," Dates codes:  10/9/15  11/23/15 (Julian Dates - 15282  - 15327)   ",12/10/2015,"12/10/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72831,"Ongoing","Pine Valley Foods Inc","131 Frost Commerical Dr",".","West Monroe","LA","71292-2479","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0431-2016","Class I","Crazy about Cookies 2lb HELLO KITTY COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4035 UPC Code - 698768034353","1801 units","Pre-portioned sugar cookie dough contains undeclared milk and pre-portioned walnut chocolate chunk cookie dough contains undeclared egg.","01/04/2016",," Dates codes:  10/9/15  11/23/15 (Julian Dates - 15282  - 15327)   ",12/10/2015,"12/10/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72832,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","US: AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NV, NJ, OK, OR, PA, SD, TN, TX, WA, WI.    OUS: AUSTRALIA, GERMANY, SWITZERLAND, SWEDEN.","Z-0625-2016","Class II","Zimmer,  Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3).     UDI Number 889024328952","372","Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.","01/09/2016",," Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869",11/17/2015,"11/17/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72833,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO.IL, MN, MD, OR, PA, SC, TX, WA","V-450-2016","Class I","Bravo Balance Turkey Dinner for dogs,  3 lb bag of 4 oz. patties  Item Number: 31-¿401  UPC: 829546314019","60 cases","May be contaminated with Salmonella","06/11/2016",," Best used by date of 11/13/16  ",12/10/2015,"12/10/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72833,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO.IL, MN, MD, OR, PA, SC, TX, WA","V-448-2016","Class I","Bravo All Natural  Chicken  Blend diet for dogs & cats,  5 lb (90 oz) chubs  Item Number: 21-¿105  UPC: 829546211059","250 cases","May be contaminated with Salmonella","06/11/2016",," Best used by date of 11/13/16  ",12/10/2015,"12/10/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72833,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO.IL, MN, MD, OR, PA, SC, TX, WA","V-447-2016","Class I","Bravo All Natural  Chicken  Blend diet for dogs & cats. 2lb (32 oz) chubS   Item Number: 21-102  UPC: 829546211028","201 cases","May be contaminated with Salmonella","06/11/2016",," Best used by date of 11/13/16  ",12/10/2015,"12/10/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72833,"Ongoing","BRAVO! LLC","349 Wetherell St.",,"Manchester","CT","06040","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO.IL, MN, MD, OR, PA, SC, TX, WA","V-449-2016","Class I","Bravo All Natural  Turkey  Blend diet for dogs & cats,  5 lb bag of 8 oz patties  Item Number: 31-¿508  UPC: 829546315085","8 cases","May be contaminated with Salmonella","06/11/2016",," Best used by date of 11/13/16  ",12/10/2015,"12/10/2015",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72835,"Terminated","BPL Plasma, Inc.","11601 E Colonial Dr",".","Orlando","FL","32817-4608","United States","Voluntary: Firm Initiated","E-Mail","Belgium; Switzerland","B-0203-16","Class II","Source Plasma","6 units","Blood products, for which donor suitability was inadequately determined, were distributed.","01/21/2016","01/21/2016"," OL0494493; OL0495217; OL0496980; OL0497940; OL0499474; OL0500401",10/21/2015,"10/21/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72836,"Ongoing","Abeon Medical Corporation","8000 Katherine Blvd",".","Brecksville","OH","44141-4202","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CT,FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, OH, SC, TN, TX, UT, VA & WI., and the countries of Austria, Germany, Italy, Japan, Spain, Sweden & Switzerland.","Z-0685-2016","Class II","TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA)     Indicated to aid in tissue retraction during a surgical procedure.","1,035 units","The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.","01/21/2016",," Part Number TLC200: Lot # 14121931 Exp Date 2017/12, Lot # 14121932 Exp Date 2017/12, Lot # 15010126 Exp Date 2018/01, Lot # 15013122 Exp Date 2018/01, Lot # 15013123 Exp Date 2018/01, Lot # 15024395 Exp Date 2018/02, Lot # 15024396 Exp Date 2018/02, Lot # 15031873 Exp Date 2018/03, Lot # 15032061 Exp Date 2017/12, Lot # 15034503 Exp Date 2017/10, Lot # 15040520 Exp Date 2018/02, Lot # 15041108 Exp Date 2017/12, Lot # 15044716 Exp Date 2018/04, Lot # 15050175 Exp Date 2018/01, Lot # 15051473 Exp Date 2018/05, Lot # 15051950 Exp Date 2018/04, Lot # 15054517 Exp Date 2018/05, Lot # 15062732 Exp Date 2018/04, Lot # 15070461 Exp Date 2018/02, Lot # 15070515 Exp Date 2018/02, Lot # 15076498 Exp Date 2018/07, Lot # 15080317 Exp Date 2018/01, Lot # 15090148 Exp Date 2018/07, Lot # 15090422 Exp Date 2018/03, Lot # 15092264 Exp Date 2018/01, Lot # 15095598 Exp Date 2018/09, Lot # 15102039 Exp Date 2018/05, Lot # 15103106 Exp Date 2018/09 & Lot # 15103112 Exp Date 2018/09.    Part Number TLC300: Lot # 14122483 Exp Date 2017/12, Lot # 15010125 Exp Date 2018/01, Lot # 15010989 Exp Date 2017/12, Lot # 15023291 Exp Date 2017/10, Lot # 15034288 Exp Date 2018/03, Lot # 15034509 Exp Date 2017/12, Lot # 15033742 Exp Date 2018/03, Lot # 15042675 Exp Date 2018/03, Lot # 15053401 Exp Date 2017/12, Lot # 15054441 Exp Date 2018/01, Lot # 15062598 Exp Date 2018/06, Lot # 15062599 Exp Date 2018/06, Lot # 15064578 Exp Date 2018/01, Lot # 15070470 Exp Date 2018/03, Lot # 15070490 Exp Date 2018/03, Lot # 15081541 Exp Date 2018/03, Lot # 15082695 Exp Date 2018/03, Lot # 15090147 Exp Date 2018/06, Lot #  15095188 Exp Date 2018/06, Lot # 15110466 Exp Date 2018/06 & Lot # 15110476 Exp Date 2018/06.",11/25/2015,"11/25/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72836,"Ongoing","Abeon Medical Corporation","8000 Katherine Blvd",".","Brecksville","OH","44141-4202","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CT,FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, OH, SC, TN, TX, UT, VA & WI., and the countries of Austria, Germany, Italy, Japan, Spain, Sweden & Switzerland.","Z-0686-2016","Class II","Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY.    Indicated to aid in tissue retraction during a surgical procedure.    ","575 units","The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.","01/21/2016",," Part Number TLC5042: Lot # 14121931 Exp Date 2017/12, Lot # 15010126 Exp Date 2018/01, Lot # 15013122 Exp Date 2018/01, Lot # 15013123 Exp Date 2018/01, Lot # 15021046 Exp Date 2018/01, Lot # 15021051 Exp Date 2018/01, Lot # 15024395 Exp Date 2018/02, Lot # 15031873 Exp Date 2018/03, Lot # 15033220 Exp Date 2018/02, Lot # 15040515 Exp Date 2017/06, Lot # 15044161 Exp Date 2017/12, Lot # 15044717 Exp Date 2018/04, Lot # 15050167 Exp Date 2017/12, Lot # 15051473 Exp Date 2018/05, Lot # 15051474 Exp Date 2018/05, Lot # 15062728 Exp Date 2017/12, Lot # 15070483 Exp Date 2018/01, Lot # 15070485 Exp Date 2018/01, Lot # 15074959 Exp Date 2018/07, Lot # 15075862 Exp Date 2018/01, Lot # 15076498 Exp Date 2018/07, Lot # 15080211 Exp Date 2018/01, Lot # 15080251 Exp Date 2018/01, Lot # 15081546 Exp Date 2018/01, Lot # 15093692 Exp Date 2018/01, Lot # 15094993 Exp Date 2018/01, Lot # 15095115 Exp Date 2018/07, Lot # 15095135 Exp Date 2018/03, Lot # 15095190 Exp Date 2017/12, Lot # 15100494 Exp Date 2018/10 & Lot # 15110293 Exp Date 2018/06.    Part Number TLC5042-I: Lot # 15010126 Exp Date 2018/01, Lot # 15021046 Exp Date 2018/01, Lot # 15023295 Exp Date 2017/06, Lot # 15042815 Exp Date 2018/01, Lot # 15044716 Exp Date 2018/04, Lot # 15044717 Exp Date 2018/04, Lot # 15080659 Exp Date 2018/04 & Lot # 15082266 Exp Date 2018/04.",11/25/2015,"11/25/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72836,"Ongoing","Abeon Medical Corporation","8000 Katherine Blvd",".","Brecksville","OH","44141-4202","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CT,FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, OH, SC, TN, TX, UT, VA & WI., and the countries of Austria, Germany, Italy, Japan, Spain, Sweden & Switzerland.","Z-0684-2016","Class II","TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY.    Indicated for use in the retraction of soft tissue away from the operative surface. ","2,570 units","The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.","01/21/2016",," Part Number M0068201750: Lot # 14112171 Exp Date 2017/11, Lot # 14112177 Exp Date 2017/11, Lot # 14120576 Exp Date 2017/05, Lot # 14120579 Exp Date 2017/11, Lot # 14121661 Exp Date 2017/12, Lot # 14121862 Exp Date 2017/12, Lot # 14121863 Exp Date 2017/12, Lot # 15010199 Exp Date 2017/12, Lot # 15010200 Exp Date 2017/12, Lot # 15011528 Exp Date 2018/01, Lot # 15011529 Exp Date 2018/01, Lot # 15011530 Exp Date 2018/01, Lot # 15011531 Exp Date 2018/01, Lot # 15012638 Exp Date 2017/12, Lot # 15012640 Exp Date 2017/11, Lot # 15013724 Exp Date 2017/11, Lot # 15013788 Exp Date 2018/01, Lot # 15013789 Exp Date 2018/01, Lot # 15013790 Exp Date 2018/01, Lot # 15013791 Exp Date 2018/01, Lot # 15020046 Exp Date 2018/01, Lot # 15020047 Exp Date 2017/12, Lot # 15020048 Exp Date 2018/01, Lot # 15021047 Exp Date 2018/01, Lot # 15021049 Exp Date 2018/01, Lot # 15021472 Exp Date 2018/02, Lot # 15021473 Exp Date 2018/02, Lot # 15021474 Exp Date 2018/02, Lot # 15024336 Exp Date 2018/01, Lot # 15030309 Exp Date 2018/01, Lot # 15030310 Exp Date 2017/11, Lot # 15030317 Exp Date 2018/01, Lot # 15032508 Exp Date 2018/03, Lot # 15034955 Exp Date 2018/03, Lot # 15035013 Exp Date 2018/03, Lot # 15040424 Exp Date 2018/02, Lot # 15040425 Exp Date 2018/01, Lot # 15040426 Exp Date 2018/01, Lot # 15040681 Exp Date 2018/04, Lot # 15040682 Exp Date 2018/04, Lot # 15041220 Exp Date 2018/04, Lot #  15050026 Exp Date 2018/01, Lot # 15050027 Exp Date 2018/03, Lot # 15050029 Exp Date 2018/03, Lot # 15061724 Exp Date 2018/04, Lot # 15061725 Exp Date 2018/04, Lot # 15082274 Exp Date 2018/04, Lot # 15082325 Exp Date 2018/04, Lot # 15082326 Exp Date 2018/05, Lot # 15082837 Exp Date 2018/08, Lot # 15082838 Exp Date 2018/08, Lot # 15082839 Exp Date 2018/08, Lot # 15084674 Exp Date 2018/08, Lot # 15084675 Exp Date 2018/08, Lot # 15084676 Exp Date 2018/08, Lot # 15084745 Exp Date 2018/08, Lot # 15084945 Exp Date 2018/08, Lot # 15084946 Exp Date 2018/08, Lot # 15090470 Exp Date 2018/08, Lot # 15090472 Exp Date 2018/08, Lot # 15090479 Exp Date 2018/08, Lot #",11/25/2015,"11/25/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72837,"Ongoing","Bigwall Enterprises","125 55th St Ste 200",,"Clarendon Hills","IL","60514-6307","United States","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution  including Washington, DC, U.S. Virgin Islands, and Puerto Rico.","Z-0698-2016","Class II","Well at Walgreens***WARM   Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies ","87503",,"02/24/2016",," Model: PJ1011  Item: 366596  UPC code: 31191717008  Lot No. 08/14: 45228pcs  Lot No. 12/14: 21096pcs  Lot No. 01/15: 14220pcs  Lot No. 03/15: 20040pcs  ",11/20/2015,"11/20/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72839,"Terminated","Nuovo Pasta Productions, Ltd","1330 Honeyspot Road Ext",".","Stratford","CT","06615-7115","United States","Voluntary: Firm Initiated","Letter","CT, MA, NJ,  NY, PA","F-0434-2016","Class II","Simply Enjoy Shrimp and Lobster Ravioli, 9 oz, refrigerated packaged in plastic tray. Distributed by Foodhold USA, Landover, MD.  UPC Code: 68826743926","129 cases (774 units)","Shrimp and Lobster Ravioli back panel incorrectly identifies Spinach and Roasted Garlic ravioli ingredients","12/30/2015","03/22/2016"," Lot code 15309  Use by Date December 20, 2015",12/8/2015,"12/08/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72840,"Ongoing","Ethicon, Inc.","US Highway 22 West",".","Somerville","NJ","08876","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: India, Belgium, Argentina, Mexico, Brazil, Canada, Colombia, Ecuador, Singapore, Aruba and Venezuela.","Z-0602-2016","Class II","Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc.    The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.","96,124 units","Stability data does not substantiate the labeled two-year shelf life of affected product.","01/06/2016",," TC003 (US Only)  TC013 (US Only)  TC033 (OUS Only)  TC043 (OUS Only).      Code, Batch:  TC04320, GMMG07; TC00320, GMMG08; TC00320, GMMG09; TC00320, GMMG10; TC04320, GMMG11; TC03320, GPMG01; TC04320, GPMG02; TC00320, GPMG03; TC00320, GPMG04; TC00320, GPMG05; TC01320, GPMG06; TC04320, GPMG07; TC03320, GPMG08; TC04320, GPMG09; TC00320, GPMG10; TC00320, GPMG11; TC00320, HAMG01; TC00320, HAMG02; TC03320, HAMG03; TC04320, HAMG04; TC00320, HAMG05; TC00320, HAMG06; TC00320, HAMG07; TC00320, HAMG08; TC01320, HAMG09; TC03320, HAMG10; TC04320, HAMG11; TC04320, HAMG12; TC00320, HAMG13; TC00320, HAMG14; TC00320, HBMG01; TC00320, HBMG02; TC04320, HBMG03; TC04320, HBMG04; TC03320, HBMG05; TC00320, HBMG06; TC00320, HBMG07; TC04320, HBMG08; TC03320, HBMG09; TC00320, HBMG10; TC00320, HCMG01; TC00320, HCMG02; TC00320, HCMG03; TC00320, HCMG04; TC04320, HCMG05; TC04320, HCMG06; TC03320, HDMG01; TC00320, HDMG02; TC00320, HDMG03; TC00320, HDMG04; TC00320, HDMG05; TC03320, HEMG01; TC04320, HEMG02; TC01320, HEMG03; TC00320, HEMG05; TC00320, HEMG06; TC00320, HEMG07; TC00320, HEMG08; TC04320, HEMG09; TC04320, HGMG01; TC03320, HGMG02; TC00320, HGMG03; TC00320, HGMG04; TC00320, HGMG05; TC00320, HGMG06; TC00320, HGMG07; TC04320, HGMG08; TC04320, HGMG09; TC04320, HGMG10; TC00320, HHMG01; TC00320, HHMG02; TC00320, HHMG03; TC00320, HHMG04; TC03320, HHMG05; TC04320, HHMG06; TC00320, HHMG08; TC00320, HHMG09; TC00320, HHMG10; TC04320, HHMG07; TC00320, HHMG11; TC00320, HHMG12; TC00320, HJMG02; TC00320, HJMG03; TC00320, HJMG04; TC00320, HJMG05; TC00320, HJMG06; TC01320, HJMG07; TC03320, HJMG08; TC04320, HJMG09; TC04320, HJMG10; TC00320, HJMG11; TC00320, HJMG12; TC00320, HJMG13; TC04320, HKMG01; TC00320, HJMG14; TC04320, HKMG02; TC03320, HKMG03; TC00320, HKMG04; TC00320, HKMG05; TC00320, HKMG06; TC04320, HKMG07; TC03320, HKMG08; TC00320, HKMG10; TC00320, HKMG09; TC00320, HKMG11; TC00320, HLMG01; TC00320, HLMG02; TC00320, HLMG03; TC01320, HLMG04; TC04320, HLMG05; TC03320, HLMG06; TC00320, HLMG07; TC00320, HLMG08; TC00320, HLMG09; TC04320, HLMG10; ",12/3/2015,"12/03/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72841,"Terminated","Lane Memorial Blood Bank","2211 Willamette St",".","Eugene","OR","97405-2847","United States","Voluntary: Firm Initiated","FAX","Oregon","B-0204-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed. ","01/07/2016","01/07/2016"," W137514209773; ",11/19/2015,"11/19/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72844,"Ongoing","Sweet Superior Ltd","2501 W Military Hwy Ste A 5/6","2101 E. Military Hwy, McAllen, TX, 78503","Mcallen","TX","78503-8961","United States","Voluntary: Firm Initiated","E-Mail","TX and IL","F-0469-2016","Class I","PICOSITO Jalapenos Distributed by: Sweet Superior Fruit LTD. CO. PRODUCE OF MEXICO","1127 cases","Tested positive for Salmonella.","01/11/2016",," LOT ORTI04",12/11/2015,"12/11/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72845,"Terminated","Vern's & Son Food Service Distributing","1952 SE Ochoco Street",,"Milwaukie","OR","97222-7315","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Oregon and Washington","F-0625-2016","Class II","Great Pacific Bagel & Cream Cheese, product is wrapped with flexible clear plastic, net weight 4.5 oz.  The UPC is UPC 92438 00300","75 units","Great Pacific Bagel & Cream Cheese was recalled due to undeclared wheat","02/24/2016","03/18/2016"," all best by dates prior to 12/23/2015.",12/8/2015,"12/08/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72847,"Terminated","Sun Noodle New Jersey, LLC","375 North St Unit O",,"Teterboro","NJ","07608-1219","United States","Voluntary: Firm Initiated","Press Release","GA, IL, NJ and NY","F-0463-2016","Class I","Tonkutsu Ramen, Net Wt. 12 oz. Made by Sun Noodle Honolulu, HI 96819/Rancho Domingo, CA 90220/Teterboro, NJ 07605  UPC 0 85315 40003 5  PACKAGED IN PLASTIC CLEAR CLAMSHELL","34,836 units","Tonkutsu Ramen may contain undeclared eggs.","02/01/2016","07/07/2016"," 3114350 3115013 3115040 3115071 3115141 3115176 3115229 3115267 3115299 3115328 3214350 3215013 3215040 3215071 3215141 3215176 3215229 3215267 3215299 3215328 3114352 3115015 3115043 3115072 3115149 3115187 3115246 3115271 3115304 3115336 3214352 3215015 3215043 3215072 3215149 3215187 3215246 3215271 3215304 3215336 3114360 3115028 3115055 3115084 3115161 3115195 3115254 3115275 3115314  3214360 3215028 3215055 3215084 3215161 3215195 3215254 3215275 3215314 3115007 3115034 3115058 3115114 3115167 3115216 3115265 3115281 3115321 3215007 3215034 3215058 3215114 3215167 3215216 3215265 3215281 3215321",12/14/2015,"12/14/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72849,"Ongoing","Casey's Bakery, Inc","251 N Main Ave Ste 301",,"Sioux Center","IA","51250-1818","United States","Voluntary: Firm Initiated","Visit","Product was distributed to retail stores in northwest Iowa.","F-1834-2016","Class II","Casey's Bakery, Almond Patties, Traditional Dutch Puff Pastry Filled with Pure Almond Paste, 6 Patties, NET WT 13.5 OZ","904 boxes"," (a component of the butter).","07/26/2016",," All codes prior to 696",11/17/2015,"11/17/2015",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72850,"Ongoing","Gutierrez Distributors, LLC","349 Chestnut St",,"Passaic","NJ","07055-3123","United States","Voluntary: Firm Initiated","Telephone","New Jersey","F-1070-2016","Class III","Gutierrez Distributor, (a) Tarugo con chile spicy tamarind, 349 Chestnut Street, Passaic, NJ 07055 UPC 8527050000904    (b) Dulce de pulpa 100% de Tamarindo, Betamex, Alamos No.7 STA. Maria Aztahuacan Deleg. Iztapalapa C.P. 09500 Mexico, D.F.","(a) 240 bags (5 pieces per bag) (b) 37 boxes (40 pounds/box)","Undeclared FD&C Red 40","04/13/2016",," UPC 852705000904",12/2/2015,"12/02/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72851,"Ongoing","Benlan, Inc.","2760 Brighton Road",".","Oakville",,,"Canada","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including GA & Internationally to Canada.","Z-0595-2016","Class II"," (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada   ","120 units","The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.","01/06/2016",," Lots 114842, 116433 & 118251",12/11/2015,"12/11/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72852,"Terminated","SNACK DEPOT, INC.","10651 Hickson St # 101",,"El Monte","CA","91731-1947","United States","Voluntary: Firm Initiated","Letter","CA","F-0509-2016","Class III","Roasted Seasoned Himego Fish (spicy)    Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag. ","30 cases","Snack Depot is recalling himego fish because it was mislabeled and misidentified.","01/12/2016","04/21/2016"," C1013h and 02",10/20/2015,"10/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72852,"Terminated","SNACK DEPOT, INC.","10651 Hickson St # 101",,"El Monte","CA","91731-1947","United States","Voluntary: Firm Initiated","Letter","CA","F-0508-2016","Class III","Roasted Seasoned Himego Fish    Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag. ","30 cases","Snack Depot is recalling himego fish because it was mislabeled and misidentified.","01/12/2016","04/21/2016"," C1013c and 01",10/20/2015,"10/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72853,"Ongoing","Aesculap, Inc.","3773 Corporate Pkwy",,"Center Valley","PA","18034-8217","United States","Voluntary: Firm Initiated","Telephone","US Nationwide Distribution","Z-1043-2016","Class II","Columbus Revision Knee System, EnduRo Knee System    Product Usage:  The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.  ","1232","Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.","03/03/2016",," All codes",11/30/2015,"11/30/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72854,"Ongoing","Freedom Pharmaceuticals Inc","801 W New Orleans St",".","Broken Arrow","OK","74011-1844","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0573-2016","Class II","Baclofen USP powder, packaged in  (a)  25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10. ","(a) 6 containers, (b) 42 containers, (c) 31 containers, (d) 253 containers","Presence of Foreign Substance","01/19/2016",," Lot #: F10918, F10918-2, Exp: 07/24/2016; F10867, F10867A, Exp date: 03/11/2016",11/9/2015,"11/09/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72856,"Completed","Trader Joes Company","800 S Shamrock Ave",,"Monrovia","CA","91016-6346","United States","Voluntary: Firm Initiated","Press Release","nationwide in US","F-1566-2016","Class III","Triple Ginger Brew, 25.4 FL OZ (750 mL) glass bottles, SKU 51857    Bottles are sold individually; there are 9 bottles per case","75,240 cases","Trader Joes recalling Triple Ginger Brew due to reports of unopened bottles potentially bursting. ","06/20/2016",," Lot No.  296153  297151  297153  296152  297151  322151  323153  323152  ",12/15/2015,"12/15/2015",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72857,"Ongoing","Stella and Chewys","111 W Oakview Parkway",,"Oak Creek","WI","53154","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Canada","V-471-2016","Class I","Stella & Chewy's brand chick chick chicken Dinner Morsels for Cats.  Keep Frozen.  Made with raw, cage-free chicken with and antibiotic-free.  Net Wt. 1.25 lbs. (570g).  UPC 186011 001448  Manufactured by:  Stella & Chewy's LLC, 2842 South 5th Court, Milwaukee, WI  53207.  ","634 cases",", during routine surveillance testing by the Michigan Department of Agriculture and Rural Development.","08/02/2016",," Lot #152-15 with Use By 7/2/2016, and Lot #160-15 with Use By 7/2/2016",12/11/2015,"12/11/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72857,"Ongoing","Stella and Chewys","111 W Oakview Parkway",,"Oak Creek","WI","53154","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Canada","V-470-2016","Class I","Stella & Chewy's brand Stella's Super Beef Dinner Morsels for Dogs.  Keep Frozen.  Made with raw, grass-fed beef with no added hormones or antibiotics.  Manufactured by:  Stella & Chewy's LLC, 2842 South 5th Court, Milwaukee, WI  53207.  Packaged in the following sizes and codes:  Net Wt. 8.5 oz. (240g), UPC 186011 001554, and Net Wt. 4 lb. (1.81kg), UPC 186011 01370.","268 cases",", during routine surveillance testing by the Michigan Department of Agriculture and Rural Development.","08/02/2016",," 8.5 oz. package: Lot #165-15, Use By 6-25-2016   4 lb. package: Lot #165-15, Use By 6-25-2016 and 6/26/2016",12/11/2015,"12/11/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72857,"Ongoing","Stella and Chewys","111 W Oakview Parkway",,"Oak Creek","WI","53154","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Canada","V-472-2016","Class I","Stella & Chewy's brand Duck Duck Goose Dinner Morsels for Cats.  Keep Frozen.  Made with raw, cage-free poultry with no added hormones and antibiotic-free.  Net Wt. 1.25 lbs. (570g).  UPC 186011-001455.  Manufactured by:  Stella & Chewy's LLC, 2842 South 5th Court, Milwaukee, WI  53207.  ","368 cases",", during routine surveillance testing by the Michigan Department of Agriculture and Rural Development.","08/02/2016",," Lot #165-15, Use By 6/25/2016",12/11/2015,"12/11/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72858,"Ongoing","Albertsons Llc","6511 Golden Gate Dr",,"Dublin","CA","94568-2907","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; TX, LA, FL  No foreign distribution.","F0534-2016","Class II","Dockside Classics  4 Gourmet  Lobster Cakes  Net Wt. 12 oz.  UPC: 045425167143","29 cases","The product may not have been transported at a safe temperature.","02/03/2016",," UPC: 045425167143",12/5/2015,"12/05/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72858,"Ongoing","Albertsons Llc","6511 Golden Gate Dr",,"Dublin","CA","94568-2907","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; TX, LA, FL  No foreign distribution.","F-0535-2016","Class II","Dockside Classics  4 Gourmet  Crab Cakes  Net Wt. 12 oz.  UPC: 045425167143","20 cases","The product may not have been transported at a safe temperature.","02/03/2016",," UPC: 045425165446",12/5/2015,"12/05/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72860,"Ongoing","Arkray Factory USA, Inc.","5182 W 76th St",".","Minneapolis","MN","55439-2900","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.","Z-0631-2016","Class I","arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484.  Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine.    For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.","11 boxes (25 foil packaged test strips per box)","One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose.  The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.","01/15/2016",," Lot Number PN5C26",12/18/2015,"12/18/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72860,"Ongoing","Arkray Factory USA, Inc.","5182 W 76th St",".","Minneapolis","MN","55439-2900","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.","Z-0630-2016","Class I","arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424.      For the in vitro quantitative determination of glucose in human plasma from whole blood samples.","88 boxes (25 foil packaged test strips per box)","One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose.  The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.","01/15/2016",," Lot Number EA4M78",12/18/2015,"12/18/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72863,"Ongoing","Thai Culinary Arts Studio LLC","58 Potato Pt",,"Yarmouth","ME","04096-5559","United States","Voluntary: Firm Initiated","E-Mail","CT, MA, ME, NH and RI","F-0568-2016","Class II","Watcharee's Thai Green Curry Sauce (UPC 094368999991), product is in a glass jar, NET WT 11.5 OZ (326 g)","4,327 Jars Total","Sauces may not meet quality standards due to the presence of mold.","02/08/2016",," Best by 9/15/17, 9/16/17 and 10/20/2017",11/24/2015,"11/24/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72863,"Ongoing","Thai Culinary Arts Studio LLC","58 Potato Pt",,"Yarmouth","ME","04096-5559","United States","Voluntary: Firm Initiated","E-Mail","CT, MA, ME, NH and RI","F-0567-2016","Class II","WATCHAREE'S Thai Massaman curry sauce (UPC 094368999984), product is in a glass jar, NET WT 11.5 OZ (326 g)","4,327 Jars Total","Sauces may not meet quality standards due to the presence of mold.","02/08/2016",," Best by 9/15/2017 and 10/28/2017",11/24/2015,"11/24/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72863,"Ongoing","Thai Culinary Arts Studio LLC","58 Potato Pt",,"Yarmouth","ME","04096-5559","United States","Voluntary: Firm Initiated","E-Mail","CT, MA, ME, NH and RI","F-0566-2016","Class II","WATCHAREE'S thai peanut sauce (UPC 094368999977), product is in a glass jar, NET WT 11.75 OZ (333 g)","4,327 Jars Total","Sauces may not meet quality standards due to the presence of mold.","02/08/2016",," Best By: 9/16/2017 and 10/28/2017",11/24/2015,"11/24/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72864,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","800 Macarthur Blvd",,"Mahwah","NJ","07430-2001","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0701-2016","Class II","Panorama Patient Monitoring Network.    Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910.    The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central viewing station. It is not intended to be directly connected to patient at any time or installed in a patient's vicinity.","63 products","An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation.  On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations are maintained.","01/29/2016",," version 11.5.1",12/15/2015,"12/15/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72865,"Ongoing","Amerisource Health Services ","2550 John Glenn Ave","Suite A","Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0565-2016","Class II","HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01","2,784 cartons (278,400 capsules)","Presence of Particulate Matter","01/08/2016",," Lot # 151379 and Lot #151380; Exp 12/16",10/29/2015,"10/29/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72866,"Terminated","Smith & Nephew, Inc.","1450 E Brooks Rd",".","Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of:FL, MO, IN and TX.","Z-0573-2016","Class II","Smith & Nephew GENESIS(R) II/LEGION(TM)  PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490    knee implant.","20 units ","One lot of 35 mm patella implants is labeled as 32 mm.  These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.","01/04/2016","03/17/2016"," Batch # 15GM07831",11/9/2015,"11/09/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72867,"Ongoing","Thornhill Research Inc","210 Dundas St W Suite 200",,"Toronto",,,"Canada","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.","Z-0586-2016","Class I","MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities.    The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation. ","83 units","Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.","01/11/2016",," MS201205001, MS201205002, MS201205003, MS201205004, MS201205005, MS201212001, MS201212002, MS201212003, MS201212004, MS201212005, MS201212006, MS201212007, MS201212008, MS201212009, MS201212010, MS201212011, MS201212012, MS201212013, MS201212024, MS201212025, MS201212026, MS201212028, MS201212029, MS201212030, MS201212031, MS201212032, MS201212033, MS201212034, MS201212035, MS201212036, MS201212037, MS201212038, MS201212039, MS201212040, MS201212041, MS201212042, MS201212053, MS201212054, MS201212055, MS201212056, MS201212057, MS201212058, MS201212059, MS201212060, MS201212061, MS201212062, MS201212062, MS201212063, MS201212064, MS201212065, MS201212066, MS201212067, MS201212068, MS201212069, MS201212070, MS201212014, MS201212015, MS201212016, MS201212017, MS201212018, MS201212019, MS201212020, MS201212021, MS201212022, MS201212023, MS201212043, MS201212044, MS201212045, MS201212046, MS201212047, MS201212048, MS201212049, MS201212050, MS201212051, MS201212052, MS201212071, MS201212072, MS201212073, MS201212074, MS201212075, MS201212076, MS201212077, MS201212078, MS201212079",11/19/2015,"11/19/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72867,"Ongoing","Thornhill Research Inc","210 Dundas St W Suite 200",,"Toronto",,,"Canada","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.","Z-0587-2016","Class I","MOVES System Lithium Polymer Batteries    The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation. ","178 units","Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.","01/11/2016",," MB201205001, MB201205002, MB201205003, MB201205004, MB201205005, MB201205006, MB201205007, MB201205008, MB201205009, MB201205010, MB201208001, MB201208002, MB201208003, MB201208004, MB201212001, MB201212002, MB201212003, MB201212004, MB201212005, MB201212006, MB201212007, MB201212008, MB201212009, MB201212010, MB201212011, MB201212012, MB201208019, MB201208020, MB201308021, MB201308022, MB201308023, MB201308024, MB201308025, MB201308026, MB201308027, MB201308028, MB201308029, MB201308031, MB201308032, MB201308033, MB201308034, MB201308035, MB201308036, MB201308038, MB201308039, MB201308040, MB201308041, MB201308042, MB201308043, MB201308044, MB201308045, MB201308046, MB201309023, MB201309024, MB201309025, MB201309026, MB201309027, MB201309028, MB201309029, MB201309030, MB201309031, MB201309032, MB201309033, MB201309034, MB201309035, MB201309036, MB201309037, MB201309038, MB201309039, MB201309040, MB201310001, MB201310002, MB201310003, MB201310004, MB201310005, MB201310006, MB201310007, MB201310008, MB201212013, MB201212014, MB201212015, MB201212016, MB201212017, MB201212018, MB201212019, MB201212020, MB201307001, MB201307002, MB201307003, MB201307004, MB201307005, MB201307006, MB201307007, MB201307008, MB201307009, MB201307010, MB201308001, MB201308002, MB201308003, MB201308004, MB201308005, MB201308006, MB201308007, MB201308008, MB201308010, MB201308011, MB201308012, MB201308013, MB201308014, MB201308015, MB201208017, MB201208018, MB201308047, MB201308048, MB201308049, MB201308050, MB201308051, MB201308052, MB201308053, MB201308054, MB201308055, MB201308056, MB201308057, MB201308058, MB201308059, MB201308060, MB201309001, MB201309002, MB201309003, MB201309004, MB201309006, MB201309007, MB201309008, MB201309009, MB201309010, MB201309011, MB201309012, MB201309013, MB201309014, MB201309015, MB201309016, MB201309017, MB201309019, MB201309020, MB201309021, MB201309022, MB201310009, MB201310010, MB201310011, MB201310012, MB201310013, MB201310014, MB201310015, MB201310016, MB201310017, MB201310018, MB201310019, MB2",11/19/2015,"11/19/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72868,"Ongoing","Becton Dickinson & Company","1 Becton Dr",".","Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.","Z-0568-2016","Class II","BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x  2.0 mL (Pink) BD Hemogard  Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA     BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory.The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. ","29,815,600 units in total","Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment. ","12/31/2015",," Catalog Reference #368047; Lot number 5154647",12/3/2015,"12/03/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72868,"Ongoing","Becton Dickinson & Company","1 Becton Dr",".","Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.","Z-0571-2016","Class II","BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x  4.0 mL (Lavender) BD Hemogard  Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA     BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.","29,815,600 units in total","Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment. ","12/31/2015",," Catalog Reference #367844; Lot number 5154624    Catalog Reference #367862; Lot numbers 5089771 and 5187753    Catalog Reference #368021; Lot number 5089820    ",12/3/2015,"12/03/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72868,"Ongoing","Becton Dickinson & Company","1 Becton Dr",".","Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.","Z-0567-2016","Class II","BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x  2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA     The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer¿ Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube.","29,815,600 units in total","Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment. ","12/31/2015",," Catalog Reference #367842; Lot numbers 5089731 and   5175923",12/3/2015,"12/03/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72868,"Ongoing","Becton Dickinson & Company","1 Becton Dr",".","Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.","Z-0570-2016","Class II","BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x  3.0 mL (Tan) BD Hemogard  Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA     BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.","29,815,600 units in total","Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment. ","12/31/2015",," Catalog Reference #367855; Lot numbers 5064684, 5120653, 5154643, 5175930, 5210765, 5237787",12/3/2015,"12/03/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72868,"Ongoing","Becton Dickinson & Company","1 Becton Dr",".","Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.","Z-0569-2016","Class II","BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x  3.0 mL (Lavender) BD Hemogard  Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA     BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.","29,815,600 units in total","Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment. ","12/31/2015",," Catalog Reference #368054; Lot numbers 5089827, 5210514, 5154646, 5210511.    Catalog Reference #367856; Lot number 5064666",12/3/2015,"12/03/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72869,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",".","Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CA, NY, PA, and the countries of  Austria, Belarus, Canada, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden and United Kingdom.","Z-0604-2016","Class II","Oncentra External Beam - VMAT - Radiation therapy planning system    Product Usage:  The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.","154"," in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume.  This could result in open MLC, and open jaws in areas away from the target volume.  ","01/06/2016",," Versions 3.3 and higher",12/18/2015,"12/18/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72871,"Terminated","OneBlood, Inc.","8669 Commodity Cir",".","Orlando","FL","32819-9054","United States","Voluntary: Firm Initiated","FAX","FL","B-0221-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Blood products, which did not meet acceptable product specifications, were distributed.","01/21/2016","01/21/2016"," W036815310964-part 1; W036815310964- part 2",11/4/2015,"11/04/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72872,"Terminated","OneBlood, Inc.","10100 Dr Martin Luther King Jr St N",,"St Petersburg","FL","33716-3806","United States","Voluntary: Firm Initiated","FAX","Florida","B-0248-16","Class III","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Misbranded red blood cells, were distributed. ","01/29/2016","01/29/2016"," W036815047136 (double collection)",11/4/2015,"11/04/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72873,"Terminated","OneBlood, Inc.","3000 W Cypress Creek Rd",".","Fort Lauderdale","FL","33309-1710","United States","Voluntary: Firm Initiated","FAX","FL","B-0222-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood product, which did not meet acceptable product specifications, was distributed.","01/21/2016","01/21/2016"," W036814155275 ",11/4/2015,"11/04/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72874,"Terminated","Fit Firm and Fabulous","1504 Lincoln Way Apt 212",,"Mc Lean","VA","22102-5856","United States","Voluntary: Firm Initiated","Visit","Nationwide in the U.S.A. via the website.","D-0722-2016","Class I","Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.","3000 bottles","Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.","02/18/2016","03/16/2016"," Lot #: 05/02/2015 to 05/01/2017 ",9/29/2015,"09/29/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72875,"Ongoing","Servatii Inc","3888 Virginia Ave",,"Cincinnati","OH","45227-3410","United States","Voluntary: Firm Initiated","Other","Product was sold in OH.","F-1122-2016","Class II"," Christmas Cookie Tray INGREDIENTS: ***Butter, Margarine***Nuts***1.51lb(682gr) EUROPEAN SPECIALTIES Cincinnati, Ohio 45227 UPC 0 36746 03992 9"," trays","The firm was notified by the Ohio Dept of Agriculture that the labeling on the product is misleading.  The firm does not accurately describe the allergens on their label.","04/21/2016",," Product code: 8975, 8977, 8979",12/23/2015,"12/23/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72876,"Ongoing","Morton Grove Pharmaceuticals, Inc.","6451 Main St",".","Morton Grove","IL","60053-2633","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0571-2016","Class III","Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60","39,187 bottles","Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.","01/15/2016",," Lot #: UP1103, Exp 04/2016; UQ1001, Exp 04/2017 ",12/15/2015,"12/15/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0617-2016","Class II","Hepasil, sold in bulk of 500,000 capsules. ","500,000 capsules","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",," Lot # 080315 Exp. Date 03/18",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0544-2016","Class II","Venocell, sold in bulk of 50,000 capsules.","100,000 capsules","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",," Lot # 160614 Exp. Date 06/17 and  Lot # 490914 Exp. Date 10/17",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0542-2016","Class II","Prostamax DUO, 60 capsules per bottle. Manufactured by Sunset Natural Products","4,000 bottles (240,000 capsules)","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",,"  Lot # 140515 Exp. Date 05/18  UPC 850993004055,",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0543-2016","Class II","Prostax Forte, sold in bulk of 50,000 capsules. ","50,000 capsules","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",," Lot # 120315 Exp. Date 03/18",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0541-2016","Class II","Prostaliv, 60 capsules per bottle. Manufactured by Sunset Natural Products","5000 bottles (300,000)","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",," Lot # 180215 Exp Date 02/18  UPC 897666001144, ",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0538-2016","Class II","Chardon de Marie, 60 capsules per bottle. Manufactured by Sunset Natural Products","3,260 bottles (200,000 caps)","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",," Lot # 141214 Exp. Date 12/17  UPC 897666001157",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0537-2016","Class II","Argindione, sold as bulk of 50,000 capsules. ","100,000 capsules","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",," Lot # 480514 Exp. Date 05/17 and  Lot # 320614 Exp. Date 06/17",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0540-2016","Class II","Neuro-Cetin, sold in bulk 50,000 capsules.","50,000 capsules","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",," Lot # 110315 Exp. Date 04/18",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0539-2016","Class II","Moinsage, 60 capsules per bottle. Manufactured by Sunset Natural Products","5,000 bottles (300,000 caps)","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",," Lot # 030615 Exp. Date 07/18  UPC 897666001164 ",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72877,"Ongoing","Sunset Natural Products Inc.","7345 SW 45th St",,"Miami","FL","33155-4509","United States","FDA Mandated","Other","FL and NV","F-0536-2016","Class II","Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products","3,149 bottles (240,000 caps)","Pursuant to a consent decree for injunctive relief the recalling firm was ordered to recall all products because lack of adequate GMPs.","02/17/2016",," Lot # 420415  Exp. Date 04/18  UPC 850993004017",10/5/2015,"10/05/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72878,"Terminated","Innovasis, Inc","614 E 3900 S",".","Salt Lake City","UT","84107-1902","United States","Voluntary: Firm Initiated","Letter","Distributed in US -- CA; KS; OH; & TX.","Z-0662-2016","Class II","Excella II Rod  Cat. No.: SR 55100 5.5 x 100 mm LOT 1502  and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502  Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.    Intended for use in the non-cervical area of the spine.","17 units Labeled SR55100 Lot 1502 with SR55110 rods in package","Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. ","01/19/2016","04/07/2016"," Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502",12/7/2015,"12/07/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72879,"Ongoing","Philips Ultrasound, Inc.","22100 Bothell Everett Hwy",".","Bothell","WA","98021-8431","United States","Voluntary: Firm Initiated","Letter","distributed in CA, CT, ND, NV, OR, RI, TN, and WA.","Z-0596-2016","Class II","Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216  Part Number: 989605449841 with 453561845331 (software version 1.0)","21 units in the US only","Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or Velocity Markers. (e.g.) When the Color Bar conveys that Red is to be displayed for color flow toward the Transducer, the system displays Blue for color flow toward the Transducer. This could result in misdiagnosis in some studies.","01/06/2016",," System Serial numbers:    USD15L0177;  USD15L0178;  USD15L0179;  USD15L0297;  USD15L0298;  USN15L0789;  USN15L0862;  USN15L0863;  USN15L0864;  USN15L0865;  USN15L0866;  USN15L0867;  USN15L0917;  USN15L0918;  USN15L0988;  USO15L0563;  USO15L0564;  USO15L0565;  USO15L0566;  USO15L1087;  and USO15L1088.  ",12/9/2015,"12/09/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72880,"Ongoing","Stryker Sustainability Solutions","1810 W Drake Dr",,"Tempe","AZ","85283-4327","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including the states of AK, NV, VT, FL, CA, CO, WI, IA, MN, OK, PA, MI, OR, KY, and MA.","Z-0629-2016","Class II","Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs    Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236    Indicated for use in patients who require surgery of the extremities.","450 devices","Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa. ","01/12/2016",," Model #5921-218-135 Lot #3490521  Model #5921-034-235 Lot #3531111  Model #5921-034-135 Lot #3733336, 4002152  Model #5921-044-135 Lot #3759409  Model #5921-024-236 Lot #3822485",12/17/2015,"12/17/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72881,"Terminated","BPL Plasma, Inc. ","3744 Blanding Blvd",,"Jacksonville","FL","32210-5243","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0206-16","Class II","Source Plasma","2 units","Blood products, collected from a donor who subsequently tested HIV reactive, were distributed.    ","01/14/2016","01/14/2016"," JK0661633; JK0662276",11/4/2015,"11/04/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72882,"Terminated","The American National Red Cross - Southern Region","9851 Commerce Way",".","Douglasville","GA","30135-3101","United States","Voluntary: Firm Initiated","Telephone","Georgia","B-0208-16","Class III","Blood and Blood Products for Reprocessing",,"Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed","01/07/2016","01/07/2016"," W200314216811",7/15/2015,"07/15/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72882,"Terminated","The American National Red Cross - Southern Region","9851 Commerce Way",".","Douglasville","GA","30135-3101","United States","Voluntary: Firm Initiated","Telephone","Georgia","B-0207-16","Class II","Cryoprecipitated AHF","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed","01/07/2016","01/07/2016"," W200314216811",7/15/2015,"07/15/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72883,"Ongoing","Zatarain's Partnership, L.P.","82 1st St",,"Gretna","LA","70053-4745","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Mississippi, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and Wisconsin","F-0462-2016","Class I","Zatarain's New Orleans Style RED BEANS AND RICE, ORIGINAL, NET WT 8 OZ, UPC 7142909849","1656 units","Zatarain's is initiating a voluntary recall of Zatarain's Red Beans And Rice Original 8 oz. package, USPC 7142909849 with date code of  BEST BY JUL 31 16Z as it may contain Creamy Parmesan Rice  Mix which has a dairy allergen (milk).  ","02/01/2016",," BEST BY JUL 31 16Z",12/17/2015,"12/17/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72885,"Ongoing","Becton, Dickinson and Company, BD Biosciences","2350 Qume Dr",,"San Jose","CA","95131-1812","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0628-2016","Class III","FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.","1,388 units","Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation.  The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%.","01/11/2016",," Lot No. 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, 5182818",12/14/2015,"12/14/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72886,"Ongoing","Fagron, Inc","2400 Pilot Knob Rd",,"Saint Paul","MN","55120-1118","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0654-2016","Class II","SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.    ","44 Bottles","Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.  ","02/05/2016",," Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406  ",11/11/2015,"11/11/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72886,"Ongoing","Fagron, Inc","2400 Pilot Knob Rd",,"Saint Paul","MN","55120-1118","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0655-2016","Class II","SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1167-9.  ","148 Bottles","Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.  ","02/05/2016",," Lot #s: 15A05-U03-022765; 15G29-U03-025975",11/11/2015,"11/11/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72886,"Ongoing","Fagron, Inc","2400 Pilot Knob Rd",,"Saint Paul","MN","55120-1118","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0656-2016","Class II","SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.  ","88 Bottles","Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.  ","02/05/2016",," Lot #s: 15J26-U05-027457; 15J26-U05-027473",11/11/2015,"11/11/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72887,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, GA, MA, MS, OH, VA, CA, IA, MD, NH, OK, VT, CO, IL, ME, NJ, OR, WA, CT, IN, MI, NM, PA, WI, DE, KS, MN, NV, RI, WY, FL, KY, MO, NY and TX.","F-0532-2016","Class I","Dove Chocolate Assortment Snowflakes Net. Wt. 24.0 oz. Distributed by Mars Chocolate na, llc Hackettstown, NJ 07840-1503 USA  UPC 400050521","6582 cases ","Dove  Chocolate Assortment Snowflakes may contain undeclared peanuts, what and egg ingredients.","02/02/2016",," Code and Best Before Dates include:  537CG4PA30: Best Before 9/2016  537DG4PA30: Best Before 9/2016  538AG4PA30: Best Before 9/2016  538AM4PA30: Best Before 9/2016  541AG4PA20: Best Before 10/2016  542EM4PA20: Best Before 10/2016",12/17/2015,"12/17/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72888,"Ongoing","AA USA Trading Inc.","47 Reid St",,"South River","NJ","08882-1185","United States","Voluntary: Firm Initiated","Letter","NJ and NY","F-0528-2016","Class I","Dried Kiwi Slice, Net Wt: 8 oz., UPC 6 944155 210041","200 bags","AA USA Trading Inc. is recalling Dried Tai Sweet Mango Slice (FL 378858) because the product contains undeclared FD&C Yellow #6 and Dried Kiwi Slice (FL 378859 because this product contains undeclared FD&C Blue #1, Yellow #5 and undeclared sulfites.","02/17/2016",," N/A",12/14/2015,"12/14/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72888,"Ongoing","AA USA Trading Inc.","47 Reid St",,"South River","NJ","08882-1185","United States","Voluntary: Firm Initiated","Letter","NJ and NY","F-0527-2016","Class I","Dried Tai Sweet Mango Slice, Net Wt: 8 oz., UPC 6 944155 210102","200 bags","AA USA Trading Inc. is recalling Dried Tai Sweet Mango Slice (NYSDAM FL: 378858) because the product contains undeclared FD&C Yellow #6 and Dried Kiwi Slice (NYSDAM FL: 378859) because this product contains undeclared FD&C Blue #1, Yellow #5 and undeclared sulfites.","02/17/2016",," N/A",12/14/2015,"12/14/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72889,"Ongoing","Lee'S Food Corp","24 Commerce Rd Ste O",,"Fairfield","NJ","07004-1600","United States","Voluntary: Firm Initiated","Letter","NJ and NY","F-0355-2017","Class III"," Biscuit Snack, Net Wt. 30 g, UPC 4 800098 122952","20 cases","Sampling analysis revealed the product contains undeclared colors (FD&C Red #3 and Red #40).","11/10/2016",," N/A",11/13/2015,"11/13/2015",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72890,"Ongoing","Maquet Datascope Corp - Cardiac Assist Division","1300 MacArthur Blvd.",,"Mahwah","NJ","07430-2052","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution- Nationwide Distribution including Puerto Rico.","Z-1248-2016","Class II","Cardiosave Hybrid and rescue IABP  ","1243 units US; 1107 units OUS","Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.","03/25/2016",," Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83",12/16/2015,"12/16/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72891,"Ongoing","Grato Holdings, Inc.","201 Apple Blvd",".","Woodbine","IA","51579-1503","United States","Voluntary: Firm Initiated","Letter","Nationwide and to Guatemala and Canada.","D-0577-2016","Class II","Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Joint Pain & Stiffness Relief, homeopathic spray, UPC 8 18692 00890 3, NDC 43846-0042-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA  ","224 bottles","Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count","01/20/2016",," Lot: G9471",12/22/2015,"12/22/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72891,"Ongoing","Grato Holdings, Inc.","201 Apple Blvd",".","Woodbine","IA","51579-1503","United States","Voluntary: Firm Initiated","Letter","Nationwide and to Guatemala and Canada.","D-0575-2016","Class II","Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and  peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA     ","118 bottles","Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count","01/20/2016",," Lot: G9471",12/22/2015,"12/22/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72891,"Ongoing","Grato Holdings, Inc.","201 Apple Blvd",".","Woodbine","IA","51579-1503","United States","Voluntary: Firm Initiated","Letter","Nationwide and to Guatemala and Canada.","D-0579-2016","Class II","Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA   ","90 bottles","Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count","01/20/2016",," Lot: G9471",12/22/2015,"12/22/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72891,"Ongoing","Grato Holdings, Inc.","201 Apple Blvd",".","Woodbine","IA","51579-1503","United States","Voluntary: Firm Initiated","Letter","Nationwide and to Guatemala and Canada.","D-0576-2016","Class II","Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell Laboratories, Muscle/Tendon Pain & Stress Relief, Topical Homeopathic Spray, NDC 50845-0219-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Muscle/Tendon Pain & Stress Relief, homeopathic spray, UPC 8 18692 00870 5, NDC 43846-0043, Dist. by Peaceful Mountain, Inc. Woodbine, IA   ","201 bottles","Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count","01/20/2016",," Lot: G9471",12/22/2015,"12/22/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72891,"Ongoing","Grato Holdings, Inc.","201 Apple Blvd",".","Woodbine","IA","51579-1503","United States","Voluntary: Firm Initiated","Letter","Nationwide and to Guatemala and Canada.","D-0578-2016","Class II","Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC 50845-0215-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Shingles Pain & Ulceration Relief, homeopathic spray, UPC 8 18692 00875 0, NDC 43845-0044-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA   ","371 bottles","Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count","01/20/2016",," Lot: G9471",12/22/2015,"12/22/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72891,"Ongoing","Grato Holdings, Inc.","201 Apple Blvd",".","Woodbine","IA","51579-1503","United States","Voluntary: Firm Initiated","Letter","Nationwide and to Guatemala and Canada.","D-0580-2016","Class II","Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray, UPC 8 18692 00895 8, NDC 43846-0045-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA   ","118 bottles","Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count","01/20/2016",," Lot: G9471",12/22/2015,"12/22/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72892,"Ongoing","GE Medical Systems, LLC","3200 N Grandview Blvd",".","Waukesha","WI","53188-1693","United States","Voluntary: Firm Initiated","Telephone","Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY.","Z-0553-2016","Class II","GE Healthcare, 3.0T 6 Channel Phased Array  Flex Coil, M0050SS.    Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.   ","90 (54 US; 36 OUS)","GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners.    Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.","12/28/2015",," 	  Mfg Lot or Serial #	System ID  00000001140049	BMDACCMR1  00000001140050	BMDACCMR1  0000011-4-0050	BMDACCMR1  0000011-4-0009	920568MR3T  0000011-4-0015	920568MR3T  0000011-4-0017	602406IMR  0000011-4-0018	602406IMR  0000011-4-0024	602406IMR  0000014-4-0007	602406IMR  0000011-4-0028	626359MR3  0000011-4-0032	626359MR3  0000011-4-0046	MSK68MR4  0000011-4-0047	MSK68MR4  0000028-3-0011	MSK68MR4  0000044-4-0046	MSK68MR4  0000011-4-0064	415CB3TW  0000011-4-0065	415CB3TW  0000011-4-0066	415723SHAW12  0000011-4-0067	415723SHAW12  0000011-4-0075	616267IMRI  0000011-4-0076	616267IMRI  011-4-0085	616267IMRI  011-4-0170	616267IMRI  0000011-4-0094	330344MR750W  011-4-0118	330344MR750W  0000011-4-0101	713792CMR1  0000011-4-0102	713792CMR1  0000011-4-0107	317887MR3  0000011-4-0108	317887MR3  0000011-4-0114	309655MR750W  0000011-4-0115	309655MR750W  011-4-0117	517353DVMR  011-4-0172	517353DVMR  011-4-0119	614293MR9  011-4-0120	614293MR9  011-4-0124	MR229050  077-4-0123	MR229050  011-4-0125	6053223TMR  011-4-0126	6053223TMR  011-4-0129	6053223TMR  011-4-0130	6053223TMR  011-4-0146	480342MR3  011-4-0149	480342MR3  011-4-0154	773665SJMR2  011-4-0155	773665SJMR2  011-4-0162	720848MR4  011-4-0164	720848MR4  0000011-4-0055	415723SCHMR2  0000011-4-0062	405271OUCMR  0000011-4-0080	847872ZMR2  0000011-4-0106	949760MR3  011-4-0169	415UCBHMR3  MISSING_SN_GON4217108	408358SHMR13  Missing_SN_GON4227287	309655IMRI  0000011-4-0019	416369MR3T  0000011-4-0020	416369MR3T  011-4-0128	E416249MR2  11-4-0127	E416249MR2  0000011-4-0027	082427040101  0000011-4-0033	082427040101  0000011-4-0133	082427040167  0000011-4-0134	082427040167  0000011-4-0086	CS1006MR03  0000011-4-0092	CS1006MR03  0000011-4-0153	CS1006MR03  0000011-4-0158	A5547422  0000011-4-0159	A5547422  0000011-4-0103	EM0229  0000011-4-0104	EM0229  0000011-4-0156	EM0276  0000011-4-0157	EM0276  0000011-4-0165	EM0276  0000011-4-0166	EM0276  0000028-4-0016	RTD0191  0000011-4-0060	RTD0191  0000011-4-0061	RTD0191  0000011-4-0093	0920279024  0000011-4-0098	0920279024  0000011-4-0034	PER08626",12/7/2015,"12/07/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72893,"Ongoing","National Vitamin Co Inc","1145 W Gila Bend Hwy",,"Casa Grande","AZ","85122-4308","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0568-2016","Class III","Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01","29,827 bottles","Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.","01/12/2016",," Lot #: 5EA46, Exp 02/17",12/18/2015,"12/18/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72894,"Ongoing","Natus Medical Incorporated","5900 1st Ave S",,"Seattle","WA","98108-3248","United States","Voluntary: Firm Initiated","Letter","Distribution US nationwide and Pakistan.","Z-1363-2016","Class II","Medix NatalCare ST-LX Intensive Care Incubator.  Neonatal incubator.","75 units (65 units in the US and 10 units in Pakistan)","NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.","04/11/2016",," Serial numbers:    5337; 5336; 5335; 5334; 5333; 5332; 5331; 5330; 5329; 5328; 5327; 5326; 5325; 5324; 5323; 5294; 5293; 5292; 5291; 5290; 5289; 5287; 5283; 5282; 5281; 5280; 5278; 5277; 5276; 5257; 5256; 5255; 5254; 5253; 5252; 5251; 5250; 5249; 5248; 5228; 5227; 5226; 5225; 5224; 5223; 5222; 5221; 5220; 5219; 5214; 5213; 5212; 5211; 5210; 5209; 5139; 5138; 5136; 5135; 5134; 5133; 5132; 5131; 5130; 5129; 5097; 5096; 5057; 5056; 5053; 5051; 5048; 5047; 5046; 5045.",1/8/2016,"01/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72895,"Terminated","American Red Cross Blood Services","700 Caldwell Trace",,"Birmingham","AL","35242","United States","Voluntary: Firm Initiated","E-Mail","Georgia","B-0210-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed","01/14/2016","01/14/2016"," 041FN84337",8/20/2015,"08/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72896,"Ongoing","Cyberonics, Inc","100 Cyberonics Blvd",".","Houston","TX","77058-2069","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.","Z-0659-2016","Class II","VNS Therapy AspireSR Generator Model 106.    Indicated for use as an adjunctive therapy in reducing the frequency of seizures. ","4,935 units"," events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.  ","01/15/2016",," All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061",12/18/2015,"12/18/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72897,"Ongoing","Skytron, Div. The KMW Group, Inc","5085 Corporate Exchange Blvd Se",,"Grand Rapids","MI","49512-5515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV  and Internationally to Canada, and Japan.","Z-0655-2016","Class II","Ergon 2 Articulating Equipment Boom Monitor Brackets    mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms","286","The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket.  A display interface falling from its mounting location may result in injury to the patient or provider. ","01/14/2016",," Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH.  VESA plates distributed from 09/26/08 to 04/30/13.",12/2/2015,"12/02/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72898,"Ongoing","A.R.Food Brokerage Corp.","Centro Comercial Turabo Gardens"," Ave. Shufford Esq. Calle 16","Caguas","PR","00725","United States","Voluntary: Firm Initiated","Letter","RA Food Brokerage, Corp. distributed the affected product to retailers located in Puerto Rico only.","F-0572-2016","Class II",".","4052 cases/24 cans per case","Product in Import Alert  (99-38) inadvertently released for distribution.","02/10/2016",," lot ID GGVBG-3615",12/10/2015,"12/10/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72898,"Ongoing","A.R.Food Brokerage Corp.","Centro Comercial Turabo Gardens"," Ave. Shufford Esq. Calle 16","Caguas","PR","00725","United States","Voluntary: Firm Initiated","Letter","RA Food Brokerage, Corp. distributed the affected product to retailers located in Puerto Rico only.","F-0571-2016","Class II",".","813 cases/24 cans ea.","Product in Import Alert (99-38) inadvertently released for distribution.","02/10/2016",," lot ID GGVBG 2915 ",12/10/2015,"12/10/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1112-2016","Class II","Product 14 consists of all product under  product code HSB  , and same usage:  Item no:	  225600230	ASIA ONE-PIECE LAG SCREW  225600232	ASIA ONE-PIECE LAG SCREW  225600235	ASIA ONE-PIECE LAG SCREW  225600237	ASIA ONE-PIECE LAG SCREW  225600240	ASIA ONE-PIECE LAG SCREW  225600242	ASIA ONE-PIECE LAG SCREW  225600245	ASIA ONE-PIECE LAG SCREW  225600227	ASIA ONE-PIECE LAG SCREW 70MM    Product Usage:  An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61902234  61930449  62238240  61781914  61818112  61873640  61873641  61921821  61930453  62142331  62171289  61656184  61656185  61663560  61818114  61818116  61818118  61873642  61930459  61969224  61969225  62118686  62238244  62250669  62279154  62279156  61640868  61781919  61781920  61866144  61866145  61969228  62122251  62142308  62171295  62255624  62279159  61663622  61781922  61781927  61831643  61862302  61930474  62142311  62232636  62238251  62283223  62283223N  61663623  61781928  61866147  62092290  62155425  62031720  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1145-2016","Class II","Product 47 consists of all product under  product code: LPH and same usage:  Item no:	  611004022	MODULAR CUP 10 DEGREE LIN  611004428	MODULAR CUP 10 DEGREE LIN  611004628	MODULAR CUP 10 DEGREE LIN  611004828	MODULAR CUP 10 DEGREE LIN  611004832	MODULAR CUP 10 DEGREE LIN  611005028	MODULAR CUP 10 DEGREE LIN  611005032	MODULAR CUP 10 DEGREE LIN  611005628	MODULAR CUP 10 DEGREE LIN  611005632	MODULAR CUP 10 DEGREE LIN  611005828	MODULAR CUP 10 DEGREE LIN  611005832	MODULAR CUP 10 DEGREE LIN  611006028	MODULAR CUP 10 DEGREE LIN  611006032	MODULAR CUP 10 DEGREE LIN  611006228	MODULAR CUP 10 DEGREE LIN  611006232	MODULAR CUP 10 DEGREE LIN  611006428	MODULAR CUP 10 DEGREE LIN  611006432	MODULAR CUP 10 DEGREE LIN  611006628	MODULAR CUP 10 DEGREE LIN  611006832	MODULAR CUP 10 DEGREE LIN  611007028	MODULAR CUP 10 DEGREE LIN  612004626	MODULAR CUP 20 DEGREE LIN  612004628	MODULAR CUP 20 DEGREE LIN  612004828	MODULAR CUP 20 DEGREE LIN  612004832	MODULAR CUP 20 DEGREE LIN  612005028	MODULAR CUP 20 DEGREE LIN  612005032	MODULAR CUP 20 DEGREE LIN  612005628	MODULAR CUP 20 DEGREE LIN  612005828	MODULAR CUP 20 DEGREE LIN  612005832	MODULAR CUP 20 DEGREE LIN  612006028	MODULAR CUP 20 DEGREE LIN  612006032	MODULAR CUP 20 DEGREE LIN  610504428	MODULAR CUP NEUTRAL LINER  610504832	MODULAR CUP NEUTRAL LINER  610505028	MODULAR CUP NEUTRAL LINER  610505032	MODULAR CUP NEUTRAL LINER  610505632	MODULAR CUP NEUTRAL LINER  610505832	MODULAR CUP NEUTRAL LINER  610506032	MODULAR CUP NEUTRAL LINER  610506232	MODULAR CUP NEUTRAL LINER    For use in total hip arthroplasty","30","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61890322  62213292  62215053  62277522  62402117  61921671  62207256  62212215  62241126  62251893  62268498  62281865  62396132  62402115  62024672  62176459  62210646  62215051  62221907  62241128  62241129  62266480  62277523  62402113  62402114  62406796  62202293  62218187  62255246  62281866  62354788  62396145  62406802  61882636  61890326  61942630  61943368  61957706  61957708  61957709  61968019  61983748  61983749  62109144  62109145  62143889  62163554  62173374  62176463  62188368  62197359  62197360  62197361  62204040  62204041  62204042  62204632  62204633  62204634  62207259  62210647  62210648  62213295  62221909  62221910  62226817  62233573  62238101  62241131  62241135  62241136  62241137  62241139  62241142  62241144  62241145  62251896  62251897  62251898  62251899  62251901  62255247  62266481  62266482  62277524  62284060  62352923  62358047  62383751  62383752  62383753  62383754  62386984  62386985  62402212  62402217  61882637  61885966  61889305  61976198  62147389  62170705  62191282  62197358  62199480  62199481  62210649  62210650  62218188  62218189  62218190  62236577  62236578  62241147  62251895  62258978  62260179  62260180  62352924  62358045  62388057  62402126  62402213  61890327  61968020  62170708  62188373  62207257  62207258  62226818  62241149  62241150  62251902  62258976  62268506  62383758  62383759  62396119  62396120  62396121  61980814  62170709  62202294  62202295  62236582  62258974  62260181  62260182  62352926  62358046  62383761  62396133  61976203  62170710  62176464  62191285  62193578  62221912  62226823  62241152  62250619  62251903  62265335  62354787  62396122  62396123  62403713  62406785  61885968  61980816  62167449  62198732  62202296  62218192  62241154  62266483  62354789  62389394  62389395  62402214  61919746  62170712  62207260  62226819  62226820  62251112  62265336  62383760  62402140  62406770  61882639  61980817  62167448  62218193  62266484  62396135  62403714  62406808  61882640  62199479  62233574  62258975  62396149  6198",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1149-2016","Class II","Product 51 consists of all product under  product code: JWH and same usage:  Item no:	  598603701	NEXGEN OPTION STEMMED TIB  598603702	NEXGEN OPTION STEMMED TIB  598604701	NEXGEN OPTION STEMMED TIB  598604702	NEXGEN OPTION STEMMED TIB  598605701	NEXGEN OPTION STEMMED TIB  598605702	NEXGEN OPTION STEMMED TIB    for use in total knee arthroplasty","29525","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61627858  61667594  61687053  61687057  61711627  61711636  61711638  61711640  61711642  61787558  61787559  61787560  61787561  61787562  61791460  61791462  61791464  61791466  61791467  61791468  61797925  61797926  61797927  61797928  61797929  61797930  61797931  61797932  61797933  61809215  61809216  61809217  61809218  61809219  61816553  61820496  61820497  61820498  61823244  61823245  61823246  61823247  61823248  61829314  61829315  61829316  61829317  61829318  61838186  61838187  61838188  61838189  61838190  61850512  61850513  61850515  61850516  61850517  61861391  61861392  61861393  61861394  61861395  61865095  61865096  61865097  61865098  61870089  61870090  61870091  61870092  61875986  61875987  61875988  61875989  61875990  61879452  61879453  61879454  61890348  61890349  61890350  61890351  61890352  61890353  61898708  61898709  61898710  61898711  61907203  61907204  61907206  61907207  61907208  61907210  61919431  61919432  61919437  61919439  61919442  61919443  61925054  61925055  61925056  61925057  61925058  61925059  61925060  61926866  61926867  61926868  61926869  61926870  61936965  61936966  61936967  61936968  61936969  61940695  61940696  61940697  61940698  61940699  61952663  61952664  61952665  61952666  61952667  61962903  61962904  61962905  61962906  61962907  61969272  61969273  61969274  61969275  61969276  61979874  61979875  61979876  61979877  61984968  61984969  61984970  61984971  61996251  61996252  61996253  61996254  61996255  61996256  61996257  62005997  62005998  62005999  62006000  62006001  62006002  62006003  62006004  62006005  62011711  62011712  62011713  62011714  62011715  62011716  62018183  62018184  62018185  62022090  62022091  62022092  62025944  62025945  62025946  62025947  62037053  62037054  62037055  62037056  62037887  62037888  62037889  62049124  62049125  62049126  62082044  62082045  62082046  62082047  62082048  62095801  62095802  62095803  62095804  62095805  62102707  62102708  62102709  62102710  62102716  6211",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1137-2016","Class II","Product 39 consists of all product under  product code: JDI  and same usage:  Item no:	  32902605800	ION IMPLANTED FEM 22MM LO  32902604900	ION IMPLANTED FEM 26MM ME  32902603900	ION IMPLANTED FEM 26MM SH    For use in total or hemi hip arthroplasty","17","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62065298  62221052  62221052N  62093457  62185967  62268539  62334044  62268539N  61555436  62162471  62221049  62268540  62285362  62268540N  62285362N  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1123-2016","Class II","Product 25 consists of all product under product code: LPH and same usage:  Item no:	  234703104	DISTAL MEDIAL FEMORAL CON  234703206	DISTAL MEDIAL FEMORAL CON  234703208	DISTAL MEDIAL FEMORAL CON  234800504	DISTAL POSTERIOR/LATERAL  234800506	DISTAL POSTERIOR/LATERAL  234800508	DISTAL POSTERIOR/LATERAL  234800510	DISTAL POSTERIOR/LATERAL  234800604	DISTAL POSTERIOR/LATERAL  234800606	DISTAL POSTERIOR/LATERAL  234800608	DISTAL POSTERIOR/LATERAL  234800610	DISTAL POSTERIOR/LATERAL  234800614	DISTAL POSTERIOR/LATERAL    For use in total hip arthroplasty","2","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62233575  62255244  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1136-2016","Class II","Product 38 consists of all product under  product code: HSB and same usage:  Item no:	  225303255	INTERLOCKING IM SCREW LG  225303555	INTERLOCKING IM SCREW LG  225303755	INTERLOCKING IM SCREW LG  225307055	INTERLOCKING IM SCREW LG  225302742	INTERLOCKING IM SCREW MED  225303242	INTERLOCKING IM SCREW MED  225307042	INTERLOCKING IM SCREW MED  225302737	INTERLOCKING IM SCREW SML  225303237	INTERLOCKING IM SCREW SML    Product Usage:  An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.  ","4752","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61793328  62253390  61641813  62194666  61993625  62262085  62313056  62313056N  62021140  62312364  62312364N  61817404  61809837  61851878  61987145  62165485  62244841  62244854  61763549  61826386  61851889  61968098  62114111  62114112  62172486  61804389  61841502  61872521  61962448  61983689  62137121  62244852  61665045  61841504  62031683  62137150  62244853  61809838  62306323  62306323N  61830462  61809839  62189554  61804722  61830471  62165499  62165501  62189558  61809843  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1103-2016","Class II","Product 5 consists of all products under  product code HWC, and same usage:  Item no:	  	  47482701001	2.7MM CORT. SCREW 10MM, S  47482701201	2.7MM CORT. SCREW 12MM, S  47482701401	2.7MM CORT. SCREW 14MM, S  47482701601	2.7MM CORT. SCREW 16MM, S  47482701801	2.7MM CORT. SCREW 18MM, S  47482702001	2.7MM CORT. SCREW 20MM, S  	  	  	Product Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","60","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no:  61920802  62254418  61920804  61920805  61920806  62040737  61920807  62040736  61929794  62040738  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1108-2016","Class II","Product 10consists of all product under product code HWC, and same usage:  Item no:	  47484502601	4.5 X 26 CORT SCREW SELF  	  	  Product Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","2","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no:61854116  61930079  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1152-2016","Class II","Product 54 consists of all product under product code: JWH and same usage:  Item no:	  596009900	NEXGEN TAPER PLUG  for use in total knee arthroplasty","1767","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61390872  61761213  61780493  61780494  61780495  61780496  61780497  61789111  61789112  61789113  61789114  61789115  61789116  61789117  61789118  61789119  61789120  61789121  61789122  61789123  61789124  61789125  61789126  61789127  61789128  61789129  61789130  61789131  61789132  61789133  61789134  61789135  61789136  61789137  61789138  61789139  61789140  61789141  61789142  61798737  61798738  61798739  61798740  61798741  61798742  61798743  61798744  61798745  61798746  61799383  61799384  61799385  61799386  61799387  61799388  61799389  61799390  61799391  61799392  61803606  61803607  61803608  61803609  61803610  61803611  61803612  61803613  61803614  61803615  61807320  61807321  61807322  61807323  61807324  61807325  61807326  61807327  61807328  61807329  61807330  61809795  61809796  61809797  61809798  61809799  61809801  61809802  61809803  61809804  61809805  61816959  61816960  61816961  61816962  61816963  61816964  61816965  61816966  61816967  61816968  61816969  61816970  61816971  61816972  61816973  61816974  61816975  61821036  61821037  61821038  61821039  61821040  61821041  61821042  61821043  61821044  61821645  61821646  61821647  61821648  61821649  61821650  61821651  61821652  61821653  61821654  61821655  61821656  61824212  61824213  61824214  61824215  61824218  61824219  61824220  61824221  61824222  61824223  61824224  61824225  61824226  61841214  61841215  61841216  61841217  61841218  61841219  61841220  61841221  61841222  61841223  61841224  61841225  61841226  61841227  61841228  61853071  61853072  61853073  61853074  61853075  61853076  61853077  61853078  61853079  61853080  61854884  61854885  61854886  61854887  61854888  61854889  61854890  61854891  61854892  61854893  61854895  61854896  61854897  61854898  61854899  61854901  61854902  61854903  61854904  61854908  61859266  61859267  61859268  61859269  61859270  61859271  61859272  61859273  61859274  61859275  61859276  61859277  61859278  61859279  61859280  61861407  61861408  6186",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1169-2016","Class II","Product 71 consists of all product under product code: JDI and same usage:  Item no:	  783401000	VERSYS PRESS FIT LD/FX ST  783401100	VERSYS PRESS FIT LD/FX SZ  783401200	VERSYS PRESS FIT LD/FX SZ  783401300	VERSYS PRESS FIT LD/FX SZ  783401400	VERSYS PRESS FIT LD/FX SZ  783401500	VERSYS PRESS FIT LD/FX SZ  783401600	VERSYS PRESS FIT LD/FX SZ    For use in total or hemi hip arthroplasty","2388","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62141788  62194578  62284482  62284482N  61870886  61885906  61952556  61952557  62024629  62065277  62076884  62097070  62125314  62147327  62167372  62193417  62194579  62221879  62270707  62298289  62310428  62340081  62360302  61886895  61953169  62036899  62046493  62055999  62065278  62097073  62106807  62125315  62127736  62141792  62151830  62167373  62183148  62194580  62208755  62210445  62291930  62310435  62324097  62333971  62340080  62358910  62362926  61881190  61890332  61953170  61964733  62033228  62056001  62073507  62076886  62080036  62080037  62097076  62106804  62137224  62141789  62147328  62151832  62165198  62165199  62178286  62181429  62183150  62204531  62207225  62208757  62210446  62270709  62291929  62310430  62310432  62320165  62333970  62340077  62340078  62345388  62345389  62354664  62358904  62358905  61873652  61882614  61885902  61885904  61891301  61969293  62033229  62042592  62052831  62060680  62097077  62100687  62106802  62106803  62137225  62141790  62165201  62165202  62183149  62203186  62210447  62215710  62227046  62240749  62240750  62291931  62312488  62324096  62333976  62333978  62358908  62358909  61834957  61878471  61952559  61957434  61964735  62017573  62033230  62073508  62076888  62100688  62106805  62133327  62141791  62161482  62181430  62203187  62218181  62240751  62270711  62298290  62325574  62340079  61864115  62033231  62056002  62076889  62106806  62137226  62165203  62194581  62218180  62312489  62340082  62358903  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1101-2016","Class II","Product 3 consists of all products under product code JDI, and same usage:  Item no:781803800	12/14 UNIPOLAR FEMORAL HE  781804000	12/14 UNIPOLAR FEMORAL HE  781804100	12/14 UNIPOLAR FEMORAL HE  781804200	12/14 UNIPOLAR FEMORAL HE  781804300	12/14 UNIPOLAR FEMORAL HE  781804400	12/14 UNIPOLAR FEMORAL HE  781804500	12/14 UNIPOLAR FEMORAL HE  781804600	12/14 UNIPOLAR FEMORAL HE  781804700	12/14 UNIPOLAR FEMORAL HE  781804800	12/14 UNIPOLAR FEMORAL HE  781804900	12/14 UNIPOLAR FEMORAL HE  781805000	12/14 UNIPOLAR FEMORAL HE  781805100	12/14 UNIPOLAR FEMORAL HE  781805200	12/14 UNIPOLAR FEMORAL HE  781805300	12/14 UNIPOLAR FEMORAL HE  781805400	12/14 UNIPOLAR FEMORAL HE  781805500	12/14 UNIPOLAR FEMORAL HE  781806300	12/14 UNIPOLAR FEMORAL HE  781809900	12/14 UNIPOLAR FEMORAL HE  781809901	12/14 UNIPOLAR FEMORAL HE  781809902	12/14 UNIPOLAR FEMORAL HE    Product For use in total or hemi hip arthroplasty  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","2,239","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.62097104  62207231  62219224  62340091  62340091N  61643437  62268552  62340092  62340092N  61679532  61928512  62340093  62340093N  61885911  61885912  61885913  61957517  62182418  62219225  62240286  61885914  61885915  61947602  62134035  62182412  62188330  62240287  62340096  62340096N  61633850  61633854  62138595  62240289  62240809  62322617  62322617N  61545831  61630163  61986626  62240291  62329068  62329068N  61664534  61847124  61923939  62134030  62142871  62175266  62180219  62199414  62199415  62211996  62216689  62234491  62249032  62249033  62322611  62334011  62322611N  62334011N  61630305  61847131  61947598  61952494  62100692  62151857  62203217  62216691  62216692  62240302  62240810  62240811  62334008  62334008N  370550  61947601  61987197  62222767  62235720  62332949  62332950  62332949N  62332950N  61825735  61856097  62175257  62211992  62275064  61658071  61947594  62260133  62334010  62334010N  61847130  61987198  62175263  62194590  62215697  62240814  62240815  62266498  62334002  62334002N  61882247  61891121  61953143  61966580  62065323  62140350  62333999  62333999N  61575673  62097102  62112174  62216690  62284346  62079945  61567514  61899124  61899125  61899126  61900614  61953163  61953164  62125310  62178695  62182839  62186365  62188290  62189402  62194575  62194576  62195515  62197292  62199391  62207223  62208752  62255219  62262673  62303511  62305939  62312480  62312481  62315850  62315851  62339012  62339013  62339014  62364761  62364762  62364763  62381462  62381463  62383206  62383308  62384251  62384252  62384253  62389775  62389776  62389777  62389779  62396405  62396482  62396483  62396484  62303511N  62305939N  62312480N  62312481N  62315850N  62315851N  61589036  61589038  61593808  62188291  62189400  62299081  62312482  62322469  62339015  62381465  62389780  62396485  62299081N  62312482N  62322469N  62076892  62125313  62172046  62189401  62315853  62364760  62315853N   ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1159-2016","Class II","Product 61 consists of all product under product code: JWH and same usage:  Item no:	  598003712	STD PRECOAT TIBIA PLATE S    for use in total knee arthroplasty","39","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61678240  61838251  61838252  61838253  61838254  61901158  61901159  61925016  61926797  61958844  61958845  61999206  61999207  62037903  62037904  62037905  62070148  62070149  62141260  62170961  62191179  62220224  62232384  62245104  62284609  62298550  62298551  62313021  62319305  62326309  62359946  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1113-2016","Class II","Product 15 consists of all product code JDI  , and same usage:  Item no:	  805002802	ASTEL FEM HEAD +0X28MM DI  805002805	ASTEL FEM HEAD +10.5X28MM  805002803	ASTEL FEM HEAD +3.5X28MM  805002804	ASTEL FEM HEAD +7X28MM DI  805002801	ASTEL FEM HEAD -3.5X28MM    Usage:  For use in total or hemi hip arthroplasty    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62154349  62263555  62270747  62315652  62389960  62212034  62270748  62389957  37107513  62154348  62212021  62270746  62299145  62389956  62299145N  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1153-2016","Class II","Product 55 consists of all product under product code: HSB and same usage:  Item no:	  225900132	ONE-PIECE LAG SCREW 11MM  225900135	ONE-PIECE LAG SCREW 11MM  225900137	ONE-PIECE LAG SCREW 11MM  225900140	ONE-PIECE LAG SCREW 11MM  225900142	ONE-PIECE LAG SCREW 11MM  225900145	ONE-PIECE LAG SCREW 11MM  225900152	ONE-PIECE LAG SCREW 11MM  Usage:  An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.  ","58320","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62133636  61882374  61964347  61987304  62133643  62171285  62298481  61969229  62080367  62292385  61657722  61930479  61930480  61930481  62109268  61136016  61930482  62098917  62098918  61764507  61764508  61764509  61895897  61895905  61895907  61895908  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1155-2016","Class II","Product 57 consists of all product code: JDI and same usage:  Item no:	  763401000	PRESSFIT FEM ST FX 10 X 115  763401100	PRESSFIT FEM ST FX 11 X 1  763401200	PRESSFIT FEM ST FX 12 X 1  763401300	PRESSFIT FEM ST FX 13 X 1  763401400	PRESSFIT FEM ST FX 14 X 1  763401500	PRESSFIT FEM ST FX 15 X 1    For use in total or hemi hip arthroplasty","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62012579  62086025  62086025N  62055993  62264285  62362923  62264285N  62151833  62284483  62362921  62284483N  62224932  62284484  62340084  61886896  62043474  62141793  62284485  62362930  62284485N  62240754  62293494  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1148-2016","Class II","Product 50 consists of all product under  product code: JWH and same usage:  Item no:	  595002701	NEXGEN MIS TIBIA PLATE PR  595002702	NEXGEN MIS TIBIA PLATE PR  595003701	NEXGEN MIS TIBIA PLATE PR  595003702	NEXGEN MIS TIBIA PLATE PR  595003712	NEXGEN MIS TIBIA PLATE PR  595004701	NEXGEN MIS TIBIA PLATE PR  595004702	NEXGEN MIS TIBIA PLATE PR  595005701	NEXGEN MIS TIBIA PLATE PR  595005702	NEXGEN MIS TIBIA PLATE PR    for use in total knee arthroplasty","5567","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61774117  62141262  62193298  62251564  62261955  61672554  61672555  61672558  61774118  61774119  61774120  61827109  61827110  61827111  61863080  61863081  61863083  61863084  61863085  61912434  61915370  61915371  61979021  61979022  61979023  62016175  62020276  62041296  62060610  62069533  62091728  62141255  62141256  62141257  62155305  62155306  62155307  62177111  62214660  62214661  62214662  62214663  62214664  62251565  62251566  62271420  62298567  62315723  62319301  62326315  62337922  62337923  61442295  61672561  61672562  61721670  61774134  61774135  61774136  61774137  61774140  61774141  61774142  61827112  61827113  61827114  61827115  61827116  61863088  61863090  61863091  61863093  61863094  61898777  61898778  61898779  61898780  61898781  61912437  61914863  61914864  61914865  61934678  61934679  61934680  61934681  61934682  61958855  61958856  61958857  61958858  61979024  61979025  61979026  61979027  61993771  61993773  61993774  61993775  61993776  62022557  62029925  62029926  62029927  62037892  62041300  62041301  62041302  62060611  62060612  62064931  62064932  62064933  62069538  62077846  62077847  62077848  62080358  62080359  62080360  62143198  62143199  62143201  62143601  62143602  62143603  62168181  62168182  62193299  62193301  62193302  62193303  62200277  62200278  62200279  62214665  62214666  62214667  62214668  62214669  62227415  62227416  62227417  62271422  62271423  62271424  62271425  62271426  62284606  62284607  62284608  62298568  62298569  62319299  62326502  62326503  62332546  62332547  62335852  62335864  62345560  62357204  62357205  61774143  61774144  61774145  61774146  61774147  61774148  61827117  61827118  61827119  61863112  61863113  61863114  61863115  61863116  61912438  61914866  61914867  61914868  61914869  61934684  61934685  61934686  61934687  61958859  61958860  61958861  61979028  61979029  61979030  62016156  62016157  62016158  62022554  62022555  62029928  62029929  62029930  62041303  62041304  62060613  6206",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1102-2016","Class II","Product 4 consists of all products under  product code HWC, and same usage:  Item no:	  47482002603	2.0 X 26 CORT SCREW CRUCI  47482002803	2.0 X 28 CORT SCREW CRUCI  47482003203	2.0 X 32 CORT SCREW CRUCI  47482003403	2.0 X 34 CORT SCREW CRUCI  47482003603	2.0 X 36 CORT SCREW CRUCI  47482003803	2.0 X 38 CORT SCREW CRUCI  47482004003	2.0 X 40 CORT SCREW CRUCI  47482004203	2.0 X 42 CORT SCREW CRUCI  47482004403	2.0 X 44 CORT SCREW CRUCI  47482004603	2.0 X 46 CORT SCREW CRUCI  47482004803	2.0 X 48 CORT SCREW CRUCI  47482005003	2.0 X 50 CORT SCREW CRUCI  47482702000	2.7 X 20 CORT SCREW HEX    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	Product Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.    	  	  	  	  	  	  	  	    ","154","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.61951256  62230459  61907760  61907764  61926199  62261661  61926201  61907767  61907769  61907771  61909381  62230462  61907772  61196133  61907773  62020888  61920808  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1158-2016","Class II","Product 60 consists of all product under product code: HSB and same usage:  Item no:	  225207055	RECON SCREW LG 5.5MM DIA  225207555	RECON SCREW LG 5.5MM DIA  225208055	RECON SCREW LG 5.5MM DIA  225208555	RECON SCREW LG 5.5MM DIA  225209055	RECON SCREW LG 5.5MM DIA  225209555	RECON SCREW LG 5.5MM DIA  225210055	RECON SCREW LG 5.5MM DIA  225210555	RECON SCREW LG 5.5MM DIA  225211555	RECON SCREW LG 5.5MM DIA  225212055	RECON SCREW LG 5.5MM DIA  225213055	RECON SCREW LG 5.5MM DIA    Usage:  An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.  ","1394","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61893774  61968082  62153448  62296426  62296426N  61983672  62153447  61827280  61920741  61964034  62108027  62108029  62153449  61835479  61878730  61878732  61940068  61940069  62121105  62121106  62121107  62121108  61621138  61878733  61929350  61940070  61940071  62086349  62086350  62086351  62086353  62086355  62086356  62153450  61763506  61878734  61878735  61940072  62121116  62121117  62121118  62121119  61878736  61929351  61940076  62121110  62121111  62121112  62121113  62103433  61597004  61597004N  61906259  61895931  61895932  61895933  61895935  61912972  61912975  61912976  61912977  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1154-2016","Class II","Product 56 consists of all product under product code: HWC and same usage:  Item no:	  47234702032	PERI SCR 3.5MM X 32MM STE  47234702018	PERI SCR. 3.5MM X 18MM ST  47234702020	PERI SCR. 3.5MM X 20MM ST  47234702022	PERI SCR. 3.5MM X 22MM ST  47234702026	PERI SCR. 3.5MM X 26MM ST  47234702030	PERI SCR. 3.5MM X 30MM ST  47234702034	PERI SCR. 3.5MM X 34MM ST  47234702036	PERI SCR. 3.5MM X 36MM ST  47234702042	PERI SCR. 3.5MM X 42MM ST  47234702046	PERI SCR. 3.5MM X 46MM ST  47234702050	PERI SCR. 3.5MM X 50MM ST  47234702080	PERI SCR. 3.5MM X 80MM ST  47234702085	PERI SCR. 3.5MM X 85MM ST  47234702155	PERI SCR. 4.0MM X 55MM  47234702160	PERI SCR. 4.0MM X 60MM  47234702210	PERI SCR. 4.0MMX10MM FULL  47234702212	PERI SCR. 4.0MMX12MM FULL  47234702214	PERI SCR. 4.0MMX14MM FULL  47234702216	PERI SCR. 4.0MMX16MM FULL  47234702260	PERI SCR. 4.0MMX60MM FULL  47234702336	PERI SCR. 4.5MM X 36MM  47234702338	PERI SCR. 4.5MM X 38MM  47234712440	PERI SCR. 6.5MM X 140MM  47234702670	PERI SCR. 6.5MM X 70MM  47234702122	PERI. SCR 4.0MM X22MM  47234702124	PERI. SCR 4.0MM X24MM  47234702126	PERI. SCR 4.0MM X26MM  47234702128	PERI. SCR 4.0MM X28MM    Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.  ","56","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62127759  62196525  61955423  62289877  62052696  62052696N  62144719  61930078  62138079  62052697  61960862  62253596  62253596N  62027415  62052698  62052699  61567438  61966260  61966261  61966262  61966263  61966264  61966265  61641810  61903337  61903338  61898112  62138080  61903334  61903335  61903336  61966254  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1110-2016","Class II","Product 12 consists of all product under product code JDI  , and same usage:  Item no:	  902602935	6 DEGREE COCR FEM HEAD 28  902602835	6 DEGREE COCR FEM HEAD 28  902603235	6 DEGREE COCR FEM HEAD 32  902603335	6 DEGREE COCR FEM HEAD 32  902603600	6 DEGREE COCR FEM HEAD 36  902603610	6 DEGREE COCR FEM HEAD 36  902603614	6 DEGREE COCR FEM HEAD 36    Product Usage:  For use in total or hemi hip arthroplasty    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","209","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no62240860  62339639  62395853  62240859  62279765  62339640  62395852  62089508  62094969  62185962  62240862  62273366  62279766  61660149  62279769  62284368  62284368N  62284371  62093453  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1164-2016","Class II","Product 66 consists of all product under product code: JDI and same usage:  Item no:	  785001100	VERSYS ADVOCATE CEMENTED  785001200	VERSYS ADVOCATE CEMENTED  785001220	VERSYS ADVOCATE CEMENTED  785001300	VERSYS ADVOCATE CEMENTED  785001320	VERSYS ADVOCATE CEMENTED  785001400	VERSYS ADVOCATE CEMENTED  785001420	VERSYS ADVOCATE CEMENTED  785001500	VERSYS ADVOCATE CEMENTED  785001520	VERSYS ADVOCATE CEMENTED  785001600	VERSYS ADVOCATE CEMENTED  785001620	VERSYS ADVOCATE CEMENTED  785001700	VERSYS ADVOCATE CEMENTED  785001305	VERSYS ADVOCATE V-LIGN CE  785001325	VERSYS ADVOCATE V-LIGN CE  785001405	VERSYS ADVOCATE V-LIGN CE  785001505	VERSYS ADVOCATE V-LIGN CE  785001525	VERSYS ADVOCATE V-LIGN CE    For use in total or hemi hip arthroplasty","4353","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61983708  62030926  62033221  62036882  62036883  62038355  62075338  62075339  62075340  62097036  62097037  62122103  62122104  62154556  62166260  62171392  62171393  62177323  62178289  62181449  62183156  62183157  62188303  62189403  62192487  62193425  62195517  62204536  62206537  62210448  62216685  62222761  62240269  62240270  62240788  62240789  62240790  62240791  62279094  62280474  62284491  62299105  62312497  62312498  62314646  62315889  62317930  62318766  62320172  62324102  62326110  62346579  62354651  61809115  61820812  61911428  62018462  62027424  62028727  62028729  62042580  62042581  62050972  62050973  62050974  62166258  62166259  62167379  62167380  62174631  62174632  62178288  62181453  62186369  62186370  62186371  62194586  62199409  62204537  62210449  62222760  62234477  62234482  62240279  62240792  62240793  62251959  62252977  62252978  62255125  62280475  62284492  62284493  62306522  62306523  62317924  62317925  62317926  62320174  62326111  62332042  62332043  62340067  62340069  62352843  62043467  62075347  62079948  62106810  62128843  62166265  62167376  62188299  62194587  62218121  62240805  62263240  62263242  62301430  62325577  62340074  62344687  61864106  61871776  61891283  61983710  62019782  62036879  62036881  62038359  62043464  62043471  62043472  62046504  62075341  62097039  62097040  62125319  62125321  62166262  62171394  62171395  62171398  62174635  62177326  62181450  62186372  62188304  62189404  62193423  62193424  62199407  62199408  62210451  62215708  62216684  62222759  62240272  62240273  62240281  62240794  62240795  62240796  62263233  62263235  62266495  62278254  62278256  62280476  62284494  62299103  62299104  62311636  62311638  62316417  62316419  62317917  62317927  62320173  62330773  62330774  62332039  62340071  62354649  62362850  61846958  61955607  62038363  62075348  62097043  62106811  62156147  62188301  62194585  62199411  62240806  62282925  62291136  62301431  62325578  61817995  61839052  61839054  6187",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1143-2016","Class II","Product 45 consists of all product under  product code: JWH and same usage:  Item no:	  511007020	MGII KNEE SLF-TAP BONE ST  511007025	MGII KNEE SLF-TAP BONE ST  511007030	MGII KNEE SLF-TAP BONE ST  511007035	MGII KNEE SLF-TAP BONE ST  511007040	MGII KNEE SLF-TAP BONE ST  511007045	MGII KNEE SLF-TAP BONE ST  for use in total knee arthroplasty","3696","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61814292  61817008  61920896  61953528  62021071  62021071N  61810760  61814293  61817010  61830536  61868946  61895893  61920897  61953529  62021042  62079774  62326383  61810761  61810762  61817013  61817014  61830551  61895895  61895896  62079775  61810763  61810764  61817016  61830553  61850598  61917456  62173492  62173493  62286109  62318820  62326381  61814296  61920901  61830534  61830534N  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1111-2016","Class II","Product 13 consists of all product under product code HWC  , and same usage:  Item no:	  47486510002	6.5 X 100 CANC SCREW, 32M    Product Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","34","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61889945  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1100-2016","Class II","Product 2 consists of all products product code LPH, and same usage:  801802202	12/14 COCR FEMORAL HEAD 2  801802220	12/14 COCR FEMORAL HEAD 2  801802230	12/14 COCR FEMORAL HEAD 2  801802601	12/14 COCR FEMORAL HEAD 2  801802602	12/14 COCR FEMORAL HEAD 2  801802603	12/14 COCR FEMORAL HEAD 2  801802604	12/14 COCR FEMORAL HEAD 2  801802605	12/14 COCR FEMORAL HEAD 2  801802801	12/14 COCR FEMORAL HEAD 2  801802802	12/14 COCR FEMORAL HEAD 2  801802803	12/14 COCR FEMORAL HEAD 2  801802805	12/14 COCR FEMORAL HEAD 2  801802814	12/14 COCR FEMORAL HEAD 2  801803201	12/14 COCR FEMORAL HEAD 3  801803202	12/14 COCR FEMORAL HEAD 3  801803203	12/14 COCR FEMORAL HEAD 3  801803205	12/14 COCR FEMORAL HEAD 3  801803214	12/14 COCR FEMORAL HEAD 3  801803601	12/14 COCR FEMORAL HEAD 3  801803602	12/14 COCR FEMORAL HEAD 3  801803603	12/14 COCR FEMORAL HEAD 3  801803604	12/14 COCR FEMORAL HEAD 3  801803605	12/14 COCR FEMORAL HEAD 3  801804001	12/14 COCR FEMORAL HEAD 4  801804002	12/14 COCR FEMORAL HEAD 4  801804003	12/14 COCR FEMORAL HEAD 4  801804004	12/14 COCR FEMORAL HEAD 4  902602100	6 DEGREE COCR FEM HEAD 22  32902603935	FEM HD 26MMDIA SHT NK+  32902603800	FEMORAL HEAD +0.5 X 22 MM  32902604810	FEMORAL HEAD +3.5 X 22 MM  32902604845	FEMORAL HEAD +7.0 X 22 MM  For use in total or hemi hip arthroplasty  ","35,032","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no. 61982251  61982253  62192505  62235729  62235730  62240303  62240304  62240305  62256057  62262795  62262796  62266503  62266504  62268529  62268530  62268533  62291950  62291952  62291954  62291955  62291956  62309178  62309180  62309182  62309184  62340128  62340129  62340130  62343407  62360082  62360083  62360103  62383105  62383106  62383107  62384211  62384212  61674847  62192500  62235731  62240306  62256051  62256052  62268531  62291959  62291960  62314454  62314455  62340132  62383102  62383103  62383104  62400488  61659979  61674849  62005410  62054842  62192496  62192498  62240307  62256054  62256055  62268532  62291957  62291958  62309177  62314456  62340133  62384213  62395856  62395857  62395858  62400490  61664630  62203617  62384215  62268528  62384214  61634943  62203620  62384216  62400542  62203620N  62384217  62400492  61670802  61683632  00370435N  61683632N  61660161  61670806  61670808  61670810  61683637  61817543  61817544  61817545  61820842  61873739  61882583  61882584  61884402  61926418  61926420  61926422  61945113  61983739  61983740  61983741  62093440  62115045  62115050  62144980  62144983  62151885  62188342  62200268  62210455  62210457  62210459  62212011  62221030  62221031  62221032  62221033  62221881  62221882  62222774  62222776  62222777  62234498  62234499  62234501  62234502  62252069  62256034  62256036  62256037  62256038  62256039  62258947  62258952  62266506  62266507  62266508  62267509  62267511  62273054  62273055  62273056  62273057  62276474  62279263  62279264  62279265  62279266  62279267  62279268  62282935  62282936  62293212  62293213  62309170  62309171  62309172  62309173  62309175  62309176  62311651  62311652  62311653  62315596  62315598  62315599  62315602  62315604  62322474  62322475  62322476  62326135  62326136  62326137  62326138  62326139  62330780  62330781  62330782  62332058  62332059  62332061  62332062  62332064  62332078  62346603  62346604  62346605  62358925  62358926  62358927  62358928  62358929  62358930  62362992  623",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1139-2016","Class II","Product 41 consists of all product under  product code: KTT and same usage:  Item no:	  119301042	LAG SCR 12.7D X 100MM STA  119301045	LAG SCR 12.7D X 105MM STA  119301047	LAG SCR 12.7D X 110MM STA  119301050	LAG SCR 12.7D X 115MM STA  119301052	LAG SCR 12.7D X 120MM STA  119301055	LAG SCR 12.7D X 125MM STA  119301057	LAG SCR 12.7D X 130MM STA  119301060	LAG SCR 12.7D X 135MM STA  119301062	LAG SCR 12.7D X 140MM STA  119301070	LAG SCR 12.7D X 155MM STA  119301020	LAG SCR 12.7D X 55MM STAN  119301022	LAG SCR 12.7D X 60MM STAN  119301025	LAG SCR 12.7D X 65MM STAN  119301027	LAG SCR 12.7D X 70MM STAN  119301030	LAG SCR 12.7D X 75MM STAN  119301032	LAG SCR 12.7D X 80MM STAN  119301035	LAG SCR 12.7D X 85MM STAN  119300537	LAG SCR 12.7D X 90MM SHOR  119301037	LAG SCR 12.7D X 90MM STAN  119301040	LAG SCR 12.7D X 95MM STAN  119301542	LAG SCR 15.8D X 100MM LAR  119301545	LAG SCR 15.8D X 105MM LAR  119301547	LAG SCR 15.8D X 110MM LAR  119301550	LAG SCR 15.8D X 115MM LAR  119301552	LAG SCR 15.8D X 120MM LAR  119301555	LAG SCR 15.8D X 125MM LAR  119301557	LAG SCR 15.8D X 130MM LAR  119301520	LAG SCR 15.8D X 55MM LARG  119301522	LAG SCR 15.8D X 60MM LARG  119301525	LAG SCR 15.8D X 65MM LARG  119301532	LAG SCR 15.8D X 80MM LARG  119301535	LAG SCR 15.8D X 85MM LARG  119301537	LAG SCR 15.8D X 90MM LARG    Product Usage:  Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical ","6059","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61644212  61792526  61815349  61828043  61850984  61890427  61921816  61934581  61969233  62017629  62093240  62093241  62093243  62171309  62197649  62197650  62299114  62318135  62318136  62318137  62318138  62318150  61644213  61815350  61828044  61873638  61934582  62002277  62067293  62075869  62160328  62213281  62263054  62263055  62267127  62267128  62267129  62267130  62267131  62267133  62267135  62267136  62267137  62267138  62267139  62267140  62294218  62294225  62294226  62294228  61803056  61873639  61895894  61912747  61912749  62227211  62299118  62299127  62299132  62299134  61764436  62213282  62322533  62322535  62322537  62322612  62322616  62322620  62322623  62322637  62227216  62322865  62322866  62322867  62322868  62322870  62322871  62322875  62322881  62322883  62322885  62322881N  62322881P  61982440  62054519  62075872  37107680  62338654  62338655  62058551  62075873  61897704  62054521  62124276  62218067  61786382  62002271  62067291  62075871  62263052  61644206  61828034  61858125  61921813  61982441  62054523  62054524  62075870  62213267  62263057  62263058  62263060  62263062  62311830  62311838  62213267N  61629787  61644207  61700053  61815343  61878336  61906727  61982442  62031691  62067292  62172859  62172863  62172866  62172869  62172875  62172881  62285701  62285703  62285704  62285705  62285706  62285707  62285719  62285735  62285736  62285737  62293594  62293596  62293598  62293601  62293603  62293604  37107683  61644208  61658563  61700054  61815344  61828036  61858129  61890423  61906729  61964352  62031692  62085434  62171298  62171299  62172882  62172883  62172901  62172902  62172903  62172922  62172924  62311864  62311865  62311867  62311868  62317534  62317535  61644209  61666067  61774943  61792524  61803051  61828037  61849828  61849829  61890424  61906732  61906734  61921814  61951257  61951258  61982444  62002272  62002273  62171301  62219423  62219424  62219425  61644210  61700056  61774945  61774946  61774949  61782868  61792525  61815347  6",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1109-2016","Class II","Product 11 consists of all product under product code JDI  , and same usage:  Item no:	  902602500	6 DEGREE COCR FEM HEAD 26  902602600	6 DEGREE COCR FEM HEAD 26  902602700	6 DEGREE COCR FEM HEAD 26  902602800	6 DEGREE COCR FEM HEAD 28  902602900	6 DEGREE COCR FEM HEAD 28  902603000	6 DEGREE COCR FEM HEAD 28  902603300	6 DEGREE COCR FEM HEAD 32  902603200	6 DEGREE COCR FEM HEAD 32  	  Product Usage:  For use in total or hemi hip arthroplasty      	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","366","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no:61603870  60973105N  60892289N  60900891N  62279763  62093449  62185961  62279764  62384218  62082438  62268537  62384219  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1118-2016","Class II","Product 20 consists of all prod oct under  poduct code: KTT and same usage:  Item no:	  47116201900	COMPRESSION SCREW 1/2IN  47116202300	COMPRESSION SCREW 1-1/2IN  47116202200	COMPRESSION SCREW 1-1/4IN  47116202400	COMPRESSION SCREW 1-3/4IN  47116202100	COMPRESSION SCREW 1IN  47116202000	COMPRESSION SCREW 3/4IN    Product Usage:  Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.  ","3415","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61678184  61839111  61852988  61862260  61875843  61882261  61898918  61974385  61988314  62002243  62002244  62024181  62031621  62090117  62109252  62263147  61875838  61895890  61895891  61912706  62037827  61649744  61660679  61764382  61882257  61887223  61988311  61988312  61988313  62009735  62037784  62090119  62109257  62153293  62160886  62263160  62109261  61396164  61634704  61664774  61777417  61777418  61782841  61782843  61782845  61782848  61810565  61810566  61810567  61810568  61810569  61810570  61810571  61839106  61839107  61839108  61839109  61852999  61853001  61853002  61853005  61875839  61875854  61882265  61887219  61887220  61893994  61894002  61915563  61915564  61915565  61938456  61938457  61938458  61938459  61980692  61980694  61980696  61980698  61985662  61985665  61985670  61985676  62009730  62009731  62009732  62009734  62017442  62017443  62017444  62024184  62024185  62024186  62031633  62038976  62038977  62038978  62090115  62097349  62097351  62097353  62120586  62120587  62120589  62120590  62120593  62134879  62134889  62134890  62150227  62150230  62150231  62153290  62153291  62153292  62160882  62160884  62193769  62193770  62193771  62204429  62204430  62204431  62204432  62204433  62263150  62263153  62263156  62263158  61649748  61782622  61782623  61782839  61810563  61810564  61839110  61852991  61852993  61875841  61875849  61882258  61887216  61887217  61898919  61985648  61985652  61985656  62002245  62002246  62002247  62009728  62009729  62024182  62024183  62031630  62090118  62118596  62134877  62150234  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1160-2016","Class II","Product 62 consists of all product under product code: LPH and same usage:  Item no:	  620003620	TRILOGY ACET SHELL 36MM OD MULTI    For use in total hip arthroplasty","400","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62313588  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1131-2016","Class II","Product 33 consists of all product under  product code: JDI and same usage:  Item no:	  662406515	HGP II ACETABULAR CUP BON  662406520	HGP II ACETABULAR CUP BON  662406525	HGP II ACETABULAR CUP BON  662406530	HGP II ACETABULAR CUP BON  662406535	HGP II ACETABULAR CUP BON  662406540	HGP II ACETABULAR CUP BON  662406550	HGP II ACETABULAR CUP BON  662406560	HGP II ACETABULAR CUP BON    For use in total hip arthroplasty","2236","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61674472  61906696  62016799  62332483  61674473  61902194  61906697  62326386  61674476  61953546  62161131  62172656  62326385  61953547  62011539  62017894  62130757  61886072  61953548  62017895  62172659  61886073  61948763  61953551  62172661  61874793  61948764  61996232  62017897  62172663  61874794  61953554  62286122  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1122-2016","Class II","Product 24 consists of all product under  product code: HRS and same usage:  Item no:	  234703104	DISTAL MEDIAL FEMORAL CON  234703206	DISTAL MEDIAL FEMORAL CON  234703208	DISTAL MEDIAL FEMORAL CON  234800504	DISTAL POSTERIOR/LATERAL  234800506	DISTAL POSTERIOR/LATERAL  234800508	DISTAL POSTERIOR/LATERAL  234800510	DISTAL POSTERIOR/LATERAL  234800604	DISTAL POSTERIOR/LATERAL  234800606	DISTAL POSTERIOR/LATERAL  234800608	DISTAL POSTERIOR/LATERAL  234800610	DISTAL POSTERIOR/LATERAL  234800614	DISTAL POSTERIOR/LATERAL    Product Usage:  Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.    ","37","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61983647  62296609  62152979  62056816  61771916  61932061  61771919  62056817  61771920  61866489  61880386  61859716  61906564  62056818  61866490  61880387  61880388  61895979  61895980  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1106-2016","Class II","Product 8 consists of all products under product code HWC, and same usage:  Item no:	  47483501201	3.5MM CORT. SCREW 12MM LN  47483501401	3.5MM CORT. SCREW 14MM LN  47483501601	3.5MM CORT. SCREW 16MM LN  47483501801	3.5MM CORT. SCREW 18MM LN  47483503601	3.5MM CORT. SCREW 36MM LN  47483507501	3.5MM CORT. SCREW 75MM LN  	  Product Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","99","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no:  61894346  61892658  61892659  61894347  61888124  61614768  62036752  62036753  62036754  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1167-2016","Class II","Product 69 consists of all product under product code: JDI and same usage:  Item no:	  785301701	VERSYS CEMENTED FEM STEM  785301521	VERSYS CEMENTED FEM STEM 15X140MM X-OFF  785301601	VERSYS CEMENTED FEM STEM 16X145MM    For use in total or hemi hip arthroplasty","13","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  370967  00370967N  62279438  62012576  62012576N  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1135-2016","Class II","Product 37 consists of all product under  product code: HSB and same usage:  Item no:	  225302055	INTERLOCKING IM SCREW LG  225303055	INTERLOCKING IM SCREW LG  225304055	INTERLOCKING IM SCREW LG  225304555	INTERLOCKING IM SCREW LG  225305055	INTERLOCKING IM SCREW LG  225305555	INTERLOCKING IM SCREW LG  225306055	INTERLOCKING IM SCREW LG  225306555	INTERLOCKING IM SCREW LG  225307055	INTERLOCKING IM SCREW LG  225307555	INTERLOCKING IM SCREW LG  225308055	INTERLOCKING IM SCREW LG  225308555	INTERLOCKING IM SCREW LG  225309055	INTERLOCKING IM SCREW LG  225302542	INTERLOCKING IM SCREW MED  225303042	INTERLOCKING IM SCREW MED  225303542	INTERLOCKING IM SCREW MED  225304042	INTERLOCKING IM SCREW MED  225304542	INTERLOCKING IM SCREW MED  225305042	INTERLOCKING IM SCREW MED  225305542	INTERLOCKING IM SCREW MED  225306042	INTERLOCKING IM SCREW MED  225306542	INTERLOCKING IM SCREW MED  225307042	INTERLOCKING IM SCREW MED  225307542	INTERLOCKING IM SCREW MED  225308042	INTERLOCKING IM SCREW MED  225308542	INTERLOCKING IM SCREW MED  225302037	INTERLOCKING IM SCREW SML  225302537	INTERLOCKING IM SCREW SML  225303037	INTERLOCKING IM SCREW SML  225303537	INTERLOCKING IM SCREW SML  225304037	INTERLOCKING IM SCREW SML  225304537	INTERLOCKING IM SCREW SML  225305037	INTERLOCKING IM SCREW SML  225305537	INTERLOCKING IM SCREW SML  225306037	INTERLOCKING IM SCREW SML  225306537	INTERLOCKING IM SCREW SML  225308537	INTERLOCKING IM SCREW SML    Product Usage:  An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.  ","1777","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61906265  61764344  61764345  61763538  61804376  61804377  61804378  61809821  61843699  61889644  61912613  61920742  61934239  61934254  61934264  61934275  61968078  61983673  62005552  62021122  62038732  62165487  62165488  62188649  62188650  62253382  62253386  61709145  61763552  61763553  61804388  61841501  61881343  61889662  61912626  61920743  61934285  61934286  61934287  61934288  61993619  62005554  62021123  62038746  62121122  62121123  62176083  62176084  62188636  62253396  62253398  62298584  61809822  61821684  61839142  61876353  61876354  61876355  61876356  61878893  61889664  61908098  61908099  61908101  61908103  61968079  61968080  61979092  62027386  62027387  62027388  62027389  62075773  62075774  62075775  62075776  62075781  62075782  62075785  62075786  62075792  62075803  62075804  62075805  62075806  62075807  62121136  62121139  62121141  62121146  62188652  62188654  62188655  62188658  62188659  62188661  62188662  62188663  62262078  61665049  61729658  61763551  61809823  61809824  61836999  61859423  61859425  61859426  61859427  61859428  61859429  61859430  61878766  61878780  61908104  61934289  61934290  61968081  61979095  61993623  62005555  62038756  62102479  62102480  62102481  62102482  62102483  62102484  62102485  62102486  62102502  62102504  62102518  62102520  62102521  62102522  62102523  62102524  62102525  62102526  62102528  62102529  62102530  62102531  62102532  62137923  62137924  62165524  62165525  62165526  62165528  62165529  62165531  62165532  62165533  62165534  61665051  61729660  61763513  61809826  61809827  61836991  61836992  61836993  61855506  61855507  61855508  61855519  61855521  61855524  61855528  61872543  61872544  61872545  61878784  61940664  61940667  61940670  61979097  61979099  62009852  62009853  62027390  62027391  62122328  62122329  62122330  62122331  62122332  62122333  62122334  62122335  62122337  62122340  62122573  62160813  62160815  62194667  62194668  62194670  62194671  62237301  62237304  6223",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1157-2016","Class II","Product 59 consists of all product under product code: JWH and same usage:  Item no:	  42540000026	PSN ALL POLY PAT PLY 26MM  42540000029	PSN ALL POLY PAT PLY 29MM  42540000032	PSN ALL POLY PAT PLY 32MM  42540000035	PSN ALL POLY PAT PLY 35MM  42540000038	PSN ALL POLY PAT PLY 38MM  42540000041	PSN ALL POLY PAT PLY 41MM  42511000510	PSN ASF CR 10MM PLY L 3-1  42511000410	PSN ASF CR 10MM PLY L 3-9  42511000610	PSN ASF CR 10MM PLY L 7-1  42521000510	PSN ASF CR 10MM PLY R 3-1  42521000410	PSN ASF CR 10MM PLY R 3-9  42521000610	PSN ASF CR 10MM PLY R 7-1  42511000511	PSN ASF CR 11MM PLY L 3-1  42511000411	PSN ASF CR 11MM PLY L 3-9  42511000611	PSN ASF CR 11MM PLY L 7-1  42521000511	PSN ASF CR 11MM PLY R 3-1  42521000411	PSN ASF CR 11MM PLY R 3-9  42521000611	PSN ASF CR 11MM PLY R 7-1  42511000512	PSN ASF CR 12MM PLY L 3-1  42511000412	PSN ASF CR 12MM PLY L 3-9  42511000612	PSN ASF CR 12MM PLY L 7-1  42521000512	PSN ASF CR 12MM PLY R 3-1  42521000412	PSN ASF CR 12MM PLY R 3-9  42521000612	PSN ASF CR 12MM PLY R 7-1  42511000513	PSN ASF CR 13MM PLY L 3-1  42511000413	PSN ASF CR 13MM PLY L 3-9  42511000613	PSN ASF CR 13MM PLY L 7-1  42521000513	PSN ASF CR 13MM PLY R 3-1  42521000413	PSN ASF CR 13MM PLY R 3-9  42521000613	PSN ASF CR 13MM PLY R 7-1  42511000514	PSN ASF CR 14MM PLY L 3-1  42511000414	PSN ASF CR 14MM PLY L 3-9  42511000614	PSN ASF CR 14MM PLY L 7-1  42521000514	PSN ASF CR 14MM PLY R 3-1  42521000414	PSN ASF CR 14MM PLY R 3-9  42521000614	PSN ASF CR 14MM PLY R 7-1  42511000516	PSN ASF CR 16MM PLY L 3-1  42511000416	PSN ASF CR 16MM PLY L 3-9  42511000616	PSN ASF CR 16MM PLY L 7-1  42521000516	PSN ASF CR 16MM PLY R 3-1  42521000416	PSN ASF CR 16MM PLY R 3-9  42521000616	PSN ASF CR 16MM PLY R 7-1  42511000518	PSN ASF CR 18MM PLY L 3-1  42511000418	PSN ASF CR 18MM PLY L 3-9  42511000618	PSN ASF CR 18MM PLY L 7-1  42521000518	PSN ASF CR 18MM PLY R 3-1  42521000418	PSN ASF CR 18MM PLY R 3-9  42521000618	PSN ASF CR 18MM PLY R 7-1  42511400810	PSN ASF PS 10MM PLY L 10-  42511401010	PSN ASF PS 10MM PLY L 10-  42511400","112588","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61987247  62060580  62095143  62234779  62244505  62244506  61987260  62060581  62095146  62113095  62190263  62190265  62268839  62268840  62268841  62284790  62284791  62299465  62299466  62318794  62326957  62328734  62332491  62346392  62363051  62363053  62376636  61987268  62060583  62095147  62113090  62113101  62132939  62132940  62132942  62190289  62190290  62268834  62268835  62268836  62268837  62268838  62284788  62284789  62299453  62299454  62318790  62318791  62326952  62326953  62332486  62332487  62332488  62337857  62337858  62346390  62346391  62352421  62352422  62352423  62363042  62363044  62363045  62371750  62371751  62376627  62376631  62376633  62382635  61987269  62060584  62095150  62113092  62113103  62132943  62143610  62190260  62268830  62268831  62268832  62268833  62284792  62284793  62299457  62299458  62299463  62318792  62326954  62326955  62332489  62332490  62337859  62352425  62363048  62363050  62376624  62376625  62382629  62389123  62394482  62394483  62394484  62401095  61987271  62060585  62095151  62113096  62132944  62190283  62190284  62268828  62268829  62292643  62306253  62306254  62318793  62352426  62389121  61987272  62060587  62095153  62190261  62190262  62268826  62284786  62284787  62389120  62057581  62170314  62205011  62205012  62263791  62263793  62280365  62292713  62304377  62311612  62311613  62324380  62324381  62332145  62332147  62332148  62339521  62339522  62344471  62344472  62344473  62361825  62361827  62205003  62205004  62263779  62280357  62288230  62292710  62304364  62304365  62311601  62311602  62324354  62324356  62338066  62338067  62338068  62338069  62338070  62344464  62344465  62344466  62361858  62361859  62363541  62363542  62170316  62209947  62209948  62209949  62263830  62263831  62292723  62292724  62292725  62324395  62324396  62324397  62344478  62344479  62363549  62170327  62224706  62244583  62263967  62263969  62280317  62288190  62292692  62304402  62311634  62311637  62311643  62324470  62324471  6233",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016","2330638  62330639  62330640  62330641  62333739  62333740  62333741  62333742  62333743  62337468  62337469  62337471  62337472  62339650  62339651  62339652  62339654  62339655  62339658  62346737  62346740  62350974  62352332  62352333  62353569  62353572  62353573  62354476  62354477  62354478  62354479  62354480  62354481  62354482  62354483  62354484  62354487  62358138  62358141  62362922  62362927  62362929  62364713  62190156  62190157  62190158  62190159  62190160  62190161  62191053  62191054  62191056  62191057  62193985  62193986  62193987  62193988  62193989  62210919  62210920  62210921  62244111  62244113  62252151  62252152  62252153  62260088  62260089  62260090  62260091  62260092  62260093  62268871  62268872  62268873  62268874  62268875  62268876  62268877  62268878  62268879  62268880  62268881  62268882  62268883  62268884  62288532  62288533  62288534  62288535  62288536  62292649  62292650  62292651  62292652  62292653  62294659  62294660  62294661  62294662  62294663  62300863  62300865  62300867  62300871  62300872  62307857  62307859  62307862  62307867  62307868  62316844  62316845  62316846  62316847  62316848  62318099  62318101  62318102  62318103  62318104  62320202  62320203  62320204  62320205  62320206  62320713  62320714  62320715  62320716  62320720  62326964  62326965  62326966  62326967  62326968  62326969  62330642  62330643  62330644  62330645  62330646  62330647  62333745  62333746  62333747  62333749  62333750  62337474  62337475  62337477  62337479  62337481  62339660  62339662  62339663  62339665  62339667  62339669  62342544  62342545  62346741  62346743  62350980  62350985  62353575  62353576  62354489  62354490  62354491  62354492  62354493  62354494  62354495  62358094  62358095  62358096  62358102  62358110  62358114  62362987  62364710  62180917  62180918  62187618  62187619  62222408  62222409  62222410  62222411  62222412  62222413  62222414  62229679  62229680  62229681  62235766  62237896  62237897  62237898  62241812  62241821  62241822  62241823  622418",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1165-2016","Class II","Product 67 consists of all product under product code: JDI and same usage:  Item no:	  785001100	VERSYS ADVOCATE CEMENTED  785001200	VERSYS ADVOCATE CEMENTED  785001220	VERSYS ADVOCATE CEMENTED  785001300	VERSYS ADVOCATE CEMENTED  785001320	VERSYS ADVOCATE CEMENTED  785001400	VERSYS ADVOCATE CEMENTED  785001420	VERSYS ADVOCATE CEMENTED  785001500	VERSYS ADVOCATE CEMENTED  785001520	VERSYS ADVOCATE CEMENTED  785001600	VERSYS ADVOCATE CEMENTED  785001620	VERSYS ADVOCATE CEMENTED  785001700	VERSYS ADVOCATE CEMENTED  785001305	VERSYS ADVOCATE V-LIGN CE  785001325	VERSYS ADVOCATE V-LIGN CE  785001405	VERSYS ADVOCATE V-LIGN CE  785001505	VERSYS ADVOCATE V-LIGN CE  785001525	VERSYS ADVOCATE V-LIGN CE    For use in total or hemi hip arthroplasty","5013","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62012574  62076883  62082566  61866199  61874734  61893708  61899069  62022707  62028699  62030919  62042521  62051543  62060669  62075336  62079977  62079978  62079980  62113214  62114829  62114830  62122093  62128919  62128920  62132260  62140346  62148554  62160578  62163478  62188294  62222803  62222804  62223792  62240251  62240759  62240760  62246361  62246362  62246363  62258940  62260127  62261929  62261930  62284475  62284476  62314462  62317914  62320163  62327664  62330771  62331423  62340088  62354662  62354663  62360329  61823659  61832951  61866206  61866208  61873629  61881191  61886904  61889280  61890330  61891276  61896738  61901567  61901568  61952538  61953162  62010628  62027792  62028704  62028706  62028707  62035446  62042575  62050380  62051541  62051542  62058542  62060667  62060668  62079983  62079984  62097006  62097008  62103562  62103563  62103564  62122094  62122095  62122096  62125316  62127721  62127722  62128921  62128922  62132261  62132262  62137771  62137772  62137773  62143839  62143840  62148555  62154549  62154550  62154551  62160579  62163479  62181431  62181432  62181433  62194583  62206546  62222805  62222806  62223794  62227040  62227042  62240250  62240757  62240758  62246352  62246353  62246354  62246356  62246357  62246359  62246360  62256014  62256015  62262776  62262777  62264267  62264268  62267506  62268568  62278687  62278688  62278689  62281832  62291932  62291933  62291934  62298285  62298286  62299084  62305940  62315887  62315888  62317130  62317139  62317912  62317913  62320164  62327665  62328991  62328998  62328999  62329007  62329009  62333972  62333973  62333974  62333975  62340087  62346567  62346568  62346569  62346570  62352851  62352853  62360334  62362908  62362909  62362910  62362913  61843197  61878448  61881192  62012581  62030922  62082173  62140347  62151836  62256013  62262778  62284474  62303508  62325573  62340086  62354659  62354660  61815836  61870883  61876364  61878470  61881189  61882613  61884453  61901598  61977873  6197",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1130-2016","Class II","Product 32 consists of all product under  product code: HWC and same usage:  Item no:	  47115401200	HERBERT BONE SCREW, 3.0MM  47115401400	HERBERT BONE SCREW, 3.0MM  47115401600	HERBERT BONE SCREW, 3.0MM  47115401800	HERBERT BONE SCREW, 3.0MM  47115402000	HERBERT BONE SCREW, 3.0MM  47115402200	HERBERT BONE SCREW, 3.0MM  47115402400	HERBERT BONE SCREW, 3.0MM  47115402600	HERBERT BONE SCREW, 3.0MM  47115402800	HERBERT BONE SCREW, 3.0MM  47115403000	HERBERT BONE SCREW, 3.0MM  47115502505	HERBERT CANNULATED BONE S  47115503005	HERBERT CANNULATED BONE S  47115503505	HERBERT CANNULATED BONE S  47115504005	HERBERT CANNULATED BONE S  47115504007	HERBERT CANNULATED BONE S  47115504505	HERBERT CANNULATED BONE S  47115504507	HERBERT CANNULATED BONE S  47115505005	HERBERT CANNULATED BONE S  47115505007	HERBERT CANNULATED BONE S  47115505505	HERBERT CANNULATED BONE S  47115505507	HERBERT CANNULATED BONE S  47115506005	HERBERT CANNULATED BONE S  47115506007	HERBERT CANNULATED BONE S  47115506505	HERBERT CANNULATED BONE S  47115506507	HERBERT CANNULATED BONE S  47115507005	HERBERT CANNULATED BONE S  47115507007	HERBERT CANNULATED BONE S  47115507505	HERBERT CANNULATED BONE S  47115507507	HERBERT CANNULATED BONE S  47115508005	HERBERT CANNULATED BONE S  47115508007	HERBERT CANNULATED BONE S  47115508505	HERBERT CANNULATED BONE S  47115508507	HERBERT CANNULATED BONE S  47115509005	HERBERT CANNULATED BONE S  47115509007	HERBERT CANNULATED BONE S  47115509505	HERBERT CANNULATED BONE S  47115509507	HERBERT CANNULATED BONE S  47115510005	HERBERT CANNULATED BONE S  47115510007	HERBERT CANNULATED BONE S  115001000	HERBERT MINI BONE SCREW 2  115001200	HERBERT MINI BONE SCREW 2  115001400	HERBERT MINI BONE SCREW 2  115001600	HERBERT MINI BONE SCREW 2  115001800	HERBERT MINI BONE SCREW 2  115002000	HERBERT MINI BONE SCREW 2  115002200	HERBERT MINI BONE SCREW 2  115002400	HERBERT MINI BONE SCREW 2  115201200	HERBERT/WHIPPLE CANN BONE  115201400	HERBERT/WHIPPLE CANN BONE  115201600	HERBERT/WHIPPLE CANN BONE  115201800	HERBERT/WHIPPLE CAN","4018","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61849585  61912445  61912446  61849586  61849587  61912447  61912448  61941352  61827182  61849582  62024187  62153287  61774747  61827165  61827167  61849584  61904625  61928623  62024188  62024188N  61827172  61827173  61865263  61865265  61904627  61912468  62024189  62031681  62211067  62024189N  61827157  61870904  61904626  61928624  62024190  62145270  62160893  61811070  61827193  61870905  61944998  62024191  62031682  62145271  62153288  62180565  61827151  61840634  61928627  61928628  62031639  62145272  62160895  61870906  61900329  62031646  62180567  61789465  61811156  61840635  61895711  61895713  61895714  61912679  61912682  61912691  61912694  61912695  61912699  61644731  61785346  61855921  61906705  62161934  61660596  61799289  61865276  61906699  61960093  61960095  62017439  62072611  62129843  62180552  62180552N  61660597  61865277  61865278  61936609  61936613  61963653  61988334  62017440  62027372  62040734  62112691  62138496  62142211  62328120  61660601  61799283  61799285  61835773  61865279  61906706  61936621  61936623  61981198  61981199  61981201  62009804  62027373  62086218  62097341  62112695  62198887  62258967  62027374  62027374N  61799286  61835774  61887206  61906707  61978705  61978706  62008674  62065599  62086222  62112699  62187870  62328128  61988338  61612598  61660607  61788245  61843085  61865281  61906701  61968182  61968183  62008675  62086226  62097343  62187869  62198874  62258968  61988351  62180554  61819964  61880819  61968184  62017438  62086230  62138499  62223009  61914885  62069022  61612601  61887207  61968185  62053620  62112701  62198875  61955489  62027384  61968186  62040193  62161936  61887209  61946364  62005539  62129844  62198877  61685418  61988350  62085978  61865282  61988337  62027385  62097346  61923065  62065601  61887210  61978707  62005540  62072612  61946365  62072613  61887212  61960099  61963652  62072614  62198878  62204637  62097339  61887213  61978710  62053628  62161940  61799296  62005538  61923068  62053629  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1104-2016","Class II","Product 6 consists of all products under  product code HWC, and same usage:  Item no:	  47493501001	3.5 X 10 CORT SCREW SELFT  47493501801	3.5 X 18 CORT SCREW SELFT    Product Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","12","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no:  61851308  61851309  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1105-2016","Class II","Product 7 consists of all products under  product code HWC, and same usage:  Item no:	  47234801435	3.5MM CORT SCR X 14MM  47234801635	3.5MM CORT SCR X 16MM  47234806535	3.5MM CORT SCR X 65MM  47234807035	3.5MM CORT SCR X 70MM  47234807535	3.5MM CORT SCR X 75MM  47234808035	3.5MM CORT SCR X 80MM  47234808535	3.5MM CORT SCR X 85MM  47234809035	3.5MM CORT SCR X 90MM  Product Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","109","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no:  62230449  62081271  62133855  62159156  62047629  62127760  61903333  62261628  61830478  61830479  62138082  62230452  61800380  61800381  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1150-2016","Class II","Product 52 consists of product code: HWC and same usage:  Item no:	  525004530	NEXGEN OSTEOTOMY CORT BON  525004540	NEXGEN OSTEOTOMY CORT BON  525006545	NEXGEN OSTEOTOMY CORT BON  525006560	NEXGEN OSTEOTOMY CORT BON  525006565	NEXGEN OSTEOTOMY CORT BON    for use in total knee arthroplasty","925","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61996176  61996176N  61996177  61996177N  61687334  61926537  62308501  61811187  61996179  61996179N  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1099-2016","Class II","Product 1 consists of all product under  , product code: JWH and same usage:  Item no:	  47481500601	1.5 X 6 CORT SCREW HEX/SE  Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61889944  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1170-2016","Class II","Product 72 consists of all  product code: JDI and same usage:  Item no:	  805002202	ZIMTRON HEAD 12/14 0X22 MM     For use in total or hemi hip arthroplasty","226","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62065589  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1126-2016","Class II","Product 28 consists of all product under product code: JDI and same usage:  Item no:	  32902605000	FEMORAL HD 28MM MEDIUM  32902604000	FEMORAL HD 28MM SHORT  32902604035	FEMORAL HD 28MM SHT+ 3.5M    For use in total or hemi hip arthroplasty","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62185968  62273370  62339644  62162469  62279774  62279774N  62221051  62279775  62279775N  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1128-2016","Class II","Product 30 consists of all product under  product code: KTT and same usage:  Item no:	  118100527	FREE-LOCK LAG SCREW, 12.7  118100535	FREE-LOCK LAG SCREW, 12.7  118100540	FREE-LOCK LAG SCREW, 12.7  118100542	FREE-LOCK LAG SCREW, 12.7  118101022	FREE-LOCK LAG SCREW, 12.7  118101025	FREE-LOCK LAG SCREW, 12.7  118101027	FREE-LOCK LAG SCREW, 12.7  118101030	FREE-LOCK LAG SCREW, 12.7  118101032	FREE-LOCK LAG SCREW, 12.7  118101035	FREE-LOCK LAG SCREW, 12.7  118101037	FREE-LOCK LAG SCREW, 12.7  118101040	FREE-LOCK LAG SCREW, 12.7  118101042	FREE-LOCK LAG SCREW, 12.7  118101045	FREE-LOCK LAG SCREW, 12.7  118101047	FREE-LOCK LAG SCREW, 12.7  118101052	FREE-LOCK LAG SCREW, 12.7  118101055	FREE-LOCK LAG SCREW, 12.7  118101057	FREE-LOCK LAG SCREW, 12.7  118101522	FREE-LOCK LAG SCREW, 15.8  118101525	FREE-LOCK LAG SCREW, 15.8  118101527	FREE-LOCK LAG SCREW, 15.8  118101530	FREE-LOCK LAG SCREW, 15.8  118101532	FREE-LOCK LAG SCREW, 15.8  118101547	FREE-LOCK LAG SCREW, 15.8  118109010	FREE-LOCK SUPRACOND TUBE/  118109510	FREE-LOCK SUPRACOND TUBE/  118113005	FREE-LOCK TUBE & SCP PLAT  118113006	FREE-LOCK TUBE & SCP PLAT  118113010	FREE-LOCK TUBE & SCP PLAT  118113504	FREE-LOCK TUBE & SCP PLAT  118113505	FREE-LOCK TUBE & SCP PLAT  118113506	FREE-LOCK TUBE & SCP PLAT  118113508	FREE-LOCK TUBE & SCP PLAT  118113510	FREE-LOCK TUBE & SCP PLAT  118113594	FREE-LOCK TUBE & SCP PLAT  118114005	FREE-LOCK TUBE & SCP PLAT  118114006	FREE-LOCK TUBE & SCP PLAT  118114008	FREE-LOCK TUBE & SCP PLAT  118114010	FREE-LOCK TUBE & SCP PLAT  118114012	FREE-LOCK TUBE & SCP PLAT  118114004	FREE-LOCK TUBE & SCP PLAT  118114008	FREE-LOCK TUBE & SCP PLAT  118114010	FREE-LOCK TUBE & SCP PLAT  118114012	FREE-LOCK TUBE & SCP PLAT  118114504	FREE-LOCK TUBE & SCP PLAT  118114505	FREE-LOCK TUBE & SCP PLAT  118114506	FREE-LOCK TUBE & SCP PLAT  118114508	FREE-LOCK TUBE & SCP PLAT  118114512	FREE-LOCK TUBE & SCP PLAT  118114594	FREE-LOCK TUBE & SCP PLAT  118114508	FREE-LOCK TUBE & SCP PLAT  118114512	FREE-LOCK TUBE & SCP PLAT  118114594	FREE-LOCK TUBE & SCP PL","3500","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61982436  61867365  61886667  61886668  61820722  61897702  61977095  61799436  61934575  61828057  61982437  61828048  61934576  61798403  61906719  62031688  62197641  61663372  61828049  61886669  61828050  62031689  61828053  62106374  61828054  62033051  62197643  61828055  61906715  61982438  61867334  61977096  61927725  61784953  61867368  61849821  61849827  61906712  62124274  62120943  61785930  61771006  61826981  61895080  61902197  61827363  61888704  61895083  62255904  61902213  61990124  61753044  62271887  61850459  61778818  61778840  61827350  61827352  61827355  61853069  61865454  61865455  61888705  61895087  61897708  61897709  61897711  61900062  61941016  61941017  61958817  61990133  62127925  62130793  62130794  62241680  62255912  62255914  62255920  62271894  61902217  61958146  62271889  61958147  61955869  62105421  61860644  61888706  61937605  370531  61853081  61870427  62230186  61777469  61923868  61940612  61940613  370989  61853082  61955870  61890945  61930189  61859417  61923869  61788809  61829108  370516  61860640  61874946  370515  370959  370956  61843251  61937601  62105422  371015  61895079  61788813  61849271  371014  370517  61860668  61869716  61874978  370990  370923  61891507  371071  61902208  370955  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1121-2016","Class II","Product 23 consists of all product code: JDI and same usage:  Item no:	  801100220	CPT 2 HIP STEM, X-OFFSET  801100320	CPT 3 HIP STEM, X-OFFSET  801100420	CPT 4 HIP STEM, X-OFFSET  801100005	CPT HIP STEM PETITE  801100700	CPT HIP STEM SZ 2 LONG  801100800	CPT HIP STEM SZ 3 LONG  801100222	CPT MOD HD ST/ST 22MED SH  801100322	CPT MOD HD ST/ST 22MMD LN  801100122	CPT MOD HD ST/ST 22MMD SH  801100126	CPT MOD HD ST/ST 26MMD SH  801100328	CPT MOD HD ST/ST 28MMD LN  801100228	CPT MOD HD ST/ST 28MMD ME  801100128	CPT MOD HD ST/ST 28MMD SH  801100332	CPT MOD HD ST/ST 32MMD LN  801100232	CPT MOD HD ST/ST 32MMD ME  801100132	CPT MOD HD ST/ST 32MMD SH  801100100	CPT MODULAR STEM SIZE 1 S  801100200	CPT MODULAR STEM SIZE 2 S  801100300	CPT MODULAR STEM SIZE 3 S  801100400	CPT MODULAR STEM SIZE 4 S  801100500	CPT MODULAR STEM SIZE 5 S  For use in total or hemi hip arthroplasty","10","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61882616  62030937  62087634  62154310  62264269  62312479  62264269N  62033232  62097081  62264270  62303492  62097082  62264271  62324103  62264271N  61833317  61936207  61942441  61955618  61964737  62024630  62024632  62028824  62028826  62028827  62028828  62041514  62041515  62041516  62042594  62042595  62043475  62094958  62094959  62103574  62103575  62105196  62105197  62106789  62118981  62121273  62121274  62122111  62148550  62148551  62240713  62249029  62255999  62284453  62094958N  62094959N  62103574N  62105196N  62105197N  62118981N  62121273N  62121274N  62122111N  62148550N  62148551N  62249029N  62255999N  62284453N  62065267  62097089  62161471  62303493  62332024  62332024N  61907672  62069520  62161473  62227021  62161473N  62227021N  61653623  61951328  62054833  62089761  62327042  62332620  62362980  62399487  62089761N  62089763  62404691  62089763N  62075382  62086078  62377682  62399485  62075382N  62086078N  62396944  60728070N  62396944V  61593599  61593603  61636319  61636320  61636321  61636323  62065349  62197304  62268534  62268535  62270745  62299141  62299142  62299144  62312516  62318744  62320124  62320125  62326145  62329082  62330793  62330794  62332318  62332319  62332320  62360010  62370903  62376915  62376916  62377681  62389961  62389962  62389963  62397791  62332319N  62332320N  61555369  61636314  61899105  61951332  62065347  62154347  62197301  62197302  62197303  62204571  62204575  62210476  62263548  62263549  62263550  62273047  62276477  62301480  62301481  62301482  62305971  62305972  62305973  62305974  62325598  62326143  62329081  62330792  62352873  62352874  62352875  62352876  62360016  62360017  62362969  62362971  62362972  62370898  62370899  62370905  62370906  62370908  62371744  62371745  62263550N  62325598N  62326143N  62330792N  61951327  61957503  62096318  62197308  62212014  62263546  62305975  62317883  62319763  62320127  62360012  62370902  62389964  62399490  62263553  62263554  62308236  62327043  61839080  62167396  621",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1140-2016","Class II","Product 42 consists of all product under  product code: HSB and same usage:  Item no:	  225224010	M/DN FEM IM NAIL 10MM DIA  225228010	M/DN FEM IM NAIL 10MM DIA  225230010	M/DN FEM IM NAIL 10MM DIA  225232010	M/DN FEM IM NAIL 10MM DIA  225234010	M/DN FEM IM NAIL 10MM DIA  225236010	M/DN FEM IM NAIL 10MM DIA  225238010	M/DN FEM IM NAIL 10MM DIA  225240010	M/DN FEM IM NAIL 10MM DIA  225242010	M/DN FEM IM NAIL 10MM DIA  225244010	M/DN FEM IM NAIL 10MM DIA  225246010	M/DN FEM IM NAIL 10MM DIA  225228011	M/DN FEM IM NAIL 11MM DIA  225230011	M/DN FEM IM NAIL 11MM DIA  225232011	M/DN FEM IM NAIL 11MM DIA  225234011	M/DN FEM IM NAIL 11MM DIA  225236011	M/DN FEM IM NAIL 11MM DIA  225238011	M/DN FEM IM NAIL 11MM DIA  225240011	M/DN FEM IM NAIL 11MM DIA  225242011	M/DN FEM IM NAIL 11MM DIA  225244011	M/DN FEM IM NAIL 11MM DIA  225246011	M/DN FEM IM NAIL 11MM DIA  225224012	M/DN FEM IM NAIL 12MM DIA  225232012	M/DN FEM IM NAIL 12MM DIA  225234012	M/DN FEM IM NAIL 12MM DIA  225236012	M/DN FEM IM NAIL 12MM DIA  225238012	M/DN FEM IM NAIL 12MM DIA  225240012	M/DN FEM IM NAIL 12MM DIA  225242012	M/DN FEM IM NAIL 12MM DIA  225244012	M/DN FEM IM NAIL 12MM DIA  225246012	M/DN FEM IM NAIL 12MM DIA  225228013	M/DN FEM IM NAIL 13MM DIA  225230013	M/DN FEM IM NAIL 13MM DIA  225232013	M/DN FEM IM NAIL 13MM DIA  225234013	M/DN FEM IM NAIL 13MM DIA  225236013	M/DN FEM IM NAIL 13MM DIA  225238013	M/DN FEM IM NAIL 13MM DIA  225240013	M/DN FEM IM NAIL 13MM DIA  225242013	M/DN FEM IM NAIL 13MM DIA  225244013	M/DN FEM IM NAIL 13MM DIA  225246013	M/DN FEM IM NAIL 13MM DIA  225236014	M/DN FEM IM NAIL 14MM DIA  225238014	M/DN FEM IM NAIL 14MM DIA  225240014	M/DN FEM IM NAIL 14MM DIA  225242014	M/DN FEM IM NAIL 14MM DIA  225244014	M/DN FEM IM NAIL 14MM DIA  225246014	M/DN FEM IM NAIL 14MM DIA  225234015	M/DN FEM IM NAIL 15MM DIA  225240015	M/DN FEM IM NAIL 15MM DIA  225242015	M/DN FEM IM NAIL 15MM DIA  225244015	M/DN FEM IM NAIL 15MM DIA  225242016	M/DN FEM IM NAIL 16MM DIA  225230008	M/DN FEM IM NAIL 8MM DIA  225232008	M/DN FEM IM NAIL 8MM DIA","1622","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  370968  61880371  61914127  61996897  62268687  370510  61815337  61853647  61935534  61993296  62099313  62248255  62248257  62305229  370703  61801434  61801435  61827733  61832893  61889074  61889075  61897803  61897804  61897805  61897806  61897807  61905777  61905788  61905791  61905793  61905855  61905856  61905857  61905858  61905859  61905860  61978492  62000674  62007971  62007972  62012314  62021552  62031759  62031760  62069152  62069153  370538  61815286  61815287  61815289  61827739  61827742  61827746  61853650  61869650  61869651  61869652  61869654  61869657  61869658  61869661  61869664  61869665  61869666  61869667  61869668  61869670  61869671  61869674  61914145  61914146  61914147  61935561  61958343  61958347  61979089  62001446  62012324  62012326  62017498  62017499  62021550  62062894  62062896  62062940  62062941  62062942  62062943  62062944  62062945  62062946  62063306  62063307  62063308  62063310  62063312  62063315  62063317  62063319  62063323  62063325  62099314  62099315  62140085  62206911  62206912  62206913  62206914  62206915  62206916  62206917  62206918  62206919  62206920  62206921  62206923  62206925  62268690  62293132  62299011  61914147R  61815301  61815303  61815305  61815306  61842709  61853661  61853663  61853665  61865666  61873539  61873540  61873541  61873542  61873543  61873545  61873546  61873547  61873548  61873549  61873552  61873553  61873554  61873555  61908125  61908133  61908136  61908137  61908138  61916605  61916608  61916609  61958349  61979093  61979094  61996878  62001449  62001450  62001451  62012320  62012321  62038950  62038951  62038952  62038953  62038954  62038955  62038956  62038957  62038958  62038959  62038960  62038961  62038962  62038963  62038964  62038966  62038967  62076535  62076536  62078721  62078722  62078723  62078724  62078725  62078726  62078727  62078728  62078729  62078731  62078733  62078734  62078736  62078737  62078739  62078740  62078741  62078742  62078743  62078744  62078745  62078746  62078747  62103747  6",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1163-2016","Class II","Product 65 consists of all product under product code: KTT and same usage:  Item no:	  119413594	VERSA-FX II KEYLESS SHORT  119413595	VERSA-FX II KEYLESS SHORT  119413596	VERSA-FX II KEYLESS SHORT  119413004	VERSA-FX II KEYLESS TUBE  119413005	VERSA-FX II KEYLESS TUBE  119413006	VERSA-FX II KEYLESS TUBE  119413008	VERSA-FX II KEYLESS TUBE  119413504	VERSA-FX II KEYLESS TUBE  119413505	VERSA-FX II KEYLESS TUBE  119413506	VERSA-FX II KEYLESS TUBE  119413508	VERSA-FX II KEYLESS TUBE  119414004	VERSA-FX II KEYLESS TUBE  119414005	VERSA-FX II KEYLESS TUBE  119414006	VERSA-FX II KEYLESS TUBE  119414008	VERSA-FX II KEYLESS TUBE  119414504	VERSA-FX II KEYLESS TUBE  119414506	VERSA-FX II KEYLESS TUBE  119414508	VERSA-FX II KEYLESS TUBE  119415004	VERSA-FX II KEYLESS TUBE  119415005	VERSA-FX II KEYLESS TUBE  119415006	VERSA-FX II KEYLESS TUBE  119415008	VERSA-FX II KEYLESS TUBE  119313094	VERSA-FX II SHORT TUBE PL  119313095	VERSA-FX II SHORT TUBE PL  119313096	VERSA-FX II SHORT TUBE PL  119313594	VERSA-FX II SHORT TUBE PL  119313595	VERSA-FX II SHORT TUBE PL  119313596	VERSA-FX II SHORT TUBE PL  119314094	VERSA-FX II SHORT TUBE PL  119314594	VERSA-FX II SHORT TUBE PL  119314595	VERSA-FX II SHORT TUBE PL  119315094	VERSA-FX II SHORT TUBE PL  119315095	VERSA-FX II SHORT TUBE PL  119313002	VERSA-FX II STD TUBE PLAT  119313003	VERSA-FX II STD TUBE PLAT  119313004	VERSA-FX II STD TUBE PLAT  119313005	VERSA-FX II STD TUBE PLAT  119313006	VERSA-FX II STD TUBE PLAT  119313008	VERSA-FX II STD TUBE PLAT  119313010	VERSA-FX II STD TUBE PLAT  119313012	VERSA-FX II STD TUBE PLAT  119313502	VERSA-FX II STD TUBE PLAT  119313503	VERSA-FX II STD TUBE PLAT  119313504	VERSA-FX II STD TUBE PLAT  119313505	VERSA-FX II STD TUBE PLAT  119313506	VERSA-FX II STD TUBE PLAT  119313508	VERSA-FX II STD TUBE PLAT  119313510	VERSA-FX II STD TUBE PLAT  119313512	VERSA-FX II STD TUBE PLAT  119314002	VERSA-FX II STD TUBE PLAT  119314003	VERSA-FX II STD TUBE PLAT  119314004	VERSA-FX II STD TUBE PLAT  119314005	VERSA-FX II STD TUBE PLAT  119314006	VERSA-","5538","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61672127  61762385  61804344  61866511  61896678  61940978  61952481  62271940  61906562  61909135  61909415  61708338  61758144  61861311  61879904  61952217  61953206  62130792  62230218  61957579  61762384  61884793  61955865  61866504  61758145  61804342  61866505  61866507  61896676  61896677  61940979  61952464  61952470  61953207  61955866  61957580  62124267  62124268  62124270  62124271  62130789  62130790  62241717  62310746  62310749  61758148  61861312  61952480  62230213  370683  61849236  61866510  61955864  62130791  62271939  370686  61758149  61925936  61640891  61714083  61804347  61884794  62127926  62230216  62271941  371037  61915562  370921  371035  37107414  61901766  62230196  61920050  61708350  370684  371070  61866503  61901767  61920919  62271937  371073  370622  62105420  370541  61828070  61808819  61843710  62016616  62103684  62136373  62141977  61835223  62136374  61839354  61672109  61753030  61753032  61753034  61824698  61844439  61867392  61888711  61936534  61964334  61977116  62005744  62024991  62050761  62050762  62073658  62073659  62076982  62136372  62152758  62152760  62170197  62262094  62279833  62279837  61758137  61822588  61835476  61918578  61948382  62050763  62141993  370396  61918579  62076939  61795499  61815573  62076932  370692  370693  370730  370964  61830495  370685  61677255  61748730  61808359  61822583  61842559  61867373  61908955  61934167  61963949  61980443  61980446  62042558  62063861  62076925  62080167  61677273  61782895  61782896  61867374  61884795  61948380  61977103  61983645  61983646  62089477  62146230  62152751  62291273  61677282  61782897  61808360  61808361  61843709  61867375  61952218  61952219  61952220  61964340  62036972  62042757  62045189  62076927  62080170  62080181  62146235  62155394  62229855  62291274  370403  61681367  61681373  61867376  61983644  62046417  62060741  370404  370646  61997574  62046418  61825005  61753013  61977113  61819370  61819371  61824612  61843711  61867377  61948381  61980449  62",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1141-2016","Class II","Product 43 consists of all product under  product code: HSB and same usage:  Item no:	  224001016	M/DN R-F IM NAIL 10MM DIA  224001018	M/DN R-F IM NAIL 10MM DIA  224001020	M/DN R-F IM NAIL 10MM DIA  224001022	M/DN R-F IM NAIL 10MM DIA  224001024	M/DN R-F IM NAIL 10MM DIA  224001026	M/DN R-F IM NAIL 10MM DIA  224001028	M/DN R-F IM NAIL 10MM DIA  224001030	M/DN R-F IM NAIL 10MM DIA  224001032	M/DN R-F IM NAIL 10MM DIA  224001034	M/DN R-F IM NAIL 10MM DIA  224001036	M/DN R-F IM NAIL 10MM DIA  224001038	M/DN R-F IM NAIL 10MM DIA  224001040	M/DN R-F IM NAIL 10MM DIA  224001042	M/DN R-F IM NAIL 10MM DIA  224001114	M/DN R-F IM NAIL 11MM DIA  224001116	M/DN R-F IM NAIL 11MM DIA  224001118	M/DN R-F IM NAIL 11MM DIA  224001120	M/DN R-F IM NAIL 11MM DIA  224001122	M/DN R-F IM NAIL 11MM DIA  224001124	M/DN R-F IM NAIL 11MM DIA  224001126	M/DN R-F IM NAIL 11MM DIA  224001128	M/DN R-F IM NAIL 11MM DIA  224001130	M/DN R-F IM NAIL 11MM DIA  224001132	M/DN R-F IM NAIL 11MM DIA  224001134	M/DN R-F IM NAIL 11MM DIA  224001136	M/DN R-F IM NAIL 11MM DIA  224001138	M/DN R-F IM NAIL 11MM DIA  224001140	M/DN R-F IM NAIL 11MM DIA  224001142	M/DN R-F IM NAIL 11MM DIA  224001144	M/DN R-F IM NAIL 11MM DIA  224001146	M/DN R-F IM NAIL 11MM DIA  224001218	M/DN R-F IM NAIL 12MM DIA  224001220	M/DN R-F IM NAIL 12MM DIA  224001224	M/DN R-F IM NAIL 12MM DIA  224001226	M/DN R-F IM NAIL 12MM DIA  224001228	M/DN R-F IM NAIL 12MM DIA  224001230	M/DN R-F IM NAIL 12MM DIA  224001232	M/DN R-F IM NAIL 12MM DIA  224001234	M/DN R-F IM NAIL 12MM DIA  224001236	M/DN R-F IM NAIL 12MM DIA  224001238	M/DN R-F IM NAIL 12MM DIA  224001240	M/DN R-F IM NAIL 12MM DIA  224001242	M/DN R-F IM NAIL 12MM DIA  224001244	M/DN R-F IM NAIL 12MM DIA  224001248	M/DN R-F IM NAIL 12MM DIA  224001318	M/DN R-F IM NAIL 13MM DIA  224001324	M/DN R-F IM NAIL 13MM DIA  224001326	M/DN R-F IM NAIL 13MM DIA  224001328	M/DN R-F IM NAIL 13MM DIA  224001330	M/DN R-F IM NAIL 13MM DIA  224001332	M/DN R-F IM NAIL 13MM DIA  224001334	M/DN R-F IM NAIL 13MM DIA  224001336	M/DN R-F IM NAIL 13MM D","1102","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  370673  370503  61929690  61929695  370525  370502  61775812  61815339  61836513  370524  62031813  61815340  61986781  62027941  62041736  62296539  370522  37107460  61986656  62031814  62296541  62304916  62337080  370666  371030  61794154  62137460  62142342  62300946  370672  37107637  61988381  62310758  62337085  370521  62019015  62337075  370671  371026  37107402  62255925  62300951  370567  37107452  370670  370527  371028  37107454  62255930  370699  61850299  62009791  62310760  370536  370596  61775816  62025367  62291092  62304917  37107456  61986657  62019062  62271634  62296587  371040  62019072  62255933  370594  61940056  62019117  62272160  370592  371027  37107403  61940058  62031817  62248168  62291094  62300957  370675  371031  37107445  61775814  61836514  62255940  62304919  370535  37107638  62025375  62293097  370678  370677  370676  370600  61621133  370679  37107451  62291097  62025380  370501  61780307  370500  370534  62304921  61929772  37107640  62000545  62255954  62304922  62337065  370560  61794155  62137461  62296599  62337067  371042  62255961  62293095  62293096  370561  62271638  370539  37107446  62291101  370604  37107516  370566  370528  371029  37107458  370569  370700  370680  61788370  37107457  62337060  62337060N  37107455  62255966  370533  62255969  62291088  370701  37107459  62291087  370601  370668  370681  370537  37107493  62322143  37107639  370588  370602  370519  370682  370698  370976  370975  37107526  37107492  61794152  370974  370669  61794153  370674  62041735  62296538  370595  37107557  37107491  370716  370623  370504  37107642  61690442  61809561  61895585  61921810  61925168  61975925  61984350  62271642  62332021  62332022  61779979  61809562  61809564  61817401  61860460  61860461  61860462  61860463  61860465  61860467  61860470  61903221  61903222  61921804  61921811  61938089  61962181  61964829  61975913  61984353  62112704  62112707  62112709  62189929  62189930  62189931  62189932  62323392  62323522  37107542  61641822  617",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1146-2016","Class II","Product 48 consists of all product under  product code: JWH and same usage:  Item no:	  597206526	NEXGEN ALL-POLY PATELLA,    for use in total knee arthroplasty","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61873094  61895696  61905916  61905918  61905920  61919766  61919767  61919768  61956249  61956250  61981202  61981204  61999375  62027331  62060784  62074467  62074469  62096750  62096751  62133740  62164984  62168517  62171693  62171694  62171696  62174936  62205101  62213332  62213333  62220943  62345691  62345692  62345693  62345694  62352447  62352450  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1127-2016","Class II","Product 29 consists of all product under  product code: LPHand same usage:  Item no:	  32902603800	FEMORAL HEAD +0.5 X 22 MM  32902604810	FEMORAL HEAD +3.5 X 22 MM  32902604845	FEMORAL HEAD +7.0 X 22 MM    For use in total or hemi hip arthroplasty","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62051735  62221046  62262799  62272099  62279770  62279770N  62079181  62162466  62185965  62185966  62221047  62262801  62262802  62262803  62279771  62285361  62311660  62393063  62279771N  62285361N  62311660N  61520812  62162464  62221048  62279772  62393064  62279772N  62393064V  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1162-2016","Class II","Product 64 consists of all product under product code: JDI and same usage:  Item no:	  902605101	UNIPOLAR ENDO FEM HEAD 51MM    For use in hemi hip arthroplasty","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62054883  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1168-2016","Class II","Product 70 consists of all product under product code: JDI and same usage:  Item no:	  785701000	VERSYS HERITAGE FEM STEM  785701100	VERSYS HERITAGE FEM STEM  785701200	VERSYS HERITAGE FEM STEM  785701300	VERSYS HERITAGE FEM STEM  785701320	VERSYS HERITAGE FEM STEM  785701400	VERSYS HERITAGE FEM STEM  785701420	VERSYS HERITAGE FEM STEM  785701500	VERSYS HERITAGE FEM STEM  785701520	VERSYS HERITAGE FEM STEM  785701600	VERSYS HERITAGE FEM STEM  785701700	VERSYS HERITAGE FEM STEM    For use in total or hemi hip arthroplasty","360","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61661156  61966578  62225735  61873650  61962858  62137227  62137228  62240762  62340060  62340060N  61820823  61881193  61957419  61962855  62172047  62175238  62234460  62262787  62291935  62298291  62298292  62310454  62314656  62340058  62298291N  62310454N  62314656N  62340058N  61878467  61881194  61883397  61886939  61899754  61968010  62221008  62284504  62285272  62291937  62291937N  61822322  62032180  62260128  62304808  62340062  62358896  62304808N  62340062N  61813932  61820819  61980168  62205493  62240263  62240771  62240772  62240773  62240774  62282932  62291138  62291938  62296576  62299089  62340063  62296576N  62340063N  61866252  62257147  62303509  62340064  62340064N  61814493  61976178  62046502  62240775  62312492  61679898  61995953  61995956  61995957  61995958  61885901  62046499  62211984  370462  61980171  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1133-2016","Class II","Product 35 consists of all product under   product code: JWH and same usage:  Item no:	  522007300	I/B II KNEE FLUTED ROD, 1    for use in total knee arthroplasty","49","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62207450  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1124-2016","Class II","Product 26 consists of all product under  product code: JWH and same usage:  Item no:	  234703104	DISTAL MEDIAL FEMORAL CON  234703206	DISTAL MEDIAL FEMORAL CON  234703208	DISTAL MEDIAL FEMORAL CON  234800504	DISTAL POSTERIOR/LATERAL  234800506	DISTAL POSTERIOR/LATERAL  234800508	DISTAL POSTERIOR/LATERAL  234800510	DISTAL POSTERIOR/LATERAL  234800604	DISTAL POSTERIOR/LATERAL  234800606	DISTAL POSTERIOR/LATERAL  234800608	DISTAL POSTERIOR/LATERAL  234800610	DISTAL POSTERIOR/LATERAL  234800614	DISTAL POSTERIOR/LATERAL      Product Usage:  For use in total or hemi hip arthroplasty  ","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61555543  61597965  61670825  62079145  62079148  62124066  62135039  62185960  62203621  62221041  62221043  62221044  62267947  62267949  62267950  62268526  62277492  62277493  62278701  62278702  62278703  62340123  62397828  62397831  62267950N  62278701N  62278702N  62278703N  61597959  61653581  62218170  62265345  62277494  62294359  62218170N  62277494N  62294359N  61292730N  62122127  62267951  62267952  62278704  62267952N  62278704N  62181482  62304835  62304835N  62203622  62203622N  62289044  62391711  62289044N  62391711V  61854615  61977887  62135046  62162460  62267946  62268527  62340121  62268527N  62289054  62289083  62304837  62289054N  62289083N  62304837N  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1151-2016","Class II","Product 53 consists of all product under:    product code: JWH and same usage:  Item no:	  597002501	NEXGEN PRECOAT PEG TIB PL  597002502	NEXGEN PRECOAT PEG TIB PL  597003501	NEXGEN PRECOAT PEG TIB PL  597003502	NEXGEN PRECOAT PEG TIB PL  597004501	NEXGEN PRECOAT PEG TIB PL  597004502	NEXGEN PRECOAT PEG TIB PL  597005501	NEXGEN PRECOAT PEG TIB PL  597005502	NEXGEN PRECOAT PEG TIB PL  597005503	NEXGEN PRECOAT PEG TIB PL  597005504	NEXGEN PRECOAT PEG TIB PL  598002701	NEXGEN PRECOAT STEMMED TI  598002702	NEXGEN PRECOAT STEMMED TI  598003701	NEXGEN PRECOAT STEMMED TI  598003702	NEXGEN PRECOAT STEMMED TI  598004701	NEXGEN PRECOAT STEMMED TI  598004702	NEXGEN PRECOAT STEMMED TI  598005701	NEXGEN PRECOAT STEMMED TI  598005702	NEXGEN PRECOAT STEMMED TI  598005703	NEXGEN PRECOAT STEMMED TI  598005704	NEXGEN PRECOAT STEMMED TI  598801510	NEXGEN SHARP FLUTED STEM  598801511	NEXGEN SHARP FLUTED STEM  598801512	NEXGEN SHARP FLUTED STEM  598801513	NEXGEN SHARP FLUTED STEM  598801514	NEXGEN SHARP FLUTED STEM  598801515	NEXGEN SHARP FLUTED STEM  598801516	NEXGEN SHARP FLUTED STEM  598801517	NEXGEN SHARP FLUTED STEM  598801518	NEXGEN SHARP FLUTED STEM  598801519	NEXGEN SHARP FLUTED STEM  598801520	NEXGEN SHARP FLUTED STEM  598801010	NEXGEN STRAIGHT STEM EXT  598801011	NEXGEN STRAIGHT STEM EXT  598801012	NEXGEN STRAIGHT STEM EXT  598801013	NEXGEN STRAIGHT STEM EXT  598801014	NEXGEN STRAIGHT STEM EXT  598801015	NEXGEN STRAIGHT STEM EXT  598801016	NEXGEN STRAIGHT STEM EXT  598801017	NEXGEN STRAIGHT STEM EXT  598801018	NEXGEN STRAIGHT STEM EXT  598801020	NEXGEN STRAIGHT STEM EXT  598801022	NEXGEN STRAIGHT STEM EXT  598801024	NEXGEN STRAIGHT STEM EXT  598801112	NEXGEN STRAIGHT STEM EXT  598801113	NEXGEN STRAIGHT STEM EXT  598801114	NEXGEN STRAIGHT STEM EXT  598801115	NEXGEN STRAIGHT STEM EXT  598801116	NEXGEN STRAIGHT STEM EXT  598801117	NEXGEN STRAIGHT STEM EXT  598801118	NEXGEN STRAIGHT STEM EXT  598801212	NEXGEN STRAIGHT STEM EXT  598801215	NEXGEN STRAIGHT STEM EXT    for use in total knee arthroplasty","202221","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61797104  61797098  61797099  61823441  61958847  61963895  62029932  62029933  62130571  62130703  62190529  62261995  62261996  62298547  61809090  61809091  61809092  61809094  61809095  61816526  61816527  61816528  61816529  61823442  61823443  61830085  61830086  61830087  61869782  61869783  61869784  61905813  61905814  61905815  61905816  61918789  61926794  61926795  61926796  61947456  61947457  61947458  61967928  61967929  61984965  61984966  61984967  62051520  62082119  62082120  62082121  62098807  62115643  62115644  62115645  62130131  62159766  62159767  62159768  62168172  62177114  62189275  62189276  62189277  62189278  62189279  62214676  62214677  62214678  62215101  62215102  62292591  62292592  62292593  62326317  62332106  62337925  62337926  61760954  61809099  61809101  61816531  61816532  61823445  61823446  61830088  61830089  61830090  61869785  61869786  61869787  61869788  61905817  61905818  61918790  61918791  61918792  61947464  61947465  61967930  61967931  61984957  61984958  62029934  62041310  62051521  62051522  62082122  62082123  62115646  62115647  62115648  62141264  62141265  62168173  62177115  62190520  62200274  62200275  62200276  62214679  62214680  62298548  62298549  62337928  62345194  61605870  61672547  61672548  61760960  61760961  61808305  61808306  61808308  61808310  61816481  61816482  61816483  61816484  61816485  61823427  61823428  61823429  61871288  61871289  61871290  61900655  61900656  61918793  61926784  61926785  61926786  61935104  61935105  61935106  61947471  61947473  61947474  61967932  61967933  61967934  61984959  61984960  61984961  62051517  62051518  62080355  62080356  62080357  62130201  62130202  62130203  62130204  62168168  62168169  62168170  62168171  62200269  62200270  62200271  62200272  62227409  62227410  62227411  62261983  62261984  62261985  62298545  62298546  62332110  62332111  61760955  61760956  61809104  61809105  61816534  61823448  61823449  61830091  61830092  61871292  61871293  61918794  6192",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016","4  61896585  61897776  61897777  61897778  61897779  61897780  61897781  61897782  61897783  61897784  61897785  61898716  61898717  61898718  61898719  61900483  61900484  61900485  61900486  61900487  61900488  61900489  61900490  61900491  61900492  61900493  61900494  61901248  61901249  61901250  61901251  61901252  61901253  61901254  61901255  61901256  61901257  61903249  61903251  61903253  61903254  61903255  61904299  61904301  61904302  61904303  61904304  61904305  61905324  61905325  61905326  61905327  61905328  61905329  61906098  61906099  61906100  61906101  61906102  61906103  61906104  61906105  61906409  61906410  61906411  61906412  61906413  61906414  61906415  61906416  61906417  61906418  61908325  61908326  61908327  61908329  61908330  61908331  61909964  61909965  61909966  61909967  61909968  61910604  61910605  61910606  61910607  61910608  61910609  61910610  61910611  61911556  61911557  61911558  61911559  61911560  61912424  61912425  61912426  61912427  61912428  61913239  61913240  61913241  61913242  61913243  61914675  61914676  61914677  61914678  61914679  61916273  61916274  61916275  61916276  61916277  61916278  61916279  61916280  61918297  61918298  61918299  61918301  61918302  61918303  61918304  61918305  61918306  61918307  61930200  61930201  61930202  61930203  61930204  61930205  61930206  61930207  61930208  61930209  61930210  61930211  61930212  61930213  61930214  61930215  61930216  61930217  61930218  61930219  61930220  61935109  61935110  61935111  61935112  61935113  61935114  61935115  61935116  61935117  61935118  61935119  61935120  61935121  61935122  61935123  61935124  61935125  61935126  61956963  61956964  61956965  61956966  61956967  61956968  61956969  61956970  61956971  61956972  61958797  61958798  61958799  61958801  61958802  61958803  61958804  61958805  61958806  61958807  61958808  61958809  61958810  61958811  61958812  61961907  61961909  61961910  61961911  61961912  61961913  61961914  61961915  61961916  61961917  61963997  61","6  62312078  62312079  62312080  62312081  62313416  62313417  62315707  62315708  62316929  62319291  62319292  62319293  62319294  62332558  62332559  62344828  62344829  62345546  62345547  62352629  62359736  370492  370518  370880  61731004  61760981  61800730  61800731  61800732  61800733  61800734  61815203  61815204  61815207  61815209  61815210  61815211  61826516  61826517  61826518  61826519  61826520  61829197  61829198  61829199  61829201  61829202  61834242  61834243  61834244  61834245  61834246  61851102  61851103  61851104  61851105  61851106  61868088  61868089  61868090  61868091  61868092  61880691  61880692  61880693  61883690  61883691  61892423  61892424  61892425  61913249  61913250  61983995  61983996  61983997  61983998  61984000  61984001  61984002  61996249  61996250  61998937  61998938  61998939  62002083  62002084  62022075  62022076  62022077  62025995  62025996  62025997  62047834  62047835  62049111  62049112  62082022  62082023  62115632  62115633  62115634  62122371  62126957  62131496  62131497  62180375  62180376  62180377  62184063  62188594  62188595  62227573  62227574  62227575  62227576  62227577  62227578  62227579  62270535  62270537  62273064  62273065  62273066  62273067  62298552  62298553  62319298  62326306  62326307  62332562  62363777  370478  370881  61685522  61838261  61862988  61870151  61925051  61925052  61943209  61958846  61999208  62019477  62019478  62065072  62065087  62115641  62115642  62156829  62156830  62220346  62227580  62227581  62263112  62263113  62319306  62332567  370482  370483  370484  370491  61798834  61798835  61798837  62070160  62143588  62180823  62227582  62227583  62291418  62328970  61954684  61984986  62117873  62117874  62160030  62160032  62292008  61954686  62117891  62117892  61875539  61885463  61885464  62117884  62126566  62141794  62195685  62211498  61798484  61808876  61946642  61946643  61954687  62171611  62211499  62255304  62255306  62333036  62333036N  61808881  61918806  61961993  62211503  62291948  62319379 ",,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1107-2016","Class II","Product 9 consists of all product under HRS, and same usage:  Item no:	  47494502601	4.5 BROAD SCP PLT, 26 HOL  	  	  	  Product Usage:  Temporary internal fixation devices designed to stabilize fractures during the normal healing process.    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no: 61889853  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1119-2016","Class II","Product 21 consists of all product under  product code: JDI and same usage:  Item no:	  811400218	CPT 12/14 COCR REVISION S  811400318	CPT 12/14 COCR REVISION S  811400420	CPT 12/14 COCR REVISION S  811400423	CPT 12/14 COCR REVISION S  811400426	CPT 12/14 COCR REVISION S  811400010	CPT 12/14 COCR SIZE 0 EXT  811400000	CPT 12/14 COCR SIZE 0 STD  811400110	CPT 12/14 COCR SIZE 1 EXT  811400100	CPT 12/14 COCR SIZE 1 STD  811400210	CPT 12/14 COCR SIZE 2 EXT  811400200	CPT 12/14 COCR SIZE 2 STD  811400230	CPT 12/14 COCR SIZE 2 XEX  811400310	CPT 12/14 COCR SIZE 3 EXT  811400300	CPT 12/14 COCR SIZE 3 STD  811400330	CPT 12/14 COCR SIZE 3 XEX  811400410	CPT 12/14 COCR SIZE 4 EXT  811400400	CPT 12/14 COCR SIZE 4 STD  811400430	CPT 12/14 COCR SIZE 4 XEX  811400510	CPT 12/14 COCR SIZE 5 EXT  811400500	CPT 12/14 COCR SIZE 5 STD  811400530	CPT 12/14 COCR SIZE 5 XEX    Product Usage:  Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.      ","1209","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61955193  61955194  61964624  61982550  62046482  62065282  62261923  62262772  62295082  62249027  62330762  62036886  62176426  62262773  61907680  62030928  62240741  62298284  62030929  61907674  61964631  61969290  61969291  62018466  62018468  62055978  62055980  62076923  62076924  62082567  62082568  62106792  62128913  62131432  62143850  62159845  62159846  62167370  62178690  62178691  62190353  62203977  62204524  62227026  62227027  62227029  62238072  62240247  62240730  62257224  62261914  62262774  62276442  62284459  62288119  62291920  62296540  62307970  62312487  62324098  62333959  62338563  62340055  62360134  62360140  61668394  61679041  61955610  61957414  61964634  61969286  61978765  61986788  61986790  62022714  62036889  62038366  62046483  62065284  62069521  62069522  62069524  62097046  62097047  62106790  62106791  62114854  62122106  62122107  62127729  62127730  62134924  62137237  62143848  62161474  62161475  62161476  62166255  62172022  62172025  62188287  62188306  62193415  62199384  62211968  62211969  62227033  62227034  62234448  62240728  62240729  62251948  62255221  62256007  62262770  62268570  62278680  62278681  62278682  62284458  62288118  62311635  62317908  62320170  62333489  62333490  62333491  62340051  62340052  62340053  62343732  62346560  62358887  62358889  62360121  62362779  61114608  61817973  61840599  61840601  61841631  61895489  61911441  61947699  61952551  61952552  61996733  62010642  62022717  62022718  62024620  62033222  62033223  62036884  62042582  62050975  62050976  62050977  62091839  62091840  62097049  62097050  62100682  62100683  62100684  62105194  62113215  62113216  62114845  62114846  62114847  62131429  62131430  62131431  62146099  62146101  62148559  62154544  62156184  62156185  62156186  62156187  62159840  62159843  62159844  62160581  62190351  62190352  62199387  62202244  62204526  62208749  62211974  62211975  62216681  62216682  62216683  62221870  62221871  62222756  62222757  62240243  62240735  6224",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1115-2016","Class II","Product 17 consists of all product under   product code: LPH and same usage:  Item no:	  625004515	BONE SCREW 4.5X15 SELF-TA  625004520	BONE SCREW 4.5X20 SELF-TA  625004525	BONE SCREW 4.5X25 SELF-TA  625004530	BONE SCREW 4.5X30 SELF-TA  625004535	BONE SCREW 4.5X35 SELF-TA  625004540	BONE SCREW 4.5X40 SELF-TA  625004550	BONE SCREW 4.5X50 SELF-TA  625006515	BONE SCREW 6.5X15 SELF-TA  625006520	BONE SCREW 6.5X20 SELF-TA  625006525	BONE SCREW 6.5X25 SELF-TA  625006530	BONE SCREW 6.5X30 SELF-TA  625006535	BONE SCREW 6.5X35 SELF-TA  625006540	BONE SCREW 6.5X40 SELF-TA  625006550	BONE SCREW 6.5X50 SELF-TA  625006560	BONE SCREW 6.5X60 SELF-TA  625006570	BONE SCREW 6.5X70 SELF-TA    Product Usage:  For use in total or hemi hip arthroplasty    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	    ","87341","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61986559  61986661  62332485  62339373  62339372  61674407  61953445  62048819  62308513  62326387  62326389  62044206  62332484  62339371  61623552  61623554  61661363  61667818  61667821  61825066  61881292  61968207  61968208  61968209  61968210  61968212  61968213  61996180  61996181  62011506  62032192  62073694  62163394  62163395  62176480  62176481  62176482  62176484  62176485  62176490  62194287  62194288  62194295  62227248  62292597  62292598  62292599  62292600  62292601  62292602  62318725  62318726  62318818  62319085  62332482  62337854  62337855  62352228  62352230  62163394N  62319085N  61623693  61661367  61667833  61667834  61674415  61674417  61801347  61801351  61836013  61836017  61836018  61868984  61874772  61874773  61878940  61878943  61878944  61878945  61885304  61885305  61890085  61890088  61908410  61908411  61929734  61929741  61929742  61929743  61943261  61943264  61948726  61948727  61953452  61953456  61953457  61974150  61974152  61974156  61974158  61980039  61980040  61980044  61980045  61983076  61983077  61983078  61996185  62011509  62011510  62011511  62011512  62011513  62016785  62021129  62021130  62021131  62021136  62032195  62073698  62089906  62089907  62089908  62090517  62090524  62110368  62110369  62110370  62163402  62163405  62163409  62163414  62176499  62176508  62188030  62188031  62188034  62188035  62194296  62194297  62194301  62194302  62211380  62221233  62256198  62256201  62256202  62256203  62256204  62256206  62256207  62256208  62256209  62256210  62256211  62256212  62256213  62256214  62256215  62256216  62292603  62292604  62292605  62292606  62292607  62292608  62292609  62292610  62292611  62292612  62292613  62292614  62313348  62313349  62313350  62313351  62318720  62318721  62318812  62318813  62318814  62318815  62319087  62326321  62326322  62326323  62326324  62326563  62326564  62332479  62332480  62337844  62337845  62337847  62337848  62346362  62346376  62346377  62358307  62292607N  62292614N  62318814N  62326323N",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1132-2016","Class II","Product 34 consists of all product under  product code: JWH and same usage:  Item no:	  522001700	I/B II KNEE DOMED PATELLA  522001800	I/B II KNEE DOMED PATELLA  522001900	I/B II KNEE DOMED PATELLA  for use in total knee arthroplasty","512","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61932449  62126613  62204611  62213348  62406239  62203954  62204587  62332733  62236654  62406245  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1142-2016","Class II","Product 44 consists of all product under  product code: HWC and same usage:  Item no:	  114607099	MAGMA-FX CANN SCREW 7.0MM  114604099	MAGNA FX CANN SCREW 7.0MM  114603000	MAGNA-FX CANN SCREW 7.0MM  114603500	MAGNA-FX CANN SCREW 7.0MM  114604000	MAGNA-FX CANN SCREW 7.0MM  114604032	MAGNA-FX CANN SCREW 7.0MM  114604500	MAGNA-FX CANN SCREW 7.0MM  114604532	MAGNA-FX CANN SCREW 7.0MM  114604599	MAGNA-FX CANN SCREW 7.0MM  114605000	MAGNA-FX CANN SCREW 7.0MM  114605032	MAGNA-FX CANN SCREW 7.0MM  114605099	MAGNA-FX CANN SCREW 7.0MM  114605500	MAGNA-FX CANN SCREW 7.0MM  114605532	MAGNA-FX CANN SCREW 7.0MM  114605599	MAGNA-FX CANN SCREW 7.0MM  114606000	MAGNA-FX CANN SCREW 7.0MM  114606032	MAGNA-FX CANN SCREW 7.0MM  114606099	MAGNA-FX CANN SCREW 7.0MM  114606500	MAGNA-FX CANN SCREW 7.0MM  114606532	MAGNA-FX CANN SCREW 7.0MM  114606599	MAGNA-FX CANN SCREW 7.0MM  114607000	MAGNA-FX CANN SCREW 7.0MM  114607032	MAGNA-FX CANN SCREW 7.0MM  114607500	MAGNA-FX CANN SCREW 7.0MM  114607532	MAGNA-FX CANN SCREW 7.0MM  114607599	MAGNA-FX CANN SCREW 7.0MM  114608000	MAGNA-FX CANN SCREW 7.0MM  114608032	MAGNA-FX CANN SCREW 7.0MM  114608099	MAGNA-FX CANN SCREW 7.0MM  114608500	MAGNA-FX CANN SCREW 7.0MM  114608532	MAGNA-FX CANN SCREW 7.0MM  114608599	MAGNA-FX CANN SCREW 7.0MM  114609000	MAGNA-FX CANN SCREW 7.0MM  114609032	MAGNA-FX CANN SCREW 7.0MM  114609099	MAGNA-FX CANN SCREW 7.0MM  114609500	MAGNA-FX CANN SCREW 7.0MM  114609532	MAGNA-FX CANN SCREW 7.0MM  114609599	MAGNA-FX CANN SCREW 7.0MM  114610000	MAGNA-FX CANN SCREW 7.0MM  114610032	MAGNA-FX CANN SCREW 7.0MM  114610099	MAGNA-FX CANN SCREW 7.0MM  114610500	MAGNA-FX CANN SCREW 7.0MM  114610532	MAGNA-FX CANN SCREW 7.0MM  114610599	MAGNA-FX CANN SCREW 7.0MM  114611000	MAGNA-FX CANN SCREW 7.0MM  114611032	MAGNA-FX CANN SCREW 7.0MM  114611099	MAGNA-FX CANN SCREW 7.0MM  114611500	MAGNA-FX CANN SCREW 7.0MM  114611532	MAGNA-FX CANN SCREW 7.0MM  114611599	MAGNA-FX CANN SCREW 7.0MM  114612000	MAGNA-FX CANN SCREW 7.0MM  114612032	MAGNA-FX CANN SCREW 7.0MM  114612500	MAGNA-FX CANN SCREW 7.0","4335","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61740618  61740619  61931831  61920071  62221457  61825071  61926436  62036483  62221458  61758528  61820880  61878510  62098534  62221459  61851882  61986815  61825053  61851890  61926437  62094921  62181573  62221461  61878509  62098535  62181574  61758529  61828387  61851894  61915518  61979050  62065546  62065954  62160485  62221462  62253412  61878508  61979052  62181575  62253417  61930994  61812109  61812110  61857821  61898941  61898944  62065556  62065966  62160486  62225720  61830574  61926438  62112852  62253418  62181576  61758530  61798087  61831417  61851896  61920073  61920076  61979053  61986817  62191389  62260412  61627280  61758593  61851898  61920080  61979057  62098542  62191391  62260435  61740613  61620151  61740615  61758597  61814991  61851906  61851908  61857822  61920081  61964951  61964953  61979058  62098544  62191387  62225721  61825064  61851910  61918613  61964954  62036488  62120735  62181577  62260456  62160478  61627282  61740616  61758600  61825051  61825052  61851911  61851913  61915519  61979059  61979060  62094922  62094923  62122194  62181545  62181546  62210926  62210928  62265689  62265690  61678540  61758601  61851912  61926442  62036492  62112496  62204454  61678541  61758603  61758605  61798068  61825059  61835206  61844448  61844451  61851918  61898975  61898978  61964957  61964960  61979062  62065551  62065961  62120742  62144846  62204457  62204458  62204460  61835208  61920082  61979063  62094924  62120743  62253422  62141639  61740623  61740625  61758611  61820859  61825063  61830556  61844453  61844454  61851926  61857823  61915364  61915365  61915366  61964962  61964963  61986818  61986819  62065542  62065944  62098546  62112497  62112498  62112499  62160487  62181578  62204470  62204474  62204478  62204481  61758631  61825125  61851930  61964458  62031594  62144847  62225722  61812106  62141640  61740632  61752977  61810352  61825057  61830554  61835211  61851932  61851935  61851939  61878511  61898980  61915520  61964964  61964965  61986820  6202",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1161-2016","Class II","Product 63 consists of all product under product code: LPH and same usage:  Item no:	  620004020	TRILOGY ACET SHELL 40MM O  620004220	TRILOGY ACET SHELL 42MM O  620004420	TRILOGY ACET SHELL 44MM O  620004620	TRILOGY ACET SHELL 46MM O  620004621	TRILOGY ACET SHELL 46MM O  620004820	TRILOGY ACET SHELL 48MM O  620004822	TRILOGY ACET SHELL 48MM O  620004823	TRILOGY ACET SHELL 48MM O  620005020	TRILOGY ACET SHELL 50MM O  620005021	TRILOGY ACET SHELL 50MM O  620005022	TRILOGY ACET SHELL 50MM O  620005220	TRILOGY ACET SHELL 52MM O  620005221	TRILOGY ACET SHELL 52MM O  620005222	TRILOGY ACET SHELL 52MM O  620005223	TRILOGY ACET SHELL 52MM O  620005420	TRILOGY ACET SHELL 54MM O  620005421	TRILOGY ACET SHELL 54MM O  620005422	TRILOGY ACET SHELL 54MM O  620005423	TRILOGY ACET SHELL 54MM O  620005620	TRILOGY ACET SHELL 56MM O  620005621	TRILOGY ACET SHELL 56MM O  620005622	TRILOGY ACET SHELL 56MM O  620005623	TRILOGY ACET SHELL 56MM O  620005820	TRILOGY ACET SHELL 58MM O  620005821	TRILOGY ACET SHELL 58MM O  620005822	TRILOGY ACET SHELL 58MM O  620005823	TRILOGY ACET SHELL 58MM O  620006020	TRILOGY ACET SHELL 60MM O  620006022	TRILOGY ACET SHELL 60MM O  620006023	TRILOGY ACET SHELL 60MM O  620006021	TRILOGY ACET SHELL 60MM OD SOLID  620006220	TRILOGY ACET SHELL 62MM O  620006221	TRILOGY ACET SHELL 62MM O  620006222	TRILOGY ACET SHELL 62MM O  620006420	TRILOGY ACET SHELL 64MM O  620006422	TRILOGY ACET SHELL 64MM O  620006620	TRILOGY ACET SHELL 66MM O  For use in total hip arthroplasty","2063","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61564135  62126347  61564135R  62251853  62298252  62298252N  61873598  62156174  61846474  61867232  61867233  61947557  62352860  62195511  61580837  61638704  61808993  61837768  62159817  62209893  62339997  62352861  61655829  61665436  61665438  61809036  61864075  61873615  61880354  61943340  61957101  61967998  62076914  62076915  62136636  62154300  62154301  62189392  62240665  62251935  62352862  61817455  61638709  61638710  61864066  61926574  62096972  62240233  62291912  62291912N  61642324  61642325  61627447  61642348  61642355  61867247  61873610  61880350  61880351  61880353  61921684  61923932  61923933  61930395  61953121  61964705  61999747  62188279  62189398  62227006  62234425  62268598  62268603  62285249  62324089  62328956  62285249N  62324089N  62328956N  62060654  62346538  61642326  62251915  61612738  61642361  61642362  61665449  61839045  61840613  61873620  61878443  61884427  61957145  61976123  62060665  62079960  62140524  62165182  62204505  62227010  62234432  62238066  62298271  62309166  62340010  62340011  62340012  62345687  62345690  62309166N  61630550  61803767  61633898  61640799  62105165  62105166  62152061  62152062  62334189  62340015  62346541  62334189N  61840614  61928503  62154514  62203160  61271342  61548278  61661050  61839048  61880361  61884428  61957158  61976135  61976136  62073495  62113213  62143832  62160167  62162433  62178685  62204506  62208743  62218101  62255990  62281822  62340018  62340019  62346543  62346544  62219404  61640807  61941685  62136643  62177334  62240689  62309157  62358865  62363071  62309157N  61813945  61813948  61885848  61873618  61986615  62147323  62154539  62154541  62174599  62188275  62317180  62354677  62354678  62354679  62358863  62358864  62317180N  61921683  62222743  61612718  61837769  61837770  61837771  61964699  62021100  62021101  62140518  62140519  62352868  62358867  62359986  61611815  62079956  62255913  62352869  61532303  61611319  61611320  61612757  61661038  61682017  61839047  6186",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1114-2016","Class II","Product 16 consists of all product under  poduct code: KWY and same usage:  Item no:	  500103822	BIPOLAR LINER 38MM OD X 2  500103922	BIPOLAR LINER 39MM OD X 2  500104022	BIPOLAR LINER 40/41MM OD  500104026	BIPOLAR LINER 40MM OD X 2  500104222	BIPOLAR LINER 42/43 OD X  500104226	BIPOLAR LINER 42MM OD X 2  500104428	BIPOLAR LINER 44/45/46MM  500104422	BIPOLAR LINER 44MM OD X 2  500104426	BIPOLAR LINER 44MM OD X 2  500104728	BIPOLAR LINER 47/48/49MM  500104722	BIPOLAR LINER 47MM OD X 2  500104726	BIPOLAR LINER 47MM OD X 2  500104732	BIPOLAR LINER 47MM OD X 3  500105028	BIPOLAR LINER 50/51/52MM  500105022	BIPOLAR LINER 50MM OD X 2  500105026	BIPOLAR LINER 50MM OD X 2  500105328	BIPOLAR LINER 53/54/55MM  500105322	BIPOLAR LINER 53MM OD X 2  500105326	BIPOLAR LINER 53MM OD X 2  500105728	BIPOLAR LINER 57/58MM OD  500105722	BIPOLAR LINER 57MM OD X 2  500106028	BIPOLAR LINER 60/62MM OD  500106828	BIPOLAR LINER 68/70MM OD  500106832	BIPOLAR LINER 68MM OD X 3  500107228	BIPOLAR LINER 72MM OD X 2  500103800	BIPOLAR SHELL 38MM OD  500103900	BIPOLAR SHELL 39MM OD  500104000	BIPOLAR SHELL 40MM OD  500104100	BIPOLAR SHELL 41MM OD  500104200	BIPOLAR SHELL 42MM OD  500104300	BIPOLAR SHELL 43MM OD  500104400	BIPOLAR SHELL 44MM OD  500104500	BIPOLAR SHELL 45MM OD  500104600	BIPOLAR SHELL 46MM OD  500104700	BIPOLAR SHELL 47MM OD  500104800	BIPOLAR SHELL 48MM OD  500104900	BIPOLAR SHELL 49MM OD  500105000	BIPOLAR SHELL 50MM OD  500105100	BIPOLAR SHELL 51MM OD  500105200	BIPOLAR SHELL 52MM OD  500105300	BIPOLAR SHELL 53MM OD  500105400	BIPOLAR SHELL 54MM OD  500105500	BIPOLAR SHELL 55MM OD  500105700	BIPOLAR SHELL 57MM OD  500105800	BIPOLAR SHELL 58MM OD  500106000	BIPOLAR SHELL 60MM OD  500106200	BIPOLAR SHELL 62MM OD  500107000	BIPOLAR SHELL 70MM OD    Product Usage:  For use in total or hemi hip arthroplasty    	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	","8773","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62219247  62363097  62363094  62389670  61875674  61925649  62033251  62170686  62175401  62183232  62194621  62204619  62204620  62210652  62215055  62215056  62216739  62226849  62226850  62238102  62238103  62250451  62261990  62261991  62268511  62321738  62338907  62338908  62354772  62363091  62378265  62378266  62384300  62389419  62389656  62389657  62389658  62389659  62389660  62396113  62402107  62402108  62402110  62188390  62215057  62247753  62340246  62389667  61839824  61875682  61884434  61902089  61902090  61939396  61941049  61980218  62188391  62188392  62194622  62195533  62207261  62207262  62208774  62208775  62208777  62210653  62210654  62210655  62210656  62216730  62216731  62216732  62222892  62226851  62226853  62226854  62232603  62232604  62234540  62234542  62238104  62238105  62239378  62240421  62240422  62240424  62250452  62250453  62250454  62250464  62250465  62266485  62266486  62268512  62268513  62268524  62283118  62285312  62293255  62320033  62346646  62346647  62352920  62352921  62358953  62358954  62358955  62358956  62363088  62363089  62363090  62378261  62378262  62378263  62378264  62378271  62378272  62396086  62396087  62396088  62396089  62396090  62396091  62396092  62396094  62396102  62396104  62396105  62396106  62402133  62137197  62188394  62212197  62219248  62221917  62233605  62248062  62248065  62249064  62283116  62288156  62360388  62363095  62371774  62384297  62389666  62406836  61815233  61871960  61895572  61923139  61952521  61957679  61957680  61957682  62027860  62033253  62033256  62141837  62141838  62175375  62175378  62181554  62188397  62191274  62193551  62198704  62198709  62203199  62203200  62203201  62203202  62203203  62204035  62204036  62204613  62204614  62207264  62207265  62208779  62208780  62210657  62210658  62210659  62210661  62213285  62213286  62213287  62216734  62216735  62216736  62221923  62221924  62222883  62222884  62222885  62222886  62224981  62224982  62224983  62224984  62226856  62226857  6222",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1156-2016","Class II","Product 58 consists of all product under product code: HRS and same usage:  Item no:	  234800904	PROXIMAL DORSAL ULNA PLT  234800906	PROXIMAL DORSAL ULNA PLT  234800908	PROXIMAL DORSAL ULNA PLT  234800910	PROXIMAL DORSAL ULNA PLT  234801004	PROXIMAL DORSAL ULNA PLT  234801006	PROXIMAL DORSAL ULNA PLT  234801008	PROXIMAL DORSAL ULNA PLT  234801010	PROXIMAL DORSAL ULNA PLT 10H LT  234701304	PROXIMAL MEDIAL TIBIAL 4.  234701306	PROXIMAL MEDIAL TIBIAL 4.  234701308	PROXIMAL MEDIAL TIBIAL 4.  234701404	PROXIMAL MEDIAL TIBIAL 4.  234701406	PROXIMAL MEDIAL TIBIAL 4.  234701408	PROXIMAL MEDIAL TIBIAL 4.    Usage:  Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.  ","119","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61895477  62274946  61771936  61859733  61895479  62049380  62274957  62274957N  61879883  61771950  61879872  61879874  61918348  61944990  62199039  62312399  62312401  62312402  62312401N  61859738  61944992  62124572  62124572N  61941119  62296602  62233795  62312404  62312404N  61944994  62134044  61771903  62152982  61941121  61944995  62233794  62233796  62296608  61771908  62180987  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1116-2016","Class II","Product 18 consists of all product under  product code: HWC and same usage:  Item no:	  47248001441	CANC SCR 4.0MM X 14MM FUL  47248001641	CANC SCR 4.0MM X 16MM FUL  47248001840	CANC SCR 4.0MM X 18MM  47248001841	CANC SCR 4.0MM X 18MM FUL  47248002041	CANC SCR 4.0MM X 20MM FUL  47248002441	CANC SCR 4.0MM X 24MM FUL  47248003641	CANC SCR 4.0MM X 36MM FUL    Product Usage:  A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.      ","83","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62050736  62230456  62261576  61976745  62127763  62230457  62261627  62261659  61955473  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1166-2016","Class II","Product 68 consists of all product under product code: JDI and same usage:  Item no:	  787101360	VERSYS CEM/REV/CALCAR 13X  787101361	VERSYS CEM/REV/CALCAR 13X  787101362	VERSYS CEM/REV/CALCAR 13X  787101363	VERSYS CEM/REV/CALCAR 13X  787101560	VERSYS CEM/REV/CALCAR 15X  787101561	VERSYS CEM/REV/CALCAR 15X  787101562	VERSYS CEM/REV/CALCAR 15X  787101563	VERSYS CEM/REV/CALCAR 15X  787101760	VERSYS CEM/REV/CALCAR 17X  787101761	VERSYS CEM/REV/CALCAR 17X  787101761	VERSYS CEM/REV/CALCAR 17X    For use in total or hemi hip arthroplasty","1220","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61750613  61750614  61868570  61952541  62024610  62030924  62038337  62042578  62050967  62050968  62055953  62058544  62062916  62067900  62076933  62079992  62086045  62097029  62112166  62114833  62132264  62134027  62134028  62143844  62143845  62159824  62199401  62199402  62202245  62222764  62225719  62236534  62240268  62240781  62240783  62244343  62244344  62256020  62256021  62256022  62264272  62270718  62277491  62277507  62277508  62305949  62305950  62312493  62312494  62315892  62318764  62320156  62325567  62326096  62332923  62332924  62332925  62340037  62340038  61843322  61856105  61864096  61868571  62042579  62055955  62055956  62076934  62076936  62086043  62112165  62114834  62132263  62143842  62197213  62199403  62207226  62244341  62244342  62256025  62257216  62266494  62268559  62279449  62287353  62291944  62298295  62299092  62305947  62317922  62326097  62340039  62340040  62005387  62024613  62069014  62097031  62134029  62192539  62202246  62225718  62234467  62255228  62264273  62268560  62291945  62325568  62333495  61925004  62050965  62060670  62079989  62105186  62240782  62257142  62260131  62260132  62312495  62333989  61708135  62030925  62050969  62055958  62067899  62079993  62097032  62194662  62195516  62234471  62234473  62256023  62256024  62256026  62291946  62291947  62317132  62317134  62318765  62333493  62338822  62338823  62055957  62079990  62112164  62159826  62207227  62244345  62257141  62277509  62293488  62305948  62320159  62330766  62043457  62079987  62194661  62244346  62249022  62264274  62326098  370621  61964719  62005385  62058545  62105185  62266493  62317921  61846922  62062915  62143841  62240784  62270717  62317920  62326099  62340042  61658292  62244347  62347297  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1138-2016","Class II","Product 40 consists of all product under  product code: HSB and same usage:  Item no:	  225706565	ITST ANTI-ROTATION SCREW  225707065	ITST ANTI-ROTATION SCREW  225708065	ITST ANTI-ROTATION SCREW  225708565	ITST ANTI-ROTATION SCREW  225709065	ITST ANTI-ROTATION SCREW    Product Usage:  An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.  ","7","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62208147  62208146  62208148  62042715  62042716  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1117-2016","Class II","Product 19 consists of all product code: JDI and same usage:  Item no:	  765301101	CEM FEM ST 11X120 NOCOAT  765301201	CEM FEM ST 12X125 NOCOAT  765301301	CEM FEM ST 13X130 NOCOAT  765301401	CEM FEM ST 14X135 NOCOAT  765301501	CEM FEM ST 15X140 NOCOAT  765301601	CEM FEM ST 16X145 NOCOAT  763301300	CEM FEM ST FX 13 X 130  763301600	CEM FEM ST FX 16 X 145    For use in total or hemi hip arthroplasty","0","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62222763  62240266  62268561  62284487  62294353  62310467  62320160  62346566  61846909  61859930  62028715  62069012  62114832  62237560  62278694  62284486  62298294  62305946  62310463  62330767  62340043  61864095  62028713  62038326  62086042  62100678  62114831  62215704  62284488  62291943  62305945  62311644  62317919  62320157  62320158  62340044  62363364  61866237  62105184  62215705  62268566  62284489  62294354  62303512  62311645  62330768  62065287  62211913  62268563  62284490  62299091  62320161  62333990  62299091N  61885871  62100679  62278695  62303703  62333992  62069011  62280472  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1129-2016","Class II","Product 31 consists of all product under  product code: KTT and same usage:  Item no:	  118113003	FREE-LOCK TUBE & SCP PLAT  118113502	FREE-LOCK TUBE & SCP PLAT  118113503	FREE-LOCK TUBE & SCP PLAT  118114002	FREE-LOCK TUBE & SCP PLAT  118114003	FREE-LOCK TUBE & SCP PLAT  118114502	FREE-LOCK TUBE & SCP PLAT  118114503	FREE-LOCK TUBE & SCP PLAT  118115002	FREE-LOCK TUBE & SCP PLAT  118115003	FREE-LOCK TUBE & SCP PLAT    Product Usage:  Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.    ","285","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61771007  61827364  61853067  61865449  61870424  61888695  61953208  62230187  61853068  61870425  61953213  62230188  61860667  61895085  61937602  61953221  62230190  62271893  61900049  61900056  61958816  62124265  62124266  62241683  62255907  61778898  61860656  61870426  61853070  61900064  370958  61777470  61834885  61934150  370957  61888707  62271892  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1120-2016","Class II","Product 22 consists of all product under   product code: JDI and same usage:  Item no:	  811400218	CPT 12/14 COCR REVISION S  811400318	CPT 12/14 COCR REVISION S  811400420	CPT 12/14 COCR REVISION S  811400423	CPT 12/14 COCR REVISION S  811400426	CPT 12/14 COCR REVISION S  811400010	CPT 12/14 COCR SIZE 0 EXT  811400000	CPT 12/14 COCR SIZE 0 STD  811400110	CPT 12/14 COCR SIZE 1 EXT  811400100	CPT 12/14 COCR SIZE 1 STD  811400210	CPT 12/14 COCR SIZE 2 EXT  811400200	CPT 12/14 COCR SIZE 2 STD  811400230	CPT 12/14 COCR SIZE 2 XEX  811400310	CPT 12/14 COCR SIZE 3 EXT  811400300	CPT 12/14 COCR SIZE 3 STD  811400330	CPT 12/14 COCR SIZE 3 XEX  811400410	CPT 12/14 COCR SIZE 4 EXT  811400400	CPT 12/14 COCR SIZE 4 STD  811400430	CPT 12/14 COCR SIZE 4 XEX  811400510	CPT 12/14 COCR SIZE 5 EXT  811400500	CPT 12/14 COCR SIZE 5 STD  811400530	CPT 12/14 COCR SIZE 5 XEX    For use in total or hemi hip arthroplasty","16","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61907682  62038367  62106797  62161479  62240743  62268577  62344683  62030932  62106796  62148557  62206538  62240742  62303507  62352823  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1125-2016","Class II","Product 27 consists of all product under  product code: HSB and same usage:  Item no:	  234703104	DISTAL MEDIAL FEMORAL CON  234703206	DISTAL MEDIAL FEMORAL CON  234703208	DISTAL MEDIAL FEMORAL CON  234800504	DISTAL POSTERIOR/LATERAL  234800506	DISTAL POSTERIOR/LATERAL  234800508	DISTAL POSTERIOR/LATERAL  234800510	DISTAL POSTERIOR/LATERAL  234800604	DISTAL POSTERIOR/LATERAL  234800606	DISTAL POSTERIOR/LATERAL  234800608	DISTAL POSTERIOR/LATERAL  234800610	DISTAL POSTERIOR/LATERAL  234800614	DISTAL POSTERIOR/LATERAL    Product Usage:  An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.  ","945","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61809193  61809203  61809206  61822572  61841518  61844443  61897681  61901015  62001246  62193768  62277477  62277478  62330721  62336479  62345698  62193768N  62277478N  62266680  61880656  62234613  62266684  62266688  62266692  62333353  61622044  62339493  62339495  62330722  61635839  62330724  61782888  61782889  61782891  61809172  61809173  61809184  61822578  61830206  61830207  61830208  61830209  61838593  61838596  61838599  61838602  61838603  61838604  61864057  61867128  61867129  61893770  61893771  61893772  61901018  61934345  61934352  61951304  61951305  61951306  61996677  62001247  62001248  62001249  62043075  62124382  62124383  62124384  62124385  62124386  62140004  62140005  62167136  62167137  62167139  62167140  62172551  62172553  62175521  62175523  62266672  62266673  62266674  62266675  62277480  62277481  62277482  62299139  62299140  62299143  62299146  62299147  62299148  62314147  62314150  62314154  62314158  62336480  62336481  62277480N  62277481N  62299140N  62299147N  62266682  62266686  61880383  62266690  61880385  62266695  62294804  62266697  62299159  62137496  62148988  62158959  62294778  62259834  62284876  62294792  61634097  62259848  62294786  62280715  62330723  62285471  62285470  61801384  61801385  61801389  61822581  61841519  61901019  61996680  61996681  62181505  62181510  62225836  62266670  62266671  62277483  62306208  62311817  62311818  62336483  62336484  62306208N  61809209  61864058  61880655  61939421  62266676  62311819  62336485  62333354  61793329  61939423  61690423  61695534  61777525  61777526  61782870  61782872  61782874  61782876  61782878  61804353  61804354  61804355  61804356  61804357  61804358  61804359  61819365  61819366  61819369  61822544  61822547  61825926  61825927  61825932  61825935  61825936  61825939  61835597  61835598  61835599  61835600  61841520  61841521  61841522  61841523  61844441  61844459  61844460  61852150  61852151  61852153  61852154  61856841  61856844  61867113  61867114  61867115  6186711",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1147-2016","Class II","Product 49 consists of all product under  product code: JWH and same usage:  Item no:	  597206529	NEXGEN ALL-POLY PATELLA,  597206532	NEXGEN ALL-POLY PATELLA,  597206535	NEXGEN ALL-POLY PATELLA,  597206538	NEXGEN ALL-POLY PATELLA,  597206541	NEXGEN ALL-POLY PATELLA,  598801713	NEXGEN CEMENTED STEM EXT  598801813	NEXGEN CEMENTED STEM EXT  598801913	NEXGEN CEMENTED STEM EXT  598801610	NEXGEN FLUTED STEM EXT, 1  598801611	NEXGEN FLUTED STEM EXT, 1  598801612	NEXGEN FLUTED STEM EXT, 1  598801613	NEXGEN FLUTED STEM EXT, 1  598801614	NEXGEN FLUTED STEM EXT, 1  598801615	NEXGEN FLUTED STEM EXT, 1  598801616	NEXGEN FLUTED STEM EXT, 1  598801618	NEXGEN FLUTED STEM EXT, 1  598801619	NEXGEN FLUTED STEM EXT, 1  598801620	NEXGEN FLUTED STEM EXT, 2  598801622	NEXGEN FLUTED STEM EXT, 2  598801624	NEXGEN FLUTED STEM EXT, 2  597206126	NEXGEN MICRO ALL-POLY PAT  597206129	NEXGEN MICRO ALL-POLY PAT  597206132	NEXGEN MICRO ALL-POLY PAT  597206135	NEXGEN MICRO ALL-POLY PAT    for use in total knee arthroplasty","53338","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61901117  61901118  61905924  61907317  61919774  61925086  61925087  61932224  61932230  61976473  61999384  61999385  61999386  61999389  61999392  61999397  61999398  62027343  62034454  62060787  62074474  62074475  62096756  62124173  62124175  62124176  62126603  62126604  62132121  62164944  62168501  62168504  62168505  62168506  62168507  62168509  62168510  62168511  62168512  62174922  62174923  62220941  62227159  62227166  62249275  62258601  62258607  62258618  62258623  62299435  62299436  62299440  62318771  62326940  62337816  62345677  62345678  62345679  62345680  62346195  62358017  62358018  62358019  62362896  62362897  62362898  62362899  62362900  62362902  62379320  62379321  62379322  62379323  62382825  62382827  62382828  62382829  62382830  62382831  62382832  62382833  62382834  62389197  62389199  62394741  62394742  62394743  62394744  62401077  62401079  62401890  62401892  61823947  61823948  61881528  61881531  61881532  61885110  61895826  61901109  61903389  61903390  61905927  61915687  61915688  61919777  61919778  61932241  61941690  61956251  61956252  61956253  61963006  61963010  61963011  61976477  61980333  61985178  61985180  61985181  61985183  61985184  61985186  61985187  61988469  61988474  61988475  61988476  61988478  61988479  61988483  61988484  61999434  61999435  61999436  61999437  61999438  61999441  62017865  62017866  62017867  62017870  62017871  62034471  62034472  62034474  62034480  62060790  62081115  62081128  62093754  62093758  62109782  62118612  62118614  62121748  62121751  62160772  62160780  62164931  62174918  62174919  62180204  62180205  62209028  62213330  62220924  62220927  62220936  62227148  62227150  62227153  62255832  62255836  62255838  62258568  62258569  62258570  62326932  62326937  62337794  62337799  62345664  62345665  62345666  62345669  62345670  62345671  62345672  62352427  62352428  62352429  62352430  62352432  62352434  62358010  62358011  62358012  62358013  62358014  62358015  62358016  62362882  6236",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1134-2016","Class II","Product 36 consists of all product under  product code: HSB and same usage:  Item no:	  225302745	INTERLOCKING IM SCREW 4.5  225303045	INTERLOCKING IM SCREW 4.5  225303245	INTERLOCKING IM SCREW 4.5  225303545	INTERLOCKING IM SCREW 4.5  225303745	INTERLOCKING IM SCREW 4.5  225304045	INTERLOCKING IM SCREW 4.5  225304245	INTERLOCKING IM SCREW 4.5  225304545	INTERLOCKING IM SCREW 4.5  225305045	INTERLOCKING IM SCREW 4.5  225305245	INTERLOCKING IM SCREW 4.5  225305545	INTERLOCKING IM SCREW 4.5  225305745	INTERLOCKING IM SCREW 4.5  225306045	INTERLOCKING IM SCREW 4.5  225306545	INTERLOCKING IM SCREW 4.5  225307045	INTERLOCKING IM SCREW 4.5    Product Usage:  An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.  ","268","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  61929352  61602065  61800233  61881344  61897089  61958884  61958885  61958886  61993617  62042512  62043576  62137020  62137021  62137022  62224312  61564745  61564747  61657666  61664936  61664937  61764346  61764347  61817406  61817407  61817408  61817409  61839143  61839144  61839145  61881305  61881306  61881307  61881322  61885590  61885592  61885593  61885594  61897083  61897084  61908110  61908114  61908115  61908116  61940081  61940086  61940088  61940090  61940092  61940093  61958887  61958888  61982446  61982447  62020899  62020900  62020901  62038717  62038721  62093613  62093615  62093617  62137023  62137024  62137025  62188625  62188626  62188627  61564754  61800242  61800243  61800244  61800245  61800251  61804379  61839148  61839149  61843698  61881323  61881328  61885595  61885596  61885598  61897085  61897086  61926555  61926556  61926558  61952708  61952709  61952710  61952711  61958889  61958890  61958891  61958892  61958893  61968087  61968088  61968090  62015514  62015520  62020902  62020903  62042513  62043577  62093623  62137026  62137028  62137029  62142069  62142072  62188628  62188629  62188638  62188640  62188643  61764348  61764349  61885603  61885605  61897087  61978180  61978181  61978182  61993618  62042514  62043578  62137030  62137032  61657688  61929353  61978183  61978184  62038740  62038741  62112767  62112769  61993622  62165490  61915262  61915263  61915264  62056670  62056673  62056674  62056675  62056676  62056677  62056678  62056679  62056680  62056681  62056682  62056683  62056684  62056685  62056686  62121124  62121125  62121126  62142063  62224315  62224317  62224320  62224321  62224322  62298604  61929356  61929357  62067205  62067217  62067222  62067225  62067228  62067229  62067241  62067242  62067244  62067245  62067246  62067253  62067255  62067257  62121153  62121154  62121155  62121156  62224328  62224329  62224330  62224331  62237601  62237605  62262081  62262081N  61993624  61915268  61915269  61915270  62130479  62130485  62130492  62130496  621",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72900,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1144-2016","Class II","Product 46 consists of all product under  product code: HWC and same usage:  Item no:	  114204012	MINI MAGNA-FX CANN SCREW  114204016	MINI MAGNA-FX CANN SCREW  114204020	MINI MAGNA-FX CANN SCREW  114204024	MINI MAGNA-FX CANN SCREW  114204028	MINI MAGNA-FX CANN SCREW  114204032	MINI MAGNA-FX CANN SCREW  114204036	MINI MAGNA-FX CANN SCREW  114204040	MINI MAGNA-FX CANN SCREW  114204044	MINI MAGNA-FX CANN SCREW  114204048	MINI MAGNA-FX CANN SCREW  114204055	MINI MAGNA-FX CANN SCREW  114204065	MINI MAGNA-FX CANN SCREW  114204124	MINI MAGNA-FX CANN SCREW  114204126	MINI MAGNA-FX CANN SCREW  114204128	MINI MAGNA-FX CANN SCREW  114204130	MINI MAGNA-FX CANN SCREW  114204132	MINI MAGNA-FX CANN SCREW  114204134	MINI MAGNA-FX CANN SCREW  114204136	MINI MAGNA-FX CANN SCREW  114204138	MINI MAGNA-FX CANN SCREW  114204140	MINI MAGNA-FX CANN SCREW  114204142	MINI MAGNA-FX CANN SCREW  114204144	MINI MAGNA-FX CANN SCREW  114204146	MINI MAGNA-FX CANN SCREW  114204148	MINI MAGNA-FX CANN SCREW  114204150	MINI MAGNA-FX CANN SCREW  114204155	MINI MAGNA-FX CANN SCREW  114204160	MINI MAGNA-FX CANN SCREW  114204165	MINI MAGNA-FX CANN SCREW  114204170	MINI MAGNA-FX CANN SCREW  114205012	MINI MAGNA-FX CANN SCREW  114205016	MINI MAGNA-FX CANN SCREW  114205020	MINI MAGNA-FX CANN SCREW  114205024	MINI MAGNA-FX CANN SCREW  114205028	MINI MAGNA-FX CANN SCREW  114205032	MINI MAGNA-FX CANN SCREW  114205036	MINI MAGNA-FX CANN SCREW  114205040	MINI MAGNA-FX CANN SCREW  114205044	MINI MAGNA-FX CANN SCREW  114205048	MINI MAGNA-FX CANN SCREW  114205055	MINI MAGNA-FX CANN SCREW  114205065	MINI MAGNA-FX CANN SCREW  114205124	MINI MAGNA-FX CANN SCREW  114205126	MINI MAGNA-FX CANN SCREW  114205128	MINI MAGNA-FX CANN SCREW  114205130	MINI MAGNA-FX CANN SCREW  114205132	MINI MAGNA-FX CANN SCREW  114205134	MINI MAGNA-FX CANN SCREW  114205136	MINI MAGNA-FX CANN SCREW  114205138	MINI MAGNA-FX CANN SCREW  114205140	MINI MAGNA-FX CANN SCREW  114205142	MINI MAGNA-FX CANN SCREW  114205144	MINI MAGNA-FX CANN SCREW  114205146	MINI MAGNA-FX CANN SCREW  114205148	MIN","3190","As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013.  The affected products are sterile.","03/12/2016",," lot no.:  62083732  62278719  62278734  62346023  62351544  62346023N  62351544N  61885643  62239545  62239546  62239547  62239548  62290035  62290040  61890456  62005296  62223791  62299098  62346024  61910239  62178894  62346025  61930882  62157290  62248127  62326540  61759543  61892650  61958361  62178895  62346026  62346027  62346026N  62346027N  61627269  61740666  61870977  62079036  62110010  62178896  62234077  62234078  62234079  62234080  62234081  62234082  62234084  62340974  62340975  62340978  62340980  62340983  62344456  62344457  62344459  62344460  62340974N  62340975N  62340978N  62340980N  62340983N  62344456N  62344457N  62344459N  62344460N  61620146  61740667  61839169  61930883  62083735  62223795  62339582  62339585  62339586  62339588  62339589  62339590  62339585N  62339586N  62339588N  62339589N  62339590N  61664666  61759547  61885657  61930884  62083738  62248129  62334669  62334674  62334676  62334680  62337028  62337030  62346148  62351545  62334669N  62334674N  62334680N  62337030N  62346148N  62351545N  61755871  61842980  61950125  62110013  62332636  62336795  62337610  62340759  61719688  61740668  61764765  61889321  61930885  61958362  62110016  62197619  61842575  61885662  61910240  61958364  62005298  62131627  62248131  61664668  61740669  61809454  61870981  61870982  61942560  61952205  62074451  62109223  62168534  62168536  62193745  62281959  61835310  61835311  61870983  61930887  61958365  62031613  62118362  62168528  62168530  62193746  62193747  61839170  61862390  61930889  61940170  61956896  62005299  62074448  62107919  62144850  62144851  62193749  62223801  61740670  61798065  61839171  61862397  61862398  61892651  61930890  61942566  61951771  61999816  61999817  62079037  62110024  62168522  62168524  62197620  62197621  62239549  61620147  61788220  61788221  61840997  61885668  61885672  61950128  62031606  62106211  62144736  62144739  62144740  62197622  62197623  61809455  61836434  61840999  61841001  61870989  61870990  61870991  61910905  ",1/11/2016,"01/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72901,"Terminated","ARUP Laboratories, Inc.","9786 S. Sandy Parkway",,"Sandy","UT","84070-2565","United States","Voluntary: Firm Initiated","Telephone","Utah","B-0216-16","Class II","Apheresis Platelets, Leukocytes Reduced","6 units","Platelet Pheresis products, labled as leuko reduced, in which WBC testing was not performed, were distributed.","01/14/2016","01/14/2016"," W158015801954 (double collection); W158015801956 (double collection); W158015801957 (double collection) ",11/2/2015,"11/02/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72902,"Terminated","Medic Inc","1601 Ailor Ave",".","Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0218-16","Class II","Apheresis Platelets, Leukocytes Reduced","3 units","Apheresis products for which pH testing was not performed, were distributed.","01/07/2016","01/07/2016"," W071215047110 (double collection); W071215037347",11/19/2015,"11/19/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72902,"Terminated","Medic Inc","1601 Ailor Ave",".","Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0217-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","2 units","Apheresis products for which pH testing was not performed, were distributed.","01/07/2016","01/07/2016"," W071215047110; W071215037347",11/19/2015,"11/19/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72903,"Ongoing","Eaton Farm Confectionaries, Inc.","30 Burbank Rd",".","Sutton","MA","01590-2426","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Massachusetts, Maine, Vermont & New Hampshire","F-0513-2016","Class II","Peanut Butter Lust Bar, Net weight 2 ounces, UPC: 1425361001","less than 800 bars","Product contains Soy Lecithin however packaging only states Lecithin.","01/18/2016",," No lot number",12/9/2015,"12/09/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72904,"Terminated","Globalmed Logistix","1880 Beaver Ridge Cir Ste D",,"Norcross","GA","30071-3833","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, CT, FL, GA, NJ and NY.","Z-0690-2016","Class II","Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue.  LGC 13G (13G x 185mm), Sterile.","118 units","The cannulae may bend during procedure.","01/25/2016","03/09/2016"," Ref # AR1318, Lot AB 0643 and AB 0732.  Expiration date 04/2020.",12/15/2015,"12/15/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0517-2016","Class II","Signature Breads Frozen Parbaked Baguette 22202, 25 UNITS - 8.75 OZ, NET WT. 13.67 LB (6.2 kg), in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/14/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0518-2016","Class II","Signature Breads Frozen Parbaked French Petit Pain 22203, 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/14/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0523-2016","Class II","Signature Breads Frozen Parbaked French Sub Grande 22089; 36 UNITS - 5.9 OZ, NET WT. 13.27 LB (6.02 kg), in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/17/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0520-2016","Class II","Piantedosi French Dinner rolls C-301, Signature Breads French Dinner Rolls 22200, 240 UNITS - 1.25 OZ, NET WT. 18.75 LB (8.5 kg), in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/15/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0519-2016","Class II","Signature Breads Frozen Parbaked French Sub Roll 22201, 72 UNITS - 3.25 OZ, NET WT. 14.62 LB (6.63 kg), in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/14/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0525-2016","Class II","Signature Breads Frozen Parbaked Assorted Dinner Rolls 22213; 240 UNITS - NET WT. 22.5 LB (10.2 kg), packed in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/17/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0521-2016","Class II","Signature Breads Frozen Parbaked French Dinner Rolls 22251; 280 Units - 1 OZ, NET WT. 17.5 LB (7.93 kg), in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/15/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0516-2016","Class II","Signature Breads Frozen Parbaked French Dinner Roll 22245; 120 units - 1.25 OZ NET WT. 9.37 LB (4.25 KG), in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/15/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0524-2016","Class II","Signature Breads Frozen Parbaked Assorted Petit Pain 22032; 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/15/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72905,"Ongoing","Signature Breads, Inc.","100 Justin Drive",,"Chelsea","MA","02150","United States","Voluntary: Firm Initiated","E-Mail","NH, PA, FL","F-0522-2016","Class II","Signature Breads Frozen Parbaked French Mini Baguette 22205; 48 UNITS - 5 OZ, NET WT. 15 LB (6.8 kg), in a cardboard box","1,893 cases Total","Product may contain metal fragments. ","02/03/2016",," Use by Date: 9/16/2016",12/20/2015,"12/20/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72907,"Terminated","Ocean Group Inc.","1100 S Santa Fe Ave",,"Los Angeles","CA","90021-1743","United States","Voluntary: Firm Initiated","Letter","U.S. distribution in CA only (Los Angeles and San Diego).  No foreign distribution.","F-0533-2016","Class I","Masago Lake Smelt Roe  6 oz.  UPC Code:4866010101","504 Packages","Product contains undeclared soy and wheat.","02/02/2016","03/16/2016"," N/A",12/16/2015,"12/16/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72908,"Ongoing","Smith & Nephew, Inc., Endoscopy Div.","130 Forbes Blvd",,"Mansfield","MA","02048","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution to the states of :  AK, AL, CA, CO,  FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.","Z-0699-2016","Class II","Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument","157","Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver. ","01/29/2016",," Lot Numbers: 50409038, 50404149, 50399964",4/4/2013,"04/04/2013",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72908,"Ongoing","Smith & Nephew, Inc., Endoscopy Div.","130 Forbes Blvd",,"Mansfield","MA","02048","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution to the states of :  AK, AL, CA, CO,  FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.","Z-0700-2016","Class II","Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument","9","Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver. ","01/29/2016",," Lot Numbers: 50410950 and 50407175",4/4/2013,"04/04/2013",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72909,"Ongoing","This Bar Saves Lives","2554 Lincoln Blvd 1067",,"Venice","CA","90291-5082","United States","Voluntary: Firm Initiated","E-Mail","U.S. distribution to the following:  Distributor- IL  Retail- MN, OK, ND, WI, IA, KS, CA, IL, MD, TN, IA, NM, FL, GA  Online Consumers- FL, PA, VA, LA, CA, MD, NC, TX, RI, NY, MA, OH, ME, TN, GA, AK, MI, CT, NJ, WA, IL, IA, OK","F-0510-2016","Class II","This Kid Saves Lives Chocolate Chip  UPC #10858497004097  UPC# 858497004090","20,829 units","This Bar Saves Lives is recalling This Kid Saves Lives Chocolate Chip because the product contains whey protein and does not identify milk.","02/01/2016",," Inner pack(5 bar carton) - BEST BY APR APR2916 and BEST BY JUL2816    Case(8 inner packs) - BEST BY APR2916 and BEST BY JUL2816  ",12/21/2015,"12/21/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72910,"Ongoing","Owens & Minor Distribution, Inc.","9120 Lockwood Blvd",,"Mechanicsville","VA","23116-2015","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0733-2016","Class II","MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging].    General Hospital Use.","42,050 ","MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.","01/30/2016",," Item No.    Lot No.   Expiration Date:  CBN1103   12113H08A   Oct-15, CBN1103   13033H08A      Feb-16, CBN1103   13053H08A      Apr-16, CBN1103   14013H08A      Dec-16, CBN1103   14043H08A      Mar-17, CBN1103   14053H08A      Apr-17, CBN1103   14083H08A   Jul-17, CBN1103   14063H08A      May-17, CBN1103   15013H08A      Dec-17, CBN1103   14123H08A      Nov-17, CBN1103   14113H08A   Oct-17, CBN1103   15023H08A   Jan-18, CBN1103   15033H08A      Feb-18, CBN1103   15043H08A      Mar-18, CBN1103   15053H08A      Apr-18, CBN1103   15063H08A      May-18, CBN1103   15073H08A   Jun-18, CBN1103   15083H08A   Jul-18.",11/17/2015,"11/17/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72910,"Ongoing","Owens & Minor Distribution, Inc.","9120 Lockwood Blvd",,"Mechanicsville","VA","23116-2015","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0734-2016","Class II","MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]  General Hospital Use.","96266","MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.","01/30/2016",," Item No.    Lot No.   Expiration Date:  CBN1104   15023H09A   Jan-18, CBN1104   15033H09A  Feb-18, CBN1104   15043H09A   Mar-18, CBN1104   15053H09A   Apr-18, CBN1104   15063H09A  May-18, CBN1104   15073H09A   Jun-18, CBN1104   15083H09A   Jul-18, CBN1104   14113H09A   Oct-17, CBN1104   14123H09A   Nov-17, CBN1104   15013H09A   Dec-17, CBN1104   14063H09A   May-17, CBN1104   14083H09A   Jul-17, CBN1104   14093H09A  Aug-17, CBN1104   14053H09A  Apr-17, CBN1104   14043H09A    Mar-17, CBN1104   14013H09A Dec-16, CBN1104   13053H09A  Apr-16, CBN1104   12113H09A   Oct-15, CBN1104   13033H09A   Feb-16, CBN1104   13083H09A   Jul-16, CBN1104   13083H09A   Jul-16, CBN1104   13103H09A  Sep-16, CBN1104   13113H09A   Oct-16, CBN1104   13123H09A   Nov-16.",11/17/2015,"11/17/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72910,"Ongoing","Owens & Minor Distribution, Inc.","9120 Lockwood Blvd",,"Mechanicsville","VA","23116-2015","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0735-2016","Class II","MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]  General Hospital Use.","64011","MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.","01/30/2016",," Item No.    Lot No.   Expiration Date, CBN1106   12113H10A   Oct-15, CBN1106   13033H10A      Feb-16, CBN1106   13053H10A      Apr-16, CBN1106   13083H10A   Jul-16, CBN1106   13103H10A      Sep-16, CBN1106   13113H10A   Oct-16, CBN1106   14013H10A      Dec-16, CBN1106   14043H10A      Mar-17, CBN1106   14053H10A      Apr-17, CBN1106   14063H10A      May-17, CBN1106   14083H10A   Jul-17, CBN1106   14093H10A      Aug-17, CBN1106   14093H10A      Aug-17, CBN1106   14113H10A   Oct-17, CBN1106   14123H10A      Nov-17, CBN1106   15013H10A      Dec-17, CBN1106   15023H10A   Jan-18, CBN1106   15033H10A      Feb-18, CBN1106   15043H10A      Mar-18, CBN1106   15053H10A      Apr-18, CBN1106   15063H10A      May-18, CBN1106   15083H10A   Jul-18, CBN1106   15073H10A   Jun-18.",11/17/2015,"11/17/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72911,"Ongoing","Smith & Nephew, Inc., Endoscopy Div.","130 Forbes Blvd",,"Mansfield","MA","02048","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK; and, country of Japan.","Z-0818-2016","Class II","High Flow Irrigation Extender; Part Number 72201021.    Arthroscopic accessories are indicated for use in access of the joint capsule.","203 units","During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery. ","02/17/2016",," 50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50256942 50263784 50279382 50291593 50302984 50303418 50327069 50330377 50351345 50361381 50404796 50408768 50419699 50433964 50250837 50256854 50269580 5027766 50304642 50342002 50401593 50417254",7/30/2013,"07/30/2013",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72912,"Ongoing","Teva North America","425 Privet Rd",,"Horsham","PA","19044-1220","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0732-2016","Class II","Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89  ","1,895 bottles","Failed Dissolution: Out of Specification test results (low) at the 18 month time-point.","03/01/2016",," Lot # 3A404012V, Exp. 4/2016",12/21/2015,"12/21/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72913,"Ongoing","Acist Medical Systems","7905 Fuller Rd",,"Eden Prairie","MN","55344-2137","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including all states except DE, MT, RI, UT, & VT and Internationally to Belgium, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Reunion, United Kingdom, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Estonia, Greece, Hong Kong, Hungary, Islamic Republic of Iran, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lithuania, Mexico, New Caledonia, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Bosnia and Herzegovina, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and Venezuela.","Z-0744-2016","Class II","ACIST Medical Systems, BT2000 Automated Manifold Kit   (SKU 014613) and CPT2000 (SKU 014623)  Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico.    The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST).    To be used for the controlled infusion of radiopaque contrast media for angiographic procedures    ","48,614 cartons or  486,140 units","Reports related to ingress of air into the manifold.","02/02/2016",," Lot Number    08915J  09015T  09115H  09315D  09615N  09615U  09715X  09815F  10115D  10215G  10415D  10415W  10415Y  10515P  11015L  11115K  11215U  11315M  11715J  11815G  11915D  12415J  12615P  13115M  13415W  13815G  13915T  14015P  14115M  14615D  14615M  15415G  15715D  16115H  16315L  16515E  16615Z  16815J  16915N  17115F  17615U  17815F  18215J  18415D  18515N  18715U  18815K  18915P  19015N  19115H  19315D  19415P  19515X  19715G  19815M  19915D  20115M  20315E  20715D  20815M  20915X  21115W  21815J  21815U  22015D  23715D  23815D  23815P  24415P  24615U  25015D  25515D  26415N  26715F  26815J  26815K  27115L  27215U  27315Z  27415H  27515D  29115D  29915E  29915F  30015E  30015F  32115M  32715G  32715V  32815M                                                                                                                                                                                                                                                                                                                ",12/21/2015,"12/21/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72914,"Ongoing","Draeger Medical, Inc.","3135 Quarry Rd",,"Telford","PA","18969-1042","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-0692-2016","Class I","Emergency Transport Ventilator  Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator  Catalog Numbers: 2M86300/2M86965 and 5704813/5704831.    Volume controlled and pressure-controlled emergency and transport ventilators.","402 units (314 - Oxylog 3000; 88 - Oxylog 3000 Plus)"," was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.","02/03/2016",," All Oxylog 3000 Ventilators and Oxylog 3000 Plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.",12/22/2015,"12/22/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72914,"Ongoing","Draeger Medical, Inc.","3135 Quarry Rd",,"Telford","PA","18969-1042","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-0691-2016","Class I","Emergency Transport Ventilator  Oxylog 2000 Plus Ventilator  Catalog Number: 5705080.    Volume controlled emergency and transport ventilator with pressure support.","0"," was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.","02/03/2016",," All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.    ",12/22/2015,"12/22/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72915,"Terminated","CompView Medical, LLC","2818 E 2nd St","Suite 200","Vancouver","WA","98661-7778","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US nationwide distribution including AZ, CA, CO, GA, OH, and TN.","Z-0644-2016","Class II","Model NuCARTGN.  The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors.  It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.","10 units","The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release and detach.","01/13/2016","03/31/2016"," Lot# T9993-02-01 /15924CARTXXTNNA / DX00357  Lot# T9993-02-02 / 15924CARTXXAZPH / DX00358  Lot# U0328-02-02 / 15A01CARTXXCOEN /DX00360  Lot# U0328-02-01 / 15A26CARTXXCAK1 / DX00359  Lot# U0718-02-01 / 15A26CARTXXCAK2 / DX00361  Lot# U0718-02-02 / 15A26CARTXXCAK3 / DX00362  Lot# U1033-02-01 / 15A19CARTXXOHCA /DX00363  Lot# U1033-02-02 / 15A26CARTXXCASJ / DX00364  Lot# U1126-02-01 / 15A26CARTXXCAK41 /DX00365  Lot# U1126-02-02 / 15806CARTXXGAAT / DX00366",12/4/2015,"12/04/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72916,"Ongoing","Swinomish Fish Company, Inc","11455 Moorage Way",,"La Conner","WA","98257-9450","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, FL and WA.","F-1124-2016","Class II",".    ","67/8 oz. pkgs, 274/14 oz. pkgs, 3/5 lbs. pkgs","Peppered flavor of Native Catch Salmon Bacon product is recalled because it has the potential to be contaminated with Clostridium botulinum.  The potential for contamination was noted after a routine Washington State Department of Agriculture (WSDA) inspection discovered that the product had potentially been under processed. ","04/21/2016",," BEST BY codes 1/23/16 and 3/16/16. ",12/17/2015,"12/17/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72916,"Ongoing","Swinomish Fish Company, Inc","11455 Moorage Way",,"La Conner","WA","98257-9450","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, FL and WA.","F-1123-2016","Class II",".    ","66/8 oz. pkgs, 372/14 oz. pkgs, 3/5 lb. pkgs; ","Traditional flavor of Native Catch Salmon Bacon product is recalled because it has the potential to be contaminated with Clostridium botulinum.  The potential for contamination was noted after a routine Washington State Department of Agriculture (WSDA) inspection discovered that the product had potentially been under processed. ","04/21/2016",," BEST BY codes 1/23/16 and 3/16/16. ",12/17/2015,"12/17/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72917,"Terminated","LifeSouth Community Blood Centers, Inc.","1221 NW 13th St",".","Gainesville","FL","32601-4111","United States","Voluntary: Firm Initiated","FAX","Georgia","B-0219-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Apheresis product, with a low platelet yield, was distributed.  ","01/07/2016","01/07/2016"," W1151153080634",12/5/2015,"12/05/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72919,"Terminated","Alabama Eye Bank","500 Robert Jemison Rd",,"Birmingham","AL","35209-3070","United States","Voluntary: Firm Initiated","Telephone","Alabama","B-0242-16","Class II","Cornea","1 cornea","Human cornea, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, was distributed. ","01/28/2016","01/28/2016"," 152213",11/6/2015,"11/06/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72920,"Terminated","Ochsner Health System  Blood Bank","1516 Jefferson Hwy",,"New Orleans","LA","70121-2429","United States","Voluntary: Firm Initiated","E-Mail","Louisiana","B-0211-16","Class II","Fresh Frozen Plasma","1 unit","Blood product, collected from a donor with a history of reactive results for HCV, was distributed.","01/14/2016","01/14/2016"," W303815001845 ",12/4/2015,"12/04/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72922,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada and Australia.","Z-1359-2016","Class II","BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model);  Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.","1,428,000 units (total)","Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.","04/08/2016",," CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.",12/18/2015,"12/18/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72922,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada and Australia.","Z-1358-2016","Class II","BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure. ","1,428,000 units (total)","Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.","04/08/2016",," Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.",12/18/2015,"12/18/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72922,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada and Australia.","Z-1357-2016","Class II","BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only.  Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.","1,428,000 units (total)","Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.","04/08/2016",," Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.",12/18/2015,"12/18/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72923,"Ongoing","MOOG Medical Devices Group","4314 S Zevex Park Ln",,"Salt Lake City","UT","84123-7881","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide), Guam, and countries of: Australia, Canada, Croatia, Turkey, New Zealand, Saudi Arabia, Japan, Korea, and Italy.","Z-0688-2016","Class II","Moog Curlin Infusion, Ambulatory Infusion Pump   The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps.   Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.","11,472","Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed.  ","02/11/2016",," All manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015.  Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.",12/23/2015,"12/23/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72924,"Ongoing","Twinings North America, Inc.","2812 Twining Rd",,"Greensboro","NC","27406-4615","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, CT, IA, IL, IN, KY, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, TN, WA, WI","F-0511-2016","Class III","TWININGS OF London ENGLISH BREAKFAST BLACK TEA DECAFFEINATED, 12-0.11OZ (3.2g)/ EA NET WT 1.34 oz (38g), UPC 00070177513078  ","4,926 cases","Twinings English Breakfast Black Tea 12ct Kcups, were packaged in cartons stating Twinings English Breakfast Black Tea Decaffeinated. ","01/13/2016",," Lot #: 105657B- Best Before Date: 04/28/17",12/16/2015,"12/16/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72925,"Terminated","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates.","Z-0649-2016","Class II","iChem 10 SG Urine Chemistry Strips, PN 800-7005.    Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.","16,206 vials total (7,827 vials in US)","Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.","01/13/2016","01/13/2016"," 510033A, expiration 2015-03  510034A, expiration 2015-04  510035A, expiration 2015-07  510035B, expiration 2015-09",12/8/2014,"12/08/2014",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72926,"Ongoing","Fresenius Medical Care Renal Therapies Group, LLC","920 Winter St",,"Waltham","MA","02451-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0693-2016","Class II","Fresenius Liberty Cycler-Peritoneal Dialysis Cycler  Model: 180111 and RTLR180111 ","14,094 units","The door latch may not fully close and the door may open unexpectedly.  The door may make physical contact with anything near the door of the machine, including the patient.  May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).","01/27/2016",," All lot numbers",12/15/2015,"12/15/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72927,"Ongoing","Bio-Rad Laboratories, Inc.","4000 Alfred Nobel Dr",,"Hercules","CA","94547-1803","United States","Voluntary: Firm Initiated","Telephone","Worldwide Distribution-US (nationwide) and the countries of   Canada, Australia, Belgium, Brazil, Brunei Darussalam, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Malaysia, Maldives, New Zealand, Norway, Austria, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, and UK.","Z-0695-2016","Class II","D-10 Rack Loader;  Model Number 220-0600;    Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis.","165 in US, 200 Internationally","On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.","01/27/2016",," All codes - 2006 to present",12/15/2015,"12/15/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72929,"Completed","Genzyme Corporation","500 Kendall Street","675 West Kendall/55 Cambridge Parkway","Cambridge","MA","02142-1108","United States","Voluntary: Firm Initiated","E-Mail","TN","D-0799-2016","Class III","Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1","24 vials","Labeling: Incorrect or Missing Lot and/or Exp Date","03/31/2016",," Lot # C5370C02; Exp. 02/18  ",12/8/2015,"12/08/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72930,"Ongoing","Yoli Inc.","4251 W 129th St",".","Alsip","IL","60803-2018","United States","Voluntary: Firm Initiated","Telephone","distributed to 13, 213 establishment. Please see attached sales document.","F-0514-2016","Class II","Roasted pumpkin seeds with salt in a clear plastic bag with a yellow and red label attatched. ",,"Undeclared wheat on the label of Roasted pumpkin seeds with salt. ","01/19/2016",," dates packed:  02/27/2015  03/06/2015  03/25/2015  04/06/2015  04/28/2015  04/29/2015  05/26/2015  06/09/2015  07/14/2015  07/28/2015  08/21/2015  09/08/2015  09/10/2015  09/24/2015  09/25/2015  10/21/2015  10/22/2015  11/03/2015  11/25/2015    ",12/7/2015,"12/07/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72932,"Terminated","Taylor Farms Pacific, Inc.","100 W Valpico Rd Ste A",,"Tracy","CA","95376-8198","United States","Voluntary: Firm Initiated","Other","CA and NV","F-0512-2016","Class I","Signature Cafe Traditional Stuffing;  Turkey Broth, Seasoned Bread Crumb Mix, Celery, Yellow Onion.  Net WT. 39 oz. (2 lbs 7 oz) 1.1 kg.  Perishable, Keep refrigerated.    UPC 21130-08320     Distributed by Lucerne Foods Inc.  PO Box 99  Pleasanton, CA  94566","190 cases (4 X 39 oz. packages per case)","Signature Cafe Traditional Stuffing may have the incorrect ingredient and nutritional label that does not declare the allergens soy, milk and wheat.","02/03/2016","02/09/2016"," Lot Code of TFPV351;  Use By Date of 12/26/2015 ",12/23/2015,"12/23/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72933,"Terminated","Milky Way Intl Trading Corp","15203 Shoemaker Ave",,"Norwalk","CA","90650-6858","United States","Voluntary: Firm Initiated","E-Mail","US distribution to Walgreens stores nationwide.","F-0515-2016","Class II","Mandarin Oranges (In Light Syrup), Net Wt. 8oz (227g), Case UPC#: 100-49022-80895-6, Product UPC#: 0-49022-80895-9  ","8309 cases","MW Polar Foods is recalling Mandarin Oranges due to possible glass in product. ","01/22/2016","04/20/2016"," Lot numbers:	H894K09A	01/11/2017  		4200/01039 	01/16/2018  		4200/01039 	02/01/2018  ",12/23/2015,"12/23/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72935,"Ongoing","Stryker Medical Division of Stryker Corporation","3800 E Centre Ave",,"Portage","MI","49002-5826","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of   Brazil, Canada, Chile, France, Hong Kong, Italy, Mexico, South Korea, Switzerland, United Kingdom.","Z-1081-2016","Class II","Stryker Position Pro Mattress.   Mattress, Air Flotation, Alternating Pressure.    PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the distribution of body weight for pressure relief. PositionPRO offers turn assist. PositionPRO is for use with GoBed II¿, Secure II/3¿, InTouch¿, and Epic II¿ 84 in. x 35 in. flat deck frames. This surface is powered via an AC power cord that comes in either a 4 foot long option (PN QDF8087) or 15 foot long option (PN QDF8088). The 4 foot long option is used when the surface is plugged into the auxiliary outlet of the bed. The 15 foot long option is utilized when the surface needs to be plugged into a wall outlet. This product uses a power cord, manufactured by ElectriCord that plugs into the wall outlet or the auxiliary outlet of the bed that the surface is placed onto.","2694","Potential for power cord to melt; hazards include electric shock and fire.     ","03/08/2016",," model number: 2920-000-000  units serialized",12/3/2015,"12/03/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72936,"Ongoing","Gsi Group Inc","125 Middlesex Tpke",,"Bedford","MA","01730-1409","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico; Internationally:  Australia, Bahamas, Canada, Germany, Finland, France, Great Britain, Hong Kong, India, Ireland, Italy, Japan, South Korea, Mauritus, Mexico, Peru, Saudi Arabia, Singapore, Taiwan, United Arab Emirates & United Kingdom","Z-0866-2016","Class II","PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01    Product Usage:  The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.  ","2257 units","The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer","02/24/2016",," Serial Number range: 1801405 through 1918761",12/2/2015,"12/02/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72937,"Terminated","Mizuho OSI","30031 Ahern Ave",,"Union City","CA","94587-1234","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US, South Africa, Japan and United Arab Emirates.","Z-0792-2016","Class II","Mizuho OSI Trios, Table Base;  Voltage: 100-240V ~ 50/60 Hz  Amps: 5,0-5.0A;  Model 7803 and 7803AP    Orthopaedic:  Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.","33","Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly.  Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult.  If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.","02/09/2016","02/10/2016"," Model numbers 7803, 7803AP.    Serial numbers 228-261.",12/14/2015,"12/14/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72938,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US including the states of CA, NY, PA, AL, FL, GA, ID, WI, MO, SC, NC, and ME, and the countries of Brazil, Dominican Republic, Taiwan, China, Uruguay, Australia, Japan, Malaysia, India, Belgium, France, Italy, Netherlands, Poland, United Arab Emirates, and Canada.","Z-0646-2016","Class II","Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length;  Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length.    Indicated for temporary internal fixation and stabilization of osteotomies and fractures.","400","Product on the package label did not match what was inside the package.    The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside the package was part number 00-2359-014-24 (Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14mm Length) lot number 62896038.","01/13/2016",," Item 00-2359-058-35, Lot 62918019  PERI LOCKING SCREW 3.5MM    Item 00-2359-014-24, Lot 62896038  PERI LOCKING SCREW 2.4MM",12/9/2015,"12/09/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72939,"Terminated","Innovative Blood Resources","737 Pelham Blvd",,"Saint Paul","MN","55114-1739","United States","Voluntary: Firm Initiated","Letter","Minnesota","B-0213-16","Class II","Red Blood Cells","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/14/2016","01/14/2016"," 1437888",10/20/2015,"10/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72939,"Terminated","Innovative Blood Resources","737 Pelham Blvd",,"Saint Paul","MN","55114-1739","United States","Voluntary: Firm Initiated","Letter","Minnesota","B-0214-16","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/14/2016","01/14/2016"," 1308087",10/20/2015,"10/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72939,"Terminated","Innovative Blood Resources","737 Pelham Blvd",,"Saint Paul","MN","55114-1739","United States","Voluntary: Firm Initiated","Letter","Minnesota","B-0215-16","Class II","Plasma Cryoprecipitated Reduced","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/14/2016","01/14/2016"," 1437888",10/20/2015,"10/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72939,"Terminated","Innovative Blood Resources","737 Pelham Blvd",,"Saint Paul","MN","55114-1739","United States","Voluntary: Firm Initiated","Letter","Minnesota","B-0212-16","Class II","Cryoprecipitated AHF","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/14/2016","01/14/2016"," 1437888",10/20/2015,"10/20/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72940,"Ongoing","Uoriki Fresh Inc","401 Penhorn Avenue #6",,"Secaucus","NJ","07094","United States","Voluntary: Firm Initiated","E-Mail","NJ","F-1067-2016","Class I","Uoriki Octopus Salad Net Weight 2.5 lbs         Two 2.5lbs pack per case  packaged in Black trays covered w/cryovac 10k film  no barcode. packaged at Wegman's deli counter for further consumption.    ","Less than 10 lbs","Octopus Salad may be contaminated with Listeria monocytogenes.","04/11/2016",," Lot# 931-36, Sell by date: 12/24/2015",12/22/2015,"12/22/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72941,"Ongoing","PD-Rx Pharmaceuticals, Inc.","727 N Ann Arbor Ave",".","Oklahoma City","OK","73127-5822","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0574-2016","Class III","Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in  a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.     ","1685 bottles","Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station","01/20/2016",," Lot #: a) H14C80, Exp 08/16; I14G36, Exp 09/16; b) H14A86, Exp 07/16;  c) H14C83, Exp 08/16, K14A21, Exp 11/16; d) H14F25, Exp 08/16; e) L14C42, Exp 12/16.  ",7/21/2015,"07/21/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72942,"Ongoing","PD-Rx Pharmaceuticals, Inc.","727 N Ann Arbor Ave",".","Oklahoma City","OK","73127-5822","United States","Voluntary: Firm Initiated","E-Mail","Alabama","D-0559-2016","Class II","Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01","9 bottles","cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer.","12/31/2015",," Lot# B14D26, Exp 02/16",7/10/2015,"07/10/2015",1/6/2016,"01/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72943,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide including PR except NH,  VT, & WY.  Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.","Z-0680-2016","Class II","GE Healthcare, Aisys, 1011-9000-000.    The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.","13","The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.","01/21/2016",," ANAU00153  ANAU00156  ANAU00152  ANAU00150  ANAU00151  ANAU00154  ANAU00155  ANAU00157  ANAU00158  ANAU00159  ANAU00160  ANAU00180  ANAU00181  ",12/15/2015,"12/15/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72943,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide including PR except NH,  VT, & WY.  Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.","Z-0681-2016","Class II","GE Healthcare, Aisys CS2,1011-9050-000;  Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000.  The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.","2627","The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.","01/21/2016",," APWU00723  APWU00724  APWU01057  APWU01058  APWU01059  APWU01785  APWU01827  APWU01988  APWU01989  APWU01990  APWU01991  APWU01992  APWU01993  APWU01994  APWU01995  APWU01996  APWU01997  APWU01576  APWU01577  APWU01578  APWU00707  APWU00708  APWU00709  APWU00710  APWU00711  APWU00712  APWU00713  APWU01486  APWU01487  APWU01488  APWU01489  APWU01490  APWU01491  APWU01492  APWU01493  APWU01494  APWU01495  APWU01825  APWU01909  APWU02017  APWU02018  APWU02019  APWU02020  APWU01054  APWU01055  APWU01056  APWU00840  APWU00841  APWU00842  APWU00843  APWU00844  APWU00845  APWU00846  APWU00847  APWU01608  APWU01609  APWU01610  APWU01611  APWU01612  APWU01613  APWU01614  APWU01615  APWU02066  APWU02067  APWU00728  APWU00729  APWU00730  APWU00751  APWU00752  APWU00753  APWU00754  APWU00755  APWU01595  APWU01240  APWU01241  APWU01242  APWU01243  APWU01244  APWU01359  APWU01949  APWU01410  APWU01411  APWU01412  APWU00767  APWU00768  APWU00769  APWU01131  APWU01132  APWU01133  APWU01340  APWU01341  APWU01342  APWU01343  APWU01344  APWU01616  APWU01617  APWU01618  APWU01619  APWU01620  APWU01621  APWU01622  APWU01623  APWU01699  APWU01700  APWU01701  APWU01702  APWU01703  APWU01704  APWU01705  APWU01706  APWU01707  APWU01708  APWU01709  APWU01710  APWU01652  APWU01653  APWU01654  APWU01655  APWU01897  APWU01096  APWU01097  APWU01098  APWU01099  APWU01100  APWU01101  APWU01102  APWU01103  APWU01104  APWU01105  APWU01106  APWU01107  APWU01108  APWU01109  APWU01496  APWU01497  APWU01498  APWU01499  APWU01500  APWU01501  APWU01502  APWU01503  APWU01504  APWU01505  APWU01736  APWU01737  APWU01579  APWU01580  APWU01581  APWU01582  APWU00864  APWU00865  APWU00866  APWU00867  APWU00868  APWU00869  APWU00870  APWU00871  APWU01149  APWU01150  APWU01910  APWU00913  APWU01265  APWU01266  APWU01911  APWU01912  APWU01913  APWU01914  APWU01922  APWU01923  APWU01929  APWU01930  APWU01931  APWU01932  APWU01933  APWU01934  APWU01935  APWU01936  APWU01937  APWU01938  APWU01422  APWU00764  APWU00765  APWU00766  APWU00889  APWU02061  APWU01443",12/15/2015,"12/15/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72943,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide including PR except NH,  VT, & WY.  Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.","Z-0682-2016","Class II","Anesthesia device service kits.    ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000    ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000    ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000    ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000    ASSY-MSN, VLV ASSY DR GAS CHK  BCG, Manufacturing assembly - Buy  1503-3006-000  Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected and could have been installed on Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2 Anesthesia, and Amingo devices. (Service kit part numbers: 1009-8216-000, 1503-3006-000, 1503-8102-000, 1009-8423-000, 1503-8101-000).","240","The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.","01/21/2016",," 11328664  11335735  11343334  11343892  11342401-2  5400168  5403740-1  5403740-2    11335499  11345497  11340364  11320301-1  11320301-2  11330567  11331744  11307341  11331786  11335845  11335293  11319820  11321192  11321193  11327291  11322915  11332821  11326031  11330266  11313876  11331340  11304929  11336322  11336553  11315455  11325139  11326345  11335028-1  11335028-2  11305735  11322211  11323901  6514379  6514380  11307579  11307579  11321258  5398226  5405405  11337945  5404884  5405628  5406602  5401553-1  5401553-2  5402221-1  5402221-2  5402221-3  5404056-1  5404056-2  5404550-1  5404550-2  5404550-3  5404550-4  5405413-1  5405413-2  5405413-3  5405699-1  5405699-2  5405699-3  11009279  5405867  5405868  5398018-1  5398018-2  5404050-1  5404050-2  5405504-1  5405504-2    11320017  11324236  11311155  11342043  5401539  5401527-1  5401527-2  5401527-3  5401527-4  11315668  5401531    11334842  11305495  11333980  11339911  11330029-2  11308028  11323566  11323905  5406531    11334842  11305495  11333980  11339911  11330029-2  11308028  11323566  11323905  5406531                  ",12/15/2015,"12/15/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72943,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide including PR except NH,  VT, & WY.  Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.","Z-0677-2016","Class II","GE Healthcare, Aespire 7900, 1009-9012-000 &   Aespire View, 1009-9212-000.  The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.","1081","The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.","01/21/2016",," AESPIRE 7900    ANCU00662  ANCU00813  ANCU00814  ANCU00815  ANCU00816  ANCU00817  ANCU00818  ANCU00597  ANCU00598  ANCU00599  ANCU00600  ANCU00601  ANCU00671  ANCU00672  ANCU00673  ANCU00676  ANCU00678  ANCU00683  ANCU00830  ANCU00832  ANCU00870  ANCU00871  ANCU00872  ANCU00873  ANCU00874  ANCU00875  ANCU00629  ANCU00630  ANCU00638  ANCU00639  ANCU00640  ANCU00641  ANCU00806  ANCU00604  ANCU00684  ANCU00836  ANCU00837  ANCU00839  ANCU00786  ANCU00680  ANCU00681  ANCU00625  ANCU00626  ANCU00677  ANCU00618  ANCU00619  ANCU00620  ANCU00602  ANCU00603  ANCU00448  ANCU00449  ANCU00770  ANCU00771  ANCU00865  ANCU00866  ANCU00867  ANCU00803  ANCU00605  ANCU00663  ANCU00682  ANCU00685  ANCU00458  ANCU00459  ANCU00831  ANCU00653  ANCU00820  ANCU00591  ANCU00592  ANCU00586  ANCU00583  ANCU00584  ANCU00585  ANCU00825  ANCU00593  ANCU00664  ANCU00838  ANCU00433  ANCU00679  ANCU00555  ANCU00456  ANCU00457  ANCU00590  ANCU00661  ANCU00669  ANCU00670  ANCU00674  ANCU00819  ANCU00807  ANCU00808  ANCU00809  ANCU00810  ANCU00811  ANCU00812  ANCU00588  ANCU00589  ANCU00455  ANCU00587  ANCU00868  ANCU00581  ANCU00582  ANCU00466  ANCU00467  ANCU00468  ANCU00469  ANCU00840  ANCU00434  ANCU00435  ANCU00436  ANCU00437  ANCU00438  ANCU00439  ANCU00440  ANCU00822  ANCU00823  ANCU00824  ANCU00827  ANCU00828  ANCU00654  ANCU00729  ANCU00730  ANCU00496  ANCU00675  ANCU00624  ANCU00826  ANCU00829  ANCU00465  ANCU00441  ANCU00844  ANCU00656  ANCU00876  ANCU00877  ANCU00878  ANCU00426  ANCU00427  ANCU00485  ANCU00470  ANCU00608  ANCU00609  ANCU00610  ANCU00611  ANCU00612  ANCU00613  ANCU00789  ANCU00617  ANCU00445  ANCU00446  ANCU00490  ANCU00491  ANCU00492  ANCU00493  ANCU00494  ANCU00495  ANCU00497  ANCU00498  ANCU00518  ANCU00519  ANCU00521  ANCU00522  ANCU00665  ANCU00666  ANCU00709  ANCU00710  ANCU00711  ANCU00772  ANCU00773  ANCU00845  ANCU00846  ANCU00687  ANCU00688  ANCU00737  ANCU00738  ANCU00859  ANCU00860  ANCU00861  ANCU00693  ANCU00694  ANCU00695  ANCU00851  ANCU00852  ANCU00853  ANCU00854  ANCU00855  ANCU00856  ANCU00857  ANCU",12/15/2015,"12/15/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72943,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide including PR except NH,  VT, & WY.  Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.","Z-0678-2016","Class II","GE Healthcare, Aestiva 7900, 1006-9305-000.  This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. ","2","The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.","01/21/2016",," AMRU01022  AMRU01023  ",12/15/2015,"12/15/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72943,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide including PR except NH,  VT, & WY.  Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.","Z-0679-2016","Class II","GE Healthcare, Aestiva MRI, 1006-9310-000.  This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The Aestiva/5 MRI anesthesia system provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment.","84","The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.","01/21/2016",," AMTU01048  AMTU01023  AMTU00163  AMTU01050  AMTU00172  AMTU00175  AMTU00176  AMTU01034  AMTU01047  AMTU01055  AMTU01001  AMTU01002  AMTU01021  AMTU01044  AMTU01042  AMTU01015  AMTU00178  AMTU00179  AMTU00162  AMTU01000  AMTU01012  AMTU01041  AMTU00167  AMTU01019  AMTU00177  AMTU01049  AMTU00171  AMTU00164  AMTU01066  AMTU01006  AMTU00168  AMTU01061  AMTU01060  AMTU01056  AMTU01057  AMTU01073  AMTU00154  AMTU00166  AMTU00174  AMTU01005  AMTU01035  AMTU00150  AMTU01024  AMTU01025  AMTU01026  AMTU01027  AMTU01037  AMTU00152  AMTU01040  AMTU01022  AMTU00157  AMTU00158  AMTU00159  AMTU00160  AMTU00170  AMTU01018  AMTU01009  AMTU01032  AMTU01046  AMTU01045  AMTU01020  AMTU01008  AMTU00165  AMTU01013  AMTU01014  AMTU01033  AMTU01016  AMTU01036  AMTU01038  AMTU00151  AMTU00169  AMTU01003  AMTU00161  AMTU01010  AMTU01064  AMTU01011  AMTU01004  AMTU01017  AMTU01031  AMTU01053  AMTU01058  AMTU01059  AMTU01039  AMTU01007  ",12/15/2015,"12/15/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72944,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated",,"Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.","Z-0654-2016","Class II","Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate  Straight 11 Holes 144mm Length  Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate  8 Holes 105mm Length.    Indicated for temporary internal fixation and stabilization of osteotomies and fractures.","52","The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.","01/14/2016",," Part 00-4936-011-13, Lot 62968956  3.5MM ULS RECON PLATE 11H  Part 00-4936-008-07, Lot 62968974  3.5MM ULS DUAL COMP PLT 8",12/9/2015,"12/09/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72945,"Terminated","Bard Peripheral Vascular Inc","1625 W 3rd St",,"Tempe","AZ","85281-2438","United States","Voluntary: Firm Initiated","Letter","Distributed to CA only.","Z-0737-2016","Class II","Denali Filter-Jugular/Subclavian DL950J  Denali Filter-Femoral Delivery DL950F.   Intravascular filters.","1,183 units","IFU missing contraindications:   Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.","02/01/2016","02/01/2016"," Product Code: DL950J  Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699    Product Code: DL950F  Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699",3/13/2015,"03/13/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72946,"Ongoing","Baxter Corporation Englewood","9540 Maroon Cir Unit 400",,"Englewood","CO","80112-5731","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.","Z-0731-2016","Class II","Baxter, RAPIDFILL Syringe Strip, 10 ml.  For use with RAPIDFILL Automated Syringe Filler (ASF)","4,695","Baxter Healthcare has issued an Urgent Product Recall communication for all lots of RAPIDFILL Syringe Strips due to lack of evidence supporting the packaging claim for 12-month shelf life on released product.","01/30/2016",," All Lots",12/21/2015,"12/21/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72947,"Terminated","Safecor Health, LLC","317 New Boston St",,"Woburn","MA","01801-6231","United States","Voluntary: Firm Initiated","Letter","NJ","D-0661-2016","Class II","Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL  amber bottle, Rx Only,  Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.","3,532 amber bottles","Defective Container: Confirmed customer complaints of leaking bottles. ","02/11/2016","02/25/2016","  Lot #846881; Exp 01/16",3/2/2015,"03/02/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72948,"Terminated","Safecor Health, LLC","317 New Boston St",,"Woburn","MA","01801-6231","United States","Voluntary: Firm Initiated","Letter","NY","D-0785-2016","Class II","Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg  DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304.  ","23 cups","Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.","03/29/2016","03/30/2016"," Lot #: 914227; Exp 06/16      ",7/16/2015,"07/16/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72949,"Ongoing","Hail Merry LLC","9755 Clifford Dr","Suite 150","Dallas","TX","75220-5335","United States","Voluntary: Firm Initiated","Letter","NH, PA, IA, WI, CA, WA, TX, CO","F-0748-2016","Class III","Chocolate Chile Pecan Mini Miracle Tart 4.87 oz (138g) NET WT Party Pack of 6 in formed plastic tray","810 cases","List of ingredient fails to include almond flour.","03/14/2016",," 42097111715, 42097112515, 42097120115, 42097121115",12/28/2015,"12/28/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72950,"Ongoing","Kraft Heinz Foods","3 Lakes Dr",,"Northfield","IL","60093-2753","United States","Voluntary: Firm Initiated","Letter","The firm distributed the product to 132 domestic firms. Please see the attached spreadsheet for a list of all consignees.","F-1392-2016","Class II","CapriSun tropical punch packaged in a blue and white box with pictures of fruit and white and black lettering. ","20, 298 cases, 4 boxes/case, 10 drinks/box. ","Possible presence of glass fragments in CapriSun and Kool-Aid Jammers. ","05/20/2016",," best when used by code date: 09 DEC 2016  GR02CT762      ",12/29/2015,"12/29/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72950,"Ongoing","Kraft Heinz Foods","3 Lakes Dr",,"Northfield","IL","60093-2753","United States","Voluntary: Firm Initiated","Letter","The firm distributed the product to 132 domestic firms. Please see the attached spreadsheet for a list of all consignees.","F-1395-2016","Class II","Kool-Aid Jammers Cherry packaged in a red box with white lettering. ","20, 298 cases, 4 boxes/case, 10 drinks/box. ","Possible presence of glass fragments in CapriSun and Kool-Aid Jammers. ","05/20/2016",," best when used by code date: 10 DEC 2016 GR02CT762 and 11 DEC 2016 Gr02CT762      ",12/29/2015,"12/29/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72950,"Ongoing","Kraft Heinz Foods","3 Lakes Dr",,"Northfield","IL","60093-2753","United States","Voluntary: Firm Initiated","Letter","The firm distributed the product to 132 domestic firms. Please see the attached spreadsheet for a list of all consignees.","F-1394-2016","Class II","Kool-Aid Jammers Grape packaged in a purple and red box with white lettering. ","20, 298 cases, 4 boxes/case, 10 drinks/box. ","Possible presence of glass fragments in CapriSun and Kool-Aid Jammers. ","05/20/2016",," best when used by code date: 10 DEC 2016 GR02CT762      ",12/29/2015,"12/29/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72950,"Ongoing","Kraft Heinz Foods","3 Lakes Dr",,"Northfield","IL","60093-2753","United States","Voluntary: Firm Initiated","Letter","The firm distributed the product to 132 domestic firms. Please see the attached spreadsheet for a list of all consignees.","F-1393-2016","Class II","Kool-Aid Jammers Strawberry Kiwi packaged in a green and red box with white lettering. ","20, 298 cases, 4 boxes/case, 10 drinks/box. ","Possible presence of glass fragments in CapriSun and Kool-Aid Jammers. ","05/20/2016",," best when used by code date: 09 DEC 2016 GR02CT762      ",12/29/2015,"12/29/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72950,"Ongoing","Kraft Heinz Foods","3 Lakes Dr",,"Northfield","IL","60093-2753","United States","Voluntary: Firm Initiated","Letter","The firm distributed the product to 132 domestic firms. Please see the attached spreadsheet for a list of all consignees.","F-1391-2016","Class II","CapriSun fruit punch roarin'waters packaged in a blue and white box with pictures of fruit and white lettering. ","20, 298 cases, 4 boxes/case, 10 drinks/box","Possible presence of glass fragments in CapriSun and Kool-Aid Jammers. ","05/20/2016",," best when used by code date: 08 DEC 2016  GR02CT762 and 09 DEC 2016  GR02CT762    ",12/29/2015,"12/29/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72950,"Ongoing","Kraft Heinz Foods","3 Lakes Dr",,"Northfield","IL","60093-2753","United States","Voluntary: Firm Initiated","Letter","The firm distributed the product to 132 domestic firms. Please see the attached spreadsheet for a list of all consignees.","F-1396-2016","Class II","Kool-Aid Jammers Tropical Punch packaged in a red blue and purple box with white lettering. ","20, 298 cases, 4 boxes/case, 10 drinks/box. ","Possible presence of glass fragments in CapriSun and Kool-Aid Jammers. ","05/20/2016",," best when used by code date: 11 DEC 2016 Gr02CT762 and 12 DEC 2016 GR02CT762.       ",12/29/2015,"12/29/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72951,"Terminated","Zingerman's Candy Manufactory","3711 Plaza Dr",,"Ann Arbor","MI","48108-1680","United States","Voluntary: Firm Initiated","Letter","Domestic: MI, NY, OH, CA, IA, IL, NH, DC, PA, TX, AZ, CO, GA, MT, MS, NV, TN, VA  Foreign: None    VA/DOD: None","F-0547-2016","Class II","Zzang! Cashew Cow Candy Bar,2 oz., packaged in reprinted cardboard boxes, UPC 8 44397 00015 7","3,242 bars","Product recalled due to undeclared sub-ingredient soy.","02/06/2016","03/09/2016"," Lot and Batch Nos are sell-by dates 12/17/2015  02/16/2016, Product/Catalog No. 120  ",12/21/2015,"12/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72951,"Terminated","Zingerman's Candy Manufactory","3711 Plaza Dr",,"Ann Arbor","MI","48108-1680","United States","Voluntary: Firm Initiated","Letter","Domestic: MI, NY, OH, CA, IA, IL, NH, DC, PA, TX, AZ, CO, GA, MT, MS, NV, TN, VA  Foreign: None    VA/DOD: None","F-0546-2016","Class II","Zzang! Original Candy Bar, 2.5 oz., packaged in preprinted cardboard boxes, UPC 8 44397 00014 0","14,433 bars","Product recalled due to undeclared soy and milk (butter declared).","02/06/2016","03/09/2016"," Lot and Batch Nos are the sell-by dates 12/17/2015  03/16/2016, Product/Catalog No. 100",12/21/2015,"12/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72951,"Terminated","Zingerman's Candy Manufactory","3711 Plaza Dr",,"Ann Arbor","MI","48108-1680","United States","Voluntary: Firm Initiated","Letter","Domestic: MI, NY, OH, CA, IA, IL, NH, DC, PA, TX, AZ, CO, GA, MT, MS, NV, TN, VA  Foreign: None    VA/DOD: None","F-0548-2016","Class II","Zzang! Wowza Candy Bar,3 oz., packaged in reprinted cardboard boxes, UPC 8 44397 00072 0","1,499 bars","Product recalled due to undeclared soy; and undeclared milk (cream declared).","02/06/2016","03/09/2016"," Lot and Batch Nos are sell-by dates 12/17/2015  02/16/2016, Product/Catalog No. 160",12/21/2015,"12/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72951,"Terminated","Zingerman's Candy Manufactory","3711 Plaza Dr",,"Ann Arbor","MI","48108-1680","United States","Voluntary: Firm Initiated","Letter","Domestic: MI, NY, OH, CA, IA, IL, NH, DC, PA, TX, AZ, CO, GA, MT, MS, NV, TN, VA  Foreign: None    VA/DOD: None","F-0550-2016","Class II","Chocolate Marshmallows, 8 oz., packaged in plastic bags, UPC 8 44397 00077 5","134","Product recalled due to undeclared soy.","02/06/2016","03/09/2016"," Lot and Batch No is sell-by date 12/24/15 (only 1 batch).  ",12/21/2015,"12/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72951,"Terminated","Zingerman's Candy Manufactory","3711 Plaza Dr",,"Ann Arbor","MI","48108-1680","United States","Voluntary: Firm Initiated","Letter","Domestic: MI, NY, OH, CA, IA, IL, NH, DC, PA, TX, AZ, CO, GA, MT, MS, NV, TN, VA  Foreign: None    VA/DOD: None","F-0549-2016","Class II","Zzang! Holiday 4 pack Candy Bars, 10.5 oz., packaged in preprinted cardboard boxes","14,433 Original Candy Bars; 3,242 Cashew Candy Bars ; 1,499 Wowza Candy Bars","Product recalled due to undeclared soy; and undeclared allergen milk (cream and butter declared).","02/06/2016","03/09/2016"," Lot and Batch Nos are the sell-by dates 12/17/2015  03/16/2016, Product/Catalog No. 100",12/21/2015,"12/21/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72952,"Ongoing","Bearded Brothers LLC","11190 Circle Dr Ste 300",,"Austin","TX","78736-7708","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-0574-2016","Class II","Bearded Brothers BOLD The Greek Net Wt. 1.5 oz/43 g  UPC: 8-50430-00414-2.","150 cases","Mold on energy bars.","02/10/2016",," The Greek Lot/Exp.: 072316",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72952,"Ongoing","Bearded Brothers LLC","11190 Circle Dr Ste 300",,"Austin","TX","78736-7708","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-0573-2016","Class II","Bearded Brothers BOLD Coconut Curry Net Wt. 1.5 oz/43 g  UPC: 8-50430-00513-5.","128 cases","Mold on energy bars.","02/10/2016",," Coconut Curry Lot/Exp. 081316",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72953,"Ongoing","Fukuda Denshi USA, Inc.","17725 NE 65th St Ste C",".","Redmond","WA","98052-4911","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.","Z-0661-2016","Class II","Fukuda Denshi patient monitor model DS-8100M and DS-8100N.    The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is  meant to acquire and monitor physiological signals from patients. ","95 units distributed in the US","A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).  ","01/15/2016",," 50400001, 50400002, 50400003, 50400004, 50400011, 50400012, 50400018, 50400019, 50400020, 50400021, 50400022, 50400023, 50400024, 50400025, 50400026, 50400027, 50400028, 50400029, 50400030, 50400031, 50400032, 50400033, 50400034, 50400035, 50400036, 50400037, 50400038, 50400039, 50400040, 50400042, 50400043, 50400044, 50400045, 50400046, 50400047, 50400048, 50400049, 50400050, 50400051, 50400052, 50400053, 50400054, 50400055, 50400056, 50400057, 50400058, 50400059, 50400060, 50400061, 50400062, 50400063, 50400064, 50400065, 50400066, 50400067, 50400068, 50400069, 50400070, 50400071, 50400072, 50400073, 50400074, 50400075, 50400076, 50400077, 50400078, 50400084, 50400093, 50400094, 50400095, 50400096, 50400097, 50400098, 50400099, 50400100, 50400101, 50400102, 50400103, 50400104, 50400105, 50400106, 50400107, 50400108, 50400109, 50400110, 50400111, 50400112, 50400113, 50400114, 50400115, 50400116, 50400117, 50400118, 50400119, and 50400120. ",12/21/2015,"12/21/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",72954,"Terminated","Michigan Blood","1036 Fuller Ave NE","PO Box 1704","Grand Rapids","MI","49501-1704","United States","Voluntary: Firm Initiated","FAX","Michigan; Switzerland","B-0231-16","Class III","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed","02/18/2016","02/18/2016"," W120615441353; W120615410654; ",12/4/2015,"12/04/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72956,"Ongoing","PD-Rx Pharmaceuticals, Inc.","727 N Ann Arbor Ave",".","Oklahoma City","OK","73127-5822","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0560-2016","Class II","Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.","45,022 bottles","cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.","01/05/2016",," Lot #s: a) J12A48, Exp 10/14, L12A23, Exp 12/14, A13G04, A13H14, Exp 01/15, B13E97, Exp 02/15, C13B55, Exp 03/15, J13F75, L13C93, A14F78, A14H17, B14A6, Exp 08/15, I13D47, I13G28, Exp 09/15, J13D73, J13D93 Exp 10/15,  K13E18, 11/15, A14H06, C14A49, C14D01, Exp 12/15, A14B95 01/16.   ",4/29/2015,"04/29/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72956,"Ongoing","PD-Rx Pharmaceuticals, Inc.","727 N Ann Arbor Ave",".","Oklahoma City","OK","73127-5822","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0561-2016","Class II","Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.","17,533 bottles","cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.","01/05/2016",," Lot #s: J12C03, J12D19, Exp 10/14, L12B52, L12E79, L12G92, Exp 12/14, A13G14, A13H49, Exp 01/15, B13G53, Exp 02/15, D13A66, Exp 04/15, E13E35, Exp 05/15, F13A58, F13D85, F13F17, F13F27, Exp 06/15, G13D37, G13E57, Exp 07/15, H13A65, H13A74, H13C13, H13G01, Exp 08/15, I13C02, I13G98, Exp 09/15,   J13C53, J13G90, Exp 10/15, K13A65, K13B73, K13C98, K13E61, Exp 11/15,   L13C59, L13F49, A14C27, A14D09, A14F11, Exp 12/15.",4/29/2015,"04/29/2015",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72957,"Ongoing","AngioDynamics Inc.","10 Glens Falls Tech Park",".","Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","US Nationwide in the states of CA, IL, MA, SC, TX","Z-1343-2016","Class II","NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111    Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire","136 kits",". ","04/07/2016",," Batch/Lot No. 4921353 Use By 2018-05 and Batch/Lot No. 4932710 Use By 2018-06-30",11/3/2015,"11/03/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72957,"Ongoing","AngioDynamics Inc.","10 Glens Falls Tech Park",".","Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","US Nationwide in the states of CA, IL, MA, SC, TX","Z-1346-2016","Class II","NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF   Catalog No. 601319810, UPN Product No. H7496013198101    Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.","45 kits",". ","04/07/2016",," Batch/Lot No. 4931728, 4933094; Use By 2017-03",11/3/2015,"11/03/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72957,"Ongoing","AngioDynamics Inc.","10 Glens Falls Tech Park",".","Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","US Nationwide in the states of CA, IL, MA, SC, TX","Z-1345-2016","Class II","NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941    Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire","8 kits",". ","04/07/2016",," Batch/Lo. 4925662 Use By 2017-02",11/3/2015,"11/03/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72957,"Ongoing","AngioDynamics Inc.","10 Glens Falls Tech Park",".","Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","US Nationwide in the states of CA, IL, MA, SC, TX","Z-1344-2016","Class II","NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291    Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire","100 kits",". ","04/07/2016",," Batch/Lot No. 4925152, 4930012; Use By 2018-08",11/3/2015,"11/03/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72958,"Ongoing","TexasStar Pharmacy","3033 W Parker Rd Ste 100",,"Plano","TX","75023-8000","United States","Voluntary: Firm Initiated","Telephone","TX","D-0733-2016","Class II","Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023 ","700 mL (7 vials of 100 mL)","Lack of  assurance of sterility ","03/02/2016",," Lot # 07142015#7192@1,  Exp 09/12/2015; 09112015#7192@1, Exp 11/10/2015; 10082015#7192@9, Exp 12/07/2015; 11302015#71920@1, Exp 1/30/2015",12/29/2015,"12/29/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72959,"Terminated","Radiometer America Inc","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of   PA, GA, MI, OH, VA, FL, AL, TX, OR, OK, TN, NY, and MA, and the countries of  Austria, Czech Republic, Denmark, Estonia, United Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Finland, France, Germany, Hungry, Ireland, United Kingdom, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Russia, Singapore, South Africa, Republic of Korea, and Malaysia.","Z-0748-2016","Class II","AQURE System; Model Number: 933-599.  The AQURE System manages blood gas and immunoassay analyzers.","375","The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.","02/03/2016","03/29/2016"," Model Number: 933-599  Version 1.8.3",12/29/2015,"12/29/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72960,"Ongoing","Otto Bock Healthcare GmbH","Max-Nader-Str. #15",".","Duderstadt",,,"Germany","Voluntary: Firm Initiated","Telephone","Nationwide Distribution.","Z-0608-2016","Class II","Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD.  Used for the prosthetic fitting of amputations of the lower. limb.","40 units","Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was  used during repair.","01/07/2016",," All serviced between 27 April 2015 and 17 November 2015",1/4/2016,"01/04/2016",1/13/2016,"01/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72961,"Ongoing","Value Plastics, Inc.","3325 S Timberline Rd",,"Fort Collins","CO","80525-2903","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","3 Consignees in NY, PA, MN.  No foreign, VA/govt.","Z-1080-2016","Class II","Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension,  Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL,  805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.","33,000","Potential for the parts to crack.","03/09/2016",," Catalog #:  FCA026-001   Lot #s:  67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015  ",12/18/2015,"12/18/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72962,"Completed","OrthoPediatrics Corp","2850 Frontier Dr",,"Warsaw","IN","46582-7001","United States","Voluntary: Firm Initiated","E-Mail","US Distribution to states of: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MO, MN, MS, NC, NJ, NY, OH, OR, TN, and TX.","Z-0622-2016","Class II","UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw    The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.    ","102","Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.","01/08/2016",," Item number; lot; product description    00-1300-1735; 44003; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 35MM.  00-1300-0735; 44601; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM.  00-1300-0740; 44602; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM.  00-1300-0740; 43926; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM.  00-1300-0740; 44252; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM.  00-1300-0745; 43927; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM.  00-1300-0750; 44619; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 50MM.  00-1300-0620; 44623; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 20MM.  00-1300-0640; 44617; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM.  00-1300-0640; 44884; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM.  00-1300-1745; 44005; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 45MM.  00-1300-0635; 44677; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 35MM.  ",11/10/2015,"11/10/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72963,"Completed","Midwest Compounders Pharmacy","13330 Santa Fe Trail Dr",,"Lenexa","KS","66215-3653","United States","Voluntary: Firm Initiated","Letter","The finished products were distributed to KS, MO, IL, NM, UT, AZ, and NV.  There was no foreign, military, or government distribution.","V-466-2016","Class II","Cyclosporine-Corn Oil 1% Ophthalmic, packaged in 10-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.","356/10-ml. bottles","Potential for cross-contamination with penicillin","07/25/2016",," 24022015@19, exp. 8/23/2015; 22012015@14, exp. 7/21/2015; 14012015@1, exp. 7/13/2015; and 09022015@13, exp. 8/8/2015.  Prescriptions were filled between 1/27/2015-3/19/2015.",3/11/2015,"03/11/2015",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72963,"Completed","Midwest Compounders Pharmacy","13330 Santa Fe Trail Dr",,"Lenexa","KS","66215-3653","United States","Voluntary: Firm Initiated","Letter","The finished products were distributed to KS, MO, IL, NM, UT, AZ, and NV.  There was no foreign, military, or government distribution.","V-465-2016","Class II","Cyclosporine-Corn Oil 2% Ophthalmic, packaged in 10-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.","93/10-ml. bottles","Potential for cross-contamination with penicillin","07/25/2016",," 22012015@15, exp. 8/8/2015; 05012015@17, exp. 7/4/2015.  Prescriptions were filled between 1/13/2015-3/18/2015.",3/11/2015,"03/11/2015",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72963,"Completed","Midwest Compounders Pharmacy","13330 Santa Fe Trail Dr",,"Lenexa","KS","66215-3653","United States","Voluntary: Firm Initiated","Letter","The finished products were distributed to KS, MO, IL, NM, UT, AZ, and NV.  There was no foreign, military, or government distribution.","V-462-2016","Class II","Idoxuridine Drops 0.1% Ophthalmic, packaged in 10-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.","115/10-ml. bottles","Potential for cross-contamination with penicillin","07/25/2016",," 09012015@16, exp. 4/14/2015 and 29012015@1, exp. 4/17/2015.  The prescriptions were filled between 1/14/2015-3/20/2015.",3/11/2015,"03/11/2015",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72963,"Completed","Midwest Compounders Pharmacy","13330 Santa Fe Trail Dr",,"Lenexa","KS","66215-3653","United States","Voluntary: Firm Initiated","Letter","The finished products were distributed to KS, MO, IL, NM, UT, AZ, and NV.  There was no foreign, military, or government distribution.","V-463-2016","Class II","Demecarium Bromide 0.125% Ophthalmic, packaged in 5-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.","84/5-ml. bottles","Potential for cross-contamination with penicillin","07/25/2016",," 23122014@42, exp. 6/9/2015.  The prescriptions were filled between 1/8/2015-3/12/2015.",3/11/2015,"03/11/2015",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72963,"Completed","Midwest Compounders Pharmacy","13330 Santa Fe Trail Dr",,"Lenexa","KS","66215-3653","United States","Voluntary: Firm Initiated","Letter","The finished products were distributed to KS, MO, IL, NM, UT, AZ, and NV.  There was no foreign, military, or government distribution.","V-464-2016","Class II","Demecarium Bromide 0.25%, packaged in 5-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.","353/5-ml. bottles","Potential for cross-contamination with penicillin","07/25/2016",," 21112014@11, exp. 5/20/2015 and 05012015@1, exp. 8/1/2015.  Prescriptions were filled between 11/21/2014-3/11/2015.",3/11/2015,"03/11/2015",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72965,"Ongoing","Cook Medical Incorporated","400 N Daniels Way",,"Bloomington","IN","47404-9155","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution and Internationally to Canada.","Z-0689-2016","Class II","Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System","372","Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event","01/22/2016",," Catalog number  Lot number  expiration date    ZIVX5-18-125-10-20  CF997863  5/26/2017  ZIVX5-18-125-10-30  C914595  9/9/2016  ZIVX5-18-125-10-40  C1007990  6/13/2017  ZIVX5-18-125-10-40  C903747  7/15/2016  ZIVX5-18-125-10-40  C912971  8/9/2016  ZIVX5-18-125-10-40  C938554  11/26/2016  ZIVX5-18-125-10-40  C958545  2/22/2017  ZIVX5-18-125-10-60  C930526  10/11/2016  ZIVX5-18-125-6-20  C930162  10/2/2016  ZIVX5-18-125-6-30  C930479  10/22/2016  ZIVX5-18-125-6-30  C943304  11/21/2016  ZIVX5-18-125-6-30  C986202  4/9/2017  ZIVX5-18-125-6-40  C900610  7/3/2016  ZIVX5-18-125-6-60  C1002991  5/30/2017  ZIVX5-18-125-6-60  C930157  10/3/2016  ZIVX5-18-125-6-60  C942893  11/20/2016  ZIVX5-18-125-6-60  C983822  4/9/2017  ZIVX5-18-125-6-80  C1002236  5/26/2017  ZIVX5-18-125-6-80  C901151  7/17/2016  ZIVX5-18-125-6-80  C930158  10/9/2016  ZIVX5-18-125-6-80  C930472  10/2/2016  ZIVX5-18-125-6-80  C939542  11/15/2016  ZIVX5-18-125-7-20  C930531  10/21/2016  ZIVX5-18-125-7-30  C912970  8/14/2016  ZIVX5-18-125-7-30  C974746  3/5/2017  ZIVX5-18-125-7-40  C903763  7/15/2016  ZIVX5-18-125-7-40  C941308  11/18/2016  ZIVX5-18-125-7-60  C907738  8/14/2016  ZIVX5-18-125-7-60  C938264  11/15/2016  ZIVX5-18-125-7-80  C939549  11/15/2016  ZIVX5-18-125-7-80  C984606  4/16/2017  ZIVX5-18-125-7-80  C985048  4/16/2017  ZIVX5-18-125-7-80  C994597  5/1/2017  ZIVX5-18-125-8-20  C930525  10/21/2016  ZIVX5-18-125-8-30  C912967  8/9/2016  ZIVX5-18-125-8-30  C967899  2/27/2017  ZIVX5-18-125-8-40  C1001407  5/26/2017  ZIVX5-18-125-8-40  C912942  8/14/2016  ZIVX5-18-125-8-60  C942433  11/18/2016  ZIVX5-18-125-8-80  C939972  11/15/2016  ZIVX5-18-125-8-80  C983347  4/9/2017  ZIVX5-18-125-8-80  C994190  4/29/2017  ZIVX5-18-125-9-20  C939000  11/15/2016  ZIVX5-18-125-9-30  C939545  11/15/2016  ZIVX5-18-125-9-40  C939544  11/15/2016",12/22/2015,"12/22/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72966,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and the countries of  Algeria, Angola, Argentina, Australia, Bahrain, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, and Yemen.","Z-0763-2016","Class II","Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems:  Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA,  INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ ","2,111 (1078 US; 1033 OUS)","GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.","02/05/2016",," Mfg Lot or Serial #/System ID, 1003/219326IN41, 20116/573632CRA, 30173/229434INNOV, 9110080/502587LAB4, 40410078/904276SP, 50410007/703689LCA2, 100300002/315448RM2, 104100042/650369SV5, 104100047/810342A41, 104100051/573632CRC1, 104100057/843674INNOVA, 106100046/603669ELCV, 110300023/315448RM1, 110310015/724656ANG, 110420162/251435I12, 120310008/804285CATH2, 123100037/617789IN1, 204110049/513861INNOVA, 204110065/623848LAB1, 304110059/908522CATH2, 304110070/519663INNOVA2, 304110071/850494WSP1, 404110063/903CSM4100, 404110077/808547QCV1A, 404110079/985867INNOVA2, 504110085/5094744100, 704120114/904202SP1, 704120117/619340VA8, 909110081/570969CATH, 1003100012/972335LIB, 1103100019/904202CATH2, 1103100026/315448RM3, 1104120128/812283IN20, 1203100022/702616INNOVA, 1203100032/515263IL4100, 1204130176/412623LAB3, 1204130198/918744JC4100, 1204930184/803329CL31, 000000007U0099/083016802100337, 00000007C20164/2706080, 00000007C20229/0835160022, 00000007C20367/MA1251VA01, 00000007C20369/00065VAS01, 00000007C20385/BY4066VA01, 00000008C20099/PK1301VA01, 00000008C20145/RU3105VA01, 00000008C20279/RU3935VA01, 0000000DUMMY12/DZ1060VA01, 0000000DUMMY16/B5811426, 0000000DUMMY20/NG1049VA01, 000000106/4051/617636CL1, 00000014926VE0/08301628448937, 00000018518VE1/0835160019, 00000024110061/S4160056, 00000025022VE5/083016007351458, 00000026276VE6/0835160016, 00000039475VE9/0850060688, 000000404/0067/239436CATH1, 000000408/0047/610645LAB10, 000000408/0048/281637SL3131, 000000408/6023/ECXV1406C, 00000052416BU0/817922BA4100, 00000052648VE3/818502INNOVA1, 00000052650VE9/0850060693, 00000052658VE2/YX1483, 00000055070VE7/083016822100563, 00000055071VE5/YX1486, 00000055072VE3/YX1484, 00000061624VE3/082416040008, 00000063253VE9/809840INNOVA, 00000065691VE8/1157760, 00000065697VE5/610988INNOVA1, 00000066919VE2/865541CCL1, 00000066929VE1/972540INN, 00000068468VE8/HC7659XR02, 00000068482VE9/0850060709, 00000068484VE5/IR1667VA01, 000000706/4011/XF0155, 000000706/4628/6106483100, 00000074876VE4/082416040007, 00000074893VE9/0856160001, 000000748",12/18/2015,"12/18/2015",2/17/2016,"02/17/2016","7464BU5/4127INV31, 00000557465BU2/EG1029VA01, 00000557684BU8/DR-2737019-CO, 00000557687BU1/0910162014, 00000557955BU2/083016842101977, 00000558163BU2/YV0088, 00000558168BU1/M2030711, 00000558895BU9/083016002102098, 00000558900BU7/082416150003, 00000558900BU7/082416150003, 00000559109BU4/082416100020, 00000559109BU4/082416100020, 00000559111BU0/34097VAS01, 00000559116BU9/082416010008, 00000559239BU9/082416140007, 00000559583BU0/083016842102488, 00000559587BU1/083016802102518, 00000559813BU1/419557ORLAB, 00000559813BU1/419557ORLAB, 00000559815BU6/082416210012, 00000560230BU5/083016002102378, 00000560328BU7/0853060200, 00000560739BU5/410740CV, 00000560739BU5/410740CV, 00000560742BU9/0853060202, 00000560908BU6/423495ENDO2, 00000560912BU8/082416210011, 00000561292BU4/082416070003, 00000561530BU7/0835160027, 00000562519BU9/0847160004, 00000562527BU2/0850060730, 00000562974BU6/083016822100478, 00000563632BU9/083016002100458, 00000563633BU7/083016807519408, 00000564218BU6/083016242100748, 00000564506BU4/64002VAS01, 00000565107BU0/M2208715, 00000565464BU5/082416210013, 00000565916BU4/0835160028, 00000565926BU3/08301686210076, 00000565927BU1/0853060203, 00000565996BU6/YV0014, 00000566147BU5/083016822100808, 00000566152BU5/082416160015, 00000566381BU0/RU2969VA01, 00000566384BU4/083016062000898, 00000566595BU5/00109VAS03, 00000566597BU1/082416230003, 00000567344BU7/082416040026, 00000567346BU2/082416120014, 00000568034BU3/082416090003, 00000568568BU0/YV0171, 00000569018BU5/YV0180, 00000569792BU5/082416120015, 00000570008BU3/542120XR02, 00000570357BU4/A5330714, 00000604/10088/B4498642, 00000604/10090/MA1020VA01, 00000604/10092/732776CATH1, 00000604/10103/PL1672VA01, 00000604/10104/80140841, 00000604/20009/856342LCLP, 00000604/20019/215823LCLP, 00000604/20096/083016822000444, 00000604/20097/4163694100, 00000604/20099/313876SP41, 00000604-10104/4103323100, 00000605/00051/804764CATH2, 00000605/14305/00234VAS01, 00000605/30017/414649INNOVA2, 00000605/40040/05208VAS02, 00000605/40207/773NORWG3100, 00000605/40220/6029234100, 000",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72967,"Terminated","Amerita Specialty Infusion Services","1151 W Iron Springs Rd Ste J",".","Prescott","AZ","86305-1614","United States","Voluntary: Firm Initiated","Telephone","AZ only.  No foreign distribution.","D-0570-2016","Class II","IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614","1 syringe","Lack of Assurance of Sterility","01/15/2016","02/10/2016"," Lot # 112621/E; Exp. 10/15  ",12/24/2015,"12/24/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72967,"Terminated","Amerita Specialty Infusion Services","1151 W Iron Springs Rd Ste J",".","Prescott","AZ","86305-1614","United States","Voluntary: Firm Initiated","Telephone","AZ only.  No foreign distribution.","D-0569-2016","Class II","Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614","1 syringe","Lack of Assurance of Sterility","01/15/2016","02/10/2016"," Lot # 112621/E; Exp 12/15  ",12/24/2015,"12/24/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72968,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide - US Nationwide including Puerto Rico, OUS: Albania, Algeria, Angola, Armenia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Iraq, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, Turkmenistan, Unit.Arab Emir., Vatican, AR,  AU,  BD, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IL, IN, JP, KR, LK, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN and ZA.","Z-0754-2016","Class II","ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit)    Product Usage:  This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.  ","55,754 kits","PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). ","02/04/2016",," SMN 10310292-100 test kits  Lot# UDI #  54637263 0063041420300354637263160223  55304263 0063041420300355304263160223  56249264 0063041420300356249264160327  76727264 0063041420300376727264160327  00825265 0063041420300300825265160424  92416265 0063041420300392416265160424  99151265 0063041420300399151265160424  12970266 0063041420300312970266160721  14158266 0063041420300314158266160721  23016266 0063041420300323016266160721  28881266 0063041420300328881266160721  40776268 0063041420300340776268160922    SMN 10310293-500 test kits  Lot# UDI #  54448263 0063041420299054448263160223  55171263 0063041420299055171263160223  56171264 0063041420299056171264160327  77560264 0063041420299077560264160327  92415265 0063041420299092415265160424  96996265 0063041420299096996265160424  12971266 0063041420299012971266160721  13429266 0063041420299013429266160721  19651266 0063041420299019651266160721  27278266 0063041420299027278266160721  35089266 0063041420299035089266160721  39805268 0063041420299039805268160922  50851268 0063041420299050851268160922",12/29/2015,"12/29/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72969,"Ongoing","Phadia Ab","Rapsgatan 7","Rapsgatan Plant","Uppsala",,,"Sweden","Voluntary: Firm Initiated","Letter","US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.","Z-0697-2016","Class II","EliA SmDP Well, Article Number 14-5624-01    Product Usage:  EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.  ","76","All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.","01/27/2016",," Product number: 14-5624-01  Lot: 0018  Exp date: 11/30/2016",12/28/2015,"12/28/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72970,"Terminated","Safecor Health, LLC","317 New Boston St",,"Woburn","MA","01801-6231","United States","Voluntary: Firm Initiated","Letter","NY","D-0657-2016","Class II","Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.","132 unit dose cups","Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.","02/10/2016","02/25/2016"," Lot: 932333, Exp 08/04/16  ",8/13/2015,"08/13/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",72971,"Ongoing","Aplicare, Inc.","550 Research Pkwy",,"Meriden","CT","06450-7172","United States","Voluntary: Firm Initiated","Letter","US: IL, AZ, CT, CA  OUS: China","F-0805-2016","Class II","Castile Soap Towelette (SKU T-3112-1S and SKU T-30120-1S","7,538,000 packets","Product is contaminated with Nesterenkonia lacusekhoensis. ","03/23/2016",," SKU: T-3112-15: 60228, 60503, 60768, 61207, 60229, 60504, 60786, 61208, 60230, 60505, 60787, 61390, 60324, 60506, 60788, 61521, 60325, 60521, 60942, 61522, 60326, 60522, 60943, 61691, 60327, 60523, 61102, 60328, 60767, 61103  SKU: T-3012-15: 60221, 60524, 60865, 61436, 61593  ",10/6/2015,"10/06/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72972,"Ongoing","Instrumentation Laboratory Co.","180 Hartwell Rd",,"Bedford","MA","01730-2443","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.","Z-0736-2016","Class II","HemosIL Plasminogen, Part No. 0020009000, IVD.  Instrumentation Laboratory Company.   Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate ","Domestic: 108 kits, Foreign: 197 kits","This Lot is not meeting labeled on-board instrument stability claims of 5 days. ","02/01/2016",," Lot No. N0455811, Expiration Date 03/31/2017",12/18/2015,"12/18/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72973,"Terminated","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0777-2016","Class III","NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61","6,816 bags","Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration ","03/17/2016","04/06/2016"," Service Code 2K6134;   15342084S, 15342191S, 15342223S, 15342224S, 15342225S, and 15342226S, exp 2/10/2016; 15343025S,   15343026S,   15343129S, and   15343131S, exp 2/11/2016;   15344157S,   15344160S, and   15344209S, exp 2/12/2016;  15345036S,   15345104S,   15345106S, and   15345142S, exp 2/13/2016;  15346015S,   15346016S,   15346017S,   15346018S,   15346019S,  15346020S,  15346022S, and   15346023S, exp 2/14/2016;  15348152S, and  15348197S, exp 2/16/2016  15350046S, and  15350154S, exp 2/18/2016  ",12/31/2015,"12/31/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72973,"Terminated","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0778-2016","Class III","NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61",,"Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration ","03/17/2016","04/06/2016"," Service Code 2K6127;     15342123S, exp 2/10/2016  15349071S, exp 2/17/2016 and    15351050S, exp 2/19/2016    ",12/31/2015,"12/31/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72974,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Lebanon, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad , Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-0769-2016","Class II","GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System    Designed to generate diagnostic radiographic images.","126","Potential safety latch mechanism failure.  The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.","02/09/2016",," Lot or serial numbers include but not limited to: 00000086177HL3, 00001028564WK1, 115226HL3, 00000083538HL9, 00000092940HL6, 00000084909HL1, 00000081798HL1, 120634HL1, 00000084729HL3, 00000084161HL9, 00000082463HL1, 00000080868HL3, 120832HL1, 00000089868HL4, 00000082736HL0, 00000093379HL6, 00000092616HL2, 00000092633HL7, 00000081160HL4, 00000077253HL3, 00000076913HL3, 00000078498HL3, 00000084160HL1, 00000078315HL9, 00000082726HL1, 00000085039HL6, 00000080635HL6, 00000091403HL6, 00000085598HL1, 00000085661HL7, 00000077923HL1, 00000081481HL4, 00001027046WK0, 00000081152HL1, 00000086364HL7, 00000092622HL0, 00000085000HL8, 00000084999HL2, 00000084725HL1, 00000083029HL9, 00000078313HL4, 00000084162HL7, 00000083020HL8, 00000077471HL1, 00000083019HL0, 00000082738HL6, 00000083598HL3, 00000092618HL8, 00000084180HL9, 00000085594HL0, 00000084917HL4, 00000076790HL5, 00000091413HL5, 00001028931WK2, 00000102856WK4, 00001028927WK0, 00001028924WK7, 00000084159HL3, 00000084422HL5, 00001029525WK1, 00000077482HL8, 00000082250HL2, 00000075962HL1, 00000079632HL6, 00000082240HL3, 00000081484HL8, 00000084732HL7, 00000077924HL9, 00000079918HL9, 00000082247HL8, 00000082245HL2, 00000082243HL7, 00000077255HL8, 00000086373HL8, 00000087093HL1, 00000102539HL4, 00000085004HL0, 00000085599HL9, 00000079559HL1, 00000079282HL0, 00000077782HL1, 00000082480HL5, 00000079116HL0, 00001028894WK2, 00000078317HL5, 00000079280HL4, 00000129740WG7, 00000079278HL8, 00000078492HL6, 00000075947HL2, 00000084908KL3, 00000084412HL6, 00000084169HL2, 00001027692WK1, 00000085036HL2, 0000000012C559, 00000084178HL3, 00000093852HL2, 00000092058HL7, 00000087079HL0, 00001029020WK3, 00001028888WK4, 00001028659WK9, 00001028662WK3, 00001028661WK5, 00000086380HL3, 00001028660WK7, 00000084172HL6, 00001028595WK5, 00000086365HL4, 00000084411HL8, 00000084402HL7, 00000084906HL7, 00001028866WK0, 00001028925WK4, and 00000085034HL7.",12/23/2015,"12/23/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72974,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Lebanon, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad , Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-0768-2016","Class II","GE Healthcare,  Optima XR220amx, Mobile Digital Ready Radiographic System    Designed to generate diagnostic radiographic images.","2389","Potential safety latch mechanism failure.  The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.","02/09/2016",," Lot or Serial numbers including but not limited to:  00001033715WK2, 12535HL3, 00000078321HL7, 00000096815HL6, 00000081147HL1, 00001032621WK3, 00000092076HL9, 00000092382HL1, 00000460115GE9, 00000079932HL0, D3s14793, 00000088642HL4, 116635HL4, 120632HL5, GEGR2411, GEGR5073, 00001027151WK8, 00000129105HL3, 261417HP0, 261416HP2, 1035189WK8, 00000084720HL2, 00000087109HL5, 00000100735HL0, 121206HL7, 125007HL5, 125019HL0, 1028231WK7, 00000126237HL7, 00000102072HL6, 00000092394HL6, 00000115802HL1, 124167HL8, 00001033721WK0, 00000108520HL8, 00000087928HL8, 00000111794HL4, 00000110657HL4, 00000092629HL5, 119090HL9, 00000442129GE3, 00000128179HL9, 00000110710HL1, 83621HL3, 00000082207HL2, 1034762WK3, 00000081499HL6, 00000088705HL9, 00000085601HL3, 00001031247WK8, 00000084721HL0, 00000084410HL0, 00000086179HL9, 1033866WK3, 00000084286HL4, 00000096817HL2, 00000092948HL9, 00000106841HL0, 00000105475HL8, 00001033220WK3, 00000106072HL2, 00000110662HL4, 00000106055HL7, 00000008789HL5, 00000084415HL9, 00000084713HL7, 00000091763HL3, 00000093367HL1, 123730HL4, 00000109436HL6, 00000078816HL6, 00000078490HL0, 120816HL4, 00000124501HL8, 00000124510HL9, 123456789, 00000095656BT5, 118267HL4, 00000081688HL4, 00000110668HL1, 123737HL9, 00000081500HL1, 00000084711HL1, 00000085596HL5, 00000118284HL9, 00000124201HL5, 00000118285HL6, 00000118462HL1, 00000118282HL3, 00000104908HL9, 00000102090HL8, 00000100174HL2, 120182HL1, D3S141084, 00000100430HL8, 00000097754HL6, 114137HL3, 00000099201HL6, 00000099204HL0, 00000111427HL1, 00000087073HL3, 120184HL7, 00000126701HL2, 00000128172HL4, 00000124478HL9, 00000124224HL7, 00000091044HL8, 00000107457HL4, 00000076792HL1, 00000112148HL2, 00001032707WK0, 00000101689HL8, 119104HL8, 00001027765WK5, 114191HL0, 00000085591HL6, 00001030627WK2, 00001030293WK3, 00001030654WK6, 00001030617WK3, GEGR3510, 119099HL0, 00000106829HL5, 120187HL0, 00000087076HL6, 00000124186HL8, 00000098182HL9, 120829HL7, 00000093383HL8, 124217HL1, 122883HL2, 121230HL7, 112145HL8, 00001033608WK9, 00000096582HL2, 121229hl9, 0000008",12/23/2015,"12/23/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72974,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Lebanon, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad , Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-0770-2016","Class II","GE Healthcare, Optima XR200amx,  Mobile Digital Ready Radiographic System    Designed to generate diagnostic radiographic images.","895","Potential safety latch mechanism failure.  The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.","02/09/2016",," Lot or serial numbers include, but not limited to: 00001031869WK9, 00001031925WK9, 00000081156HL2, GEGR2170,  00001033726WK9, 00000119120HL4, 00000084104HL9, 00001033405WK0, 00000085648HL4, 00001033548WK7, 1035415WK7,  124175HL1, 122205HL8, 1036207WK7, 00000086387HL8,  00000104902HL2, 00000087904HL9, 00000087902HL3, 00000106045HL8, 00000105791HL8, 00000083607HL2, 00000090594HL3, 00000090597HL6, 00001030061WK4, 00001030140WK6, 00001030142WK2, 114185HL2, 00001031534WK9, 00001031533WK1, 00001031696WK6, 00000092062HL9, 00001028273WK9, 00000106054HL0, 00000106067HL2, 00000105797HL5, 00000106074HL8, 00000105801HL5, 00000104928HL7, 00000093370HL5, 00000089482HL4, 00000085430HL7, 00000091765HL8, 120821HL4, 00000086171HL6, 00000089492HL3, 00000089863HL5, 00000104898HL2, 00000108421HL9, 00000092383HL9, 00000093388HL7, 00001032768WK2, 00000104929HL5, 00000104507HL9, 00000105458HL4, 00000090610HL7, 00000086388HL6, 00000083023HL2, 00000085899HL3, 00000080694HL3, 00000102536HLO, 00000092384HL7, 115224HL8, 00000090608HL1, 00000091221HL2, 00000087939HL5, 00000087912HL2, 00000086382HL9, 00000091420HL0, 00001031277WK5, 00000085023HL0, 00000100184HL1, 00000082246HL0, 00000089865HL0, 00001029027WK8, 00000108416HL9, 00001029021WK1,  00000117417HL6, 00000090227HL0, 00000090593HL5, 00000089495HL6, 00000087096HL4, 00000101153HL5, old-pos,  00000108581HL0, 00000110652HL5, 00000081168HL7, 00000107465HL7, GEGR4022, 1035828WK1, 00000108579HL4, 00000110665HL7,  00000098205HL8,   00000117423HL4,  00000086166HL6, 00000082242HL9, 427332GE2, 00001033782WK2, 119096hl6, 00000120673HL9, 00000083021HL6, 00000085425HL7, 00000086976HL8,  00000086973HL5, 00000094572BT5, 1035839WK8, 00000085428HL1,  120672HL1, 00000091392HL1, 00001028490WK9, 00000115766HL8, 00000118540HL4, 125111BT5, 00000115498HL8, 00000115243HL8, 00000117429HL1,  00000084397HL9,   00000092632HL9, ASTE-51009, 00000117424HL2, 436814GE8, 00000102543HL6,  00001030548WK0, 00000076405HL0, 00000081685HL0, 00000098618HL2, 00000099170HL3,   00000124188HL4, 00000120637HL4,   00000109390HL5,",12/23/2015,"12/23/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72975,"Terminated","Bulletproof Digital Inc","1750 112th Ave NE Ste C242",,"Bellevue","WA","98004-3727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, OR, and TX.  Products sold from bulletproof.com to internet customers nationwide and Canada.","F-0577-2016","Class III","FATwater bottle, 16.9 fl. oz., Tangerine flavor, UPC 6 41871 93693 9","5,748 bottles","FATwater bottles, Tangerine flavor, are recalled due to microbial growth detection.  No E.coli or other pathogens were detected.","02/11/2016","04/01/2016"," LOT number:  B151005-4U.    EXPIRATION DATE: 10/5/2016.    ",12/10/2015,"12/10/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72975,"Terminated","Bulletproof Digital Inc","1750 112th Ave NE Ste C242",,"Bellevue","WA","98004-3727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, OR, and TX.  Products sold from bulletproof.com to internet customers nationwide and Canada.","F-0575-2016","Class III","FATwater bottle, 16.9 fl. oz., Berry flavor, UPC 6 09015 50477 2","12,583 bottles","FATwater bottles, Berry flavor, are recalled due to microbial growth detection.  No E.coli or other pathogens were detected.","02/11/2016","04/01/2016"," LOT numbers:    B150608-2U;  B150710-2U;  B150720-2U;  B150819-2U;  B150820-2U;  B151005-1U;  B151020-2U;      EXPIRATION DATES:    7/9/2016;  7/28/2016;  8/19/2016;  8/20/2016;  10/5/2016;  10/20/2016;  ",12/10/2015,"12/10/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72975,"Terminated","Bulletproof Digital Inc","1750 112th Ave NE Ste C242",,"Bellevue","WA","98004-3727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, OR, and TX.  Products sold from bulletproof.com to internet customers nationwide and Canada.","F-0576-2016","Class III","FATwater bottle, 16.9 fl. oz., Lemon flavor, UPC 6 09015 50475 8","12,776 bottles","FATwater bottles, Lemon flavor, are recalled due to microbial growth detection.  No E.coli or other pathogens were detected.","02/11/2016","04/01/2016"," LOT numbers:    B150608-1U;  B150710-1U;  B150720-1U;  B150819-1U;  B150820-1U;  B151005-2U;        EXPIRATION DATES:    7/9/2016  7/28/2016  8/19/2016  8/20/2016  10/5/2016  ",12/10/2015,"12/10/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72976,"Ongoing","NeoCoil, LLC","N27W23910 Paul Rd Ste A",,"Pewaukee","WI","53072-6204","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1027-2016","Class II","NeoCoil 3.0T GEM Flex Coil.   The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box.    3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5.  3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2.  3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3.  3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4.    The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner","2121","Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.","02/29/2016",," Mfg Lot or Serial #	System ID  0000034-4-0130	608263MR5W  0000040-4-0135	608263MR5W  000032E-4-0151	608263MR5W  033-4-0151	608263MR5W  0000040-4-0202	602863MR  0000033-4-0204	602863MR  034-4-0265	602863MR  040-4-0076	602863MR  0000034-4-0250	703478MR2DV  0000040-4-0270	703478MR2DV  033-4-022	703478MR2DV  0000033-4-0272	703478MR2DV  034-4-0255	506648MR4  040-4-0275	506648MR4  040-4-0020	506648MR4  033-4-0277	506648MR4  034-4-0071	608265MR750W  0000040-4-0381	608265MR750W  0000033-4-0384	608265MR750W  034-4-0345	608265MR750W  0000034-4-0093	708346MR3  0000040-4-0096	708346MR3  0000033-4-0088	708346MR3  034-4-0352	269DVMR  040-4-0392	269DVMR  033-4-0395	269DVMR  0000034-4-0144	808873MR750W  0000033-4-0151	808873MR750W  0000040-4-0150	808873MR750W  0000034-4-0112	270798MR2  0000040-4-0118	270798MR2  0000033-4-0118	270798MR2  034-4-0089	650723NCMR1  033-4-0258	650723NCMR1  033-4-0134	650723NCMR1  0000034-4-0086	281274MR2  0000040-4-0089	281274MR2  0000033-4-0090	281274MR2  0000034-4-0076	757827MR2  0000033-4-0081	757827MR2  0000SGH225PYJJ	757827MR2  0000034-4-0007	305461MR1  0000040-4-0070	305461MR1  0000033-4-0070	305461MR1  0000034-4-0110	847872ZMR2  0000040-4-0114	847872ZMR2  0000033-4-0114	847872ZMR2  0000034-4-0095	330344MR750W  0000040-4-0098	330344MR750W  0000033-4-0099	330344MR750W  0000034-4-0094	616774MR750W  0000040-4-0097	616774MR750W  0000033-4-0098	616774MR750W  0000040-4-0276	386FNSBMR3T  0000033-4-0279	386FNSBMR3T  0000034-4-0260	386FNSBMR3T  0000034-4-0140	217876DMH3T  0000040-4-0145	217876DMH3T  0000033-4-0146	217876DMH3T  0000034-4-0216	410328MR3T  0000040-0-0224	410328MR3T  0000033-4-0227	410328MR3T  034-4-0313	716740MR1  040-4-0329	716740MR1  033-4-0329	716740MR1  0000034-4-0177	415CBMRP  0000040-4-0182	415CBMRP  0000033-4-0183	415CBMRP  0000034-4-0043	808485MR2  0000040-4-0047	808485MR2  033-4-0323	808485MR2  034-4-0267	415UCBHMR1  040-4-0284	415UCBHMR1  033-4-0285	415UCBHMR1  033-4-0352	843815750W  040-4-0055	843815750W  0000034-4-0221	843815750W  034-4-0272	415UCBHMR2  040-4-0288	415UCBHMR2",12/18/2015,"12/18/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72977,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution - in the states of:  AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico","Z-0812-2016","Class III","REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units.    Product Usage:  Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.  ","15,400 units","Report by a customer of an open package seal.","02/16/2016",," Lot Number NGZE1190",1/4/2016,"01/04/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72978,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution to the states of : MN, WI, IL, PA, AL,  MO, MT, AZ, CA, OH, FL, SC, MI, TN, CO, NV, IN, NY, MD, AR, KS, NY, IN, IA, TX, OK, NC, WA and DC.","Z-0794-2016","Class II","RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E,   5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560,   5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.  ","164","Potential incorrect Standardized Uptake Values (SUV)  measurements in RadSuite.","02/10/2016",," Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E,   5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560,   5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.  ",12/17/2015,"12/17/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72979,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany,  India, Italy, Japan, Mexico, Panama, Singapore, Spain, and  Venezuela","Z-1072-2016","Class II","VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD.    Product Usage:  For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.  ","US = 885; Foreign: 3221","Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954.  A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).","03/08/2016",," Software Version 9.4 and below; Serial Numbers J27000001 - 27004539",12/21/2015,"12/21/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72979,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany,  India, Italy, Japan, Mexico, Panama, Singapore, Spain, and  Venezuela","Z-1074-2016","Class II","VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD.    Product Usage:  For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.  ","US = 1009; Foreign = 1003","Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954.  A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).","03/08/2016",," Software Version 3.2 and below; Serial Numbers J56000024  - 56002339",12/21/2015,"12/21/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72979,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany,  India, Italy, Japan, Mexico, Panama, Singapore, Spain, and  Venezuela","Z-1075-2016","Class II","VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD.    Product Usage:  The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)  ","US = 994; Foreign = 1405","Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954.  A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).","03/08/2016",," Software Version 2.8 and below; VITROS 5,1 FS Chemistry System Serial Numbers: J34000119 - J34002323; VITROS 5,1 FS Chemistry System (Refurbished) Serial Numbers: 34000133, 34000193, 34000197, 34000212,   34000285, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451,  34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557,   34000590, 34000596, 34000601, 34000631, 34000642, 34000761, 34000799,   34000805, 34000833, 34000851, 34000893, 34000946, 34000947, 34001006,   34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274,   34001297, 34001317, 34001345, 34001378, 34001379, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001612, 34001626, 34001633, 34001668, 34001755, 34001809, 34001840, 34001850,   34001875, 34001897, 34000123, 34000143, 34000191, 34000215, 34000219,   34000235, 34000251, 34000256, 34000260, 34000261, 34000319, 34000331,  34000380, 34000382, 34000406, 34000408, 34000412, 34000426, 34000431,   34000454, 34000464, 34000473, 34000501, 34000523, 34000530, 34000541,   34000542, 34000546, 34000548, 34000553, 34000558, 34000576, 34000577,  34000584, 34000585, 34000609, 34000612, 34000615, 34000616, 34000617,   34000618, 34000620, 34000625, 34000637, 34000644, 34000672, 34000744,   34000745, 34000755, 34000759, 34000767, 34000776, 34000793, 34000800,  34000814, 34000831, 34000844, 34000846, 34000852, 34000856, 34000870,   34000876, 34000887, 34000892, 34000902, 34000912, 34000920, 34000938,   34000956, 34000969, 34000976, 34001007, 34001009, 34001044, 34001045,   34001052, 34001071, 34001075, 34001098, 34001099, 34001111, 34001129,   34001154, 34001161, 34001171, 34001182, 34001192, 34001195, 34001201,   34001204, 34001208, 34001212, 34001234, 34001247, 34001254, 34001271,   34001278, 34001284, 34001288, 34001289, 34001293, 34001298, 34001301,   34001302, 34001316, 34001325, 34001337, 34001340, 34001348, 34001367,   34001369, 34001399, 34001400, 34001407, 34001410, 34001416, 34001423,   34001427, 34001429, 34001457, 34001490, 3400151",12/21/2015,"12/21/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72979,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany,  India, Italy, Japan, Mexico, Panama, Singapore, Spain, and  Venezuela","Z-1073-2016","Class II","VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD.    Product Usage:  For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)  ","US = 163; Foreign = 286","Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954.  A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).","03/08/2016",," Software Version 3.2 and below; Serial Numbers J46000001 - 46000678",12/21/2015,"12/21/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72979,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany,  India, Italy, Japan, Mexico, Panama, Singapore, Spain, and  Venezuela","Z-1071-2016","Class II","VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD.    Product Usage:  For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.  ","US: 802; Foreign: 2472","Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954.  A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).","03/08/2016",," Software Version 9.4 and below; VITROS 250 Serial Numbers: 25010043 - 25055306; VITROS 250 Refurbished Serial Numbers: 25010582, 25010617, 25010638, 25010782, 25011056, 25011074, 25011176, 25011192, 25011196, 25011246, 25011317, 25011383, 25011408, 25011435, 25011448, 25011517, 25011647, 25011648, 25011777, 25011957, 25012025, 25012058, 25012062, 25012073, 25012078, 25012140, 25012259, 25012267, 25012323, 25012344, 25012487, 25012505, 25012521, 25012574, 25012629, 25012654, 25012672, 25012765, 25012782, 25012838, 25012931, 25012938, 25013036, 25013100, 25013139, 25013216, 25013245, 25013313, 25013389, 25013391, 25013448, 25013473, 25013497, 25013583, 25013597, 25013719, 25013757, 25013787, 25013790, 25013870, 25013879, 25013971, 25013982, 25014033, 25014196, 25014201, 25014209, 25014272, 25014278, 25014286, 25014318, 25014404, 25014409, 25014412, 25014448, 25014449, 25014459, 25014562, 25014609, 25014610, 25014655, 25014657, 25014663, 25014728, 25014741, 25014775, 25014788, 25014832, 25014849, 25014927, 25015076, 25015132, 25015133, 25015169, 25015223, 25015242, 25015277, 25015389, 25015430, 25015445, 25015463, 25015678, 25015770, 25015847, 25015914, 25015915, 25015976, 25015990, 25015998, 25016011, 25016177, 25016218, 25016429, 25016463, 25016517, 25016528, 25016552, 27000025, 27000054, 27000132, 27000156, 27000216, 27000317, 27000488, 27000870, 27000936, 27001058, 27001124, 27001471, 27001644, 27001651, 27001763, 27002256, 27002351, 27002714, R2500159, R2500179, R2500217, 25010122, 25010187, 25010220, 25010320, 25010332, 25010360, 25010362, 25010380, 25010394, 25010429, 25010450, 25010465, 25010522, 25010584, 25010648, 25010677, 25010690, 25010691, 25010694, 25010697, 25010709, 25010713, 25010719, 25010725, 25010735, 25010749, 25010751, 25010753, 25010770, 25010772, 25010774, 25010775, 25010802, 25010809, 25010817, 25010841, 25010845, 25010848, 25010850, 25010859, 25010864, 25010865, 25010867, 25010872, 25010885, 25010889, 25010908, 25010919, 25010923, 25010949, 25010954, 25010955, 25010962, 25010965, 25010",12/21/2015,"12/21/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72987,"Ongoing","Gwenstone, Inc.","1121 Industrial Pkwy Ste D",,"Brick","NJ","08724-2591","United States","Voluntary: Firm Initiated","Press Release","Nationwide","V-0009-2017","Class I","BDN pet foods Chicken Supreme, packaged in 1 lb. and 5 lb. pouches and 10 lb. vacuum bags,   BDN Pet Foods, Inc. 1121 Industrial Parkway Suite D Brick, NJ 08724   FOR INFO: Email info@bigdognatural.com  CALL 732-785-2600 - TOLL FREE 877 K9 MEATS",,"Dog food may be contaminated with Salmonella and Listeria monocytogenes as per FDA sampling and analysis.","10/21/2016",," all products shipped from 10/31/2015 to 11/13/2015",1/4/2016,"01/04/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",72987,"Ongoing","Gwenstone, Inc.","1121 Industrial Pkwy Ste D",,"Brick","NJ","08724-2591","United States","Voluntary: Firm Initiated","Press Release","Nationwide","V-0010-2017","Class I","BDN pet foods Fish Supreme, packaged in 1 lb. and 5 lb. pouches and 10 lb. vacuum bags,  BDN Pet Foods, Inc. 1121 Industrial Parkway Suite D Brick, NJ 08724   FOR INFO: Email info@bigdognatural.com  CALL 732-785-2600 - TOLL FREE 877 K9 MEATS",,"Dog food may be contaminated with Salmonella and Listeria monocytogenes as per FDA sampling and analysis.","10/21/2016",," all products shipped from 10/31/2015 to 11/13/2015",1/4/2016,"01/04/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72988,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0566-2016","Class II","DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA  18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.","9,717 bottles","Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.","01/11/2016",," Lot #: 34015516A, Exp 05/16",11/12/2015,"11/12/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72989,"Terminated","CJ Distribution (Oakland) Inc.","155 98th Ave",,"Oakland","CA","94603-1003","United States","Voluntary: Firm Initiated","Telephone","Northern CA Bay area only.","F-0747-2016","Class II","CJ Extra Fancy Long Grain Enriched Rice.  NET WT. 80 lbs (36.20 kg);  nylon bag;  Product of USA.  Item number RG80","15  x 80 lb. bags (7 bags already returned)","FDA inspection found rodent urine stains on pallets of long grain rice in 80 lb. bags. ","03/14/2016","03/14/2016"," Lot numbers #873, #876, #878. These numbers are according to supplier information on pallets; bags to not have lot numbers.",12/29/2015,"12/29/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72991,"Ongoing","MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK","6-22, 4-CHOME, KAN-ON-SHIN-MACHI","NISHI-KU","HIROSHIMA",,,"Japan","Voluntary: Firm Initiated","Letter","Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea,  & Belgium.","Z-1244-2016","Class II","MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after)  Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.","25 devices (4 domestically in U.S.A. and 21 internationally)"," under specific conditions.","03/24/2016",," Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929. ",12/15/2015,"12/15/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1477-2016","Class II","Catalog Number:  900547  BASIC SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","10","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15187 (150719805)	31-JUL-16  SL15245 (150820338)	31-AUG-16  SL15264 (150920833)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1406-2016","Class II","Catalog Number:  900064 WOUND CLOSURE TRAY II  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","600","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15169 (150619313)	31-MAY-16  SL15174 (150619313)	31-MAY-16  SL15197 (150719820)	31-JUL-16  SL15202 (150719820)	31-JUL-16  SL15208 (150719820)	31-JUL-16  SL15274 (150920664)	30-SEP-16  SL15274 (150920144)	30-SEP-16  SL15275 (150920664)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1433-2016","Class II","Catalog Number:  900169  UNIVERSAL SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","9","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15210 (150719663)	31-JUL-16  SL15244 (150820222)	31-AUG-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1455-2016","Class II","Catalog Number:  9002618  OPEN HEART SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","47","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15177 (150619477)	30-JUN-16  SL15181 (150619477)	30-JUN-16  SL15212 (150719843)	31-JUL-16  SL15215 (150719843)	31-JUL-16  SL15219 (150719843)	31-JUL-16  SL15271 (150920812)	30-SEP-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1492-2016","Class II","Catalog Number:  900946  STRABISMUS SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","8","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOT:  SL15215 (150719817)	31-JUL-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1460-2016","Class II","Catalog Number:  900281A  LAPAROTOMY PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","597","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15194 (150719776)	31-JUL-16  SL15197 (150719778)	31-JUL-16  SL15199 (150719777)	31-JUL-16  SL15201-01 (150719777)	31-JUL-16  SL15217 (150720038)	31-AUG-16  SL15219 (150720039)	31-AUG-16  SL15222 (150720039)	31-AUG-16  SL15222 (150720038)	31-AUG-16  SL15225 (150720040)	31-AUG-16  SL15231 (150720040)	31-AUG-16  SL15271 (150920908)	30-SEP-16  SL15271 (150920640)	30-SEP-16        ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1485-2016","Class II","Catalog Number:  900741A  ORTHO-IMPLANT SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","153","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15174 (150619406)	30-JUN-16  SL15197 (150719810)	31-JUL-16  SL15201-02 (150719810)	31-JUL-16  SL15231 (150820049)	31-AUG-16  SL15232 (150820049)	31-AUG-16  SL15243 (150820049)	31-AUG-16  SL15265 (150820558)	31-AUG-16  SL15268 (150920711)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1462-2016","Class II","Catalog Number:  9002830  ORTHOPEDIC SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","85","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15187 (150619316)	30-JUN-16  SL15195-01 (150719785)	31-JUL-16  SL15265 (150820310)	30-SEP-16  SL15271 (150820311)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1446-2016","Class II","Catalog Number:  9002256  NEUROSURGERY PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","24","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15201-02 (150619399)	30-JUN-16  SL15203 (150619399)	30-JUN-16  SL15210 (150719862)	31-JUL-16  SL15260 (150820588)	30-SEP-16  SL15261 (150820588)	30-SEP-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1450-2016","Class II","Catalog Number:  9002511  MINOR SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","344","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15170 (150317841)	30-APR-16  SL15170 (150317843)	30-APR-16  SL15180 (150619260)	30-JUN-16  SL15184 (150317844)	30-APR-16  SL15199 (150719841)	31-JUL-16  SL15203 (150719841)	31-JUL-16  SL15229 (150820295)	31-AUG-16  SL15245 (150820296)	31-AUG-16  SL15246 (150820296)	31-AUG-16  SL15267 (150920885)	31-AUG-16  SL15268 (150920886)	31-AUG-16  SL15271 (150920887)	31-AUG-16  SL15273 (150920884)	31-AUG-16  SL15273 (150920809)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1407-2016","Class II","Catalog Number:  900080 CYSTOSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","140","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15187 (150619473)	30-JUN-16  SL15197 (150719616)	31-JUL-16  SL15240 (150820571)	31-AUG-16  SL15251 (150920666)	30-SEP-16  SL15259 (150920926)	30-SEP-16  SL15259 (150920925)	30-SEP-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1422-2016","Class II","Catalog Number:  9001402  PLASTIC SURGERY PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","15","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15175 (150619485)	30-JUN-16  SL15225 (150719857)	31-AUG-16  SL15230 (150820074)	31-AUG-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1464-2016","Class II","Catalog Number:  9002940  OBSTETRICAL SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","304","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15197 (150719792)	31-JUL-16  SL15208 (150719793)	31-JUL-16  SL15216 (150719793)	31-JUL-16  SL15225 (150820315)	31-AUG-16  SL15225 (150820314)	31-AUG-16  SL15230 (150820315)	31-AUG-16  SL15243 (150719793)	31-JUL-16  SL15272 (150920895)	30-SEP-16  SL15272 (150920819)	30-SEP-16  SL15272 (150920897)	30-SEP-16  SL15272 (150920896)	30-SEP-16  SL15273 (150920897)	30-SEP-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1438-2016","Class II","Catalog Number:  9001780  OPHTHALMIC SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","168","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15169 (150518594)	30-JUN-16  SL15170 (150518592)	30-JUN-16  SL15199 (150719720)	30-JUN-16  SL15199 (150719719)	30-JUN-16  SL15203 (150719720)	30-JUN-16  SL15230 (150819721)	30-JUN-16  SL15231 (150819722)	30-JUN-16  SL15231 (150820230)	30-JUN-16  SL15243 (150820231)	30-JUN-16  SL15243 (150820229)	30-JUN-16  SL15259 (150920791)	30-JUN-16  SL15259 (150920917)	30-JUN-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1404-2016","Class II","Catalog Number:  900052 MINOR PROCEDURE SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","40","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15170 (150619101)	30-JUN-16  SL15202 (150719613)	31-JUL-16  SL15245 (150820662)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1491-2016","Class II","Catalog Number:  900944  CATARACT SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","576","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15180 (150619377)	30-JUN-16  SL15184 (150619377)	30-JUN-16  SL15229 (150619378)	31-AUG-16  SL15230 (150819814)	31-AUG-16  SL15231 (150820356)	31-AUG-16  SL15231 (150819816)	31-AUG-16  SL15231 (150819815)	31-AUG-16  SL15259 (150920355)	30-SEP-16  SL15261 (150920357)	30-SEP-16  SL15266 (150920358)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1410-2016","Class II","Catalog Number:  9001091 PERY-GYN SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","80","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15202 (150719622)	31-JUL-16  SL15211 (150720064)	31-JUL-16  SL15212 (150720065)	31-JUL-16  SL15245 (150820677)	31-AUG-16  SL15245 (150820676)	31-AUG-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1435-2016","Class II","Catalog Number:  900176  LAPAROTOMY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","938","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15170 (150619367)	30-JUN-16  SL15170 (150619366)	30-JUN-16  SL15170 (150619364)	30-JUN-16  SL15170 (150619365)	30-JUN-16  SL15187 (150719668)	31-JUL-16  SL15191-01 (150719669)	31-JUL-16  SL15191-01 (150719670)	31-JUL-16  SL15191-01 (150719667)	31-JUL-16  SL15211 (150720120)	31-JUL-16  SL15211 (150720142)	31-JUL-16  SL15211 (150720122)	31-JUL-16  SL15212 (150720143)	31-JUL-16  SL15212 (150720142)	31-JUL-16  SL15212 (150720121)	31-JUL-16  SL15215 (150720122)	31-JUL-16  SL15215 (150720141)	31-JUL-16  SL15215 (150720121)	31-JUL-16  SL15222 (150720120)	31-JUL-16  SL15233 (150820566)	31-AUG-16  SL15233 (150820568)	31-AUG-16  SL15240 (150820569)	31-AUG-16  SL15243 (150820567)	31-AUG-16  SL15243 (150820566)	31-AUG-16  SL15245 (150820698)	31-AUG-16  SL15245 (150820697)	31-AUG-16  SL15245 (150820696)	31-AUG-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1453-2016","Class II","Catalog Number:  9002614  HIP AND KNEE REPLACEMENT SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","18","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15212 (150719962)	31-JUL-16  SL15274 (150920990)	30-JUN-16  SL15274 (150920989)	30-SEP-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1408-2016","Class II","Catalog Number:  9001061 PERI-GYN SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","30","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15194 (150719821)	31-JUL-16  SL15243 (150820582)	31-AUG-16  SL15274 (150920674)	30-SEP-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1437-2016","Class II","Catalog Number:  9001771  MAYO STAND COVER STERILE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","540","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15215 (150719671)	31-JUL-16  SL15222 (150719671)	31-JUL-16  SL15246 (150820227)	31-AUG-16  SL15252 (150820227)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1487-2016","Class II","Catalog Number:  900774  INCISION AND DRAINAGE TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","800","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15177 (150619315)	30-JUN-16  SL15268 (150719854)	30-SEP-16  SL15271 (150719854)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1479-2016","Class II","Catalog Number:  900576A  LAP-CHOLECYSTECTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","144","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15197 (150719807)	31-JUL-16  SL15240 (150820565)	31-AUG-16  SL15240 (150820339)	31-AUG-16  SL15261 (150920708)	30-SEP-16  SL15261 (150920707)	30-SEP-16  SL15264 (150920707)	30-SEP-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1480-2016","Class II","Catalog Number:  900582  UTILITY DRAPE WITH TAPE, SMS  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","800","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15187 (150518831)	30-JUN-16  SL15217 (150719853)	31-JUL-16  SL15233 (150820340)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1444-2016","Class II","Catalog Number:  9002193  SHOULDER ARTHROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","42","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15229 (150719755)	31-AUG-16  SL15230 (150719755)	31-AUG-16  SL15231 (150719755)	31-AUG-16  SL15240 (150719755)	31-AUG-16  SL15260 (150820264)	30-SEP-16  SL15260 (150820265)	30-SEP-16  SL15261 (150820264)	30-SEP-16  SL15272 (150820264)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1463-2016","Class II","Catalog Number:  9002899  CYSTO TUR SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","72","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15174 (150518912)	30-JUN-16  SL15240 (150820312)	31-AUG-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1468-2016","Class II","Catalog Number:  900410  CESAREAN SECTION SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","96","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15177 (150619275)	30-JUN-16  SL15233 (150719849)	31-JUL-16  SL15240 (150719849)	31-JUL-16  SL15264 (150820590)	30-SEP-16  SL15264 (150920589)	30-SEP-16  SL15266 (150820590)	30-SEP-16  SL15274 (150920824)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1423-2016","Class II","Catalog Number:  9001408  UMBILICAL VESSEL CATHETER KIT   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","40","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15169 (140814647)	30-JUN-16  SL15202 (150719858)	31-JUL-16  SL15225 (150820446)	31-AUG-16        ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1427-2016","Class II","Catalog Number:  9001496  D&C LAPAROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","12","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15181 (150619167)	30-JUN-16  SL15181 (150619386)	30-JUN-16  SL15209 (150619386)	30-JUN-16  SL15209 (150719646)	31-JUL-16  SL15224 (150820077)	31-AUG-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1481-2016","Class II","Catalog Number:  900618A  LAPAROSCOPY-GYN SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","36","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15197 (150719808)	31-JUL-16  SL15240 (150820341)	31-AUG-16  SL15271 (150920991)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1413-2016","Class II","Catalog Number:  9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","380","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15194 (150719924)	31-JUL-16  SL15210 (150719924)	31-JUL-16  SL15216 (150719925)	31-JUL-16  SL15218 (150719925)	31-JUL-16  SL15222 (150719824)	31-JUL-16  SL15224 (150719824)	31-JUL-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1466-2016","Class II","Catalog Number:  900345  BASIC SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","55","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15203 (150719872)	31-JUL-16  SL15225 (150820317)	31-AUG-16  SL15274 (150920821)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1401-2016","Class II","Catalog Number:  900028 LAPAROSCOPY SURGICAL PACK   ","60","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15194 (150719926)	31-JUL-16  SL15194 (150719927)	31-JUL-16  SL15195-02 (150719927)	31-JUL-16  SL15195-02 (150719926)	31-JUL-16  SL15258 (150719926)	31-JUL-16  SL15258 (150719927)	31-JUL-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1397-2016","Class II","Catalog Number:  9001771 MAYO STAND COVER STERILE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","540","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15215 (150719671)	31-JUL-16  SL15222 (150719671)	31-JUL-16  SL15246 (150820227)	31-AUG-16  SL15252 (150820227)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1417-2016","Class II","Catalog Number:  9001294  PREMIUM CESAREAN PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","45","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15202 (150719828)	31-JUL-16  SL15203 (150719828)	31-JUL-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1419-2016","Class II","Catalog Number:  9001297  PREMIUM OBSTETRICAL SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","220","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15169 (150619380)	30-JUN-16  SL15174 (150619380)	30-JUN-16  SL15201-01 (150719634)	31-JUL-16  SL15212 (150720070)	31-JUL-16  SL15212 (150720071)	31-JUL-16  SL15272 (150920769)	30-SEP-16  SL15273 (150920769)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1448-2016","Class II","Catalog Number:  9002469  BASIC  SURGICAL PACK IV  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","30","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15181 (150619410)	30-JUN-16  SL15184 (150619410)	30-JUN-16  SL15223 (150820284)	31-AUG-16  SL15223 (150820283)	31-AUG-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1434-2016","Class II","Catalog Number:  9001738  UROLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","25","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOT:  SL15209 (150719960)	31-JUL-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1412-2016","Class II","Catalog Number:  9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","2920","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15183 (150619119)	30-JUN-16  SL15184 (150619119)	30-JUN-16  SL15187 (150619119)	30-JUN-16  SL15212 (150719823)	31-JUL-16  SL15215 (150719823)	31-JUL-16  SL15216 (150719823)	31-JUL-16  SL15217 (150720152)	31-JUL-16  SL15217 (150719823)	31-JUL-16  SL15219 (150719823)	31-JUL-16  SL15219 (150720152)	31-JUL-16  SL15223 (150720152)	31-JUL-16  SL15224 (150720152)	31-JUL-16  SL15225 (150719823)	31-JUL-16  SL15252 (150820683	31-AUG-16  SL15254 (150820683)	31-AUG-16  SL15257 (150820683)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1439-2016","Class II","Catalog Number:  9001933  OPHTALMIC SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","168","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15176 (150619390)	30-JUN-16  SL15231 (150819833)	31-AUG-16  SL15233 (150619391)	31-AUG-16  SL15240 (150819834)	31-AUG-16  SL15259 (150920237)	30-SEP-16  SL15259 (150920236)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1482-2016","Class II","Catalog Number:  900629  STERILE OR CLOTH TOWEL BLUE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","125","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15170 (150619291)	30-JUN-16  SL15191-01 (150719893)	31-JUL-16  SL15223 (150820342)	31-AUG-16  SL15225 (150820343)	31-AUG-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1432-2016","Class II","Catalog Number:  900168  LABOR & DELIVERY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","15","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15244 (150820587)	30-JUN-16  SL15245 (150820587)	30-JUN-16  SL15251 (150719662)	30-JUN-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1449-2016","Class II","Catalog Number:  9002510  UROLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","90","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15201-02 (150719840)	31-JUL-16  SL15259 (150920293)	30-SEP-16  SL15259 (150920294)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1425-2016","Class II","Catalog Number:  9001460  REYITO PLUS UROLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","35","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15202 (150619550)	30-JUN-16  SL15202 (150619235)	30-JUN-16  SL15209 (150719642)	31-JUL-16  SL15209 (150619550)	30-JUN-16          ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1476-2016","Class II","Catalog Number:  900540  WOUND MANAGEMENT TRAY III  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","620","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15195-01 (150719852)	31-JUL-16  SL15195-02 (150719852)	31-JUL-16  SL15218 (150719852)	31-JUL-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1471-2016","Class II","Catalog Number:  900474  LAPAROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","120","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15169 (150619284)	30-APR-16  SL15173 (150619372)	30-JUN-16  SL15195-02 (150619554)	30-JUN-16  SL15195-02 (150719804)	30-APR-16  SL15264 (150820330)	31-AUG-16  SL15274 (150920828)	31-AUG-16  SL15275 (150920828)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1469-2016","Class II","Catalog Number:  900419  LABOR & DELIVERY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","44","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15180 (150619283)	30-JUN-16  SL15194 (150719803)	31-JUL-16  SL15243 (150820325)	31-AUG-16  SL15243 (150820324)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1441-2016","Class II","Catalog Number:  9002123  KNEE ARTHROSCOPY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","12","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:SL15177 (150619394)	30-JUN-16  SL15181 (150619394)	30-JUN-16  SL15203 (150719752)	31-JUL-16  SL15223 (150820261)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1399-2016","Class II","Catalog Number:  900012 OB SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","32","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," Catalog Number:  900012  LOTS:  SL15202 (150719606)	31-JUL-16  SL15210 (150720034)	31-JUL-16  SL15219 (150720056)	31-JUL-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1405-2016","Class II","Catalog Number:  900063 WOUND CLOSURE TRAY I  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","4550","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15169 (150317576)	28-FEB-16  SL15169 (150619102)	31-MAY-16  SL15169 (150518600)	31-MAY-16  SL15170 (150518600)	31-MAY-16  SL15173 (150619102)	31-MAY-16  SL15175 (150418229)	31-MAY-16  SL15199 (150719614)	31-MAY-16  SL15203 (150719614)	31-MAY-16  SL15225 (150719614)	31-MAY-16  SL15231 (150820140)	31-AUG-16  SL15243 (150820140)	31-AUG-16  SL15251 (150820140)	31-AUG-16  SL15272 (150920663)	30-SEP-16  SL15273 (150920663)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1398-2016","Class II","Catalog Number:  900010 SUTURE REMOVAL KIT  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","9000","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SV15168 (141015851)	31-OCT-15  SL15187 (150619088)	30-JUN-16  SL15187 (150719604)	31-JUL-16  SL15191-01 (150719604)	31-JUL-16  SL15261 (150920134)	30-SEP-16  SL15264 (150920725)	30-SEP-16  SL15264 (150920134)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1431-2016","Class II","Catalog Number:  900164  FEMORAL SURGICAL PACK    Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","55","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15177 (150619358)	30-JUN-16  SL15191-01 (150619359)	31-JUL-16  SL15211 (150719661)	31-JUL-16  SL15217 (150719661)	31-JUL-16  SL15245 (150720128)	31-AUG-16  SL15245 (150720127)	31-AUG-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1484-2016","Class II","Catalog Number:  900740A  ARTHROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","108","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15169 (150619188)	30-JUN-16  SL15174 (150619405)	30-JUN-16  SL15202 (150719809)	31-JUL-16  SL15208 (150719809)	31-JUL-16  SL15210 (150720043)	31-JUL-16  SL15222 (150720043)	31-JUL-16  SL15233 (150720042)	31-JUL-16  SL15251 (150720042)	31-JUL-16  SL15260 (150920709)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1454-2016","Class II","Catalog Number:  9002615  EXTREMITY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","136","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15181 (150619402)	30-JUN-16  SL15184 (150619402)	30-JUN-16  SL15184 (150619265)	30-JUN-16  SL15274 (150820300)	30-SEP-16  SL15275 (150820301)	30-SEP-16  SL15275 (150820300)	30-SEP-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1470-2016","Class II","Catalog Number:  900450  LAPAROTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","110","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15170 (150418502)	30-APR-16  SL15173 (150619371)	30-JUN-16  SL15180 (150619553)	30-JUN-16  SL15180 (150619552)	30-JUN-16  SL15184 (150619553)	30-JUN-16  SL15195-01 (150719884)	31-JUL-16  SL15195-02 (150719884)	31-JUL-16  SL15197 (150719884)	31-JUL-16  SL15265 (150920827)	30-SEP-16  SL15273 (150920592)	30-SEP-16  SL15274 (150920592)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1478-2016","Class II","Catalog Number:  900548A  PERY-GYN SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","150","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15176 (150619404)	30-JUN-16  SL15199 (150719806)	31-JUL-16  SL15203 (150719806)	31-JUL-16  SL15211 (150720041)	31-JUL-16  SL15259 (150920577)	31-AUG-16  SL15260 (150920577)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1429-2016","Class II","Catalog Number:  9001538  DRESSING CHANGE TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","550","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15169 (150619169)	31-MAY-16  SL15187 (150619170)	31-MAY-16  SL15201-01 (150719651)	31-MAY-16  SL15201-01 (150719650)	31-MAY-16  SL15233 (150820175)	31-AUG-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1426-2016","Class II","Catalog Number:  9001482  ENT SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","70","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15201-01 (150719645)	31-JUL-16  SL15222 (150719959)	30-JUN-16  SL15223 (150719959)	30-JUN-16          ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1459-2016","Class II","Catalog Number:  900278  URETHRAL CATHETER TRAY  14FR  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","2450","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SV15168 (150217396)	28-FEB-16  SL15201-02 (150719848)	31-JUL-16  SL15208 (150719848)	31-JUL-16  SL15229 (150820306)	31-AUG-16  SL15231 (150820306)	31-AUG-16  SL15265 (150920815)	31-AUG-16  SL15266 (150920815)	31-AUG-16  SL15267 (150920815)	31-AUG-16        ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1494-2016","Class II","Catalog Number:  900996  LAPAROTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","111","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15177 (150619484)	30-JUN-16  SL15181 (150619555)	30-JUN-16  SL15222 (150820359)	31-AUG-16  SL15271 (150920720)	30-SEP-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1400-2016","Class II","Catalog Number:  900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","4400","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15180 (150619409)	31-MAY-16  SL15181 (150619409)	31-MAY-16  SL15197 (150719607)	31-MAY-16  SL15201-01 (150719607)	31-MAY-16  SL15230 (150820136)	31-AUG-16  SL15251 (150820136)	31-AUG-16  SL15265 (150920652)	30-SEP-16  SL15266 (150920652)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1402-2016","Class II","Catalog Number:  900032 UNIVERSAL DRAINAGE TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","900","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15173 (150619057)	30-JUN-16  SL15174 (150619057)	30-JUN-16  SL15175 (150619057)	30-JUN-16  SL15209 (150719928)	31-JUL-16  SL15210 (150719928)	31-JUL-16  SL15216 (150719928)	31-JUL-16  SL15224 (150820057)	31-AUG-16  SL15229 (150820057)	31-AUG-16  SL15258 (150920726)	30-SEP-16  SL15259 (150920726)	30-SEP-16  SL15260 (150920726)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1424-2016","Class II","Catalog Number:  9001456  WOUND MANAGEMENT TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","200","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15197 (150719929)	30-APR-16  SL15201-01 (150719929)	30-APR-16  SL15218 (150719929)	30-APR-16  SL15266 (150920778)	31-MAY-16          ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1467-2016","Class II","Catalog Number:  900403  CESAREAN SECTION SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","48","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15176 (150619271)	30-JUN-16  SL15177 (150619271)	30-JUN-16  SL15181 (150619271)	30-JUN-16  SL15201-01 (150719797)	31-JUL-16  SL15217 (150720129)	31-JUL-16  SL15217 (150720130)	31-JUL-16  SL15219 (150720131)	31-JUL-16  SL15219 (150720130)	31-JUL-16  SL15223 (150720129)	31-JUL-16  SL15224 (150720131)	31-JUL-16  SL15268 (150920822)	30-SEP-16  SL15271 (150920822)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1409-2016","Class II","Catalog Number:  9001062 ARTHROSCOPY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","16","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15202 (150719822)	31-JUL-16  SL15203 (150719822)	31-JUL-16  SL15215 (150720063)	31-JUL-16  SL15216 (150720063)	31-JUL-16  SL15244 (150820583)	31-AUG-16  SL15246 (150820583)	31-AUG-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1458-2016","Class II","Catalog Number:  900277  SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","5650","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15175 (150518789)	30-APR-16  SL15177 (150518789)	30-APR-16  SL15180 (150619314)	30-APR-16  SL15183 (150619314)	30-APR-16  SL15232 (150820305)	31-MAY-16  SL15233 (150820305)	31-MAY-16  SL15233 (150719845)	31-MAY-16  SL15243 (150719845)	31-MAY-16  SL15268 (150920814)	31-MAY-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1475-2016","Class II","Catalog Number:  900522  SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","1148","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15174 (150518822)	31-MAY-16  SL15176 (150317997)	31-MAR-16  SV15168 (150418241)	30-APR-16  SV15168 (150117022)	31-MAR-16  SL15180 (150418241)	30-APR-16  SL15209 (150720052)	31-JUL-16  SL15210 (150720052)	31-JUL-16  SL15218 (150720052)	31-JUL-16  SL15219 (150720052)	31-JUL-16  SL15222 (150720052)	31-JUL-16  SL15246 (150820337)	31-AUG-16  SL15251 (150820337)	31-AUG-16  SL15252 (150820337)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1483-2016","Class II","Catalog Number:  900633  FAN FOLD SHEET 44 X 58  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","1920","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15203 (150719894)	31-JUL-16  SL15208 (150518835)	31-MAY-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1415-2016","Class II","Catalog Number:  9001198 WOUND MANAGE II   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","1020","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SV15168 (150518595)	31-MAY-16  SL15223 (150719827)	31-JUL-16  SL15224 (150719827)	31-JUL-16  SL15225 (150719827)	31-JUL-16  SL15245 (150820633)	31-AUG-16  SL15246 (150820633)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1452-2016","Class II","Catalog Number:  9002609  ARTHOSCOPY PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","18","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15202 (150719846)	31-JUL-16  SL15203 (150719846)	31-JUL-16  SL15229 (150820299)	31-AUG-16  SL15231 (150820299)	31-AUG-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1414-2016","Class II","Catalog Number:  9001154 WOUND MANAGEMENT TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","2088","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15195-01 (150719825)	31-JUL-16  SL15195-02 (150719825)	31-JUL-16  SL15197 (150719825)	31-JUL-16  SL15218 (150719825)	31-JUL-16  SL15232 (150820156)	31-AUG-16  SL15233 (150820156)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1430-2016","Class II"," CUFF  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","270","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15194 (150719656)	31-JUL-16  SL15223 (150820181)	31-AUG-16  SL15223 (150820180)	31-AUG-16  SL15223 (150820182)	31-AUG-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1445-2016","Class II","Catalog Number:  9002224  SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","280","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15177 (150519027)	30-JUN-16  SL15191-01 (150519026)	30-JUN-16  SL15211 (150719756)	31-JUL-16  SL15229 (150820266)	31-AUG-16  SL15258 (150920880)	30-SEP-16  SL15258 (150920802)	30-SEP-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1421-2016","Class II","Catalog Number:  9001300  NEURO-SPINE SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","81","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15202 (150619129)	30-JUN-16  SL15209 (150619381)	31-JUL-16  SL15215 (150619381)	31-JUL-16  SL15265 (150919830)	30-SEP-16  SL15265 (150920072)	30-SEP-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1456-2016","Class II","Catalog Number:  9002726  HIP AND KNEE REPLACEMENT SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","24","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15201-02 (150619403)	31-JUL-16  SL15201-02 (150619266)	31-JUL-16  SL15202 (150619403)	31-JUL-16  SL15208 (150619403)	31-JUL-16  SL15232 (150820302)	31-AUG-16  SL15243 (150820302)	31-AUG-16  SL15246 (150820303)	31-AUG-16  SL15251 (150820303)	31-AUG-16      ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1457-2016","Class II","Catalog Number:  9002766  SHOULDER PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","39","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15184 (150518788)	30-JUN-16  SL15210 (150719844)	31-JUL-16  SL15212 (150719844)	31-JUL-16  SL15243 (150820304)	31-AUG-16  SL15244 (150820304)	31-AUG-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1440-2016","Class II","Catalog Number:  9001966  LIVER & PANCREAS SURGERY   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","20","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15195-01 (150619229)	31-JUL-16  SL15210 (150619392)	31-JUL-16  SL15211 (150619392)	31-JUL-16  SL15223 (150719733)	31-AUG-16  SL15224 (150719733)	31-AUG-16  SL15275 (150920795)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1473-2016","Class II","Catalog Number:  900486  LAPAROSCOPY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","60","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15203 (150719886)	31-JUL-16  SL15243 (150820332)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1461-2016","Class II","Catalog Number:  9002829  BASIC  SURG PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","152","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15187 (150719782)	31-JUL-16  SL15191-01 (150719783)	31-JUL-16  SL15244 (150820308)	31-AUG-16  SL15264 (150820309)	30-SEP-16  SL15273 (150820307)	30-SEP-16  SL15274 (150820307)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1436-2016","Class II","Catalog Number:  9001765  MINOR LACERATION TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","3700","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15199 (150719930)	31-JUL-16  SL15203 (150719930)	31-JUL-16  SL15232 (150820226)	31-AUG-16  SL15268 (150920789)	30-SEP-16  SL15243 (150820226)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1465-2016","Class II","Catalog Number:  9003190  SURG GOWN SMS AMMI IV FULL  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","96","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15195-02 (150619269)	31-JUL-16  SL15251 (150820570)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1403-2016","Class II","Catalog Number:  900036 LAPAROTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","132","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15170 (150418257)	30-APR-16  SL15170 (150418258)	30-APR-16  SL15181 (150619549)	30-JUN-16  SL15181 (150619548)	30-JUN-16  SL15199 (150719611)	31-JUL-16  SL15215 (150719612)	31-JUL-16  SL15216 (150719612)	31-JUL-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1418-2016","Class II","Catalog Number:  9001296  PREMIUM LAPAROTOMY PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","258","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15197 (150719633)	31-JUL-16  SL15201-01 (150719633)31-JUL-16  SL15201-02 (150719632)31-JUL-16  SL15203 (150719632)	31-JUL-16  SL15240 (150720068)	31-AUG-16  SL15240 (150820069)	31-AUG-16  SL15243 (150820069)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1447-2016","Class II","Catalog Number:  9002259A  LAPAROSCOPY-COLORECTAL SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","84","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15173 (150418356)	31-MAY-16  SL15195-01 (150619256)	30-JUN-16  SL15199 (150619256)	30-JUN-16  SL15208 (150719758)	31-JUL-16  SL15212 (150719758)	31-JUL-16  SL15224 (150719758)	31-JUL-16  SL15243 (150820288)	31-AUG-16  SL15260 (150920289)	30-SEP-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1474-2016","Class II","Catalog Number:  900521  SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","5712","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SV15168 (150418240)	30-APR-16  SL15209 (150719850)	31-JUL-16  SL15218 (150719850)	31-JUL-16  SL15229 (150719850)	31-JUL-16  SL15244 (150820336)	31-AUG-16  SL15251 (150719850)	31-JUL-16  SL15252 (150719850)	31-JUL-16  SL15254 (150719850)	31-JUL-16  SL15254 (150820336)	31-AUG-16  SL15257 (150820336)	31-AUG-16  SL15258 (150820336)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1420-2016","Class II","Catalog Number:  9001298  PREMIUM ARTHROSCOPY PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","85","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15195-02 (150719829)	31-JUL-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1428-2016","Class II","Catalog Number:  9001521  UROLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","24","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15173 (150619387)	30-JUN-16  SL15174 (150619387)	30-JUN-16  SL15194 (150719649)	31-JUL-16  SL15211 (150720078)	31-JUL-16  SL15211 (150720079)	31-JUL-16  SL15273 (150920693)	30-SEP-16  SL15275 (150920693)	30-SEP-16        ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1486-2016","Class II","Catalog Number:  900742A  CARPAL TUNEL LARGE SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","162","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15174 (150619190)	30-JUN-16  SL15181 (150619407)	30-JUN-16  SL15191-01 (150619407)	30-JUN-16  SL15197 (150719811)	31-JUL-16  SL15201-01 (150719811)	31-JUL-16  SL15254 (150820367)	30-SEP-16  SL15265 (150920712)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1488-2016","Class II","Catalog Number:  900782  SKIN STAPLE REMOVER STERILE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","580","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15191-01 (150719819)	31-JUL-16  SL15264 (150719819)	31-JUL-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1411-2016","Class II","Catalog Number:  900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","2800","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15170 (150619116)	30-JUN-16  SL15175 (150619116)	30-JUN-16  SV15168 (150518601)	30-JUN-16  SV15168 (150318049)	30-JUN-16  SL15199 (150719623)	31-JUL-16  SL15224 (150719623)	31-JUL-16  SL15225 (150820150)	31-AUG-16  SL15264 (150920928)	30-SEP-16  SL15264 (150920679)	30-SEP-16  SL15268 (150920928)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1442-2016","Class II","Catalog Number:  9002164  FEMORAL SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","24","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15169 (150619249)	30-JUN-16  SL15174 (150619249)	30-JUN-16  SL15184 (150619395)	30-JUN-16  SL15210 (150719753)	31-JUL-16  SL15210 (150619395)	30-JUN-16  SL15273 (150920799)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1451-2016","Class II","Catalog Number:  9002516  LAPAROTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","76","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15203 (150719261)	31-JUL-16  SL15203 (150719842)	31-JUL-16  SL15211 (150719261)	31-JUL-16  SL15211 (150719842)	31-JUL-16  SL15244 (150820297)	31-AUG-16  SL15245 (150820297)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1496-2016","Class II","Catalog Number:  900998  CESAREAN SECTION SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","32","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15208 (150719996)	31-JUL-16  SL15222 (150820360)	31-AUG-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1490-2016","Class II","Catalog Number:  900921A  C-SECTION SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","238","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15175 (150619191)	30-JUN-16  SL15177 (150619191)	30-JUN-16  SL15197 (150719813)	31-JUL-16  SL15199 (150719813)	31-JUL-16  SL15222 (150820354)	31-AUG-16  SL15222 (150820353)	31-AUG-16  SL15224 (150820353)	31-AUG-16  SL15225 (150820354)	31-AUG-16  SL15261 (150920717)	30-SEP-16  SL15261 (150920716)	30-SEP-16  SL15264 (150920716)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1489-2016","Class II","Catalog Number:  900796  FEMORAL ANGIOGRAPHY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","16","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15173 (150418424)	30-JUN-16  SL15175 (150619376)	30-JUN-16  SL15176 (150619376)	30-JUN-16  SL15202 (150619296)	31-JUL-16  SL15202 (150619470)	31-JUL-16  SL15203 (150719296)	31-JUL-16  SL15208 (150719812)	31-JUL-16  SL15211 (150719812)	31-JUL-16  SL15216 (150719812)	31-JUL-16  SL15266 (150920349)	30-SEP-16  SL15267 (150920350)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1443-2016","Class II","Catalog Number:  9002167  LITHOTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","150","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15177 (150619250)	30-JUN-16  SL15180 (150619397)	30-JUN-16  SL15180 (150619396)	30-JUN-16  SL15180 (150619250)	30-JUN-16  SL15202 (150719754)	31-JUL-16  SL15225 (150820263)	31-AUG-16  SL15225 (150820262)	31-AUG-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1493-2016","Class II","Catalog Number:  900982  ARTHROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","25","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15170 (150518850)	30-JUN-16  SL15210 (150720045)	31-JUL-16  SL15210 (150720044)	31-JUL-16    ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1472-2016","Class II","Catalog Number:  900484  LAPAROSCOPIC GYNECOLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","30","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15203 (150719885)	31-JUL-16  SL15271 (150920829)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1416-2016","Class II","Catalog Number:  9001202 LAMINECTOMY PK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","42","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15208 (150719625)	31-JUL-16  SL15209 (150719625)	31-JUL-16  SL15217 (150720066)	31-JUL-16  SL15267 (150920686)	30-SEP-16  SL15271 (150920686)	30-SEP-16  SL15272 (150920686)	30-SEP-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72992,"Ongoing","Customed, Inc","Calle Igualdad Final #7",,"Fajardo","PR","00738","United States","Voluntary: Firm Initiated","Letter","Distributed only in Puerto Rico.","Z-1495-2016","Class II","Catalog Number:  900997  PERI-GYN SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.  ","30","Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.","04/14/2016",," LOTS:  SL15210 (150720046)	31-JUL-16  SL15210 (150719995)	31-JUL-16  SL15217 (150720047)	31-JUL-16  SL15244 (150720047)	31-JUL-16  ",1/7/2016,"01/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72993,"Ongoing","Giant Eagle, Inc.","101 Kappa Dr",,"Pittsburgh","PA","15238-2809","United States","Voluntary: Firm Initiated","E-Mail","PA, OH, IN","F-0616-2016","Class I","Baked, W/WO Icing Soft Pretzel in rigid plastic labeled as:  New Year's Pretzel  Sell By: 01/04/2016    PLU: 39739  UPC: 23979 80499","est. 23,000 units","Product contained undeclared walnuts","02/17/2016",," Sell By: 01/04/2016",1/2/2016,"01/02/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72996,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0668-2016","Class I","Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-6729-24.","213,600 bags","Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.","02/16/2016",," Lot: 53-113-JT, Exp 1NOV2016",1/5/2016,"01/05/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72997,"Ongoing","Rymed Technologies, LLC","6000 W William Cannon Dr Ste B300",".","Austin","TX","78749-1991","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0676-2016","Class II","InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001.  Disposable, Single Use.     Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.","46,600 units","Potential for the female luer component of the InVision-Plus IV connector to crack during use.","01/21/2016",," Catalog number RYM-7001 Lots: R01842, R01889, R01891, and R01897, Expire 03/2016. ",1/5/2016,"01/05/2016",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",72997,"Ongoing","Rymed Technologies, LLC","6000 W William Cannon Dr Ste B300",".","Austin","TX","78749-1991","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0675-2016","Class II","InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use    Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.","496,400 units","Potential for the female luer component of the InVision-Plus IV connector to crack during use.","01/21/2016",," InVision-Plus Catalog number RYM-5000 Lots 610, 611, 613, 614; Catalog number RYM-5001 Lots R01777, R01789, R01807, R01817, R01822, R01827, R01839, R01848, R01857, R01860, R01871, and R01874; Catalog number RYM-5001CL Lots R01825, R01887, and R01890.  InVision Plus Junior Catalog number RYM-8001 Lot R01853.",1/5/2016,"01/05/2016",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72998,"Ongoing","FreshPoint Corporate","711 North Orlando Avenue","Suite 201","Maitland","FL","32751","United States","Voluntary: Firm Initiated","E-Mail","Florida and Georgia","F-0569-2016","Class I","Whole cucumbers ","1507 cases","Possible contamination of Salmonella","02/09/2016",," 15355, 15356, 15357",12/31/2015,"12/31/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",72998,"Ongoing","FreshPoint Corporate","711 North Orlando Avenue","Suite 201","Maitland","FL","32751","United States","Voluntary: Firm Initiated","E-Mail","Florida and Georgia","F-0570-2016","Class I","Sliced cucumbers ",,"Possible contamination of Salmonella","02/09/2016",," 7415/356, 7415/357, 7415/358",12/31/2015,"12/31/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",72999,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-0773-2016","Class III","NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL","576 bottles","Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.","03/11/2016",," Lot #: 05N533, Exp 11/16",11/19/2015,"11/19/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73000,"Terminated","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of  AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA and HI, and the countries of Germany, Hong Kong, Chile, Israel, Poland, Italy, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, Netherlands, France, Japan, Sweden, Switzerland, Austria, China, India, Thailand, Russia, New Zealand, Zaire, Australia, Taiwan, and Malaysia.","Z-0747-2016","Class II","Synthes Small Electric Drive (SED).  For use in general traumatology.","599 each","The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.","02/03/2016","02/05/2016"," All Lots",8/14/2014,"08/14/2014",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73001,"Ongoing","Thomas Produce Co.","9905 Clint Moore Rd",,"Boca Raton","FL","33496-1016","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to firms in Florida and Georgia","F-1085-2016","Class I","Cucumbers packed in 1 1/9 cardboard bushel boxes (~55-lb) and 1000-lb cardboard bins.  Refrigerate at 40-60 degF. Pick date of 12/15/2015.","166 boxes, 8 bins","Cucumbers contaminated with Salmonella","04/15/2016",," Box Lots: 1554311HDNK, 1554311JDNK, 15143115DNK.    Bin Lots: 15NKJD-1554311-D, 15NKHD-1554311-D, 15NK5D-1514311-D",12/31/2015,"12/31/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73003,"Terminated","American National Red Cross Great Lakes Region","1800 E Grand River Ave",".","Lansing","MI","48912-2305","United States","Voluntary: Firm Initiated","Telephone","Ohio; Michigan","B-0243-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","3 units","Apheresis Leukoreduced products, with an elevated WBC count, were distributed.","01/20/2016","01/20/2016"," W201815816599; W201815816609 (double)",11/12/2015,"11/12/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73005,"Terminated","DCI Donor Services Tissue Services Division","1714 Hayes St",,"Nashville","TN","37203-3013","United States","Voluntary: Firm Initiated","Visit","Nationwide","B-0240-16","Class II","Amniotic membrane","145 amniotic membrane allografts","Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.","01/14/2016","01/14/2016"," 031123702; 031123703; 031123704; 031123705; 031123706; 031123707; 031123708; 031123709; 031123710; 031123711; 031123712; 031123713; 031123714; 031123715; 031123716; 031123717; 031123718; 031123719; 031123720; 031123721; 031123722; 031123723; 031123724; 031123725; 031123726; 031123727; 031123728; 031123729; 031123730; 031123731; 031123732; 031123733; 031123735; 031123736; 031123737; 031123738; 031123739; 031123740; 031123741; 031123742; 031123743; 031092407; 031092408; 031092409; 031092410; 031092411; 031092412; 031092420; 031092421; 031092422; 031092423; 031092424; 031092413; 031092446; 031092447; 031092448; 031092414; 031092415; 031092416; 031092417; 031092418; 031092425; 031092426; 031092427; 031092428; 031092429; 031092430; 031092431;031105565, 031105566, 031105567, 031105568, 031105569, 031105570, 031105571, 031105572, 031105573, 031105574, 031105575, 031105576, 031105577, 031105578, 031105579, 031105580, 031105581, 031105582, 031105583, 031105584, 031105585, 031105586, 031105587, 031105588, 031105589, 031105590, 031109009, 031109010, 031109011, 031109012, 031109013, 031109014, 031109016, 031109017, 031109018, 031109019, 031109020, 031109021, 031109022, 031109023, 031109024, 031109025, 031109026, 031109027, 031109028, 031109029, 031109030 031092432; 031092433; 031092434; 031092435; 031092436; 031092437; 031092438; 031092439; 031092441; 031092442; 031092443; 031092444; 031092445; 031092449; 031092450; 031105551; 031105552; 031105553; 031105554; 031105555; 031105556; 031105557; 031105558; 031105559; 031105560; 031092419; 031105561; 031105562; 031105563; 031105564; ",12/14/2015,"12/14/2015",1/20/2016,"01/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73006,"Terminated","HCSC-Blood Center","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","Telephone","PA, NJ","B-0258-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","3 units","Blood products, which did not meet acceptable product specifications, were distributed.","02/04/2016","02/04/2016"," W050915058626; W050915053498; W050915053408",10/13/2015,"10/13/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73006,"Terminated","HCSC-Blood Center","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","Telephone","PA, NJ","B-0259-16","Class II","Apheresis Platelets, Leukocytes Reduced","18 units","Blood products, which did not meet acceptable product specifications, were distributed.","02/04/2016","02/04/2016"," W050915058630; W050915058630; W050915058939; W050915058939; W050915058938; W050915058938; W050915053497; W050915053497; W050915056257; W050915058947; W050915058944; W050915058944; W050915056265; W050915056265; W050915053408; W050915053412; W050915056240; W050915056240",10/13/2015,"10/13/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73007,"Terminated","JosNoe Medical, Inc.","1303 S Main St",,"Chelsea","MI","48118-1483","United States","Voluntary: Firm Initiated","E-Mail","Distributed US (nationwide) and in Canada.","Z-0732-2016","Class II","PS-500 Scope Warmer; 10 units per box.    Pre-heating scope for laparoscopy surgery.","1008 boxes","Damage to package seals potentially compromising sterility.","01/30/2016","03/22/2016"," Lot# G154341  Exp: 4/14/18",12/1/2015,"12/01/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73008,"Ongoing","Becton Dickinson & Company","1 Becton Dr",,"Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","US Distribution to:California and Utah.","Z-1076-2016","Class II","BD Intelliport Medication Management System Sensor    The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications.","250 units","The sterility of the product cannot be assured. This may result in increased risk of infection. ","03/08/2016",," Catalog (Ref) # 516700 Lot numbers 5222723, 5251583 and 5253723.",12/9/2015,"12/09/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73009,"Ongoing","Steris Corporation","5960 Heisley Rd",,"Mentor","OH","44060-1834","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and United Kingdom.","Z-1180-2016","Class II","Quick Connects. Steris Corporation.  Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.","809 units","The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions.","03/16/2016",," All Lots. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT.",12/4/2015,"12/04/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73010,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and in DC and PR and in the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Cayman Islands, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestinian, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.","Z-1022-2016","Class II","BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.","427 units","The firm discovered four issues with the BrightView Family systems.    Issue 1:   During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet.  If this occurs, collision sensors would pause the scan.    Issue 2:  During a scan, the gantry motion may halt prematurely.  This cause","02/26/2016",," Model #: 882482; Serial #'s: 6000016, 6000111, 6000114, 6000122, 6000002, 6000003, 6000004, 6000005, 6000006, 6000010, 6000011, 6000012, 6000013, 6000015, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000032, 6000033, 6000035, 6000036, 6000037, 6000038, 6000040, 6000041, 6000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000057, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000068, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000075, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 6000106, 6000107, 6000108, 6000109, 6000110, 6000112, 6000113, 6000115, 6000116, 6000117, 6000118, 6000119, 6000120, 6000121, 6000123, 6000125, 6000126, 6000127, 6000128, 6000129, 6000130, 6000131, 6000132, 6000133, 6000134, 6000135, 6000136, 6000138, 6000139, 6000140, 6000141, 6000142, 6000143, 6000144, 6000145, 6000146, 6000147, 6000148, 6000149, 6000150, 6000151, 6000152, 6000153, 6000154, 6000155, 6000156, 6000157, 6000158, 6000159, 6000160, 6000161, 6000162, 6000164, 6000165, 6000166, 6000167, 6000168, 6000169, 6000170, 6000171, 6000172, 6000173, 6000174, 6000175, 6000176, 6000177, 6000178, 6000179, 6000180, 6000181, 6000182, 6000183, 6000184, 6000185, 6000186, 6000187, 6000188, 6000189, 6000190, 6000191, 6000192, 6000193, 6000194, 6000195, 6000196, 6000197, 6000198, 6000199, 6000200, 6000201, 6000202, 6000203, 6000204, 6000205, 6000206, 6000207, 6000208, 6000209, 6000210, 6000211, 6000212, 6000213, 6000214, 6000215, 6000216, 6000217, 6000218, 6000219, 6000220, 6000221, 6000222, 6000223, 6000224, 6000225, 6000226, 6000227, 6000228, 6000229, 6000230, 6000231, 6000232, 6000233, 6000234, 6000235, 6000236, 6000237,",12/17/2015,"12/17/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73010,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and in DC and PR and in the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Cayman Islands, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestinian, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.","Z-1020-2016","Class II","BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.","677 units","The firm discovered four issues with the BrightView Family systems.    Issue 1:   During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet.  If this occurs, collision sensors would pause the scan.    Issue 2:  During a scan, the gantry motion may halt prematurely.  This cause","02/26/2016",," Model # 882480; Serial #'s: 4000002, 4000002.75, 4000003, 4000004, 4000006, 4000007, 4000008, 4000009, 4000010, 4000011, 4000013, 4000030, 4000031, 4000032, 4000033, 4000034, 4000035, 4000036, 4000037, 4000038, 4000039, 4000040, 4000041, 4000043, 4000044, 4000045, 4000046, 4000047, 4000048, 4000049, 4000050, 4000051, 4000052, 4000053, 4000054, 4000055, 4000056, 4000057, 4000058, 4000059, 4000060, 4000061, 4000062, 4000064, 4000065, 4000066, 4000068, 4000070, 4000071, 4000072, 4000073, 4000074, 4000075, 4000076, 4000077, 4000078, 4000079, 4000080, 4000081, 4000082, 4000083, 4000086, 4000087, 4000088, 4000089, 4000090, 4000091, 4000093, 4000094, 4000095, 4000096, 4000099, 4000100, 4000102, 4000103, 4000104, 4000105, 4000106, 4000107, 4000108, 4000109, 4000110, 4000111, 4000112, 4000113, 4000114, 4000115, 4000116, 4000117, 4000118, 4000119, 4000120, 4000121, 4000122, 4000123, 4000124, 4000125, 4000126, 4000127, 4000128, 4000129, 4000130, 4000132, 4000133, 4000134, 4000135, 4000136, 4000137, 4000138, 4000139, 4000140, 4000141, 4000142, 4000143, 4000144, 4000145, 4000146, 4000148, 4000149, 4000151, 4000152, 4000153, 4000154, 4000155, 4000156, 4000157, 4000158, 4000159, 4000160, 4000161, 4000162, 4000163, 4000164, 4000165, 4000166, 4000167, 4000168, 4000169, 4000170, 4000171, 4000173, 4000174, 4000175, 4000176, 4000177, 4000178, 4000179, 4000180, 4000181, 4000182, 4000183, 4000184, 4000185, 4000186, 4000187, 4000188, 4000189, 4000190, 4000191, 4000192, 4000193, 4000194, 4000196, 4000197, 4000198, 4000199, 4000200, 4000202, 4000203, 4000204, 4000205, 4000206, 4000207, 4000208, 4000209, 4000211, 4000212, 4000214, 4000215, 4000216, 4000218, 4000219, 4000220, 4000221, 4000222, 4000223, 4000224, 4000225, 4000226, 4000227, 4000228, 4000229, 4000230, 4000231, 4000232, 4000233, 4000234, 4000235, 4000236, 4000237, 4000238, 4000239, 4000240, 4000241, 4000242, 4000243, 4000244, 4000245, 4000246, 4000247, 4000248, 4000249, 4000250, 4000251, 4000253, 4000254, 4000255, 4000256, 4000257, 4000258, 4000259, 4000260, 4000261, 400026",12/17/2015,"12/17/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73010,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and in DC and PR and in the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Cayman Islands, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestinian, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.","Z-1021-2016","Class II","BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.","117 units","The firm discovered four issues with the BrightView Family systems.    Issue 1:   During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet.  If this occurs, collision sensors would pause the scan.    Issue 2:  During a scan, the gantry motion may halt prematurely.  This cause","02/26/2016",," Model #: 882478; Serial #'s: 11000003, 11000008, 11000030, 11000004, 11000005, 11000006, 11000007, 11000009, 11000010, 11000011, 11000012, 11000013, 11000014, 11000016, 11000017, 11000018, 11000019, 11000020, 11000022, 11000023, 11000024, 11000025, 11000026, 11000027, 11000028, 11000029, 11000031, 11000032, 11000033, 11000034, 11000035, 11000036, 11000037, 11000038, 11000039, 11000040, 11000041, 11000042, 11000043, 11000044, 11000045, 11000046, 11000047, 11000048, 11000049, 11000050, 11000051, 11000052, 11000054, 11000055, 11000056, 11000057, 11000058, 11000059, 11000060, 11000061, 11000062, 11000063, 11000064, 11000065, 11000066, 11000067, 11000068, 11000069, 11000070, 11000071, 11000072, 11000073, 11000074, 11000075, 11000076, 11000077, 11000078, 11000079, 11000080, 11000081, 11000083, 11000084, 11000085, 11000086, 11000087, 11000088, 11000089, 11000090, 11000091, 11000092, 11000093, 11000094, 11000095, 11000096, 11000097, 11000098, 11000099, 11000100, 11000101, 11000102, 11000103, 11000104, 11000105, 11000106, 11000107, 11000108, 11000109, 11000110, 11000112, 11000113, 11000114, 11000115, 11000116, 11000117, 11000118, 11340001, 11340002, 11340003, 11340004, 11340005 & 11000015.",12/17/2015,"12/17/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73011,"Terminated","Cape Cod Provisions LLC","31 Jonathan Bourne Dr Ste 1",,"Pocasset","MA","02559-4919","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: AL CA CT FL IL MA MI MS MT NJ NY OH OK ON PA SC TX VA VT WA WI  OUS: Canada and Bermuda","F-0597-2016","Class I"," UPC 6 12681 44259 0.","5,760 units","Product may contain undeclared almonds","02/17/2016","05/25/2016"," Lot # of 5230-1 on the inside bag.",1/6/2016,"01/06/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73012,"Ongoing","Therakos Inc","10 N High St",".","West Chester","PA","19380-3003","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AZ, CA, CO, DC, FL, ID, IL, IN, MA, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, UT, VT, AND WI.","Z-1322-2016","Class II","The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA.    Manufacturing lot D342  UDI: 20705030200003  The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿ (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis","729 units","The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of Kits from Lot D 342.","04/05/2016",," Mfr lot #D342",12/21/2015,"12/21/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0784-2016","Class II","IMPLANT,TM, MTX FULL  3.7 mm x 16 mm  diameter 3.5 mm  Catalog #TMTB16    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63192173",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0775-2016","Class II","IMPLANT,TM, MTX  3.7 mm x 10 mm  diameter 3.5 mm  Catalog #TMMB10    Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.","1050","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63193919  63212189",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0781-2016","Class II","IMPLANT,TM, MTX FULL  3.7 mm x 10 mm  diameter 3.5 mm  Catalog #TMTB10    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63193918  63223934",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0779-2016","Class II","IMPLANT,TM, MTX FULL  4.1 mm x 11.5 mm  diameter 3.5 mm  Catalog #TMT4B11    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63192990  63203112  63236810",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0783-2016","Class II","IMPLANT,TM, MTX FULL  3.7 mm x 13 mm  diameter 3.5 mm  Catalog #TMTB13    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63193921  63236806",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0772-2016","Class II","IMPLANT,TM, MTX  4.1 mm x 10 mm  diameter 3.5 mm  Catalog #TMM4B10    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63192993  63216163",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0774-2016","Class II","IMPLANT,TM, MTX  4.1 mm x 13 mm  diameter 3.5 mm  Catalog #TMM4B13    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1050","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63203121  63207952  63216164",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0776-2016","Class II","IMPLANT,TM, MTX  3.7 mm x 11.5 mm  diameter 3.5 mm  Catalog #TMMB11    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63212190",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0777-2016","Class II","IMPLANT,TM, MTX  3.7 mm x 13 mm  diameter 3.5 mm  Catalog #TMMB13    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63216838",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0773-2016","Class II","IMPLANT,TM, MTX  4.1 mm x 11.5 mm  diameter 3.5 mm  Catalog #TMM4B11    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63192991  63207953",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0782-2016","Class II","IMPLANT,TM, MTX FULL  3.7 mm x 11.5 mm  diameter 3.5 mm  Catalog #TMTB11    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63193920  63244217",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0780-2016","Class II","IMPLANT,TM, MTX FULL  4.1 mm x 13 mm  diameter 3.5 mm  Catalog #TMT4B13    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63203119  63207951  63232552",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73013,"Ongoing","Zimmer Dental Inc","1900 Aston Ave",,"Carlsbad","CA","92008-7308","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy","Z-0778-2016","Class II","IMPLANT,TM, MTX FULL  4.1 mm x 10 mm  diameter 3.5 mm  Catalog #TMT4B10    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.  ","1059","Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.","02/08/2016",," Lot #  63187148  63192992  63212188  63216161",1/6/2016,"01/06/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73014,"Ongoing","Verathon, Inc.","20001 N Creek Pkwy",,"Bothell","WA","98011-8218","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, U.A.E., and United Kingdom.","Z-1035-2016","Class I","GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor.     The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording.    Affected Product Names and Part Numbers:    -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10)  -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10)  -MAC   S3: 0574-0132 (single blade) or 0270-0771 (box of 10)  -MAC   S4: 0574-0133 (single blade) or 0270-0772 (box of 10)    The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.","7733 units (6377 units in the US and 1356 units International)"," appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.","03/10/2016",," LOT Number ranges:    -LoPro S3: 081814 - 093015;  -LoPro S4: 081114 - 090315;  -MAC   S3: 080814 - 101315;  -MAC   S4: 022514 - 082115;",1/29/2016,"01/29/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73015,"Terminated","Blood Systems, Inc","3231 11th St S",,"Fargo","ND","58104-6238","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0260-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. ","02/18/2016","02/18/2016"," W0423150153377",12/3/2015,"12/03/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73016,"Ongoing","Nuway Distributors, LLC","9020 Pecky Cypress Way",,"Orlando","FL","32836-6562","United States","Voluntary: Firm Initiated","Other","All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.","D-0667-2016","Class I","APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL  USA; UPC 7 05105 96361 7.","100,000 blister cards","Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.","02/16/2016",," All lots",12/23/2015,"12/23/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73017,"Ongoing","Macleods Pharma Usa Inc","666 Plainsboro Rd","Bldg 200  Ste 230","Plainsboro","NJ","08536-3030","United States","Voluntary: Firm Initiated","Letter","US Nationwide.","D-0653-2016","Class II","Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10. ",,"Presence of Foreign Tablets/Capsules:  Presence of a comingled Carbimazole 5 mg tablet.","02/05/2016",," Lot #: BPA512A; Expiry: 06/2017.",12/24/2015,"12/24/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0902-2016","Class I","Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0894-2016","Class I","Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0891-2016","Class I","Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0901-2016","Class I","Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0887-2016","Class I","Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0893-2016","Class I","African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0889-2016","Class I","African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0906-2016","Class I","Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0904-2016","Class I","Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0903-2016","Class I","Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0897-2016","Class I","Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0899-2016","Class I","Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0892-2016","Class I","Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0896-2016","Class I","Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0905-2016","Class I","Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0890-2016","Class I","Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0898-2016","Class I","Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0907-2016","Class I","Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0888-2016","Class I","Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0900-2016","Class I","Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0885-2016","Class I","Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0886-2016","Class I","Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0884-2016","Class I","Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73018,"Ongoing","R Thomas Marketing, LLC","3704 White Plains Rd",,"Bronx","NY","10467-5710","United States","Voluntary: Firm Initiated","Press Release","Nationwide via Internet sales","D-0895-2016","Class I","Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467","unknown","Marketed Without An Approved NDA/ANDA ","05/26/2016",," all lots",1/9/2016,"01/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73019,"Ongoing","Madison One Acme Inc","215 W Ann St",,"Los Angeles","CA","90012-1812","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, CO, AZ, WA, OH, NC, AL, NJ, CT, IL, HI, NY, TX, OR, FL, GA, NM, VA, MD, LA, MA, MI, ME, MN, PA, NC, AK, KS    Foreign distribution to the following: CA","F-0526-2016","Class II","Tong Ren Tang  Shenjing Shuairuo Wan  Herbal Supplement  240 pills    UPC Code: 6 904579 129602    Distributed by: Solstice Medicine Company","12500","Madison One Acme, Inc. dba Solstice Medicine is recalling Tong Ren Tang Shenjing Shuairuo Wan because it contains the unapproved dietary ingredient human placenta which may transmit disease. ","01/29/2016",," SMC Code: TRT10  Lot #2080130",1/7/2016,"01/07/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73020,"Ongoing","SHAKTI GROUP USA LLC","14 van Dyke Ave",,"New Brunswick","NJ","08901-3253","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NH, NJ, PA, OH & VA","F-1121-2016","Class I",,"approximately 10000 bottles","L.G. compounded Asafoetida powder has the potential to be contaminated with Salmonella.","04/20/2016",," Lot 2323",1/7/2016,"01/07/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73021,"Ongoing","Virbac AH, Inc","3200 Meacham Blvd",,"Fort Worth","TX","76137-4611","United States","Voluntary: Firm Initiated","Letter","Product was distributed to MO.  There was no foreign, military, or government distribution.","V-454-2016","Class II","Thyrosyn 0.5 mg (Levothyroxine Sodium) Tablets packaged 1000 tablets per bottle, NDC 50989-275-53, UPC 3 50989 27553 2.  The responsible firm name on the label is Vedco Inc., St. Joseph, MO 64507.","876 bottles","Product bears the incorrect expiration date and is also past expiry.","07/21/2016",," lot# 140112, expiration date 12/2016",1/6/2016,"01/06/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73022,"Terminated","Bard Peripheral Vascular Inc","1625 W 3rd St",,"Tempe","AZ","85281-2438","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of AL, TX, and CA.","Z-0786-2016","Class II","Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm.  Intended for bypass or reconstruction of peripheral arterial blood vessels.","4 units","Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.","02/09/2016","03/25/2016"," Product Code: DF8006SC  Lot Number: VTZE1783",1/5/2016,"01/05/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73022,"Terminated","Bard Peripheral Vascular Inc","1625 W 3rd St",,"Tempe","AZ","85281-2438","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of AL, TX, and CA.","Z-0785-2016","Class II","Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm.  Intended for bypass or reconstruction of peripheral arterial blood vessels.","4 units","Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.","02/09/2016","03/25/2016"," Product Code: DF6006SC  Lot Number: VTZE1782    ",1/5/2016,"01/05/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73023,"Ongoing","Philips Medical Systems","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US: Nationwide Distribution in the states of FL, OH, and MO.","Z-0745-2016","Class II","DS/US Proton Feature with Pinnacle3  Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621","3","In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation. ","02/02/2016",," Software Version 10.0.0 and 14.0.0 ",1/8/2016,"01/08/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0966-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549520  (XMD P/N 70-0050-824)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","38","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549520  (XMD P/N 70-0050-824)    Lot Number:  930828",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0941-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548380  (XMD P/N 70-0050-514)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","205","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548380  (XMD P/N 70-0050-514)    Lot Number:  911109  915409  915909  920609  928910  930840",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0933-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548250  (XMD P/N 70-0050-412)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","38","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548250  (XMD P/N 70-0050-412)    Lot Number:  929601",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1015-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549460  (XMD P/N 70-0050-G22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","32","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549460  (XMD P/N 70-0050-G22)    Lot Number:  930152",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0989-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548610  (XMD P/N 70-0050-C16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548610  (XMD P/N 70-0050-C16)    Lot Number:  929703",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0914-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548220  (XMD P/N 70-0050-112)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","260","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548220  (XMD P/N 70-0050-112)    Lot Numbers:  911102  915402  915902  919001  920602  928902  930823",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0946-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M005489490  (XMD P/N 70-0050-524)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","34","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M005489490  (XMD P/N 70-0050-524)    Lot Number:  930155",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0932-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549470  (XMD P/N 70-0050-324)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","37","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549470  (XMD P/N 70-0050-324)    Lot Number:  930153",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0958-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548880  (XMD P/N 70-0050-720)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","37","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548880  (XMD P/N 70-0050-720)    Lot Number:  930129",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1006-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548640  (XMD P/N 70-0050-F16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","31","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548640  (XMD P/N 70-0050-F16)    Lot Number:  929706",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0921-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548350  (XMD P/N 70-0050-214)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","326","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548350  (XMD P/N 70-0050-214)    Lot Numbers:  911106  915906  919003  920606  928907  930837",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0943-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548700  (XMD P/N 70-0050-518)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","80","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548700  (XMD P/N 70-0050-518)    Lot Number:  928921  929711",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0926-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548240  (XMD P/N 70-0050-312)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","235","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548240  (XMD P/N 70-0050-312)    Lot Number:  911104  915404  915904  920604  928904  930821",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1005-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548480  (XMD P/N 70-0050-F14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548480  (XMD P/N 70-0050-F14)    Lot Number:  929616",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1001-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548790  (XMD P/N 70-0050-E18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548790  (XMD P/N 70-0050-E18)    Lot Number:  929721",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1008-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548960  (XMD P/N 70-0050-F20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548960  (XMD P/N 70-0050-F20)    Lot Number:  930136",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0951-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548870  (XMD P/N 70-0050-620)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","37","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548870  (XMD P/N 70-0050-620)    Lot Number:  929729",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1013-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548810  (XMD P/N 70-0050-G18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548810  (XMD P/N 70-0050-G18)    Lot Number:  929723",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0928-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548520  (XMD P/N 70-0050-316)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","191","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548520  (XMD P/N 70-0050-316)    Lot Number:  911110  915910  920210  920610  928915  930825",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0998-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549570  (XMD P/N 70-0050-D24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549570  (XMD P/N 70-0050-D24)    Lot Number:  930831",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0996-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548780  (XMD P/N 70-0050-D20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548780  (XMD P/N 70-0050-D20)    Lot Number:  929720",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0982-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548440  (XMD P/N 70-0050-B14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548440  (XMD P/N 70-0050-B14)    Lot Number:  929612",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0959-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549370  (XMD P/N 70-0050-722)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","31","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549370  (XMD P/N 70-0050-722)    Lot Number:  930144",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0983-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548600  (XMD P/N 70-0050-B16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548600  (XMD P/N 70-0050-B16)    Lot Number:  929702",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1011-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548490  (XMD P/N 70-0050-G14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","37","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548490  (XMD P/N 70-0050-G14)    Lot Number:  929617",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0999-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548470  (XMD P/N 70-0050-E14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","38","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548470  (XMD P/N 70-0050-E14)    Lot Number:  929615",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0955-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548400  (XMD P/N 70-0050-714)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548400  (XMD P/N 70-0050-714)    Lot Number:  928912",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0913-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548330  (XMD P/N 70-0050-014)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","91","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548330  (XMD P/N 70-0050-014)    Lot Numbers:  928905  930835",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0960-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549510  (XMD P/N 70-0050-724)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","43","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549510  (XMD P/N 70-0050-724)    Lot Number:  930827",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0927-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548360  (XMD P/N 70-0050-314)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","331","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548360  (XMD P/N 70-0050-314)    Lot Number:  911107  915907  919004  920607  928908  930838",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0980-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549540  (XMD P/N 70-0050-A24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549540  (XMD P/N 70-0050-A24)    Lot Number:  930829",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0945-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M005489350  (XMD P/N 70-0050-522)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M005489350  (XMD P/N 70-0050-522)    Lot Number:  930142",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0948-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548390  (XMD P/N 70-0050-614)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548390  (XMD P/N 70-0050-614)    Lot Number:  928911",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0975-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number  M00548430  (XMD P/N 70-0050-A14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548430  (XMD P/N 70-0050-A14)    Lot Number:  929611",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1009-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549450  (XMD P/N 70-0050-F22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549450  (XMD P/N 70-0050-F22)    Lot Number:  930151",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0938-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549340  (XMD P/N 70-0050-422)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549340  (XMD P/N 70-0050-422)    Lot Number:  930141",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0985-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548920  (XMD P/N 70-0050-B20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00M00548920  (XMD P/N 70-0050-B20)    Lot Number:  929132",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0990-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548770  (XMD P/N 70-0050-C18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548770  (XMD P/N 70-0050-C18)    Lot Number:  929718",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0934-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548370  (XMD P/N 70-0050-414)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","323","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548370  (XMD P/N 70-0050-414)    Lot Number:  911108  915408  915908  920608  928909  930839",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0920-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548230  (XMD P/N 70-0050-212)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","243","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548230  (XMD P/N 70-0050-212)    Lot Numbers:  911103  915403  915903  919002  920603  928903  930822",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0942-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548540  (XMD P/N 70-0050-516)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","186","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548540  (XMD P/N 70-0050-516)    Lot Number:  911112  915912  919006  920612  929624",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0935-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548530  (XMD P/N 70-0050-416)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","189","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548530  (XMD P/N 70-0050-416)    Lot Number:  911111  915911  920211  919005  920611  928916  930826",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1007-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548800  (XMD P/N 70-0050-F18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548800  (XMD P/N 70-0050-F18)    Lot Number:  929722",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0971-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548900  (XMD P/N 70-0050-920)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548900  (XMD P/N 70-0050-920)    Lot Number:  930130",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0981-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548320  (XMD P/N 70-0050-B12)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548320  (XMD P/N 70-0050-B12)    Lot Number:  929608",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0986-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549410  (XMD P/N 70-0050-B22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549410  (XMD P/N 70-0050-B22)    Lot Number:  930148",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0984-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548760  (XMD P/N 70-0050-B18)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","37","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548760  (XMD P/N 70-0050-B18)    Lot Number:  929717",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0917-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548660  (XMD P/N 70-0050-118)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","165","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548660  (XMD P/N 70-0050-118)    Lot Numbers:  923307  929719",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0957-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548720  (XMD P/N 70-0050-718)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","76","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548720  (XMD P/N 70-0050-718)    Lot Number:  928923  929713",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0924-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548830  (XMD P/N 70-0050-220)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548830  (XMD P/N 70-0050-220)    Lot Number:  929725",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0991-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548930  (XMD P/N 70-0050-C20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548930  (XMD P/N 70-0050-C20)    Lot Number:  930133",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0953-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549500  (XMD P/N 70-0050-624)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549500  (XMD P/N 70-0050-624)    Lot Number:  930156",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0936-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548690  (XMD P/N 70-0050-418)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","77","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548690  (XMD P/N 70-0050-418)    Lot Number:  928920  929710  ",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0967-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548300  (XMD P/N 70-0050-912)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","38","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548300  (XMD P/N 70-0050-912)    Lot Number:  929606",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0937-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548850  (XMD P/N 70-0050-420)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","37","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548850  (XMD P/N 70-0050-420)    Lot Number:  929727",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0970-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548740  (XMD P/N 70-0050-918)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548740  (XMD P/N 70-0050-918)    Lot Number:  929715",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0939-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549480  (XMD P/N 70-0050-424)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","35","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549480  (XMD P/N 70-0050-424)    Lot Number:  930154",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0962-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  MM00548410  (XMD P/N 70-0050-814)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  MM00548410  (XMD P/N 70-0050-814)    Lot Number:  929609",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0974-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548310  (XMD P/N 70-0050-A12)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548310  (XMD P/N 70-0050-A12)    Lot Number:  929607",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0993-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549560  (XMD P/N 70-0050-C24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549560  (XMD P/N 70-0050-C24)    Lot Number:  930830",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0918-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548820  (XMD P/N 70-0050-120)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548820  (XMD P/N 70-0050-120)    Lot Numbers:  929724",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1003-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549440  (XMD P/N 70-0050-E22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","37","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549440  (XMD P/N 70-0050-E22)    Lot Number:  930150",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0925-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549320  (XMD P/N 70-0050-222)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","33","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549320  (XMD P/N 70-0050-222)    Lot Number:  930139",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0988-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548450  (XMD P/N 70-0050-C14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548450  (XMD P/N 70-0050-C14)    Lot Number:  929613",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0979-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549400  (XMD P/N 70-0050-A22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549400  (XMD P/N 70-0050-A22)    Lot Number:  930147",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0923-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548670  (XMD P/N 70-0050-218)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","77","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548670  (XMD P/N 70-0050-218)    Lot Numbers:  928918  929708",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0964-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548890  (XMD P/N 70-0050-820)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","126","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548890  (XMD P/N 70-0050-820)    Lot Number:  923308",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0954-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548280  (XMD P/N 70-0050-712)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","32","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548280  (XMD P/N 70-0050-712)    Lot Number:  929604",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0919-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549310  (XMD P/N 70-0050-122)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549310  (XMD P/N 70-0050-122)    Lot Numbers:  930138",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1012-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548650  (XMD P/N 70-0050-G16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548650  (XMD P/N 70-0050-G16)    Lot Number:  929707",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0969-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548580  (XMD P/N 70-0050-916)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","38","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548580  (XMD P/N 70-0050-916)    Lot Number:  929623",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0995-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548620  (XMD P/N 70-0050-D16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548620  (XMD P/N 70-0050-D16)    Lot Number:  929704",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1016-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549600  (XMD P/N 70-0050-G24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","162","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549600  (XMD P/N 70-0050-G24)    Lot Number:  923310",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0944-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548860  (XMD P/N 70-0050-520)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548860  (XMD P/N 70-0050-520)    Lot Number:  929728",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0912-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548460  (XMD P/N 70-0050-D14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548460  (XMD P/N 70-0050-D14)    Lot Number:  929614",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0976-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548590  (XMD P/N 70-0050-A16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548590  (XMD P/N 70-0050-A16)    Lot Number:  929701",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0929-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548680  (XMD P/N 70-0050-318)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","78","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548680  (XMD P/N 70-0050-318)    Lot Number:  928919  929709",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1010-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549590  (XMD P/N 70-0050-F24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549590  (XMD P/N 70-0050-F24)    Lot Number:  930833",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0997-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549430  (XMD P/N 70-0050-D22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549430  (XMD P/N 70-0050-D22)    Lot Number:  930149",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0978-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548910  (XMD P/N 70-0050-A20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548910  (XMD P/N 70-0050-A20)  Lot Number:  930131",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0992-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549420  (XMD P/N 70-0050-C22)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","126","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549420  (XMD P/N 70-0050-C22)    Lot Number:  923309",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0949-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548550  (XMD P/N 70-0050-616)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","154","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548550  (XMD P/N 70-0050-616)    Lot Number:  928917  929625",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0977-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548750  (XMD P/N 70-0050-A18)","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548750  (XMD P/N 70-0050-A18)    Lot Number:  929716",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0950-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548710  (XMD P/N 70-0050-618)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","77","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548710  (XMD P/N 70-0050-618)    Lot Number:  928922  929712",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0965-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549380  (XMD P/N 70-0050-822)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549380  (XMD P/N 70-0050-822)    Lot Number:  930145",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1014-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548970  (XMD P/N 70-0050-G20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","38","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548970  (XMD P/N 70-0050-G20)    Lot Number:  930137",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0956-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548560  (XMD P/N 70-0050-716)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","115","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548560  (XMD P/N 70-0050-716)    Lot Number:  929626",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0922-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548510  (XMD P/N 70-0050-216)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548510  (XMD P/N 70-0050-216)    Lot Numbers:  928914",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0987-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549550  (XMD P/N 70-0050-B24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","38","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549550  (XMD P/N 70-0050-B24)    Lot Number:  930834",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1000-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548630  (XMD P/N 70-0050-E16)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548630  (XMD P/N 70-0050-E16)    Lot Number:  929705",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0947-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548270  (XMD P/N 70-0050-612)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548270  (XMD P/N 70-0050-612)    Lot Number:  929603",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1004-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549580  (XMD P/N 70-0050-E24)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","37","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549580  (XMD P/N 70-0050-E24)    Lot Number:  930832",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0916-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548500  (XMD P/N 70-0050-116)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548500  (XMD P/N 70-0050-116)    Lot Numbers:  928913",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-1002-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548950  (XMD P/N 70-0050-E20)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548950  (XMD P/N 70-0050-E20)    Lot Number:  930135",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0968-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548420  (XMD P/N 70-0050-914)","40","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548420  (XMD P/N 70-0050-914)    Lot Number:  929610",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0931-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549330  (XMD P/N 70-0050-322)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","32","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549330  (XMD P/N 70-0050-322)    Lot Number:  930140",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0952-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549360  (XMD P/N 70-0050-622)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","35","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549360  (XMD P/N 70-0050-622)    Lot Number:  930143",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0963-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548570  (XMD P/N 70-0050-816)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","91","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548570  (XMD P/N 70-0050-816)    Lot Number:  929622",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0940-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548260  (XMD P/N 70-0050-512)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","39","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548260  (XMD P/N 70-0050-512)    Lot Number:  929602",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0961-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548290  (XMD P/N 70-0050-812)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548290  (XMD P/N 70-0050-812)    Lot Number:  929605",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0915-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548340  (XMD P/N 70-0050-114)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","199","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548340  (XMD P/N 70-0050-114)    Lot Numbers:  911105  915905  920605  928906  930863",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0973-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549530  (XMD P/N 70-0050-924)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","34","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549390  (XMD P/N 70-0050-922)    Lot Number:  930841",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0930-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548840  (XMD P/N 70-0050-320)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","34","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548840  (XMD P/N 70-0050-320)    Lot Number:  929726",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0972-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00549390  (XMD P/N 70-0050-922)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","37","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00549390  (XMD P/N 70-0050-922)    Lot Number:  930146",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73024,"Ongoing","Xeridiem Mediem Medical Devices Inc","4700 S Overland Dr",,"Tucson","AZ","85714-3430","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MA only.","Z-0994-2016","Class II","EndoVive 3s Low Profile Balloon Kits  Part Number:  M00548460  (XMD P/N 70-0050-D14)  The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.","36","A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.","02/25/2016",," Part Number:  M00548460  (XMD P/N 70-0050-D14)    Lot Number:  929614",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73026,"Terminated","LifeSouth Community Blood Centers, Inc.","4039 W Newberry Rd",,"Gainesville","FL","32607-2342","United States","Voluntary: Firm Initiated","FAX","AL; FL; GA","B-0266-16","Class II","Red Blood Cells, Leukocytes Reduced","8 units","Blood products, in which NAT testing was performed incorrectly, were distributed.","02/04/2016","02/04/2016"," W115115179244U; W1151152762001; W1151152778856; W1151152783707; W115115285076Z; W115115285295D; W115115291023J; W115115311197J",12/4/2015,"12/04/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73026,"Terminated","LifeSouth Community Blood Centers, Inc.","4039 W Newberry Rd",,"Gainesville","FL","32607-2342","United States","Voluntary: Firm Initiated","FAX","AL; FL; GA","B-0263-16","Class II","Red Blood Cells","6 units","Blood products, in which NAT testing was performed incorrectly, were distributed.","02/04/2016","02/04/2016"," W1151152734529; W1151152734545; W1151152734553; W1151152734713; W115115289769O; W1151152935379",12/4/2015,"12/04/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73026,"Terminated","LifeSouth Community Blood Centers, Inc.","4039 W Newberry Rd",,"Gainesville","FL","32607-2342","United States","Voluntary: Firm Initiated","FAX","AL; FL; GA","B-0262-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood products, in which NAT testing was performed incorrectly, were distributed. ","02/04/2016","02/04/2016"," W115115278374-part 1; W115115278374-part 2 ",12/4/2015,"12/04/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73026,"Terminated","LifeSouth Community Blood Centers, Inc.","4039 W Newberry Rd",,"Gainesville","FL","32607-2342","United States","Voluntary: Firm Initiated","FAX","AL; FL; GA","B-0261-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","2 units","Blood products, in which NAT testing was performed incorrectly, were distributed. ","02/04/2016","02/04/2016"," W115115230331I; W1151152539084",12/4/2015,"12/04/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73026,"Terminated","LifeSouth Community Blood Centers, Inc.","4039 W Newberry Rd",,"Gainesville","FL","32607-2342","United States","Voluntary: Firm Initiated","FAX","AL; FL; GA","B-0265-16","Class II","Apheresis Platelets, Leukocytes Reduced","17 units","Blood products, in which NAT testing was performed incorrectly, were distributed.","02/04/2016","02/04/2016"," W115115230331I; W1151152499294-part 1; W1151152499294-part 2; W115115251300Q-part 1; W115115251300Q- part 2; W115115269743Y-part 1; W115115269743Y-part 2; W1151152990160- part 1; W1151152990160-part 2; W115115302083I-part 1; W115115302083I-part 2; W1151153020896; W115115302893O-part 1; W115115302893O-part 2; W115115306031F-part 1; W115115306031F-part 2; W115115308091X",12/4/2015,"12/04/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73026,"Terminated","LifeSouth Community Blood Centers, Inc.","4039 W Newberry Rd",,"Gainesville","FL","32607-2342","United States","Voluntary: Firm Initiated","FAX","AL; FL; GA","B-0264-16","Class II","Fresh Frozen Plasma","3 units","Blood products, in which NAT testing was performed incorrectly, were distributed.","02/04/2016","02/04/2016"," W1151152734529; W1151152734553; W115115299009Z",12/4/2015,"12/04/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73027,"Ongoing","bioMerieux, Inc.","100 Rodolphe St",,"Durham","NC","27712-9402","United States","Voluntary: Firm Initiated","E-Mail","Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.","Z-0750-2016","Class II","BacT/ALERT¿ FA, bioM¿rieux, Inc.,    Product Usage:  BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).  ","2741 units in total","Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.","02/03/2016",," Reference number: 259791, Lot number: 1042923, Expiry: 25JAN2016 and Lot number 1042979, Expiry: 28JAN2016.",12/24/2015,"12/24/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73027,"Ongoing","bioMerieux, Inc.","100 Rodolphe St",,"Durham","NC","27712-9402","United States","Voluntary: Firm Initiated","E-Mail","Distributed in the countries of Angola, Austria, Bosnia, Bulgaria, Cameroon, Czech Republic, Democratic Republic of Congo, France, Germany, Greece, Hungary, Italy, Kazakhstan, Kingdom of Saudi Arabia, Kosovo, Lebanon, Netherlands, Niger, Pakistan, Poland, Republic of Belarus, Romania, Russia, Serbia, Sri Lanka, Spain, Sweden, Switzerland, United Arab Emirates, Turkey and Zimbabwe.","Z-0749-2016","Class II","BacT/ALERT¿ SN, bioM¿rieux, Inc.    Product Usage:  BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).  ","2741 units in total","Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.","02/03/2016",," Reference number: 259790, Lot number: 1042739, Expiry: 09JAN2016.",12/24/2015,"12/24/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73028,"Ongoing","Good Earth Egg Company","4411 Highway K",,"Bonne Terre","MO","63628-3533","United States","Voluntary: Firm Initiated","Telephone","Product was directly distributed to restaurant, retail, and wholesale customers in GA. IL, KS, and MO.  The GA firm sent product to a public storage facility in TX.  There was no foreign, military, or government distribution.","F-0147-2017","Class I","Shell eggs, various sizes, packaged in the following ways:  6-count cartons, 10-count cartons, 12-count cartons, 18-count cartons, 15 dozen cases, and 30 dozen cases; under the brand name Good Earth Egg Company and MO license # D-01124.  The responsible firm name is Good Earth Egg Company, Bonne Terre, MO","approximately 2,232,000","May be contaminated with Salmonella.","10/14/2016",," all date codes up to and including 006 -- Sell by 02/05/2016",1/8/2016,"01/08/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73029,"Ongoing","Intervet, Inc","2 Giralda Farms",,"Madison","NJ","07940-1026","United States","Voluntary: Firm Initiated","Letter","Nationwide","V-482-2016","Class III","Merck Salix (furosemide 5% injection   50ml   Made in Germany by: Intervet International GmbH Distributed by: Intervet Inc (d/b/a Merck Animal Health) Madison, NJ 07940 www.merck-animal-health-usa.com  UPC 021784-46150-4  NDC 57926-465-01   amber glass bottle, type 1","840 vials","An incorrect expiry was assigned to one batch of Salix 5%.","08/15/2016",," Lot  #A157V01",12/22/2015,"12/22/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73030,"Ongoing","Bio-Rad Laboratories, Inc.","6565 185th Ave NE",,"Redmond","WA","98052-5039","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including Puerto Rico.","Z-0807-2016","Class II","EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic      Product Usage:  EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.  ","278 units"," level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter. ","02/12/2016",," The EVOLIS Microplate System instrument is not lot controlled, however for traceability purposes each instrument is assigned a unique serial number.    SERIAL NUMBERS:    9163700126, 9163700175, 9163700187, 9163700196, 9163700208, 9163700210, 9163700231, 9163700266, 9163700278, 9163700320, 9163700328, 9163700336, 9163700337, 9163700349, 9163700354, 9163700368, 9163700402, 9163700431, 9163700449, 9163700478, 9163700480, 9163700481, 9163700495, 9163700498, 9163700499, 9163700501, 9163700510, 9163700527, 9163700530, 9163700531, 9163700544, 9163700556, 9163700558, 9163700559, 9163700560, 9163700567, 9163700585, 9163700587, 9163700594, 9163700595, 9163700623, 9163700624, 9163700625, 9163700629, 9163700656, 9163700695, 9163700696, 9163700722, 9163700743, 9163700744, 9163700745, 9163700764, 9163700765, 9163700772, 9163700775, 9163700776, 9163700810, 9163700821, 9163700822, 9163700823, 9163700835, 9163700836, 9163700843, 9163700844, 9163700846, 9163700850, 9163700851, 9163700853, 9163700855, 9163700857, 9163700862, 9163700863, 9163700864, 9163700868, 9163700873, 9163700874, 9163700875, 9163700877, 9163700879, 9163700883, 9163700884, 9163700885, 9163700887, 9163700888, 9163700889, 9163700890, 9163700891, 9163700892, 9163700893, 9163700895, 9163700898, 9163700899, 9163700901, 9163700902, 9163700906, 9163700907, 9163700909, 9163700910, 9163700911, 9163700912, 9163700913, 9163700914, 9163700916, 9163700917, 9163700918, 9163700919, 9163700920, 9163700921, 9163700922, 9163700926, 9163700927, 9163700928, 9163700929, 9163700930, 9163700931, 9163700932, 9163700933, 9163700934, 9163700935, 9163700936, 9163700937, 9163700938, 9163700939, 9163700941, 9163700942, 9163700943, 9163700945, 9163700946, 9163700947, 9163700948, 9163700949, 9163700950, 9163700952, 9163700956, 9163700957, 9163700959, 9163700960, 9163700961, 9163700962, 9163700964, 9163700965, 9163700966, 9163700967, 9163700968, 9163700972, 9163700973, 9163700974, 9163700975, 9163700977, 9163700978, 9163700979, 9163700980, 9163700981, 9163700982, 9163700984, 9163700985, 9",12/22/2015,"12/22/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",73031,"Ongoing","Genosco DBA Kleancolor","12801 Busch Pl",,"Santa Fe Springs","CA","90670-3023","United States","Voluntary: Firm Initiated","E-Mail","U.S. distribution to the following; CA, TX, GA, NY, and FL  No foreign distribution.","F-0584-2016","Class II","Kleancolor   Bow-Tux Volumizing Mascara  10.94 ml    UPC Codes: 8-10236-00878-3","13,932 pieces","Genosco dba Kleancolor is recalling Kleancolor Lash Bow-Tux Volumizing Mascara because of potential Bacillus cereus, Staphylococcus epidermidis, and Staphylococcus warneri contamination.","02/12/2016",," LOT NUMBER: GMX414A  Item number: MS1878",1/11/2016,"01/11/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73032,"Ongoing","Bausch & Lomb, Inc.","8500 Hidden River Pkwy",,"Tampa","FL","33637-1014","United States","Voluntary: Firm Initiated","Letter","U.S. Nationwide including Puerto Rico.","D-0645-2016","Class III","Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.","a) 905,956 Bottles, b) 191,375 Bottles","Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.","01/28/2016",," a) Lot #: 199691, Expiry: 02/2016; Lot # 221481, Expiry: 03/2016, Lot #: 223921, Expiry: 05/2016; Lot #: 226211, Expiry: 06/2016; Lot #: 228611, Expiry: 08/2016; Lot #: 230711, Expiry: 09/2016; Lot #: 232591, Expiry: 11/2016; Lot #: 234551, Expiry: 12/2016; Lot #: 238871, Expiry: 01/2017; Lot #: 239801, Expiry: 02/2017; Lot #: 240951, Expiry: 02/2017; Lot #: 242801, Expiry: 04/2017; Lot #: 246551, Expiry: 06/2017. b) Lot #: 199011, Expiry: 01/2016; Lot #: 199692, Expiry: 02/2016; Lot #: 221482, Expiry: 03/2016; Lot #: 222601, Expiry: 04/2016; Lot #: 223922, Expiry: 05/2016; Lot #: 226212, Expiry: 06/2016; Lot #: 228612, Expiry: 08/2016; Lot #: 230712, Expiry: 09/2016; Lot #: 232592, Expiry: 11/2016; Lot #: 234552, Expiry: 12/2016; Lot #: 238872, Expiry: 01/2017; Lot #: 239802, Expiry: 02/2017; Lot #: 240952, Expiry: 02/2017; Lot #: 242802, Expiry: 04/2017; Lot #: 246552, Expiry: 06/2017.",1/18/2016,"01/18/2016",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73032,"Ongoing","Bausch & Lomb, Inc.","8500 Hidden River Pkwy",,"Tampa","FL","33637-1014","United States","Voluntary: Firm Initiated","Letter","U.S. Nationwide including Puerto Rico.","D-0646-2016","Class III","Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.","119,393 Bottles","Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.","01/28/2016",," Lot #:199001, Expiry: 01/2016; Lot #: 222591, Expiry: 04/2016; Lot #: 224491, Expiry: 06/2016; Lot #: 229241, Expiry: 08/2016; Lot #: 232941, Expiry: 11/2016; Lot #: 239921, Expiry: 02/2017; Lot #: 241701, Expiry: 04/2017; Lot #: 246851, Expiry: 07/2017.",1/18/2016,"01/18/2016",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73032,"Ongoing","Bausch & Lomb, Inc.","8500 Hidden River Pkwy",,"Tampa","FL","33637-1014","United States","Voluntary: Firm Initiated","Letter","U.S. Nationwide including Puerto Rico.","D-0647-2016","Class III","Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.","a) 416,441 Bottles b) 674,177 Bottles","Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.","01/28/2016",," a) Lot #: 232601, Expiry: 01/2016; Lot #: 233471, Expiry: 02/2016; Lot #: 234901, Expiry: 03/2016; Lot #: 238861, Expiry: 04/2016; Lot #: 239781, Expiry: 04/2016; Lot #: 243351, Expiry: 08/2016; Lot #: 244931, Expiry: 09/2016. b) Lot #: 198821, Expiry: 01/2016; Lot #: 198901, Expiry: 01/2016; Lot #: 199961, Expiry: 02/2016; Lot #: 220111, Expiry: 02/2016; Lot #: 222281, Expiry: 04/2016; Lot #: 222291, Expiry: 04/2016; Lot #: 224841, Expiry: 06/2016; Lot #: 228281, Expiry: 07/2016; Lot #: 228291, Expiry: 07/2016; Lot #: 231531, 10/2016; Lot #: 232671, Expiry: 11/2016; Lot #: 232681, Expiry: 11/2016; Lot #: 238931, 01/2017; Lot #: 238941, Expiry: 01/2017; Lot #: 240331, Expiry: 02/2017; Lot #: 242341, Expiry: 04/2017; Lot #: 242351, Expiry: 04/2017; Lot #: 243391, Expiry: 05/2017; Lot #: 246171, Expiry: 06/2017; Lot #: 246341, Expiry: 07/2017.   ",1/18/2016,"01/18/2016",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73033,"Ongoing","Horiba Instruments Inc","9755 Research Dr",,"Irvine","CA","92618-4626","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN    No foreign distribution.","Z-0740-2016","Class II","ABX PENTRA Glucose PAP CP ref. A11A01668  reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.","216","N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.","02/02/2016",," All Lots",1/11/2016,"01/11/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73033,"Ongoing","Horiba Instruments Inc","9755 Research Dr",,"Irvine","CA","92618-4626","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN    No foreign distribution.","Z-0738-2016","Class II","The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.","216","N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.","02/02/2016",," All Lots",1/11/2016,"01/11/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73033,"Ongoing","Horiba Instruments Inc","9755 Research Dr",,"Irvine","CA","92618-4626","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN    No foreign distribution.","Z-0742-2016","Class II","ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.  ","216","N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.","02/02/2016",," All Lots",1/11/2016,"01/11/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73033,"Ongoing","Horiba Instruments Inc","9755 Research Dr",,"Irvine","CA","92618-4626","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN    No foreign distribution.","Z-0743-2016","Class II","ABX PENTRA Uric Acid CP ref. A11A01670  is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method).   ","216","N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.","02/02/2016",," All Lots",1/11/2016,"01/11/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73033,"Ongoing","Horiba Instruments Inc","9755 Research Dr",,"Irvine","CA","92618-4626","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN    No foreign distribution.","Z-0741-2016","Class II","ABX PENTRA Lactic Acid CP ref. A11A01721  reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).","216","N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.","02/02/2016",," All Lots",1/11/2016,"01/11/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73033,"Ongoing","Horiba Instruments Inc","9755 Research Dr",,"Irvine","CA","92618-4626","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN    No foreign distribution.","Z-0739-2016","Class II","ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.   ","216","N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.","02/02/2016",," All Lots",1/11/2016,"01/11/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73034,"Ongoing","Pro-Dex Inc","2361 McGaw Ave",,"Irvine","CA","92614-5831","United States","Voluntary: Firm Initiated","Letter","Distributed in FL.","Z-1095-2016","Class II","Battery Pack  KLS-SD-1000  Single  Models: KLS-BP-001  Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).","1995 total","The sterile battery may contain particulates within the sterile package.","03/11/2016",," Lots 509567, K055R",12/23/2015,"12/23/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73034,"Ongoing","Pro-Dex Inc","2361 McGaw Ave",,"Irvine","CA","92614-5831","United States","Voluntary: Firm Initiated","Letter","Distributed in FL.","Z-1094-2016","Class II","Battery Pack  KLS-SD-1000  Case (40 ct)  Models: KLS-BP-040    Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).","1995 total","The sterile battery may contain particulates within the sterile package.","03/11/2016",," Lots 509567, K055R",12/23/2015,"12/23/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73035,"Ongoing","Sandoz Inc","100 College Rd W",,"Princeton","NJ","08540-6604","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0659-2016","Class III","Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540","277,267 bottles","Failed Impurities/Degradation Specifications; 9 month stability timepoint","02/11/2016",," a)   3022288 12/2015  3025988 03/2016  3025989 04/2016  3030459 08/2016  3030460 08/2016  3032087 10/2016  3032088 10/2016  3034506 12/2016  3035952 01/2017  3035953 01/2017    b)   3022287 12/2015  3025990 04/2016  3030458 08/2016  3032086 09/2016  3035954 01/2017",12/31/2015,"12/31/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73036,"Ongoing","Iba Dosimetry Gmbh","Bahnhofstr. 5",".","Schwarzenbruck",,,"Germany","Voluntary: Firm Initiated","E-Mail","Nationwide and International:    Algeria, Angola, Arab Republic of Egypt, Austria, Belarus, Belgium, Bulgaria, Bosnia and Herzegovina, Croatia, Czech Republic, Denmark, Ethiopia, France, Germany, Ghana, Greece, Hungary, Iraq, Ireland, Islamic Republic Iran, Italy, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Libya, Morocco","Z-0683-2016","Class II","IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2",,"When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.","01/21/2016",," Serial numbers:  9204,9296,9297,9298,9299,9300,9445,9446,9447,9448,9596,9597,9598,9599,9600,9626,9627,9628,9629,9630,9631,9632,9633,9634,9635,9735,9736,9737,9738,9739,9744,9745,9746,9747,9748,9749,9750,9751,9752,9753,9754,9756,9838,9839,9840,9841,9842,9843,9844,9845,9846,9847,9848,9849,9850,9986,9987,9988,9989,9990,9991,10158,10159,10160,10184,10185,10186,10187,  10236,10237,10238,10239,10240,10241,10242,10243,10244,10245,10286,  10287,10288,10289,10304,10306,10307,10308,10309,10310,10312,10616,  10617,10618,10619,10635,10636,10663,10665,10666,10667,10668,10765,  10766,10839,10847,10848,10849,10850,10932,10936,10970,10972,10990,  10991,10992,10993,10994,10995,10996,10997,10998,10999,11000,11001,  11002,11003,11004,11005,11006,11007,11008,11009,11010,11011,11012,  11013,11014,11015,11016,11017,11018,11019,11020,11021,11022,11023,  11024,11025,11026,11027,11028,11029,11030,11031,11032,11033,11034,  11035,11036,11037,11038,11039,11540,11541,11542,11543,11544,11545,  11546,11547,11548,11549,11550,11551,11552,11553,11554,11555,11556,  11557,11558,11559,11560,11561,11562,11563,11564,11565,11566,11567,  11568,11569,12000,12001,12002,12003,12004,12005,12006,12007,12008,  12009,12010,12011,12012,12013,12014,12015,12016,12017,12018,12019,  12020,12021,12022,12023,12024,12025,12026,12027,12028,12029,12493,  12494,12495,12496,12497,12498,12499,12500,12501,12502,12503,12504,  12505,12506,12507,12508,12509,12510,12511,12512,12513,12514,12515,  12516,12517,12518,12519,12520,12521,12522,12892,12893,12894,12895,  12896,12897,12898,12899,12900,12901,12902,12903,12904,12905,12906,  12907,12908,12909,12910,12911,12912,12913,12914,12915,12916,12917,  12918,12919,12920,12921,12922,12923,12924,12925,12926,12927,12928,  12929,12930,12931,12932,12933,12934,12935,12936,12937,12938,12939,  12940,12941,13490,13491,13492,13493,13494,13495,13496,13497,13498,  13499,13500,13501,13502,13503,13504,13505,13506,13507,13508,13509,  13510,13511,13512,13513,13514,13515,13516,13517,13518,13519,13520,  13521,13522,13523,13524,13525,13526,13527,1352",12/10/2015,"12/10/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73037,"Terminated","Exempla Saint Joseph Hospital","1835 N Franklin St Rm IN-174",,"Denver","CO","80218-1126","United States","Voluntary: Firm Initiated","Telephone","CO","B-0268-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, labeled RBC antigen negative tested RBC antigen positive, was distributed.","02/04/2016","02/04/2016"," W036215409255",1/5/2016,"01/05/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73038,"Ongoing","Siemens Medical Solutions USA, Inc.","2501 Barrington Rd",".","Hoffman Estates","IL","60192-2061","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of  Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.","Z-0687-2016","Class II","The e.cam Dual Signature Gamma Camera system.  Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.","10","To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.","01/21/2016",," e.cam systems that were refurbished from 04/06/15 to 10/06/15.  Material number 10151531, serial number 70004; Material number 10151532 serial numbers 70038, 70040, 70041, 70042, 70043, 70044, 70039, 70045, and 70046.",12/31/2015,"12/31/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73039,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","FAX","TX","B-0267-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","02/04/2016","02/04/2016"," W035213335087H-part 1; W035213335087H-part 2 ",12/28/2015,"12/28/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0556-2016","Class II","Signature Kitchens 100% Whole Wheat Hot Dog Buns;  8 buns; NET WT 16 oz   454 g  UPC 0 21130 15456 2;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.","843 x 16 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/25/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0561-2016","Class II","Coast to Coast San Francisco Style Sourdough 6 Hoagie Rolls;  6 Hoagie Rolls; NET WT 16.5 oz   468 g  UPC 0 21130 18091 2;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.","218 x 16.5 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/25/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0553-2016","Class II","Safeway Kitchens Enriched Hamburger Buns;  8 buns; NET WT 17 oz (1 lb 1 oz) 482 g  UPC 0 21130 18456 9;  Distributed by:Safeway Inc.  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.","788 x 17 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by Date 1/25/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0551-2016","Class II","Open Nature Whole Grain White Hot Dog Buns;  8 buns; NET WT 12 oz (340 g)  UPC 0 79893 11057 8;  Distributed by: Lucerne Foods, inc.  Pleasanton, CA 94566    Contains: Wheat, milk  May Contain egg, milk.","1394  x 12 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/20/2016 and 1/21/2016",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0562-2016","Class II","Coast to Coast Traditional Hawaiian Sweet 12 Dinner Rolls;  12 Dinner Rolls; NET WT 14 oz   397 g  UPC 0 21130 18580 1;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat. milk  May Contain eggs",,"Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/25/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0558-2016","Class II","Signature Kitchens Crushed Wheat Hot Dog;  8 buns; NET WT 12 oz   340 g  UPC 0 21130 18496 5;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.","184 x 12 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/25/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0552-2016","Class II","Open Nature Seeded Sandwich Rolls;  8 buns; NET WT 21 oz (1 lb 5 oz) 595 g  UPC 0 79893 11439 2;  Distributed by: Lucerne Foods, inc.  Pleasanton, CA 94566    Contains: Wheat  May Contain egg, milk.","890 x 21 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by dates 1/19/16, 1/20/16 and 1/21/16.",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0563-2016","Class II","Old Fashioned White Diner Rolls 8 Count  Pack size 20 oz.  UPC 2 24246 00000    ","746 x 20 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Julian Date 009",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0555-2016","Class II","Pantry Essentials Hamburger Buns;  8 buns; NET WT 12 oz 340 g  UPC 0 21130 27085 9;  Distributed for: Lucerne Foods Inc.  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.","1060 x 12 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/25/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0557-2016","Class II","Signature Kitchens Enriched Hamburger Buns, Sesame;  8 buns; NET WT 12 oz   340 g  UPC 0 21130 18467 5;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.","1907 x 12 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/25/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0554-2016","Class II","Pantry Essentials Hot Dog Buns;  8 buns; NET WT 12 oz 340 g  UPC 0 21130 27084 2;  Distributed for: Lucerne Foods Inc.  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.","1393 x 12 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/25/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0564-2016","Class II","Old Fashioned Wheat Diner Rolls 8 Count  Pack size 20 oz.  UPC 2 24247 00000    ","619 x 20 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Julian Date 009",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0559-2016","Class II","Signature Kitchens Enriched  Hot Dog;  8 buns; NET WT 12 oz   340 g  UPC 0 21130 18501 6;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.","1178 x 12 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/26/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73040,"Terminated","Albertsons Companies, Inc.","5918 Stoneridge Mall Rd",,"Pleasanton","CA","94588-3229","United States","Voluntary: Firm Initiated","E-Mail","CA, HI, NV","F-0560-2016","Class II","Coast to Coast Parisian Style French 6 Hoagie Rolls;  6 Hoagie Rolls; NET WT 16.5 oz   468 g  UPC 0 21130 18090 5;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.","337 x 16.5 oz. packages","Cloth material that is part of the production equipment may be in the product.","02/05/2016","02/09/2016"," Sell by 1/25/16",1/10/2016,"01/10/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73041,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL  CA  CT  FL  IN  KS  LA  MA  MD  MI  MN  MO  MS  NE  NY  OH  OR  PA  TX  WA  WI","Z-0862-2016","Class II","Syngo Plaza Picture archiving and communication system.  Software only.  PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.","68"," since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.","02/23/2016",," Device model numbers:  10863171, 10863172, 10863173",12/22/2015,"12/22/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73042,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0855-2016","Class II","Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. ","3,741 units"," label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized.  Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided.  ","02/23/2016",," All lots of the following Catalog Numbers: 2704-1-024; 2704-3-018; 6703-1-018; 6703-2-120; 6704-1-018; 6704-2-120 and 6704-3-120.",12/23/2015,"12/23/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73043,"Ongoing","Pfizer Inc.","235 East 42nd Street",,"New York","NY","10017-5703","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0649-2016","Class II","Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68","116,400 bottles ","FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. ","02/01/2016",," Lot #: M07862, Exp 05/2018;  M07865, Exp 06/2018",1/11/2016,"01/11/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73043,"Ongoing","Pfizer Inc.","235 East 42nd Street",,"New York","NY","10017-5703","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0648-2016","Class II","Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68","30,672 bottles ","FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. ","02/01/2016",," Lot #: M07861, Exp 05/2018",1/11/2016,"01/11/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73044,"Ongoing","Perrigo Company PLC","515 Eastern Ave",,"Allegan","MI","49010-9070","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0587-2016","Class II","Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Rite-Aid, Camp Hill, PA 17011, NDC 11822-0419-1; c) Topcare, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-419-26; d) Kroger, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: The Kroger Co., Cincinnati, OH 46202, NDC 30142-419-26; e) GoodSense, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: Perrigo, Allegan, MI 49010, NDC 0113-0419-26; f) Dollar General, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: DolgenCorp, LLC, Goodlettsville, TN 37072, NDC 55910-419-26; g) Care One, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Gluten Free, Distributed by: American Sales Company, Lancaster, NY 14086, NDC 41520-419-26; h) CVS, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppr",,"Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. ","01/22/2016",," Lot #s: 5LK0528, 5LK0630, 5LK0779, Exp 03/17",1/8/2016,"01/08/2016",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73044,"Ongoing","Perrigo Company PLC","515 Eastern Ave",,"Allegan","MI","49010-9070","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0586-2016","Class II","Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26.",,"Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. ","01/22/2016",," Lot #s: 5MK0340, 5LK0592, Exp 08/17",1/8/2016,"01/08/2016",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73045,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including    AL  AR  AZ  CA  CO  CT  DE  FL  GA  IA  ID  IL  IN  KY  LA  MA  MD  MI  MN  MO  MS  MT  NC  ND  NE  NH  NJ  NM  NV  NY  OH  OK  OR  PA  RI  SC  TN  TX  UT  VA  VT  WA  WI  WV","Z-1064-2016","Class II","Super Arrow-Flex Percutaneous Sheath Introducer Sets    REF CL-07035 or CL-07635 or CL-07735 or CL-07835  Super Arrow-Flex  Percutaneous Sheath Introducer Set  with Integral Hemostasis Valve/Side Port  and Radiopaque Tip Marker Band  Contents:  1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque  with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator  1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 Fr.  Rx only.    The Arrow Percutaneous Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.","56,521 units","Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.","03/07/2016",,"  Material number :CL-07035  Batch #'s: CF0045142  CF0087118  CF0090127  CF0128575  CF1022799  CF1034863  CF1046302  CF1060275  CF1083652  CF2019968  CF2021329  CF2045237  CF2056298  CF2092322  CF2125658  CF3031070  14F13G0157  14F13H0140  14F13K0108  14F13K0334  14F14A0435  14F14B0295  14F14C0449  14F14F0184  14F14F0282  14F14J0055  14F14L0126  14F15A0097  14F15A0473  14F15C0455  14F15C0455  14F15E0083  14F15E0392  14F15G0350  14F15L0009    Material #: CL-07635  Batch #'s: CF0014629  CF0016145  CF0026765  CF0027875  CF0029004  CF0031879  CF0043747  CF0044445  CF0045312  CF0046072  CF0057307  CF0058371  CF0058639  CF0059715  CF0060443  CF0061539  CF0062000  CF0062968  CF0074416  CF0074954  CF0086388  CF0088268  CF0098848  CF0099814  CF0090135  CF0090990  CF0104732  CF0115512  CF0115640  CF0117991  CF0128581  CF0129532  CF1022803  CF1022900  CF1023194  CF1035539  CF1046005  CF1046603  CF1057461  CF1058601  CF1069026  CF1069417  CF1071115  CF1071530  CF1082816  CF1083655  CF1084050  CF1094408  CF1095121  CF1095422  CF1106140  CF1106463  CF1106567  CF1106866  CF1117776  CF1118184  CF2010024  CF2010554  CF2011013  CF2021345  CF2021568  CF2022380  CF2032704  CF2033760  CF2044057  CF2044557  CF2044918  CF2055632  CF2055879  CF2067193  CF2067783  CF2068117  CF2078723  CF2079280  CF2079792  CF2079893  CF2080185  CF2080838  CF2081222  CF2114750  CF2115091  CF2125371  CF2125810  CF3016842  CF3017268  CF3017895  CF3018102  CF3028486  CF3028692  CF3029687  CF3030417  CF3031073  CF3041971  CF3064771  CF3065130  14F13G0058  14F13G0104  14F13G0229  14F13H0292  14F13H0421  14F13J0267  14F13K0066  14F13K0171  14F13L0012  14F13L0105  14F13M0040  14F14A0310  14F14A0420  14F14B0167  14F14B0309  14F14C0077  14F14C0191  14F14D0013  14F14D0155  14F14D0351  14F14D0373  14F14F0230  14F14F0284  14F14G0425  14F14H0028  14F14H0309  14F14J0021  14F14J0098  14F14J0336  14F14K0036  14F14K0099  14F14K0382  14F14L0352  14F14M0121  14F15A0234  14F15A0341  14F15B0076  14F15B0156  14F15B0372  14F15C0066  14F15D0009  14F15D0089  14F15D0183  14F15",1/12/2016,"01/12/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73046,"Terminated","Global Healthcare Inc","11350 Old Roswell Rd","Suite 700","Alpharetta","GA","30009-2291","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution to state of: GA only.","Z-0696-2016","Class II","ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China ","2,000 cases (100 individual units per case)","Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.","02/03/2016","03/25/2016"," Lot Number 1505201",1/6/2016,"01/06/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73048,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","TN","B-0269-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product collected from a donor whose suitability to donate was not adequately determined, was distributed.","02/04/2016","02/04/2016"," W043215085630",12/29/2015,"12/29/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73049,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","424 S Mesa Hills Dr",,"El Paso","TX","79912-5441","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0271-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed","02/04/2016","02/04/2016"," W041214048548P",11/25/2015,"11/25/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73050,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","4139 Carmichael Rd",,"Montgomery","AL","36106-2803","United States","Voluntary: Firm Initiated","FAX","AL","B-0270-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood product, with a low pH, was distributed.","02/04/2016","02/04/2016"," W115115296332O",12/7/2015,"12/07/2015",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73052,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.","Z-1240-2016","Class II","Siemens ADVIA Centaur Enhance Estradiol  Test Code eE2  Catalog Number: 10490889, 10491445, 10697757    Product Usage:  For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.  ","33604 units","The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.","03/24/2016",," All lots",1/13/2016,"01/13/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73052,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.","Z-1243-2016","Class II","IMMULITE 2000 EstradiolTest Code E2  Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D)  SMN: 10381178, 10702833, 10381177, 10702834    Product Usage:  For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders  ","9334 units","The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.","03/24/2016",," All lots",1/13/2016,"01/13/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73052,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.","Z-1242-2016","Class II","IMMULITE 1000 Estradiol  Test Code E2  Catalog Number: LKE21, LKE21(D), LKE25  SMN: 10381132, 10702832, 10381142    Product Usage:  For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal sexual disorders  ","9251 units","The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.","03/24/2016",," All lots",1/13/2016,"01/13/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73052,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.","Z-1241-2016","Class II","Dimension Vista LOCI Estradiol  Test Code E2  Catalog Number: K6463  SMN: 10489099    Product Usage:  The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.  ","1945 units","The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.","03/24/2016",," All lots",1/13/2016,"01/13/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73053,"Ongoing","Pharmacaribe llc","3513 Dileuca St",,"Punta Gorda","FL","33950-7835","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of FL, LA, TX and VA","Z-0795-2016","Class II","PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4   For Inhalation Only Rx    Product Usage:  The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.  ","7,020 vials","Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)","02/10/2016",," Lot # CIY Exp.Date August 2017  UPC Number: 030915339988 (on the box of 60 vials)  UPC Number: 10030915339985 (on the shipping case of 12 boxes)",12/29/2015,"12/29/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73054,"Ongoing","Arjo, Inc. dba ArjoHuntleigh","2349 W Lake St",,"Addison","IL","60101-6183","United States","Voluntary: Firm Initiated","Letter","US Consignees; 222 units distributed in the following states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV.  ***Foreign Consignees; 1374 units distributed in the following countries:  Australia, Austria, Belgium, Bosnia & Hercegovina, Brazil, CANADA, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Iceland, Ireland, Italy, Japan, Lithuania, Luxemburg, Netherlands, New Zealand, Nigeria, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan and  UK.","Z-1388-2016","Class II","The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use. ","1,596 units","Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose. ","04/13/2016",," All Concerto & Basic Shower Trolleys manufactured by ArjoHuntleigh Polska Sp. z o.o, March 7, 2014 through April 20, 2015 with serial numbers from P0227559 - P0322393    ",12/21/2015,"12/21/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73055,"Completed","Kwik Trip, Inc.","1626 Oak St",,"La Crosse","WI","54603-2308","United States","Voluntary: Firm Initiated","E-Mail","WI, IA, MN.","F-1835-2016","Class II","Ice Nuggets, 10 lb plastic bag, UPC 3977919140."," approx. 115339.3 10 lb/bag","Kwik Trip Inc reported a plastic fan broke which lead to pieces of plastic contaminating the ice. ","07/26/2016",," All lots with dates prior to 01/11/16.",1/12/2016,"01/12/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73056,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada","Z-0800-2016","Class I","Single Lumen Pressure Monitoring Sets and Trays    The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.","2280","A manufacturing process may lead to catheter tip fracture and or separation.  Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids","02/24/2016",," RPN/Catalog number:  C-PMS-250  C-PMS-2502-15-3.5  C-PMS-2502-15-5.0  C-PMS-250-MONTES-A-092084  C-PMS-251  C-PMS-251J  C-PMS-300  C-PMS-300-CHILDRENS-A-032988  C-PMS-300J  C-PMS-301  C-PMS-301J  C-PMS-301J-PKG  C-PMS-400J    Lots:  6028502  6034979  6083984  6194848  NS6014456  NS6014457  6148788  6254047  5906417  6160213  NS6064797  NS6014483  NS6175149  NS6184593  NS6187516  NS6014458  5889463  5898283  5922849  5941909  5964565  5976506  6021072  6028497  6143834  6160238  NS5933957  5828147  5941919  NS5932835  NS5932836  NS6050233  NS6072523  NS6108227  NS6130497  5803601  6034985  6075213  NS5833882  NS5892109  NS5892110  NS5919920  NS6021136  NS6054843  NS6072524  NS6075557  NS6082375  NS6108228  NS6148658  6067668  ",1/6/2016,"01/06/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73056,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada","Z-0801-2016","Class I","Femoral Artery Pressure Monitoring Catheter Sets and Trays    The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.","1515","A manufacturing process may lead to catheter tip fracture and or separation.  Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids","02/24/2016",," RPN/Catalog number:  C-NPMS-501J-15  C-NPMSY-501J-15  C-PMS-300-FA  C-PMS-300J-FA  C-PMS-301-FA  C-PMS-301J-FA  C-PMS-400-FA  C-PMS-401-FA  C-PMS-401J-FA  C-PMSY-300-FA  C-PMSY-300J-FA  C-PMSY-400J-FA  C-PMSY-401-FA    Lots:  6054830  6054831  6072436  6078670  6081720  6083977  NS6054841  NS6054842  NS6075552  NS6082372  NS6082373  NS5833881  NS5881267  NS5881268  NS5892106  NS5892107  NS5892108  NS5914766  NS5922706  NS5928596  NS5932820  NS5932821  NS5967447  NS5967448  NS5967449  NS6014474  NS6014475  NS6014484  NS6014485  NS6042778  NS6042795  NS6042796  NS6050046  NS6063330  NS6063354  NS6075555  NS6100599  NS6100600  NS6108225  NS6124985  NS5888542  NS5928597  NS6028553  NS6042797  NS6090273  NS6090274  NS6100601  NS6130149  5800570  5860387  5891906  5980254  6003160  6062725  6143835  NS5830771  NS5866956  NS5866957  NS5881269  NS6014460  NS6042798  NS6050047  NS6075534  NS6075556  5895598  6129058  6148613  NS5932822  NS5932837  NS5994907  NS6130498  6067782  6139280  NS6042805  NS6130500  6049951  6137353  6139281  6034986  6049957  6067784  NS5833887  NS5866959  NS5881272  NS5881334  NS5881335  NS5919925  NS6047449  NS6054847  NS6054848  NS6072526  NS6072555  NS6082379  NS6090277  NS6105921  NS6124989  NS6130501  NS6148639  NS5866961  NS5866962  NS5892115  NS5922709  NS5932844  NS5974256  NS6031988  NS6031990  NS6042578  NS6050052  NS6050053  NS6031992  NS6031993  NS6130504  NS6137424  NS6054849  ",1/6/2016,"01/06/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73056,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada","Z-0802-2016","Class I","Radial Artery Pressure Monitoring Catheter Sets and Trays    The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.","12691","A manufacturing process may lead to catheter tip fracture and or separation.  Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids","02/24/2016",," RPN/Catalog number:  C-PMS-250-RA  C-PMS-251-RA  C-PMS-300-RA  C-PMS-300-RA-CHOP  C-PMS-301J-RA  C-PMS-301-RA  C-PMS-400-RA  C-PMSY-250-RA  C-PMSY-300-RA  C-PMSY-301-RA    Lots:  6049998  6160195  6160212  NS5898558  NS6063328  NS6178204  NS6178206  5895605  6191185  5793196  5800313  5800443  5800569  5806981  5810905  5810917  5824484  5824546  5824547  5824548  5866984  5866985  5866986  5870319  5881447  5881519  5889496  5891905  5911486  5922847  5922848  5925742  5928632  5939446  5939447  5939448  5976502  6025016  6025094  6033768  6034981  6034983  6050000  6062738  6062742  6067675  6067676  6075206  6075207  6083936  6083954  6083985  6083986  6129056  6148790  6160236  6165591  6174974  6175289  6191362  6269150  NS6063331  NS6108226  NS6170739  NS6170767  5905252  6003109  NS6072553  5793197  5800571  5800572  5824485  5824551  5845063  5864072  5866988  5873125  5881151  5881152  5884641  5884642  5889464  5892063  5892064  5922850  5939431  5942091  5951549  5953768  5954322  5967404  5974281  5994817  5996926  6003161  6003162  6017048  6025095  6025145  6034984  6042699  6050002  6075210  6075211  6075212  6081723  6083988  6100756  6124809  6125111  6148791  6153122  6160239  6160240  6168131  6171368  6187477  6250532  6059759  NS6047396  NS6047397  NS6047398  NS6047399  NS6047440  NS6047442  6124812  5793192  5824526  5884647  5892068  5942090  5967410  6003167  6059765  6134128  6153124  6168137  6254068  5793193  5866995  5892069  5942092  6003168  6025099  6067664  6168138  ",1/6/2016,"01/06/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73056,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada","Z-0799-2016","Class I","Single Lumen Central Venous Catheter Sets and Trays    The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.","1341","A manufacturing process may lead to catheter tip fracture and or separation.  Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids","02/24/2016",," RPN/Catalog number:  C-PMS-250-PED  C-PMS-251J-PED  C-PMS-300-CHILDRENS-032285  C-PMS-301J-PED  C-PMS-301J-PED-BH  C-PMS-301-PED  C-PMSY-250  C-PMSY-251  C-PMSY-251J  C-PMSY-300  C-PMSY-300J  C-PMSY-300J-UT-A  C-PMSY-300-PED  C-PMSY-301J  C-PMSY-301J-BH  C-PMSY-301J-PED  C-PMSY-301J-PED-OTP  C-PMSY-400-HURLEY-022388  C-PUM-300J  C-PUM-301  C-PUM-301J  C-PUMY-301J    Lots:  NS6168054  NS6178118  NS6063352  NS5855441  5824486  5898058  5967405  6079119  NS5932737  NS6028554  NS6042799  NS5922707  NS5932811  NS6145002  5987014  NS6178099  NS6028540  NS5830758  NS5866960  NS5918174  NS5974263  NS6042577  NS6047450  NS6090278  NS6105922  NS6124990  NS5881337  NS5892116  NS6031991  5782006  5855241  NS5881336  NS5892113  NS5945282  6062729  NS5970950  NS6108255  NS6153173  5793198  5925744  6010406  6148800  NS5796483  NS5928602  NS6047451  NS5970942  NS5954223  5945120  NS5954224  5973354  ",1/6/2016,"01/06/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73057,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","US distribution in the state of FL and PA.","Z-0809-2016","Class II","Exactech Acapella One Interbody Fusion Device Parallel.  Orthopedic Spinal Surgery Device.      Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.  ","19 pieces","Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel (05-090-02-1610)","02/12/2016",," Catalog # 05-090-02-1610 // Expiration 07/2023  Serial #'s: 4053365, 4053366, 4053367, 4053368, 4053369, 4053370, 4053371, 4053372, 4053373, 4053374, 4053375, 4053376, 4053377, 4053378, 4053379, 4053380, 4053381, 4053382, and 4053383",9/28/2015,"09/28/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73058,"Ongoing","Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy","200 E Willow Ave",,"Wheaton","IL","60187-5463","United States","Voluntary: Firm Initiated","Telephone","Distributed in IL.","B-0448-16","Class II","Autologous serum mixed with sodium chloride solution for ophthalmic application.","185 vials, 3 mL each","Autologous Drops (serum tears), that may be associated with lack of stability and sterility assurance, were distributed. ","04/22/2016",," Lot# 06092415, Rx# 485751, Dispense date 09/24/2015, Exp date: 03/23/2016 (30 vials distributed)  Lot# 06092415, Rx# 485755, Dispense date 09/24/2015, Exp date: 03/23/2016 (40 vials distributed)  Lot# 15062615, Rx# 482608, Dispense date 06/26/2015, Exp date 12/26/2015 (35 vials distributed)  Lot# 18061815, Rx# 480967, Dispense date 06/18/2015, Exp date 12/18/2015 (40 vials distributed)  Lot# 19061815, Rx# 476601, Dispense date 06/18/2015, Exp date 12/18/2015 (40 vials distributed)  ",12/30/2015,"12/30/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73059,"Ongoing","Olympus Corporation of the Americas","3500 Corporate Pkwy","PO Box 610","Center Valley","PA","18034-0610","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution except PR","Z-0757-2016","Class II","Olympus TJF-Q180V flexible gastrointestinal Duodenoscope    Product Usage:  This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.  ","4436","Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.","02/04/2016",," all codes",1/8/2016,"01/08/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73060,"Ongoing","BioMerieux SA","Chemin De L'Orme",,"Marcy L'Etoile",,,"France","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of: AL, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TX, VT, VA, WA, WV, WI, WY","Z-0756-2016","Class II","API ZYM Bx2 (Ref 70493)    Product Usage:  ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.  ","13,271","Discrepant identification results related to API identification strips.  These discrepant identification results are due to false negative results on the tests of the strips linked to the ZYM B reagent.","02/04/2016",," Lot No. PF - 1003765610/Lot No. Ampules - 1003693040/Exp. date 1/15/16  Lot No. PF - 1003772410/Lot No. Ampules - 1003711170/Exp. date 1/19/16  Lot No. PF - 1003772470/Lot No. Ampules - 1003733320/Exp. date 1/29/16  Lot No. PF - 1003787970/Lot No. Ampules - 1003693020/Exp. date 1/12/16  Lot No. PF - 1003790030/Lot No. Ampules - 1003790010/Exp. date 2/26/16  Lot No. PF - 1004077210/Lot No. Ampules - 1004024590/Exp. date 5/25/16  Lot No. PF - 1004097610/Lot No. Ampules - 1004040410/Exp. date 6/2/16  Lot No. PF - 1004355410/Lot No. Ampules - 1004306800/Exp. date 9/20/16  Lot No. PF - 1004355730/Lot No. Ampules - 1004306790/Exp. date 9/20/16",1/8/2016,"01/08/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73061,"Terminated","The American National Red Cross - Southern Region","9851 Commerce Way",".","Douglasville","GA","30135-3101","United States","Voluntary: Firm Initiated","Other","California; Georgia","B-0247-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","01/20/2016","01/20/2016"," W200315913640",12/10/2015,"12/10/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73061,"Terminated","The American National Red Cross - Southern Region","9851 Commerce Way",".","Douglasville","GA","30135-3101","United States","Voluntary: Firm Initiated","Other","California; Georgia","B-0246-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","01/20/2016","01/20/2016"," W200315444309",12/10/2015,"12/10/2015",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73062,"Terminated","The American National Red Cross - Southern Region","9851 Commerce Way",,"Douglasville","GA","30135-3101","United States","Voluntary: Firm Initiated","FAX","Georgia","B-0316-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Mislabelled RBC was distributed.","02/25/2016","02/25/2016"," W200315456802",11/20/2015,"11/20/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73064,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.","Z-1175-2016","Class II","Toshiba DRAD-3000E FPD Wireless System      Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices.   ","28"," and the same message  window appeared. This sam","03/21/2016",," Serial number : USB1522023",1/14/2016,"01/14/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73065,"Terminated","National Fish & Seafood, Inc.","11-15 Parker St",,"Gloucester","MA","01930-3017","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio, Michigan, Indiana, Maryland, New York, Illinois, Texas, Florida, Wisconsin, Minnesota, Georgia, Pennsylvania, Utah, California, Oregon, New Jersey, Tennessee","F-1048-2016","Class I"," MATLAW'S INDIVIDUALLY QUICK FROZEN FROZEN SHRIMP Farm Raised Product of: Vietnam Distributed by: National Fish & Seafood Inc., Gloucester, MA 01930 U.S.A 10 X 2 LB (0.907 Kg) Bags Net WT 20 LB (9.07 Kg).    Catalog Number: :  MLBG76006880  UPC Code: 0 41625 12012 4","32, 080 lbs - 1604 cases","Salmonella","04/08/2016","06/23/2016"," Lot Numbers: 20860R 20001Q:   Best By 02 23 17 Production Code 26021023515;  Best By 02 26 17 Production Code 26021023815;  Best By 02 25 17 Production Code 26021023715;  Best By 02 27 17 Product.ion Code 26021023915;  Best By 02 28 17 Production Code 26021024015;  Best By 02 24 17 production Code 26021023615",1/12/2016,"01/12/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73066,"Ongoing","Carnivore Meat Company, LLC","2878 Ontario Rd",,"Green Bay","WI","54311-6877","United States","Voluntary: Firm Initiated","Telephone","CA, CO, FL, GA, RI, TX, and WA","V-530-2016","Class I","Vital Essentials Frozen Chicken Patties Entree for Dogs, Net Wt. 6 lbs. (2.72kg).  Keep Frozen. UPC 33211-00807.","1872 lbs.","Carnivore Meat Company is recalling one batch (lot # 11475) of Vital Essentials 6 lb. Frozen Chicken Patties Entree for Dogs  because it has the potential to be contaminated with Salmonella.","09/28/2016",," Lot # 11475, Best By date 20161108 (11/08/2016)",1/12/2016,"01/12/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73067,"Terminated","EndoChoice, Inc.","11810 Wills Rd Ste 100","ATTN: Theron Gober","Alpharetta","GA","30009-2081","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution.  US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.","Z-0694-2016","Class II","Fuse 1C Colonoscope","253 units","The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma.","01/27/2016","03/24/2016"," Item number: FSC-3300-SL, Model number: C38s, Serial numbers: F1C0218FUSE1CS,  F1C0219FUSE1CS,  F1C0220FUSE1CS,  F1C0221FUSE1CS,  F1C0222FUSE1CS,  F1C0223FUSE1CS,  F1C0224FUSE1CS,  F1C0225FUSE1CS,  F1C0228FUSE1CS, F1C0229FUSE1CS,  F1C0230FUSE1CS, F1C0231FUSE1CS,  F1C0232FUSE1CS, F1C0233FUSE1CS,  F1C0235FUSE1CS,  F1C0236FUSE1CS,  F1C0237FUSE1CS,  F1C0238FUSE1CS,  F1C0239FUSE1CS,  F1C0241FUSE1CS,  F1C0243FUSE1CS,  F1C0245FUSE1CS,  F1C0246FUSE1CS,  F1C0247FUSE1CS,  F1C0248FUSE1CS,  F1C0249FUSE1CS,  F1C0250FUSE1CS,  F1C0251FUSE1CS, F1C0252FUSE1CS,  F1C0253FUSE1CS,  F1C0254FUSE1CS,  F1C0255FUSE1CS,  F1C0256FUSE1CS,  F1C0257FUSE1CS,  F1C0258FUSE1CS,  F1C0259FUSE1CS, F1C0261FUSE1CS,  F1C0262FUSE1CS, F1C0263FUSE1CS,  F1C0264FUSE1CS,  F1C0266FUSE1CS,  F1C0267FUSE1CS,  F1C0268FUSE1CS,  F1C0269FUSE1CS,  F1C0270FUSE1CS,  F1C0271FUSE1CS,  F1C0272FUSE1CS,  F1C0273FUSE1CS,  F1C0274FUSE1CS,  F1C0276FUSE1CS,  F1C0277FUSE1CS,  F1C0278FUSE1CS,  F1C0279FUSE1CS,  F1C0280FUSE1CS,  F1C0281FUSE1CS, F1C0282FUSE1CS, F1C0284FUSE1CS,   F1C0285FUSE1CS, F1C0287FUSE1CS, F1C0288FUSE1CS, F1C0289FUSE1CS, F1C0290FUSE1CS, F1C0291FUSE1CS, F1C0292FUSE1CS, F1C0293FUSE1CS, F1C0294FUSE1CS, F1C0296FUSE1CS, F1C0297FUSE1CS, F1C0298FUSE1CS, F1C0299FUSE1CS, F1C0300FUSE1CS, F1C0301FUSE1CS, F1C0305FUSE1CS ; Item number: FSC-330-C6333, Model number: C38s-150, Serial numbers: 0600200, 0600201, 0600202, 0600203, 0600204, 0600205 and 0600206; Item number: FSC-3300-ST, Model number: F1C,  Serial numbers: F1C0214FUSE1C-150F1C0241FUSEC1, F1C0244FUSE1C-A, F1C0244FUSEC1, F1C0255FUSE1C-A, F1C0259FUSE1C, F1C0271FUSE1C, F1C0283FUSE1C, F1C0312FUSE1C, F1C0313FUSE1C, F1C0322FUSE1C, F1C0334FUSE1C, F1C0356FUSE1C, F1C0382FUSE1C, F1C0388FUSE1C, F1C0425FUSE1C, F1C0433FUSE1C, F1C0437FUSE1C, F1C0447FUSE1C,  F1C0449FUSE1C, F1C0458FUSE1C, F1C0461FUSE1C, F1C0475FUSE1C, F1C0479FUSE1C, F1C0484FUSE1C, F1C0488FUSE1C, F1C0489FUSE1C, F1C0516FUSE1C, F1C0526FUSE1C, F1C0530FUSE1C, F1C0531FUSE1C, F1C0536FUSE1C, F1C0537FUSE1C, F1C0540FUSE1C, F1C0542FUSE1C, F1C0543FUSE1C, F1C0544FUSE1C, F1C05",12/18/2015,"12/18/2015",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73068,"Ongoing","S & S Foods, Inc.","1209 E Highline Ln",,"Mustang","OK","73064-6406","United States","Voluntary: Firm Initiated","E-Mail","Oklahoma","F-1253-2016","Class III","Suan's Scotch Bonnet Pepper Relish 9.8 oz. packaged in a glass jar with a metal lid.","262 jars","Some jars were reported to have swollen or leaking lids.","04/27/2016",," BEST By date 12-01-2016 to 07-31-2017.",1/14/2016,"01/14/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73069,"Ongoing","Orthofix, Inc","3451 Plano Pkwy",,"Lewisville","TX","75056-9453","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, Spain, Italy, and Australia.","Z-0797-2016","Class II","Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512)    Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).","36 units","There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization.  In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.","02/10/2016",," BS535418105,  BS535419118,  BS535420030,   BS535419124,  BS562325021,  BS535418158,  BS535418038,  BS535418138,  BS535418012,  BS535419006,  BS535420039,   BS535418127,   BS549024010,  BS535419141,  BS535418081,  BS535418111,  BS535418117,  BS535420041,  BS535418144,  BS535420081,  BS535419151,  BS562325006,  BS546825008,  BS535418002,  BS535418013,  BS535418131,  BS535420006,  BS535420010,  BS535420026,  BS535420047,  BS556219012,  BS556219026,  BS535418109,  BS535420082,  BS557717009, and   BS562325023.",1/8/2016,"01/08/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73070,"Completed","Family Dollar Stores - NC Distribution Center","10401 Old Monroe Rd",,"Matthews","NC","28105-8332","United States","Voluntary: Firm Initiated","E-Mail","Nationwide - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, SD, TX, UT, VT, VA, WV, WI, WY","F-1261-2016","Class II","Family Gourmet Natural Whole Grain Brown Rice, 32 oz. (2 lb.) plastic bag (SKU: 1230394) ","315,590 units (total rice)","Live insects were noted inside several unopened bags of product.","04/28/2016",," Lot # 3047GP15; Best By Date: February 16, 2016  Lot # 3076GP15; Best By Date: March 17, 2016",9/8/2015,"09/08/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73070,"Completed","Family Dollar Stores - NC Distribution Center","10401 Old Monroe Rd",,"Matthews","NC","28105-8332","United States","Voluntary: Firm Initiated","E-Mail","Nationwide - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, SD, TX, UT, VT, VA, WV, WI, WY","F-1260-2016","Class II","Family Gourmet Long Grain Enriched White Rice, 32 oz. (2 lb.) plastic bag (SKU: 1218898)  ","315,590 units (total rice)","Live insects were noted inside several unopened bags of product.","04/28/2016",," Lot # 061HO415; Best By Date: March 02, 2017  Lot # 054HO215; Best By Date : February 23, 2017  ",9/8/2015,"09/08/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73071,"Terminated","Resmed Corporation","9001 Spectrum Center Blvd",,"San Diego","CA","92123-1438","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR.","Z-0746-2016","Class II","Astral 100, 150  Model: 27001, 27003  In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.","14,736","Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.","02/03/2016","04/22/2016"," Serial Numbers:  22141311907  22151237236  22141311910  22151237228  22151572231  22151666684  22151237233  22151135073  22141458006  22151572230  22151135061  22151397090  22151008941  22141311872  22151614456  22151135058  22141269867  22151555593  22151483516  22151483534  22151325490  22151163315  22141308812  22151555584  22151311349  22141311870  22151602423  22151325513  22151555618  22151165427  22151165476  22151468419  22151397046  22151073624  22151165376  22151602615  22151445731  22151326787  22151483592  22151602601  22151165492  22151555637  22151311317  22151608382  22151608488  22151310708  22151326727  22151165536  22151468487  22151165539  22151503647  22151310704  22151602504  22141311844  22151572224  22151503641  22151399554  22141668174  22151468486  22151397041  22151602409  22151311327  22151483580  22151483551  22151602621  22151614517  22151602637  22151445633  22151602631  22151009061  22151397094  22151397076  22151445751  22151483560  22151555656  22151483543  22151555621  22151325478  22151614509  22151445655  22151161883  22141668179  22151310724  22151445705  22151468414  22151326801  22151135048  22151349223  22151298935  22151165471  22151445645  22151326730  22151515901  22151483517  22151602491  22151514288  22151483533  22151163339  22151224469  22151602641  22151326810  22151555589  22151468523  22151445643  22151326723  22151602608  22151445756  22151399564  22151399540  22151349248  22151326815  22141322503  22151310718  22151608454  22151326837  22151468411  22151483527  22151397132  22151325496  22151326710  22141308814  22151602448  22151022615  22151009030  22151515943  22151031747  22151073632  22151602650  22151311328  22151514256  22151608420  22151163319  22141381474  22151022621  22141620659  22141297647  22151468485  22151483825  22151468517  22151483490  22151165378  22151445755  22151399532  22151555653  22151009060  22151515947  22151397033  22141308871  22151445725  22151249725  22151483572  22151483601  22151399539  22151468483  22151468475  22141322553 ",1/13/2016,"01/13/2016",2/10/2016,"02/10/2016","62  22151325491  22151602459  22151009049  22151163300  22151602669  22151165349  22151326777  22141647484  22151311487  22151325505  22151445709  22151503599  22151165452  22151009053  22151445703  22151009052  22151483823  22151515946  22151483546  22151602626  22151572222  22151022626  22151468522  22151483564  22151602432  22151311360  22151602494  22151602478  22151445717  22151349247  22151310747  22151483827  22151445779  22151397100  22151165515  22141644767  22151165490  22151073627  22151165401  22151325507  22151602698  22151468404  22151298945  22151483605  22151298948  22151163317  22151614498  22151009039  22151311362  22151608445  22151397109  22151349243  22151073641  22151311319  22151375652  22141311893  22151483567  22141308819  22151311496  22141322526  22151608476  22151165457  22151514294  22151326788  22151397089  22151483822  22151397110  22151310750  22151483588  22151602582  22151514275  22151483508  22151468462  22151483597  22151311332  22151602682  22151399559  22151135050  22151572260  22151608423  22151445708  22151515923  22151572239  22151514257  22151397115  22151608385  22151397142  22141308882  22151503607  22151555590  22151468510  22151602585  22151445670  22151468452  22151602586  22151326770  22151555666  22151163330  22151325518  22151602499  22151572263  22151602643  22151311480  22151445758  22141647450  22151514276  22151224513  22151161876  22151445671  22151608480  22151555670  22151311515  22141336216  22151483554  22151483821  22151468468  22151602451  22151326757  22151311367  22151399521  22151165425  22151483529  22151445650  22151163328  22151311350  22151325464  22151349241  22151468455  22141311900  22151614506  22151602495  22151163342  22151602439  22151445681  22151515932  22151009045  22151468459  22151503645  22141311882  22151602465  22151602690  22151161870  22151326776  22151310691  22151445715  22151165393  22151022618  22151515903  22141311841  22151311461  22151445760  22141322581  22151326725  22151298931  22151445771  22151602502  22151468436  ",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73072,"Ongoing","Mayne Pharma Usa","1240 Sugg Pkwy",".","Greenville","NC","27834-9006","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0585-2016","Class II","Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505","a) 52034 bottles and b) 22074 bottles","Lack of Assurance of Sterility: Failed preservative effectiveness testing","01/20/2016",," a) Lot numbers: 0378-7110-35 AD4819, Exp. Date: 08-2016; 0378-7110-35 AC7894, Exp. Date: 05-2016; 0378-7110-35 AD2527, Exp. Date: 06-2016; 0378-7110-35 AC6330, Exp. Date: 05-2016; 0378-7110-35 AC2330, Exp. Date: 04-2016 and     b) Lot numbers: 0378-7109-35 AD4515, Exp. Date: 04-2016 and 0378-7109-35 AC2328, Exp. Date: 01-2016.",1/5/2016,"01/05/2016",1/27/2016,"01/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73075,"Terminated","Central California Blood Center","4343 W Herndon Ave",,"Fresno","CA","93722-3794","United States","Voluntary: Firm Initiated","E-Mail","California","B-0252-16","Class II","Apheresis Platelets, Leukocytes Reduced","3 units","Apheresis products, in which leuko reduced units did not meet WBC count specification, were distributed.","02/08/2016","02/08/2016"," W115915014061 (triple collection)",12/22/2015,"12/22/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73076,"Ongoing","DePuy Orthopaedics, Inc.","700 Orthopaedic Dr",,"Warsaw","IN","46582-3994","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South Africa, Spain, Sweden, South Korea, Switzerland, Thailand, Turkey, UAE, UK, and Brazil.","Z-0787-2016","Class II","SIGMA HP MBT Non-Keel Punch Knee Instrument.  Designed to be used as an option in stabilizing the tibial trial during trial reduction. ","351","Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin.  Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space.  Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.","02/09/2016",," Cat. No.  GTIN  Lot  Description    950502016  10603295227366  ABB92402  SIGMA HP MBT Cemented Punch size 1-1.5    950502017  10603295227373  ABB84491  SIGMA HP MBT Cemented Punch size SZ 2-3    950502018  10603295227380  ABB92358  SIGMA HP MBT Cemented Punch size SZ 4-7    950502020  10603295227403  ABC33125  SIGMA HP MBT Noncemented Punch size 2-3    950502020  10603295227403  ABB81733  SIGMA HP MBT Noncemented Punch size SZ 2-3    950502020  10603295227403  ABB81732  SIGMA HP MBT Noncemented Punch size SZ 2-3    950502021  10603295227410  ABB39952  SIGMA HP MBT Noncemented Punch size SZ 4-7    950502021  10603295227410  ABC33123  SIGMA HP MBT Noncemented Punch size SZ 4-7",1/8/2016,"01/08/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73077,"Ongoing","Fresenius Medical Care Renal Therapies Group, LLC","920 Winter St",,"Waltham","MA","02451-1521","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: KS, LA, MS, OK, and TX.","Z-0887-2016","Class II","Fresenius Naturalyte Liquid Acid Concentrate  Catalog Number: 08-2301-3    Intended Use: Acid Concentrate for Bicarbonate Dialysis","848 (212 cases)","On the label calcium (Ca)  listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.","02/25/2016",," Lot Number: 15STAC072  Exp Date: 2017-12-31",1/18/2016,"01/18/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73078,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution to OH and NY","Z-0752-2016","Class II","INFX-8000V Bi-Plane X-Ray Interventional System        X-ray systems","4",".","02/09/2016",," Serial Numbers  ACA1492002, AAA1492001, W4B1442020, and W4B1432018.",8/14/2015,"08/14/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73080,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution and US in the state of CA.","Z-1030-2016","Class II","Dimension Vista System  B2 Microglobulin Flex reagent cartridge and urine stabilizer       Catalog #K7024  SMN: 10445889	Lot #15246MA    Product Usage:  The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.  ","1637 units.","Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer B2MIC. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the patients clinical status and other marker","03/01/2016",," Lot #: 15037MA - foreign  15175MA - foreign  15204MA- foreign  15246MA (Distributed in US)  15267MA - foreign  ",11/3/2015,"11/03/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0589-2016","Class II","Custard Bismark 9999954007,  540070, 24 per bulk tote.  ","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0591-2016","Class II","Cinnamon Cinnsations,  4 count Net WT 19 oz (540g),  3977953052,  530530.  ","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0593-2016","Class II","KBS Bagel Cinnamon Crunch Bagel,  9999953939,  539160, 24 per bulk tote.  ","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0595-2016","Class II","KBS Plain Bagel,  9999953936,  539157,  24 per bulk tote.  ","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0587-2016","Class II","Filled Long Johns 9999954006,  540062, 28 per bulk tote.  ","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0590-2016","Class II","Triple Choc Bismark 9999954048,  540484,  24 per bulk tote.  ","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0585-2016","Class II","Glazers Donuts,  3977904033 040337, 6 PK in cardboard bakery box (fresh).","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0592-2016","Class II"," Persian,  9999954011 540112,  24 per bulk tote, frozen.  ","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0586-2016","Class II","Plain Long Johns 9999954013,  540138 each, product shipped frozen (28 per bulk tote).","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0588-2016","Class II","Jelly Bismark 9999954008,  540088,  24 per bulk tote.  ","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73081,"Ongoing","Kwik Trip Bakery","2306 Commerce St",,"La Crosse","WI","54603-1701","United States","Voluntary: Firm Initiated","E-Mail","WI, MN, IA","F-0594-2016","Class II","KBS Cinn Raisin  Bagel,  9999953937,  539158,  24 per bulk tote.","approx. 288755.44 product counts for all products","Kwik Trip, Inc. is recalling various bakery goods which might be contaminated with pieces of  plastic due to using plastic contaminated ice nuggets as an ingredient.","02/12/2016",," All lots manufactured prior to but not including 01/13/2016.",1/13/2016,"01/13/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73083,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..","Z-1028-2016","Class II","Kopans Breast Lesion Localization Needle  The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.","134","Product potentially exposed to body fluids during processing.  Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.","02/29/2016",," Catalog # DKBL-20-7.0-A  Lot # 6215428  date of manufacture 09/17/2015",1/8/2016,"01/08/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73084,"Ongoing","Smith & Nephew, Inc.","150 Minuteman Rd",,"Andover","MA","01810-1031","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US Nationwide and countries of AT, AU, BE, CA, CH, CL, CN, CZ, DB, DE, DK, EE, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, LT, LV, NL, NO, PL, PR, PT, RO, SE, SG, SI, TH, TR, and ZA.","Z-0793-2016","Class II","Smith & Nephew BEAVER Blade 4.0mm  Part Number: 72203307  Orthopedic surgical instrument used in hip arthroscopy.","69043 units","Blade exhibiting fracture during hip arthroscopy procedures","02/10/2016",," Lot Codes: ( Devices within Expiry)  3009063  3009559  3010117  3010720  3011688  3012095  3012366  3014560  3016455  3018390  3020194  3022929  3025736  3027818  3030178  3032892  3036529  3071312  3071546  3074279  3074280  3076377  3076427  3085969  3089220  3093258  3098516  3101929  3104300  3107341  3111387  3114657  3115976  3119607  3123832  3124356  3124896  3125448  3128384",1/11/2016,"01/11/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73086,"Ongoing","Viewray Incorporated","2 Thermo Fisher Way",,"Oakwood Village","OH","44146-6536","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA, FL, MO & WI., and Internationally to Republic of Korea.","Z-0806-2016","Class II","MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. ","5 units","The system loaded a completion fraction in the incorrect order after a treatment interruption.","02/12/2016",," Model #: 10000, Serial #'s: 100, 101, 102, 104 & 105",12/24/2015,"12/24/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73087,"Ongoing","Fresh Express Incorporated","900 E Blanco Rd",,"Salinas","CA","93901-4419","United States","Voluntary: Firm Initiated","Telephone","CT, FL and MD.","F-1252-2016","Class I","Fresh Express, Family Size Baby Spinach, Net Wt. 12oz in clear flexible plastic bags.","350 Cases x 8 bags of 12oz each = 2800 12 oz bags.","Undeclared allergen: Almonds.","04/27/2016",," Use By Jan 24, Product Code: G010A17A, Product of USA",1/15/2016,"01/15/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0892-2016","Class II","Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope","111 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2203925,2001221,2205721,2102757,2102758,2000420,2419219,2001053,2001248,2001285,  2103701,2307844,2408213,2419900,2419587,2419391,2307188,2408135,2408138,2205035,  2205321,2306154,2103419,2000710,2408319,2103515,2204385,2204384,2510491,2419538,  2001154,2103711,2101909,2306353,2103416,2000041,2103345,2408554,2408663,2307057,  2103617,2419115,2306153,2205297,2205019,2306510,2419520,2000431,2408693,2205441,  2419920,2204907,2102886,2102877,2306758,2306495,2000590,2510424,2205820,2307047,  2307014,2307030,2307052,2307066,2306132,2204209,2204663,2204110,2419379,2205371,  2205380,2205384,2408566,2204782,2103708,2101363,2419549,2001300,2103162,2103161,  2510637,2419320,2204264,2204882,2408764,2408487,2419319,2510526,2204325,2419745,  2204606,2103269,2102524,2419255,2419198,2204551,2000906,2307366,2307304,2103274,  2510151,2419258,2102792,2307251,2102786,2307350,2419462,2407416,2306959,2306800,  2307470  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0899-2016","Class II","Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope","9 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2813102,2914792,2711389,2711291,2812266,2812356,2802476,2600371,2914632,  2914333  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0894-2016","Class II","Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope ","185 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2501321,2603572,2603751,2707414,2500011,2705546,2604232,2603079,2500780,2808458,  2001720,2002054,2001724,2001723,2501905,2809593,2705417,2500916,2808421,2809413,  2705911,2203846,2808998,2501295,2809000,2705264,2603152,2809444,2706645,2102694,  2203503,2809061,2705453,2706361,2102880,2002142,2500236,2705566,2705242,2500869,  2501511,2603466,2706515,2706908,2706905,2706442,2001193,2501087,2501807,2705697,  2705333,2900664,2501186,2800014,2707065,2705978,2501786,2002139,2002083,2809935,  2809951,2707769,2304352,2707593,2304332,2001807,2808518,2602866,2602846,2706687,  2001864,2808509,2705957,2706072,2705888,2602226,2102504,2501901,2501941,2900354,  2501928,2203680,2500463,2203472,2707126,2603744,2707886,2901047,2603180,2604176,  2707760,2502049,2602102,2706079,2706071,2603287,2602732,2602730,2900859,2705386,  2808456,2705662,2809750,2705605,2705589,2808232,2706404,2500529,2602714,2501738,  2706823,2809590,2604997,2604999,2604989,2808704,2808713,2604264,2706028,2800064,  2808452,2500660,2501776,2808455,2501961,2501854,2809540,2501472,2602442,2603316,  2808333,2707097,2706919,2707574,2501001,2706156,2605035,2501890,2603001,2603053,  2706604,2707840,2501962,2605156,2808499,2304527,2603134,2604932,2102468,2500067,  2501704,2501595,2603135,2705891,2807973,2705461,2603530,2707882,2706068,2807964,  2706013,2705465,2707101,2705475,2707892,2500032,2602610,2501680,2707346,2707374,  2707382,2500458,2500653,2808341,2808894,2603444,2001317,2602502,2604160,2500576,  2706920,2808353,2705694,2705593,2900826,2900764,2604623,2901059  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0909-2016","Class II","Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope","2 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2913081,2600279    ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0902-2016","Class II","Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope","43 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2427253,2528563,2315445,2314847,2212887,2315826,2000027,2314864,2315955,  2213834,2212872,2315727,2315729,2213866,2416648,2427952,2416195,2314929,  2111326,2416125,2213186,2111744,2315611,2213344,2314241,2427731,2427747,  2314885,2314876,2314596,2010689,2314038,2315864,2010526,2315138,2315140,  2315540,2111669,2212839,2212640,2427816,2314895,2427562  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0890-2016","Class II","Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope","275 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2003035,2704738,2704724,2809007,2808939,2105965,2808765,2004365,2004669,2902353,  2902347,2902342,2004663,2602122,2105267,2601317,2806231,2805648,2808714,2807053,  2807205,2705548,2806959,2704571,2704560,2704611,2705574,2805740,2004809,2703149,  2601037,2901878,2702879,2702870,2703000,2704441,2902854,2003990,2003988,2705078,  2004004,2702967,2808478,2809057,2601256,2601255,2808955,2808944,2807181,2809202,  2206863,2900222,2900226,2900745,2901670,2900229,2003063,2902820,2002897,2600226,  2602014,2003460,2900362,2900112,2806936,2003147,270517S,2704934,2909893,2909872,  2909863,2901323,2806640,2704259,2106188,2106273,2601745,2704573,2003712,2807584,  2807557,2807713,2106293,2106290,2106303,2106300,2807679,2704771,2704770,2704792,  2704800,2602187,2704885,2808319,2602175,2808317,2602190,2702863,2808937,2809103,  2901274,2002984,2002916,2901389,2901374,2601611,2805999,2004421,2704766,2703778,  2705367,2795393,2805917,2805916,2809093,2902295,2004720,2902215,2809055,2004871,  2705449,2809016,2809050,2808936,2808938,2805816,2809044,2900211,2901687,2601179,  2602413,2704897,2705037,2808546,2808581,2808537,2808530,2004462,2004461,2004458,  2004457,2004452,2900338,2806650,2900337,2704236,2704202,2806696,2902604,2703089,  2601468,2004949,2702732,2602089,2808410,2808402,2808413,2808391,2808412,2808415,  2808405,2808379,2807126,2705106,2805727,2702820,2705110,2702954,2704316,2103301,  2901080,2901329,2901326,2900094,2807461,2807463,2600468,2600432,2600183,2003532,  2602342,2901759,2901798,2901789,2901786,2004023,2004047,2601355,2206691,2807571,  2601721,2900252,2808516,2809385,2809049,2809068,2809056,2809060,2806692,2806772,  2702822,2807586,2703753,2106008,2902452,2704036,2601438,2703138,2601515,2703127,  2703134,2105807,2806871,2806863,2003144,2902409,2806880,2809409,2703670,2900905,  2900885,2900901,2900907,2900902,2900892,2902465,2105610,2600472,2602482,2004043,  2909906,2808548,2602237,2901669,2900507,2705345,2703372,2600645,2003099,2807855,  2806888,2807784,2807852,2704075,2900761,2806646,2900595,280",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0895-2016","Class II","Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope","21 devices","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2000023,2110370,2211004,2210975,2110666,2110583,2411739,22109S9,2311220,2812668,  2311177,2110498,2411568,2110745,2110711,2000181,2211040,2812506,2110504,  2311372,2012921  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0907-2016","Class II","Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope","3 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2700328,2912416,2811408    ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0903-2016","Class II","Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope","9 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2127866,2712435,2914674,2026893,2916216,2813792,2228261,2711888,2600329  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0905-2016","Class II","Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope","16 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2201503,2000062,2000105,2100621,2301997,2100999,2201555,2302025,2000061,  2201491,2000039,2100930,2402518,2302084,2100852,2101121  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0891-2016","Class II","Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope","232 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2601800,2807942,2104002,2807968,2003519,2003522,2003506,2003533,2003517,2807849,  2807869,2106004,2001560,2602147,2806411,2900360,2001561,2602228,2602229,2309559,  2309556,2602230,2805615,2103724,2103717,2002975,2805586,2806264,2806591,2705038,  2908746,2808043,2704335,2705017,2002983,2106012,2105987,2106009,2106019,2002580,  2002571,2104510,2002603,2900105,2001677,2105162,2909901,2703303,2909972,2601007,  2601084,2104893,2704419,2806374,2806356,2104903,2908799,2601095,2807327,2640009,  2702843,2207664,2207660,2702782,2106428,2806318,2908674,2702730,2704143,2703560,  2106031,2908845,2908846,2908841,2908838,2908852,2908837,2908840,2908843,2106106,  2601525,2807589,2808233,2309810,2805782,2909109,2601535,2104776,2104781,2806163,  2908908,2103829,2104924,2002427,2909718,2002323,2703941,2601588,2601200,2600263,  2309366,2602033,2602034,2900148,2106202,2003379,2000851,2003280,2106797,2003653,  2106800,2807548,2106791,2909657,2003008,2003228,2003232,2106134,2808000,2900241,  2900656,2000774,2106423,2003189,2106410,2309513,2900683,2106413,2807888,2309493,  2106264,2106409,2106422,2107166,2909809,2107149,2808271,2702536,2702344,2704544,  2704568,2704587,2703158,2104281,2703144,2602024,2002832,2805717,2002833,2600272,  2704020,2001762,2207531,2900586,2003128,2208594,2002620,2309683,2001688,2104750,  2104891,2309573,2000881,2309635,2001645,2001650,2106010,2104981,2104993,2104937,  2104890,2900413,2703200,2601190,2309828,2909966,2601218,2001712,2601205,2806343,  2704399,2704716,2105584,2105562,2105559,2104847,2601672,2601642,2602223,2808051,  2703078,2002521,2601938,2601866,2908548,2908499,2105744,2909315,2105988,2106017,  2309497,2309262,2104662,2806423,2105002,2105542,2001423,2309783,2703663,2703654,  2001547,2600215,2001708,2001468,2001514,2001519,2309845,2001311,2309105,2208046,  2208058,2806987,2704187,2208651,2309470,2003116,2003086,2003104,2208215,2001850,  2805888,2309542  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0910-2016","Class II","Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope","1 instrument","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Number 240T024    ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0896-2016","Class II","Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope","82 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2807123,2706168,2704697,2704696,2706205,2603823,2500832,2806683,2706253,  2706256,2704313,2704314,2008421,2602202,2602873,2806818,2704323,2603826,  2806676,2807264,2603013,2602S15,2501708,2806563,2501622,2602650,2501251,  2704932,2501637,2705315,2208812,2603725,2806595,2601980,2500885,2603935,  2705615,2705705,2705305,2500522,2907865,2705498,2603941,2807163,2807143,  2501819,2704886,2501553,2501744,2501768,2603178,2603044,2704755,2501372,  2807593,2705425,2208838,2208833,2706176,2008309,2704655,2705847,2706206,  2603321,2705005,2501169,2704832,2704839,2602446,2806333,2705983,2500287,  2601941,2501912,2604229,2501770,2806741,2806744,2603057,2704336,2806592,  2500217  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0908-2016","Class II","Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope","1 instrument","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Number 2303917    ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0901-2016","Class II","Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope","122 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:2707306,2705876,2807674,2706579,2009538,2706717,2604531,2706710,2501499,  2808113,2705777,2705730,2707016,2808779,2808777,2707125,2603799,2603795,  2603779,2603825,2604265,2807420,2604568,2501361,2500180,2602289,2909274,  2808355,2808217,2808957,2808020,2602290,2707346,2707406,2808556,2807468,  2603295,2604460,2705711,2009462,2602564,2501493,2808528,2500150,2603952,  2603243,2807523,2500982,2500983,2706852,2706892,2009425,2500420,2501392,  2603200,2807685,2501550,2501315,2706332,2604191,2604217,2706407,2603757,  2603028,2603031,2501324,2300253,2300252,2603975,2704883,2603976,2807640,  2808342,2707351,2602872,2808599,2706811,2707210,2500216,2501543,2808299,  2808816,2100010,2807695,2009697,2500686,2604024,2705191,2808911,2808139,  2602993,2705168,2500369,2500602,2501796,2705522,2009502,2808909,2808836,  2601829,2601832,2807758,2707152,2808449,2501699,2601820,2501213,2200069,  2808356,2704854,2704864,2603401,2704735,2603647,2705203,2808490,2501463,  2602027,2705832,2501166,2603137,2603106  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0889-2016","Class II","Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope","190 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2005030,2800270,2007268,2802306,2802294,2108696,2801707,2006928,2201349,2904573,  2108936,2006513,2107568,2801235,2800468,2200301,2006896,2802237,2802245,2109496,  2109225,2006520,2200358,2200372,2200370,2200350,2200356,2200364,2200351,2200345,  2005915,2109239,2109237,2904265,2108385,2100007,2904378,2801427,2200930,2107811,  2700057,2004864,2004924,2800273,2109999,2100088,2301603,2107560,2200701,2200648,  2904362,2802353,2802234,2801828,2801792,2903393,2903491,2109241,2109087,2109090,  2201179,2109261,2109234,2802808,2801887,2801892,2007452,2801960,2006598,2903718,  2007242,2007253,2903751,2006554,2006560,2802465,2007275,2004893,2802541,2903876,  2903913,2200971,2700124,2904046,2904425,2007142,2802500,2904240,2109319,2800517,  2802466,2802455,2200168,2006418,2200172,2006479,2108689,2201411,2201402,2005274,  2005123,2005141,2201410,2201389,2903348,2800505,2006883,2801725,2200481,2903648,  2903632,2108188,2108969,2109228,2109233,2802031,2802017,2802028,2802016,2802029,  2108350,2108320,2801583,2903806,2904150,2007033,2903029,2802758,2802794,2802793,  2005497,2005545,2700076,2903964,2903965,2903969,2201427,2100108,2007401,2802654,  2005642,2802394,2903060,2903059,2903756,2200703,2200988,2201112,2903499,2904701,  2802756,2005665,2800338,2108452,2100110,2201023,2301893,2301911,2904358,2904345,  2904344,2904356,2904336,2802111,2005706,2005255,2200750,2200766,2200880,2200769,  2200774,2005599,2802920,2006131,2006639,2006641,2006642,2006638,2006640,2006632,  2006628,2006635,2006634,2903927,2005006,2904212,2903346,2802333,2904016,2903343  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0898-2016","Class II","Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope","26 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2000158, 2203109,2000413,2101113,2304140,2203874,2405424,2203295,2203853,  2517622,2101047,2102290,2102302,2102305,2102303,2203697,2102317,2102297,  2202898,2203059,2203471,2304922,2202617,2416261,2102141,2101633  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0897-2016","Class II","Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope","5 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2123053,2337714,2338700,2337727,2112612  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0893-2016","Class II","Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope","180 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2102433,2102439,2102434,2002026,2002023,2000101,2000567,2001703,2317892,2001252,  2103738,2206336,2001183,2317780,2317782,2001658,2002113,2002108,2001058,2205716,  2103267,2206418,2104707,2104698,2000541,2001445,2000352,2104483,2104215,2001040,  2104379,2104209,2103329,2103015,2104488,2102974,2206175,2001272,2001664,2001241,  2317793,2105371,2001462,2418248,2418397,2105032,2418202,2001127,2001130,2206216,  2104357,2104490,2103447,2205654,2103446,2103440,2205664,2001504,2001507,2104514,  2001451,2104498,2104528,2104474,2001880,2001877,2104733,2104747,2104736,2104746,  2206304,2001661,2001630,2001629,2001626,2001641,2104502,2206298,2104780,2104768,  2104772,2317557,2001884,2317515,2104773,2105392,2205478,2105396,2205463,2205479,  2102775,2217033,2217029,2217036,2104347,2002170,2206318,2317401,2317975,2103228,  2317752,2216831,2317699,2317693,2317691,2103700,2103695,2104487,2104491,2103098,  2103009,2103295,2104653,2317589,2104541,2002004,2002001,2104533,2001862,2103606,  2103935,2104349,2000395,2103657,2317957,2000953,2206569,2103744,2217195,2002120,  2317577,2104489,2103049,2317690,2103060,2317683,2317684,2103375,2000500,2216960,  2000389,2000634,2105256,2105255,2105150,2317905,2317875,2103770,2103557,2103574,  2216820,2217126,2217122,2206257,2206237,2206196,2206239,2206200,2206049,2001713,  2206052,2206240,2001536,2317519,2216863,2102463,2102459,2102464,2102474,2001783,  2001781,2001788,2001747,2001770,2001778,2001756,2001755,2001785,2105103,2001731  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0900-2016","Class II","Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope","12 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2801185,2801376,2700216,2903833,2903851,2700830,2801154,2700481,2700049,  2025259,2802540,2700325  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0906-2016","Class II","Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope","4 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2600297,2601232,2600397,2013906  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73088,"Ongoing","Integrated Medical Systems Inc","3200 2nd Ave N",,"Birmingham","AL","35222-1212","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-0904-2016","Class II","Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope","54 instruments","If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.","02/25/2016",," Serial Numbers:  2407409,2407584,2306291,2204284,2305898,2406901,2306874,2000549,2203971,  2407393,2203790,2000405,2306456,2102668,2203672,2406988,2102128,2103100,  2103035,2204108,2204527,2000464,2204116,2102323,2417865,2102954,2519556,  2418512,2306371,2305350,2407684,2519174,2519207,2519210,2102734,2205217,  2001322,2418634,2406987,2418156,2305446,2204190,2204202,2103307,2101785,  2518969,2519343,2102896,2203946,2001430,2305568,2102316,2305870,2204258  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73089,"Ongoing","Heritage International","1125 W Victoria St",,"Compton","CA","90220-5812","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following Trader Joe's distribution center locations; WA, CT, PA    No foreign distribution.","F-1004-2016","Class I","Trader Joe's Nuts   Raw Cashew Pieces  NET Wt. 18 oz (1 LB)   UPC Code: 0050 5154  Product of Thailand, Vietnam, & India  Packaged in Thailand","374 cases","Heritage International USA, Inc. is recalling Trader Joe's Raw Cashew Pieces because of potential Salmonella contamination.","03/31/2016",," BEST BEFORE 07.17.2016TF4  ",1/15/2016,"01/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0714-2016","Class II","papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL,  10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0694-2016","Class II","papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL;  5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0704-2016","Class II","papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL;  5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","5 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0702-2016","Class II","papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705    ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0699-2016","Class II","papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL  unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","5 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0697-2016","Class II","papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0689-2016","Class II","papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size;  refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705",,"Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0709-2016","Class II","papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0705-2016","Class II","papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL;  5 mL, 7 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","62 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0707-2016","Class II","papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL;   5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","40 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0687-2016","Class II","methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","35 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0712-2016","Class II","papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL,  10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0706-2016","Class II","papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL;  5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0718-2016","Class II","papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size  Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705            ","20 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0688-2016","Class II","papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","5 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0708-2016","Class II","papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL;   5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","5 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0693-2016","Class II","papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL  5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0696-2016","Class II","papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","5 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0680-2016","Class II","Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","6 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All Lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0692-2016","Class II","papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0717-2016","Class II","testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705      ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots ",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0695-2016","Class II","papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0686-2016","Class II","methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","41 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0684-2016","Class II","Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0710-2016","Class II","papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0691-2016","Class II","papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL  unit size;   refrigerate,This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 ","5 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0698-2016","Class II","papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","5 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0713-2016","Class II","papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL,  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0700-2016","Class II","papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0690-2016","Class II","papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","30 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0676-2016","Class II","Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","7200 mL ","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0682-2016","Class II","hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","38 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0677-2016","Class II","calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","200 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All Lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0679-2016","Class II","Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","30 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0681-2016","Class II","Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate,   This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","90 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All Lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0711-2016","Class II","papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL,  5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","5 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0716-2016","Class II","testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","36 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0715-2016","Class II","progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705        ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0701-2016","Class II","papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL;  5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","25 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0685-2016","Class II","methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","22 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All Lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0678-2016","Class II","Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","5 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All Lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0703-2016","Class II","papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL;  10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705    ","10 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73090,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA","D-0683-2016","Class II","hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705","20 ml","Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","02/17/2016",," All lots",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73091,"Ongoing","Richard Wolf Medical Instruments Corp.","353 Corporate Woods Pkwy",,"Vernon Hills","IL","60061-3110","United States","Voluntary: Firm Initiated","Letter","Distributed in Washington.","Z-0790-2016","Class II","Reuseable rotary blade/abrader, product number 899751504.  The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.","four units","Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.","02/09/2016",," Affected lot 0207201502.",11/25/2015,"11/25/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73091,"Ongoing","Richard Wolf Medical Instruments Corp.","353 Corporate Woods Pkwy",,"Vernon Hills","IL","60061-3110","United States","Voluntary: Firm Initiated","Letter","Distributed in Washington.","Z-0789-2016","Class II","Reuseable rotary blade/abrader, product number 899751305.   The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.","Ten units","Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.","02/09/2016",," Affected lot 4500170289.",11/25/2015,"11/25/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73091,"Ongoing","Richard Wolf Medical Instruments Corp.","353 Corporate Woods Pkwy",,"Vernon Hills","IL","60061-3110","United States","Voluntary: Firm Initiated","Letter","Distributed in Washington.","Z-0791-2016","Class II","Reuseable rotary blade/abrader, product number 899751514.  The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.","2 units","Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.","02/09/2016",," Affected lot 4500166254.",11/25/2015,"11/25/2015",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73092,"Ongoing","Varian Medical Systems, Inc.","911 Hansen Way",,"Palo Alto","CA","94304-1028","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Albania, Guadeloupe, Norway,Algeria, Guam, Pakistan, Argentina, Guatemala, Panama,Australia, Hong Kong, Paraguay, Austria, Hungary, Peru,Azerbaijan, Iceland, Philippines, Bangladesh, India, Poland,Belgium,  Indonesia ,Portugal, Belorussia, Iran, Puerto Rico,Brazil, Iraq, Qatar, Brunei Darussalam, Ireland, Reunion,Bulgaria, Israel, Romania, Burma, Italy, Russia,'Canada, Jamaica, Saudi Arabia, Chile, Japan, Singapore, China,  Kazakhstan, Slovakia, Colombia, Kuwait, South Africa, Costa Rica, Latvia, South Korea,Czech Republic, Lebanon, Spain, Denmark, Libya, Sweden, Dominican Republic, Lithuania, Switzerland, Ecuador, Luxembourg, Taiwan, Egypt, Macau, Thailand, El Salvador, Macedonia, Trinidad and Tobago, Estonia, Madagascar, Tunisia, Finland, Malaysia, Turkey, France, Malta, Ukraine, French Polynesia, Mexico, United Arab Emirates, Georgia, Monaco, United Kingdom, Germany, Morocco, Venezuela, Ghana, Netherlands, Vietnam,Greece, New Zealand, and  Zimbabwe.","Z-0805-2016","Class II","Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6;  Model number: H48;    Product Usage:  The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.","9499","When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU).  Potential for unintended radiation exposure.","02/12/2016",," Model: H48:    Serial numbers:   H480110	H48C045	H488552	H480119	H487642	H480345	H480409  H480541	H480814	H48D577	H481205	H48D125	H48I971	H488466      H48A830	H48G592	H48L819  H480267	H48C046	H488553	H480123	H48B153	H480348	H489828	H480542	H480819	H48D580	H481206	H48D126	H48I972	H489917	H48K547	H48G593	H48L823  H480268	H48K563	H48I901	H480124	H48B154	H480349	H48E077	H480566	H480820	H48I607	H481262	H48E255	H48I973	H48A912	H481952	H486308	H48J014  H482174	H48L882	H48I790	H480126	H48F494	H480350	H487078	H480590	H480821	H480981	H485005	H48F454	H481213	H48A913	H48C377	H486311	H48J017  H482934	H487080	H48I793	H480132	H48F495	H480357	H48D491	H480591	H480849	H480982	H485006	H48F864	H48L831	H48A914	H48C381	H48A679	H48J019  H484123	H487081	H48J346	H480133	H48F496	H480362	H480410	H480596	H480850	H48G047	H48F796	H48F974	H48L833	H48A915	H482311	H48K023	H481437  H486422	H487130	H48J354	H480137	H48F497	H480365	H480422	H480599	H480869	H481010	H484510	H48L347	H48H963	H48A916	H482312	H48K024	H481449  H486423	H487132	H48J355	H480822	H480189	H480371	H480423	H480600	H480883	H481011	H484511	H48L348	H48H964	H48A917	H482313	H48K025	H481451  H486653	H487133	H48J356	H480823	H480207	H480372	H480424	H480645	H480884	H481012	H48J026	H48L353	H481215	H48C365	H482314	H48K026	H481452  H486654	H487134	H485375	H480824	H480208	H480373	H480433	H480646	H480886	H481014	H48J027	H48L354	H481216	H48C366	H482315	H48K027	H481453  H48D648	H487135	H485376	H480825	H480209	H480374	H480434	H480647	H480887	H481015	H48F657	H48L355	H481217	H48E610	H482316	H48K028	H481454  H48D649	H487136	H485377	H48I594	H480219	H480378	H480438	H480651	H480894	H481016	H48F658	H48L356	H481234	H48E615	H482317	H481099	H481455  H48B995	H487137	H485378	H48I596	H480245	H480379	H480439	H480652	H480897	H481036	H48F659	H48L487	H481235	H48E616	H484880	H481100	H481456  H48B996	H486633	H48B178	H48I597	H480246	H480382	H480440	H480659	H480898	H481037	H48F660	H48L488	H481818	H48K780	H484881	H482730	H48J416  H48G455	H486634	H48B179	H48I599	H480247	H480384	H480446	H480665	H480899	H481038	H48F671",1/11/2016,"01/11/2016",2/24/2016,"02/24/2016","71	H48C437	H489016	H485681	H48A755	H489468	H48C025  H488374	H488541	H48L444	H48E556	H489200	H48H788	H489616	H48D940	H489920	H487566	H48K945	H48A184	H48F763	H489023	H48I373	H48A756	H489469	H48H698  H488387	H488546	H480896	H48H891	H489201	H48H789	H489619	H48D941	H489940	H489968	H48K946	H48A188	H48F766	H48K374	H48A668	H48A760	H48B576	H48H701  H488388	H488547	H487426	H48H892	H489204	H48H790	H489639	H482214	H489953	H48C374	H48K947	H48A199	H48F769	H488884	H48A669	H48A762	H48I595	H48L352  H488389	H488548	H48D774	H48H893	H489205	H48H795	H489640	H484268	H489954	H48K331	H48K948	H48A201	H48J625	H488885	H48A681	H48A766	H48I600	H48L358  H483241	H488568	H48D778	H48K486	H489206	H48I998	H489641	H48G405	H489956	H48K336	H48K949	H48A202	H48J636	H48H926	H48A685	H48A767	H48I601	H483509  H48C016	H488578	H48F810	H48J281	H489207	H48K857	H489642	H48H538	H489957	H48K342	H48K951	H488774	H48K354	H48H927	H48A686	H48A782	H48I624	H48M901  H481713	H488580	H48H326	H48J282	H489208	H48K858	H489643	H48H939	H489958	H48A155	H48K952	H48E488	H48K360	H48A488	H48A710	H48A792	H48K371	H48A809  H481756	H488581	H48H327	H48J283	H489209	H48K862	H489644	H48H945	H489959	H48A157	H48K953	H48H670	H48A317	H48A489	H48A711	H48A793	H48K372	H48A810  H489894	H488582	H48B973	H48J284	H481761	H48M810	H489659	H48I606	H489964	H48A158	H48K954	H48J880	H48A321	H48A491	H48A712	H48A795	H48K373	H48A812  H488390	H488612	H48L346	H48J285	H486902	H482697	H489660	H48D976	H489965	H48A159	H48K955	H48A213	H48A328	H48L332	H48A713	H48A796	H48L843	H48A816  H480473	H488613	H48J590	H48J286	H48I950	H48F723	H489661	H48D977	H489966	H48K077	H48K956	H48A214	H48A329	H48L333	H487473	H48F139	H48D323	H48A817  H480474	H488647	H48J594	H48J287	H48L415	H48F726	H489664	H48J321	H489991	H48K079	H48K957	H48H584	H48A333	H48A495	H487474	H48F140	H48H838	H48A818  H480475	H488648	H480890	H48J288	H48L449	H48F770	H489665	H48J322	H489992	H48K081	H48K960	H48H586	H48A344	H48A512	H487475	H48F141	H48H839	H48A819  H480980	H489553	H486287	H48J289	H48L450	H48F152	H489666	H487587	H489993	H48K091	H48K961	H48H587	H48A345	H48A","995	H48K776	H482115	H48F167	H48I637	H481606	H48B100	H48C993	H48L365	H48L259  H48H375	H480278	H48L455	H48J495	H48J563	H48J929	H48H037	H482353	H48C996	H48H114	H482792	H48F168	H48I638	H483705	H48B101	H48L047	H48L366	H48L260  H48H376	H480279	H48J231	H48J501	H48J587	H48J933	H48H038	H482354	H48C997	H48H137	H484079	H48F169	H48I639	H486842	H48B102	H48L048	H48L368	H48L261  H48J172	H485607	H48J232	H48J502	H48J588	H48I244	H48H039	H482355	H48H580	H48H143	H486617	H48F170	H48H940	H486843	H48B103	H48L049	H48L369	H48L262  H48J173	H48A349	H48J233	H48J503	H48J589	H48J958	H48H040	H482356	H48H581	H48H145	H48A108	H48K685	H48H941	H486844	H48B104	H48L050	H48D658	H48L263  H48J174	H48D984	H48J240	H48J504	H48J591	H48J959	H48H041	H484551	H48H582	H488634	H48C231	H48K686	H48A797	H486845	H48B105	H48L051	H486494	H48L264  H48J175	H48G338	H48J241	H48J507	H48J592	H48J960	H48J993	H487079	H48K824	H48H697	H48F404	H48K688	H48A798	H486846	H48B106	H48L052	H489090	H48L265  H48J176	H48G477	H48J245	H48J508	H48J611	H48J961	H48J997	H48F057	H48M860	H48I031	H48L838	H48K689	H48I924	H48C874	H48B107	H48L055	H48H191	H48L266  H48J177	H48H752	H48J246	H48J509	H48J612	H48J963	H48J998	H482520	H48M861	H48I032	H489486	H48K690	H48I925	H48F789	H48I258	H48L056	H48H218	H48L267      H48L268	H48B740	H480925	H48L994	H485507	H48M393	H48M699	H48M812	H48N068	H48E821	H48H612	H48E555  H489657	H482539	H481322	H48L995	H485508	H48M409	H48M708	H48M813	H48N072	H48I784	H48H613	H48E557  H48K362	H489617	H481841	H48L997	H485509	H48M410	H48M714	H48A509	H48N073	H48I923	H48H614	H48E587  H48L439	H48B308	H481842	H48L998	H485510	H48M411	H48M715	H48A510	H482835	H48F391	H48H615  H48L440	H48F584	H488802	H48L999	H485511	H48M412	H48M720	H48A511	H482836	H48F425	H48I904  H48L441	H487326	H488803	H48M101	H485512	H48M413	H48M721	H48D918	H483120	H48H436	H48G050  H482584	H487327	H488806	H48M110	H485513	H48M414	H48M732	H48D919	H485261	H48H440	H48G057  H48G249	H487328	H488807	H484475	H485514	H48M415	H48M733	H485589	H486319	H48I138	H48G058  H48G250	H48I634	H488808	H485974	H485515	H48M416	H48M734	H487488	H486",,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73093,"Ongoing","CareFusion 303, Inc.","10020 Pacific Mesa Blvd",,"San Diego","CA","92121-4386","United States","Voluntary: Firm Initiated","Letter","Worldwide:Distribution - US Nationwide and the countries of  Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas.","Z-0814-2016","Class II","Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32.      Product Usage:   An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.","9,345 units","Customers reported issues when scanning medications with the scanners.  When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product.","02/16/2016",," 14488129  14488133  14488134  14463683  14463684  14463687  14463688  14463689  14463690  14463691  14463692  14463693  14463694  14463695  14463696  14463697  14463698  14463700  14463701  14463702  14463703  14463704  14463707  14463708  14463709  14463710  14463711  14463712  14463713  14463714  14463715  14463716  14463717  14467646  14467647  14513579  13941887  13941888  13941889  13941890  13941891  13941892  13941893  13941894  13941895  13941896  13941897  13941898  13941899  13943819  13943820  13972753  14474968  14510555  14510556  14510165  14510164  14510494  14510495  14510557  14510559  14510561  14510563  14510564  14510565  14510569  14510570  14510571  14510572  14454894  14477691  14477692  14477693  14477694  14477695  14477696  14477697  14477698  14477699  14477700  14477701  14477702  14477703  14477704  14477705  14495537  14387081  14387087  14387088  14387089  14387090  14387091  14387093  14387094  14387095  14387098  14387099  14387100  14387101  14387102  14387103  14387104  14387105  14387106  14387107  14405257  14405258  13966765  13966766  13966767  13966768  13966769  13966770  13966771  13966772  13966773  13966774  14398441  14398442  14398443  14398446  14398447  14398448  14398449  14398450  14398451  14398453  14398455  14398456  14398457  14398458  14398460  14398461  14398462  14398463  14398465  14398466  14398467  14398468  14469978  14475143  14440312  14440314  14440315  14440317  14232880  14232881  14232884  14232890  14232892  14250969  14043833  14043835  14043837  14043839  14463731  14463732  14463734  14463735  14463736  14398404  14423374  14423375  14423376  14423377  14423379  14423380  14423381  14423382  14423383  14423384  14423385  14423386  14423388  14423389  14423390  14423391  14423392  14423393  14423394  14423395  14423396  14423397  14423400  14423401  14423402  14423403  14423404  14232847  14232850  14232856  14232858  14232861  14232862  14232864  14232865  14232866  14232867  14232869  14232870  14232871  14232873  14232874  14232916  1424",1/15/2016,"01/15/2016",2/24/2016,"02/24/2016","4157607  14279677  14355667  14355668  14159803  14230229  14230230  14262688  14262689  14262690  14262691  14262692  14262693  14262694  14262695  14262696  14290473  14290474  14290475  14290476  14290477  14290478  14290479  14290480  14290481  14290482  14290483  14290484  14290485  14290487  14290488  14290490  14290491  14290493  14290494  14290495  14290496  14290497  14290498  14291742  14318073  14318075  14318076  14318077  14318078  14318079  14318081  14318083  14318085  14318087  14318090  14318091  14318092  14344110  14344111  14344112  14344113  14344114  14344115  14390244  14390245  14474279  14474280  14474281  14298700  14298701  14298702  14298703  14298704  14298705  14298706  14298707  14374224  14374225  14374226  14374227  14374228  14374229  14374230  14374231  14374232  14398390  14398391  14398392  14398393  14356226  14356227  14356228  14355673  14355674  14355675  14355676  14355677  14202232  14202233  14202234  14202235  14202236  14202237  14202238  14202239  14202240  14458437  14260035  14260036  14260037  14260038  14260039  14260040  14260041  14260042  14260043  14260044  14260045  14260046  14455524  14455525  14455528  14442362  14442363  14442364  14159410  14159411  14159412  14159413  14159414  14159415  14163098  14160680  14160681  14136358  14136359  14343561  14344100  14344101  14344102  14344103  14344104  14344105  14344106  14344107  14344108  14344109  14383625  14383627  14071099  14071101  14071104  14071106  14071108  14071109  14071112  14071114  14389222  14389223  14389224  14389225  14389226  14389227  14389228  14389229  14389230  14390579  14508283  14508284  14508285  14250336  14250338  14250339  14250341  14250343  14421072  14421073  14421075  14421077  14421078  14421079  14421080  14421081  14421082  14421083  14421084  14421085  14421086  13946924  13946925  13946926  13946927  13946928  13946929  13946930  14437890  14437891  14318873  14318874  14318875  14451613  14451614  14451615  14004757  14004760  14004763  14004764  14004765  140047"," 13877292  13877293  13877294  13877295  13877296  13877297  13877298  13877299  13877300  13877301  13877302  13877303  13877304  13877306  13877308  13877309  13877310  13877328  13891415  14245379  14245380  14245381  13902673  13902674  13902675  13902676  13902677  13902678  14457517  14457518  14457520  14457521  14457522  14457523  14457524  14457525  14457526  14163099  14163100  13890396  13890399  13890400  13890401  13890402  13890403  13890404  13890406  13896490  13896493  13896496  13896497  13909247  13909248  13909249  13909250  13890409  13890411  14175826  14175827  14175828  14175829  14472414  14472415  14472416  14472418  14167196  14194940  14194941  14194945  14194949  14194951  14194952  14194953  14194954  14194955  14194956  14194957  14194958  14194959  14194960  14194961  14194962  14194963  14194964  14194966  14514807  14514808  14221498  14221499  14221500  14221501  14221502  14221503  14221504  14221506  14250939  14250940  14250941  14250942  14250943  14250944  14250945  14250946  14250947  14352089  14352090  14112789  14112790  14112791  14112792  14112793  14112794  14136560  14136562  14136563  13928248  13928249  13928250  13928251  13928252  13928253  13940429  13940430  13940431  13940432  14158713  14029989  14029992  14029996  14029997  14029998  14029999  13883677  13888643  13888644  13888646  13888647  13888648  13888649  13987442  13987443  13987444  13987445  13987446  13987447  13987448  14007685  14007686  14007687  14007688  14007689  14022348  14034337  14469967  14184863  14513576  14024683  14024684  14024685  14024686  14048634  14166359  14166360  14166361  14166362  14166363  14166364  14166366  14166367  14166370  13887735  13887736  13887737  13887739  13887741  13887743  13887744  13887745  13908533  13909093  13909208  13909210  13909211  13909212  14127117  14127122  14127125  14127130  14127131  14127132  14127133  14127134  14127135  14127136  14127137  14127138  14127139  14136553  14136554  14136555  14136556  14136557  14136558  14136559  1429",,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73094,"Ongoing","Amerisource Health Services ","2550 John Glenn Ave","Suite A","Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0610-2016","Class II","Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.","3,888 cartons","Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.","01/27/2016",," Lot # 151387, Exp 10/31/16",1/18/2016,"01/18/2016",2/3/2016,"02/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73095,"Ongoing","Leica Microsystems, Inc.","1700 Leider Ln",,"Buffalo Grove","IL","60089-6622","United States","Voluntary: Firm Initiated","Letter","US Consignees incluude: AR ,AZ ,CA ,CO ,CT ,DC ,DE ,FL ,GA ,HI ,IA ,IL ,KY ,LA ,MA ,MD ,MI ,MN ,MO ,MT ,NC ,NH ,NJ ,NY ,OH ,OK ,PA ,PR ,SC ,TN ,TX ,UT ,VA ,VT ,WA ,WI and WV. Foreign Consignees include:Argentina , Australia , Brazil , Bulgaria , Chile , China , Ecuador ,Egypt , El Salvador , Finland , France , Georgia , Germany , Greece , India , Italy , Japan , Jordan , Kuwait , Lebanon , Malaysia , Philippines , Poland , Portugal , Romania , Russian Fed. , Singapore , South Korea , Spain , Sweden , Switzerland , Thailand , Tunisia , Turkey , United Kingdom and United Arab Emirates.","Z-0823-2016","Class II","This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.","1700 units"," Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase Block is applied after the primary marker incubation as specified in the Instructions for Use Following the Instructions for Use.","02/19/2016",," Product Code/Name: PA0552 (All Lots) Bond Ready-to-Use Primary Antibody PAX-5 (1EW).     Detection Kit: DS9800 BondTM Polymer Refine Detection Kit. Affected Detection Kit Lots: 42314, 42388, 42474, 42486, 42499, 42555, 42570, 42579, 42627, 42645, 42683, 42780, 42802, 42823, 42852, 43050.",12/30/2015,"12/30/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73096,"Ongoing","Covidien LP (formerly Nellcor Puritan Bennett Inc.)","6135 Gunbarrel Ave",,"Boulder","CO","80301-3214","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait,  Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania.","Z-1181-2016","Class II","Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx).    Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.","1,864 units ","Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances.  Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator.","03/16/2016",," all versions of software.  ",1/15/2016,"01/15/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0604-2016","Class II","Umpqua Mountain Blackberry Revel Ice Cream, Item no. 12823, 1.75 quart container, UPC 0 71203 08758 7  ","2321/1.75 quarts containers","Umpqua Mountain Blackberry Revel Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," Sell by 12/15/16",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0601-2016","Class II","Pint Umpqua Dairy Cultured Sour Cream, Item no. 03654, net w. 16 oz.; UPC 0 71203 00403 4.    Half Pint Umpqua Dairy Cultured Sour Cream, Item no. 03751, net w. 18 oz.; UPC 0 71203 00401 0.","5340/16 oz. cups; 1975/8 oz. cups","Sour cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," Sell by 2/5/16",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0605-2016","Class II","Umpqua Peppermint Candy Ice Cream, Item no. 12904, 1.75 quart container, UPC 0 71203 08793 8  ","354/1.75 quart containers","Umpqua Peppermint Candy Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," Sell by 12/15/16",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0603-2016","Class II","Umpqua Birthday Cake Ice Cream, Item no. 12815, 1.75 quart container, UPC 0 71203 08793 8  ","8922/1.75 quart containers","Umpqua Birthday Cake Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," Sell by 12/15/16",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0610-2016","Class II","Umpqua Vanilla Ice Cream, item no. 09997, 3 gallon container. UPC 0 71203 08620 7  ","400/3 gallon Containers","Umpqua Vanilla Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," 15-348 (production date)",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0606-2016","Class II","Umpqua Peppermint Candy Ice Cream, Item no. 11150, 3 Gallon container, UPC 0 71203 08645 0  ","26/3 Gallon Containers","Umpqua Peppermint Candy Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," 15-349 (production date)",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0602-2016","Class II","Umpqua French Vanilla Ice Cream, Item no. 12750, 1.75 Quart container, UPC 0 71203 08751 8  ","4809/1.75 quart containers","Umpqua French Vanilla Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," Sell by 12/15/16",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0614-2016","Class II","Pint Umpqua Dairy Nonfat Cottage Cheese, item no. 04847, Net wt. 16 oz., UPC 0 71203 00373 0  ","1313/16 oz. units","Umpqua Dairy Nonfat Cottage Cheese was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," Sell by 1/13/16",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0613-2016","Class II","Pint Umpqua Dairy 1.5% Lowfat Cottage Cheese, item no. 04839, net wt. 16 oz. UPC 0 71203 00360 0.    3 lbs. Umpqua Dairy 1.5% Lowfat Cottage Cheese, item no. 04146, net wt. 3 lbs.. UPC 0 71203 00376 1.  ","2070/16 oz. units and 880/3 lbs. units","Umpqua Dairy 1.5% Lowfat Cottage Cheesewas made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," sell by 1/13/16",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0609-2016","Class II","Dairy Queen Chocolate Soft Serve Mix, item no. 04979, 5 gallon container.  UPC 0071203004874  ","138/5 gallon containers","Dairy Queen Chocolate Soft Serve Mix was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," 010816 ",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0611-2016","Class II","Sunshine Empress Vanilla Ice Cream, item no. 12175, 3 gallon container. No UPC code.","160/3 gallon Containers","Sunshine Empress Vanilla Ice Cream was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," 15-348 (production date)",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0612-2016","Class II","Pint Umpqua Dairy 4% Cottage Cheese, item no. 04308, Net wt. 16 oz. UPC 0 71203 00248 1    24 oz. Umpqua Dairy 4% Cottage Cheese, item no. 04286, UPC 0 71203 00255 9.    3 lbs.  Umpqua Dairy 4% Cottage Cheese, item no. 03980, UPC 0 71203 00280 1.      ","2656/16 oz. units; 2001/24 oz. units; and 957/3 lbs. units.","Umpqua Dairy 4% Cottage Cheese was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," Sell by 1/13/16",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0607-2016","Class II","Umpqua Lowfat Vanilla Soft Serve Ice Cream Mix 4% (Red), item no. 04952, Half gallon container.  UPC 0 71203 00494 2.","745/ half gallon containers","Umpqua Lowfat Vanilla Soft Serve Ice Cream Mix 4% (Red) was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," Sell by 1/9/16",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73097,"Ongoing","Umpqua Dairy Products Co","333 Southeast Sykes Ave",,"Roseburg","OR","97470-3414","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, ID, CA, MT, OR, and WA.","F-0608-2016","Class II","Dairy Queen Vanilla Soft Serve Mix, item no. 04960, 5 gallon container. UPC 0 71203 00489 8  ","3406/5 gallon containers","Dairy Queen Vanilla Soft Serve Mix was made from milk which was tested presumptive positive for beta lactam antibiotics. The firm did not conduct any confirmation test.","02/17/2016",," 010716 and 010816",1/14/2016,"01/14/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73098,"Ongoing","Spectranetics Corp.","9965 Federal Dr",,"Colorado Springs","CO","80921-3617","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to Florida, North Carolina and Pennsylvania.","Z-0758-2016","Class II"," Excimer Laser System.    ","8 units","The product is labeled with an expiration date that is past its shelf life.","02/05/2016",," Lot CMP15J28A",1/15/2016,"01/15/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73099,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of   Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hungary, Italy, Kuwait, Latvia, Lebanon, Libya, Macedonia, Mexico, Montenegro, Netherlands, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and Uruguay.","Z-0824-2016","Class II","BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966","1680 units total","False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur.  This has also an effect for false low PT INR values.  These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients.  The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not","02/19/2016",," All serial numbers",1/14/2016,"01/14/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73099,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the countries of   Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hungary, Italy, Kuwait, Latvia, Lebanon, Libya, Macedonia, Mexico, Montenegro, Netherlands, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and Uruguay.","Z-0825-2016","Class II","BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED);  IVD --- Device Listing D060801","1895 units total","False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur.  This has also an effect for false low PT INR values.  These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients.  The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not","02/19/2016",," All serial numbers",1/14/2016,"01/14/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73100,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Affected geographies: Argentina, Australia, Austria, Bangladesh, Bermuda, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico , Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic, United States (including Puerto Rico), and Venezuela","Z-1067-2016","Class II","iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720    iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001 ","2,661 units total (1,424 units in US)","Iris International noted loose or missing analyte pads  found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCITY System.","03/07/2016",," all serial numbers",1/13/2016,"01/13/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73101,"Ongoing","Perrigo Company PLC","515 Eastern Ave",,"Allegan","MI","49010-9070","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0651-2016","Class II","Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.    ","948 units","Labeling: label error on declared strength. ","02/04/2016",," Lot #:  2015050194, Exp 2/2016",1/18/2016,"01/18/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73101,"Ongoing","Perrigo Company PLC","515 Eastern Ave",,"Allegan","MI","49010-9070","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0652-2016","Class II","Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157","918 units","Labeling: label error on declared strength. ","02/04/2016",," Lot #: 2015080484, Exp 02/2016",1/18/2016,"01/18/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73102,"Ongoing","Master Herbs, Inc./Li","1452 W Holt Ave",,"Pomona","CA","91768-2832","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0908-2016","Class I","Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01    ","6024 bottles","Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. ","05/26/2016",," all lots",1/15/2016,"01/15/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73103,"Ongoing","Trumpf Medical Systems, Inc.","1046 Legrand Blvd",,"Charleston","SC","29492-7672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.","Z-0759-2016","Class II","Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems).  The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.","1284 affected units","Complaints were received of  the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.","02/05/2016",," Product: Shuttle 2.7, Material Number: 1254362, Serial Number Range: 100801175  101349420; Product: Shuttle 2.7 360, Material Number: 1459862, Serial Number Range: 100843669-101212847; Product: Shuttle 3.7, Material Number: 1254363, Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360, Material Number: 1459863, Serial Number Range: 100787418-101334652. ",1/19/2016,"01/19/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73104,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","U.S. consignees nationwide.*** Foreign consignees in: Canada.","Z-0863-2016","Class II","The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner.  It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion, Centers, Hospice, Sub acute facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices.","6634 units.","Potential for the Symbiq pole clamp assemblies to be missing the  rubber stop pad.","02/23/2016",," Lot Code 16026 &16027 with the following serial numbers: 14339221, 14339224, 14339232, 14339261, 14339275, 14339296, 14339308, 14339321, 14339335, 14339349, 14339353, 14339357, 14339371, 14339372, 14339378, 14339387, 14339391, 14339396, 14339401, 14339504, 14339515, 14339553, 14339710, 14339719, 14339725, 14339733, 14339738, 14339742, 14339748, 14339761, 14339769, 14339771, 14339799, 14339815, 14339822, 14339851, 14339887, 14339888, 14339904, 14339913, 14339964, 14339989, 14339998, 14339999, 14340001, 14340014, 14340041, 14340042, 14340069, 14340070, 14340071, 14340094, 14340096, 14340110, 14340117, 14340119, 14340120, 14340122, 14340123, 14340124, 14340127, 14340133, 14340134, 14340138, 14340143, 14340144, 14340146, 14340147, 14340153, 14340154, 14340158, 14340163, 14340176, 14340182, 14340184, 14340186, 14340188, 14340200, 14340209, 14340211, 14340214, 14340225, 14340227, 14340232, 14340245, 14340248, 14340251, 14340253, 14340255, 14340263, 14340264, 14340268, 14340274, 14340276, 14340281, 14340285, 14340293, 14340304, 14340317, 14340318, 14340320, 14340323, 14340324, 14340325, 14340376, 14340377, 14340382, 14340383, 14340384, 14340387, 14340388, 14340390, 14340392, 14340405, 14340407, 14340412, 14340415, 14340417, 14340422, 14340423, 14340425, 14340426, 14340430, 14340433, 14340434, 14340437, 14340438, 14340440, 14340443, 14340448, 14340449, 14340450, 14340451, 14340453, 14340456, 14340458, 14340463, 14340465, 14340467, 14340470, 14340473, 14340474, 14340475, 14340476, 14340479, 14340480, 14340481, 14340485, 14340489, 14340491, 14340493, 14340496, 14340499, 14340501, 14340502, 14340503, 14340509, 14340510, 14340513, 14340514, 14340523, 14340526, 14340528, 14340533, 14340534, 14340536, 14340538, 14340540, 14340541, 14340542, 14340544, 14340545, 14340546, 14340549, 14340550, 14340551, 14340552, 14340555, 14340558, 14340562, 14340563, 14340567, 14340569, 14340571, 14340572, 14340577, 14340581, 14340583, 14340587, 14340588, 14340589, 14340590, 14340591, 14340592, 14340593, 14340596, 14340599, 14340600, 1434060",12/22/2015,"12/22/2015",3/2/2016,"03/02/2016","1522, 14591523, 14591527, 14591529, 14591533, 14591534, 14591535, 14591538, 14591543, 14591545, 14591548, 14591551, 14591558, 14591569, 14591572, 14591580, 14591581, 14591589, 14591592, 14591595, 14591596, 14591600, 14591605, 14591607, 14591614, 14591615, 14591616, 14591622, 14591632, 14591634, 14591635, 14591646, 14591651, 14591653, 14591654, 14591657, 14591664, 14591685, 14591705, 14591708, 14591713, 14591714, 14591721, 14591725, 14591726, 14591727, 14591730, 14591731, 14591736, 14591738, 14591739, 14591740, 14591742, 14591743, 14591748, 14591750, 14591756, 14591758, 14591760, 14591762, 14591766, 14591770, 14591771, 14591774, 14591777, 14591778, 14591779, 14591781, 14591785, 14591787, 14591789, 14591793, 14591797, 14591800, 14591806, 14591810, 14591815, 14591816, 14591823, 14591825, 14591827, 14591830, 14591834, 14591836, 14591837, 14591841, 14591843, 14591847, 14591854, 14591872, 14591879, 14591894, 14591895, 14591906, 14591912, 14591918, 14591922, 14591926, 14591933, 14591939, 14591947, 14591948, 14591957, 14591959, 14591972, 14591975, 14591980, 14591983, 14591988, 14591989, 14591995, 14591999, 14592000, 14592001, 14592005, 14592009, 14592011, 14592024, 14592029, 14592036, 14592039, 14592044, 14592045, 14592050, 14592058, 14592059, 14592062, 14592063, 14592076, 14592082, 14592083, 14592094, 14592096, 14592109, 14592111, 14592114, 14592116, 14592117, 14592124, 14592128, 14592131, 14592137, 14592138, 14592146, 14592147, 14592148, 14592149, 14592161, 14592182, 14592183, 14592187, 14592208, 14592211, 14592214, 14592221, 14592222, 14592228, 14592230, 14592232, 14592235, 14592241, 14592244, 14592246, 14592250, 14592251, 14592267, 14592286, 14592300, 14592311, 14592321, 14592322, 14592323, 14592330, 14592335, 14592339, 14592340, 14592344, 14592345, 14592350, 14592351, 14592353, 14592359, 14592368, 14592382, 14592383, 14592404, 14592407, 14592417, 14592424, 14592426, 14592431, 14592435, 14592436, 14592437, 14592444, 14592445, 14592448, 14592449, 14592450, 14592451, 14592452, 14592453, 14592457, 14592459, 14592460,",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73105,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0257-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","02/18/2016","02/18/2016"," W270112230651 ",12/10/2015,"12/10/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73114,"Terminated","Nihon Kohden America Inc","15353 Barranca Pkwy",,"Irvine","CA","92618-2216","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.","Z-0817-2016","Class II","MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers)  Electromyography. (EMG)","477 units total (137 units in US)","The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow. ","02/17/2016","02/22/2016"," Serial Numbers:  MS-110B: (17 units) 00013-00019, 00023- 00032  MS-120BK: (6 units) 0009- 00014  JB-116B: (31 units), 0008, 00012, 00014, 00016, 00018, 00019, 00020, 00021, 00023, 00025, 00026, 00027, 00028, 00029, 00031, 00032, 00034, 00035, 00039, 00043, 00102,00103, 00122-00128, 00134, 00135  JB-132B: (83 units) 00009, 00011, 00012, 00014, 00015, 00016, 00018, 00019, 00020, 00021, 00023, 00024, 00025, 00026, 00027, 00036, 00037, 00038, 00041, 00042, 00043, 00044, 00046, 00047, 00049, 00061, 00062, 00066, 00067, 00068, 00069,00071, 00072, 00074, 00075, 00082, 00084, 0085, 00086, 00090, 00095, 00099, 00120, 00121-00129, 00131-00147, 00149-00155, 00157, 00161, 00164-00168",1/19/2012,"01/19/2012",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73115,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.","Z-1034-2016","Class II"," (51 cm); Catalog Number: 461701.    Intended for pediatric feeding.    ","1,330 units","8FR 16 PVC tubes were  packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs","03/02/2016",," Lot Code: 521808064X  ",1/21/2016,"01/21/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73115,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.","Z-1033-2016","Class II"," (91 cm), Sterile; Catalog Number: 461438.    Intended for pediatric feeding.    ","1,010 units","8FR 16 PVC tubes were  packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs","03/02/2016",," Lot Code: 521807764X ",1/21/2016,"01/21/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73116,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA only.","V-483-2016","Class II","Cyclosporine 1%, 10 ml;  store at room temperature","40 ml","Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","08/17/2016",," compounded from 11/19/15 to 12/22/15.",1/15/2016,"01/15/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73116,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA only.","V-485-2016","Class II","prednisolone acetate, 25 mg/ml, 40 ml unit size;  store at room temperature","40 ml","Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","08/17/2016",," compounded  09/09/15.",1/15/2016,"01/15/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73116,"Ongoing","Abbott's Compounding Pharmacy, Inc.","2320 Woolsey St",,"Berkeley","CA","94705-1973","United States","Voluntary: Firm Initiated","Press Release","CA only.","V-484-2016","Class II","Cyclosporine 2%, 15 ml;  store at room temperature","15 ml","Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.","08/17/2016",," compounded  12/22/15.",1/15/2016,"01/15/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73117,"Ongoing","3M Company - Health Care Business","3m Center 2510 Conway Ave , B# 275-5-W-6",,"Saint Paul","MN","55144-0001","United States","Voluntary: Firm Initiated","Letter","AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include:  Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.","Z-1563-2016","Class II","3M Steri-Vac Gas Sterilizer/Aerator,  models 5XL and 8XL.","74 valves"," orientation.  This defect can result in the valve being installed backwards, creating a remote possibility of valve failure.  A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.","04/24/2016",," Model 5XL, Serial Numbers:  722612 - 722683, 820352 - 820360    Model 8XL, Serial Numbers:  351303 - 351399, 450144 - 450147",1/22/2016,"01/22/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73118,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0861-2016","Class II","0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product Code 2B0043, NDC 0338-0553-18.","282,080 bags","Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.","05/23/2016",," Lot #: P337857, Exp 07/31/16",1/21/2016,"01/21/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73118,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0863-2016","Class I","Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.","334,560 bags","Presence of Particulate Matter: identified as a cloth fiber.","05/23/2016",," Lot #: P339135, Exp 08/31/2017",1/21/2016,"01/21/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73118,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0862-2016","Class I","0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product Code 2B0043, NDC 0338-0553-18.","273,520 bags","Presence of Particulate Matter: identified as cardboard.","05/23/2016",," Lot #: P328997, Exp 01/31/2016",1/21/2016,"01/21/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73118,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0864-2016","Class I","CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product Code 2B7721, NDC 0338-1123-04.","7,436 bags","Presence of Particulate Matter: identified as dried skin.","05/23/2016",," Lot #: P333930, Exp 05/31/2017",1/21/2016,"01/21/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73119,"Ongoing","Heartland Products, Inc.","849 14th St SW",,"Valley City","ND","58072-4201","United States","Voluntary: Firm Initiated","E-Mail","US: ND, WA, CA, RI, SD,  IL.    OUS: CANADA","F-0710-2016","Class I","Heartland Flax 14 Mesh Brown RCM Flax Certified Organic, Net WT 50 lbs. Product packaged in 50 lb Food Grade Plastic bags. ","43,950 lbs","Heartland Products Inc., has initiated a recall due to potential contamination with Salmonella involving Milled Flax.","03/02/2016",," Lot 2T330-040515-101",1/14/2016,"01/14/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73120,"Ongoing","Lab Vision Corporation","46117 Landing Pkwy",,"Fremont","CA","94538-6407","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia.","Z-0815-2016","Class III","  CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each.      Description  Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+).    This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.   ","RB-368-R7 - 30; RB-368-R1 -2","Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.","02/17/2016",," Product Code: RB-368-R7; RB368-R1,  Lot Number  368R1407A  368R1407C  368R1407D  368R1407E, all with expiry dates of July 2016.  Product code: RB368-R1,  Lot Number 368R1407B.      ",1/18/2016,"01/18/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1212-2016","Class II","Covidien Dover   P400 PREM U/M 16FR SLVR FLY  Item Code: P4P16XSD  Castile soap towelettes are used to clean the genital area for male and female patients","31200","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  513256264X  515358164X  517457064X  520550064X  520857464X  521058564X  522958064X  525153264X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1207-2016","Class II","Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE  Item Code:  P4P16CSD     Castile soap towelettes are used to clean the genital area for male and female patients","4200","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  515358964X  517457664X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1215-2016","Class II","Covidien Dover   P400 UM 18FR SIL COUDE SECURE   Item Code: P4P18CSDK  Castile soap towelettes are used to clean the genital area for male and female patients","11400","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  511752564X  516054164X  520853264X  525450264X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1210-2016","Class II","Covidien Dover  P400 PREM U/M 16FR TMP SNS CSD  Item Code: P4P16TSD  Castile soap towelettes are used to clean the genital area for male and female patients","7200","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  520858164X  525756164X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1214-2016","Class II","Covidien Dover  P400 PREM U/M 18FR SIL COUDE CATH SECURE   Item Code: P4P18CSD  Castile soap towelettes are used to clean the genital area for male and female patients","600","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  515359164X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1224-2016","Class II","Covidien Dover  PREM 16FR UL LTX FOLEY TRY CSD  Item Code:  PP16ULD  Castile soap towelettes are used to clean the genital area for male and female patients","13060","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  511059764X  516853664X  521750064X  525350464X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1220-2016","Class II","Covidien Dover PRECSION PRM 14FR SIL FLY   Item Code:  ¿ PP14SD   ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients    ","16500","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  511059164X  511851264X  515358364X  516853364X  517457264X  520150864X  522958264X  525153564X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1219-2016","Class II","Covidien Dover  400 PREM U/M 18FR SLVR FLY  Item Code:  ¿¿¿ P4P18XSD  Castile soap towelettes are used to clean the genital area for male and female patients","4500","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  516853264X  517457164X  525153464X    ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1199-2016","Class II","Covidien Dover EASY CATCH MIDSTREAM KT W/CAST  Item Code:   25015   Castile soap towelettes are used to clean the genital area for male and female patients","74300 kits","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  518151164X  519450564X  520850264X  521250764X  522951064X  525150364X  525251064X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1204-2016","Class II","Covidien Dover  PREM U/M 14FR SIL FLY  Item Code:  P4P14SD P400   Castile soap towelettes are used to clean the genital area for male and female patients","20400","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  513256364X  514555864X  516050164X  516852964X  517456764X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1196-2016","Class II","Covidien Dover CATCH KIT SOAP  Item Code: 5205  Castile soap towelettes are used to clean the genital area for male and female patients","33312","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  525157164X  524356164X       522957364X       522355664X       521058064X       520856764X       520159364X       ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1205-2016","Class II","Covidien Dover  PREM U/M 14FR TMP SNS CSD  Item Code:  P4P14TSD P400   Castile soap towelettes are used to clean the genital area for male and female patients","3000","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  520858064X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1198-2016","Class II","Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP   Item Code:  24035  Castile soap towelettes are used to clean the genital area for male and female patients",,"Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  523657764X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1208-2016","Class II","Covidien Dover  P400 UM 16FR SIL COUDE SECURE  Item Code:  P4P16CSDK  Castile soap towelettes are used to clean the genital area for male and female patients","71430","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  511053864X  514553364X  515354264X  516054064X  516853764X  518154764X  518854864X  520155564X  520853164X  522550264X  522950064X  524353064X  525450164X  525752564X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1202-2016","Class II","Covidien Dover MIDSTREAM KIT RING CASTILE  Item Code:  4090SA   Castile soap towelettes are used to clean the genital area for male and female patients","207000","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  513287864X  514688164X  518187764X  520288464X  523087364X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1226-2016","Class II","Covidien Dover  PRECISION PRM 18FR SIL COUDE CATH SECURE   Item Code:  PP18CSD  Castile soap towelettes are used to clean the genital area for male and female patients","1950","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  512551364X  516051164X  521750164X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1211-2016","Class II","Covidien Dover   P400 PREM U/M 16FR UL FOLY CSD  Item Code:P4P16ULD  Castile soap towelettes are used to clean the genital area for male and female patients","3600","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  509759364X  513256864X  516050864X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1223-2016","Class II","Covidien Dover PRECSION PRM 16FR SIL FLY   Item Code:  PP16SD   Castile soap towelettes are used to clean the genital area for male and female patients","95700","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  511059464X  511851964X  513256664X  514650264X  515358464X  516050764X  516858564X  517457464X  520151064X  521058864X  522551264X  522958464X  523657064X  524357064X  525755764X  525755864X    ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1229-2016","Class II","Covidien Dover  PREC PRM 18FR SILVER FLY TY  Item Code: PP18XSD  Castile soap towelettes are used to clean the genital area for male and female patients","3280","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  512550464X  525153664X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1201-2016","Class II","Covidien Dover  MIDSTREAM KIT CASTILE SOAP  Item Code:  2090SA  Castile soap towelettes are used to clean the genital area for male and female patients","18000 kits","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  512590564X  516087864X  517488664X  518889264X  520288264x  521689164X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1197-2016","Class II","Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL   Item Code:  24015  Castile soap towelettes are used to clean the genital area for male and female patients","16500 units","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  522959464X  525757064X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1228-2016","Class II","Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD      Item Code: P18ULD   Castile soap towelettes are used to clean the genital area for male and female patients","1980","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  509054664X  512550964X  525154064X    ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1217-2016","Class II","Covidien Dover P400 PREM U/M 18FR UL FOLY CSD   Item Code:  P4P18ULD   Castile soap towelettes are used to clean the genital area for male and female patients","600","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  516050964X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1206-2016","Class II","Covidien Dover PREM U/M 14FR SLVR FLY  Item Code:  P4P14XSD P400   Castile soap towelettes are used to clean the genital area for male and female patients","1800","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  516050264X  522957864X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1218-2016","Class II","Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD¿ TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD TRAY COMPONENTS INCLUDING HAND SANITIZER AND SKIN BARR     Item Code:  P4P18XCSDK¿¿¿¿  Castile soap towelettes are used to clean the genital area for male and female patients","300","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  524356364X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1213-2016","Class II","Covidien Dover  P400 PREM UM 16FR SILV TMP CSD   Item Code: P4P16XTSD   Castile soap towelettes are used to clean the genital area for male and female patients","7200","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  515358664X  518150564X  522551064X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1225-2016","Class II","Covidien Dover   PREC PRM 16FR SILVER FLY TY  Item Code:  PP16XSD  Castile soap towelettes are used to clean the genital area for male and female patients","25080","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:    511851364X  512550364X  515357964X  518150364X  520150964X  523656964X  524356864X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1200-2016","Class II","Covidien Dover MIDSTREAM KIT CASTILE SOAP  Item Code:  2040SA   Castile soap towelettes are used to clean the genital area for male and female patients","118400 kits","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  518151164X  519450564X  520850264X  521250764X  522951064X  525150364X  525251064X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1209-2016","Class II","Covidien Dover P400 PREM U/M 16FR SIL FLY  Item Code: P4P16SD   Castile soap towelettes are used to clean the genital area for male and female patients","83400","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  511053864X  514553364X  515354264X  516054064X  516853764X  518154764X  518854864X  520155564X  520853164X  522550264X  522950064X  524353064X  525450164X  525752564X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1203-2016","Class II","Covidien Dover  KIT/STERILE PRESERVE CULT   Item Code:  8000SA  Castile soap towelettes are used to clean the genital area for male and female patients","10,000","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  510450164X  524350264X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1221-2016","Class II","Covidien Dover  PREC PRM 14FR SILVER FLY TY  Item Code: PP14XSD  ¿  ¿¿   Castile soap towelettes are used to clean the genital area for male and female patients    ","1320","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  518150464X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1222-2016","Class II","Covidien Dover  PRECISION PRM 16FR SIL COUDE CATH SECURE  Item Code: PP16CSD  Castile soap towelettes are used to clean the genital area for male and female patients","5940","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  512551264X  515359064X  523657564X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1227-2016","Class II","Covidien Dover   PRECSION PRM 18FR SIL FLY  Item Code: PP18SD   Castile soap towelettes are used to clean the genital area for male and female patients","9200","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  512550564X  513256764X  515358564X  522551364X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73121,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","US (nationwide) and to Canada.","Z-1216-2016","Class II","Covidien Dover  P400 PREM U/M 18FR SIL FLY     Item Code: P4P18SD   Castile soap towelettes are used to clean the genital area for male and female patients","7200","Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria","03/21/2016",," Lot Codes:  520857564X  522553864X  522958164X  523656864X  525153364X  525755664X  ",1/22/2016,"01/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73123,"Ongoing","ConMed Corporation","525 French Rd",,"Utica","NY","13502-5945","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA;  International: Canada, Wales","Z-1842-2016","Class II","Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13  The ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic surgical procedures","991 pieces","Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly.  During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.  ","05/31/2016",," Lot Numbers: 1) 569449, 577583, 577969, 579655, 580365, 581176, 581198, 582216, 587320, 594569, 658219, 669615, 673913 & 688136; 2) 569462, 577800, 577971 & 579652; 3) 569468, 577835, 577974, 579650, 583736, 583742, 587514, 627923, 659317 & 664751.   ",12/21/2015,"12/21/2015",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73124,"Terminated","Mahina Mele Farm","87-2642 Mamalahoa Hwy",,"Captain Cook","HI","96704-8703","United States","Voluntary: Firm Initiated","Press Release","US","F-0629-2016","Class I","Izzie Macs! Macadamia Nuts - Unsalted.  Certified Organic Macadamia Nuts, 100% Big Island Grown  A raw food.  Sold in 6 oz. plastic bag and 16 oz. plastic bag.    UPC - 6 oz.: 689076793575;  UPC 16 oz.: 689076792776.    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704","All lots - approximately 5676 total pounds of nuts and nut butters","IEH sampling found samples of raw macadamia nuts to be positive for Salmonella.","02/25/2016","04/19/2016"," All lots currently is commerce",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73124,"Terminated","Mahina Mele Farm","87-2642 Mamalahoa Hwy",,"Captain Cook","HI","96704-8703","United States","Voluntary: Firm Initiated","Press Release","US","F-0631-2016","Class I","Baby Bruddah's Mac Nut Buttah;  Certified Organic by International Certification Services Inc.. From the Big Island,   A raw food.  Sold in 12 oz. plastic tub.    UPC number:  753182242019    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704","All lots - approximately 5676 total pounds of nuts and nut butters","IEH sampling found samples of raw macadamia nuts to be positive for Salmonella.","02/25/2016","04/19/2016"," All lots currently in commerce",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73124,"Terminated","Mahina Mele Farm","87-2642 Mamalahoa Hwy",,"Captain Cook","HI","96704-8703","United States","Voluntary: Firm Initiated","Press Release","US","F-0632-2016","Class I","Baby Bruddah's Chocolate Mac Nut Buttah;  Certified Organic by International Certification Services Inc. From the Big Island,   A raw food.  Sold in 12 oz. plastic tub.    UPC number:  75318224204    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704","All lots - approximately 5676 total pounds of nuts and nut butters","IEH sampling found samples of raw macadamia nuts to be positive for Salmonella.","02/25/2016","04/19/2016"," All lots currently in commerce",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73124,"Terminated","Mahina Mele Farm","87-2642 Mamalahoa Hwy",,"Captain Cook","HI","96704-8703","United States","Voluntary: Firm Initiated","Press Release","US","F-0630-2016","Class I","Bulk Macadamia Nuts - (salted, unsalted; whole and pieces)  Certified Organic Macadamia Nuts, 100% Big Island Grown  A raw food.  Sold in 5 lb. bag.    NO UPC number.    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704","All lots - approximately 5676 total pounds of nuts and nut butters","IEH sampling found samples of raw macadamia nuts to be positive for Salmonella.","02/25/2016","04/19/2016"," All lots currently in commerce",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73124,"Terminated","Mahina Mele Farm","87-2642 Mamalahoa Hwy",,"Captain Cook","HI","96704-8703","United States","Voluntary: Firm Initiated","Press Release","US","F-0628-2016","Class I","Izzie Macs! Macadamia Nuts - Salted.  Certified Organic Macadamia Nuts, 100% Big Island Grown  A raw food.  Sold in 6 oz. plastic bag and 16 oz. plastic bag.    UPC - 6 oz.: 689076792677;  UPC 16 oz.: 689076792974.    Mahina Mele Farm  87-2642 Mamalahoa Hwy.  Captain Cook, HI 96704","All lots - approximately 5676 total pounds of nuts and nut butters","IEH sampling found samples of raw macadamia nuts to be positive for Salmonella.","02/25/2016","04/19/2016"," All Lots currently in commerce",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73125,"Ongoing","Scenic Fruit Company","7510 Se Altman Rd",,"Gresham","OR","97080-8808","United States","Voluntary: Firm Initiated","Letter","distributed in CA, KY, NC, ND, NV, PA and Canada.  The firm also sold product online.","F-0702-2016","Class II","Freeze Dried Black Raspberry Powder, Item no. 30007 or 30041. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00019 0.","4813 units","Label error in the supplement facts panel indicating 0 gram of sugar in each serving. The correct amount is 2 grams of sugar per serving.      ","02/29/2016",," Best by dates:    2/5/2016  3/12/2016  5/17/2016  8/23/2016  9/11/2016  10/23/2016  11/21/2016  1/21/2017  2/7/2017  2/27/2017  3/23/2017  4/13/2017  4/19/2017  4/30/2017        LOT NUMBERS (INTERNAL):    Lot No.  D1417217  D1902255  D2251321  E0237054  E0308070  E0595113  E0746141  E1148202  E1258219  E1347239  E1428266  E1482286  E1507292  E1542303  ",1/25/2016,"01/25/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73125,"Ongoing","Scenic Fruit Company","7510 Se Altman Rd",,"Gresham","OR","97080-8808","United States","Voluntary: Firm Initiated","Letter","distributed in CA, KY, NC, ND, NV, PA and Canada.  The firm also sold product online.","F-0701-2016","Class II","Freeze Dried Mango Powder, Item no. 30042. Nutrifruit brand.  Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00110 4. ","331 units","Label error in the supplement facts panel indicating 625.7 grams of carbohydrates in each serving. The correct amount is 6 grams carbohydrate per serving.  ","02/29/2016",," best by dates:  3/12/2016  8/2/2016  9/11/2016  4/13/2017    Lot code (internal):    D1888255  E0140033  E0307070  E1486286  ",1/25/2016,"01/25/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73126,"Ongoing","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution and Canada.","Z-1018-2016","Class III","CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack.      Product Usage:  Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.  ","6859"," error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.","02/25/2016",," Catalog Number 6922, 1/2 inch -lots TE27, TH06 and TK03  Catalog Number 6923, 3/8 inch - lots TE13, TE18, TG15, TH20 and TK17  b.	Model Number(s): 020204612, 020208807, 020210805, 020211806, 020493806, 044002300, 044003200, 044004102, 044004700, 044010200, 044016900, 044017601, 044018700, 044019901, 044027700, 044035101, 075104103, 075104404, 020135802, 088511700, 084103204, 047000500, 046001601, 065255600, 066110500, 075203800, 627265002, 627304502, 084118101, 020277801, 075101900, 627309201, 075104800, 627138002, 627241801, 627305101, 627239301, 044006801, 627347601, 075203501, 627232601, 627123006, 627280901, 088523400, 627282602, 044022001, 627252001, 044020900, 627147304, 627147403, 627153904, 046003400, 627308201, 044013600, 088511801, 084515200, 044009000, 627282001, 044022000, 066109900, 627286901, 075201201, 075202000, 084103204, 088504901, 088508000, 088513300, 088513501, 627133104, 627139306, 627165604, 627166101, 627167301, 627167501, 627167601, 627167701, 627168001, 627168101, 627179903, 627190501, 627190801, 627197802, 627198001, 627198102, 627212201, 627297401, 047002300, 044000600, 627251001, 627254501, 627283501, 627283601, 627321201, 044003901, 088504400, 627198903, 627214003, 044028900, 627231801, 627240802, 627243501, 627243601, 627243701, 627244602, 627244701, 627246002, 627252001, 627256901, 627260701, 627262303, 627266301, 627269502, 627286802, 627286901, 627290001, 627303901, 627304901, 627336301, 627336402, 627343801, 627346601, 627346701, 627349401  Catalog Number 6924, 1/4 inch - lots TE20, TF11, TG01 , TG15, TH 13 and TH27",1/19/2016,"01/19/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73127,"Ongoing","Phibro Animal Health Corporation","300 Frank W Burr Blvd Ste 21",,"Teaneck","NJ","07666-6704","United States","Voluntary: Firm Initiated","E-Mail","IN & TX","V-486-2016","Class II","Stafac 50 Type A Medicated Articles  NDC# 66104-8815  Packed in a 50 lb/bag (22.6 kg/bag) Multi-wall bag, with the following  construction/configuration: 4 ply Natural Kraft and 1 ply of HDPE 2.0 mil.","115 bags/units","This recall was initiated because Stafac 50 lot number R40430001VA tested below (41.7 g/lb) the potency specification of (42.5 - 57.5 g/lb) at the 18-month stability interval under VICH long-term conditions.","08/17/2016",," Lot R40430001VA Expiration Date: 02/28/2016 (February 28, 2016)",9/8/2015,"09/08/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0652-2016","Class I","Colorful Coleslaw Display,  2 lb. bag - Sam's Club;  Colorful Coleslaw  - 14 oz. bag- Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Sam's Club production code -  503;  Dole production code- 2662.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0643-2016","Class I","Italian Blend, 9 oz. bag,  - Aldi; Kroger; Dole.     All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Aldi - production code 3215;   Kroger - production code 3010;  Dole - production code 686.  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0665-2016","Class I","Veggie Blend, 12 oz. bag - Kroger;  Very Veggie, 12 oz. bag - Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3013.  Dole production code - 694  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0646-2016","Class I","Leafy Romaine Salad, 10 oz.  10 oz. bag,  - Walmart;  Leafy Romaine, 10 oz. bag - Kroger  Romaine Blend - 10 oz. bag - Kroger       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Walmart - production code 3141;  Kroger- production code: 3005, 3011 (leafy romaine)  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0650-2016","Class I","Chop Romaine Display,  2 lb. bag - Sam's Club;  Chopped Romaine - 16 oz. bag  and 2 lb bag- Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Sam's Club production code -  501;  Dole production code- 963 (16 oz) and 675, 78 (2 lb)",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0645-2016","Class I","Leafy Romaine Salad, 10 oz.  10 oz. bag,  - Walmart;  Leafy Romaine, 10 oz. bag - Kroger  Romaine Blend - 10 oz. bag - Kroger       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Walmart - production code 3141;  Kroger- production code: 3005, 3011 (leafy romaine)  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0642-2016","Class I","Spring Salad Mix,  5 oz. bag,  - Aldi; Walmart;   5 oz, and 10 oz. clamshell - Kroger;  Dole - 3 lb. bag,  11 oz and 5 oz.. clamshell       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Aldi - production code 3213;   Walmart - production code 3145;  Kroger - production code 3017 (10 oz. ) 3023 (5 oz.);  Dole - production cide 682 (3 lb),  665 and 336 (11 oz. clamshell), 946 (5 oz. clamshell)",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0670-2016","Class I","All Natural Chopped Chipotle & Cheddar Kit; 12.9 oz. bag and Chopped Chipotle & Cheddar kit, 12,9 oz. - Dole brand.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 613 (all natural) and 993     ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0668-2016","Class I","All Natural Chopped BBQ Ranch Kit; 14.4 oz.  and Chopped BBQ Ranch 14.4oz. bag - Dole brand.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 611 (14.4 oz all natural) and  991 (14.4 oz)    ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0659-2016","Class I","Organic Baby Romaine  - 5 oz. clamshell - Loblaw      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Loblaw production code -  3226.  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0640-2016","Class I","Classic Garden Salad, 12 oz. bag: Aldi, Kroger  24 oz. bag. - Kroger      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility.","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Aldi Production code 3210:  Kroger production codes: 3007  (12 oz.) and 3009. (24 oz.).  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0648-2016","Class I","Baby Spinach ,  6 oz. bag,  - Walmart;  6 oz and 10 oz. clamshell -  Kroger;  11 oz and 5 oz. clamshell - Dole     All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Walmart - production code 3131 (10 oz) and  3025 (6 oz.)  Kroger - production code 3015;  Dole - production code 337 (11 oz), 949 (5 oz.).  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0688-2016","Class I","Cole Slaw with Carrots Separate, 5 lb. bag, Dole brand.     All marketed Dole and private label salads produced in the Springfield, OH facility.   Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," Dole production code:  24",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0673-2016","Class I","Baby Romaine, 5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 942.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0664-2016","Class I","Field Greens, 8 oz. bag - Kroger;        All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3008.  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0666-2016","Class I","50/50 mix, 5.5 oz. bag - Kroger;  50/50 blend, 10 oz. bag - Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3024.  Dole production code - 938  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0672-2016","Class I","Baby Arugula with Spinach Clamshell, 5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 941.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0647-2016","Class I","Leafy Romaine Salad, 10 oz.  10 oz. bag,  - Walmart;  Leafy Romaine, 10 oz. bag - Kroger  Romaine Blend - 10 oz. bag - Kroger       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Walmart - production code 3141;  Kroger- production code: 3005, 3011 (leafy romaine)  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0654-2016","Class I","All Natural Chopped Sunflower Family Crunch,  27.2 oz.  bag - Sam's Club; 13.6 oz. Dole brand    All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Sam's Club production code -  619;  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0683-2016","Class I","Sweet Kale Kit Bag, 9.5 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 704.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0660-2016","Class I","Organic Baby Kale  - 5 oz. clamshell - Loblaw      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Loblaw production code -  3227.  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0680-2016","Class I","Southwest Salad, 13 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 2976",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0678-2016","Class I","Ultimate  Caesar, 11.3 oz. bag, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 953.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0667-2016","Class I","House Ranch, 10.6 oz. bag - Kroger;      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3021    ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0662-2016","Class I","Greener Supreme , 12 oz. bag - Kroger;  Greener Selection, 12 oz. bag - Dole  Value Size Greener Selection , 18 oz. bag - Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3004.  Dole production code - 695 (12 oz. and  159 (18 oz.).",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0674-2016","Class I","Baby Spinach with Tender Reds,  5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 943.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0681-2016","Class I","Endless Summer Kit Bag, 8.8 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 2701.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0653-2016","Class I","All Natural Chopped Sesame Asian Family Kit,  27.2 oz. bag - Sam's Club; 13.6 oz. Dole Brand    All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Sam's Club production code -  618;  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0655-2016","Class I","Organic Baby Spinach - 11 oz.  and 5 oz. clamshell - Loblaw  5 oz and 16 oz, Clamshell - Kroger    All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Loblaw production code -  3220 (11 oz) and 3224 (5 oz);  Kroger production code - 3031 (5 oz) nd 3032 (16 oz).",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0686-2016","Class I","Classic Iceberg Blend, 5 lb. bag, Dole brand.     All marketed Dole and private label salads produced in the Springfield, OH facility.   Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," Dole production code:  76",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0657-2016","Class I","Southwest Salad, 13 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 2976.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0679-2016","Class I","Asian Island Crunch, 13 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 930.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0687-2016","Class I","Classic Iceberg Blend w/Red Cabbage and Carrots Separate, 5 lb. bag, Dole brand.     All marketed Dole and private label salads produced in the Springfield, OH facility.   Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," Dole production code:  77",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0677-2016","Class I","Light Caesar, 10 oz. bag, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 699.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0669-2016","Class I","All Natural Chopped Bacon & Bleu Kit; 12.9 oz.  bag - Dole brand.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 612     ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0663-2016","Class I","Coleslaw, 12 oz. bag - Kroger;        All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3000.  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0641-2016","Class I","Spinach,  8 oz. bag,  - Aldi;  Teen Spinach -  10 oz. bag - Walmart.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Aldi - production code 3211;   Walmart - production code_ 34123.  Walmart - production code- 3123.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0671-2016","Class I","Mediterranean, 8 oz. bag. Dole brand.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 645",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0676-2016","Class I","Arugula, 5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 950.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0682-2016","Class I","Kale Caesar Kit Bag, 9.2 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 703.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0644-2016","Class I","Caesar Kit, 10 oz. bag,  - Aldi; Dole  14.53 oz bag, 22.30 oz.  - Walmart;  Value Size All Natural Caesar Kit , 15 oz. bag - Dole       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Aldi - production code 3214;   Walmart - Production code 3124, Family size 3114;  Dole - production code 678 (10 oz), 158 (15 oz.).  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0651-2016","Class I","Colorful Coleslaw Display,  2 lb. bag - Sam's Club;  Colorful Coleslaw  - 14 oz. bag- Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Sam's Club production code -  503;  Dole production code- 2662.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0685-2016","Class I","Chopped Sesame Ginger Kit, 13.6 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 996.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0661-2016","Class I","Shredded Lettuce , 11 oz. bag - Kroger  Value Size Shredded Lettuce -  16 oz. bag - Dole; 1/4'' Shredded Lettuce-Dole brand  Chopped lettuce  5 lb bag - Dole.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3029.  Dole production code - 157 (186 oz) 75 (5 lb. bag) and 72 (1/4') ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0675-2016","Class I","Sweet Baby lettuces,  5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 948.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0684-2016","Class I","Chopped Italienne Kit, 12.6 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 992.",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0658-2016","Class I","Organic Baby Arugula  - 5 oz. clamshell - Loblaw      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Loblaw production code -  3225.  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0649-2016","Class I","Caesar Bacon Salad Kit, 14.54 oz. bag - Walmart;      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Walmart - production code 3111.  ",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73128,"Terminated","Dole Fresh Vegetables Inc","2959 Salinas Hwy",,"Monterey","CA","93940-6400","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Canada","F-0656-2016","Class I","Organic Baby Spinach - 11 oz.  and 5 oz. clamshell - Loblaw  5 oz and 16 oz, Clamshell - Kroger    All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.","All product produced in the facility","Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.","02/26/2016","03/23/2016"," All packaged salads with manufacturing code beginning with the letter A.  Loblaw production code -  3220 (11 oz) and 3224 (5 oz);  Kroger production code - 3031 (5 oz) nd 3032 (16 oz).",1/22/2016,"01/22/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73129,"Ongoing","Sekisui Diagnostics P.E.I. Inc.","70 Watts Ave",,"Charlottetown",,,"Canada","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA,  ID,  IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.","Z-1171-2016","Class II","Sekure Chemistry Sekisui  Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic  Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml  Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml    In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity. ","14,407 kits.","Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover","03/14/2016",," Catalog Number: 506-10  Lot Codes  47677  47694  47649  47650  47662  47663  48253  48385  48386  Catalog Number: 506-30  Lot Codes:  47695  48294",1/22/2016,"01/22/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73130,"Terminated","Salter Labs","2365 Camino Vida Roble",,"Carlsbad","CA","92011-1505","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.","Z-0796-2016","Class II","T-piece Nebulizer with in-line connectors, Part number 8915-7-50.  Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.  ","70 units","Reports that the T-piece does not fit on the nebulizer.  ","02/10/2016","04/21/2016"," Lot No. 083115, 090715, and 122815",1/5/2016,"01/05/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73131,"Ongoing","Stryker Medical Division of Stryker Corporation","3800 E Centre Ave",,"Portage","MI","49002-5826","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of AL, AZ, FL, GA, HI, IA, IL, KS, LA, MI, MN, MO, NE, NJ, OH, PA, SC, TN, and TX, and the countries of Canada and UK.","Z-1556-2016","Class II","Spirit One A-C Powered Hospital Bed","143","Inaccurate scale systems","04/22/2016",," MDL#: E341062; Serial Numbers: B5A00-029643 029644 029537 029538 029539 029412  029413 029092 029093 029430 029431 029432 029433 029411 029479 029480 029463  029658 029461 029462 027773 029536 029420 029421 029423 029424 029094 029095  029096 029097 029098 029458 029459 027772 028853 028854 029563 029564 029639  029640 028835 030097 030099 028845 028846 028847 028848 029416 028003 029177  029418 029427 029428 029558 029559 029560 028834 029419 029429 029416 028840  028842 028843 028844 028836 028837 028838 028839 028849 028850 028851 028852  028841 028957 028958 028959 029460 029466 029467 029468 029415 029648 029460  029466 029645 029649 029650 029652 029654 029655 029657 029659 030096 030098  029467 029468 029656 029417 030154 030157 030158 030159 030161 030223 030225  030226 030354 030100 030152 030439; B5F00-029179 028654 028655 028656 028659 028660  028661 028663 028664 028793 028657 029540 029541 029646 029642 028788 029176  029175 029414 029178 029561 028216 029464 030151; B5C00-029182 029183 029184  029185 029186 029187 029188 029189",7/2/2015,"07/02/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73136,"Ongoing","Mary's Gone Crackers, Inc.","100 Kentucky St",,"Gridley","CA","95948-3038","United States","Voluntary: Firm Initiated","Letter","Two distributors with locations in CT, CA. PA, SC and NJ.","F-0621-2016","Class II","Mary's Gone Crackers Thins, Light and Tasty Snack Crackers; Lightly salted.  Organic, gluten free, non gmo, vegan;  NET WT. 4.5 oz (127 g);  UPC: 10897580000707;    Mary's Gone Crackers, Inc.  199 Kentucky St., Gridley, CA 95948","1160 cases (6 x 4.5 oz. boxes)","Gluten Free product may have gluten levels above the >20 ppm limit  in FDA regulations for gluten free products.","02/19/2016",," Lot: 15120003;  Best By: 09SEPT201 A3433",1/22/2016,"01/22/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73137,"Terminated","Maquet Cardiovascular Us Sales, Llc","45 Barbour Pond Drive",,"Wayne","NJ","07470","United States","Voluntary: Firm Initiated","Letter","US Nationwide in the states of CA, NY, and OR","Z-0804-2016","Class I","Flow-i Anesthesia System    Product Usage:  The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.  ","7 units within US","Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues.    Only the Model C20 is affected in the US.","02/22/2016","07/06/2016"," Model numbers: C20, C30 and C40 (Only Model # C20 for US)    Part numbers:  66 77 200 (US Only), 66 77 300 and 66 77 400    Serial numbers (2743, 2852, 2854, 2855, 2856, 2858",12/10/2015,"12/10/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73138,"Ongoing","Hill-Rom, Inc.","1069 State Road 46 E",,"Batesville","IN","47006-7520","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY, VA Medical Center and Internationally to Canada and Mexico.    **Consumer Recommended Depth - Consumers/User**","Z-0860-2016","Class II","Hill-Rom Bariatric Power Recliner, Product Model # P9096   Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.","216","The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury. ","02/23/2016",," Bariatric Power Recliner, Product Model # P9096; all power bariatric chairs that are affected by this field action is distributed within the following serial number range:   L341RW9151 through P070RW0812  ",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73139,"Ongoing","Medtronic Neuromodulation","7000 Central Ave Ne",,"Minneapolis","MN","55432-3568","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution, including US Nationwide.","Z-0859-2016","Class II","Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286.  Spinal cord stimulation leads.  Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.","51,138 (44,006 US; 9,132 OUS)","Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.","02/23/2016",," All lot/serial numbers are affected for both Model numbers: 39565 and 39286",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73140,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Panama; Korea; Japan; Netherlands; Ecuador; Chile; Canada; and Australia.","Z-1082-2016","Class II","Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation    The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.","21,268","Components of the DVR ePAKs can oxidize during shipment and storage prior to use.  A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product.   If oxidative material would flake off a component contained within the ePAK and enter the surgical field/wound an inflammatory reaction may occur. The inflammatory reaction may result in a foreign body r","03/08/2016",," All Lots.    Part number:                    Description:   811810050 	DVR EPAK EX NRW LOCK PLT RIGHT  811811040 	DVR EPAK NRW MINI LOCK PLT R  811811050 	DVR EPAK NRW LOCK PLT R  811812040 	DVR EPAK MINI LOCK PLT R  811812050 	DVR EPAK DIST VLR PT STD R  811812060 	DVR EPAK DISTAL VLR PLT MED RT  811812090 	DVR EPAK DISTAL PLT LONG RT  811812125 	DVR EPAK EXT LONG LOCK PLT R  811812175 	DVR EPAK EX-EXT LONG LK PLT R  811813050 	DVR EPAK WIDE LOCK PLT R  811814050 	DVR EPAK VOLAR RIM PLATE RIGHT  811815050 	DVR EPAK VOLAR RIM NRW PLT RT  811817050 	DVR EPAK DORSAL PLATE STD RT  811817150 	DVR EPAK DORSAL PLATE WIDE RT  811818060 	DVR EPAK RADIAL PLT STD RIGHT  811818160 	DVR EPAK RADIAL PLATE WIDE RT  811820050 	DVR EPAK EX NRW LOCK PLT LEFT  811821040 	DVR EPAK NRW MINI LOCK PLT L  811821050 	DVR EPAK NRW LOCK PLT L  811822040 	DVR EPAK MINI LOCK PLT L  811822050 	DVR EPAK LOCK PLT L  811822060 	DVR EPAK MEDIUM LOCK PLT L  811822090 	DVR EPAK LONG LOCK PLT L  811822125 	DVR EPAK EXT LONG LOCK PLT L  811822175 	DVR EPAK EX-EXT LONG LK PLT L  811823050 	DVR EPAK WIDE LOCK PLT L  811824050 	DVR EPAK VOLAR RIM PLATE LEFT  811825050 	DVR EPAK VOLAR RIM NRW PLT LT  811827050 	DVR EPAK DORSAL PLATE STD LEFT  811827150 	DVR EPAK DORSAL PLATE WIDE LT  811828060 	DVR EPAK RADIAL PLATE STD LEFT  811828160 	DVR EPAK RADIAL PLATE WIDE LT  811839050 	DVR EPAK ULNA PLATE BILATERAL  811899001 	DVR EPAK RIGHT DNI  811899002 	DVR EPAK LEFT DNI  811899003 	EPAK DVR C/LCK VOLR RIM RT DNI  811899004 	EPAK DVR C/LCK VOLR RIM LT DNI  811899005 	EPAK DVR DORSAL PLATE RT DNI  811899006 	EPAK DVR DORSAL PLATE LT DNI  811899007 	EPAK DVR RDL COLUMN PLT RT DNI  811899008 	EPAK DVR RDL COLUMN PLT LT DNI  811899009 	EPAK DVR ULNA PLT BILAT DNI  811911050 	DVR EPAK NRW LOCK PEG RT  811912050 	DVR EPAK LOCK PEG RT  811913050 	DVR EPAK WIDE LOCK PEG RT  811921050 	DVR EPAK NRW LOCK PEG LT  811922050 	DVR EPAK LOCK PEG LT  811923050 	DVR EPAK WIDE LOCK PEG LT  811999001 	DVR EPAK PEG RIGHT DNI  811999002 	DVR EPAK PEG LEFT DNI  ",1/29/2016,"01/29/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73141,"Ongoing","Biomet France SARL","Plateau de Lautagne",,"Valence Cedex 9",,,"France","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AL, AK, AR, AK, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Japan, Europe.","Z-0788-2016","Class II"," Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.","145,116 units","Cytotoxicity tests were not passed at 36 months.  Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury. ","02/09/2016",," Item Numbers &Lot Numbers:  ROX05	S016303  ROX05	S016304  ROX05	S0163056  ROX05	S0163059  ROX05	S0171051  ROX05	S017105R  ROX05	S0171098  ROX05	T0001122  ROX05	T0001133  ROX05	T0001136  ROX05	T0001141  ROX05	T0001147  ROX05	T0025073  ROX05	T0034084  ROX05	T0045150  ROX05	T0045157  ROX05	T0052108  ROX05	T0064164  ROX05	T0064168  ROX05	T0064175  ROX05	T0096191  ROX05	T0104217  ROX05	T0104238  ROX05	T0114238  ROX05	T0122226  ROX05	T0122238  ROX05	T0134261  ROX05	T0134269  ROX05	T0142245  ROX05	T0142248  ROX05	T0162294  ROX05	T0183280  ROX05	T0192311  ROX05	T0192316  ROX05	T0205297  ROX05	T0214319  ROX05	T0224329  ROX05	T0224333  ROX05	T0224338  ROX05	T0224346  ROX05	T0224357  ROX05	T0234357  ROX05	T0245006  ROX05	T0245009  ROX05	T0254015  ROX05	T0266030  ROX05	T0273037  ROX05	T0273051  ROX05	T0281043  ROX05	T0281065  ROX05	T0281078  ROX05	T0291099  ROX05	T0291106  ROX05	T0291118  ROX05	T0291125  ROX05	T0291134  ROX05	U0013175  ROX05	U0025142  ROX05	U0025170  ROX05	U0035175  ROX05	U0055155  ROX05	U0055170  ROX05	U0084189  ROX05	U0084209  ROX05	U0092202  ROX05	U0092237  ROX05	U0102265  ROX05	U0114279  ROX05	U0124272  ROX05	U0132289  ROX05	U0132307  ROX05	U0132316  ROX05	U0141251  ROX05	U0141254  ROX05	U0141265  ROX05	U0153300  ROX05	U0171316  ROX05	U0181349  ROX05	U0193328  ROX05	U0193349  ROX05	U0201005  ROX05	U0201019  ROX05	U0201337  ROX05	U0201349  ROX05	U0213019  ROX05	U0213040  ROX05	U0242047  ROX05	U0253061  ROX05	U0253068  ROX05	U0253075  ROX05	U0253082  ROX05	U0253089  ROX05	U0253138  ROX05	U0261131  ROX05	U0261148  ROX05	U0261159  ROX05	V0021138  ROX05	V0021176  ROX05	V0034194  ROX05	V0044201  ROX05	V0044208  ROX05	V0044239  ROX05	V0051267  ROX05	V0082187  ROX10	S0171056  ROX10	S0171065  ROX10	S0171108  ROX10	T0001119  ROX10	T0001122  ROX10	T0001133  ROX10	T0001136  ROX10	T0001141  ROX10	T0001147  ROX10	T0025073  ROX10	T0025098  ROX10	T0034084  ROX10	T0045150  ROX10	T0045157  ROX10	T0052108  ROX10	T0064168  ROX10	T0074175  ROX10	T0074179  ROX10	T0084189  ROX10	T0096191  ROX10	T0104217  ROX10	T0114238  RO",1/21/2016,"01/21/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0848-2016","Class II","        ","1305"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-7843-011-26  00-7843-011-56  00-7843-012-26  00-7843-012-56  00-7843-013-26  00-7843-013-56  00-7843-014-26  00-7843-014-56  00-7843-015-26  00-7843-015-46  00-7843-015-56  00-7843-016-26  00-7843-016-46  00-7843-016-56  00-7843-017-26  00-7843-017-46  00-7843-017-56  00-7843-018-26  00-7843-018-46  00-7843-018-56  00-7843-019-26  00-7843-019-46  00-7843-019-56  00-7843-020-26  00-7843-020-46  00-7843-020-56  00-7843-021-26  00-7843-021-46  00-7843-021-56  00-7843-022-26  00-7843-022-46  00-7843-022-56  lot numbers:  11003828  11004140  11004141  11004945  11005429  11005666  61633498  61699577  61704382  61710259  61710265  61721708  61735803  61735804  61735807  61735808  61735811  61741803  61741804  61741807  61746866  61752732  61757179  61757188  61759235  61759263  61759264  61759265  61760620  61768678  61768681  61769239  61775245  61775247  61781979  61781993  61781994  61786857  61786859  61786862  61807096  61815089  61829365  61829366  61834825  61840229  61840235  61840236  61840240  61840243  61844742  61844743  61848234  61848238  61848248  61852817  61852823  61876837  61879443  61879446  61879450  61884825  61884826  61884830  61902329  61902374  61902382  61910047  61910048  61910049  61910050  61910051  61910057  61910058  61915343  61915348  61920858  61920859  61920860  61932609  61932610  61932611  61937670  61937671  61937679  61937680  61946016  61946017  61946018  61946026  61956713  61956714  61956724  61963719  61963728  61974966  61993630  62003641  62003642  62003643  62003719  62006778  62011971  62025498  62025499  62025503  62025504  62025509  62029069  62034134  62043097  62043107  62045160  62053687  62053689  62053692  62054926  62054928  62067444  62067446  62071763  62071764  62077676  62077680  62077681  62085290  62085291  62085293  62085296  62089502  62089504  62089509  62097215  62097232  62097258  62097289  62097296  62102129  62107875  62107877  62107878  62116476  62116532  62132186  62132187  62133140  62135309  62135311  62135317  62135322  621",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0833-2016","Class II",,"18093"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5970-011-31  00-5970-011-32  00-5970-012-31  00-5970-012-32  00-5970-013-31  00-5970-013-32  00-5970-013-33  00-5970-013-34  00-5970-014-31  00-5970-014-32  00-5970-014-33  00-5970-014-34  00-5970-015-31  00-5970-015-32  00-5970-015-33  00-5970-015-34  00-5970-016-31  00-5970-016-32  00-5970-017-31  00-5970-017-32  00-5970-018-31  00-5970-018-32  00-5972-011-31  00-5972-011-32  00-5972-012-31  00-5972-012-32  00-5972-013-33  00-5972-013-34  00-5972-014-33  00-5972-014-34  00-5972-015-33  00-5972-015-34  00-5972-016-31  00-5972-016-32  00-5972-017-31  00-5972-017-32  00-5972-018-31  00-5972-018-32    Lot numbers:  11003380  11003415  11003477  11003574  11003583  11003586  11003597  11003601  11003602  11003612  11003613  11003626  11003644  11003666  11003673  11003832  11003870  11003871  11003889  11003890  11003893  11003941  11003942  11003954  11004035  11004058  11004080  11004189  11004302  11004500  11004566  11004597  11004683  11004766  11004817  11004868  11004869  11004870  11004946  11004950  11004952  11004954  11004957  11004958  11004972  11004980  11005018  11005054  11005068  11005096  11005100  11005232  11005248  11005320  11005328  11005374  11005425  11005444  11005461  11005491  11005561  11005594  11005629  11005632  11005647  11005674  11005677  11005678  11005685  11005697  11005707  11005747  11005795  11005796  11005820  11005891  11005911  11006035  11006059  11006084  11006245  11006248  11006249  11006316  11006332  11006362  11006365  11006403  11006458  11006471  11006538  11006588  11006605  11006607  11006631  11006640  11006670  11006718  11006728  11006736  11006738  11006792  11006810  11006812  11006828  11006877  11006926  11006963  11007047  11007070  11007080  11007161  11007163  11007179  11400178  11400200  11400224  11400230  11400233  11400234  61768186  61777574  61777575  61777578  61777590  61777594  61777595  61777597  61782669  61782670  61782671  61782672  61782673  61782674  61782675  61782676  61782677  61782678  61782679  61782680  61782",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0837-2016","Class II",,"5103"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5926-011-01  00-5926-011-02  00-5926-012-01  00-5926-012-02  00-5926-013-01  00-5926-013-02  00-5926-014-01  00-5926-014-02  00-5926-015-01  00-5926-015-02    Lot numbers:  11003385  11003487  11003827  11003957  11004055  11004100  11004102  11004106  11004145  11004378  11004444  11004449  11004454  11004464  11004499  11005712  11005779  11005783  11006058  11006623  11006851  11006878  11006925  11006973  11008245  11008259  11008270  11008331  11008381  61771793  61771795  61777453  61777454  61777455  61777456  61777457  61782636  61782637  61782638  61782639  61782640  61782641  61782642  61788821  61788822  61788823  61788824  61788825  61788826  61788827  61795693  61795694  61795695  61795696  61795697  61795698  61801039  61801040  61801041  61801042  61801043  61801044  61805590  61805591  61805592  61805593  61805594  61805595  61809895  61809897  61809898  61809899  61809901  61809902  61815366  61815367  61815368  61815369  61815370  61815371  61822252  61822253  61822254  61822255  61822256  61822257  61822258  61822259  61824055  61824056  61824057  61824058  61824059  61824060  61824061  61830909  61830910  61830911  61830912  61830913  61830914  61830915  61836415  61836416  61836417  61836418  61836419  61836420  61846210  61846211  61846212  61846213  61846214  61846215  61846216  61848468  61848469  61848470  61848471  61848472  61848473  61848474  61853892  61853893  61853896  61853897  61853898  61853899  61853901  61857280  61857281  61857282  61857283  61857284  61857286  61857287  61861620  61861621  61861622  61861623  61861624  61861625  61861626  61866469  61866470  61866471  61866472  61866473  61866474  61866475  61871356  61871357  61871358  61871359  61871360  61871361  61871362  61871854  61871855  61871856  61871857  61871858  61871859  61871860  61876121  61876122  61876123  61876124  61876125  61885074  61885075  61885076  61885077  61885078  61885079  61889296  61889297  61889298  61889301  61889302  61889303  61894348  61894349  61894350  61894351  618",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0842-2016","Class II",,"4567"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5930-010-01  00-5930-010-02  00-5930-020-01  00-5930-020-02  00-5930-030-01  00-5930-030-02  00-5930-040-01  00-5930-040-02  00-5930-040-41  00-5930-040-42  00-5930-050-01  00-5930-050-02  00-5930-060-01  00-5930-060-02  00-5930-070-01  00-5930-070-02  00-5930-080-01  00-5930-080-02    Lot numbers:  11002165  11002170  11002753  11002755  11004006  11004022  11004039  11004084  11004256  11004347  11004558  11004696  11005020  11005211  11005470  11005509  11005570  11005571  11005811  11006243  11006977  11007624  61785664  61785665  61785666  61785667  61790305  61790857  61795385  61800855  61800872  61803287  61806782  61812454  61812455  61812456  61812463  61812467  61812468  61812471  61818233  61818234  61822441  61822442  61822449  61822451  61822452  61827033  61827040  61827041  61827045  61827085  61827094  61827096  61833079  61833080  61833081  61833102  61833105  61833106  61833108  61833110  61833112  61833116  61833119  61833155  61837978  61837979  61837996  61838014  61842438  61842441  61845754  61849851  61849859  61849879  61854971  61854972  61854979  61854980  61854981  61859585  61859594  61859595  61859609  61859626  61859627  61864921  61864945  61868377  61868390  61868395  61873107  61873122  61873124  61877688  61877689  61877690  61877699  61877701  61877702  61882313  61882314  61882315  61886843  61886845  61886874  61886875  61886876  61886877  61886878  61890992  61890993  61890995  61890996  61890997  61890999  61901917  61901946  61901947  61901948  61901949  61901955  61906759  61906796  61911201  61911202  61911203  61911204  61911221  61916704  61916711  61922810  61922811  61922812  61922821  61922830  61922832  61927192  61927193  61927203  61927205  61927211  61927212  61932746  61943653  61943654  61943655  61943656  61947321  61947322  61947323  61947337  61947338  61947342  61947349  61947350  61953668  61953679  61953680  61953681  61959719  61959720  61959721  61959722  61959724  61959725  61959740  61959745  61959749  61963554  61963558  61963",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0844-2016","Class II",,"24272"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-8114-000-00  00-8114-000-10  00-8114-001-00  00-8114-001-10  00-8114-002-00  00-8114-002-10  00-8114-002-18  00-8114-002-30  00-8114-003-00  00-8114-003-10  00-8114-003-18  00-8114-003-30  00-8114-004-00  00-8114-004-10  00-8114-004-20  00-8114-004-23  00-8114-004-26  00-8114-004-30  00-8114-005-00  00-8114-005-10  00-8114-005-30  00-8114-012-18  00-8114-013-18  Lot numbers:  61744462  61744471  61767815  61770620  61774067  61774069  61774070  61774071  61778347  61778352  61779345  61783709  61783710  61783712  61783713  61783715  61783716  61783717  61787012  61787026  61787032  61787033  61787039  61790491  61790493  61790501  61790503  61794997  61794998  61794999  61795001  61795002  61798096  61798097  61801163  61801166  61801167  61801169  61801170  61801172  61801173  61801175  61803852  61803853  61803854  61803855  61803856  61803857  61806780  61806781  61806783  61806784  61806785  61806786  61806795  61809116  61809117  61809118  61809119  61809120  61809121  61812094  61812095  61812096  61812097  61812098  61812101  61812102  61812502  61813926  61813927  61813928  61813929  61813930  61814507  61815827  61815828  61815829  61815830  61815831  61817968  61817970  61817972  61817973  61818534  61818535  61820815  61820816  61822313  61822314  61822317  61824704  61824705  61824706  61824707  61824708  61824709  61824710  61824711  61827848  61827849  61829560  61829562  61829563  61829564  61833280  61833301  61833302  61833303  61833304  61833305  61833306  61833307  61837744  61837745  61840597  61840598  61840599  61840601  61840602  61841627  61841628  61841629  61841630  61841631  61844297  61844298  61846959  61846960  61846961  61846962  61846963  61846964  61846965  61846966  61846967  61846968  61851867  61851868  61851869  61853681  61855217  61855219  61855220  61856107  61856108  61859387  61859950  61860466  61860468  61860469  61862656  61863697  61863702  61863704  61863740  61864107  61864108  61868120  61868121  61868122  61868140  61868141  61868226  6186822",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0834-2016","Class II",,"88389"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5992-017-91  00-5992-017-92  00-5994-013-01  00-5994-013-02  00-5994-013-91  00-5994-013-92  00-5994-014-01  00-5994-014-02  00-5994-014-91  00-5994-014-92  00-5994-015-01  00-5994-015-02  00-5994-015-91  00-5994-015-92  00-5994-016-01  00-5994-016-02  00-5994-016-91  00-5994-016-92  00-5994-017-01  00-5994-017-02  00-5994-017-91  00-5994-017-92  00-5996-011-01  00-5996-011-02  00-5996-011-51  00-5996-011-52  00-5996-012-01  00-5996-012-02  00-5996-012-51  00-5996-012-52  00-5996-013-01  00-5996-013-02  00-5996-013-51  00-5996-013-52  00-5996-014-01  00-5996-014-02  00-5996-014-51  00-5996-014-52  00-5996-015-01  00-5996-015-02  00-5996-015-51  00-5996-015-52  00-5996-016-01  00-5996-016-02  00-5996-016-51  00-5996-016-52  00-5996-017-01  00-5996-017-02  00-5996-017-51  00-5996-017-52  00-5996-017-91  00-5996-017-92  00-5996-018-01  00-5996-018-02  00-5996-018-51  00-5996-018-52  00-5996-018-91  00-5996-018-92    Lot numbers:  11002128  11002763  11003329  11003332  11003363  11003364  11003379  11003386  11003422  11003470  11003480  11003481  11003483  11003484  11003485  11003486  11003527  11003529  11003530  11003531  11003572  11003573  11003582  11003604  11003614  11003616  11003632  11003648  11003656  11003657  11003662  11003676  11003677  11003678  11003679  11003681  11003682  11003683  11003684  11003693  11003694  11003808  11003809  11003811  11003831  11003839  11003845  11003846  11003920  11003936  11003946  11003948  11003983  11004007  11004008  11004038  11004044  11004057  11004062  11004088  11004142  11004185  11004214  11004250  11004253  11004268  11004270  11004297  11004301  11004307  11004356  11004358  11004458  11004529  11004633  11004634  11004650  11004674  11004703  11004771  11004794  11004822  11004824  11004831  11004832  11004854  11004857  11004859  11004867  11004884  11004893  11004900  11004903  11004916  11004917  11004929  11004951  11004979  11004983  11004995  11004998  11004999  11005002  11005023  11005030  11005053  11005056  11005060  11005",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016","996799  61996876  61996957  61996958  61997347  61997525  61997526  61997527  61997528  61997529  61997530  61998645  61998647  61998649  61998945  61998946  61998947  61998948  61998949  61998951  61999727  61999728  61999729  61999730  61999731  61999732  62000731  62000732  62000733  62000734  62000735  62000736  62000737  62000738  62000739  62000740  62000741  62000742  62000743  62000744  62000745  62000746  62001107  62001108  62001109  62001110  62001111  62001112  62001113  62002148  62002149  62002385  62002388  62002389  62002392  62002393  62003830  62003831  62003832  62003833  62005361  62005364  62005365  62005366  62005367  62005368  62005457  62005458  62005459  62005460  62005461  62005462  62005463  62005464  62005465  62005466  62005467  62005468  62005469  62005470  62005471  62005472  62005718  62006096  62006097  62006098  62006099  62007661  62007663  62007664  62007665  62007666  62007667  62007668  62007669  62008303  62008304  62008305  62008306  62008307  62008308  62008309  62009666  62009667  62009668  62009670  62009672  62009673  62010930  62010931  62010932  62010933  62010934  62010935  62011839  62011840  62011841  62011842  62011843  62011844  62011846  62012293  62012294  62012295  62012296  62012297  62012298  62012299  62012300  62012301  62012302  62012303  62013157  62013159  62013161  62013163  62013164  62013166  62014192  62014193  62014194  62014195  62014196  62016167  62016169  62016170  62016171  62016173  62016488  62016489  62016490  62016491  62016809  62017267  62017617  62017618  62017620  62017621  62017622  62017630  62017631  62018148  62018149  62018415  62018417  62018418  62018420  62018421  62019092  62019094  62019095  62019096  62019097  62019099  62019100  62019101  62019102  62019103  62019104  62019105  62019106  62019118  62019119  62019375  62019376  62019377  62019499  62019500  62019502  62019749  62019750  62019751  62019752  62019753  62019754  62019755  62019756  62019757  62020212  62020810  62020811  62020812  62020813  62020817  6202081",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0849-2016","Class II",,"4844"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-7843-011-06  00-7843-011-08  00-7843-011-36  00-7843-012-06  00-7843-012-08  00-7843-012-36  00-7843-013-06  00-7843-013-08  00-7843-013-36  00-7843-014-06  00-7843-014-08  00-7843-014-36  00-7843-015-06  00-7843-015-08  00-7843-015-36  00-7843-016-06  00-7843-016-08  00-7843-016-36  00-7843-017-06  00-7843-017-08  00-7843-017-36  00-7843-018-06  00-7843-018-08  00-7843-018-36  00-7843-019-06  00-7843-019-36  00-7843-020-06  00-7843-020-08  00-7843-020-36  00-7843-021-06  00-7843-021-36  00-7843-022-06  00-7843-022-36  Lot numbers:  11003968  11003975  11004089  11004219  11004274  11004333  11004746  11005067  11005118  11008034  61669552  61669554  61669559  61669561  61669563  61695978  61699465  61704396  61704397  61714436  61721717  61721719  61721720  61729915  61729916  61729917  61729919  61735802  61735816  61735817  61735818  61741801  61741802  61741815  61746858  61746859  61746860  61746875  61746876  61746878  61746888  61746890  61746892  61752717  61752718  61752719  61752722  61752738  61752739  61752740  61759256  61759257  61759271  61759272  61759273  61759274  61759275  61759276  61768675  61768676  61768677  61768689  61768690  61768691  61768692  61768693  61768695  61768696  61768697  61768698  61768699  61775242  61775243  61775251  61775252  61775253  61775254  61781978  61781998  61781999  61782001  61782002  61786858  61786866  61786867  61792530  61792544  61792545  61792546  61792547  61792561  61797304  61797305  61797306  61797307  61797308  61797309  61797310  61797311  61797312  61797314  61797315  61797316  61797317  61797318  61797319  61797320  61797321  61797322  61797323  61803226  61803227  61803229  61803230  61803231  61803233  61807094  61807095  61807106  61807107  61807108  61807109  61807110  61807111  61807112  61807113  61807114  61813331  61813332  61813336  61813345  61813352  61813353  61813356  61813363  61813364  61813367  61813369  61813370  61813371  61813372  61813373  61813374  61814011  61814012  61814013  61814014  61814015  6181401",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0841-2016","Class II",,"115796"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5960-011-51  00-5960-011-52  00-5960-012-51  00-5960-012-52  00-5960-013-51  00-5960-013-52  00-5960-014-51  00-5960-014-52  00-5960-015-51  00-5960-015-52  00-5960-016-51  00-5960-016-52  00-5960-017-51  00-5960-017-52  00-5960-018-51  00-5960-018-52  00-5964-011-51  00-5964-011-52  00-5964-012-51  00-5964-012-52  00-5964-013-51  00-5964-013-52  00-5964-014-51  00-5964-014-52  00-5964-015-51  00-5964-015-52  00-5964-016-51  00-5964-016-52  00-5964-017-51  00-5964-017-52    Lot numbers:  11003819  11003822  11003824  11003955  11003973  11003997  11004042  11004086  11004103  11004104  11004105  11004160  11004166  11004173  11004174  11004188  11004190  11004223  11004252  11004255  11004271  11004280  11004300  11004336  11004373  11004377  11004469  11004503  11004546  11004552  11004559  11004565  11004598  11004628  11004629  11004630  11004654  11004675  11004680  11004682  11004706  11004716  11004722  11004723  11004755  11004756  11004759  11004767  11004768  11004793  11004795  11004821  11004871  11004899  11004901  11004902  11004947  11004949  11004973  11005026  11005029  11005058  11005063  11005064  11005085  11005098  11005102  11005114  11005123  11005133  11005146  11005154  11005198  11005205  11005213  11005223  11005241  11005271  11005278  11005319  11005321  11005331  11005336  11005344  11005377  11005378  11005382  11005438  11005445  11005477  11005488  11005556  11005562  11005572  11005575  11005578  11005592  11005596  11005614  11005631  11005664  11005665  11005671  11005679  11005681  11005689  11005706  11005714  11005716  11005717  11005726  11005730  11005733  11005739  11005751  11005754  11005765  11005770  11005778  11005780  11005784  11005785  11005798  11005802  11005803  11005818  11005819  11005861  11005866  11005867  11005869  11005892  11005909  11005915  11005964  11005979  11005981  11005983  11006022  11006047  11006053  11006057  11006064  11006066  11006079  11006080  11006120  11006152  11006156  11006177  11006184  11006185  11006195  110",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016","61987739  61987741  61987742  61987797  61987798  61987799  61987800  61987801  61987802  61987803  61987804  61987805  61987806  61987807  61987808  61987809  61987810  61987811  61987812  61987813  61987814  61987815  61987816  61987817  61987818  61987819  61987820  61987821  61987822  61987824  61987825  61987826  61987827  61987828  61987829  61987830  61987831  61987832  61988117  61988127  61988128  61988445  61988447  61988448  61988449  61988461  61988462  61988554  61989033  61989034  61989036  61989088  61989663  61989664  61989666  61989667  61989672  61989673  61989674  61990659  61990907  61990908  61990910  61992033  61992050  61992702  61992977  61992978  61992979  61992980  61992982  61993578  61993579  61993580  61993581  61993583  61993585  61993586  61993588  61993593  61993599  61993601  61993604  61993605  61993606  61993607  61993608  61993611  61993613  61993614  61993615  61993620  61993621  61993649  61993650  61993652  61993653  61993654  61993655  61993656  61993657  61993923  61993924  61995663  61995683  61995687  61996342  61996343  61996351  61996967  61997335  61998616  61998617  61998798  61998837  61999551  61999552  61999553  61999554  61999574  61999925  61999973  62000378  62000379  62000380  62000386  62000387  62000388  62000389  62000390  62000391  62000392  62000393  62000394  62000395  62000396  62000397  62000399  62000400  62000401  62000402  62000403  62000404  62000405  62000406  62000407  62000408  62000411  62000413  62000414  62000415  62000416  62000417  62000418  62000419  62000420  62000421  62000422  62000446  62000447  62000969  62000970  62000985  62000990  62002011  62002012  62002013  62002022  62002024  62002050  62002052  62002061  62002062  62002064  62002078  62002251  62002480  62002481  62002482  62002483  62002484  62003646  62003654  62003763  62003764  62003766  62003767  62003775  62003961  62003963  62004486  62004487  62004488  62004489  62004490  62004491  62004492  62004493  62004494  62004495  62004496  62004498  62004499  62004500  62004",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0831-2016","Class II",,"42064"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5950-012-01  00-5950-012-02  00-5950-013-01  00-5950-013-02  00-5950-013-05  00-5950-013-06  00-5950-014-01  00-5950-014-02  00-5950-014-05  00-5950-014-06  00-5950-015-01  00-5950-015-02  00-5950-015-05  00-5950-015-06  00-5950-016-01  00-5950-016-02  00-5950-016-05  00-5950-016-06  00-5950-017-01  00-5950-017-02  00-5950-017-05  00-5950-017-06  00-5952-012-01  00-5952-012-02  00-5952-013-01  00-5952-013-02  00-5952-013-05  00-5952-013-06  00-5952-014-01  00-5952-014-02  00-5952-014-05  00-5952-014-06  00-5952-015-01  00-5952-015-02  00-5952-015-05  00-5952-015-06  00-5952-016-01  00-5952-016-02  00-5952-016-05  00-5952-016-06  00-5952-017-01  00-5952-017-02  00-5952-017-05  00-5952-017-06  00-5956-012-01  00-5956-012-02  00-5956-013-01  00-5956-013-02  00-5956-013-05  00-5956-013-06  00-5956-014-01  00-5956-014-02  00-5956-014-05  00-5956-014-06  00-5956-015-01  00-5956-015-02  00-5956-015-05  00-5956-015-06  00-5956-016-01  00-5956-016-02  00-5956-016-05  00-5956-016-06  00-5956-017-01  00-5956-017-02  00-5956-017-05  00-5956-017-06    Lot numbers:  11003331  11003479  11004184  11004653  11004819  11004864  11004891  11004997  11005134  11005150  11005197  11005206  11005279  11005343  11005424  11005628  11005673  11005698  11005702  11005794  11005844  11005855  11005857  11005897  11005937  11005939  11005982  11006036  11006046  11006061  11006062  11006063  11006070  11006106  11006198  11006211  11006214  11006272  11006310  11006376  11006438  11006476  11006477  11006485  11006525  11006589  11006590  11006594  11006651  11006717  11006799  11006813  11006891  11006943  11006976  11007101  11007410  11007427  11400110  11400113  11400131  11400138  11400146  11400150  11400155  11400160  11400162  11400169  11400174  11400179  11400180  11400181  11400183  11400195  11400206  11400231  11400236  11400241  11400250  11400251  11400257  11400258  11400260  11400281  11400293  11400355  11400361  11400365  11400369  11400370  11400371  11400372  11400376  11400377  11400378  1140037",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0835-2016","Class II"," ","32508"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5966-013-01  00-5966-013-02  00-5966-014-01  00-5966-014-02  00-5966-015-01  00-5966-015-02  00-5966-016-01  00-5966-016-02  00-5966-017-01  00-5966-017-02  00-5970-011-01  00-5970-011-02  00-5970-012-01  00-5970-012-02  00-5970-013-01  00-5970-013-02  00-5970-013-03  00-5970-013-04  00-5970-014-01  00-5970-014-02  00-5970-014-03  00-5970-014-04  00-5970-015-01  00-5970-015-02  00-5970-015-03  00-5970-015-04  00-5970-016-01  00-5970-016-02  00-5970-017-01  00-5970-017-02  00-5970-018-01  00-5970-018-02  00-5972-011-01  00-5972-011-02  00-5972-012-01  00-5972-012-02  00-5972-013-01  00-5972-013-02  00-5972-013-03  00-5972-013-04  00-5972-014-01  00-5972-014-02  00-5972-014-03  00-5972-014-04  00-5972-015-01  00-5972-015-02  00-5972-015-03  00-5972-015-04  00-5972-016-01  00-5972-016-02  00-5972-017-01  00-5972-017-02  00-5972-018-01  00-5972-018-02  00-5990-011-01  00-5990-011-02  00-5990-011-31  00-5990-011-32  00-5990-012-01  00-5990-012-02  00-5990-012-31  00-5990-012-32  00-5990-013-01  00-5990-013-02  00-5990-013-31  00-5990-013-32  00-5990-014-01  00-5990-014-02  00-5990-014-31  00-5990-014-32  00-5990-015-01  00-5990-015-02  00-5990-015-31  00-5990-015-32  00-5990-016-01  00-5990-016-02  00-5990-016-31  00-5990-016-32  00-5990-017-01  00-5990-017-02  00-5990-017-31  00-5990-017-32  00-5990-017-91  00-5990-017-92  00-5990-018-01  00-5990-018-02  00-5990-018-31  00-5990-018-32  00-5992-012-01  00-5992-012-02  00-5992-012-31  00-5992-012-32  00-5992-013-01  00-5992-013-02  00-5992-013-31  00-5992-013-32  00-5992-014-01  00-5992-014-02  00-5992-014-31  00-5992-014-32  00-5992-015-01  00-5992-015-02  00-5992-015-31  00-5992-015-32  00-5992-016-01  00-5992-016-02  00-5992-016-31  00-5992-016-32  00-5992-017-01  00-5992-017-02  00-5992-017-31  00-5992-017-32  00-5992-018-01  00-5992-018-02  00-5992-018-31  00-5992-018-32    Lot numbers:  11002771  11003380  11003415  11003450  11003451  11003469  11003477  11003574  11003575  11003576  11003583  11003586  11003593  11003597  11003601  1100360",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0840-2016","Class II",,"18482"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5752-013-01  00-5752-013-02  00-5752-013-05  00-5752-013-06  00-5752-014-01  00-5752-014-02  00-5752-014-05  00-5752-014-06  00-5752-015-01  00-5752-015-02  00-5752-015-05  00-5752-015-06  00-5752-016-01  00-5752-016-02  00-5752-016-05  00-5752-016-06  00-5752-017-01  00-5752-017-02  00-5752-017-05  00-5752-017-06  00-5762-013-51  00-5762-013-52  00-5762-014-51  00-5762-014-52  00-5762-015-51  00-5762-015-52  00-5762-016-51  00-5762-016-52  00-5762-017-51  00-5762-017-52  00-5962-012-51  00-5962-012-52  00-5962-013-51  00-5962-013-52  00-5962-014-51  00-5962-014-52  00-5962-015-51  00-5962-015-52  00-5962-016-51  00-5962-016-52  00-5962-017-51  00-5962-017-52  00-5962-018-51  00-5962-018-52    Lot numbers:  11003002  11003328  11003397  11003526  11003606  11003637  11003639  11003667  11003972  11004037  11004739  11004835  11004913  11004915  11005025  11005124  11005180  11005183  11005286  11005287  11005288  11005389  11005454  11005613  11005669  11005756  11005843  11005917  11006049  11006065  11006143  11006207  11006225  11006244  11006412  11006591  11006650  11006688  11006696  11006700  11006733  11006807  11006834  11007020  11007021  11007087  11007099  11007174  11007191  11007205  11007274  11007372  11007386  11007388  11007411  11007457  11007477  11007542  11007660  11007662  11007669  11007681  11007683  11007703  11007741  11007752  11007821  11007866  11007872  11007896  11007936  11008030  11008283  11008308  11008313  11008324  11008378  11008402  61759051  61777352  61782446  61782447  61782448  61782449  61782450  61782451  61782452  61782453  61782454  61782455  61789737  61789738  61789747  61789748  61789749  61789759  61789761  61789762  61789763  61789764  61795241  61795242  61795243  61795245  61795246  61795248  61795249  61795250  61795251  61795252  61800466  61800467  61800478  61800479  61800480  61800481  61800482  61800483  61800484  61800485  61805217  61805218  61805219  61805220  61805221  61805226  61805227  61805228  61805229  61805230  61809915 ",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0838-2016","Class II",,"61485"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5410-014-01  00-5410-014-02  00-5410-015-01  00-5410-015-02  00-5410-016-01  00-5410-016-02  00-5410-017-01  00-5410-017-02  00-5410-018-01  00-5410-018-02  00-5412-014-02  00-5412-015-01  00-5412-016-02  00-5414-013-01  00-5414-014-01  00-5414-014-02  00-5414-015-01  00-5414-015-02  00-5414-016-01  00-5414-016-02  00-5416-013-01  00-5416-013-02  00-5416-014-01  00-5416-014-02  00-5416-015-01  00-5416-015-02  00-5416-016-01  00-5416-016-02  00-5416-017-01  00-5416-017-02  00-5750-013-01  00-5750-013-02  00-5750-013-05  00-5750-013-06  00-5750-014-01  00-5750-014-02  00-5750-014-05  00-5750-014-06  00-5750-015-01  00-5750-015-02  00-5750-015-05  00-5750-015-06  00-5750-016-01  00-5750-016-02  00-5750-016-05  00-5750-016-06  00-5750-017-01  00-5750-017-02  00-5750-017-05  00-5750-017-06    Lot numbers:  11001439  11002693  11003150  11003160  11003161  11003162  11003163  11003168  11003169  11003173  11003174  11003175  11003176  11003185  11003186  11003187  11003198  11003202  11003203  11003210  11003215  11003219  11003229  11003233  11003234  11003237  11003243  11003246  11003247  11003254  11003977  11004073  11004242  11004243  11004264  11004265  11004293  11004308  11004329  11004366  11004474  11004485  11004487  11004489  11004509  11004515  11004517  11004518  11004528  11004570  11004594  11004646  11004672  11004678  11004685  11004686  11004749  11004757  11004758  11004760  11004763  11004764  11004774  11004775  11004776  11004777  11004778  11004779  11004780  11004781  11004782  11004786  11004787  11004788  11004789  11004804  11004805  11004809  11004810  11004811  11004812  11004842  11004843  11004856  11004881  11004883  11004897  11004898  11004920  11004922  11004923  11004924  11004926  11004935  11004965  11004994  11005008  11005009  11005010  11005045  11005065  11005122  11005127  11005128  11005129  11005159  11005160  11005161  11005179  11005187  11005188  11005189  11005191  11005192  11005193  11005210  11005219  11005220  11005235  11005237  11005238  110",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016","62013598  62013599  62013600  62013601  62013602  62013603  62013604  62013605  62013606  62013607  62013608  62013610  62013611  62013612  62013613  62013614  62013615  62013617  62013618  62013619  62013620  62013621  62013625  62013627  62013628  62013629  62013631  62013632  62013633  62013634  62013635  62013636  62013637  62013639  62014078  62017259  62017260  62017584  62017586  62017587  62017588  62018050  62018051  62018052  62018143  62018555  62019293  62019294  62019295  62020359  62020360  62020361  62020362  62020363  62020366  62020367  62020368  62020369  62020370  62020371  62020372  62020373  62020375  62020377  62020378  62020379  62020380  62020381  62020382  62020388  62020389  62020390  62020391  62020396  62020397  62020398  62020399  62020400  62020401  62020402  62020403  62020404  62020406  62020407  62020408  62020409  62020410  62020411  62020412  62020413  62020414  62020415  62020416  62020820  62020821  62020822  62022106  62022107  62022292  62022336  62022337  62025698  62025699  62025700  62025701  62025786  62025787  62025789  62025790  62025791  62025792  62025793  62025794  62025795  62025796  62025797  62025798  62025799  62025802  62025809  62025810  62025811  62025812  62025813  62025814  62025816  62025817  62025818  62025819  62025828  62025829  62025830  62025831  62025832  62025833  62025834  62025835  62025836  62025837  62025838  62025839  62025840  62025841  62025842  62027214  62028180  62028436  62028461  62028462  62029496  62029560  62029562  62029861  62029862  62029863  62029872  62029874  62030306  62030473  62030474  62031961  62031962  62031963  62031964  62031965  62032683  62032684  62032685  62032686  62032687  62032688  62032689  62032690  62032691  62032692  62032693  62032694  62032696  62032697  62032698  62032699  62032701  62032702  62032703  62032704  62032705  62032706  62032707  62032708  62032710  62032714  62032715  62032721  62032722  62032723  62032724  62032725  62032726  62032727  62032728  62032729  62032730  62032731  62032732  62032",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0830-2016","Class II","    ","84396"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5764-013-51  00-5764-013-52  00-5764-014-51  00-5764-014-52  00-5764-015-51  00-5764-015-52  00-5764-016-51  00-5764-016-52  00-5764-017-51  00-5764-017-52    Lots:  11003937  11004287  11004298  11004337  11004544  11004612  11004769  11004797  11004818  11005062  11005066  11005155  11005276  11005598  11005680  11005705  11005748  11005900  11005931  11005959  11005980  11006190  11006737  11006764  11006827  11006840  11006882  11006922  11006986  11007165  11007217  11007272  11007323  11007651  11007849  11007988  11008186  11008197  11008221  11008231  11008311  11400099  11400104  11400119  11400120  11400122  11400125  11400126  11400134  11400152  11400165  11400170  11400187  11400203  11400215  11400218  11400244  11400247  11400270  11400271  11400274  11400284  11400339  11400359  11400360  11400364  11400381  11400417  11400418  11400427  11400428  11400448  11400449  11400451  11400452  11400455  11400456  11400457  11400464  11400482  11400488  11400489  11400490  11400492  11400499  11400500  11400506  11400510  11400526  11400532  11400550  11400553  61772478  61777279  61777283  61777284  61782390  61782391  61782393  61782394  61782395  61789567  61789568  61789569  61789570  61789572  61789574  61789575  61789576  61789577  61789578  61792783  61793532  61793549  61793551  61793552  61793554  61794709  61794711  61794712  61794730  61795524  61795525  61795526  61795527  61795528  61795529  61795530  61795531  61795532  61795533  61795534  61795535  61796363  61796380  61796381  61796382  61796461  61796463  61796474  61796476  61797741  61797742  61797743  61797744  61797745  61797746  61797747  61797748  61797749  61797757  61797758  61797759  61797760  61798618  61798619  61798620  61798621  61798622  61798623  61798625  61798637  61798638  61798639  61800345  61800346  61800347  61800348  61800349  61800350  61800351  61800352  61800353  61800354  61800355  61800356  61800357  61800358  61800603  61800604  61800605  61800606  61800607  61800608  61800609  61800628  ",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016","8  62118629  62118630  62118631  62118632  62118633  62118634  62118635  62118636  62118637  62118640  62118654  62118660  62119499  62119501  62120511  62120514  62120531  62121207  62121208  62121209  62121210  62121211  62121212  62121236  62121237  62121238  62121239  62121783  62121785  62121805  62121806  62121807  62122584  62122592  62122608  62122618  62122623  62122624  62122663  62122664  62122665  62122666  62122667  62122668  62122674  62122712  62122713  62122715  62122716  62122717  62122718  62122872  62122873  62122874  62122875  62122876  62122877  62122878  62123099  62123107  62123894  62123895  62123896  62123897  62123898  62123899  62123901  62123902  62124877  62124878  62124879  62126103  62126129  62126130  62126819  62126821  62127095  62127096  62127098  62127122  62127123  62127126  62127127  62127490  62127529  62127534  62127540  62127558  62128212  62128213  62128214  62128215  62128216  62128218  62128219  62128220  62128221  62128368  62128370  62128371  62128381  62128383  62128384  62129238  62129241  62129244  62129245  62129246  62129248  62129374  62129413  62129418  62129423  62129428  62129498  62129500  62129503  62129609  62129620  62129643  62129824  62129826  62129827  62129885  62131190  62131191  62131258  62131259  62131260  62131272  62131273  62131274  62132090  62132091  62132093  62132114  62132117  62132203  62132204  62132205  62132206  62132207  62132738  62132739  62132868  62132870  62132871  62132884  62132885  62133193  62133201  62133830  62133831  62133832  62133836  62133837  62133838  62133839  62133840  62133841  62133842  62133845  62133846  62133847  62133848  62133849  62133856  62133857  62133858  62133859  62134317  62134320  62134324  62134327  62134715  62134716  62134717  62134729  62134730  62134752  62135974  62135976  62135983  62135988  62135993  62136389  62136390  62136391  62136392  62137125  62137138  62137160  62137163  62137168  62137175  62137466  62137468  62137470  62137522  62137524  62137525  62137526  62137527  62137542  62",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0839-2016","Class II",,"13483"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  6212-00-007  6212-00-008  6212-00-009  6212-00-010  6212-00-011  6212-00-020  6212-00-021  6212-00-030  6212-00-031  6212-00-040  6212-00-041  6212-00-050  6212-00-051  6307-00-006  6307-00-007  6307-00-008  6307-00-009  6307-00-010  6307-00-011  6307-00-020  6307-00-021  6307-00-030  6307-00-031  6307-00-040  6307-00-041  6307-00-050  6307-00-051    Lot numbers:  11002695  11003148  11003157  11003159  11003165  11003167  11003170  11003181  11003190  11003192  11003193  11003195  11003196  11003201  11003212  11003214  11003216  11003223  11003228  11003230  11003231  11003232  11003235  11003236  11003240  11003241  11003244  11003248  11003249  11003251  11003252  11003253  11003255  11003257  11003258  11003259  11003261  11003267  11003981  11004011  11004072  11004206  11004207  11004208  11004247  11004248  11004286  11004310  11004330  11004367  11004383  11004384  11004385  11004386  11004410  11004411  11004426  11004427  11004473  11004475  11004541  11004550  11004551  11004588  11004589  11004590  11004592  11004593  11004603  11004604  11004610  11004636  11004637  11004644  11004664  11004783  11004784  11004785  11004800  11004802  11004803  11004839  11004841  11004844  11004846  11004876  11004879  11004937  11004938  11004939  11004940  11004960  11004967  11004968  11004969  11005012  11005013  11005014  11005015  11005039  11005040  11005041  11005042  11005178  11005267  11005295  11005299  11005300  11005380  11005512  11005514  11005590  11005591  11005603  11005604  11005619  11005620  11005713  11005745  11005774  11005777  11005876  11005923  11005924  11005951  11006034  11006104  11006123  11006124  11006125  11006147  11006148  11006216  11006217  11006218  11006293  11006294  11006326  11006393  11006394  11006395  11006426  11006427  11006446  11006475  11006502  11006503  11006528  11006532  11006533  11006559  11006560  11006568  11006569  11006606  11006636  11006637  11006643  11006678  11006679  11006680  11006681  11006724  11006725  11006757  11006766  11",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0846-2016","Class II","    ","130"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-7843-011-16  00-7843-012-16  00-7843-013-16  00-7843-014-16  00-7843-015-16  00-7843-016-16  Lot numbers:  61760685  61781980  61840199  61844725  61844726  61951281  61956725  61968111  61987956  62011958  62029062  62034145  62097248  62097288  62120672    ",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0850-2016","Class II",,"194"," LDPE is softer than the two mating materials o","02/22/2016",," Item number:  00-8770-040-02  Lots:  2564467  2573371  2625382  2631721  2655075  2655076  2685143   ",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0843-2016","Class II"," ","289"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-8114-040-00  00-8114-050-00  Lot numbers:  61790499  61878931  61891348  61907682  61993208  61993210  62030932  62038367  62106796  62106797  62148557  62161479  62206538  ",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0836-2016","Class II"," ","32537"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5842-011-01  00-5842-011-02  00-5842-012-01  00-5842-012-02  00-5842-013-01  00-5842-013-02  00-5842-014-01  00-5842-014-02  00-5842-015-01  00-5842-015-02  00-5842-016-01  00-5842-016-02  00-5842-017-01  00-5842-017-02    Lot numbers:  11002504  11002764  11002766  11002767  11002780  11002782  11002784  11003009  11003028  11003042  11003048  11003345  11003366  11003367  11003370  11003371  11003384  11003398  11003399  11003413  11003414  11003433  11003452  11003488  11003490  11003491  11003584  11003587  11003588  11003589  11003603  11003611  11003635  11003642  11003649  11003658  11003659  11003660  11003661  11003689  11003855  11003868  11003878  11003904  11003921  11003944  11003959  11003960  11003974  11004052  11004056  11004074  11004146  11004150  11004152  11004161  11004204  11004306  11004335  11004401  11004402  11004408  11004446  11004450  11004451  11004452  11004455  11004463  11004553  11004563  11004564  11004626  11004677  11004707  11004715  11004720  11004726  11004754  11004790  11004798  11004825  11004830  11004833  11004834  11004851  11004852  11004911  11004912  11004918  11004930  11004986  11004987  11004988  11004993  11005001  11005003  11005031  11005032  11005087  11005090  11005093  11005120  11005121  11005126  11005168  11005194  11005203  11005204  11005214  11005239  11005240  11005242  11005244  11005251  11005349  11005350  11005357  11005414  11005583  11005607  11005608  11005610  11005646  11005749  11005750  11005781  11005800  11005804  11005932  11005938  11005984  11005995  11006023  11006025  11006048  11006060  11006068  11006075  11006145  11006153  11006161  11006162  11006169  11006172  11006200  11006215  11006222  11006223  11006253  11006255  11006271  11006311  11006411  11006439  11006480  11006539  11006550  11006596  11006625  11006715  11006739  11006743  11006751  11006761  11006836  11006884  11006885  11006991  11007049  11007051  11007090  11007212  11007276  11007277  11007311  11007334  11007337  11007439  11007565 ",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0845-2016","Class II"," ","72806"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5001-038-00  00-5001-039-00  00-5001-040-00  00-5001-041-00  00-5001-042-00  00-5001-043-00  00-5001-044-00  00-5001-045-00  00-5001-046-00  00-5001-047-00  00-5001-048-00  00-5001-049-00  00-5001-050-00  00-5001-051-00  00-5001-052-00  00-5001-053-00  00-5001-054-00  00-5001-055-00  00-5001-057-00  00-5001-058-00  00-5001-060-00  00-5001-062-00  00-5001-064-00  00-5001-066-00  00-5001-068-00  00-5001-070-00  00-5001-072-00  Lot numbers:  00370174  00370176  00370178  00370181  00370453  00370454  00370455  00370457  00370461  00370665  00370751  00370810  00370858  00370859  00370860  00370866  00370867  00370868  00370869  00370870  00370871  00370875  00370893  00370894  00370895  00370908  00370909  00370910  00370911  00370912  00370920  00370924  00370925  00370945  00370946  00370947  00370948  00370949  00370950  00370951  00370952  00370953  00370954  00370986  00370988  61762024  61774923  61774933  61779294  61783774  61783798  61783801  61786883  61786899  61786901  61786902  61786903  61786904  61786905  61786906  61786910  61786911  61786912  61786913  61786915  61786916  61786918  61786921  61786922  61786923  61786924  61786925  61786926  61789197  61790398  61790399  61790400  61790402  61790403  61790406  61790407  61790408  61790409  61790410  61790411  61790413  61790414  61795021  61795024  61795025  61795026  61795027  61795028  61795029  61795030  61795031  61795032  61795033  61795034  61795035  61795036  61795037  61795038  61795039  61795040  61798106  61798107  61798108  61798109  61798110  61798111  61798112  61798113  61798114  61798115  61798116  61798117  61798118  61798119  61798120  61798121  61798122  61798123  61798124  61798125  61798126  61798127  61798684  61798685  61798686  61798687  61798689  61798690  61798691  61798692  61798693  61798694  61798695  61798696  61798697  61798698  61798699  61798701  61802418  61802419  61802420  61802422  61802423  61802424  61802425  61802426  61802427  61803796  61803797  61803798  61803799  61803801  61803802  618",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0847-2016","Class II","      ","101"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-7843-012-18  00-7843-013-18  00-7843-015-18  00-7843-015-24  00-7843-016-18  00-7843-016-24  00-7843-018-18  00-7843-018-24  00-7843-019-18  00-7843-019-24  00-7843-021-18  00-7843-021-24  00-7843-022-18  00-7843-022-24  Lot numbers:  11006277  61775244  61781982  61786860  61815081  61879442  61937678  61956718  61956722  61981808  61993659  62029064  62043111  62143772  77000810  77000822  ",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73142,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to   ARGENTINA               AUSTRALIA  AUSTRIA  BARBADOS  BELGIUM  BERMUDA  BOLIVIA  BRAZIL  CARIBBEAN  CHILE  CHINA  COLOMBIA  COST RICA  DENMARK  DOMINICAN REPUBLIC  DORAL FL  ECUADOR  EL SALVADOR  ENGLAND  FRANCE  GERMANY  GUATEMALA  HONDURAS  HONG KONG  INDIA  ISRAEL  ITALY  JAMAICA  JAPAN  KOREA  MALAYSIA  MEXICO  NEW ZEALAND  NICARAGUA  PANAMA  PERU  SINGAPORE  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  VENEZUELA  WEST INDIES  Canary Islands  Croatia  Cyprus  Czech Republic  Canada","Z-0832-2016","Class II","    ","117359"," LDPE is softer than the two mating materials o","02/22/2016",," Item numbers:  00-5960-011-31  00-5960-011-32  00-5960-012-31  00-5960-012-32  00-5960-013-31  00-5960-013-32  00-5960-014-31  00-5960-014-32  00-5960-015-31  00-5960-015-32  00-5960-016-31  00-5960-016-32  00-5960-017-31  00-5960-017-32  00-5964-012-01  00-5964-012-02  00-5964-013-01  00-5964-013-02  00-5964-014-01  00-5964-014-02  00-5964-015-01  00-5964-015-02  00-5964-016-01  00-5964-016-02  00-5964-017-01  00-5964-017-02    Lot numbers:  11003819  11003822  11003824  11003955  11003973  11003997  11004030  11004042  11004076  11004086  11004103  11004104  11004105  11004160  11004166  11004173  11004174  11004188  11004190  11004223  11004252  11004255  11004271  11004280  11004300  11004336  11004373  11004377  11004469  11004503  11004546  11004552  11004559  11004565  11004598  11004628  11004629  11004630  11004654  11004675  11004680  11004682  11004706  11004716  11004721  11004722  11004723  11004755  11004756  11004759  11004767  11004768  11004793  11004795  11004821  11004871  11004899  11004901  11004902  11004947  11004949  11004973  11005024  11005026  11005029  11005058  11005063  11005064  11005085  11005098  11005102  11005114  11005123  11005133  11005146  11005154  11005198  11005205  11005213  11005223  11005241  11005271  11005278  11005319  11005321  11005331  11005335  11005336  11005340  11005344  11005377  11005378  11005379  11005382  11005438  11005445  11005477  11005488  11005556  11005562  11005572  11005575  11005578  11005580  11005592  11005596  11005614  11005631  11005664  11005665  11005671  11005679  11005681  11005689  11005706  11005714  11005716  11005717  11005726  11005730  11005733  11005739  11005751  11005754  11005765  11005770  11005778  11005780  11005784  11005785  11005798  11005802  11005803  11005818  11005819  11005861  11005866  11005867  11005869  11005892  11005909  11005915  11005964  11005979  11005981  11005983  11006022  11006047  11006053  11006057  11006064  11006066  11006079  11006080  11006120  11006152  11006156  11006177  11006184  1100618",1/11/2016,"01/11/2016",3/2/2016,"03/02/2016","4845  61984857  61984862  61985019  61985020  61985021  61985038  61985042  61986242  61986412  61986413  61986414  61986415  61986417  61986427  61986428  61986689  61986693  61986696  61986697  61986698  61986734  61986735  61986853  61986854  61987056  61987057  61987058  61987059  61987074  61987408  61987410  61987537  61987538  61987539  61987540  61987541  61987542  61987543  61987544  61987568  61987739  61987741  61987742  61987797  61987798  61987799  61987800  61987801  61987802  61987803  61987804  61987805  61987806  61987807  61987808  61987809  61987810  61987811  61987812  61987813  61987814  61987815  61987816  61987817  61987818  61987819  61987820  61987821  61987822  61987824  61987825  61987826  61987827  61987828  61987829  61987830  61987831  61987832  61988117  61988127  61988128  61988445  61988447  61988448  61988449  61988461  61988462  61988554  61989033  61989034  61989036  61989088  61989663  61989664  61989666  61989667  61989672  61989673  61989674  61990659  61990907  61990908  61990910  61992033  61992050  61992702  61992977  61992978  61992979  61992980  61992982  61993578  61993579  61993580  61993581  61993583  61993585  61993586  61993588  61993593  61993599  61993601  61993602  61993603  61993604  61993605  61993606  61993607  61993608  61993611  61993613  61993614  61993615  61993620  61993621  61993649  61993650  61993652  61993653  61993654  61993655  61993656  61993657  61993923  61993924  61995663  61995683  61995687  61996342  61996343  61996351  61996967  61997335  61998616  61998617  61998798  61998837  61999551  61999552  61999553  61999554  61999574  61999925  61999973  62000378  62000379  62000380  62000386  62000387  62000388  62000389  62000390  62000391  62000392  62000393  62000394  62000395  62000396  62000397  62000399  62000400  62000401  62000402  62000403  62000404  62000405  62000406  62000407  62000408  62000411  62000413  62000414  62000415  62000416  62000417  62000418  62000419  62000420  62000421  62000422  62000446  62000447  62000969  62000970 ",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73145,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9054","United States","Voluntary: Firm Initiated","FAX","Florida","B-0317-16","Class II","Apheresis Fresh Frozen Plasma","3 units","Blood products, for which donor eligibility was inadequately determined, were distributed.","02/26/2016","02/26/2016"," 2547204; 2302217; 2349650",12/18/2015,"12/18/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73145,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9054","United States","Voluntary: Firm Initiated","FAX","Florida","B-0318-16","Class II","Apheresis Platelets, Leukocytes Reduced","3 units","Blood products, for which donor eligibility was inadequately determined, were distributed.","02/26/2016","02/26/2016"," 2547204; 2302217; 2349650",12/18/2015,"12/18/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73147,"Terminated","HCSC-Blood Center","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","Letter","Pennsylvania","B-0309-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Blood product, in which donor screening/donor record incomplete or incorrect, was distributed.","03/09/2016","03/09/2016"," W050911029884; ",11/24/2015,"11/24/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73148,"Terminated","HCSC-Blood Center","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","Letter","Pennsylvania","B-0311-16","Class II","Fresh Frozen Plasma","1 unit","Blood products, in which donor screening/donor record incomplete or incorrect, were distributed.","03/09/2016","03/09/2016"," W050911039712; ",11/19/2015,"11/19/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73148,"Terminated","HCSC-Blood Center","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","Letter","Pennsylvania","B-0310-16","Class II","Red Blood Cells","1 unit","Blood products, in which donor screening/donor record incomplete or incorrect, were distributed.","03/09/2016","03/09/2016"," W050911039712; ",11/19/2015,"11/19/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",73149,"Ongoing","Rockline Industries, Inc","4343 S Taylor Dr",,"Sheboygan","WI","53081-8485","United States","Voluntary: Firm Initiated","Telephone","All products were distributed to SCA North America in both the US and Canada","F-0714-2016","Class II","ULTRA Washcloths - 48 count wipes per pack; ULTRA Washcloths Scent Free - 48 count wipes per pack; Ultra Flush Washcloths - 48 count wipes per pack; ULTRA Adult Wipe - 48 count wipes per pack. All packaged in flexible plastic.","104,743 cases","Odor reported in a complaint is characteristic of product spoilage.","03/04/2016",," Date range being recalled is June 1, 2015 (1525 R) to December 31, 2015 (3655 R)",1/21/2016,"01/21/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73150,"Ongoing","QiG Group LLC","10675 Naples St NE",,"Blaine","MN","55449-5802","United States","Voluntary: Firm Initiated","Letter","Distributed in Germany and Luxembourg.","Z-1192-2016","Class II","Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)","40","The implantable pulse generator (IPG) model 2408  had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm).  The following functions may not be available:  Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.","03/18/2016",," Serial Numbers:  03EDBF, 03EDC1, 03EDC5, 03EDC7, 03EDC9, 03EDCA, 03EDCE, 03EDD0, 03EDE5, 03EDE8, 03EDE9, 03EDEA, 03EDEF, 03EDF0, 03EE01, 03EE03, 03EE05, 03EE1C, 03EE1F, 03EE24, 03EE25, 03EE26, 03EE28, 03EE34, 03EE35, 03EE36, 03EE37, 03EE3A, 03EE3B, 03EE5A, 03EE5B, 03EE60, 03EE96, 03EE97, 03EE98, 03EE9D, 03EE9F, 03EEA2, 03EEA3, 03EEA4, 03EEAC.    ",1/26/2016,"01/26/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73150,"Ongoing","QiG Group LLC","10675 Naples St NE",,"Blaine","MN","55449-5802","United States","Voluntary: Firm Initiated","Letter","Distributed in Germany and Luxembourg.","Z-1193-2016","Class II","Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)","34","The implantable pulse generator (IPG) model 2408  had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm).  The following functions may not be available:  Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.","03/18/2016",," Serial Numbers:  03EDB5, 03EDD9, 03EDDA, 03EDDB, 03EDDD, 03EDE0, 03EDE4, 03EDF5, 03EDF6, 03EDFA, 03EDFC, 03EDFF, 03EE07, 03EE08, 03EE0A, 03EE0D, 03EE0E, 03EE12, 03EE13, 03EE1A, 03EE30, 03EE3C, 03EE3F, 03EE44, 03EE48, 03EE4C, 03EE4D, 03EE6D, 03EE74, 03EE82, 03EE88, 03EE89, 03EE8F, 03EE94.    ",1/26/2016,"01/26/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73150,"Ongoing","QiG Group LLC","10675 Naples St NE",,"Blaine","MN","55449-5802","United States","Voluntary: Firm Initiated","Letter","Distributed in Germany and Luxembourg.","Z-1194-2016","Class II","Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400","31","The implantable pulse generator (IPG) model 2408  had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm).  The following functions may not be available:  Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.","03/18/2016",," Serial Numbers:  01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6, 01DCB  ",1/26/2016,"01/26/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73151,"Ongoing","Gi Supply","200 Grandview Ave",,"Camp Hill","PA","17011-1706","United States","Voluntary: Firm Initiated","Letter","Distributed in DC and the following states CA, FL, IA, KY, MA, MO, NH, NJ, NY, OH, OR, PA, SC, and TN.","Z-1047-2016","Class II"," Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag.    Catalog #: GIS-28  Lot #: 61442434  Expiration Date: 2018/04","390 Kits","Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.","03/04/2016",," Lot #: 61442434  Expiration Date: 2018/04",1/28/2016,"01/28/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73152,"Ongoing","Golden State Medical Supply Inc.","5187 Camino Ruiz",,"Camarillo","CA","93012-8601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0767-2016","Class III","Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only  Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77    ","222 100-count packages (22,000 tablets)","Failed Impurities/Degradation Specifications","03/09/2016",," Lot #GS005602; Exp. 10/15  Lot #GS008855; Exp. 09/17  Lot #GS009074; Exp. 08/17  Lot #GS009393; Exp. 08/17  Lot #GS009760; Exp. 10/17  Lot #GS010599; Exp. 11/17  ",1/27/2016,"01/27/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73152,"Ongoing","Golden State Medical Supply Inc.","5187 Camino Ruiz",,"Camarillo","CA","93012-8601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0769-2016","Class III","Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only  Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77  ","172 100-count packages (17,200 tablets)","Failed Impurities/Degradation Specifications","03/09/2016",," Lot #GS009075; Exp. 09/17  Lot #GS009763; Exp. 09/17  Lot #GS010178; Exp. 10/17  ",1/27/2016,"01/27/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73152,"Ongoing","Golden State Medical Supply Inc.","5187 Camino Ruiz",,"Camarillo","CA","93012-8601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0768-2016","Class III","Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only  Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77  ","74 100-count packages (7,400 tablets)","Failed Impurities/Degradation Specifications","03/09/2016",," Lot #GS008856; Exp. 09/17  Lot #GS010268; Exp. 09/17  Lot #GS010600; Exp. 11/17  ",1/27/2016,"01/27/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73152,"Ongoing","Golden State Medical Supply Inc.","5187 Camino Ruiz",,"Camarillo","CA","93012-8601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0770-2016","Class III","Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only  Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77  ","168 100-count packages (16,800 tablets)","Failed Impurities/Degradation Specifications","03/09/2016",," Lot #GS005603; Exp. 10/15  Lot #GS006691; Exp. 08/17  Lot #GS009073; Exp. 08/17  Lot #GS009395; Exp. 08/17  Lot #GS009764; Exp. 10/17  ",1/27/2016,"01/27/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73153,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","E-Mail","New York; California","B-0313-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor who was permanently deferred, were distributed.","03/09/2016","03/09/2016"," W047015323172; ",12/24/2015,"12/24/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73153,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","E-Mail","New York; California","B-0312-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor who was permanently deferred, were distributed.","03/09/2016","03/09/2016"," W047015323172; ",12/24/2015,"12/24/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73154,"Terminated","Central California Blood Center","4343 W Herndon Ave",,"Fresno","CA","93722-3794","United States","Voluntary: Firm Initiated","Telephone","California","B-0314-16","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.","03/09/2016","03/09/2016"," W115915252610; W115915252611; ",12/23/2015,"12/23/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73155,"Ongoing","Becton, Dickinson and Company, BD Biosciences","2350 Qume Dr",,"San Jose","CA","95131-1812","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan.","Z-0851-2016","Class III","BD FMC7 FITC: Model 430918.  FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.    Product Usage:  Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.  ","78","Becton,  Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed  on the vial label.","02/22/2016",," Model number: 340918: Lot number: 5341918.  Incorrect  expiry date on label 03/31/2017. correct expiry should be 6/30/16.",1/25/2016,"01/25/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0879-2016","Class II","Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-0090S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0870-2016","Class II","Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1210-6451S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0883-2016","Class II","Stryker, T2 K-Wire, 3.2x400mm, Recon    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-3030S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0877-2016","Class II","Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-0084S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0884-2016","Class II","Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-3031S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0874-2016","Class II","Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-0051S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0881-2016","Class II","Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-1250S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0868-2016","Class II","Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 0190-2000S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0869-2016","Class II","Stryker, Gamma K-Wire 3.2x450 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 12106450S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0878-2016","Class II","Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-0085S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0867-2016","Class II","Stryker, T2 K-Wire 1.8 x 310 mm, Sterile    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 0152-0218S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0872-2016","Class II","Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1320-0016S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0873-2016","Class II","Stryker, T2 K-Wire, 3x285 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-0050S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0882-2016","Class II","Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-1417S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0876-2016","Class II","Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-0083S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0875-2016","Class II","Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-0080S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0871-2016","Class II","Stryker, Gamma Guide Pin, 4x400 mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1213-9091S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73156,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0880-2016","Class II","Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm    Product Usage:  Intended for the temporary stabilization of bone segments or fragments.  ","147,838 units in total","During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.","02/24/2016",," Catalog number 1806-0093S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73157,"Ongoing","PMBS, LLC","40 Milltown Rd",,"Stockton","NJ","08559-1303","United States","Voluntary: Firm Initiated","Letter","FL, GA, MN, NY, OH, OR SC, and TN","Z-1266-2016","Class II","The S.C.O.R.E.S. Unit (self contained operating room equipment  sterilization unit) ","58 units","Water retention issues.  Units with filters that remain wet after the sterilization may compromised sterility.","03/25/2016",," ALL distributed S.C.O.R.E.S. units are affected.",1/13/2016,"01/13/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73158,"Terminated","House Of Flavors, Inc.","110 N William St",,"Ludington","MI","49431-1674","United States","Voluntary: Firm Initiated","Press Release","Domestic: IL, IN, KY, MI, OH, WI    Foreign: None","F-0623-2016","Class I","Purple Cow Limited Edition Cookie Butter Ice Cream, 8 oz. cups, packed in paper cartons","17,352    8 oz. containers","House of Flavors, Inc. is voluntarily recalling a small batch of 8 oz. cups of Purple Cow Limited Edition Cookie Butter Ice Cream, sold at Meijer stores, that contain Purple Cow Butter Pecan Ice Cream with a Purple Cow Butter Pecan lid.","02/23/2016","04/28/2016"," UPC Code 13733 61945 and marked Best By November 21, 2016",1/27/2016,"01/27/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73159,"Ongoing","Karman Healthcare Inc","19255 San Jose Ave",,"City of Industry","CA","91748-1418","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following states -- WA, CA, NY, and TX.","Z-1025-2016","Class II","Karma Flexx Wheelchair    Manual Wheelchair.","35","Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.","02/27/2016",," Item #	  935-0245H6 Flexx (KM852216)  Serial #	  TM14-A03982-TM14-A03991    Item #  935-0246H6 Flexx (KM852218)  Serial #	  TM14-A03992-TM14-A04012    Item #  935-0247H6 Flexx (KM852220)  Serial #	  TM14-A4013-TM14-A04017  ",1/27/2016,"01/27/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73160,"Ongoing","Jody's Gourmet Popcorn","1160 Millers Ln",,"Virginia Beach","VA","23451-5716","United States","Voluntary: Firm Initiated","Telephone","The fudge was distributed in fulfillment of seven school fundraising projects.  The fudge was delivered to the schools from October 26, 2015 through November 12, 2015.    There were no foreign accounts, and there were no US government accounts (military or civilian).      The schools that received the product, and the number of units delivered,  are listed below, along with the school organizer, who we have alerted to the recall:      Portsmouth Christian School  - 52 units  3214 Elliott Ave  Portsmouth, Va 23702  Jan Collins  jancollins@portsmouthchristian.org      Hodges Manor ES  19 units  1201 Cherokee Rd  Portsmouth, Va 23701  Vallery Theus  vallery.theus@yahoo.com    JEJ Moore MS  39 units  11455 Prince George Dr  Disputanta, Va 23842  Tracy Brunner  tbrunner@outlook.com    Moyock MS  11 units  216 Survey Rd  Moyock, NC 27958  Elizabeth Sweeney  sweeneyelizabeth27@yahool.com    Lynnhaven ES  2 units  210 Dillon Dr.  Va. Beach, Va 23452  Laurent Bracey  csarecovery@gmail.com    Simonsdale ES PTA  29 units  4841 Clifford Street  Portsmouth, VA 23707  Amy Beaulier  amybeaulieupta1516@gmail.com    Glen Allen High School  10700 Staples Mill Rd.  Glen Allen, VA 23060  Sherry Ingram  Note: The distributor, Sterling Ideas Unlimited handled communication with this school.","F-0622-2016","Class II","Jody's Gourmet Popcorn, Fabulous Fudge Chocolate Walnut,  net weight 8 oz. , one unit per package, packed in clear clamshell,  expiration date 12/22/15","215 packages of fudge were produced and distributed ","Jody's Inc. received a few notifications from people who bought the fudge as part of a school fund raiser that the fudge had mold on it.  The expiration date of the fudge is 12/22/15, and it should not be growing mold yet.  The firm immediately recalled  the fudge.  ","02/19/2016",," Batch Numbers: 1528802-F and 1528801-F",12/3/2015,"12/03/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73161,"Terminated","BPL Plasma, Inc","5789 Airport Blvd",,"Austin","TX","78752-4201","United States","Voluntary: Firm Initiated","E-Mail","California","B-0359-16","Class III","Source Plasma","1 unit","Blood product, in which quality control and failure to quarantine unit due to medical history, was distributed.","03/14/2016","03/14/2016"," AU0644073; ",10/13/2015,"10/13/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73162,"Completed","Kassik Milling Co Inc","309 Main St","PO Box 128","Milligan","NE","68406-3949","United States","Voluntary: Firm Initiated","Telephone","Nebraska","V-481-2016","Class III","Western Gold 14% Horse Pellet packaged in bags, Net Weight 50 lbs (22.68 kg).  The responsible firm name on the label is Kassik Milling Co., Milligan, NE.","7 - 50 lb. bags","Product contaminated with monensin.","08/12/2016",," lot #15120125",1/26/2016,"01/26/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73163,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.","Z-0865-2016","Class II","Flexor Check-Flo Introducer, Catheter introducer,   Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC    Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices","25","Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.","02/24/2016",," Catalog #:   KCFW-6.0-35-70-RB-HFANL0-HC    Lot:  6166304",1/20/2016,"01/20/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73164,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","E-Mail","Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.","Z-0816-2016","Class II","LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL;  Tibial knee prosthesis, augment.","8 units","The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were  too long.","02/17/2016",," 14KM16422",1/18/2016,"01/18/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73165,"Ongoing","Penta Intenational, Inc.","125 Northfield Ave",,"Edison","NJ","08837-3856","United States","Voluntary: Firm Initiated","Telephone","NJ","F-0626-2016","Class II","STREGA Araldi allo (Chocolate nougat)","3 cases (8 cartons per case)","Undeclared gluten","02/24/2016",," Barcode #8001975006112; Codice 011104925/E",12/21/2015,"12/21/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73167,"Ongoing","Bee Xtreme","506 N Penn St",,"Punxsutawney","PA","15767-1527","United States","Voluntary: Firm Initiated","E-Mail","Unknown","D-0021-2017","Class I","Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA  ","13 bottles","Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein","10/12/2016",," All Lots",12/23/2015,"12/23/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73167,"Ongoing","Bee Xtreme","506 N Penn St",,"Punxsutawney","PA","15767-1527","United States","Voluntary: Firm Initiated","E-Mail","Unknown","D-0019-2017","Class I","La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles,  Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104,   distributed by BeeXtreme LLC, Punxsutawney PA","589 bottles","Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein","10/12/2016",," All Lots",12/23/2015,"12/23/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73167,"Ongoing","Bee Xtreme","506 N Penn St",,"Punxsutawney","PA","15767-1527","United States","Voluntary: Firm Initiated","E-Mail","Unknown","D-0020-2017","Class I","Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA  ","732 bottles","Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein","10/12/2016",," All Lots",12/23/2015,"12/23/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73168,"Ongoing","Centurion Medical Products Corporation","100 Centurion Way",,"Williamston","MI","48895-9086","United States","Voluntary: Firm Initiated","Letter","US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.","Z-0861-2016","Class II","Convenience Kits from Centurion that contain an In-Vision-  Plus Needleless IV Connector, Model: code RYM5001    InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.","1130","Convenience Kits from Centurion contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. According to the RyMed Technologies recall notice, the recall was initiated due to the identification of a component molding  abnormality that may lead to female luer threads to crack, leading to potential for the mating tubing set to ","02/23/2016",," ECVC1010	  CVC INSERTION BUNDLE - 3L, 16CM  Batch                                 Exp.  2015042150	12/2016  2015061050	01/2017  2015062650	02/2017  2015071050	03/2017  2015081150	03/2017    ECVC1025	  16CM  CENTRAL LINE BUNDLE	  Batch                                 Exp.  2015052750	12/2016  2015062250	01/2017  2015070150	02/2017  2015070950	03/2017  2015080650	03/2017    ECVC1425	  20CM CENTRAL LINE BUNDLE	  Batch                                 Exp.  2015041450	12/2016  2015052250	12/2016  2015062250	01/2017  2015070150	02/2017    ECVC1780	  TRIPLE LUMEN BUNDLE  Batch                                 Exp.  2015041450	01/2017  2015081350	05/2017    ECVC1785	  QUAD LUMEN BUNDLE  Batch                                 Exp.  2015052150	01/2017  2015061850	03/2017    ECVC3015	  CVC TRIPLE LUMEN BUNDLE  Batch                                 Exp.  2015061050	01/2017  2015061850	01/2017    ECVC3260	  CVC INSERT BUNDLE 16CM	  Batch                                 Exp.  2015061150	09/2016  2015061550	09/2016    ECVC3540	  TRIPLE LUMEN PI CVC BUNDLE	  Batch                                 Exp.  2015041350	12/2016    ECVC3575	  CVC TRIPLE LUMEN BUNDLE - 20CM	  Batch                                 Exp.  2015041550	10/2016  2015061050	01/2017    ECVC3915	  VANTEX TLC KIT: CURVED SUTURE NEEDLE	  Batch                                 Exp.  2015040850	02/2017  2015042750	02/2017  2015070250	03/2017  2015081150	05/2017    ECVC3925	  9F INTRODUCER: CURVED SUTURE NEEDLE  Batch                                 Exp.  2015071750	01/2017    ECVC405	  CVC MULTI-LUMEN INSERTION BUNDLE	  Batch                                 Exp.  2015041750	12/2016  2015061050	01/2017    ECVC4095	  AVA HIGH FLOW BUNDLE  Batch                                 Exp.  2015060450	08/2016    ECVC4110	  MULTI-MED TLC KIT: CURVED SUTURE NDL	  Batch                                 Exp.  2015060150	03/2017  2015061550	03/2017  2015080750	04/2017    ECVC4115	  6FR INTRODUCER: CURVED SUTURE NEEDLE	  Batch                                 Exp.  2015080550	01/2017   ",1/19/2016,"01/19/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73169,"Ongoing","Natus Medical Incorporated","5900 1st Ave S",,"Seattle","WA","98108-3248","United States","Voluntary: Firm Initiated","Letter","Worldwide Distributed - US Nationwide in the US including American Samoa, Guam Puerto Rico and in the following countries:    Argentina, Australia, Austria, Bangladesh, Belgium, Bermuda, Bolivia, Brunei Darussalam, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, , Kenya, , Kuwait, Latvia, Lithuania, Malaysia, Moldova Republic of, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Virgin Islands (British), and Yemen.","Z-2001-2016","Class II","Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066.  Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680.    Product Usage:  Used to provide treatment for neonatal hyperbilirubinemia       ","13541 units total (7840 units in the US and 5701 units outside the US)","The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.","06/15/2016",," Serial numbers of units distributed in American Samoa, Guam, Puerto Rico and in the US:    .22938, .23282, .23283, .23289, .23291, .23302, .23307, .23471, .23473, .23478, .23479, .23480, .23481, .23483, .23538, .23697, .23708, .23887, .23888, .23895, .23916, .23939, .23968, .23969, .23972, .23983, .23993, .23994, .23998, 040756-1, 040756-2, 1, 10090, 10507, 10559, 10592, 10595, 10597, 10598, 10613, 10633, 10634, 10635, 10636, 10637, 10638, 10639, 10640, 10642, 10643, 10645, 10646, 10659, 10660, 10661, 10662, 10663, 10666, 10667, 10668, 10671, 10678, 10679, 10680, 10681, 10682, 10683, 10684, 10684, 10685, 10686, 10687, 10688, 10701, 10702, 10703, 10704, 10705, 10706, 10707, 10708, 10709, 10710, 10711, 10712, 10713, 10714, 10715, 10716, 10717, 10718, 10719, 10725, 10727, 10728, 10730, 10731, 10732, 10734, 10739, 10740, 10743, 10744, 10759, 10760, 10761, 10762, 10763, 10764, 10765, 10766, 10767, 10768, 10771, 10773, 10774, 10775, 10776, 10777, 10778, 10779, 10781, 10782, 10783, 10784, 10785, 10786, 10787, 10788, 10789, 10791, 10793, 10794, 10795, 10796, 10797, 10799, 10800, 10824, 10825, 10826, 10841, 10842, 10843, 10844, 10846, 10847, 10848, 10849, 10850, 10851, 10852, 10853, 10854, 10855, 10856, 10857, 10858, 10859, 10860, 10863, 10869, 10870, 10871, 10872, 10873, 10875, 10877, 10878, 10879, 10880, 10881, 10882, 10883, 10884, 10885, 10886, 10887, 10888, 10889, 10895, 10896, 10897, 10898, 10899, 10905, 10906, 10907, 10908, 10909, 10910, 10911, 10912, 10913, 10914, 10915, 10916, 10917, 10918, 10919, 10920, 10921, 10922, 10923, 10924, 10927, 10928, 10929, 10930, 10931, 10936, 10937, 10938, 10939, 10962, 10963, 10964, 10965, 10966, 10967, 10968, 10969, 10970, 10971, 10972, 10973, 10974, 10975, 10976, 10977, 10978, 10979, 10980, 10998, 10999, 11000, 11001, 11002, 11003, 11004, 11006, 11007, 11008, 11009, 11013, 11020, 11021, 11022, 11023, 11024, 11025, 11026, 11028, 11029, 11030, 11031, 11032, 11033, 11034, 11035, 11036, 11037, 11038, 11039, 11040, 11041, 11042, 11043, 11044, 11045, 11069, 11070, 11071, 11072, 1107",4/11/2016,"04/11/2016",6/22/2016,"06/22/2016","25, 22226, 22227, 22228, 22233, 22234, 22235, 22236, 22237, 22238, 22254, 22255, 22256, 22257, 22258, 22259, 22260, 22261, 22262, 22263, 22264, 22265, 22266, 22267, 22268, 22269, 22270, 22271, 22272, 22273, 22274, 22276, 22277, 22278, 22279, 22280, 22281, 22282, 22283, 22284, 22285, 22286, 22287, 22288, 22289, 22290, 22291, 22292, 22293, 22294, 22295, 22296, 22297, 22299, 22300, 22301, 22302, 22303, 22304, 22305, 22306, 22307, 22308, 22309, 22310, 22311, 22312, 22313, 22314, 22315, 22316, 22317, 22318, 22319, 22320, 22321, 22322, 22323, 22324, 22325, 22326, 22327, 22328, 22329, 22330, 22331, 22332, 22333, 22334, 22335, 22336, 22337, 22338, 22339, 22340, 22341, 22342, 22343, 22344, 22345, 22346, 22347, 22348, 22349, 22350, 22351, 22352, 22353, 22354, 22355, 22356, 22357, 22358, 22359, 22361, 22362, 22363, 22372, 22373, 22374, 22375, 22379, 22380, 22381, 22383, 22384, 22385, 22386, 22387, 22388, 22389, 22390, 22391, 22393, 22394, 22395, 22396, 22397, 22398, 22399, 22400, 22440, 22441, 22442, 22444, 22445, 22446, 22447, 22448, 22449, 22450, 22451, 22452, 22453, 22454, 22455, 22456, 22457, 22458, 22459, 22460, 22461, 22464, 22465, 22467, 22468, 22469, 22470, 22471, 22472, 22475, 22476, 22477, 22478, 22479, 22480, 22481, 22482, 22483, 22484, 22485, 22486, 22487, 22488, 22489, 22490, 22493, 22494, 22495, 22496, 22497, 22498, 22499, 22500, 22501, 22502, 22503, 22505, 22506, 22511, 22513, 22514, 22515, 22516, 22517, 22518, 22519, 22520, 22521, 22522, 22524, 22525, 22527, 22528, 22529, 22530, 22531, 22532, 22533, 22534, 22535, 22536, 22537, 22538, 22539, 22540, 22541, 22542, 22543, 22544, 22545, 22547, 22548, 22549, 22552, 22565, 22568, 22569, 22570, 22571, 22573, 22574, 22575, 22576, 22577, 22578, 22579, 22580, 22581, 22582, 22583, 22584, 22586, 22587, 22588, 22589, 22590, 22591, 22592, 22593, 22594, 22595, 22596, 22598, 22599, 22600, 22607, 22608, 22609, 22610, 22611, 22612, 22613, 22628, 22629, 22630, 22631, 22632, 22633, 22634, 22635, 22636, 22637, 22638, 22639, 22640, 22641, 22642, 22643, 22644, 22645, 22646, 2264","9, 18570, 18571, 18572, 18573, 18574, 18575, 18576, 18577, 18578, 18579, 18580, 18581, 18582, 18583, 18584, 18585, 18586, 18587, 18588, 18589, 18590, 18591, 18592, 18593, 18594, 18595, 18596, 18597, 18598, 18599, 18600, 18601, 18602, 18603, 18604, 18605, 18606, 18607, 18608, 18609, 18610, 18611, 18612, 18613, 18614, 18615, 18616, 18617, 18618, 18619, 18620, 18621, 18622, 18623, 18624, 18625, 18626, 18627, 18628, 18629, 18630, 18631, 18632, 18633, 18634, 18635, 18636, 18637, 18638, 18639, 18640, 18641, 18642, 18643, 18644, 18645, 18646, 18647, 18648, 18649, 18650, 18651, 18652, 18653, 18654, 18655, 18656, 18657, 18658, 18659, 18660, 18661, 18662, 18663, 18715, 18716, 18717, 18721, 18722, 18723, 18724, 18727, 18748, 18749, 18750, 18751, 18752, 18753, 18754, 18755, 18756, 18757, 18758, 18759, 18760, 18761, 18762, 18817, 18818, 18819, 18820, 18821, 18822, 18823, 18824, 18825, 18826, 18827, 18828, 18829, 18830, 18831, 18832, 18833, 18834, 18835, 18836, 18869, 18872, 18882, 18883, 18890, 18891, 18892, 18904, 18905, 18906, 18907, 18908, 18909, 18915, 18916, 18917, 18918, 18940, 18941, 18946, 18947, 18948, 18949, 18950, 18952, 18953, 18955, 18956, 18957, 19012, 19013, 19014, 19015, 19016, 19023, 19024, 19025, 19026, 19027, 19037, 19038, 19039, 19040, 19041, 19042, 19043, 19045, 19046, 19047, 19053, 19054, 19055, 19056, 19057, 19058, 19059, 19060, 19061, 19067, 19071, 19072, 19073, 19074, 19075, 19076, 19077, 19078, 19079, 19080, 19081, 19082, 19083, 19084, 19089, 19090, 19091, 19092, 19093, 19094, 19095, 19096, 19097, 19098, 19099, 19125, 19135, 19140, 19144, 19145, 19148, 19149, 19151, 19152, 19153, 19154, 19155, 19156, 19157, 19158, 19159, 19160, 19161, 19162, 19163, 19164, 19165, 19166, 19167, 19168, 19169, 19170, 19171, 19172, 19173, 19174, 19175, 19176, 19177, 19178, 19179, 19180, 19181, 19182, 19183, 19184, 19185, 19186, 19187, 19188, 19189, 19190, 19191, 19192, 19193, 19194, 19195, 19196, 19197, 19198, 19199, 19200, 19201, 19202, 19203, 19204, 19205, 19206, 19207, 19208, 19209, 19210, 19211, 19212, 19213, 19214",,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73170,"Ongoing","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","1718 Northrock Ct",,"Rockford","IL","61103-1201","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0650-2016","Class III","Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21","868 unit cartons (86,800 tablets)","Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.","02/02/2016",," Lot # 3063759, Exp.07/16",1/28/2016,"01/28/2016",2/10/2016,"02/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73171,"Ongoing","Us Endovascular","1150 Milwaukee St",,"Saint Louis","MO","63122-7336","United States","Voluntary: Firm Initiated","E-Mail","US Distribution to the states of :  AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.","Z-1362-2016","Class II"," rapid exchange (RX) Peripheral Dilatation Catheter.  Distributed by US Endovascular, St. Louis, MO.","843 catheters","Product may kink during use rendering the product unusable.","04/11/2016",," All references USE .014RX.    Lot numbers:    1717082810164720  1717082810164720  1717082810164720  1717082810164720  1717082810164720      1717082810164730  1717101610166230  1717101610166230  1717101610166230  1717101610166230  1717101610166230  1717101610166230  1717101610166230  1717101610166230  1717101610166230  1717101610166230  1717101610166230  1717101610166230      1717101610166250  1717101610166250  1717082810164740  1717101610166250  1717101610166250  1717082810164740  1717101610166250  1717101610166250      1717082810164760  1717101610166240  1717082810164760      1717082810164770  1717082810164770  1717101610166260  1717101610169180  1717101610169180  1717101610169180  1717101610166260  1717101610169180  1717101610166260  1717082810164770  1717101610166260  1718041510177220  1717082810164770  1717101610169180      1717082810164780  1717101610166270  1717082810164780  1717101610166270  1717101610166270      1717101610169190  1717082810164800  1717101610169190  1717101610169190  1717101610169190  1717101610166280      1717082810164810  1717082810164810  1717101610166290  1717082810164810  1717082810164810  1717101610166290  1717101610166290  1717101610166290  1717082810164810  1717082810164810  1717101610166290  1717101610166290  1717101610166290  1717101610166290  1717082810164810  1717101610166290  1717082810164810  1717082810164810  1717082810164810  1717082810164810      1717082810164820  1717082810164820  1717101610166300  1717082810164820  1717101610166300  1717101610166300  1717082810164820  1717101610166300  1717082810164820  1717101610166300  1717082810164820  1717082810164820  1717082810164820  1717101610166300      1717101610166310  1717101610166310  1717101610166310      1717082810164850  1717082810164850  1717101610166320  1717101610166320  1717101610166320  1717101610166320  1717101610166320  1717101610166320  1717101610166320  1717082810164850  1717082810164850      1717082810164860  1717101610166330  1717101610166330  1717101610166330  1717101610166330      1717101610166340  171710",2/11/2016,"02/11/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73172,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.","Z-1037-2016","Class II","(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.    ","5,800 units total","During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.","03/03/2016",," Stryker Model: 0900-300-000; With lot numbers: 61405002, 61406007, 61408002, and 61509002.  Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.",2/4/2016,"02/04/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73172,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.","Z-1039-2016","Class II","50000  (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.    ","5,800 units total","During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.","03/03/2016",," 50000  Lot numbers: 61305001, 61310001, 61312001, 61404006  Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.",2/4/2016,"02/04/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73172,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.","Z-1040-2016","Class II","50001  (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.","5,800 units total","During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.","03/03/2016",," 50001  Lot numbers: 61303001, 61309001, 61310001, 61404006  Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.",2/4/2016,"02/04/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73172,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.","Z-1038-2016","Class II","(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.    ","5,800 units total","During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.","03/03/2016",," Stryker Model: 0900-400-000; With lot numbers: 61406002, 61505003.  Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.",2/4/2016,"02/04/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73173,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, NY, VA, IL, IN, SC, NC, AR, MO, ND, AL, PA, MI, WA, OR, LA, FL, GA, OH, KS, KY, TX, MA, AZ, NJ, UT, IO, NM, WV, MS, NE, and MD   OUS: Australia, Chile, Columbia, Costa Rica, Argentina, Korea, Japan, Panama, Malaysia, Puerto Rico, Canada, and The Netherlands.","Z-1093-2016","Class II","Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor)  Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.","1261 units","Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) supplied by Kirkstall Precision was made according to the W1.4034 (420 stainless) which does not conform to 420 S29 indicated on the print.  All units manufactured to date were manufactured using 420 stainless. Therefore, all lots of PN: 402852 are considered in scope.","03/10/2016",," all lots of PN: 402852",2/16/2016,"02/16/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73174,"Ongoing","Bonita Pharmaceuticals, LLC","6380 Commerce Drive",,"Westland","MI","48185-9120","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0665-2016","Class II","Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI  48185-9120, USA NDC 53598-0012-15","3,308 boxes","Marketed without an approved NDA/ANDA","02/12/2016",," Lot#: 20150326, Exp 03/2018",1/27/2016,"01/27/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73175,"Terminated","International Tea Importers","5830 Triangle Dr",,"Commerce","CA","90040-3637","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AZ, CA, CO, FL, GA, ID, KY, LA, MD, NY, OR, PA, TX, VA, WA, and WI.   Worldwide to Canada, Chili, Colombia, Mexico","F-0635-2016","Class I","Apple Caramel Almond Tea, Bag Size -  2lbs Minimum, Bulk Packaging, Item No. FB-004","427 lbs.","International Tea Importers is recalling Apple, Caramel & Almond Tea because it contains undeclared milk. ","02/26/2016","03/16/2016"," No codes, Distributed from 01/01/2014 To 01/25/2016.",1/29/2016,"01/29/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73177,"Ongoing","Philips Respironics","1740 Golden Mile Hwy",,"Monroeville","PA","15146-2012","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.","Z-1065-2016","Class II","Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202,  Trilogy EC, Garbin, Garbin Plus    Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.","104,508 units","Software Issue","03/07/2016",," 11 digit S/N begginning with GV or TV; also TGY1D01463",1/18/2016,"01/18/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73179,"Ongoing","Stryker Spine","2 Pearl Ct",,"Allendale","NJ","07401-1611","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0852-2016","Class II"," The PL and TL Tubing Sets are Class 2 instruments not intended to sustain or support life.","413 units","There were two potential interference conditions identified with the way the tubing set attaches to the inserter.","02/23/2016",," Catalog number 900301, Lot #01131543, 01261508, 10151404, 10271408, 12161403, 12161404, 09021404, 01261509, 10271407, 01261507, 10071415, 05011403, 06241407, 08071402, 10091305, 03041403, 01271412, 07281401, and 11061303.  Catalog number  905103, 01131542, 11241408, 12161405, 12161406, 0211501, 01211502, 11241406, 02031403, 06241408, 07161407, 09101402, 09281401, 10251303, 05301402, 11241407, and 12101305. ",12/16/2015,"12/16/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73180,"Ongoing","Stryker Spine","2 Pearl Ct",,"Allendale","NJ","07401-1611","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0828-2016","Class II","Stryker Aero-AL Impaction handle Catalog Number 48921007.  Stryker Spine Manufactured by : Stryker Spine SAS France     Used to facilitate insertion of the Aero-AL cage into the disc space.","31 units","Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.","02/19/2016",," Lot #144933, 14D252, and 14D253.  ",12/18/2015,"12/18/2015",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73181,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution in the state of CA, MI, NC, PA, TX, VA, and the countries of Canada, Korea & Belgium","Z-0886-2016","Class II","Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965    Product  Usage:  The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.      ","543 ea.","The clip in the applier may be missing a boss.  A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application. ","02/25/2016",," 73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, 73K1500193",2/2/2016,"02/02/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73182,"Terminated","Braga Organic Farms, Inc.","10668 Road 26 1/2",,"Madera","CA","93637-9303","United States","Voluntary: Firm Initiated","Letter","OR, FL. CA and internet sales  in the following states:  Washington D.C.        Connecticut                 Oregon  Georgia                       Texas                           Indiana  Illinois                         Massachusetts             New Mexico  California                    Pennsylvania               Ohio  Michigan                     Arizona                       Colorado  Maryland                     Kansas                         North Dakota  Virginia                       North Carolina            New Jersey  New York                   Mississippi                   New Hampshire  Missouri                      Utah                            Alaska  Tennessee                    Maine                          Rhode Island  Washington                 Wisconsin                    South Dakota  Idaho                           Nevada                        Louisiana  Alabama                      Delaware                     Montana  Florida                         West Virginia              Hawaii  Minnesota                   Oklahoma                    South Carolina","F-0637-2016","Class I","Braga Organic Farms Organic Trail Mix, Raw;  Certified Organic, USDA Organic.  GMO Free, Peanut Free, Gluten Free  Packed in 8 oz. 1 lb. 2. lb and 5 lb and 25 lb. clear or green standup bags.    Ingredients: Organic Pistachios, organic almonds, Organic walnuts, Organic Jumbo Flame Raisins, Organic Cranberries, Organic Evaporated Cane Juice, Organic Sunflower oil.    Braga Organic Farms, Madera, CA.","750 lbs. total, all products","IEH sample had a positive result for Salmonella in Braga Organic Pistachios","02/26/2016","04/11/2016"," Trail Mix:  8 oz, UPC:  896S47002139: Best by JUN 29 2016, JUL 7 2016, JUL 11 2016, JUL 26 2016;  1 lb, UPC:  81012602045: Purchased 12/28 to 1/29  21bs, UPC:  896S47002320; Purchased 12/28 to 1/29, JUL 01 2016  5 lbs, UPC:  896S47002603; Purchased 12/28 to 1/29  25 lbs., UPC: 896S47002492 Purchased 12/28 to 1/29.    Lot codes 15-25 and 16-01.",1/31/2016,"01/31/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73182,"Terminated","Braga Organic Farms, Inc.","10668 Road 26 1/2",,"Madera","CA","93637-9303","United States","Voluntary: Firm Initiated","Letter","OR, FL. CA and internet sales  in the following states:  Washington D.C.        Connecticut                 Oregon  Georgia                       Texas                           Indiana  Illinois                         Massachusetts             New Mexico  California                    Pennsylvania               Ohio  Michigan                     Arizona                       Colorado  Maryland                     Kansas                         North Dakota  Virginia                       North Carolina            New Jersey  New York                   Mississippi                   New Hampshire  Missouri                      Utah                            Alaska  Tennessee                    Maine                          Rhode Island  Washington                 Wisconsin                    South Dakota  Idaho                           Nevada                        Louisiana  Alabama                      Delaware                     Montana  Florida                         West Virginia              Hawaii  Minnesota                   Oklahoma                    South Carolina","F-0638-2016","Class I","Braga Organic Farms Organic Nut l Mix, Raw;  Certified Organic, USDA Organic.  GMO Free, Peanut Free, Gluten Free  Packed in 8 oz. 1 lb. 2. lb and 5 lb and 25 lb. clear or green standup bags.    Ingredients: Organic Pistachios, Organic almonds, Organic Cashews, Organic walnuts.     Braga Organic Farms, Madera, CA.","750 lbs. total - all products","IEH sample had a positive result for Salmonella in Braga Organic Pistachios","02/26/2016","04/11/2016"," Nut Mix:    8 oz., UPC:  896S47002177; Best by: JUL 06 2016, JUL 07 2016, JUL 11 2016, JUL 18 2016;;  1 lb., UPC: 810126020192;  Purchased 12/28 to 1/27/6;  2 1bs,  UPC: 896S47002351; Best by: JUL 01 2016, Purchased 12/28/15 to 1/27/16;  5 lbs., UPC: 810126020208,  Purchased 12/28/15to 1/27/16;  25 lb. UPC: 896S47002412;  Purchased 12/28/15 to 1/27/16. Lots 15-51 and 16-01)",1/31/2016,"01/31/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73182,"Terminated","Braga Organic Farms, Inc.","10668 Road 26 1/2",,"Madera","CA","93637-9303","United States","Voluntary: Firm Initiated","Letter","OR, FL. CA and internet sales  in the following states:  Washington D.C.        Connecticut                 Oregon  Georgia                       Texas                           Indiana  Illinois                         Massachusetts             New Mexico  California                    Pennsylvania               Ohio  Michigan                     Arizona                       Colorado  Maryland                     Kansas                         North Dakota  Virginia                       North Carolina            New Jersey  New York                   Mississippi                   New Hampshire  Missouri                      Utah                            Alaska  Tennessee                    Maine                          Rhode Island  Washington                 Wisconsin                    South Dakota  Idaho                           Nevada                        Louisiana  Alabama                      Delaware                     Montana  Florida                         West Virginia              Hawaii  Minnesota                   Oklahoma                    South Carolina","F-0636-2016","Class I","Braga Organic Farms Organic Pistachio Kernels, Raw;  Certified Organic, USDA Organic.  Packed in 8 oz. 1 lb. 2. lb and 5 lb clear or green standup bags.  Ingredients: Organic Pistachios    Braga Organic Farms, Madera, CA.","750 lbs. total - all products.","IEH sample had a positive result for Salmonella in Braga Organic Pistachios","02/26/2016","04/11/2016"," Raw Pistachio Kernels:  8 oz - UPC: 896547002047,  Best by or purchase date:JUN 29 2016, JUL  04 2016, JUL 18 2016, JUL  25 2016, JUL 26 2016:  1 lb - UPC: 810126020215, Purchased 12/28/15 to 1/27/16;  2 lbs - UPC:	896547002306; Best by or purchase date:JUN 28 2016, JUL 13 2016, JUL 27 2016;  5 lbs - UPC	896547002641; Purchased 12/28/15 to 1/27/16    Lot code: 15352 ",1/31/2016,"01/31/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73183,"Ongoing","Cordis Corporation","14201 Nw 60th Ave",,"Miami Lakes","FL","33014-2802","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii.","Z-1174-2016","Class II","CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM    The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. ","1,985 units","Incorrect cannula of the sheath introducer (smaller than intended).","03/14/2016",," Catalog No. 504656X (GTIN: 20705032010389)  Lot No. 17305580, Expiration date: 2018-07-31.  ",12/31/2015,"12/31/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2483-2016","Class II","Certain Implant Cover Screw  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  ICS375, ICS500 and ICS600.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2486-2016","Class II","Certain IOL Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items: IIOL55S and IIOL70S",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2411-2016","Class II","Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H)  Item: IWPP552G  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1147381, 1153937, and 1153938",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2442-2016","Class II","Quickbridge TM Cap  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  QBCAP",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2427-2016","Class II","Locator Extended Range Males 4pk    Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: LAERM",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2484-2016","Class II","Certain Implant EP Twist Lock TM Coping   Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IWIT67",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2424-2016","Class II","O-Ring Abutment 4.1mm(D) x 2mm(H)  Item: OSO20  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1002024, 1014103, 1022623, 1030863, 1031271, 1051924, 1054014, 1057816, 1068294, 1069738, 1071756, 1078857, 1082342, 1095159, 1095387, 1129684, 1131304, 1141288, 1161312, 1168381, 1169242, 1169931, 1170162, 1173357, 987787, and 987884",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2503-2016","Class II","Certain Twist Lock TM Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IWIT66.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2485-2016","Class II","Certain Implant Straight Cover Screw  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  ICS400",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2436-2016","Class II","Preformance Post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: MPFP34, MPFP36, PFP454, PFP456, WPFP554, WPFP556 and WPFP666.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2426-2016","Class II","O-Ring Abutment 4.1mm(D) x 6mm(H)  Item: OSO60  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1068337, 1116902, and 997344",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2461-2016","Class II","DAL-RO Threaded Female  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: DRAF ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2490-2016","Class II","Certain Pick-up Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMIC33, IIIC60, IIIC75, IWIP56, IWIP57, IWIP66 and IWIP67. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2507-2016","Class II","Conical  Abutment Gold Standard ZR TM  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  SCA001, SCA002, SCA003, SCA004, SCA055, SWCA51, SWCA52, SWCA53, SWCA54 and SWCA55.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2480-2016","Class II","Locator Abutment  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  MLOA001, MLOA002, MLOA003, MLOA004, MLOA005, MLOA006, LOA001, LOA002, LOA003, LOA004, LOA005 and LOA006.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2487-2016","Class II","Certain Locator Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items: IMLOA001, IMLOA002, IMLOA003, IMLOA004, IMLOA005, IMLOA006, ILOA001, ILOA002, ILOA003, ILOA004, ILOA005, and ILOA006.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2410-2016","Class II","Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H)  Item: IPAP454G.  Dental implants","1,648,273  devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1154388-5",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2512-2016","Class II","Certain Bellatek Encode Healing Abutment  Dental implants","1,648,273 devices  (all products subject to this recall) ","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IEHA343,  IEHA344, IEHA346,  IEHA348, IEHA353, IEHA354, IEHA356, IEHA358, IEHA443, IEHA444, IEHA446, IEHA448, IEHA453, IEHA454, IEHA456, IEHA458, IEHA463, IEHA464, IEHA466, IEHA468, IEHA473, IEHA474, IEHA476, IEHA478, IEHA553, IEHA554, IEHA556, IEHA558, IEHA563, IEHA564, IEHA566, IEHA568, IEHA573, IEHA574, IEHA576. IEHA578, IEHA663, IEHA664, IEHA666, IEHA668, IEHA673, IEHA674, IEHA676 and IEHA678.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2446-2016","Class II","Standard Abutment Transfer Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  SIC70",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2459-2016","Class II","DAL-RO Housing, Female Assembly  Dental implants","1,648,273devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  DRTH",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2504-2016","Class II","Conical 17 degree Angled Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  AC4217 and  AC4417.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2517-2016","Class II","Certain EP Healing Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMHA352, IMHA353, IMHA356, ITHA58, ITHA63, ITHA64, ITHA66. ITHA68, ITHA73, ITHA74, ITHA76, ITHA78, IWTH52, IWTH54, IWTH56, IWTH58, IWTH562, IWTH564,  IWTH566, IWTH568, IWTH572, IWTH573, IWTH574, IWTH576, IWTH578, IWTH62, IWTH63, IWTH64, IWTH66, IWTH68, IWTH672, IWTH673, IWTH674, IWTH676 AND IWTH678. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2475-2016","Class II","IOL Distal Extension  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IOLDE",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2496-2016","Class II","Certain Straight Healing Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  ISMHA32, ISMHA33, ISMHA34, ISMHA36, ISHA46, ISHA48, ISWHA52, ISWHA53, ISWHA54, ISWHA56, ISWHA58, ISWHA62, ISWHA63, ISWHA64, ISWHA66 and ISWHA68. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2438-2016","Class II","Prep-tite Cap  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: MPFTC34, MPTC32, PFTC41, PFTC42, WPFTC51, WPFTC52, WPFTC61 and WPFTC62.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2513-2016","Class II","Certain Conical 17 degree Angled Abutment  Dental implants","1,648,273 devices  (all products subject to this recall) ","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IAC4217 and IAC4417",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2452-2016","Class II","Conical EP Healing Cap  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: CS250, CS260 and CS270.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2477-2016","Class II","IOL Pick-Up Impression Coping  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:   IOLPIC",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2518-2016","Class II","Certain EP Pick-Up Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IMIC35",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2447-2016","Class II","Temporary Healing Retention Cylinder  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  THRC4 and THRC6.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2467-2016","Class II","Gold -Tite Hexed Retaining Screw  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items: GS200 and GS300. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2435-2016","Class II","Preformance 15 degrees pre-angled post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: MPAPF34, MPAPF36, PAPF454, PAPF456, PAPF554, PAPF556 and PAPF666",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2498-2016","Class II","Certain Temporary Hexed Cylinder  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMMTCS1, IITCS41, IWTCS51 and  IWTCS61.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2522-2016","Class II","Certain Gingihue 15 degree Pre- Angled Post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMPAP352G and IMPAP354G",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2412-2016","Class II","Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H)  Item: IMAP32G  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1151936, 1151937, and 1151938",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2453-2016","Class II","Conical EP Pick-Up Coping (Hexed)   Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:CNRIC",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2515-2016","Class II","Certain Conical  Abutment  Dental implants","1,648,273 devices  (all products subject to this recall) ","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMCA31, IMCA32, IMCA33, IMCA34, ICA001, ICA002, ICA003, ICA004, IWCA51, IWCA52, IWCA53, IWCA54 and IWCA55.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2439-2016","Class II","Prep-Tite Post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: APP42,  WPP552 and WPP662.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2460-2016","Class II","DAL-RO Abutment  Dental implants","1,648,273 deices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  DRH20, DRH40 and DRH60",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2523-2016","Class II","Certain Gingihue  Post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMAP352G,  IMAP354G, IAPP462G, IAPP464G, IAPP472G, IAPP474G, IWPP564G, IWPP572G, IWPP574G, IWPP662G, IWPP664G, IWPP672G AND IWPP674G. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2491-2016","Class II","Certain Preformance 15 degrees Pre-Angled Post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMPAPF36, IMPAPF354 and IMPAPF356. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2469-2016","Class II","Implant Cover Screw  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  MMCS1",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2500-2016","Class II","Certain Titanium Large Hexed Screw  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  ILRGHT",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2524-2016","Class II","Certain Gingihue 15 degree Angled  Post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IPAP464G, IPAP472G, IPAP474G, IPAP462G, IPAP554G, IPAP562G,  IPAP564G, IPAP572G, IPAP574G, IPAP662G, IPAP664G, IPAP672G AND IPAP674G. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2455-2016","Class II","Conical EP Twist Lock TM Coping    Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  CIC55, CIC56 and CIC57.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2516-2016","Class II","Certain Cover Screw  Dental implants","1,648,273 devices  (all products subject to this recall) ","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IMMCS1",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2481-2016","Class II","Locator Abutment Impression Coping  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  LAIC1.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2457-2016","Class II","Cover Screw  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  CS375, CS500 and CS600. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2499-2016","Class II","Certain Temporary Non-Hexed Cylinder  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IITCS42, IWTCS52 and  IWTCS62.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2471-2016","Class II","Implant EP Twist Lock TM Coping  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IIC46, IIC47, WIT56, WIT57, WIT55, WIT66 and WIT67",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2479-2016","Class II","IOL Transfer Impression Coping  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:   IOLTIC",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2456-2016","Class II","Conical Healing Cap  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  MHC33",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2492-2016","Class II","Certain Preformance Post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMPFP34, IMPFP36, IMPFP354, IMPFP356, IPFP456, IWPFP554, IWPFP556, IWPFP664 and IWPFP666. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2434-2016","Class II","Pick-Up Impression Coping  Dental implants","1,648,273 (all products subject to thIs recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: MIC33",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2519-2016","Class II","Certain EP Twist Lock TM Coping   Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IMIT35 ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2462-2016","Class II","Drill Stop  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: DS2310, DS2315, DS2320, DS4513, DS4518 and DS458",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2506-2016","Class II","Conical  Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  MCA31, MCA33, MCA34, CA001, CA002, CA004, WCA51 and WCA53.  ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2497-2016","Class II","Certain Straight Pick Up Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMIC30 and IWIP60",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2413-2016","Class II","Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H)  Item: IAPP454G  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1148354 and 1155382",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2416-2016","Class II","Certain Pick-Up Coping 5mm(D) x 5mm(P)  Item:IWIP55  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1152487",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2445-2016","Class II","Standard Abutment Temporary Screw   Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  TS250",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2508-2016","Class II","Conical  Abutment Pick-up Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  MEC33.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2521-2016","Class II","Certain Gingihue TM 15 degree Angled Post   Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IMPAP34G ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2431-2016","Class II","Locator Replacement Housing  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:LOAH",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2458-2016","Class II","Cover Screw, Headless  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  CS275",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2425-2016","Class II","O-Ring Abutment 4.1mm(D) x 4mm(H)  Item: OSO40  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1014104, 1022991, 1033058, 1041417, 1052716, 1054542, 1060675, 1069646, 1088483, 1094776, 1106610, 1129686, 1141289, 1168523, 1168829, 1172024, and 996069.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2417-2016","Class II","Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H)  Item:ISHA44  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1155282 and 1155283",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2472-2016","Class II","Implant Twist Lock TM Coping  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IIC44.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2415-2016","Class II","Certain Pick-Up Coping 4.1mm(D) x 5mm(P)  Item: IIIC12  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1154337 and 1154338",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2463-2016","Class II","EP Healing Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items: MHA32, MHA33, MHA34, MHA36, THA58, THA63, THA64, THA66, THA68, THA73, THA74, THA76, THA78, WTH52, WTH53, WTH54, WTH56, WTH58, WTH562, WTH563, WTH564, WTH566, WTH568, WTH572, WTH573, WTH574, WTH576, WTH578, WTH62, WTH63, WTH64, WTH66, WTH68, WTH672, WTH673, WTH674, WTH676 and WTH678.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2422-2016","Class II","LDA Screw SBL 3mm(D)   Item: SCRSBL1  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1087614",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2449-2016","Class II","Temporary Non-Hexed Cylinder  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  ITCS42, WTCS52 and WTCS62.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2423-2016","Class II","LDA Screw SBL 4mm(D)   Item: SCRSBL2  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1087616",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2441-2016","Class II","Provide Protection Cap  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: PPC484, PPC485, PPC654 and PPC655.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2443-2016","Class II","Standard Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  AB200, AB300, AB400, AB500 and AB700. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2451-2016","Class II","Titanium Square Uniscrew  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: UNIST",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2511-2016","Class II","Certain EP Twist Lock TM Coping  Dental implants","1,648,273 devices (all products subject to this recall).","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IMIT33",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2419-2016","Class II","Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H)   Item: PAP452G  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1154271-5",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2505-2016","Class II","Conical 25 degree Angled Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  AC4225 and  AC4425.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2476-2016","Class II","IOL Healing Cap  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IOLHC",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2473-2016","Class II","Index Coping Surgical  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IC100.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2478-2016","Class II","IOL Titanium Temporary Cylinder  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:   IOLTC",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2493-2016","Class II","Certain Preformance Temporary Cylinder  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IMPFTC34, IMPFTC32, IPFTC41, IPFTC42, IWPFTC51, IWPFTC52, IWPFTC61 and IWPFTC62.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2444-2016","Class II","Standard Abutment Pick -Up Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  SQIC7",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2448-2016","Class II","Temporary Hexed Cylinder  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  MMTCS1, ITCS41, WTCS51 and WTCS61.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2468-2016","Class II","Healing Abutment   Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items: THA42, THA43, THA44, THA46 and THA48.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2437-2016","Class II","Preformance Temporary Cylinder  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: MPFTC34, MPTC32, PFTC41, PFTC42, WPFTC51, WPFTC52, WPFTC61 and WPFTC62.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2406-2016","Class II","Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H)  Item: IWTH52  Dental implants","1,648,273 devices","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1152118",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2418-2016","Class II","Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1157768-CN, 1160929-CN, 1160930-CN, 1160931-CN, 987129-5, 996343-5, and 998147-5",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2414-2016","Class II","Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P)  Item: IIIC41  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1152085",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2407-2016","Class II","Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H)  Item: IWTH54  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1153081",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2466-2016","Class II","Gold Slotted Screw  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items: GS200 and GS300. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2420-2016","Class II","Gold-Tite Hexed Retaining Screw 3mm   Item: GSH30  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1071150, 1071151, 1071152, and 1071190",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2440-2016","Class II","Provide Impression Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:PIC484, PIC485, PIC654, PIC655, PIC484H, PIC485H and PIC654H.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2482-2016","Class II","Certain Hex Try-in Screw (5 pk)   Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IUNITS",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2421-2016","Class II","Gold-Tite Square Uniscrew   Item: UNISG  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1152611 and 1153193",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2488-2016","Class II","Certain Micromini Flat Implant Cover Screw  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IMCSF34",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2464-2016","Class II","Gingihue 15 Degree Pre-Angled Post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items: MPAP32G, MPAP34G, PAP454G, PAP462G, PAP464G, PAP472G, PAP474G, PAP552G, PAP554G, PAP562G, PAP564G, PAP572G, PAP574G, PAP662G, PAP664G, PAP672G and PAP674G. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2495-2016","Class II","Certain Standard Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IAB200, IAB300, IAB400, IAB550 and IAB700. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2520-2016","Class II","Certain Flat Implant Cover Screw  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  ICSF41, ICSF50 and ICSF60",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2409-2016","Class II","Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H)  Item: IMPAP32G  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1154709-5",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2501-2016","Class II","Certain Twist Lock TM Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IIIC46, IIIC47,  IWIT55, IWIT56 and IWIT57.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2428-2016","Class II","Locator Extra Light Angled Replacement Males 4pk  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: LELARM",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2465-2016","Class II","Gingihue Post  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items: MAP32G, MAP34G, APP462G, APP464G, APP472G, APP474G, WPP554G, WPP562G, WPP564G, WPP572G, WPP574G, WPP662G, WPP664G, WPP672G and WPP674G. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2408-2016","Class II","Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H)  Item: IWTH564  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Lot # 1150836",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2474-2016","Class II","IOL Abutment and Screw  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IOL20T, IOL55T and IOL70T",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2454-2016","Class II","Conical EP Pick-Up Coping (Non-Hexed)   Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  CSQ17, CSQ06 and CSQ07.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2450-2016","Class II","Titanium Hexed Uniscrew  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item: UNIHT",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2432-2016","Class II","Locator Replacement Housing Kit  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:LORHK",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2433-2016","Class II","Locator Replacement Males 4pk  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:LARMS",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2470-2016","Class II","Implant EP Pick-Up Coping  Dental implants","1, 648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IIC60, IIC75, WIP55, WIP56, WIP57, WIP66 and WIP67",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2494-2016","Class II","Certain Provide Abutment  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IPA4140, IPA4155, IPA4240, IPA4255, IPA4340, IPA4355, IPA4440, IPA4455, IPA5140, IPA5155, IPA5240, IPA5255, IPA5340, IPA5355, IPA5440, IPA5455, IPA6140, IPA6155, IPA6240, IPA6255, IPA6340, IPA6355, IPA6440 and  IPA6455. ",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2514-2016","Class II","Certain Conical 25 degree Angled Abutment  Dental implants","1,648,273 devices  (all products subject to this recall) ","Pouches may not have been sealed during packing.","08/16/2016",," Items:  IAC4225 and IAC4425",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2429-2016","Class II","Locator Extra Light Retention Males 4pk  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:LAELM",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2502-2016","Class II","Certain Twist Lock TM Straight Transfer Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Items: IWIT50 and  IWIT60.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2489-2016","Class II","Certain Non-Hexed Implant Pick-up Coping  Dental implants","1,648,273 devices (all products subject to this recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:  IMCSF34",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2509-2016","Class II","Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H)    Item: ITHA52  Dental implants","1,648,273 devices (all products subject to this recall.","Pouches may not have been sealed during packing.","08/16/2016",," Lot No. 1152783",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2430-2016","Class II","Locator Light Retention Replacement Males 4pk  Dental implants","1,648,273 (all products subject to these recall)","Pouches may not have been sealed during packing.","08/16/2016",," Item:LLRMS",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73184,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.","Z-2510-2016","Class II","Bellatek Encode Healing Abutment  Dental implants  ","1,648,273 devices (all products subject to this recall).","Pouches may not have been sealed during packing.","08/16/2016",," Items:  EHA343, EHA344, EHA346,  EHA348, EHA353, EHA354, EHA356, EHA358, EHA443, EHA444, EHA446, EHA448, EHA453, EHA454, EHA456, EHA458, EHA463, EHA464, EHA466, EHA468, EHA473, EHA474, EHA476, EHA478, EHA553, EHA554, EHA556, EHA558, EHA563, EHA564, EHA566, EHA568, EHA573, EHA574, EHA576. EHA578, EHA663, EHA664, EHA666, EHA668, EHA673, EHA674, EHA676 and EHA678.",11/25/2015,"11/25/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73185,"Ongoing","Halperns' Steak & Seafood Company LLC","2158 W Northwest Hwy Ste 410",,"Dallas","TX","75220-4222","United States","Voluntary: Firm Initiated","E-Mail","Texas","F-0704-2016","Class II","Sebastian Super Lump Pasteurized Crab Meat, Blue Swimming Crab Meat, Wild Caught, 16 ounce","47 cans","Product time/temperature abuse.","04/20/2016",," Lot: 78229C",10/12/2015,"10/12/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73186,"Ongoing","European Natural Foods & Trading Company, Inc.","72 Lehigh Ave",,"Paterson","NJ","07503-1729","United States","Voluntary: Firm Initiated","Letter","CT, MA,  NJ  &  NY","F-1082-2016","Class I","Brians Cauliflower 83 oz Imported by EUROPEAN NATURAL FOOD & TRADING CO. Inc, 72 Lehigh Avenue Paterson, NJ 07593  UPC 858567002421","300 jars","Brian's Cauliflower may contain undeclared sulfites.","04/15/2016",," 28/11/2016",1/26/2016,"01/26/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73190,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","WI","B-0227-16","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","03/09/2016","03/09/2016"," W036315291017",12/16/2015,"12/16/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73191,"Terminated","American Red Cross Blood Services","700 Caldwell Trace",,"Birmingham","AL","35242","United States","Voluntary: Firm Initiated","FAX","Tennessee","B-0319-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Mislabelled RBC was distributed.","02/26/2016","02/26/2016"," W204115150499",11/20/2015,"11/20/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73192,"Ongoing","The Sausage Maker, Inc.","Building 7","1500 Clinton Street","Buffalo","NY","14206","United States","Voluntary: Firm Initiated","E-Mail","Nationwide via internet sales and directly via wholesalers located in CA, IN, FL, NY, PA, NV & WV","F-1380-2016","Class I","THE SAUSAGE MAKER SEASONING Smoked Pepperoni under the following labels: 1) Net Wt 2 lbs, 2) Net Wt 25 lbs, 3) Smoked Pepperoni Kit w/Home Pak, 4) Smoked Pepperoni Salami Kit","462 total units (336 units/2lbs, 4 units/25lbs, 86 units/home pak, 72 units/kit)","Fermento ingredient contains undeclared whey protein and skim milk powder","05/20/2016",," SKUs: 1) 91110 & 12-1030, 2) 91110-25, 3) 81260 & 12-1623, 4) 81150 & 12-1625",2/4/2016,"02/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73192,"Ongoing","The Sausage Maker, Inc.","Building 7","1500 Clinton Street","Buffalo","NY","14206","United States","Voluntary: Firm Initiated","E-Mail","Nationwide via internet sales and directly via wholesalers located in CA, IN, FL, NY, PA, NV & WV","F-1381-2016","Class I","THE SAUSAGE MAKER SEASONING Summer Sausage under the following labels: 1) Net Wt 8 oz, 2) Net Wt 2 lbs. 8 oz., 3 ) Net Wt 25 lbs, 4) Summer Sausage Kit","1,545 total units(1,220 units/2lbs8oz, 16 units/25lbs, 326 units/kit, 93 units/8oz)","Fermento ingredient contains undeclared whey protein and skim milk powder","05/20/2016",," SKUs: 1) 91160 & 12-1012, 2) 91160-25, 3) 81214 & 12-1610, 4) 91160-10 & 12-1212",2/4/2016,"02/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73192,"Ongoing","The Sausage Maker, Inc.","Building 7","1500 Clinton Street","Buffalo","NY","14206","United States","Voluntary: Firm Initiated","E-Mail","Nationwide via internet sales and directly via wholesalers located in CA, IN, FL, NY, PA, NV & WV","F-1377-2016","Class I","THE SAUSAGE MAKER SEASONING Dried Sausage Sticks  under the following labels: 1) Net Wt 6.5 oz, 2) Net Wt 2 lbs, 3) Net Wt 25 lbs, 4) Dried Sausage Stick Kit, 5) Dried Sticks Assortment Kit ","886 total units (39 units/6.5oz, 508 units/2lbs, 5 units/25lbs, 102 units/kit, 273 units/assortment kit)","Fermento ingredient contains undeclared whey protein and skim milk powder","05/20/2016",," SKUs: 1) 91500-10 & 12-1218, 2) 91500 & 12-1023, 3) 91500-25, 4) 81130 & 12-1615, 5) 81135 & 12-1611",2/4/2016,"02/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73192,"Ongoing","The Sausage Maker, Inc.","Building 7","1500 Clinton Street","Buffalo","NY","14206","United States","Voluntary: Firm Initiated","E-Mail","Nationwide via internet sales and directly via wholesalers located in CA, IN, FL, NY, PA, NV & WV","F-1382-2016","Class I","THE SAUSAGE MAKER SEASONING Trail Bologna under the following labels: 1) Net Wt 2 lbs. 8 oz, 2) Net Wt 25 lbs, 3) Trail Bologna Kit","227 total units (143 units/2lbs8oz, 3 units/25lbs, 84 units/kit)","Fermento ingredient contains undeclared whey protein and skim milk powder","05/20/2016",," SKUs: 1) 91170 & 12-1045, 2) 91170-25, 3) 81140 & 12-1621",2/4/2016,"02/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73192,"Ongoing","The Sausage Maker, Inc.","Building 7","1500 Clinton Street","Buffalo","NY","14206","United States","Voluntary: Firm Initiated","E-Mail","Nationwide via internet sales and directly via wholesalers located in CA, IN, FL, NY, PA, NV & WV","F-1379-2016","Class I","THE SAUSAGE MAKER SEASONING Goetburg Summer Sausage under the following labels: 1) Net Wt: 2 lbs.8 oz, 2) Goteborg Summer Sausage Kit","82 total units (48 units/2lbs8oz & 35 units/kit, 20units)","Fermento ingredient contains undeclared whey protein and skim milk powder","05/20/2016",," SKUs: 1) 91700 &12-1082, 2) 81280 & 12-1627",2/4/2016,"02/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73192,"Ongoing","The Sausage Maker, Inc.","Building 7","1500 Clinton Street","Buffalo","NY","14206","United States","Voluntary: Firm Initiated","E-Mail","Nationwide via internet sales and directly via wholesalers located in CA, IN, FL, NY, PA, NV & WV","F-1378-2016","Class I","THE SAUSAGE MAKER SEASONING Dried Sticks Hot under the following labels: 1) Net Wt 2 lbs, 2) Net Wt 25 lbs, 3) Hot Dried Sausage Sticks Kit w/19mm","256 units total (232 units/2lbs, 0 units/25lbs, 32units/kit","Fermento ingredient contains undeclared whey protein and skim milk powder","05/20/2016",," SKUs: 1) 91502 & 12-1046, 2) 91502-25, 3) 81134 & 12-1626",2/4/2016,"02/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73193,"Ongoing","Accuray Incorporated","1310 Chesapeake Ter",,"Sunnyvale","CA","94089-1100","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, Ireland, India, Greece, Germany, France, Finland, Czech Republic, Colombia, China, Canada, and Belgium.","Z-0771-2016","Class II","CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package.    Product Usage:  The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.  ","226","The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.","02/08/2016",," Catalog/part numbers 032000 and 033000;  Serial numbers:  United States:  C0063  C0064  C0074  C0088  C0090  C0091  C0092  C0095  C0096  C0098  C0099  C0100  C0101  C0102  C0103  C0104  C0106  C0108  C0111  C0112  C0114  C0118  C0119  C0123  C0126  C0127  C0128  C0131  C0133  C0134  C0135  C0136  C0137  C0143  C0144  C0146  C0149  C0150  C0151  C0152  C0155  C0158  C0159  C0162  C0163  C0165  C0172  C0174  C0177  C0178  C0179  C0181  C0182  C0183  C0184  C0186  C0192  C0194  C0196  C0197  C0198  C0199  C0200  C0201  C0203  C0205  C0206  C0207  C0208  C0209  C0210  C0213  C0214  C0219  C0220  C0222  C0224  C0226  C0233  C0244  C0246  C0247  C0248  C0252  C0253  C0254  C0256  C0259  C0260  C0261  C0262  C0263  C0273  C0274  C0278  C0283  C0284  C0285  C0290  C0291  C0293  C0296  C0303  C0304  C0312  C0316  C0323  C0328  C0353  C0355  C0124:  International:   C0170  C0171  C0180  C0216  C0236  C0264  C0269  C0326  C0204  C0125  C0175  C0189  C0191  C0215  C0227  C0279  C0315  C0166  C0147  C0168  C0187  C0105  C0242  C0185  C0286  C0306  C0188  C0218  C0237  C0240  C0265  C0268  C0288  C0314  C0324  C0251  C0272  C0322  C0153  C0289  C0235  C0267  C0120  C0138  C0148  C0157  C0212  C0229  C0239  C0297  C0241  C0281  C0300  C0307  C0308  C0313  C0320  C0327  C0329  C0331  C0333  C0340  C0341  C0347  C0350  C0392  C0115  C0117  C0154  C0161  C0228  C0255  C0266  C0270  C0294  C0339  C0176  C0195  C0309  C0319  C0321  C0093  C0221  C0234  C0249  C0275  C0277  C0299  C0305  C0325  C0110  C0113  C0130  C0232  C0245  C0276  C0287  C0295  C0217  C0282  C0107  C0258  C0271  C0280  C0298  C0301  C0302  C0310  C0317  C0357  C0365  C0202  C0231  C0238  C0230.  ",1/22/2016,"01/22/2016",2/17/2016,"02/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73194,"Ongoing","Diamedix Corporation","14100 Nw 57th Ct",,"Miami Lakes","FL","33014-3107","United States","Voluntary: Firm Initiated","Letter","AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.","Z-1689-2016","Class II","Diamedix Is-CMV IgG Test Kit","150 kits","Product contained an incorrect substrate.","05/17/2016",," Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016",3/26/2015,"03/26/2015",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73195,"Terminated","EKOS Corporation","11911 N Creek Pkwy S",,"Bothell","WA","98011-8809","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of AZ, CA, MA, MI, OH, and VA.","Z-0864-2016","Class II","EkoSonic Endovascular System, Catalog Number 500-56112.    It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System.     During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site.     The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface  Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.","10 units","The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.","02/24/2016","03/15/2016"," Lot Number 150910004. Expiration date is August 15, 2018.    Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010",1/21/2016,"01/21/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73196,"Ongoing","Invivo Corporation","12151 Research Pkwy Ste 200",,"Orlando","FL","32826-3286","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to the states of :AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, TN, UT, VA, WA, WI, WV, Alaska, Hawaii, & Washington, DC.     Worldwide Distribution to the countries of : Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Cayman Islands, Chile, Columbia, Croatia, Democratic Republic of Congo, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Republic of Korea, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, State of Palestine, Panama, Papua New Guinea, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Taiwan Province, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United Republic of Tanzania, Uzbekistan, & Vietnam.","Z-2760-2016","Class II","The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.","2,929","Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze","09/08/2016",," Product: Xper Flex Cardio Patient Monitoring System  Model Numbers FC2010 and FC2020  Serial Numbers by Product:  453564241901  USI203010414 USI244000011 USI234000052 USI521000021  USI343000067 USI343000030 USI337000084 USI334000030  USI331000048 US 1328000004 USI324000049 USI324000017  USI319000088 US1319000043 USI319000016 USI251000082  USI251000054 USI251000042 USI251000007 USI25000054  USI248000041 USI234000090 USI224000028 USI203010318  USI202010188 USI343000053 USI251000005 USI231000001  US1334000034 USI334000018 USI319000053 USI234000045  us 1343000064 us 1343000018 us 1334000026 us 1334000008  USI324000025 USI311000001 USI239000005 USI234000054  USI224000026 USI203010419 USI203010418 USI203010411  USI203010403 USI203010391 US1203010372 USI203010301  US120301 0256 USI20201 0209 USII0701 0022 USI343000015  USI334000028 USI319000077 USI337000059 US1337000022  USI33!000014 USI319000087 USI319000061 US1319000002  USI244000002 USI239000049 USI203010392 USI203010264  US1201010131 USI109010102 USII08010061 USII08010051  USI319000034 USI319000071 USI311000015 USI203010326  US1203010289 US1109010105 USI337000014 USI234000065  USII08010062 USI319000046 USI324000021 USI2440000043  US1203010306 USI251000040 USI343000076 USI343000055  US 1337000010 US 1337000004 USI331000055 US 1319000070  USI319000042 US1311000051 USI251000073 USI239000036  USI234000060USI234000043 USI231000063 USI203010424  USI203010312 USI203010292 USI343000074 USI343000045  us 1343000040 us 1343000038 us 133 7000073 us 1337000069  USI337000001 USI324000037 USI319000086 USI311000061  USI251000076 USI251000057 USI248000079 USI234000058  US 1234000025 USI231000089 USI224000008 US 1203010417  USI203010331 USI203010302 USI203010250USI202010242  USI202010171 USI201010122 USII09010065 USI343000054  USI239000024 USI2440000019 USI23000048 USI201010120  us 1331000045 us 1343000070 us 1343000062 us 1343000048  USI343000047 USI337000072 USI337000044 USI337000013  USI337000012 USI337000002 USI334000029 USI334000013  US 1334000003 USI331000060 USI331000035 U",10/19/2015,"10/19/2015",9/14/2016,"09/14/2016","433000079  US1433000067 US1433000064 USI431000040 US1431000027  US1431000026 US1431000014 US1431000011 US1431000005  USI424000018 US1424000010 USI419000052 US1419000042  US1419000026 US1419000023 US1419000004 US1417000023  US1412000045 USI412000038 US1408000036 US1408000018  us 1408000015 us 1408000002 us 1407000063 us 1407000060  US1407000059 US1407000058 US1407000056 US1407000053  us 1407000048 us 1407000046 us 1407000041 us 1407000040  us 1407000038 us 1407000027 us 1407000020 us 1407000016  US1407000012 US1352000062 US1352000060 US1352000059  US1352000057 US1352000054 US1352000052 USI352000048  US1352000046 US1352000045 US1352000044 US1352000042  USI352000041 US1352000036 USI352000035 US1352000032  US1352000028 USI352000024 US1352000023 USI352000022  US1352000017 US1352000015 US1352000006 USI352000001  us 1343000092 us 1343000089 us 1343000088 us 1343000087  us 1343000086 us 1343000085 us 1343000084 us 1343000075  US1343000061 US1343000057 US1343000039 US1343000034  US1343000033 US1343000028 US1343000005 US1338000001  US1337000029 US1337000025 US1337000023 USI337000008  us 133 7000007 us 1311000082 us 1251000085 us 1239000034  US1238000001 US1202010150  989803178281  US1231000043 US1244000047 US1239000003 US1203010263  US1231000072 US1203010389 US1203010365 US1244000059  US1234000007 US1231000061 US1244000051 US1244000030  US1203010305 US203010289 US1203010405 US1231000068  US1203010409 US1203010268 US1203010369 US1234000044  US1234000041 US1234000038 US1244000044 US1234000085  US1234000027 US1231000065 US1231000048 US1231000039  US1203010343 US1244000040 US1244000024 US1203010406  US1203010252 US1231000041 US1224000005 US1203010304  US1234000023 US1224000031 US1234000075 US1203010269  989803185601  us 1248000077 us 1248000069 us 1251000009 us 1311000067  us 1319000092 us 1311000079 us 1311000068 us 1304000028  US1251000094 US1210000003 US1311000072 US1231000087  US1319000081 US1319000096 US1319000074 US1319000050  US1311000041 US1311000040 US1251000056 USI319000080  US1304000038 US1311000074 US1319000076 ",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73197,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of PA and MN, and the country of Switzerland.","Z-1246-2016","Class II","Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.","50 clips","Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).","03/24/2016",," Model/Catalog: IRR-Clip-30  Lot # J023101962",11/2/2015,"11/02/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73198,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","US Distribution to the state of : VA  and Internationally to:  Thailand and UK","Z-2126-2016","Class II","Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.","20 hand pieces",".","07/05/2016","."," Part Number 530.710, Serial Numbers 101066, 101067, 101068, 101069, 101070, 101071, 101072, 101073, 101074, 101075, 101076, 101077, 101078, 101079, 1011080, 101081, 101082, 101083, 101084, 101085    ",11/25/2015,"11/25/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73199,"Ongoing","Mako Surgical Corporation","2555 Davie Rd Ste 110",,"Plantation","FL","33317-7424","United States","Voluntary: Firm Initiated","Letter","CO, KY, MN, WA and WV","Z-1588-2016","Class II","MAKOplasty Hip Array Kit Laminate 150230  ","10 units. ","Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.","04/29/2016",," Catalog No. 210540, Lot Code: 150324",11/25/2015,"11/25/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73200,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.","Z-1904-2016","Class II","Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper,  Femoral Stem;  Catalog Number 160-10-16; For use in primary total hip arthroplasty.","1 device. ","Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.","06/02/2016",," Product Codes:  LPH, MEH, LWJ, JDI;  Catalog Number 160-10-16, Serial Number: 4256338, Exp. 1/27/2021.  ",4/12/2016,"04/12/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73200,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.","Z-1900-2016","Class II","Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup),  Catalog Number 140-01-54; For use in primary total hip arthroplasty.","3 devices ","Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.","06/02/2016",," Product Code: MRA;  Catalog Number 140-01-54, Serial Numbers: 4296076, 4296078, 4296079, Exp. 2/23/2021",4/12/2016,"04/12/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73200,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.","Z-1901-2016","Class II","Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup),  Catalog Number 140-01-56;  For use in primary total hip arthroplasty.","2 devices.","Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.","06/02/2016",," Product Code: MRA,  Catalog Number 140-01-56, Serial Numbers:  4268399 and 4268400, Exp. 2/6/2021.",4/12/2016,"04/12/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73200,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.","Z-1903-2016","Class II","Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem,  Catalog Number 160-00-14; For use in primary total hip arthroplasty.","1 device. ","Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.","06/02/2016",," Product Codes:  LPH, MEH, LWJ, JDI;  Catalog Number 160-00-14, Serial Number: 4252802, Exp. 1/25/2021. ",4/12/2016,"04/12/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73200,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.","Z-1905-2016","Class II","Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11,   Femoral Stem;  Catalog Number 160-30-11; For use in primary total hip arthroplasty.","9 devices. ","Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.","06/02/2016",," Product Codes:  LPH, MEH, LWJ, JDI;   Catalog Number 160-30-11, Serial Numbers:  4273184, 4273185, 4273187, 4273188, 4273189, 4273190, 4273191, 4273192 and 4273186,  Exp. 2/8/2021.",4/12/2016,"04/12/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73200,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.","Z-1902-2016","Class II","Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem,  Catalog Number 160-00-13; For use in primary total hip arthroplasty.","4 devices. ","Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.","06/02/2016",," Product Codes:  LPH, MEH, LWJ, JDI;  Catalog Number 160-00-13, Serial Numbers: 4333544, 4333545, 4333546, Exp.3/22/2021 and Serial Number 4335281,  Exp. 3/23/2021.",4/12/2016,"04/12/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73201,"Ongoing","Mako Surgical Corporation","2555 Davie Rd Ste 110",,"Plantation","FL","33317-7424","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and WY ; and countries of: Italy, Scotland, Turkey, Greece, Germany, and Singapore.","Z-1031-2016","Class II","Restoris Multicompartmental Knee (MCK) System    RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.","146","Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.","03/01/2016",," Catalog # 180601 - Lot #'s: 26110111, 26300512-01, 26110112-01, and 26090311-01  Catalog # 180602 - Lot #'s: LET1484311012, 26020812-01, 26220512-01, 26180711-0126120211-01, 26301011-01, 26161111-01, and 26220512-02.  Catalog # 180603 - Lot #'s: LET 1388860512, 26010511-01, 26310811-01 and 26050112-01  Catalog # 180604 - Lot #'s: 26090512-01 and 26280412-01  Catalog # 180605 - Lot #'s: 26310512-01, 26270512-01, and 26250511-01  Catalog # 180606 - Lot #'s: LET1464570912, 26300412-01, 26140412-01, and 26050212-01.  Catalog # 180607 - Lot #'s: 26211011-01, 26040212-01, 26330512-01, 26090611-02, 26070811-01, LET1406460512, and 26230411-01.  Catalog # 180608 - Lot # 26141111-01  Catalog # 180611 - Lot #'s 26131111-01 and 26050211-01  Catalog # 180612 - Lot #'s 26190911-01, 36010112-1, 26070212-01, 26410611-01, 26020411-01, and 26060211-01  Catalog # 180613 Lot #'s 26271011-01 and 26240711-01  Catalog # 180614 - Lot #'s 36031211-1, 26180512-01, 26440611-01, and 26190612-01  Catalog # 180615 Lot # 2610012-01  Catalog # 180616 Lot #'s 26160212-01, 2634012-01, 26300811-01, 26171111-01, 26350512-01, and 26310612-01.  Catalog # 180617 Lot #'s 26310412-01, 26160711-01, 26210511-02, 26061011-01, 26061011-01, and LOT1388810512.  Catalog # 180618 Lot #'s: 26360512-01, 26060311-01, and 26061211-01.",1/15/2016,"01/15/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73202,"Ongoing","Mako Surgical Corporation","2555 Davie Rd Ste 110",,"Plantation","FL","33317-7424","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.","Z-1508-2016","Class II","Robotic Arm Interactive Orthopedic System (RIO)","249","Revision of the field manual","04/18/2016",," Catalog # 203900 & 207092 All lots",4/30/2014,"04/30/2014",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73203,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","USA Distribution to the states of : AR, AZ, CA, CO, FL, IL, IN, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OK, OR, PA, SC, TN, TX, VA, WA, WI and Hawaii","Z-1994-2016","Class II","Universal Battery Charger II (UBC II)","1,992","The device is reported to enter safe mode and is no longer able to charge batteries.","06/15/2016",," Part # 05.001.204 Serial #'s 10615 thru 12616",1/15/2016,"01/15/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73204,"Ongoing","Arthrex, Inc.","1370 Creekside Blvd",,"Naples","FL","34108-1945","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- AR, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, WA, WI and District of Columbia.","Z-1195-2016","Class II","Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size  4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ.    Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).","2,378 units. ","Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous  that had a textured outer surface.","03/18/2016",," Size 2   Unique Device Identifier: 00888867106703 Batch #'s: 927692, 915207, 982771, 979834, 982774, 1206164, 1206165, 1206167, 1206166, 1227388, 1227387, 1257195, 1233620, 1289648, 1233621, 1289653, 1289736, 1289654, 1336430, 1336431, 1305721, 1306332, 1352062, 1336433, 1336436, 1352058, 1352063, 1376104, 1376106,  and 1376107.   Size 3   Unique Device Identifier: 00888867106710 Batch #'s: 780838, 952789, 1206169, 1206170, 1206168, 1191337, 1191337, 1272728, 1297048, 1297044, 1297049, 1272730, 1272729, 1307262, 1297060, 1297057, 1297365, 1307263, 1336445, 1307267, 1336451, 1336448, 1336451, 1307265, 1336453, 1346958, 1346962, 1346982, 1346994, 1346965, 1336452, 1379085, 1379104, 1379110, 1379113, 1379114, 1346999, and 1379084.   Size 4   Unique Device Identifier: 00888867106727 Batch #'s: 894339, 913623, 874733, 876482, 876478, 1191338, 1206172, 1206173, 1297075, 1297084, 1315459, 1297086, 1297366, 13115453, 1315454, 1315459, 1315462, 1315464, 1336466, 1336465, 1336467, 1336455, 1336468, 13336469, 1356527, 1356530, 1356531, 1356529, 1356574, 1379205, 1379203, 1379204, 1379206, 1379200, 1356576, 1379196, and 1379201.  Size 5   Unique Device Identifier: 00888867106734 Batch #'s:780840, 971202, 1206176, 1206177, 1356586, 1322523, 1380216, 1380223, 1380224, 1356588, 1380221, 1380226, 1555653, and 1555654.  Size 6   Unique Device Identifier: 00888867106741 Batch #'s:780841, 970368, 1206178, 1206179, 1322459, 1322460, 1322524, 1357785, 1380243, 1380244, 1380245, 1380246, 1357786, and 1380242.  Size 7    Unique Device Identifier: 00888867106758 Batch #'s: 780842, 982767, 984546, 1206180, 1337230, 1206181, 1337234, 1337237, 1337240, 1337241, 1337256, 1358297, 1358299, 1358298, 1358300, 1358302, 1380708, 1380709, and 1380710.  Size 8   Unique Device Identifier: 00888867106765 Batch #'s: 913624, 970865, 957056, 1191342, 1224471, 120800, 1191341, 1191339, 876484, 876485, 1228632, 1251021, 1292154, 1251022, 1281699, 1292161, 1293756, 1293758, 1307294, 1307295, 1308538, 1337262, 1337300, 1337303, 1347012, 1347013, 133732",12/17/2015,"12/17/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73205,"Ongoing","Corin USA Limited","5670 W Cypress St Ste C",,"Tampa","FL","33607-1774","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy,  Japan, Poland, South Africa and UK.","Z-1526-2016","Class II","Trinity Acetabular System    Product Usage - Total Hip Replacement.","629 devices in total","Potential for abrasion of the sterile barrier pouches of the new packaging system. ","04/22/2016",," Non Occluded TPS Shell 048mm Taper SZ2, Lot Code:  323741",1/29/2016,"01/29/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73205,"Ongoing","Corin USA Limited","5670 W Cypress St Ste C",,"Tampa","FL","33607-1774","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy,  Japan, Poland, South Africa and UK.","Z-1528-2016","Class II","Trinity Acetabular Shell    Product Usage Total Hip Replacement.","629 devices in total","Potential for abrasion of the sterile barrier pouches of the new packaging system. ","04/22/2016",," No Hole Shell 048mm Taper Size 2,  Lot Codes: 322986, 323743, 320026, 322977,  323744;  No Hole Shell 052mm Taper Size 3, Lot Codes: 322396, 322971, 322403, 322984, 322985, 323750. ",1/29/2016,"01/29/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73205,"Ongoing","Corin USA Limited","5670 W Cypress St Ste C",,"Tampa","FL","33607-1774","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy,  Japan, Poland, South Africa and UK.","Z-1527-2016","Class II","Trinity Acetabular Shell     Product Usage: Total Hip Replacement.","629 devices in total","Potential for abrasion of the sterile barrier pouches of the new packaging system. ","04/22/2016",," Cluster Shell 044mm Taper Size 1,  Lot Code:  320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298;  Cluster Shell 050mm Taper Size 2, Lot Codes:  321954, 322753, 322980;  Cluster Shell 050mm Taper Size 3, Lot Codes:",1/29/2016,"01/29/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73206,"Ongoing","Collagen Matrix Inc","509 Commerce St",,"Franklin Lakes","NJ","07417-1374","United States","Voluntary: Firm Initiated","Letter","US Distribution to state of: MA.","Z-1097-2016","Class II","NuOss XC Sinus  Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height)  Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height)    Manufacturer:- Collagen Matrix,   Distributor:- ACE Surgical Supply Co, Inc,     Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration","347 units","During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which requires that the compressed product fully expand within 1 minute of hydration time.","03/11/2016",," Lot BMCXU11P1. BMCXU11H3    Lot BMCXU11P1, BMCXU12P1",5/13/2013,"05/13/2013",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73207,"Ongoing","Isomeric Pharmacy Solution, LLC","2401 S Foothill Dr",,"Salt Lake City","UT","84109-1479","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0728-2016","Class III","Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109","114 vials"," date or BUD (Before Use Date) that may be longer than intended.","02/25/2016",,,2/2/2016,"02/02/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73208,"Ongoing","Collagen Matrix Inc","509 Commerce St",,"Franklin Lakes","NJ","07417-1374","United States","Voluntary: Firm Initiated","Letter","US in the state of TX","Z-1173-2016","Class III","ZCORE Porcine Xenograft Particulate in Syringe    Product Intended for use in dental surgery such as:  -Augmentation or reconstructive treatment of alveolar ridge  -filling of defects after root resection, apicoectomy and cystectomy  -Filling of extraction sockets to enhance preservation of the alveolar ridge  -elevation of maxillary sinus floor  -Filling of periodontal defects in conjunction with products  -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)  -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.","200 units","The distributor, Osteogenics Biomedical,  notified the firm that the syringes were not working properly and the syringes were being held in quarantine.","03/14/2016",," PMCS025     Lot No. PMCSU15A1    PMCS05    Lot No. PMCSU15A1      PMCS10    Lot No. PMCSU15A1    PMCS05    Lot No. PMCSU15A2        PMCS10  Lot No. PMCSU15A2    ",11/17/2015,"11/17/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73209,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran ( Islamic Republic of ) Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania,  Luxembourg, Malaysia, Morocco, Myanmar(Burma) Netherlands Antilles, Norway, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka,   Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.","Z-0854-2016","Class II","Philips IntelliVue Module Measurement X2		  Model: M3002A","13,300","The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound  when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor ","02/23/2016",," Software Revision: K.21.54 or L.00.96 ",1/4/2016,"01/04/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73209,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran ( Islamic Republic of ) Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania,  Luxembourg, Malaysia, Morocco, Myanmar(Burma) Netherlands Antilles, Norway, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka,   Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.","Z-0853-2016","Class II","Philips IntelliVue Measurement Module X1   Model: M3001A  ","13,300","The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound  when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor ","02/23/2016",," Software Revision:K.21.54 or L.00.96",1/4/2016,"01/04/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",73210,"Ongoing","Mentality Cosmetics","1097 N State St Spc 221",,"Hemet","CA","92543-1536","United States","Voluntary: Firm Initiated","Other","Canada, Sweden, France, China, and United States.","F-1251-2016","Class II","Mentality Nail Polish 0.5 oz/15 ml, all colors    All nail polish produced in the following packaging-  Round bottle, black cap, white screen printed logo  Round bottle, black cap, black screen printed logo  Round bottle, black cap, white or clear vinyl label with either 5 Free, Matte, Gloss, Glaze, Texture, or Opaque on the lower left portion of the label.   Round bottles with 3 Free printed on the label ARE NOT included in this recall.  ","2,000 bottles","Mentality Cosmetics is recalling Mentality Nail Polish that were sold from 4/22/15 through 6/19/15 due to problematic batches that were manufactured with Arminex International nail polish bases.","04/27/2016",," no codes.    Lot numbers were not assigned by us per bottle. These bottles were small batch-colored, hand-mixed, hand poured items. Official recall includes product sold April 2015 to June 2015. ",7/22/2015,"07/22/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73211,"Ongoing","Garden Of Life Llc","4200 Northcorp Pkwy Ste 200",,"West Palm Beach","FL","33410-4314","United States","Voluntary: Firm Initiated","Press Release","Distributed nationwide throughout the U.S.A.      Also distributed internationally to the following countries: AU, BG, CA, CZ, DE, GB, HK, IE, IN, SE, SG, NL.","F-1329-2016","Class I","Raw Meal Organic Original Powder; Organic Shake and Meal Replacement; 908 g, 454 g, and 10-ct tray (65 g each).  Packaged in plastic bottle with colored label.","Total (including all flavors) of 422,923 bottles/units ","Products possibly contaminated with Salmonella","05/11/2016",," Lot code (Exp Date): 47214600 (09/01/2017), 47236000 (09/30/2017), 47248901 (09/30/2017), 47246500 (10/31/2017), 47225800 (09/30/2017), 47214800 (09/01/2017), 47222300 (08/01/2017), 47246501 (11/30/2017), 47248900 (08/01/2017), 47198700 (08/01/2017), 47225700 (08/01/2017), 47269900 (11/30/2017).",1/29/2016,"01/29/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73211,"Ongoing","Garden Of Life Llc","4200 Northcorp Pkwy Ste 200",,"West Palm Beach","FL","33410-4314","United States","Voluntary: Firm Initiated","Press Release","Distributed nationwide throughout the U.S.A.      Also distributed internationally to the following countries: AU, BG, CA, CZ, DE, GB, HK, IE, IN, SE, SG, NL.","F-1327-2016","Class I","Raw Meal Organic Vanilla Powder; Organic Shake and Meal Replacement; 949 g, 475 g, and 10-ct tray (68 g each).  Packaged in plastic bottle with colored label.","Total (including all flavors) of 422,923 bottles/units ","Products possibly contaminated with Salmonella","05/11/2016",," Lot code (Exp Date): 47216100 (09/01/2017), 47225500 (09/01/2017), 47198601 (09/30/2017), 47225600 (09/30/2017), 47253900 (09/30/2017), 47216200 (10/31/2017), 47225601 (10/31/2017), 47226400 (09/30/2017), 47257401 (09/30/2017), 47198600 (08/01/2017), 47200100 (08/01/2017), 47202100 (08/31/2017), 47225602 (11/30/2017), 47257100 (12/31/2017), 47198500 (08/01/2017), 47247900 (11/30/2017), 47273200 (11/30/2017), 47287600 (12/31/2017), 47275400 (11/30/2017), 4728000 (09/30/2017).",1/29/2016,"01/29/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73211,"Ongoing","Garden Of Life Llc","4200 Northcorp Pkwy Ste 200",,"West Palm Beach","FL","33410-4314","United States","Voluntary: Firm Initiated","Press Release","Distributed nationwide throughout the U.S.A.      Also distributed internationally to the following countries: AU, BG, CA, CZ, DE, GB, HK, IE, IN, SE, SG, NL.","F-1328-2016","Class I","Raw Meal Organic Chocolate Powder; Organic Shake and Meal Replacement; 986 g, 493 g, and 10-ct tray (65 g each).  Packaged in plastic bottle with colored label.","Total (including all flavors) of 422,923 bottles/units ","Products possibly contaminated with Salmonella","05/11/2016",," Lot code (Exp Date): 47198800 (09/01/2017), 47225900 (09/01/2017), 47249200 (09/01/2017), 47226000 (10/01/2017), 47226100 (10/31/2017), 47226200 (09/30/2017), 47226201 (10/31/2017), 47200000 (08/31/2017), 47215800 (08/01/2017), 47243600 (08/01/2017), 47247700 (11/30/2017), 47256902 (12/31/2017), 47198400 (08/01/2017), 47243000 (08/31/2017), 47247801 (11/30/2017), 47257001 (11/30/2017), 47200200 (08/01/2017), 47247800 (10/31/2017).",1/29/2016,"01/29/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73211,"Ongoing","Garden Of Life Llc","4200 Northcorp Pkwy Ste 200",,"West Palm Beach","FL","33410-4314","United States","Voluntary: Firm Initiated","Press Release","Distributed nationwide throughout the U.S.A.      Also distributed internationally to the following countries: AU, BG, CA, CZ, DE, GB, HK, IE, IN, SE, SG, NL.","F-1330-2016","Class I","Raw Meal Organic Vanilla Spiced Chai Powder; Organic Shake and Meal Replacement; 909 g, 455 g, and 10-ct tray (65 g each).  Packaged in plastic bottle with colored label.","Total (including all flavors) of 422,923 bottles/units ","Products possibly contaminated with Salmonella","05/11/2016",," Lot code (Exp Date): 47215500 (09/01/2017), 47215501 (09/01/2017), 47226300 (10/31/2017), 47247600 (10/31/2017), 47206000 (09/30/2017), 47215600 (08/31/2017), 47247601 (11/30/2017), 47202000 (08/01/2017), 47215400 (08/01/2017), 47183200 (08/01/2017), 47183201 (09/30/2017).",1/29/2016,"01/29/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73212,"Ongoing","Maquet Cardiovascular Us Sales, Llc","45 Barbour Pond Drive",,"Wayne","NJ","07470","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -  US including AZ and MO.  Foreign distribution to Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, and Venezuela.","Z-1045-2016","Class II","Maquet Getinge Group 1180.19XO Extension Device.  Manufacturer MAQUET GmbH,   Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.","2 within US; 247 OUS","MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0).  The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system.  Maquet GmbH was made aware of a potential issue that can result in the Extension Device becoming unlocked from the table top, cau","03/03/2016",," Catalog Number 1180.19F0; Serial numbers 00003 and 00004.",1/7/2016,"01/07/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73213,"Ongoing","Volk Optical Inc","7893 Enterprise Dr",,"Mentor","OH","44060-5309","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.","Z-1177-2016","Class III","Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602  for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities","9 lens","The firm discovered that the incorrect lot number was engraved on the product.","03/15/2016",," Model #: VG4SNF, Lot: BE05200",2/2/2016,"02/02/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73215,"Ongoing","R. J. Van Drunen and Sons Inc.","300 6th Street",,"Momence","IL","60954","United States","Voluntary: Firm Initiated","E-Mail","sold to distributors and manufacturers. See attached.","F-1593-2016","Class I","Freeze dried banana 1/4 diced packaged in 20 lb. containers with white label and black lettering. ","2, 560 lbs. distributed in bulk 20 lb. container. ","Customer received a 1,000g sample of freeze dried bananas, had it tested at 3rd party lab and received a positive test result for Salmonella. ","06/28/2016",," Lot number: 13955642709",1/29/2016,"01/29/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73217,"Ongoing","Jel Sert Co.","Highway 59 & Conde St",,"West Chicago","IL","60185","United States","Voluntary: Firm Initiated","Letter","65 cases were used for sales samples and gifts.  Of those cases (520 cartons) ~ 20 cartons are not accounted for and were most likely given to employees and or consumed.  17 other cases were used by Marketing and R&D.","F-1594-2016","Class I","Margaritaville 4.16 ounce packages of Banana creme pie filling mix packaged in a yellow, red, and blue box with white lettering. ","65 cases, 8 boxes/case. ","There was a positive salmonella sample from another customer of the supplier that tested it. This firm uses the freeze dried bananas in their Banana creme pie filling mix. ","06/28/2016",," Lot Code: WC5257    Best before Sept 2017   Universal Product Code: 7239202925  ",2/3/2016,"02/03/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73218,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9054","United States","Voluntary: Firm Initiated","FAX","Florida","B-0305-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who travelled in a malarial endemic country within 12 months of donating, was distributed.","02/25/2016","02/25/2016"," W036815167510",1/2/2016,"01/02/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73219,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9054","United States","Voluntary: Firm Initiated","FAX","Florida","B-0360-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected within a year from a donor who lived in a malarial endemic area, was distributed.","03/15/2016","03/15/2016"," W036815050510",11/24/2015,"11/24/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73221,"Ongoing","Zydus Pharmaceuticals USA Inc","73 Route 31 N",,"Pennington","NJ","08534-3601","United States","Voluntary: Firm Initiated","Letter","US Nationwide including Puerto Rico","D-0725-2016","Class III","risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India.  Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ  08534. NDC: 68382-156-06.","9504 Bottles","Failed Impurities/Degradation Specifications: Out of specification for a known degradant.","02/22/2016",," Lot #: MP4967, Expiry: 04/2016.",1/14/2016,"01/14/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73222,"Ongoing","Collagen Matrix Inc","509 Commerce St",,"Franklin Lakes","NJ","07417-1374","United States","Voluntary: Firm Initiated","Letter","US Distribution to the state of : MA","Z-1096-2016","Class II","NuOSS Cancellous    Intended for use in dental surgery.","171 units","On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.","03/11/2016",," Reference No. BM2C20010-U  Lot no. BM2CU15E2  ",8/25/2015,"08/25/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73223,"Ongoing","Star Snacks Co., Llc.","105 Harbor Drive",,"Jersey City","NJ","07305-4505","United States","Voluntary: Firm Initiated","E-Mail","IA, IL, IN, KS, MI, OH, SD, WI, and WY.","F-0783-2016","Class II","Parade Salted Peanuts Dry Roasted, Net Wt. 8 oz   Distributed by Federated Group, Inc. 3025 W. Salt Creek Ln Arlington Heights, IL 60005 UPC 050700569376","7764 cans","Parade Salted Peanuts Dry Roasted, 8 oz can may contain undeclared wheat.","03/22/2016",," 11H5, exp 08/11/2017",1/13/2016,"01/13/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73224,"Ongoing","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Letter","US Distribution to CA., and Internationally to Canada.","Z-0813-2016","Class II","Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case.  Cardiopulmonary bypass catheter.","60","Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case. ","02/16/2016",," lot - 1529300018",1/25/2016,"01/25/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73225,"Ongoing","Novadaq Technologies Inc.","8329 Eastlake Dr Unit 101",,"Burnaby",,,"Canada","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.","Z-1032-2016","Class II","PINPOINT Endoscopic Fluorescence Imaging System","110 units","It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.","03/02/2016",," Rev. J, Rev. K, Rev. L and Rev. M    Model Number : PC9000",1/29/2016,"01/29/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73228,"Terminated","American Red Cross Blood Services Heart of America Region","405 W John H Gwynn Jr Ave",,"Peoria","IL","61605-2440","United States","Voluntary: Firm Initiated","FAX","California","B-0245-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","02/12/2016","02/12/2016"," W204015192537 ",12/22/2015,"12/22/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0977-2016","Class II","WF Low Sodium Turkey, sold in a deli bag.  This is a deli service item ",,"Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0989-2016","Class II","CITTERIO HOT CAPICOLLA, sold in a deli bag.  This is a deli service item ","2587","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0954-2016","Class II","ESSKAY LS FF HAM, sold in a deli bag.  This is a deli service item ",,"Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0951-2016","Class II","EL TORO CUBAN PORK, sold in a deli bag.  This is a deli service item ","1","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0963-2016","Class II","KUNZLER LEBANON BOLOGNA, sold in a deli bag.  This is a deli service item ","1664","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0929-2016","Class II","APPLEGATE ROASTED TURKEY, packaged in deli bag.  This is a deli service item. ","2292","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0947-2016","Class II","D&W Signature Platter.  This is a deli service item ","25","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0965-2016","Class II","THE PREP ENTERTAINER.  This is a deli service item ","229","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0962-2016","Class II","Kunzler Sweet Bologna, sold in a deli bag.  This is a deli service item ","1627","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0953-2016","Class II","ESSKAY BBQ LOAF, sold in a deli bag.  This is a deli service item ","1","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0935-2016","Class II","D&W Black Forest Turkey, packaged in deli bag.  This is a deli service item. ","2481","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0990-2016","Class II","CITTERIO GENOA SALAMI, sold in a deli bag.  This is a deli service item ","10104","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0930-2016","Class II","APPLEGATE SLOW COOKED HAM, packaged in deli bag.  This is a deli service item. ","79","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0946-2016","Class II","D&W PEPPERED HAM, packaged in deli bag.  This is a deli service item ","3825","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0931-2016","Class II","ARMOUR MEAT BOLOGNA, packaged in deli bag.  This is a deli service item. ","5750","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0934-2016","Class II","D&W BEEF BOLOGNA, packaged in deli bag.  This is a deli service item. ",,"Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0939-2016","Class II","D&W Gourmet LITE Turkey, packaged in deli bag.  This is a deli service item. ","4954","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0975-2016","Class II","WF Lighter Fare substitute Turkey.  This is a deli service item ","3","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0941-2016","Class II","D&W HOME TURKEY BREAST, packaged in deli bag.  This is a deli service item. ","6063","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0976-2016","Class II","WF Oven Honey Chicken, sold in a deli bag.  This is a deli service item ","3704","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0944-2016","Class II","D&W MAPLE HONEY TURKEY, packaged in deli bag.  This is a deli service item. ","4678","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0950-2016","Class II","D&W Sandwich Ring.  This is a deli service item ","26","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0991-2016","Class II","CITTERIO HARD SALAMI, sold in a deli bag.  This is a deli service item ","7837","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0932-2016","Class II","D&W SRIRACHA CHICKEN, packaged in deli bag.  This is a deli service item. ","3066","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0980-2016","Class II","WF Sandwich Ring substitute Turkey.  This is a deli service item ","12","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0936-2016","Class II","D&W Black Pepper Turkey, packaged in deli bag.  This is a deli service item. ","5251","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0972-2016","Class II","WF Entertainer Platter.  This is a deli service item ","12","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0952-2016","Class II","DAK HAM, sold in a deli bag.  This is a deli service item ","16394","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0957-2016","Class II","Harvestland Roasted Turkey, sold in a deli bag.  This is a deli service item ","2592","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0992-2016","Class II","CITTERIO CHORIZO, sold in a deli bag.  This is a deli service item ","1","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0948-2016","Class II","D&W Rotissere Chicken Breast, packaged in a deli bag.  This is a deli service item ","1897","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0968-2016","Class II","WF Black Forest Ham, sold in a deli bag.  This is a deli service item ","7669","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0933-2016","Class II","D&W BBQ CHICKEN, packaged in deli bag.  This is a deli service item. ","2878","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0940-2016","Class II","D&W GOURMET LITE HAM, packaged in deli bag.  This is a deli service item. ","4569","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0995-2016","Class II","3FT American Substitute Turkey.  This is a deli service item ","5","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0986-2016","Class II","Citterio Sweet Capicolla, sold in a deli bag.  This is a deli service item ","79","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0984-2016","Class II","D&W Sandwich Ring substitute Roast Beef.  This is a deli service item ","1","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0958-2016","Class II","HORMEL COOKED HAM, sold in a deli bag.  This is a deli service item ","9354","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0994-2016","Class II","3FT Italian Hero.  This is a deli service item ","331","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0993-2016","Class II","3FT American Hero.  This is a deli service item ","4","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0943-2016","Class II","D&W LOW SALT BOLOGNA, packaged in deli bag.  This is a deli service item. ","669","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0960-2016","Class II","ITALIAN SANDWICH RING.  This is a deli service item ","19","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0982-2016","Class II","Wellsley Farms Deli Sandwich Ring.  This is a deli service item ","7 days","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0927-2016","Class II","APPLEGATE HAM BLACK FOREST, packaged in deli bag.  This is a deli service item. ","1776","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0978-2016","Class II","WF PASTRAMI, sold in a deli bag.  This is a deli service item ","7304","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0942-2016","Class II","D&W LONDON BROIL ROAST BEEF, packaged in deli bag.  This is a deli service item. ","6063","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0985-2016","Class II","Croissant Sandwich Platter.  This is a deli service item ",,"Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0955-2016","Class II","ESSKAY MEAT BOLOGNA, sold in a deli bag.  This is a deli service item ","2614","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0970-2016","Class II","WF CORNED BEEF, sold in a deli bag.  This is a deli service item ","7334","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0956-2016","Class II","Harvestland Honey Roasted Turkey, sold in a deli bag.  This is a deli service item ","663","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0961-2016","Class II","Krakus Imported Polish Ham, sold in a deli bag.  This is a deli service item ","10,407","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0974-2016","Class II","WF Light Platter.  This is a deli service item ","26","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0987-2016","Class II","CITTERIO PROSCIUTTO, sold in a deli bag.  This is a deli service item ","4187","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0969-2016","Class II","WF Buffalo Chicken , sold in a deli bag.  This is a deli service item ","3694","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0926-2016","Class I","Cittero Mortadella, packaged in deli bags.  This is a deli service item.  ","300 cases","Product contains undeclared tree nuts (pistachios).  ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0959-2016","Class II","ITALIAN MEAT PLATTER.  This is a deli service item ","62","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0996-2016","Class II","3FT American Substitute Roast Beef.  This is a deli service item ","4","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0949-2016","Class II","D&W Smoked Ham All Natural, packaged in a deli bag.  This is a deli service item ","2542","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0966-2016","Class II","WELLSLEY FARM HONEY TURKEY. This is a deli service item ","22129","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0981-2016","Class II","WF SMOKED TURKEY, sold in a deli bag.  This is a deli service item ","6673","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0967-2016","Class II","WELLSLEY FARMS ROAST BEEF, sold in a deli bag.  This is a deli service item ","18,977","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0945-2016","Class II","D&W OLIVE LOAF, packaged in deli bag.  This is a deli service item. ","999","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0964-2016","Class II","SAUGY NATURAL CASING FRANKS, sold in a deli bag.  This is a deli service item ","1","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0938-2016","Class II","D&W BUFFALO CHICKEN, packaged in deli bag.  This is a deli service item. ","3469","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0973-2016","Class II","WF Honey Ham.  This is a deli service item ","24000","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0979-2016","Class II","WF Sandwich Ring substitute Roast Beef.  This is a deli service item ","1","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0983-2016","Class II","DELI SANDWICH RING WF CPREP.  This is a deli service item ",,"Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0937-2016","Class II","D&W BRAUNSCHWEIGER, packaged in deli bag.  This is a deli service item. ","5251","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0988-2016","Class II","CITTERIO PEPPERONI, sold in a deli bag.  This is a deli service item ","4604","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0928-2016","Class II","APPLEGATE Honey Maple Turkey, packaged in deli bag.  This is a deli service item. ","60","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73233,"Ongoing","Bj Wholesale Club","25 Research Dr",".","Westborough","MA","01581-3680","United States","Voluntary: Firm Initiated","Press Release","BJs locations in Delaware, Maryland, New Jersey, New York, North Carolina, Ohio, Pennsylvania and Virginia","F-0971-2016","Class II","WF Croissant Platter substitute Roast Beef.  This is a deli service item ","1","Product may have been sliced on the same equipment where the mortadella with pistachios was sliced. ","04/06/2016",," Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list). ",2/5/2016,"02/05/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73234,"Ongoing","Baroody Imports Inc.","1500 Main Ave",,"Clifton","NJ","07011-2120","United States","Voluntary: Firm Initiated","Letter","CT, NJ & NY","F-0323-2017","Class II","Beirut Lift Turnip Pickles   Imported & Distributed By: Baroody Import Inc. 1500 B Main Ave. -Clifton, NJ 07011 Tel: 973.3404832    700 g - UPC 642036014141  2 kg - UPC 642036014219  10 kg - UPC","700 g - 5,580 containers; 2 kg - 1200 containers; 10 kg- 50 pails","Beirut Lift Turnip Pickles contain undeclared beet root red color.","11/04/2016",," no lot codes    dates of distribution:  3/11/2015-8/12/2015",1/4/2016,"01/04/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73235,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0731-201","Class II","0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03","257,364 bottles","PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect. ","02/26/2016",," Lot # G120162, Exp 11/18",2/5/2016,"02/05/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73236,"Ongoing","HEB Retail Support Center","4710 N Pan Am Expy",,"San Antonio","TX","78218-5415","United States","Voluntary: Firm Initiated","Press Release","Texas and Mexico.","F-0775-2016","Class III","HEB Creamy Creations Caramel Pecan Turtle Ice Cream Half Gallon/Cont. Net. 1.89 L packaged in cardboard container","37,432 units","Wood pieces in the product.","03/18/2016",," SELL BY: 20 APR(ABR)16, 10 MAY(MAY)16, 07 JUN(JUN)16, 18 JUL(JUL)16",2/4/2016,"02/04/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73237,"Ongoing","Medical Action Industries Inc","25 Heywood Rd",,"Arden","NC","28704-9302","United States","Voluntary: Firm Initiated","E-Mail","Nationwide distribution to MO, NE and TX .","Z-1036-2016","Class II","PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC.  This kit is used by clinicians to change dressings","9 cases (180 kits) ","Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling","03/02/2016",," Kit #73775, Lot 213403 ",2/3/2016,"02/03/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73238,"Ongoing","CareFusion 303, Inc.","10020 Pacific Mesa Blvd",,"San Diego","CA","92121-4386","United States","Voluntary: Firm Initiated","Letter","Michigan","Z-1179-2016","Class II","Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 ","5,760 units","CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.","03/17/2016",," Lot No. 13085603",2/15/2016,"02/15/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73239,"Terminated","T.F. Foods Incorporated","15131 Garfield Ave",,"Paramount","CA","90723-4019","United States","Voluntary: Firm Initiated","Telephone","US: NY, CA","F-0732-2016","Class I","Bean Snacks (NA-PIA-JO), Net Wt. 10.60 oz (300G), 50 bgs/case","20 cases","TF Foods is recalling Bean Snacks because it contains undeclared peanut allergen.","03/08/2016","04/11/2016"," 15C-4331",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73240,"Ongoing","Giant Eagle, Inc.","101 Kappa Dr",,"Pittsburgh","PA","15238-2809","United States","Voluntary: Firm Initiated","E-Mail","PA  OH","F-0726-2016","Class I","Refrigerated, fresh, Panko breaded cod fillet packed in blue foam tray with plastic overwrap. Label reading:  Giant Eagle Japanese Breaded Cod Fillet various weights.  Distributed by: Giant Eagle, Inc., Pittsburgh, PA 15238  Sold from August 2015 to present with various expiration dates.","420 units","All lot codes up to and including February 8, 2016 of Giant Eagle brand Japanese Breaded Cod Fillets, prepared and sold from the Seafood department inside Giant Eagle and Market District supermarkets through February 4, 2016 have been voluntarily recalled by Giant Eagle due to an undeclared soy allergen. ","03/07/2016",," UPC: starting with 268106",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73241,"Ongoing","Draeger Medical, Inc.","3135 Quarry Rd",,"Telford","PA","18969-1042","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including Puerto Rico.","Z-0827-2016","Class I","Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator.  Ventilation.","2553","The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.  ","02/25/2016",," Catalog #s 8416400 and 8417400",2/4/2016,"02/04/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73242,"Ongoing","Shearer's Snacks","3000 Mount Pleasant St",,"Burlington","IA","52601-2064","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to customer distribution centers in FL, IA, IL, IN, KY, NC, NY, OK, TX, and VA.","F-2398-2016","Class III","Family Gourmet, Sugar Wafers, Strawberry, Net Wt 8 OZ (227 g), Distributed By: Family Dollar Services, Inc. Charlotte, NC 28201 USA Product of Canada","3059 boxes","Sugar wafer cookies contain an ingredient that was recalled by the ingredient manufacturer due to the presence of extraneous foreign matter in the refined granulated sugar (ingredient in the finished product).","09/21/2016",," 08276AG, 08276BG",2/1/2016,"02/01/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73242,"Ongoing","Shearer's Snacks","3000 Mount Pleasant St",,"Burlington","IA","52601-2064","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to customer distribution centers in FL, IA, IL, IN, KY, NC, NY, OK, TX, and VA.","F-2399-2016","Class III","Keebler, Sugar Wafers, Vanilla, Net Wt 2.75 OZ (77 g), Made in Canada Distributed By Kellogg Sales Co, Battle Creek, MI 49016 USA ","381 boxes","Sugar wafer cookies contain an ingredient that was recalled by the ingredient manufacturer due to the presence of extraneous foreign matter in the refined granulated sugar (ingredient in the finished product).","09/21/2016",," TM10246 A4",2/1/2016,"02/01/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73242,"Ongoing","Shearer's Snacks","3000 Mount Pleasant St",,"Burlington","IA","52601-2064","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to customer distribution centers in FL, IA, IL, IN, KY, NC, NY, OK, TX, and VA.","F-2345-2016","Class III","Family Gourmet, Sugar Wafers, Vanilla, Net Wt 8 OZ (227 g), Distributed By: Family Dollar Services, Inc. Charlotte, NC 28201 USA Product of Canada","4293 boxes","Sugar wafer cookies contain an ingredient that was recalled by the ingredient manufacturer due to the presence of extraneous foreign matter in the refined granulated sugar (ingredient in the finished product).","09/21/2016",," 08276BG, 08276CG, 08286AG",2/1/2016,"02/01/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73242,"Ongoing","Shearer's Snacks","3000 Mount Pleasant St",,"Burlington","IA","52601-2064","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to customer distribution centers in FL, IA, IL, IN, KY, NC, NY, OK, TX, and VA.","F-2400-2016","Class III","Keebler, Sugar Wafers, Strawberry, Net Wt 2.75 OZ (77 g), Made in Canada Distributed By Kellogg Sales Co, Battle Creek, MI 49016 USA ","1472 boxes","Sugar wafer cookies contain an ingredient that was recalled by the ingredient manufacturer due to the presence of extraneous foreign matter in the refined granulated sugar (ingredient in the finished product).","09/21/2016",," TM10246 B4, TN10236 C4, TM10256 A4, TM10256 B4",2/1/2016,"02/01/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73243,"Terminated","Abbott Vascular","26531 Ynez Rd",,"Temecula","CA","92591-4630","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina Luxembourg Australia Malaysia Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway Colombia Philippines Corrientes Poland Czech Republic Portugal Denmark Egypt Romania Finland Saudi Arabia France Slovenia Germany Spain Greece Sweden Hong Kong Switzerland Hungary Thailand Indonesia Turkey Israel United Arab Emirates Italy United Kingdom Kuwait and Vietnam.","Z-0911-2016","Class I","MitraClip Clip Delivery System, product number MSK0101. The MitraClip System  contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921.    The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.    ","7,600 units total (2,300 units in US)","Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture.  ","03/07/2016","05/12/2016"," Lot number   50811U1  50811U2  50812U1  50813U1  50814U1  50826U1  50826U2  50827U1  50908U1  50908U2  50909U1  50910U1  50910U2  50911U1  50924U1  50925U1  50928U1  50929U1  51010U1  51012U1  51012U2  51013U1  51014U1  51014U2  51026U1  51027U3  51028U1  51028U2  51029U1  51030U1  51105U1  51106U1  51109U1  51109U2  51110U1  51110U2  51117U1  51203U1  51204U1  51205U1  51207U1  ",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73244,"Ongoing","JNC International Inc.","67 Porete Ave",,"North Arlington","NJ","07031-6734","United States","Voluntary: Firm Initiated","Letter","NY, OH, & VA","F-0583-2016","Class II","Little Temptations Sour Strawberries Net Wt. 7.5 oz (213g)   Packed by: Crystal Temptations, North Arlington, NJ 07031  UPC 611190469401","348 units","Sour strawberries contain undeclared FD&C Blue #1 and Yellow #5.","02/12/2016",," BB JUNE 15 2016 C 223 1504",12/31/2015,"12/31/2015",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73245,"Ongoing","Fresh Express Incorporated","900 E Blanco Rd",,"Salinas","CA","93901-4419","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, FL, MA and MD.","F-0634-2016","Class I","Fresh Express, Club Size, Chopped Romaine Lettuce, 32 oz., in clear flexible plastic bags, containing condiments in a separate clear flexible plastic bag.","322 Cases x 8 bags of 32 oz. each = 2576 32 oz. bags.","Undeclared Allergens: milk, eggs, wheat and fish.","02/25/2016",," Use By Feb 19, G034A06A",2/6/2016,"02/06/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73247,"Terminated","Illes Food Ingredients Ltd.","2200 Luna Rd","Ste 120","Carrollton","TX","75006-6560","United States","Voluntary: Firm Initiated","Telephone","AR","F-0725-2016","Class I","Asiago Cheese Sauce Seasoning NET CONTENTS: 44.3 POUNDS 20.1 KILOGRAMS packed in flexible bags","50 bags","Product tested positive for Salmonella","03/07/2016","04/11/2016"," Lot 0106160154",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73248,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including all states in including PR except ND, VT & WY.  Foreign Distribution:  ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA  .","Z-1050-2016","Class II","Discovery ST, , 2339985  LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slic","522","GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.","03/04/2016",," Mfg Lot or Serial #	System ID  00000312256CN1	4860LS16GS  00000312256CN1	4860LS16GS  00000312256CN1	4860LS16GS  00000294153CN2	0910212097  00000309306CN9	0910212101  00000309960CN3	0910212104  00000309960CN3	0910212104  00000311052CN5	0910212105  00000321402CN0	0910212106  00000321402CN0	0910212106  00000337340CN4	0910212115  00000337340CN4	0910212115  00000337340CN4	0910212115  00000297003CN6	0910213064  00000313645CN4	0910213070  00000301209CN3	0910215018  00000313097CN8	0910216036  00000337344CN6	0910216041  00000297460CN8	AH1410CT06  00000325191CN5	AH5362CT02  00000310728CN1	110037CT01  00000310728CN1	110037CT01  00000299935CN7	190020CT03  00000311058CN2	190052CT06  00000297386CN5	190059CT04  00000311058CN2	190052CT06  00000311426CN1	030018CT01  00000297596CN9	BA4142CT01  00000297596CN9	BA4142CT01  00000297596CN9	BA4142CT01  00000327271CN3	10026  00000346702CN4	1350651  00000310682CN0	2850998  00000310682CN0	2850998  00000327815CN7	CT327815CN7  00000332075CN1	BG4037CT01  UNK23399850000	BG4037CT01  00000316663CN4	BG4042CT01  00000316663CN4	BG4042CT01  00000327081CN6	BG4608CT01  00000314635CN4	BG4600CT01  00000357475CN3	CM1007CT02  00000357475CN3	CM1007CT02  00000357475CN3	CM1007CT02  00000361978CN0	082445020003  00000361978CN0	082445020003  00000361978CN0	082445020003  00000352887CN4	082445030003  00000347756CN9	082445100008  00000347756CN9	082445100008  00000309961CN1	082445150001  00000336259CN7	082445150008  00000359854CN7	082445160007  00000354676CN9	082445250002  00000294148CN2	HLGSCTD10002  00000294148CN2	HLGSCTD10002  00000299483CN8	082421111101  00000334898CN4	082421140150  00000322331CN0	082421160145  00000298653CN7	082421030115  00000333002CN4	082421030162  00000295411CN3	082421030340  00000299934CN0	082421040093  00000295644CN9	082421040096  00000299483CN8	082421111101  00000308733CN5	082421040103  00000299951CN4	082421030354  00000299951CN4	082421030354  00000299951CN4	82421030354  00000322333CN6	082421040120  00000295409CN7	082421050034  00000323331CN9	082421050038  00000343124CN4	082421060040",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73248,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including all states in including PR except ND, VT & WY.  Foreign Distribution:  ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA  .","Z-1051-2016","Class II","LightSpeed 16 (MDAS only  , , 2339985  LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging s","324","GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.","03/04/2016",," Mfg Lot or Serial #	System ID  00000350495CN8	A5333025  00001001853YM9	AL4004CT01  00000953838YM0	AL4023CT01  00001001879YM4	0002876927  00000357924CN0	1577LS16  00001001879YM4	0002876927  00001001879YM4	0002876927  00001001879YM4	0002876927  00001010424YM8	0910212127  00001010461YM0	0910212129  00001010461YM0	0910212129  00001010471YM9	0910213084  00000980093YM9	0910212119  00000980093YM9	0910212119  00000994084YM2	0910212123X  00000984698YM1	0910213080  00001010387YM7	0910215023  00001010475YM0	0910215025  00001001897YM6	AH5703CT01  00000980120YM0	AH4001PE01  00000988410YM7	110002CT02  00000953828YM1	110017CT01  00000980106YM9	110040CT03  00000953853YM9	110059CT01  00000988410YM7	110002CT02  00000980111YM9	030355CT03  00000980111YM9	030355CT03  00001002103YM8	2858149  00000383739CN0	CT383739CN0  00000980108YM5	BF1012CT01  00000980108YM5	BF1012CT01  00000980108YM5	BF1012CT01  00000988391YM9	CT988391YM9  00000988391YM9	CT988391YM9  00000988391YM9	CT988391YM9  00001002107YM9	082421120191  00000364134CN7	082445160009  00000365398CN7	082445040002  00000363607CN3	082421100316  00001002106YM1	082421110048  00000953856YM2	082421120171  00001001852YM1	082421120187  00001010423YM0	082421100294  00001010444YM6	082421100301  00000941008YM5	082421020154  00000988393YM5	082421030172  00000996079YM0	082421030175  00000988398YM4	082421050047  00000996082YM4	082421100157  00000984688YM2	082421100270  00000988395YM0	082421100276  00000988397YM6	082421100278  00000984685YM8	082421100283  00001010426YM3	082421160169  00001010436YM2	082421160176  00000980095YM4	082421180052  00001010457YM8	082421180061  00001023062YM1	082421180064  00000984699YM9	082421010160  00000941008YM5	082421020154  00000994089YM1	082421100284  00001002104YM6	082421120188  00000984700YM5	082421130071  00000988386YM9	082421130073  00001010451YM1	082421100307  00001010455YM2	082421290042  00001010478YM4	EE1020CT01  00001010478YM4	EE1020CT01  00000953833YM1	FI1052CT02  00000994076YM8	A9885025  00000994074YM3	C2195260  00000994074YM3	C2195260  00000994076YM8	",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73248,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including all states in including PR except ND, VT & WY.  Foreign Distribution:  ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA  .","Z-1048-2016","Class II","LightSpeed Ultra (8-slice MDAS), 5120327-3    LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic im","25","GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.","03/04/2016",," Mfg Lot or Serial #	System ID  00001035638YM4	082421010179  00000001887YC9	082421010327  00001035639YM2	082421020108  00001035636YM8	082421020109  00001031633YM9	082421030253  00001031634YM7	082421030254  00000003852YC1	082421030266  00001031640YM4	082421040157  00001035634YM3	082421060051  00000001885YC3	082421060054  00001035641YM8	082421080078  00001031632YM1	082421090164  00001035640YM0	082421090168  00001031639YM6	082421100318  00001031638YM8	082421120200  00000003853YC9	082421140187  00001031637YM0	082421150068  00000001883YC8	082421200244  00000001888YC7	082421270069  00001035633YM5	082421310091  00000001891YC1	082421040171  00000001892YC9	082421040177  00000001889YC5	082421090174  00000001890YC3	082421090175  00000001886YC1	082421310106  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73248,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including all states in including PR except ND, VT & WY.  Foreign Distribution:  ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA  .","Z-1052-2016","Class II","LightSpeed Plus (4-slice MDAS  LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. ","1","GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.","03/04/2016",," Mfg Lot or Serial #	System ID  00000002493PT5	0850450029  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73248,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including all states in including PR except ND, VT & WY.  Foreign Distribution:  ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA  .","Z-1053-2016","Class II","LightSpeed QX/I (4-slice MDAS)    LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system","104","GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.","03/04/2016",," Mfg Lot or Serial #	System ID  00000006841PT1	PET368725CN8  00000004411PT5	4512-1  00000004411PT5	4512-1  00000006841PT1	PET368725CN8  00000005376PT9	PET357769CN9  00000005670PT5	082426140014  00000006610PT0	082445020003  00000006610PT0	082445020003  00000006610PT0	082445020003  00000006119PT2	082445030003  00000005815PT6	082445050003  00000006146PT5	082445090002  00000005808PT1	082445100008  00000006177PT0	082445100009  00000006175PT4	082445130004  00000005670PT5	082426140014  00000005808PT1	082445100008  00000006500PT3	082445160007  00000006242PT2	082445190002  00000006200PT0	082445250002  00000005251PT4	H4858964  00000005121PT9	M4143813  00000005352PT0	M4144860  00000005323PT1	X105967801  00000006194PT5	HU1167PT01  00000006762PT9	0004168403  00000006762PT9	0004168403  00000005809PT9	IE1005PT01  00000004588PT0	IL1062NM18  00000006120PT0	A5107746  UNK51012720002	A5107746  UNK51012720001	A5215931  00000006003PT8	A5333025  00000004619PT3	A99263301  00000006292PT7	YD0024  00000006293PT5	YD0025  00000006039PT2	YE0001  00000006273PT7	YE0002  00000006272PT9	YE0003  00000006345PT3	YE0004  00000006346PT1	YE0005  00000006808PT0	YE0006  00000006488PT1	YE0007  00000006403PT0	YE0008  00000006368PT5	YE0011  00000006274PT5	YE0077  00000005920PT4	YE0101  00000006141PT6	YE0102  00000006076PT4	YE0103  00000006404PT8	YE0104  00000006496PT4	YE0105  00000006405PT5	YE0106  00000006453PT5	YE0107  00000006636PT5	YE0108  00000006331PT3	YE0110  00000006347PT9	YE0111  00000006454PT3	YE0112  00000006115PT0	YE0201  00000006407PT1	YE0202  00000006611PT8	YE0203  00000006245PT5	YE0205  00000006810PT6	YE0210  00000006843PT7	YE0211  00000005813PT1	YE0214  00000006367PT7	YE0109  00000006304PT0	YE0204  00000005813PT1	YE0214  00000004967PT6	0850450042  00000004967PT6	0850450042  00000004967PT6	0850450042  00000004967PT6	0850450042  00000004463PT6	0850450055  00000005495PT7	0850450056X1  00000005342PT1	0850450057  00000005342PT1	0850450057  00000005878PT4	0850450058  00000006176PT2	0850450059  00000006176PT2	0850450059  00000005785PT1	083445000",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73248,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including all states in including PR except ND, VT & WY.  Foreign Distribution:  ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA  .","Z-1049-2016","Class II","Discovery LS, 2286327    LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slic","817","GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.","03/04/2016",," Mfg Lot or Serial #	System ID  00000002631PT0	4860AW442  00000002631PT0	4860AW442  00000318118CN7	0910213115  00000002808PT4	0910453003P  00000318118CN7	0910213115  00000318118CN7	0910213115  00000980093YM9	0910212119  00000002247PT5	090016PT01  00000326200CN3	110012CT01  00000311426CN1	030018CT01  00000002103PT0	2728449  00000003306PT8	2757760XXX  00000003306PT8	2757760XXX  00000003310PT0	47867  00000002103PT0	2728449  00000002103PT0	2728449  00000339630CN6	BG4029CT01  00000298328CN6	204787LS1  00000298660CN2	204787LSPD2  00000307018CN2	416249LS16  00000309304CN4	519744LS16  00000309524CN7	819379LS  00000310680CN4	418862LS  00000312264CN5	450656LS  00000316257CN5	613761LS16  00000317195CN6	604988LS16  00000318444CN7	514499LS  00000318927CN1	514468BLS  00000319310CN9	519421LS16  00000324459CN7	450466LS  00000328940CN2	450654LS  00000329994CN8	819561LS  00000332076CN9	506648LS16  00000335314CN1	514934CLS16  00000341799CN5	416284LS16  00000341801CN9	416744LS16  00000341802CN7	905883LS16  00000347191CN9	450778LS  00000348810CN3	416924DST  00000349405CN1	514934BDST  00000994091YM7	418549LS  00000334561CN8	26329CT4X  00000002642PT7	082445310001  00000002660PT9	082445310003  00000340577CN6	082421120176  00000340630CN3	082421140148  00000989604YM4	082421030247  00000989603YM6	082421040128  00000989606YM9	082421080068  00000989606YM9	082421080068  00000989602YM8	082421100277  00000989607YM7	082421210116  00000352887CN4	USONCDST16  00000346880CN8	2532905LIG16  00000295643CN1	FI1017CT02  00000334897CN6	A9190135  00000001843PT2	B4155412  00000334897CN6	A9190135  00000002494PT3	GOLD010013  00000341585CN8	GOLD010316  00000336468CN4	M4143946  00000002494PT3	GOLD010013  00000339849CN2	M4215541  00000339849CN2	M4215541  00000336833CN9	M4434860  00000341585CN8	GOLD010316  00000341585CN8	GOLD010316  00000341585CN8	GOLD010316  00000001843PT2	B4155412  00000293499CN0	M5481223  00000302751CN3	M4516011  00000309305CN1	M4491923  00000310268CN8	M4191025  00000313650CN4	C6010809  00000326112CN0	M1279722  00000329304CN0	X993729001  00",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73250,"Terminated","Ventura Foods LLC","6000 Industrial Rd",,"Saint Joseph","MO","64504-3503","United States","Voluntary: Firm Initiated","Telephone","One distribution center in Tennessee. Product was further distributed to other distribution centers in Tennessee, Kentucky, and Louisiana.","F-0723-2016","Class II","Land O Lakes, Fresh Buttery Taste Spread, 48% Vegetable Oil Spread, A product of Land O'Lakes Inc. Arden Hills, MN. Packaged in 5 gram plastic cups.","96/920/5 grams/individual cups/cases","Cases of 5 gram portion cups of margarine for the food service market were distributed without label information. The cups therefore failed to disclose the margarine contained the allergens milk and soy.","03/07/2016","04/26/2016"," Production date J28115 Lot number 150528116",2/5/2016,"02/05/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73251,"Ongoing","Olympus Scientific Solutions Americas","48 Woerd Ave",,"Waltham","MA","02453-3824","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution","Z-0803-2016","Class II","Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer .  This is a  Analytical X-ray system","US - 5000 units","The Firm has discovered a Software bug.","02/19/2016",," All models of the Delta XRF Analyzer",1/13/2016,"01/13/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73252,"Terminated","Living Tree Community Foods","1455 5th St",,"Berkeley","CA","94710-1337","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution only: AZ, WA, MN, CA, CT, FL, NV, UT, MA, PA, CO. MS, GA, NY, TX, IL, OH, OR, KS, MO, NC, ID, VA","F-0733-2016","Class I","Living Tree Community Foods Organic Macadamia Nuts, 4 oz. plastic pouch.  Certified Organic    ","195 x 4 oz. pouches","Recall of macadamia nuts and macadamia butter after notification by immediate supplier that the product is under recall due to potential contamination Salmonella","03/08/2016","04/11/2016"," Lot 153442",2/5/2016,"02/05/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73252,"Terminated","Living Tree Community Foods","1455 5th St",,"Berkeley","CA","94710-1337","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution only: AZ, WA, MN, CA, CT, FL, NV, UT, MA, PA, CO. MS, GA, NY, TX, IL, OH, OR, KS, MO, NC, ID, VA","F-0734-2016","Class I","Living Tree Community Foods Organic Macadamia Butter, 8 oz. glass jar.  Certified Organic.  UPC 64143200987    ","204 x 8 oz. jars","Recall of macadamia nuts and macadamia butter after notification by immediate supplier that the product is under recall due to potential contamination Salmonella","03/08/2016","04/11/2016"," Lots 134415, 136215, 101716.",2/5/2016,"02/05/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73253,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV.","Z-1172-2016","Class II","Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System  Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.","US 5,604 devices, OUS 91,925","Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). The issue will only occur at sites using POTCT1-A communication via USB.","03/14/2016",," Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through  UU41122741.",2/11/2016,"02/11/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73254,"Ongoing","Volcano Corporation","2870 Kilgore Rd",,"Rancho Cordova","CA","95670-6133","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.","Z-1042-2016","Class II","Volcano SpinVision Sterile Equip cover II; Sterile;    General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.","1355 total ","Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date. ","03/03/2016",," REF numbers: 891BG and 891BG-10 (10 pack): all lots",2/5/2016,"02/05/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73254,"Ongoing","Volcano Corporation","2870 Kilgore Rd",,"Rancho Cordova","CA","95670-6133","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.","Z-1041-2016","Class II","Volcano R100 Sterile Equipment Cover; Sterile;    General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.","1355 total","Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date. ","03/03/2016",," REF numbers: PBKGB and PBKBG-10 (10 pack): all lots",2/5/2016,"02/05/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73255,"Ongoing","Stryker Medical Division of Stryker Corporation","3800 E Centre Ave",,"Portage","MI","49002-5826","United States","Voluntary: Firm Initiated","Letter","Distribution US nationwide, Canada, and Mexico.","Z-2353-2016","Class II","S3 MedSurg Bed, Model 3005.	Stryker Medical ","8490","CPU board failures cause fowler (backrest) electronic controls to stop working.","08/08/2016",," MDL#: E341062; 3005S3EX; 3005S3Patriot; 3005S3Signature; 3005S3PX1; 3005S3PX2; 3005S3PX3; 3005S3PX4; 3005S3EX; Serial Numbers: 141115067 through  150615027; Serial Numbers: 141115067                  141115068                  141115069                  141115070                  141115071                  141115072                  141115073                  141115074                  141115075                  141115076                  141115077                  141115078                  141115079                  141115080                  141115081                  141115082                  141115083                  141115084                  141115085                  141115086                  141115087                  141115088                  141115089                  141115090                  141115091                  141115092                  141115093                  141115094                  141115095                  141115096                  141115097                  141115098                  141115099                  141115100                  141115101                  141115102                  141115103                  141115104                  141115105                  141115106                  141115107                  141115108                  141115109                  141115110                  141115111                  141115112                  141115113                  141115114                  141115115                  141115116                  141115117                  141115118                  141115119                  141115120                  141115121                  141115122                  141115123                  141115124                  141115125                  141115126                  141115127                  141115128                  141115129                  141115130                  141115131                  141115132                  141115133                  141115134                  141115135                  14111515",2/2/2016,"02/02/2016",8/17/2016,"08/17/2016","         141216032                  141216033                  141216034                  141216035                  141216036                  141216037                  141216038                  141216039                  141216040                  141216041                  141216042                  141216043                  141216044                  141216045                  141216046                  141216047                  141216048                  141216049                  141216050                  141216051                  141216052                  141216053                  141216054                  141216055                  141216056                  141216057                  141216058                  141216059                  141216060                  141216061                  141216062                  141216063                  141216064                  141216065                  141216066                  141216067                  141216068                  141216069                  141216070                  141216071                  141216072                  141216073                  141216074                  141216075                  141216076                  141216077                  141216078                  141216079                  141216080                  141216081                  141216082                  141216083                  141216084                  141216085                  141216086                  141216087                  141216088                  141216089                  141216090                  141216091                  141216092                  141216093                  141216094                  141216095                  141216096                  141216097                  141216098                  141216099                  141216100                  141216101                  141216102                  141216103                  141216104                  141216105                  141216106                  141216107  ","      150115730                  150115731                  150115732                  150115733                  150115734                  150115735                  150115736                  150115737                  150115738                  150115739                  150115740                  150115741                  150115742                  150115743                  150115744                  150115745                  150115746                  150115747                  150115748                  150115749                  150115750                  150115751                  150115752                  150115753                  150115754                  150115755                  150115756                  150115757                  150115758                  150115759                  150115760                  150115761                  150115762                  150115763                  150115764                  150115765                  150115766                  150115767                  150115768                  150115769                  150115770                  150115771                  150115772                  150115773                  150115774                  150115775                  150115776                  150115777                  150115778                  150115779                  150115780                  150115781                  150115782                  150115783                  150115784                  150115785                  150115786                  150115787                  150115788                  150115789                  150115790                  150115791                  150115792                  150115793                  150115794                  150115795                  150115796                  150115797                  150115798                  150115799                  150115800                  150115801                  150115802                  150115803                  150115804                  150115805     ","   150116978                  150116979                  150116980                  150116981                  150116982                  150116983                  150116984                  150116985                  150116986                  150116987                  150116988                  150116989                  150116990                  150215001                  150215002                  150215003                  150215004                  150215005                  150215006                  150215007                  150215008                  150215009                  150215010                  150215011                  150215012                  150215013                  150215014                  150215015                  150215016                  150215017                  150215018                  150215019                  150215020                  150215021                  150215022                  150215023                  150215024                  150215025                  150215026                  150215027                  150215028                  150215029                  150215030                  150215031                  150215032                  150215033                  150215034                  150215035                  150215036                  150215037                  150215038                  150215039                  150215040                  150215041                  150215042                  150215043                  150215044                  150215045                  150215046                  150215047                  150215048                  150215049                  150215050                  150215051                  150215052                  150215053                  150215054                  150215055                  150215056                  150215057                  150215058                  150215059                  150215060                  150215061                  150215062                  150215063        ","150216269                  150216270                  150216271                  150216272                  150216273                  150216274                  150216275                  150216276                  150216277                  150216278                  150216279                  150216280                  150216281                  150216282                  150216283                  150216284                  150216285                  150216286                  150216287                  150216288                  150216289                  150216290                  150216291                  150216292                  150216293                  150216294                  150216295                  150216296                  150216297                  150216298                  150216299                  150216300                  150216301                  150216302                  150216303                  150216304                  150216305                  150216306                  150216307                  150216308                  150216309                  150216310                  150216311                  150216312                  150216313                  150216315                  150216316                  150216317                  150216318                  150216319                  150216320                  150216321                  150216322                  150216323                  150216324                  150216325                  150216326                  150216327                  150216328                  150216329                  150216330                   150216331                  150216332                  150216333                  150216334                  150216335                  150216336                  150216337                  150216338                  150216339                  150216340                  150216341                  150216342                  150216343                  150216344                  150216345          ","316187                  150316188                  150316189                  150316190                  150316191                  150316192                  150316193                  150316194                  150316195                  150316196                  150316197                  150316198                  150316199                  150316200                  150316201                  150316202                  150316203                  150316204                  150316205                  150316206                  150316207                  150316208                  150316209                  150316210                  150316211                  150316212                  150316213                  150316214                  150316215                  150316216                  150316217                  150316218                  150316219                  150316220                  150316221                  150316222                  150316223                  150316224                  150316225                   150316226                  150316227                  150316228                  150316229                  150316230                  150316231                  150316232                  150316233                  150316234                  150316235                  150316236                  150316237                  150316238                  150316239                  150316240                  150316241                  150316242                  150316243                  150316244                  150316245                  150316246                  150316247                  150316248                  150316249                  150316250                  150316251                  150316252                  150316253                  150316254                  150316255                  150316256                  150316257                  150316258                  150316259                  150316260                  150316261                  150316262             ","405                  150415406                  150415407                  150415408                  150415409                  150415410                  150415411                  150415412                  150415413                  150415414                  150415415                  150415416                  150415417                  150415418                  150415419                  150415420                  150415421                   150415422                  150415423                  150415424                  150415425                  150415426                  150415427                  150415428                  150415429                  150415430                  150415431                  150415432                  150415433                  150415434                  150415435                  150415436                  150415437                  150415438                  150415439                  150415440                  150415441                  150415442                  150415443                  150415444                  150415445                  150415446                  150415447                  150415448                  150415449                  150415450                  150415451                  150415452                  150415453                  150415454                  150415455                  150415456                  150415457                  150415458                  150415459                  150415460                  150415461                  150415462                  150415463                  150415464                  150415465                  150415466                  150415467                  150415468                  150415469                  150415470                  150415471                  150415472                  150415473                  150415474                  150415475                  150415476                  150415477                  150415478                  150415479                  150415480                ","3                  150515434                  150515435                  150515436                  150515437                  150515438                  150515439                  150515440                  150515441                  150515442                  150515443                  150515444                  150515445                  150515446                  150515447                  150515448                  150515449                  150515450                  150515451                  150515452                  150515453                  150515454                  150515455                  150515456                  150515457                  150515458                  150515459                  150515460                  150515461                  150515462                  150515463                  150515464                  150515465                  150515466                  150515467                  150515468                  150515469                  150515470                  150515471                  150515472                  150515473                  150515474                  150515475                  150515476                  150515477                  150515478                  150515479                  150515480                  150515481                  150515482                  150515483                  150515484                  150515485                  150515486                  150515487                  150515488                  150515489                  150515490                  150515491                  150515492                  150515493                  150515494                  150515495                  150515496                  150515497                  150515498                  150515499                  150515500                  150515501                  150515502                  150515503                  150515504                  150515505                  150515506                  150515507                  150515508                  1",,,,,,,,,,,,,,,,,,,,,
"Biologics",73257,"Completed","Our Lady Of The Lake Hospital Inc","Attn: Blood Bank","5000 Hennessy Blvd","Baton Rouge","LA","70808-4375","United States","Voluntary: Firm Initiated","FAX","Louisiana","B-0376-16","Class II","Plasma Frozen within 24 hours (FP24)","five units","Blood products, in which labeling/labels applied to blood units or products with incorrect or missing information, were distributed.","03/24/2016","03/24/2016"," W165715002984X; W165715016623O; W1657150194907; W1657150194915; W1657150208116; ",1/14/2016,"01/14/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73257,"Completed","Our Lady Of The Lake Hospital Inc","Attn: Blood Bank","5000 Hennessy Blvd","Baton Rouge","LA","70808-4375","United States","Voluntary: Firm Initiated","FAX","Louisiana","B-0375-16","Class II","Fresh Frozen Plasma","six units","Blood products, in which labeling/labels applied to blood units or products with incorrect or missing information, were distributed.","03/24/2016","03/24/2016"," W1657150042159; W165715006095Z; W165715008135J; W165715020326W; W165715020963B; W165715023419B; ",1/14/2016,"01/14/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73258,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.","Z-0885-2016","Class II","HipLOC CHS Plate/Lag Screw Introducer","23 units","A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked. ","02/25/2016",," Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.",2/16/2016,"02/16/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73259,"Ongoing","MicroAire Surgical Instruments, LLC","3590 Grand Forks Blvd",".","Charlottesville","VA","22911-9006","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution.  US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.","Z-1323-2016","Class II","MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula","37","Complaints that the cannula bent/broke during surgery. ","04/05/2016",," 0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.        ",2/8/2016,"02/08/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73260,"Ongoing","International Foodsource, LLC","52 Richboynton Rd",,"Dover","NJ","07801-2650","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-2008-2016","Class I","IFS Club Bag Pistachio Raw Shelled 80% Wholes Net Wt. 3 lb. (1 kg)  International Foodsource LLC 52 Richboynton Rd. Dover NJ 07801 UPC 790429243026","2 bags ","Raw pistachios may be contaminated with Salmonella which was determined through FDA contract laboratory testing.","08/26/2016",," Lot #78634",2/11/2016,"02/11/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73260,"Ongoing","International Foodsource, LLC","52 Richboynton Rd",,"Dover","NJ","07801-2650","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-2006-2016","Class I","Sam International Bulk Raw Whole Pistachio 80% VP  Net Wt. 30 lb  Packaged in Boxes","2 boxes ","Raw pistachios may be contaminated with Salmonella which was determined through FDA contract laboratory testing.","08/26/2016",," Lot #102914",2/11/2016,"02/11/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73260,"Ongoing","International Foodsource, LLC","52 Richboynton Rd",,"Dover","NJ","07801-2650","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-2007-2016","Class I","Valued Natural Raw Pistachio Kernels Net Wt 5 oz. (141 g)  International Foodsource LLC 52 Richboynton, Rd. Dover, NJ 07801 UPC 790429241428","9756 bags","Raw pistachios may be contaminated with Salmonella which was determined through FDA contract laboratory testing.","08/26/2016",," Lot #79249",2/11/2016,"02/11/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73260,"Ongoing","International Foodsource, LLC","52 Richboynton Rd",,"Dover","NJ","07801-2650","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-2009-2016","Class I","IFS Web Bulk Pistachio Raw Shelled 80% Wholes Net Wt. 30 lb. (13 kg)  International Foodsource LLC 52 Richboynton Rd. Dover NJ 07801 UPC 790429239630","2 boxes","Raw pistachios may be contaminated with Salmonella which was determined through FDA contract laboratory testing.","08/26/2016",," Lot #78998",2/11/2016,"02/11/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73261,"Ongoing","Medtronic Perfusion Systems","7611 Northland Dr N",,"Brooklyn Park","MN","55428-1088","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including US: AK, AZ, CA, DE, FL, HI, IL, LA, MD. MA. MN, MS, MO, NE,  NJ,. NHY, NC, ND, OH, OR, PAM TN, TX, VA, WA, WV, and WI.  Internationally to Australia, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, France, Germany, Israel, Japan, Netherlands, Serbia, South Africa, and Switzerland.","Z-1023-2016","Class III","Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO.    Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.  This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures","9890 (7773 US, 2117 OUS)","Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS).       Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and","02/26/2016",," Catalog No. 	Lot Number	UPN / GTIN   BB8B09R4	209857492 	00643169624436   BB8B09R4	210031260 	00643169624436   BB8B09R4	210258522 	00643169624436   BB8S23R	                     209685753 	00643169624849   BB8S23R	                     209685754 	00643169624849   BB8S23R      	210141006 	00643169624849   HY1W12R28	209821189 	00643169620155   M273205G 	210135065 	00643169651258   M311110F 	210007560 	20643169409662   M311110F 	210305334 	20643169409662   M311110F 	210646326 	 20643169409662   M311129K 	210216215 	00643169399280   M311129K 	210637628 	00643169399280   M311135D 	210386285 	00643169478183   M311136L 	210100436	                     00643169515598   M311136L 	210433599 	00643169515598   M311151D 	209903218 	00643169475311   M321304B 	210165927	                     20643169460694   M321709C 	210129241 	20643169636716   M322225D 	210075636	                     00643169510203   M322225D 	210175891 	00643169510203   M322225D 	210296690 	00643169510203   M330119D 	209872946 	00643169583542   M331831E 	210181103 	00643169608412   M331831E 	210322907 	00643169608412   M334821J  	210276579 	00643169690967   M337503K 	210300696 	00643169490284   M338803C 	210302285 	00643169332539   M381004M 	209998094 	20643169299959   M381007B 	209998093	                     20643169299942   M382206C 	209998091 	00643169480193   M421709C 	210245944 	00643169407367   M450202E 	210093488 	00643169648869   M450202E 	210307287 	00643169648869   M450311C 	210143630 	00643169617865   M450467K 	210137624 	00643169409781   M450467K 	210188072 	00643169409781   M450467K 	210296689 	00643169409781   M490753H 	209918242 	00643169472112   M490817B 	210075633 	00643169096271   M490817B 	210513258 	00643169096271   M491217D 	210435629 	00643169169197   M491546B 	210006820 	00643169415676   M491546B 	210093491 	00643169415676   M491547B 	210254924 	00643169415683   M491547B 	210368459 	00643169415683   M491908D 	209930663	                      00643169655140   M494833B 	209974536 	00643169620087   M494833B 	210099871 	00643169620087   M49",2/4/2016,"02/04/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73262,"Ongoing","FABI - SAA Inc.","39 Montgomery St","Belleville Business Center","Belleville","NJ","07109-1305","United States","Voluntary: Firm Initiated","Letter","NY, NJ","F-0806-2016","Class III","Fabi-Saa Mote Blanco Net Wt. 14 oz. (397 g)   Imported and Distributed by Fabi-Saa Inc.   Belleville, NJ 07109 UPC 874093000090   Made in USA","5400 units","Fabi-Saa Mote Blanco contains undeclared sulfites at 2.61 mg.","03/24/2016",," 4-30-16",12/16/2015,"12/16/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73263,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (nationwide) and Internationally to:  Canada  AR                    AU                    BD                    BR                    CA                    CH                    CL                    CN                    CO                    DO                    EC                    GT                    HK                    ID                    IE                    IL                    IN                    JP                    KR                    LK                    MM                    MX                    MY                    NI                    NP                    NZ                    PE                    PH                    PY                    SA                    SG                    TH                    TW                    UY                    VN                    ZA","Z-1077-2016","Class II","Siemens Healthcare Diagnostics  ADVIA Centaur Calibrator E - 2-Pack   Catalog Number: 04634452   SMN: 10309079  ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems","15224  (2-pack)","ADVIA Centaur Systems Calibrator E Lot  42  and 43 Bias with the Testosterone Assay","03/08/2016",," Lot codes/Exp Date:  87226A42 May 9, 2016;  55811 A42 May 9, 2016;  53650A42 May 9, 2016;  53624A42 May 9, 2016;  15612A43 November 27, 2016;  17909A43 November 27, 2016;  22868A43 November 27, 2016;  45084A43 November 27, 2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73263,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (nationwide) and Internationally to:  Canada  AR                    AU                    BD                    BR                    CA                    CH                    CL                    CN                    CO                    DO                    EC                    GT                    HK                    ID                    IE                    IL                    IN                    JP                    KR                    LK                    MM                    MX                    MY                    NI                    NP                    NZ                    PE                    PH                    PY                    SA                    SG                    TH                    TW                    UY                    VN                    ZA","Z-1078-2016","Class II","Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762   SMN: 10321075  ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems","6455 (6 pack)","ADVIA Centaur Systems Calibrator E Lot  42  and 43 Bias with the Testosterone Assay","03/08/2016",," Lot code/ Exp.Date:  86344A42    May 9, 2016;  55437A42    May 9, 2016;  54801A42    May 9, 2016;  53651A42    May 9, 2016;  53625A42    May 9, 2016;  15610A43   November 27, 2016;  18375A43   November 27, 2016;  24990A43   November 27, 2016;  38988A43    November 27, 2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73263,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (nationwide) and Internationally to:  Canada  AR                    AU                    BD                    BR                    CA                    CH                    CL                    CN                    CO                    DO                    EC                    GT                    HK                    ID                    IE                    IL                    IN                    JP                    KR                    LK                    MM                    MX                    MY                    NI                    NP                    NZ                    PE                    PH                    PY                    SA                    SG                    TH                    TW                    UY                    VN                    ZA","Z-1079-2016","Class II","Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference)   Catalog Number: 04636889   SMN: 10335532  ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems","519 pack","ADVIA Centaur Systems Calibrator E Lot  42  and 43 Bias with the Testosterone Assay","03/08/2016",," Lot codes/Exp Date:  91005A42   May 9, 2016;  53698A42   May 9, 2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73264,"Ongoing","Ecolab Inc","370 Wabasha St N",,"Saint Paul","MN","55102-1323","United States","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico and Canada","D-0766-2016","Class III","Scrub-Stat 4 (chlorhexidine gluconate) Foam  Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102        ","706 bottles","Subpotent drug","03/08/2016",," Lot #: a) L041051, Exp 04 /17; L060151, L061951, Exp 06 /17; b) L060151, L061951, Exp 06 /17    ",2/12/2016,"02/12/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73265,"Ongoing","Zimmer Spine, Inc.","7375 Bush Lake Rd",,"Minneapolis","MN","55439-2027","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in the countries of Australia and Germany.","Z-1019-2016","Class II","Virage OCT Spinal Fixation System.  Intended to promote fusion of the  Occipital-Cervical-Thoracic spine (Occiput-T3).  ","15,753","Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.  ","02/26/2016",," Surgical Technique Manual  L1637 Rev B (2014-06)",2/3/2016,"02/03/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73266,"Ongoing","Arrow International, Inc., Division of Teleflex Medical Inc.","9 Plymouth St",,"Everett","MA","02149-1814","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).","Z-1063-2016","Class I","Percutaneous Insertion Tray; Product Code: IAK-S7IT    The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.","13,405 US and 33,735 OUS in total","The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.","03/10/2016",," Batch: 18F14A0037  18F14B0040  18F14E0027  18F14F0027  18F14F0028  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73266,"Ongoing","Arrow International, Inc., Division of Teleflex Medical Inc.","9 Plymouth St",,"Everett","MA","02149-1814","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).","Z-1059-2016","Class I","UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U    The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.","13,405 US and 33,735 OUS in total","The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.","03/10/2016",," Batch: 18F13M0016  18F14A0017  18F14A0018  18F14A0022  18F14A0046  18F14E0054  18F14E0070  18F14G0038  18F14G0078  18F14H0007  18F14J0007  18F14J0025  18F14K0016  18F15A0035  18F15B0006  18F15B0014  18F15C0019  18F15E0028  18F15F0016  18F15G0007  18F15H0009  18F15H0035  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73266,"Ongoing","Arrow International, Inc., Division of Teleflex Medical Inc.","9 Plymouth St",,"Everett","MA","02149-1814","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).","Z-1060-2016","Class I","UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U    The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.","13,405 US and 33,735 OUS in total","The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.","03/10/2016",," Batch:18F13M0017  18F13M0019  18F13M0021  18F14A0012  18F14A0013  18F14A0015  18F14A0016  18F14A0044  18F14A0047  18F14B0042  18F14B0043  18F14D0068  18F14E0005  18F14E0007  18F14E0031  18F14E0053  18F14E0069  18F14F0030  18F14F0031  18F14F0066  18F14G0020  18F14G0039  18F14G0066  18F14H0003  18F14H0010  18F14H0023  18F14H0024  18F14H0056  18F14J0006  18F14J0016  18F14J0027  18F14J0051  18F15A0008  18F15A0015  18F15A0023  18F15B0003  18F15B0007  18F15B0021  18F15C0006  18F15C0011  18F15C0027  18F15D0010  18F15D0019  18F15D0045  18F15E0002  18F15E0012  18F15F0008  18F15F0028  18F15F0038  18F15F0041  18F15G0016  18F15G0027  18F15H0005  18F15H0020  18F15H0032  18F15H0041  18F15J0007  18F15J0010  18F15J0021  18F15J0029  18F15J0039  18F15J0056  18F15K0016  18F15K0032  18F15L0001  18F15L0010  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73266,"Ongoing","Arrow International, Inc., Division of Teleflex Medical Inc.","9 Plymouth St",,"Everett","MA","02149-1814","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).","Z-1058-2016","Class I","Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U    The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.    ","13,405 US and 33,735 OUS in total","The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.","03/10/2016",," Batch: 18F14B0044  18F14B0045  18F14E0060  18F14F0019  18F14G0067  18F14H0002  18F14J0026  18F15A0033  18F15B0009  18F15B0019  18F15C0012  18F15D0016  18F15D0037  18F15D0044  18F15F0001  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73266,"Ongoing","Arrow International, Inc., Division of Teleflex Medical Inc.","9 Plymouth St",,"Everett","MA","02149-1814","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).","Z-1057-2016","Class I","FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS    The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.","13,405 US and 33,735 OUS in total","The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.","03/10/2016",," Batch: 18F14A0025  18F14A0026  18F14A0030  18F14A0049  18F14A0050  18F14A0051  18F14A0054  18F14A0057  18F14A0066  18F14A0067  18F14D0045  18F14E0004  18F14E0006  18F14E0016  18F14E0017  18F14E0052  18F14F0017  18F14F0047  18F14F0049  18F14F0080  18F14G0003  18F14G0004  18F14G0021  18F14G0037  18F14G0055  18F14G0056  18F14G0068  18F14G0070  18F14G0071  18F14G0076  18F14H0009  18F14H0030  18F14H0054  18F14H0055  18F14H0060  18F14H0061  18F14J0003  18F14J0005  18F14J0037  18F14K0006  18F14M0001  18F14M0014  18F14M0032  18F15A0005  18F15A0011  18F15A0026  18F15A0034  18F15B0005  18F15B0008  18F15B0010  18F15B0018  18F15B0020  18F15B0027  18F15C0002  18F15C0007  18F15C0010  18F15C0015  18F15C0024  18F15C0030  18F15C0036  18F15D0017  18F15D0032  18F15D0034  18F15D0043  18F15D0049  18F15E0003  18F15E0011  18F15E0014  18F15E0023  18F15E0029  18F15E0037  18F15F0011  18F15F0017  18F15F0021  18F15F0032  18F15G0001  18F15G0013  18F15G0021  18F15G0028  18F15G0034  18F15H0010  18F15H0015  18F15H0021  18F15H0024  18F15H0033  18F15J0013  18F15J0028  18F15J0038  18F15J0044  18F15J0049  18F15K0001  18F15K0007  18F15L0002  18S14G0068  18S14M0001  18S15C0002  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73266,"Ongoing","Arrow International, Inc., Division of Teleflex Medical Inc.","9 Plymouth St",,"Everett","MA","02149-1814","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).","Z-1055-2016","Class I","FiberOptix Ultra 8 IAB: 8Fr 30cc    The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.","13,405 US and 33,735 OUS in total","The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.","03/10/2016",," Batch: 18F14A0031  18F14A0032  18F14A0033  18F14D0066  18F14E0018  18F14E0072  18F14F0067  18F14F0079  18F14G0045  18F14G0046  18F14G0081  18F14H0037  18F14J0023  18F14L0014  18F14M0033  18F15A0010  18F15B0015  18F15C0004  18F15C0023  18F15D0025  18F15D0052  18F15E0020  18F15F0002  18F15F0039  18F15G0005  18F15G0015  18F15H0006  18F15H0037  18F15H0051  18F15J0026  18F15L0007  18S14G0046  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73266,"Ongoing","Arrow International, Inc., Division of Teleflex Medical Inc.","9 Plymouth St",,"Everett","MA","02149-1814","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).","Z-1061-2016","Class I","RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C    The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.","13,405 US and 33,735 OUS in total","The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.","03/10/2016",," Batch:18F14A0041  18F14C0003  18F14C0006  18F14C0021  18F14C0026  18F14C0027  18F14C0028  18F14E0039  18F14E0055  18F14E0058  18F14F0035  18F14F0038  18F14F0054  18F14G0057  18F14G0077  18F14H0011  18F15B0023  18F15C0001  18F15C0008  18F15C0026  18F15D0028  18F15F0027  18F15F0037  18F15G0003  18F15G0011  18F15G0032  18F15H0046  18F15M0009  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73266,"Ongoing","Arrow International, Inc., Division of Teleflex Medical Inc.","9 Plymouth St",,"Everett","MA","02149-1814","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).","Z-1062-2016","Class I","Percutaneous Insertion Tray; Product Code: IAK-06845    The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.","13,405 US and 33,735 OUS in total","The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.","03/10/2016",," Batch: 18F14A0037  18F14B0040  18F14E0027  18F14F0027  18F14F0028  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73266,"Ongoing","Arrow International, Inc., Division of Teleflex Medical Inc.","9 Plymouth St",,"Everett","MA","02149-1814","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).","Z-1056-2016","Class I","Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U    The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.","13,405 US and 33,735 OUS in total","The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.","03/10/2016",," Batch: 18F14A0031  18F14A0032  18F14A0033  18F14D0066  18F14E0018  18F14E0072  18F14F0067  18F14F0079  18F14G0045  18F14G0046  18F14G0081  18F14H0037  18F14J0023  18F14L0014  18F14M0033  18F15A0010  18F15B0015  18F15C0004  18F15C0023  18F15D0025  18F15D0052  18F15E0020  18F15F0002  18F15F0039  18F15G0005  18F15G0015  18F15H0006  18F15H0037  18F15H0051  18F15J0026  18F15L0007  18S14G0046  ",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73267,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","US Distribution to the state of : UT","Z-1178-2016","Class II","Pilling Modular Verres Body/Obturator, Product Code 140880","8","Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly provided with product code 140878 (Verres cannula with integral needle tip).","03/16/2016",," Lot K3",1/8/2015,"01/08/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73270,"Terminated","BPL Plasma, Inc.","2631 Dunn Ave",,"Jacksonville","FL","32218-4656","United States","Voluntary: Firm Initiated","E-Mail","Belgium","B-0377-16","Class II","Source Plasma","2 units","Blood products, which were not quarantined due to medical history, were distributed.","03/25/2016","03/25/2016"," JV0317041; JV0317555; ",12/6/2015,"12/06/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73271,"Terminated","BPL Plasma, Inc. ","3744 Blanding Blvd",,"Jacksonville","FL","32210-5243","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom; California","B-0378-16","Class II","Source Plasma","6 units","Blood products, which were not quarantined subsequent to receiving information regarding a post donation information, were distributed.","03/25/2016","03/25/2016"," JK0657010; JK0658495; JK0659062; JK0660442; JK0661083; JK0662486; ",11/20/2015,"11/20/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73272,"Terminated","HCSC-Blood Center","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","E-Mail","Pennsylvania; New Jersey","B-0354-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.","03/17/2016","03/17/2016"," W050911030059; ",11/17/2015,"11/17/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73272,"Terminated","HCSC-Blood Center","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","E-Mail","Pennsylvania; New Jersey","B-0353-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.","03/17/2016","03/17/2016"," W050911030059; ",11/17/2015,"11/17/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73273,"Ongoing","The Kroger Co","1014 Vine St",,"Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to Colorado & Utah","F-0737-2016","Class I","King Soopers City Market GOURMET BREAD PUDDING; Various Sizes, INGREDIENTS: HALF & HALF***APPLES, LIQUID EGG***SPICES, SALT***RAISINS, CINNAMON. CONTAINS EGG, MILK, SOY, WHEAT; UPC 2 47460 0XXXX","340 pounds","Product is being recalled due to undeclared walnuts.","03/08/2016",," All codes",2/8/2016,"02/08/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73274,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.","Z-0826-2016","Class II","software for Syngo Dynamics     a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. ","151","Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients. ","02/19/2016",," For model #10091673",1/29/2016,"01/29/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73275,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0666-2016","Class II","TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX  76134, Barcode 90016741106, UPC 3 00650 41636 8.","12,648 cartons","Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.","02/16/2016",," Lot #: KRJ006, Exp 09/17",2/9/2016,"02/09/2016",2/24/2016,"02/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0758-2016","Class I","Wilderness Family Naturals Cacao, Organic Hot Chocolate Mix Packaged in the following sizes:  1 lb. Foil Bag, UPC 898392-007765;    12 lb. (12 - 1 lb. Foil Bags in a cardboard box), UPC 01002464;    5 lb. Foil Bag, UPC 898392-007772;  and   30 lb. (6-5lb. Foil Bags in a cardboard box), UPC 01002465 ","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:  1000011523, 1000011666,1000011881  1000011894  1000011923  1000012202  1000012262  1000012512  1000012623  1000013259  1000013381  1000013416  1000013439  1000013580 .    Best By Dates:  4/23/2016, 5/25/2016, 6/30/2016  7/7/2016  7/16/2016  8/10/2016  9/17/2016  10/30/2016  12/1/2016  4/22/2017  5/20/2017  6/11/2017  6/22/2017  7/18/2017",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0757-2016","Class I","Wilderness Family Naturals Coconut Milk, Powdered, Organic packaged in the following sizes:    1) 16 oz foil pouch, UPC 98392-00769;  2)  12 lb. Case of 12 - 1 lbs packages, UPC 01002457  3) 5 lb. bag, UPC 98392-00770  4) 30 lb. Case of 6 - 5 lb. packages, UPC 01002458  5)  Case of 1-55 lb. package, UPC 01002459  6) Trial Sample size, UPC 01002463","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:  1000011218, 1000012366, 1000013229.    Best By Dates:  5/20/2017, 12/8/2017, 8/15/2018",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0764-2016","Class I","Morning Star Disaster Supplies Quick Meal  Mexican Corn Soup Mix Net Wt. 8.1 oz (230g)., Foil Bag.  UPC 853328-006090      Wilderness Family Naturals  Quick Meal  Mexican Corn Soup Mix., Net Wt 8.1 oz (230 g)., Foil Bag. UPC 898392-007949","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers: 1000013050.  Best By Dates:  9/9/2020.      Lot Numbers:1000013303, 1000013367.  Best By Dates:11/6/2020, 11/17/2020.  ",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0765-2016","Class I","Morning Star Disaster Supplies ,Creamy Potato Corn Chowder, Net Wt. 7.88 oz (223 g).  UPC 853328-006052, Foil Bag     Wilderness Family Naturals  Quick Meal  Potato Corn Chowder, Net Wt 7.88 oz (223 g). UPC 853328-006199, Foil Bag","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers: 1000013057.  Best By Dates:  9/16/2020.      Lot Numbers:1000013296, 1000013344.  Best By Dates: 11/6/2020, 11/12/2020.  ",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0762-2016","Class I","Wilderness Family Naturals Choco Maca Strawberry Cereal  Organic  8 oz.., Foil Bag    UPC 898392-007819","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers: 1000011562  1000011878  1000012058  1000012564  1000012758  1000013171  1000013541    Best By Dates:  11/3/2017 12/31/2017 2/2/2018 5/14/2018 7/7/2018 10/5/2018 1/11/2018",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0769-2016","Class I","Morning Star Disaster Supplies  Jamaican Beans and Rice, Net Wt 8.62 oz (244 g). UPC 853328-006076, Foil Bag    Wilderness Family Naturals Quick Meal  Jamaican Beans and Rice, Net Wt 8.62 oz (244 g). UPC 898392-007987, Foil Bag","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:1000013032.  Best By Dates: 9/8/2020.    Lot Numbers:1000013284.  Best By Dates: 11/2/2020.  ",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0770-2016","Class I","Morning Star Disaster Supplies Broccoli Potato Soup Mix, Net Wt 6.91 oz (196 g). UPC 853328-006014, Foil Bag    Wilderness Family Naturals  Quick Meal  Broccoli Potato Soup Mix, Net Wt 6.91, (196 g). UPC 898392-007963, Foil Bag","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:1000013038.   Best By Dates: 9/8/2020.     Lot Numbers:1000013305, 1000013345.  Best By Dates:11/6/2020, 11/12/2020.    ",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0759-2016","Class I","Wilderness Family Naturals Coconut Chia Pudding Mix Organic, packaged in the following sizes:    1.1 lb Plastic Bag, UPC 898392-007789, and 13.2 lb.  (12 plastic bags in a cardboard box) UPC 01002466","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:    1000011555  1000011643  1000012297  1000012705  1000013578.      Best By Dates:    10/31/2017  11/19/2017  3/27/2018  6/22/2018  1/14/2019",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0768-2016","Class I","Morning Star Disaster Supplies Coconut Vegetable Curry over Quinoa, Net Wt 4.95 oz (115 g). UPC 853328-006069, Foil Bag    Wilderness Family Naturals  Quick Meal  Coconut Vegetable Curry over Quinoa,  Net Wt 4.95 oz (115 g). UPC 853328-006229, Foil Bag","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:1000013027,   Best By Dates: 9/3/2020.      Lot Numbers:1000013292, 1000013343.  Best By Dates: 11/5/2020, 11/12/2020.  ",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0767-2016","Class I","Morning Star Disaster Supplies  Creamy Coconut Rice Soup, Net Wt 7.25 oz (206 g). UPC 853328-006038, Foil Bag    Wilderness Family Naturals  Quick Meal  Creamy Coconut Rice Soup, Net Wt  7.25 oz (206 g). UPC 853328-006038, Foil Bag","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers: 1000013070, 1000013214.  Best By Dates: 9/17/2020, 10/7/2020.      Lot Numbers:1000013293, 1000013369.  Best By Dates: 11/5/2020, 11/17/2020.",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0766-2016","Class I","Morning Star Disaster Supplies Tomato Basil Soup, Net Wt 3.88 oz (110 g),   UPC 853328-006120, Foil Bag    Wilderness Family Naturals  Quick Meal  Tomato Basil Soup, Net Wt 3.88 oz (110 g). UPC 853328-006243, Foil Bag","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers: 1000013142, 1000013071.  Best By Dates:  9/30/2020, 9/17/2020.      Lot Numbers:1000013294, 1000013376.  Best By Dates: 11/6/2020, 11/17/2020.  ",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0772-2016","Class I","Morning Star Disaster Supplies  Butternut Squash Soup, Net Wt 4.75oz (135 g).  UPC 853328-006113, Foil Bag    Wilderness Family Naturals Quick Meal  Butternut Squash Soup, Net Wt 4.75 oz (135 g). UPC 853328-006182, Foil Bag","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:1000013059, 1000013057.  Best By Dates: 9/16/2020.      Lot Numbers:1000013309, 1000013377.  Best By Dates:11/9/2020, 11/18/2020.    ",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0763-2016","Class I","Wilderness Family Naturals Banana Blueberry Cereal  Organic  8 oz.., Foil Bag    UPC 898392-007833","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers: 1000011563  1000011877  1000012054  1000012561  1000012757  1000013086  1000013170  1000013313    Best By Dates:  11/3/2017 12/31/2017 2/2/2018 5/14/2018 7/7/2018 9/23/2018 10/5/2018 11/10/2018",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0761-2016","Class I","Wilderness Family Naturals Mango Raspberry Cereal  Organic  8 oz., Foil Bag.    UPC 898392-007826.","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:  1000011560  1000011879  1000012057  1000012634  1000013087  1000013170  1000013312    Best By Dates:  10/31/2017  12/31/2017  2/2/2018  6/3/2018 9/23/18 10/5/2018 11/10/2018",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0771-2016","Class I","Morning Star Disaster Supplies Creamy Mushroom Wild Rice Soup, Net Wt 7.3 oz (207 g). UPC 853328-006045, Foil Bag    Wilderness Family Naturals  Quick Meal  Creamy Mushroom Wild Rice Soup Mix, Net Wt 7.3 oz (207 g). UPC 898392-007994, Foil Bag","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:1000013041.  Best By Dates: 9/9/2020.      Lot Numbers:1000013306, 1000013365.  Best By Dates:11/6/2020, 11/16/2020.    ",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73276,"Ongoing","Wilderness Family Naturals, LLC","99 Edison Blvd Ste 1",,"Silver Bay","MN","55614-1211","United States","Voluntary: Firm Initiated","Press Release","USA: Nationwide    OUS: Canada","F-0760-2016","Class I","Wilderness Family Naturals Coconut Chia Pudding Mix  Sweetened with Coconut Sap Sugar  Organic  Packaged in the following sizes:  1.1 lb. Plastic Bag, UPC 898392-007796 and 13.2 lb. (12 Plastic Bags in a cardboard box), UPC  01002467 ","Over 5500 total units for all products","Wilderness Family Naturals Organic Coconut Milk Powder and other products that contain this as an ingredient are being recalled  due to potential milk contamination.","03/16/2016",," Lot Numbers:    1000011556  1000011723  1000012520  1000012648  1000013015    Best By Dates:   10/31/2017  12/5/2017  5/4/2018  6/9/2018  9/1/2018",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73277,"Ongoing","NutraKey, Inc.","975 Bennett Dr",".","Longwood","FL","32750-6352","United States","Voluntary: Firm Initiated","E-Mail","Nationwide.","F-1040-2016","Class I","VPro Raw Plant Protein, Vanilla. Packaged in a plastic bottle with green, white, and black adhesive label.  Packaged in 1 lb (15 serving) and 2 lb (30 serving). ","Total product including all flavors: 17,730 total units","Undeclared Soy","04/06/2016",," VPro Chocolate 15 serving: UPC 820103309660, LOT VP007668 (EXP 02/2017)       VPro Chocolate 30 serving: UPC 820103309653, LOT VP005640 (EXP 10/2017) and LOT VP005681 (EXP 02/2018).",1/15/2016,"01/15/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73277,"Ongoing","NutraKey, Inc.","975 Bennett Dr",".","Longwood","FL","32750-6352","United States","Voluntary: Firm Initiated","E-Mail","Nationwide.","F-1038-2016","Class I","VPro Raw Plant Protein, Natural. Packaged in a plastic bottle with green, white, and black adhesive label.  Packaged in 2 lb (30 serving). ","Total product including all flavors: 17,730 total units","Undeclared Soy","04/06/2016",," UPC 820103456432, LOT VP004617 (EXP 07/2017) and LOT VP004688 (EXP 02/2018).",1/15/2016,"01/15/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73277,"Ongoing","NutraKey, Inc.","975 Bennett Dr",".","Longwood","FL","32750-6352","United States","Voluntary: Firm Initiated","E-Mail","Nationwide.","F-1039-2016","Class I","VPro Raw Plant Protein, Chocolate. Packaged in a plastic bottle with green, white, and black adhesive label.  Packaged in 1 lb (15 serving) and 2 lb (30 serving). ","Total product including all flavors: 17,730 total units","Undeclared Soy","04/06/2016",," VPro Chocolate 15 serving: UPC 820103309776, LOT VP004341 (EXP 12/2016) and LOT VP125703 (EXP 02/2018).      VPro Chocolate 30 serving: UPC 820103309769, LOT VP007668 (EXP 12/2017).",1/15/2016,"01/15/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73277,"Ongoing","NutraKey, Inc.","975 Bennett Dr",".","Longwood","FL","32750-6352","United States","Voluntary: Firm Initiated","E-Mail","Nationwide.","F-1037-2016","Class I","VPro Raw Plant Protein, Mocaccino. Packaged in a plastic bottle with green, white, and black adhesive label.  Packaged in 1 lb (15 serving) and 2 lb (30 serving). ","Total product including all flavors: 17,730 total units","Undeclared Soy","04/06/2016",," VPro Mocha 15 serving: UPC 820103979917, LOT VP006956, EXP 12/2016.      VPro Mocha 30 serving: UPC 820103456456, LOT VP006336 (EXP 10/2016), LOT VP241708 (EXP 02/2018).",1/15/2016,"01/15/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73278,"Ongoing","Dawn's Foods, Inc.","1530 La Dawn Dr",,"Portage","WI","53901-8823","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","F-0749-2016","Class I","Dawn's Deviled Egg Potato Salad, Net Wt. 15 oz. (397g), UPC 32345-10107. Keep Refrigerated.","2424 units","Dawn's Foods is recalling Dawn's Deluxe Potato Salad and Dawn's Deviled Egg Potato Salad due to mis-labeling and potential undeclared milk, wheat and soy.  Some containers labeled as Dawn's Deluxe Potato Salad may inadvertently contain Dawn's Deviled Egg Potato Salad, which contains soy and wheat.  Some containers of Dawn's Deviled Egg Potato Salad may inadvertently contain Dawn's Deluxe Macaroni ","03/15/2016",," Expiration Date:  3/15/16",2/8/2016,"02/08/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73278,"Ongoing","Dawn's Foods, Inc.","1530 La Dawn Dr",,"Portage","WI","53901-8823","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","F-0750-2016","Class II","Dawn's Deluxe Potato Salad, Net Wt. 15 oz. (425g), UPC 32345-10015. Keep Refrigerated.","720 units","Dawn's Foods is recalling Dawn's Deluxe Potato Salad and Dawn's Deviled Egg Potato Salad due to mis-labeling and potential undeclared milk, wheat and soy.  Some containers labeled as Dawn's Deluxe Potato Salad may inadvertently contain Dawn's Deviled Egg Potato Salad, which contains soy and wheat.  Some containers of Dawn's Deviled Egg Potato Salad may inadvertently contain Dawn's Deluxe Macaroni ","03/15/2016",," Expiration Date:  3/13/16",2/8/2016,"02/08/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73279,"Ongoing","Cary's of Oregon LLC","413 Union Ave",,"Grants Pass","OR","97527-5541","United States","Voluntary: Firm Initiated","Letter","distributed in AK, AZ, CA, CO, ID, IL, MA, MT, NE, NV, NY, OR, and WA.","F-0715-2016","Class II","Carys Dark Chocolate Almond Toffee with Hawaiian Salt.  Product is packaged in printed cardboard packages in 1.3 oz ,  4 oz, and 8 oz sizes. There are 12 packages per case.    UPC 8 31617 00515, net wt. 1.3 oz.  UPC 8 31617 00504, net wt. 4 oz.  UPC 8 31617 00580, net wt. 8 oz.","613 cases of 1.3oz, 3,231 cases of 4oz, 247 cases of 8oz.","Carys Dark Chocolate Almond Toffee with Hawaiian Salt is recalled because lecithin is declared in the ingredients statement but the Contains statement does not declare soy.","03/04/2016",," Best By dates starting 2.01.16 through 8.01.16.",2/11/2016,"02/11/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73280,"Ongoing","DEOLEO USA, Inc.","10700 North Freeway","Suite 800","Houston","TX","77037","United States","Voluntary: Firm Initiated","Letter","Throughout the US in the following states: MA, OH, WI, IN, MS, AR, OK, MO, AZ, AL, NM, TX, FL, IA, ME, IL, VA, NY, PA, GA","F-0736-2016","Class III","Bertolli Extra Virgin Olive Oil, 8.5 oz. and Carapelli Extra Virgin Olive Oil, 25.5 oz., packaged in glass bottles.","2,154 cases","The product is being recalled due to the detection of trace amounts of two pesticides, Trifloxystrobin and Tebuconazole, that do not have a tolerance in the US for olive oil. ","03/08/2016",," 5251R, 5351R, 5551R",2/12/2016,"02/12/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73281,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to Ohio only.","Z-1316-2016","Class II","evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim  A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur","539.156","eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.","04/04/2016",," All in distribution. ",2/10/2016,"02/10/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73281,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to Ohio only.","Z-1317-2016","Class II","eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima  A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur","539.156","eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.","04/04/2016",," All in distribution. ",2/10/2016,"02/10/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73282,"Ongoing","Urban Oven, LLC","2431 N Arizona Ave Suite 4",,"Chandler","AZ","85225-1376","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, AZ, WA, TX, OR, UT, IL  No foreign distribution.","F-0743-2016","Class II","Urban Oven   Artisan-Baked Short Bread Cookies  Cocoa  All Natural  NET Wt. 5 oz.    UPC Code: 7 18122 06354 3  SKU #: C2000","99 cases","Urban Oven, LLC is recalling Urban Oven Butter Cookies, Cocoa Cookies, Pecan Cookies, and Lemon Pistachio Cookies because it does not declare milk on the label from the ingredient butter.","03/09/2016",," LOT NUMBER  21616  21616  30416  30616  30716  31616  32016  42116  42816  50516  50516  52016  52616  61816  62516  72717  70616  72416  81416  90416  100216  100616  102016  101916  110616  113016  111016  111716  111216  120116  120416  120716  120916  121116  10617  10717  11317  11417  11517  20217  ",2/9/2016,"02/09/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73282,"Ongoing","Urban Oven, LLC","2431 N Arizona Ave Suite 4",,"Chandler","AZ","85225-1376","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, AZ, WA, TX, OR, UT, IL  No foreign distribution.","F-0745-2016","Class II","Urban Oven   Artisan-Baked Short Bread Cookies  Lemon Pistachio  All Natural  NET WT. 5 oz    UPC Code: 7 18122 06374 1  SKU #: C4000","286 cases","Urban Oven, LLC is recalling Urban Oven Butter Cookies, Cocoa Cookies, Pecan Cookies, and Lemon Pistachio Cookies because it does not declare milk on the label from the ingredient butter.","03/09/2016",," LOT NUMBER  21616  21616  30416  30616  30716  31616  32016  42116  42816  50516  50516  52016  52616  61816  62516  72717  70616  72416  81416  90416  100216  100616  102016  101916  110616  113016  111016  111716  111216  120116  120416  120716  120916  121116  10617  10717  11317  11417  11517  20217  ",2/9/2016,"02/09/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73282,"Ongoing","Urban Oven, LLC","2431 N Arizona Ave Suite 4",,"Chandler","AZ","85225-1376","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, AZ, WA, TX, OR, UT, IL  No foreign distribution.","F-0742-2016","Class II","Urban Oven   Artisan-Baked Short Bread Cookies  Classic Butter  All Natural  NET WT. 5 oz.    UPC Code: 7 18122 06344 4  SKU #: C1000","757 cases","Urban Oven, LLC is recalling Urban Oven Butter Cookies, Cocoa Cookies, Pecan Cookies, and Lemon Pistachio Cookies because it does not declare milk on the label from the ingredient butter.","03/09/2016",," LOT NUMBER  21616  21616  30416  30616  30716  31616  32016  42116  42816  50516  50516  52016  52616  61816  62516  72717  70616  72416  81416  90416  100216  100616  102016  101916  110616  113016  111016  111716  111216  120116  120416  120716  120916  121116  10617  10717  11317  11417  11517  20217  ",2/9/2016,"02/09/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73282,"Ongoing","Urban Oven, LLC","2431 N Arizona Ave Suite 4",,"Chandler","AZ","85225-1376","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, AZ, WA, TX, OR, UT, IL  No foreign distribution.","F-0744-2016","Class II","Urban Oven   Artisan-Baked Short Bread Cookies  Pecan   All Natural  NET. WT. 5 oz.    UPC Code: 7 18122 06364 2  SKU #: C3000","125 cases","Urban Oven, LLC is recalling Urban Oven Butter Cookies, Cocoa Cookies, Pecan Cookies, and Lemon Pistachio Cookies because it does not declare milk on the label from the ingredient butter.","03/09/2016",," LOT NUMBER  21616  21616  30416  30616  30716  31616  32016  42116  42816  50516  50516  52016  52616  61816  62516  72717  70616  72416  81416  90416  100216  100616  102016  101916  110616  113016  111016  111716  111216  120116  120416  120716  120916  121116  10617  10717  11317  11417  11517  20217  ",2/9/2016,"02/09/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73283,"Terminated","Focus Diagnostics Inc","11331 Valley View St",".","Cypress","CA","90630-5366","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of:  Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and  United Kingdom.","Z-1273-2016","Class II","Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)     Model Number: MOL2650, MOL1451, MOL1452, MOL1455","7421 units","Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.","04/01/2016","06/16/2016"," Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770,  160008, 160009, 160198, 160201, 160248, 160262.    Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.     3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.  		   ",2/10/2016,"02/10/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73283,"Terminated","Focus Diagnostics Inc","11331 Valley View St",".","Cypress","CA","90630-5366","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of:  Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and  United Kingdom.","Z-1272-2016","Class I","Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)    Model Number: MOL2150, MOL1451, MOL1452, MOL1455","1845 units","Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.","04/01/2016","06/16/2016"," Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770,  160008, 160009, 160198, 160201, 160248, 160262.    Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.     3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.  		   ",2/10/2016,"02/10/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73283,"Terminated","Focus Diagnostics Inc","11331 Valley View St",".","Cypress","CA","90630-5366","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of:  Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and  United Kingdom.","Z-1274-2016","Class I","Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)     Model Number: MOL2850, MOL1451, MOL1452, MOL1455","41 units","Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.","04/01/2016","06/16/2016"," Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770,  160008, 160009, 160198, 160201, 160248, 160262.    Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.     3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.  		   ",2/10/2016,"02/10/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73284,"Ongoing","Keystone Laboratories Inc","1103 Kansas St",,"Memphis","TN","38106-1913","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada","D-0726-2016","Class II","Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN  38101-2026, UPC 0 70596 00422 5.","134 cases of 12 bottles/case","Microbial Contamination of a Non-Sterile Products:   The product had a positive Staphylococcus aureus test result.  ","02/22/2016",," Lot #: 9AD5",2/8/2016,"02/08/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73285,"Ongoing","Pfizer Inc","100 North Route 206",,"Peapack","NJ","07977","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0800-2016","Class III","Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18","63,636 plastic bottles","Labeling: Label Mix-Up","03/31/2016",," Lot #: R29364; Exp. 10/17    ",2/10/2016,"02/10/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73286,"Ongoing","Battle Creek Equipment Co.","702 S Reed Rd",,"Fremont","IN","46737-2098","United States","Voluntary: Firm Initiated","Letter","Distributed within the United States, Canada, Mexico, Puerto Rico and Columbia","Z-0349-2017","Class II","    Used for the temporary relief of joint and muscle pain.","99,060","Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.","11/03/2016",," Model F00055-055 Standard Thermophore Lot codes:    0552712, 0552812, 0552912, 0553012, 0553112, 0553212, 0553312, 0553412, 0553512 , 0553612, 0553712, 0553812, 0553912, 0554012, 0554112, 0554212, 0554312, 0554412, 0554512, 0554612, 0554712, 0554812, 0554912, 0555012, 0555112, 0555212, 0550112, 0550213, 0550313, 0550413, 0550513, 0550613, 0550713, 0550813, 0550913, 0551013, 0551113, 0551213, 0551313, 0551413, 0551513, 0551613, 0551713, 0551813, 0551913, 0552013, 0552113, 0552213, 0552313, 0552413, 0552513, 0552613, 0552713, 0552813, 0552913, 0553013, 0553113, 0553213, 0553313, 0553413, 0553513, 0553613, 0553713, 0553813, 0553913, 0554013, 0554113, 0554213, 0554313, 0554413, 0554513, 0554613, 0554713, 0554813, 0554913, 055013, 0555113, 0555213, 0550113, 0550214, 0550314, 0550414, 0550514, 0550614, 0550714, 0550814, 0550914, 0551014, 0551114     Model F00255-255 Standard Thermophore Plus Lot codes:  2552712, 2552812, 2552912, 2553012, 2553112, 2553212, 2553312, 2553412, 2553512, 2553612, 2553712, 2553812, 2553912, 2554012, 2554112, 2554212, 2554312, 2554412, 2554512, 2554612, 2554712, 2554812, 2554912, 2555012, 2555112, 2555212, 2550112, 2550213, 2550313, 2550413, 2550513, 2550613, 2550713, 2550813, 2550913, 2551013, 2551113, 2551213, 2551313, 2551413, 2551513, 2551613, 2551713, 2551813, 2551913, 2552013, 2552113, 2552213, 2552313, 2552413, 2552513, 2552613, 2552713, 2552813, 2552913, 2553013, 2553113, 2553213, 2553313, 2553413, 2553513, 2553613, 2553713, 2553813, 2553913, 2554013, 2554113, 2554213, 2554313, 2554413, 2554513, 2554613, 2554713, 2554813, 2554913, 2555013, 2555113, 2555213, 2550113, 2550214, 2550314, 2550414, 2550514, 2550614, 2550714, 2550814, 2550914, 2551014, 2551114    Model F80095-095 Standard CSA Thermophore Lot code:  0952712, 0952812, 0952912, 0953012, 0953112, 0953212, 0953312, 0953412, 0953512, 0953612, 0953712, 0953812, 0953912, 0954012, 0954112, 0954212, 0954312, 0954412, 0954512, 0954612, 0954712, 0954812, 0954912, 0955012, 0955112, 0955212, 0950112, 0950213, 0950313, 0950413, 0950513",9/15/2016,"09/15/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73287,"Ongoing","Faye's Texas Naturals","123 South Courthouse Square",,"Goliad","TX","77963","United States","Voluntary: Firm Initiated","Letter","TX, GA, WY, CA, CO, MA, NH, FL, NY, AZ, MT","F-0753-2016","Class II","Faye's Texas Naturals Chili Petin Corn Relish Net Wt. 10 oz./283.59 grams in glass jars; 123 S. Courthouse Square Goliad, Texas 77963 (361)645-3136 FAYESTEXASNATURALS.NET","1979 jars","pH for the products were not tested and recorded as required by acidified food regulation.","03/16/2016",," All lots",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73287,"Ongoing","Faye's Texas Naturals","123 South Courthouse Square",,"Goliad","TX","77963","United States","Voluntary: Firm Initiated","Letter","TX, GA, WY, CA, CO, MA, NH, FL, NY, AZ, MT","F-0754-2016","Class II","Faye's Texas Naturals Chili Petin Picante Caliente Net Wt. 16oz./452 grams in glass jars; 123 S. Courthouse Square Goliad, Texas 77963 (361)645-3136 FAYESTEXASNATURALS.NET","1140 jars","pH for the products were not tested and recorded as required by acidified food regulation.","03/16/2016",," All lots.",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73287,"Ongoing","Faye's Texas Naturals","123 South Courthouse Square",,"Goliad","TX","77963","United States","Voluntary: Firm Initiated","Letter","TX, GA, WY, CA, CO, MA, NH, FL, NY, AZ, MT","F-0755-2016","Class II","Faye's Texas Naturals Chili Petin Pepper Sauce Net Wt. 2 fl. oz./.59 ml in glass jars; South Courthouse Square Goliad, Texas 77963 1-800-231-FAYE","65 bottles","pH for the products were not tested and recorded as required by acidified food regulation.","03/16/2016",," All lots",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73287,"Ongoing","Faye's Texas Naturals","123 South Courthouse Square",,"Goliad","TX","77963","United States","Voluntary: Firm Initiated","Letter","TX, GA, WY, CA, CO, MA, NH, FL, NY, AZ, MT","F-0752-2016","Class II","Faye's Texas Naturals Chili Petin Picante Muy Caliente Net Wt. 16 oz./452 grams in glass jars; 123 S. Courthouse Square Goliad, Texas 77963 (361)645-3136 FAYESTEXASNATURALS.NET","816 jars","pH for the products were not tested and recorded as required by acidified food regulation.","03/16/2016",," all lots",2/12/2016,"02/12/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73288,"Terminated","American Red Cross Blood Services Tennessee Valley Region","2201 Charlotte Ave",,"Nashville","TN","37203-1817","United States","Voluntary: Firm Initiated","Other","California","B-0362-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom eligibility was inadequately determined, was distributed. ","03/22/2016","03/22/2016"," W201915194563",12/18/2015,"12/18/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73289,"Terminated","Innovative Blood Resources","100 N 84th St",,"Lincoln","NE","68505-3101","United States","Voluntary: Firm Initiated","FAX","Nebraska","B-0363-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor for whom eligibility was inadequately determined, was distributed.","03/22/2016","03/22/2016"," W087916801063",1/21/2016,"01/21/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73290,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9054","United States","Voluntary: Firm Initiated","FAX","Florida","B-0361-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected within a year from a donor who lived in a malarial endemic area, was distributed.","03/22/2016","03/22/2016"," W036815701497",12/29/2015,"12/29/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73291,"Ongoing","Ingredion Incorporated","5 Westbrook Corporate Ctr Ste 5",,"Westchester","IL","60154-5749","United States","Voluntary: Firm Initiated","Telephone","The product was shipped to 2 U.S.  firm ins: Cereal Ingredients Inc. 4720 S. 13th St, Leavenworth Kansas, 606048 and Rohtstein Corp, Walnut Hill Station, 70 Olympia Ave, Woburn, Mashachusetts. The product was also distributed to foreign firms, please see attached documents.","F-0741-2016","Class II","Cornstach packaged in a 50lb. bag with white and green label containing black lettering. ","1, 402, 243 lbs. of product. product was shipped in 50 lb. bags.","Food grade Cornstarch may contain metal fragments >1 mm in width and up to 50 mm in length. ","03/09/2016",," batch numbers: 2605354100, 2605361100, 2605361101, 2605362101, 260535365102, 2606012101, 2606013101.  ",2/9/2016,"02/09/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73292,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA","Z-1233-2016","Class II","cobas p 512 pre-analytical system    Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.","35 Units","Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.","03/23/2016",," Part numbers:05083435001 and 06268854001",2/23/2016,"02/23/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73293,"Ongoing","Ormco/Sybronendo","1332 S Lone Hill Ave",,"Glendora","CA","91740-5339","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH","Z-1083-2016","Class II","TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541    Intended to fill a endontontically obturated root canal treatment","5,568 units total (2,070 units in US)","Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3.  The products outer package is identified as SM3 which matches the product inside.","03/08/2016",," GE15011637",2/8/2016,"02/08/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73294,"Ongoing","R&D Technical Center","5126 W Terrace Dr Ste 100",,"Madison","WI","53718-8346","United States","Voluntary: Firm Initiated","E-Mail","MD, MI, MN, NJ, and TX.  Outside the US to include:  Canada","F-0740-2016","Class I","Clasen Quality Coatings NH Atlas 1M Creamy Peanut Drop, Item # 12649, Net Wt. 50 lbs (22.68 KG)","41,200 lbs.  (824 boxes)","Clasen Quality Coatings received notification of a positive Listeria monocytogenes micro test in NH Atlas 1M Creamy Peanut Drop.","03/09/2016",," Lot # 5364PB11CL3  DOM:  12/30/2015",2/10/2016,"02/10/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73295,"Ongoing","Virtus Pharmaceuticals, Llc","2649 Causeway Center Dr",".","Tampa","FL","33619-6102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0801-2016","Class III","VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305","688 bottles ( 20,640 softgel capsules)","Defective Delivery System: Product may contain leaking capsules.","04/01/2016",," Lot #21506132; Exp. 05/17",12/17/2015,"12/17/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73296,"Ongoing","Dollar Only Wholesale","14358 N Frank Lloyd Wright Blvd Ste 5",,"Scottsdale","AZ","85260-8845","United States","Voluntary: Firm Initiated","Letter","US: MN, MI, PA","F-0639-2016","Class II","8pk Strawberry Waffy Wafers, Global Brands item UPC 876274000806  BB 8/14/16 20142nj, BB 10/27/16 20145nj  ","12,547 cases","Dollar Only Wholesale is recalling Strawberry Wafers because it may contain undeclared FD&C Red#3 and Yellow#6.","03/09/2016",," 20142nj BB 8/4/16, 20145nj BB10/27/16",2/12/2016,"02/12/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73297,"Ongoing","Pharmakon Pharmaceuticals","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Telephone","IN and IL","D-0871-2016","Class I","Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride,  Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.","75 Syringes","Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.    ","05/25/2016",," Lot #: E52418EV11C, Exp 03/19/2016",2/11/2016,"02/11/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73298,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.","Z-1046-2016","Class II","M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093","9 units","Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis.  single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended.  Offset, and the device is an extended offset stem.","03/04/2016",," Item: 00-7711-012-20, Lot: 62937093",2/11/2016,"02/11/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73299,"Terminated","Hoxworth Blood Center","PO Box 67005","3130 Highland Ave Ml#0055","Cincinnati","OH","45267-0001","United States","Voluntary: Firm Initiated","Telephone","Kentucky","B-0358-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood product, collected from a donor whose suitability to donate were not adequately determined, were distributed.","03/17/2016","03/17/2016"," W037715067674; W037715067674; ",12/7/2015,"12/07/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73300,"Terminated","Biotest Pharmaceuticals","4391 Colonial Blvd Ste 106",,"Fort Myers","FL","33966-1087","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0374-16","Class II","Source Plasma","1 unit","Source plasma product, in quarantine pending post donation investigation regarding prior incarceration, was distributed.","03/24/2016","03/24/2016"," 0011352373 ",12/15/2015,"12/15/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73301,"Ongoing","Genzyme Corporation","500 Kendall Street","675 West Kendall/55 Cambridge Parkway","Cambridge","MA","02142-1108","United States","Voluntary: Firm Initiated","Telephone","Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.","D-0730-2016","Class II","Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.","4669 Cartons","Presence of Particulate Matter: Glass particles found in the product after reconstitution.","02/26/2016",," Lot #s: E4029Y03, E4029Y04, E4029Y06, E4029Y07, Exp 12/2017",2/16/2016,"02/16/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73301,"Ongoing","Genzyme Corporation","500 Kendall Street","675 West Kendall/55 Cambridge Parkway","Cambridge","MA","02142-1108","United States","Voluntary: Firm Initiated","Telephone","Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.","D-0729-2016","Class II","Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only,  Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.    ","27,022 vials","Presence of Particulate Matter: Glass particles found in the product after reconstitution.","02/26/2016",," Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016",2/16/2016,"02/16/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73302,"Ongoing","King Henry's, Inc.","29124 Hancock Pkwy",,"Valencia","CA","91355","United States","Voluntary: Firm Initiated","Letter","US: AL, AZ, CA, NC, TX, FL, GA, SC, ID, IL, LA, MI, NC, NE, MS, NV, NY, OR, Puerto Rico, TN, UT, VA, WA, WI, VT    Non US: British Columbia","F-0774-2016","Class II","Fruit & Nut Medley, Snacks Fit for a King, King Size, 12 per case.  NP- UPC 61054645419 and 61054645119.","3,242 units","King Henry is recalling Fruit and Nut Medley because it may contain undeclared FD&C Yellow #6.","03/18/2016",," LOT numbers-   2142016  2192016  2282016  3032016  3152016  3292016  4142016  4272016  8032016  8172016  8092016  8252016  9092016  10072016  10142016  10202016  10292016  11032016      ",2/15/2016,"02/15/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73303,"Terminated","Medtronic Navigation, Inc.","300 Foster St",,"Littleton","MA","01460-2017","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution to Austria only.","Z-1088-2016","Class II","Medtronic 0-arm 02 Imaging System  Catalog Number: Bl-700-02000  The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.    The O-arm O2 Imaging System is compatible with certain image guided surgery systems.  ","1 unit","Screws holding the detector panel in as a result  the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality","03/08/2016","03/10/2016"," Serial Number: C0936",1/29/2016,"01/29/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0742-2016","Class II","Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0754-2016","Class II","Morphine Sulfate 1.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","2 syringes","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0750-2016","Class II","Hydromorphone HCL 25 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0743-2016","Class II","Morphine Sulfate 0.6 mg/ml, vol. 200 ml syringe, Rx only,   Hartley Med Ctr Pharmacy, Long Beach, CA","2 syringes","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0737-2016","Class II","Baclofen 5000 mcg/ml, vol. 20 ml syringe, Rx only,   Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0744-2016","Class II","Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0749-2016","Class II","Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml, vol. 20 ml syringe Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0748-2016","Class II","Baclofen 2000 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0751-2016","Class II","Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0738-2016","Class II","Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0756-2016","Class II","Hydromorphone HCL 1 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","2 syringes","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0741-2016","Class II","Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml, vol. 20 ml vial, Rx only,   Hartley Med Ctr Pharmacy, Long Beach, CA","1 vial","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0763-2016","Class II","Morphine Sulfate 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0759-2016","Class II","Morphine Sulfate 11 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0758-2016","Class II","Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0764-2016","Class II","Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only,  Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0753-2016","Class II","Hydromorphone HCL 2 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0740-2016","Class II","Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml, vol. 20 ml, syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0747-2016","Class II","Morphine Sulfate 10 mg/ml, vol. 20 ml syringe, Rx only,   Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0736-2016","Class II","Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0739-2016","Class II","Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0762-2016","Class II","Morphine Sulfate 20 mg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0765-2016","Class II","Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0760-2016","Class II","Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml,  vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0755-2016","Class II","Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/  Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0745-2016","Class II","Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0761-2016","Class II","Sufentanil Cit 200 mcg/ml/Clonidine HCL 1600 mcg/ml, vol. 42 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0752-2016","Class II","Hydromorphone HCL 10 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0746-2016","Class II","Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml,   vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73304,"Ongoing","Hartley Medical Center Pharmacy, Incorporated","113 W Victoria St",,"Long Beach","CA","90805-2162","United States","Voluntary: Firm Initiated","Telephone","Nationwide. No foreign distribution.","D-0757-2016","Class II","Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml,   vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA","1 syringe","Lack of Assurance of Sterility","03/04/2016",," BUD: 5/3/2016",2/4/2016,"02/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73305,"Ongoing","Pastry Food Products Inc.","932 Calle Eider","1ra Ext Country Club","San Juan","PR","00924-2339","United States","Voluntary: Firm Initiated","Visit","Puerto Rico only.","F-1101-2016","Class II","TRIGAL*** Empanadillas Sabor a Carne (meat flavored turnovers)***Peso neto 3 lbs (Net Weight 3 pounds)*** Pqte. de 12 (12 units package)***Pastry Foods Inc. Rio Piedras PR "," 20 packets/24 units each","Undeclared Food Allergens: yellow #5, soy protein","04/29/2016",," Lot code 21/07/2016",2/15/2016,"02/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73305,"Ongoing","Pastry Food Products Inc.","932 Calle Eider","1ra Ext Country Club","San Juan","PR","00924-2339","United States","Voluntary: Firm Initiated","Visit","Puerto Rico only.","F-1102-2016","Class II","Rellenos de Papa (meat flavored potato balls): This product is distributed without label.","78 boxes/20 units ea","Undeclared Food Allergens: yellow #5, soy protein, and sodium bisulfite","04/29/2016",," Lot code 21/07/2016	",2/15/2016,"02/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73305,"Ongoing","Pastry Food Products Inc.","932 Calle Eider","1ra Ext Country Club","San Juan","PR","00924-2339","United States","Voluntary: Firm Initiated","Visit","Puerto Rico only.","F-1103-2016","Class II","Trigal***Arepas de Coco (Coconut Flavored Arepas)***Mant¿ngase refrigerado (Keep refrigerated)***Peso Neto 1.12 lb (509 g)***Paquete de 12 (12 units package)***Manufacturado Por (Manufactured by): Pastry Foods Inc.","8 packets/12 units each","Undeclared Food Allergens: Sodium metabisulfite","04/29/2016",," Lot code 21/07/2016",2/15/2016,"02/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73306,"Terminated","Forever Cheese","3636 33rd St Ste 307",,"Astoria","NY","11106-2329","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","California, Ohio, Pennsylvania, New York, Colorado, Vermont, Virginia, Florida and Connecticut","F-2624-2016","Class I","Mitica brand PECORINO AGED IN WALNUTS LEAVES (PECORINO FOGLIE di NOCI), SEMI-HARD SHEEP'S MILK CHEESE, Minimum Weight 2 lbs. -- Product of Romagna - Italy --- Imported by Forever Cheese, L.I.C., NY 11106 --- There are 2 wheels of cheese per shipping case.","31 cases (80 wheels)","The Mitica brand Aged Pecorino Cheese may be contaminated with Listeria monocytogenes based on private laboratory testing.","09/30/2016","09/30/2016"," Production Code NOC15313 (found on shipping case only),  invoiced as Lot X2537 ",2/8/2016,"02/08/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73307,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including Puerto Rico and to the states of : AR, CA, CO, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA and WI.","Z-0888-2016","Class II","Mammomat Inspiration with Tomosynthesis functionality","76 units","A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, reconstruction of the data will be aborted. The syste","02/25/2016",," Model number: 10140000",2/12/2016,"02/12/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73308,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Buffalo","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.","Z-1026-2016","Class II","Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and  Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant","Domestic: 406 units ","Complaints were received claiming the material failed to polymerize under the curing light.  After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear.  This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.","02/29/2016",," REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020 all lots)  ",2/12/2016,"02/12/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73309,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","Press Release","NY, FL","F-1709-2016","Class I","Pecorino Aged in Walnut Leaves Mitica, PLU 0294239, Whole Foods, 95 Houston St. New York, NY 10002 wrapped in plastic wrap; Pecorino Aged in Walnut Leaves Product of Italy, PLU 290107, Dist. by Whole Foods Market 50 Bowie Street Austin, TX 78703, wrapped in plastic wrap.,","Approximately 12 pounds","Product has the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Sell by dates: 03/03/16 through 03/08/16 and 02/29/16 through 03/08/16",2/16/2016,"02/16/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73310,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","North Carolina","B-0355-16","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.","03/17/2016","03/17/2016"," W038315023409; ",12/31/2015,"12/31/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73311,"Terminated","American National Red Cross Great Lakes Region","1800 E Grand River Ave",,"Lansing","MI","48912-2305","United States","Voluntary: Firm Initiated","FAX","Ohio; Michigan","B-0357-16","Class II","Apheresis Platelets, Leukocytes Reduced","3 units","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.","03/17/2016","03/17/2016"," W201815819081; W201815819081; W201815819081; ",12/29/2015,"12/29/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73311,"Terminated","American National Red Cross Great Lakes Region","1800 E Grand River Ave",,"Lansing","MI","48912-2305","United States","Voluntary: Firm Initiated","FAX","Ohio; Michigan","B-0356-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed.","03/17/2016","03/17/2016"," W201815819087; ",12/29/2015,"12/29/2015",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73312,"Terminated","Department of Army US Army Blood Bank Center","2250 761st Tank Battallion Avenue",,"Fort Hood","TX","76544","United States","Voluntary: Firm Initiated","FAX","PA, CA","B-0384-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","03/31/2016","03/31/2016"," W012013200343; W012015200028",12/8/2015,"12/08/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73312,"Terminated","Department of Army US Army Blood Bank Center","2250 761st Tank Battallion Avenue",,"Fort Hood","TX","76544","United States","Voluntary: Firm Initiated","FAX","PA, CA","B-0383-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","03/31/2016","03/31/2016"," W012013002629",12/8/2015,"12/08/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73312,"Terminated","Department of Army US Army Blood Bank Center","2250 761st Tank Battallion Avenue",,"Fort Hood","TX","76544","United States","Voluntary: Firm Initiated","FAX","PA, CA","B-0382-16","Class II","Red Blood Cells","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","03/31/2016","03/31/2016"," W012013002629",12/8/2015,"12/08/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73313,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide and Hong Kong","D-0727-2016","Class III","Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.","10,778 bags",".","02/24/2016",," Lot #: 56-853-FW, Exp 01AUG2017",2/2/2016,"02/02/2016",3/2/2016,"03/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73314,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","Letter","US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France,  Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Monaco, Netherlands, Philippines, Portugal,  Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela.","Z-1191-2016","Class II","da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary  anastomosis during cardiac revascularization.    ","542  (351 SCC Touchpads and 191 PSC touchpads)",,"03/18/2016",," Model # M187505-04 - IS3000/IS4000 SCC Touchpad:  IS4000 PSC Touchpad.  Serial numbers:  SH2188  SK0391  SK0392  SK0454  SK0569  SK0577  SK0583  SK0613  SK0686  USG642  SK0482  SH0034  SH2321  SK0321  SK0426  SK0566  SK0603  SK0614  SH2312  SH2338  SH2339  SH2341  SH2344  SH2360  SH2361  SH2362  SH0948  SH1104  SH2240  SK0648  SH2328  SH2329  SH2337  SH2342  SH2346  SH2350  SH2351  SH2352  SH2356  SH2363  SH2364  SH2365  SK0329  SK0588  SK0591  SK0428  SK0429  SK0453  SH0607  SH2340  SK0503  SK0598  SH0280  SH2331  SH2333  SH2345  SK0479  SK0499  SK0528  SK0567  SK0568  SK0584  USG122  SK0563  SK0576  SH1228  SK0447  SK0530  SK0670  SH0329  SH0881  SH2347  SH2348  SH2349  SK0089  SK0336  SK0395  SK0421  SK0517  SK0592  SK0593  SK0595  SK0596  SK0597  SH1802  SH2332  SK0305  SK0367  SK0374  SK0386  SK0388  SK0411  SK0424  SK0431  SK0462  SK0472  SK0473  SK0481  SK0520  SK0526  SK0575  SK0581  SK0586  SK0624  SK0639  SK0647  SH2318  SK0529  SK0335  SK0507  SK0632  SH0416  SK0611  SH2354  SK0460  SK0497  SK0381  SH1869  SK0405  SK0475  SK0510  SK0658  SK0407  SK0413  SK0540  SK0564  SK0565  SK0582  SK0315  SK0501  SH2313  SK0515  SK0580  SK0217  SK0318  SK0322  SH1380  SH2323  SH2326  SH2327  SH2359  SK0562  RSH0020  SD0003  SD0004  SD0005  SH0074  SH0164  SH0272  SH0473  SH0741  SH0934  SH0938  SH1011  SH1350  SH1356  SH1378  SH1394  SH1522  SH1983  SH2311  SH2315  SH2316  SH2320  SK0240  SK0281  SK0285  SK0299  SK0300  SK0301  SK0307  SK0309  SK0314  SK0317  SK0320  SK0331  SK0338  SK0339  SK0340  SK0342  SK0343  SK0346  SK0349  SK0352  SK0360  SK0372  SK0375  SK0376  SK0382  SK0383  SK0384  SK0385  SK0389  SK0390  SK0398  SK0400  SK0401  SK0402  SK0406  SK0408  SK0409  SK0412  SK0414  SK0415  SK0416  SK0417  SK0418  SK0419  SK0420  SK0423  SK0425  SK0430  SK0432  SK0433  SK0434  SK0435  SK0436  SK0437  SK0438  SK0439  SK0440  SK0441  SK0443  SK0444  SK0445  SK0446  SK0448  SK0449  SK0452  SK0455  SK0456  SK0457  SK0458  SK0459  SK0463  SK0464  SK0466  SK0467  SK0468  SK0471  SK0477  SK0478  SK0480  SK0483  SK",2/16/2016,"02/16/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73315,"Ongoing","CareFusion 303, Inc.","10020 Pacific Mesa Blvd",,"San Diego","CA","92121-4386","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.","Z-1239-2016","Class II","Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092  ","170 units"," error code (120.4630).  ","03/24/2016",," Serial No.  4044845  9950535  4064411  12475162  4045659  9899143  3606478  4021398  4093501  4043745  4063430  4094994  9907675  9945292  9922622  4043375  12409069  4020663  12498854  4044531  4058193  12351849  4064030  9925068  12426138  4063830  4063911  9945269  ",2/12/2016,"02/12/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73316,"Ongoing","Nidek Inc","47651 Westinghouse Dr",,"Fremont","CA","94539-7474","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1245-2016","Class II","RT-5100 (Epic 5100) Refractor and RT 3100 Refractor:    Product Usage:  Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.      ","2703 separate serial numbers","There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.","03/24/2016",," serial numbers: See attached distribution list.  128 RT -3100 and 2565 RT-5100.",2/29/2016,"02/29/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73317,"Ongoing","Ventura Foods Calttn Hq Ap Bulk Oil","40 Pointe Dr",,"Brea","CA","92821-3652","United States","Voluntary: Firm Initiated","Letter","nationwide","F-0812-2016","Class II","45532-ATL	:	Atlantic Food Distributors Premium Clear Liquid Fry Shortening 35 lb.	;  45531-ATL	:	Atlantic Food Distributors Premium Creamy Liquid Fry Shortening 35 lb.	;  45531-CHP	:	Chef's Pride Creamy Liquid Fry Shortening 35 lb.	;  45531-UBA	:	Creamy Liquid Fry Shortening 35 lb.	;  45532-FAR	:	Frosty Acres Restaurant's Pride Clear Liquid Fry Shortening 35 lb.	;  45531-GOL	:	Golbon Creamy Liquid Fry Shortening 35 lb.	;  45532-NIF	:	NIFDA Clear Liquid Shortening 35 lb.	;  45531-NIF	:	NIFDA Creamy Liquid Shortening 35 lb.	;  45532-NGT	:	Nugget Brand Clear Liquid Frying Shortening 35 lb.	;  45532-PLF	:	Planet Fry Clear Liquid Fry Shortening 35 lb.	;  45532-POC	:	Pocahontas Clear Fry Liquid Shortening 35 lb.	;  45532-SSC	:	Smart Source Clear Liquid Fry Shortening 35 lb.	;  45531-SSC	:	Smart Source Creamy Liquid Fry Shortening 35 lb.	;  90101-COM	:	Sysco Classic Clear Canola Frying Shortening ZTF 35 lb.	;  15172-COM	:	Sysco Fry-One ZTF Clear Canola/Corn Frying Shortening 35 lb.	;  99880-COM	:	Sysco Reliance Clear Soybean Frying Shortening ZTF 35 lb.	;  99947-COM	:	Sysco Reliance Creamy Soybean Frying Shortening ZTF 35 lb.	;  45531-TXR	:	Texas Roadhouse Trans Fat Free Liquid Fry Shortening 35 lb.	;  ","84,708 cases, 12-35 lb. jugs per case","Ventura Foods is recalling various brands of cooking oil in 35 lb. jugs due to the presence of plastic. jug supplier reported that the manufacturing defect in the 35 lb. jugs was caused by the sealing surface trim possibly being pushed into the jug during the trimming process.","03/25/2016",," 45532-ATL	;  45531-ATL	;  45531-CHP	;  45531-UBA	;  45532-FAR	;  45531-GOL	;  45532-NIF	;  45531-NIF	;  45532-NGT	;  45532-PLF	;  45532-POC	;  45532-SSC	;  45531-SSC	;  90101-COM	;  15172-COM	;  99880-COM	;  99947-COM	;  45531-TXR	;    And Julian day codes (DDY): 226 through 406",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73317,"Ongoing","Ventura Foods Calttn Hq Ap Bulk Oil","40 Pointe Dr",,"Brea","CA","92821-3652","United States","Voluntary: Firm Initiated","Letter","nationwide","F-0815-2016","Class II","18168-BLN	:	Brilliance Clear Premium Frying Oil 35 lb.	;  16763-MFY	:	Mel-Fry Essential High Performance Liquid Frying Oil 35 lb.	;  16502-MFY	:	Mel-Fry Premium High Performance Liquid Frying Oil 35 lb.	;  ","3681 cases, 12-35 lb jugs/case","Ventura Foods is recalling various brands of cooking oil in 35 lb. jugs due to the presence of plastic. jug supplier reported that the manufacturing defect in the 35 lb. jugs was caused by the sealing surface trim possibly being pushed into the jug during the trimming process.","03/25/2016",," 18168-BLN	:  16763-MFY	:  16502-MFY	:      And Julian day codes (DDY): 226 through 406",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73317,"Ongoing","Ventura Foods Calttn Hq Ap Bulk Oil","40 Pointe Dr",,"Brea","CA","92821-3652","United States","Voluntary: Firm Initiated","Letter","nationwide","F-0814-2016","Class II","18159-BLN	:	Brilliance Clear Zero Premium Clear Canola Frying Oil 35 lb.	;  58503-CHP	:	Chef's Pride Canola Clear Fry Oil 35 lb.	;  58503-FLV	:	Flavorite Canola Clear Fry Oil 35 lb.	;  58503-PLF	:	Planet Fry Canola Clear Fry Oil 35 lb.	;  58503-NGT	:	Nugget Brand Canola Clear Fry Oil 35 lb.	;  ","3264 cases, 12-35 lb jugs/case","Ventura Foods is recalling various brands of cooking oil in 35 lb. jugs due to the presence of plastic. jug supplier reported that the manufacturing defect in the 35 lb. jugs was caused by the sealing surface trim possibly being pushed into the jug during the trimming process.","03/25/2016",," 18159-BLN  58503-CHP  58503-FLV  58503-PLF  58503-NGT      And Julian day codes (DDY): 226 through 406",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73317,"Ongoing","Ventura Foods Calttn Hq Ap Bulk Oil","40 Pointe Dr",,"Brea","CA","92821-3652","United States","Voluntary: Firm Initiated","Letter","nationwide","F-0813-2016","Class II","45532-CHP: Chef's Pride Soybean Clear Fry Oil 35 lb.;   54135-CHP: Chef's Pride Soybean Salad Oil 35 lb.;   45635-CHP: Chef's Pride Soybean Pan & Grill Frying Oil 35 lb.;   54135-TXR: Texas Roadhouse Soybean Salad Oil 35 lb.;   54135-PAD: Panda Express Soybean Salad Oil 35 lb.  ","9,072 cases, 12-35 lb jugs/case","Ventura Foods is recalling various brands of cooking oil in 35 lb. jugs due to the presence of plastic. jug supplier reported that the manufacturing defect in the 35 lb. jugs was caused by the sealing surface trim possibly being pushed into the jug during the trimming process.","03/25/2016",," 45532-CHP:   54135-CHP:   45635-CHP:   54135-TXR:   54135-PAD      And Julian day codes (DDY): 226 through 406",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73318,"Ongoing","Applied Medical Technology Inc","8000 Katherine Blvd",,"Brecksville","OH","44141-4202","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI.    Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.","Z-1608-2016","Class II","TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY   Product Usage:  Indicated to aid in tissue retraction during a surgical procedure.  ","5,334 units","The firm received a complaint of an open pouch which breaches the sterilization validation.","05/04/2016",," Part #: M0068201750;     Part #: M0068201761; ",2/17/2016,"02/17/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73318,"Ongoing","Applied Medical Technology Inc","8000 Katherine Blvd",,"Brecksville","OH","44141-4202","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI.    Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.","Z-1611-2016","Class II","Wilson Implantation System    Product Usage:  Indicated to aid in tissue retraction during a surgical procedure.  ","1,100 units","The firm received a complaint of an open pouch which breaches the sterilization validation.","05/04/2016",," Part #: TLC5042-M",2/17/2016,"02/17/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73318,"Ongoing","Applied Medical Technology Inc","8000 Katherine Blvd",,"Brecksville","OH","44141-4202","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI.    Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.","Z-1610-2016","Class II","Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize   Product Usage:  Indicated to aid in tissue retraction during a surgical procedure.  ","2,263 Units","The firm received a complaint of an open pouch which breaches the sterilization validation.","05/04/2016",," Part #: TLC5042 & TLC5042-I",2/17/2016,"02/17/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73318,"Ongoing","Applied Medical Technology Inc","8000 Katherine Blvd",,"Brecksville","OH","44141-4202","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI.    Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.","Z-1609-2016","Class II","TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize.  Product Usage:  Indicated to aid in tissue retraction during a surgical procedure.  ","3,754 Units","The firm received a complaint of an open pouch which breaches the sterilization validation.","05/04/2016",," Part #: TLC200 & TLC300",2/17/2016,"02/17/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73319,"Ongoing","Reily Foods Co.","640 Magazine St",,"New Orleans","LA","70130-3406","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-0735-2016","Class II","CARROLL SHELBY'S(R) ORIGINAL TEXAS BRAND White CHICKEN CHILI KIT, NET WT 3 OZ (85g), DIST. BY REILY FOODS COMPANY, NEW ORLEANS, LA 70130, UPC 7239610019","15518 Cases of 12 units","Cartons of Carroll Shelby White Chicken Chili (3oz retail carton) produced before 03/03/2015 state that the sodium per serving was 0 mg, the correct amount is 590 mg per serving.","03/08/2016",," 1501228101, BEST BY JAN 22 2017;   1501238101, BEST BY JAN 23 2017;   1502098101, BEST BY FEB 09 2017;   1503028101, BEST BY MAR 02 2017;  1503038101, BEST BY MAR 02 2017  ",2/17/2016,"02/17/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73320,"Ongoing","Peking Food LLC","47 Stewart Ave",".","Brooklyn","NY","11237-1517","United States","Voluntary: Firm Initiated","Press Release","New York, New Jersey, Connecticut, Massachusetts, Pennsylvania, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Kentucky, Ohio, Illinois, Michigan, Missouri, Alabama, Arkansas, Mississippi, Texas, and Puerto Rico.","F-0904-2016","Class I","Chef Hon brand STEAMED BUNS WITH SEAFOOD MARINATED IN XO-SAUCE, Net Wt. 1 lb. 8 oz. (682g), UPC 7 47518 00163 0, KEEP FROZEN --- Peking Food LLC Brooklyn, NY","40 cases","Undeclared eggs from component used in production of the finished product.   ","04/06/2016",," Lot numbers: 16021 (BEST BEFORE 01/21/17), 15348 (Best Before 12/14/16), 15337 (BEST BEFORE 12/3/16), 15271 (BEST BEFORE 9/28/16), 15240 (BEST BEFORE 8/28/16), 15176 (BEST BEFORE 6/25/16), and 15120 (BEST BEFORE 4/30/16).  -- The lot and BEST BEFORE code is printed on the front of the package.",2/18/2016,"02/18/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73320,"Ongoing","Peking Food LLC","47 Stewart Ave",".","Brooklyn","NY","11237-1517","United States","Voluntary: Firm Initiated","Press Release","New York, New Jersey, Connecticut, Massachusetts, Pennsylvania, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Kentucky, Ohio, Illinois, Michigan, Missouri, Alabama, Arkansas, Mississippi, Texas, and Puerto Rico.","F-0903-2016","Class I","Chef Hon brand STEAMED BUNS WITH SEAFOOD & VEGETABLE, Net Wt. 1 lb. 8 oz. (682g), UPC 7 47518 00156 2, Product Code # 69, KEEP FROZEN --- Peking Food LLC Brooklyn, NY","37 cases","Undeclared eggs from component used in production of the finished product.   ","04/06/2016",," Lot numbers: 16021 (BEST BEFORE 01/21/17), 15348 (Best Before 12/14/16), 15337 (BEST BEFORE 12/3/16), 15271 (BEST BEFORE 9/28/16), 15240 (BEST BEFORE 8/28/16), 15176 (BEST BEFORE 6/25/16), and 15120 (BEST BEFORE 4/30/16).  -- The lot and BEST BEFORE date is printed on the front of the package.",2/18/2016,"02/18/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73321,"Terminated","LifeSouth Community Blood Centers, Inc.","1221 NW 13th St",,"Gainesville","FL","32601-4111","United States","Voluntary: Firm Initiated","FAX","FL","B-0380-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood product, with a low pH, was distributed.","03/31/2016","03/31/2016"," W1151160209208",1/28/2016,"01/28/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73322,"Terminated","Bergen Comm Reg Blood Center","102 Chestnut Ridge Rd",,"Montvale","NJ","07645-1856","United States","Voluntary: Firm Initiated","FAX","NJ","B-0381-16","Class II","Red Blood Cells, Leukocytes Reduced","3 units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ","03/31/2016","03/31/2016"," W065615020916; W065615029138; W065615010283",2/1/2016,"02/01/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73324,"Ongoing","Amd Ritmed","1200 Av 55e",,"Lachine",,,"Canada","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and to the states of :  DE, FL, KY, MI, NE and NJ., and Internationally to the country of Canada.","Z-1251-2016","Class II","IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use     To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities","126 cases total (87 cases domestically and 39 cases internationally)","Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus. ","03/25/2016",," Lot 63927, expiration 2017-04",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73325,"Terminated","Northeast Laboratory Services, Inc.","227 China Rd",".","Winslow","ME","04901-0629","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1314-2016","Class II","NEL- GBS Medium (Broth  3 ml Fill 13 x 100 mm Screw Cap Tube  Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).","11720","Product marketed without a 510 (k)","04/01/2016","04/07/2016"," Al lot codes",12/21/2015,"12/21/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73325,"Terminated","Northeast Laboratory Services, Inc.","227 China Rd",".","Winslow","ME","04901-0629","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1313-2016","Class II","NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish)  Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).","9300","Product marketed without a 510 (k)","04/01/2016","04/07/2016"," Al lot codes",12/21/2015,"12/21/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73326,"Ongoing","Apace KY LLC","12954 Fountain Run Rd",".","Fountain Run","KY","42133-7914","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All product was shipped to KY and further distributed Nationwide","D-0811-2016","Class III","Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.","291 cartons","Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.","04/05/2016",," Outer Cases and Cartons Lot #: 13650, EXP 06/2017; Blisters Lot #: 13560, EXP 06/2017",2/12/2016,"02/12/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73327,"Ongoing","Maytag Dairy Farms Inc","2282 E 8th St N",,"Newton","IA","50208-8732","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed Nationwide.  There was no military, government, or foreign distribution.","F-1595-2016","Class I","Maytag Blue Cheese. Wedges and wheels are packaged in an aluminum foil wrapper and shipped in cardboard box. The wedges and wheels are packaged in the following sizes:     1) 4 LB. wheel, UPC 8 54089 00114 0;  2) 2 LB. wheel, UPC 8 54089 00112 6;  3) 1 oz. wedges, UPC 8 54089 00102 7;  4) 4 oz. wedges, UPC 8 54089 00104 1;  5) 8 oz. wedges, UPC  8 54089 00108 9;     Maytag Blue Cheese Crumbles are packaged in    6) 8 oz. plastic cups (UPC 8 54089 00183 6);  7) 5lb.bulk box (UPC 8 64089 00181 2)    The responsible name of the label and shipping box is Maytag Dairy Farms, Newton, IA 50208. ","30,254.77 lbs","Product is contaminated with Listeria monocytogenes.","06/28/2016",," Lots (wedges and wheels):  150479, 150480, 150481, 150482, 150484, 150485, 150486, 150488, 150489, 150492, 150493, 150495, 150498, 150499, 150500, 150501, 150506, 150508, 150509, 150514, 150515, 150516, 150517, 150518, 150532, 150533, 150534, 150535, 150538, 150539, 150648, 150649, 150650, 150651;    Batches (crumbles): 950804, 950805, 950806, 950807, 950808, 950809, 950813, 950818, 950825, 950830, 950848, 950826, 950849, 960053, 950851, 960067, 950853, 960068, 950855, 950856, 950858, 950859, 960001, 960002, 960004, 960025, 960034, 960036, 960051, 960055, 960065, 960066",2/12/2016,"02/12/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73328,"Ongoing","Michel Cordon Bleu Inc","3625 S Western Ave",,"Los Angeles","CA","90018-3826","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA.  No foreign distribution.","F-2151-2016","Class I","Michel Cordon Bleu, Inc.  Fresh Smoked Trout Plain, sold in various sizes","479.20 lbs. Total","Product is being recalled due to potential Clostridium botulinum contamination.","09/13/2016",," Lot #140936929  ",2/18/2016,"02/18/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73328,"Ongoing","Michel Cordon Bleu Inc","3625 S Western Ave",,"Los Angeles","CA","90018-3826","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA.  No foreign distribution.","F-2152-2016","Class I","Michel Cordon Bleu, Inc.  Fresh Smoked Trout With Herbs, sold in various sizes","479.20 lbs. Total","Product is being recalled due to potential Clostridium botulinum contamination.","09/13/2016",," Lot #140936929",2/18/2016,"02/18/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73329,"Terminated","CooperSurgical, Inc.","75 Corporate Dr",,"Trumbull","CT","06611-1350","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : OR and NY","Z-1054-2016","Class II","Milex Arcing Diaphragm Size 95; Model Number: MXWS95","2 units","The products have been identified to contain an incorrect size Diaphragm. ","03/04/2016","03/29/2016"," Lot# 130438",2/16/2016,"02/16/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73330,"Ongoing","Oak Haven, Inc dba Country Life Natural Foods.","641 52nd St",".","Pullman","MI","49450-9200","United States","Voluntary: Firm Initiated","Telephone","AR, CA, FL, IA, IL, IN, MI, MN, MO, OK, SC, SD, TN, and WI","F-1020-2016","Class I","Country Life Natural Foods Labeled SHELLED PISTACHIOS RAW NET WT. 2lb (906 g) plastic bags item 030244 and Batch 1357    batch number 1357 in the lower left corner of the label ","516 pounds","Country Life Natural foods shelled raw pistachios, sold in 2 lb bags and SAM International labeled 30lb boxes because it has the potential to be contaminated with Salmonella. ","04/07/2016",," Item 030244 with batch number 1357",2/18/2016,"02/18/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73330,"Ongoing","Oak Haven, Inc dba Country Life Natural Foods.","641 52nd St",".","Pullman","MI","49450-9200","United States","Voluntary: Firm Initiated","Telephone","AR, CA, FL, IA, IL, IN, MI, MN, MO, OK, SC, SD, TN, and WI","F-1030-2016","Class I","SAM International RAW WHOLE PISTACHIO 80%VP Labeled 30 pound box","516 pounds","Country Life Natural foods shelled raw pistachios, sold in 2 lb bags and SAM International labeled 30lb boxes because it has the potential to be contaminated with Salmonella. ","04/07/2016",," LOT# 102914",2/18/2016,"02/18/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73331,"Ongoing","D.S. Waugh","14 Bennett St",,"Lynn","MA","01905-3002","United States","Voluntary: Firm Initiated","Press Release","ME,MA,NH,VT,RI,CT,NY,NJ,PA,MV,DC,VA,NC,SC,OH, IL","F-0777-2016","Class I","Chappaqua Crunch Simply Granola with Blueberries & Bananas, in 13 ounce clear plastic pouch. UPC:7 86516 16007 9","3430 lb","Product may be contaminated with Salmonella. ","03/18/2016",," Best by dates Feb 5, 2016 through May 31, 2016. Best by dates are on the back of the plastic pouch. ",2/18/2016,"02/18/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73332,"Ongoing","J. Strickland and Co","10420 Desoto Rd",,"Olive Branch","MS","38654-5301","United States","Voluntary: Firm Initiated","Letter","Nationwide, Jamaica and Bahamas","D-0734-2016","Class III","sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654","1170 cases","Subpotent Drug: failed at the 3 and 6 month stability time points.","03/02/2016",," Lot #: 33UF",2/11/2016,"02/11/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73333,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US: Nationwide  OUS: Canada, Afghanistan  Albania  Algeria  Andorra  Argentina  Australia  Austria  Azerbaijan  Bahamas  Bangladesh  Belarus  Belgium  Bolivia  Bosnia and Herzegovina  Botswana  Brazil  Burkina Faso  Chile  China  Colombia  Columbia  Congo, Democratic  Costa Rica  Croatia  Cyprus  Czech Republic  Denmark  Dominican Republic  Ecuador  Egypt  Estonia  Ethiopia  Finland  France  Georgia  Germany  Ghana  Greece  Guadeloupe  Hong Kong  Hungary  Iceland  India  Indonesia  Iran  Iraq  Ireland  Israel  Italy  Japan  Jersey  Jordan  Kazakhstan  Kenya  Korea, Republic of  Kuwait  Kyrgyzstan  Latvia  Lebanon  Libya  Lithuania  Luxembourg  Malaysia  Malta  Martinique  Mauritius  Mexico  Monaco  Mongolia  Morocco  Mozambique  Nepal  Netherlands  New Caledonia  New Zealand  Norway  Oman  Pakistan  Palestinian territory, occupied  Panama  Papua New Guinea  Peru  Philippines  Poland  Portugal  Puerto Rico  Romania  Russian Federation  Rwanda  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sri Lanka  Sudan  Sweden  Switzerland  Syrian Arab Republic  Taiwan  Tanzania  Thailand  Tunisia  Turkey  Uganda  Ukraine  United Arab Emirates  United Kingdom  Venezuela  Viet Nam  Yemen  Zimbabwe","Z-1024-2016","Class II","SENSE Body Coil 1.5T with identification;  used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system","5672","Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.","02/26/2016",," 4522 131 5575x  4522 132 1985x  4522 132 7619x  4598 000 5187x  4598 000 5189x  4598 003 59051  ",7/6/2015,"07/06/2015",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73334,"Ongoing","Richard-Allan Scientific Company","4481 Campus Dr",".","Kalamazoo","MI","49008-2590","United States","Voluntary: Firm Initiated","Letter","Worldwide  distribution to AZ , CA , FL , GA ,  IL , MI , MN , NM , NY , OH , TX , UT and Internationally to Germany and the United Kingdom.    6 distributed to OUS accounts: Germany, and the United Kingdom","Z-1319-2016","Class III"," Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place","29 cases (10 bags per case)","Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside.","04/04/2016",," Product code: 8335 and lot code: 348248",2/16/2016,"02/16/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73335,"Ongoing","ConAgra Foods Inc","1 Conagra Dr",,"Omaha","NE","68102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, MI, OR and TN.    No distribution to schools or military.  No distribution outside the U.S.","F-0794-2016","Class II","    Product is blanched then frozen and placed in a plastic lined cardboard box.    UPC 1 06 81241 05167 8","3298 cs - 20lbs/cs","ConAgra is recalling one lot of Watts Bros Super Sweet Cut Corn bulk packed, due to the potential to be contaminated with Listeria monocytogenes.","03/23/2016",," Lot code on package P: 2015. 12. 05.  Manufacturing date December 5, 2015.  Expiration date December 5, 2017 (E: 2017. 12. 05).  ",2/18/2016,"02/18/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0787-2016","Class II","Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47    "," 3 bottles","Lack of Assurance of Sterility","03/29/2016",," Lot #: 012516, 020516",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0792-2016","Class II","Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78","4 bottles","Lack of Assurance of Sterility","03/29/2016",," Lot #: 012216, 012616, 012816, 020316, 020616;",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0794-2016","Class II","Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only,  Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33","2 bottles","Lack of Assurance of Sterility","03/29/2016",," Lot #: 012116, 012516",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0793-2016","Class II","Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09  ","22 bottles","Lack of Assurance of Sterility","03/29/2016",," Lot #: 112015, 112715, 113015,120515, 120715, 121215, 121515, 122115, 010516, 010716, 010816, 011116, 012016, 012816, 012916, 020316, 020416, 020516.  ",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0797-2016","Class II","Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54","1 bottle","Lack of Assurance of Sterility","03/29/2016",," Lot #: 020216",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0795-2016","Class II","Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47    ","1 bottle","Lack of Assurance of Sterility","03/29/2016",," Lot #: 012116, #012516",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0790-2016","Class II","Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92    ","1 bottle","Lack of Assurance of Sterility","03/29/2016",," Lot #012516",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0789-2016","Class II","Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706","3 bottles","Lack of Assurance of Sterility","03/29/2016",," Lot #: 012516",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0798-2016","Class II","Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60","1 bottle","Lack of Assurance of Sterility","03/29/2016",," Lot #: 020216",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0796-2016","Class II","Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61   ","5 bottles","Lack of Assurance of Sterility","03/29/2016",," Lot #: 020216",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0791-2016","Class II","Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35","2 bottles","Lack of Assurance of Sterility","03/29/2016",," Lot #: 020316 and 011216 ",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0786-2016","Class II","Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA  610-435-4706, NDC 99999-9999-69 / 89999-9001-04","4 bottles","Lack of Assurance of Sterility","03/29/2016",," Lot #: 012216, 012816, 012616, 020616",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73336,"Ongoing","Walter's Pharmacy","401 N 17th St",,"Allentown","PA","18104-5034","United States","Voluntary: Firm Initiated","Telephone","PA","D-0788-2016","Class II","Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99","5 bottles ","Lack of Assurance of Sterility","03/29/2016",," Lot #: 010516, 012016",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73337,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: FL, NJ, AZ, and NC.","Z-1234-2016","Class II","BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization    The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System. ","4","Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.  ","03/23/2016",," The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010.",2/22/2016,"02/22/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73338,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV.  Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-1354-2016","Class II","Ingenuity Core Computed Tomography X-ray Systems,    Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes","88","The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.","04/08/2016",," Model No. 728321; S/N: 31001, 52000, 52012, 52015, 52018, 52020, 52022, 52030, 52031, 52044, 52050, 52063, 310001, 310022, 310023, 310026, 310032, 310039, 310065, 310077, 310078, 310096, 310102, 310105, 310115, 310125, 310133, 310135, 310157, 310160, 310164, 310209, 310210, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310236, 310237, 310238, 310239, 310240, 310241, 310242, 310243, 310245, 310246, 310247, 310248, 310249, 310250, 310252, 310253, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310279, 310280, 310281, 310282, 310283, 310284, 310285, 310287, 310288, 310289, 310290, 310291, 310292, 333002, 333005, 333008, 333010, 333015, 333018, 333021, 333042, 333043, 333051, 333060, 333061, 333064, 333106, 333107, 333108, 333109, 333110, 333112, 333114, 333115, 333116, 333117, 333121, 52062, 52066, 52080, 52081 52082, 52083, 52084, 310286, 333004, 333111, 333113, 333118, 333119 & 333120.",2/5/2016,"02/05/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73338,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV.  Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-1353-2016","Class II","Brilliance iCT SP Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes","49 Units","The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.","04/08/2016",," Model No. 728311; S/N: 200011, 200013, 200017, 200022, 200027, 200030, 200032, 200038, 200040, 200047, 200049, 200051, 200061, 200063, 200067, 200068, 200074, 200088, 200093, 200097, 200100, 200101, 200105, 200107, 200109, 200111, 200117, 200121, 200127, 200131, 200138, 200200, 200201, 200202, 200203, 200204, 200205, 200206, 200207, 200208, 200209, 200210 & 200211.",2/5/2016,"02/05/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73338,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV.  Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-1352-2016","Class II","Brilliance iCT Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes","324 uNITS","The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.","04/08/2016",," Model No. 728306; S/N: 85004, 85010, 85012, 85013, 85014, 85015, 85016, 85017, 85018, 85021, 85022, 85023, 85024, 85025, 85026, 85027, 85028, 85029,  85032, 85033, 85034, 85035, 85036, 85037, 85038, 85039, 85040,  85043, 85044, 85045, 85046, 85047, 85048, 85049, 85050, 85051, 85054, 85055, 85056, 85057, 85058, 85059, 85060, 85061, 85062, 85065, 85066, 85067, 85068, 85069, 85070, 100016, 100018, 100019, 100025, 100037, 100038, 100040, 100044, 100048, 100049, 100050, 100051, 100058, 100062, 100064, 100065, 100070, 100072, 100082, 100084, 100091, 100099, 100101, 100103, 100111, 100113, 100114, 100115, 100119, 100122, 100133, 100134, 100135, 100140, 100144, 100149, 100153, 100161, 100162, 100170, 100178, 100180, 100181, 100184, 100185, 100190, 100191, 100192, 100200, 100214, 100215, 100217, 100221, 100222, 100228, 100231, 100236, 100247, 100260, 100270, 100271, 100273, 100274, 100278, 100280, 100281, 100302, 100304, 100308, 100309, 100310, 100314, 100318, 100325, 100329, 100343, 100346, 100350, 100351, 100356, 100360, 100365, 100368, 100370, 100374, 100393, 100396, 100398, 100399, 100400, 100402, 100405, 100406,   100416, 100423, 100436, 100441, 100446, 100449, 100450, 100452, 100453, 100461, 100462, 100463, 100464, 100465, 100466, 100469, 100472, 100483, 100493, 100494, 100498, 100503, 100506, 100507, 100508, 100509, 100511, 100517, 100518, 100520, 100521, 100522, 100600, 100601, 100602, 100603, 100606, 100607, 100608, 100609, 100610, 100611, 100612, 100613, 100614, 100617, 100618, 100619, 100620, 100621, 100622, 100623, 100624, 100625, 100628, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100636, 100639, 100640, 100641, 100642, 100643, 100644, 100645, 100646, 100647, 100650, 100651, 100652, 100653, 100654, 100655, 100656, 100657, 100658, 100661, 100662, 100663, 100664, 100665, 100666, 100667, 100668, 100669, 100673, 100674, 100675, 100676, 100677, 100678, 100679, 100680, 100681,   100684, 100685, 100686, 100687, 100688, 100689, 100690, 100691, 100692, 100693, 100695, 100696, 100697, 100698, 100699, 10",2/5/2016,"02/05/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73338,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV.  Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-1351-2016","Class II","Brilliance 64:Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes","285 units","The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.","04/08/2016",," Model No. 728231; S/N: 1,  2, 4001, 9056, 9074, 9099, 9134, 9251, 9515, 9529, 9538, 9549, 9554, 9573, 9574, 9618,  9625, 9638, 9646, 9653, 9656, 9659, 9667, 9670, 9686, 9689, 9690, 9703, 9738, 9740,  9755,  9782, 9811, 9822, 9833, 9837, 9838, 9859, 9862, 9898, 9901, 9909, 9910, 9917, 9920, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 10021, 10024, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10180, 10189, 10193, 10206, 10206, 10208, 10213, 10250, 10253, 10299, 10379, 10394, 10422, 10670, 10671, 10677, 10678, 10683, 10684, 10685, 10695, 10698, 10794, 10799, 10803, 29002, 29014, 29056, 29070, 29107, 29115, 90100, 90124, 90150, 90154, 91003, 95022, 95024, 95100, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95258, 95261, 95333, 95351, 95364, 95387, 95399, 95410, 95473, 95475, 95496, 95504, 95507, 95512, 95524, 95551, 95563, 95614, 95616, 95668, 95688, 95691, 95703, 95704, 95705, 95706, 95707, 95708, 95709, 95710, 95711, 95713, 95716, 95717, 95718, 95720, 95721, 95722, 95723, 95724, 95725, 95726, 95727, 95728, 95729, 95730, 95731, 95732, 95733, 95734, 95735, 95736, 95737, 95738, 95739, 95740, 95741, 95742, 95744, 95745, 95746, 95747, 95748, 95749, 95750, 95751, 95752, 95753, 95754, 95755, 95756, 95757, 95758, 95759, 95760, 95761, 95762, 95764, 95765, 95766, 95767, 95769, 95770, 95772, 95773, 95774, 95775, 95776, 95777, 95778, 95779, 95780, 95781, 95786, 95787, 95788, 95789, 95790, 95791, 95794, 95795, 95797, 95798, 95799, 95800, 95801, 95802, 95803, 95804, 95805, 95806, 95807, 95808, 95809, 95810, 95811, 95812, 95813, 95815, 95817, 95821, 95824, 95830, 95831, 95832, 95834, 95835, 95837, 95842, 95843, 95845, 95849, 95852,  95853, 95854, 95855, 95857, 95864, 95869, 95874, 95876, 95877, 95881, 95886, 95900, 95901, 95902, 95903, 95904, 95906, 95907, 95910, 95911, 95912, 95915, 95916, 95917, 95918, 95919, 95922, 95924, 95925, 95927, 95928, 95929, 95930, 95934, 95938, 95940, 95941, 95942, 95944, 95946, 95341A, 123002 & 123029.",2/5/2016,"02/05/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73338,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV.  Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-1356-2016","Class II","Ingenuity CT Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes","82 Units","The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.","04/08/2016",," Model No. 728326; S/N: 30003, 30005, 30006, 30007, 30008, 30009, 30010, 30011, 30012, 30013, 30014, 30015, 30017, 30018, 30019, 30020, 30021, 30022, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 30044, 30045, 30046, 32083, 52051, 300004, 300015, 300033, 300037, 300038, 300045, 300054, 300057, 300066, 300068, 300072, 300081, 300082, 300084, 30008, 300091, 300107, 300109, 300120, 300122, 300141, 300142, 300149, 300150, 300156, 300157, 300207, 300208, 300209, 300210, 300211, 30004-1, 1, 3, 941055, 30047, 30049, 300146, 300212, 95742 & 941091.",2/5/2016,"02/05/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73338,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV.  Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-1355-2016","Class II","Ingenuity Core 128 Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes","174 Units","The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.","04/08/2016",," Model No. 728323; S/N: 30016, 30023, 30151, 30153, 32000, 32001, 32008, 32012, 32042, 32044, 32057, 32061, 32065, 32067, 32068, 32069, 32076, 32100, 32106, 32138, 32139, 32140, 32141, 32142, 32143, 32144, 32145, 32146, 32147, 32148, 32149, 32150, 32151, 32152, 32153, 32154, 32155, 32156, 32157, 32158, 32159, 32160, 32161, 32162,   32163, 32164, 32165, 32166, 32167, 52023, 52028, 52049, 320001, 320003, 320006, 320008, 320010, 320024, 320026, 320029, 320031, 320037, 320054, 320070, 320078 320090, 320092, 320107, 320202, 320207, 320224, 320225, 320226, 320227, 320228, 320229 320230, 320231,  320232, 320233, 320234, 320235, 320236, 320238, 320239, 320240, 320241, 320242, 320243, 320245, 320246, 320247, 320248, 320250, 320251, 320252, 320254, 320255, 320256, 320258, 336011, 336012, 336015, 336016, 336018, 336025, 336027, 336028, 336029, 336034, 336040, 336044, 336068, 336072, 336076, 336092, 336100, 336102, 336104, 336142, 336148, 336149, 336150, 336151, 336152, 336153, 336154, 336155, 336156, 336157, 336158, 336159, 336160, 336161, 336162, 336163, 336164, 336166, 336167, 336168, 336170, 336171, 336172, 336173, 336174, 336175, 336176, 336177, 336178, 336180, 336181, 336182, 336183, 336184, 336185, 336186, 336188, 336190, 336192, 336193, 336194, 30035, 320257, 333047, 336165, 336179, 336187, 336189, 336191, 336195, 336196, 336197, 336199 & 336200.",2/5/2016,"02/05/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73339,"Ongoing","Applied Medical Technology Inc","8000 Katherine Blvd",,"Brecksville","OH","44141-4202","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.","Z-1497-2016","Class II","AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE.  For use in patients who cannot absorb adequate nutrition through the stomach.","20 units","The firm received complaints that the product is shorter in length than indicated on the label.","04/14/2016",," Model #GJ-1415-45, Lot # 15104750, Exp Date: 2018/09",1/26/2016,"01/26/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73340,"Terminated","Figi's, Inc","3200 S Central Ave",,"Marshfield","WI","54449","United States","Voluntary: Firm Initiated","Press Release","Nationwide","F-1047-2016","Class I","Figi's Classic Marzipan, item 100-0034-200, 8 ounce","1422  units"," because the ingredients are not properly labeled and the product contains almonds.","04/08/2016","05/25/2016"," Codes:  5 190, 5 194, 5 253, 5 328.",1/27/2016,"01/27/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73341,"Completed","Sweetwater Farms LLC","158 Chisholm Rd",".","Inman","KS","67546-8506","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Arkansas, Kansas, and Oklahoma","F-1031-2016","Class I","Sweetwater Sprouts 100% Pure Sprouted Alfalfa packaged in the following configurations:     4 oz. plastic bags (UPC 7 56733 00104 2) packed 12 per case;  16 oz. (1 lb.) plastic bags;  and 5 lb. bulk boxes    The product is shipped in cardboard cases labeled with product and lot number. The responsible name on the label is Sweetwater Farms LLC, Inman, KS 67456.","3,828/4 oz/ bags; 639/1 lb./bags; 285/5 lb./cases (1881 lbs.)","Sprouts are potentially contaminated with Salmonella","04/05/2016",," lot 039016, sell by date 2/29/2016;   lot 042016, sell by date 3/3/2016;   lot 046016, sell by 3/7/2016;   and lot 053016, sell by 3/14/2016",2/19/2016,"02/19/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73341,"Completed","Sweetwater Farms LLC","158 Chisholm Rd",".","Inman","KS","67546-8506","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Arkansas, Kansas, and Oklahoma","F-1032-2016","Class I","Sweetwater Sprouts100% Pure Sprouted Clover packaged in plastic bags and shipped in cardboard cases labeled with product, Net Wt. 5 lb. and lot number. The responsible name on the label is Sweetwater Farms, Inman, KS 67546.","145/1 lb./cases  (725 lbs.)","Sprouts are potentially contaminated with Salmonella","04/05/2016",," lot 039016, sell by date 2/29/2016;   lot 046016, sell by 3/7/2016;   and lot 053016, sell by 3/14/2016",2/19/2016,"02/19/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73341,"Completed","Sweetwater Farms LLC","158 Chisholm Rd",".","Inman","KS","67546-8506","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Arkansas, Kansas, and Oklahoma","F-1033-2016","Class I","Sweetwater Sprouts 100% Pure Sprouted Mung Bean packaged in the following configurations:  8 oz. plastic bags packed 10 per case;  16 oz. plastic bags packed  in cases of 5 or 10;  5 lb. bulk case;  10 lb. bulk case.     The product is shipped in cardboard cases labeled with product and lot number. The responsible name on the label is Sweetwater Farms, Inman, KS 67546.","3900/ 8oz./bags; 2585/ 16 oz./bags; 454/5 lb./cases; 427/10 lb./cases (11,075 lbs.)","Sprouts are potentially contaminated with Salmonella","04/05/2016",," lot 039016, sell by  2/22/2016;   lot 040016, sell by 2/232016;  lot 041016, sell by  2/24/2016;  lot 042016, sell by  2/25/2016;  lot 043016, sell by 2/26/2016;  lot 044016, sell by 2/27/2016;  lot 046016, sell by 2/29/2016;  lot 047016, sell by 3/1/2016;  lot 048016, sell by 3/2/2016;  lot 050016, sell by 3/4/2016;  lot 051016, sell by 3/5/2016;   and lot 053016, sell by 3/7/2016",2/19/2016,"02/19/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73342,"Ongoing","Medical Park Homecare, Inc","139 Se Katherine Ave",,"Bartlesville","OK","74006-2316","United States","Voluntary: Firm Initiated","Telephone","U.S. Including: Oklahoma","D-0776-2016","Class III","Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only.  Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.","a) 289 M6-Tank Cylinders, b) 49 D-Tank Cylinders, c) 743 E-Tank Cylinders.","CGMP Deviations: Cylinders filled using out of date gauges.","03/15/2016",," a) Lot #'s: 202166, 202167, 202168, 120164, 120165, 120166, 112161, 112162, 107161, 1230151, 1212151, 1212152, 1212153, 1208154, 1208155, 1208156, 1204152, 1204153, 1203151, 1116156, 1112151, 1112152.  b) Lot #'s: 120164, 1212153, 1208154, 1204151, 1116156, 1112151.  c)  Lot #'s: 202161, 202162, 202163, 202164, 202165, 120161, 120162, 120163, 120164, 119161, 119162, 119163, 112163, 112164, 107162, 107163, 1230152, 1208151, 1208152, 1208153, 1204152, 1203152, 1203153, 1202151,  1202152, 1202153, 1125151, 1125152, 1116151, 1116152,  1116153, 1116154, 1116155, 1116156, 1112151, 1109151, 1109152, 1109153, 1109154, 1109155, 1109156, 1103151, 1103152, 1103153, 1103154, 1102151, 1102152, 1102153, 1102154.   ",2/5/2016,"02/05/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73343,"Ongoing","AcuFocus, Inc.","32 Discovery Ste 200",,"Irvine","CA","92618-3161","United States","Voluntary: Firm Initiated","Letter","International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.","Z-1235-2016","Class II","KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10    (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.    ","182 units","AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.","03/24/2016",," Lots A534-1014 and A535-1014",2/11/2016,"02/11/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73344,"Ongoing","Health Matters America, Inc.","2501 Broadway St",,"Cheektowaga","NY","14227-1042","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1126-2016","Class I","Organic traditions SPROUTED FLAX SEED POWDER, NET WT. 8 oz/227g, UPC 854260006261 --- The product is packed in a sealed flexible plastic bag.","359 units","The repacked product has the potential to be contaminated with Salmonella. ","04/22/2016",," Lots: AHM626151103 Exp. 09/2017, AHM626151229 Exp.10/2017 (lot located near UPC barcode on back of bag)",2/11/2016,"02/11/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73344,"Ongoing","Health Matters America, Inc.","2501 Broadway St",,"Cheektowaga","NY","14227-1042","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1127-2016","Class I","Organic traditions SPROUTED CHIA & FLAX SEED POWDER, NET WT. 8 oz./227g (UPC barcode 854260006216), and NET WT. 16oz./454g bag (UPC barcode 85426000547) --- The product is packed in a sealed flexible plastic bag.","293 units","The repacked product has the potential to be contaminated with Salmonella. ","04/22/2016",," 8 oz. (UPC barcode 854260006216) Lots AHM621151217 Exp. 10/2017; AHM621151229 Exp. 10/2017; 16 oz. (UPC barcode 854260005479) Lot AHM547151217 Exp. 10/2017 (lot located near UPC barcode on back of bag)",2/11/2016,"02/11/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73345,"Ongoing","Karl Bissinger, LLC","1600 N Broadway",,"Saint Louis","MO","63102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Shipped to nineteen retail accounts nationwide (Colorado, New Jersey, New Mexico, New York, Oregon, Utah, and Washington) and two direct consumer accounts (Missouri and New York). There was no military/government/foreign distribution.","F-1246-2016","Class III","Bissinger's Milk Chocolate Eggs packaged in 6.5 oz (UPC 846107009382) Item: #11108 or 1 lb. (UPC 846107003458) Item: # 111049 plastic bags.  Bissinger's Handcrafted Chocolatier, St. Louis, MO.","22-12 ct. case of 6.5 oz. bags of foil wrapped milk chocolate eggs and 2-1 lb. bags of foil wrapped milk chocolate eggs","The chocolate used in the product contains vanillin (an artificial ingredient) but is labeled to contain vanilla.","04/27/2016",," Bissingers 6.5 oz bag Milk Chocolate Foil Eggs  Lot Numbers: 2015-10209 & 2016-10967  Best By: 2/3/17 & 2/4/17  and  Bissingers 1 lb bag Milk Chocolate Foil Eggs  Lot Numbers: 2016-11057  Best By: 2/3/17  ",2/22/2016,"02/22/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73346,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0774-2016","Class II","Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.","30,891 Bottles","Failed Impurities/Degradation Specifications: Out of specification test results for impurities during stability testing.","03/11/2016",," Lot #: 13013.009A, Exp. 02/2016",2/5/2016,"02/05/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73347,"Ongoing","Fresh Creative Foods","3285 Corporate Vw",,"Vista","CA","92081-8528","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; TX.  No foreign distribution.","F-0816-2016","Class I","H-E-B Tartar Sauce  8 oz.  UPC: 41220 33244","1202 cases (14,424 units)","Fresh Creative Foods is recalling H-E-B Tartar Sauce because of undeclared fish from using the incorrect pre-printed label.","03/25/2016",," USE BY 04/19/2016  Lot Number#:  L0458791  L0458805  L0458854  L0458898  L0458949  L0458982  L0459008  L0459036",2/21/2016,"02/21/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73349,"Ongoing","Horiba Instruments Inc","9755 Research Dr",,"Irvine","CA","92618-4626","United States","Voluntary: Firm Initiated","Letter","USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.","Z-1553-2016","Class II","ABX Pentra 400 (version 5.0.8 or lower)    The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.","201","Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.                 ","04/22/2016",," All lot/serial #s",2/19/2016,"02/19/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73349,"Ongoing","Horiba Instruments Inc","9755 Research Dr",,"Irvine","CA","92618-4626","United States","Voluntary: Firm Initiated","Letter","USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.","Z-1554-2016","Class II","Pentra C400 (version 1.1.2 or lower)    The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.","201","Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.                 ","04/22/2016",," All lot/serial #s",2/19/2016,"02/19/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73350,"Terminated","NatureBox, Inc.","100 Redwood Shores Pkwy Fl 2",,"Redwood City","CA","94065-1155","United States","Voluntary: Firm Initiated","E-Mail","Direct consumers through mail order.","F-0756-2016","Class II","NatureBox Cinnamon Yogurt Mini Grahams, 6 oz. (170g) customer stand up pouches.    UPC 8 58590 00528 4    Ingredients: Graham Crackers (unbleached unenriched wheat flour, whole wheat graham flour, sugar, palm and palm kernel oil, molasses, honey, salt, sodium bicarbonate). Yogurt Coating (sugar, palm kernel and/or palm oil, whey powder, Dry nonfat yogurt, soy lecithin (an emulsifier) salt, vanilla extract) Cinnamon.    Contains:Wheat, Milk and Soy.    Packed in a facility that also processes tree nuts, peanuts, milk, wheat, egg, soy and fish.    Distributed by:  Nature Box  San Carlos, CA 94070","7419 x 6 oz. bags.","Third party warehouse discovered that they found bags of Cinnamon Yogurt Mini Graham products that were packaged in Probiotic Power Mix bags. Probiotic bags do not properly declare wheat as an allergen.","03/16/2016","03/18/2016"," Best by 10-12-16.",2/22/2016,"02/22/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73352,"Completed","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide, VA/govt/military","Z-1186-2016","Class II","Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz.   Device Listing E572259","1125 units","On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.","03/17/2016",," All Serial Numbers for  Item Number 16-02-81, 16-02-82, 16-02-85; ",8/15/2012,"08/15/2012",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73353,"Ongoing","Savory Foods, Inc.","900 Hynes Ave SW",,"Grand Rapids","MI","49507-1076","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: Jackson, MI; Toledo, OH; Grand Rapids, MI; Urbana, OH; Hudsonville, MI; Columbus, OH; Lansdale, PA; and Charlton, MA.    No Foreign or DOD/VA","F-2473-2016","Class I","1.5 oz PEANUT BUTTER COOKIES, 80/case","15 cases","Savory Foods Inc. has initiated a voluntary recall due to the potential for contamination with Listeria monocytogenes.","09/30/2016",," 1.5 oz PEANUT BUTTER COOKIES, 80/case; Product Code/Lot Code: 16033",2/11/2016,"02/11/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73353,"Ongoing","Savory Foods, Inc.","900 Hynes Ave SW",,"Grand Rapids","MI","49507-1076","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: Jackson, MI; Toledo, OH; Grand Rapids, MI; Urbana, OH; Hudsonville, MI; Columbus, OH; Lansdale, PA; and Charlton, MA.    No Foreign or DOD/VA","F-2472-2016","Class II","PRE-PORTION MASTER DOUGH (PEANUT BUTTER)- Raw cookie dough with 192 pucks/case","208 Cases","Savory Foods Inc. has initiated a voluntary recall due to the potential for contamination with Listeria monocytogenes.","09/30/2016",," PRE-PORTION MASTER DOUGH (PEANUT BUTTER)- Raw cookie dough with 192 pucks/case; Product Code/Lot Code: 16038",2/11/2016,"02/11/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73353,"Ongoing","Savory Foods, Inc.","900 Hynes Ave SW",,"Grand Rapids","MI","49507-1076","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: Jackson, MI; Toledo, OH; Grand Rapids, MI; Urbana, OH; Hudsonville, MI; Columbus, OH; Lansdale, PA; and Charlton, MA.    No Foreign or DOD/VA","F-2471-2016","Class I","CARAMEL CORN PEANUT BUTTER DELIGHT¿ CRYSTAL SHORT (18 oz..) & Tall (22 oz..)","15 units of 18 oz. tubs; and 16 units of 22 oz. tubs.","Savory Foods Inc. has initiated a voluntary recall due to the potential for contamination with Listeria monocytogenes.","09/30/2016",," CARAMEL CORN PEANUT BUTTER DELIGHT¿CRYSTAL SHORT (18 oz.) & Tall (22 oz.), Production Code/Lot Code: 16027 (18 oz.) & 16028 (22 oz.)",2/11/2016,"02/11/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73354,"Ongoing","Best Foods NJ, Inc.","30 Saw Mill Pond Rd",,"Edison","NJ","08817-6024","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, DE, MA, PA, NJ, NY & VA","F-2135-2016","Class II","Deer Cumin Powder      7 oz.., UPC 714760027497    14 oz UPC 714760027503    Packed for: Best Foods Inc. Edison, NJ 08817","130 Bags","Cumin may contain undeclared peanut.","09/13/2016",," no lot codes on product.  distribution dates include  1/1/2015-2/3/2016",2/9/2016,"02/09/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73355,"Ongoing","Marathon Ventures Inc","901 Fort Crook Rd N",,"Bellevue","NE","68005-4335","United States","Voluntary: Firm Initiated","Press Release","Product was distributed to CA, CO, GA, IA, IN, MN, MO, NC, NE, OR, SC, TX, UT, VA, and WI.  There was no military/government/foreign distribution.","F-1244-2016","Class I","Macadamia Diced Nuts packaged under the following brands:    1) Shurfine, Item no. 86635, 5 OZ (142 g) plastic bags, packed 12 bags per case, UPC 0 15400 86635 4.  Distributed by Western Family Foods, Inc., Portland OR.     2) Western Family, 5 OZ (142 g) plastic bags, packed 12 per case, UPC 0 15400 16635 5.  Distributed by Western Family Foods, Inc., Portland, OR.     3)  HyVee, 2 OZ (57 g) plastic bags, packed 12 per case, UPC 0 75450 13287 8.  Distributed by HyVee, Inc., West Des Moines, IA.     4) Market Pantry, 2.25 OZ (64 g) plastic bags, packed 12 bags per case, UPC 0 85239 52108 3.  Distributed by Target Corp., Minneapolis, MN.    5) Pear's Gourmet, 16 OZ (454 g) plastic bags, UPC 0 75049 42186 4.  Pear's Gourmet, Bellevue, NE 68005.    6) CWD, 5 LBS. (2.27 kg) per 1-count case, UPC 06509.  Packed for and distributed by Cash-Wa Distributing Co. Kearney, North Platte, Sidney, NE.    and  7) Nutpro C.C. Macadamia Nuts Style #5, 25 LBS., bulk case item no. N0609.  The responsible firm is Nutpro South Africa.","5890 lbs.","Product potentially contaminated with Salmonella. Routine, random product sampling by FDA revealed the presence of Salmonella in a retail package of macadamia nuts packaged by the recalling firm.","04/27/2016",," Product 1 - Shurfine) Best By: 2 SEP 2016;  Product 2 - Western Family) Best By:  3 AUG 2016, 4 AUG 2016, 2 SEP 2016  Product 3 - HyVee) Best By:  10 JUL 2016  Product 4 - Market Pantry) Best By:  13 AUG 2016, 11 SEP 2016  Product 5 - Pear's Gourmet) Best By:  11 SEP 2016, 25 SEP 2016  Product 6 - CWD) lots 15204 andn 15260  Product 7 - Nutpro, bulk) lot 79818",2/23/2016,"02/23/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73356,"Ongoing","Wakefern Foods Corp.","5000 Riverside Dr",,"Keasbey","NJ","08832-1209","United States","Voluntary: Firm Initiated","Letter","CT, DE, MA, NJ, NY, PA & RI","F-0773-2016","Class II","ShopRite Dry Roasted Unsalted Cashews 7 oz. (198 g)  Distributed by Wakefern Food Corp., Elizabeth, NJ 07207  UPC 4119001620   ","1,680 units","Recalled product may be mislabeled as ShopRite Unsalted Dry Roasted Cashews.","03/18/2016",," NOV 19 16 ",2/16/2016,"02/16/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73357,"Ongoing","TEM Systems Inc","3210 E Nc Hwy 54",,"Durham","NC","27709","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.","Z-1090-2016","Class II","ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only.  Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.","476 boxes x 5 vials","Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.","03/09/2016",," Lot 41925401",2/18/2016,"02/18/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73358,"Ongoing","Mt Perry Foods Inc","5705 State Route 204 NE",,"Mount Perry","OH","43760-9733","United States","Voluntary: Firm Initiated","Telephone","Product was sold in OH & WV.","F-1046-2016","Class I","Chicken Salad Croissant Sandwich along with black fine tip marker with hand written reverse Julian date reading 318.","36 sandwiches","Product labeled Chicken Salad Croissant sandwiches were made using Albacore Tuna Salad filling, therefore containing undeclared fish.","04/08/2016",," SELL BY: 02/21/16",2/18/2016,"02/18/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73359,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","The products were distributed to cabela's and bass pro shops throughout the U.S. (nationwide).  It was sent to 134 locations total.  Including 2 consignees in Canada.","F-0006-2017","Class I","Uncle Buck's Maple Nut candy packaged in a clear plastic 2.7 oz. bag with attached green, orange, and white label with Organe and black writing. ","6,000 bags to Bass Pro Shops"," product label does not include peanuts as an ingredient. Peanuts are an allergen. ","10/12/2016",," Item number 7101  UPC 752545071013",2/22/2016,"02/22/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73359,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","The products were distributed to cabela's and bass pro shops throughout the U.S. (nationwide).  It was sent to 134 locations total.  Including 2 consignees in Canada.","F-0007-2017","Class I","Cabela's classic candies Maple nut packaged in 2.7 oz. clear plast ice bag with brown label attached with brown lettering. ","3,000 bags"," product label does not include peanuts as an ingredient. Peanuts are an allergen. ","10/12/2016",," Item number 7101  UPC 752545071013",2/22/2016,"02/22/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73360,"Ongoing","Lipari Foods, Inc.","26661 Bunert Rd",,"Warren","MI","48089-3650","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: Indiana, Kentucky, Michigan, Ohio, Pennsylvania,  Tennessee, Wisconsin and West Virginia.    Foreign: None  VA/DOD: None","F-0776-2016","Class I","Dark Chocolate Covered Coffee Beans, packaged in 12 oz. tubs","26 cases  477308 (Tub LG Dark Chocolate Coffee Beans 12-12oz) & 17 cases  510526 (Tub LG PL Dark Chocolate Coffee Beans 12-12oz) ","Lipari Foods, LLC has issued a voluntary recall of dark chocolate covered coffee beans packaged by sister company JLM due to an undeclared allergen of tree nuts (almonds).","03/18/2016",," Dark Chocolate Covered Coffee Beans, packaged in 12 oz. tubs; (Multiple Brands including: Angeli Foods, Hardings Markets,  Goosberries Fresh Food Market, Marthas Vineyard, Hollywood Market, Daniels Foods, Snooks Butcher Shoppe, Martins, Holiday Market, The Purple Onion, Remke Market) Lipari Product Number 510526, Lot #  22201512, Weight 12oz Tubs, Best By Date: 12/21/16, UPC # 094776131761; and Generic brand Lipari Product Number 477308, Lot #  22201512, Weight 12oz Tubs, Best By Date: 12/21/16, and UPC # 094776131761.",2/23/2016,"02/23/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73361,"Ongoing","Super Herbs","10740 Sw 222nd Dr",,"Miami","FL","33170-6544","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","9 consignees - only 9 bottles distributed","D-0909-2016","Class I","SUPER HERBS 350 mg, 30 capsules per bottle.  ","9 bottles","Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.","05/26/2016",," All lots",11/23/2015,"11/23/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73362,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, Iowa, Illinois, Maryland, Michigan, New York, Ohio, Pennsylvania, Virginia, Wisconsin, West Virginia","F-0811-2016","Class II","Trio¿ Low Sodium Brown Gravy, 16 ounce, flexible pouch, NET WT 16 OZ CONTAINS: MILK, SOY, WHEAT, INGREDIENTS MAY CONTAIN EGGS DISTRIBUTED BY: NESTLE PROFESSIONAL NORTH AMERICA SOLON, OH 44139 ","1005 cs/8/1 lb pouches","The firm was notified by one of their ingredient suppliers that an ingredient used to manufacture the recalled product may contain metal fragments.","03/25/2016",," ¿ SAP number = 11250795, Batch number = 60250443  ¿ SAP number = 11250795, Batch number = 60260443",2/11/2016,"02/11/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73363,"Ongoing","Zimmer Spine, Inc.","7375 Bush Lake Rd",,"Minneapolis","MN","55439-2027","United States","Voluntary: Firm Initiated","Letter","US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.","Z-1189-2016","Class II","Universal Clamp¿ System (IFU reference: SNA027-N-90001).    Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.","3484","Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001).","03/18/2016",," All  lots",2/12/2016,"02/12/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73363,"Ongoing","Zimmer Spine, Inc.","7375 Bush Lake Rd",,"Minneapolis","MN","55439-2027","United States","Voluntary: Firm Initiated","Letter","US (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.","Z-1190-2016","Class II","Instinct¿ Java¿ System (IFU reference: 046WAN0000T) .    Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.        ","2506","Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001).","03/18/2016",," All  lots",2/12/2016,"02/12/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73364,"Ongoing","GE Inspection Technologies, LP","50 Industrial Park Rd",".","Lewistown","PA","17044-9312","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, MD CO, GA, SC, OH and DC.","Z-1231-2016","Class II","GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.","55 US Distribution",") has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration's (FDA) Cabinet X¿ ray System  performance  standards,  21  C.F.R.  ¿  1020.40(c)(1)(i)","04/01/2016",," phoenix micrornelx and nanomelx cabinet x-ray systems ",12/16/2015,"12/16/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73365,"Ongoing","Bard Peripheral Vascular Inc","1625 W 3rd St",,"Tempe","AZ","85281-2438","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including DC and  PR, and the states of MN, TX, PA, OH, IL, OR, CA, SC, NC, AK, NY, MD, GA, NJ, AZ, KY, OH, WI, AL, AR, MO, FL, MA, MT, TN, LA, CT, NE, WV, VA, NV, ME, UT, CO, WY, AR, DE, NM, IN, MN, MS, NH, IA, MI, WA, VA, KS, HI, RI, SD, VT, and the countries of Hong Kong, Malaysia, Canada, Chile.","Z-1069-2016","Class II","Denali Filter-Femoral Delivery System  Product Code: DL900F/DL950F;  Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.","3572","Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.","03/08/2016",," Product #      Lot #  DL900F	GFZJ0276  DL900F	GFZJ0278  DL900F	GFZJ0277  DL900F	GFZJ0279  DL900F	GFZJ0421  DL900F	GFZJ0425  DL900F	GFZJ0430  DL900F	GFZJ0432  DL900F	GFZJ0429  DL950F	GFZJ0223  DL900F	GFZJ0433  DL900F	GFZJ0434  DL950F	GFZJ1174  DL900F	GFZJ0436  DL900F	GFZJ0435  DL900F	GFZJ0442  DL900F	GFZJ0443  DL900F	GFZK0287  DL900F	GFZJ0446  DL900F	GFZK0291  DL900F	GFZK0288  DL900F	GFZJ0444  DL900F	GFZK0290  DL900F	GFZK0289  DL900F	GFZK0292  DL900F	GFZK0294  DL900F	GFZK0296  DL900F	GFZK0293  DL900F	GFZK0294  DL900F	GFZK0297  DL900F	GFZK0295  DL900F	GFZK0299  DL900F	GFZK0298  DL900F	GFZK0300  DL900F	GFZK0301  DL900F	GFZK0302  DL900F	GFZK0351  DL900F	GFZK0352  DL900F	GFZK0356  DL900F	GFZK0355  DL900F	GFZK0357  DL900F	GFZK0337  DL900F	GFZK0354  DL900F	GFZK0338  DL900F	GFZK0364  DL900F	GFZK0339  DL950F	GFZK2368  DL900F	GFZK3526  DL900F	GFZK0367  DL900F	GFZK3527  DL900F	GFZK3524  DL900F	GFZK3525  DL900F	GFZK0328  DL900F	GFZK0330  DL900F	GFZK0331  DL900F	GFZK0332  DL900F	GFZK0333  DL900F	GFZK0334  DL900F	GFZK3523  DL900F	GFZK0336  DL900F	GFZK0335  DL900F	GFZK3528  DL900F	GFZK3529  DL900F	GFZK3530  DL900F	GFZK3538  DL900F	GFZK3543  DL950F	GFZK2369  ",2/9/2016,"02/09/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73365,"Ongoing","Bard Peripheral Vascular Inc","1625 W 3rd St",,"Tempe","AZ","85281-2438","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including DC and  PR, and the states of MN, TX, PA, OH, IL, OR, CA, SC, NC, AK, NY, MD, GA, NJ, AZ, KY, OH, WI, AL, AR, MO, FL, MA, MT, TN, LA, CT, NE, WV, VA, NV, ME, UT, CO, WY, AR, DE, NM, IN, MN, MS, NH, IA, MI, WA, VA, KS, HI, RI, SD, VT, and the countries of Hong Kong, Malaysia, Canada, Chile.","Z-1068-2016","Class II","Denali Filter-Jugular/Subclavian Delivery System  Product Code: DL900J/DL950J;  Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.","2904","Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.","03/08/2016",," Product #     Lot #  DL900J	GFZJ0450  DL900J	GFZJ0452  DL900J	GFZJ0455  DL900J	GFZK0303  DL900J	GFZJ0454  DL900J	GFZK0304  DL900J	GFZK0306  DL950J	GFZJ1176  DL950J	GFZJ1177  DL900J	GFZK0309  DL900J	GFZK0305  DL900J	GFZK0308  DL900J	GFZJ0456  DL900J	GFZK0307  DL900J	GFZJ0460  DL900J	GFZJ0459  DL900J	GFZK0310  DL900J	GFZK0311  DL900J	GFZK0314  DL900J	GFZK0313  DL900J	GFZK0312  DL900J	GFZK0315  DL900J	GFZK0316  DL900J	GFZK0317  DL900J	GFZK0358  DL900J	GFZK0318  DL900J	GFZK0319  DL900J	GFZK0360  DL900J	GFZK0361  DL950J	GFZK0350  DL900J	GFZK0359  DL900J	GFZK0362  DL900J	GFZK0363  DL900J	GFZK0365  DL900J	GFZK0344  DL900J	GFZK0345  DL900J	GFZK0346  DL950J	GFZK2376  DL900J	GFZK3551  DL900J	GFZK3553  DL900J	GFZK3555  DL900J	GFZK3552  DL900J	GFZK3554  DL900J	GFZK3557  DL900J	GFZK0340  DL900J	GFZK0341  DL900J	GFZK0342  DL900J	GFZK0343  DL900J	GFZK0348  DL900J	GFZK0349  DL900J	GFZK3556  DL900J	GFZK0347  DL900J	GFZK3558  DL900J	GFZK3559  DL900J	GFZK3560  DL900J	GFZK3561  ",2/9/2016,"02/09/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73366,"Ongoing","Ambu Inc.","6230 Old Dobbin Ln Ste 250",,"Columbia","MD","21045-5955","United States","Voluntary: Firm Initiated","E-Mail","Please see attached consignee list","Z-1236-2016","Class II","Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile   for use as an alternative to a face mask for achieving and maintaining control of the airway during routine  emergency anesthetic procedures.","Total Numbers of unit distributed: 45990 pes (USA)","Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the  problem  during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product  and,ultimately,patient complications.","03/24/2016",," Catalog Number:408300000    Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239,  1795914      Catalog Number: 408400000  Size #4 All lots from 1632799 through lot number 1790075.      Catalog Number:408500000  Size #5 All lots from 1632802 through lot number 1810863. ",2/10/2016,"02/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73367,"Terminated","BloodSource, Inc.","10536 Peter a McCuen Blvd",,"Mather","CA","95655-4128","United States","Voluntary: Firm Initiated","Telephone","Armed Forces Americas except Canada; California","B-0320-16","Class II","Apheresis Fresh Frozen Plasma","8 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","03/04/2016","03/04/2016"," W035815187225 (double collection); W035815194403; W035815214016 (double collection); W035815162726; W035815216944 (double collection) ",1/5/2016,"01/05/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73368,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0322-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","03/04/2016","03/04/2016"," W270115505285",1/26/2016,"01/26/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73368,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0321-16","Class II","Fresh Frozen Plasma","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","03/04/2016","03/04/2016"," W270115505285",1/26/2016,"01/26/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73369,"Terminated","Puget Sound Blood Center and Program","921 Terry Ave",".","Seattle","WA","98104-1239","United States","Voluntary: Firm Initiated","Letter","Washington","B-0395-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Apheresis Platelets, collected from an ineligible donor, were distributed. ","04/05/2016","04/04/2016"," W141615115318",1/13/2016,"01/13/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73370,"Terminated","Arc Blood Services, New England Region","180 Rustcraft Rd Ste 115",,"Dedham","MA","02026-4551","United States","Voluntary: Firm Initiated","Telephone","New Hampshire","B-0323-16","Class III","Apheresis Red Blood Cells, Leukocytes Reduced","1 unit","Apheresis product, for which the attached label was missing required information was distributed.","03/04/2016","03/04/2016"," W203415330983 ",12/18/2015,"12/18/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73371,"Terminated","DCI Plasma Center Of Duluth, LLC","1720 W Superior St",,"Duluth","MN","55806-2137","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0324-16","Class II","Source Plasma","29 units","Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed","03/04/2016","03/04/2016"," DU0860731; DU0861388; DU0861655; DU0862068; DU0862332; DU0862738; DU0862991; DU0864295; DU0864696; DU0864806; DU0865270; DU0865403; DU0865843; DU0866008; DU0866434; DU0866632; DU0867065; DU0867352; DU0867692; DU0867984; DU0868353; DU0868732; DU0868996; DU0869513; DU0869624; DU0870112; DU0870205; DU0870662; DU0870782 ",1/2/2016,"01/02/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73372,"Terminated","Arc Blood Services, New England Region","180 Rustcraft Rd Ste 115",,"Dedham","MA","02026-4551","United States","Voluntary: Firm Initiated","Telephone","Massachusetts","B-0345-16","Class II","Apheresis Platelets, Leukocytes Reduced","4 units","Apheresis products, for which quality control testing for residual white blood cell count was not performed, were distributed.","03/04/2016","03/04/2016"," W200415875987; W200415875989; W200415875996 (double collection) ",1/4/2016,"01/04/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73373,"Ongoing","MicroAire Surgical Instruments, LLC","3590 Grand Forks Blvd",".","Charlottesville","VA","22911-9006","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide","Z-1328-2016","Class II","MicroAire PAL¿ Cannula     Product Usage - Power Aspiration Device","145 manufactured and distributed","MicroAire has initiated a recall on product  PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery.    Accordingly, the PAL-R4011XL has also been put on production hold until further notice.","04/05/2016",," Include lot numbers/serial numbers    0913228216, 0414243005, 0215266350, 0415269875, 0515271334  ",2/8/2016,"02/08/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73374,"Terminated","Jack And The Green Sprouts, Inc.","N8477 770th St",,"River Falls","WI","54022-4246","United States","Voluntary: Firm Initiated","Telephone","MN, WI, ND","F-0795-2016","Class I","Jack and the Green Sprouts, Alfalfa Sprouts, Net Wt 5 oz (142 g), UPC 7 6324719891 5      Retail:  5 oz clam shell (cup) . Shipping cases hold 12 x 5 oz or 6 x 5 oz clam shells.","4,620 lbs for all products","Alfalfa Sprouts might be contaminated with E.coli 0157","03/25/2016","05/25/2016"," Batch/Product #s and Pull Date #s, 213-2/8/16, 607-2/11/16, 955-2/15/16, 434-2/18/16, 372-2/22/16. Seed Lot # AT-X4018, Manufacturer #s 6324719891 and 6324719594, expiration date is 2 weeks from Pull Date.",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73374,"Terminated","Jack And The Green Sprouts, Inc.","N8477 770th St",,"River Falls","WI","54022-4246","United States","Voluntary: Firm Initiated","Telephone","MN, WI, ND","F-0796-2016","Class I","Jack and the Green Sprouts, Alfalfa & Onion Sprouts, Net Wt 5 oz (142 g),  UPC 7 6324719594 5.      Retail:  5 oz clam shell (cup) . Shipping cases hold 12 x 5 oz or 6 x 5 oz clam shells.","4,620 lbs for all products","Alfalfa Sprouts might be contaminated with E.coli 0157","03/25/2016","05/25/2016"," Batch/Product #s and Pull Date #s, 213-2/8/16, 607-2/11/16, 955-2/15/16, 434-2/18/16, 372-2/22/16. Seed Lot # AT-X4018, Manufacturer #s 6324719891 and 6324719594, expiration date is 2 weeks from Pull Date.",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73376,"Ongoing","Argon Medical Devices, Inc","1445 Flat Creek Rd",,"Athens","TX","75751-5002","United States","Voluntary: Firm Initiated","Letter","Distributed in IL.","Z-1029-2016","Class II","ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11.  Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.","2000 units","The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.","03/01/2016",," Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)",2/17/2016,"02/17/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73377,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Nationwide","Z-1835-2016","Class II","Video Duodenoscope  ","423 units","Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.","05/27/2016",," A110021, A110022, A110023, A110024, A110025, A110026, A110027, A110028, A110029, A110030, A110031,  A110032, A110033, A110034, A110035, A110036, A110037, A110038, A110039, A110043, A110046, A110051,  A110055, A110056, A110057, A110058, A110059, A110060, A110061, A110062, A110063, A110064, A110065,  A110067, A110068, A110070, A110071, A110072, A110073, A110074, A110075, A110076, A110077, A110078,  A110079, A110080, A110081, A110082, A110083, A110086, A110087, A110088, A110089, A110090, A110091,  A110092, A110095, A110098, A110099, A110100, A110114, A110115, A110116, A110117, A110118, A110121,  A110122, A110127, A110128, A110129, A110130, A110131, A110132, A110133, A110134, A110135, A110136,  A110137, A110138, A110140, A110142, A110143, A110150, A110152, A110156, A110157, A110158, A110159,  A110160, A110162, A110163, A110164, A110165, A110166, A110167, A110168, A110169, A110170, A110173,  A110174, A110177, A110178, A110179, A110180, A110182, A110183, A110190, A110191, A110192, A110193,  A110194, A110203, A110204, A110206, A110207, A110208, A110209, A110210, A110211, A110213, A110214,  A110215, A110216, A110217, A110218, A110229, A110230, A110231, A110232, A110233, A110234, A110235,  A110236, A110237, A110243, A110244, A110246, A110247, A110248, A110249, A110250, A110251, A110252,  A110258, A110259, A110260, A110268, A110269, A110272, A110273, A110274, A110275, A110276, A110277,  A110278, A110279, A110280, A110281, A110283, A110284, A110285, A110287, A110288, A110289, A110290,  A110293, A110297, A110301, A110302, A110304, A110305, A110306, A110307, A110308, A110316, A110317,  A110318, A110319, A110320, A110321, A110322, A110323, A110324, A110325, A110326, A110327, A110328,  A110329, A110331, A110333, A110338, A110339, A110345, A110347, A110352, A110362, A110363, A110385,  A110386, A110387, A110388, A110389, A110390, A110391, A110392, A110393, A110399, A110403, A110405,  A110406, A110407, A110409, A110410, A110412, A110413, A110415, A110416, A110417, A110418, A110419,  A110421, A110422, A110424, A110438, A110439,",2/22/2016,"02/22/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73378,"Ongoing","Lipari Foods, Inc.","26661 Bunert Rd",,"Warren","MI","48089-3650","United States","Voluntary: Firm Initiated","Telephone","Retail and foodservice establishments in the following states:   IA, IL, IN, KY, MI, MN, MO, NE, NV, OH, PA, TN, WI, WV","F-0902-2016","Class I","Fancy Fruit & Nut Mix   9-oz. retail plastic tub or 25-lb. bulk plastic bag.    12, 9-oz.  tubs per case.    1, 25-lb. bag per case.  ","90 Cases  464677 (25# Fancy Fruit & Nut Mix); 113 Cases  582164 (12-9oz Fancy Fruit & Nut Mix); 33 Cases  - 583524 (12-9oz. Private Label Fancy Fru ","The pistachio products are being recalled as they have the potential to be contaminated with Salmonella.","03/30/2016",," Fancy Fruit & Nut Mix   Generic (packaged by JLM)    Product # 464677   25 Pound Bag UPC 094776129195  Lot numbers   12201508 best by 8/11/2016   01201509 best by 8/31/2016     Product # 582164  9 oz tub UPC 094776144594  Lot numbers  26201508 best by 8/25/2016   07201510 best by 10/6/2016   04201512 best by 12/3/2016   13201601 best by 1/12/2017     Fancy Fruit & Nut Mix  Private labeled (Blue Goose Market, Hollywood  Market, Market Fresh Fine Foods,  Market Square, Rogers Foodland,  Trentwood Farms)     Product # 583524  9 oz tub UPC 094776144594  Lot numbers  26201508 best by 8/25/2016   07201510 best by 10/6/2016   04201512 best by 12/3/2016   13201601 best by 1/12/2017      ",2/10/2016,"02/10/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73378,"Ongoing","Lipari Foods, Inc.","26661 Bunert Rd",,"Warren","MI","48089-3650","United States","Voluntary: Firm Initiated","Telephone","Retail and foodservice establishments in the following states:   IA, IL, IN, KY, MI, MN, MO, NE, NV, OH, PA, TN, WI, WV","F-0901-2016","Class I","Pistachio Raw Whole Shelled  9-oz. retail plastic tub or 5-lb. bulk plastic bag.    12, 9-oz  tubs per case.    1, 5# bag per case.  ","94 Cases  481966 (5# Pistachio Raw Whole Shelled; 164 Cases  333803 (12-9oz. Pistachio Meat Raw); 46 Cases  206661 (12-9oz. Private Label Pistachi ","The pistachio products are being recalled as they have the potential to be contaminated with Salmonella.","03/30/2016",," Pistachio Raw Whole Shelled  Generic (packaged by JLM)    Product # 481966   5 Pound Bag UPC 094776132119  Lot numbers   22201508 best by  8/21/2016   14201509 best by 9/13/2016     Product # 333803  9 oz tub UPC 760208123818  Lot numbers  25201511 best by 11/24/16   21201510 best by 10/20/16   26201508 best by 8/25/16   29201601 best by 1/28/17   04201601 best by 1/3/17     Pistachio Meat Raw  Private labeled (Marv & Alisons Marketplace, Long  Lake Market, Martins, Holiday Market,  The Purple Onion, Trentwood Farms,  Angeli Foods, Market Square, Village  Food Market, Marthas Vineyard,  Remke Market)     Product # 206661  9 oz tub UPC 760208123818  Lot numbers  25201511 best by 11/24/16   21201510 best by 10/20/16   26201508 best by 8/25/16   29201601 best by 1/28/17   ",2/10/2016,"02/10/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1288-2016","Class II","Miami J Collar    Product Usage:  Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.  ","15,825","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  MJ-200B  MJ-200L  MJ-200LFRT  MJ-200S  MJ-200SFRT  MJ-250  MJ-250FRT  MJ-2530  MJ-300  MJ-300FRT  MJ-400  MJ-400FRT  MJ-500  MJ-500FRT  MJ-P2  MJ-P3  MJR-200L  MJR-200S  MJR-250  MJR-2530  MJR-300  MJR-400  MJR-500  MJR-P2  MJR-P3  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1291-2016","Class II","Rebound Air Walker    Product Usage:  Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.  ","7623","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  B-242900001  B-242900001E  B-242900001SE  B-242900002  B-242900002E  B-242900002SE  B-242900003  B-242900003E  B-242900003SE  B-242900004  B-242900004E  B-242900004SE  B-242900005  B-242900005E  B-242900005SE  B-242900061  B-242900061E  B-242900061SE  B-242900062  B-242900062E  B-242900062SE  B-242900063  B-242900063E  B-242900063SE  B-242900064  B-242900064E  B-242900064SE  B-242900065  B-242900065E  B-242900065SE  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1297-2016","Class II","Extreme Custom    Product Usage:  Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.  ","7","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  B-108500010  B-108500020  B-108600010  B-108600020  B-123500020  B-123600020  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1289-2016","Class II","Rebound Cartilage    Product Usage:  Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.  ","1030","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  B-254510002  B-254510003  B-254510004  B-254510005  B-254520002  B-254520003  B-254520004  B-254520005  B-254610002  B-254610003  B-254610004  B-254610005  B-254620002  B-254620003  B-254620004  B-254620005  B-254710002  B-254710003  B-254710004  B-254710005  B-254720002  B-254720003  B-254720004  B-254720005  B-254810002  B-254810003  B-254810004  B-254810005  B-254820002  B-254820003  B-254820004  B-254820005  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1295-2016","Class II","Unloader Custom Lite    Product  Usage:  Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.  ","9","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  B-107500020  B-107600020  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1293-2016","Class II","Back Support Suspenders Clip on Black  Back Support Suspenders Sew on Black","2","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  10912  10913  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1292-2016","Class II","Rebound Diabetic Walker    Product Usage:  Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.  ","34","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  B-242500002  B-242500003  B-242500004  B-242500005  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1294-2016","Class II","Unloader XT    Product Usage:  Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.  ","15","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  B-102500010  B-102500020  B-102600010  B-102600020  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1287-2016","Class II","NecLoc Extrication Collar    Product Usage:  Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.  ","2010","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No.:  NL-200EL  NL-250E  NL-300E  NL-400E  NL-500E  NL-P1  NL-P2  NL-P3  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1296-2016","Class II","Unloader Custom    Product Usage:  Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.  ","456","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  B-122500020  B-122600020  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1285-2016","Class II","Knee Shield (Patella Cup)    Product Usage:  Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities.  ","7","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No: B-250110000",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1298-2016","Class II","Papoose Infant Spine Immobilizer  Item #	Item Description:  PA-100	Papoose  PAR-100	Papoose w/replacement pads  PO-100	Papoose w/o PO front  POR-100	Papoose w/o PO front w/pad     Product Usage:  The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.  ","401","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item #	Item Description:  PA-100	Papoose  PAR-100	Papoose w/replacement pads  PO-100	Papoose w/o PO front  POR-100	Papoose w/o PO front w/pad     All lot numbers from MX140101 to MX150930 ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1286-2016","Class II","Knee Undersleeve Gray    Product Usage:  Knee undersleeves are worn as an accessory for comfort under knee braces.  ","456","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  B-250150201  B-250150202  B-250150203  B-250150204  B-250150205  B-250150206  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73380,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV","Z-1290-2016","Class II","Rebound Cartilage Custom    Product Usage:  Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.  ","24","Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p","03/31/2016",," Item No:  B-254500001  B-254600001  B-254700001  B-254800001",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73381,"Ongoing","Scottcare Corporation","4791 W 150th St",".","Cleveland","OH","44135-3301","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of CA, CT, DE, FL, IL, KS, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, & WV; and, the country of Canada.","Z-1315-2016","Class II","TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation.     Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. ","9,067 batteries","The firm received a complaint of the battery exploding while recharging.","04/01/2016",," Model # TS01; Part #101109; Serial #'s: 27313, 27314, 27315, 27316, 27317, 27318, 27319, 27320, 27321, 27322, 27323, 27324, 27325, 27326, 27327, 27328, 27329, 27330, 27331, 27332, 27333, 27334, 27335, 27336, 27337, 27338, 27339, 27340, 27341, 27342, 27343, 27344, 27345, 27346, 27347, 27348, 27349, 27350, 27351, 27352, 27353, 27354, 27355, 27356, 27357, 27358, 27359, 27360, 27361, 27362, 27522, 27523, 27524, 27525, 27526, 27527, 27528, 27529, 27530, 27531, 27532, 27533, 27534, 27535, 27536, 27537, 27538, 27539, 27540, 27541, 27542, 27543, 27544, 27545, 27546, 27547, 27548, 27549, 27550, 27551, 27552, 27553, 27554, 27555, 27556, 27557, 27558, 27559, 27560, 27561, 27562, 27563, 27564, 27565, 27566, 27567, 27568, 27569, 27570, 27571, 27604, 27605, 27606, 27607, 27608, 27609, 27610, 27611, 27612, 27613, 27614, 27615, 27616, 27617, 27618, 27619, 27620, 27621, 27622, 27623, 27624, 27625, 27626, 27627, 27628, 27629, 27630, 27631, 27632, 27633, 27634, 27635, 27636, 27637, 27638, 27639, 27640, 27641, 27642, 27643, 27644, 27645, 27646, 27647, 27648, 27649, 27650, 27651, 27652, 27653, 29704, 29705, 29706, 29707, 29708, 29709, 29710, 29711, 29712, 29713, 29714, 29715, 29716, 29717, 29718, 29719, 29720, 29721, 29722, 29723, 29724, 29725, 29726, 29727, 29728, 29729, 29730, 29731, 29732, 29733, 29734, 29735, 29736, 29737, 29738, 29739, 29740, 29741, 29742, 29743, 29744, 29745, 29746, 29747, 29748, 29749, 29750, 29751, 29752, 29753, 29754, 29755, 29756, 29757, 29758, 29759, 29760, 29761, 29762, 29763, 29764, 29765, 29766, 29767, 29768, 29769, 29770, 29771, 29772, 29773, 29774, 29775, 29776, 29777, 29778, 29779, 29780, 29781, 29782, 29783, 29784, 29785, 29786, 29787, 29788, 29789, 29790, 29791, 29792, 29793, 29794, 29795, 29796, 29797, 29798, 29799, 29800, 29801, 29802, 29803, 29804, 29805, 29806, 29807, 29808, 29809, 29810, 29811, 29812, 29813, 29814, 29815, 29816, 29817, 29818, 29819, 29820, 29821, 29822, 29823, 29824, 29825, 29826, 29827, 29828, 29829, 29830, 29831, 29832, 29833, 29834, 29835, 29836, 29837, 29838, 29839, 29",2/25/2016,"02/25/2016",4/13/2016,"04/13/2016","8852, 38853, 38854, 38855, 38856, 38857, 38858, 38859, 38860, 38861, 38862, 38863, 38864, 38865, 38866, 38867, 38868, 38869, 38870, 38871, 38872, 38873, 38874, 38875, 38876, 38877, 38878, 38879, 38880, 38881, 38882, 38883, 38884, 38885, 38886, 38887, 38888, 38889, 38890, 38891, 38892, 38893, 38894, 38895, 38896, 38897, 38898, 38899, 38900, 38901, 38902, 38903, 38904, 38905, 38906, 38907, 38908, 38909, 38910, 38911, 38912, 38913, 38914, 38915, 38916, 38917, 38918, 38919, 38920, 38921, 38922, 38923, 38924, 38925, 38926, 38927, 38928, 38929, 38930, 38931, 38932, 38933, 38934, 38935, 38936, 38937, 38938, 38939, 38940, 38941, 38942, 38943, 38944, 38945, 38946, 38947, 38948, 38949, 38950, 38951, 38952, 38953, 38954, 38955, 38956, 38957, 38958, 38959, 38960, 38961, 38962, 38963, 38964, 38965, 38966, 38967, 38968, 38969, 38970, 38971, 38972, 38973, 38974, 38975, 38976, 38977, 38978, 38979, 38980, 38981, 38982, 38983, 38984, 38985, 38986, 38987, 38988, 38989, 38990, 38991, 38992, 38993, 38994, 38995, 38996, 38997, 38998, 38999, 39000, 39001, 39002, 39003, 39004, 39005, 39006, 39007, 39008, 39009, 39010, 39011, 39012, 39013, 39014, 39015, 39016, 39017, 39018, 39019, 39020, 39021, 39022, 39023, 39024, 39025, 39026, 39027, 39028, 39029, 39030, 39031, 39032, 39033, 39034, 39035, 39036, 39037, 39038, 39039, 39040, 39041, 39042, 39043, 39044, 39045, 39046, 39047, 39048, 39049, 39050, 39051, 39052, 39053, 39054, 39055, 39056, 39057, 39058, 39059, 39060, 39061, 39062, 39063, 39064, 39065, 39066, 39067, 39068, 39069, 39070, 39071, 39072, 39073, 39074, 39075, 39076, 39077, 39078, 39079, 39080, 39081, 39082, 39083, 39084, 39085, 39086, 39087, 39088, 39089, 39090, 39091, 39092, 39093, 39094, 39095, 39096, 39097, 39098, 39099, 39100, 39101, 39102, 39103, 39104, 39105, 39106, 39107, 39108, 39109, 39110, 39111, 39112, 39113, 39114, 39115, 39116, 39117, 39118, 39119, 39120, 39121, 39122, 39123, 39124, 39125, 39126, 39127, 39128, 39129, 39130, 39131, 39132, 39133, 39134, 39135, 39136, 39137, 39138, 39139, 39140, 39141, 39142, 39143, 39",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73382,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","Distribution US Nationwide and Hong Kong","Z-1512-2016","Class II","Ossur  Lil Angel Vest P2 Sorbatex.  Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. ","435 total all models","There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.","04/19/2016",," P/N: 545100S  units from 2008 to current",3/14/2016,"03/14/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73382,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","Distribution US Nationwide and Hong Kong","Z-1513-2016","Class II","Ossur Lil Angel Vest P3 Kodel.  Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. ","435 total all models","There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.","04/19/2016",," P/N: 545150K  units from 2008 to current",3/14/2016,"03/14/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73382,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","Distribution US Nationwide and Hong Kong","Z-1515-2016","Class II","Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. ","435 total all models","There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.","04/19/2016",," P/N: 545150S  units from 2008 to current",3/14/2016,"03/14/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73382,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","Distribution US Nationwide and Hong Kong","Z-1514-2016","Class II","Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. ","435 total all models","There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.","04/19/2016",," P/N: 545150L  units from 2008 to current",3/14/2016,"03/14/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73382,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","Distribution US Nationwide and Hong Kong","Z-1511-2016","Class II","Ossur Lil Angel Vest P2 Lambswool.  Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. ","435 total all models","There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.","04/19/2016",," P/N: 545100L  units from 2008 to current",3/14/2016,"03/14/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73382,"Ongoing","Ossur H / F","Grjothals 5",,"Reykjavik",,,"Iceland","Voluntary: Firm Initiated","Letter","Distribution US Nationwide and Hong Kong","Z-1510-2016","Class II","Ossur Lil Angel Vest P2 Kodel.  Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. ","435 total all models","There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.","04/19/2016",," P/N: 545100K  units from 2008 to current",3/14/2016,"03/14/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73383,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI.    OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY,GREECE, HELSINKI, HONG KONG, HUNGARIA, ICELAND, INDIA, IRAQ, IRELAND, ITA LY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,URUGUAY, VIETNAM.","Z-1382-2016","Class II","GE Healthcare, Aisys Carestation.","1294","GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.","04/13/2016",," ANAS00632  ANAR00333  ANAR00334  ANAR05370  ANAR05371  ANAR05372    TOUCHSCREEN DISPLAY  Kits (Each to be instaleed in device. Device serial number to be provided later)  5395419-1  5395419-2  5395419-3  5405365  5391200-1  5391200-10  5391200-11  5391200-12  5391200-2  5391200-3  5391200-4  5391200-5  5391200-6  5391200-7  5391200-8  5391200-9  5402182  5393755-1  5393755-2  5403569-1  5403569-10  5403569-11  5403569-12  5403569-13  5403569-2  5403569-3  5403569-4  5403569-5  5403569-6  5403569-7  5403569-8  5403569-9  5403570-1  5403570-2  5403570-3  5403570-4  5403570-5  5392643-1  5392643-10  5392643-11  5392643-12  5392643-13  5392643-2  5392643-3  5392643-4  5392643-5  5392643-6  5392643-7  5392643-8  5392643-9  5393856-1  5393856-10  5393856-11  5393856-12  5393856-13  5393856-14  5393856-15  5393856-2  5393856-3  5393856-4  5393856-5  5393856-6  5393856-7  5393856-8  5393856-9  5404595-1  5404595-10  5404595-11  5404595-12  5404595-13  5404595-14  5404595-15  5404595-16  5404595-17  5404595-18  5404595-19  5404595-2  5404595-3  5404595-4  5404595-5  5404595-6  5404595-7  5404595-8  5404595-9  5404596-1  5404596-2  5404596-3  5404596-4  5404596-5  5392846-1  5392437-1  5392437-2  5392437-3  5392437-4  5400852-1  5400852-10  5400852-11  5400852-12  5400852-2  5400852-3  5400852-4  5400852-5  5400852-6  5400852-7  5400852-8  5400852-9  5399939  5393121-1  5395521-1  5395521-2  5394120-1  5394120-2  5394120-3  5394120-4  5394120-5  5394120-6  5394120-7  5401872-1  5401872-2  5401872-3  5401872-4  5391217-1  5391217-2  5391217-3  5391217-4  5391217-5  ANAS00222  ANAS00223  ANAS01491  ANAS01492  ANAS01493  ANAS01494  ANAS01495  ANAS01496  ANAS01497  ANAS01498  ANAS01499  ANAS01500  ANAS01501  5403246-1  5403246-2  5403246-3  5402722-1  5402722-2  5402722-3  5402722-4  5402722-5  5402722-6  5402198-1  5402198-2  5402198-3  5401596-1  5401596-2  5401596-3  5398908-1  5398908-10  5398908-11  5398908-12  5398908-13  5398908-14  5398908-15  5398908-16  5398908-17  5398908-18  5398908-19  5398908-2  5398908-20  5",2/17/2016,"02/17/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73383,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI.    OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY,GREECE, HELSINKI, HONG KONG, HUNGARIA, ICELAND, INDIA, IRAQ, IRELAND, ITA LY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,URUGUAY, VIETNAM.","Z-1381-2016","Class II","GE Healthcare, Aisys CS2 anesthesia..","5496","GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.","04/13/2016",," APWU00723  APWU00724  APWU01057  APWU01058  APWU01059  APWU02682  APWU02683  APWU02684  APWU02685  APWU02686  APWU02687  APWU02688  APWU02689  APWU02690  APWU02691  APWU02692  APWU02693  APWU02694  APWU02695  APWU01240  APWU01241  APWU01242  APWU01243  APWU01244  APWU01785  APWU01827  APWU01988  APWU01989  APWU01990  APWU01991  APWU01992  APWU01993  APWU01994  APWU01995  APWU01996  APWU01997  APWU02708  APWT02996  APWT02384  APWT02254  APWT02255  APWT02256  APWT02257  APWT02258  APWT03126  APWT03127  APWT02326  APWU02707  APWT00391  APWT00392  APWT00393  APWT00394  APWT00395  APWU01576  APWU01577  APWU01578  APWU00363  APWU00364  APWU00365  APWU00366  APWT00898  APWT00899  APWT02417  APWV00144  APWU00707  APWU00708  APWU00709  APWU00710  APWU00711  APWU02287  APWU00190  APWU02166  APWU02167  APWU02168  APWU02169  APWU02170  APWU02171  APWU02172  APWU02316  APWU02317  APWU02318  APWU02319  APWU02320  APWU02321  APWU02322  APWT02043  APWT02044  APWT02045  APWT02046  APWT02047  APWT02048  APWT02049  APWT02050  APWT02051  APWT02052  APWU00712  APWT03125  APWT02250  APWT02251  APWU00505  APWU00506  APWU00507  APWT02328  APWT02329  APWT02330  APWT02331  APWT02332  APWU00474  APWU00475  APWU00476  APWU00477  APWU00478  APWU00479  APWT00589  APWT00590  APWT00591  APWT00592  APWT00593  APWT00603  APWT00977  APWT00978  APWU01486  APWU01487  APWU01488  APWU01489  APWU01490  APWU01491  APWU01492  APWU01493  APWU01494  APWU01495  APWT00561  APWT00562  APWU00611  APWU00612  APWU00613  APWU00614  APWU00145  APWU00146  APWU02163  APWU02164  APWU02165  APWU02051  APWU02052  APWU01825  APWU01909  APWU01599  APWU01600  APWU01601  APWU01602  APWU02017  APWU02018  APWU02019  APWU02020  APWT02407  APWT02408  APWT02409  APWU02576  APWT02385  APWU02237  APWU02648  APWU00297  APWU01054  APWU01055  APWU01056  APWU01608  APWU01609  APWU01610  APWU01611  APWU01612  APWU01613  APWU01614  APWU01615  APWU02066  APWU02067  APWT02750  APWT02746  APWT02747  APWT02748  APWT02749  APWT02751  APWT02752  APWT02851  APWT02852  APWT02853  APWT02854",2/17/2016,"02/17/2016",4/20/2016,"04/20/2016","U00433  APWU00434  APWU00435  APWU00436  APWU00437  APWU00438  APWU00439  APWU00440  APWU00441  APWU00442  APWU00443  APWU00444  APWU00445  APWU00446  APWU00447  APWT00448  APWU00367  APWU00368  APWU00369  APWU01461  APWU01462  APWU01463  APWU01596  APWU01597  APWU01512  APWT00533  APWT00534  APWT00535  APWT00536  APWT00537  APWT00538  APWT00949  APWT00178  APWT00179  APWT00180  APWT00181  APWT00182  APWT02647  APWT02648  APWT02649  APWT02650  APWT02651  APWT02652  APWT02653  APWT02654  APWT02655  APWT02656  APWS00514  APWT00184  APWT00185  APWT00186  APWT00187  APWU00209  APWT02019  APWT02020  APWT02021  APWT02022  APWT02023  APWT02024  APWT02025  APWT02026  APWT02027  APWT02028  APWT02029  APWT02030  APWU00374  APWU00375  APWU00376  APWU00377  APWU00378  5404025  5407086-1  5407086-2  5407086-3  5408547-1  5408547-2  5409649-1  5409649-2  5409858-1  5409858-2  5409858-3  5410348-1  5410348-2  5410348-3  5410348-4  5410348-5  APWU01850  APWU02229  APWU02230  APWU02231  APWU02388  APWU02511  APWU02512  APWU02573  APWU02574  APWU02575  APWU02599  APWU02600  APWU02601  APWU02602  APWU02603  APWT00353  APWT00354  APWT00355  APWT00356  APWT00357  APWT00358  APWU00908  APWU00909  APWU00910  APWU00911  APWS00438  APWU00405  APWU00406  APWU00407  APWU00408  APWU01711  APWU00344  APWU00345  APWU01511  APWU01534  APWU01678  APWU01729  APWU01730  APWU01731  APWU01749  APWU01750  APWU01778  APWU01881  APWU02198  APWU02199  APWU02236  APWU02307  APWU02308  APWU02315  APWU02347  APWU02362  APWU02363  APWU02364  APWU02365  APWU02366  APWU02367  APWU02368  APWU02369  APWU02370  APWU02371  APWU02406  APWT02128  APWT02129  APWT02130  APWT02131  APWU00126  APWU00848  APWU00849  APWU00850  APWU01776  APWU00127  APWS00414  APWU01892  APWU01893  APWU01894  APWU01895  APWU01896  APWT00748  APWT02159  APWT02202  APWT02660  APWT02713  APWU01533  APWU02037  APWU02038  APWU02380  APWU02478  APWU02479  APWU02480  APWU02562  APWU02563  APWU01148  APWT01034  APWT00599  APWT00600  APWT02657  APWT02470  APWT00445  APWT00968  APWU01429  APWU",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73384,"Ongoing","Qiagen Sciences LLC","19300 Germantown Rd",,"Germantown","MD","20874-1415","United States","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.","Z-1230-2016","Class II","QFT TB Antigen Tube.    QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)","The total amount of product distributed 152,900 Tubes","Potential for obtaining a false positive  result  due  to  the  possibility  of  endotoxin presence.","03/22/2016",," CODE(S):     a.   Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016    b.   Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016    c.   Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016    d.   Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016    e.   Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016  ",2/2/2016,"02/02/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73385,"Terminated","True Nature LLC","635 N Killingsworth Ct",,"Portland","OR","97217-2396","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Retail stores in OR and WA","F-1009-2016","Class II","Garlic Hummus - 9 oz container","414 units","True Nature Garlic Hummus is being recalled due to undeclared soy from the ingredient Tamari.","04/19/2016","04/19/2016"," All products dated prior to 3/9/16 - specifically best-by 3/5, 2/28. and 2/21",2/23/2016,"02/23/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73385,"Terminated","True Nature LLC","635 N Killingsworth Ct",,"Portland","OR","97217-2396","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Retail stores in OR and WA","F-1010-2016","Class II","Arugula Hazelnut Pesto 7oz container","384 units","True Nature Arugula Hazelnut  Pesto is being recalled due to undeclared milk in the parmesan cheese ingredient.","04/19/2016","04/19/2016"," All products dated prior to 3/9/16 - specifically 3/8, 3/1, and 2/23",2/23/2016,"02/23/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73385,"Terminated","True Nature LLC","635 N Killingsworth Ct",,"Portland","OR","97217-2396","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Retail stores in OR and WA","F-1008-2016","Class II","Original Hummus 9oz container","464 units","True Nature Original Hummus is being recalled due to undeclared soy from the ingredient Tamari.","04/19/2016","04/19/2016"," All products dated prior to 3/9/16 - specifically best-by dates of 3/5, 2/28, and 2/21",2/23/2016,"02/23/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73386,"Ongoing","Innovative Ophthalmic Products, Inc","3184 Airway Ave Ste B",,"Costa Mesa","CA","92626-4619","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1252-2016","Class II","Molteno3 Glaucoma Implants G-Series:    GS-Single Plate 175mm2 (IOP reorder#: M3-175)  GL-Single Plate 230mm2 (IOP reorder#: M3-230)","278 units","Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement to minimize off-label use. ","03/25/2016",," GS2014  GL2014  GL2015  GS2015  ",2/22/2016,"02/22/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73387,"Ongoing","Fresenius Medical Care Renal Therapies Group, LLC","920 Winter St",".","Waltham","MA","02451-1521","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.","Z-1324-2016","Class II","Fresenius Hemoflow F3 Dialyzer  Part Number: 0520165A    Indicated for Acute and Chronic Hemodialysis","1,650 units","Dialyzer header leak due to possible improper torque","04/05/2016",," Lot Number: 15KU04011  Exp. Date : 08/31/2013",2/26/2016,"02/26/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73388,"Ongoing","R.J. Van Drunen & Sons Field Facility","214 Mechanic St",".","Momence","IL","60954-1151","United States","Voluntary: Firm Initiated","E-Mail","The firm distributed the recalled product to domestic firms  and one firm located in Australia. The company in Austraila is Phyto-thereapy PT LTD-PO BOX 5018, Elanra Heights NSW 2100 Australia.","F-1027-2016","Class I","Air dried Organic Spinach Powder  packaged in 50 lb. polyethylene liner inside of a cardboard box.","4398.59 pounds distributed to customers in bulk","FDA sample of Spinach powder came back positive for Salmonella. ","04/04/2016",," 19553568N808.1  ",2/25/2016,"02/25/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73388,"Ongoing","R.J. Van Drunen & Sons Field Facility","214 Mechanic St",".","Momence","IL","60954-1151","United States","Voluntary: Firm Initiated","E-Mail","The firm distributed the recalled product to domestic firms  and one firm located in Australia. The company in Austraila is Phyto-thereapy PT LTD-PO BOX 5018, Elanra Heights NSW 2100 Australia.","F-1028-2016","Class I","GSN organic Mediterranean Blend packaged in 44 lb. polyethylene liner inside of a cardboard box.","220 pounds distributed to customers in bulk","FDA sample of Spinach powder came back positive for Salmonella. ","04/04/2016",," 26650000N639.1   ",2/25/2016,"02/25/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73389,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","Letter","New York; California","B-0352-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from an ineligible donor, were distributed. ","03/02/2016","03/02/2016"," W047015411341",2/1/2016,"02/01/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73389,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","Letter","New York; California","B-0351-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from an ineligible donor, were distributed. ","03/02/2016","03/02/2016"," W047015411341",2/1/2016,"02/01/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73389,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","Letter","New York; California","B-0350-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from an ineligible donor, were distributed. ","03/02/2016","03/02/2016"," W047015411341",2/1/2016,"02/01/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73390,"Ongoing","Maquet Cardiovascular Us Sales, Llc","45 Barbour Pond Drive",,"Wayne","NJ","07470","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-1371-2016","Class II","QUADROX-i oxygenators     Custom tubing packs for the oxygenator","72,000 units in total","Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.","04/12/2016",," All sizes and membrane types of QUADROX-i oxygenators, QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; BE-HMOD xxxxx, BEQ-HMO xxxxx,  BEQ-HMOD xxxxx, BO-VKMO xxxxx, HMO xxxxx, HMOD xxxxx, VKMO xxxxx, X HMO xxxxx U,  X HMOD 30000 U, X VKMO xxxxx U, and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating; XVIVO HMO 70100 ",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73390,"Ongoing","Maquet Cardiovascular Us Sales, Llc","45 Barbour Pond Drive",,"Wayne","NJ","07470","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-1373-2016","Class II","Rotaflow Centrifugal Pump    Custom tubing packs for the oxygenator","72,000 units in total","Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.","04/12/2016",," BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, RF-32u.",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73390,"Ongoing","Maquet Cardiovascular Us Sales, Llc","45 Barbour Pond Drive",,"Wayne","NJ","07470","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-1374-2016","Class II","Custom Tubing Packs     Custom tubing pack for oxygenators","72,000 units in total","Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.","04/12/2016",," containing products included in this action which include the following serial numbers; T xxxxx, TOP xxxxx, BE-TOP xxxxx, BO-TOP xxxxx, BO-T xxxxx, BEQ-T xxxxx,  and BEQ-TOP xxxxx.",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73390,"Ongoing","Maquet Cardiovascular Us Sales, Llc","45 Barbour Pond Drive",,"Wayne","NJ","07470","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-1372-2016","Class II","HLS Set Advanced with BIOLINE Coating    Custom tubing packs for the oxygenator","72,000 units in total","Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.","04/12/2016",," HLS Set Advanced:  Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73392,"Ongoing","Merial Limited","3239 Satellite Blvd Bldg 500",,"Duluth","GA","30096-4640","United States","Voluntary: Firm Initiated","Letter","AL, AZ, AR, CA, CO, CT, FL, GA, HI, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, & Puerto Rico","V-487-2016","Class II","Ivomec (Ivermectin) Injection for Cattle and Swine 1% Sterile Solution, 50 mL, Distributed by Merial Limited, Duluth, GA 30096, Product 67306; Ivomet (Ivermectin) Injection for Cattle and Swine 1% Sterile Solution, 500 mL, Distributed by Merial Limited, Duluth, GA 30096, Product 67308","40,540 bottles","Out-of-specification (OOS) assay value for the 12 month, 25C/60% RH, ongoing stability sample of Ivomec (Ivermectin 1%) Injection.","08/23/2016",," 50 mL - Code BA270/14, BB270/14, BC270/14; 500 mL - Code AA246/14, AB246/14, BC246/14",3/2/2016,"03/02/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73393,"Ongoing","Spacelabs Healthcare Inc","35301 SE Center St",,"Snoqualmie","WA","98065-9216","United States","Voluntary: Firm Initiated","Letter","distributed in AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WY and Guam and in the following countries AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, EL SALVADOR, FRANCE, GERMANY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ITALY, KUWAIT, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and UNITED KINGDOM.","Z-1092-2016","Class II","Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. ","total 1075 units (614 units in the US and 461 outside the US)","The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error.","03/10/2016",," **SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US*******    SALA0315F01025, SLA0114F00426, SLA0114F00434, SLA0114F00435, SLA0114F00444, SLA0114F00445, SLA0114F00446, SLA0114F00447, SLA0114F00448, SLA0114F00449, SLA0114F00451, SLA0114F00452, SLA0114F00453, SLA0114F00454, SLA0114F00457, SLA0114F00458, SLA0114F00460, SLA0114F00461, SLA0114F00462, SLA0114F00463, SLA0114F00464, SLA0114F00466, SLA0114F00468, SLA0114F00469, SLA0115F00916, SLA0115F00917, SLA0115F00918, SLA0115F00919, SLA0115F00921, SLA0115F00923, SLA0115F00924, SLA0115F00925, SLA0115F00926, SLA0115F00927, SLA0115F00928, SLA0115F00929, SLA0115F00931, SLA0115F00933, SLA0115F00934, SLA0115F00935, SLA0115F00936, SLA0115F00937, SLA0115F00948, SLA0115F00950, SLA0115F00955, SLA0115F00959, SLA0115F00961, SLA0115F00963, SLA0115F00964, SLA0115F00968, SLA0115F00969, SLA0115F00971, SLA0115F00972, SLA0115F00976, SLA0115F00979, SLA0115F00983, SLA0115F00986, SLA0115F00987, SLA0115F00991, SLA0115F00993, SLA0124F00910, SLA0214F00484, SLA0214F00485, SLA0214F00486, SLA0214F00489, SLA0214F00492, SLA0214F00493, SLA0214F00494, SLA0214F00497, SLA0214F00499, SLA0214F00501, SLA0214F00520, SLA0214F00521, SLA0214F00522, SLA0214F00525, SLA0214F00527, SLA0314F00529, SLA0314F00530, SLA0314F00531, SLA0314F00532, SLA0314F00534, SLA0314F00535, SLA0314F00536, SLA0314F00537, SLA0314F00538, SLA0314F00539, SLA0314F00539, SLA0314F00540, SLA0314F00542, SLA0314F00543, SLA0314F00544, SLA0314F00545, SLA0314F00546, SLA0314F00547, SLA0314F00548, SLA0314F00549, SLA0314F00550, SLA0314F00551, SLA0314F00551, SLA0314F00552, SLA0314F00553, SLA0314F00556, SLA0314F00557, SLA0314F00558, SLA0314F00559, SLA0314F00561, SLA0314F00562, SLA0314F00563, SLA0314F00565, SLA0314F00567, SLA0315F01027, SLA0315F01030, SLA0315F01031, SLA0315F01032, SLA0315F01033, SLA0315F01034, SLA0315F01035, SLA0315F01038, SLA0315F01039, SLA0315F01040, SLA0315F01041, SLA0315F01042, SLA0315F01043, SLA0315F01044, SLA0315F01045, SLA0315F01046, SLA0315F01047, SLA0315F01048, SLA0315F01049, SLA0315F01050, SLA0315F01051, SLA0315F01052, SLA03",2/26/2016,"02/26/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73394,"Completed","Progressive Gourmet Inc.","330 Ballardvale St",,"Wilmington","MA","01887-1012","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AK, NC,OK, TX, MD, LA","F-0005-2017","Class II","Sausage, Egg, and Cheese on English Muffin, Fully Cooked, Keep Frozen, Perishable-30/case  Manufactured Exclusively for Starbucks Coffee Company, Seattle, WA 98134  Product Date: 10/FEB/2016  SKU: 11041857  Not Labeled for Retail Sale","1168 cases (30/case)","Manufactured in a plant where routine environmental swabs tested positive for Listeria monocytogenes on a food contact surface.  ","10/03/2016",," Lot 04116  Exp. Date 07/AUG/2016",2/16/2016,"02/16/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73395,"Ongoing","Nephron Pharmaceuticals Corp.","4121 SW 34th St",,"Orlando","FL","32811-6475","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV and Internationally to Canada.","Z-2053-2016","Class II","Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only,  NDC 0487-9003-60.  A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer","11,208 cartons ","Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.","06/27/2016",," Lot Number N4745A, Exp 09/16",11/16/2015,"11/16/2015",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73395,"Ongoing","Nephron Pharmaceuticals Corp.","4121 SW 34th St",,"Orlando","FL","32811-6475","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV and Internationally to Canada.","Z-2054-2016","Class II","Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60.  A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer","13,692 cartons ","Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.","06/27/2016",," Lot Number N4753A, Exp 11/16",11/16/2015,"11/16/2015",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73396,"Ongoing","Ingredients Corporation Of America","1270 Warford St",,"Memphis","TN","38108-3421","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS, AL, TN, TX","F-0800-2016","Class II","KD's GOOD STUFF SEASONING, NET WT. 5#, KD's, 5395 McKinstry, Moscow, TN, 38057 ","10 units","Glass shards were found in a sealed bag of dehydrated minced garlic.  Parts of this shipment of garlic were used to manufacture other products.","03/23/2016",," lot number 19223",2/16/2016,"02/16/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73396,"Ongoing","Ingredients Corporation Of America","1270 Warford St",,"Memphis","TN","38108-3421","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS, AL, TN, TX","F-0801-2016","Class II","C & J BUTCHER SHOP, Recipe #10 BBQ Sauce, Net Wt. 763 oz. and 18.5oz., developed by & Available only from C&J Butcher Shop, Granbury, TN 76048 ","5 units, 763 oz. and 48 units 18.5oz","Glass shards were found in a sealed bag of dehydrated minced garlic.  Parts of this shipment of garlic were used to manufacture other products.","03/23/2016",," lot number 19226  ",2/16/2016,"02/16/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73396,"Ongoing","Ingredients Corporation Of America","1270 Warford St",,"Memphis","TN","38108-3421","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS, AL, TN, TX","F-0803-2016","Class II","BIG BOB GIBSON B-B-Q Seasoning and dry rub, 6.35 oz, 180.0225 g., Distributed by Mrs. Stratton's Salads, Inc., Birmingham, AL, UPC 8366577777","1800 units","Glass shards were found in a sealed bag of dehydrated minced garlic.  Parts of this shipment of garlic were used to manufacture other products.","03/23/2016",," lot number 19207",2/16/2016,"02/16/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73396,"Ongoing","Ingredients Corporation Of America","1270 Warford St",,"Memphis","TN","38108-3421","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS, AL, TN, TX","F-0802-2016","Class II","ICA GOURMET SEASONINGS, SESAME GARLIC DIP, 02-4772R1, NET WEIGHT 25 POUNDS, INGREDIENTS CORP. OF AMERICA, INC.","1 unit","Glass shards were found in a sealed bag of dehydrated minced garlic.  Parts of this shipment of garlic were used to manufacture other products.","03/23/2016",," lot number 19197",2/16/2016,"02/16/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73396,"Ongoing","Ingredients Corporation Of America","1270 Warford St",,"Memphis","TN","38108-3421","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS, AL, TN, TX","F-0799-2016","Class II","ICA GOURMET SEASONINGS, SIDE CAR HOUSE BLEND LESS SALT, 02-3992R4, NET WEIGHT 25 POUNDS, INGREDIENTS CORP. OF AMERICA, INC.    ","1 unit","Glass shards were found in a sealed bag of dehydrated minced garlic.  Parts of this shipment of garlic were used to manufacture other products.","03/23/2016",," lot number 19229",2/16/2016,"02/16/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73396,"Ongoing","Ingredients Corporation Of America","1270 Warford St",,"Memphis","TN","38108-3421","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MS, AL, TN, TX","F-0798-2016","Class II","ICA GOURMET SEASONINGS, No Salt Added, nsa SEASONING, House Seasoning, NET W. 20 oz  (1 LB. 4 OZ.) 567g, Packed by Ingredients Inc., Memphis, TN","400 units","Glass shards were found in a sealed bag of dehydrated minced garlic.  Parts of this shipment of garlic were used to manufacture other products.","03/23/2016",," lot number 19198  ",2/16/2016,"02/16/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73397,"Ongoing","Flowers For Less","1343 S Main St",,"Monmouth","IL","61462-2607","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Illinois only.","F-0810-2016","Class II","Linda's Black Bean and Corn Salsa in 16 oz. glass jars","58 units","Products produced under insanitary conditions following a breach in security.","03/25/2016",," Batch number 89123015",2/29/2016,"02/29/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73397,"Ongoing","Flowers For Less","1343 S Main St",,"Monmouth","IL","61462-2607","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Illinois only.","F-0808-2016","Class II","Linda's Salsa Medium in 16 oz. glass jars","76 units","Products produced under insanitary conditions following a breach in security.","03/25/2016",," Batch number 134123015",2/29/2016,"02/29/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73397,"Ongoing","Flowers For Less","1343 S Main St",,"Monmouth","IL","61462-2607","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Illinois only.","F-0809-2016","Class II","Linda's Salsa Hot in 16 oz. glass jars","71 units","Products produced under insanitary conditions following a breach in security.","03/25/2016",," Batch number 96123015",2/29/2016,"02/29/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73397,"Ongoing","Flowers For Less","1343 S Main St",,"Monmouth","IL","61462-2607","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Illinois only.","F-0807-2016","Class II","Linda's Salsa Mild in 16 oz. glass jars","129 units","Products produced under insanitary conditions following a breach in security.","03/25/2016",," Batch numbers 116122915 and 117123115",2/29/2016,"02/29/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73398,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally  to CHINA.","Z-1237-2016","Class II"," Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.","20"," Nephrostomy Balloon Set actually containing the  Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set and vice versa.","03/24/2016",," Catalog # UNBS-1 0-15-CS  GPN# G30357  Lot# 5082013  Exp: 06/01/2017",1/27/2016,"01/27/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73398,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally  to CHINA.","Z-1238-2016","Class II","Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set  The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.","20"," Nephrostomy Balloon Set actually containing the  Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set and vice versa.","03/24/2016",," Catalog # AUBS-6-4  GPN# G32840  Lot# 5083854  Exp: 06/01/2017",1/27/2016,"01/27/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0327-16","Class II","Apheresis Plasma Frozen withing 24 Hours After Phlebotomy",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615091607",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0331-16","Class II","Red Blood Cells, Leukocytes Reduced",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W038315020693, W038315020695, W038315020700, W038315020704, W038315020705, W038315020709, W038315020710, W038315020886, W038315020890, W038315021363, W038315021366, W333415009431, W333415013141, W333415013143, W333415013145, W333415013146, W333415013147, W333415016286, W333415016287, W333415016290, W333415017208, W333415017210, W333415017213, W333415017225, W333415017226, W333415017245, W333415020127, W333415020129, W333415020130, W333415020131, W333415020133, W333415020134, W333415020135, W333615048426, W333615066050, W333615066051, W333615066052, W333615066053, W333615066054, W333615066056, W333615066057, W333615066058, W333615066059, W333615066060, W333615066062, W333615066064, W333615066066, W333615066067, W333615066068, W333615066069, W333615066070, W333615066071, W333615066072, W333615066075, W333615066076, W333615066077, W333615066078, W333615067904, W333615075655, W333615075656, W333615075658, W333615075659, W333615075660, W333615075661, W333615075662, W333615075663, W333615075664, W333615075665, W333615075666, W333615079933, W333615080681, W333615080682, W333615080684, W333615080686, W333615080687, W333615080689, W333615080692, W333615080693, W333615080694, W333615080695, W333615080697, W333615080698, W333615080699, W333615080700, W333615080702, W333615082478, W333615082479, W333615082482, W333615083986, W333615083995, W333615083997, W333615083998, W333615084989, W333615084992, W333615084993, W333615084996, W333615084997, W333615084998, W333615085477, W333615085478, W333615086165, W333615086185, W333615086192, W333615086201, W333615086205, W333615086206, W333615086207, W333615087373, W333615087375, W333615087377, W333615087380, W333615087381, W333615087382, W333615087383, W333615087387, W333615090125, W333615090126, W333615090135, W333615090137, W333615090895, W333615090897, W333615090898, W333615090902, W333615090903, W333615090906, W333615090907, W333615090909, W333615090912, W333615091622, W333615091623, W333615091624, W333615091626, W333615091631, W333615092253, W333615092257, W333615092258, W333",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0329-16","Class II","Plasma Frozen Within 24 Hours After Phlebotomy (FP24)",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W038315020705, W038315020710, W038315021362, W038315021363, W333415009431, W333415013144, W333415013145, W333415013148, W333415016287, W333415016290, W333415017213, W333415020127, W333415020129, W333415020130, W333415020131, W333415020133, W333415020135, W333615048425, W333615066053, W333615066060, W333615066063, W333615066077, W333615067904, W333615080681, W333615080689, W333615080694, W333615082478, W333615082479, W333615084992, W333615084996, W333615085477, W333615086165, W333615086192, W333615087373, W333615087375, W333615087380, W333615087382, W333615090135, W333615090895, W333615090902, W333615091626, W333615093502",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0343-16","Class III","Red Blood Cells, Leukocytes Reduced, Irradiated",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W038315020708, W333615085479, W333615090117,   W333615090129  ",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0325-16","Class II","Cryoprecipitated AHF",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615066058, W333615066069, W333615075655, W333615075663, W333615080682, W333615080693, W333615080699, W333615083998, W333615084997, W333615086201, W333615087383, W333615090139, W333615090907, W333615090912, W333615091631, W333615092255, W333615093503",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0341-16","Class III","Red Blood Cells, Leukocytes Reduced",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W038315020692, W038315020885, W038315020887, W038315020888, W038315020891, W038315021358, W038315021361, W038315021365, W333415009427, W333415009428, W333415009429, W333415009430, W333415016284, W333415016293, W333415016295, W333415017215, W333415017216, W333415017220, W333415017228, W333415017229, W333415017230, W333415017233, W333615048429, W333615048432, W333615062098, W333615066055, W333615066074, W333615067902, W333615067906, W333615075657, W333615079924, W333615079932, W333615080688, W333615082483, W333615082484, W333615082486, W333615082490, W333615082491, W333615083996, W333615083999, W333615084000, W333615084994, W333615085476, W333615086159, W333615086164, W333615086179, W333615086187, W333615086194, W333615086200, W333615086203, W333615087374, W333615087385, W333615087393, W333615090115, W333615090121, W333615090130, W333615090133, W333615090134, W333615090899, W333615090900, W333615090901, W333615090905, W333615090910, W333615091612, W333615091613, W333615091618, W333615091619, W333615091633, W333615092251, W333615092252, W333615092254, W333615092256, W333615093504",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0330-16","Class II","Platelets",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615066051, W333615066053, W333615066054, W333615066056, W333615066057, W333615066058, W333615066060, W333615066061, W333615066062, W333615066063, W333615066064, W333615066068, W333615066069, W333615066070, W333615066071, W333615066072, W333615066075, W333615066077, W333615075655, W333615075656, W333615075658, W333615075659, W333615075660, W333615075661, W333615075662, W333615075663, W333615075664, W333615075665, W333615075666, W333615080684, W333615080686, W333615080688, W333615080689, W333615080692, W333615080693, W333615080694, W333615082478, W333615082479, W333615084989, W333615084992, W333615084996, W333615084997, W333615084998, W333615086165, W333615086185, W333615086192, W333615090125, W333615090135, W333615090139, W333615090895, W333615090897, W333615090906, W333615090907, W333615090908, W333615090911, W333615090912, W333615093506 ",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0334-16","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W038315021362, W333415013142, W333415013144, W333415013148, W333615062095, W333615066061, W333615066063, W333615086182, W333615090139, W333615090908, W333615090911",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0342-16","Class III","Platelets, Irradiated",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615066074, W333615082486, W333615090130  ",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0336-16","Class II","Blood and Blood Products for Reprocessing",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W038315020693, W038315020695, W038315020700, W038315020704, W038315020709, W038315020886, W038315020890, W038315021366, W333415013141, W333415013142, W333415013143, W333415013146, W333415013147, W333415016286, W333415017208, W333415017210, W333415017225, W333415017226, W333415017245, W333415020134, W333615048426, W333615062095, W333615066050, W333615066051, W333615066052, W333615066054, W333615066056, W333615066057, W333615066058, W333615066059, W333615066061, W333615066062, W333615066064, W333615066066, W333615066067, W333615066068, W333615066069, W333615066070, W333615066071, W333615066072, W333615066075, W333615066078, W333615075655, W333615075656, W333615075658, W333615075659, W333615075660, W333615075661, W333615075662, W333615075663, W333615075664, W333615075665, W333615075666, W333615079933, W333615080682, W333615080684, W333615080686, W333615080687, W333615080692, W333615080693, W333615080695, W333615080697, W333615080698, W333615080699, W333615080700, W333615080702, W333615083986, W333615083995, W333615083997, W333615083998, W333615084989, W333615084993, W333615084997, W333615084998, W333615085478, W333615086182, W333615086185, W333615086201, W333615086205, W333615086206, W333615086207, W333615087377, W333615087381, W333615087383, W333615087387, W333615090125, W333615090126, W333615090137, W333615090139, W333615090897, W333615090898, W333615090903, W333615090906, W333615090907, W333615090908, W333615090909, W333615090911, W333615090912, W333615091622, W333615091623, W333615091631, W333615092253, W333615092255, W333615092257, W333615092258, W333615093503, W333615093506 ",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0335-16","Class II","Apheresis Platelets, Leukocytes Reduced",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615089879, W333615091606, W333615091606, W333615091607, W333615091607",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0344-16","Class III","Blood and Blood Products for Reprocessing",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W038315020692, W038315020885, W038315020887, W038315020891, W038315021358, W333415009427, W333415009428, W333415009429, W333415009430, W333415009432, W333415009433, W333415016293, W333415017220, W333415017230, W333615048421, W333615048422, W333615048427, W333615048429, W333615048432, W333615062098, W333615062102, W333615066055, W333615066074, W333615075657, W333615079926, W333615079932, W333615079940, W333615080688, W333615080691, W333615082481, W333615082482, W333615082483, W333615082483, W333615082485, W333615082491, W333615083996, W333615083999, W333615084000, W333615084994, W333615085476, W333615085480, W333615086159, W333615086164, W333615086166, W333615086174, W333615086180, W333615086187, W333615086188, W333615086191, W333615086197, W333615086200, W333615086203, W333615087385, W333615087393, W333615090109, W333615090112, W333615090115, W333615090116, W333615090122, W333615090123, W333615090129, W333615090130, W333615090133, W333615090134, W333615090899, W333615090900, W333615090905, W333615090910, W333615091604, W333615091612, W333615091613, W333615091614, W333615091618, W333615091619, W333615091633, W333615092251, W333615092252, W333615092254, W333615092256, W333615092634, W333615092634, W333615093504",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0328-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333415009425 (double collection)",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0332-16","Class II","Pooled Cryoprecipitated AHF",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615077462, W333615077463, W333615077465, W333615077466, W333615077483, W333615091985, W333615091986, W333615091987, W333615091988, W333615091989, W333615091990, W333615091991, W333615091993, W333615094251, W333615094252, W333615094253, W333615094254, W333615094255, W333615094256, W333615094257, W333615094258, W333615094259, W333615094260, W333615094261, W333615094262, W333615094263, W333615094264, W333615094265, W333615094266, W333615094267, W333615094269, W333615094270, W333615094271, W333615094272, W333615094275, W333615094278, W333615094284, W333615094285, W333615094286, W333615094289, W333615094291, W333615094292 , W333615094294, W333615094307, W333615094308, W333615094347, W333615094348, W333615094351, W333615094352, W333615094366 ",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0337-16","Class III","Cryoprecipitated AHF",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615062102, W333615075657, W333615079940, W333615082491, W333615090109, W333615090130, W333615090905, W333615091633, W333615092254",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0339-16","Class III","Plasma Frozen within 24 Hours After Phlebotomy (FP24)",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W038315020708, W038315020888, W038315020895, W038315020896, W038315021361, W038315021365, W333415016284, W333415016295, W333415017212, W333415017215, W333415017216, W333415017228, W333415017229, W333415017233, W333615067902, W333615067906, W333615079924, W333615080703, W333615082480, W333615082484, W333615082486, W333615082487, W333615082488, W333615082489, W333615082490, W333615084991, W333615085479, W333615086175, W333615086179, W333615086194, W333615087374, W333615087376, W333615090117, W333615090121, W333615090140, W333615090901, W333615091610, W333615091611",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0333-16","Class II","Platelets, Irradiated",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615066050, W333615066059, W333615066067, W333615080681, W333615084993, W333615086182, W333615090137, W333615090898",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0326-16","Class II","Plasma Cryoprecipitate Reduced",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615075654, W333615091624  ",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0340-16","Class III","Platelets",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615066055, W333615075657, W333615082490, W333615082491, W333615084994, W333615086159, W333615086164, W333615086179, W333615086187, W333615086194, W333615090115, W333615090117, W333615090121, W333615090133, W333615090134, W333615090899, W333615090900, W333615090905, W333615090910, W333615093504 ",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73399,"Completed","Mississippi Valley Regional Blood Center","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Nationwide and Switzerland","B-0338-16","Class III","Apheresis Plasma Frozen withing 24 hours After Phlebotomy",,"Blood products, incorrectly tested for antibodies to HCV (anti-HCV), were distributed. ","03/07/2016",," W333615086168",11/20/2015,"11/20/2015",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73400,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","UT  Netherlands","Z-1265-2016","Class II","Vanguard XP Knee System  Porous Femoral Component  various sizes and orientation a total knee replacement system.    prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous,  coated, polymer/metal/polymer","890","The anterior/posterior (AP) dimension may be oversized by 0.016.   If the femoral component does not fit as tightly as intended, bony ingrowth may not occur causing loosening of the femoral component. A revision surgery may be necessary.   ","03/25/2016",," Part number; Description; Lot number    195929	Vanguard XP Porous Femoral Rt 52.5	055330  195929	Vanguard XP Porous Femoral Rt 52.5	105710  195929	Vanguard XP Porous Femoral Rt 52.5	105820  195929	Vanguard XP Porous Femoral Rt 52.5	273570  195929	Vanguard XP Porous Femoral Rt 52.5	727260  195929	Vanguard XP Porous Femoral Rt 52.5	727280  195930	Vanguard XP Porous Femoral Rt 55	054980  195930	Vanguard XP Porous Femoral Rt 55	727270  195930	Vanguard XP Porous Femoral Rt 55	727290  195930	Vanguard XP Porous Femoral Rt 55	727310  195930	Vanguard XP Porous Femoral Rt 55	886090  195930	Vanguard XP Porous Femoral Rt 55	961570  195930	Vanguard XP Porous Femoral Rt 55	961580  195931	Vanguard XP Porous Femoral Rt 57.5	054700  195931	Vanguard XP Porous Femoral Rt 57.5	054760  195931	Vanguard XP Porous Femoral Rt 57.5	054990  195931	Vanguard XP Porous Femoral Rt 57.5	055340  195931	Vanguard XP Porous Femoral Rt 57.5	105720  195931	Vanguard XP Porous Femoral Rt 57.5	105730  195931	Vanguard XP Porous Femoral Rt 57.5	105830  195931	Vanguard XP Porous Femoral Rt 57.5	624770  195931	Vanguard XP Porous Femoral Rt 57.5	624940  195932	Vanguard XP Porous Femoral Rt 60	054770  195932	Vanguard XP Porous Femoral Rt 60	054780  195932	Vanguard XP Porous Femoral Rt 60	055000  195932	Vanguard XP Porous Femoral Rt 60	055160  195932	Vanguard XP Porous Femoral Rt 60	105840  195932	Vanguard XP Porous Femoral Rt 60	519250  195932	Vanguard XP Porous Femoral Rt 60	624780  195932	Vanguard XP Porous Femoral Rt 60	624950  195932	Vanguard XP Porous Femoral Rt 60	624960  195932	Vanguard XP Porous Femoral Rt 60	961610  195932	Vanguard XP Porous Femoral Rt 60	961620  195932	Vanguard XP Porous Femoral Rt 60	996930  195933	Vanguard XP Porous Femoral Rt 62.5	054600  195933	Vanguard XP Porous Femoral Rt 62.5	054790  195933	Vanguard XP Porous Femoral Rt 62.5	055010  195933	Vanguard XP Porous Femoral Rt 62.5	055170  195933	Vanguard XP Porous Femoral Rt 62.5	055350  195933	Vanguard XP Porous Femoral Rt 62.5	105850  195933	Vanguard XP Porous Femoral Rt 62.5	",2/5/2016,"02/05/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73401,"Ongoing","Naturmed Inc DBA Institute for Vibrant Living","661 E Howards Rd Ste C",,"Camp Verde","AZ","86322-6521","United States","Voluntary: Firm Initiated","Letter","US","F-1005-2016","Class II","All Day Energy Greens (ADEG), Original Flavor, Net Wt 11.36 oz (322g), UPC Code 893320002096","563,499 units ","NatureMed Inc. dba Institute for Vibrant Living is recalling All Day Energy Greens powdered green drink due to some reported cases of gastrointestinal distress. ","03/30/2016",," 1406027  1406028  1406029  1406030  1406326  1406327  1406328  1406329  1406330  1406331  1406332  1406333  1406334  1406335  1406338  1406339  1406340  1406341  1406398  1406399  1406400  1406401  1406402  1406403  1412322  1412323  1412324  1412325  1412326  1412327  1412328  1412329  1412330  1412331  1412406  1412407  1412408  1412409  1412410  1412411  1412412  1412413  1501255  1501256  1501257  1501258  1505189  1505190  1505191",3/11/2016,"03/11/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73401,"Ongoing","Naturmed Inc DBA Institute for Vibrant Living","661 E Howards Rd Ste C",,"Camp Verde","AZ","86322-6521","United States","Voluntary: Firm Initiated","Letter","US","F-1006-2016","Class II","All Day Energy Greens Fruity (ADEGF), Great Fruity Taste!, Net Wt 10.5 oz (299g), UPC Code 893320002096 and 893320002423.  ","376,878 units ","NatureMed Inc. dba Institute for Vibrant Living is recalling All Day Energy Greens powdered green drink due to some reported cases of gastrointestinal distress. ","03/30/2016",," 1405460  1405461  1405462  1405463  1405464  1405465  1405466  1405467  1407114  1407115  1407116  1407117  1407118  1407119  1412332  1412333  1412337  1412334  1412335  1412336  1412338  1412339  1412340  1412341  1412415  1412416  1412417  1412418  1412419  1412420  1412421  1505180  1505181  1505182  1505183",3/11/2016,"03/11/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73402,"Ongoing","Biomet Spine, LLC","310 Interlocken Pkwy Ste 120",,"Broomfield","CO","80021-3464","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide - one foreign consignee (not Canada).","Z-1253-2016","Class II","10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Model Number 1400-1230.    Product Usage:  The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SOLITAIRETM ANTERIOR SPINAL SYSTEM is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SolitaireTM System is also indicated for treating fractures of the thoracic and lumbar spine. The SolitaireTM System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.  ","10","Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees.","03/25/2016",," P/N1400-1230 from Lot#2350871 from either loose inventory  or Kit 555000162, Date of Manufacture: April 16, 2013",2/12/2016,"02/12/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73403,"Ongoing","Stryker Medical Division of Stryker Corporation","3800 E Centre Ave",,"Portage","MI","49002-5826","United States","Voluntary: Firm Initiated","Letter","Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.","Z-1185-2016","Class II","Transport Stretcher, and Head and Neck Surgery Stretcher    Non-powered stretcher","36","The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events we","03/17/2016",," The hydraulic jack assemblies (Part numbers: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) used as service parts on Stretchers assembled from 8/28/15 - 8/29/15",2/5/2016,"02/05/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73403,"Ongoing","Stryker Medical Division of Stryker Corporation","3800 E Centre Ave",,"Portage","MI","49002-5826","United States","Voluntary: Firm Initiated","Letter","Distributed in DC and the states of AL, CA, FL, MN, MT, NC, NE, NY, PA, RI, TN, TX, UT, and WV.","Z-1184-2016","Class II","Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom)    Powered stretcher","36","The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear resistance additives as the specified oils and therefore its use increases the potential for wear which may cause a leak event or jack drift. Testing was done to evaluate the jacks with incorrect oil and leak events we","03/17/2016",," The hydraulic jack assemblies (Part numbers: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) used as service parts on Stretchers assembled from 8/28/15 - 8/29/15",2/5/2016,"02/05/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73406,"Terminated","BPL Plasma, Inc.","2631 Dunn Ave",,"Jacksonville","FL","32218-4656","United States","Voluntary: Firm Initiated","E-Mail","Belgium","B-0428-16","Class II","Source Plasma","1 unit","Blood product, in which quality control and distribution/testing not performed, incompletely performed, or not documented, was distributed.","04/14/2016","04/14/2016"," JV0305482; ",12/16/2015,"12/16/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73407,"Terminated","Neurotherm, Inc.","600 Research Dr Ste 1",,"Wilmington","MA","01887-4438","United States","Voluntary: Firm Initiated","Telephone","US Nationwide Distribution in the states of CA ,CO, OH, OR","Z-1247-2016","Class II","Neurotherm  Curved Radiofrequency (RF) cannnula 10 cm   18 gauge, 10 mm active tip  Model Number: C-1010-R-18    Product Usage:  The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.  ","135 cannulas (27 boxes/5)","Straight needle labeled as a curved needle","03/24/2016","03/25/2016"," Lot number: 12131-1C",2/26/2013,"02/26/2013",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73408,"Ongoing","Whole Foods Market","550 Bowie St",".","Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","Press Release","Nationwide","F-1002-2016","Class I","Whole Foods Market Maytag Blue Cheese, Maytag Blue Raw Milk, Maytag Iowa Blue Cheese cut and wrapped in clear plastic wrap, Dist. by Whole Foods Market 550 Bowie Street Austin, TX 78703, PLU: 0293308","1156 pounds","Possible contamination with Listeria monocytogenes.","04/07/2016",," PLU numbers beginning with 293308 with sell by dates of 1/20/2016 through 3/21/2016.",2/29/2016,"02/29/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73409,"Ongoing","Northwest Specialty, Inc.","2624 112th St S Ste E2",,"Lakewood","WA","98499-8867","United States","Voluntary: Firm Initiated","E-Mail","distributed in AK, OR, and WA","F-0784-2016","Class II","Dried lactose powder, product sold under brand Wine-King Beer-King,  packaged in three consumer-sized plastic bags of 4 oz., 1 Lb. and 5 Lb. net weight.  ","55/4 oz. bags; 247/1 lb. bags; and 45/5 lbs. bags","Dried Lactose powder product, which is used in brewery to make beer, does not declare whey or milk and the label declared lactose only.","03/22/2016",," None",2/25/2016,"02/25/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73410,"Terminated","Neurotherm, Inc.","600 Research Dr Ste 1",,"Wilmington","MA","01887-4438","United States","Voluntary: Firm Initiated","Telephone","CA, CO, IA, ME, NJ,  NY,  SC, TX, WI","Z-1361-2016","Class II","Neurotherm  NT2000iX RF Generator  Model Number: RFG-NT -2000iX","25","NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use.","04/09/2016","04/14/2016"," Serial Numbers:  2593-13, 2717-13,  2616-13, 2704-13, 2735-13, 2360-12, 2732-13, 2727-13,   2284-11, 2726-13,  2728-13, 2426-12, 2700-13, 2508-12, 2643-13, 2733-13,   2730-13,  2724-13, 2453-12,  2631-13, 2171-11, 2059-10, 2729-13 ,2294-12,  2725-13",10/9/2013,"10/09/2013",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73411,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including Puerto Rico.","Z-1277-2016","Class II"," Estradiol II  Elecsys and cobas e analyzers REF 03000079 190;  M 6.5mL, R1 8 mL, R2 8 mL, IVD,    For USA: CONTENT  M Streptavidin-coated microparticles 0.72 mg/mL; R1 Biotinylated polyclonal anti-estradiol antibody (rabbit) 45 ng/mL; Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruthenium complex 2.75 ng/mL    Product Usage:  Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.  ","102,312","Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant.  Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug.  If treatment with fulvestrant has been altered or discontinued as a result  of falsely elevated e","03/31/2016",," Part Number  Elecsys Estradiol II : 03000079190; all lot numbers are affected.",3/7/2016,"03/07/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73411,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including Puerto Rico.","Z-1276-2016","Class II","Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL,    For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruthenium complex 4.5 ng/mL; Rx only    Product Usage:  Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.  ","23,630","Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant.  Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug.  If treatment with fulvestrant has been altered or discontinued as a result  of falsely elevated e","03/31/2016",," Elecsys Estradiol III: 06656021190; all lot numbers are affected.",3/7/2016,"03/07/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73412,"Ongoing","Dexcom Inc","6340 Sequence Dr",,"San Diego","CA","92121-4356","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.","Z-1335-2016","Class I","Dexcom G4 PLATINUM (Pediatric) Receiver  Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics).  Intended to detect trends and track glucose patterns in persons with diabetes.","18,004","Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.","04/11/2016",," Receiver Kit Number:  STK-KD-001  STK-KX-001  STR-KD-001  STK-KD-PNK  STK-KX-PNK  STR-KD-PNK  STK-KD-BLU  STK-KX-BLU  STR-KD-BLU    Lot Number:  5120310  5135364  5135371  5136498  5150416  5150452  5159486  5166429  5166430  5178449  5179449  5187476  5189594  5190724  5191132  5191133  5191174  5191809  5191810  5191849  5192890  5194119  5194120  5194121  5194431  5195411  5195746  5195763  5195776  5195784  5196133  5196159  5197032  5197033  5197647  5120312  5135362  5135368  5135380  5136502  5139380  5150418  5150454  5153433  5159487  5166433  5166449  5166450  5171430  5178418  5178456  5179453  5187474  5189590  5190725  5191105  5191134  5191135  5191408  5191839  5191840  5191841  5192942  5193958  5193959  5193960  5194123  5194432  5194433  5195412  5195459  5195747  5195766  5195965  5195969  5195972  5196087  5196134  5196918  5197034  5197035  5197614  5197615  5120311  5135363  5135366  5135381  5136500  5139379  5150417  5150453  5159488  5166434  5166435  5171431  5178451  5179451  5187426  5187475  5188748  5191106  5191136  5191409  5191836  5191837  5193810  5194186  5194335  5194400  5194563  5195413  5195745  5195768  5195785  5195973  5197036  5197037  5197038  5197608  5126237  5135369  5136504  5142406  5142408  5142415  5167425  5179455  5189600  5194188  5194562  5195759  5195786  5196151  5197648  5126238  5135370  5136505  5142417  5167426  5176427  5179457  5189602  5191151  5191838  5194192  5195760  5195787  5197563  5197649  5126239  5135361  5139386  5142416  5167427  5179456  5189601  5191103  5194190  5194191  5195761  5196995  5197650  5120293  5135365  5150455  5153439  5166437  5179450  5191101  5191811  5194201  5195416  5195966  5197505  5197571  5197676  5201468  5120294  5135379  5139382  5150439  5152419  5166440  5173415  5178458  5179454  5187477  5191099  5191410  5191812  5191848  5194202  5194561  5195415  5195750  5195793  5195967  5195976  5196156  5196157  5197641  5197642  5198439  5120309  5135367  5139381  5153441  5166438  5179452  5189593  5191100  ",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73412,"Ongoing","Dexcom Inc","6340 Sequence Dr",,"San Diego","CA","92121-4356","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.","Z-1334-2016","Class I","Dexcom G4 PLATINUM Receiver  Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue.  Intended to detect trends and track glucose patterns in persons with diabetes.","131,768","Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.","04/11/2016",," Receiver Kit Number:  STK-GL-001  STK-RX-001  STR-GL-001  STK-GL-PNK  STK-RX-PNK  STR-GL-PNK  STK-GL-BLU  STK-RX-BLU  STR-GL-BLU    Lot Number:  2009655  5022776  5022797  5032813  5032814  5032815  5039607  5045819  5045820  5045821  5045822  5045823  5045824  5045825  5045826  5045827  5046248  5046249  5046250  5046251  5046252  5046254  5046344  5046345  5046346  5046347  5046348  5046349  5046350  5046351  5046352  5046353  5046354  5046355  5046356  5046464  5046465  5046466  5046467  5046468  5046469  5047822  5047823  5047824  5047825  5047826  5047827  5047828  5047829  5047830  5049500  5049501  5049502  5049503  5049504  5049505  5049506  5049507  5049508  5049509  5049510  5049511  5049512  5049513  5049514  5049515  5053609  5053610  5053611  5053612  5053613  5053614  5053615  5053616  5053617  5053618  5053619  5053620  5053621  5053622  5053623  5053624  5055634  5055635  5055636  5055637  5060693  5067169  5067170  5067171  5067172  5067173  5067174  5067175  5067176  5067181  5067182  5067183  5067184  5067185  5067187  5067188  5067189  5067190  5067191  5067192  5067193  5067194  5067195  5069027  5069028  5069029  5069030  5069031  5069032  5069033  5069034  5073057  5073058  5073059  5073060  5073061  5073062  5073063  5073064  5073065  5073066  5073067  5073068  5073069  5073070  5073071  5073072  5073073  5076223  5076224  5076225  5076226  5076227  5076229  5076305  5076306  5076307  5076308  5076309  5076310  5076311  5076312  5076313  5076314  5078033  5078034  5079118  5079119  5079120  5079121  5079122  5079123  5079124  5086279  5086280  5086281  5086282  5089155  5090161  5091222  5091223  5091224  5091225  5091227  5091228  5091229  5091230  5091232  5091233  5091234  5091237  5091238  5091239  5100224  5101229  5101230  5105229  5105259  5106224  5106228  5106229  5106230  5106240  5106241  5106242  5106247  5106248  5117263  5117264  5117265  5117266  5117267  5117268  5117269  5117284  5117285  5117286  5117287  5117289  5118235  5118236  5118237  5118238  5118239  5129232  ",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73412,"Ongoing","Dexcom Inc","6340 Sequence Dr",,"San Diego","CA","92121-4356","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.","Z-1339-2016","Class I","Dexcom G5 Mobile Receiver  Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK,  Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue.  Intended to detect trends and track glucose patterns in persons with diabetes.","41,925","Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.","04/11/2016",," Receiver Kit Number:  STK-GF-001  STK-RF-001  STR-GF-001  STK-GF-PNK  STK-RF-PNK  STR-GF-PNK  STK-GF-BLU  STK-RF-BLU  STR-GF-BLU    Lot Number:  5204518  5204520  5204526  5204529  5204546  5204644  5204647  5204697  5204752  5204756  5204760  5204764  5204941  5204959  5204995  5205003  5205015  5205024  5205039  5205057  5205059  5206564  5206577  5206601  5206618  5206630  5206724  5207977  5207978  5207983  5207994  5208000  5208001  5208013  5208014  5208017  5208026  5208027  5208030  5208034  5208263  5208264  5208349  5208350  5208512  5208515  5208524  5208525  5208799  5208803  5208817  5209310  5209311  5209313  5209657  5209660  5210388  5210468  5204519  5204525  5204528  5204545  5204645  5204648  5204698  5204754  5204758  5204952  5205007  5205029  5205050  5206565  5206576  5206606  5206623  5207980  5207987  5207996  5208009  5208513  5208523  5208815  5209314  5209317  5209319  5209658  5209661  5210391  5204521  5204527  5204530  5204646  5204699  5204757  5204761  5204947  5205008  5205036  5205045  5206569  5206615  5206622  5206653  5206657  5206725  5208024  5208519  5208808  5208822  5209320  5209659  5209662  5210397  5210475  5204522  5204539  5204687  5204753  5204953  5204999  5205011  5205035  5206570  5206580  5206610  5209664  5209694  5204523  5204540  5204690  5204783  5204996  5205019  5205061  5206568  5209665  5209669  5204524  5204541  5204693  5204759  5205004  5205062  5206578  5209666  5209670  5204542  5204694  5204955  5205023  5205044  5205052  5209919  5210031  5210040  5210395  5210474  5204543  5204695  5204956  5205030  5205056  5209920  5210032  5210396  5204544  5204696  5204957  5205017  5205040  5210016  5210033",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73412,"Ongoing","Dexcom Inc","6340 Sequence Dr",,"San Diego","CA","92121-4356","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.","Z-1336-2016","Class I","Dexcom G4 PLATINUM (Professional) Receiver  Receiver Part Number: MT20649 Receiver (mg/dL), Black.  Intended to detect trends and track glucose patterns in persons with diabetes.    The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.  ","5,722","Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.","04/11/2016",," Receiver Kit Number:  STK-PU-001    Lot Number:  5176532  5176533  5176534  5176535  5176536  5188586  5189596  5190560  5191152  5191737  5191738  5192934  5193038  5194193  5194322  5195147  5195148  5195352  5195803  5195913  5196152  5197013  5197677  5198614  5200903  5200904  5200916  5201455  5201669  5202100  5202149  5202429  5202646  5202790  5202795  5202803  5202804  5202906  5203313  5203474  5203485  5203536  5204330  5204333  5205041  5206612  5206643  5208018  5208332  5208810  5210472  ",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73412,"Ongoing","Dexcom Inc","6340 Sequence Dr",,"San Diego","CA","92121-4356","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.","Z-1337-2016","Class I","Dexcom G4 PLATINUM Receiver with Share  Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK,  Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue.  Intended to detect trends and track glucose patterns in persons with diabetes.","53,106","Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.","04/11/2016",," Receiver Kit Number:  STK-DR-001  STK-RR-001  STR-DR-001  STK-DR-PNK  STK-RR-PNK  STR-DR-PNK  STK-DR-BLU  STK-RR-BLU  STR-DR-BLU    Lot Number:  5197900  5197901  5197902  5197903  5197904  5197905  5197906  5197907  5197908  5197909  5197962  5197964  5197965  5198423  5198424  5198425  5198432  5198433  5198446  5198448  5198455  5198456  5198457  5198463  5198493  5198495  5198496  5198497  5198505  5198506  5198557  5198558  5198559  5198560  5198561  5198567  5198607  5198608  5198894  5198895  5199491  5200521  5200548  5200612  5200682  5200688  5200833  5200834  5201244  5201245  5201282  5201292  5201378  5201380  5201418  5201419  5201420  5201422  5201423  5202036  5202037  5202038  5202039  5202040  5202041  5202042  5202043  5202044  5202045  5202046  5202047  5202048  5202049  5202050  5202051  5202052  5202247  5202301  5202304  5202410  5202411  5202426  5202776  5202777  5202786  5202787  5202796  5202797  5202866  5202869  5202873  5202879  5203264  5203296  5203305  5203315  5203323  5203324  5203503  5204322  5204943  5204949  5205009  5205058  5206616  5206626  5206726  5207988  5208004  5208038  5208514  5208516  5208520  5208809  5208888  5209615  5209667  5209671  5210272  5197928  5197929  5197930  5197931  5197932  5197969  5197983  5198394  5198395  5198414  5198415  5198417  5198426  5198428  5198429  5198449  5198893  5199015  5199034  5199035  5199211  5199212  5200520  5200549  5200611  5200686  5200828  5201241  5201242  5201246  5201259  5201260  5201261  5201406  5201407  5201409  5201410  5201411  5202026  5202028  5202029  5202030  5202031  5202032  5202033  5202034  5202111  5202116  5202129  5202305  5202422  5202732  5202781  5202792  5202865  5202870  5202872  5203284  5203321  5203325  5203473  5204315  5204318  5204948  5205016  5206631  5208010  5208379  5208521  5208889  5209672  5209673  5210392  5197944  5197972  5197974  5197978  5197979  5197980  5198483  5198508  5198509  5198510  5198903  5199014  5199161  5199463  5199464  5199466         5200552             ",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73412,"Ongoing","Dexcom Inc","6340 Sequence Dr",,"San Diego","CA","92121-4356","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.","Z-1338-2016","Class I","Dexcom G4 PLATINUM (Pediatric) Receiver with Share  Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics).  Intended to detect trends and track glucose patterns in persons with diabetes.","19,586","Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.","04/11/2016",," Receiver Kit Number:  STK-PR-001  STK-CR-001  STR-PR-001  STK-PR-PNK  STK-CR-PNK  STR-PR-PNK  STK-PR-BLU  STK-CR-BLU  STR-PR-BLU    Lot Number:  5197950  5198382  5199018  5200680  5201286  5201394  5202064  5202065  5202311  5202779  5203297  5204321  5197967  5198434  5198901  5199013  5199213  5200586  5201276  5201288  5201391  5202073  5202074  5202420  5202801  5203631  5204325  5205014  5197968  5198378  5198896  5201272  5201376  5202084  5202085  5202432  5202881  5203322  5204328  5197951  5197952  5197953  5197954  5198371  5198372  5198373  5198381  5198488  5198489  5198490  5198491  5198511  5198711  5199020  5199021  5199206  5199208  5201231  5201232  5201283  5201284  5201388  5201389  5201995  5201998  5202066  5202067  5202068  5202069  5202070  5202071  5202072  5202308  5202417  5202421  5202780  5202877  5203320  5203472  5204962  5208005  5209676  5209677  5197955  5197956  5197957  5198374  5198409  5198418  5198419  5198435  5198436  5198437  5198450  5198613  5198710  5198898  5198902  5198998  5199000  5199017  5199215  5199216  5199217  5200587  5200652  5200653  5200654  5200655  5200656  5200657  5201233  5201234  5201243  5201247  5201248  5201249  5201277  5201278  5201279  5201287  5201386  5201393  5202075  5202076  5202077  5202078  5202079  5202080  5202081  5202082  5202307  5202412  5202418  5202799  5202896  5203291  5203316  5205000  5207992  5210398  5210399  5197958  5197959  5197960  5197961  5198375  5198376  5198377  5198386  5198387  5198427  5198447  5198712  5198742  5198743  5198744  5198900  5198999  5199019  5200588  5200589  5200590  5200591  5201235  5201236  5201237  5201238  5201239  5201273  5201274  5201997  5202086  5202093  5202094  5202095  5202096  5202423  5202428  5202785  5202802  5202878  5203286  5203328  5204311  5209680  5209681  5197910  5198379  5198899  5200522  5201285  5201387  5201398  5202312  5202424  5202897  5205010  5206620  5208805  5210020  5210067  5210394  5197966  5199016  5199214  5200583  5201250  5201275  5201289  5201385  ",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73413,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.","Z-1645-2016","Class I","Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.","5,575 kits","Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.","05/11/2016",," Lots 744357740 exp. 9/29/16, 744383620 exp. 6/15/17, and 744389320 exp. 8/11/17.",2/24/2016,"02/24/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73413,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.","Z-1641-2016","Class I","Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579),  20 cards/kit.     Product  Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.  ","7,497 kits","Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.","05/11/2016",," Lots 740340920 exp. 4/14/16, 740350820 exp. 7/22/16, 740356320 exp. 9/15/16, 740361110 exp. 11/2/16, 740371720 exp. 2/16/17, 740386420 exp. 7/13/17, and 740388520 exp. 8/3/17. ",2/24/2016,"02/24/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73413,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.","Z-1646-2016","Class I","Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.","1,524 kits","Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.","05/11/2016",," Lots 745363420 exp. 11/25/16 and 745375920 exp. 3/30/17.",2/24/2016,"02/24/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73413,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.","Z-1639-2016","Class I","Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.  ","495 kits","Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.","05/11/2016",," Lots 736336020 exp. 2/25/16, 736340920 exp. 4/14/16, and 736388620 exp. 8/4/17.  ",2/24/2016,"02/24/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73413,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.","Z-1642-2016","Class I","Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.","3,594 kits","Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.","05/11/2016",," Lots 741340920 exp. 4/14/16, 741350820 exp. 7/22/16, 741356320 exp. 9/15/16, 741357020 exp. 9/22/16, and 741366820 exp. 12/29/16.",2/24/2016,"02/24/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73413,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.","Z-1647-2016","Class I","Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.","1,035 kits","Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.","05/11/2016",," Lots 746382820 exp. 6/7/17 and 746386520 exp. 7/14/17 .",2/24/2016,"02/24/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73413,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.","Z-1644-2016","Class I","Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.","2,570 kits","Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.","05/11/2016",," Lots 743357720 exp. 9/29/16, 743366820 exp. 12/29/16, 743376510 exp. 4/5/17, 743380820 exp. 5/18/17, and 743387820 exp. 7/27/17.",2/24/2016,"02/24/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73413,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.","Z-1640-2016","Class I","Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit.     Product  Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.  ","180 kits","Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.","05/11/2016",," Lots 739348620 exp. 6/30/16, 739348622 exp. 6/30/16, and 739348623 exp. 6/30/16. ",2/24/2016,"02/24/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73413,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.","Z-1643-2016","Class I","Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit.     Product Usage:  The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.","15,006 kits","Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.","05/11/2016",," Lots 742343610 exp. 5/11/16, 742347220 exp. 6/16/16, 742350010 exp. 7/14/16, 742352820 exp. 8/11/16, 742355710 exp. 9/9/16, 742362540 exp. 11/16/16, 742364020 exp. 12/1/16, 742368210 exp. 1/12/16, 742376540 exp. 4/5/17, 742383610 exp. 6/15/17, and 742389220 exp. 8/10/17.",2/24/2016,"02/24/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73414,"Terminated","Community Blood Center of Carolinas","4447 South Blvd",,"Charlotte","NC","28209-2674","United States","Voluntary: Firm Initiated","FAX","North Carolina","B-0429-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.","04/14/2016","04/14/2016"," W398516008348K; ",1/18/2016,"01/18/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73415,"Ongoing","Constantine Poulos and Company dba International Foods, Inc.","220 Pioneer Dr",,"Williston","VT","05495-7526","United States","Voluntary: Firm Initiated","Letter","Product was distributed prior to February 11, 2016 in OH, MA, NH, NC, and ME","F-0819-2016","Class II","DELPHI GREEK PEPPERONCINI; Peppers, Water, Salt, Vinegar, Citric Acid, Sodium Benzoate.  INTERNATIONAL FOODS, INC. BURLINGTON, VT 05401 NET Weight 3 lb. 8 oz.   Product is stored at ambient temperature.  ","Unknown by firm. ","Product contains undeclared sulfites. ","03/30/2016",," LOT# OCT 28 USE BY JUNE 30, 2016  LOT# 1120 USE BY JULY 30, 2016",3/4/2016,"03/04/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73416,"Terminated","Southeastern Grocers","5050 Edgewood Ct",,"Jacksonville","FL","32254-3601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA","F-0779-2016","Class I","Bi-Lo, Fresh Cantaloupe, Chunks Medium Container, Chunks Large Container, Halves and Slices, various net wt., in clear plastic containers.","10 containers (various cuts and sizes)","Product sample result tested positive for Listeria species.","03/21/2016","04/12/2016"," Cantaloupe Chunks Medium Container  UPC 020436000000, SELL BY 2/24/16, Cantaloupe Chunks Large Container  UPC 020463100000, SELL BY 2/24/16 and Cantaloupe Halves  UPC 020434600000, SELL BY 2/24/16.",2/26/2016,"02/26/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73416,"Terminated","Southeastern Grocers","5050 Edgewood Ct",,"Jacksonville","FL","32254-3601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA","F-0782-2016","Class I","Bi-Lo, Walters Fruit Tray Cantaloupe (Cantaloupe, Grapes and Strawberries), various net wt., in clear plastic trays.","1 tray","Product sample result tested positive for Listeria species.","03/21/2016","04/12/2016"," UPC 020031400000, SELL BY 2/24/16.",2/26/2016,"02/26/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73416,"Terminated","Southeastern Grocers","5050 Edgewood Ct",,"Jacksonville","FL","32254-3601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA","F-0781-2016","Class I","Bi-Lo, Mixed Fruit Bowl (in Medium, and Large containers), containing Strawberries, Grapes, Honeydew, Cantaloupe, Pineapple, Watermelon, Blueberries, Blackberries, Raspberries and Kiwi, various net wt., in clear plastic containers.","5 containers (medium and large)","Product sample result tested positive for Listeria species.","03/21/2016","04/12/2016"," Mixed Fruit Bowl Medium Container  UPC 020448300000, SELL BY 2/24/16 and Mixed Fruit Bowl Large Container  UPC 020448100000, SELL BY 2/24/16.  ",2/26/2016,"02/26/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73416,"Terminated","Southeastern Grocers","5050 Edgewood Ct",,"Jacksonville","FL","32254-3601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA","F-0780-2016","Class I","Bi-Lo, Mixed Melon Chunks (in Medium, and Large containers), containing Cantaloupe, Honeydew and Watermelon, various net wt. in clear plastic containers.","7 containers (medium and large)","Product sample result tested positive for Listeria species.","03/21/2016","04/12/2016"," Mixed Melon Chunks Medium Container  UPC 020436300000, SELL BY 2/24/16 and  Mixed Melon Chunks Large Container  UPC 020436400000, SELL BY 2/24/16",2/26/2016,"02/26/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73417,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.","Z-1269-2016","Class II","MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41    Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026.    Japan:  10638819 LabPro v4.11 Software Update Kit  10638820 LabPro v4.11 System Software  10805072 LabPro MBT Non-Connect Systems v4.30  10805073 LabPro MBT Connect Systems v4.30  Canada:  6000-0008 LabPro v4.41 Panel Update-06 Kit  6000-0026 LabPro Connect v4.41 Panel Update-06 Kit  10638823 LabPro v4.11 Software Update Kit  10638825 LabPro v4.11 System Software  10638824 LabPro v4.11 Software Update Kit  Europe:  10638824 LabPro v4.11 Software Update Kit  10638826 LabPro v4.11 System Software  USA:  10714149, LabPro v4.11 Software Update Kit  10714150 LabPro v4.11 System Software  10975000 ASM LabPro-MBT v4.40  10975001 ASM LabPro-MBT v4.40 for Connect  6000-0008 LabPro v4.41 Panel Update-06 Kit  6000-0026 LabPro Connect v4.41 Panel Update-06 Kit  ROW:  6000-0008 LabPro v4.41 Panel Update-06 Kit  10638823 LabPro v4.11 Software Update Kit  10638825 LabPro v4.11 System Software  10638824 LabPro v4.11 Software Update Kit  10638826 LabPro v4.11 System Software    Product Usage:  LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.  ","2,702 units total (1,032 units in US)","Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.","03/28/2016",," not applicable",2/11/2016,"02/11/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73418,"Ongoing","ProSupps USA LLC","2801 E Plano Pkwy",,"Plano","TX","75074-7418","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US including: PA, FL, NV, WI, UT, NC, CA, TX, OH, CT, VA, AZ, SC, IN, AR, GA, MS, CO, NJ","F-1000-2016","Class III","Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 30 SERVINGS WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 7.5 OZ (213 GRAMS) and Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 15.0 OZ (426 GRAMS) both packaged in red plastic jars with black lids.","3890 units","Product could be potentially mislabeled and contain non-dietary ingredient Picamilon.","03/29/2016",," 110625 and 138201115",3/2/2016,"03/02/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73418,"Ongoing","ProSupps USA LLC","2801 E Plano Pkwy",,"Plano","TX","75074-7418","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US including: PA, FL, NV, WI, UT, NC, CA, TX, OH, CT, VA, AZ, SC, IN, AR, GA, MS, CO, NJ","F-1001-2016","Class III","Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 15 SERVINGS BLUERAZZ NATURAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 3.7 OZ (105 GRAMS) packaged in red plastic jars with black lids.","33 units","Product could be potentially mislabeled and contain non-dietary ingredient Picamilon.","03/29/2016",," 120785",3/2/2016,"03/02/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73418,"Ongoing","ProSupps USA LLC","2801 E Plano Pkwy",,"Plano","TX","75074-7418","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US including: PA, FL, NV, WI, UT, NC, CA, TX, OH, CT, VA, AZ, SC, IN, AR, GA, MS, CO, NJ","F-0999-2016","Class III","Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 15 SERVINGS ORANGE BURST  NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 4.0 OZ (113 GRAMS) and Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 30 SERVINGS ORANGE BURST NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 7.9 OZ (225 GRAMS) both packaged in red plastic jars with black lids.","4897 units","Product could be potentially mislabeled and contain non-dietary ingredient Picamilon.","03/29/2016",," 110635 and 110575",3/2/2016,"03/02/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73418,"Ongoing","ProSupps USA LLC","2801 E Plano Pkwy",,"Plano","TX","75074-7418","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US including: PA, FL, NV, WI, UT, NC, CA, TX, OH, CT, VA, AZ, SC, IN, AR, GA, MS, CO, NJ","F-0997-2016","Class III","Prosupps Dr. Jekyll INTENSE PUMP PRE WORKOUT, 30 SERVINGS, WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 11.1 OZ (315 GRAMS) packaged in red plastic jars with black lids.","4402 units","Product could be potentially mislabeled and contain non-dietary ingredient Picamilon.","03/29/2016",," 110725",3/2/2016,"03/02/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73418,"Ongoing","ProSupps USA LLC","2801 E Plano Pkwy",,"Plano","TX","75074-7418","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US including: PA, FL, NV, WI, UT, NC, CA, TX, OH, CT, VA, AZ, SC, IN, AR, GA, MS, CO, NJ","F-0998-2016","Class III","Prosupps Dr. Jekyll, INTENSE PUMP PRE WORKOUT, 30 SERVINGS, FRUIT PUNCH NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 11.4 OZ (324 GRAMS) packaged in red plastic jars with black lids.","5014 units","Product could be potentially mislabeled and contain non-dietary ingredient Picamilon.","03/29/2016",," 120795",3/2/2016,"03/02/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73419,"Ongoing","Apotex Scientific, Inc","2100 Rd To Six Flags Dr",,"Arlington","TX","76011","United States","Voluntary: Firm Initiated","Letter","Nationwide, Alaska, Hawaii, and Puerto Rico.","D-1435-2016","Class III","Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by  Apotex  Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;  ","107,880 (60 ct bottle)","Failed Dissolution Specification: Out of specification dissolution results when testing product stability.","07/14/2016",," Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.                  ",1/26/2016,"01/26/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73419,"Ongoing","Apotex Scientific, Inc","2100 Rd To Six Flags Dr",,"Arlington","TX","76011","United States","Voluntary: Firm Initiated","Letter","Nationwide, Alaska, Hawaii, and Puerto Rico.","D-1436-2016","Class III","Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by  Apotex  Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;  ","605,989 (30 ct) bottles","Failed Dissolution Specification: Out of specification dissolution results when testing product stability.","07/14/2016",," Lot #: KW2167,KY9960, KV9789, KV9788; Exp 02/29/2016;   Lot #: KY9961, Exp 04/30/2016;  Lot #: KX6311, KX6312, KY7795, KX6315, Exp 05/31/2016; Lot #: KX6317, Exp 06/30/2016.  ",1/26/2016,"01/26/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73419,"Ongoing","Apotex Scientific, Inc","2100 Rd To Six Flags Dr",,"Arlington","TX","76011","United States","Voluntary: Firm Initiated","Letter","Nationwide, Alaska, Hawaii, and Puerto Rico.","D-1437-2016","Class III","Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by  Apotex  Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.  ","750,273 (30 ct) bottles","Failed Dissolution Specification: Out of specification dissolution results when testing product stability.","07/14/2016",," Lot #: KY5120, KW2164, KY9953, KV9791, KV9792, Exp 03/31/2016. ",1/26/2016,"01/26/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73420,"Ongoing","Sun Pharma Global Fze","Office # 43 Block Y Saif Zone",,"Sharm",,,"United Arab Emirates","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-0735-2016","Class II","Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ  08512; NDC 41616-638-68, UPC 3 41616 63868 4.","381,120 cartons","Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.","03/03/2016",," Lot #s: JKP2234A, JKP2235A, Exp 04/17  ",2/11/2016,"02/11/2016",3/9/2016,"03/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73421,"Ongoing","Deerfield Imaging","5101 Shady Oak Rd S",,"Minnetonka","MN","55343-4100","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including the states of CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX, UT, VA, and WI; and ,countries of CHINA, CANADA, AUSTRALIA, FRANCE, JAPAN, and GERMANY.","Z-1098-2016","Class II","Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S.    Indicated for use as a magnetic resonance diagnostic device (MRDD).","35 USA, 14 OUS","Emergency helium venting lines (i.e. quench lines) may not have been properly installed.  ","03/11/2016",," 70036, 10076-21, M00004, 10073-01, 23529, 40481, M00152, M00005,  30445, M00169, 060014, 10043-00, 30823, 10004680, 10050-01, 40662, 30935, 31084, 31203, 10002221, 40510, 40613, 30719, 31046, 30910, 30832, 30623, 31213, 10004152, 10072-01, 31250, 40815, 31049, 30068, 40412, M0038, M00106, M00367, 10035-01, 40475, 40495, 10007498, 10005946, 40263, 40688, 10058-00, 40619, 31085, and 10005639.",2/10/2016,"02/10/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73422,"Ongoing","CHG Hospital Beds Inc","153 Towerline Place",,"London",,,"Canada","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Canada.","Z-1176-2016","Class II","The Spirit TM Select bed is a Med-Surg bed intended to support and transport  low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.","1892","It was identified that in some situations the bed exit alarm may not function as intended. The software code for the bed exit system has the potential to auto-reset erroneously. In some situations, the software code does not allow enough time for the weight value to fall to zero once the patient egresses from the bed, in which case, the bed has the potential to reset the bed exit alarm even with","03/15/2016",," Model number 5700  Individual bed SN  029873                     030162                     030163                     030184                     030185                     030186                     030187                     030188                     030189                     030190                     030191                     030192                     030193                     030194                     030195                     030196                     030197                     030198                     030199                     030200                     030201                     030202                     030203                     030222                     030233                     030234                     030235                     030239                     030240                     030398                     030399                     030400                     030401                     030402                     030403                     030404                     030405                     030406                     030419                     030420                     030421                     030422                     030423                     030424                     030425                     030426                     030427                     030428                     030429                     030430                     030431                     030432                     030433                     030434                     030435                     030436                     030437                     030438                     030528                     030529                     030530                     030531                     030532                     030533                     030534                     030535                     030536                     030537                     030990                     030992                     030993                     030994                     030995                     030996                     030997  ",2/18/2015,"02/18/2015",3/23/2016,"03/23/2016","         032887                     032888                     032889                     032890                     032891                     032892                     032893                     032894                     032895                     032896                     032897                     032898                     032899                     032900                     032901                     032902                     032903                     032904                     032905                     032906                     032907                     032908                     032909                     032910                     032911                     032912                     032913                     032914                     032915                     032916                     032917                     032918                     032919                     032920                     032921                     032922                     032923                     032924                     032925                     032926                     032927                     032928                     032929                     032930                     032931                     032932                     032933                     032934                     032935                     032936                     032937                     032938                     032939                     032940                     032941                     032942                     032943                     032944                     032945                     032946                     032947                     032948                     032949                     032950                     032951                     032952                     032953                     032954                     032955                     032956                     032957                     032958                     032959                     032960                     032961                     032962     ",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73423,"Ongoing","NP Nutra","15171 S Figueroa St",,"Gardena","CA","90248-1723","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, KS, TX, NE, NY, IL, MT, MO, UT, ID, AZ, HI, TN, OR, NJ, GA, WI, FL.    Foreign distribution to the following; QC, UK, PH","F0778-2016","Class I","NP Nutra  Spinach Powder Organic   SKU: 790  Net Weight: 22.72kg  Gross Weight: 24kg  Product of USA","134.85 kg","Np Nutra is recalling Spinach Powder (Organic) because of potential Salmonella contamination.  ","03/21/2016",," Lot Code: USOG8746002",3/1/2016,"03/01/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73424,"Ongoing","Casper's Ice Cream, Inc","11805 N 200 E",,"Richmond","UT","84333-1408","United States","Voluntary: Firm Initiated","Telephone","Utah, Idaho, Montana, Nevada, Wyoming, Washington. No foreign or VA/govt/military consignees.","F-0751-2016","Class II","Sea Salt Caramel Pretzel Ice Cream, Red Button Vintage Creamery, 56 fluid ounce, Paper Tub, 6 tubs per case, Distributed by Associated Foods, Inc. Utah; Manufactured by Caspers Ice Cream, Inc. Utah","124 cases"," ice cream which presents a potential allergen threat.","03/15/2016",," Lot # 3201561 xx:xx:xx (hour:minute:second) BB 05/16/2017 UPC 077865010048",3/1/2016,"03/01/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73425,"Ongoing","Nestle USA","800 N Brand Blvd",,"Glendale","CA","91203-1245","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, FL, TX, IL, GA, NJ, MI, MA, PA, NY, NC, OH, MD, NM, SC, AL, TN, OK, MS, AZ, ME, VA, NV, WY, UT, AL.    No foreign distribution.","F-0797-2016","Class II","MAGGI Chicken Flavor Bouillon   6Tab, 12Tab  UPC Codes: 028000247959, 028000115678, 028000115678","558,325 units","Nestle USA is recalling MAGGI Chicken Bouillon tablets because of undeclared wheat.","03/25/2016",," Production Codes: All Best Before ending in years 2015, 2016, 2017",3/2/2016,"03/02/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73426,"Ongoing","Medtronic Neuromodulation","7000 Central Ave Ne",,"Minneapolis","MN","55432-3568","United States","Voluntary: Firm Initiated","Letter","Internationally to Japan.","Z-1271-2016","Class II"," Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.","9 (1 still unused)"," Intrathecal Catheter kit.  We have identified that this kit may have been produced with incorrect outer package labels.  As a result, it may not contain all components necessary to complete the implant procedure.  ","03/29/2016",," N558983006",2/9/2016,"02/09/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1854-2016","Class II"," (45.7 cm x 45.7 cm)  Item Number:6522","3152197","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110000161662 through lot 15G255462X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1847-2016","Class II"," (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number:  397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.","713600","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110000037462 through Lot 120002259962",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1855-2016","Class II"," (30.5 cm x 30.5 cm)  Item Number:6534","350550","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110000476162 through lot 15J070162X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1852-2016","Class II"," (45.7 cm x 45.7 cm)  Item Number: 6022","996002","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110000463762 through lot 15K235262",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1858-2016","Class II"," (20.3 cm x 10.2 cm)  Item Number: 7319","372480","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 100000010062 through lot 15J162962X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1848-2016","Class II"," (40.6 cm x 43.2 cm)  Item Number:  4034","114720","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110000142862 through lot 130002191062X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1851-2016","Class II"," (20.3 cm x 81.3 cm)  Item Number: 4037","28085","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110000311262 through lot 15G162262X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1853-2016","Class II"," (20.3 cm x 91.4 cm  Item Number: 6056","36040","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110001358162 through lot 15C033262X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1850-2016","Class II"," (43.2 cm x 66 cm)  Item Number: 4031","208348","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110000311162 through lot 15J101262X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1859-2016","Class II"," (20.3 cm x 10.2 cm)  Item Number: 7321","199488","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 100000009962 through lot 15J163262X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1849-2016","Class II"," (10.2 cm x 10.2 cm)  Item Number: 8047","2418560","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110000233562 through lot 120002651262X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1857-2016","Class II"," (20.3 cm x 91.4 cm)  Item Number: 6556","87680","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 100000055262 through lot 15B223462X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73427,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.","Z-1856-2016","Class II"," (10.2 cm x 45.7 cm)  Item Number: 6545","70960","Compromised sterility due to breach of barrier","05/31/2016",," All lots beginning with 110001420362 through lot 15C151862X",3/3/2016,"03/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73428,"Ongoing","Sedecal S.A.","Pol. Industrial Rio De Janiero","Calle Pelaya 9-13","Algete",,,"Spain","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI.","Z-1084-2016","Class II","Mobile wDR motorized portable diagnostic X-ray systems.  Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.","349 systems","This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior.","03/08/2016",," Serial Numbers: 485886/SN11000007, 485062/SN11000009, 488169/SN11000011, 485061/SN11000012, 485059/SN11000013, 485060/SN11000015, 489089/SN11000016, 489616/SN11000033, 490027/SN11000034, 489694/SN11000035, 489695/SN11000036, 489696/SN11000037, 490221/SN11000039, 489088/SN11000040, 493566/SN11000047, 493565/SN11000048, 494867/SN11000051, 494941/SN11000052, 492417/SN11000053, 494456/SN11000055, 494865/SN11000056, 494864/SN11000060, 495286/SN11000061, 494866/SN11000062, 494464/SN11000065, 497570/SN11000066, 488171/SN11000068, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494063/SN11000073, 494064/SN11000074, 494065/SN11000075, 497715/SN11000080, 496446/SN11000082, 496387/SN12000003, 495938/SN12000007, 495939/SN12000008, 493364/SN12000022, 493462/SN12000023, 501028/SN12000026, 500739/SN12000027, 500740/SN12000028, 502424/SN12000034, 503143/SN12000036, 503142/SN12000037, 503141/SN12000038, 503144/SN12000039, 503541/SN12000040, 500466/SN12000045, 502721/SN12000047, 505077/SN12000048, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 500468/SN12000058, 496401/SN12000059, 500467/SN12000060, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 510607/SN12000072, 512160/SN12000077, 513477/SN12000080, 513478/SN12000081, 512892/SN12000082, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 508699/SN12000088, 514462/SN12000089, 514461/SN12000090, 514104/SN12000091, 514103/SN12000092, 509062/SN12000107, 508783/SN12000108, 516891/SN12000110, 516896/SN12000111, 497572/SN12000112, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 12000166, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519506/SN13000011, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 520251/SN13000016, 520253/SN13000017, 519762/SN13000018, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 5202",1/18/2016,"01/18/2016",3/16/2016,"03/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73429,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",".","Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including Puerto Rico  and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.","Z-1348-2016","Class II","VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110.  Intended for use in the in vitro measurement of a variety of analytes of clinical interest.","2,101 Total units (1,043 domestically & 1,058 internationally)","The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.  ","04/07/2016",," Product Codes: 6802413, 6802915 (Refurbished)  Serial numbers: J56000024 - J56002387",2/16/2016,"02/16/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73430,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide throughout the US and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Czech Republic, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Greece, Guatlemala, Hungary, India, Indoesia, Isreal, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Panama, Philippines, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, UK, Ukrain, United Arab Emirates","Z-1394-2016","Class II","VERION Reference Unit (Vision Planner)    Product Usage:  The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.  "," 97 units","Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after receiving reports concerning the inclusion of unplanned arcuates on printed, saved (.pdf) or exported surgical plans.  ","04/14/2016",," Serial Numbers: 1017, 1119, 1123, 1125, 1126, 1128, 1133, 1135, 1136, 1137, 1138, 1139, 1142, 1147, 1150, 1153, 1155, 1161, 1165, 1168, 1172, 1178, 1181, 1182, 1183, 1188, 1190, 1191, 1193, 1196, 1197, 1198, 1199, 1201, 1203, 1206, 1207, 1220, 1226, 1228, 1230, 1232, 1250, 1256, 1258, 1259, 1421, 1433, 1435,  1439, 1451, 1452, 1506, 1508, 1509, 1523, 1536, 1548, 1559, 1562, 1565, 1568, 1581, 1597, 1606, 1628, 1632, 1649, 1661, 1663, 1668, 1671, 1694, 1696, 1705, 1716, 1726, 1729, 1798, 1816, 1818, 1820, 1824, 1829,  1921, 1922, 1934, 1937, 1938, 1940, 1942, 1954, 1957, 2057, 2069, 2086, 2092    ",3/1/2016,"03/01/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73431,"Terminated","Hy-Vee Stores Inc","5820 Westown Pkwy",,"West Des Moines","IA","50266-8223","United States","Voluntary: Firm Initiated","Press Release","Product was distributed to IA, IL, MO, KS, NE, SD, MN, and WI.  There was no foreign/government/military distribution.","F-1572-2016","Class I","Whole wheels and cuts of Maytag blue cheese re-packaged in foil or clear plastic wrap with scale labels in various weights.  Product was labeled as Maytag Blue Raw Milk, Maytag Blue, or Maytag Iowa Blue Cheese with PLU numbers beginning with 854089001.","1552 lbs.","Product may be contaminated with Listeria monocytogenes.","08/26/2016","08/26/2016"," Use by dates:  Jan. 20, 2016 through May 3, 2016.",3/3/2016,"03/03/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73431,"Terminated","Hy-Vee Stores Inc","5820 Westown Pkwy",,"West Des Moines","IA","50266-8223","United States","Voluntary: Firm Initiated","Press Release","Product was distributed to IA, IL, MO, KS, NE, SD, MN, and WI.  There was no foreign/government/military distribution.","F-1573-2016","Class I","Maytag Blue cheese crumbles re-packaged and sold in plastic containers with scale labels in various weights.  Product was labeled as Maytag Blue Raw Milk, Maytag Blue, or Maytag Iowa Blue Cheese with PLU numbers beginning with 854089001.","210 lbs.","Product may be contaminated with Listeria monocytogenes.","08/26/2016","08/26/2016"," Use by dates:  Jan. 20, 2016 through May 3, 2016.",3/3/2016,"03/03/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73433,"Ongoing","Ab Sciex","500 Old Connecticut Path",,"Framingham","MA","01701-4574","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and Internationally to the following countries:  AUSTRIA  CANADA  CHINA  FRANCE  GERMANY  INDIA  IRELAND  ITALY  KOREA  MALAYSIA  NETHERLANDS  NORWAY  RUSSIA  SINGAPORE  SPAIN  SWITZERLAND  UNITED KINGDOM","Z-1586-2016","Class II"," 4500MD LC/MS/MS System, Instrument Part Number:  5031257; QTRAP¿ 4500MD LC/MS/MS System, Instrument Part Number:  5031231  3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.","279","Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.","04/29/2016",," Software Versions: Version 1.6.1 and 1.6.2",2/24/2016,"02/24/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73434,"Ongoing","Sagent Pharmaceuticals Inc","1901 N Roselle Rd Ste 700",,"Schaumburg","IL","60195-3194","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0780-2016","Class II","Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82","37,450 bags","Cross contamination with other products: metronidazole","03/22/2016",," Lot #: 40608, Exp 5/17",3/1/2016,"03/01/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73435,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","US Consignee: NY ***Foreign Consignee: Ecuador","Z-1565-2016","Class II","Automated peritoneal dialysis (APD) cycler","10 units","Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations.     The tot","04/25/2016",," N/A",2/16/2016,"02/16/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73436,"Ongoing","MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK","6-22, 4-CHOME, KAN-ON-SHIN-MACHI","NISHI-KU","HIROSHIMA",,,"Japan","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution including New York, Texas, Florida, and Ohio","Z-1308-2016","Class II","VERO (TM) MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator  MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.","25 Worldwide, US: 4 units","The foreign manufacturer became aware of a potential safety issue associated with the VERO/MHI-TM2000 Linear Accelerator System.  In rare cases it may happen that the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met.  If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is awar","03/31/2016",," Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924",3/7/2016,"03/07/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73437,"Ongoing","Loki Fish Company","309 S Cloverdale St Ste C37",".","Seattle","WA","98108-4579","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in OR and WA and sold via mail orders to customers in FL, GA, and OH","F-1012-2016","Class I",".","total 492.32 lbs.","Wild Smoked Pink Salmon is recalled due to a positive test result for Listeria monocytogenes.","04/01/2016",," Lot: 121215 5594 or 121215 5613 ",3/2/2016,"03/02/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73438,"Ongoing","Covidien Medical Products (Shanghai) Manufacturing L.L.C.","Building 10 789 Puxinglu","Pujiang, Minhang","Shanghaishi",,,"China","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide, VA/govt/military consignees.","Z-1187-2016","Class II"," Technology    Product Usage:  The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures  ","4,920 units"," Percutaneous Antenna.","03/17/2016",," Model Numbers: CA15L1, CA20L1 and CA30L1",2/23/2016,"02/23/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73439,"Terminated","Blood Systems, Inc.  dba UBS -Coast","2223 Eastman Ave Ste A",,"Ventura","CA","93003-8050","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0408-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.","04/11/2016","04/11/2016"," W041915031786I",1/29/2016,"01/29/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73440,"Terminated","American Natl. Red Cross-Greater Chesapeake & Potomac Region","4700 Mount Hope Dr",,"Baltimore","MD","21215-3200","United States","Voluntary: Firm Initiated","FAX","Maryland","B-0364-16","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Misbranded Red Blood Cells were distributed. ","03/22/2016","03/22/2016"," W205313029881; W205314011157",9/8/2015,"09/08/2015",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73441,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Nationwide  Distribution.","Z-1700-2016","Class II","1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack  (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.    ","14,780 pieces","When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)). ","05/20/2016",," Product Codes: 6802220, 6802221; Affected Lot Numbers: 1410, 1420, 1430 (With Expiry Date 17-Jun-2016), Lot Number: 1440 (With Expiry Date 15-Aug-2016, Lot Numbers: 1450, 1460, 1470 (With Expiry Date 17-Aug-2016) and Lot Number 1480 distributed only outside of U.S. (With Expiry Date 30-Sept-2016)",2/18/2016,"02/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73442,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution and US including Puerto Rico and to the states of : TX, FL, CA, LA, DC, GA, IL, AR, WI, MI and MD.","Z-1633-2016","Class II","Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability    The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.","394   ","Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension¿ SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days.  ","05/10/2016",," Lot # EB6064",2/9/2016,"02/09/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73443,"Ongoing","Cosmetic Labs LP","3131 Premier Dr",,"Irving","TX","75063-2636","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the US","F-1045-2016","Class III","L'Bri Pure N' Natural Nutri Aloe Health Juice Drink 960 mL 32 FL. OZ. and L'Bri Pure N' Natural Nutri Aloe Health Juice Drink 1 FL OZ./29 mL","29,694 units","Product contains ingredients that are not on the label including sodium metabisulfite, to which a part of the population may be sensitive.","04/13/2016",," 401 5B, 414 1N, 426 3I, 444 2B, 444 2C, 444 2D, 505 2G, 517 3G, 517 3H, 517 3I, 517 3J, 517 3K",3/2/2016,"03/02/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73444,"Ongoing","Purina Animal Nutrition Feed LLC","5500 N Cotner Blvd",,"Lincoln","NE","68507-1083","United States","Voluntary: Firm Initiated","Telephone","One customer in Nebraska received the recalled product.","V-528-2016","Class I","PURINA COMMERCIAL STARTER BASE 1200, Manufactured by Purina Animal Nutrition LLC, Shoreview, MN 55126-2910","9875 lb","Analytical testing revealed the presence of monensin in the swine starter feed. Monensin is toxic to pigs. User of the final feed reported a mortality of 100 pigs out of 2000.","09/28/2016",," 12/21/15",3/2/2016,"03/02/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73445,"Completed","Schnucks Markets Corporate Office","11420 Lackland Rd",,"Saint Louis","MO","63146-3559","United States","Voluntary: Firm Initiated","Other","Product was distributed to MO, IL, and IA.  There was no military/foreign/government distribution.","F-1586-2016","Class I","Maytag Blue cheese cut and wrapped in clear plastic wrap at store level, sold in various sizes (approximately 3-4 oz pieces), labeled with company issued Maytag Blue cheese label and Schnuck Markets scale label, UPC 0021806200000.","15.3 lbs.","Product may be contaminated with Listeria monocytogenes.","09/02/2016",," Product was sold from 2/4/2016 throught 2/29/2016",2/29/2016,"02/29/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73446,"Ongoing","Clorox Co (The)","1221 Broadway",,"Oakland","CA","94612-1837","United States","Voluntary: Firm Initiated","E-Mail","Nationwide distribution.","F-1074-2016","Class III","Hidden Valley Original Ranch dressing, 16 fl oz. ( 473 ml). plastic bottles;    Ingredients: Vegetable oil (soybean and/or Canola oil) water, egg yolk, sugar, Salt, Cultured non fat buttermilk, natural flavors (milk, soy), less than 1% spiced, dried garlic, dried onion, vinegar, phosphoric acid, xanthan gum, modified food starch, monosodium glutamate, artifical flavors, disodium phosphate, sorbic acid and calcium disodium EDTS as preservatives, disodium inosinate, disodium guanylate. Contains Egg, Milk, Soy, Gluten.    HV Food Products Co. Oakland, CA 94612","318 cases  ( 2910 x 16 oz. bottles)","Incorrect ingredient labels inadvertently put on some bottles of salad dressing and therefore there is no declaration  of  soy lecithin as an ingredient.","04/13/2016",," Lot Number: 200551  (22:00 to 22:59)    G115315 B 27AUG16 22",3/3/2016,"03/03/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73447,"Ongoing","Delicious Food Distributors Inc","10010 91st Ave",,"Richmond Hill","NY","11418-2118","United States","Voluntary: Firm Initiated","Telephone","NY, MA, PA","F-1099-2016","Class I","33 Kopobbi A WHOLE MILK CHEESE, Ricotta, Net Weight: 17.14 lb.","47 tubs","The Massachusetts Department of Public Health sampled the product which tested positive for the  presence of  Listeria monocytogenes.  ","04/20/2016",," Sell By: 03/16/16    LOT: 16-26-02",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73448,"Ongoing","Implant Direct Sybron Manufacturing, LLC","3050 E Hillcrest Dr",,"Westlake Village","CA","91362-3171","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution to the states of : FL, AZ, IL, MS, TX, CA, ID, AL, MO, MN, NY, CO, GA, ME, NJ, NC, NV, LA, KS, MN, KY, PA, UT, OH, MI, SC, MD, WA, WI., and to the countries of : Canada, Honduras and Dominican Republic.","Z-1267-2016","Class II","The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system.     GoDirect Implants  Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710","2033","Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level.","03/28/2016",," Lot Number: 29707, 29708, 29709, 32444, 37438, 38159, 39506, 40394, 40542, 44661, 46030, 50644, 50824, 51092, 51249, 52798, 54274, 54275, 54617, 55407,60158",3/4/2016,"03/04/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73450,"Terminated","Pacific Coast Fruit Company","201 NE 2nd Ave",".","Portland","OR","97232","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Canada","F-1025-2016","Class I","VA Kit Roasting Brussel Sprouts, Item #72893.  Each case contains 2/6.15 lb. bags.  The UPC is 0 20728 72893 2","25 cases","VA Kit Roasting Brussel Sprouts, Item #72893, is recalled due to a possible exposure to walnut.","04/06/2016","05/25/2016"," Best Used by March 07",3/4/2016,"03/04/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73452,"Ongoing","Mckesson Medical Immaging","Suite 130-10711 Cambie Road",,"Richmond","British Columbia",,"Canada","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) including Puerto Rico and to the states of : AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY.,  and the countries of : Guam, Great Britain, France, Canada, Ireland and Australia","Z-1182-2016","Class II","McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.","631 devices","McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory.  This issue may cause incorrect images to be displayed for a patient.","03/17/2016",," McKesson Radiology Versions- 12.1.1, 12.0; Horizon Medical Imaging Versions -11.9, 11.8, 11.7, 11.6, 11.5.2, 11.5.1,11.0.8, 5.0, 4.6.1",2/18/2016,"02/18/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73453,"Ongoing","Coca-Cola Company  (The)","1 Coca Cola Plz Nw",,"Atlanta","GA","30313-2420","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL, IN & OH","F-0746-2016","Class II","Citrus Flavored Soda Mello Yello, 12 fl. oz. (355 ml), Canned under authority of The Coca-Cola Company, Atlanta, GA 30313, UPC 497250","2,522 cases","Undeclared aspartame in the product.","03/11/2016",," Date Code OCT2416 HO D, OCT2416 HO E",3/2/2016,"03/02/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73454,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, , South Korea, Kuwait, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay and Vietnam.","Z-1395-2016","Class II","BARD ArcticGel Pads    Product Usage:  The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.  ","21,412 units","Complaints were received of restricted/inaccurate flow rate.","04/14/2016",," All lots with Catalog numbers: 31700 (Universal Pad), 3170004 (Universal Pad 4 pk), 31703 (XSmall pad kit), 3170302 (XSmall pad kit 2 pk), 31705 (Small pad kit), 3170502 (Small pad kit 2 pk), 31707 (Medium pad kit), 3170702 (Medium pad kit 2 pk), 31709 (Large pad kit) and 3170902 (Large pad kit 2 pk), that are within their current expiration dates.",3/4/2016,"03/04/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73455,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0859-2016","Class I","Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL)  4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03","6,291 units","Presence of Particulate Matter:  particulate matter identified as glass in one vial.  ","05/23/2016",," Lot #: 4750915, Exp 9/2017",3/9/2016,"03/09/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73456,"Ongoing","Applied Medical Resources Corp","22872 Avenida Empresa",".","Rancho Santa Margarita","CA","92688-2650","United States","Voluntary: Firm Initiated","Letter","U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ.    Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain","Z-1330-2016","Class II","STD GK258, AME Standard Kit 44    Product Usage:   The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.  ",,"Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.","04/05/2016",," Lot #: 1238155, 1238402, 1238845",12/22/2015,"12/22/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73456,"Ongoing","Applied Medical Resources Corp","22872 Avenida Empresa",".","Rancho Santa Margarita","CA","92688-2650","United States","Voluntary: Firm Initiated","Letter","U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ.    Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain","Z-1331-2016","Class II","STD KIT GK213, AME Standard Kit 15    Product Usage:   The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.  ",,"Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.","04/05/2016",," Lot #: 1239287",12/22/2015,"12/22/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73456,"Ongoing","Applied Medical Resources Corp","22872 Avenida Empresa",".","Rancho Santa Margarita","CA","92688-2650","United States","Voluntary: Firm Initiated","Letter","U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ.    Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain","Z-1329-2016","Class II","CA500 Epix Universal Clip Applier    Product Usage:   The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.  ","1771 units","Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.","04/05/2016",," Lot #: 1231562",12/22/2015,"12/22/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73456,"Ongoing","Applied Medical Resources Corp","22872 Avenida Empresa",".","Rancho Santa Margarita","CA","92688-2650","United States","Voluntary: Firm Initiated","Letter","U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ.    Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain","Z-1332-2016","Class II","STD KIT GK260, Standard Set 360 Z    Product Usage:   The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.  ",,"Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.","04/05/2016",," Lot #: 1237620, 1238063",12/22/2015,"12/22/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73457,"Ongoing","Gold Medal Products Co","10700 Medallion Dr",,"Cincinnati","OH","45241-4807","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AZ, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NM, OH, OK, TN & WI.      Product was also shipped to Ireland.","F-1026-2016","Class I","#2473 CINCINNATI STYLE CHILI Savory Net Wt. 4 lbs (1.8kg) UPC 0 90939 12473 1 GOLD MEDAL PRODUCTS 10700 MEDALLION DRIVE CINCINNATI, OHIO 45241 ","88/4 lb plastic jars","The firm discovered that the product failed to declare milk on the label.  ","04/13/2016",," Lot:  15112425001 Best by: 11/24/2016",3/10/2016,"03/10/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73458,"Ongoing","Prayon Inc.","1610 Marvin Griffin Rd",,"Augusta","GA","30906-3808","United States","Voluntary: Firm Initiated","Letter","AL, GA, IN, MD, MO, OH, PA, TN, TX","F-1335-2016","Class III","Phosphoric Acid, 75% and 85% Food Grade (Brand Name PRAYPHOS PPA 75% FG and PRAYPHOS PPA 85% FG) ","844,999 lbs (food grade customers) ","Potential contamination with trace levels of 1-methylethyl benze (more commonly known as cumene).","05/17/2016",," BATCH - 75% -A054519, A054520, A054533, A054570, A054601, A054602, A054603, A054620, A054634, A054635, A054637, A054643, A054647, A054649, A054663, A054665, A054664, A054690, A054691 - 85% A054521, & A054636",3/7/2016,"03/07/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73460,"Ongoing","Pelton & Crane / Marus / DCI Equipment / KaVo","11727 Fruehauf Dr",,"Charlotte","NC","28273-6507","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AZ, AR, CA, CO, CT, FL, IA, ID, IL, IN, MA, MI, MN, NJ, NY, NC, OH, OR, PA, TN, TX, UT, VA, WI and Canada","Z-1268-2016","Class II","Helios HL3T and HLT Track Mounted Dental Lights    Product Usage:  The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.  ","156 units","The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the initial installation of the dental light.","03/28/2016",," Model/Serial No. - HLT-5535, 5543, 5536, 5537, 5538, 5556, 5540, 5541, 5545, 5546, 5515, 5500, 5503, 5520, 5521, 5547, 5548, 5549, 5550, 5551, 5552, 5510, 5558, 5522, 5523, 5524, 5525, 5526, 5527, 5528, 5529, 5530, 5531, 5532, 5501, 5502, 5504, 5505, 5534, 5508, 5509, 5533, 5516, 5517, 5518, 5519, 5544, 5553, 5554, 5555, 5542, 5557, 5506, 5507, 5511, 5498, 5539, 5499, 5512, 5513, 5514; Model/Serial No.  HL3T-11110, 11102, 11103, 11104, 11105, 11106, 11099, 11164, 11165, 11166, 11167, 11193, 11170, 11171, 11118, 11119, 11120, 11145, 11146, 11147, 11148, 11149, 11121, 11123, 11150, 11113, 11114, 11115, 11116, 11117, 11168, 11169, 11158, 11187, 11133, 11144, 11136, 11137, 11138, 11139, 11140, 11141, 11142, 11143, 11177, 11111, 11112, 11135, 11190, 11191, 11192, 11100, 11182, 11183, 11185, 11186, 11134, 11122, 11124, 11125. 11126, 11127, 11128, 11129, 11130, 11131, 11132, 11155, 11156, 11157, 11159, 11160, 11161, 11107, 11108, 11176, 11172, 11173, 11174, 11175, 11109. 11151, 11152, 11153, 11154, 11101, 11181, 11184, 11188, 11189, 11178, 11179, 11180, 11162, 11163   ",3/8/2016,"03/08/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73461,"Ongoing","Hummingbird Med","20371 Lake Forest Dr Ste A6",,"Lake Forest","CA","92630-8106","United States","Voluntary: Firm Initiated","Letter","US Distribution in the state of CA.","Z-1908-2016","Class I","ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.","62,400","Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw because of insertion difficulties.","07/05/2016","."," Lot Numbers:  20140510  20140513  20140516  20140519  20140603  20140606  20140609  20140612  14299",3/11/2015,"03/11/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73462,"Ongoing","JRZ Dairy Products Inc.","21 Industrial Park Rd",,"Selinsgrove","PA","17870-8196","United States","Voluntary: Firm Initiated","Visit","Central NJ","F-1034-2016","Class II","Puredesi Whole Milk Yogurt in 5 lb.  plastic containers    Patidar Whole Milk Yogurt in 5 lb. plastic containers  Puredahi Whole Milk Yogurt in 5 lb. plastic containers    Sell by: 5/08/2016","228 - 5 lb. Puredesi containers; 180 - 5lb. Patidar containers; 480 - 5lb. Puredahi containers","yogurt that was produced on 2 different dates (February 23, 2016 and February 29, 2016)  in which the hold time was not held for the proper length of time to meet the requirements of pasteurization.","04/08/2016",," Sell by 5/08/2016",3/4/2016,"03/04/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73462,"Ongoing","JRZ Dairy Products Inc.","21 Industrial Park Rd",,"Selinsgrove","PA","17870-8196","United States","Voluntary: Firm Initiated","Visit","Central NJ","F-1035-2016","Class II","Puredesi Low Fat Yogurt in 2 lb. plastic containers  Puredesi Low Fat Yogurt in 5 lb. plastic containers  Puredahi Low Fat Yogurt in 2 lb. plastic containers  ","176 - 2lb. containers Puredesi; 156 - 5lb. containers Puredesi; 200 - 5lb Puredahi.","yogurt that was produced on 2 different dates (February 23, 2016 and February 29, 2016)  in which the hold time was not held for the proper length of time to meet the requirements of pasteurization.","04/08/2016",," Sell by 5/12/2016",3/4/2016,"03/04/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-499-2016","Class II","Beneful Chopped Blends Lamb canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-15498 and Canada UPC 55800-21238.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","39,984 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-494-2016","Class II","Beneful Prepared Meals Roasted Chicken Recipe canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10764 and Canada UPC 55800 10554.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","45,779 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-502-2016","Class II","Beneful Chopped Blends Turkey canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-16966.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","15,781 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-511-2016","Class II","Pro Plan Savory Meals braised turkey canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16147.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","2989 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-512-2016","Class II","Pro Plan Savory Meals grilled salmon canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16155.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","1536 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-507-2016","Class II","Beneful Prepared Meals 6-count variety pack containing wet dog food packaged in 10 oz. plastic tubs:  2 tubs savory rice and lamb stew, 2 tubs chicken stew, and 2 tubs beef stew with UPC 17800 - 15030.  Product is shipped in cases of 6 packs.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","26130 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-500-2016","Class II","Beneful Chopped Blends Chicken and Liver canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-16960.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","30,385 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-503-2016","Class II","Beneful Prepared Meals Savory Rice and Lamb Stew canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10967 and Canada UPC 55800 10556.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","71,045 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-505-2016","Class II","Beneful Prepared Meals Simmered Beef canned wet dog food packaged in 10 oz. plastic tubs with Canada UPC 55800 11649.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","8546 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-490-2016","Class II","Beneful Prepared Meals Simmered Beef Entree' canned wet dog food packaged in 10 oz. plastic tubs with UPC 17800-10963.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","39,529 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-492-2016","Class II","Beneful Prepared Meals Chicken Stew canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-12861 and Canada UPC 55800-11564.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","61,497 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-496-2016","Class II","Beneful Prepared Meals Roasted Turkey Medley canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10968 and Canada UPC 55800-11562.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","231,885 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-513-2016","Class II","Pro Plan Savory Meals braised beef canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16143.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","640 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-498-2016","Class II","Beneful Chopped Blends Chicken canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-15496 and Canada UPC 55800-21254.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","59,797 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-497-2016","Class II","Beneful Chopped Blends Beef canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-15494.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","51,454 cases ","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-509-2016","Class II","Pro Plan Savory Meals braised chicken canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16148.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","902 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-510-2016","Class II","Pro Plan Savory Meals braised pork canned wet dog food packaged in 10 oz. plastic tubs with UPC 38100-16151.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","832 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-501-2016","Class II","Beneful Chopped Blends Salmon canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-16962.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","9,805 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-491-2016","Class II","Beneful Prepared Meals Simmered Chicken Medley canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10964 and Canada UPC 55800-10549.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","67,850 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-493-2016","Class II","Beneful Prepared Meals Beef Stew canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-10965.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","120,868 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-495-2016","Class II","Beneful Prepared Meals Beef and Chicken Recipe canned wet dog food packaged in 10 oz. plastic tubs with US UPC 17800-12859.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","43,583 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-506-2016","Class II","Beneful Prepared Meals 12-count variety pack containing wet dog food packaged in 10 oz. plastic tubs:  4 tubs savory rice and lamb stew, 4 tubs chicken stew, and 4 tubs beef stew with UPC 17800 - 16814.  Product is shipped in cases of 12 packs.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","13,104 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-504-2016","Class II","Beneful Prepared Meals Beef Stew canned wet dog food packaged in 10 oz. plastic tubs with Canada UPC 55800 11651.  Product is shipped 8 tubs per case.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","924 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73463,"Ongoing","Nestle Purina PetCare Co","Checkerboard Square","Attn Christopher S Cowell","Saint Louis","MO","63164-0001","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide and Puerto Rico.  Product was also distributed to Ontario, Canada.  There was no military or government distribution.","V-508-2016","Class II","Beneful Chopped Blends 6-count variety pack containing wet dog food packaged in 10 oz. plastic tubs:  2 tubs lamb, 2 tubs chicken, and 2 tubs beef  with UPC 17800 - 16627.  Product is shipped in cases of 6 packs.  Manufactured by Nestle Purina PetCare Company, St. Louis, MO 63164.","1480 cases","Product may contain less vitamins and minerals than label purports.","08/31/2016",," 5363 to 6054; Best Buy Jun 2017 to Aug 2017",3/9/2016,"03/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73464,"Ongoing","Rich Products Corp","One Robert Rich Way",,"Buffalo","NY","14213-1701","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: Nationwide in USA; Internationally: Canada","F-0328-2017","Class II","New York Style Chocolate Iced ¿clairs under the following labels: 1) Richs New York Style Chocolate Iced ¿clairs, NET WT 8 oz (226g) (UPC Code:049800147799), 2) Bakery Fresh Goodness NY Style Chocolate ¿clairs, NET WT 8 oz (226g) (UPC Code:011110456601), 3) Food Lion NY Style Chocolate Iced ¿clairs, NET WT 8 oz (226g) (UPC Code: 035826088604)","53, 746 Total cases","Products were recalled due to the potential presence of plastic foreign material.","11/04/2016",," Product Codes & Julian Dates: 1) Product Code:14779, Julian Dates:1665275, 1665280, 1665281, 1665288, 1665289, 1665295, 1665307, 1665308, 1665316, 1665322, 1665323, 1665329, 1665335, 1666005, 1666006, 1666011, 1666013, 1666014, 1666022, 1666029, 1666032, 1666035, 1666039, 1666040, 1666047; 2) Product Code:14506, Julian Dates: 1665294, 1665313, 1665357, 1665363, 1666011, 1666019, 1666042; 3) Product Code:  15090, Julian Dates: 1665314, 1665322, 1666004, 1666048",2/26/2016,"02/26/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73465,"Completed","Avid Medical, Inc.","9000 Westmont Dr",,"Toano","VA","23168-9351","United States","Voluntary: Firm Initiated","E-Mail","Recalled product was distributed to 2 states:  Virginia and Massachusetts.","Z-2590-2016","Class II"," PROCEDURE TRAY","240"," (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.","08/18/2016",," Catalog No. MCVA0089-04 , LOT#   1027144",10/5/2015,"10/05/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73465,"Completed","Avid Medical, Inc.","9000 Westmont Dr",,"Toano","VA","23168-9351","United States","Voluntary: Firm Initiated","E-Mail","Recalled product was distributed to 2 states:  Virginia and Massachusetts.","Z-2592-2016","Class II","MAMMOGRAPHY","200"," (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.","08/18/2016",," Catalog No. LGHM022-02  , LOT# 1021706",10/5/2015,"10/05/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73465,"Completed","Avid Medical, Inc.","9000 Westmont Dr",,"Toano","VA","23168-9351","United States","Voluntary: Firm Initiated","E-Mail","Recalled product was distributed to 2 states:  Virginia and Massachusetts.","Z-2591-2016","Class II","PEDIATRIC KIDNEY BIOPSY TRAY","20"," (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.","08/18/2016",," Catalog No. MCVA0091-01 , LOT# 1029428",10/5/2015,"10/05/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73465,"Completed","Avid Medical, Inc.","9000 Westmont Dr",,"Toano","VA","23168-9351","United States","Voluntary: Firm Initiated","E-Mail","Recalled product was distributed to 2 states:  Virginia and Massachusetts.","Z-2589-2016","Class II","  PROCEDURE TRAY  ","240"," (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.","08/18/2016",," Catalog No. MCVA0089-04  , LOT# 1010997  ",10/5/2015,"10/05/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73466,"Ongoing","Torrent Pharmaceuticals Limited","Ahmedabad Mehsana Highway",,"Kadi",,,"India","Voluntary: Firm Initiated","Letter","Nationwide","D-0824-2016","Class III","Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.","20,952 cartons","Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.","04/18/2016",," Lot#: BBV8B002R, Exp 12/16",2/25/2016,"02/25/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73467,"Ongoing","Specialty Commodities, Inc.","1530 47th St NW",,"Fargo","ND","58102-2858","United States","Voluntary: Firm Initiated","Telephone","CO, AZ, and CA. See distribution spreadsheet in the attached email.","F-1084-2016","Class II","Almonds, dry roasted, not salted, packaged in 25 lb. cardboard cartons","394 cases (9850 lbs.)","Cashews were mixed with almonds but allergen was not declared on outside packaging.","04/20/2016",," Item number ALMO-033; Manufacturer lot number 1050188-1-16007 (on container label); Warehouse lot number LV0206674",3/1/2016,"03/01/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73468,"Ongoing","Laserex Systems Inc.","7138 SHADY OAK RD",".","EDEN PRAIRIE","MN","55344-3517","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution","Z-1270-2016","Class II","Ellex Medical Fixed eye Safety filters Model  Integre S LP5532.    The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment  laser light to physician eyes while the  aiming beam to remain visible.      .","72 units plus 2 spare units","The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.","04/07/2016",," Model Number : 3143270",2/1/2016,"02/01/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73469,"Ongoing","Fujifilm Medical Systems U.S.A., Inc.","10 Highpoint Dr",,"Wayne","NJ","07470-7431","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1861-2016","Class II","Endoscope  ED-250XL5 Operations Manual: Cleaning, Disinfection  ","98 units","This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.","05/31/2016",," All  distribution dates :3/2003-4/2016",12/23/2015,"12/23/2015",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73469,"Ongoing","Fujifilm Medical Systems U.S.A., Inc.","10 Highpoint Dr",,"Wayne","NJ","07470-7431","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1860-2016","Class II","Endoscope; ED-530XT Operation Manual  'Operation and Preparation' and 'Cleaning, Disinfection and Storage'  ","1473 units","This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.","05/31/2016",," All  distribution dates :3/2003-4/2016",12/23/2015,"12/23/2015",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73469,"Ongoing","Fujifilm Medical Systems U.S.A., Inc.","10 Highpoint Dr",,"Wayne","NJ","07470-7431","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1862-2016","Class II","Endoscope  ED-250XT5  Operations Manual: Cleaning Disinfection and Storage  ","882 units","This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.","05/31/2016",," All  distribution dates :3/2003-4/2016",12/23/2015,"12/23/2015",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73469,"Ongoing","Fujifilm Medical Systems U.S.A., Inc.","10 Highpoint Dr",,"Wayne","NJ","07470-7431","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1863-2016","Class II","Endoscope  ED-450XT5  Operation Manual: Cleaning, Disinfection and Storage  ","484 units","This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.","05/31/2016",," All  distribution dates :3/2003-4/2016",12/23/2015,"12/23/2015",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73469,"Ongoing","Fujifilm Medical Systems U.S.A., Inc.","10 Highpoint Dr",,"Wayne","NJ","07470-7431","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1864-2016","Class II","Endoscope  ED-450XL5  Operation Manual: Cleaning, Disinfection and Storage  ","94 units","This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.","05/31/2016",," All  distribution dates :3/2003-4/2016",12/23/2015,"12/23/2015",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73470,"Ongoing","Ortho Clinical Diagnostics Inc","1001 US Highway 202",,"Raritan","NJ","08869-1424","United States","Voluntary: Firm Initiated","Letter","MD, TN, FL, NY & MN; Puerto Rico; Canada","B-0372-16","Class III"," Analyzer with Software Version 1.2.10","5 units"," Analyzer with Software Version 1.2.10, with a glitch, was distributed. ","03/25/2016",," Catalog Number:  6904577    Serial Numbers:  50002015  50002018  50002027  50002048  50002080",12/9/2015,"12/09/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1109-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 4x18, Apple/Berry Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1104-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, 6 x12, 1 x 18, 1 x 48, 1 x100, 36 x 4,  Mighty Mango Fruit & Veggies on the Go, (Apple/Mango/ButternutSquash) Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeze¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1107-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, 6 x12, 1x18, 4 x16, Apple/Cinnamon Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1115-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Pear/Carrot (Zippin'Zingin'Pear) Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1119-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Yellow Carrot/Banana (Boatin' Banana) Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1111-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, 6 x 12, Apple/Mango Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1106-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, Apple/Peach Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1120-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 4 x 16, 120 x 12, 180 x 4, 360 x 4, 6 x 12, 7/16, 1 x 20, 1 x 24, and 36 x 4; Variety Packs/Multi-Packs with Multiple Flavor Varieties","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1108-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, 6 x12, Apple/Banana Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1114-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Pumpkin Spice  Flavor Variety","7,214 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1113-2016","Class II","Gogo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Strawberry Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1116-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Peach/SweetPotato (Pedal Pedal Peach) Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1117-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Mixed Berry/Carrot (Boulder Berry) Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1112-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Pineapple Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1118-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Grape/Sweet Potato (Grateful Grape) Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1110-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, 6 x 12, Apple/Grape Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73471,"Ongoing","Materne North America Corp","20 W 22nd St","Ste 1604","New York","NY","10010-5875","United States","Voluntary: Firm Initiated","Press Release","Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France","F-1105-2016","Class II","GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, Apple/Pear Flavor Variety","4,780,784 cases","Materne North America Corp. is voluntarily recalling specific packages of GoGo squeeZ¿ applesauce pouches due to potential adulteration from food product residue. ","04/20/2016",,", and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08. ",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73472,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US: Nationwide and Singapore","D-0829-2016","Class II","Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2","552 bags","Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.","04/21/2016",," Lot# 52-114-JT, Exp 10/16",3/8/2016,"03/08/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73472,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US: Nationwide and Singapore","D-0828-2016","Class II","Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9    ","4368 bags","Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.","04/21/2016",," Lot # 52-002-JT, Exp 04/17",3/8/2016,"03/08/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73472,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US: Nationwide and Singapore","D-0827-2016","Class II","Dextrose Injection, USP, 70%, Packaged as  500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5    ","11256 bags","Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.","04/21/2016",," Lot# 48-010-JT, Exp 12/16",3/8/2016,"03/08/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73472,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US: Nationwide and Singapore","D-0831-2016","Class II","Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL  60045,  NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2  ","22292 bags","Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.","04/21/2016",," Lot# 52-031-JT, Exp 10/16",3/8/2016,"03/08/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73472,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US: Nationwide and Singapore","D-0830-2016","Class II","Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5","1776 bags","Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.","04/21/2016",," Lot# 49-047-JT, Exp: 07/16",3/8/2016,"03/08/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73472,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US: Nationwide and Singapore","D-0832-2016","Class II","Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-7077-14","81888 bags","Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.","04/21/2016",," Lo# 53-006-JT, Exp 11/16",3/8/2016,"03/08/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73473,"Ongoing","Physio-Control, Inc.","11811 Willows Rd NE",,"Redmond","WA","98052-2003","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Eritrea, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guinea, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Papua New Guinea, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.","Z-1993-2016","Class II","LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed.      Part numbers:   V15-2-xxxxxx (includes software version 1 and version 2);  V15-5-xxxxxx (inclues software version 4).  The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.","44798 units total (23189 units in US; 21609 units international)","The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 value. This affects all LIFEPAK 15 with an EtC02 feature installed and configured to the kPa or % setting.","06/15/2016",," ***************SERIAL NUMBERS IN THE US ************************  37241684, 37870230, 37870231, 37870232, 37870234, 37870235, 37870237, 37870238, 37870240, 37870241, 37870242, 37870245, 37900601, 37923078, 37923079, 37923100, 37923153, 37923162, 37923203, 37923205, 37923208, 37923213, 37923214, 37924152, 37924153, 37928794, 37928964, 37930942, 37930944, 37930946, 37930962, 37930964, 37930966, 37930968, 37930977, 37930986, 37930987, 37930988, 37930990, 37930993, 37931003, 37933241, 37933244, 37933246, 37933249, 37933250, 37933254, 37933257, 37933262, 37933263, 37933267, 37933268, 37933271, 37933278, 37937842, 37937843, 37937846, 37937848, 37937849, 37937851, 37937854, 37937855, 37937856, 37937862, 37937863, 37937864, 37937865, 37937866, 37937867, 37937868, 37937870, 37937871, 37937872, 37937873, 37937874, 37937881, 37937885, 37937886, 37937887, 37937889, 37937891, 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"Drugs",73474,"Ongoing","Actavis Elizabeth LLC","200 Elmora Ave",".","Elizabeth","NJ","07202-1106","United States","Voluntary: Firm Initiated","Letter","US: Nationwide","D-0814-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.    ","257,746 Bottles","Failed Impurities/Degradation Specifications: Out of specification for impurities.","04/07/2016",," Lot #: 3992J141, Expiry: 5/16; Lot #: 3993J142, Expiry: 5/16; Lot #: 0695B151, Expiry: 7/16; Lot #: 0696B151, Expiry: 7/16; Lot #: 0378A151, Expiry: 7/16; Lot #: 0379A151, Expiry: 7/16; Lot #: 0697B151, Expiry: 8/16; Lot #: 2427F151, Expiry: 11/16; Lot #: 1947E151, Expiry: 11/16; Lot #: 1330C151, Expiry: 11/16; Lot #: 1331C151, Expiry: 11/16; Lot #: 1946E151, Expiry: 11/16; Lot #: 3652H151, Expiry: 2/17; Lot #: 3653H151, Expiry: 3/17, Lot #: 3654H151, Expiry: 3/17; Lot #: 4251K151, Expiry: 3/17; Lot #: 4250K151, Expiry: 4/17; Lot #: 4252K151, Expiry: 4/17; Lot #: 4249K151, Expiry: 4/17; Lot #: 5101M151, Expiry: 5/17.",2/16/2016,"02/16/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73474,"Ongoing","Actavis Elizabeth LLC","200 Elmora Ave",".","Elizabeth","NJ","07202-1106","United States","Voluntary: Firm Initiated","Letter","US: Nationwide","D-0813-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.    ","114,388 Bottles","Failed Impurities/Degradation Specifications: Out of specification for impurities.","04/07/2016",," Lot #: 2172#141, Expiry: 3/16; Lot #: 4217K141, Expiry: 3/16;  Lot #: 0420A151, Expiry: 7/16; Lot #: 0421A151, Expiry: 7/16; Lot #: 0854B151, Expiry: 10/16; Lot #: 1329C151, Expiry: 10/16; Lot #: 2692F151, Expiry; 2/17; Lot #: 3202G151, Expiry: 3/17; Lot #: 3796J151, Expiry: 3/17; Lot #: 3797J151, Expiry: 4/17.",2/16/2016,"02/16/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73474,"Ongoing","Actavis Elizabeth LLC","200 Elmora Ave",".","Elizabeth","NJ","07202-1106","United States","Voluntary: Firm Initiated","Letter","US: Nationwide","D-0816-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.      ","38,507 Bottles","Failed Impurities/Degradation Specifications: Out of specification for impurities.","04/07/2016",," Lot #: 5245M141, Expiry: 6/16; Lot #: 0953C151, Expiry date: 8/16Lot #: 1728D151, Expiry: 9/16; Lot #: 3205G152, Expiry: 3/17.",2/16/2016,"02/16/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73474,"Ongoing","Actavis Elizabeth LLC","200 Elmora Ave",".","Elizabeth","NJ","07202-1106","United States","Voluntary: Firm Initiated","Letter","US: Nationwide","D-0815-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.    ","182,378 Bottles","Failed Impurities/Degradation Specifications: Out of specification for impurities.","04/07/2016",," Lot #: 1879E141, Expiry 02/16; Lot #: 1880E141, Expiry: 02/16; Lot #: 5034M142; Expiry: 5/16; Lot #: 0422A151, Expiry: 7/16; Lot #: 0423A151, Expiry: 7/16; Lot #: 1053C151, Expiry: 8/16; Lot #: 1054C151, Expiry: 8/16; Lot #: 2197E152, Expiry: 11/16; Lot #: 2198E151, Expiry: 12/16; Lot #: 2662F151, Expiry: 12/16; Lot #: 2672F152, Expiry: 3/17; Lot #: 3121G152, Expiry: 3/17; Lot #: 3798J151, Expiry: 4/17; Lot #: 5104M151, Expiry: 5/17.",2/16/2016,"02/16/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73475,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",".","Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.","Z-1349-2016","Class II","A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.","49 imaging systems","To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.  ","04/07/2016",," Model # 10014063",1/18/2016,"01/18/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73476,"Ongoing","International Trading & Import I","5850 Washington Blvd",".","Culver City","CA","90232-7338","United States","Voluntary: Firm Initiated","Letter","US","F-1042-2016","Class III","Novo Bnei Darom Green Olives in Jar, 48 cases, 6 jars, 1.04kg, UPC Code 7290002016175","48 cases","International Trading & Import Inc. dba Nuts & More is recalling Novo Bnei Darom Green Olives because it contains an unapproved pesticide (Chlorpyrifos)","04/07/2016",," KD71 4126",3/4/2016,"03/04/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73477,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.","Z-1306-2016","Class II","Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. ","124 units",".","03/31/2016",," Model Number: SOMATOM Sensation Cardic - 7543106",2/15/2016,"02/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73477,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.","Z-1305-2016","Class II","Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. ","124 units",".","03/31/2016",," Model Number: SOMATOM Sensation 64/ Cardiac 64 - 8377520",2/15/2016,"02/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73477,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.","Z-1301-2016","Class II","Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. ","124 units",".","03/31/2016",," Model Number: SOMATOM Emotion 16 - 7734713",2/15/2016,"02/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73477,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.","Z-1304-2016","Class II","Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. ","124 units ",".","03/31/2016",," Model Number: SOMATOM Sensation 16 - 7393114",2/15/2016,"02/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73477,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.","Z-1300-2016","Class II","Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. ","124 units",".","03/31/2016",," Model Number # SOMATOM Emotion 6 - 3815490",2/15/2016,"02/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73477,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.","Z-1302-2016","Class II","Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. ","124 units ",".","03/31/2016",," Model Number: SOMATOM Emotion Duo (2003) - 3813933",2/15/2016,"02/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73477,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.","Z-1307-2016","Class II","Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. ","124 units ",".","03/31/2016",," Model Number: SOMATOM Sensation Open - 8872017",2/15/2016,"02/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73477,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US (nationwide) including Guam and the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, MA, MD, ME, MI, MN, MO, NC, NJ, NM, NY, OH, PA, SC, TN, TX, VA, and WA.","Z-1303-2016","Class II","Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. ","124 units ",".","03/31/2016",," Model # SOMATOM Sensation 10 - 7543015",2/15/2016,"02/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73478,"Ongoing","Dutch Cheesemaking","542 County Road 7",".","Farwell","TX","79325-3508","United States","Voluntary: Firm Initiated","Telephone","Texas","F-1036-2016","Class I","DUTCH FARMSTEAD CHEESE SMOKED PLAIN GOUDA ","3.5 pounds","Product tested positive for Salmonella","04/06/2016",," Sell by August 6, 2016",3/8/2016,"03/08/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73479,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution including states of: MN, NC, NE, FL, TX, CA, AR, MI, MA, IL, DE, VA, SC, OH, CO, WI, MO, NY, CT, UT, PA, WA, NJ, GA, IN, MD, TN, LA, OR, AZ, ND, KS, AL, NM.","Z-1183-2016","Class II","Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673      intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.","228 units","Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.","03/17/2016",," Serial #:   85170, 85175, 85346, 85362, 85082, 85083, 85450, 85479, 85035, 85476, 85358,8 4184, 85191, 85377,8 5387, 85903, 85487, 85060, 85415, 85857, 85858,85856,85339,85410,85381,85189,85860, 85447, 85448, 85895,85896, 85401,85368, 85307, 85308, 85309, 85310, 85396, 85399, 85400, 85872, 85873, 85874, 85875, 85876, 85899, 85341, 85421, 85422, 85485, 85332, 85409, 85870, 85850,85851,85360,85143, 85395, 85359,85879, 85108,85225, 85234, 85235, 85194,85195,85436, 85437,85334 85239, 85322, 85462, 85355, 85356, 85364, 85365, 85433, 85910,85881,85149, 85354, 85366, 85199, 85364,85040,85474, 85282,85054,85382,85049, 85085,85338,85865, 85147,85148, 85115, 85866, 85867,85073, 85440,85319,85342, 85343, 85438, 85426, 85062, 85067, 85353, 85918,85145,85441, 85330,85909,85407, 85079, 85080, 85456, 85050, 85908, 85176, 85172, 85335, 85484, 85424,85859, 85177,85045,85047,85897,85389, 85051, 85053, 85036, 85244,85248,85340, 85884,85886,85118, 85329, 85852,85418,85390, 85391,85361,85146, 85090, 85091, 85458,85092, 85099, 85880, 85883,85394,85403,85404, 85465, 85086, 85081,85414, 85416,85393, 85887, 85420, 85376, 85427, 85380, 85041,85042, 85891, 85186,85477, 85020, 85021,85325, 85350,85023,85024,85066, 85057, 85178,85900, 85871, 85435, 85345, 85352, 85481,85482, 85167,85168, 85470, 85453, 85442, 85321, 8585893,85468,85469, 85388,85157, 85232, 85187, 85439, 85848, 85223, 85016, 85017,85375, 85383,85384,85385, 85373, 85374, 85281, 85344, 85905,85904, 85906,85144,85326, 85327, 85473,85467, 85134, 85133, 85238, 85370, 85911, 85357",1/25/2016,"01/25/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73480,"Ongoing","Virtus Pharmaceuticals, Llc","2649 Causeway Center Dr",,"Tampa","FL","33619-6102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MI","D-0775-2016","Class III","Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL","1,139 bottles total","Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate). ","03/14/2016",," Lot code M143810A, exp 7/2017, NDC 69543-264-10, UPC 369543264105, and Lot code M143810, exp 7/2017,  NDC 76439-264-10, UPC 376439264109 ",1/15/2016,"01/15/2016",3/23/2016,"03/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73481,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to  IL, NY, MT, and MN.","Z-1232-2016","Class II","syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media.  It is used for diagnostic image viewing and post processing during interventional procedures.   .","6","After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.","03/23/2016",," Serial # 20119, 20098, 20041, 20124, 12177, 20026",2/24/2016,"02/24/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73482,"Ongoing","Ruiz Food Products Inc","501 S Alta Ave",,"Dinuba","CA","93618-2100","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US and Canada","F-1007-2016","Class II","Cheesy Pepper Jack Wrapped In A Battered Flour Tortilla For Institutional Use Only. Net Weight 4.5 lb 2 kg packaged in a cardboard box with black inkjet printing.","10,261 cases","Plastic was found in a food product by a customer.","03/30/2016",," 15 329 0:700 through 17:00",3/9/2016,"03/09/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73483,"Terminated","Paige Common","722 N Sumner St",,"Portland","OR","97217-2641","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon retail stores only","F-1971-2016","Class I","Eatin' Alive VEGAN GLUTEN FREE RAW thai peanut noodles.  Keep Refrigerated.  8oz  UPC 0 91037 56624 9","24 units","Paige Common dba Eatin' Alive is recalling Thai Peanut Noodles and Thai Wrap due to undeclared allergen soy.  The soy is a sub ingredient of tamari. ","08/23/2016","08/23/2016"," SELL BY:  3/8",3/4/2016,"03/04/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73483,"Terminated","Paige Common","722 N Sumner St",,"Portland","OR","97217-2641","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon retail stores only","F-1972-2016","Class I","Eatin' Alive VEGAN GLUTEN FREE RAW thai wrap.  Keep Refrigerated.  6oz  UPC 0 91037 56620","42 units","Paige Common dba Eatin' Alive is recalling Thai Peanut Noodles and Thai Wrap due to undeclared allergen soy.  The soy is a sub ingredient of tamari. ","08/23/2016","08/23/2016"," SELL BY:  3/8",3/4/2016,"03/04/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73484,"Terminated","Northern Tier Bakery (dba\ Super Mom's)","625 2nd St",,"St Paul Park","MN","55071-1807","United States","Voluntary: Firm Initiated","E-Mail","MN and WI only.  No OUS distribution","F-1066-2016","Class I","Tuna Salad Sandwich, Net Wt. 4.5 oz (128g) sold under the following brands and UPC:  1.  SuperMom's Bakery, UPC:  76391380124;  2. TakeAway Cafe, UPC:  76391310702;  3. Express Cafe, UPC:  76391380124  Keep Refrigerated.","385 sandwiches","Supermom's identified that the Tuna Salad Sandwich contains an undeclared allergen (milk).","04/11/2016","05/25/2016"," Enjoy Through:  3/11",3/8/2016,"03/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73485,"Ongoing","Wonderful Pistachios & Almonds, LLC.","13646 Highway 33",,"Lost Hills","CA","93249-9719","United States","Voluntary: Firm Initiated","Press Release","United states and Canada, Mexico and Peru.","F-1289-2016","Class I","Roasted Sweet Chili Pistachios  Packaged under brand name of  Wonderful   Packed in 1.25 oz., 4.5 oz. bags.     UPC - 1.25 oz bag 014113913331;  Outer box UPC 014113913348    UPC 4.5 oz bag 014113910309  Outer box UPC 014113913379","1,065,747 lbs (total)","Firm is recalling all Pistachio products produced in one of their  processing buildings in a two week time frame due to a link with a current outbreak of Salmonellosis.","04/29/2016",," 1.25 oz bag lot code 1510123307901, Expiry date 2016 NOV 04.    4.5 oz. bag lot code 1510123308101, Expiry date 2016 NOV 05.",3/9/2016,"03/09/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73485,"Ongoing","Wonderful Pistachios & Almonds, LLC.","13646 Highway 33",,"Lost Hills","CA","93249-9719","United States","Voluntary: Firm Initiated","Press Release","United states and Canada, Mexico and Peru.","F-1287-2016","Class I","Roasted Salted Inshell Pistachios:  Packaged under brand name of  Wonderful, Paramount   Packed in 1.5 oz., 24 oz., 5 oz., 13 oz., 40 oz., 1 oz,. bags and 25 lb. box.    UPC - 1.5 oz. bag: 014113911856  Outer Box UPC: 014113911863    UPC 24 oz. bag: 014113911979    UPC 5 oz. bag: 014113910088  Outer box UPC: 014113910156    UPC 13 oz. bag: 014113913706    UPC 40 oz. bag: 014113913638    UPC 1 oz. bag: 014113912839  UPC Outer Box: 014113910323    UPC 25 lbs box: 00014113910255","1,065,747 lbs (total)","Firm is recalling all Pistachio products produced in one of their  processing buildings in a two week time frame due to a link with a current outbreak of Salmonellosis.","04/29/2016",," 1.5 oz bag lot codes 1509123256701, Expiry date 10/26/16;  1509123256801, Expiry date 10/28/2016.    24 oz. bag lot codes 1509123260601, expiry date 2016 OCT 27; 1509123260601, expiry date, 2016 NOV 02 -     5 oz. bag lot code 1509123289801, expiry date  2016 OCT 30 -     13 oz. bag lot code 1510123332601, expiry date 2016 NOV 02 -     40 oz. bag lot code 1509123260401, expiry date 11/05/2016 -     1 oz. bag lot codes 1509123255401, expiry date 2016 OCT 26;   1509123255501, Expiry date 2016 OCT 29;  1510123294801, expiry date 2016 NOV 02 -     25 lb. box lot codes 1510123294601, Expiry date 2016/11/02; 1510123332501, Expiry date 2016/11/05; 1509123280901, Expiry Date 2016 OCT 27; 1510123332401, Expiry Date 2016 NOV 05.    ",3/9/2016,"03/09/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73485,"Ongoing","Wonderful Pistachios & Almonds, LLC.","13646 Highway 33",,"Lost Hills","CA","93249-9719","United States","Voluntary: Firm Initiated","Press Release","United states and Canada, Mexico and Peru.","F-1286-2016","Class I","Roasted Salt and Pepper Inshell Pistachios:  Packaged under brand name of  Wonderful.    Packed in 4.50oz. bag.    UPC - Bag  014113910293,   Outer Box UPC: 014113913362","1,065,747 lbs (total)","Firm is recalling all Pistachio products produced in one of their  processing buildings in a two week time frame due to a link with a current outbreak of Salmonellosis.","04/29/2016",," 4.5 oz bag lot code 1510123307001, Expiry date 2016 NOV 05.",3/9/2016,"03/09/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73485,"Ongoing","Wonderful Pistachios & Almonds, LLC.","13646 Highway 33",,"Lost Hills","CA","93249-9719","United States","Voluntary: Firm Initiated","Press Release","United states and Canada, Mexico and Peru.","F-1291-2016","Class I"," Dry Roasted & Unsalted Inshell Pistachios;  Packaged for Trader Joe's.  Packaged in 16 oz. bag.    UPC 00079990","1,065,747 lbs (total)","Firm is recalling all Pistachio products produced in one of their  processing buildings in a two week time frame due to a link with a current outbreak of Salmonellosis.","04/29/2016",," 16 oz. bag lot codes 1509123256101, Expiry date 2016 OCT 27; 15091232562011509123256301, Expiry date 2016 OCT 28 .",3/9/2016,"03/09/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73485,"Ongoing","Wonderful Pistachios & Almonds, LLC.","13646 Highway 33",,"Lost Hills","CA","93249-9719","United States","Voluntary: Firm Initiated","Press Release","United states and Canada, Mexico and Peru.","F-1288-2016","Class I","Roasted Salted Shelled Pistachios  Packaged under brand name of  Wonderful   Packed in 6 oz.., 2.5 oz., 24 oz., 6 oz., 225 g  bags.     UPC - 6 oz. bag 014113734066    UPC 2.5 oz. bag 014113910132  Outer box UPC 014113913386    UPC 24 oz bag 014113910125    UPC  6 oz. bag 014113734066    UPC 225 g 014113912044    ","1,065,747 lbs (total)","Firm is recalling all Pistachio products produced in one of their  processing buildings in a two week time frame due to a link with a current outbreak of Salmonellosis.","04/29/2016",," 6 oz. bag lot code 1509123260401, Expiry date 10/26/2016; 1510123295301, Expiry date 11/02/2016 .    2.5 oz bag lot code 1510123295001, Expiry date 2016 NOV 02.    24 oz. bag lot code 1510123331501. Expiry date 2016 NOV 04;  1510123305001, Expiry date 2016 NOV 02.    225 g bag lot code 1509123259801, 2016/10/27.",3/9/2016,"03/09/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73485,"Ongoing","Wonderful Pistachios & Almonds, LLC.","13646 Highway 33",,"Lost Hills","CA","93249-9719","United States","Voluntary: Firm Initiated","Press Release","United states and Canada, Mexico and Peru.","F-1290-2016","Class I","50% Less Salt Dry Roasted & Salted Inshell Pistachios;  Packaged for Trader Joe's.  Packaged in 16 oz. bag.    UPC 00111348","1,065,747 lbs (total)","Firm is recalling all Pistachio products produced in one of their  processing buildings in a two week time frame due to a link with a current outbreak of Salmonellosis.","04/29/2016",," 16 oz. bag lot codes 1509123256501, Expiry Date 2016 OCT 28; 1509123256401, Expiry date 2016 OCT 28; 1509123256601, Expiry Date 2016 OCT 29; 1510123307101, Expiry date 2016 NOV 03; 1510123307201, 1510123307301 Expiry Date 2016 NOV 04.",3/9/2016,"03/09/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73485,"Ongoing","Wonderful Pistachios & Almonds, LLC.","13646 Highway 33",,"Lost Hills","CA","93249-9719","United States","Voluntary: Firm Initiated","Press Release","United states and Canada, Mexico and Peru.","F-1292-2016","Class I"," Dry Roasted & Salted Inshell Pistachios;  Packaged for Trader Joe's.  Packaged in 16 oz. bag.    UPC 00079983","1,065,747 lbs (total)","Firm is recalling all Pistachio products produced in one of their  processing buildings in a two week time frame due to a link with a current outbreak of Salmonellosis.","04/29/2016",," 16 oz. bag lot codes 1509123259901, 1509123260001, Expiry date 2016 OCT 28;   1509123260101, Expiry Date 2016 OCT 29; 1510123294901, Expiry date 2016 NOV 03.",3/9/2016,"03/09/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73485,"Ongoing","Wonderful Pistachios & Almonds, LLC.","13646 Highway 33",,"Lost Hills","CA","93249-9719","United States","Voluntary: Firm Initiated","Press Release","United states and Canada, Mexico and Peru.","F-1285-2016","Class I","Roasted No Salt  Inshell Pistachios:  Packaged under brand name of  Wonderful.    Packed in 16 oz., 8 oz., 200 grams and 225 grams bags.    UPC - 16 oz: 014113910064  UPC - 8 oz:.014113910187  UPC - 200 grams: 014113913652  UPC - 225 grams: 014113912532","1,065,747 lbs (total)","Firm is recalling all Pistachio products produced in one of their  processing buildings in a two week time frame due to a link with a current outbreak of Salmonellosis.","04/29/2016",," 16 oz. lot codes:150912325560115091232557011509123255901; all with expiry of 2016 OCT 26. Lot code 1509123256001, Expiry 2016 OCT 27.  8 oz. - lot code: 1509123259601; Expiry Date 10/26/2016.  200 g - lot code: 1509123260301, Expiry date 10/26/2016;  225 g - lot code: 1509123256901, Expiry date 10/26/2016.  ",3/9/2016,"03/09/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73486,"Ongoing","Livongo Health","444 N Michigan Ave Ste 2880",,"Chicago","IL","60611-3998","United States","Voluntary: Firm Initiated","Letter","US consignees: Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington.","Z-1587-2016","Class II","The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. ","63,000 units","The instructional insert for the In Touch Control  Solution for use with the In Touch meter and In Touch strips as a quality control check  did not contain the limitation of sensor accuracy:   (1) with the use of acetaminophen (Tylenol)  (2) with the use of Ascorbic Acid (vitamin C) supplementation  (3) in the presence of uric acid    ","04/29/2016",," Model/Reorder Number 3614-001-001 with the following lot numbers 890071  890072, 890073, 890074, 890075, 890076, 890077, 890078 and 890079.  ",2/18/2016,"02/18/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73487,"Ongoing","Fresenius Medical Care Renal Therapies Group, LLC","920 Winter St",".","Waltham","MA","02451-1521","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1325-2016","Class II","Fresenius 2008 Series Hemodialysis  Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home:  Models:  Fresenius 2008K and 2008K2 Dialysate Delivery System  Fresenius 2008K@home Hemodialysis Machine with bibag System  2008T Hemodialysis Machine  The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy","8384 units (8369 US) (15 OUS)","Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)","04/05/2016",," Fresenius 2008 Series Hemodialysis  Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home:  Models:  Fresenius 2008K and 2008K2 Dialysate Delivery System  Fresenius 2008K@home Hemodialysis Machine with bibag System  2008T Hemodialysis Machine",3/10/2016,"03/10/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73489,"Ongoing","Biomet, Inc.","56 E Bell Dr",".","Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.","Z-1318-2016","Class II","All instrumentation associated with the Prelude PF Resurfacing Knee System.      ","576","Inadequate design control.      ","04/04/2016",," All Lots of All Prelude PF instrumentation part numbers.     Part Number	Description  110004338:	No. 1 Femoral Trial, Left   110004248:	No. 1 Femoral Trial, Right   110004339:	No. 2 Femoral Trial, Left  110004250:	No. 2 Femoral Trial, Right  110004344:	No. 3 Femoral Trial, Left  110004252:	No. 3 Femoral Trial, Right  110004342:	No. 4 Femoral Trial, Left  110004254:	No. 4 Femoral Trial, Right  110004341:	No. 5 Femoral Trial, Left  110004256:	No. 5 Femoral Trial, Right  110004337:	No. 6 Femoral Trial, Left  110004258:	No. 6 Femoral Trial, Right  110004340:	No. 6W Femoral Trial, Left  110004260:	No. 6W Femoral Trial, Right  110004343:	No. 7W Femoral Trial, Left  110004262:	No. 7W Femoral Trial, Right  110004345:	No. 8W Femoral Trial, Left  110004264:	No. 8W Femoral Trial, Right  110004105:	No. 1 Drill Guide, Left   110004106:	No. 1 Drill Guide, Right  110004107:	No. 2 Drill Guide, Left   110004108:	No. 2 Drill Guide, Right  110004109:	No. 3 Drill Guide, Left   110004110:	No. 3 Drill Guide, Right  110004111:	No.4 Drill Guide, Left  110004112:                     No.4 Drill Guide, Right  110004113:	No. 5 Drill Guide, Left  110004114:	No. 5 Drill Guide, Right  110004115:	No. 6 Drill Guide, Left  110004116:	No. 6 Drill Guide, Right  110004117:	No. 6W Drill Guide, Left  110004118:	No. 6W Drill Guide, Right  110004119:	No. 7W Drill Guide, Left  110004120:	No. 7W Drill Guide, Right  110004121:	No. 8W Drill Guide, Left  110004122:	No. 8W Drill Guide, Right  010001763:	25MM Reamer  010001768:	31MM Reamer  110004151:	25MM Stop Collar  110004165:	31MM Stop Collar  110007428:	Stop Collar Push Button  110004170:	2.1MM Guide Pin  110004169:	Trial Remover  110004172:	Impactor Handle  110007398:	15 Degree Rasp  597004:	                      Instrument Case  110018820:	25MM Peek Bushing  110018821:	31MM Peek Bushing  ",3/9/2016,"03/09/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73490,"Ongoing","Flying Foods LLC","1257 Minters Chapel Rd",,"Grapevine","TX","76051-4150","United States","Voluntary: Firm Initiated","Other","FL, TX, OK","F-1081-2016","Class II","Starbuck's Cheese & Fruit Bistro Box NET WT 5.3 OZ/150g packaged in non-flexible plastic container.","8,591 units","Product may contain undeclared cashews.","04/20/2016",," Enjoy by 02/26, 02/27, 02/28, 02/29, 03/01, 03/02, 03/03, 03/04",3/2/2016,"03/02/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73491,"Ongoing","Akorn, Inc.","1925 W Field Ct Ste 300",,"Lake Forest","IL","60045-4862","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0875-2016","Class II","Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16","3,112,657 mL","Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.","05/25/2016",," Lot # 627528, 627763, 627766, 627921, 627924, 627927, 627930, 627933, 627953, 627956, 627959, 628040, Exp 5/16; 628148, 628151, 628230, 628232, 628365, Exp 6/16; 628589	, 628592, 628598, 628802, 628805, 628808, 628811, 628814, Exp 7/16	; 629059, 629204, 629207, 629232, 629235, 629307, 629310, 629313, 629316, Exp 8/16; 629687, 629693, 629696, 629882, 629888, 630058, Exp 9/16; 630061, 630064, 630221, 630224, 630362, 630365, 630613, Exp 10/16; 630615, 630732, 630735, 630853, 630856, 630859, 631008, Exp 11/16; 631026, 631027, 631169, 631172, 631175, 631655, 631658, Exp 12/16; 631704, 631707, 631861, 631864, 631867, 632059, 632062, 632065, 632068, 632071, 632074, 632211, 632214 Exp 1/17; 632328, 632331, 632334, 632337, 632472, 632475, 632504, 632507, 632697, Exp 2/17; 633090, 633093, 632776, 632781, 632784, 632790, 632793, 632796, 632805, 632808, 632811, 632814, 633072, 633078, 633081, 633084, 633087, Exp 3/17; 633681, 633682, 633099, 633684, 633111, Exp 4/17; 345607, 345618, 345620, Exp 5/17; 346575, 346863, 346571, 346720,3 46573, Exp 7/17  ",3/23/2016,"03/23/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73491,"Ongoing","Akorn, Inc.","1925 W Field Ct Ste 300",,"Lake Forest","IL","60045-4862","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0876-2016","Class II","PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701","294,090 mL","Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.","05/25/2016",," Lot # 627525, Exp 5/16; 628362, Exp 6/16; 628595, Exp 7/16; 629319, Exp 8/16; 629885, Exp 9/16; 630467,Exp10/16; 32218, 632500, Exp 2/17; 633075,  632799, Exp 3/17; 345624, 345679, Exp 5/17; 347420, 347662, Exp 9/17",3/23/2016,"03/23/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73491,"Ongoing","Akorn, Inc.","1925 W Field Ct Ste 300",,"Lake Forest","IL","60045-4862","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0874-2016","Class II","ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O","33,862 mL","Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.","05/25/2016",," Lot # 628146, Exp 6/16; 629690, Exp 9/16; 348295, Exp 10/17	",3/23/2016,"03/23/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73492,"Ongoing","Stratas Foods Llc","7130 Goodlett Farms Pkwy Ste 200",,"Cordova","TN","38016-4992","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD and NY","F-1061-2016","Class II","Silver Source Canola Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 42770 7  ","218 cases","Stratas Foods was informed by their 5 Galloon container Supplier, Ring Container that it is possible a 53 mm in diameter piece of plastic from the neck finish could be in the jugs that went to their co-manufacturer Oasis Foods.","04/08/2016",," Product Code 104440, Lot #012716J",2/12/2016,"02/12/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73492,"Ongoing","Stratas Foods Llc","7130 Goodlett Farms Pkwy Ste 200",,"Cordova","TN","38016-4992","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD and NY","F-1060-2016","Class II","Silver Source Creamy Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 02236 0  ","840 cases","Stratas Foods was informed by their 5 Galloon container Supplier, Ring Container that it is possible a 53 mm in diameter piece of plastic from the neck finish could be in the jugs that went to their co-manufacturer Oasis Foods.","04/08/2016",," Product Code 102040, Lot #012816J",2/12/2016,"02/12/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73492,"Ongoing","Stratas Foods Llc","7130 Goodlett Farms Pkwy Ste 200",,"Cordova","TN","38016-4992","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD and NY","F-1059-2016","Class II","Burger King Liquid Frying Oil, Net Wt. 35 LB (15.9 kg), Miami, Florida 33126, UPC 2 06 75258 06956 3 ","6,137 cases","Stratas Foods was informed by their 5 Galloon container Supplier, Ring Container that it is possible a 53 mm in diameter piece of plastic from the neck finish could be in the jugs that went to their co-manufacturer Oasis Foods.","04/08/2016",," Product Code 104180, Lot #'s 0122616J, 020116J and 030216J",2/12/2016,"02/12/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73492,"Ongoing","Stratas Foods Llc","7130 Goodlett Farms Pkwy Ste 200",,"Cordova","TN","38016-4992","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD and NY","F-1063-2016","Class II","Silver Source Clear  Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 008 06795 02237 3  ","3,660 cases","Stratas Foods was informed by their 5 Galloon container Supplier, Ring Container that it is possible a 53 mm in diameter piece of plastic from the neck finish could be in the jugs that went to their co-manufacturer Oasis Foods.","04/08/2016",," Product Code 104052, Lot #012816J",2/12/2016,"02/12/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73492,"Ongoing","Stratas Foods Llc","7130 Goodlett Farms Pkwy Ste 200",,"Cordova","TN","38016-4992","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MD and NY","F-1062-2016","Class II","Silver Source Clear Canola Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 02237 7  ","540 cases","Stratas Foods was informed by their 5 Galloon container Supplier, Ring Container that it is possible a 53 mm in diameter piece of plastic from the neck finish could be in the jugs that went to their co-manufacturer Oasis Foods.","04/08/2016",," Product Code 104450, Lot #012716J",2/12/2016,"02/12/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73493,"Ongoing","Rajbhog Foods (NJ) Inc.","60 Amity St",,"Jersey City","NJ","07304-3510","United States","Voluntary: Firm Initiated","Letter","NY, NJ","F-2286-2016","Class II","Rajbhog Foods No Eggs Butter Cookies 5 oz.  Distributed by Rajbhog Foods (NJ) Inc., Jersey City NJ 07304  UPC 735426355066  item B006","3400  units","Rajhbog Foods no Eggs Butter Cookies contain undeclared wheat based on NYSDAM Sampling.","09/18/2016",," 34515, 35315",2/2/2016,"02/02/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73494,"Ongoing","Medtronic Inc.","8200 Coral Sea St Ne",,"Saint Paul","MN","55112-4391","United States","Voluntary: Firm Initiated","Visit","Worldwide Distribution-US (nationwide) including DC and the countries of Andorra, Australia, Austria, Belgium, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic,  Denmark, Faroe Islands , Finland, France, Germany, Greece, Hong Kong,  Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kenya,  Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Namibia,  Netherlands, New Caledonia, New Zealand, Norway, Oman, Philippines,   Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore,  Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania,  Thailand, Turkey, United Arab Emirates and United Kingdom.","Z-1249-2016","Class II","Reveal LINQ insertable Cardiac Monitor, Model LNQ11.  Monitors subcutaneous ECG continuously.","189,009","Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal ","03/25/2016",," All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.    ",2/23/2016,"02/23/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73496,"Ongoing","Camericam International Inc","480 Alfred Ave",,"Teaneck","NJ","07666-5756","United States","Voluntary: Firm Initiated","Telephone","IL","F-1091-2016","Class II","Seasons Choice Prince Edward Medley   Net Wt. 16 oz.  Distributed by: Aldi Inc.  Batavia, IL 60510    Product of Netherlands  UPC will be entered.","47,562 Bags ","The recall is being issued as a precaution after a limited number of product tested positive for the presence of Listeria monocytogenes.  ","04/20/2016",," Best Before: Jun 28 2017  Lot 152212  ",3/1/2016,"03/01/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73497,"Ongoing","Cardinal Health","1430 Waukegan Rd",".","Mc Gaw Park","IL","60085-6726","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.","Z-1320-2016","Class II"," Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.  ","SSI-0034: 380 units and 10-1100: 60 units","Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.","04/05/2016",," SSI-0034 with  LOT# 462799 & 476803    10-1100 with LOT# 462788 & 485406    ",2/29/2016,"02/29/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73498,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",".","Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO,   NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).","Z-1340-2016","Class II","Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty.  REF 42-5114-005-14","TBD","The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides.  One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.","04/06/2016",," lot 62646580",3/17/2016,"03/17/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73498,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",".","Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO,   NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).","Z-1341-2016","Class II","Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty.  REF 42-5114-008-18","TBD","The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides.  One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.","04/06/2016",," lot 62632101",3/17/2016,"03/17/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73499,"Ongoing","Abbott Nutrition","1518 Main St",".","Altavista","VA","24517-1132","United States","Voluntary: Firm Initiated","Telephone","Lot 57642RA00,  Beginning Date of distribution in US  10/12/15  End Date of distribution in US- 12/4/15 .      AN distributed this lot to151 Distributors, 32 Medical Facilities and 25 Other types of consignees (2 of these were internal sales reps).    No foreign accounts.      There are 12 US government consignees.","F-1041-2016","Class II","The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : 8 oz. , Container description : Metal Can, Total package size : 24 cans per case .     ","15,609 cases (374,616 units)","Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla is product because the product may have a different color, smell, taste or texture  inconsistent with other lots of PediaSure Grow & Gain Vanilla.     Abbott Nutrition  also recognized a complaint trend for physical stability and sensory on this batch on 1/25/16 and an investigation revealed a possibility that a small portion of cans may","04/06/2016",," List Number 55897  , Lot 57642RA00    ",3/10/2016,"03/10/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73500,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Telephone","Nationwide","F-0790-2016","Class II","Lean Cuisine Marketplace Spinach Artichoke Ravioli, UPC 13800-55806,  Keep Frozen.  Net Wt. 9 oz (255g) ","23,601 cases","Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.","03/23/2016",," Production codes:  5362587812, 5363587812.  Best Before:  Jan 2017",3/10/2016,"03/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73500,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Telephone","Nationwide","F-0792-2016","Class II","Stouffer's vegetable lasagna.  Keep Frozen. Sold in the following sizes and UPC:  1.  Party Size  Net Wt. 96 oz (6 lb) 2.72kg  UPC 13800-19002.  2.  Net Wt. 10 1/2 oz (297g)  UPC 13800-10323.  3.  Family Size Net Wt. 37 1/2 oz (2 lbs. 5 1/2 oz) 1.06 kg, UPC 13800-55510.  4.  Food Service Professional Product Net Wt. 6 lbs (2.72 kg)  UPC 13800-30322.(this product is not available in retail stores)","28,785 cases","Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.","03/23/2016",," Production codes  and Best Before dates:    1.  5351595916, 5353595915, 5353595916, Best Before March 2017  6004595916,  Best Before:  April 2017    2.  5353595913, Best Before:  March 2017.  6011595513, Best Before:  April 2017.      3.  5349595914, Best Before:  Jan 2017.    4.  5346595916, Best Before:  March 2017",3/10/2016,"03/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73500,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Telephone","Nationwide","F-0787-2016","Class II","DiGiorno pizzeria thin crust spinach & mushroom pizza, UPC 71921-58570,  Keep Frozen.  Net Wt. 18 oz (1 lb 2 oz) 511g ","2,642 cases","Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.","03/23/2016",," Production code:  6009525952.  Best Before:  Aug 2016",3/10/2016,"03/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73500,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Telephone","Nationwide","F-0785-2016","Class II","DiGiorno Rising Crust Spinach and Mushroom Pizza, UPC 71921-00335, Keep Frozen.  Net Wt. 30.3 oz (1 lb 14.3 oz) 858g","23,424 cases","Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.","03/23/2016",," Batch code:  6004525932, 6005525931, 6020525932, 6021525931.  Best Before:  Aug 2016",3/10/2016,"03/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73500,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Telephone","Nationwide","F-0786-2016","Class II","DiGiorno Thin & Crispy Spinach and Garlic Pizza, UPC 71921-45143, Keep Frozen.  Net Wt. 11.9 oz (337g) ","21,997 cases","Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.","03/23/2016",," Production code:  5363525921, 5363525922, 5364525921.   Best Before:  July 2016  Production code:  6019525921, 6019525922.  Best Before:  Aug 2016",3/10/2016,"03/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73500,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Telephone","Nationwide","F-0791-2016","Class II","Lean Cuisine Marketplace Ricotta Cheese & Spinach Ravioli, UPC 13800-93052,  Keep Frozen.  Net Wt. 8 oz (226g) ","21,204 cases","Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.","03/23/2016",," Production codes:  6004595912, 6005595912.  Best Before:  Feb 2017",3/10/2016,"03/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73500,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Telephone","Nationwide","F-0793-2016","Class II","Stouffer's spinach souffle.  Simple Dishes.  Keep Frozen. Net Wt. 12 oz (340 g)  UPC 13800-10585.",,"Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.","03/23/2016",," Production codes  5353595528, 5353595538 and Best Before:  July 2016    ",3/10/2016,"03/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73500,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Telephone","Nationwide","F-0789-2016","Class II","Lean Cuisine Marketplace Mushroom Mezzaluna Ravioli, UPC 13800-58358,  Keep Frozen.  Net Wt. 8-5/8 oz (244g) ","26,724 cases","Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.","03/23/2016",," Production codes:  5348587812 and 5349587812.  Best Before:  Jan 2017",3/10/2016,"03/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73500,"Ongoing","Nestle USA","30003 Bainbridge Rd",,"Solon","OH","44139-2205","United States","Voluntary: Firm Initiated","Telephone","Nationwide","F-0788-2016","Class II","Lean Cuisine Craveables Deep Dish Spinach & Mushroom pizza, UPC 13800-13520,  Keep Frozen.  Net Wt. 6-1/8 oz (173g) ","70,085 cases","Nestle is recalling a limited number of DiGiorno, Lean Cuisine, and Stouffer's products due to the potential presence of glass pieces.","03/23/2016",," Production code:  5339587814, 5340587814, 5340587815, 6003587814.  Best Before:  Nov 2016",3/10/2016,"03/10/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73501,"Ongoing","Healthy Solutions LLC","16047 N 82nd St",,"Scottsdale","AZ","85260-1800","United States","Voluntary: Firm Initiated","Letter","US distribution to CA for further distribution within the US by own label distributor.","F-1003-2016","Class I","Wellco Super Elixir Pouches   The Super Elixir  150g, 300g","56 cartons","Healthy Solutions is recalling Super Elixir Pouches because of potential Salmonella contamination.","03/31/2016",," Lot #: 0116015",3/4/2016,"03/04/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73502,"Ongoing","Kanan Enterprises, Inc.","31900 Solon Rd",,"Solon","OH","44139-3536","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AR, AZ, IL, IN & MI.","F-0817-2016","Class I","Favorites Natural Pistachios, roasted & salted, 4.5 oz (128g)  pouch UPC 0 38445 12286 5 Proudly distributed by Circle K Stores, Inc.  P.O. Box 52085 Phoenix, AZ 85072 www.circlek.com","408 cases/ 24/4.5 oz packages","The firm was notified by their  supplier that the product may contain Salmonella.","03/28/2016",," BEST BEFORE 15 Feb 2017 and 16 Feb 2017",3/10/2016,"03/10/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73503,"Ongoing","Phibro Animal Health Corporation","300 Frank W Burr Blvd Ste 21",,"Teaneck","NJ","07666-6704","United States","Voluntary: Firm Initiated","Letter","CA, MN, WI","V-489-2016","Class II","Phibro Animal Health Corporation  NeoTerramycin 100/100D Type A Medicated Article  Net Weight 50 lb (22.7 kg)  Distributed by Phibro Animal Health Corporation Teaneck NJ 07666  NDC 66104-8851-0    Packed in a 50 lb bag (22.6 kg/bag); Multi-wall bag with the following construction/configuration; 4 ply Natural Kraft and 1 ply 2.0 mil HDPE","3,900 pounds","This recall was initiated because NeoTerramycin (100/100D lot number A41770017NK tested below (88.5 g/lb) the potency specification of 89.5-115.4 g/lb at the 18 month stability interval under VICH long-term conditions.","08/31/2016",," Lot number A41770017NK Expiration Date 03/31/2016 (March 31, 2016).  ",1/13/2016,"01/13/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73504,"Ongoing","Siemens Medical Solutions USA, Inc.","2501 Barrington Rd",,"Hoffman Estates","IL","60192-2061","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.***** Foreign Consignees: Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kosovo, Kuwait, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China, Pakistan, Palestinian Ter, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Tunisia, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay and  Vietnam.","Z-1262-2016","Class II","The E.CAM gamma camera system     Product Usage:  The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body  ","3090 units","We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002).  The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbia E systems that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper collimator change ","03/25/2016",," 10275879, 10413009, 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823920, 07823938, 07823946, 07823953, 07823961, 07823979, 10151531, 10151532, 10520745",2/26/2016,"02/26/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73504,"Ongoing","Siemens Medical Solutions USA, Inc.","2501 Barrington Rd",,"Hoffman Estates","IL","60192-2061","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.***** Foreign Consignees: Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kosovo, Kuwait, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China, Pakistan, Palestinian Ter, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Tunisia, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay and  Vietnam.","Z-1263-2016","Class II","The Symbia gamma camera system     Product Usage:  The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.  ","726 units","We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002).  The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbia E systems that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper collimator change ","03/25/2016",," 10275879, 10413009, 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823920, 07823938, 07823946, 07823953, 07823961, 07823979, 10151531, 10151532, 10520745",2/26/2016,"02/26/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73505,"Terminated","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution","Z-1507-2016","Class II","VariAx Compression Plating System","118 units","Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.","04/18/2016","04/21/2016"," catalog numbers  629503S, 629504S, 629505S, 629506S, 629507S, 629508S, 629509S, 629510S, 629527S, 629537S, 629543S, 629544S, 629545S, 629546S, 629547S, 629548S, 629559S, 629560S, 629561S, 629562S, 629564S, 629566S, 629568S, 629570S",10/10/2013,"10/10/2013",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73506,"Ongoing","Temptime Corporation","116 The American Rd",,"Morris Plains","NJ","07950-2443","United States","Voluntary: Firm Initiated","Telephone","Nationwide","B-0371-16","Class III","Safe-T-Vue 10 and Safe-T-Vue 6  Temptime  116 The American Road  Morris Plains, NJ 07950  www.williamlabs.com","1,819,250 units","Updated Instructions for Use with revised storage instructions for some lots of Safe-T-Vue 6 and Safe-TuVue 10 was distributed. ","03/25/2016",," Part Number 7206; Lots:   S6102615, S6 011315, S6 090914, S6 070914, S6 021814  Part Number 7201; Lots:    S10 112315, S10 091815, S10 051315, S10 032615, S10 021015, S10 120814, S10 111314, S10 101314, S10 082114, S10 062414, S10 053014, S10 050514, S10 040214   ",2/11/2016,"02/11/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73507,"Ongoing","Texas Star Nut and Food Co., Inc.","206 Market Ave",,"Boerne","TX","78006-3003","United States","Voluntary: Firm Initiated","E-Mail","TX and LA","F-1242-2016","Class I","Nature's Eats Almond & Pistachio Duo NET WT 6 OZ (170g) packaged in clear cello bag","186 cases","Potential to be contaminated with Salmonella.","04/26/2016",," Lot code: 40798",3/9/2016,"03/09/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73507,"Ongoing","Texas Star Nut and Food Co., Inc.","206 Market Ave",,"Boerne","TX","78006-3003","United States","Voluntary: Firm Initiated","E-Mail","TX and LA","F-1241-2016","Class I","Nature's Eats Austin's Nutty All-Terrain NET WT 12 OZ (340g) packaged in clear cello bag","283 cases","Potential to be contaminated with Salmonella.","04/26/2016",," Lot code: 39786, 40660",3/9/2016,"03/09/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73507,"Ongoing","Texas Star Nut and Food Co., Inc.","206 Market Ave",,"Boerne","TX","78006-3003","United States","Voluntary: Firm Initiated","E-Mail","TX and LA","F-1238-2016","Class I","Nature's Eats Natural Pistachios NET WT 8 OZ (227g) packaged in clear cello bag and Bulk RAW PISTACHIO - 25 LBS and Bulk RAW PISTACHIO - 5 LBS packaged in corrugated box","1,083 cases","Potential to be contaminated with Salmonella.","04/26/2016",," Lot code: 38774, 39492, 39991, 40262, 40446, 39200, 39201, 39211, 39250",3/9/2016,"03/09/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73507,"Ongoing","Texas Star Nut and Food Co., Inc.","206 Market Ave",,"Boerne","TX","78006-3003","United States","Voluntary: Firm Initiated","E-Mail","TX and LA","F-1243-2016","Class I","Nature's Eats Simply Go Raw NET WT 8 OZ (227g) packaged in clear cello bag","1,187 cases","Potential to be contaminated with Salmonella.","04/26/2016",," Lot code: 40099, 40283, 40527, 40596",3/9/2016,"03/09/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73507,"Ongoing","Texas Star Nut and Food Co., Inc.","206 Market Ave",,"Boerne","TX","78006-3003","United States","Voluntary: Firm Initiated","E-Mail","TX and LA","F-1239-2016","Class I","Fresh Choices Survivor Mix NET WT 4.75 OZ (135g) packaged in clear cello bag and Nature's Eats Survivor Mix NET WT 10 OZ (284g) packaged in clear cello bag and Southern Grove Survival Trail Mix NET WT 10 OZ (283g) packaged in clear cello bag","5,128 cases","Potential to be contaminated with Salmonella.","04/26/2016",," Lot code: 38882, 39115, 40256, 40386, 38913, 40109, 40495, 40461, 39400, 40539",3/9/2016,"03/09/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73507,"Ongoing","Texas Star Nut and Food Co., Inc.","206 Market Ave",,"Boerne","TX","78006-3003","United States","Voluntary: Firm Initiated","E-Mail","TX and LA","F-1240-2016","Class I","Nature's Eats Hill Country Ramblin' NET WT 15 OZ (425g) packaged in clear cello bag","410 cases","Potential to be contaminated with Salmonella.","04/26/2016",," Lot code: 40703, 40182, 39772",3/9/2016,"03/09/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73508,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","E-Mail","AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, KS, KY, LA, MD, MS, NJ, NM, NC, NV, NY, OH, OK, PA, SC, TX, TN, VT, VA, Canada","F-2290-2016","Class II","365 Everyday Value Mango Frozen Fruit Bars 4 Bars-4 fl. oz. (118 mL) each-Net 16 fl. oz. (472 mL) in a cardboard carton, UPC: 0-99482-41344-6, Distributed By: Whole Foods Market Austin, Texas 78703","1336 cases (12 cartons per case)","Undeclared coconut","09/28/2016",," UPC: 9948241344 Best By: Dec 10 2016",3/9/2016,"03/09/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73509,"Ongoing","Acorn Stairlifts Inc","7335 Lake Ellenor Dr",,"Orlando","FL","32809-6219","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution to the states of :  AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, ME, MD, MI,  MO, NH, NJ, NY, NC, OH, PA, RI, SC, TN, TX, UT, VT, VI, WA, WV, WI, and District of Columbia and to the countries of UK and Germany.","Z-1530-2016","Class II","Acorn 180 Curved Stairlift","1,290 USA and 9,607 Foreign","Aluminum rivets holding the base squab to the framer under prolonged customer use were seen to elongate and subsequently break. ","04/20/2016",," Serial Numbers: 140401487591 to 140410249946.  All models manufactured before April 2012",2/17/2016,"02/17/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1497-2016","Class II","Oasis Foods Golden Fry Clear Liquid Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10458 7","14,476 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCL02OA, Lot #'s 01262016, 01272016, 01282016, 01292016, 02012016, 02022016, 02032016, 02042016 and 02052016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1502-2016","Class II","Chef's Quality Corn Oil, Net Wt. 35 LBS (15.87 KG), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00934 3","Unknown","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FOCO02QB, Lot #02032016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1501-2016","Class II","Chef's Quality Soybean Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: RD/JET LLC, 15-24 132nd Street, College Point, NY 11356, UPC 7 60695 00931 2","3,557 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FOSB02QB, Lot #01302016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1506-2016","Class II","Silver Source Creamy Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795022360","360 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCR023Y, Lot #01272016 and Product Code: TMCX023Y, Lot #01282016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1494-2016","Class II","Oasis Foods Canola Oil, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10841 7","60 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FOCA02OA, Lot #01292016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1493-2016","Class II","Masbia Canola Oil, Net Wt. 35 LB (15.88), Distributed by Dependable Food Corp, Edison, NJ 08817, UPC 7 32146 50866 8","1,200 containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FOCA022M, Lot #01262016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1503-2016","Class II","Chef's Quality Canola Frying Oil for Heavy Duty Frying, Net Wt. 35 LBS (15.87 KG), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00938 1","Unknown","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," N/A",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1495-2016","Class II","Oasis Foods Soybean Oil, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 11099 1","11,338 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FOSB02OA, Lot #'s 01272016, 01282016, 01302016, 02012016 and 02022016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1499-2016","Class II","Chef's Quality Clear Liquid Shortening, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00481 2","18,690 containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCL02QB, Lot #'s 01262016, 01272016, 01292016, 01302016, 02022016, 020420016 and 02052016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1496-2016","Class II","Ex-Seed Premium Creamy Liquid Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 18896 9","124 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCE02EX, Lot #02052016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1490-2016","Class II","Frosty Acres Restaurant's Pride Advantage Clear Fry Oil, Net Wt. 35 LB (15.88), Packed for F.A.B. Inc., General Offices: Alpharetta, GA 30005, UPC 0 4820054764 2","180 containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCL021L, Lot # 02022016  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1498-2016","Class II","Oasis Foods Soybean Cooking & Frying Oil, Net Wt. 35 LB (15.88), Manufactured d by Oasis Foods Company. Hillside, NJ 07205, UPC 7 32146 11212 4","9,207 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FOSF02OA, Lot #'s 01262016, 01282016, 01292016, 01302016, 02012016 and 02032016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1508-2016","Class II","Silver Source Soy Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795022346","1,200 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FOSB023Y, Lot #01282016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1504-2016","Class II","Chef's Quality 100% Canola Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00935  0","4,339 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FOCA02QB, Lot #'s 01282016, 01292016, 01302016, 02022016 and 02032016.",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1507-2016","Class II","Silver Source Canola Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795427707","540 Containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FOCA023Y, Lot #02042016 and Product Code: TMCA02E, Lot #01272016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1509-2016","Class II","Silver Source Clear Canola Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 008 06795 02237 7","Unknown","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: TMCF023Y, Lot #01272016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1489-2016","Class II","Town & Country Pan & Grill Oil Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 24948 4","unknown","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCG02TO, Lot #'s 02042016 and  02082016  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1492-2016","Class II","Oasis Foods Creamy Liquid Fry Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc., Hillside, NJ 07205, UPC 7 32146 10540 9","2,360 containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCR02OA, Lot #'s 01272016 and 01292016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1488-2016","Class II","Oasis Foods Canola Fry Shortening, Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10378 8","6,443 containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCF020A - Lot #'s 01292016, 01302016 and 02092016;  Product Code: FLCF02QB- Lot #'s 01282016, 01292016, 02032016 and 02042016  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1500-2016","Class II","Chef's Quality Creamy Liquid Fry Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00482 9","8,399 containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCR02QB, Lot #'s 01262016, 01272016, 01292016, 02022016 and 020420016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1505-2016","Class II","Silver Source Clear Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food group, Richmond, VA 23238, UPC 00806795022353","13,740 containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCL023Y, Lot #'s 01252016, 01262016, 01272016, 01282016, 02012016, 02022016, 02032016, 02042016 and 02052016.",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73510,"Ongoing","Oasis Trading Co., Inc.","465 Hillside Ave",,"Hillside","NJ","07205-1121","United States","Voluntary: Firm Initiated","Letter","CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA","F-1491-2016","Class II","Pocahontas Clear Liquid Frying Shortening, Net Wt. 35 LB (15.88), Distributed by Progressive Group Alliance, Inc., Richmond, VA 23228, UPC 7 32146 18196 0","4,905 containers","Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.","06/16/2016",," Product Code: FLCL02PH Lot #'s 01252016, 02012016, 02022016 and 02082016.  ",2/12/2016,"02/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73511,"Ongoing","Ortho Clinical Diagnostics Inc","1001 US Highway 202",,"Raritan","NJ","08869-1424","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","B-0373-16","Class III","Ortho Vision Analyzer for ID-Micro Typing System MTS Gel Cards  Ortho Clinical Diagnostics, Rx Only  Catalog #6904577    Labeling is Ortho Vision Analyzer ID-MTS Gel Cards Reference Guide","107 units","Urgent Product Correction Notification for the Ortho Vision Analyzers with Software version 2.12.13 and Below, was distributed. ","03/25/2016",," Catalog Number:  6904577    Serial Numbers:  50002038-50002150  ",2/24/2016,"02/24/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73512,"Ongoing","Mako Surgical Corporation","2555 Davie Rd Ste 110",,"Plantation","FL","33317-7424","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, and WI.","Z-1583-2016","Class II","RESTORIS PST RIO Offset Shell Impactor    For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.      ","96","Potential disassociation of the orientation pin.","04/28/2016",," Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.",2/23/2016,"02/23/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73513,"Terminated","Test Valley LLC. dba. Amniotic Therapies LLC.","11496 Luna Rd Ste 800",,"Farmers Branch","TX","75234-9417","United States","Voluntary: Firm Initiated","Telephone","Ohio; Texas; New Mexico; Hawaii; New Jersey; Florida; Georgia","B-0379-16","Class I","Amniotic membrane","25 allografts","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ","04/29/2016","04/29/2016"," Lot Number:  150792; Additional Product IDs:  AG10042915248, AG10042915249, AG10042915245, AG10042915246, AG10042915247, AG10042915242, AG10042915243, AG10042915244, AG10042915241, AG10042915239, AG10042915240, AG10042915237, AG10042915238, AG10042915236, AG10042915223, AG10042915220, AG10042915221, AG10042915222, AG10042915219, AG10042915217, AG10042915218, AG10042915165, AG10042915203, AG10042915204, AG10042915212  ",2/16/2016,"02/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73514,"Terminated","KED Plasma LLC","5301 Moffett Rd",,"Mobile","AL","36618-2924","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0430-16","Class III","Source Plasma","2 units","Source Plasma, collected from an ineligible donor, was distributed. ","04/14/2016","04/14/2016"," 3280358926; 3280359406",12/10/2015,"12/10/2015",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73515,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0365-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Apheresis products, for which quality control testing for residual white blood cell count was not performed, were distributed.","03/22/2016","03/22/2016"," W071215051680 (double collection)",2/2/2016,"02/02/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73516,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","1200 N Highland Ave",,"Aurora","IL","60506-1401","United States","Voluntary: Firm Initiated","Letter","Illinois; Switzerland","B-0439-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from an ineligible donor, were distributed. ","04/21/2016","04/21/2016"," W039715123738U; ",3/3/2016,"03/03/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73516,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","1200 N Highland Ave",,"Aurora","IL","60506-1401","United States","Voluntary: Firm Initiated","Letter","Illinois; Switzerland","B-0438-16","Class II","Red Blood Cells","1 unit","Blood products, collected from an ineligible donor, were distributed. ","04/21/2016","04/21/2016"," W039715123738U; ",3/3/2016,"03/03/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73517,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","TN","B-0409-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Blood products, which did not meet the acceptable product specifications, were distributed.","04/11/2016","04/11/2016"," W043216001065",2/19/2016,"02/19/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73517,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","TN","B-0410-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood products, which did not meet the acceptable product specifications, were distributed.","04/11/2016","04/11/2016"," W043216001065",2/19/2016,"02/19/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73518,"Terminated","DCI Biologicals Greenville, Inc","2727 E 10th St",,"Greenville","NC","27858-3127","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0370-16","Class III","Source Plasma","29 units","Blood products, exposed to unacceptable temperatures during storage, were distributed.","03/25/2016","03/25/2016"," GL0582841; GL0583592; GL0589175; GL0589607; GL0590083; GL0591203; GL0589774; GL0598738; GL0598820; GL0598832; GL0599351; GL0599354; GL0599468; GL0600858; GL0600875; GL0601453; GL0601477; GL0601650; GL0602724; GL0602822; GL0603205; GL0603247; GL0603346; GL0603614; GL0604119; GL0604676; GL0604997; GL0606069; GL0605215; ",12/10/2015,"12/10/2015",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73519,"Terminated","Arc Blood Services, New England Region","180 Rustcraft Rd Ste 115",,"Dedham","MA","02026-4551","United States","Voluntary: Firm Initiated","Telephone","New York; Massachusetts","B-0470-16","Class II","Apheresis Platelets, Leukocytes Reduced","5 units","Leukoreduced Plateletpheresis products, that failed residual WBC counts, were distributed. ","04/22/2016","04/22/2016"," W203416843518 (triple collection); W203416843522 (double collection)",1/26/2016,"01/26/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73521,"Terminated","St Mary's Hospital and Medical Center, Inc.","2635 N 7th St","P.O. Box 1628","Grand Junction","CO","81501-8209","United States","Voluntary: Firm Initiated","FAX","Colorado","B-0367-16","Class III","Apheresis Fresh Frozen Plasma","4 units","Apheresis products collected from a donor who should have been deferred for reactive syphilis test were distributed.","03/22/2016","03/22/2016"," W056315004183; W056315006454 (triple collection)",1/27/2016,"01/27/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73521,"Terminated","St Mary's Hospital and Medical Center, Inc.","2635 N 7th St","P.O. Box 1628","Grand Junction","CO","81501-8209","United States","Voluntary: Firm Initiated","FAX","Colorado","B-0366-16","Class III","Apheresis Platelets, Leukocytes Reduced","1 unit","Apheresis products collected from a donor who should have been deferred for reactive syphilis test were distributed.","03/22/2016","03/22/2016"," W056315004183",1/27/2016,"01/27/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73522,"Terminated","LifeShare Community Blood Services","333 E Bridge St",,"Elyria","OH","44035-5222","United States","Voluntary: Firm Initiated","Letter","Ohio","B-0471-16","Class II","Red Blood Cells, Leukocytes Reduced","3 units","Blood products, collected from an ineligible donor, were distributed. ","04/22/2016","04/22/2016"," W043815003685; W043814013417; W043815900581",2/11/2016,"02/11/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73523,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","IL","B-0419-16","Class III","Apheresis Platelets, Leukocytes Reduced","2 units","Blood products, exposed to unacceptable temperatures during storage, were distributed.","04/11/2016","04/11/2016"," W333415027964-part 1; W333415027964-part 2",1/18/2016,"01/18/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73524,"Terminated","BPL Plasma, Inc. ","3744 Blanding Blvd",,"Jacksonville","FL","32210-5243","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0368-16","Class III","Source Plasma","1 unit","Blood product for which donor screener failed to ask donor Pre-Donation Health History questions, was distributed.","03/25/2016","03/25/2016"," JK0674757",1/15/2016,"01/15/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73525,"Ongoing","ArthroCare Corporation","7000 W William Cannon Dr Bldg 1",".","Austin","TX","78735-8509","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) and the following countries-Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, China, Hong Kong, India, Lebanon, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arabic Emirates, Vietnam, Australia, Japan, New Zealand, Brazil, and Chile.","Z-1321-2016","Class II","TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01","26,903 devices","During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.","04/05/2016",," 1031506, 1031507, 1032123, 1032325, 1032741, 1032742, 1033443, 1033965, 1033966, 1034397, 1039120, 1041765, 1044089, 1044090, 1045862, 1048237, 1048933, 1049185, 1052071, 1056212, 1060586, 1060979, 1063394, 1064599, 1067696, 1067748, 1069174, 1071358, 1074125, 1075714, 1070521, 1070812, 1071974, 1078025, 1077499, 1082811, 1084095, 1084094, 1085458, 1086436, 1086437, 1087917, 1094313, 1097573, 1103824, 1107183, 1107297, 1113562, 1113563, 1114534, 1114535, 1114536, 1115896, 1031518, 1032308, 1032309, 1032310, 1032755, 1032756, 1033972, 1033973, 1034225, 1034226, 1035283, 1035284, 1038547, 1043507, 1046556, 1047064, 1048722, 1049266, 1051812, 1052070, 1054443, 1055730, 1059865, 1063661, 1067691, 1067273, 1067747, 1068019, 1069172, 1071357, 1072853, 1072854, 1070497, 1070808, 1071971, 1076849, 1077450, 1079140, 1079220, 1078115, 1081753, 1082361, 1082810, 1086380, 1094312, 1094312, 1094721, 1097571, 1101041, 1107295, 1109045, 1111935, 1111936, 1113534, 1113535, 1113536, 1114532, 1115888, 1115891, 1116959, 1116130, 1116720, 1117209, 1117214, 1031341, 1032311, 1033761, 1034446, 1035691, 1035692, 1041775, 1043962, 1046557, 1048236, 1050067, 1052651, 1057008, 1058808, 1059867, 1063665, 1064594, 1067695, 1068021, 1071319, 1071320, 1073441, 1074876, 1077498, 1080520, 1114533, 1115893, 1031340, 1032962, 1033266, 1045359, 1047065, 1051331, 1056849, 1064592, 1067694, 1070709",3/3/2016,"03/03/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73526,"Ongoing","Awareness Corporation","1201 S Alma School Rd /#4750 Az",,"Mesa","AZ","85210","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; CA, OR, UT, HI, TX, AZ, NV, NY, OH, VA, SD, NJ, FL, WA, ID, GA, MD, AK, CO, IL, MN, NM, TX, OK, MO, LA, DC, IN, NE, NC, WI, SC, CT, TN    No foreign distribution.","F-0118-2017","Class I","Awareness  Boost Tea  Dietary Supplement  Passion Fruit    Net Wt 7.4 oz.    Distributed by & for all inquiries: Awareness Corporation  P.O. Box 2289 Chandler, AZ 85244","2697 bottles","Boost Tea is being recalled for potential Salmonella contamination.","10/14/2016",," Lot 022615 (Expiry: 10/17)",3/11/2016,"03/11/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73527,"Ongoing","Dr. Reddy's Laboratories, Inc.","107 College Rd E",,"Princeton","NJ","08540-6623","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0784-2016","Class II","Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA   NDC 55111-688-52  ","3,342 vials","Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial","03/28/2016",," Lot BS523, exp 10/2017",3/3/2016,"03/03/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73528,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA..    Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR.","Z-1369-2016","Class II","Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.","49 units","ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.","04/11/2016",," All Serial Numbers",3/8/2016,"03/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73528,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA..    Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR.","Z-1367-2016","Class II","Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.","4 units","ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.","04/11/2016",," All Serial Numbers",3/8/2016,"03/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73528,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA..    Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR.","Z-1366-2016","Class II","Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.","3 units","ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.","04/11/2016",," All Serial Numbers",3/8/2016,"03/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73528,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA..    Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR.","Z-1368-2016","Class II","Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.","47 units","ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.","04/11/2016",," All Serial Numbers",3/8/2016,"03/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73528,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA..    Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR.","Z-1365-2016","Class II","Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.","57 units","ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.","04/11/2016",," All Serial Numbers",3/8/2016,"03/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73528,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA..    Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR.","Z-1364-2016","Class II","Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.","36 units","ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.","04/11/2016",," All Serial Numbers",3/8/2016,"03/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73529,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0388-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/11/2016","04/11/2016"," W036315291776; ",2/1/2016,"02/01/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73529,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0387-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/11/2016","04/11/2016"," W036315291776; ",2/1/2016,"02/01/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73530,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Michigan; Switzerland","B-0389-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/11/2016","04/11/2016"," W036315029871; ",2/1/2016,"02/01/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73530,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Michigan; Switzerland","B-0390-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/11/2016","04/11/2016"," W036315029871; ",2/1/2016,"02/01/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73531,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0391-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/11/2016","04/11/2016"," W036315413576; ",1/27/2016,"01/27/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73531,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0392-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/11/2016","04/11/2016"," W036315413576; ",1/27/2016,"01/27/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73532,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Michigan; Switzerland","B-0393-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/11/2016","04/11/2016"," W036315261679; ",2/1/2016,"02/01/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73532,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Michigan; Switzerland","B-0394-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/11/2016","04/11/2016"," W036315261679; ",2/1/2016,"02/01/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73533,"Ongoing","Terumo Cardiovascular Systems Corporation","6200 Jackson Rd",,"Ann Arbor","MI","48103-9586","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Canada, Japan , Singapore and United Arab Emirates.","Z-1250-2016","Class II","CDI Blood Parameter Monitoring System 500  Cardiopulmonary bypass on-line blood gas monitor","222","Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may cause inaccurate temperature measurement and inaccurate analyte display values on the CDI System 500 monitor.  Terumo Car","03/25/2016",," CDI 500 MONITOR WITH ART/HS   (500AHCT item number 137613)  SN #'s:  1190  1310  1346  1594  1647  1687  1693  1706  1769  1866  2028  2220  2242  2294  2311  2394  2460  2485  2506  2519  2644  2729  2776  2780  2821  2827  2858  2898  2900  3002  3092  3163  3184  3325  3513  3805  3808  3818  3823  3842  4061  4102  4109  5173  5264  5806  8003  8006  8007  8008  8009  8010  8011  8012  8013  8016  8018  8020  8026  8031  8034  8035  8040  8056  8060  500AHCT MTR - CON LOANER        (500AHCTCL item number 411150)  SN #'s:  1035  1060  1178  1198  1199  1228  1280  1325  1364  1535  1540  1545  1553  1557  1615  1689  1695  1743  1759  1850  1862  1942  1949  1988  2014  2147  2336  2359  2360  2557  2563  2609  3097  3337  3431  3433  3527  4059  4324  4327  5609  5698  5700  5701  5809  5820  5889  5894  5945  5991  7028  7029  7030  7034  7038  7061  500AHCT MONITOR - LOANER        (500AHCTL item number 418538)  SN #'s:  1283  2209  5546  CDI 500 MONITOR WITH ART/VEN    (500AV item number 137621)  SN #'s:  3132  6004  CDI 500 MONITOR W/ ART/VEN/HS   (500AVHCT item number 137630)  SN #'s:  1304  1405  1905  2105  2224  2495  2580  2633  2867  3332  3404  4224  5076  5096  8000  8002  8023  500AVHCT MTR - CON LOANER       (500AVHCTCL item number 411168)  SN #'s:  1036  1043  1046  1149  1151  1152  1264  1353  1354  1381  1389  1393  1624  1954  2074  2126  6016  6041  6042  6046  500AVHCT MONITOR-LOANER         (500AVHCTL item number 372200)  SN #'s:  1015  1038  1466  2035  7081  500AVHCT MONITOR - TRIAL        (500AVHCTTK item number 476543)  SN #'s:  1953  3425  500AV MONITOR - LOANER          (500AVL item number 418520)  SN #:  2023    Outside US.  BPM SENSOR HEAD ASSY CDI 500    item number 145891  SN#'s:  B019781                         B019782                         B019783                         B019784                         B019790                         B019791                         B019792                         B019793                         B019794                         B019795    ",3/14/2016,"03/14/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73534,"Ongoing","Fromm Family Foods, LLC","13145 Green Bay Rd",,"Mequon","WI","53097-2206","United States","Voluntary: Firm Initiated","Letter","US: MN, WI, WY, NY, MA, TN, WA, IL, CO, CA, RI, MI, TX, GA, AZ, NJ, OH.    OUS:  CANADA","V-521-2016","Class II","Fromm Family, 12 oz. (340 G), Grain Free, Gold Salmon & Chicken Pate, Food For Dogs,  can 12/case code 11891, individual can upc  0 72705 1189 08.  			  ","5,759 cases","Fromm has discovered through its own analysis that the some varieties canned dog foods do not contain recommended levels of vitamins and minerals. These products may contain elevated levels of Vitamin D.  ","09/20/2016",," All Lot numbers and best before dates of the above referenced product codes",3/14/2016,"03/14/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73534,"Ongoing","Fromm Family Foods, LLC","13145 Green Bay Rd",,"Mequon","WI","53097-2206","United States","Voluntary: Firm Initiated","Letter","US: MN, WI, WY, NY, MA, TN, WA, IL, CO, CA, RI, MI, TX, GA, AZ, NJ, OH.    OUS:  CANADA","V-520-2016","Class II","Fromm Family, 12 oz (340 G), Grain Free, Gold Chicken & Duck Pate, Food for  Dogs,  can 12/case code 11895, individual can upc 0 72705 11894 6.    			  ","9,075 cases","Fromm has discovered through its own analysis that the some varieties canned dog foods do not contain recommended levels of vitamins and minerals. These products may contain elevated levels of Vitamin D.  ","09/20/2016",," All Lot numbers and best before dates of the above referenced product codes",3/14/2016,"03/14/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73534,"Ongoing","Fromm Family Foods, LLC","13145 Green Bay Rd",,"Mequon","WI","53097-2206","United States","Voluntary: Firm Initiated","Letter","US: MN, WI, WY, NY, MA, TN, WA, IL, CO, CA, RI, MI, TX, GA, AZ, NJ, OH.    OUS:  CANADA","V-519-2016","Class II","Fromm Family, 12 oz.(340 G), Grain Free,  Gold Chicken Pate,  Food For Dogs,  can 12/case code 11893, individual can upc 0 72705 11892 2.      			  ","11,659 cases","Fromm has discovered through its own analysis that the some varieties canned dog foods do not contain recommended levels of vitamins and minerals. These products may contain elevated levels of Vitamin D.  ","09/20/2016",," All Lot numbers and best before dates of the above referenced product codes",3/14/2016,"03/14/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73536,"Ongoing","Zimmer Trabecular Metal Technology, Inc.","10 Pomeroy Rd",,"Parsippany","NJ","07054-3722","United States","Voluntary: Firm Initiated","Letter","Nationwide and Foreign.","Z-1955-2016","Class II","00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM   00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM   00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM   00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM   00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM   00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM   00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM   00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM   00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM   00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM   00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM   00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM   00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM   00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM    00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM   00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM  00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM   00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM   00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM   00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM   00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM   00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM   00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM   00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM   00725505432 ACET CUP, 0 DEG, 32MM X 54MM   00725505632 ACET CUP, 0 DEG, 32MM X 56MM   00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM   00725505832 ACET CUP, 0 DEG, 32MM X 58MM   00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM   00725506032 ACET CUP, 0 DEG, 32MM X 60MM   00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM   00725506232 ACET CUP, 0 DEG, 32MM X 62MM   00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM   00725506432 ACET CUP, 0 DEG, 32MM X 64MM   00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM   00725506632 ACET CUP, 0 DEG, 32MM X 66MM   00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM   00725506832 ACET CUP, 0 DEG, 32MM X 68MM   00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM   00725507032 ACET CUP, 0 DEG, 32MM X 70MM   00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM   00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM   00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM       00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM   00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM   00726005432 ACET CUP, 10 DEG, 32MM X 54MM   ","19,884 total","Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity. ","06/10/2016",," 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 61868161  00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 62075682  00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 61868174  00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 62099999  00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 61985379  00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 61739647  00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 61859335  00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 61868180  00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 61885454 61912432  00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 61763307  00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 62075683  00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 61792574  00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 61747148 61770547 61859658  00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 61747106 61812211 61830726  00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 62020209  00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 61836505 61855146 61954911  00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 61830949  00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 61885408  00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 61830844 61859307  00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 61770545 61804351 61763316 61786342 61786341  61804383  00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 61770407 61804495  00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 61836909  00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 61947556  00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 61747107 61763580 61786278 61830727 61859504  61859551 61879091 61879090 61912430 62002120  62075898 62100011 62115299  00725505432 ACET CUP, 0 DEG, 32MM X 54MM 61763443 61786289 61812220 61854565 61868305  61879040 61912416 61947555 61985264 62013146  62066591 62115776  00725505632 ACET CUP, 0 DEG, 32MM X 56MM 61763600 61804444 61912435 62002156 62039255  62062844 62062845 62115784  00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 61804502 61837084  00725505832 ACET CUP, 0 DEG, 32MM X 58MM 62039086  00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 61855145  00725506032 ACET CUP, 0 DEG, 32MM X 60MM 62075897 62100842  00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 61770404 ",4/15/2016,"04/15/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73536,"Ongoing","Zimmer Trabecular Metal Technology, Inc.","10 Pomeroy Rd",,"Parsippany","NJ","07054-3722","United States","Voluntary: Firm Initiated","Letter","Nationwide and Foreign.","Z-1954-2016","Class II","REV. SHELL LINER 0D 28X48 00700504828    REV. SHELL LINER 10D 28X50 00701005028     REV. SHELL LINER 10D 28X52 00701005228     REV. SHELL LINER 10D 28X54 00701005428    REV. SHELL LINER 10D 28X56 00701005628     REV. SHELL LINER 10D 28X58 00701005828     REV. SHELL LINER 10D 28X60 00701006028  REV. SHELL LINER 10D 28X62 00701006228   REV. SHELL LINE 10D 28X66 00701006628  REV. SHELL LINER 20D 28X48 00702004828   REV. SHELL LINER 20D 28X50 00702005028  REV. SHELL LINER 20D 28X52 00702005228   REV. SHELL LINER 20D 28X54 00702005428   REV. SHELL LINER 20D 28X56 00702005628   REV. SHELL LINER 20D 28X60 00702006028   REV. SHELL LINER 20D 28X62 00702006228   REV. SHELL LINER 20D 28X66 00702006628 ","19,884 total","Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity. ","06/10/2016",," 00700504828 REV. SHELL LINER 0D 28X48 62192382 61924517 61979224 62102328  00701005028 REV. SHELL LINER 10D 28X50 61787378 61979209 62165315 62188095  00701005228 REV. SHELL LINER 10D 28X52 61979218  00701005428 REV. SHELL LINER 10D 28X54 61787382 62077039  00701005628 REV. SHELL LINER 10D 28X56 61799041 61976886 62165323 62188094  00701005828 REV. SHELL LINER 10D 28X58 61886620 62103434  00701006028 REV. SHELL LINER 10D 28X60 61979220 61979221 62077046  00701006228 REV. SHELL LINER 10D 28X62 61986244 62101503 62192380  00701006628 REV. SHELL LINE 10D 28X66 61787381 61979212 62042739 62042740  00702004828 REV. SHELL LINER 20D 28X48 61987076  00702005028 REV. SHELL LINER 20D 28X50 61987075  00702005228 REV. SHELL LINER 20D 28X52 62102429  00702005428 REV. SHELL LINER 20D 28X54 62103435  00702005628 REV. SHELL LINER 20D 28X56 61964049 62029515 62077034 62102329  00702006028 REV. SHELL LINER 20D 28X60 61787385 61853155  00702006228 REV. SHELL LINER 20D 28X62 61915568 61979214 62102867  00702006628 REV. SHELL LINER 20D 28X66 61787383 61787384 62102865",4/15/2016,"04/15/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73536,"Ongoing","Zimmer Trabecular Metal Technology, Inc.","10 Pomeroy Rd",,"Parsippany","NJ","07054-3722","United States","Voluntary: Firm Initiated","Letter","Nationwide and Foreign.","Z-1952-2016","Class II","TM LPS TIB SZ 3 C/D, 10MM - 00588605310    TM LPS TIB SZ 3 C/D, 12MM - 00588605312    TM LPS TIB SZ 3 C/D, 14MM - 00588605314    TM LPS TIB SZ 3 C/D, 17MM - 00588605317    TM LPS TIB SZ 4 C/D, 10MM - 00588605410    TM LPS TIB SZ 4 C/D, 12MM - 00588605412    TM LPS TIB SZ 4 C/D, 14MM - 00588605414    TM LPS TIB SZ 5 E/F 10 MM -  00588605510    TM LPS TIB SZ 5 E/F, 12MM - 00588605512    TM LPS TIB SZ 5 E/F, 14MM - 00588605514    TM LPS TIB SZ 5 E/F, 17MM - 00588605517    TM LPS TIB SZ 6 E/F, 10MM - 00588605610    TM LPS TIB SZ 6 E/F, 12 mm - 00588605612    TM LPS TIB SZ 6 E/F, 17MM - 00588605617    TM LPS TIB SZ 7 G/H, 10MM - 00588605710    TM LPS TIB SZ 7 G/H, 12MM - 00588605712    TM LPS TIB SZ 7 G/H, 14MM - 00588605714    TM LPS TIB SZ 8 G/H, 10MM - 00588605810    TM LPS TIB SZ 8 G/H, 12MM - 00588605812    TM LPS TIB SZ 8 G/H, 14MM - 00588605814    TM LPS TIB SZ 8 G/H, 14MM - 00588605814    TM LPS TIB SZ 8 G/H, 17MM - 00588605817     TM LPS TIB SZ 3 E/F, 10MM - 00588606310    TM LPS TIB SZ 3 E/F, 12MM - 00588606312    TM LPS TIB SZ 3 E/F, 14MM - 00588606314    TM LPS TIB SZ 3 E/F, 17MM - 00588606317    TM LPS TIB SZ 4 E/F, 10MM - 00588606410    TM LPS TIB SZ 4 E/F, 12MM -00588606412    TM LPS TIB SZ 4 E/F, 14MM - 00588606414            ","19,884 total","Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity. ","06/10/2016",," 00588605310  TM LPS TIB SZ 3 C/D, 10MM  61776840  61770817  61785352  61792636  61814243  61833815  61844337  61844340  61844341  00588605312  TM LPS TIB SZ 3 C/D, 12MM  61746696  61770813  61785354  61797196  61851748  00588605314  TM LPS TIB SZ 3 C/D, 14MM  61759785  61770812  61797197  00588605317  TM LPS TIB SZ 3 C/D, 17MM  61746694  61759789  61785353  00588605410  TM LPS TIB SZ 4 C/D, 10MM  61733406  61803955  61808992  61833823  61839387  61839369  00588605412  TM LPS TIB SZ 4 C/D, 12MM  61733410  61844343  00588605414  TM LPS TIB SZ 4 C/D, 14MM  61759795  61803956  00588605510  TM LPS TIB SZ 5 E/F, 10MM  61746720  61769557  61769558  61770832  61780784  61780785  61785367  61785368  61785373  61797210  61803932  61809010  61809011  61814248  61828080  61833827  61833828  61844353  61851754  61857226  00588605512  TM LPS TIB SZ 5 E/F, 12MM  61769560  61770830  61780783  61785371  61792657  61809008  61820712  61844345  61857227  00588605514  TM LPS TIB SZ 5 E/F, 14MM  61746717  61770829  61785372  61792662  00588605517  TM LPS TIB SZ 5 E/F, 17MM  61746718  61770828  61809007  00588605610  TM LPS TIB SZ 6 E/F, 10MM  61746706  61769562  61770835  61780792  61785382  61792667  61809028  61820717  61844374  61851755    00588605612  TM LPS TIB SZ 6 E/F, 12MM  61759777  61769563  61770836  61785383  61792668  61809022  61844375  00588605617  TM LPS TIB SZ 6 E/F, 17MM  61733395  00588605710  TM LPS TIB SZ 7 G/H, 10MM  61739892  61746727  61769584  61776823  61770841  61785389  61792684  61814253  61814254  61828091  00588605712  TM LPS TIB SZ 7 G/H, 12MM  61770842  61776824  61797215  61792686  00588605714  TM LPS TIB SZ 7 G/H, 14MM  61739886  61770843  61797216  61792687  00588605810  TM LPS TIB SZ 8 G/H, 10MM  61733386  61776828  00588605812  TM LPS TIB SZ 8 G/H, 12MM  61733388  00588605814  TM LPS TIB SZ 8 G/H, 14MM  61769564  61776829  00588605814  TM LPS TIB SZ 8 G/H, 14MM  61803938  61809059  00588605817  TM LPS TIB SZ 8 G/H, 17MM  61769565  61792690  00588606310  TM LPS TIB SZ 3 E/F, 10MM  61759790  61",4/15/2016,"04/15/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73536,"Ongoing","Zimmer Trabecular Metal Technology, Inc.","10 Pomeroy Rd",,"Parsippany","NJ","07054-3722","United States","Voluntary: Firm Initiated","Letter","Nationwide and Foreign.","Z-1953-2016","Class II","TM MONO TIB STR GRN SZ 5 - 00588606510  TM MONO TIB STR GRN SZ 5 12MM - 00588606512  TM MONO TIB STR GRN SZ 5 14MM - 00588606514   TM MONO TIB STR GRN SZ 5 17MM  - 00588606517  TM MONO TIB STR GRN SZ 6 10MM - 00588606610     TM MONO TIB STR GRN SZ 6 12MM - 00588606612     TM MONO TIB STR GRN SZ 6 14MM - 00588606614  TM MONO TIB STR GRN SZ 6 17MM - 00588606617  TM MONO TIB STR BLUE SZ 7 10MM - 00588606710  TM MONO TIB STR BLUE SZ 7 12MM - 00588606712  TM MONO TIB STR BLUE SZ 7 14MM - 00588606714  TM MONO TIB STR BLUE SZ 7 17MM - 00588606717   TM MONO TIB STR GRN SZ 5 10MM - 00588607510  TM MONO TIB STR GRN SZ 5 12MM - 00588607512  TM MONO TIB STR GRN SZ 5 14MM - 00588607514   TM MONO TIB STR GRN SZ 5 17MM - 00588607517","19,884 total","Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity. ","06/10/2016",," 00588606510 TM MONO TIB STR GRN SZ 5 10MM 61769554 61780786 61803934  00588606512 TM MONO TIB STR GRN SZ 5 12MM 61769555 61785358  00588606514 TM MONO TIB STR GRN SZ 5 14MM 61746710 61769556 61785359 61803935  00588606517 TM MONO TIB STR GRN SZ 5 17MM 61739874 61780787 61785360 61792655 61803936  61809005  00588606610 TM MONO TIB STR GRN SZ 6 10MM 61770839 61780793 61785374 61809020 61820718  61839382  00588606612 TM MONO TIB STR GRN SZ 6 12MM 61739882 61733397 61759778 61770840 61785375  61809018 61844376  00588606614 TM MONO TIB STR GRN SZ 6 14MM 61739885 61759779 61780795 61785376 61809015  00588606617 TM MONO TIB STR GRN SZ 6 17MM 61739883 61785377 61820719  00588606710 TM MONO TIB STR BLUE SZ 7 10MM 61769582 61792678 61797213 61851763  00588606712 TM MONO TIB STR BLUE SZ 7 12MM 61785386 61792681 61797214 61857235  00588606714 TM MONO TIB STR BLUE SZ 7 14MM 61780797 61785387 61809058  00588606717 TM MONO TIB STR BLUE SZ 7 17MM 61785388 61814249  00588607510 TM MONO TIB STR GRN SZ 5 10MM 61785366 61803928 61820713 61844346  00588607512 TM MONO TIB STR GRN SZ 5 12MM 61770823 61792661 61803929 61851753  00588607514 TM MONO TIB STR GRN SZ 5 14MM 61739865 61785369 61803931  00588607517 TM MONO TIB STR GRN SZ 5 17MM 61785370",4/15/2016,"04/15/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73536,"Ongoing","Zimmer Trabecular Metal Technology, Inc.","10 Pomeroy Rd",,"Parsippany","NJ","07054-3722","United States","Voluntary: Firm Initiated","Letter","Nationwide and Foreign.","Z-1951-2016","Class II","TM CR TIB SZ 3 C-H, 10MM- 00588604310      TM CR TIB SZ 3 C-H, 12 mm - 00588604312    TM CR TIB SZ 3 C-H, 14MM - 00588604314    TM CR TIB SZ 3 C-H, 17MM - 00588604317    TM CR TIB SZ 4 C-H 10 MM - 00588604410    TM CR TIB SZ 4 C-H, 12MM - 00588604412    TM CR TIB SZ 4 C-H, 14MM - 00588604414    TM CR TIB SZ 4 C-H, 17MM - 00588604417, 00588604510    TM CR TIB SZ 5 C-H, 12MM - 00588604512    TM CR TIB SZ 5 C-H, 14MM - 00588604514    TM CR TIB SZ 5 C-H, 17MM - 00588604517, 00588604610    TM CR TIB SZ 6 C-H, 12MM 00588604612    TM CR TIB SZ 6 C-H, 14 MM  00588604614    TM CR TIB SZ 6 C-H, 17 MM 00588604617    TM CR TIB SZ 7 C-H, 10MM - 00588604710    TM CR TIB SZ 7 C-H, 12MM - 00588604712    TM CR TIB SZ 7 C-H, 14MM - 00588604714    TM CR TIB SZ 7 C-H, 17MM - 00588604717    TM CR TIB SZ 8 C-H, 10MM - 00588604810    TM CR TIB SZ 8 C-H, 12MM - 00588604812    TM CR TIB SZ 8 C-H, 14MM - 00588604814    ","19,884 total","Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity. ","06/10/2016",," 00588604310  TM CR TIB SZ 3 C-H, 10MM  61746701  61746701  61746702  61752725  61759780  61769546  61776838  61776839  61770816  61785348  61797187  61792632  61792633  61797183  61797182  61797181  61797184  61820708  61820710  61820709  61833813  61839384  61833812  61844335  61844336  00588604312  TM CR TIB SZ 3 C-H, 12MM  61746699  61759781  61776842  61770815  61785349  61797192  61797191  61808975  61833814  61851747  00588604314  TM CR TIB SZ 3 C-H, 14MM  61740710  61785350  61797194  61808984  00588604317  TM CR TIB SZ 3 C-H, 17MM  61746678  61759782  61785351  00588604410  TM CR TIB SZ 4 C-H, 10MM  61733408  61752758  61752759  61759791  61759792  61776830  61770821  61770822  61792647  61792649  61792648  61803945  61803944  61803946  61809003  61809004  61820711  61828074  61828075  61833817  61833818  61839368  61839376  61839390  61857205  61857207  00588604412  TM CR TIB SZ 4 C-H, 12MM  61759793  61776831  61770818  61792651  61803950  61803951  61803952  61809002  61828076  61833821  61833822  61844350  61857204  00588604414  TM CR TIB SZ 4 C-H, 14MM  61733409  61769569  61792653  61803953  61808998  61839386  61857217  00588604417  TM CR TIB SZ 4 C-H, 17MM  61759794  61792654  61803954  00588604510  61746703  61746726  61769547  61770833  61770824  61769548  61780780  61785361  61785362  61780778  61780779  61797201  61792658  61803927  61809014  61809013  61814245  61797202  61814246  61828082  61828083  61828084  61833824  61833825  61839378  61844352  61851749  61857222  61857228  00588604512  TM CR TIB SZ 5 C-H, 12MM  61746719  61769550  61770831  61769551  61785363  61780782  61792659  61797204  61814247  61828085  61833829  61833826  61839380  61851752  00588604514  TM CR TIB SZ 5 C-H, 14MM  61770827  61785364  61797205  61792660  61828081  61844344  61857223  00588604517  TM CR TIB SZ 5 C-H, 17MM  61746709  61770825  61785365    00588604612  TM CR TIB SZ 6 C-H, 12MM  61733401  61746705  61759774  61770838  61780791  61785379  61792665  61809052  61809053  61828087  61851757  00588604614",4/15/2016,"04/15/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73536,"Ongoing","Zimmer Trabecular Metal Technology, Inc.","10 Pomeroy Rd",,"Parsippany","NJ","07054-3722","United States","Voluntary: Firm Initiated","Letter","Nationwide and Foreign.","Z-1950-2016","Class II","POROUS PATELLA 32MM X 10MM - 00587806532    POROUS PATELLA 35MM X 10MM-  00587806535    POROUS PATELLA 38MM X 10MM - 00587806538    POROUS PATELLA 41MM X 10MM - 00587806541","19,884 total","Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity. ","06/10/2016",," POROUS PATELLA 32MM X 10MM  61728647 61762587 62028703 62082384 61998061  61728648 61781040 62028701 62082387 61998065  61762578 61781037 62028702 62100771 62003279  61762581 61781039 62028705 62100774 62003280  61762584 61796452 62051894 62100773 61998062  61762585 61796458 62051896 62100775 61998064  61770640 61770641 62051895 62100777 62003281  61770642 61796459 62109088 62109087 62003282  61762579 61781036 62109089 62100768 62003283  61762580 61770638 62100770 62100769 62007635  61762582 61781038 62109090 62100772 62007636  61762583 61796451 62119906 62100776 61874756  61770639 61796460 62119907 62109086 61874758  61890052 61910583 61890055 61914846 61878840  61890053 61910584 61890054 61914845 61878841  61890056 61896662 61910581 61830190 61878844  61844395 61890050 61910582 61830189 61890058  61914849 61830191 61844393 62007641 62082386  61914848 61850552 61850551 62022120 62082388  61946320 61874757 61850549 62022121 62082383  61952743 61878842 61850553 62022123 62082379  61977124 61878843 61890057 62028698 62082381  61977125 61762586 61830192 62119909 62119910  61977130 61796453 61834679 62082385 62119908  61977123 61796455 61834680 62007643 61986196  61977129 61796456 61834681 62009518 61998059  61986193 61796454 61834682 62016304 62051893  61986194 61796457 61834683 62007642 62051890  61896664 61807383 61840029 62016301 62051891  61890051 61814825 61840032 62016303 62051892  61896660 61807384 61840031 62007637 62051897  61896661 61814823 61840030 62007640 62051898  61896663 61814824 61840033 62007644 62051899  61910585 61818410 61844394 62016305 62082380  62016306 61844396 62009517 61914847 62082382    POROUS PATELLA 35MM X 10MM    61722891 61722891 61752727 61752729 61752730  61752728 61762601 61770637 61762596 61762603  61762599 61762602 61776851 61776852 61762597  61762604 61781047 61781046 61796468 61776850  61796465 61796466 61776853 61796467 61796464  61796469 61807385 61818413 61807386 61814827  61818412 61807387 61830194 61830202 61830195  61834685 61834684 61834686 61840037 61840039  618443",4/15/2016,"04/15/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73537,"Ongoing","Meditech Laboratories, Inc","3200 Polaris Ave Ste 27",".","Las Vegas","NV","89102-8379","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0806-2016","Class II","Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.  ","1320 vials - all formulas","Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. ","04/01/2016",," Lot#: 011716-3,  Exp 04/17/16; 012416-3,  Exp 04/24/16. ",3/14/2016,"03/14/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73537,"Ongoing","Meditech Laboratories, Inc","3200 Polaris Ave Ste 27",".","Las Vegas","NV","89102-8379","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0802-2016","Class II","Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.","1320 vials - all formulas","Superpotent Drug: one ingredient was found to be above assay specification.","04/01/2016",," Lot #: 110115-2, Exp 01/01/16",3/14/2016,"03/14/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73537,"Ongoing","Meditech Laboratories, Inc","3200 Polaris Ave Ste 27",".","Las Vegas","NV","89102-8379","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0805-2016","Class II","Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.","1320 vials - all formulas","Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.","04/01/2016",," Lot#: 011916-1, Exp 04/19/16; 020316-1, Exp 05/03/16",3/14/2016,"03/14/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73537,"Ongoing","Meditech Laboratories, Inc","3200 Polaris Ave Ste 27",".","Las Vegas","NV","89102-8379","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0803-2016","Class II","Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102. .  ","1320 vials - all formulas","Lack of Assurance of Sterility: incomplete or missing data regarding production.","04/01/2016",," Lot#: 022316-4, Exp 04/08/16 ",3/14/2016,"03/14/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73537,"Ongoing","Meditech Laboratories, Inc","3200 Polaris Ave Ste 27",".","Las Vegas","NV","89102-8379","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0804-2016","Class II","Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.","1320 vials - all formulas","Lack of Assurance of Sterility: incomplete or missing data regarding production.","04/01/2016",," Lot#: 022416-9, Exp 04/09/16.",3/14/2016,"03/14/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73537,"Ongoing","Meditech Laboratories, Inc","3200 Polaris Ave Ste 27",".","Las Vegas","NV","89102-8379","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0807-2016","Class II","Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.","1320 vials - all formulas","Lack of Assurance of Sterility: incomplete or missing data regarding production.","04/01/2016",," Lot#: 020716-0, Exp 05/07/16",3/14/2016,"03/14/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73537,"Ongoing","Meditech Laboratories, Inc","3200 Polaris Ave Ste 27",".","Las Vegas","NV","89102-8379","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0808-2016","Class II","Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.","1320 vials - all formulas","Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.","04/01/2016",," Lot #: 12216-2, Exp 04/22/16",3/14/2016,"03/14/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73538,"Ongoing","AstraZeneca Pharmaceuticals LP","1800 Concord Pike, P.O. Box 15437","Health Services Medical FOC 1","Wilmington","DE","19850-5437","United States","Voluntary: Firm Initiated",,"US: Nationwide Including Puerto Rico","D-0781-2016","Class II","Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.","148,331 Inhalers","Defective Delivery System: Some units have actuation counters set to a number other than 60.","03/22/2016",," Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.",2/5/2016,"02/05/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73539,"Ongoing","King Soopers Bakery","60 Yuma Street",,"Denver","CO","80223-1204","United States","Voluntary: Firm Initiated","E-Mail","Distributed to Colorado, Wyoming, Utah, and New Mexico (149 King Soopers and City Market stores).  No foreign or govt/military/VA consignees.","F-0804-2016","Class II","Bakery Fresh Goodness Apple Strudel 5 count, 24oz, packaged in Plastic container, distributed by King Soopers Bakery, Denver, CO.","up to 411 packages","King Soopers is recalling Apple Strudel 5 Count because they were incorrectly labeled and does not declare pecans in the ingredient statement.","03/23/2016",," Sell By date of 03/20/2016 ",3/14/2016,"03/14/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73540,"Ongoing","Bumble Bee Foods LLC","280 10th Ave",,"San Diego","CA","92101","United States","Voluntary: Firm Initiated","Press Release","Nationwide in US: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI","F-1073-2016","Class II","Bumble Bee Chunk Light Tuna in Water, 6cans, 4pk, 5oz, UPC 8660000736","20,721 cases ","Bumble Bee Foods is recalling 3 specific UPC codes of canned Chunk Light tuna due to process deviations that occurred in a co-pack facility not owned or operated by Bumble Bee.","04/13/2016",," Can Codes: TOODGSCEFBTO9BBSCAFB, TO9DBSCAFB, TOA2BSCAFB, TON2BSCAFB, TON4BSCAFB, TON8BSCAFB, TONBBSCAFB, TONDBSCAFB, TONFBSCAFB, TOW1BSCAFB, TOW2BSCAFB, TOW3BSCAFB, TOW4BSCAFB, TOW5BSCAFB, TOWBBSCAFB, TOWEBSCAFB.    Best Buy Dates: 02/9/2019, 02/10/2019, 02/22/2019, 02/29/2019.",3/16/2016,"03/16/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73540,"Ongoing","Bumble Bee Foods LLC","280 10th Ave",,"San Diego","CA","92101","United States","Voluntary: Firm Initiated","Press Release","Nationwide in US: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI","F-1072-2016","Class II","Bumble Bee Chunk Light Tuna in Oil, 48cans/case, 5oz., UPC 8660000021","410 cases ","Bumble Bee Foods is recalling 3 specific UPC codes of canned Chunk Light tuna due to process deviations that occurred in a co-pack facility not owned or operated by Bumble Bee.","04/13/2016",," Can Codes: TOODGSCEFB      Best Buy Dates: 02/23/2019",3/16/2016,"03/16/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73540,"Ongoing","Bumble Bee Foods LLC","280 10th Ave",,"San Diego","CA","92101","United States","Voluntary: Firm Initiated","Press Release","Nationwide in US: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI","F-1071-2016","Class II","Bumble Bee Chunk Light Tuna in Water, 48cans/case, 5oz, UPC 8660000020","10,448 cases ","Bumble Bee Foods is recalling 3 specific UPC codes of canned Chunk Light tuna due to process deviations that occurred in a co-pack facility not owned or operated by Bumble Bee.","04/13/2016",," Can Codes:    TOA2BSCAFB, TOA3BSCAFB,  TOA4BSCAFB, TOA5BSCAFB, TOABBSCAFB, TOACBSCAFB, TOADBSCAFB, TOAEBSCAFB, TOG3BSCAFB, TOG4BSCAFB, TOH6BSCAFB, TOH7BSCAFB, TOHABSCAFB, TOHBBSCAFB, TOHCBSCAFB, TOHDBSCAFB, TOJ1BSCAFB, TOJ2BSCAFB, TOJ3BSCAFB, TOJ4BSCAFB, TON1BSCAFB, TON3BSCAFB, TOO1BSCAFB, TOO2BSCAFB, TOO3BSCAFB, TOO4BSCAFB, TOO5BSCAFB, TOOABSCAFB, TOOBBSCAFB, TOODBSCAFB, TOOEBSCAFB, TOOFBSCAFB,   TOR1BSCAFB, TOR4BSCAFB, TOR5BSCAFB      Best Buy Dates: 02/10/2019, 02/16/2019, 02/17/2019, 02/18/2019, 02/22/2019, 02/23/2019,  02/25/2019",3/16/2016,"03/16/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73542,"Ongoing","Tri-Union Seafoods, L.L.C dba Chicken of the Sea.","9330 Scranton Rd Ste 500","Sorrento South Corporate Center","San Diego","CA","92121-7706","United States","Voluntary: Firm Initiated","Press Release","Nationwide in US: FL, SC, TX, OH, AL, NC","F-1065-2016","Class II","Chicken of the Sea 5 Oz. Canned Chunk Light Tuna in Water, 48 cans per case, UPC code is 0 4800000245 7","1501 cases ","Tri-Union Seafoods LLC is voluntarily recalling a limited amount of Chicken of the Sea brand 5 oz. canned chunk light tuna in oil and 5 oz. canned chunk light tuna in water.  This recall has been initiated because the product may have been undercooked due to an equipment malfunction, which was uncovered during a routine inspection. ","04/11/2016",," 6OJEB SCAEB  6OJCB SCAFB  6ONEBSCAIB  6OOFZ SCAFB  6ORDB SCAFB  6ORAB SCAFB   6L2CB SCAFB  6L32B SCAEB  6L33B SCAEB  6L35B SCAEB  6L3CB SCAEB  ",3/17/2016,"03/17/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73542,"Ongoing","Tri-Union Seafoods, L.L.C dba Chicken of the Sea.","9330 Scranton Rd Ste 500","Sorrento South Corporate Center","San Diego","CA","92121-7706","United States","Voluntary: Firm Initiated","Press Release","Nationwide in US: FL, SC, TX, OH, AL, NC","F-1064-2016","Class II","Chicken of the Sea 5 Oz. Canned Chunk Light Tuna in Oil, 48 cans per case, UPC code is 0 4800000195 5 ","1244 cases ","Tri-Union Seafoods LLC is voluntarily recalling a limited amount of Chicken of the Sea brand 5 oz. canned chunk light tuna in oil and 5 oz. canned chunk light tuna in water.  This recall has been initiated because the product may have been undercooked due to an equipment malfunction, which was uncovered during a routine inspection. ","04/11/2016",," 6OA3Z SCEES  6OAAZ SCEES  6OABZ SCEEB  6OACZ SCEEB  ",3/17/2016,"03/17/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73543,"Ongoing","Wfr/aquaplast Corp","440 Church Rd",,"Avondale","PA","19311-9786","United States","Voluntary: Firm Initiated",,"Worldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX.    Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain.","Z-1264-2016","Class II","Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device     Product Usage:  Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire images for radiation therapy planning.  ","18 units of RT-4545CV-17 and 12 units of RT-4545CV-20","Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices.  This can result in differences in scale orientation.","03/25/2016",," device model numbers: RT-4545CV-17, RT-4545CV-20",1/7/2016,"01/07/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73544,"Ongoing","X-NAV Technologies, LLC","1555 Bustard Rd Ste 75",,"Lansdale","PA","19446-5731","United States","Voluntary: Firm Initiated",,"US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.","Z-1391-2016","Class II","X-Guide Surgical Navigation System, X-Clip Bulk Kit    The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.","845 units (P007665)","The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy.  The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures.  The X-Clip contains three fiducial markers made from a Stainless Steel material.  The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3","04/14/2016",," Model Numbers: P007665 X-Clip; Component of System P007839.  Note: P007665 X-Clip Component is distributed as X-Clip Bulk Kit PN P008381, package of 12 pieces P007665.",2/23/2016,"02/23/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73545,"Terminated","Alk-abello, Inc.","35 Channel Dr",,"Port Washington","NY","11050-2216","United States","Voluntary: Firm Initiated","Telephone","New York","B-0369-16","Class III","Insects (Whole Body), Mite Dermatophagoides farinae","Six (6) 10mL vials have been distributed to one customer.","Misbranded allergenic extracts, were distributed. ","03/24/2016","03/24/2016"," 0001811695",3/2/2016,"03/02/2016",3/30/2016,"03/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73546,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"US Nationwide Distributed in the states of AR, CA, NE and UT","Z-1281-2016","Class II","CIOS ALPHA (Image-intensified fluoroscope x-ray system)    Product Usage:  The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.  ","4 units","Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance.  The risk of an electrical shock is only present when a service technician ignores several steps listed in the service manual as precautionary actions during device maintenance.  ","03/31/2016",," Model Number: 10308191",2/16/2016,"02/16/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73547,"Ongoing","Chicago Kimchee","9971 Pacific Ave",,"Franklin Park","IL","60131-1920","United States","Voluntary: Firm Initiated","Telephone","Products were distributed to several distributors in the chicagoland area.","F-1097-2016","Class I","Korea white Kimchee packaged in 1 gallon, 1/2 gallon, packaged in glass jars inside plastic containers with multi colored label and black lettering. ","1 gallon: 3 boxes, 4 jars/box, 1/2 gallon: 1 box, 6 jars/box","Undeclared anchovies in Kimchee product. ","04/20/2016",," This product does not contain any codes or expiration dates. ",3/10/2016,"03/10/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73547,"Ongoing","Chicago Kimchee","9971 Pacific Ave",,"Franklin Park","IL","60131-1920","United States","Voluntary: Firm Initiated","Telephone","Products were distributed to several distributors in the chicagoland area.","F-1098-2016","Class I","Korea whole Kimchee packaged in 1 gallon packaged in glass jars inside plastic containers with multi colored label and black lettering. ","1 gallon: 8 boxes, 4 jars/box","Undeclared anchovies in Kimchee product. ","04/20/2016",," This product does not contain any codes or expiration dates. ",3/10/2016,"03/10/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73547,"Ongoing","Chicago Kimchee","9971 Pacific Ave",,"Franklin Park","IL","60131-1920","United States","Voluntary: Firm Initiated","Telephone","Products were distributed to several distributors in the chicagoland area.","F-1096-2016","Class I","Korea chopped Kimchee packaged in 1 gallon, 1/2 gallon, 1/4 gallon, and 1/8 gallon packaged in glass jars inside plastic containers with multi colored label and black lettering. ","1 gallon: 401 boxes, 4 jars/box 1/2 gallon: 167 boxes, 6 jars/box 1/4 gallon: 371 boxes, 12 jars/box 1/8 gallon: 113 boxes: 12 jars/box","Undeclared anchovies in Kimchee product. ","04/20/2016",," This product does not contain any codes or expiration dates. ",3/10/2016,"03/10/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73548,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and PUERTO RICO.","Z-1299-2016","Class II","system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959    Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.","552 units","In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage.  In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator.","03/31/2016",," Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959",2/26/2016,"02/26/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73549,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of NC, CA, NY, TX, NJ, CO and the countries of: Ontario and Canada.","Z-1524-2016","Class II","Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879","30 units of Lot # 9666776 and 11 units of Lot # 9671879","DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of 450.136 screws (4mm Cancellous Self Tapping Screw, Length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm Cortex Standard Screw, length 16 mm, lot ","04/19/2016",," Lot # 9666776 (catalog ID 450.136) and 9671879 (catalog ID 450.016)",1/6/2016,"01/06/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73550,"Ongoing","Viewray Incorporated","2 Thermo Fisher Way",,"Oakwood Village","OH","44146-6536","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, FL, MO & WI., and International distribution to the Republic of Korea and The Netherlands.","Z-1309-2016","Class II","MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated","5 units","When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter.  As  a result there is the potential to deliver dose to the initial isocenter rather than the new location. ","03/31/2016",," Model number: 10000  Catalog/Part Number: 10000  Serial Numbers: 100, 101, 102, 104 & 105  ",3/7/2016,"03/07/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73551,"Ongoing","Impax Laboratories, Inc.","31153 San Antonio Street",,"Hayward","CA","94544","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0820-2016","Class III","Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02  ","28,001 HDPE bottles (14,000,500 capsules)","Labeling: Incorrect or Missing Lot and/or Exp. Date","04/14/2016",," Lot # 10008624, 10008831; Exp. 10/16  Lot # 10009339; Exp. 02/17  Lot # 10009566,10009627; Exp. 04/17  Lot # 10010200, 20001419A, 20001426A; Exp. 10/17  Lot # 20001732A; Exp. 04/18  Lot # 20001790A, 20001791A, 20001792A; Exp. 05/18    ",3/17/2016,"03/17/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73551,"Ongoing","Impax Laboratories, Inc.","31153 San Antonio Street",,"Hayward","CA","94544","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0821-2016","Class III","Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02   ","42,239 HDPE bottles ( 21,119,500 capsules)","Labeling: Incorrect or Missing Lot and/or Exp. Date","04/14/2016",," Lot # 10008320; Exp. 05/16     Lot # 10008744, 10008974; Exp. 11/16   Lot # 10009342; Exp. 03/17    Lot # 10010202; Exp. 09/17     Lot # 20001416A; Exp. 10/17  Lot # 20001557A; Exp. 01/18   Lot # 20001675A; Exp. 03/18   Lot # 20001831A; Exp. 06/18   ",3/17/2016,"03/17/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73552,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated",,"Distributed in the US:  OH and ND","Z-1392-2016","Class II","Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve    Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.","6 units","The label on the outer packaging does not match the product inside and intended use of the device.","04/14/2016",," Lot # 9984134, Catalog ID 08.803.051, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve",2/18/2016,"02/18/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73553,"Ongoing","Vascular Solutions, Inc.","6464 Sycamore Ct N",".","Maple Grove","MN","55369-6032","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution in the states of  AL, AR, CA, CO, DE, FL, GA, ID, IL IN, IA,KY, LA, MD, MA, MI, MO, NE,NV, NH, NY, NC, OH, PA, SD, TN, TX, UT, VA, WA, and WV.","Z-1275-2016","Class I","Guardian II Hemostasis Valve, models 8210 and 8211.  The following models are only available Outside the US:  FH101, FH101-T, FH101-25, and FH101-50.      Product Usage:  The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system.  The devices have two seals:  the low-pressure seal, and the high-pressure seal.  Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.","5283","Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves.  The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.","04/07/2016",," Lot numbers:  41776, 41777,  41874, 42108, 42525, 581766, 581767, 583285, and 583286.      ",3/4/2016,"03/04/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73554,"Ongoing","Nuwati Herbals Inc","201 Compass Point Dr",,"Saint Charles","MO","63301-4407","United States","Voluntary: Firm Initiated","Telephone","Nationwide.","F-1331-2016","Class II","Nuwati Herbals SeeLessO'Me Diet and Weight Management Tea packaged in two different size amber glass jars with Net Wt 3 oz. or Net Wt 6 oz.  The responsible name on the label is Nuwati Herbals Inc., House Springs, MO.","2,600 6 oz jars and 5,500 3 oz jars","Product contains undeclared soy.","05/12/2016",," all codes from 2011 through 2016",3/15/2016,"03/15/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73555,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of SC,  NC and the countries of Australia, Canada, France. Germany, Japan and Turkey.","Z-1347-2016","Class II","SIGNA Pioneer MR Systems    Product Usage:  The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.  ","16 (2 US; 14 OUS)","Ferrous material in the  SIGNA Pioneer Table Control Box (TCB)  could cause unexpected attraction to the MR system's high strength  magnetic field during servicing activities. This could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the TCB from  the magnetic field. There have been no events reported as a result of this issue. Clinical  scanni","04/07/2016",," Mfg Lot or Serial #   System ID    001612TA1                N/A  001718TA6               336397P3T   002331TA7              083132425984  001719TA4             250598MR1  001424TA1             M2850013  001537TA0             TP0008MR07  001662TA6             157022MR01  001184TA1             ZC0002  001652TA7               N/A  002227TA7             ZC0003  002278TA0             ZC0004  002330TA9             ZC0006  002529TA6             N/A  001485TA2            34026MRS05  002279TA8            34225MRS02  002395TA2            34185MRS02                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            ",3/1/2016,"03/01/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73556,"Completed","Battle Creek/ CHS LLC","PO Box 56","1500 E Omaha Ave","Norfolk","NE","68701-6194","United States","Voluntary: Firm Initiated","Telephone","Product was distributed to one customer in NE.","V-0011-2017","Class I","Meyer Calf Starter 18 Pellets B68 Medicated.  For all classes of calves up to 200 pounds.  Active Drug Ingredient Lasalocid (34 mg/lb) 68 g/ton.  Product is shipped in bulk.  The responsible firm name on the label is Progressive Nutrition, Norfolk, NE 68701.","12,660 lbs","Product contains elevated levels of monensin.","10/21/2016",," M899380",2/8/2016,"02/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73557,"Ongoing","Leica Microsystems, Inc.","1700 Leider Ln",,"Buffalo Grove","IL","60089-6622","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including Puerto Rico and the states of  MA, CA, SC, NJ, TX, CO, FL, PA, NY, MO, WI, NC, UT, ID, AZ, MI, KY, CT, OR, , IL, AL, MN, MT, OH, NE, GA, IN, SD, TN, OK, AK, KS, NV, NM, , ND, VA, WA, WY and MD, and the countries of China, Belgium, France, Germany, Great Britain, Italy, Norway, Portugal, Spain, Sweden, Switzerland, India, Japan, Argentina, Chile, Colombia, Mexico, Peru, Belarus, Egypt, Greece, Morocco, Poland, Qatar, Romania, Russian Fed., Saudi Arabia, South Africa, Turkey, Canada, , Australia, Malaysia and Taiwan.","Z-1499-2016","Class II","Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device.  Intended for improving the visibility of objects through magnification and illumination. ","381 units","An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.","04/15/2016",," OH5-51313; OH4-112214; OH5-49112; OH5-67914; OH4-101213; OH5-20238; OH4-91913; OH5-43312; OH5-54113; OH5-64514; OH4-103014; OH4-106514; OH4-87112; OH4-95413; OH4-94213; OH4-106014; OH4-105514; OH4-94813; OH4-102514; OH4-91113; OH4-87312; OH4-106714; OH5-62113; OH5-46112; OH5-50512; OH4-85912; OH4-81512; OH5-61013; OH5-53913; OH4-95013; OH4-91413; OH4-110614; OH4-94613; OH4-104714; OH4-87212; OH4-85712; OH5-50212; OH4-96213; OH4-88913; OH4-89613; OH5-55113; OH4-99413; OH5-48112; OH4-90713; OH5-66314; OH5-68314; OH4-109414; OH4-83912; OH5-48012; OH4-101313; OH4-86812; OH5-60113; OH5-60313; OH5-37311; OH4-86612; OH5-62913; OH4-95813; OH4-90613; OH4-103614; OH5-48212; OH5-48312; OH5-58313; OH5-53513; OH5-63313; OH4-92613; OH5-43812; OH5-56713; OH5-68114; OH4-81412; OH4-98013; OH5-33911; OH5-61913; OH5-52813; OH4-110714; OH5-46312; OH5-51113; OH4-106814; OH4-112714; OH5-63514; OH5-39012; OH5-63013; OH4-111614; OH4-97013; OH4-97613; OH4-107414; OH4-109514; OH4-109614; OH4-92513; OH4-104614; OH4-93113; OH4-85812; OH4-105414; OH4-99913; OH4-91813; OH4-94913; OH4-107914; OH4-83812; OH4-100413; OH4-107214; OH5-41012; OH5-56013; OH4-85612; OH4-99713; OH4-97513; OH5-50312; OH4-109814; OH5-52013; OH5-61413; OH5-61513; OH5-62613; OH5-68614; OH5-51413; OH4-83112; OH4-108114; OH5-68214; OH4-96513; OH5-51513; OH4-100613; OH4-88213; OH5-58813; OH4-91613; OH5-53713; OH5-53813; OH4-98513; OH4-97713; OH5-36411; OH4-106414; OH5-63213; OH5-63413; OH4-100313; OH4-105914; OH5-67214; OH4-81612; OH4-108314; OH5-46612; OH5-46512; OH5-51913; OH4-96713; OH4-103314; OH4-83212; OH4-87012; OH4-95513; OH4-95713;OH5-35611; OH4-86512; OH4-104314; OH4-104414; OH4-110814; OH4-92413; OH4-100013; OH5-54913; OH5-56213; OH4-102414; OH5-39512; OH5-43712; OH4-98713; OH4-98813; OH4-98913; OH5-43912; OH5-39812; OH5-49012; OH5-39112; OH5-48712; OH5-50813; OH5-35811; OH5-55713; OH4-92713; OH5-58213; OH5-50713; OH4-102214; OH4-112614; OH4-96913; OH4-85512; OH4-92213; OH4-100513; OH4-101113; OH4-20446; OH4-20977; OH4-21557; OH4-22207; OH4-22378; OH4-24019; O",1/11/2016,"01/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73558,"Ongoing","Paradise Farm Organics Inc","1000 Wild Iris Ln",,"Moscow","ID","83843","United States","Voluntary: Firm Initiated","Visit","sold on  AK, AL, AZ, CA, FL, GA, ID, IN, MA, MN, NJ, NY, OR, UT, and WA and in Netherland. Products were sold from www.maryjanesfarm.org.","F-0818-2016","Class I","Thai Fusion Outpost, net weight 5.1 oz.  UPC 0 99853 34255 9.    Thai Fusion Bulk bag, packaged in a ziploc plastic bag, net weight 3 lbs. UPC 0 99853 35255 8.    Thai Fusion On the Go, packaged in microwave able paper cup with plastic lid, net wt. 3.4 oz. UPC 0 99853 38255 5.  ","15/5.1 oz. pouches of Outpost; 6/3.4 oz. cups of On the Go; and 12/3 lbs bags.","Organic Thai Fusion Outpost 5.1 oz. packages, Organic Thai Fusion 3 lbs. bulk bags, and  Organic On the Go Thai Fusion 3.4 oz cups are recalled due to undeclared milk.","03/28/2016",," Lot # 021091  Lot # 022492  Product was made on 02/10/16 and 02/24/16.",3/17/2016,"03/17/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73560,"Ongoing","Pacifico National, Inc. dba AmEx Pharmacy","1515 Elizabeth St Ste J",,"Melbourne","FL","32901-3000","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0870-2016","Class I","Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.","836 syringes","Non-Sterility: Product tested positive for bacterial contamination.","05/25/2016",,"  Lot #: 150116B, Exp. 04/16/2015; 150119R, Exp. 04/19/2015; 150316H, Exp. 06/14/2015",1/20/2015,"01/20/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73560,"Ongoing","Pacifico National, Inc. dba AmEx Pharmacy","1515 Elizabeth St Ste J",,"Melbourne","FL","32901-3000","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0869-2016","Class I","Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.","45 syringes","Non-Sterility: Product tested positive for bacterial contamination.","05/25/2016",,"  Lot #: 141224C, Exp. 03/24/2015; 150915B, Exp. 12/14/2015",1/20/2015,"01/20/2015",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73561,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of  Canada and Switzerland.","Z-1327-2016","Class II","Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E    Product Usage:  The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.  ","150 units distributed in US, 1439 units distributed OUS (foreign)","Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.","04/05/2016",," Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833E, Lot numbers: 9958565, 9951621, 9952976, 9955377, 9962314, 9968868, 9969645",2/23/2016,"02/23/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73561,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of  Canada and Switzerland.","Z-1326-2016","Class II","Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E    Product Usage:  The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.  ","500 units distributed in USA,  and 35 units distributed OUS","Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.","04/05/2016",," Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833, Lot numbers: 9960359, 9962300, 9967875",2/23/2016,"02/23/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1050-2016","Class II","Blue Ridge Farms Macaroni Salad; 05021  Net Weight: 1 X 10 LB., Keep Refrigerated; Use by: 03/14/16; Lot # 430;   Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    ","44","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use By: 03/14/216, Lot # 430",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1051-2016","Class II","Blue Ridge Farms Supreme Tuna Salad; 09648; Net Weight 1 X 5 lb. Keep Refrigerated; Use By: 03/15/16; 03/17/16, 03/18/16; Lot # 436, 438, 439; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350","201 - 5 lb. containers","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use By: 03/15/16; 03/17/16, 03/18/16; Lot # 436, 438, 439;",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1058-2016","Class II","Blue Ridge Farms Cole Slaw Dressing; 23105; Net Weight: 1 X 10 lbs.; Keep Refrigerated; Use By: 03/26/16; Lot # 438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350        ","20/10 lb. tubs","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use By: 03/26/16; Lot # 438",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1049-2016","Class II","Blue Ridge Farms  Vinegar & Oil Cole Slaw, 03010, Net Weight: 1 X 10 LB., Keep Refrigerated; Use by: 3/09/16, 3/20/16, 3/20/16; Lot # 425, 429, 436;   Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    Picnic Cole Slaw; 2493 Net Weight: 10lbs; Keep Refrigerated; Use By: 03/22/16, 03/23/16; Lot #438, 439;  Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350      Picnic Cole Slaw 2505; Net Weight: 1-10lb.; Keep Refrigerated; Use By 03/22/16; Lot #438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    Blue Ridge Farms; Cole Slaw, 03054, Net Weight: 1 X 10 LB., Keep Refrigerated; Use by: 3/23/16; Lot # 439; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350  ","711 - 10 lb. containers","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use by: 3/09/16, 3/20/16, 3/20/16; Lot # 425, 429, 436;     Use By: 03/22/16, 03/23/16; Lot #438, 439;    Use By 03/22/16; Lot #438;     Use by: 3/23/16; Lot # 439",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1053-2016","Class II","Blue Ridge Farms Potato Salad 01045;   Net Weight: 1 X 10 LB., Keep Refrigerated; Use by: 03/15/16, 03/22/16; Lot # 431, 438, Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    Blue Ridge Farms Three Potato Salad; 01604; Net Weight: 1 X 10 lb.; Keep Refrigerated; Use by: 3/22/16; Lot #438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    Three Potato Salad; 2992; Net Weight: 1-10 lbs.; Keep Refrigerated; Use By: 03/11/16; Lot # 438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350  ","Potato Salad - 95/10 lb. tubs; Three Potato Salad - 7/10 lb. tubs","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use by: 03/15/16, 03/22/16; Lot # 431, 438    Use by: 3/22/16; Lot #438    Use By: 03/11/16; Lot # 438;",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1052-2016","Class II","Edamame In Oil; 2092; Net Weight:4 LB., Keep Refrigerated; Use by: 02/19/16, 02/24/16; Lot # 429, 433; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    ","150-4lb containers","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use by: 02/19/16, 02/24/16; Lot # 429, 433",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1055-2016","Class II","Shrimp Salad; 0139; Net Weight: 5 lbs.; Keep Refrigerated; Use By: 03/19/16; Lot #440; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350;    ","9/5 lb. tubs","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use By: 03/19/16; Lot #440;",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1054-2016","Class II","Blue Ridge Farms Krab Salad;09328; Net Weight 1 X 10 lb.; Keep Refrigerated; Use By: 03/15/16, 03/17/16;  Lot #436, 438;  Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350;    Krab Salad; 2872; Net Weight: 5 lb.; Keep Refrigerated; Use By: 3/02/16; Lot # 438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350;  ","09328: 80/10 lb. tubs; 2872: 2/10 lb. tubs","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use By: 03/15/16, 03/17/16;  Lot #436, 438;    Use By: 3/02/16; Lot # 438",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1057-2016","Class II","Blue Ridge Farms Lemon Seafood Salad; 09526; Net Weight: 5 lbs.; Keep Refrigerated; Use By: 03/15/16; Lot # 436; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350        ","10/5 lb. tubs","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use By: 03/15/16; Lot # 436",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73562,"Ongoing","Winter Gardens Quality Foods, Inc.","304 Commerce St",,"New Oxford","PA","17350-1723","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MD  NC  NJ  NY  PA  VA","F-1056-2016","Class II","Blue Ridge Farms Seafood Salad; 09526; Net Weight: 5 lbs.; Keep Refrigerated; Use By: 03/10/16, 03/15/16, 03/17/16, 03/18/16; Lot #431, 436, 438, 439; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350        ","272/5 lb. tubs","The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain. ","04/08/2016",," Use By: 03/10/16, 03/15/16, 03/17/16, 03/18/16; Lot #431, 436, 438, 439",2/15/2016,"02/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73563,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","424 S Mesa Hills Dr",,"El Paso","TX","79912-5441","United States","Voluntary: Firm Initiated","FAX","NM","B-0467-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor who possibly traveled to a malarial endemic area, was distributed.","04/25/2016","04/25/2016"," W041216004989M",1/29/2016,"01/29/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73564,"Terminated","Blood Systems, Inc.  dba UBS - California","2223 Eastman Ave Ste A",,"Ventura","CA","93003-8050","United States","Voluntary: Firm Initiated","Telephone","CA","B-0468-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, possibly collected from a donor who traveled to a malarial endemic area, were distributed.","04/25/2016","04/25/2016"," W142815048717S",1/28/2016,"01/28/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73565,"Terminated","Bergen Comm Reg Blood Center","102 Chestnut Ridge Rd",,"Montvale","NJ","07645-1856","United States","Voluntary: Firm Initiated","FAX","New Jersey","B-0396-16","Class III","Apheresis Platelets, Leukocytes Reduced","1 unit","Platelet product, which reached an unacceptable temperature during shipment, was distributed.","04/08/2016","04/08/2016"," W035815167851G",1/26/2016,"01/26/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73566,"Terminated","United Blood Services","6220 E Oak St",,"Scottsdale","AZ","85257-1101","United States","Voluntary: Firm Initiated","FAX","Arizona","B-0385-16","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","Blood products, collected from donors who were not appropriately evaluated for travel to a malarial endemic area, were distributed.","04/08/2016","04/08/2016"," W0410151916235 ",1/28/2016,"01/28/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73566,"Terminated","United Blood Services","6220 E Oak St",,"Scottsdale","AZ","85257-1101","United States","Voluntary: Firm Initiated","FAX","Arizona","B-0386-16","Class II","Red Blood Cells, Leukocytes Reduced","7 units","Blood products, collected from donors who were not appropriately evaluated for travel to a malarial endemic area, were distributed.","04/08/2016","04/08/2016"," W041015173989E; W041015173993M; W041015184943V; W041015185756L; W041015195097R; W041015195755S; W041016002147F",1/28/2016,"01/28/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73567,"Terminated","Carter BloodCare, Inc.","815 S Baxter Ave",,"Tyler","TX","75701-2205","United States","Voluntary: Firm Initiated","Telephone","TX","B-0469-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","04/25/2016","04/25/2016"," W035216027778U",2/15/2016,"02/15/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73568,"Ongoing","Cygnus Medical","965 W Main St",,"Branford","CT","06405-3431","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.","Z-1389-2016","Class III"," Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).    ","39 cases of 120 units","Foreign material in container","04/14/2016",," Lot Numbers:  EX20170714A and EX201720A  ",3/17/2016,"03/17/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73569,"Ongoing","Allegiant Health","75 N Industry Ct",,"Deer Park","NY","11729-4601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0856-2016","Class III","col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.  ","a) 9816 bottles; b) 9648 bottles","Superpotent Drug: High out of specification results for assay at the 6 month time point interval.","05/17/2016",," Lot #: 5C344105, Exp 02/17  ",2/29/2016,"02/29/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73570,"Ongoing","Pinnacle Foods, LLC","399 Jefferson Rd",,"Parsippany","NJ","07054-3707","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL and IL","F-1247-2016","Class II","Duncan Hines Signature Swiss Chocolate Cake Mix, 16.5 oz. cartons, Distributed by: Pinnacle Foods, Cherry Hill, New Jersey USA, UPC 6 44209 41120 7","240 cases","A natural flavoring containing a milk ingredient was inadvertently used to manufacture the Duncan Hines Signature Swiss Chocolate Cake Mix, 16.5 oz. cartons and the Duncan Hines Swiss Moist Deluxe Swiss Chocolate (Chocolate Suizo) 16.5 oz. cartons. The incorrect labeling was used on this product declaring that these products were a NON-milk containing product.","04/26/2016",," Case Lot #6521017E31 with Best By: Jan 21 2017",3/3/2016,"03/03/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73570,"Ongoing","Pinnacle Foods, LLC","399 Jefferson Rd",,"Parsippany","NJ","07054-3707","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL and IL","F-1248-2016","Class II","Duncan Hines Moist Deluxe Swiss Chocolate (Chocolate Suizo) Cake Mix, Net Wt. 16.5 oz. (1 LB 5 oz.) 468 g, Distributed by: Pinnacle Foods, Cherry Hill, New Jersey USA, UPC 6 44209 309748 7","1,600 cases","A natural flavoring containing a milk ingredient was inadvertently used to manufacture the Duncan Hines Signature Swiss Chocolate Cake Mix, 16.5 oz. cartons and the Duncan Hines Swiss Moist Deluxe Swiss Chocolate (Chocolate Suizo) 16.5 oz. cartons. The incorrect labeling was used on this product declaring that these products were a NON-milk containing product.","04/26/2016",," Case Lot #6521017E31 with Best By: Jan 21 2017",3/3/2016,"03/03/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73571,"Ongoing","TMIG Inc","3535 Roswell Rd Ste 21",,"Marietta","GA","30062-6252","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0855-2016","Class II","Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03 ","unknown","Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.","05/17/2016",," All lots ",3/23/2016,"03/23/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73572,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","United States and Singapore","B-0484-16","Class III","6% Hetastarch in 0.9% Sodium Chloride Injection, 500 mL, NOVAPLUS, NDC: 0409724849;  HEXTEND, 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, NDC: 0409155554","NOVAPLUS (5148 units); HEXTEND( 9156 units)","Hetastarch products, with potential contact of products with an aromatic hydrocarbon resin during manufacturing, were distributed.","04/29/2016",," NOVAPLUS, NDC: 0409724849;  Lot Number:  50087JT  HEXTEND, NDC: 0409155554; Lot Number 5180JT",3/8/2016,"03/08/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73573,"Ongoing","MFA Inc","303 W Olive St","PO Box 108","Aurora","MO","65605-0108","United States","Voluntary: Firm Initiated","E-Mail","Feed was distributed through the firm's own retail stores in located in the state of Missouri.","V-536-2016","Class I","16% Rabbit Pellet, Guaranteed Analysis *** Salt (NaCl) (min) 0.3 (max) 0.8 %, Packaged in 50 lb (22.6 kg) bags or bulk by truck. Manufactured by MFA Incorporated, Columbia, Missouri 65201","2.05 tons of bulk and 80 50# bags","Excessive salt in rabbit feed","09/30/2016",," Bulk lot: 218666; Bag lot: 213802",3/18/2016,"03/18/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73573,"Ongoing","MFA Inc","303 W Olive St","PO Box 108","Aurora","MO","65605-0108","United States","Voluntary: Firm Initiated","E-Mail","Feed was distributed through the firm's own retail stores in located in the state of Missouri.","V-538-2016","Class I","17% Rabbit Pellet, Guaranteed Analysis *** Salt (NaCl) (min) 0.2 (max) 0.7 %, Packaged in 50 lb (22.6 kg) bags or bulk by truck. Manufactured by MFA Incorporated, Columbia, Missouri 65201","23.18 tons of bulk and 1,783 50# bags.","Excessive salt in rabbit feed","09/30/2016",," Bag lots: 213877, 214865, 216032, 216427, 217549; Bulk lots: 213207, 213898, 214890, 217178, and 217243;",3/18/2016,"03/18/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73573,"Ongoing","MFA Inc","303 W Olive St","PO Box 108","Aurora","MO","65605-0108","United States","Voluntary: Firm Initiated","E-Mail","Feed was distributed through the firm's own retail stores in located in the state of Missouri.","V-537-2016","Class I","16% Rabbit Shield Pellet, Guaranteed Analysis *** Salt (NaCl) (min) 0.3 (max) 0.8 %, Packaged in bulk by truck. Manufactured by MFA Incorporated, Columbia, Missouri 65201","4.15 tons of bulk","Excessive salt in rabbit feed","09/30/2016",," 218665",3/18/2016,"03/18/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73575,"Ongoing","RAYSEARCH LABORATORIES AB","Sveavaegen 9",,"Stockholm",,,"Sweden","Voluntary: Firm Initiated","E-Mail","**Domestic** AR, AZ, CA, CT, CO, DE, FL, GA, IL, LA, MI, MD, MS, MA, NY, NV, NJ, OH, OR, PA, NC, RI, TN, WA & Washington D.C; **Internationally** Algeria, Australia, Austria, Belgium, Canada, China, France, French Polynesia, Germany, Iran, Italy, Japan, Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Switzerland, Thailand & United Kingdom","Z-1712-2016","Class II","RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy. ","1,264 Total units (552 units domestically & 711 units internationally)","A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized with the stored data if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down. This bug does not affect dose computations, which are based on the stored system state.","05/24/2016",," 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13 or 4.7.4.4",2/10/2016,"02/10/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73576,"Ongoing","HEB Retail Support Center","4710 N Pan Am Expy",,"San Antonio","TX","78218-5415","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-1083-2016","Class II","Hill Country Fare Chunk Light Tuna in pure vegetable oil NET WT. 5 OZ (142g) packaged in a metal can.","5,376 units","The product may have been under processed.","04/15/2016",," UPC 041220653355 lot code 6O9FZ SCEES",3/16/2016,"03/16/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73577,"Ongoing","Invacare Corporation","1200 Taylor St",,"Elyria","OH","44035-6248","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including  DC and  PR.  Internationally Canada.","Z-2402-2016","Class II","Junction Boxes,     Product Usage:  The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.  ","1,011 units","The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. ","08/11/2016",," Model #'s:1104343 & 1104345 ",3/15/2016,"03/15/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73577,"Ongoing","Invacare Corporation","1200 Taylor St",,"Elyria","OH","44035-6248","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including  DC and  PR.  Internationally Canada.","Z-2400-2016","Class II","Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes,     Product Usage:  The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.  ","2,702 units","The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. ","08/11/2016",," Model #: BARPKGIVC-1633; Serial #s: 15BF015617  15BF015618  15IF040586  15LF007886  15LF030500  15IF044964  15JF027523  15DF039684  15IF000656  15JF039196  15LF025841  15GF013405  15IF001676  15IF003788  15IF028783  15IF028784  15JF010270  15JF014683  15KF033384  16AF011108  15LF003819  16AF024508  16AF024509  15BF015622  15BF024675  15BF024678  15DF001324  15DF011345  15DF016457  15DF038243  15DF038244  15FF043818  15FF043822  15GF013418  15GF013419  15GF030895  15IF022355  15BF015626  15BF018543  15BF018544  15BF018545  15BF018546  15BF018547  15BF019841  15BF015624  15BF031157  15CF035105  15CF035106  15EF028981  15GF011720  15GF011721  15BF010327  15BF015640  15CF037855  15CF037856  15CF037857  15DF006120  15DF006121  15DF006122  15DF006123  15EF037541  15EF037542  15GF006873  15LF016357  15DF031032  15LF023497  16AF014286  16AF014287  15EF027547  15EF027552  15CF001424  15CF001425  15DF038252  15DF038253  15BF007598  15BF007599  15BF007600  15CF008156  15CF024415  15CF024416  15CF024417  15CF024418  15CF048563  15CF048564  15CF048565  15DF011352  15FF043823  15FF043826  15FF043827  15KF009783  15KF009784  15KF009785  15LF023499  15LF025846  16BF020108  16BF020109  16BF020110  16BF022580  16BF022581  16BF022582  15CF035118  15CF048566  15CF035123  15CF055440  15IF026984  15IF040587  15KF014079  15JF005606  15JF005607  16AF026276  15EF028976  15KF009791  15EF014829  15GF006890  15LF039839  15DF025056  15DF025057  15DF025058  15DF025059  15DF025060  15GF013370  15GF013371  15GF013372  15GF013373  15GF013374  15HF041628  15HF041629  15HF041630  15HF041631  15HF041632  15HF041633  15HF041634  15HF041635  15HF041636  15HF041637  15IF003770  15IF003771  15IF003772  15IF003773  15IF003774  15LF007897  15CF055423  15CF048577  15CF048578  15CF048579  15CF048580  15LF037329  16AF027999  15BF042550  15CF009491  15BF018527  15BF018528  15BF051617  15BF051618  15BF051619  15BF051620  15EF012112  15EF014821  15EF014822  15EF022750  15EF022751  15EF022752  15EF022753  15EF028971  15EF028972  15FF000654  15FF000655  15FF",3/15/2016,"03/15/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73577,"Ongoing","Invacare Corporation","1200 Taylor St",,"Elyria","OH","44035-6248","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including  DC and  PR.  Internationally Canada.","Z-2399-2016","Class II","Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes,     Product Usage:  The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.  ","2,184 units","The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. ","08/11/2016",," Model #: BAR600IVC; Serial #s:15BF054037  15BF004216  15BF004217  15BF012364  15EF005762  15EF005763  15EF012120  15EF012121  15GF006881  15BF048555  15DF039686  15DF039687  15LF016359  15LF016361  15HF010997  15HF025587  15HF025588  15IF014204  15IF014205  15IF014206  15IF014207  15IF014208  15IF014209  16AF014283  15DF013421  15DF027839  15DF027840  15DF027841  15DF027842  15EF025665  15EF025676  15HF002806  15HF002807  15HF002808  15HF002809  16BF020092  15IF040576  15JF003246  15KF016696  15KF016697  15LF001343  16AF030663  15EF027538  15EF027541  15JF035242  15JF035243  15JF035244  15JF035245  15JF035246  15LF032425  15LF032426  15GF003764  15JF040948  16AF016782  15DF019105  15DF033803  15DF033804  15EF005756  15EF031153  15EF031163  15EF031164  15EF031165  15DF001325  15EF025678  15FF022339  15FF037337  15HF025599  15IF024195  15IF036443  15LF009178  15LF039840  16AF041543  16AF041549  16BF002993  15LF014902  15FF022337  15BF042553  15BF042554  15CF023283  15CF023284  15DF022408  15DF039689  15DF039690  15DF039691  15JF019607  16BF033772  16BF033773  15BF045966  15LF001337  15IF026992  15IF026996  16AF016787  16AF040813  16BF033768  15EF035410  15EF027548  15EF027549  15FF027574  15DF049778  15DF049779  15DF049783  16BF000448  16BF000449  16BF000450  16BF000451  16AF011604  15BF023717  15BF010347  15DF016465  15GF021631  15IF003775  15BF012365  15BF012366  15IF040589  15CF048586  15CF048587  16AF037620  16AF037621  16AF037622  15EF038971  15EF038972  15BF024687  15BF042549  15DF003876  15DF036551  15DF039702  15EF025682  15KF023904  16AF040812  15DF049437  15AF051096  15DF025051  15EF025679  15EF025680  15EF025681  15DF027835  15FF026857  15FF026858  15GF028723  15GF028724  15DF022425  15LF009182  16AF040800  16BF000456  15JF019603  15LF037321  16AF040801  16AF040811  15GF013353  15DF036960  15DF036961  15FF034711  15FF031482  15GF022843  15GF028721  15IF000650  15IF008414  15IF036428  15JF007591  15JF019596  15LF023483  15LF025849  15LF032422  15BF019847  15DF016477  15KF018084  15BF015649  15DF016466",3/15/2016,"03/15/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73577,"Ongoing","Invacare Corporation","1200 Taylor St",,"Elyria","OH","44035-6248","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including  DC and  PR.  Internationally Canada.","Z-2401-2016","Class II","Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes,     Product Usage:  The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.  ","3,050 units","The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. ","08/11/2016",," Model #: BAR5490IVC; Serial #s: 15BF023716  15CF008150  15JF012488  15JF012489  15JF012490  15BF048545  15BF039458  15BF039459  15BF039460  15BF039461  15BF039462  15BF039463  15BF039464  15BF039465  15BF039466  15BF039467  15BF045955  15BF045956  15CF020336  15CF020337  15CF020338  15CF020339  15CF020340  15CF020341  15CF037863  15DF027823  15DF027824  15DF027825  15DF027826  15DF027827  15DF042103  15DF042105  15DF046695  15EF007464  15EF013525  15EF014826  15EF014827  15EF014828  15GF006921  15GF006925  15GF013384  15GF013385  15GF013386  15GF030883  15GF030885  15GF033318  15HF027020  15HF034771  15HF034775  15HF043300  15HF043301  15IF020130  15IF020131  15IF028759  15IF028760  15IF028761  15IF028762  15IF028763  15IF028764  15IF044966  15IF044967  15IF044968  15IF044969  15KF014068  15KF018077  15LF011111  15LF011112  15LF011113  15LF011114  15LF011115  15LF013140  16AF003847  16AF009018  16AF026282  16AF026283  16AF026284  16AF026285  16AF026286  16AF044630  16BF020098  16BF024626  15AF016197  15AF016198  15BF007602  15AF051670  15BF000847  15AF048735  15AF048736  15AF048737  15AF048738  15AF048739  15AF051666  15BF000861  15CF055428  15DF027818  15AF034671  15BF004206  15BF007603  15FF022340  15AF051103  15LF013148  15LF025830  15BF010331  15BF012341  15BF012342  14LF046072  15AF051112  15GF027655  15AF051095  15AF048745  15DF027837  15DF013439  15AF048750  15BF034208  15IF033597  15DF011339  15IF033598  15IF033599  15AF048746  15AF051113  15CF024425  15BF034211  15EF005745  15AF034667  15BF000846  15BF035731  15EF025673  15BF000856  16AF003844  15EF018852  16AF018116  16AF018117  15IF026982  15AF051667  15AF051668  15BF023707  15BF034202  15GF000934  15AF051660  15CF003032  15CF003033  15FF000659  15HF010984  15HF010985  15HF010986  15HF010987  15GF035697  15JF007592  15LF016363  15CF020342  15CF020343  15CF020344  15CF020345  15CF020346  15CF020347  15BF048546  15BF048547  15BF048548  15AF048743  15FF022349  15FF022350  15FF029234  15FF029235  16AF037634  15BF004207  15BF023702  15BF023704  15IF0201",3/15/2016,"03/15/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73578,"Ongoing","Ascom US, INC.","300 Perimeter Park Dr Ste D",,"Morrisville","NC","27560-9703","United States","Voluntary: Firm Initiated","Letter","CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii.  Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.","Z-1638-2016","Class II","Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).","319","Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored.","05/10/2016",," Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and  Ascom Unite Connect for Nurse Call version 2.2.0",12/10/2015,"12/10/2015",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73579,"Ongoing","Arthrex, Inc.","1370 Creekside Blvd",,"Naples","FL","34108-1945","United States","Voluntary: Firm Initiated","Letter","Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.","Z-1360-2016","Class II","Arthrex Deltoid Ligament Reconstruction Implant System.    Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons. ","117 devices","Potential for a component contained in the Implant System to be non-sterile. ","04/08/2016",," Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.",1/11/2016,"01/11/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0394-2017","Class I","Refrigerated, ready-to-eat marinated oyster mushrooms packaged in a 4.5 Lb. small clear plastic bucket labeled in part ***204139**MARINATED OYSTERS BY LB*** ","35 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 03/02",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0402-2017","Class I","Refrigerated, Ready to Eat Salad Izolda packaged in 25 Lb. bulk white plastic bucket labeled in part ***204129**SALAD IZOLDA BY LB*** ","16 buckets","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 3/11",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0406-2017","Class I","Refrigerated, Ready to Eat Mushrooms Maslyata Korolevskie packaged in 4.5  Lb. bulk white plastic bucket labeled in part ***204394**MUSHROOMS MASLYATA KOROLEVSKIE POD RUMOCHKU BY LB *** ","52 buckets","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 3/10",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0399-2017","Class I","Refrigerated, Ready to Eat Herring Super Dunayskaya packaged in clear vacuum package labeled in part ***204450**HERRING SUPER DUNAYSKAYA IN VACUUM BY PC*** ","10 cases x 20 pcs per case","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 3/14",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0386-2017","Class I","Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 16.2 oz. (460g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Herring Fillet in Oil**Net Wt. 16.2 oz. (460g)*** UPC # 825512 004984 ","300 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," lot code 05.15.2016.",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0385-2017","Class I","Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 10.9 oz. (310g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Herring Fillet in Oil Forelka Style**Net Wt. 10.0 oz. (310g)** UPC # 825512 004915 ","120 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," lot code 05.15.2016.",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0408-2017","Class I","Refrigerated, Ready to Eat Marinated Shitake Mushrooms packaged in 4.5 Lb. bulk white plastic bucket labeled in part ***204138**HERRING IVASI BY PC*** ","20 buckets","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 3/8",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0398-2017","Class I","Refrigerated, Ready to Eat Herring Ivasi packaged in   Lb. bulk white plastic bucket labeled in part ***204183**HERRING IVASI BY PC*** ","8 buckets x 30 pc ","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 3/11",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0396-2017","Class I","Refrigerated, ready-to-eat sour pickles packaged in a 18 Lb. bulk white plastic bucket labeled in part ***204112**SOUR PICKLES BY LB*** ","54 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 03/02",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0392-2017","Class I","Refrigerated, ready-to-eat Korean Carrot Salad packaged in bulk 25 Lb. white plastic bucket labeled in part ***204034**SALAD KOREAN CARROT BY LB***","30 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 03/02",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0389-2017","Class I","Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a plastic bucket labeled in part ***204311**HERRING SUPER DUNAYSKAYA BY PC***","400 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 02/29",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0409-2017","Class I","Refrigerated, Ready to Eat Holland Herring in Oil under firms brand name FRESH SEAFOOD packaged in a 24 oz. (680g) plastic retail container labeled in part ***FRESH**SEAFOOD**Holland Herring in Oil**Net Wt. 24 oz. (680g)*** UPC # 825512008128 ","15 cases x 12 pcs per case","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code Best By 06.15.16.",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0412-2017","Class I","Refrigerated, Ready to Eat Herring Fillets in Oil Lightly Salted under firms brand name FRESH SEAFOOD packaged in a 16 oz. (454g) plastic retail container labeled in part ***FRESH**SEAFOOD**Herring Fillets in Oil Lightly Salted**Net Wt. 16 oz. (454g)***UPC # 825512014044 ","4 cases x 12 pcs per case","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code Best By 06.04.16",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0388-2017","Class I","Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a   plastic bucket labeled in part ***204883**HERRING DUNAYSKAYA BY PC***","80 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 02/29",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0405-2017","Class I","Refrigerated, Ready to Cabbage Boyarskaya packaged in 25 Lb. bulk white plastic bucket labeled in part ***204259**CABBAGE BOYARSKAYA BY LB*** ","163 buckets","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 3/9, 3/11, & 3/16",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0395-2017","Class I","Refrigerated, ready-to-eat marinated apples packaged in 15 Lb. bulk white plastic bucket labeled in part ***204022**MARINATED APPLES BY LB*** ","16 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 03/01",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0390-2017","Class I","Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a   plastic bucket labeled in part ***204857**HERRING NORWAY SUPER JUMBO BY PC*** ",,"Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 02/29",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0413-2017","Class I","Refrigerated, Ready to Eat Herring in Spicy Brine under firms brand name FRESH SEAFOOD packaged in a 46 oz. (1275g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Herring in Spicy Brine**Net Wt. 46 oz. (1275g)***UPC # 825512008166 ","12 cases x 6 pcs per case","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code Best by 06.08.16.",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0387-2017","Class I","Refrigerated, Ready to Eat Herring in Brine under firms brand name FRESH SEAFOOD packaged in a 16.2 oz. (460g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Pacific Herring Fillet in Oil**Net Wt. 16.2 oz. (460g)*** UPC # 825512 004946 ","300 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," lot code 05.15.2016.",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0400-2017","Class I","Refrigerated, Ready to Eat Cherry Tomatoes packaged in 15 Lb. bulk white plastic bucket labeled in part ***204017**CHERRY TOMATOES BY LB*** ","65 buckets ","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 3/10 & 3/17",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0397-2017","Class I","Refrigerated, ready-to-eat red tomatoes packaged in a 15 Lb. bulk white plastic bucket labeled in part ***204061**RED TOMATOES BY LB*** ","80 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 03/01",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0403-2017","Class I","Refrigerated, Ready to Eat Pickles Half Sour packaged in 18 Lb. bulk white plastic bucket labeled in part ***204062**PICKLES HALF SOUR BY LB***","102 buckets","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",,"  Lot code in black ink on label: 3/8 & 3/15",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0410-2017","Class I","Refrigerated, Ready to Eat Herring Fillets In Oil under firms brand name FRESH SEAFOOD packaged in a 28.2oz. (800g) plastic retail container  labeled in part ***FRESH**SEAFOOD**SUPER DUNAYSKAYA**Herring Fillets in Oil**Net Wt. 28.2 oz. (800g) ","14 cases x 9 pcs per case","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code Best By 06.14.16.",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0391-2017","Class I","Refrigerated, Ready to Eat Herring in Brine with no brand name as packaged bulk in a    plastic bucket labeled in part ***204709**HERRING FILLET SUPER DUNAYSKAYA BY PC***","200 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 02/29",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0404-2017","Class I","Refrigerated, Ready to Eat Red Cabbage packaged in 18 Lb. bulk white plastic bucket labeled in part ***204070**RED CABBAGE BY LB*** ","22 buckets","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 3/10",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0411-2017","Class I","Refrigerated, Ready to Eat Herring Fillets Matjes under firms brand name FRESH SEAFOOD packaged in a 16.2 oz. (460g) plastic retail container  labeled in part ***FRESH**SEAFOOD**Herring Fillet Matjes**Net Wt. 16.2 oz. (460g)*** UPC # 825512004960 ","6 cases x 12 pcs per case","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code Best By 06.04.16.",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0407-2017","Class I","Refrigerated, Ready to Eat Marinated Opyata Mushrooms packaged in 4.5 Lb. bulk white plastic bucket labeled in part ***204136**MARINATED OPYATA MUSHROOMS BY LB *** ","38 buckets","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 3/14",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0393-2017","Class I","Refrigerated, ready-to-eat SOUR CABBAGE BY LB packaged in a 25 Lb. bulk white plastic bucket labeled in part ***204023**MARINATED CABBAGE BY LB*** ","92 units","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",," Lot code in black ink on label: 03/02",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73580,"Ongoing","Royal Seafood Baza","175 Lake Ave",,"Staten Island","NY","10303-2727","United States","Voluntary: Firm Initiated","E-Mail","NY & PA via retail stores","F-0401-2017","Class I","Refrigerated, Ready to Eat Salad Pikantniy packaged in 25 Lb. bulk white plastic bucket labeled in part ***204143**SALAD PIKANTNIY BY LB***","24 buckets","Royal Seafood Baza, Inc. has recalled all pickled products produced on 3/1/2016, 3/2/2016 and also all herring products produced on 2/29/2016 due to possible contamination with Listeria monocytogenes. ","11/08/2016",,"  Lot code in black ink on label: 3/9 & 3/16",3/18/2016,"03/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73581,"Ongoing","RESEARCH INSTRUMENTS LTD - SITE B","Bickland Ind. Park",,"Falmouth",,,"United Kingdom","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria,  Australia,  Austria,  Bahrain,  Belgium,  British Virgin Islands,  Bulgaria,  Canada,  Denmark,  Egypt,  Estonia,  Finland,  France,  Georgia,  Germany,  Greece,  Hong Kong,  India,  Iran,  Iraq,  Ireland,  Israel,  Italy,  Japan,  Jordan,  Korea,  Kuwait,  Libya,  Lithuania,  Macedonia,  Malaysia,  Malta,  Mexico,  Nigeria,  Norway,  Pakistan,  Peru,  Poland,  Romania,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sri Lanka,  Sweden,  Taiwan,  Thailand,  Tunisia,  Turkey,  UAE,  Ukraine,  United Kingdom,  and Vietnam,","Z-1584-2016","Class II","Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160    Product Usage:  The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.  ","380 units","The units have been fitted with a potentially faulty power supply cable.","04/28/2016",," Serial numbers: 2-381",3/11/2016,"03/11/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1340-2016","Class II","Harvest Value Canola Salad Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 02454 5","240 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6028012218",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1348-2016","Class II","Smart Source Creamy Soybean Frying Oil (Aceite de Soja Cremosa Para Freir), Net Wt./Peso Neto, 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, Product of USA/Producto de EE.UU., UPC 0 08 22486 13045 9","60 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6028012252",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1358-2016","Class II",", Net Wt 35 lb (17.4 Liter), Distributed By. IAS International American Supermarkets, 226 Old New Brunswick Road, Piscataway, NJ 08854, Mfd By: Bunge, Bradley, IL 60915, UPC 0 00 78684 69024 4","1,400 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6026012210",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1351-2016","Class II","EB Golden Fry Clear Liquid Shortening, 35 lbs. (15.88 kg), Distributed By: EB Express Provisions, Inc., 181-191 Vanderpool Street, Newark, NJ 07114, UPC 0 00 78684 73630 0","720 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6025012218",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1342-2016","Class II","Katy's Kitchen Soybean Salad Oil (Soya Aceite Para Ensalada), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, Product of USA/Producto de EE.UU., UPC 0 08 22486 13034 3","60 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6033012211",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1336-2016","Class II","Bunge Soy Clear Fry Oil OU, 35 lb., Manufactured by: Bunge Oils, Inc. Kearny, NJ 07032, UPC 00078684692026","3,240 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #'s 6028012257 and 6029012210",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1355-2016","Class II","Hooters Creamy Liquid soybean Frying Oil, Net Wt 35 lb (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 73746 8","120 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6028012253",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1357-2016","Class II","Bunge Corn Oil (Aceite de maiz), Net Wt 35 lb (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 69118 0","180 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6028012213",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1353-2016","Class II","Daily Chef Food Service Pure Soybean Oil (Aceite de Soya), Net/Neto 4.5 Gal (17L) and Net Wt/Peso Neto, 35 lbs. (15.8 kg), Distributed By: Sam's West Inc., Bentonville, AR 72716, UPC 0 78742 06151 1","2,100 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #'s 6026012215, 6028012219, 6033012212 and 6032012252",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1350-2016","Class II","Nathan's Pure Corn Oil, Net Weight 35 lb (15.88 kg), Packed Exclusively for: Nathan's, General Offices: One Jericho Plaza, Jericho, NY 11753, UPC 0 07 16071 99955 5","540 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6028012214",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1354-2016","Class II","Daily Chef Food Service Pure Canola Oil (Aceite de Canola Para Ensaladas), Net/Neto 4.5 Gal (17L) and Net Wt/Peso Neto, 35 lbs. (15.8 kg), Distributed By: Sam's Inc., Bentonville, AR 72716, UPC 0 78742 06149 8","1,080 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #'s 6025012211, 6028012211 and 6032012212",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1341-2016","Class II","Taco Bell Liquid Canola Frying Oil, 35 lb., (15.88 kg), Packaged Exclusively for use by Taco Bell and its franchisees. Taco Bell Corp, Irvine, CA 92618","250 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6034012214",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1337-2016","Class II","Nutra-Clear NT Ultra - Bunge Canola Deep Frying Oil (High Stability), 35 lb., (15.88 kg), MFD in USA by: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 72477 2","2,698 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #'s 6025012210, 6027012214 and 6029012213 ",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1349-2016","Class II","Yum Canola Frying Oil Blend, Net Wt., 35 lbs. (15.88 kg), Packaged Exclusively for use by Yum! Brands Global Restaurants, Yum Brands, Louisville, KY 40232","1,923 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6033012254",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1360-2016","Class II","Smart Source Canola Salad Oil (Aceite de Canola Para Ensalada), Net Wt./Peso Neto 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, UPC 0 08 22486 17655 6","60 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6028012210",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1346-2016","Class II","Old World Soybean Oil (Aceite de Soja), Net Wt.35 lbs. (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 70011 0","2,449 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #'s 6028012212 and 6033012214",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1339-2016","Class II","Harvest Value Clear Vegetable Frying Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 00302 1","3,120 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6029012211",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1347-2016","Class II","Bunge Creamy Soy Liquid Frying Oil (Aceite de Soja Para Freir Liquido y Cremosa), Net Wt. 35 lbs. (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 73353 8","2,040 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #'s 6028012254 and 6033012252",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1356-2016","Class II","Bunge Clear Liquid Canola Frying Oil (Aceite de Canola para freir liquido y transparente), Net Wt 35 lb (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 69266 8","660 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #'s 6028012215 and 6034012210",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1343-2016","Class II","Smart Source Clear Soybean Frying Oil (Aceite de Soya Transparente Para Freir), Net Wt./Peso Neto 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, UPC 0 08 22486 13046 6","1,080 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6033012211",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1352-2016","Class II","Daily Chef Food Service Pure Clear Frying Oil (Aceite Transparente Para Freir), Net/Neto 4.5 Gal (17L) and Net Wt/Peso Neto, 35 lbs. (15.8 kg), Distributed By: Sam's West Inc., Bentonville, AR 72716, UPC 0 78742 06148 1","9,460 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #'s 6019012257, 6020012215, 6026012217, 6028012256 and 6033012215",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1344-2016","Class II","Old World Canola Oil (Aceite de Canola), Net Wt. 35 lbs. (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 70020 2","360 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #'s 6027012213 and 6029012217",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1338-2016","Class II","Harvest Value Canola Liquid Frying Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 01988 6","2,040 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6028012217",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73583,"Ongoing","Bunge Oil North America Inc.","125 Sanford Ave ","Building 22","Kearny","NJ","07032-5918","United States","Voluntary: Firm Initiated","Telephone","CT, MA, MD, NH, NJ, NY, PA, VA and VT","F-1345-2016","Class II","Old World Clear Canola Liquid Frying Oil (Aceite de Canola Para Freir Liquido y Transparente), Net Wt.35 lbs. (15.88 kg), MFD in USA By: Bunge Oils, St. Louis, MO 63146-1000, UPC 0 00 78684 70021 9","420 cases","The presence of a foreign material inside jugs of Bunge Vegetable Oil.","05/16/2016",," Lot #6028012216",2/8/2016,"02/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73584,"Ongoing","Dynarex Corporation","10 Glenshaw St",,"Orangeburg","NY","10962-1207","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International:  Canada","Z-2057-2016","Class II","dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only    Product Usage:containers for sample collection    ","399 cases/25 sleeves/20 cups & lids per sleeve","Exterior carton is mis-labeled as Sterile.  Non-sterile, bulk specimen containers were packed in incorrect exterior carton.   ","06/27/2016",," Lot Numbers: 31899, 32014, 32015, 32410 & 32411",3/3/2016,"03/03/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73585,"Ongoing","Biomerieux Inc","595 Anglum Rd",,"Hazelwood","MO","63042-2320","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to China  Taiwan region; No US/military/government distribution.","Z-1596-2016","Class II","VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712.  VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.","337 Kits of 20 Cards/Kit","Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae  to Minocycline.","05/03/2016",," Lot/Serial:  485368220  Expiry:  12-JAN-17",2/24/2016,"02/24/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73586,"Ongoing","Jubilant Draximage Inc","16751 Rte Trans-Canada",".","Kirkland",,,"Canada","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0812-2016","Class III","SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05","90 vials (450 capsules) ","Labeling: Label Error on Declared Strength","04/06/2016",," Lot Number 1670123; Exp 04/16",3/11/2016,"03/11/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73588,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including Puerto Rico and to the states of : California, Illinois, Washington and Wisconsin., and to the countries of :  Angola, Austria, Canada, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Kenya, Netherlands, Norway, Portugal, Singapore, Slovenia, Spain, Turkey, Uganda and United Kingdom.","Z-1500-2016","Class II","ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD    The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories","US: 8 systems; Foreign: 64 systems","Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively.  The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should.  As defined in t","04/20/2016",," All serial numbers of ADVIA 560 Hematology Systems.",3/10/2016,"03/10/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73589,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"Nationwide distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico","Z-1311-2016","Class II"," Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.  ","1757 systems","Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet.  This leak can occur sporadically in affected systems.","03/31/2016",," Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959",2/19/2016,"02/19/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73589,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"Nationwide distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico","Z-1310-2016","Class II","AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.  ","1757 angiography systems ","Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet.  This leak can occur sporadically in affected systems.","03/31/2016",," Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959",2/19/2016,"02/19/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73590,"Terminated","American Red Cross Blood Services Heart of America Region","405 W John H Gwynn Jr Ave",".","Peoria","IL","61605-2440","United States","Voluntary: Firm Initiated","FAX","Illinois","B-0397-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, for which quality control testing was not performed, was distributed.","04/07/2016","04/07/2016"," W204016353661 ",2/3/2016,"02/03/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73591,"Terminated","Innovative Blood Resources","737 Pelham Blvd",".","Saint Paul","MN","55114-1739","United States","Voluntary: Firm Initiated","Letter","Minnesota","B-0398-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood products, lacking product quality control testing, were distributed.","04/07/2016","04/07/2016"," W051515105668 (Double collection)",12/22/2015,"12/22/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73592,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Worldwide distribution -  US (nationwide) distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. , and to the countries of : Canada, United Arab Emir, Australia, Austria, Belgium, Switzerland, Bahamas, Czech Republic, Germany, Denmark, Spain, Finland, France, Italy, Netherland, Norway, Portugal, Slovakia, Slovenia, Japan, Republic of Korea, New Zealand.","Z-1622-2016","Class II","Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge    The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.","18668 units","Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results.  The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities. ","05/06/2016",,"  Device Listing # D011374, Lot # 15341AC, 15320BB, 15300BA, 15299BB, 15264BA, 15243BB and 15215AE",2/16/2016,"02/16/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73593,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT,  DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-1519-2016","Class II","Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body.  Computed tomography (CT) x-ray system.","1096 ","Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.","04/19/2016",," Model Number: 8098027 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.",3/2/2016,"03/02/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73593,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT,  DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-1518-2016","Class II","Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body.  Computed tomography (CT) x-ray system.","1096 ","Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.","04/19/2016",," Model Number: 7740769 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.",3/2/2016,"03/02/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73593,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT,  DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-1521-2016","Class II","Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body.  Computed tomography (CT) x-ray system.","1096 ","Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.","04/19/2016",," Model Number: 10590000 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.",3/2/2016,"03/02/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73593,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated",,"Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT,  DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-1520-2016","Class II","Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body.  Computed tomography (CT) x-ray system.","1096 ","Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.","04/19/2016",," Model Number: 10430603 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.",3/2/2016,"03/02/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73594,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Units were shipped to MI, FL, NJ, NY, DC, CA, GA, MI, MT, VA, NC, TX, PA, Australia, Belgium, Czech Republic, Finland, Japan, Republic of Korea, Italy, Saudi Arabia, Slovakia, Slovenia, Spain and Switzerland.","Z-1618-2016","Class II","Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma. ","18364 units","Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased. ","05/06/2016",," Lot # F1, F2, G1, G2, H1, and H2",3/8/2016,"03/08/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73595,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AR, AZ, CA, CT, FL, GA, IN, LA, MD, MN, MO, MS, NJ, NM, NY, OH, SC, SD, TN, TX and  UT.","Z-1379-2016","Class II","SurgiCounter scanner, part of the SurgiCount Safety-Sponge System.   Model numbers 0694-097-000 and 0694-097-001.      Product Usage:   The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.","286","The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2).  Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.","04/13/2016",," Model Number(s):   0694-097-000  0694-097-001    Units individually serialized, SN numbers included in recall Letter.   Units distributed 11/1/2015-12/17/2015    Stryker Product Number: 0694097000  Serial#  1525901643   1526602693   1526603463   1526708353   1531400083   1531400453   1531400823  1525901653   1526602713   1526603473   1526708393   1531400093   1531400463   1531400833  1525901663   1526602723   1526603483   1526708403   1531400103   1531400473   1531400843  1525901673   1526602733   1526603493   1526708413   1531400113   1531400483   1531400853  1525901683   1526602743   1526603503   1526708423   1531400123   1531400493   1531400863  1525901693   1526602753   1526603513   1526708443   1531400133   1531400503   1531400873  1525901703   1526602863   1526603523   1526708463   1531400143   1531400513   1531400883  1525901713   1526602873   1526603533   1526708473   1531400153   1531400523   1531400893  1525901723   1526602883   1526603543   1526708493   1531400163   1531400533   1531400903  1525901733   1526602893   1526603553   1526708503   1531400173   1531400543   1531400913  1526106133   1526602903   1526603563   1526708523   1531400183   1531400553   1531400923  1526106143   1526602913   1526603573   1526708533   1531400193   1531400563   1531400933  1526106153   1526602923   1526603583   1526708543   1531400203   1531400573   1531400943  1526106163   1526602933   1526603593   1526708563   1531400213   1531400583   1531400953  1526106173   1526602943   1526603603   1526708573   1531400223   1531400593   1531400963  1526106183   1526602953   1526603613   1526708583   1531400233   1531400603   1531400973  1526106193   1526602963   1526603623   1527101333   1531400243   1531400613   1531400983  1526106203   1526602973   1526603633   1527207393   1531400253   1531400623   1531400993  1526106213   1526602983   1526603643   1527207413   1531400263   1531400633   1531401003  1526106223   1526602993   1526603653   1527207523   1531400273   1531400643   1531503063  1526106233   1526603003   152670809",3/21/2016,"03/21/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73597,"Ongoing","Becton, Dickinson and Company, BD Biosciences","2350 Qume Dr",,"San Jose","CA","95131-1812","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution to the states of : CT, MN, FL, NY, CA, MA, DC, UT, VA and IN.,  and to the countries of :  Belgium, Brazil, Canada, China, India, Japan, Korea, Singapore and Taiwan.","Z-1390-2016","Class III","BD-Retic-Count Reticulocyte Reagent System;    Hematology: Used for in vitro diagnostics","205","The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are correct.","04/14/2016",," Product number 349214, Lot number 5175559, Expiry 5/31/16.",3/18/2016,"03/18/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1969-2016","Class II","Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY.  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.","1,786 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 1) 4724924, 4724925 & 4730412 with Use By 2016-03-31.    Batch/Lots: 2) 4724929, 4724923, 4725426, 4730400 & 4753766 with Use By Range 2016-03-31 to 2016-07-31.   Batch/Lots: 3) 4724927 Use By 2016-03-31.   ",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1977-2016","Class II","Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","2 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4743467 & 4759480   Use By 2016-04-30 and 2016-05-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1967-2016","Class II","Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY.  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.","328 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots:1) 4714745 with Use By 2016-03-31.  Batch/Lots: 2) 4745413,  4819467, 4827954, 4725425 & 4726948 with Use By Date Range 2016-03-31 to 2016-11-30.",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1983-2016","Class II","BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","376 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4720503, 4778382, 4799263, 4824908, 4744027, 4752337, 4762746, 4786750, 4797579, 4824615, 4831212 & 4841018.  Use By Date Range 2016-03-31 to 2016-12-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1985-2016","Class II","BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","445 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4773627, 4780053 & 4782468.  Use By Date Range 2016-05-31 to 2016-07-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1976-2016","Class II","Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440  Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","55 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4718004, 4783051, 4788340 & 4796128.  Use By Date Range 2016-03-31 to 2016-08-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1984-2016","Class II","BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","2 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4824806  Use By 2016-10-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1970-2016","Class II","Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.","5,566 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 1) 4724945, 4731137, 4738296, 4895232, 4912062, 4933353, 2) 4731139, 4738302, 4748674, 4776152, 3) 4721239, 4784467, 4810672, 4812161, 4821239, 4821511, 4824106, 4830612, 4832722, 4836599, 4724949, 4724950, 4738298, 4738299, 4773297, 4773298, 4786764, 4823438, 4829478, 4832723,4845209,  4724926 & 4734253 with Use By Date Range 2016-03-31 to 2017-09-30.",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1966-2016","Class II","Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY.  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.","2,716 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 1) 4732402, 4745359, 4824107, 4827333, 4835750, 4860987 & 48698433, 2) 4772713, 4786763, 4790018, 4817452 & 3) 4725793, 4745367, 4748673, 4756297, 4765394, 4773295, 4784468, 4788536 & 4845665 with Use By 2016-04-30.   ",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1973-2016","Class II","Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","150 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4815673  Use By 2016-10-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1971-2016","Class II","Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.","210","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 1) 4732403, 4776151, 4792223, 4810671 with Use By 2015-08-31.",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1982-2016","Class II","BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","438 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4732400, 4753201, 4776149, 4783743, 4797578, 4819459, 4830558 & 4836573.  Use By Date Range 2016-05-31 to 2016-12-31.  ",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1978-2016","Class II","Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","100 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4759481, 4807952, 4746868, 4752404 & 4788361.   Use By 2015-08-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1980-2016","Class II","Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","357 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4719661, 4746382, 4752893, 4790027, 4815993, 4830605, 4735062, 4759816, 4775599, 4785918, 4812167 & 4819162.  Use By Date Range 2016-03-31 to 2016-10-31  ",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1975-2016","Class II","Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","568 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4721803, 4732391, 4767156, 4768679, 4784455, 4789995,  4809602, 4728559, 4752329, 4768072 & 4783738.  Use By Date Range 2016-03-31 to 2016-10-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1981-2016","Class II","BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","60 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4788244, 4814218, 4835795 & 4842658.  Use By Date Range 2016-07-31 to 2017-01-31  ",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1974-2016","Class II","Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","105 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4712504, 4732394 & 4800179   Use By 2016-09-30",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1968-2016","Class II","Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.","2,260 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 1) 4748893, 4766101, 4773293 & 4814220 with Use By Range 2016-05-31 to 2016-10-31.    Batch/Lots: 2) 4752348, 4784466, 4735032, 4738833, 4765395 & 4814222 with Use By Range 2016-05-31 to 2016-07-31.   Batch/Lots: 3) 4752881, 4765393 & 4942171 with Use By Range 2016-05-31 to 2017-09-30.   ",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1979-2016","Class II","Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","157 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4762475, 4780075, 4797006, 4807953, 4730240 & 4757886.  Use By Date 2016-03-31 to 2016-09-30.",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1988-2016","Class II","BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","275 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4749414, 4766098, 4770315, 4776150 & 4790009.  Use By Date Range 2016-05-31 to 2016-09-30",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1986-2016","Class II","BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","10 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4806370  Use By 2016-10-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1972-2016","Class II","Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.","1,127 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 1) 4738829, 2) 4732404, 4749417, 4774464, 4793677, 4819468, 4829479, 3) 4725435, 4745700, 4755306, 4764067, 4801103 & 4827331 with Use By Date 2016-04-30 to 2016-10-31.",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73598,"Ongoing","Navilyst Medical, Inc., an AngioDyamics Company","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.","Z-1987-2016","Class II","BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring","190 units","PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.  ","06/14/2016",," Batch/Lots: 4732401, 4737713, 4752342, 4766669 & 4792819.  Use By Date Range 2016-03-31 to 2016-08-31",3/14/2016,"03/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73599,"Ongoing","Zochem Inc.","1 Tilbury Crt",,"Brampton",,,"Canada","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","(2) lots (Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) were made and distributed to Brand Nu Laboratories (distributor) at the following address: 377  Research Parkway, Meriden, CT 06450.     One (1) lot (LOT#700792) of 450 kg was made and distributed to M K Impex, Canada at the following address: C/O Rexway Transport, Ltd. 2869 Slough Street, Mississauga, ON. L4T 1G4.     Additional information: In the US, all of the potentially contaminated product was used in the manufacturing of drugs. In Canada, 200 kg of 450 kg of the potentially contaminated product has been distributed in Saudi Arabia while the remaining 200 kg is in the distributors control and has been put on hold.","F-1402-2016","Class III","Zinc Oxide Powder (API) used in the manufacturing of dietary supplements  .  ","(Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) , lot (LOT#700792) of 450 kg was made and distributed ","ZoChem Inc. received a complaint from  a customer who noticed black specs of contamination in one specific lot (#700792) of product (zinc oxide) that they received, an investigation by ZoChem Inc.  was launched .       The retained sample representing this lot was analyzed and the contaminant was determined to be iron.  The issue is potentially present in two other lots (#700785 & 700804) produced","05/26/2016",," Lot # 700785; expiration date: 07/19/2017 (manufactured 07/20/15) - US  Lot #700804; expiration date: 07/28/2017 (manufactured 07/29/15) - US   Lot# 700792; expiration date: 07/22/2017 (manufactured 07/23/15) - Canada  ",3/11/2016,"03/11/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73600,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.","Z-1312-2016","Class II","Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument","42 plate systems","DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System.  The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi","03/31/2016",," Lot Number# 1776197 (5706588), 1782340 and 1868678  Catalog ID 03.120.027  For lot 1776197, the part is etched with 1776197; the package label documents 5706588.",2/16/2016,"02/16/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73601,"Ongoing","Radiometer America Inc","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution to the states of :  MO, NE, AL, PA, IL, MN, TX, ID, CO, UT, NV, CA, NY, RI, OR, NJ, AZ, GA, IN, VA, LA, NM, MD and AR., and to the countries of :  Canada, Austria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, United Kingdom, Italy, Netherlands, Norway, Spain, Sweden, United Arab Emirates, Kuwait, Qatar, Saudi Arabia, Oman, Jordan, Croatia, Malta, Iceland, Brazil, Thailand, Philippines, Peru, Honduras, Mexico, Kenya, Israel, Romania, Russia, Poland, Turkey, Australia, New Zealand, China, Hong Kong, South Africa, India, Korea, Singapore and Taiwan.","Z-1595-2016","Class II","TCM CombiM   Modules 903-111","1488","Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.","05/02/2016",," Part Number: 903-111  Lot Number: Below R0174",11/18/2015,"11/18/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73602,"Ongoing","Mevion Medical Systems, Inc.","300 Foster Street",,"Littleton","MA","01460-2017","United States","Voluntary: Firm Initiated","Letter","US nationwide distribution to MO, OK, FL, and NJ.","Z-1529-2016","Class II","MEVION S250 for Proton Radiation Therapy","5","Possibility of Gantry Motion with Aperture or Compensator only partially inserted.  An Aperture may fall out during Gantry motion.  It is possible that it can hit a patient and cause traumatic injury or death.","04/20/2016",," S250-0002",3/15/2016,"03/15/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73604,"Ongoing","Coloplast Manufacturing US, LLC","1601 W River Rd",,"Minneapolis","MN","55411-3431","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AL, AR, C, FL, IL KY, LA, MD, MA, MI, MN, MO, NJ,NY, NC, OK,OR, PA, TN, TX, VA and WA.","Z-1525-2016","Class II","Self-Cath¿ Pediatric Catheter Size CH 06, Product #  5044101400, Catakig # 306.    Product Usage:  The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain.  ","31,320","Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 catheters  because a small portion of the lot was identified to have missing eyelets. This recall is based upon a  complaint Coloplast received regarding a catheter malfunction.","04/19/2016",," 4464131",3/22/2016,"03/22/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73605,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI","Z-1278-2016","Class II","Cios Alpha, mobile X-ray system","89 systems","Software issues on Cios Alpha mobile C-Arm system","03/31/2016",," Model # 10308191",2/19/2016,"02/19/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73606,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Michigan only","Z-1282-2016","Class II","Artis One, Interventional, Fluoroscopic, x-ray system  Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.","1 angiography system","After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc. ","03/31/2016",," Serial # 82010, material # 10848600",3/11/2016,"03/11/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73607,"Ongoing","Conmed Corporation","310 Broad St",,"Utica","NY","13501-1203","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.","Z-2596-2016","Class II","Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410.    Intended to be used for the dispersion and return to the electrosurgical generator.    ","4,480 units","A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.   ","08/19/2016",," Beginning Lot Code 141001X with Ending Lot Code 20150705X.",5/18/2016,"05/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73607,"Ongoing","Conmed Corporation","310 Broad St",,"Utica","NY","13501-1203","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.","Z-2597-2016","Class II","Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710.    Intended to be used for the dispersion and return to the electrosurgical generator.","6,640 units","A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.   ","08/19/2016",," Beginning Lot Code 141001X with Ending Lot Code 20150705X.",5/18/2016,"05/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73607,"Ongoing","Conmed Corporation","310 Broad St",,"Utica","NY","13501-1203","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.","Z-2599-2016","Class II","Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-383.    Intended to be used for the dispersion and return to the electrosurgical generator.","4,560 units","A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.   ","08/19/2016",," Beginning Lot Code 141001X with Ending Lot Code 20150705X.",5/18/2016,"05/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73607,"Ongoing","Conmed Corporation","310 Broad St",,"Utica","NY","13501-1203","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.","Z-2595-2016","Class II","Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310.    Intended to be used for the dispersion and return to the electrosurgical generator.","307,684 units","A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.   ","08/19/2016",," Beginning Lot Code 141001X with Ending Lot Code 20150705X.",5/18/2016,"05/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73607,"Ongoing","Conmed Corporation","310 Broad St",,"Utica","NY","13501-1203","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.","Z-2598-2016","Class II","Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-382.    Intended to be used for the dispersion and return to the electrosurgical generator. ","124,333 units","A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.   ","08/19/2016",," Beginning Lot Code 141001X with Ending Lot Code 20150705X.",5/18/2016,"05/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73608,"Ongoing","Circulatory Technology Inc","21 Singworth St",,"Oyster Bay","NY","11771-3703","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA","Z-2050-2016","Class II"," ID tubing, ITEM BBB38","72 units","The seal between the balloon and the housing may leak.","06/27/2016",," Lot # 014603  USE BY: 9/2018",3/3/2016,"03/03/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1548-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","33 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch numbers:  B1500308, B1504018, B1500952",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1551-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","6 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch numbers:  B1509884, B1503362",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1542-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","1 unit","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch number C1507672",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1550-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","1 unit","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch number B1505699",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1540-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","1 unit","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch number C1507853",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1537-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","2 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch Number C1507852",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1543-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","6 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch number C1507674",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1547-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","33 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch numbers:  B1512224, B1509601, B1506853, B1501435, B1500308",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1549-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","34 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch numbers:  B1514883, B1509344, B1504926, B1502141, ",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1539-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","3 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch number C1507675",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1546-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","15 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch numbers:  B1506274, B1501722",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1541-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","4 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch number C1507159",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1538-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","6 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch number C1507158",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1544-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","24 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch numbers:  B1508762, B1504644, B1500721",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73609,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","International Distribution only in countries of: Germany and Switzerland.","Z-1545-2016","Class II","TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis","22 units","The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.","04/21/2016",," Batch numbers:  B1510531, B1506602, B1502407",3/11/2016,"03/11/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73610,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of AZ, CA, CO, CT, IL, IN, MD, MI, MN, NY, PA, SC, TN, WA, WI, and VA, and in the NETHERLANDS.","Z-1378-2016","Class II"," Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic Handpiece.","140 units "," Tip, a surgical delay may occur while an alternate Tip Sleeve Assembly is retrieved.","04/13/2016",," 5450-800-311  Lot Number 0545410  5450-800-313  Lot Number 0555170",3/22/2016,"03/22/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73611,"Ongoing","AbbVie Inc.","1 N Waukegan Rd",,"North Chicago","IL","60064-1802","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0833-2016","Class III","Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.","307 bottles","Failed Content Uniformity Specifications","04/21/2016",," Lot #1055586, Exp.1/21/ 2018",3/24/2016,"03/24/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73613,"Ongoing","Elanco Animal","250 Innovation Way",,"Greenfield","IN","46140","United States","Voluntary: Firm Initiated","Letter","US only:  MN, NC, IA, FL, UT, AR, KS, IN, NE, SD, MO, CA, IL, OK, OH, GA, TX, MI","V-527-2016","Class III"," 2.3% Concentrate Solution contains 23 mg florfenicol. Florvio is for use in swine drinking water only.  Rx.  Florvio is packaged in a 4 liter plastic bottle containing 2.17 liters of solution. Florvio are packed 4 bottles per case. Florvio is distributed to distributors by the case.","55,169 4L bottles","analytical test results that fall outside of the Florvio  US stability specifications. This failure may directly impact the performance of the marketed  product.","09/28/2016",," Item code 613117  Lot P811 all batches   Expiration dates 1/2016 thru 5/2016  ",3/23/2016,"03/23/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73614,"Ongoing","AA USA Trading Inc.","47 Reid St",,"South River","NJ","08882-1185","United States","Voluntary: Firm Initiated","Press Release","NY, NJ","F-1321-2016","Class I","AA USA Trading Inc. Ginger Slice   Net Wt: 8 oz., AA USA Trading Inc. 47 Reid St. South River, NJ 08882","Unknown","Ginger slices contain undeclared sulfites. ","05/24/2016",," no codes  distribution July 2014",3/23/2016,"03/23/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73615,"Ongoing","Nestle Infant Nutrition","12 Vreeland Rd Fl 2","PO Box 697","Florham Park","NJ","07932-0697","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI    Foreign: None  VA/DOD: None","F-1093-2016","Class II","GERBER Organic 2ND FOODS Pears, Carrots & Peas, 3.5 oz., film pouches,  6 pouches per display box/ 2 display boxes per case; Asst Ecom PK2 18 pc, 3.94 Lbs.","51945335XX:  7196 cases (86,353 pouches), 51955335XX: 3060 cases (36,840 pouches)","Gerber is voluntarily recalling two batches of GERBER¿ Organic 2ND FOODS¿ Pouches, varieties Pears, Carrots & Peas; and Carrots, Apples & Mangoes because the products produced do not meet quality standards.  The packaging may contain air holes, which could result in product spoilage from mold and yeast growth, as well as an off smell and taste.","04/20/2016",," UPC: 15000074319 GERBER Organic 2ND FOODS¿ Pears, Carrots & Peas  Batch 51945335XX manufactured July 13, 2105 Best By: July 12, 2016   Batch 51955335XX manufactured July 14, 2015 Best By: July 13, 2016   ",3/24/2016,"03/24/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73615,"Ongoing","Nestle Infant Nutrition","12 Vreeland Rd Fl 2","PO Box 697","Florham Park","NJ","07932-0697","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI    Foreign: None  VA/DOD: None","F-1094-2016","Class II","GERBER Organic 2ND FOODS¿ Carrots, Apples & Mangoes, 3.5 oz., film pouches,  6 pouches per display box/ 2 display boxes per case, 9Pc AsstA CbPk 1.96 Lbs; Asst EcomPk1 18 pc, 3.94 Lbs.; 48 Pc 10.48 Lbs.; 4 x 3.5 oz.","51955335XX: 2685 cases (26,592 pouches), 51965335XX:  734 cases (8,808 pouches)","Gerber is voluntarily recalling two batches of GERBER¿ Organic 2ND FOODS¿ Pouches, varieties Pears, Carrots & Peas; and Carrots, Apples & Mangoes because the products produced do not meet quality standards.  The packaging may contain air holes, which could result in product spoilage from mold and yeast growth, as well as an off smell and taste.","04/20/2016",," UPC: 15000074395 GERBER Organic 2ND FOODS¿ Carrots, Apples & Mangoes, Batch 51955335XX manufactured July 14, 2015 Best By: July 13, 2016; Batch 51965335XX manufactured July 15, 2015 Best By: July 14, 2016   ",3/24/2016,"03/24/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73616,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of MD, NY, ID, NC, CO, OH, PA, TN, MS, MO, CA, DE, FL, GA, AZ, NJ, and WV and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, France, India,  Italy, Norway, Portugal, Saudi Arabia, Spain, Sweden, Thailand, and United Kingdom.","Z-1569-2016","Class II","enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code  6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File.  The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.  The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate.  The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage.  The Recapper Module is supplied by Thermo Fisher Scientific.","US: 19, Foreign: 30","The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate.  If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the under carriage of the support plate.","04/26/2016",," US Serial Numbers: JFBX395J, GBX395J, J953252, JJXBQW4J, J3RHC23J, J86PWC5J, J5LQ6Q2J, JFCM073J, J54FC01J, J5J4B45J, J7KSC15J, J4HX7S4J, JGWXQ52J, J953221, JG7BFB5J, JHPKG25J, JCXL941J, J736BM4J, JFXCBG3J; -- Foreign Serial Numbers: J89133 (VAS), JHWJZY4J, J3J4B45J,  J953244, JCT20Q3J, J16XQH4J, GWJVY4J, DWX052J,   J271264, J271368, J271371, J271269, J85206, J953216, DP2LF62, J7023874, J7023847, J7025017, J7024893, J7023645, J7023435,  J57663, J800103, S/N 89VQ762 (VAS), J75863, J75691, J30372, J3055503, J3055496.      ",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73617,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, to the states of AZ, CA, DC, FL, GA, ID, IL IN, KY, MD, MI, MN, MO, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and, to the countries of AUSTRALIA, BELGIUM. BOLIVIA, CANADA, CHILE, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARIA, INDIA, IRELAND, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, NETHERLANDS, NEW ZEALAND, SAUDI ARABIA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.","Z-1562-2016","Class II","GE Healthcare, Aisys and Aisys CS2.    Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).","952 (488 US; 464 OUS)","The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient. ","04/22/2016",," Mfg Lot or Serial #	UDI IDENTIFIER  APWU00723	not applicable  APWU00724	not applicable  APWU01988	010084068210229221APWU0198811150921  APWU01989	010084068210229221APWU0198911150921  APWU01990	010084068210229221APWU0199011150921  APWU01991	010084068210229221APWU0199111150921  APWU01992	010084068210229221APWU0199211150921  APWU01993	010084068210229221APWU0199311150921  APWU01994	010084068210229221APWU0199411150921  APWU01995	010084068210229221APWU0199511150921  APWU01996	010084068210229221APWU0199611150921  APWU01997	010084068210229221APWU0199711150921  APWU00707	not applicable  APWU00708	not applicable  APWU00709	not applicable  APWU00710	not applicable  APWU00711	not applicable  APWU02166	010084068210229221APWU0216611151014  APWU02170	010084068210229221APWU0217011151014  APWU02171	010084068210229221APWU0217111151014  APWU02172	010084068210229221APWU0217211151014  APWU00712	not applicable  APWU00505	not applicable  APWU00506	not applicable  APWU00507	not applicable  APWU00474	not applicable  APWU00475	not applicable  APWU00476	not applicable  APWU00477	not applicable  APWU00478	not applicable  APWU00479	not applicable  APWU01486	not applicable  APWU01487	not applicable  APWU01488	not applicable  APWU01489	not applicable  APWU01490	not applicable  APWU01491	not applicable  APWU01492	not applicable  APWU01493	not applicable  APWU01494	not applicable  APWU01495	not applicable  APWU00611	not applicable  APWU00612	not applicable  APWU00613	not applicable  APWU00614	not applicable  APWU02163	010084068210229221APWU0216311151014  APWU02164	010084068210229221APWU0216411151014  APWU02165	010084068210229221APWU0216511151014  APWU02051	010084068210229221APWU0205111151002  APWU01909	010084068210229221APWU0190911150902  APWU02017	010084068210229221APWU0201711150921  APWU02018	010084068210229221APWU0201811150921  APWU00297	not applicable  APWU01608	not applicable  APWU01609	not applicable  APWU01610	not applicable  APWU01611	not applicable  APWU01612	not applicable  APWU01613	not applicable  APWU01614	not applicable  APWU016",3/15/2016,"03/15/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73618,"Terminated","American Gourmet","1259 Activity Drive, Suite A",,"Vista","CA","92081","United States","Voluntary: Firm Initiated","Telephone","CA: distributed in San Diego, Riverside, and San Bernardino counties","F-1996-2016","Class I","Roasted & Salted Pistachios, size: 2.5 oz, 4 oz, 7.5 oz., UPC 1578600108, 1578600135, 1578600123","27,467 units","American Gourmet is recalling American Gourmet Roasted and Salted Pistachios because they may be contaminated with Salmonella.","08/29/2016","08/29/2016"," Best By: 11.5.2016 through 1.13.2017	",3/18/2016,"03/18/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73619,"Ongoing","Welle Pty Ltd","2a Railway St",,"Cottesloe",,,"Australia","Voluntary: Firm Initiated","E-Mail","U.S. distribution via online sales to the following; CA, TX, MI, PA, NY, MD, FL, GA, MS, MO, NC, IL, OH, CT, WY, MN, KS, IN, VA, OR, NJ, AL, AZ, MA, RI, CO, TN, KY, UT, DE, WA, NH, OK           No foreign distribution.","F-1069-2016","Class I","The Super Elixir  By WelleCo  Australia    Alkalising Greens  150g/5.3 oz net, 300g/10.6 oz net  Fine Powder    welleco.com","1224 (150g) and 6300 (300g) pouches","Welle Pty Ltd is recalling Wellco Super Elixir pouches because of potential Salmonella contamination","04/27/2016",," Lot #0116015",3/8/2016,"03/08/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73620,"Terminated","Community Blood Center Of Gtr KC","4040 Main St",,"Kansas City","MO","64111-2308","United States","Voluntary: Firm Initiated","FAX","Kansas; New York","B-0412-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/08/2016","04/08/2016"," W045015087374",2/17/2016,"02/17/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73620,"Terminated","Community Blood Center Of Gtr KC","4040 Main St",,"Kansas City","MO","64111-2308","United States","Voluntary: Firm Initiated","FAX","Kansas; New York","B-0411-16","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/08/2016","04/08/2016"," W045015087374",2/17/2016,"02/17/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73621,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","1001 N Lincoln Blvd",,"Oklahoma City","OK","73104-3299","United States","Voluntary: Firm Initiated","Other","Switzerland; Oklahoma","B-0405-16","Class II","Blood and Blood Products for Reprocessing","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/08/2016","04/08/2016"," W091014337723; W091014281218",2/2/2016,"02/02/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73621,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","1001 N Lincoln Blvd",,"Oklahoma City","OK","73104-3299","United States","Voluntary: Firm Initiated","Other","Switzerland; Oklahoma","B-0404-16","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/08/2016","04/08/2016"," W091014337723; W091014281218",2/2/2016,"02/02/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73622,"Terminated","Michigan Blood","1036 Fuller Ave NE","PO Box 1704","Grand Rapids","MI","49501-1704","United States","Voluntary: Firm Initiated","FAX","Michigan; Switzerland","B-0407-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","04/08/2016","04/08/2016"," W120615640654",2/3/2016,"02/03/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73622,"Terminated","Michigan Blood","1036 Fuller Ave NE","PO Box 1704","Grand Rapids","MI","49501-1704","United States","Voluntary: Firm Initiated","FAX","Michigan; Switzerland","B-0406-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","04/08/2016","04/08/2016"," W120615640654",2/3/2016,"02/03/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73624,"Terminated","San Diego Blood Bank","3636 Gateway Center Ave Ste 100",,"San Diego","CA","92102-4508","United States","Voluntary: Firm Initiated","Telephone","California","B-0401-16","Class III","Red Blood Cells, Leukocytes Reduced","2 units","RBC's, collected using a Whole Blood Collection Scale for which quality control testing was not performed, were distributed.","04/08/2016","04/08/2016"," W044216507143; W044216507147",1/19/2016,"01/19/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73625,"Ongoing","Farmers Coop Association","101 S Pine St","PO Box 38","Lindsay","NE","68644-6132","United States","Voluntary: Firm Initiated","Telephone","Nebraska.","V-531-2016","Class I","PUR STARTER 2 NO PORCINE, custom started feed manufactured from Purina's Commercial Starter Base 1200, bulk feed.","12,016.53 lbs","Feed was being refused by pigs. Testing later revealed the presence of Rumensin in the feed.","09/29/2016",," Delivery ticket numbers 201199 and 201392",1/14/2016,"01/14/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73626,"Terminated","B. Braun Medical Inc","2525 McGaw Ave",,"Irvine","CA","92614-5841","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0094-2017","Class I","5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32     ","57,408 units","Non-Sterility: fungal contamination due to leaking containers.","10/12/2016","10/12/2016"," Lot #:  J5J706, Exp. 10/31/2016",3/25/2016,"03/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1295-2016","Class II","Cold smoked white fish, vacuum packaged, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","167.1 lbs","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Lot codes are also expiration dates 0418W (exp 04/18/2016), 0425W (exp 04/25/2016), 0430W (exp 04/30/2016)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1296-2016","Class II","Salted Mackerel, vacuum packaged, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","160 pieces","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Unknown",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1298-2016","Class II","Cold smoked sliced Salmon 8 oz and 1 lb, vacuum packaged.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","8 oz - 308 pieces, 1 lb - 72 pieces","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Lot codes are also expiration dates: 8 oz - 0404S (exp 04/04/2016), 0411S (exp 04/11/2016):  1 lb - 0328S (exp 03/28/2016), 0404S (exp 04/04/2016)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1300-2016","Class II","Hot smoked Mackerel, vacuum packaged, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","628 lbs","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Lot codes are also expiration dates: 01118MH (exp 01/18/2016), 0314MH (exp 03/14/2016), 0425MH (exp 04/25/2016)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1305-2016","Class II","Hot smoked Escolar chunks, vacuum packaged, one chunk per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","40 packages","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Lot code is also expiration date: 0217E (exp 02/17/2016)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1299-2016","Class II","Hot smoked Atlantic Ocean Perch, vacuumed package, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","108.1 lbs","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Lot code is also expiration date: 0328PH (exp 03/28/2016)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1304-2016","Class II","Cold smoked Sliced Fish Assorted (cold smoked Salmon and Escolar), 8 oz and 1 lb, vacuum packaged.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","8 oz 0 195 pieces, 1 lb - 118 pieces","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Lot codes are also expiration dates: 0328S (exp 03/28/2016), 0314E (exp 03/14/2016), 0404S (exp 04/04/2016), 0404E (exp 04/04/2016), 0411S (exp 04/11/2016), 0411E (exp 04/11/2016)  (Lots listed are same for both package sizes)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1301-2016","Class II","Sliced cold smoked Escolar, 8 oz and 1 lb, vacuum packaged.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","8 oz - 145 pieces, 1 lb - 72 pieces","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Lot codes are also expiration dates: 8 oz - 0314E (exp 03/14/2016), 0404E (exp 04/04/2016), 0411E (exp 04/11/2016); 1 lb - 0404E (exp 04/04/2016), 0411E (exp 04/11/2016)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1297-2016","Class II","Salted Herring in pail, 30 pieces per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","2,748 pieces","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood , and the salted herring were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products and the salted herring.","05/02/2016",," Lot codes are also expiration dates: 0208H (exp02/08/2016), 0328H (exp 03/28/2016), 0411H (exp 04/11/2016)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1302-2016","Class II","Cold smoked Saira (Saury), vacuum packaged, 3 pieces per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","186.2 lbs","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Lot code is also expiration date: 0328SR (exp 03/28/2016)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73627,"Ongoing","North Fish Usa","2681 S Park Rd",,"Hallandale Beach","FL","33009-3815","United States","Voluntary: Firm Initiated","Telephone","Nationwied to the following states: FL, PA, NY","F-1303-2016","Class II","Cold smoked Mackerel, vacuum packaged, one fish per package.  Manufactured by North Fish USA, Pembroke Pines, FL 33009","1447.1 lbs","The Florida Department of Agriculture and Consumer Services, during the last inspection, found that the hot and cold smoked, vacuum packaged seafood were not produced under an adequate HACCP plan and held in unsanitary conditions.  The Florida Department of Agriculture and Consumer Services requested a recall of all vacuum packaged seafood products. ","05/02/2016",," Lot codes are also expiration dates: 0215M (exp 02/15/2016), 0411M (exp 04/11/2016), 0425M (exp 04/25/2016), 0430M (exp 04/25/2016)",3/16/2016,"03/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73628,"Ongoing","Bravo Packing, Inc","59 N Golfwood Ave",,"Carneys Point","NJ","08069-9710","United States","Voluntary: Firm Initiated","Telephone","LA, FL, and TX","V-0012-2017","Class I",,"11,600 lbs","Horse meat may contain pentobarbital","10/21/2016",," none; distribution date from November 2015 to 1/29/16",3/16/2016,"03/16/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73629,"Ongoing","CMP Industries, Llc","413 N Pearl St",,"Albany","NY","12207-1311","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA","Z-2089-2016","Class II","IMPAK Liquid Acrylic Resin sold under the following labels:  1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314  2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748  3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306  4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450,   5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465  Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base            ","236 pieces (25 pieces/11 oz, 211 pieces/1 Quart)","Possible presence of foreign material (rust). ","06/29/2016",," Lot Number 101113  ",3/2/2016,"03/02/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73630,"Ongoing","Merit Medical Systems, Inc.","1600 West Merit Parkway",,"South Jordan","UT","84095","United States","Voluntary: Firm Initiated","Letter","Distributed to one customer in the US.","Z-1375-2016","Class II","Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o;  Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side. ","25"," Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging.  The curve dimensional values on the labels of this lot incorrectly indicate a 50¿ curve, rather than the correct 86¿ curve","04/12/2016",," Lot Q823423, Exp 7/31/2018",3/15/2016,"03/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73631,"Ongoing","CareFusion 303, Inc.","10020 Pacific Mesa Blvd",,"San Diego","CA","92121-4386","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of:  Australia, Great Britain and Canada.","Z-1606-2016","Class II","Alaris PC unit, Model 8015    The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.","23,397 units","The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.","05/04/2016",," Serial no.  13734283  13734308  13734309  13734310  13734312  13734313  13734337  13734339  13734345  13734351  13734352  13734353  13734354  13734355  13734361  13734364  13734365  13734366  13734367  13734368  13734370  13734374  13734376  13734377  13734379  13734382  13734383  13734408  13734413  13734414  13734415  13734418  13734424  13734427  13734430  13734431  13734432  13734435  13734437  13734440  13734441  13734452  13734453  13734454  13734455  13734456  13734457  13734458  13734459  13734460  13734461  13734462  13734463  13734464  13734465  13734466  13734467  13734468  13734469  13734470  13734474  13734476  13734479  13734486  13734487  13734488  13734489  13734491  13734496  13734498  13734510  13734511  13734512  13734518  13734559  13734560  13734582  13734583  13734584  13734585  13734586  13734589  13734590  13734591  13734595  13734600  13734601  13734607  13734608  13734613  13734614  13734621  13734626  13734627  13734630  13734634  13734635  13734636  13734640  13734645  13734646  13734653  13734659  13734661  13734665  13734668  13734669  13734670  13734671  13734674  13734675  13734676  13734677  13734678  13734680  13734719  13734735  13734738  13734743  13734744  13734745  13734746  13734748  13734752  13734757  13734760  13734765  13734766  13734767  13734768  13734776  13734785  13734786  13734787  13734788  13734789  13734793  13734804  13734809  13734821  13734823  13734828  13734831  13734839  13734847  13734849  13734852  13734855  13734871  13734872  13734873  13734874  13734875  13734876  13734877  13734883  13734884  13734886  13734891  13734892  13734893  13734894  13734904  13734923  13734924  13734931  13734932  13734933  13734934  13734935  13734937  13734938  13734946  13734947  13734948  13734952  13734953  13734954  13734956  13734957  13734958  13734959  13734960  13734961  13734962  13734963  13734964  13734965  13734967  13734968  13734975  13734990  13734997  13735001  13735002  13735003  13735004  13735005  13735012  13735016  13735017  13735020  13735023  13",3/24/2016,"03/24/2016",5/11/2016,"05/11/2016"," 13766172  13766173  13766174  13766175  13766176  13766177  13766178  13766189  13766190  13766191  13766192  13766193  13766194  13766195  13766196  13766197  13766205  13766206  13766209  13766210  13766213  13766215  13766216  13766217  13766221  13766227  13766228  13766229  13766243  13766244  13766245  13766246  13766247  13766248  13766249  13766250  13766251  13766253  13766254  13766255  13766256  13766257  13766260  13766261  13766262  13766263  13766264  13766265  13766266  13766267  13766268  13766270  13766271  13766272  13766273  13766274  13766275  13766276  13766277  13766278  13766279  13766280  13766285  13766286  13766287  13766288  13766289  13766293  13766303  13766312  13766315  13766947  13766958  13766969  13766971  13766984  13766985  13766992  13766996  13767031  13767037  13767038  13767069  13767102  13767103  13767128  13767129  13767145  13767146  13767147  13767167  13767173  13767202  13767204  13767214  13767215  13767226  13767228  13767235  13767236  13767248  13767253  13767265  13767267  13767290  13767319  13767330  13767333  13767342  13767348  13767350  13767351  13767401  13767402  13767450  13767463  13767477  13767478  13767489  13767490  13767491  13767514  13767522  13767523  13767547  13767549  13767550  13767577  13767626  13767627  13767628  13767637  13767668  13767670  13767713  13767723  13767724  13767725  13767730  13767748  13767749  13767753  13767813  13767814  13767815  13767816  13767817  13767896  13767897  13767913  13767914  13767918  13767943  13767944  13767945  13767946  13767947  13767993  13767994  13767995  13767996  13767997  13768058  13768079  13768083  13768115  13768116  13768117  13768129  13768132  13768133  13768134  13768141  13768145  13768148  13768149  13768183  13768184  13768185  13768186  13768215  13768218  13768223  13768224  13768225  13774088  13774090  13774091  13774092  13774131  13774166  13774175  13774178  13774182  13774188  13774194  13774222  13774225  13774242  13774264  13774265  13774271  13774272  13774314  1377","3742915  13742916  13742917  13742925  13742933  13742939  13742945  13742953  13742954  13742955  13742961  13742962  13742972  13742978  13742988  13742989  13742991  13742992  13742994  13743000  13743001  13743008  13743011  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"Food",73632,"Ongoing","Centro Naturista","14211 Coit Rd","Ste H","Dallas","TX","75254-2862","United States","Voluntary: Firm Initiated","Press Release","Nationwide","F-1095-2016","Class II","Smart Lipo Dietary Supplement capsules, 950 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011","Unknown","Multiple dietary supplement regulation violations.","04/21/2016",," All lots",6/3/2015,"06/03/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73633,"Ongoing","Boston Scientific Corporation","2 Scimed Pl",,"Maple Grove","MN","55311-1565","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including DC &  VI except DE, ID, SD, and WY and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Chile, Croatia, Cyprus, Ecuador, France, Germany, Great Britain, Hungary, Italy, Japan, Jordan, Korea, Malaysia, Mauritius, Mexico, Netherlands, Philippines, Portugal, South Africa, Spain, Sweden, Thailand, Trinidad, Tobago, and Uruguay.","Z-1342-2016","Class I","Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001.      Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.","21,155 units","Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.  ","04/18/2016",," BATCH  129496  130473  139577  141089  141570  142212  145520  145783  148859  149263  153368  153847  154650  154786  155675  155908  156690  156822  158009  158494  158598  159368  159902  160530  161209  162814  162893  162943  163987  164148  166281  166646  168472  169484  169638  170169  170464  170471  171178  171385  171800  172254  172375  172518  172831  173151  173398  173897  173902  174153  174431  174617  174619  174721  174722  174727  174728  174804  174805  175189  175190  175782  175783  176048  176221  176385  176437  176438  176843  177414  177415  177970  177971  178252  178253  178254  178764  178848  178849  178894  178935  178936  180305  180306  180367  180368  180370  180747  181168  181169  181285  181933  181934  182257  182258  182259  182927  183220  183221  183451  183452  183539  183540  183974  184091  184092  184093  184244  184245  184478  184479  184531  184532  184633  184634  185180  185182  185354  185355  185395  185396  185397  185632  185633  185958  185959  185960  186145  186146  186147  186148  186149  186150  186151  186152  186153  186154  186326  186338  186498  186553  186554  186555  186556  186557  186558  186559  186732  186733  186765  186766  186767  186768  186769  186839  186876  186877  186938  186939  186940  187157  187158  187238  187239  187778  187779  187811  187812  188206  188207  188208  188758  188759  189082  189230  189231  189232  189233  189234  189235  189236  189237  189238  189239  189240  189241  189242  189243  189244  189245  189273  189274  189374  191401  191402  191403  191404  191405  191406  191407  191408  191409  191802  191803  192256  192257  192355  192356  192466  192467  192468  192469  192470  192471  192483  192484  192485  192486  192777  192778  192779  192780  192784  192785  192786  192914  192915  192916  192917  192918  192919  192921  192922  192923  192925  192926  192927  192928  192929  192930  192931  192932  192933  193146  193147  193148  193149  193150  193151  193152  193153  193154  193155  193156  19315",3/22/2016,"03/22/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73635,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of CA, TN, UT, OK, FL, MI, MN, NY, CT, NC, KS, TX, CO, WA, NM, and OR; and, the countries of Austria, Australia, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany. Great Britain, Italy, Latvia, Netherland, Norway,  Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, India, New Zealand, Thailand, Turkey, and Russian Fed.","Z-1670-2016","Class II","ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575.    For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.  ","7,433 units (4,228 for lot 348297 and 3,199 for lot # 359932)","Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.  ","05/13/2016",," Kit lots 348297 & 359932.",3/7/2016,"03/07/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73636,"Ongoing","HeartWare Inc","14400 NW 60th Ave",,"Miami Lakes","FL","33014-2807","United States","Voluntary: Firm Initiated","Letter","US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.","Z-1887-2016","Class I","HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US)  and 1650, 1650-DE and A00035 (OUS)    Product Usage:  Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.  ","18, 631","Heartware Ventricular Assist System Battery Cell experiencing premature depletion.","07/08/2016",," Serial numbers ranging BAT000001 to BAT199999.",1/7/2016,"01/07/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73637,"Ongoing","Tarry Medical Products, Inc.","22 Shelter Rock Ln Ste 36",,"Danbury","CT","06810-8267","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, GA, IA, MA, NJ, NY,  PA, WI, TX","F-1250-2016","Class II","DandleLION Kisses, 24% Sterile Organic Sucrose In Purified Water, 2 ml polyethylene vial. For oral use  Part Number D 12442  C384","86 cases (33024 vials)","Microbial  contamination","04/28/2016",," Lot: CJB  Exp: Sep 2017",3/16/2016,"03/16/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73638,"Terminated","American National Red Cross, Greater Ozark-Arkansas Region","401 S Monroe St",,"Little Rock","AR","72205-5410","United States","Voluntary: Firm Initiated","Telephone","Texas; California","B-0403-16","Class III","Blood and Blood Products for Reprocessing","4 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/08/2016","04/08/2016"," W205516169533; W205515150141; W205515134546; W205515107990",2/18/2016,"02/18/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73638,"Terminated","American National Red Cross, Greater Ozark-Arkansas Region","401 S Monroe St",,"Little Rock","AR","72205-5410","United States","Voluntary: Firm Initiated","Telephone","Texas; California","B-0402-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/08/2016","04/08/2016"," W205516169533",2/18/2016,"02/18/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73639,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Distributed to: Cincinnati, OH.","Z-1350-2016","Class II","SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.  ","1 CT system","Siemens became aware that the front cover on some Siemens CT system was not properly welded.  It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service.  This could not happen during clinical operation.  Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during ","04/08/2016",," Model Number: SOMATOM Definition AS-8098027  Serial # SOMATOM Definition AS- 95766",3/22/2016,"03/22/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73640,"Ongoing","Olympus Corporation of the Americas","3500 Corporate Pkwy","PO Box 610","Center Valley","PA","18034-0610","United States","Voluntary: Firm Initiated","Letter","Nationwide:","Z-1845-2016","Class II","EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF  used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.",,"New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.  ","05/31/2016",," Models: TJF-160F and TJF-160VF, all serial numbers",3/15/2016,"03/15/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73641,"Ongoing","Ferno-Washington Inc","70 Weil Way",,"Wilmington","OH","45177-9371","United States","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall.  and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR  and AUSTRALIA..","Z-1603-2016","Class II"," sticker.    Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.","153","On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the  traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult  contained a pediatric splint strap and the packaging labeled pediatric  cont","05/04/2016",," Strap Kit Pediatric Model 443  ",3/10/2016,"03/10/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73641,"Ongoing","Ferno-Washington Inc","70 Weil Way",,"Wilmington","OH","45177-9371","United States","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall.  and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR  and AUSTRALIA..","Z-1604-2016","Class II"," sticker.    Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.","270","On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult  contained a pediatric splint strap and the packaging labeled Pediatric  conta","05/04/2016",," Strap Kit Adult Model 444  ",3/10/2016,"03/10/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73642,"Ongoing","Akorn, Inc.","1925 W Field Ct Ste 300",,"Lake Forest","IL","60045-4862","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0835-2016","Class II","Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087,   NDC 46122-199-05,  ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle,  Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.   ","10,060 bottles (Good Neighbor Pharmacy: 6,731 bottles/Premier Value Brand: 3,323 bottles)","Presence of Particulate Matter","05/04/2016",," Good Neighbor Pharmacy Batch Number 4H76A; Exp 07/16  Premier Value Batch Number 4H76B; Exp 07/16",4/7/2016,"04/07/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73643,"Ongoing","OraSure Technologies, Inc.","1745 Eaton Ave",,"Bethlehem","PA","18018-1769","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.","Z-1509-2016","Class III","OraQuick HCV Visual Reference Panel     Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.","244 Visual Reference Panel Kits ","OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.","04/18/2016",," Item Number 1001-0343, Lot # 6648737",1/15/2016,"01/15/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73644,"Completed","Specialty Produce Corporation","481 Dyer Ave",,"Cranston","RI","02920-7036","United States","Voluntary: Firm Initiated","Telephone","RI","F-1310-2016","Class II",,"2 - 30 pound bags","Undeclared sulfites. ","05/03/2016",," N/A",2/16/2016,"02/16/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73646,"Terminated","Trader Joes Company","800 S Shamrock Ave",,"Monrovia","CA","91016-6346","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US","F-0312-2017","Class I","Trader Joe's Chocolate Orange Sticks, Net Wt. 18 oz (1lb 2oz) 510g, 36 units per case, UPC 00847162","8115 cases","Trader Joe's Co. is recalling all codes of Trader Joe's Chocolate Orange Sticks and Trader Joe's Chocolate Raspberry Sticks because the products may contain more than the stated traces of milk on the label.  ","11/04/2016","11/04/2016"," all lot codes",3/25/2016,"03/25/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73646,"Terminated","Trader Joes Company","800 S Shamrock Ave",,"Monrovia","CA","91016-6346","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US","F-0313-2017","Class I","Trader Joe's Chocolate Raspberry Sticks, Net Wt. 18 oz (1lb 2oz) 510g, 36 units per case, UPC 00847122","6181 cases","Trader Joe's Co. is recalling all codes of Trader Joe's Chocolate Orange Sticks and Trader Joe's Chocolate Raspberry Sticks because the products may contain more than the stated traces of milk on the label.  ","11/04/2016","11/04/2016"," all lot codes",3/25/2016,"03/25/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73647,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0836-2016","Class III","Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA,  NDC 0409-6629-02","103,600 vials","Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.","05/04/2016",," Lot 52-045-EV, Exp 07/1/2016",3/15/2016,"03/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73648,"Ongoing","Strong America Limited","239 54th Ave",,"Long Island City","NY","11101-5922","United States","Voluntary: Firm Initiated","FAX","NY","F-1309-2016","Class III","Welltop Fried Dace, Net Weight 184g, Product of China, packed for Hui Zhou Welltop Foods Import and Export Co. Ltd. Importer: Guong Aik Sdn. Bhd No. 13 Long Bridge Road, PO Box 1056, 96008, Sibu, Sarawak, East Malaysia, Importer Strong America Ltd, 2-39 54th Ave., Long Island City, NY","10 cases/48 cans","FDA sampling discovered the presence of leucomalachite green","05/02/2016",," N/A",3/25/2016,"03/25/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73649,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-1376-2016","Class II","da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory.    Product Usage:  The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.","248 - all models","Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large  Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.","04/12/2016",," Model 550675; IS1200/IS2000/IS3000 - User Manual, Instrument & Accessory - all languages.",3/16/2016,"03/16/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73649,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-1377-2016","Class II","da Vinci S Surgical System (IS4000) user manual English and OUS.    Product Usage:  The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.  ","248 - total all models","Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large  Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.","04/12/2016",," Model number 551457- IS4000 English:  Model number 551706 - IS4000 OUS",3/16/2016,"03/16/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73650,"Ongoing","Jas Diagnostics/Drew Scientific","14100 NW 57th Ct",,"Miami Lakes","FL","33014-3107","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -  US Distribution including the states of : AL, AR, CA, FL, GA, IA, IN, KS, KY, LA, MA, MN, MO, MS, NC, NE, NY, SC, TN, and TX.  and to the countries of : Bolivia, Cairo, Columbia, Ecuador, Italy, Moscow, Netherlands, Pakistan, Peru, Slovenia, Spain, and Venezuela.","Z-1576-2016","Class II","Drew Scientific Inc. Drew3-PAC.  This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a  lysing reagent 125 mL.  ","7,691","The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.","04/27/2016",," Lot # 0825, exp 01/06/2018; Lot # 0826, exp 01/06/2018; Lot # 0827, exp 01/06/2018; Lot # 0828, exp 01/21/2018; Lot # 0829, exp 01/21/2018; Lot # 0830, exp 01/21/2018; Lot # 0831, exp 01/21/2018; and Lot # 0832, exp 01/21/2018. ",3/10/2016,"03/10/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73652,"Ongoing","Fresenius Kabi USA, LLC","3 Corporate Dr",,"Lake Zurich","IL","60047-8930","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0818-2016","Class III","Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.","48,210 units","Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.","04/11/2016",," Lot #: 6111080, Exp. 01/2017",4/7/2016,"04/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73653,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0865-2016","Class I","8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02","72,000 units","Presence of Particulate Matter:  particulate matter identified as an insect in one vial.","05/23/2016",," Lot # 56-148-EV, Exp 8/1/2017",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73654,"Ongoing","Smallbatch Pets, Inc.","2452 NE 51st Ave",,"Portland","OR","97213-2520","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, CO, OR, and WA.","V-529-2016","Class I",,"80 cases","One lot of frozen Duckbatch Sliders for dog food is recalled due to contamination with Salmonella and Listeria monocytogenes.","09/28/2016",," Lot C027, Sell By 012717",3/25/2016,"03/25/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73655,"Ongoing","Abbott Laboratories","4551 Great America Pkwy",,"Santa Clara","CA","95054-1208","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including  Puerto Rico and the countries of Austria, Bosnia & Herze, Cameroon, Egypt, Germany, Indonesia, Iraq, Lebanon, Mali, Montenegro, Netherlands, Philippines, Tanzania, Thailand, UAE, New Zealand, Malaysia, Mexico, South Korea, Jamaica, Turks & Caicos, Italy, Canada, Vietnam, Singapore, Argentina, Colombia, France, Paraguay, Australia, Uruguay, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Ethiopia, Finland, Greece, Switzerland, United Kingdom, Brazil, Hong, Kong, Hungary, India, Ireland, Israel, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Turkey, Jamaica, St. Martin, Nigeria, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Guatemala, Peru, and Uruguay.","Z-1522-2016","Class II","CELL-DYN Emerald Cleaner, product number 09H46-02.  960mL.   IVD;    Hematology:  The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.","10,364 ","Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.","04/19/2016",," Lot 6853, Expiration date: 31 JUL2017;  Lot 6901, Expiration date: 31JUL2017;  Lot 6953, Expiration date: 30SEP2017; ",3/24/2016,"03/24/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73656,"Ongoing","The Kroger Co","1014 Vine St",,"Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Oregon and Washington","F-2386-2016","Class I","Fresh Food Market Cranberry Chicken Salad, UPC 207063-4XXXX, various package sizes.  Product sold both from bulk service case and self-service case random weight in deli cups. Product is privately labeled and the address is shown as QFC, 10116 NE 8th, Bellevue, WA 98004.","810 lbs.","Fresh Food Market Cranberry Chicken Salad is recalled because product may be mislabeled and may contain undeclared pecans, wheat, and soy. ","09/22/2016",," Sell by March 28, 2016 and Before",3/25/2016,"03/25/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73657,"Completed","Atlas Spine, Inc.","1555 Jupiter Park Dr Ste 4",,"Jupiter","FL","33458-8085","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution to FL, MO, and WV.","Z-1616-2016","Class II","Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000  Used to rotate implant into position","16","The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. ","05/06/2016",," Lots #:  8887, 000073, 000135, 00434, and 02518.",7/26/2013,"07/26/2013",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73658,"Ongoing","Remel Inc","12076 Santa Fe Trail Dr",".","Lenexa","KS","66215-3519","United States","Voluntary: Firm Initiated","Letter","US distribution in MO.","Z-1921-2016","Class II","Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd.  For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic","2 units were imported and distributed domestically","Individual bottles of product may produce weak beta-lactamase reactions.  Use may result in delayed or false negative reporting. ","06/07/2016",," Lot 1717357 Exp: 31Aug2017",3/24/2016,"03/24/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73660,"Ongoing","Boston Scientific Corporation","100 Boston Scientific Way",,"Marlborough","MA","01752-1234","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, CA,  MA, and TX.","Z-1567-2016","Class II","Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm  Material Number: M00576550     The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths","4 units","Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm","04/25/2016",," Lot Number: 18876596 Exp Date: February 1, 201 8  ",3/18/2016,"03/18/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73661,"Ongoing","MicroAire Surgical Instruments, LLC","3590 Grand Forks Blvd",,"Charlottesville","VA","22911-9006","United States","Voluntary: Firm Initiated","Letter","United States","Z-1834-2016","Class II","Pneumatic Impactor, General Surgery, With Microaire Hose Connector     Professional Use, Medical Industry","20 units","MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.  ","05/27/2016",," 2500-100 Ser#s 1547,1546,1545,1544, 1543,1542, 1541,1540,1539,1538,1537,1536,1535,1534,1533,1532    2500-200 Ser#s 1464,1463,1462,1461  ",3/11/2016,"03/11/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1105-2016","Class II","All T3 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1096-2016","Class II","All Jack Newman Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1106-2016","Class II","All mirtazapine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1128-2016","Class II","All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1112-2016","Class II","All Coal Tar Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1113-2016","Class II","All phenylephrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1068-2016","Class I","CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1130-2016","Class II","All Nitro Paste (nitroglycerin) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1087-2016","Class II","All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry. ",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1102-2016","Class II","All triamcinolone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1067-2016","Class II","All 4-aminopyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1123-2016","Class II","All doxycycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1101-2016","Class II","All melatonin Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1126-2016","Class II","All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1092-2016","Class II","All minocycline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1124-2016","Class II","All dyclonine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1074-2016","Class II","All carbomer Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1069-2016","Class II","All testosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1080-2016","Class II","All propylparaben Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1118-2016","Class II","All diltiazem Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1103-2016","Class II","All lidocaine, meloxicam, diclofenac and baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1111-2016","Class II","All retinoic acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1089-2016","Class II","All quinine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1093-2016","Class II","All lidocaine/tetracaine/benzocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1117-2016","Class II","All cocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1104-2016","Class II","All thyroid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1134-2016","Class II","All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1071-2016","Class II","All TRIE Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1097-2016","Class II","All hydrocortisone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1075-2016","Class II","All monobenzone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1119-2016","Class II","All hydroxyurea Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1076-2016","Class II","All betamethasone diproprionate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1099-2016","Class II","All naltrexone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1122-2016","Class II","All sucralfate Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1070-2016","Class II","All estriol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1125-2016","Class II","All estradiol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1079-2016","Class II","All methimazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1083-2016","Class II","All thymol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1108-2016","Class II","All squaric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1098-2016","Class II","All spironolactone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1109-2016","Class II","All sulfapyridine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1082-2016","Class II","All PCCA Lipoderm Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1114-2016","Class II","All Arimidex (anastrozole) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1078-2016","Class II","All fluocinonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1131-2016","Class II","All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.. ",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1121-2016","Class II","All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry. ",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1116-2016","Class II","All capsicum Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1088-2016","Class II","All hydroxyzine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1136-2016","Class II","All Malarone (atovaquone and proguanil) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.. ",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1086-2016","Class II","All cetirizine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1127-2016","Class II","All methyltestosterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1135-2016","Class II","All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1132-2016","Class II","All e2-e3-p4 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1081-2016","Class II","All tetracaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1100-2016","Class II","All nifedipine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1110-2016","Class II","All Midrin (isometheptene mucate, dichloralphenazone and acetaminophen) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1091-2016","Class II","All fluoxymesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry. ",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1077-2016","Class II","All Germall (diazolidinyl urea and iodopropynyl butylcarbamate) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1084-2016","Class II","All T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1120-2016","Class II","All acyclovir and lidocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1090-2016","Class II","All citalopram Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry. ",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1085-2016","Class II","All arginine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1095-2016","Class II","All Stanford Magic Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.. ",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1107-2016","Class II","All ketoprofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1133-2016","Class II","All diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1129-2016","Class II","All hydroquinone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1094-2016","Class II","All boric acid Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1115-2016","Class II","All quinacrine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1072-2016","Class II","All Peterson Cream Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73662,"Ongoing","Reliable Rexall-A Compounding Pharmacy","801 Irving St",,"San Francisco","CA","94122-2310","United States","Voluntary: Firm Initiated","Press Release","U.S. Including: CA, HI, NM","D-1073-2016","Class II","All progesterone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.",,"Lack of Processing Controls","07/06/2016","."," All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..",3/25/2016,"03/25/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",73663,"Ongoing","Minko Inc","4707 95th St N",,"St Petersburg","FL","33708-3723","United States","Voluntary: Firm Initiated","Letter","FL","F-2136-2016","Class II","Blacker brand liner tattoo ink","Unknown","FDA Sample of Blacker brand liner tattoo ink was positive for contamination with Norcadia spp.","09/13/2016",," Unknown",2/20/2014,"02/20/2014",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73664,"Ongoing","Medscience Inc","16469 Bridlewood Cir",,"Delray Beach","FL","33445-6679","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.","Z-1843-2016","Class II","AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests.  Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine","11,400 (Item 1000) & 380 (Item 1001)","During an FDA inspection it was found that the products are marketed without a cleared 510k.","05/31/2016",," All lots",3/22/2016,"03/22/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73665,"Ongoing","Philips Ultrasound, Inc.","22100 Bothell Everett Hwy",,"Bothell","WA","98021-8431","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Washington, D.C., and countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mayotte, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿¿union, Romania, Russia , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam.","Z-1380-2016","Class II","EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W.    Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal. ","11,085 units total (4909 units in the US and 6176 units outside the US)","The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system.","04/13/2016",," All Serial numbers",3/28/2016,"03/28/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73666,"Ongoing","Mondelez Puerto Rico","Montehiedra Office Center",,"San Juan","PR","00926","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only.","F-1512-2016","Class II","    ","9,329 cases (total)","The Clight brand products in flavors Orange, Lemon, Tangerine, and Lemon Tea contain a small amount of soy lecithin but are not labeled to declare soy lecithin in the ingredient list and do not otherwise disclose soy as an ingredient.","06/14/2016",," TBD",3/17/2016,"03/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73666,"Ongoing","Mondelez Puerto Rico","Montehiedra Office Center",,"San Juan","PR","00926","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only.","F-1510-2016","Class II","    ","9,239 cases (total)","The Clight brand products in flavors Orange, Lemon, Tangerine, and Lemon Tea contain a small amount of soy lecithin but are not labeled to declare soy lecithin in the ingredient list and do not otherwise disclose soy as an ingredient.","06/14/2016",," TBD",3/17/2016,"03/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73666,"Ongoing","Mondelez Puerto Rico","Montehiedra Office Center",,"San Juan","PR","00926","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only.","F-1513-2016","Class II","    ","9,239 cases (total)","The Clight brand products in flavors Orange, Lemon, Tangerine, and Lemon Tea contain a small amount of soy lecithin but are not labeled to declare soy lecithin in the ingredient list and do not otherwise disclose soy as an ingredient.","06/14/2016",," TBD",3/17/2016,"03/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73666,"Ongoing","Mondelez Puerto Rico","Montehiedra Office Center",,"San Juan","PR","00926","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only.","F-1511-2016","Class II","    ","9,239 cases (total)","The Clight brand products in flavors Orange, Lemon, Tangerine, and Lemon Tea contain a small amount of soy lecithin but are not labeled to declare soy lecithin in the ingredient list and do not otherwise disclose soy as an ingredient.","06/14/2016",," TBD",3/17/2016,"03/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1653-2016","Class II"," Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: Direct HDL Cholesterol: D126055; Catalog # 74073",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1662-2016","Class II","Dimension Assays: Uric Acid (URCA)","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: D011436 Uric Acid (URCA), Catalog # DF77",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1659-2016","Class II","Dimension Assays: Direct HDL Cholesterol (AHDL)","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: D 044702 - Direct HDL Cholesterol (AHDL), Catalog # DF48B",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1665-2016","Class II","Dimension Vista Assays: Triglycerides (TRIG)","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: D011436 - Triglycerides (TGL),  Catalog # DF69A",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1654-2016","Class II","ADVIA CHEMISTRY ENZYMATIC CREATININE_2","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: Enzymatic Creatinine_2 D033075; Catalog # 74330",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1661-2016","Class II","Dimension Assays: Triglycerides (TGL)","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: D011286 Triglycerides (TGL), Catalog # DF69A",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1666-2016","Class II","Dimension Vista Assays: Uric Acid (URCA)","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: D011436 - Uric Acid (URCA),  Catalog # K1077",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1655-2016","Class II","ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: Glucose Oxidase (GLUO) D11793, Catalog # 74020 & Concentrated Glucose Oxidase (GLUO_c) D117943, Catalog # 74721",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1652-2016","Class II","Advia Chemistry Assay: LDL Cholesterol, Direct ","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: LDL Cholesterol, Direct: D126056; Catalog # 74028",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1664-2016","Class II","Dimension Vista  Assays: Enzymatic Creatine (ECRE)","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: D089144 Enzymatic Creatinine (ECRE),  Catalog # K1270A",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1658-2016","Class II","Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: Uric Acid (UA) - D033081, Catalog # 74021 and Uric Acid, concentrated  (UA_c) - D033081, Catalog # 74715",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1660-2016","Class II","Dimension Assays: ENZYMATIC CREATININE ","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: D089144(Enzymatic Creatine (ECRE) Catalog # DF270B",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1657-2016","Class II","ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: D126071, Triglyceride_2, Catalog # 74082  Device Listing: D211156, Triglyceride Concentrated, Catalog # 74084",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1663-2016","Class II","Dimension Vista  Assays: Direct HDL Cholesterol (AHDL)","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Device Listing: D056475 Direct HDL Cholesterol (TRIG) Catalog # K3048A",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1651-2016","Class II","Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Cholesterol_2 (CHOL2): 74719  Cholesterol_concentrated (CHOL_c): 74718",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73667,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated",,"Nationwide: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, St. Thomas, VI, Guam, Pacific Mariana Islands","Z-1656-2016","Class II","Advia Chemistry Assay: Lactate","137422 units total","Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays.  Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole.  NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific","05/11/2016",," Lactate: E103611, Catalog # (LAC) 74051",3/17/2016,"03/17/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73668,"Ongoing","Fujifilm Medical Systems U.S.A., Inc.","419 West Ave",,"Stamford","CT","06902-6343","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1599-2016","Class II","Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU","2,062 devices","Reports of failure of the device's power supply. ","05/03/2016",," All serial numbers. ",4/1/2016,"04/01/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73669,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.","Z-1649-2016","Class II","Covidien Kangaroo Connect Enteral Feeding Pump  Item Number: 584400 (OUS)    Intended to provide enteral nutrition to a patient for hospital and acute care settings.","145 units","Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm ","05/10/2016",," Serial Numbers:  AS1400000006  AS1400000007  AS1400000008  AS1400000010  AS1400000011  AS1400000012  AS1400000013  AS1400000014  AS1400000015  AS1400000016  AS1400000017  AS1400000020  AS1400000022  AS1400000023  AS1400000024  AS1400000025  AS1400000026  AS1400000027  AS1400000028  AS1400000029  AS1400000031  AS1400000032  AS1400000033  AS1400000034  AS1400000035  AS1400000036  AS1400000037  AS1400000038  AS1400000039  AS1400000040  AS1400000041  AS1400000042  AS1400000043  AS1400000045  AS1400000046  AS1400000047  AS1400000049  AS1400000050  AS1400000051  AS1400000052  AS1400000054  AS1400000055  AS1400000057  AS1400000058  AS1400000059  AS1400000060  AS1400000061  AS1400000062  AS1400000063  AS1400000064  AS1400000065  AS1400000066  AS1400000067  AS1400000068  AS1400000069  AS1400000070  AS1400000072  AS1400000077  AS1400000078  AS1400000079  AS1400000080  AS1400000081  AS1400000082  AS1400000083  AS1400000089  AS1400000091  AS1400000092  AS1400000101  AS1400000103  AS1400000104  AS1400000105  AS1400000107  AS1400000108  AS1400000112  AS1400000113  AS1400000115  AS1400000116  AS1400000117  AS1400000118  AS1400000119  AS1400000120  AS1400000121  AS1400000122  AS1400000124  AS1400000126  AS1400000127  AS1400000128  AS1400000130  AS1400000131  AS1400000132  AS1400000133  AS1400000136  AS1400000139  AS1400000140  AS1400000141  AS1400000142  AS1400000143  AS1400000144  AS1400000145  AS1400000146  AS1400000148  AS1400000149  AS1400000150  AS1400000151  AS1400000152  AS1400000155  AS1400000157  AS1400000158  AS1400000160  AS1400000161  AS1400000163  AS1400000165  AS1400000166  AS1400000169  AS1400000170  AS1400000171  AS1400000173  AS1400000174  AS1400000178  AS1400000179  AS1400000180  AS1400000181  AS1400000184  AS1400000189  AS1400000190  AS1500000277  AS1500000376  AS1500000412  AS1500000416  AS1500000420  AS1500000444  AS1500000457  AS1500000479  AS1500000504  AS1500000515  AS1500000522  AS1500000526  AS1500000531  AS1500000555  AS1500000563  AS1500000711  AS1500000721  AS1500000728  AS1500000730  AS150000073",4/1/2016,"04/01/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73669,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.","Z-1648-2016","Class II","Covidien Kangaroo Connect Enteral Feeding Pump  Item Number: 384400 (US)    Intended to provide enteral nutrition to a patient for hospital and acute care settings.","223 units","Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm ","05/10/2016",," Serial Numbers:  AS1500000614  AS1500000615  AS1500000620  AS1500000621  AS1500000628  AS1500000630  AS1500000631  AS1500000633  AS1500000637  AS1500000638  AS1500000639  AS1500000640  AS1500000641  AS1500000643  AS1500000680  AS1500000681  AS1500000683  AS1500000685  AS1500000686  AS1500000687  AS1500000694  AS1500000695  AS1500000696  AS1500000697  AS1500000698  AS1500000699  AS1500000702  AS1500000703  AS1500000814  AS1500000820  AS1500000823  AS1500000824  AS1500000826  AS1500000827  AS1500000828  AS1500000830  AS1500000831  AS1500000833  AS1500000836  AS1500000837  AS1500000839  AS1500000842  AS1500000843  AS1500000845  AS1500000847  AS1500000849  AS1500000850  AS1500000852  AS1500000854  AS1500000856  AS1500000857  AS1500000858  AS1500000859  AS1500000860  AS1500000861  AS1500000862  AS1500000863  AS1500000866  AS1500000869  AS1500000872  AS1500000873  AS1500000874  AS1500000875  AS1500000876  AS1500000880  AS1500000883  AS1500000885  AS1500000887  AS1500000889  AS1500000891  AS1500000892  AS1500000894  AS1500000895  AS1500000896  AS1500000897  AS1500000898  AS1500000901  AS1500000902  AS1500000903  AS1500000904  AS1500000906  AS1500000907  AS1500000909  AS1500000911  AS1500000912  AS1500000913  AS1500000915  AS1500000916  AS1500000917  AS1500000921  AS1500000922  AS1500000923  AS1500000924  AS1500000925  AS1500000926  AS1500000927  AS1500000928  AS1500000929  AS1500000930  AS1500000932  AS1500000933  AS1500000934  AS1500000935  AS1500000936  AS1500000941  AS1500000942  AS1500000947  AS1500000948  AS1500000951  AS1500000952  AS1500000955  AS1500000970  AS1500000974  AS1500000975  AS1500000976  AS1500000977  AS1500000978  AS1500000979  AS1500000981  AS1500000996  AS1500000998  AS1500001002  AS1500001009  AS1500001044  AS1500001045  AS1500001058  AS1500001061  AS1500001069  AS1500001075  AS1500001084  AS1500001125  AS1500001134  AS1500001137  AS1500001145  AS1500001146  AS1500001148  AS1500001149  AS1500001151  AS1500001158  AS1500001163  AS1500001166  AS1500001171  AS1500001172  AS1500001175  AS150000117",4/1/2016,"04/01/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73670,"Ongoing","Ouhlala Gourmet Llc","2655 S Le Jeune Rd Ste 1011",,"Coral Gables","FL","33134-5803","United States","Voluntary: Firm Initiated","Letter","Product distributed nationwide an internationally to the following countries: Egypt, Bermuda, and United Arab Emirates","F-1419-2016","Class II","Fruit Tartlets, lemon flavor, 9 - 0.53oz (15 g) tartlets - Net Wt. 4.8 oz (135 g).  Manufactured in France.  Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL ","9,159 12-ct cases","Products contain undeclared milk on finished product labeling","06/02/2016",," Lot Code (Exp date): 08192016 (08192016), 09292016 (09292016), 10092015 (10092015), 10302016 (10302016), 10312016 (10312016), 111216 (111216), 10012016 (10012016), 09292016 (09292016), 10312016 (10312016).  Item GTIN #00810387020566. Case UPC #20854417002430.  ",1/20/2016,"01/20/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73670,"Ongoing","Ouhlala Gourmet Llc","2655 S Le Jeune Rd Ste 1011",,"Coral Gables","FL","33134-5803","United States","Voluntary: Firm Initiated","Letter","Product distributed nationwide an internationally to the following countries: Egypt, Bermuda, and United Arab Emirates","F-1420-2016","Class II","Fruit Tartlets, Raspberry flavor, 9 - 0.56oz (16 g) tartlets - Net Wt. 5.1oz (145 g).  Manufactured in France.  Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL ","8,651 12-ct cases","Products contain undeclared milk on finished product labeling","06/02/2016",," Lot Code (Exp date): 08212016 (08212016), 100116 (100116), 100122016 (100122016), 100216 (100216), 10302016 (10302016), 111316 (111316).  ",1/20/2016,"01/20/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73671,"Ongoing","Mylan Pharmaceuticals Inc.","781 Chestnut Ridge Rd",,"Morgantown","WV","26505-2730","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0840-2016","Class II","Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93    ","2928 bottles ","Failed Dissolution Specifications; three month stability time point.    ","05/06/2016",," Lot: 2005441, 01/2017, Code: 0378-3978-93    ",2/12/2016,"02/12/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73672,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including Puerto Rico.","Z-1284-2016","Class II","AXIOM Artis zee/zeego, system, x-ray, angiographic    Product Usage:  AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.","986 systems in total","Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet.  Loss of coolant can result in a cooling system failure and subsequent system failure.  This leak can occur sporadically in affected systems.","03/31/2016",," Serial Numbers:   Artis Q Ceiling      109033, 109135, 109141, 109123, 109080, 109074, 109119, 109016, 109118, 109155, 109067, 109066, 109068, 109134, 109133, 109084, 109011, 109096, 109159, 109130, 109143, 109102, 109015, 109144, 109009, 109057, 109108, 109103, 109038, 109040, 109034, 109129, 109137, 109029, 109136, 109064, 109132, 109058, 109145, 109050, 109076, 109007, 109072, 109075, 109071, 109091, 109090, 109041, 109039, 109060, 109146, 109088, 109092, 109032, 109021, 109048, 109020, 109036, 109043, 109161, 109101, 109105, 109104, 109107, 109047, 109031, 109028, 109027, 109120, 109010, 109093, 109157, 109156, 109069, 109158, 109044  ",2/18/2016,"02/18/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73672,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including Puerto Rico.","Z-1283-2016","Class II","AXIOM Artis zee/zeego, system, x-ray, angiographic    Product Usage:  AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.  ","986 systems in total","Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet.  Loss of coolant can result in a cooling system failure and subsequent system failure.  This leak can occur sporadically in affected systems.","03/31/2016",," Serial Numbers:   Artis Q biplane Serial #   121061, 121089, 121094, 121006, 121013, 121040, 121062, 121082, 121011, 121039, 121134, 121053, 121054, 121014, 121112, 121051, 121004, 121133, 121018, 121036, 121137, 121012, 121049, 121078, 121019, 121010, 121139, 121081, 121096, 121015, 121115, 121016, 121138, 121020, 121140, 121106, 121120, 121122, 121121, 121109, 121144, 121047, 121088, 121027, 121136, 121141, 121069, 121009, 121057, 121056, 121034, 121008, 121058, 121085, 121071, 121023, 121079, 121041, 121037, 121046, 121072  ",2/18/2016,"02/18/2016",4/6/2016,"04/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73673,"Ongoing","Philips Visicu","217 E Redwood St Ste 1900",,"Baltimore","MD","21202-3315","United States","Voluntary: Firm Initiated","Letter","US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.","Z-1557-2016","Class II","eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure).    For medical use by professional medical staff.","9","The adherence check generates a software error.  Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later.   An error message is generated and forwarded to operations.   Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement.    If the pa","04/22/2016",," 453564506091 eCareCoordinator 1.3",3/10/2016,"03/10/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73674,"Ongoing","Stryker Endoscopy","5900 Optical Ct",,"San Jose","CA","95138-1400","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan,  Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala.","Z-1566-2016","Class II","PneumoSure XL High Flow Insufflator and  PneumoSure High Flow Insufflator;  High pressure units  (HPU) (40L and 45L).    Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684    The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.","489","When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.","04/25/2016",," HPUs affected lot numbers 0005051337-000505052795;  PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581",3/28/2016,"03/28/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73675,"Ongoing","English Bay Batter Inc (Toronto) US Division","2241 Citygate Dr",,"Columbus","OH","43219-3564","United States","Voluntary: Firm Initiated","Telephone","Product was shipped to New York only and then redistributed by the consignee to Connecticut, Massachusetts, Pennsylvania, Vermont, New Hampshire. No government accounts, no Canadian or Mexican accounts and no other foreign accounts.","F-1968-2016","Class II","CINNAMON ROLLS WITH CREAM CHEESE ICING Quality & Value pics BY PRICE CHOPPER NET WT 12.4 OZ (351g) INGREDIENTS: ***CREAM CHEESE (PASTEURIZED MILK AND CREAM, CHEESE CULTURES***. CONTAINS WHEAT. MAY CONTAIN MILK, EGGS, SOY, PEANUTS AND TREE NUTS. DISTRIBUTED BY: PRICE CHOPPER, INC. SCHENECTADY, NY 12306 UPC 0 41735 07338 9.","414 cs/12/12.4 oz canisters",,"08/22/2016",," Best by: June 07,2016, June 20, 2016, and June  28, 2016",3/29/2016,"03/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73676,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, LA, MD, MA, MI, MS, MO. MT, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WV, Puerto Rico, Belgium, Canada, Chile, Dominican Republic & Germany","Z-1582-2016","Class II","Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical.    Product Usage:  Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use  ","12,124 ea.","The label on the Tyvek bag is missing.  This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box. ","04/27/2016",," Product Code A-1500-08LF - Lot/Batch Numbers: 74J1501715, 74K1501006, 74L1500163; Product Code A-430-08LF - Lot/Batch Numbers: 74K1500975, 74K1502313, 74L1500164, 74L1500165; Product Code A-6000-08LF - Lot/Batch Numbers: 74K1500364, 74K1500365, 74K1500367, 74K1500907, 74K1500908, 74K1501007, 74K1501008, 74K1501010, 74K1501014, 74K1502274, 74L1502302, 74L1502304; Product Code A-6002-08LF - Lot/Batch Numbers: 74K1500391, 74K1500909, 74K1500910, 74K1503003, 74L1500179; Product Code A-6020-08LF - Lot/Batch Number: 74L1500180; Product Code A-7000-08LF - Lot/Batch Numbers: 74K1500372, 74K1500913, 74K1501021, 74K1502277; Product Code A-8000-08LF - Lot/Batch Numbers: 74K1500369, 74K1500915, 74K1501025, 74K1501026, 74K1501028, 74K1502263, 74K1502264, 74L1500190; Product Code A-8002-08LF - Lot/Batch Numbers: 74K1500376, 74K1501032; Product Code S-0500 - Lot/Batch Number: 74K1500379; Product Code S-100-08LF - Lot/Batch Number: 74K1501039; Product Code S-1100-08LF - Lot/Batch Numbers: 74K1500381, 74K1501041, 74K1502267, 74L1500208, 74L1500209, 74L1500210; Product Code S-1102-08LF - Lot/Batch Numbers: 74K1500382, 74K1500383; Product Code S-1103-08LF - Lot/Batch Number: 74K1500922; Product Code S-1150-08LF - Lot/Batch Number: 74J1501725; Product Code S-1200-08LF - Lot/Batch Numbers: 74K1500385, 74K1501043    ",3/30/2016,"03/30/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73677,"Ongoing","Hansen Medical Inc","800 E Middlefield Rd",,"Mountain View","CA","94043-4030","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OH, TX. FL, CA and GA.","Z-1564-2016","Class II","Magellan Robotic Catheter Accessory Kits,  Model number MACC 50 and MACC80.    Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.  ","8 kits","Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.","04/25/2016",," Lot number 20151117",3/25/2016,"03/25/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73678,"Ongoing","Valeant Pharmacueticals International","400 Somerset Corporate Blvd",,"Bridgewater","NJ","08807-2867","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1699-2016","Class II","Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02.   Manufactured for Onpharma Inc. Los Gratos, CA 95030    The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.","7,716","It has been determined that the Onset Mixing Pen has an optimal use period of 18 months from start of use.  However, the current labeling and IFU does not stipulate this time period.  ","05/19/2016",," Dosing Mechanism Lot Entry  14090  14452  17133  18004  18403  18583  18757  ",1/29/2016,"01/29/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73679,"Ongoing","Impax Laboratories, Inc.","215 Wood Ave",,"Middlesex","NJ","08846-2554","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0826-2016","Class II","Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10","18,936 bottles","Failed Impurities/Degradation Specifications","04/21/2016",," Lot #: 112565, Exp 03/17; 113458, Exp 08/17     ",3/14/2016,"03/14/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73679,"Ongoing","Impax Laboratories, Inc.","215 Wood Ave",,"Middlesex","NJ","08846-2554","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0825-2016","Class II","Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10","67,428 bottles","Failed Impurities/Degradation Specifications","04/21/2016",," Lot # 112579, 112580, Exp 03/17; 111013A, Exp 04/16; 111014, Exp 05/16; 113292, 113332, 113386, 113387, Exp 07/17; 111671,111673, Exp 09/16; 113806, 113807, Exp 10/17; 111874, 111875, 111876, Exp 11/16          ",3/14/2016,"03/14/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73680,"Ongoing","Roche Molecular Systems, Inc.","1080 US Highway 202 S",,"Branchburg","NJ","08876-3733","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1578-2016","Class II","Hand-Held Scanner USB IT3800  For sample identification and tracking when used with various systems","6,939 pieces","The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.","04/27/2016",," Material Number - IVD: 5401062001",3/3/2016,"03/03/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73681,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago","D-0854-2016","Class III","Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5. ","715,200 vials ","Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.","05/16/2016",," Lot #: 42-335-DK, Exp 1JUN2016; 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, Exp 1DEC2016; 52-361-DK, Exp 1APR2017; note that the lot number may be followed by numbers from 01 to 99.",3/23/2016,"03/23/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1264-2016","Class II","Bliss Moose Tracks Ice Cream 64oz    Product Code: 51049","36 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6053  ",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1269-2016","Class II","Cresent Ridge Choc Chip Cookie Dough 48oz  Product Code:  35418","5 units","Product failed to meet air space specifications","04/28/2016",," Date Code: 6068",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1282-2016","Class II","Newport Creamery Butter Crunch Ice Cream,  3Gal  Product Code:  35108","8 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6022",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1276-2016","Class II","Emack & Bolios Grasshopper Ice Cream 3gal  Product Code:  36272","240 units","Product failed to meet air space specifications","04/28/2016",," Date Code: 6022",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1271-2016","Class II","Cresent Ridge Oreo Cookie Ice Cream  48oz  Product Code: 35424",,"Product failed to meet air space specifications","04/28/2016",," Date Code: 6068",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1268-2016","Class II","Cresent Ridge Coffee Ice Cream 3 gallon   Product Code:    36102              ","8 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6068",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1267-2016","Class II","Cresent Ridge Vanilla Ice Cream  48oz  Product Code:   35410                 ","2 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6068",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1273-2016","Class II","Emack & Bolios Serious Choc Addiction Ice Cream 3gal  Product Code: 36271","181 units","Product failed to meet air space specifications","04/28/2016",," Date Code: 6021",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1281-2016","Class II","Emack & Bolios Space Cake Ice Cream, 3gal  Product Code:  36273","150 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6027",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1265-2016","Class II","Bliss Mix 5% Yog 5gal FRESH  Product Code: 79801","40 cases","Product failed to meet air space specifications","04/28/2016",," Day Code :6069  ",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1266-2016","Class II","Cresent Ridge ChocChp CookiDgh WRAP Ice Cream 48oz  Product Code:  35403                            ","1 unit","Product failed to meet air space specifications","04/28/2016",," Date Code: 6068  ",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1263-2016","Class II","Bliss Toffee Crunch Ice Cream 64oz  Product Code:51065","1 case","Product failed to meet air space specifications","04/28/2016",," Date Code: 6014",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1277-2016","Class II","Emack & Bolios Stoney's Dream Ice Cream, 3gal  Product Code:  36276","50 units","Product failed to meet air space specifications","04/28/2016",," Date Code: 6026",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1274-2016","Class II","Emack & Bolios Mud Pie Ice Cream, 3gal  Product Code: 36269",,"Product failed to meet air space specifications","04/28/2016",," Date Code: 6022",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1278-2016","Class II","Emack & Bolios Oreo  Ice Cream ,3gal  Product Code:  36265","472 units","Product failed to meet air space specifications","04/28/2016",," Date Code: 6026",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1270-2016","Class II","Cresent Ridge Vanilla  Ice Cream 3gal  Product Code:  36100","4 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6068",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1275-2016","Class II","Emack & Bolios Caramel Moose Prints Ice Cream, 3gal  Product Code: 36285","150 units","Product failed to meet air space specifications","04/28/2016",," Date Code: 6022",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1279-2016","Class II","Emack & Bolios Pistachio Ice Cream, 3gal  Product Code:  36262","50 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6027",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1272-2016","Class II","Emack & Bolios  Moose  Ice Cream 3gal  Product Code: 36257  ","90 units","Product failed to meet air space specifications","04/28/2016",," Date Code: 6021",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1283-2016","Class II","Newport Creamery Coffee Ice Cream,  3Gal  Product Code:  35104","20 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6048",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1280-2016","Class II","Emack & Bolios Cake Batter Ice Cream, 3gal  Product Code: 36266","40 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6027",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73682,"Ongoing","Bliss Bros Dairy, Inc.","711 Park St",,"Attleboro","MA","02703-3211","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China","F-1262-2016","Class II","Bliss French Vanilla Ice Cream 64oz  Product Code: 51051  ","42 cases","Product failed to meet air space specifications","04/28/2016",," Date Code: 6014  ",3/17/2016,"03/17/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73683,"Ongoing","Bryant Ranch Prepack Inc.","1919 N Victory Pl",,"Burbank","CA","91504-3425","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0837-2016","Class III","Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only,  Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.    ","21 bottles (910 extended release tablets)","Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation. ","05/04/2016",," Lot # 94983; Exp 10/17",3/25/2016,"03/25/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73684,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI","Z-1867-2016","Class II","Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments","2,487 Instruments","Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.","05/31/2016",," Catalogue No: CEV669E.     All batch numbers distributed from January 2011 to February 17, 2016.",3/7/2016,"03/07/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73684,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI","Z-1866-2016","Class II","Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments","30,146 Instruments","Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.","05/31/2016",," Catalogue No's:    CEV649B5, CEV649BGP, CEV649GP, CEV8649B5, CEV8649BGP, CEV646B5, CEV647B5, CEV648B5, CEV649-5B,  CEV649-5N, CEV8646B5, CEV8647B5, CEV8648B5, CEV1019-5B, CEV10195C, CEV10195D, CEV1019-5N, CEV10195NA, CEV10195R, CEV1039-5-B, CEV10395D, CEV1039-5N, CEV3911, CEV3931, CEV3941, CEV3951, CEV3961, CEV3981, CEV3991, CEV8991, CEV104M, CEV114M, CEV211, CEV220, CEV391B, CEV394B, CEV395B, CEV399B, CEV899, CEV405, CEV406, CEV407, CEV460, CEV470, CEV470-1, CEV511M, CEV514M, CEV515M, MCLP20, MCLP25, MCLP30, MCLP40, CEV8649GP, DEV9649B5, CEV9649BGP, CEV9649GP, CEV8649-5-B, CEV8649-5N, CEV9646B5, CEV9647B5, CEV9648B5, CEV9649-5-B, CEV9649-5N, CEV10395R, CEV1039G5, CEV618-5N, CEV6185R, CEV638-5N, CEV6385R, CEV720BR, CEV720R, CEV7285R, CEV605-5, CEV8911, CEV8931, CEV8941, CEV8951, CEV8961, CEV8981, CEV520M, CEV525M, CEV531-3, CEV815M, CEV891M, CEV894M, CEV895M, CEV995M, CEV996M, CEV997M, CEV998M, CM107, CM110, CM111, CM111R, CM112, CM113, CM115 and CM120.  All batch numbers distributed from January 2011 to February 17, 2016.",3/7/2016,"03/07/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73685,"Ongoing","Ad-Tech Medical Instrument Corporation","1901 William St",,"Racine","WI","53404-1876","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of GA and  MI, and the countries of FRANCE, UNITED KINGDOM, COLOMBIA, and  BRAZIL.","Z-1503-2016","Class II","Ad-Tech Electrode Connection System/Cables.  Lightweight TECH-ATTACH Cable Models:    1.  L-DCL-4DINX (4 contacts:  1 terminal block with 4 connectors each);    2.  L-DCL-6DINX (6 contacts:  1 terminal block with 6 connectors each);     3.  L-DCL-8DINX (8 contacts:  1 terminal block with 8 connectors each);     4.  L-DCL-16BDINX (16 contacts:  1 terminal block with 16 connectors each);     5.  L-DCL-32BDINX (32 contacts:  2 terminal blocks with 16 connectors each);    6.  L-DCL-64BDINX (64 contacts:  4 terminal blocks with 16 connectors each).    FO TECH-ATTACH Connection Cable model FO-LDC-4DINX (4 contacts:  1 terminal block with 4 connectors each).  Tech-Attach:  these cables require the use of an additional component - the connector block.  The tail of the electrode is inserted into the block and the block in turn mates with the cable.  A key-pin is used to ensure proper orientation.  The cable terminated in EEG compatible connector sockets.    Lightweight CABRIO Cable, model L-SRL-64BDINX (64 contacts:  4 terminal blocks with 16 connectors each).  Cabrio cables are similar to Tech-Attach cables except that the block portion is pre-attached.  The tail of an electrode is inserted into this portion which then hinges shut.          ","197","Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators.  This recall has been initiated due to package failures (i.e. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.  ","04/15/2016",," Lot Numbers:  208140507, 208140552, 208140556, 208140559, 208140560, 208140561, 208140562, 208140563, 208140564R, 208140579, 208140581, 208140586, 208140588R, 208140590, 208140604.    ",3/29/2016,"03/29/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73686,"Ongoing","Lee Seed Co Inc","2242 Hwy 182",".","Inwood","IA","51240","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Sold via the firm's website and distributed by mail nationwide since at least November 2013 to March 2016.  No government/military consignees.","F-1426-2016","Class I","Yogurt Super Soynuts packaged in 16 oz. plastic bags and packaged in holiday tins. Lee Seed Company, Inc., Inwood, Iowa.",,"Product contains undeclared milk.","06/03/2016",," No lot code or expiration date are on the product labels/labeling.",3/29/2016,"03/29/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73687,"Completed","Xtra Factors","211 Pedigo Dr",,"Pratt","KS","67124-3624","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to TX.  There was no foreign/military/government distribution.","V-523-2016","Class III","MPF Classic Dry Custom Canine Premix, Product No. 4629, packaged in bulk 2000 lb totes.  Manufactured for XF Enterprises, Inc., Hereford, TX 79045.","5 bulk totes (7975 lbs.)","Product labeled for canine use is contaminated with monensin.","09/21/2016",," P161401-07",3/30/2016,"03/30/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73688,"Ongoing","Hardy Diagnostics","1430 W McCoy Ln",,"Santa Maria","CA","93455-1005","United States","Voluntary: Firm Initiated","Telephone","U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.","Z-1571-2016","Class II","Hardy Diagnostics GBS Detect  Cat no. A300.    Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus. ","3,530 (353 pk/10)","Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.","04/26/2016",," Lot H16054 and H15056.",3/21/2016,"03/21/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73689,"Ongoing","Integra LifeSciences Corporation","105 Morgan Ln",,"Plainsboro","NJ","08536-3339","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to PA","Z-2777-2016","Class II","Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only   Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient        Manufactured by:  Integra LifeSciences Corporation  311 Enterprise Drive, Plainsboro, NJ 08536  877-444-1122 USA n 609-936-5400 outside USA  866-800-7742 fax    ","14 packages","Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for a single Lot (Lot 105A00324750).  ","09/09/2016",," Catalogue No. MIDRT 8101  Lot No. 105A00324750",3/11/2016,"03/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73690,"Terminated","Flowers Foods","1919 Flowers Cir",,"Thomasville","GA","31757-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Connecticut, Delaware, Kentucky, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, Washington DC, and West Virginia.","F-2337-2016","Class I","Cobblestone Bread Co. Wheat English Muffins, 12 oz. (6 count)plastic bag (340g)  UPC: 0 72250 01316 1","10,0000 units","Product contains undeclared milk","09/16/2016","09/16/2016"," BEST BY DATES OF OCTOBER 28, 2015 THROUGH APRIL 10, 2016",3/30/2016,"03/30/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73691,"Ongoing","Becton Dickinson & Company","1 Becton Dr",,"Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Nationwide","Z-1690-2016","Class II"," shielded  IV catheter (0.7 mm x 14 mm) made of FEP polymer    catalog number 381720","1,305,150 units ","The device may have a defect in the catheter. In some instances this defect could result in catheter  separation or breakage.","05/18/2016",," shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer    3045792  3106688  3289840  4059581  4203557  5002915  5063827  5125565  5300772  ",3/18/2016,"03/18/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73692,"Ongoing","Med Tec Inc","PO Box 320","1401 8th St SE","Orange City","IA","51041-7463","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution including the countries of  Switzerland, Germany..","Z-1992-2016","Class II","Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041","9","When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.","06/15/2016",," Versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1)",3/31/2016,"03/31/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73693,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","800 Macarthur Blvd",,"Mahwah","NJ","07430-2001","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1575-2016","Class II","Panorama Patient Monitoring Network  Mindray DS USA   The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.","1447 units US, 45 units OUS","Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions.","04/27/2016",," Panorama Central Station's CPU Unit, Tower (p/n 0998-00-0709-01)  Panorama Central Station's CPU Unit, 2U case (p/n 0998-00-0708-01)  Panorama Centrall Station's eGateway Tower (p/n 0998-00-0709-03)  Panorama Central Station's eGateway 2U case (p/n 0998-00-0708-03)",3/9/2016,"03/09/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73694,"Ongoing","Diamedix Corporation","14100 Nw 57th Ct",,"Miami Lakes","FL","33014-3107","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.","Z-1685-2016","Class II","Diamedix Is-Mumps IgG Test Kit     Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.","697 kits","A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. ","05/16/2016",," Lot # 20804, Catalog # 720-540. Expiration Date August 31, 2015",10/20/2014,"10/20/2014",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73694,"Ongoing","Diamedix Corporation","14100 Nw 57th Ct",,"Miami Lakes","FL","33014-3107","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.","Z-1686-2016","Class II","Diamedix Is-EBV-VCA IgG Test Kit     Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.","588 kits","A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. ","05/16/2016",," Lot # 30804, Catalog # 720-600 Expiration Date April 30, 2015",10/20/2014,"10/20/2014",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73694,"Ongoing","Diamedix Corporation","14100 Nw 57th Ct",,"Miami Lakes","FL","33014-3107","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.","Z-1687-2016","Class II","Diamedix Is-EBV-EA-D IgG Test Kit     Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.","94 kits","A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.","05/16/2016",," Lot # 51104, Catalog # 720-640 Expiration Date August 31, 2015",10/20/2014,"10/20/2014",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73695,"Ongoing","NOW Foods","395 Glen Ellyn Rd",,"Bloomingdale","IL","60108-2176","United States","Voluntary: Firm Initiated","Press Release","Distributed to 499 consignees in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and PR. The one foreign consignee is Natulab in Japan.","F-1130-2016","Class II","Elderberry 500 mg packaged in a white and orange bottle containing 60 capsules. The bottle has a blue cap and white lettering. ","57 bottles","Undeclared soy lecithin in 5 dietary supplements.","04/22/2016",," Lot# 1966914, Batch# 582660 ",3/18/2016,"03/18/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73695,"Ongoing","NOW Foods","395 Glen Ellyn Rd",,"Bloomingdale","IL","60108-2176","United States","Voluntary: Firm Initiated","Press Release","Distributed to 499 consignees in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and PR. The one foreign consignee is Natulab in Japan.","F-1129-2016","Class II","Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering. ","8 bottles","Undeclared soy lecithin in 5 dietary supplements.","04/22/2016",," Lot# 1966914, Batch# 582660",3/18/2016,"03/18/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73695,"Ongoing","NOW Foods","395 Glen Ellyn Rd",,"Bloomingdale","IL","60108-2176","United States","Voluntary: Firm Initiated","Press Release","Distributed to 499 consignees in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and PR. The one foreign consignee is Natulab in Japan.","F-1133-2016","Class II","Cranberry extract packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering. ","3 bottles","Undeclared soy lecithin in 5 dietary supplements.","04/22/2016",," Lot# 1961645, Batch# 579391    ",3/18/2016,"03/18/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73695,"Ongoing","NOW Foods","395 Glen Ellyn Rd",,"Bloomingdale","IL","60108-2176","United States","Voluntary: Firm Initiated","Press Release","Distributed to 499 consignees in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and PR. The one foreign consignee is Natulab in Japan.","F-1132-2016","Class II","Goldenseal Root 500 mg  packaged in a white and orange bottle containing 100 capsules. The bottle has a blue cap and white lettering. ","12 bottles ","Undeclared soy lecithin in 5 dietary supplements.","04/22/2016",," Lot# 1961645, Batch# 579391",3/18/2016,"03/18/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73695,"Ongoing","NOW Foods","395 Glen Ellyn Rd",,"Bloomingdale","IL","60108-2176","United States","Voluntary: Firm Initiated","Press Release","Distributed to 499 consignees in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and PR. The one foreign consignee is Natulab in Japan.","F-1131-2016","Class II","Gingko Biloba 60mg  packaged in a white and orange bottle containing 120 capsules. The bottle has a blue cap and white lettering. ","2 bottles","Undeclared soy lecithin in 5 dietary supplements.","04/22/2016",," Lot# 1969778, Batch# 582552",3/18/2016,"03/18/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73696,"Terminated","Amd-Ritmed,  Inc.","295 Fire Tower Dr",,"Tonawanda","NY","14150-5833","United States","Voluntary: Firm Initiated","E-Mail","US Distribution in states of: NY, CA, and TN.","Z-2213-2016","Class II","AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC.  Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150  -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case.    Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.","US: 107 cases (48 rolls per case)","The product lot did not meet sterility requirements based on FDA sampling and analysis.","07/15/2016","07/15/2016"," Lot 64155, Expiration Date 2017-06",3/30/2016,"03/30/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73697,"Ongoing","FKC International, Inc.","1300 Valley Vista Dr Ste 102",,"Diamond Bar","CA","91765-3940","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, LA, AZ, NV, NY    Foreign distribution to the following; China, Indonesia, Hong Kong, Srilanka","F-1998-2016","Class II","Wonder Meal  Net Weight 455 grams 15.75 oz  UPC Code: 6 03808 12813","15580 bottles","Undeclared milk from the listed ingredient of whey protein.","08/26/2016",," Lot Number: 1510003",3/30/2016,"03/30/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73698,"Ongoing","Invisiblu International LLC","620 SE 13th St",,"Fort Lauderdale","FL","33316-2023","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Brazil.","D-0910-2016","Class II","LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle,  Manufactured for Continuum Labs, Fort Lauderdale, FL ","3,319 bottles","Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033","05/27/2016",," Lot # 21511166, Exp 11/18",3/31/2016,"03/31/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73699,"Ongoing","Biocon Inc","485 US Highway 1 S Ste B305",,"Iselin","NJ","08830-3009","United States","Voluntary: Firm Initiated","Letter","PA, CA, & OH","D-0817-2016","Class III","Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134 ","5505 bottles","Subpotent Drug","04/08/2016",," Lot # 14S0042F5B, exp. 4/2016",3/24/2016,"03/24/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73700,"Ongoing","R.W. Bakers Co. Inc.","1129 E Mount Garfield Rd",,"Norton Shores","MI","49441-6078","United States","Voluntary: Firm Initiated","Telephone","Domestic: MI, OH, WI, KY, IN, IL    Foreign: None; VA/DOD: None","F-1307-2016","Class II","Assorted Dinner Rolls, 128 ct., Net Wt. 10.2 lbs; 16/ 8 ct./case","47 cases"," and 8 ct. packages of Assorted Dinner Rolls 128 ct. because they may contain trace amounts of undeclared peanuts.","05/02/2016",," The lot number is 16041 with a production date of 2/10/16; Product number 4180. This information is found on the master case of the product.  This product does not have a UPC number",3/28/2016,"03/28/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73700,"Ongoing","R.W. Bakers Co. Inc.","1129 E Mount Garfield Rd",,"Norton Shores","MI","49441-6078","United States","Voluntary: Firm Initiated","Telephone","Domestic: MI, OH, WI, KY, IN, IL    Foreign: None; VA/DOD: None","F-1306-2016","Class II","Meijer Plain Knot Rolls, 8 ct., Net Wt. 10 oz.; 12/case, 9.4 lbs/case","370 cases"," and 8 ct. packages of Assorted Dinner Rolls 128 ct. because they may contain trace amounts of undeclared peanuts.","05/02/2016",," The lot number on the master case 16061 with a production date of 3/1/16. Product number 2035; the UPC code is 0-41250-09971-0 and is located at the bottom of the package label underneath the bar code",3/28/2016,"03/28/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73701,"Ongoing","Medtronic","6135 Gunbarrel Ave",,"Boulder","CO","80301-3214","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Product was also distributed worldwide. There is 1 VA customer.","Z-1577-2016","Class I","20p is a combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport environments","9,817 batteries (8,170 with monitors and 1,647 as spare parts)","20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor. ","05/12/2016",," Product # 016400; All SNs, irrespective of production date. Product # 010520; All SNs with production date starting 14.14 ",4/13/2016,"04/13/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73702,"Ongoing","Greater Pittsburgh Community Food Bank","1 N Linden St",,"Duquesne","PA","15110-1097","United States","Voluntary: Firm Initiated","E-Mail","Southwest PA","F-1245-2016","Class III","Imperial Choice Mandarin Oranges Broken Segments in Light Syrup; Net WT. 11 oz.; Imported by Acme Food Sales, Seattle, WA 98108; Product of China;     4200/01029; PRO: DEC 21, 2013; Best By: Dec 21, 2016","2200 cases (cans per case unk.)","Greater Pittsburgh Community Food Bank is announcing  a voluntary recall of one lot of Imperial Choice Mandarin Oranges Broken Segments in Light  Syrup because some of the cans from this lot may leak, bulge or burst open. The product may  be contaminated by spoilage organisms or pathogens, which could lead to serious or life threatening  illness if consumed. This recall only affects cans marked wi","05/06/2016",," On can end: 4200/01029; PRO: DEC 21, 2013; Best By: Dec 21, 2016",3/11/2016,"03/11/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73703,"Ongoing","Roche Molecular Systems, Inc.","1080 US Highway 202 S",,"Branchburg","NJ","08876-3733","United States","Voluntary: Firm Initiated","Letter","Hungary","Z-1830-2016","Class II","cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample  Preparation Hungarian Translation Instructions for Use   ","8 kits","An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N  07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use  (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).","05/26/2016",," EGFR v2: 07248563190  cfDNA: 07247737190",3/15/2016,"03/15/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73704,"Ongoing","Skytron, Div. The KMW Group, Inc","5085 Corporate Exchange Blvd SE",,"Grand Rapids","MI","49512-5515","United States","Voluntary: Firm Initiated","Telephone","Worldwide distribution.  US states: VA, VT, UT, GA, NJ, and IL; Japan.","Z-1871-2016","Class II","Ergon III Series Skyboom Monitor Bracket.  Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size  ","24","Potential for the weld to fail at the pivot point of the monitor bracket.  This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.","05/31/2016",," Model Number(s): 3FCM1; Manufactured Date: September 2015;  Serial Numbers 1507T719-00-0-0074, 1507T719-00-0-0091, 1507T719-00-0-0095, 1507T719-00-0-0096, 1507T719-00-0-0102, 1507T719-00-0-0107, 1508T719-00-0-0129, 1507T719-00-0-0087, 1507T719-00-0-0069, 1507T719-00-0-0103, 1507T719-00-0-0104, 1507T719-00-0-0066, 1507T719-00-0-0072, 1507T719-00-0-0073, 1507T719-00-0-0075, 1507T719-00-0-0088, 1507T719-00-0-0101, 1507T719-00-0-0108, 1507T719-00-0-0112, 1507T719-00-0-0113, 1507T719-00-0-0090, 1507T719-00-0-0097, 1507T719-00-0-0099, and 1507T719-00-0-0100",3/28/2016,"03/28/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73705,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.","Z-1517-2016","Class II","GDC-18 360 11MM X 30CM Detachable Coil  Sterile;  Model number: M0033471020SR0    Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms that¿a because of their morphology, their location, or the patients  general medical condition are considered by the treating neurosurgical team to be  a) very high risk for management by traditional operative techniques, or  b) inoperable.","316 devices, both models","The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.","04/19/2016",," Model Number: GDC-18 360 11MM X 30CM;  Lot numbers: 17723781, 17735100 and 17818842.",3/21/2016,"03/21/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73705,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.","Z-1516-2016","Class II","GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil  Sterile;  Model number: M0033471020SR0;    Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that  because of their morphology, their location, or the patients general medical condition  are considered by the treating neurosurgical team to be  a) very high risk for management by traditional operative techniques, or  b) inoperable.","316 total, both models","The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.","04/19/2016",," Model number: M0033471020SR0;  Lot codes: 17074659, 17581672, and 18617200.",3/21/2016,"03/21/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73706,"Ongoing","ev3, Inc.","3033 Campus Drive",,"Minneapolis","MN","55441","United States","Voluntary: Firm Initiated","Letter","US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX.    OUS: SINGAPORE","Z-1552-2016","Class II"," OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.","27 (25 US, 2 OUS)"," ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.","04/22/2016",," A213373 and A216702",3/29/2016,"03/29/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73707,"Ongoing","Aloha Medicinals, Inc.","2300 Arrowhead Dr",,"Carson City","NV","89706-0405","United States","Voluntary: Firm Initiated","Letter","No US Distribution.  Three customers in Europe - Italy, Germany and Austria.","F-1284-2016","Class I","Organic Auricularia auricular (Dried Mushroom Powder (Jelly Ear Mushroom).    60 kg 4 mil polyethylene bags inside plastic polyethylene black drum.  Certified Organic by QAI - Made in USA.    Aloha Medicinals Inc.  2300 Arrowhead Drive  Carson City, NV 89706    ","502 kgs.","One retained sample of Auricularia auricular tested positive for E-Coli. Product was tested after firm received reports  of stomach issues from wholesale customer.","05/20/2016",," Lot AA091215; Expiration date: 12/08/2018",3/29/2016,"03/29/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73708,"Ongoing","Geneva Foods, LLC","2664 Jewett Ln",,"Sanford","FL","32771-1678","United States","Voluntary: Firm Initiated","Letter","Distributed nationwide to the following states: AK, AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY.","F-2079-2016","Class II","Lysander's Premium Teriyaki Marinade, 1 oz (28 g), polypropylene and clamshell style card, 12 units per case.  Manufactured by Geneva Foods, LLC.","65.8 cases (790 units)","Product contains undeclared allergens soy and wheat. Also does not declare sulfites. ","09/02/2016",," Cases coded 2014-2015, if not visible all lots; UPC: 0-34795-00036-5.",2/1/2016,"02/01/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73708,"Ongoing","Geneva Foods, LLC","2664 Jewett Ln",,"Sanford","FL","32771-1678","United States","Voluntary: Firm Initiated","Letter","Distributed nationwide to the following states: AK, AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY.","F-2081-2016","Class II","Lysander's All Natural Bourbon Flavor Rub; for beef, chicken, pork, and fish; 3.8 oz (107.7 g), foil bag, 6 units per case.  Manufactured by Geneva Foods, LLC.","5,145 cases (30,870 units)","Product contains undeclared allergens soy and wheat. Also does not declare sulfites. ","09/02/2016",," Lot codes ending in 14 or 15; UPC: 0-34795-00049-5.",2/1/2016,"02/01/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73708,"Ongoing","Geneva Foods, LLC","2664 Jewett Ln",,"Sanford","FL","32771-1678","United States","Voluntary: Firm Initiated","Letter","Distributed nationwide to the following states: AK, AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY.","F-2080-2016","Class II","Lysander's All Natural Spicy Bourbon Flavor Rub; for beef, chicken, pork, and fish; 3.8 oz (107.7 g) foil bag, 6 units per case. Manufactured by Geneva Foods, LLC.","3,166 cases (18,996 units)","Product contains undeclared allergens soy and wheat. Also does not declare sulfites. ","09/02/2016",," Lot codes ending in 14 or 15; UPC: 0-34795-00051-8",2/1/2016,"02/01/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73709,"Ongoing","Purdue Pharma L.P.","201 Tresser Blvd",".","Stamford","CT","06901-3435","United States","Voluntary: Firm Initiated","Letter","U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.","D-0810-2016","Class III","Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only.  Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.","2172 Cartons","Failed Dissolution Specifications","04/04/2016",," Lot #: 3126431B, Expiry: 09/30/17",3/31/2016,"03/31/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73710,"Ongoing","QuVa Pharma, Inc.","1075 W Park One Dr Ste 100",,"Sugar Land","TX","77478-2576","United States","Voluntary: Firm Initiated","E-Mail","CA","D-1066-2016","Class I","PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only,  Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35.","20 cases","Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe. ","07/06/2016","."," Lot #: 14312-0, Exp 4/15/2016  ",3/30/2016,"03/30/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73711,"Ongoing","R.A.B. Food Group LLC","80 Avenue K",,"Newark","NJ","07105","United States","Voluntary: Firm Initiated","Letter","CA, FL, IL, MD, NY, PA and foreign","F-1333-2016","Class III","Manischewitz Pistachio Orange Macaroons 10 oz.     Distributed by: The Manischewitz Company Newark, NJ 07105  Product of USA        UPC 0-7270000119-6","1888 cases","Manischewitz Pistachio Orange macaroons may contain pistachio shell fragments.","05/13/2016",," Lot #N5336A  September 1, 2016",3/30/2016,"03/30/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73712,"Completed","MFA Agri Services","61338 Highway 50",,"California","MO","65018-3136","United States","Voluntary: Firm Initiated","Telephone","Product distributed to MO.  There was no foreign/military/government distribution.","V-540-2016","Class I","Bulk grain bank-corn-10920#-Ground #4 Stock Salt.  Manufactured by MFA Agri Services, California, MO 65018.","6 tons","Product misbranded to contain salt; animal deaths confirmed due to bloat associated with the consumption of the feed.","09/30/2016",," lot #: 53246",3/10/2016,"03/10/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73713,"Ongoing","Way Fong LLC","5729 49th St",,"Maspeth","NY","11378-2014","United States","Voluntary: Firm Initiated","FAX","New York","F-1628-2016","Class I","SEAFOOD BALL COMBO ASSORTI BOULETTES AUX PRODUCTS DE MER FISH BALL, FRIED FISH BALL, FRIED SHRIMP BALL, FISH BALL WITH DACE, CUTTLEFISH BALL, Net Wt 260g/9.2oz, UPC 0 68636 05205 2, Product of Canada, KEEP REFRIGERATED","58 cases","Canadian Food Inspection Agency analytical results revealed the presence of undeclared egg allergen.  ","07/07/2016",".",,3/16/2016,"03/16/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73713,"Ongoing","Way Fong LLC","5729 49th St",,"Maspeth","NY","11378-2014","United States","Voluntary: Firm Initiated","FAX","New York","F-1629-2016","Class I","FRIED SHRIMP FLAVOURED FISH BAR, Net Wt 9.07 Kg 4 X 5 lbs. bulk,  Product of Canada, KEEP REFRIGERATED","15 cases","Canadian Food Inspection Agency analytical results revealed the presence of undeclared egg allergen.  ","07/07/2016",".",,3/16/2016,"03/16/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73714,"Ongoing","Alimentos Congelados, S.A. (Pinula)","Km 18.5 Carretera A San Jose Pinula",".","Fraijanes",,,"Guatemala","Voluntary: Firm Initiated","Telephone","FL, GA, KY","F-1439-2016","Class I","Wylwood Fresh Frozen Broccoli Cuts, NET WT. 16 OZ  Code: A25335P and A15335P    Dist By: Save-A-Lot Stores, Earth City, MO.","1800 cases","Alimentos Congelados, S.A. (Pinula) is voluntarily recalling 1,800 cases of Frozen Broccoli Cuts because it has the potential to be contaminated with Listeria Monocytogenes,","06/09/2016",," Code: A25335P and A15335P  ",3/30/2016,"03/30/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73715,"Ongoing","Amerisource Health Services ","2550 John Glenn Ave","Suite A","Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0823-2016","Class III","Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.   ","5,034 cartons (151,020 capsules)","Labeling: Incorrect or Missing Lot and/or Exp Date","04/14/2016",," Lot #142548; Exp. 05/16  Lot #145036; Exp. 10/16  Lot #151170; Exp. 03/17   Lot #152978; Exp. 09/17   Lot #155080; Exp. 01/18.",3/31/2016,"03/31/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73715,"Ongoing","Amerisource Health Services ","2550 John Glenn Ave","Suite A","Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0822-2016","Class III","Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.   ","228 cartons ( 4,560 capsules)","Labeling: Incorrect or Missing Lot and/or Exp Date","04/14/2016",," Lot #144332C; Exp. 04/16   Lot #155224; Exp. 05/17",3/31/2016,"03/31/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73716,"Ongoing","Roland Foods, LLC.","71 W 23rd St",,"New York","NY","10010-4102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and Canada","F-1249-2016","Class II","Roland (R) Fire Roasted Red Pepper Strips, NET WT. 5 LB. 8 OZ. (2.5 kg), UPC 10041224456287 (carton) and 04122456280 (can), PRODUCT OF PERU --   Packed Exclusively For: ROLAND FOODS, LLC, New York, NY 10070","3592 cartons (6 cans per carton)","Possible presence of glass fragments in the product lots. ","04/26/2016",," Lot #s 427, 428, 432, 437; Production Codes:  G1 MSS 1 P0929 and G1 MSS 2 P092 (code is ink jet printed on the top of the can) ",4/1/2016,"04/01/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73718,"Ongoing","Noven Pharmaceuticals, Inc.","11960 SW 144th St",,"Miami","FL","33186-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1440-2016","Class II","Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL  33186; By Noven Pharmaceuticals, Inc., Miami, FL  33186, NDC 68968-5555-3.","12285 boxes","Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. ","07/14/2016",," Lot #s: 77379, 77380, Exp 05/16; 76944, Exp 03/16",12/21/2015,"12/21/2015",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73718,"Ongoing","Noven Pharmaceuticals, Inc.","11960 SW 144th St",,"Miami","FL","33186-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1439-2016","Class II","Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL  33186; By Noven Pharmaceuticals, Inc., Miami, FL  33186, NDC 68968-5554-3.","2088 boxes","Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. ","07/14/2016",," Lot # 77140, Exp 05/16",12/21/2015,"12/21/2015",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73718,"Ongoing","Noven Pharmaceuticals, Inc.","11960 SW 144th St",,"Miami","FL","33186-6109","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1438-2016","Class II","Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL  33186; By Noven Pharmaceuticals, Inc., Miami, FL  33186, NDC 68968-5553-3.","7850 boxes","Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. ","07/14/2016",," Lot #: 77303, Exp 06/16",12/21/2015,"12/21/2015",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73719,"Ongoing","Boston Scientific Corporation","2 Scimed Pl",,"Maple Grove","MN","55311-1565","United States","Voluntary: Firm Initiated","Letter","US nationwide in the states of ME, LA, and TN","Z-1370-2016","Class II","¿ Tip.  The PT Graphix Magnet Guidewire features a 10 or 38 cm polymer sleeve, coated with ICE Hydrophilic Coating, jacketing the distal tapered core wire.  The proximal section of the PT Graphix Magnet Guidewire is coated with a fluorinated polymer.   ","47 units","Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires.  Boston Scientific has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do not have the pre-formed J-tip.  The most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has","04/12/2016",," Lot:  17971870",3/28/2016,"03/28/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73720,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Austria; Illinois","B-0499-16","Class III","Blood and Blood Products for Reprocessing","2 units","Blood products, in which donor screening/deferral screening not done or incorrectly performed were distributed.","05/04/2016","06/01/2016"," W040715149357; W040714539719; ",3/15/2016,"03/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73720,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Austria; Illinois","B-0455-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, in which donor screening/deferral screening not done or incorrectly performed were distributed.","05/04/2016","06/01/2016"," W040715149357; ",3/15/2016,"03/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73721,"Terminated","LifeSource","5505 Pearl St Floor 1",,"Rosemont","IL","60018-5317","United States","Voluntary: Firm Initiated","Telephone","Illinois","B-0425-16","Class III","Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced","12 units","Blood products,  in which labeling/labels applied to blood unit or product incorrect or missing information, were distributed.","04/28/2016","04/28/2016"," W288316000022; W288316000022; W288316000022; W288516000046(Part A), W288516000046(Part B); W288516000047; W288516000048; W288516000053; W288516000056; W288516000056; W288516000057; W288516000057; ",2/23/2016,"02/23/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73722,"Terminated","LifeSource dba Central Blood Bank","875 Greentree Rd",,"Pittsburgh","PA","15220-3508","United States","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0426-16","Class III","Apheresis Plasma Frozen within 24 hours After Phlebotomy","11 units","Blood products, in which labeling/labels applied to blood units or products incorrect or missing information, were distributed.","04/28/2016","04/28/2016"," W085516000120; W085516000120; W085516000120; W085516000120; W085316000126; W085316000126; W085316000126; W085316000126; W085516000128; W085516000128; W085516000128; ",2/4/2016,"02/04/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73723,"Terminated","BPL Plasma, Inc.","2320 E Bell Rd Ste 101",".","Phoenix","AZ","85022-2902","United States","Voluntary: Firm Initiated","E-Mail","Kentucky","B-0414-16","Class II","Source Plasma","3 units","Source Plasma was inappropriately distributed.","04/07/2016","04/07/2016"," PH0051268; PH0052430; PH0052787",2/2/2016,"02/02/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73724,"Terminated","BPL Plasma, Inc.","11601 E Colonial Dr",,"Orlando","FL","32817-4608","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0427-16","Class II","Source Plasma","3 units","Blood products, collected from a donor whose physical examination was not documented, were distributed.","05/04/2016","05/04/2016"," OL0562326; OL0563109; OL0564429; ",3/2/2016,"03/02/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73725,"Completed","BPL Plasma, Inc.","4223 Wellborn Rd",".","Bryan","TX","77801-4622","United States","Voluntary: Firm Initiated","E-Mail","Kentucky","B-0413-16","Class III","Source Plasma","1 unit","Source Plasma, collected from an ineligible donor, was distributed. ","04/07/2016","04/07/2016"," BY0532260",12/31/2015,"12/31/2015",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73726,"Terminated","BloodSource, Inc.","10536 Peter a McCuen Blvd",,"Mather","CA","95655-4128","United States","Voluntary: Firm Initiated","Telephone","Texas; California","B-0424-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Platelet products, not prepared according to specifications, were distributed.","04/15/2016","04/15/2016"," W035815193523 (Double collection)",1/28/2016,"01/28/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73727,"Terminated","Blood Bank of Alaska, Inc.","1215 Airport Heights Dr",,"Anchorage","AK","99508","United States","Voluntary: Firm Initiated","FAX","Indiana; New York; California","B-0421-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","05/02/2016","05/02/2016"," W066515424102",2/10/2016,"02/10/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73727,"Terminated","Blood Bank of Alaska, Inc.","1215 Airport Heights Dr",,"Anchorage","AK","99508","United States","Voluntary: Firm Initiated","FAX","Indiana; New York; California","B-0422-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","05/02/2016","05/02/2016"," W066515424102",2/10/2016,"02/10/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73727,"Terminated","Blood Bank of Alaska, Inc.","1215 Airport Heights Dr",,"Anchorage","AK","99508","United States","Voluntary: Firm Initiated","FAX","Indiana; New York; California","B-0423-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","05/02/2016","05/02/2016"," W066515980231 ",2/10/2016,"02/10/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73728,"Terminated","South Dakota Lions Eye Bank, Inc","4501 W 61st St N",".","Sioux Falls","SD","57107-6411","United States","Voluntary: Firm Initiated","E-Mail","Pakistan; Egypt","B-0415-16","Class II","Cornea","2 human corneas","Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ","04/07/2016","04/07/2016"," 15000176V0004; 15000176V0003",2/3/2016,"02/03/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73729,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","North Carolina; Missouri;","B-0416-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from an ineligible donor, were distributed. ","04/08/2016","04/08/2016"," W333615099802; ",2/8/2016,"02/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73729,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","North Carolina; Missouri;","B-0417-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from an ineligible donor, were distributed. ","04/08/2016","04/08/2016"," W333615123849; ",2/8/2016,"02/08/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73730,"Terminated","The American National Red Cross - Southern Region","9851 Commerce Way",,"Douglasville","GA","30135-3101","United States","Voluntary: Firm Initiated","Telephone","Georgia","B-0431-16","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood product, for which donor eligibility was inadequately determined, was distributed.","04/26/2016","04/26/2016"," W200315452096",1/16/2016,"01/16/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73731,"Terminated","BPL Plasma, Inc.","2309A E Nettleton Ave",,"Jonesboro","AR","72401-4510","United States","Voluntary: Firm Initiated","E-Mail","Belgium","B-0495-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.","05/16/2016","05/16/2016"," JB0466375",1/8/2016,"01/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73732,"Terminated","BPL Plasma, Inc.","2631 Dunn Ave",,"Jacksonville","FL","32218-4656","United States","Voluntary: Firm Initiated","E-Mail","Belgium","B-0496-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.","05/16/2016","05/16/2016"," JV0319400",1/12/2016,"01/12/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73733,"Ongoing","Diamond Foods, Inc.","1050 Diamond St",,"Stockton","CA","95205-7020","United States","Voluntary: Firm Initiated","Press Release","AL, AZ, CA, CO, GA, IA, IL, IN, KS, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TX, VA, WA, WI.","F-1293-2016","Class II","Emerald 100 Calorie Packs of Cashew Halves & Pieces, roasted and salted.  7 pack/ 0.62 oz. each (17.5 g).    Ingredients: Cashews, Vegetable Oil/Safflower, Sunflower and/or Canola Oil, Salt, Rosemary extract (to preserve freshness:    Retail Carton UPC: 0 10300 33324 1;  Inner Package UPC: 0 10300 33399 9;    Distributed by:  Diamond Foods, Inc., San Francisco, CA 94111.    ","10,623 X 7 pack","There is the potential for small glass fragments in Emerald  100 calorie packs of cashews halves and pieces.","04/29/2016",," Best Before Date: 12 DEC 16        Code:  15346D346S                                13 DEC 16                   15347D346S                                18 DEC 16                   15352D346S                                 21 DEC 16                  15355D346S",4/1/2016,"04/01/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1773-2016","Class II","  Ref Number: 60-22  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","27 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:     2015/10 BV  2015/10 CC  2015/12 CM  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1803-2016","Class II","  Ref Number: 80-09    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","178 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:     2015/09 CC  2015/10 BL  2015/12 BI  2016/01 AP  2015/12 CZ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1802-2016","Class II","   Ref Number: 80-08    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","4 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot number:2015/11 BP  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1805-2016","Class II","  Ref Number: 80-12    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","10 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 CI  2015/12 CU  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1750-2016","Class II","American Surgical Ultracot 15 mm x 15 mm (Glassine)  Ref Number: 23-12G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","6 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AF  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1764-2016","Class II","  Ref Number: 60-02  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","165 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:     2015/09 AX  2015/10 BU  2015/10 BZ  2015/11 BN  2015/12 BK  2015/12 AF  2015/12 CL  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1807-2016","Class II","  Ref Number: 90-02    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","3 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BE",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1723-2016","Class II","  Ref Number: 20-01S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","54 cases","Product packaging defective compromising sterility","05/26/2016",," Lot number:   2015/09 AB  2015/12 BS  2015/12 BN  2016/01 AC  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1768-2016","Class II","  Ref Number: 60-08  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","28 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/11 AJ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1808-2016","Class II","  Ref Number: 90-06    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","5 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BI  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1770-2016","Class II","  Ref Number: 60-12  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","102 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BB  2015/12 BM  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1787-2016","Class II","American Surgical Delicot 13 mm x 60 mm  Ref Number: 63-08  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","409 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 AK  2015/09 BS  2015/10 AY  2015/10 BO  2015/11 BF  2015/12 AC  2015/12 CI  2015/12 CS  2015/12 CX  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1792-2016","Class II","American Surgical Delicot X 6 mm x 50 mm  Ref Number: 63x06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","3 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 CG  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1772-2016","Class II","  Ref Number: 60-15  Product Usage:  Neurosurgical and Nonneurosurgical Sponges      ","16 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/11 AT  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1745-2016","Class II","American Surgical Ultracot 13 mm x 60 mm (Glassine)  Ref Number: 23-08G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","45 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AI  2015/11 AD  2015/11 BU      ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1724-2016","Class II","  Ref Number: 20-04S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","262 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 CM  2015/09 AJ  2015/10 BI  2015/11 AY  2015/12 CJ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1747-2016","Class II","American Surgical Ultracot 20 mm x 60 mm (Glassine)  Ref Number: 23-09G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","155 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 AZ  2015/10 AD  2015/10 BQ  2015/10 CQ  2015/11 AE  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1794-2016","Class II","  Ref Number: 67-02  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","39 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 CN  2015/10 AU    ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1766-2016","Class II","  Ref Number: 60-06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","266 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 AO  2015/09 BU  2015/11 BW  2015/12 BX  2015/12 DN  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1777-2016","Class II","American Surgical Delicot-J 5 mm x 8 mm  Ref Number: 63-01J (Japan Only)  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","27 boxes ","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 BS  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1729-2016","Class II","  Ref Number: 20-14S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","37 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 CU  2015/11 BK  2015/12 DB  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1721-2016","Class II","American Surgical Delicot 15mm x 20mm  Ref: 63-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","351 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot Number:/  2015/08 BH  2015/09 BP  2015/10 BM  2015/11 BL  2015/12 AX  2015/12 CR  2016/01 AN  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1799-2016","Class II","  Ref Number: 70-02  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","11 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:     2015/11 AN  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1762-2016","Class II","  Ref Number: 31-07  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","7 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/12 AW  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1809-2016","Class II","  Ref Number: 90-08    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","4 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BA  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1771-2016","Class II","  Ref Number: 60-13  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","209 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 CD  2015/09 CB  2015/10 AV  2015/12 BL  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1734-2016","Class II","American Surgical Americot White 1.5 cm x 5.5 cm  Ref  Number: 20-31SW  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","35 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/11 AV  2015/12 BC  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1790-2016","Class II","American Surgical Delicot 30 mm x 70 mm  Ref Number: 63-10    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","338 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 BZ  2015/10 AG  2015/09 AW  2015/10 CD  2015/11 AZ  2015/11 BT  2015/12 AY  2015/11 BH  2015/12 CO  2015/12 DD  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1767-2016","Class II","  Ref Number: 60-07  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","165 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   Lot Number  2015/09 BV  2015/11 BE  2015/12 AG  2015/12 AV  2015/12 AB  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1781-2016","Class II","American Surgical Delicot non-xray 10 mm x 13 mm  Ref Number: 63-03 non-xray    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","4 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 CB  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1757-2016","Class II","  Ref Number: 30-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","237 units","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 AI  2015/09 AA  2015/09 CL  2015/10 AT  2015/11 CH  2015/12 CB  2015/12 AJ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1783-2016","Class II","American Surgical Delicot-J 15 mm x 20 mm  Ref Number: 63-04J (Japan Only)    Product Usage:  Neurosurgical and Nonneurosurgical Sponges      ","68 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2016/01 AQ    ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1769-2016","Class II","  Ref Number: 60-09  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","449 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 AC  2015/09 BH  2015/10 AA  2015/10 BJ  2015/11 BC  2015/12 AU  2015/12 AK  2015/12 CK    ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1797-2016","Class II","  Ref Number: 67-09  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","15 cases","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AN  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1738-2016","Class II","American Surgical Ultracot 5 mm x 13 mm (Glassine)  Ref Number: 23-02G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","15 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 AY  2015/11 AA  2015/12 BB  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1763-2016","Class II"," Large  Ref Number: 50-01  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","4 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/12 BE  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1736-2016","Class II","American Surgical Ultracot 5 mm x 8 mm	  Ref Number: 23-01  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","114 cases","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 CG  2015/09 CA  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1746-2016","Class II","American Surgical Ultracot 20 mm x 60 mm   Ref Number: 23-09  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","33 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 CJ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1740-2016","Class II","American Surgical Ultracot 15 mm x 20 mm   Ref Number: 23-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","22 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/12 BP  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1755-2016","Class II","  Ref Number: 30-02  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","182 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BN  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1796-2016","Class II","  Ref Number: 67-08  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","4 cases","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/12 CD  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1731-2016","Class II","  Ref Number: 20-22S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","24 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AR  2015/11 BX  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1776-2016","Class II","American Surgical Delicot non-xray 5 mm x 8 mm  Ref Number: 63-01 Non X-Ray  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","24 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 BY  2015/10 CV    ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1756-2016","Class II","  Ref Number: 30-03  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","70 units","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 AD  2015/11 AP  2015/12 CE  2015/12 DA  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1754-2016","Class II","  Ref Number: 30-01  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","13 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BN  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1801-2016","Class II","  Ref Number: 80-06    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","24 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 BK  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1743-2016","Class II","American Surgical Ultracot 9 mm x 50 mm  (Glassine)  Ref Number: 23-07G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","32 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:     2015/10 CF  2015/12 AO  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1798-2016","Class II","  Ref Number: 67-29  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","3 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BG  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1784-2016","Class II","American Surgical Delicot 4 mm x 50 mm  Ref Number: 63-05  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","99 units","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AQ  2015/10 BC  2015/10 BW  2015/11 AK  2015/11 CJ  2015/12 AH  2015/12 CH      ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1795-2016","Class II","  Ref Number: 67-06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","7 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2016/01 AG  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1752-2016","Class II","American Surgical Ultracot 70 mm x 10090 mm   Ref Number: 23-24  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","27 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BZ  2015/11 BA  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1782-2016","Class II","American Surgical Delicot 4 mm x 50 mm  Ref Number: 63-05    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","99 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AQ  2015/10 BC  2015/10 BW  2015/11 AK  2015/11 CJ  2015/12 AH  2015/12 CH  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1730-2016","Class II","  Ref Number: 20-19S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","4 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2016/01 AD  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1722-2016","Class II","American Surgical Delicot 30mm x 70mm  Ref: 63-10  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","689 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot number:   2015/08 BH  2015/09 BP  2015/10 BM  2015/11 BL  2015/12 AX  2015/12 CR  2016/01 AN  2015/08 BZ  2015/10 AG  2015/09 AW  2015/10 CD  2015/11 AZ  2015/11 BT  2015/12 AY  2015/11 BH  2015/12 CO  2015/12 DD  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1725-2016","Class II","  Ref Number: 20-05S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","35 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AB  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1741-2016","Class II","American Surgical Ultracot 15 mm x 20 mm (Glassine)  Ref Number: 23-04G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","39 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 CJ  2015/11 AC  2015/12 BQ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1753-2016","Class II","  Ref Number: 30-00  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","87 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 CM  2015/11 AO  2015/12 BR  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1793-2016","Class II","American Surgical Delicot X 9 mm x 50 mm  Ref Number: 63x07  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","1 box","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 CH  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1749-2016","Class II","American Surgical Ultracot 30 mm x 70 mm (Glassine)  Ref Number: 23-10G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","23 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AE  2015/10 BP  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1785-2016","Class II","American Surgical Delicot 6 mm x 50 mm  Ref Number: 63-06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","113 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BC  2015/11 BB  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1804-2016","Class II","  Ref Number: 80-11    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","7 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/12 AP  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1726-2016","Class II","  Ref Number: 20-06S    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","78 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BR  2015/12 BO  2015/12 BU  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1806-2016","Class II","  Ref Number: 80-13    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","57 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 BS  2015/12 AR  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1789-2016","Class II","American Surgical Delicot 20 mm x 60 mm  Ref Number: 63-09    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","343 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BK  2015/10 AZ  2015/10 CK  2015/10 CO  2015/10 CW  2015/11 BJ  2015/11 BR    ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1727-2016","Class II","  Ref Number: 20-07S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","33 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/12 CG  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1739-2016","Class II","American Surgical Ultracot 10 mm x 13 mm (Glassine)  Ref Number: 23-03G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","41 Boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AH  2015/10 CE  2015/11 AB  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1779-2016","Class II","American Surgical Delicot non-xray 5 mm x 13 mm  Ref Number: 63-02 non-xray    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","21 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10R CL  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1800-2016","Class II","  Ref Number: 80-05    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","11 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/12 AD  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1760-2016","Class II","  Ref Number: 31-03  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","10 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AO  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1791-2016","Class II","American Surgical Delicot-J 30 mm x 70 mm  Ref Number: 63-10J  (Japan Only)    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","37 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 BH  2015/11 CC  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1735-2016","Class II","  Ref Number: 20-32S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","37 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 CO  2016/01 AH  2016/01 AE  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1758-2016","Class II","  Ref Number: 30-05  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","25 units","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 CK  2015/10 BF  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1765-2016","Class II","  Ref Number: 60-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","3 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/12 AA  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1737-2016","Class II","American Surgical Ultracot 5 mm x 8 mm (Glassine)  Ref Number: 23-01G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","11 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AJ  2015/10 CP  2015/11 BM  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1742-2016","Class II","American Surgical Ultracot 6 mm x 50 mm   Ref Number: 23-06  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","1 box","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 CT  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1748-2016","Class II","American Surgical Ultracot 30 mm x 70 mm   Ref Number: 23-10    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","2 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/11 CG  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1733-2016","Class II","  Ref Number: 20-30S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","22 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 BL  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1810-2016","Class II","  Ref Number: 90-29    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","2 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2016/01 AF  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1761-2016","Class II","  Ref Number: 31-04  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","3 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 BR  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1778-2016","Class II","American Surgical Delicot 5 mm x 13 mm  Ref Number: 63-02    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","97 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:     2015/08 CK  2015/10 BE  2015/10 CN  2015/11 AI  2015/12 AQ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1751-2016","Class II","American Surgical Ultracot 30 mm x 90 mm (Glassine)  Ref Number: 23-15G  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","33 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 BK  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1774-2016","Class II","  Ref Number: 60-29  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","38 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 CS  2015/11 CD  2015/12 BJ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1759-2016","Class II","  Ref Number: 30-07  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","34 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   Lot Number  2015/11 AL  2015/12 AS  2015/12 BD  2015/12 DJ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1728-2016","Class II","  Ref Number: 20-10S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","103 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:     2015/10 AL  2015/11 BZ  2015/12 CC  2016/01 AB  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1780-2016","Class II","American Surgical Delicot 10 mm x 13 mm  Ref Number: 63-03  Product Usage:  Neurosurgical and Nonneurosurgical Sponges      ","442 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 CL  2015/09 BT  2015/10 BT  2015/11 BG  2015/12 AI  2015/12 CF  2015/12 CQ  2016/01 AK  2016/01 AA  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1744-2016","Class II","American Surgical Ultracot 13 mm x 60 mm   Ref Number: 23-08  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","23 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 AP    ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1775-2016","Class II","American Surgical Delicot 5 mm x 8 mm  Ref Number: 63-01  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","287 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/08 CF  2015/09 CI  2015/10 CM  2015/11 AH  2015/10 CA  2015/11 AM  2015/11 BO  2015/12 AL  2015/11 BS  2015/11 BV  2015/11 BY  2015/12 AT  2015/12 BF  2015/12 CA  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1732-2016","Class II","  Ref Number: 20-26S  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","15 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/09 BJ  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1786-2016","Class II","American Surgical Delicot 9 mm x 50 mm  Ref Number: 63-07    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","315 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   Lot Number  2015/08 CE  2015/10 AS  2015/11 BD  2015/10 BX  2015/12 BH  2015/12 BW  2015/12 CP  2015/12 DC  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1788-2016","Class II","American Surgical Delicot-J 13 mm x 60 mm  Ref Number: 63-08J (Japan only)  Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","33 boxes","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:   2015/10 BN  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73734,"Ongoing","American Surgical Company","45 Congress St",,"Salem","MA","01970-5579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.","Z-1811-2016","Class II","Mass Eye & Ear Finger Cot Nasal 2's  Ref Number: 41-04    Product Usage:  Neurosurgical and Nonneurosurgical Sponges  ","16 BOXES","Product packaging defective compromising sterility","05/26/2016",," Lot numbers:     Lot Number  2015/09 AI  2015/10 CR  2015/12 BV  2015/12 CV  ",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73735,"Completed","Flying Food Group LLC","2 Airport Park Rd",,"East Granby","CT","06026-9523","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, NH, RI, MA, and MI","F-1257-2016","Class II","Dietz & Watson Brand Roasted Veggie White Tortilla Wrap  - 9.68 oz wrapped in plastic in a open paper box","11 units","Potential for glass fragments due to suppliers raw material recall","04/27/2016",," Best By 04/06/16",4/2/2016,"04/02/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73735,"Completed","Flying Food Group LLC","2 Airport Park Rd",,"East Granby","CT","06026-9523","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, NH, RI, MA, and MI","F-1258-2016","Class II","Shaw's Brand Market Fresh Eggplant & Cheese Wrap, 10.0 oz packaged in plastic inside a paper open box","63 units","Potential for glass fragments due to suppliers raw material recall","04/27/2016",," Sell By 04/07/16",4/2/2016,"04/02/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73735,"Completed","Flying Food Group LLC","2 Airport Park Rd",,"East Granby","CT","06026-9523","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, NH, RI, MA, and MI","F-1259-2016","Class II","Shaw's Brand Market Fresh Shaw Market Fresh Italian Sub, 8.3 oz. wrapped in plastic in open paper box container","109 units","Potential for glass fragments due to suppliers raw material recall","04/27/2016",," Sell By 04/06/16 ",4/2/2016,"04/02/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73735,"Completed","Flying Food Group LLC","2 Airport Park Rd",,"East Granby","CT","06026-9523","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, NH, RI, MA, and MI","F-1255-2016","Class II","Dietz & Watson Brand Italian Sub 7.3 oz bag","33 units","Potential for glass fragments due to suppliers raw material recall","04/27/2016",," Best By 04/06/16",4/2/2016,"04/02/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73735,"Completed","Flying Food Group LLC","2 Airport Park Rd",,"East Granby","CT","06026-9523","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, NH, RI, MA, and MI","F-1256-2016","Class II","Shaw's Brand Market Fresh Turkey & Roasted Red Peppers on Wheat, 5.4 oz. packaged in a wedge container","41 units","Potential for glass fragments due to suppliers raw material recall","04/27/2016",," Sell By 04/06/16 ",4/2/2016,"04/02/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73735,"Completed","Flying Food Group LLC","2 Airport Park Rd",,"East Granby","CT","06026-9523","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, NH, RI, MA, and MI","F-1254-2016","Class II","Dunkin Donuts Brand Italian Sub, Net Wt 7.7 oz packaged in   Bag, Clear View ","28 units","Potential for glass fragments due to suppliers raw material recall","04/27/2016",," Use By 04/07/16",4/2/2016,"04/02/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73736,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of: WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL.","Z-1568-2016","Class II","EndoWrist Stapler 45 and Stapler 30 instruments used on the  da Vinci Xi systems (IS4000)  with p5 software.    General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical  procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.  ","43","Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.","04/26/2016",," da Vinci systems with serial numbers:  SK0036  SK0292  SK0650  SK0039  SK0293  SK0652  SK0057  SK0294  SK0653  SK0101  SK0326  SK0654  SK0106  SK0358  SK0665  SK0119  SK0360  SK0701  SK0143  SK0382  SK0702  SK0144  SK0408  SK0710  SK0146  SK0438  SK0722  SK0171  SK0456  SK0728  SK0173  SK0484  SK0181  SK0492  SK0216  SK0496  SK0230  SK0516  SK0233  SK0548  SK0237  SK0552  SK0238  SK0610  SK0263  SK0612  SK0286  SK0631  SK0291  SK0649.",3/25/2016,"03/25/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73737,"Ongoing","Applied Medical Resources Corp","22872 Avenida Empresa",,"Rancho Santa Margarita","CA","92688-2650","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR    Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico, Switzerland, Austria, Bahrain, Lebanon, Brazil, Belgium, United Kingdom, Finland, Japan, Argentina, Ireland, Iran, Denmark, Norway, Colombia, Serbia, Uruguay, Sweden, Canada, Costa Rica, South Africa, Czech Republic, Chile, Finland, India, Thailand, Malaysia","Z-1621-2016","Class II","Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.     Distributed individually and in kits.","559,274","Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.","05/06/2016",," CA090 Direct Drive Clip Applier Lots:  1190181 to 1265006    Kit Lots (containing CA090 Direct Drive Clip Applier recalled lot(s)):  1247881 1252438 1255011 1257686 1261514 1263870 1265289 1248696 1254259 1262161 1262467 1241744 1242506 1241942 1242530 1244945 1246374 1247757 1248255 1248753 1251538 1254642 1256360 1265424 1266435 1241831 1242149 1242700 1244651 1244720 1244857 1246492 1246909 1247486 1248756 1251861 1257536 1258435 1261116 1266358 1243272 1234619 1235710 1237695 1238548 1238846 1240793 1244468 1246491 1247651 1247655 1248775 1250498 1250581 1255478 1257218 1258823 1262556 1264157 1238840 1242936 1245022 1245534 1248456 1251192 1252437 1252548 1230056 1235603 1234727 1235922 1237439 1238326 1238403 1238545 1238839 1239478 1240334 1225992 1233274 1235045 1235785 1235914 1237299 1238555 1240591 1249603 1251343 1253126 1255634 1257818 1260397 1263662 1225996 1237442 1237866 1238404 1238477 1238547  1239373 1239475 1239693 1239787 1240084 1252145 1255075 1255630 1256446 1257220 1258017 1258726 1260294 1261907 1263948 1226411 1236219 1241391 1242529 1243974 1244946 1248224 1226407 1235931 1237674 1242254 1243047 1243791 1243891 1249850 1256895 1259667 1259851 1219268 1221879 1225510 1227601 1231153 1232472 1234612 1235932 1237776 1237685 1237613 1241065 1243412 1248933 1252254 1258822 1262980 1263752 1221402 1224448 1225688 1228275 1229519 1231540 1233085 1237208 1208179 1212899 1218330 1220676 1224025 1226700 1228640 1231752 1235420 1235933 1237446 1238957 1244715 1248930 1260050 1262974 1207582 1211964 1213348 1215655 1220773 1224677 1225541 1229358 1229814 1232136 1235934 1237296 1237441 1238664 1241637 1245210 1249328 1250670 1252542 1255884 1258623 1208188 1214348 1215395  1217487 1220675 1222617 1224446 1225988 1229518 1232390 1237297 1202209 1219277 1220672 1222920 1228476 1231546 1234608 1235936 1236369 1237554 1237672 1240275 1244243 1246668 1248037 1250377 1250501 1254776 1255888 1258022 1259190 1200914 1206845 1209215 1212044 1214049 1216162 1218416 1221878 1225800 1229460 1232826 12359",4/1/2016,"04/01/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73738,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","US Distribution in the states of KY and TX.","Z-1668-2016","Class II","ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD    Product Usage:  The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.  ","27 devices ","Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size. ","05/19/2016",," Model/Catalog #: OCM7-2SD, 2.0 MM Diamond Ball, Lot Numbers: J473111699.",3/28/2016,"03/28/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73738,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","US Distribution in the states of KY and TX.","Z-1667-2016","Class II","ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD     Product  Usage:  The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.  ","27 devices","Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size. ","05/19/2016",," Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705",3/28/2016,"03/28/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73739,"Ongoing","Msu Dept Of Fd Sci Dairy Plant","165 Anthony Hall",,"East Lansing","MI","48824-1225","United States","Voluntary: Firm Initiated","Letter","Domestic: Al, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, LA, MD, ME, MI, MN, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TX, VA, WA, WI    Foreign, VA./DOD: None","F-1334-2016","Class III","Colby Jack cheese, 8 oz. and 16 oz, Vacuumed plastic pouches","Colby Jack- 943 lbs","Michigan State University Dairy is conducting a voluntary recall of Colby Jack cheese due to the potential for metal fragments to be present in the finished products. ","05/13/2016",," Colby Jack batch 11/10/15, 11/18/15-Dates Manufactured: Colby Jack 11/10/15 to 11/18/15; use by date between 3/07/16 to 6/29/16. ",4/11/2016,"04/11/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73740,"Ongoing","ADM Alliance Nutrition, Inc.","1000 N 30th St","P.O. Box C1","Quincy","IL","62301-3400","United States","Voluntary: Firm Initiated","Telephone","Domestic only: IN    No Foreign or VA/DOD","V-532-2016","Class I","Tyson Swine N5 Meal AS; Swine Starter Feed; Bulk product, listed as pounds, 48,500# loaded on trailer","48,500 lbs","ADM Animal Nutrition, Inc. is voluntarily recalling 48,500 pounds of Tyson Swine N5 medicated animal feed, Product G3039AWO10, due to excessive levels of magnesium; which could result in magnesium toxicity causing symptoms of increased water intake, severe, painful scours, and cardiac arrest leading to death in swine.","09/30/2016",," Product #G3039AWO10; Lot #BF06816 ",3/11/2016,"03/11/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73741,"Ongoing","Philips and Neusoft Medical Systems Co., Ltd.","No. 2 Xiu xiu Street","Hunnan; Sujiatun","Shenyang",,,"China","Voluntary: Firm Initiated","Letter","NC, OH, NE, SC, TX, LA, PR, MO, FL, CT","Z-1573-2016","Class II","NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501  a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.","37 units","The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be ","04/27/2016",," Serial Numbers: N16E090002, N16E090003, N16E090007, N16E090008, N16E090010, N16E100023, N16E110023, N16E110026, N16E120016, N16E120023, N16E120052, N16E120053, N16E130012, N16E130038, N16E130045, N16E140008, N16E140007, N16E140012, N16E140017, N16E140020, N16E140029, N16E140056, N16E140057, N16E140058, N16E150004, N16E150014, N16E150013, N16E150015, N16E150025, N16E150024, N16E150027, N16E150038, N16E150039, N16E150040, N16E100017, N16E140030 and N16E140031",3/24/2016,"03/24/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73742,"Ongoing","Carestream Health Inc","150 Verona St",,"Rochester","NY","14608-1733","United States","Voluntary: Firm Initiated","Letter","NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Liechtenstein, Lithuania, Macao, Malaysia, Mexico, Montenegro, Myanmar (Burma), Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Peru, Philippines,  Poland, Portugal, Romania, Russia, Saudi Arabia, Scotland, Serbia, Singapore, Slovakia, South Africa, South Korea,  Spain, Sri Lanka, Taiwan, thailand, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam.","Z-1593-2016","Class II","CARESTREAM Image Suite V3:  MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608  --- CLASSIFICATION NAME: System, Image Processing, Radiological   The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.","US: 50 units; Foreign: 2499 units",".  ","05/02/2016",," Equipment ID Numbers: US units: 8501-2596, 85018860, 8501-0954, 5241-2596,  5241-2546, 5241-2713, 5296-3447, 52414419, 52414455, 5241-2640, 5241-2716, 54838552, 5483-8502, 8501-4665, 52408158, 85014687, 54839128,  5483-9212, 52412539, 52414661, 52962897, 4745-3986, 5241-2337, 85012262, 8501-5898, 8501-2602, 54838630, 52412670, 5296-3450, 5296-3449, 54838554, 52408157, 54838618, 5241-4547, 54842652, 52420675, 8501-2861,   52414685, 52414751, 5484-3086, 54838598, 52412367, 52414417, 54839211, 54838616, 4745-5991, 52412243, 54842667, 52417149, 52412340; -- Equipment ID Numbers for Foreign Units:  Please contact CDRH Recall Group for list of affected Equipment ID Numbers. ",4/15/2016,"04/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73742,"Ongoing","Carestream Health Inc","150 Verona St",,"Rochester","NY","14608-1733","United States","Voluntary: Firm Initiated","Letter","NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Liechtenstein, Lithuania, Macao, Malaysia, Mexico, Montenegro, Myanmar (Burma), Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Peru, Philippines,  Poland, Portugal, Romania, Russia, Saudi Arabia, Scotland, Serbia, Singapore, Slovakia, South Africa, South Korea,  Spain, Sri Lanka, Taiwan, thailand, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam.","Z-1594-2016","Class II","CARESTREAM Image Suite V4;  Image Suite V4: DICOM STORE SCP:  REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop:  REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered  System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer:  Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY 14608   --- CLASSIFICATION NAME: System, Image Processing, Radiological  The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States","US: 37 units, Foreign: 269 units",".  ","05/02/2016",," Equipment ID Numbers for US units:  54842754, 54841669, 54842420, 85013694, 54842411, 54840875, 54841972, 54841973, 85017625, 85017625, 58000559, 85013233, 6482124, 54841111, 54842348, 54842197, 54842276, 52412604, 47441885, 85013624, 85013511, 85013710, 85012718, 54842406, 54843508, 5241714; -- Equipment ID Numbers for Foreign Units:  Please contact CDRH Recall Group for list of affected Equipment ID Numbers.     ",4/15/2016,"04/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73743,"Ongoing","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","E-Mail","Nationwide distribution to Louisiana and Montana.","Z-1869-2016","Class II","Laparotomy Pack Latex Free, part number 007725-7.  This is a custom convenience surgical instrument disposable kit.      There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.","40 units","These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.","06/01/2016",," lot 55689, 55263, and 57680",3/21/2016,"03/21/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73743,"Ongoing","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","E-Mail","Nationwide distribution to Louisiana and Montana.","Z-1870-2016","Class II","General Surgery Pack, part number 006880-3.  This is a custom convenience surgical instrument disposable kit.      There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.","170 units","These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.","06/01/2016",," lot 56402, 57255, 60542, and 61506",3/21/2016,"03/21/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73743,"Ongoing","Windstone Medical Packaging, Inc.","1602 4th Ave N",,"Billings","MT","59101-1521","United States","Voluntary: Firm Initiated","E-Mail","Nationwide distribution to Louisiana and Montana.","Z-1868-2016","Class II"," W/L.   ","386 units","These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.","06/01/2016",," Lot: 55950, 56349, 57461, 58034, 58492, 70671, 70930, 71324, 71726, 71892, 72656, 73071, 74331, 75004, and 75545. ",3/21/2016,"03/21/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73744,"Ongoing","B Braun Medical Inc","824 12th Ave",,"Bethlehem","PA","18018-3524","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX,  NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI","Z-1535-2016","Class I","Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.","68","Potential leakage of conductivity sensors of the Dialog Dialysis machines.","05/03/2016",," Item # 3456102A",4/1/2016,"04/01/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73744,"Ongoing","B Braun Medical Inc","824 12th Ave",,"Bethlehem","PA","18018-3524","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX,  NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI","Z-1532-2016","Class I","Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V  Product Code 710200K  Serial # >202169 and < 203249  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.","40 units","Potential leakage of conductivity sensors of the Dialog Dialysis machines.","05/03/2016",," Product Code 710200K, Serial Number Range; 202169 - 203249",4/1/2016,"04/01/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73744,"Ongoing","B Braun Medical Inc","824 12th Ave",,"Bethlehem","PA","18018-3524","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX,  NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI","Z-1534-2016","Class I","Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC  Product Code # 710200U  Serial # 202136 and < 203837  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.","90 units","Potential leakage of conductivity sensors of the Dialog Dialysis machines.","05/03/2016",," Product Code 710200 USerial Number Range; 202136-203837",4/1/2016,"04/01/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73744,"Ongoing","B Braun Medical Inc","824 12th Ave",,"Bethlehem","PA","18018-3524","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX,  NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI","Z-1536-2016","Class I","Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.","147","Potential leakage of conductivity sensors of the Dialog Dialysis machines.","05/03/2016",," Item # 3456103A",4/1/2016,"04/01/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73744,"Ongoing","B Braun Medical Inc","824 12th Ave",,"Bethlehem","PA","18018-3524","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX,  NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI","Z-1533-2016","Class I","Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL  Product Code # 710200S  Serial # >200805 and <204001  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.","318 units","Potential leakage of conductivity sensors of the Dialog Dialysis machines.","05/03/2016",," Product Code 710200S Serial Number Range; 200805-204001",4/1/2016,"04/01/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73744,"Ongoing","B Braun Medical Inc","824 12th Ave",,"Bethlehem","PA","18018-3524","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX,  NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI","Z-1531-2016","Class I","Dialog+ Hemodialysis machines: Dialog A + HE/BIC  Product Code 710200L  Serial # >200318 and < 2039222  The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.","370 units","Potential leakage of conductivity sensors of the Dialog Dialysis machines.","05/03/2016",," Product Code 710200L, Serial Number Range 200318 -203922 distributed between 08/05/2013 - 07/07/2014.",4/1/2016,"04/01/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73745,"Ongoing","Shimadzu Medical Systems","20101 S Vermont Ave",,"Torrance","CA","90502-1328","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1585-2016","Class II","X-Ray Diagnostic Table, Model No. YSF-300  Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography","185 units","Report of unintentional movement of table to reverse tilting.","04/28/2016",," Serial No.  0162A80301  0162A80302  0162A80303  0162A80401  0162A80403  0162A81001  0162A81002  0162A81003  0162A81101  0162A81102  0162A81103  0162A81104  0162A81105  0162A81106  0162A81301  0162A81302  0162A81303  0162A81304  0162A81501  0162A81502  0162A81503  0162A81504  0162A81505  0162A81601  0162A81602  0162A81603  0162A81701  0162A81702  0162A81703  0162A81704  0162A81705  0162A81801  0162A81803  0162A82101  0162A82102  0162A82202  0162A82203  0162A82301  0162A82302  0162A82501  0162A82502  0162A82601  0162A82602  0162A82701  0162A82702  0162A82703  0162A82801  0162A82802  0162A82902  0162A83001  0162A83002  0162A83101  0162A83201  0162A83202  0162A83301  0162A83302  0162A83401  0162A83501  0162A83502  0162A83601  0162A83602  0162A83702  0162A83801  0162A83901  0162A83902  0162A84001  0162A84101  0162A84102  0162A84201  0162A84202  0162A84203  0162A84301  0162A84302  0162A84401  0162A84402  0162A84501  0162A84502  0162A84601  0162A84602  0162A84701  0162A84702  0162A84802  0162A84901  0162A84902  0162A85001  0162A85002  0262A80101  0262A80102  0262A80201  0262A80202  0262A80301  0262A80302  0262A80501  0262A80502  0262A80701  0262A80702  0262A80801  0262A80802  0262A80901  0262A80902  0262A81001  0262A81101  0262A81202  0262A81301  0262A81302  0262A81401  0262A81402  0262A81501  0262A81502  0262A81601  0262A81701  0262A81702  0262A81801  0262A81802  0262A81902  0262A82002  0262A82101  0262A82102  0262A82201  0262A82202  0262A82402  0262A82502  0262A82601  0262A82701  0262A82702  0262A82901  0262A83201  0262A83202  0262A83401  0262A83501  0262A83502  0262A83602  0262A83701  0262A83702  0262A83801  0262A83802  0262A83902  0262A84101  0262A84102  0262A84201  0262A84302  0262A84401  0262A84501  0262A84502  3YAFC840A002  3YAFC840A003  3YAFC840A004  3YAFC8411001  3YAFC8413001  3YAFC8415001  3YAFC8415002  3YAFC8418001  3YAFC8418002  3YAFC841A001  3YAFC841A002  3YAFC841B001  3YAFC841B002  3YAFC841C001  3YAFC841C002  3YAFC8422001  3YAFC8422002  3YAFC8422003  3YAFC8425001  3YAFC8425002  3YAFC8427001  3YAFC84270",3/31/2016,"03/31/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73747,"Ongoing","Hologic, Inc","10210 Genetic Center Dr",,"San Diego","CA","92121-4362","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.","Z-1579-2016","Class II","CF InPlex ASR Card; Catalog Number: 95-0501.","2580 total","Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.","04/27/2016",," Lot Numbers:  U34xx  U35xx  (xx denotes sublots)",3/31/2016,"03/31/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73747,"Ongoing","Hologic, Inc","10210 Genetic Center Dr",,"San Diego","CA","92121-4362","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.","Z-1580-2016","Class II","Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.","2580 total","Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.","04/27/2016",," Lot Numbers:  C33xx  C34xx  C35xx  (xx denotes sublots)",3/31/2016,"03/31/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73748,"Ongoing","Becton, Dickinson and Company, BD Biosciences","2350 Qume Dr",,"San Jose","CA","95131-1812","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India.","Z-1570-2016","Class II","BD Trucount Absolute Counting Tubes:  Model number: 340334  IVD;    BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader. ","1743; 467 US and 1276 International","One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.","04/26/2016",," Model: 340334;  Manufacaturing lot: 534964",3/31/2016,"03/31/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73749,"Terminated","International Sprout Holding Inc.","1011 Volunteer Dr",,"Cookeville","TN","38506-5026","United States","Voluntary: Firm Initiated","Telephone","CA, FL, TN, VA, TX and  PR","F-1308-2016","Class I","ALFALFA SEED, NET WT. 50 LB. International Specialty Supply LLC, Cookeville, TN","39,909 lbs","One sample taken were positive for Salmonella Poly B","05/02/2016","07/07/2016"," SAL2-5CF",3/31/2016,"03/31/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73750,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-2371-2016","Class II","Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","29 units","Software defect causing intermittently slow response of Host.","08/09/2016",," Model #: 728321; Serial #s: 310004, 310005, 310012, 310016, 310020, 310021, 310027, 310028, 310033, 310034, 310041, 310044, 310045, 310057, 310061, 310065, 310072, 310074, 310076, 310077, 310078, 310094, 310099, 310100, 310103, 310105, 310117, 310120, 310135.",3/24/2016,"03/24/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73750,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-2366-2016","Class II","Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","318 units","Software defect causing intermittently slow response of Host.","08/09/2016",," Model #: 728231; Serial #s: 9009, 9029, 9033, 9037, 9038, 9043, 9045, 9051, 9052, 9056, 9058, 9064, 9065, 9067, 9068, 9070, 9072, 9073, 9075, 9086, 9089, 9092, 9104, 9105, 9106, 9107, 9108, 9112, 9120, 9139, 9151, 9152, 9156, 9190, 9243, 9259, 9502, 9503, 9504, 9507, 9508, 9511, 9512, 9515, 9516, 9522, 9525, 9526, 9529, 9530, 9531, 9533, 9534, 9545, 9547, 9550, 9551, 9556, 9561, 9564, 9572, 9577, 9580, 9584, 9591, 9594, 9596, 9598, 9603, 9606, 9607, 9608, 9612, 9613, 9614, 9618, 9620, 9624, 9625, 9626, 9628, 9630, 9633, 9634, 9635, 9639, 9640, 9641, 9642, 9646, 9648, 9650, 9655, 9663, 9666, 9667, 9672, 9676, 9678, 9685, 9686, 9690, 9691, 9692, 9694, 9695, 9697, 9700, 9705, 9706, 9709, 9713, 9716, 9726, 9729, 9732, 9735, 9736, 9738, 9740, 9750, 9751, 9752, 9753, 9754, 9757, 9759, 9760, 9761, 9775, 9777, 9780, 9781, 9788, 9790, 9793, 9794, 9802, 9805, 9809, 9811, 9812, 9821, 9823, 9826, 9830, 9833, 9835, 9843, 9846, 9855, 9857, 9860, 9861, 9866, 9869, 9870, 9873, 9875, 9876, 9878, 9879, 9881, 9882, 9885, 9888, 9889, 9890, 9894, 9895, 9902, 9906, 9910, 9916, 9917, 9918, 9924, 9936, 9937, 9938, 9942, 9948, 9951, 9954, 9960, 9961, 9965, 9966, 9968, 9969, 9974, 9975, 9978, 9980, 9982, 9985, 9992, 9993, 9994, 9999, 10001, 10005, 10014, 10018, 10026, 10030, 10031, 10035, 10036, 10037, 10041, 10045, 10046, 10051, 10054, 10065, 10067, 10070, 10072, 10079, 10080, 10085, 10086, 10094, 10095, 10096, 10098, 10103, 10111, 10112, 10113, 10120, 10122, 10125, 10141, 10148, 10190, 10194, 10200, 10202, 10203, 10211, 10224, 10256, 10263, 10291, 10292, 10310, 10332, 10353, 10359, 10363, 10365, 10370, 10371, 10372, 10373, 10380, 10381, 10386, 10388, 10413, 10417, 10424, 10426, 10473, 10486, 10505, 10513, 10527, 10535, 10561, 10570, 10645, 10651, 10655, 10673, 10686, 10733, 10743, 10773, 10776, 29005, 29007, 29016, 29018, 29025, 29027, 29035, 29037, 29053, 29054, 29068, 29097, 64015, 90031, 90047, 90062, 90063, 90128, 95003, 95008, 95022, 95057, 95058, 95068, 95149, 95197, 95210, 95348, 95357, 95377, 95392, 95403, 95811, 95341A, 985",3/24/2016,"03/24/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73750,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-2369-2016","Class II","Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","203 units","Software defect causing intermittently slow response of Host.","08/09/2016",," Model #: 728246; Serial #s: 3010, 3017, 3031, 3040, 3043, 3070, 3072, 3085, 3090, 3117, 3123, 3149, 3179, 3216, 3247, 3293, 3314, 3324, 3411, 3465, 3490, 5006, 5009, 5012, 5018, 5020, 5024, 5026, 5028, 5030, 5031, 5035, 5044, 5045, 5048, 5052, 5053, 5054, 5055, 5058, 5059, 5060, 5064, 5069, 5070, 5075, 5077, 5081, 5086, 5088, 5091, 5093, 5097, 5099, 5101, 5103, 5107, 5108, 5110, 5111, 5113, 5115, 5116, 5118, 5120, 5123, 5126, 5127, 5128, 5131, 5135, 5138, 5140, 5147, 5155, 5160, 5161, 5163, 5166, 5181, 5184, 5186, 5188, 5190, 5191, 5192, 5193, 5195, 5197, 5208, 5209, 5216, 5219, 5224, 5231, 5235, 5236, 5237, 5270, 5272, 5279, 5282, 5285, 5287, 5288, 5294, 5295, 5315, 5316, 5347, 5348, 5350, 5354, 5357, 5360, 5368, 5394, 5405, 5412, 5433, 5434, 5443, 5453, 5457, 5474, 5480, 5487, 5501, 5502, 5505, 5516, 5519, 5523, 5526, 5554, 5572, 5573, 5576, 5609, 5615, 5633, 5647, 5653, 5674, 5683, 5703, 5723, 5758, 5762, 5764, 5771, 5811, 5897, 5929, 5937, 5956, 5974, 5995, 6021, 6022, 6031, 6033, 6048, 6053, 6072, 6154, 6220, 6229, 6243, 6280, 6283, 6298, 6299, 6309, 6321, 6360, 6375, 6405, 6426, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6549, 6555, 6559, 30011, 30049, 30110, 32287, 32366, 50011, 50053, 50087, 50180, 50181, 5238A.",3/24/2016,"03/24/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73750,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-2367-2016","Class II","Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","8 units","Software defect causing intermittently slow response of Host.","08/09/2016",," Model #: 728243; Serial #s: 7063, 7116, 7169, 7205, 7309, 7314, 7354, 7611.",3/24/2016,"03/24/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73750,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-2368-2016","Class II","Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","17 units","Software defect causing intermittently slow response of Host.","08/09/2016",," Model #: 728244; Serial #s: 7052, 7172, 7200, 7244, 7252, 7375, 7380, 7384, 7390, 7514, 7533, 7546, 7614, 7633, 7708, 7781, 7789. ",3/24/2016,"03/24/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73750,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-2372-2016","Class II","Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","5 units","Software defect causing intermittently slow response of Host.","08/09/2016",," Model #: 728323; Serial #s: 310067, 320002, 320004, 320053, 320056. ",3/24/2016,"03/24/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73750,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.","Z-2370-2016","Class II","Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","55 units","Software defect causing intermittently slow response of Host.","08/09/2016",," Model #: 728240; Serial #s: 3100, 3236, 5043, 5047, 5280, 5345, 5390, 5395, 5413, 5430, 5476, 5495, 5499, 5500, 5512, 6007, 6009, 6013, 6032, 6041, 6045, 6049, 6051, 6058, 6062, 6064, 6066, 6067, 6070, 6071, 6077, 6080, 6081, 6084, 6089, 6095, 6098, 6100, 6106, 6109, 6113, 6115, 6116, 6119, 6120, 6123, 6124, 6131, 6132, 6134, 6141, 6144, 6155, 6161, 6162.",3/24/2016,"03/24/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73751,"Ongoing","Fresenius Kabi USA, LLC","3 Corporate Dr",,"Lake Zurich","IL","60047-8930","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0819-2016","Class II","Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC  Lake Zurich, IL 60047, NDC 63323-417-10","94,560 vials","Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label.  The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative. ","04/12/2016",," Lot #: 6010157, Exp. 01/2017 ",4/5/2016,"04/05/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73752,"Ongoing","Biocare Medical, LLC","4040 Pike Ln",,"Concord","CA","94520-1227","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: KS, CA, AZ, OR, FL, KS, CO, MA, KY, NY, IL, OR, MO, NC, TX, PA, OK. SC, TN, PA, TN, GA, and OR.    Hungary, Canada, Boliva","Z-1523-2016","Class III","Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit;  Catalog number M4U534L;  For In Vitro Use    Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.  ","93","Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer.","04/19/2016",," Lot number 082715;   Expiry 01/2017.",3/31/2016,"03/31/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73753,"Terminated","Puget Sound Blood Center and Program","921 Terry Ave",,"Seattle","WA","98104-1239","United States","Voluntary: Firm Initiated","Telephone","Washington","B-0465-16","Class III","Washed Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","RBC product, not prepared in accordance with specifications, was distributed.","04/25/2016","04/25/2016"," W141616550467",2/25/2016,"02/25/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73755,"Terminated","Innovative Blood Resources","100 N 84th St",,"Lincoln","NE","68505-3101","United States","Voluntary: Firm Initiated","FAX","Tennessee","B-0466-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who traveled within one year to a malarial endemic area, was distributed.","04/25/2016","04/25/2016"," W087915311438 ",3/7/2016,"03/07/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73756,"Terminated","Houchin Community Blood bank","11515 Bolthouse Drive",,"Bakersfield","CA","93311","United States","Voluntary: Firm Initiated","FAX","California","B-0420-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ","04/25/2016","04/25/2016"," W224315315964",2/23/2016,"02/23/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73757,"Completed","Walter L. Shepeard Community Blood Center, Inc.","1533 Wrightsboro Rd",".","Augusta","GA","30904-4024","United States","Voluntary: Firm Initiated","FAX","Kentucky; Georgia","B-0418-16","Class II","Red Blood Cells, Leukocytes Reduced","5 units","Blood products, collected from an ineligible donor, were distributed. ","04/07/2016",," W038516800324; W038515806864; W038515804514; W038515803243; W038515801812",3/23/2016,"03/23/2016",4/13/2016,"04/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73758,"Terminated","Blood Bank of Alaska, Inc.","1215 Airport Heights Dr",,"Anchorage","AK","99508","United States","Voluntary: Firm Initiated","Telephone","Alaska","B-0441-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Misbranded Red Blood Cells were distributed.  ","04/25/2016","04/25/2016"," W066515653503",1/31/2016,"01/31/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73759,"Terminated","American National Red Cross The","100 Red Cross Cir",,"Pomona","CA","91768-2580","United States","Voluntary: Firm Initiated","Telephone","CA","B-0498-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","05/16/2016","05/16/2016"," W200615922497",2/18/2016,"02/18/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73759,"Terminated","American National Red Cross The","100 Red Cross Cir",,"Pomona","CA","91768-2580","United States","Voluntary: Firm Initiated","Telephone","CA","B-0497-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","05/16/2016","05/16/2016"," W200615520367",2/18/2016,"02/18/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73760,"Terminated","Innovative Blood Resources","100 N 84th St",,"Lincoln","NE","68505-3101","United States","Voluntary: Firm Initiated","FAX","NJ","B-0494-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.","05/16/2016","05/16/2016"," W087916300520",3/7/2016,"03/07/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73761,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WV, WI, and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom","Z-1561-2016","Class II","Radionuclide Radiation Therapy System    Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.","217","The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.","04/22/2016",," Perfexion - 14753-099/6052, 12579-007/6250, 10394-LGK01/6144, 11920-C5210/6088, 17397-001/6158, 105528-001/6122, 14857-001/6028, 12236-006/6097, 12473-003/6005, 14857-001/6028, 16867-001/6166, 12668-003/6145  10208-003/6215, 10698-001/6237, 10979-002/6213, 10316-500/6210, 21061-001/6195, 20364-001/6103, 11720-002/6143, 12620-002/6120, 10611-001/6081, 12846-004/6064, 11524-002/8001, 11420-001/6212, 11420-001/6228, 14983-001/6076, 11083-HOM001/6070, 10247-002/6136,10684-002/6090,11868-004/6002, 10795-K08002/6063, 20354-ENS/6160, 11792-005/6077, 11291-001/6018, 10326-003/6105, 18630-001/6031, 17322-001/6121, 30000656-002/6227, 12629-003/6026, 10924-001/6089, 11154-003/6050, 20438-003/6013  17522-001/6214, 17525-002/6038, 11414-LGK002/6205, 11940-LGK002/6181, 10514-LGK002/6183, 11639-LGK001/6042, 11390-LGK001/6109, 10416-LGK001/6125, 11670-LGK001/6133, 11990-LGK001/6118, 10648-LGK001/6098,  15104-LGK001/6080, 10654-LGK001/6096, 10959-LGK001/6132, 10997-LGK001/6087, 15748-LGK001/6106, 11149-LGK002/6206, 11986-LGK002/6218,  10929-LGK002/6175, 10879-LGK002/6234, 11434-LGK002/6255, 11991-LGK002/6198, 13480-LGK002/6148, 10425-LGK002/6254, 10583-LGK002/6161,  11563-LGK002/6162, 10103-LGK02/6149, 10541-LGK002/6142, 10848-LGK001/6108, 11433-LGK001/6116, 14900-LGK001/6058, 15045-LGK001/6091  11784-LGK001/6055, 30000732-001/6223, 40017-002/6170, 12085-006/6163,   12109-002/6169, 12959-002/6033, 10209-001/6046, 10960-005/6193, 0002718-001/6113, 30001751-WOJ701/6068, 12451-001/6019, 14878-003/6067, 105618-001/6110, 19634-001/6155, 16647-001/6187, 14891-001/6104, 30001527-001/6231, 12028-LGK002/6217, 11586-001/6157, 10728-001/6062, 11999-001/6126, 15416-001/6086, 10459-001/6123, 10158-001/6177, 10234-002/6111, 40023-001/6178, 10444-001/6085, 17033-003/6043, 11530-001/6101, 11553-001/6024, 10779-07/6069, 13465-CHUV03/6094, 10424-001/6182, 13370-002/6075, 12214-003/6007, 30000655-001/6199, 10152-001/6159, 11550-001/6065, 10118-001/6230, 12766-001/6112, 13160-001/6039, 11042-001/6003,   12270-001/6017, 18062-001/6146, 11710-004/",4/19/2016,"04/19/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73762,"Ongoing","Vaughan Foods","216 NE 12th Street",,"Moore","OK","73160","United States","Voluntary: Firm Initiated","Telephone","MO, IL, IN, WI, and IA","F-1319-2016","Class II","La Fiesta Bean Salad (2/5 LB Tubs) Made By Fresh Creative Foods Moore, OK 73160 UPC 013454371763 packaged in white plastic tub with lid","126 cases","Undeclared Wheat.","05/05/2016",," Product ID #: 402690; Best if Used By: 05/07/2016, Lot: BFEGJD and Best if Used By: 05/11/2016, Lot: BFGHFE",4/4/2016,"04/04/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0222-2017","Class I","HEB Ready Fresh Go Carrots, Apples & Celery with Ranch Dip 6.75 oz. UPC 4122054448 packaged in clear plastic tray","11,192 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/2016 to 04/03/2016",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0217-2017","Class I","Fruit Party Tray 45 oz. UPC 4122087997 packaged in clear plastic rectangle container","86,144 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/2016 to 04/03/2016",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0220-2017","Class I","Fruit & Veg Combo Tray 40 oz. UPC 4279796688 packaged in clear plastic rectangle tray","2,121 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/2016 to 04/03/2016",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0218-2017","Class I","Deluxe Fruit Tray 52 oz. UPC 427979661 packaged in clear plastic round container","18,392 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/2016 to 04/03/2016",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0214-2017","Class I","HEB Ready Fresh Go Sliced Red Apples 22.5 oz UPC 4122018603 packaged in clear plastic bag and Value Pack Sliced Apples 28 oz. UPC 4279796149 packaged in clear non-flexible plastic bowl and Large Sliced Red Apples 17 oz. UPC 4122087646 packaged in a clear non-flexible plastic container.","55,014 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16 to 04/11",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0223-2017","Class I","HEB Ready Fresh Go Carrots, Apples with Sesame Sticks & Hummus 6 oz. UPC 4122002144 packaged in clear plastic tray","5,072 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/2016 to 04/03/2016",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0215-2017","Class I","HEB Ready Fresh Go Sliced Red Apples With Caramel Dip 16 oz UPC 4122079830 packaged in clear plastic bag","5,824 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16 to 04/11",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0225-2017","Class I","HEB Ready Fresh Go Pineappple, Grapes & Apples with Banana Chips 6 oz. UPC 4122002138 packaged in clear plastic tray","10,520 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/2016 to 04/03/2016",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0216-2017","Class I","Red & Green Apples Large 17 oz. UPC 4122087649 packaged in clear plastic container","34,425 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/16 to 04/11/16",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0221-2017","Class I","HEB Ready Fresh Go Fresh Fruit Medley 7 oz. UPC 4122002402 packaged in clear plastic tray","12,376 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/2016 to 04/03/2016",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0224-2017","Class I","HEB Ready Fresh Go Carrots, Apples with Yogurt Pretzels and Ranch Dip 4.75 oz. UPC 4122002119 packaged in clear plastic tray","5,888 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/2016 to 04/03/2016",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73763,"Ongoing","Fresh From Texas Inc.","3602 Highpoint St",,"San Antonio","TX","78217-2864","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0219-2017","Class I","Apples & Grapes 10 oz. UPC 4122087666 packaged in clear plastic container","137,376 units","Product has the potential to be contaminated with Listeria monocytogenes.","10/20/2016",," Best By Date 03/16/2016 to 04/03/2016",4/5/2016,"04/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73764,"Ongoing","Veterinary Pharmacy Corporation","2008 North Sunrise Drive",,"Saint Peter","MN","56082-2044","United States","Voluntary: Firm Initiated","Telephone","OH","V-517-2016","Class II","RX 214-650; Iron  20% ( 200 mg /ml), Pharmacosmos Lot # P926, Vet Rx Lot # V20030716, Beyond Use Date: 03/17 Made by JBE, Volume 1000 ml bag","#20  1000ml bags","Vet Rx Pharmacy is recalling RX 215-650, 200 mg/ml Iron 1000 ml bag because product failed the sterility test.","09/20/2016",," Vet Rx Lot # V20030716, Product Code 4001500",3/22/2016,"03/22/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73765,"Ongoing","Lumenis Ltd","13 Hayetzira St.,Yokneam Ind. Park",,"Yokneam",,,"Israel","Voluntary: Firm Initiated","Letter","Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.","Z-1669-2016","Class II","Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).","33 filters","Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.","05/13/2016",," Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) All Acne Filters manufactured and Distributed Between: August 04 2015 and November 06 2015",11/17/2015,"11/17/2015",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73766,"Ongoing","Ventlab LLC","2710 Northridge Dr NW Ste A",,"Grand Rapids","MI","49544-9112","United States","Voluntary: Firm Initiated","E-Mail","Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.","Z-1880-2016","Class II","STAT-Check Resuscitation Bag  Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer  Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).","2430","Stat-check CO2 indicators are non-functional.  The indicator is yellow when not in use and should be purple when not in use.  The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly.  The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.     ","06/01/2016",," Model SC9001B  Adult STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask  Lot numbers 303320 and 303612    Model SC9001C  Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir & Mask  Lot number 303400    Model SC9001C-C  Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir, Mask & Straight Connector  Lot numbers 303523 and 303791    Model SC8001B  Pediatric STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask  Lot number 303833        ",3/15/2016,"03/15/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73767,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1597-2016","Class II","INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723.  An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.","6597 packs","The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.","05/03/2016",," Lot numbers: 1623139H, 1623140H, 1623138H, 1623141H, 1623765H, 1623148H, 1623766H, 1623767H, 1623768H, 1623142H",10/6/2014,"10/06/2014",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73768,"Ongoing","Sparhawk Laboratories Inc","12340 Santa Fe Trail Dr",,"Lenexa","KS","66215-3587","United States","Voluntary: Firm Initiated","Telephone","Product was distributed to wholesalers in KS, MO, and OH.  There was no foreign/military/government distribution.","V-0028-2017","Class II","GentaVed Topical Spray.  For Animal Use Only. ANADA 200-416. Each mL contains: gentamicin sulfate, USP equivalent to 0.57 mg gentamicin base, betamethasone valerate, USP equivalent to 0.284 mg betamethasone.  12-60 mL bottles/carton, Sparhawk Laboratories, Inc., Lenexa, KS 66215-3591.","9,250 cartons","Betamethasone Valerate in recalled product found below specification at the 18 month stability time point.","11/23/2016","."," Lot 140566, expiration date 10/2016",4/7/2016,"04/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73769,"Ongoing","Sparhawk Laboratories Inc","12340 Santa Fe Trail Dr",,"Lenexa","KS","66215-3587","United States","Voluntary: Firm Initiated","Telephone","Product was distributed to KS, MO, and OH.  There was no military/government/foreign distribution.","V-0015-2017","Class III","Phenylbutazone 20% Injection 200 mg/ ml - 100 ml glass vials packed in cartons of 12 (ANADA 200-371) manufactured by Sparhawk Laboratories, Inc. Lenexa, KS 66215.  Distributed under the following brands:  (1) Sparhawk Laboratories Inc. Lenexa, KS 66215; (2) Vet One NDC 13985-825-04, Distributed by MWI, Boise, ID 83705; (3) Henry Schein Animal Health, Dublin, OH 43017; (4) Phoenix NDC 57319-508-05 - Clipper Distributing Company LLC, St. Joseph, MO 64507; (5)  Aspen Veterinary Resources, Ltd., Liberty, MO 64068; and (6) Vedco, Inc. NDC 60989-425-12, St. Joseph, MO 64507.","14,553 cartons","The product pH was found to be out of specification at the 6-month stability time point. ","11/15/2016",," lot 150906, exp. date 8/24/2017",4/6/2016,"04/06/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73770,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed in IL and IN.","Z-1574-2016","Class II","5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile;  Catalog ID # 02.221.462S  Indicated for fixation of various long bones.","15 units","This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.  ","04/27/2016",," Lot Number 5539094, Catalog ID # 02.221.462S  Manufacture date 07/02/2007  Expiration date 05/31/2012",4/4/2016,"04/04/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73771,"Terminated","BPL Plasma, Inc.","11601 E Colonial Dr",,"Orlando","FL","32817-4608","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0515-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor with no documentation of general appearance or arm inspection, was distributed.","05/16/2016","05/16/2016"," OL0564600",3/2/2016,"03/02/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73773,"Terminated","Rhode Island Blood Center","405 Promenade St",,"Providence","RI","02908-4811","United States","Voluntary: Firm Initiated","Telephone","CT","B-0512-16","Class II","Pooled Platelets, Leukocytes Reduced","1 unit ","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.","05/16/2016","05/16/2016"," W051716800850",3/7/2016,"03/07/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73774,"Terminated","BPL Plasma, Inc","5789 Airport Blvd",,"Austin","TX","78752-4201","United States","Voluntary: Firm Initiated","E-Mail","NC","B-0511-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.","05/16/2016","05/16/2016"," AU0702568",2/26/2016,"02/26/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73775,"Terminated","BPL Plasma, Inc.","2631 Dunn Ave",,"Jacksonville","FL","32218-4656","United States","Voluntary: Firm Initiated","E-Mail","Switzerland","B-0514-16","Class III","Source Plasma"," 1 unit","Blood product, collected from a donor whose suitability was not adequately determined, was distributed.","05/16/2016","05/16/2016"," JV0291267",1/12/2016,"01/12/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73776,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.","Z-1505-2016","Class II","Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH.    Provides software applications used to process, analyze, and display medical images/data.","37 Units","The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another.  However, certain gamma cameras allow for other relative detector angles.  Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.","04/15/2016",," M/N 882488; S/N: 66565, 66586, 66589, 66670, 66681, 66672, 66644, 66888, 66374, 66371, 66305, 66824, 66261, 66356, 66059, 66056, 67027, 66248, 66590, 66240, 66097, 66268, 66555, 66500, 66754, 66469, 66411, 66252, 66263, 66307, 66311, 66310, 66306, 66259, 67054, 67000 & 67017.",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73776,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.","Z-1506-2016","Class II","IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH.    Provides software applications used to process, analyze, and display medical images/data. ","33 Units","The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another.  However, certain gamma cameras allow for other relative detector angles.  Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.","04/15/2016",," M/N 881001; S/N: 85254, 82202, 85330, 82117, 7000022, 105009, 970001, 850001, 870030, 82141, 95068, 87182, 87197, 95078, 82140, 11017, 98139, 95035, 87200, 980047, 85314, 85303, 980046, 85298, 822022, 7000019, 950076, 950115, 95043, 95047, 950021, 960123 & 105006.",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73776,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.","Z-1504-2016","Class II","Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH.    Provides software applications used to process, analyze, and display medical images/data.","126 Units","The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another.  However, certain gamma cameras allow for other relative detector angles.  Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.","04/15/2016",," M/N 882489; S/N: 66794, 66798, 66836, 66009,66011, 67154, 66828, 67058, 67050, 67031, 67284, 66332, 66335, 66397, 67026, 67040, 66084, 66089, 66092, 67007, 67011, 67226, 66956, 66454, 66447, 66413, 66129, 66128,	66300, 66023, 11728, 66000, 66938, 67270, 67252, 66571, 66443, 66324, 66869, 68477,	66682, 66815, 66284, 67263, 66265, 66277, 66880, 66892, 66258, 66079, 66181, 66451,	66627, 66187, 66806, 67016, 67008, 66706, 66745, 66817, 66822, 66910, 66908, 66811,	67087, 67094, 66241, 66825, 66632, 66624, 66854, 66689, 66690, 66906, 66792, 67173,	67069, 67166, 68290, 67182, 66785, 67292, 67286, 66768, 66769, 66550, 66113, 67220,	67193, 67186, 66657, 66668, 66564, 66065, 67065, 67208, 67204, 66818, 66819, 67122,	66818, 66819, 66456, 67212, 66019, 67057, 67172, 67157, 67167, 67162, 66737, 68361,	66183, 66368, 66387, 66376, 66415, 66136, 66137, 66960, 66958, 67142 & 67165.",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73777,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay","Z-1692-2016","Class II","Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.","83,448 units","The product has potential to leak beyond their design specification.","05/18/2016",," Lot Numbers: 15011624X, 15013312X,  15013313X,  15014272X,  15014273X,  15015769X,  15016782X,  15016783X,  15016784X,  15018549X,  15018550X,  15018554X,  15018602X,  15018603X,  15018606X,  15018888X,  15018890X,  15020828X,  15020830X,  15021333X,  15021337X,  15022350X,  15022414X,  15022416X,  15025385X,  15025395X,  15027298X,  15027819X,  15027820X,  15027834X,  15027843X,  15028267X,  15028268X,  15031226X,  15031229X,  15031231X,  15031232X,  15032112X,  15034244X,  15034779X",8/11/2015,"08/11/2015",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73777,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay","Z-1694-2016","Class II","Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.","30,701 units","The product has potential to leak beyond their design specification.","05/18/2016",," Lot Numbers: 1707828H  1710591H  1710852H  1710853H  1713426H  1713909H  1714519H  1714520H  1715966H  1715967H  1715968H  1715969H  1715973H  1715974H  1715975H  1715978H  1715985H  1715987H  1715990H  1715991H  1715998H  1715999H  1716000H  1716820H  1716821H  1717967H  1718269H  1718273H  1718369H  1718370H  1719092H  1720758H  1720765H  1721380H  1721388H  1721395H  1721590H  1721896H  1722499H  1723082H  1723088H  1723124H  1723841H  1723845H  1723846H  1723876H  1724755H  1724756H  1726782H  1726930H  1726931H  1727056H  1727768H  1729898H  1729997H  1730138H  1730976H  1731351H  1732658H  1732662H  1733829H  1733830H  1734007H  1734008H  1734911H  1735731H  1735814H  1735911H  1735923H  1735928H  1736349H  1736859H  1736860H  1736862H  1736864H  1736865H  1736867H  1736870H  1736874H  1736877H  1736885H  1737097H  1738696H  1738899H  1738938H  1739014H  1739016H  1739025H  1739336H  1739338H  1739341H  1739346H  1741490H  1741507H  1741519H  1741573H  1741945H  1742057H  1742059H  1742062H  1742068H  1742070H  1742071H  1742072H  1742079H  1742650H  1742654H  1742972H  1742973H  1742976H  1742978H  1743078H  1743400H  1744476H  1744481H  1744485H  1744825H  1744938H  1745226H  1745227H  1745228H  1745236H  1745239H  1745240H  1745241H  1745242H  1745795H  1746416H  1746876H  1747429H  1747430H  1747431H  1747432H  1747433H  1747434H  1747435H  1747440H  1747441H  1747450H  1747453H  1747454H  1748102H  1748377H  1748380H  1748381H  1748382H  1748383H  1748385H  1748387H  1748389H  1748390H  1748394H  1748396H  1748397H  1748402H  1748403H  1748404H  1748958H  1748982H  1749454H  1749765H  1749769H  1750191H  1750258H  1750264H  1750493H  1750496H  1750506H  1750508H  1750509H  1750516H  1750517H  1750674H  1750675H  1750677H  1751954H  1752223H  1752819H  1752838H  1752974H  1753131H  1753135H  1753136H  1753143H  1753144H  1754060H  1754092H  1754115H  1754122H  1754127H  1754939H  1755021H  1755151H  1755152H  1755163H  1755416H  1755417H  1755418H  1756025H  1756136H  1756242H  1756243H  1756437H  1",8/11/2015,"08/11/2015",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73777,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay","Z-1693-2016","Class II","23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.","225,000 units","The product has potential to leak beyond their design specification.","05/18/2016",," Lot Numbers: 1711482H  1711485H  1714709H  1714711H  1714712H  1714713H  1714715H  1714716H  1714717H  1714736H  1714737H  1714738H  1714739H  1717871H  1717872H  1717874H  1717895H  1717896H  1717902H  1726095H  1726102H  1726103H  1726104H  1726105H  1726106H  1726107H  1726118H  1726119H  1726120H  1726121H  1726122H  1731592H  1731595H  1731929H  1731930H  1731931H  1731932H  1731933H  1734476H  1734478H  1734479H  1734480H  1734481H  1734546H  1734547H  1734548H  1734549H  1734550H  1734551H  1734552H  1734559H  1734560H  1734561H  1734562H  1734563H  1734564H  1734565H  1734566H  1734567H  1734568H  1734569H  1734570H  1734571H  1734572H  1734573H  1734574H  1735125H  1735126H  1735127H  1735128H  1735129H  1735130H  1735131H  1735132H  1746173H  1746197H  1746198H  1746199H  1746200H  1746201H  1747011H  1747012H  1747013H  1747014H  1747015H  1749215H  1749216H  1749217H  1749218H  1749219H  1749220H  1749221H  1751293H  1753301H  1753302H  1753303H  1753323H  1753324H  1753325H  1753326H  1753327H  1753328H  1753329H  1753339H  1753342H  1753346H  1753347H  1753348H  1753360H  1753361H  1753362H  1753363H  1756285H  1756286H  1759094H  1759095H  1759096H  1759097H  1759098H  1759099H  1759100H  1759101H  1759171H  1759172H  1759173H  1759174H  1759175H  1759176H  1759182H  1759183H  1759185H  1759186H  1759195H  1759196H  1759197H  1759198H  1764487H  1764488H  1764489H  1764710H  1764711H  1764712H  1764713H  1764714H  1764715H  1764716H  1764717H  1764718H  1764719H  1764720H  1764721H  1764722H  1764723H  1764735H  1764736H  1767599H  1773000H  1773001H  1773015H  1773016H  1773017H  1773018H  1775519H  1775520H  1775521H  1775522H  1775523H  1775524H  1775525H  1775526H  1780757H  1780758H  1780759H  1780760H  1780761H  1780762H  1780763H  1783252H  1783259H  1783260H  1783261H  1783272H  1783273H  1783274H  1783275H  1783276H  1783293H  1783294H  1783295H  1783296H  1783298H  1783299H  1783300H  1785543H  1791450H  1791452H  1791478H  1791481H  1791484H  1791485H  1791486H  1794207H  1794208H  1",8/11/2015,"08/11/2015",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73778,"Ongoing","Actavis Pharma Inc","400 Interpace Pkwy",,"Parsippany","NJ","07054-1120","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1060-2016","Class III","Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10","447,150 Bottles","Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).","06/30/2016",," Lot #s: a)  626487, Exp. 3/31/2016, 628181, Exp. 6/30/2016, 629827, Exp.  9/30/2016, 630495, Exp. 10/31/2016, 632266, Exp. 2/28/2017, 633683 Exp.  4/30/2017, 347742, Exp. 09/30/2017;     b) 626487, Exp. 3/31/2016, 627438, 628080, Exp. 5/31/2016, 628181, 628491, Exp. 6/30/2016, 628634, Exp. 7/31/2016, 629141 Exp.  8/31/2016, 629827, Exp. 9/30/2016, 630495, Exp. 10/31/2016, 631528, Exp. 12/31/2016, 632266, Exp.  2/28/2017,  347613, Exp. 9/30/2017, 348175, Exp. 10/31/2017;     c) 628398 Exp. 6/30/2016, 630495, Exp.10/31/ 2016, 630511, Exp. 10/31/2016 347361, Exp. 8/31/2017 ",3/16/2016,"03/16/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73779,"Ongoing","LED Technologies, LLC","6000 Greenwood Plaza Blvd","Ste 110","Greenwood Village","CO","80111-4816","United States","Voluntary: Firm Initiated","Letter","Distributed to 1 consignee located in the United States.","Z-1581-2016","Class II","reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS)      Product Usage:  The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.  ","32 units","Incorrect Power Supply in the package, rendering the device inoperable. ","04/27/2016",," Manufactured between 12/15/2015 and 12/28/2015 for specific lot #1052",3/30/2016,"03/30/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73780,"Ongoing","Medtronic Inc., Cardiac Rhythm and Heart Failure","8200 Coral Sea St NE",,"Mounds View","MN","55112-4391","United States","Voluntary: Firm Initiated","Letter","AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.","Z-1605-2016","Class II"," Monitor (2020B)    Product Usage:  The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician. The data is transmitted either through an analog telephone line, a cellular connection or an internet connection.  ","5038","A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the CareLink Network. This incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment of phone numbers for other select cou","05/04/2016",," Model	Serial Number  2020B	LPH003245P  2020B	LPH004235P  2020B	LPH004270P  2020B	LPH004448P  2020B	LPH004578P  2020B	LPH006282P  2020B	LPH006598P  2020B	LPH006892P  2490C	IJX010143A  2490C	IJX010218A  2490C	IJX010291A  2490C	IJX010304A  2490C	IJX010320A  2490C	IJX010414A  2490C	IJX010416A  2490C	IJX010441A  2490C	IJX010474A  2490C	IJX010489A  2490C	IJX010501A  2490C	IJX010521A  2490C	IJX014234A  2490C	IJX014380A  2490C	IJX014382A  2490C	IJX014387A  2490C	IJX014436A  2490C	IJX014473A  2490C	IJX014502A  2490C	IJX014591A  2490C	IJX019468A  2490C	IJX019469A  2490C	IJX019550A  2490C	IJX019568A  2490C	IJX019647A  2490C	IJX019681A  2490C	IJX019716A  2490C	IJX019729A  2490C	IJX019731A  2490C	IJX019752A  2490C	IJX019753A  2490C	IJX019756A  2490C	IJX019782A  2490C	IJX019824A  2490C	IJX019845A  2490C	IJX019905A  2490C	IJX019933A  2490C	IJX019944A  2490C	IJX019947A  2490C	IJX020167A  2490C	IJX020175A  2490C	IJX020197A  2490C	IJX020240A  2490C	IJX020247A  2490C	IJX020371A  2490C	IJX020403A  2490C	IJX020409A  2490C	IJX020419A  2490C	IJX020450A  2490C	IJX020467A  2490C	IJX020566A  2490C	IJX020620A  2490C	IJX020715A  2490C	IJX020774A  2490C	IJX020781A  2490C	IJX020803A  2490C	IJX020806A  2490C	IJX020811A  2490C	IJX020846A  2490C	IJX020861A  2490C	IJX020862A  2490C	IJX020914A  2490C	IJX020920A  2490C	IJX020987A  2490C	IJX020988A  2490C	IJX021117A  2490C	IJX021158A  2490C	IJX021172A  2490C	IJX021239A  2490C	IJX021335A  2490C	IJX021355A  2490C	IJX021422A  2490C	IJX021477A  2490C	IJX021512A  2490C	IJX021545A  2490C	IJX021551A  2490C	IJX021582A  2490C	IJX021599A  2490C	IJX021610A  2490C	IJX021621A  2490C	IJX021631A  2490C	IJX021646A  2490C	IJX021684A  2490C	IJX021777A  2490C	IJX021783A  2490C	IJX021804A  2490C	IJX021809A  2490C	IJX025346A  2490C	IJX028261A  2490C	IJX028274A  2490C	IJX028283A  2490C	IJX028314A  2490C	IJX028322A  2490C	IJX028333A  2490C	IJX028351A  2490C	IJX028406A  2490C	IJX028432A  2490C	IJX028434A  2490C	IJX028495A  2490C	IJX028503A  2490C	IJX028515A  2490C	IJX028537A  2490C	IJX028543A  2490C	IJX028550A  2490C	I",3/31/2016,"03/31/2016",5/11/2016,"05/11/2016","X261271A  2490C	IJX261278A  2490C	IJX261280A  2490C	IJX261299A  2490C	IJX261302A  2490C	IJX261338A  2490C	IJX261361A  2490C	IJX261362A  2490C	IJX261370A  2490C	IJX261428A  2490C	IJX261445A  2490C	IJX261454A  2490C	IJX261456A  2490C	IJX261468A  2490C	IJX261470A  2490C	IJX261499A  2490C	IJX261500A  2490C	IJX261509A  2490C	IJX261518A  2490C	IJX261519A  2490C	IJX261522A  2490C	IJX261526A  2490C	IJX261532A  2490C	IJX261552A  2490C	IJX261561A  2490C	IJX261613A  2490C	IJX261625A  2490C	IJX261631A  2490C	IJX261643A  2490C	IJX261646A  2490C	IJX261651A  2490C	IJX261672A  2490C	IJX261674A  2490C	IJX261680A  2490C	IJX261702A  2490C	IJX261719A  2490C	IJX261742A  2490C	IJX261771A  2490C	IJX261773A  2490C	IJX261791A  2490C	IJX261795A  2490C	IJX261814A  2490C	IJX261815A  2490C	IJX261816A  2490C	IJX261830A  2490C	IJX261865A  2490C	IJX261869A  2490C	IJX261890A  2490C	IJX261936A  2490C	IJX261946A  2490C	IJX261951A  2490C	IJX261958A  2490C	IJX261968A  2490C	IJX261969A  2490C	IJX264663A  2490C	IJX264672A  2490C	IJX264680A  2490C	IJX264696A  2490C	IJX264702A  2490C	IJX264709A  2490C	IJX264734A  2490C	IJX264738A  2490C	IJX264745A  2490C	IJX264751A  2490C	IJX264761A  2490C	IJX264771A  2490C	IJX264782A  2490C	IJX264786A  2490C	IJX264789A  2490C	IJX264818A  2490C	IJX264823A  2490C	IJX264828A  2490C	IJX264837A  2490C	IJX264840A  2490C	IJX264842A  2490C	IJX264853A  2490C	IJX264855A  2490C	IJX264857A  2490C	IJX264861A  2490C	IJX264886A  2490C	IJX264887A  2490C	IJX264897A  2490C	IJX264904A  2490C	IJX264916A  2490C	IJX264919A  2490C	IJX264924A  2490C	IJX264935A  2490C	IJX264956A  2490C	IJX264957A  2490C	IJX264962A  2490C	IJX264964A  2490C	IJX264965A  2490C	IJX264970A  2490C	IJX264972A  2490C	IJX264975A  2490C	IJX264985A  2490C	IJX265002A  2490C	IJX265013A  2490C	IJX265020A  2490C	IJX265021A  2490C	IJX265054A  2490C	IJX265074A  2490C	IJX265085A  2490C	IJX265087A  2490C	IJX265090A  2490C	IJX265091A  2490C	IJX265125A  2490C	IJX265127A  2490C	IJX265134A  2490C	IJX265182A  2490C	IJX265201A  2490C	IJX265205A  2490C	IJX265227A  2490C	IJX265240A  2","90C	IJX370137A  2490C	IJX370140A  2490C	IJX373397A  2490C	IJX373399A  2490C	IJX373447A  2490C	IJX373472A  2490C	IJX373485A  2490C	IJX373488A  2490C	IJX373494A  2490C	IJX373495A  2490C	IJX373496A  2490C	IJX373500A  2490C	IJX373503A  2490C	IJX373526A  2490C	IJX373549A  2490C	IJX373552A  2490C	IJX373553A  2490C	IJX373571A  2490C	IJX373578A  2490C	IJX373604A  2490C	IJX373623A  2490C	IJX373630A  2490C	IJX373634A  2490C	IJX373637A  2490C	IJX373655A  2490C	IJX373659A  2490C	IJX373662A  2490C	IJX373670A  2490C	IJX373671A  2490C	IJX373687A  2490C	IJX373694A  2490C	IJX373702A  2490C	IJX373725A  2490C	IJX376161A  2490C	IJX376173A  2490C	IJX376180A  2490C	IJX376188A  2490C	IJX376190A  2490C	IJX376194A  2490C	IJX376195A  2490C	IJX376199A  2490C	IJX376201A  2490C	IJX376203A  2490C	IJX376213A  2490C	IJX376219A  2490C	IJX376228A  2490C	IJX376242A  2490C	IJX376250A  2490C	IJX376273A  2490C	IJX376289A  2490C	IJX376294A  2490C	IJX376297A  2490C	IJX376301A  2490C	IJX376303A  2490C	IJX376307A  2490C	IJX376308A  2490C	IJX376310A  2490C	IJX376324A  2490C	IJX376328A  2490C	IJX376332A  2490C	IJX376338A  2490C	IJX376345A  2490C	IJX376346A  2490C	IJX376352A  2490C	IJX376353A  2490C	IJX376399A  2490C	IJX376413A  2490C	IJX376418A  2490C	IJX376423A  2490C	IJX376426A  2490C	IJX376437A  2490C	IJX376443A  2490C	IJX376446A  2490C	IJX376453A  2490C	IJX376456A  2490C	IJX376464A  2490C	IJX376466A  2490C	IJX376494A  2490C	IJX376512A  2490C	IJX376519A  2490C	IJX376530A  2490C	IJX376533A  2490C	IJX376557A  2490C	IJX376562A  2490C	IJX376565A  2490C	IJX376571A  2490C	IJX376575A  2490C	IJX376577A  2490C	IJX376630A  2490C	IJX376634A  2490C	IJX376636A  2490C	IJX376641A  2490C	IJX376647A  2490C	IJX376650A  2490C	IJX376652A  2490C	IJX376657A  2490C	IJX376658A  2490C	IJX376681A  2490C	IJX376682A  2490C	IJX376691A  2490C	IJX376722A  2490C	IJX376727A  2490C	IJX376764A  2490C	IJX376765A  2490C	IJX376786A  2490C	IJX376840A  2490C	IJX376847A  2490C	IJX376856A  2490C	IJX376881A  2490C	IJX376884A  2490C	IJX376890A  2490C	IJX376914A  2490C	IJX376915A  2490C	IJX3769",,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73782,"Ongoing","Granna's, LLC","412 N Main",,"Bessie","OK","73622","United States","Voluntary: Firm Initiated","E-Mail","Oklahoma","F-1326-2016","Class I","Granna's 808 French Toast, Diced Potatoes, Mandarin Oranges in three compartment black, plastic tray, stored frozen","54 cases","Product has whey listed on the label, not milk.","05/09/2016",,"  Product Code: 808; Best By Dates 04/05/2016 through 04/05/2017",4/6/2016,"04/06/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73783,"Ongoing","Becton Dickinson & Co.","7 Loveton Cir","BD Diagnostic Systems","Sparks","MD","21152-9212","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA.","Z-1559-2016","Class II","Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar  Cat. Number 221291, 	Lot Number	6034889, Exp. Date : April 20, 2016  Product is sold in cartons of 100 plates each.     Product Usage:  Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.  ","88,300 plates (883 cartons)","Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes.  The device is a non-sterile prepared plated media.    ","04/22/2016",," Cat. Number	Lot Number  221291	                    6034889  ",3/28/2016,"03/28/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73784,"Completed","Michel et Augustin Inc","98 4th St",,"Brooklyn","NY","11231-4884","United States","Voluntary: Firm Initiated","Press Release","New York, New Jersey, Connecticut","F-1365-2016","Class II"," but no nuts/tree nuts are listed in the ingredient statement.","2408 units (6-packs)","Undeclared hazelnuts due to miss-packaging by the foreign manufacturer.  ","05/17/2016",," Best Before 07 2016",4/7/2016,"04/07/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73785,"Ongoing","Oregon Potato Company","302 N. Venture Road",,"Pasco","WA","99302","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND","F-1938-2016","Class I"," IQF 45#CS, item number 104155, bulk cases, net wt. 45 lbs.  ","325,620 lbs."," Frozen Yellow Onion Dice is voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.","08/18/2016",," Lot numbers:    6078;  6082;  161A068;  161A075;  161A076;  161A086;  161B068;  161B071;  161B074;  161B075;  161B076;  161B085;  161B086.  ",4/6/2016,"04/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73785,"Ongoing","Oregon Potato Company","302 N. Venture Road",,"Pasco","WA","99302","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND","F-1944-2016","Class I"," White Onion Strip-FRESH, item number 105196, bulk totes, net wt. 1200 lbs.	","51,988 lbs."," White Onion Strip-FRESH was voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.","08/18/2016",," LOT number: 161B077          ",4/6/2016,"04/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73785,"Ongoing","Oregon Potato Company","302 N. Venture Road",,"Pasco","WA","99302","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND","F-1943-2016","Class I"," White Onion Dice- FRESH, item number 105197, bulk tote, net wt. 1250 lbs.	  ","160,134 lbs. "," White Onion Dice- FRESH is voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.","08/18/2016",," LOT numbers:  161A077;  161B076;  161B077;  ",4/6/2016,"04/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73785,"Ongoing","Oregon Potato Company","302 N. Venture Road",,"Pasco","WA","99302","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND","F-1941-2016","Class I"," Yellow Onion Dice, Frozen, item number 101430, bulk tote, net wt. 1200 lbs.  ","42,000 lbs."," Frozen Yellow Onion Dice is voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.","08/18/2016",," LOT number: 161A079    ",4/6/2016,"04/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73785,"Ongoing","Oregon Potato Company","302 N. Venture Road",,"Pasco","WA","99302","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND","F-1945-2016","Class I","IQF 1/4 x 1/4 Yellow Onion Dice, item number 102654, bulk cases, net wt. 40 lbs.    Onion 1/4 x1/4 Dice, Item number 103205, bulk cases, net wt. 45 lbs.  ","160,465 lbs.","1/4 x 1/4 Frozen Yellow Onion Dice was voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.","08/18/2016",," LOT numbers:  161A075;  161A076;  161B068;  161B075;  161B076.            ",4/6/2016,"04/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73785,"Ongoing","Oregon Potato Company","302 N. Venture Road",,"Pasco","WA","99302","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND","F-1940-2016","Class I"," Un-Blanched Yellow Onion Dice, Frozen, item number 103349, bulk cases, net wt. 45 lbs.  ","70,200 lbs."," Un-Blanched, Frozen, Yellow Onion Dice is voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.","08/18/2016",," LOT numbers:  161A068;  161A079;  161B078.  ",4/6/2016,"04/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73785,"Ongoing","Oregon Potato Company","302 N. Venture Road",,"Pasco","WA","99302","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND","F-1939-2016","Class I"," Yellow ORGANIC Onion Strip, Item number 103356, bulk tote, net wt. 1150 lbs.      ","477,030 lbs."," Yellow ORGANIC Onion Strip are voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.","08/18/2016",," LOT numbers:    161A073;  161A080;  161A084;  161A085;  161B068;  161B073;  161B080;  161B084;  163A089.  ",4/6/2016,"04/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73785,"Ongoing","Oregon Potato Company","302 N. Venture Road",,"Pasco","WA","99302","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND","F-1942-2016","Class I"," Frozen WHITE Onion Dice, item number 103342, bulk cases, net wt. 45 lbs.","25,200 lbs."," White Onion Dice is voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.","08/18/2016",," LOT number: 161A078 and 161B077.      ",4/6/2016,"04/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73785,"Ongoing","Oregon Potato Company","302 N. Venture Road",,"Pasco","WA","99302","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND","F-1946-2016","Class I"," Yellow Onion Dice, item number 101578, bulk container      ","999,825 lbs."," Frozen Yellow Onion Dice was voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.","08/18/2016",," LOT numbers:  161A070, 161A071, 161A072, 161A073, 161A074, 161A075, 161A076, 161A079, 161A080, 161A081, 161A082, 161A083, 161A084, 161A089, 161B069, 161B070, 161B071, 161B072, 161B074, 161B079, 161B081, 161B083, 161B088.",4/6/2016,"04/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73786,"Completed","Ab Sciex","500 Old Connecticut Path",,"Framingham","MA","01701-4574","United States","Voluntary: Firm Initiated","Visit","Distributed to the state of NC.","Z-1671-2016","Class II","AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231.    Mass spectrometers for in vitro diagnostic use only.      ","2 units","Under certain conditions, mass spectrometers may report incorrect quantitative results.","05/15/2016",," Serial  Numbers:   Triple Quad 4500MD LC/MS/MS System  BX21081601  BX21101601  BX21091601  BX21111601  BX21121602  BX21131602  BX21141602  BX21151602    QTRAP 4500MD LC/MS/MS System  BW20251601  BW20241601  BW20261602",3/25/2016,"03/25/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73787,"Terminated","Blood Systems, Inc. DBA United Blood Services","1503 Bertrand Dr",,"Lafayette","LA","70506-3049","United States","Voluntary: Firm Initiated","FAX","Mississippi","B-0490-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, for which donor eligibility was inadequately determined, was distributed.","05/02/2016","05/02/2016"," W041615038815L",2/29/2016,"02/29/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73788,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","424 S Mesa Hills Dr",,"El Paso","TX","79912-5441","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0489-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Mislabeled RBC products were distributed.","05/02/2016","05/02/2016"," W0411150823983 (Double collection)",3/7/2016,"03/07/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73789,"Terminated","BloodSource, Inc.","10536 Peter a McCuen Blvd",,"Mather","CA","95655-4128","United States","Voluntary: Firm Initiated","FAX","France","B-0454-16","Class II","Source Plasma","1 unit","Blood product, collected from a donor who did not have a complete physical examination, was distributed.","04/28/2016","04/28/2016"," W035815216819; ",2/26/2016,"02/26/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73791,"Terminated","BloodSource, Inc.","10536 Peter a McCuen Blvd",,"Mather","CA","95655-4128","United States","Voluntary: Firm Initiated","FAX","France","B-0442-16","Class II","Source Plasma","1 unit","Blood product, collected from a donor who was allowed to donate without a current physical, was distributed. ","04/29/2016","04/29/2016"," W035815162511",2/26/2016,"02/26/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73792,"Terminated","American Natl Red Cross Mid Atlantic Region","611 W Brambleton Ave",,"Norfolk","VA","23510-1004","United States","Voluntary: Firm Initiated","Other","California","B-0443-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","04/29/2016","04/29/2016"," W202915286655",2/28/2016,"02/28/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73793,"Terminated","American Natl Red Cross Mid Atlantic Region","611 W Brambleton Ave",,"Norfolk","VA","23510-1004","United States","Voluntary: Firm Initiated","FAX","Virginia; California","B-0445-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/29/2016","04/29/2016"," W202915268393",2/20/2016,"02/20/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73793,"Terminated","American Natl Red Cross Mid Atlantic Region","611 W Brambleton Ave",,"Norfolk","VA","23510-1004","United States","Voluntary: Firm Initiated","FAX","Virginia; California","B-0444-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","04/29/2016","04/29/2016"," W202915268393",2/20/2016,"02/20/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73794,"Terminated","OneBlood, Inc.","1951 NW 7th Ave. Suite 14201","UM Life Science Park Bldg. #1","Miami","FL","33136","United States","Voluntary: Firm Initiated","FAX","Florida","B-0446-16","Class III","Apheresis Fresh Frozen Plasma","19 units","Misbranded Blood Products were distributed.","04/29/2016","04/29/2016"," W304215001779; W115115138273; W115115088801; W036815081268; W039415019133; W141615014136; W141615196019; W141615218192; W036815662270; W036815662269 (double collection); W036815645473; W036815367202; W036815367201; W036815436694; W036815367099; W304215002202; W304215002140; W304215001847",2/5/2016,"02/05/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73794,"Terminated","OneBlood, Inc.","1951 NW 7th Ave. Suite 14201","UM Life Science Park Bldg. #1","Miami","FL","33136","United States","Voluntary: Firm Initiated","FAX","Florida","B-0447-16","Class III","Fresh Frozen Plasma","21","Misbranded Blood Products were distributed.","04/29/2016","04/29/2016"," W304115007380; W115115125951; W036815099918; W036815054639; W036815480455; W036815506365; W036815480376; W036815545109; W036815557566; W036815536628; W036815512643; W036815551777; W036815512433; W036815549160; W036815730346; W036815728959; W304115008945; W036815537242; W304115007905; W304115007922; W304115007884; ",2/5/2016,"02/05/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73795,"Terminated","OneBlood, Inc.","3451 Northlake Blvd",,"Lake Park","FL","33403-1700","United States","Voluntary: Firm Initiated","FAX","Florida","B-0449-16","Class III","Fresh Frozen Plasma","6 units","Misbranded Blood Products were distributed.","04/29/2016","04/29/2016"," W036815468059; W036815238077; W036815279675; W036815241814; W036815234619; W036815258577",2/5/2016,"02/05/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73795,"Terminated","OneBlood, Inc.","3451 Northlake Blvd",,"Lake Park","FL","33403-1700","United States","Voluntary: Firm Initiated","FAX","Florida","B-0450-16","Class III","Apheresis Fresh Frozen Plasma","3 units","Misbranded Blood Products were distributed.","04/29/2016","04/29/2016"," W036815612546; W036815382677; W036815100890",2/5/2016,"02/05/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73796,"Terminated","OneBlood, Inc.","3000 W Cypress Creek Rd",,"Fort Lauderdale","FL","33309-1710","United States","Voluntary: Firm Initiated","FAX","Florida","B-0436-16","Class III","Fresh Frozen Plasma","24 units","Mislabeled plasma products were distributed.","05/17/2016","05/25/2016"," W036815124630; W036815187764; W036815187295; W036815235034; W036815240724; W036815241639; W036815241641; W036815250013; W036815288420; W036815482241; W036815533306; W036815533309; W036815732233; W036815779014; W115115006825; W036815078262; W036815137152; W036815533833; W036815561040; W036815719882; W222115130703; W222115421973; W036815506352; W036815554285",2/5/2016,"02/05/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73796,"Terminated","OneBlood, Inc.","3000 W Cypress Creek Rd",,"Fort Lauderdale","FL","33309-1710","United States","Voluntary: Firm Initiated","FAX","Florida","B-0437-16","Class III","Apheresis Fresh Frozen Plasma","5 units","Mislabeled plasma products were distributed.","05/17/2016","05/25/2016"," W036815419075 (Triple collection); W036815073269; W036815808262",2/5/2016,"02/05/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73797,"Terminated","Talecris Plasma Resources","6582 University Ave NE",,"Fridley","MN","55432-4330","United States","Voluntary: Firm Initiated","Letter","North Carolina; New York","B-0529-16","Class III","Source Plasma","20 units","Blood products, collected from an ineligible donor, were distributed. ","05/17/2016","05/17/2016"," 5090346264; 5090344420; 5090344107;  5090343851; 5090343800; 5090343756; 5090343584; 5090343583; 5090342908; 5090342829; 5090342616; 5090342629; 5090342351; 5090342383; 5090342242; 5090341976; 5090341916; 5090341867; 5090341445; 5090341170; ",9/24/2015,"09/24/2015",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73798,"Ongoing","Progressive Gourmet Inc.","330 Ballardvale St",,"Wilmington","MA","01887-1012","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY , ME","F-1128-2016","Class I","Taste of Inspirations Edamame Rangoon 9 oz . carton, frozen  UPC: 072543998453","70 cases(12/case)","Product contains undeclared allergen-crabmeat","04/22/2016",," Use By 01/11/2017",4/7/2016,"04/07/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73799,"Ongoing","Hospira Inc.","275 N Field Dr",".","Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.","Z-1832-2016","Class II","The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more rigid or flexible fluid containers. The Plum 360  infuser features Concurrent, Secondary, and Piggyback infusions. A positive valving cassette allows two lines to be delivered at independent rates. The volume to be infused (VTBI) is delivered through one line to a patient. The two lines can be delivered in Concurrent mode (together) or Piggyback mode (one after another) without raising or lowering I.V. bags. The Plum 360 infuser also enables fluid pathway troubleshooting such as removing proximal air in line, without is disconnecting the patient line.    The Plum 360 can act as a stand-alone infuser, or in conjunction with the Hospira MedNet software to provide medication safety software at the point of care, with customized drug libraries to support hospital defined protocols by  clinical care area. In such a configuration, the Plum 360 infuser can communicate with systems on the network via Ethernet or state of the art wireless communication using an 802.11 a/b/g/n/, 2.4 GHz/5 GHz dual-band radio. The Plum 360 infuser and Hospira MedNet software interface with other hospital systems such as Electronic Health records, Electronic Medication Administration Records, Bar Code Point of Care, Real Time Location Services, and there systems.    Each infuser includes a Connectivity Engine (CE) which provides both wired Ethernet and wireless 802.11 a/b/g/ networking capabilities. The Plum 360 infuser interfaces with Hospira MedNet application software to download drug library and infuser software updates and enable auto-programming of the infuser.The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.","1490 infusion pumps.","Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.","06/03/2016",," PLum 360 devices with the following list number: 300100405, 300100406, 300100605 , 300101305 , 300102705 , 300105405 and 300106507.   ",3/25/2016,"03/25/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73799,"Ongoing","Hospira Inc.","275 N Field Dr",".","Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.","Z-1833-2016","Class II","The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories.     Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming  feature.","2567 Plum A+ infusion pumps.","Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.","06/03/2016",," PLum A+ devices with the following list numbers: 12391-04-25, 12391-22-05, 12391-23-05, 12391-23-15, 12391-36-07, 12391-54-05, 12391-88-01, 12391-88-02, 12391-88-03, 12391-88-04, 12391-88-05, 20792-04-25, 20792-13-09, 20792-57-15, 20792-65-01, 20792-65-02 and 20792-88-69.",3/25/2016,"03/25/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73800,"Ongoing","Back To Nature Foods, Llc","10641 Airport Pulling Rd N Ste 2",,"Naples","FL","34109-7334","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product shipped nationwide to the following states: AZ, CA, FL, IA, IL, ME, MI, MO, NH, NJ, NY, PA, TN VA, WA, WI","F-1318-2016","Class I","Classic Creme Cookies, Net wt. 12 oz cartons, 6 cartons per case.  Manufactured for Back To Nature Foods Co., LLC","16,521 cases, 99,126 cartons (6 cartons per case).","Undeclared milk","05/05/2016",," UPC 819898011032, Lot code: 10 SEP 16 TBPC and 16 SEP 16 TBPC.  Lot code is also expiration date.    Expansion includes UPC 19898-01103 and lot codes 13 AUG 16, 08 OCT 16, 21 OCT 16, and 22 OCT 16.",4/8/2016,"04/08/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73801,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution -  USA (nationwide) and to the countries of :  Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey,  United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen.","Z-1615-2016","Class III","ADVIA Centaur CP Immunoassay System,  Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers.    This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. ","US: 442 units; Foreign: 3237 units","The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide. ","05/06/2016",," All serial numbers",3/30/2016,"03/30/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73802,"Ongoing","Leica Microsystems, Inc.","1700 Leider Ln",,"Buffalo Grove","IL","60089-6622","United States","Voluntary: Firm Initiated","Letter","Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.","Z-1876-2016","Class II","Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation. ","270 units","Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.  ","06/01/2016",," 1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.",4/5/2016,"04/05/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73802,"Ongoing","Leica Microsystems, Inc.","1700 Leider Ln",,"Buffalo Grove","IL","60089-6622","United States","Voluntary: Firm Initiated","Letter","Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.","Z-1877-2016","Class II","Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.","90 Units","Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.  ","06/01/2016",," 1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.",4/5/2016,"04/05/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73803,"Ongoing","Salsa Dianne","218 N 5th St",,"Union","OR","97883-9215","United States","Voluntary: Firm Initiated","Visit","distributed in Oregon","F-1322-2016","Class II",".","firm did not provide","Classic Pesto Sauce (with a twist) is recalled because Parmesan cheese is declared but milk is not declared on label.","05/11/2016",," best if used (or frozen) by 4/30/2016",4/7/2016,"04/07/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73803,"Ongoing","Salsa Dianne","218 N 5th St",,"Union","OR","97883-9215","United States","Voluntary: Firm Initiated","Visit","distributed in Oregon","F-1323-2016","Class II",".","firm did not provide","Lemon Pesto Sauce recalled because parmesan cheese is declared but milk is not declared on label.","05/11/2016",," best if used (or frozen) by 4/30/2016",4/7/2016,"04/07/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73804,"Terminated","Michigan Blood","1036 Fuller Ave NE","PO Box 1704","Grand Rapids","MI","49501-1704","United States","Voluntary: Firm Initiated","FAX","Michigan","B-0457-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, in which donor screening/donor record incomplete or incorrect, were distributed.","04/28/2016","04/28/2016"," W120615293203; ",2/24/2016,"02/24/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73804,"Terminated","Michigan Blood","1036 Fuller Ave NE","PO Box 1704","Grand Rapids","MI","49501-1704","United States","Voluntary: Firm Initiated","FAX","Michigan","B-0456-16","Class II","Fresh Frozen Plasma","1 unit","Blood products, in which donor screening/donor record incomplete or incorrect, were distributed.","04/28/2016","04/28/2016"," W120615293203; ",2/24/2016,"02/24/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73805,"Terminated","Biomat USA, Inc.","3515 Alameda Ave",,"El Paso","TX","79905-2401","United States","Voluntary: Firm Initiated","Letter","North Carolina","B-0485-16","Class II","Source Plasma","1 unit","Blood product, collected from a donor who was previously deferred, was distributed.","04/28/2016","04/28/2016"," 3330504776; ",11/9/2015,"11/09/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73806,"Terminated","American National Red Cross","995 E Broad St","Central Ohio Region","Columbus","OH","43205-1322","United States","Voluntary: Firm Initiated","Telephone","Ohio; California","B-0487-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","05/04/2016","05/04/2016"," W201615950040; ",2/26/2016,"02/26/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73806,"Terminated","American National Red Cross","995 E Broad St","Central Ohio Region","Columbus","OH","43205-1322","United States","Voluntary: Firm Initiated","Telephone","Ohio; California","B-0486-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","05/04/2016","05/04/2016"," W201615259391; ",2/26/2016,"02/26/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73807,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","1212 E California Rd",,"Fort Wayne","IN","46825-5812","United States","Voluntary: Firm Initiated","Letter","Indiana","B-0488-16","Class III","Blood and Blood Products for Reprocessing","1 unit ","Blood product, for which donor suitability was inadequately determined, was distributed.","05/02/2016","05/02/2016"," W203815168326 ",2/27/2016,"02/27/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73808,"Terminated","American National Red Cross (the)","Carolinas Region","2425 Park Rd","Charlotte","NC","28203-5926","United States","Voluntary: Firm Initiated","Letter","California","B-0491-16","Class III","Blood and Blood Products for Reprocessing","2 units","Plasma products, for which donor suitability was inadequately determined, were distributed.","05/03/2016","05/03/2016"," W201213095512; W201213107656 ",2/13/2016,"02/13/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73809,"Terminated","American National Red Cross (the)","Carolinas Region","2425 Park Rd","Charlotte","NC","28203-5926","United States","Voluntary: Firm Initiated","Letter","California","B-0459-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","04/29/2016","04/29/2016"," W201215537608",10/29/2015,"10/29/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73810,"Terminated","American National Red Cross (the)","Carolinas Region","2425 Park Rd","Charlotte","NC","28203-5926","United States","Voluntary: Firm Initiated","Letter","California","B-0458-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","04/29/2016","04/29/2016"," W20121541764200",9/1/2015,"09/01/2015",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73811,"Ongoing","Fresenius Kabi USA, LLC","3 Corporate Dr",,"Lake Zurich","IL","60047-8930","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-0866-2016","Class II","OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.","355,150 vials","Failed Impuities/Degradation Specifications","05/24/2016",," Lot # 6108322; Exp. 04/16  Lot # 6108824; Exp. 07/16",5/4/2016,"05/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73811,"Ongoing","Fresenius Kabi USA, LLC","3 Corporate Dr",,"Lake Zurich","IL","60047-8930","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-0867-2016","Class II","OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04","40,280 vials","Failed Impuities/Degradation Specifications","05/24/2016",,"  Lot # 6108831; Exp. 07/16",5/4/2016,"05/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73812,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0852-2016","Class II","Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87","11,630 babs","Discoloration:  presence of atypical yellow discoloration of the solution .","05/12/2016",," Lot # C989954, Exp 9/17",4/12/2016,"04/12/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73813,"Terminated","Whole Foods Market North Atlantic Kitchen","9 Commercial St","Suite 300","Everett","MA","02149-5506","United States","Voluntary: Firm Initiated","E-Mail","MA, RI, CT, NY, NJ","F-0374-2017","Class I","Whole Foods Asparagus Pea & Ricotta Salad, 10 Ounces ","83 units","Product contains undeclared allergen-eggs","10/28/2016","10/31/2016"," Sell By Date: 04/14/2016",4/10/2016,"04/10/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73814,"Ongoing","Empirical Laboratories, Incorporated","1501 Academy Court","No. 5","Fort Collins","CO","80524","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.  No foreign or govt/VA/military consignees.","F-1366-2016","Class II","Liposomal Magnesium Nutritional Supplement. 6 FL. OZ (180 ml) The product is packaged in a six ounce, plastic, Royalty Bottle, with a 24mm vented flip top lid. item number: DES004Z. Sold under brands DESBIO and Seeking Health","1972 bottles","Empirical Labs is recalling Liposomal Magnesium because of the potential for mold contamination.","05/19/2016",," Lot Number: 5101206 and 5111003",4/5/2016,"04/05/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73815,"Ongoing","Angiodynamics Inc. (Navilyst Medical Inc.)","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1702-2016","Class II","AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.  ","Domestic: 377 kits","Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.","05/20/2016",," Lot Numbers: 4876386, 4889699,  4889700, 4898652, 4902111, 4902117, 4906576, 4941511, 4941511D, 4943459, 4955686, 4956929, 4969475, 4975493, 4991710, 4999714. ",3/21/2016,"03/21/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73815,"Ongoing","Angiodynamics Inc. (Navilyst Medical Inc.)","10 Glens Falls Tech Park",,"Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1701-2016","Class II","Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula. ","Domestic: 339 kits","Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.","05/20/2016",," Lot Numbers 37FE2901, 37GD2908, 37KD2405  ",3/21/2016,"03/21/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73816,"Ongoing","Hamilton Medical, Inc.","4990 Energy Way",,"Reno","NV","89502-4123","United States","Voluntary: Firm Initiated","Letter","US distribution only.","Z-1624-2016","Class II","Hamilton G5 with software version between v2.41, v2.42, v2.50.  Catalog number: 1590001 and 1590002.    Anesthesiology:  Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.","1115","After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.","05/09/2016",," Serial numbers  :  1278  1639  1686  1689  1691  1692  1695  1697  1699  1864  1984  2412  2413  2414  2417  2465  2505  2506  2521  2522  2523  2524  2525  2526  2527  2530  2531  2532  2591  2592  2593  2594  2595  2776  2780  2876  2877  2878  2880  2881  2882  2883  2884  2885  2886  2890  2894  3365  3366  3368  3370  3377  3611  3881  3882  3884  3885  3886  3887  3888  3889  3890  3914  4041  4044  4047  4057  4073  4074  4075  4077  4079  4080  4081  4088  4090  4091  4092  4093  4094  4095  4096  4097  4098  4099  4100  4101  4103  4104  4106  4108  4109  4110  4111  4112  4113  4115  4117  4118  4141  4144  4144  4145  4146  4147  4148  4149  4150  4223  4224  4226  4227  4345  4348  4351  4353  4354  4356  4357  4358  4359  4360  4365  4366  4598  4607  4625  4666  4671  4774  4779  4780  4781  4782  4783  4794  4904  4939  4946  4952  4956  5025  5026  5027  5028  5029  5030  5032  5038  5039  5040  5044  5045  5046  5047  5048  5050  5051  5052  5053  5054  5056  5057  5058  5061  5063  5064  5065  5080  5217  5248  5251  5252  5254  5256  5312  5357  5361  5362  5363  5374  5390  5395  5397  5437  5452  5457  5462  5465  5466  5468  5481  5523  5764  5774  5791  5794  5803  5815  5816  5818  5820  5825  5826  5827  5828  5829  5830  5831  5832  5834  5835  5836  5839  5842  5843  5888  5915  5930  5932  5933  5941  5948  6029  6031  6039  6062  6066  6072  6074  6075  6077  6078  6079  6080  6082  6083  6144  6211  6241  6247  6251  6261  6265  6276  6277  6278  6279  6291  6292  6293  6300  6303  6305  6306  6307  6309  6312  6315  6337  6377  6409  6411  6419  6422  6423  6432  6434  6438  6440  6441  6445  6451  6454  6470  6494  6495  6498  6499  6503  6504  6507  6508  6509  6511  6512  6515  6520  6556  6561  6614  6621  6625  6644  6647  6650  6653  6655  6656  6657  6658  6659  6661  6664  6669  6710  6740  6761  6763  6791  6795  6806  6832  6833  6835  6837  6838  6841  6856  6859  6890  6985  6986  6991  6992  6995  6999  7001  7021  7022  7030  7061  7077  7100  7329  7330  7336  745",3/7/2016,"03/07/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73818,"Ongoing","Reser's Fine Foods, Inc. - Century","6999 NW Century Blvd",,"Hillsboro","OR","97124-8528","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AL, AR, AZ, CA, CO, HI, ID, IL, IN, KS, KY, MI, MN, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, SD, TN, TX, UT, WA, WI, WY, and British Columbia.","F-1577-2016","Class I","Stonemill Kitchens Classic Potato Salad, Refrigerated, Retail net wt. 5lb.  UPC 0 71117 61576 0.","806 cases total","Stonemill Kitchens Classic Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.","06/27/2016",," Use By Date: 04/27/2016",4/10/2016,"04/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73818,"Ongoing","Reser's Fine Foods, Inc. - Century","6999 NW Century Blvd",,"Hillsboro","OR","97124-8528","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AL, AR, AZ, CA, CO, HI, ID, IL, IN, KS, KY, MI, MN, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, SD, TN, TX, UT, WA, WI, WY, and British Columbia.","F-1574-2016","Class I","Reser's Deviled Egg Potato Salad, Refrigerated, Retail package, Net wt. 3 lbs. UPC 0 71117 00480 9;    Reser's Deviled Egg Potato Salad, Refrigerated, Foodservice product, net wt. 8 lbs. UPC  71117 00225;    Safeway Deviled Egg Potato Salad, Refrigerated, Net wt. 16 oz.   UPC 0 21130 06688 9.","3,642 cases total","Deviled Egg Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.","06/27/2016",," Reser's brand- Retail packages have the Use by Date: 04/29/2016;  Reser's brand- 8 lb. Foodservice packages have the Use by Date: 4/28/2016;  Safeway brand has the Used by Date: 4/28/2016;",4/10/2016,"04/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73818,"Ongoing","Reser's Fine Foods, Inc. - Century","6999 NW Century Blvd",,"Hillsboro","OR","97124-8528","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AL, AR, AZ, CA, CO, HI, ID, IL, IN, KS, KY, MI, MN, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, SD, TN, TX, UT, WA, WI, WY, and British Columbia.","F-1576-2016","Class I","Reser's Macaroni Salad, Refrigerated, Retail package, Net Wt. 8 oz.   UPC  0 71117 18224 8.    Reser's Macaroni Salad, Refrigerated, Retail package, Net Wt. 16 oz.  UPC 0 71117 19007 6.    Reser's Macaroni Salad, Refrigerated, Retail package, Net Wt. 3 lb.  UPC 0 71117 19305 3.    Sysco Elbow Macaroni Salad, Refrigerated, Food Service package, Net wt. 8 lb. UPC 71117 67702","5665 cases total","Macaroni Refrigerated Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.","06/27/2016",," Reser's brand, Net Wt. 8 oz packages have the Use By Date: 5/10/2016;  Reser's brand,Net Wt. 16 oz packages have the Use By Date: 5/9/2016;  Reser's brand,Net Wt. 3 lb. packages have the Use By Dates: 5/9/2016 and 5/10/2016;  Sysco brand - food service packages have the Use By Date: 5/7/2016.",4/10/2016,"04/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73818,"Ongoing","Reser's Fine Foods, Inc. - Century","6999 NW Century Blvd",,"Hillsboro","OR","97124-8528","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AL, AR, AZ, CA, CO, HI, ID, IL, IN, KS, KY, MI, MN, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, SD, TN, TX, UT, WA, WI, WY, and British Columbia.","F-1575-2016","Class I","Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 3.5 oz.   UPC 0 71117 17000 9.    Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 5.5 oz.   UPC 0 71117 17100 6.    Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 8 oz.   UPC 0 71117 18223 1.    Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 16 oz.   UPC 0 71117 19000 7.    Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 3 lb.   UPC 0 71117 19300 8.    Food Service of America (FSA) Potota Salad, Refrigerated, Foodservice package, Net wt. 8 lb. UPC 0 41493 41720 3.","6,143 cases total","Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.","06/27/2016",," Reser's brand, Net wt. 3.5 oz, 5.5 oz,  and 16 oz, retail packages have the Use By Date: 05/10/2016;    Reser's brand, Net wt. 8 oz and 3 lb., retail packages have the Use By Date: 5/9/2016;    FSA, net wt. 8 lbs., Foodservice packages have the Use By Date: 5/10/2016.",4/10/2016,"04/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73818,"Ongoing","Reser's Fine Foods, Inc. - Century","6999 NW Century Blvd",,"Hillsboro","OR","97124-8528","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AL, AR, AZ, CA, CO, HI, ID, IL, IN, KS, KY, MI, MN, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, SD, TN, TX, UT, WA, WI, WY, and British Columbia.","F-1579-2016","Class I","Safeway Tuna Salad, Refrigerated, Retail package, Net wt. 15 oz.   UPC 021130 06742  8.    Safeway Tuna Salad, Refrigerated, Foodservice package, net wt. 3 lbs.   UPC 0 71117 06036 2.","438 cases","Safeway Tuna Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.","06/27/2016",," Use By Date: 04/27/2016",4/10/2016,"04/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73818,"Ongoing","Reser's Fine Foods, Inc. - Century","6999 NW Century Blvd",,"Hillsboro","OR","97124-8528","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AL, AR, AZ, CA, CO, HI, ID, IL, IN, KS, KY, MI, MN, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, SD, TN, TX, UT, WA, WI, WY, and British Columbia.","F-1580-2016","Class I","Walmart Redskin Potato Salad, Refrigerated, Retail net wt. 4lb.   UPC 81131 91693 6.    ","237 cases total","Walmart Redskin Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.","06/27/2016",," Use By Date: 5/1/2016",4/10/2016,"04/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73818,"Ongoing","Reser's Fine Foods, Inc. - Century","6999 NW Century Blvd",,"Hillsboro","OR","97124-8528","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AL, AR, AZ, CA, CO, HI, ID, IL, IN, KS, KY, MI, MN, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, SD, TN, TX, UT, WA, WI, WY, and British Columbia.","F-1581-2016","Class I","Savemart Potato Salad, Refrigerated, Foodservice package, Net wt. 8 lbs.  UPC 71117 00443   ","125 cases total","Savemart Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.","06/27/2016",," Use By Date: 5/10/2016",4/10/2016,"04/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73818,"Ongoing","Reser's Fine Foods, Inc. - Century","6999 NW Century Blvd",,"Hillsboro","OR","97124-8528","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AL, AR, AZ, CA, CO, HI, ID, IL, IN, KS, KY, MI, MN, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, SD, TN, TX, UT, WA, WI, WY, and British Columbia.","F-1578-2016","Class I","Safeway Classic Potato Salad, Refrigerated, Retail package, net wt. 5.5oz.  UPC 0 21130 06716 9.","430 cases total","Safeway Classic Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.","06/27/2016",," Use By Date: 5/10/2016",4/10/2016,"04/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73819,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania; Rhode Island","B-0461-16","Class II","Pooled Platelets, Leukocytes Reduced","1 unit","Blood Products collected from a donor who traveled to a malaria endemic area were distributed.","04/29/2016","04/29/2016"," W270115205132 ",3/28/2016,"03/28/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73819,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania; Rhode Island","B-0460-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood Products collected from a donor who traveled to a malaria endemic area were distributed.","04/29/2016","04/29/2016"," W270115206294",3/28/2016,"03/28/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73820,"Terminated","HCSC-Blood Center dba as Miller-Keystone Blood Center ","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","E-Mail","Pennsylvania; New Jersey","B-0462-16","Class II","Red Blood Cells","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","05/05/2016","05/05/2016"," W050910067346",1/15/2016,"01/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73820,"Terminated","HCSC-Blood Center dba as Miller-Keystone Blood Center ","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","E-Mail","Pennsylvania; New Jersey","B-0463-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","05/05/2016","05/05/2016"," W050910067346",1/15/2016,"01/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73821,"Terminated","HCSC-Blood Center dba as Miller-Keystone Blood Center ","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","Letter","New Jersey","B-0464-16","Class III","Red Blood Cells","1 unit","Blood product, collected from donors for whom donor suitability was not adequately determined, was distributed.","04/26/2016","04/26/2016"," W050910067866",2/1/2016,"02/01/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73822,"Ongoing","Dr. Reddy's Laboratories, Inc.","107 College Rd E",,"Princeton","NJ","08540-6623","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0841-2016","Class II","Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30","50,280 bottles","Failed Impurities/Degradation Specifications; 12 month stability time point","05/09/2016",," Lot number C500691, exp 12/2016",3/30/2016,"03/30/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73823,"Ongoing","Leica Microsystems, Inc.","1700 Leider Ln",,"Buffalo Grove","IL","60089-6622","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.","Z-1704-2016","Class II","Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566.    Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.","290 units","Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining. ","05/20/2016",," Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.",3/22/2016,"03/22/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73824,"Ongoing","Qtrade Teas And Herb","16205 Distribution Way",,"Cerritos","CA","90703-2329","United States","Voluntary: Firm Initiated","Letter","US: NJ, OH","F-1312-2016","Class II",,"1,267.3 lbs","QTrade Teas & Herbs is recalling Organic Chamomile Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella.","05/03/2016",," Lot No. L06091368123864101",4/11/2016,"04/11/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73825,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.","Z-1612-2016","Class II","HeartStart MRx Monitor/Defibrillator  The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.","17","MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.  ","05/05/2016",," US00586611, US00589878, US00594232, US00588464, US00591080, US00594779, US00588657, US00592182, US00594913, US00589391, US00593861, US00595298, US00589472, US00594092, US00595443, US00589851, US00594168",4/14/2016,"04/14/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73826,"Ongoing","Abbott Laboratories","100 Abbott Park Rd",,"Abbott Park","IL","60064-3502","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution --  US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY; and, the countries of ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVI, BRAZIL, BRUNEI, BULGARIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALI, MAURITIUS, MEXICO, MONTENEGRO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TOGO, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM and ZIMBABWE.","Z-1865-2016","Class II","The ARCHITECT Estradiol Kit     Intended to measure estradiol, an estrogenic steroid, in plasma.","39,346 units","Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.","05/31/2016",," Product List Number 07K7220 with Lot #: 55900UI01with expiration date of 04/23/2016, Lot #: 55908UI01 with expiration date of 04/29/2016, Lot #: 55941UI00 with expiration date of 04/23/2016, Lot #: 57929UI00 with expiration date of 07/16/2016, Lot #: 57931UI01 with expiration date of 07/27/2016, Lot #: 60105UI00 with expiration date of 10/02/2016 and Lot #: 61106UI00 with expiration date of 11/27/2016.    Product List Number 07K7225 - Lot #: 55900UI00 with expiration date of 04/23/2016, Lot #:  55908UI00 with expiration date of 04/29/2016,  Lot #:  57929UI01 with expiration date of 07/16/2016, Lot #: 57931UI00 with expiration date of 08/27/2016, Lot #: 60105UI01 with expiration date of 02/10/2016, Lot #: 61106UI01 with expiration date of 11/27/2016 and Lot #:  62263UI00 with expiration date of 11/27/2016.",3/24/2016,"03/24/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73827,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and Internationally  to Argentina, Australia, Austria,  Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Finland, France, Germany, Gibraltar, Greece, Guam, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait,  Luxembourg, Malaysia, Mexico, Netherlands, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia,  Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab  Emirates, United Kingdom","Z-1617-2016","Class II","Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V  The product is a thermal regulating system indicated for monitoring and controlling patient temperature","2613","The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM).  This premature coin cell battery drainage could render the device unresponsive upon System startup. ","05/06/2016",," Product Codes - 5000-00-00, 5000-01-01, 5000-01-02, 5000-01-03, 5000-01-04, 5000-01-05",11/9/2015,"11/09/2015",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73828,"Ongoing","Becton Dickinson & Company","1 Becton Dr",".","Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to NY only","Z-1936-2016","Class II","Henry Schein Single Use Syringe Luer-Lock, 10 mL,    Intended for use by health care professionals for general purpose fluid aspiration/injection","176,000 units","BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.","06/09/2016",," Catalog (REF #) 9004476, Lot #4163707",3/25/2016,"03/25/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73828,"Ongoing","Becton Dickinson & Company","1 Becton Dr",".","Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to NY only","Z-1937-2016","Class II","Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection","811,200 units","BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.","06/09/2016",," Catalog (REF #) 309642, Lot #'s 4163814, 4252723, 4252726, 4252729, 4293878, 4340516, 5017729 and 5017735",3/25/2016,"03/25/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73829,"Ongoing","Taro Pharmaceuticals U.S.A., Inc.","3 Skyline Dr",,"Hawthorne","NY","10532-2174","United States","Voluntary: Firm Initiated","Letter","U.S. Including: CA, CT, MA, MD, NY, NJ, OK, TX, and WA","D-0950-2016","Class III","¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532.  NDC: 51672-5205-5.   ","62,800 Tubes","Subpotent Drug","05/31/2016",," Lot # A5192-18338, Expiry: 12/2016",3/31/2016,"03/31/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73830,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-0954-2016","Class III","Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.","570 vials","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.","06/02/2016",," Lot #: C500037, Exp 01/18",3/11/2016,"03/11/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73830,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-0951-2016","Class III","Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.","15408 vials","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.","06/02/2016",," Lot #: a) C500031, Exp 12/17; b) C500026, Exp 12/17; C500036, C500043, Exp 01/18",3/11/2016,"03/11/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73830,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-0953-2016","Class III","Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.","30586 vials","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.","06/02/2016",," Lot #: C400180, Exp 07/17; C500003, C500028, C500029, Exp 122/17; C500038, Exp 01/18; C500044, Exp 02/18  ",3/11/2016,"03/11/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73830,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-0952-2016","Class III","Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.","7908 vials","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.","06/02/2016",," Lot #: a) C500006, Exp 11/17; b) C500001, Exp 11/17",3/11/2016,"03/11/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73830,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-0955-2016","Class III","Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.","741.171 kg","CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.","06/02/2016",," Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18",3/11/2016,"03/11/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73831,"Terminated","The Coca-Cola Company","Po Drawer 1734",".","Atlanta","GA","30301","United States","Voluntary: Firm Initiated","Letter","CA","F-0561-2017","Class II","Dr. Pepper Cherry, 12oz (12 pack cans), Manufactured under the authority of Doctor Pepper  Company, 5301 Legacy Drive, Plano, TX.","1,020 cases","The product contains undeclared High-fructose Corn Syrup (HFCS).","12/05/2016","12/05/2016"," Date Code: NOV2116DDB",3/31/2016,"03/31/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73832,"Ongoing","Neusoft Medical Systems Co., Ltd.","NO. 16 Shiji Road","Hunnan Industrial Area","Shenyang",,,"China","Voluntary: Firm Initiated","Letter","US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE","Z-1650-2016","Class II","NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)","7 units"," in the system setting - scanner options.","05/11/2016",," Serial Numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, N64I140077E",5/2/2015,"05/02/2015",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73833,"Ongoing","Terumo Medical Corporation","950 Elkton Blvd",,"Elkton","MD","21921-5322","United States","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution","Z-2738-2016","Class II"," Introducer Sheath  PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath  ","1,370,995 eaches have been distributed to the field","Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue.  If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.","09/06/2016",," Please see Attachment 3",3/16/2016,"03/16/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73834,"Ongoing","Arkray Factory USA, Inc.","5182 W 76th St",,"Minneapolis","MN","55439-2900","United States","Voluntary: Firm Initiated","Letter","USA: All states in USA including PR except AK, HI, WV, DE & RI.","V-0041-2017","Class II"," II Glucose, For Veterinary in Vitro Diagnostic Use, 25 strips.","2390 boxes total for all products","Arkray Factory is recalling Spotchem ll Glucose and Spotchem ll EZ Check Health Check Vet Multistrip [Panel-V] because the test strips are incorrectly reporting low blood glucose at levels above 265/dL..","12/19/2016",," EA5A79  EA5F85  EA5G86  ",2/10/2016,"02/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",73834,"Ongoing","Arkray Factory USA, Inc.","5182 W 76th St",,"Minneapolis","MN","55439-2900","United States","Voluntary: Firm Initiated","Letter","USA: All states in USA including PR except AK, HI, WV, DE & RI.","V-0042-2017","Class II"," II EZ Health Check Vet Multistrip [Panel-V], For Veterinary in Vitro Diagnostic Use, 25 strips.","2390 boxes total for all products","Arkray Factory is recalling Spotchem ll Glucose and Spotchem ll EZ Check Health Check Vet Multistrip [Panel-V] because the test strips are incorrectly reporting low blood glucose at levels above 265/dL..","12/19/2016",," PL4L91  PL4M92  PL5A93  PL5B94  PL5C96  PL5E98  PL5G01  PL5H02  ",2/10/2016,"02/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73835,"Ongoing","Stryker Sustainability Solutions","1810 W Drake Dr",,"Tempe","AZ","85283-4327","United States","Voluntary: Firm Initiated","Letter","US distribution to KY.","Z-1626-2016","Class II","Launcher Guiding Catheter  Model #LA6EBU30.  Used in the coronary or peripheral vascular system..","2","Device packaging may not be sealed.","05/09/2016",," Lot #481938U",4/4/2016,"04/04/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73835,"Ongoing","Stryker Sustainability Solutions","1810 W Drake Dr",,"Tempe","AZ","85283-4327","United States","Voluntary: Firm Initiated","Letter","US distribution to KY.","Z-1625-2016","Class II","Mallinckrodt Evac Tracheal Tubes  Model #124170-MALLINCKRODT & 124175","4","Device packaging may not be sealed.","05/09/2016",," Lot #481938U",4/4/2016,"04/04/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73836,"Ongoing","Germinados Campo Verde","Carr 119 Km 30.6 Bo Hoyamala","Sector Planta de Gas","San Sebastian","PR","00685","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico only.","F-1332-2016","Class I","Alfalfa Sprout Product***Germinados Campo Verde***San Sebastian, Puerto Rico","TBD","Alfalfa sprout product lot is being recalled due to its link to seed lot SAL2-5CF contaminated with Salmonella.","05/13/2016",," A040316149",4/8/2016,"04/08/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73837,"Ongoing","St Jude Medical Inc.","15900 Valley View Ct",,"Sylmar","CA","91342-3577","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CT, NJ, SC, FL, GA   and countries of: Finland, France, Germany, Great Britain, Greece, Israel, Italy, Japan, Kuwait, Lebanon, Netherlands, Northern Ireland, Poland, Romania, Slovakia, Spain, Tunis, United Arab Emirates, and Vietnam.","Z-1632-2016","Class II","Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C    Product Usage:  Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.        ","127 units","St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.","05/09/2016",," Serial No.  7263877  7263892  7263900  7263904  7264199  7265399  7265400  7265401  7263916  7264214  7264398  7265581  ",3/31/2016,"03/31/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73838,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA","Z-1558-2016","Class II","SOMATOM Force, Computed Tomography x-ray system     intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission. ","37 CTsystems","The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected).  There is also a risk of a potential misdiagnosis in using this protocol for surgery planning.  Investigations revealed an incorrect parameterizatio","04/22/2016",," SOMATOM Force Material # 10742326, serial numbers 75550, 75526, 75512, 75567, 75536, 75514, 75563, 75510, 75454, 75540, 75571, 75437, 75500, 75527, 75475, 75535, 75481, 75439, 75450, 75482, 75460, 75493, 75476, 75458, 75528, 75467, 75487, 75478, 75513, 75532, 75555, 75524, 75515, 75559, 75501, 75570, 75576, 75450, 75482, 75528, 75576",4/1/2016,"04/01/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73839,"Terminated","LifeServe Blood Center","431 E Locust St",,"Des Moines","IA","50309-1909","United States","Voluntary: Firm Initiated","Telephone","Iowa","B-0432-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","2 units","Apheresis Platelets, lacking proper quality control testing, were distributed. ","04/14/2016","04/14/2016"," W037916558062; W037916558070; ",3/15/2016,"03/15/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73840,"Terminated","Delta Blood Bank","65 N Commerce St",,"Stockton","CA","95202-2318","United States","Voluntary: Firm Initiated","FAX","California","B-0433-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from an ineligible donor, was distributed. ","04/14/2016","04/14/2016"," W128716420356; ",3/7/2016,"03/07/2016",4/20/2016,"04/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73841,"Terminated","Central Texas Regional Blood & Tissue Center","4300 N Lamar Blvd",,"Austin","TX","78756-3421","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0440-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Apheresis red cells, not meeting product specifications, were distributed. ","04/21/2016","04/21/2016"," W221616350524; ",2/16/2016,"02/16/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73842,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","E-Mail","Switzerland","B-0451-16","Class III","Blood and Blood Products for Reprocessing","2 units","Blood products, collected from an ineligible donor, were distributed. ","04/21/2016","04/21/2016"," W036315105221; W036315118180",2/29/2016,"02/29/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73843,"Ongoing","FoodState, Inc ","4 Delta Dr",,"Londonderry","NH","03053-2347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1362-2016","Class II","MegaFood  Multi for Women 40+, Multivitamin & Mineral Dietary Supplement packaged in glass bottles  UPC:5149410321 -Packaged 60 tablets;  UPC:5149410322 -Packaged 120 tablets","2953 bottles","Multi Vitamin label fails to have  required warning statement for iron and child resistant cap","05/17/2016",," Item  Number:10321 (60 count) - Lot Numbers: 10321004 & 10321005  Item Number: 10322 (120 count)-Lot Number 10322004",4/15/2016,"04/15/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73844,"Ongoing","Dmh Ingredients Inc","1228 American Way",,"Libertyville","IL","60048-3936","United States","Voluntary: Firm Initiated","E-Mail","The product was distributed to one Manufacturer in New Jersey.     Harris Freeman (Southern Tea Company)  344 New Albany Road   Moorestown, New Jersey 08057","F-1294-2016","Class II","Organic Lemon Myrtle packed in a 12.5kg plastic bag inside of a cardboard box. ","20 cases, 12.5kg per case","The Organic Lemon Myrtle tested positive for Salmonella. ","05/05/2016",," Lot# SKF330015/ SKF2271115",4/8/2016,"04/08/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73845,"Ongoing","DNE Nutraceuticals Inc.","700 Central Ave",,"Farmingdale","NJ","07727-3787","United States","Voluntary: Firm Initiated","Letter","NY","F-0190-2017","Class II","Adwe Naturals Prenatal Vitamin Manufactured for: Adwe Laboratories 1274 49 Street Brooklyn, NY 11219   UPC 040168805079","1200 bottles","Adwe Prenatal tablets are being recalled due to a concern of potency of folic acid.","10/19/2016",," Lot 8990 ",2/8/2016,"02/08/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73846,"Ongoing","Stryker Corporation","5900 Optical Ct",,"San Jose","CA","95138-1400","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in  Australia, Switzerland, Netherlands, Spain and Sweden.","Z-1635-2016","Class II","CinchLock Flex Knotless Anchor with Inserter;  Model number CAT02643;    Orthopedic:  The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.","3100 total devices, both models","Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking  upon deployment of the anchor.  ","05/10/2016",," Model number: CAT02643;  Serial numbers: 15122202, 16011301,16020802",4/12/2016,"04/12/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73846,"Ongoing","Stryker Corporation","5900 Optical Ct",,"San Jose","CA","95138-1400","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in  Australia, Switzerland, Netherlands, Spain and Sweden.","Z-1634-2016","Class II","CinchLock SS Knotless Anchor with Inserter;  Model number CAT02462;     Orthopedic:  The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.","3100 total device, both model numbers.","Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking  upon deployment of the anchor.  ","05/10/2016",," Model number: CAT02462  Serial numbers: 15120801, 15121401, 16010402, 16011901, 16012501.",4/12/2016,"04/12/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73848,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-1051-2016","Class III","Lisinopril Tables, USP 40 mg, 1000-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, NDC 68180-517-03","5,880 Bottles","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.","06/24/2016",," Lot #: H303449, Exp 09/2016",4/4/2016,"04/04/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73848,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-1050-2016","Class III","Lisinopril Tablets, USP 30mg, packaged in a) 500 count bottles, and b)100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-516-02, b) 68180-516-01","20587 Bottles","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.","06/24/2016",," Lot #: a)  H303487, H303488; b) H303489, Exp. 09/2016",4/4/2016,"04/04/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73848,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-1052-2016","Class III","Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30","59,520 Bottles","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.","06/24/2016",," Lot #: a) H303459, b) H303460, Exp 09/2016",4/4/2016,"04/04/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73849,"Ongoing","Monteris Medical Corp","16305 36th Ave N Suite 200",,"Plymouth","MN","55446-2884","United States","Voluntary: Firm Initiated","Visit","Nationwide Distribution in the states of KS, MO, NC, OH, and VA.","Z-1614-2016","Class I","NeuroBlate System SideFire Select  2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01.  NeuroBlate System SideFire  Select Directional Laser Probes are part of the NeuroBlate System.  The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization.  It also provides real-time thermographic analysis of selected MRI images. The laser delivery probes direct the laser energy to the proper treatment location.","121","Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.","05/16/2016",," All unexpired lots of these models are being removed from the market.",3/25/2016,"03/25/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73850,"Ongoing","Frank L Harter & Sons Inc","3778 Frondorf Ave",,"Cincinnati","OH","45211-4421","United States","Voluntary: Firm Initiated","Letter","Product was shipped to KY & OH","F-1315-2016","Class I","SPINACH DIP ING: VEGETABLE SOUP MIX, MAYONAISE, SOUR CREAM, SPINACH, WATER CHESTNUTS, DRY ONIONS KEEP REFRIGERATED NET WT. 5LB. (KG) F.L.HARTER & SONS INC. CINCINNATI, OHIO 45211 ","40 cases/2/5 lb containers","The firm failed to include the allergens, Milk and Soy, on the label.","06/02/2016",," Exp Dates: 2 24 16, 3 02 16, 3 10 16, 3 16 16, 3 30 16, 4 06 16, 4 13 16, 4 20 16, 5 04 16 &  5 11 16.",4/15/2016,"04/15/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73850,"Ongoing","Frank L Harter & Sons Inc","3778 Frondorf Ave",,"Cincinnati","OH","45211-4421","United States","Voluntary: Firm Initiated","Letter","Product was shipped to KY & OH","F-1316-2016","Class I","PASTA SALAD ING: PASTA, ITALIAN DRESSING, DRY ONIONS, PARSLEY, RED PEPPERS, PARMESON CHEESE, SPICES. CONTAINS MILK KEEP REFRIGERATED NET WEIGHT 5LB.(2.26KG.) F.L. HARTER & SONS INC. 3778 FRONDORF AVE. CINTI OH. 45211","548 cases/2/5 lb containers","The firm failed to include the allergens, Milk and Soy, on the label.","06/02/2016",," Exp. Dates: 1 25 16, 1 27 16, 2 02 16, 2 04 16, 2 08 16, 2 15 16, 2 17 16, 2 22 16, 2 24 16, 2 29 16, 3 02 16, 3 07 16, 3 09 16, 3 14 16, 3 16 16, 3 21 16, 3 23 16, 3 28 16 & 3 30 16.",4/15/2016,"04/15/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73850,"Ongoing","Frank L Harter & Sons Inc","3778 Frondorf Ave",,"Cincinnati","OH","45211-4421","United States","Voluntary: Firm Initiated","Letter","Product was shipped to KY & OH","F-1314-2016","Class I","HAWAIIAN DELIGHT ING: IMITATION SOUR DRESSING, PEACHES, PINEAPPLE, MANDERIN ORANGES, SUGAR CHERRIES KEEP REFRIGERATED NET WT. 4.5 LB. & 9 LB. (4.06KG) (2.03KG) F.L. HARTER & SONS INC. CINCINNATI, OHIO 45211 ","96 CS/2/4.5 lb containers + 139 cs/2/9lb containers","The firm failed to include the allergens, Milk and Soy, on the label.","06/02/2016",," Exp. Date: 2 18 16, 3 03 16, 3 17 16, 3 24 16, 3 31 16, 4 07 16, 4 21 16 & 4 28 16.",4/15/2016,"04/15/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73851,"Terminated","American National Red Cross","3131 N Vancouver Ave",,"Portland","OR","97227-1560","United States","Voluntary: Firm Initiated","Other","California","B-0452-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from an ineligible donor, was distributed. ","04/21/2016","04/21/2016"," W202115453675",3/4/2016,"03/04/2016",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73852,"Terminated","American National Red Cross","3131 N Vancouver Ave",,"Portland","OR","97227-1560","United States","Voluntary: Firm Initiated","Other","California","B-0453-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from an ineligible donor, was distributed. ","04/21/2016","04/21/2016"," W202114317120",10/19/2015,"10/19/2015",4/27/2016,"04/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1663-2016","Class I","PICTSWEET(R) Steam'ables, Seasoned Summer Vegetables, with Cracked Pepper Seasoning, NET WT 10 OZ (283g), UPC 70560 98001, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006  ","65880 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," Best if Used by 03/28/2018:  0886BB,0886BC,0886BD,0886BE,0886BF,0886BG,0886BH,0886BJ,0886BK,  0886BL,0886BM,0886BN,0886BP,0886BQ,0886BR,0886BT,0886BU,0886BV  ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1655-2016","Class I","Frozen chopped onions labeled as:    a) Kroger(R) CHOPPED ONIONS, RECIPE BEGINNINGS(R), NET WT 12 OZ (340g), UPC 11110 89791, DISTRIBUTED BY THE KROGER COMPANY, CINCINNATI, OH 45202    b) PICTSWEET(R) Chopped Onions, recipe helper, NET WT 10 OZ (283g), UPC 70560 96609, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006  ","81752 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," a) UPC 11110 89791: Lot Codes:  0896BG, 0896BH, 0896BJ, 0896BK, 0896KA, 0896KB, 0956BA, 0956BB, 0956BC, 0956BD, 0956BG, 0956BJ    b) UPC 70560 96609: Lot Codes:  0826BA, 0826BB, 0826BC, 0826BD, 0826BE, 0826BF, 0826BG, 0826BH, 0906BA, 0906BB",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1656-2016","Class I","Kroger(R) CAJUN STYLE MIREPOIX BLEND, onions, celery, and green bell peppers, RECIPE BEGINNINGS(R), NET WT 12 OZ (340g), UPC 11110 89787, DISTRIBUTED BY THE KROGER COMPANY, CINCINNATI, OH 45202","11704 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," Sell by SEP-17: 0896BR, 0896BS, 0896BU,0896BT  ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1658-2016","Class I","Kroger(R) VEGETABLES, broccoli, sugar snap peas, green bean carrots, celery, onions, mushrooms, & red bell peppers, STIR FRY STARTERS(R), NET WT 12 OZ (340g), UPC 11110 89775, DISTRIBUTED BY THE KROGER COMPANY, CINCINNATI, OH 45202","126060 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," Sell by SEP-17:   0796KB,0796KC,0796KD,0796KE,0796KF,0796KG,0796KH, 0796KJ,0796KK,0796KL,0796KM,0796KN,0796KP,0796KQ,0796KR,0796KS,0796KT,0796KU,  0916BK,0916BL,0916BM,0916BN,0916BP,0916BQ,0916BR,0916BS,0916BT,  0916BU,0916BV,0916BW,  Sell by: OCT-17: 0956KG,0956KH,0956KJ,0956KP, 0956KT,0956KV  ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1661-2016","Class I","PICTSWEET(R) Vegetables for Cajun Gumbo, Seasoned with a blend of Cajun Spices, NET WT 12 OZ (340g), UPC 70560 95818, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006","1362 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," Best if Used by 4/05/2018 0966BR  ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1653-2016","Class I","Frozen three pepper and onion blends labeled as:    a) Harris Teeter(TM) brand THREE PEPPER & ONION BLEND, NET WT 12 OZ (340g), UPC 72036 71681, PROUDLY DISTRIBUTED BY HARRIS TEETER, LLC, MATTHEWS, NC 28105    b) Kroger(R) 3 PEPPER & ONION BLEND, onions, green bell peppers, yellow bell peppers, & red bell peppers, RECIPE BEGINNINGS(R), NET WT 12 OZ (340g), UPC 11110 89786, DISTRIBUTED BY THE KROGER COMPANY, CINCINNATI, OH 45202    c) PICTSWEET(R) 3 Pepper & Onion blend, NET WT 22 OZ, (1 LB 6 OZ ) 624g, UPC 70560 95891, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006    ","146898 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," a) UPC 72036 71681: Lot Codes:  0926BB, 0926BC    b) UPC 11110 89786: Lot Codes:  0796KB, 0796KC, 0796KD, 0796KE, 0796KF, 0796KG, 0796KH, 0796KJ, 0796KK, 0796KL, 0796KM, 0796KQ, 0796KR, 0796KS, 0796KT, 0796KU, 0796KV, 0896KL, 0896KM, 0896KN, 0896KP, 0896KQ, 0896KR, 0896KS, 0896KT, 0896KT, 0896KU, 0896KV, 0906KE, 0906KF, 0906KG, 0906KH, 0906KJ, 0906KL, 0906KM, 0906KP, 0906KQ, 0906KR, 0906KS, 0906KT, 0906KU, 0906KU, 0906KV    c) UPC 70560 95891: Lot Codes: 0826KB, 0826KC, 0826KD, 0826KE, 0826KF, 0826KG, 0826KH, 0826KJ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1660-2016","Class I","Frozen seasoning blend labeled as:    a) PICTSWEET(R) Seasoning Blend, recipe helper, NET WT 10 OZ (283g), UPC 70560 96902, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006    b) PICTSWEET(R) Seasoning Blend, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 70560 96911, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006    c) PICTSWEET(R) Seasoning Blend, Onions, Celery, Green & Red Peppers, Parsley NET WT 80 OZ (5 LB 20 OZ) 680g, UPC 70560 96927, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006  ","213830 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," a) UPC 70560 96902: Lot Codes:  0826BH, 0826BJ, 0826BK, 0826BL, 0826BM, 0826BN, 0826BP, 0826BQ, 0826BR, 0826BS, 0826BT, 0826BU, 0826BV, 0826BW, 0836BL, 0836BM, 0836BN, 0836BP, 0836BQ, 0836BR, 0836BR, 0836BS, 0836BT, 0836BU, 0836BV, 0906BK, 0906BN, 0906BP, 0906BQ, 0906BR, 0906BS, 0906BT, 0906BU, 0906BV, 0906BW, 0936BA, 0936BF, 0936BG, 0936BH, 0936BJ, 0936BK, 0936BL, 0936BM, 0936BN, 0936BP, 0936BR, 0936BS, 0936BT, 0936BU, 0936BW    b) UPC 70560 96911: Lot Codes:  0826KL,0826KM, 0826KN, 0826KQ, 0826KU, 0826KV    c) UPC 70560 96927: Lot codes:  0836KA, 0836KC, 0836KD, 0836KE, 0836KF, 0836KH  ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1659-2016","Class I","PICTSWEET(R) Steamables, Seasoned Spring Vegetables, with Asparagus and Ground Peppercorn Seasoning, NET WT 10 OZ (283g), UPC 70560 97826, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006  ","79932 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," 969 cases of 8 units:   Best if Used by 3/28/2018: 0886KH,0886KQ,0886KR,0886KR,0886KR,0886KT;  Best if Used by 4/5/2018: 0966KB,0966KD,0966KE,0966KJ    6015 Cases of 12 units:  Best if Used by 3/19/2018:  0796KD,0796KE,0796KF,0796KG,0796KJ,0796KK,0796KL,0796KN,0796KP,  0796KQ,0796KR,0796KS,0796KT,0796KU,0796KV;  ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1664-2016","Class I","PICTSWEET(R) Deluxe Stir-Fry Chinese Style Vegetables, Oriental Seasoning, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 70560 95689, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006","960 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," Best if Used by 4/2/2018: 0936BE, 0936BF  ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1654-2016","Class I","Harris Teeter(TM) brand SOUP MIX VEGGIES, carrots, potatoes, corn, green beans, lima beans, okra, green peas, celery, onions, NET WT 12 OZ (340g), UPC 72036 71683, PROUDLY DISTRIBUTED BY HARRIS TEETER, LLC, MATTHEWS, NC 28105","4032 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," Best if Used by SEP-17: 0836BL, 0836BM",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1657-2016","Class I","Kroger(R) VEGETABLES WITH NOODLES, egg noodles, broccoli, carrots, green bell peppers, mushrooms, onions & red bell peppers, STIR FRY STARTERS(R), NET WT 12 OZ (340g), UPC 11110 89776, DISTRIBUTED BY THE KROGER COMPANY, CINCINNATI, OH 45202    ","1680 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," Sell by SEP-17: 0926BQ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73853,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1662-2016","Class I","PICTSWEET(R) Gumbo Vegetables, NET WT 12 OZ (340g), UPC 70560 95995, DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38006","809 cases of 6 units","Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.","07/07/2016","."," Best if Used by 3/21/2018: 0816BT,0816BV  ",4/9/2016,"04/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73854,"Ongoing","Siemens Medical Solutions USA, Inc.","685 E Middlefield Rd",,"Mountain View","CA","94043-4045","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Austria, Canada, China, Germany, India, Italy, Spain, Sweden, and Switzerland.","Z-1592-2016","Class II","ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M.  Model number: 10433816.","87","While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.","05/02/2016",," Model number 10433816;  Serial numbers:  402192  400889  402498  402549  400887  402791  401002  402278  402289  402301  401182  402879  400462  400649  402206  402211  402496  402499  401631  402475  400456  402392  402828  402814  400852  401010  402509  400221  400312  402413  402568  402460  402652  402673  402664  400234  402789  401751  401040  400519  402800  400775  400671  401445  402546  402542  402771  402764  401117  401252  402454  402476  402500  402513  402511  401305  401130.  ",4/8/2016,"04/08/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73855,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide, United Arab Emirates, Kuwait, and Bahrain","D-1137-2016","Class I","Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5. ","88,500 vials","Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.","07/06/2016","."," Lot #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.",3/23/2016,"03/23/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73856,"Ongoing","Stanmore Implants Worldwide Ltd.","210 Centennial Avenue Centennial Park","Centennial Park","Borehamwood",,,"United Kingdom","Voluntary: Firm Initiated","Letter","US distribution to OH.","Z-1623-2016","Class II","Distal Femoral Replacement (patient specific, custom made orthopedic implant device).  PIN 19960","1","Incorrect component used to manufacture distal femoral replacement.","05/09/2016",," Device Identifier: PIN 19960, Lot: 19960",4/12/2016,"04/12/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73857,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","Voluntary: Firm Initiated","Letter","US in the state Nevada","Z-1560-2016","Class II","Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03    Product Usage:  Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.  ","1 unit","Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.","04/22/2016",," Serial No. 2DA15Y2036",4/12/2016,"04/12/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73858,"Ongoing","Porfirios Italian Foods, Inc.","320 Anderson St",,"Trenton","NJ","08611-1106","United States","Voluntary: Firm Initiated","Letter","NJ, PA","F-0184-2017","Class II","Porfirio's 12 Jumbo Cheese Ravioli Net Wt. 14 oz. Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611","1400 lbs. total","Pasta Products which contain cheese may contain undeclared wheat and milk.","10/24/2016",," no codes",2/15/2016,"02/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73858,"Ongoing","Porfirios Italian Foods, Inc.","320 Anderson St",,"Trenton","NJ","08611-1106","United States","Voluntary: Firm Initiated","Letter","NJ, PA","F-0178-2017","Class II","Porfirio's Potato Gnocchi Net Wt. 16 oz. (1 LB.) 453 g  Manufactured by Porfirio's  Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611 UPC 016105000319","1400 lbs. total","Pasta Products which contain cheese may contain undeclared wheat and milk.","10/24/2016",," no codes    ",2/15/2016,"02/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73858,"Ongoing","Porfirios Italian Foods, Inc.","320 Anderson St",,"Trenton","NJ","08611-1106","United States","Voluntary: Firm Initiated","Letter","NJ, PA","F-0185-2017","Class II","Porfirio's Egg Fettucine   Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611","1400 lbs. total","Pasta Products which contain cheese may contain undeclared wheat and milk.","10/24/2016",," no codes  ",2/15/2016,"02/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73858,"Ongoing","Porfirios Italian Foods, Inc.","320 Anderson St",,"Trenton","NJ","08611-1106","United States","Voluntary: Firm Initiated","Letter","NJ, PA","F-0182-2017","Class II","Porfirio's 6 Cheese Manicotti Net Wt. 22 oz.  Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611","1400 lbs. total","Pasta Products which contain cheese may contain undeclared wheat and milk.","10/24/2016",," no codes  ",2/15/2016,"02/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73858,"Ongoing","Porfirios Italian Foods, Inc.","320 Anderson St",,"Trenton","NJ","08611-1106","United States","Voluntary: Firm Initiated","Letter","NJ, PA","F-0181-2017","Class II","Porfirio's 12 Jumbo Spinach Ravioli  Net Wt. 14 oz. (1 LB.) 453 g Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611","1400 lbs. total","Pasta Products which contain cheese may contain undeclared wheat and milk.","10/24/2016",," no codes  ",2/15/2016,"02/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73858,"Ongoing","Porfirios Italian Foods, Inc.","320 Anderson St",,"Trenton","NJ","08611-1106","United States","Voluntary: Firm Initiated","Letter","NJ, PA","F-0180-2017","Class II","Porfirio's Homeade Ricotta Cavatelli  Net Wt. 1Lb Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ ","1400 lbs. total","Pasta Products which contain cheese may contain undeclared wheat and milk.","10/24/2016",," no codes  ",2/15/2016,"02/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73858,"Ongoing","Porfirios Italian Foods, Inc.","320 Anderson St",,"Trenton","NJ","08611-1106","United States","Voluntary: Firm Initiated","Letter","NJ, PA","F-0179-2017","Class II","Porfirio's Homeade Ricotta Gnocchi Net Wt. 16 oz (1 LB.) 453 g Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611 UPC 016105000319","1400 lbs. total","Pasta Products which contain cheese may contain undeclared wheat and milk.","10/24/2016",," no codes",2/15/2016,"02/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73858,"Ongoing","Porfirios Italian Foods, Inc.","320 Anderson St",,"Trenton","NJ","08611-1106","United States","Voluntary: Firm Initiated","Letter","NJ, PA","F-0183-2017","Class II","Porfirio's 12 Jumbo Stuffed Shells Net Wt. 24 oz.  Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611","1400 lbs. total","Pasta Products which contain cheese may contain undeclared wheat and milk.","10/24/2016",," no codes  ",2/15/2016,"02/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73858,"Ongoing","Porfirios Italian Foods, Inc.","320 Anderson St",,"Trenton","NJ","08611-1106","United States","Voluntary: Firm Initiated","Letter","NJ, PA","F-0186-2017","Class II","Porfirio's Cheese & Spinach Manicotti Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611","1400 lbs. total","Pasta Products which contain cheese may contain undeclared wheat and milk.","10/24/2016",," no codes",2/15/2016,"02/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73861,"Ongoing","Nubreed Nutrition, Inc","318 John R Rd Ste 310",,"Troy","MI","48083-4542","United States","Voluntary: Firm Initiated","Press Release","Domestic: Unknown    Foreign: Unknown    VA/DOD:","F-1386-2016","Class II","Undisputed , all lot codes, Flavors: Watermelon, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case","600"," because it contains the ingredient Acacia rigidula which does not meet the definition of a dietary ingredient. ","05/20/2016",," All lot codes including the following: Watermelon    DOM 6/2014   600 Units     Lot #190353NBWW (Only run they did of this)",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73861,"Ongoing","Nubreed Nutrition, Inc","318 John R Rd Ste 310",,"Troy","MI","48083-4542","United States","Voluntary: Firm Initiated","Press Release","Domestic: Unknown    Foreign: Unknown    VA/DOD:","F-1385-2016","Class II","Undisputed , all lot codes, Flavors:Fruit Punch, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case",," because it contains the ingredient Acacia rigidula which does not meet the definition of a dietary ingredient. ","05/20/2016",," All lot codes including the following: Fruit Punch     DOM 4/24/15   200 Units    Lot #36143399  ",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73861,"Ongoing","Nubreed Nutrition, Inc","318 John R Rd Ste 310",,"Troy","MI","48083-4542","United States","Voluntary: Firm Initiated","Press Release","Domestic: Unknown    Foreign: Unknown    VA/DOD:","F-1389-2016","Class II","Undisputed , all lot codes, Flavors: Mango Orange , 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case","200 units"," because it contains the ingredient Acacia rigidula which does not meet the definition of a dietary ingredient. ","05/20/2016",," All lot codes including the following: Mango Orange DOM 6/16/15   200 Units    Lot #31159399",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73861,"Ongoing","Nubreed Nutrition, Inc","318 John R Rd Ste 310",,"Troy","MI","48083-4542","United States","Voluntary: Firm Initiated","Press Release","Domestic: Unknown    Foreign: Unknown    VA/DOD:","F-1388-2016","Class II","Undisputed , all lot codes, Flavors: Juicy Pineapple, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case","300"," because it contains the ingredient Acacia rigidula which does not meet the definition of a dietary ingredient. ","05/20/2016",," All lot codes including the following: Pineapple      DOM 5/2014    300 Units    Lot #190337NB",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73861,"Ongoing","Nubreed Nutrition, Inc","318 John R Rd Ste 310",,"Troy","MI","48083-4542","United States","Voluntary: Firm Initiated","Press Release","Domestic: Unknown    Foreign: Unknown    VA/DOD:","F-1367-2016","Class II","Undisputed , all lot codes, Flavors: Blue Raspberry, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case","2700 units"," because it contains the ingredient Acacia rigidula which does not meet the definition of a dietary ingredient. ","05/20/2016",," All lot codes including the following: Blue Raspberry  DOM 6/17/15  200 Units    Lot #30759499; Blue Raspberry DOM 7/2014  200 Units    Lot #190370UBR;  Blue Raspberry DOM 12/2014 300 Units   Lot #150429BR;    ",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73861,"Ongoing","Nubreed Nutrition, Inc","318 John R Rd Ste 310",,"Troy","MI","48083-4542","United States","Voluntary: Firm Initiated","Press Release","Domestic: Unknown    Foreign: Unknown    VA/DOD:","F-1387-2016","Class II","Undisputed , all lot codes, Flavors: Lemon Lime, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case","400 units"," because it contains the ingredient Acacia rigidula which does not meet the definition of a dietary ingredient. ","05/20/2016",," All lot codes including the following: Lemon Lime     DOM 4/24/15   200 Units    Lot #36243599; Lemon Lime   DOM 06/2014   200 Units    Lot # 190351ULL",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73861,"Ongoing","Nubreed Nutrition, Inc","318 John R Rd Ste 310",,"Troy","MI","48083-4542","United States","Voluntary: Firm Initiated","Press Release","Domestic: Unknown    Foreign: Unknown    VA/DOD:","F-1390-2016","Class II","Undisputed , all lot codes, Flavors: Sour Apple, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty  (40) powder servings; 12 /case","300 units"," because it contains the ingredient Acacia rigidula which does not meet the definition of a dietary ingredient. ","05/20/2016",," All lot codes including the following: Sour Apple      DOM 5/5/14     100 Units    Lot #190339NBUSA  Sour Apple     DOM 8/20/14    200 Units    Lot # 190385NBUSA  ",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73862,"Ongoing","Biosense Webster, Inc.","15715 Arrow Hwy",,"Irwindale","CA","91706-2006","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Hong Kong, Indonesia, India, Japan, Korea, Malaysia, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Austria, Belgium, Bulgaria, Switzerland, Czech Republic, Germany, Denmark, Algeria, Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Israel, Iraq, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Turkey, South Africa.","Z-1590-2016","Class II","Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206    The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.","13,912 units ","Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.","04/29/2016",," 15798659L  15795833L  15805361L  15782835L  15793498L  15795840L  15808937L  15803354L  15801125L  15805364L  15808933L  15808940L  15790718L  15799746L  15800549L  15795194L  15795197L  15800489L  15814334L  15814875L  15811695L  15811699L  15815788L  15782017L  15801124L  15801127L  15799738L  15799744L  15819531L  15800485L  15804551L  15814337L  15814339L  15814869L  15811196L  15811200L  15816732L  15806214L  15820998L  15805358L  15825347L  15808939L  15784813L  15787804L  15825339L  15815350L  15819522L  15819524L  15819529L  15825880L  15809778L  15810494L  15814871L  15820209L  15820199L  15820207L  15820210L  15816738L  15820991L  15820993L  15821008L  15803346L  15805362L  15808934L  15825889L  15825893L  15828085L  15828089L  15795201L  15809773L  15816737L  15820994L  15805360L  15808932L  15808938L  15825342L  15825881L  15825887L  15825891L  15828086L  15828087L  15828088L  15828090L  15831087L  15803968L  15814332L  15822449L  15822451L  15826600L  15828094L  15825882L  15811195L  15811692L  15827318L  15815787L  15825348L  15835412L  15835415L  15820212L  15821738L  15822458L  15822463L  15826605L  15828092L  15831082L  15831085L  15832438L  15832441L  15833155L  15833156L  15833158L  15833160L  15833164L  15835566L  15835571L  15831852L  15831854L  15839707L  15839406L  15847790L  15831855L  15837113L  15803352L  15808935L  15808941L  15830258L  15830262L  15830263L  15835408L  15835417L  15845015L  15825341L  15810500L  15828093L  15836394L  15840280L  15814849L  15839402L  15839404L  15843376L  15844332L  15844335L  15849431L  15821006L  15815791L  15816734L  15830260L  15830261L  15830267L  15835410L  15845014L  15845016L  15845017L  15847690L  15847691L  15847697L  15837784L  15840292L  15843380L  15832440L  15833157L  15833159L  15839401L  15844340L  15849432L  15839408L  15843374L  15844333L  15844347L  15844350L  15840932L  15840935L  15837774L  15837778L  15839410L  15843377L  15850674L  15859160L  15862714L  15820205L  15821731L  15832445L  15845949L  15867139L  15832444L  15843381L",4/14/2016,"04/14/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73862,"Ongoing","Biosense Webster, Inc.","15715 Arrow Hwy",,"Irwindale","CA","91706-2006","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Hong Kong, Indonesia, India, Japan, Korea, Malaysia, New Zealand, Singapore, Thailand, Taiwan, United Arab Emirates, Austria, Belgium, Bulgaria, Switzerland, Czech Republic, Germany, Denmark, Algeria, Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Israel, Iraq, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Turkey, South Africa.","Z-1591-2016","Class II","Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212    The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.","59,672 units","Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.","04/29/2016",," 16050993L  16052415L  16050242L  16049660L  16054298L  16053514L  16054297L  16052414L  16053513L  16053516L  16050992L  15990830L  16012853L  16047426L  16054299L  16048721L  17055438L  17058924L  17064807L  17066297L  17055454L  17069067L  17064806L  17069961L  17069964L  17051780L  17069065L  17069066L  17052759L  17052760L  17053741L  17065103L  17053740L  17053742L  17059593L  17059595L  17058925L  17058929L  17059594L  17058930L  17059596L  17059592L  17055455L  17055437L  17050534L  17066833L  17066832L  17103225L  17100630L  17103709L  17104144L  17100633L  17187339L  17187331L  17186424L  17187338L  17187334L  17183074L  17173411L  17172912L  17172049L  17186423L  17186426L  17173416L  17183072L  17186422L  17169225L  17166017L  17173131L  17182426L  17181315L  17182429L  17177947L  17177950L  17173419L  17173414L  17177952L  17148553L  17148570L  17152997L  17165843L  17165844L  17165845L  17176640L  17177946L  17182419L  17182416L  17176183L  17177228L  17182424L  17183068L  17183066L  17182423L  17182420L  17183069L  17183070L  17183071L  17172068L  17172069L  17173137L  17173445L  17173133L  17173443L  17171926L  17172070L  17173134L  17176182L  17173417L  17173418L  17177945L  17177951L  17176180L  17176181L  17175535L  17182425L  17172050L  17172910L  17172045L  17190460L  17190462L  17172906L  17172911L  17187336L  17187341L  17165854L  17166016L  17182427L  17182417L  17182415L  17183067L  17172908L  17183062L  17182422L  17183061L  17182421L  17182414L  17165787L  17172038L  17172042L  17172041L  17172043L  17177230L  17181313L  17177948L  17173132L  17180290L  17177949L  17172039L  17173130L  17177229L  17180288L  17187337L  17186425L  17177953L  17172047L  17173413L  17172913L  17173412L  17173420L  17172907L  17172040L  17172909L  17187340L  17177231L  17177234L  17177233L  17180289L  17177235L  17177232L  17172044L  17173415L  17172048L  17172046L  17181314L  17183063L  17181311L  17182418L  17183073L  17183065L  17180287L  17181312L  17176641L  17182428L  17238463L  17237752L  17239368L",4/14/2016,"04/14/2016",5/11/2016,"05/11/2016","  17088960L  17094945L  17090149L  17090151L  17071877L  17098796L  17093188L  17073953L  17085405L  17081946L    17084550L  17088962L  17070921L  17080025L  17073956L  17066844L  17083856L  17095176L  17088963L  17085406L  17154738L  17154884L  17154340L  17161964L  17161959L  17154890L  17161963L  17148565L  17154337L  17161965L  17161974L  17145507L  17154891L  17154892L  17147161L  17154883L  17147164L  17154330L  17147162L  17161972L  17161961L  17147166L  17145506L  17122896L  17147165L  17154893L  17145511L  17152605L  17142361L  17154334L  17161968L  17161971L  17142167L  17161973L  17154739L  17161969L  17122879L  17161960L  17142357L  17189331L  17194209L  17206422L  17194724L  17201455L  17194717L  17212028L  17177969L  17154328L  17216069L  17212029L  17206423L  17211080L  17212021L  17211087L  17211085L  17211082L  17201456L  17211088L  17211090L  17206420L  17194216L  17201459L  17201457L  17201458L  17194208L  17194214L  17176652L  17212023L  17211083L  17212022L  17191153L  17211086L  17175545L  17212027L  17176202L  17190483L  17190485L  17227513L  17220342L  17243442L  17234946L  17200846L  17234941L  17220690L  17199857L  17238483L  17199869L  17219234L  17237774L  17200842L  17227327L  17200840L  17200849L  17234942L  17199861L  17200847L  17206963L  17220688L  17215387L  17227330L  17200848L  17199862L  17200845L  17199868L  17236857L  17283414L  17361825L  17333211L  17376534L  17384183L  17368974L  17362539L  17349936L  17369964L  17368972L  17323417L  17346829L  17369179L  17310315L  17361824L  17367651L  17356412L  17376198L  17367652L  17367656L  17365104L  17367657L  17380499L  17367655L  17388301L  17343257L  17359070L  17380497L  17388450L  17378435L  17387058L  17367660L  17346826L  17376200L  17373258L  17356155L  17351970L  17347503L  17380498L  17373260L  17373264L  17365106L  17278988L  17356156L  17345506L  17356415L  17347146L  17355322L  17373457L  17356416L  17369963L  17359069L  17356154L  17355319L  17332771L  17359177L  17376197L  17356284L  17344198L  17355318L  173510",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73863,"Ongoing","Mary's Homemade","829A Strasburg Rd",,"Paradise","PA","17562-9661","United States","Voluntary: Firm Initiated","Telephone","Products distributed in PA, MD and DE","F-0693-2017","Class II","Mary's Home Made Vegetable Soup; 16 FL. OZ. (1 Pint) OR 32 FL. OZ. (1 Quart); Heat and Serve  ","12 jars per case (total 516 16 oz. jars and 1128 32 oz. jars)","This low-acid canned soup is underprocessed and may be a Clostridium Botulinum hazard.","12/12/2016",," No codes associated with this product    ",4/13/2016,"04/13/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73864,"Terminated","OLMA-XXI INC.","204 28th St",,"Brooklyn","NY","11232-1604","United States","Voluntary: Firm Initiated","Press Release","NY, NJ, CT, MA, PA, IL, MD, VA, KY, SC, GA, FL, and CA.","F-1317-2016","Class I","NORVEN herring in oil, Net Wt. 17.6 oz. (500g), UPC barcode 856687004196, and Net Wt. 10.6 oz. (300g), UPC barcode 856687004189 -- Product of Ukraine -- Distributed by: OLMA-XXI Inc. 204 28th Street, Brooklyn, NY 11232","300 g: 7951 units; 500 g: 4708 units","The lot was found to be contaminated with Listeria monocytogenes based on FDA sampling and analysis.","05/05/2016","07/07/2016"," Lot # 530611, Best before: 10/27/16 (stamped on bottom label).  ",4/14/2016,"04/14/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73866,"Terminated","Community Blood Center Of Gtr KC","4040 Main St",,"Kansas City","MO","64111-2308","United States","Voluntary: Firm Initiated","FAX","Missouri","B-0493-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected within one year from a donor who travelled to a malarial endemic country, was distributed. ","05/17/2016","05/17/2016"," W045015084636",3/30/2016,"03/30/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73867,"Terminated","American National Red Cross (The)","6230 Claremont Ave",,"Oakland","CA","94618-1324","United States","Voluntary: Firm Initiated","FAX","California","B-0518-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Mislabeled blood product was distributed.","05/17/2016","05/17/2016"," W208415254367",11/19/2015,"11/19/2015",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0896-2017","Class I","1 GL PAIL SYSCO IMP. CANTALOUPE/GRAPE JUICE,  UPC 7486562450                                                      ","10 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/19/2016                                  ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0898-2017","Class I","4/1 GL SYSCO FRUIT MIX GRAPE JUICE, UPC 10074865624296                                                                ","24 cases","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/22/2016                                      ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0894-2017","Class I","1 GL PAIL SYSCO CANTALOUPE CHUNKS - LS, UPC 7486548718                                              ","30 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/20/2016                            ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0883-2017","Class I","4 GL PAIL FRUIT MIX-SMALL CUT, UPC 4294710455            ","11 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/25/2016  and 4/27/2106",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0881-2017","Class I","4 GL PAIL SFF FRUIT MIX - Light Syrup, UPC 4294710455        ","2 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/27/2016  ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0897-2017","Class I","2 GL PAIL SYSCO IMP. FRUIT MIX W/GRAPE JUICE, UPC 7486563430                                                          ","20 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/21/2016                                    ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0900-2017","Class I","1 GL CVF FRUIT SALAD DELUXE IN GRAPE JUICE, UPC 50758108455745                                                                                ","10 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/22/2016                                            ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0895-2017","Class I","1 GL PAIL SYSCO FRUIT MIX - LS, UPC 7486540223; 4 GL Pail UPC 7486572788                                                ","1GL - 470 pails; 4 GL 40 Pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/27/2016                              ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0893-2017","Class I"," 2/1 GL SYSCO IMP. FRUIT MIX  -LS, UPC 10074865081938;                                            ","373 cases","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/26/2016 and 4/27/2016                        ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0904-2017","Class I","3 GL PAIL SFF SEASONAL FRUIT MIX B, UPC 4294710277                                                                                                                              ","4 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/27/2016                                                                ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0901-2017","Class I","1 GL CVF CANTALOUPE CHUNKS - LS, UPC 50758108449775;                                                                                    ","276 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/20/2016                                              ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0891-2017","Class I","1 GL PAIL SYSCO CANTALOUPE CHUNKS - LS, UPC 7486548718                                      ","50 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/20/2016                    ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0885-2017","Class I","1 GL JAR SFF CANTALOUPE CHUNKS - Light Syrup, UPC 4294700119                    ","29 jars","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/19/2016 and 4/20/2016    ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0886-2017","Class I","4 GL PAIL SFF FRUIT MIX N/O - Light Syrup, UPC 4294710455                      ","1 pail","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/27/2016    ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0880-2017","Class I",", UPC 4210119      ","3 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/19/2016  ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0882-2017","Class I","4 GL PAIL SFF CANTALOUPE CHUNKS, UPC 4294710419; 4/1 GL Case Cantaloupe Chunks UPC 4294740119            ","28 pails; 8 cases","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/19/2016  and 4/20/2016",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0892-2017","Class I","4/1 GL SYSCO IMP FRUIT MIX, UPC 10074865435236                                        ","96 cases","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 5/4/2016 and 4/27/2016                      ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0902-2017","Class I","**1) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #5075810  8449874; **2) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #50758108449904;    **3) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874  ; **4) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874  ;  **5) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449904;    **6)  1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449898  ;   **7) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449898  ;  **8)  1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449904  ; **9) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874  ; **10)  1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874   **11) 1 GL CVF FR.UIT SALAD DELUXE - LS, UPC 758108563858                                                                                        ","**1) 40 Pails; **2) 4 Pl; **3) 40 Pl; **4) 40 Pl; **5) 5 Pl; **6) 15 Pl; **7) 6 Pl; **8) 30 Pl; **9) 50 Pl; **19) 60 Pl; **11) 24 Cases.","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/27/2016                                              ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0903-2017","Class I","2/1 GL SFF TROPICAL MIX IN GRAPE JUICE, UPC 4294727161                                                                                                              ","10 cases","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/22/2016                                                          ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0889-2017","Class I","1 GL PAIL SYSCO FRUIT MIX - LS, UPC 47486540223                                      ","210 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/27/2016                ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0888-2017","Class I","1 GL PAIL and 2x1 GL/case SFF FRUIT MIX IN GRAPE JUICE, UPC 4294717155                                    ","15 GL pails and 7- 2x1 GL cases","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/22/2016              ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0879-2017","Class I","1 GAL PAIL SYSCO IMP. TROPICAL SALAD - LS, UPC 7486563429                                                  ","60 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/27/2016                              ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0890-2017","Class I","2/1 GL JAR SYSCO IMP. SPRING MIX                                  ","30 cases","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 5/4/2016                  ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0899-2017","Class I","2 GL, 1 GL PAIL SFF CANT/CHUNKS GRAPE JUICE, UPC 4294717119                                                                            ","1GL 37 pails; 2 GL 20 pails","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/20/2016                                          ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0887-2017","Class I",", UPC 4294740192                        ","13 cases","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/27/2016 and 4/26/2016    ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73868,"Terminated","Simply Fresh Fruit","4383 Exchange Ave",,"Vernon","CA","90058-2619","United States","Voluntary: Firm Initiated","Letter","Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA","F-0884-2017","Class I","**1) 1 GL PAIL SFF FRUIT MIX, UPC #3522300553 and UPC4294710155;   **2) 3 GL PAIL SFF FRUIT MIX, UPC #4294710355; **3) 4GL PAIL SFF FRUIT MIX UPC #4294710455; **4) 2/1 GL Case SFF Fruit Mix UPC 4294720155; **5) 4/1 GL case SFF Fruit Mix UPC #4294740155.        ...  **3) 4 GL PAIL SFF FRUIT MIX, UPC #4294710455  ...  **4) 1 GL PAIL SFF FRUIT MIX, UPC #3522300553  ...  **5) 2/1 GL PAIL SFF FRUIT MIX, UPC #4294720155   ...  **6) 4/1 GL PAIL SFF FRUIT MIX, UPC #4294740155  ...  **7) 4/1 GL PAIL SFF FRUIT MIX, UPC #4294740155.                  ","**1) 16 pails; **2) 5 pails; **3) 110 pails; **4) 21 cases **5) 70 cases ","Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.","12/22/2016","12/27/2016"," 4/26/2016  ",4/14/2016,"04/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73869,"Ongoing","Medtronic Sofamor Danek Usa, Inc - Dallas Distribution","4620 N Beach St",,"Haltom City","TX","76137-3219","United States","Voluntary: Firm Initiated","Letter","Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.","Z-1602-2016","Class II","Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM.  Intended for use in neurosurgery.   ","81 tools","Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.","05/04/2016",," Product Catalog Number: 10BA40D, Lot Number: H5237248",4/8/2016,"04/08/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73870,"Ongoing","Limacorporate S.p.A","Via Nazionale 52",,"San Daniele Del Friuli",,,"Italy","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Australia.","Z-1711-2016","Class II","SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.","314 units","Complaints of intra-operative breakage of the glenosphere impactors/extractors.  ","05/24/2016",," Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600",4/8/2016,"04/08/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73871,"Ongoing","STERILMED, INC.","11400 73rd Ave N",,"Maple Grove","MN","55369-5561","United States","Voluntary: Firm Initiated","Letter","US: AL, AR, CA, CO, FL, GA, IN,IA, KY, MD, MA, MI, MN, MO, NV, NJ, NC, OH, OK, OR, PA,, SC, TN, TX, VA, WA, WV, WI.    Canada","Z-1846-2016","Class II","Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.","11,326","Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.","05/31/2016",," Lot Number  MIC3112 /  1850033  1851382  1852899  1853678  1855660  1856511  1856900  1859438  1859965  1860367  1861563  1862954  1863647  1864260  1865162  1865993  1867015  1867706  1868934  1870036  1870103  1871206  1872270  1873830  1874518  1875721  1876911  1878327  1879082  1880420  1880667  1880964  1882288  1883924  1884996  1886199  1886912  1887725  1889721  1889771  1890036  1890089  1891061  1891534  1891745  1892678  1893796  1893818  1893872  1894880  1895807  1896467  1897219  1898693  1899180  1900106  1901160  1901950  1903029  1903645  1904549  1905627  1906345  1907168  1907920  1908583  1909201  1910229  1911281  1912196  1912496  1913274  1913316  1914703    MIC3122/  1850033  1851382  1856511  1856900  1859438  1861563  1868934  1870103  1872882  1875721  1878327  1879082  1896467  1897219  1898693  1899795  1900106  1901160  1903029  1905604  1906345  1907168  1910229  1911281  1912196    MIC3132 /  1850033  1851382  1852883  1852899  1853678  1854157  1856900  1859965  1860367  1861563  1862954  1863647  1864094  1864260  1865993  1867706  1868934  1870036  1870103  1871206  1872882  1874798  1874852  1875721  1878327  1879082  1879555  1880420  1880964  1883924  1884996  1886199  1886912  1887725  1889721  1891061  1891534  1891745  1892678  1899180  1899795  1900106  1901160  1905627  1909201  1910229  1910810  1911873  1912496  1913520    MIC3142 /  1850033  1851382  1852859  1852883  1852899  1852905  1853937  1854157  1855660  1855815  1856511  1856900  1859438  1859745  1859965  1860193  1860367  1861563  1862228  1862954  1863647  1864260  1865162  1865902  1867015  1867706  1868934  1869589  1870103  1871206  1872270  1872882  1873830  1874518  1874798  1875721  1876911  1878327  1879082  1880420  1880667  1880964  1881991  1882288  1883924  1884996  1886199  1886912  1887725  1889044  1889486  1889720  1889721  1889771  1890036  1890089  1891060  1891061  1891745  1892678  1893536  1893796  1893872  1894880  1895806  1895807  1896467  1897219  1898693  1899180  1900106  190",4/26/2016,"04/26/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73872,"Ongoing","Thomas Star Bakery of Ohio","3238 Hill Ave",".","Toledo","OH","43607-2935","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: IL, IN & OH.","F-0679-2017","Class I","Thomas' Buns Bread Net Weight 1.5 lbs. (682 grams) . Thomas Star Bakery of Ohio ","9,936 loaves","The firm failed to declare the allergens Milk & Eggs on their ingredient statement.","12/08/2016",," Best By 4/24/2016 and before.",4/14/2016,"04/14/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73873,"Ongoing","Bradshaw Medical Inc.","10325 58th Pl",,"Kenosha","WI","53144-7872","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM","Z-1637-2016","Class II","Axial Torque Limiting Driver    Product Usage:  The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.  ","3,760 units","Bradshaw is recalling 1st Generation Axial Torque Limiting Driver because the firm became aware of a component failure that had the potential to cause a situation where the applied torque was significantly higher than the calibrated torque setting.","05/10/2016",," 		  		  Part Number	BMI #	Customer Lot Code  11-5000-018	512833	102551  	                     512835	102848  	                      527192	OP-CS-I-0026 TO 0046  	                      550398	OP-CS-I-0223 TO 0232  	                      561041	561041-001 TO -030  6200-1109              	513884	2009300543  	                     514227	2009300643  	                     514228	2009300743  	                     514229	2009300843  	                     514230	2009300993  	                     516828	2009411377  	                     518909	2010082257  	                     519942	2010152571  	                     522701	2010373025-2010373174  14-525035-00	538133	538133 001-030  	                      538134	538134 001-015  	                      548080	548080 001-015  	                      550475	550475 001-015  	                      552169	552169 001-020  	                      553131	553131 001-015  	                      553710	553710 001-015  	                      558873	558873 001-010  	                      567568	567568 001-010  	                      569141	569141 001-015  PARD01085	530249	351400 001-002   L070-0045	570659	1525-10-1 THRU 1525-10-2  694.002	                      523947	BRL237AA001  	                      523948	BRL237AA 002 TO 092  	                      527249	BRM032AA-001 TO 015  	                      529395	BRM061AA 001 TO 030  	                      528469	BRM061AA 001 TO 050  	                      534799	BRM259FA  	                      535830	BRM292GA  	                      537840	BRM362AA  	                      539698	BRN046AA  	                      540726	BRN073AA  	                      543837	BRN171BA  	                      544323	BRN194AA003  	                      544323-1	BRN194AA  001-002 AND 004-014  	                      547606	BRN285EA  	                      548612	BRN317DA  	                      549604	BRN348VA  	                      554050	BRP102AA  	                      555027	BRP107CA-001 TO 010 CHANGED TO                                                    ",2/2/2015,"02/02/2015",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73874,"Ongoing","Mckesson Packaging Services","7101 Weddington Rd NW",,"Concord","NC","28027-3412","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0834-2016","Class III","SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01. ","1,676 boxes","Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. ","04/28/2016",," Lot 0110701",4/12/2016,"04/12/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73875,"Ongoing","Milky Way Intl Trading Corp","15203 Shoemaker Ave",,"Norwalk","CA","90650-6858","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-1372-201","Class II","Mixed Fruit (In Light Syrup), Net Wt. 8oz (227g), Bottle Label UPC 0-49022-80896-6, Case UPC 100-49022-80896-3","838 cases","MW Polar Foods is recalling Nice! Peach Slices and Nice! Mixed Fruit in 8-ounce glass jars due to potential glass in the product.","05/18/2016",," 3700/01069    12/08/2017",4/11/2016,"04/11/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73875,"Ongoing","Milky Way Intl Trading Corp","15203 Shoemaker Ave",,"Norwalk","CA","90650-6858","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-1371-2016","Class II","Sliced Peaches (In Light Syrup), Net Wt. 8oz (227g), Bottle Label UPC 0-49022-80894-2, Case UPC 100-49022-80894-9","3,900 cases","MW Polar Foods is recalling Nice! Peach Slices and Nice! Mixed Fruit in 8-ounce glass jars due to potential glass in the product.","05/18/2016",," 3700/01069    12/15/2017",4/11/2016,"04/11/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73876,"Ongoing","Platinum Distribution Inc","9 Whistler Ct",,"Wilmington","DE","19808-1111","United States","Voluntary: Firm Initiated","E-Mail","Nationwide direct to customers.","F-1588-2016","Class I","R    No Sugar Added;  Dark Chocolate  34 g/1.2 oz.  Ross Chocolates, 4061 Butters Road, Scotch Creek, BC  UPC 726007100054  Best Before: 191018","4,128 bars","Manufacturer Ross Chocolates, Coquitlam, BC Canada recalled these chocolate bars as the new labels failed to declare the possible milk allergen.","06/24/2016",," Best Before: 191018",4/1/2016,"04/01/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73877,"Ongoing","Wise Foods Inc","228 Raseley St",,"Berwick","PA","18603","United States","Voluntary: Firm Initiated","E-Mail","NC distribution center","F-1311-2016","Class II","Cha-Ching Original Potato Chips Net Wt 10 OZ.;  Distributed by OZA Brands, LLC, Salisbury, NC 28147 ","400 bags","Original Potato Chip packaging was filled with BBQ Seasoned product. Ingredient statement does not declare wheat allergen.","05/04/2016",," JUN1316HMB",4/5/2016,"04/05/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73878,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","1200 N Highland Ave",,"Aurora","IL","60506-1401","United States","Voluntary: Firm Initiated","Other","Illinois; Switzerland","B-0516-16","Class II","Red Blood Cells","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ","05/17/2016","05/17/2016"," W039715106051Y",3/4/2016,"03/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73878,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","1200 N Highland Ave",,"Aurora","IL","60506-1401","United States","Voluntary: Firm Initiated","Other","Illinois; Switzerland","B-0517-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ","05/17/2016","05/17/2016"," W039715106051Y",3/4/2016,"03/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73879,"Terminated","OneBlood, Inc.","10100 Dr Martin Luther King Jr St N",,"St Petersburg","FL","33716-3806","United States","Voluntary: Firm Initiated","Telephone","Florida","B-0434-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood products collected within three years from a donor immigrating from a malarial endemic area, were distributed.","05/17/2016","05/25/2016"," W036815719480 (Double collection)",3/25/2016,"03/25/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73879,"Terminated","OneBlood, Inc.","10100 Dr Martin Luther King Jr St N",,"St Petersburg","FL","33716-3806","United States","Voluntary: Firm Initiated","Telephone","Florida","B-0435-16","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products collected within three years from a donor immigrating from a malarial endemic area, were distributed.","05/17/2016","05/25/2016"," W036815500030; W036815027131",3/25/2016,"03/25/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73880,"Completed","OneBlood, Inc.","10100 Dr Martin Luther King Jr St N",,"St Petersburg","FL","33716-3806","United States","Voluntary: Firm Initiated","Telephone","Florida","B-0528-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from an ineligible donor, were distributed. ","05/17/2016",," W036816132870 (double collection)",3/11/2016,"03/11/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73881,"Terminated","OneBlood, Inc.","10100 Dr Martin Luther King Jr St N",,"St Petersburg","FL","33716-3806","United States","Voluntary: Firm Initiated","Telephone","Florida","B-0492-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who was not deferred or follow up questions were not asked, was distributed.","05/05/2016","05/05/2016"," W036816026024",3/15/2016,"03/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73882,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.","Z-1620-2016","Class II","Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack.  In- Vitor Diagnostic for pH monitoring of gastric reflux  Item Number: FGS-0313    The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.","1,305 units","Potential of an allergic reaction in a patient with nickel sensitivity.","05/06/2016",," All lot numbrs",4/15/2016,"04/15/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73882,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.","Z-1619-2016","Class II","Given Imaging Bravo¿ pH capsule delivery device, 5-pack.  In-Vitro Diagnostic for pH monitoring of gastric reflux  Item Number: FGS-0312    The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.","12,895 units","Potential of an allergic reaction in a patient with nickel sensitivity.","05/06/2016",," All lot numbers",4/15/2016,"04/15/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73883,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine","Z-1688-2016","Class II","LenSx Laser System.  Indicated for use in patients undergoing cataract surgery and refractive surgery.","81 units","Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.  ","05/17/2016",," Serial Numbers: 0511-A013  0313-A345  0713-A455  0415-A019  0912-A258  0313-A359  1213-A613  0412-A142  0412-A137  1114-A943  0212-A112  0313-A357  0813-A469  1113-A605  0314-A697  0315-A981  0913-A530  1012-A286  0515-A037  1112-A291  0515-A042  1011-A065  1012-A284  1013-A555  1211-A086  1012-A287  0912-A245  0614-A783  1113-A596  1014-A916  1011-A062  0615-A044  0913-A506  0313-A353  0615-A050  0615-A056  0912-A247  1114-A938  0712-A202  0714-A824  0113-A320  0212-A117  0614-A782  0614-A784  1112-A294  0712-A201  0514-A749  0715-A071  1111-A067  1214-A948  1013-A542  0314-A687  1213-A614  0215-A976  0312-A135  1012-A285  1013-A548  0215-A978  0412-A139  1113-A586  0312-A129  1011-A050  1213-A612  0314-A685  1112-A292  1012-A264  1015-A126  1111-A077  1013-A547  1114-A931  0112-A099  0112-A101  0413-A372  0413-A380  0512-A157  0612-A200  0715-A073  0811-A034  0815-A097  1013-A554  1113-A587  ",4/14/2016,"04/14/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73884,"Ongoing","Nuvectra","10675 Naples St NE",,"Blaine","MN","55449-5802","United States","Voluntary: Firm Initiated","Letter","Germany","Z-1600-2016","Class II","s use of the system.     The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator.  In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs     ","17 OUS","If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG.  This safety notice only applies to CPs Model 4500.","05/03/2016",," Serial  000010  000011  FF0043  FF0045  000014  000015  000016  FF0054  FF0048  FF004B  FF005D  FF0064  FF0065  FF0067  FF00A9  FF00AD  FF00BB      Lot   P178713  P185700  P187989  P195875  P213108  P257056      ",4/6/2016,"04/06/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73885,"Ongoing","Siemens Healthcare Diagnostics Inc.","101 Silvermine Rd",,"Brookfield","CT","06804-2047","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.","Z-1885-2016","Class II","Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2,  Device listing # D011374, All serial numbers and lots are affected.  The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use","1301 units","Discrepant patient results on Dimension Vista Intelligent Lab Systems.  Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.  ","06/01/2016",," All serial numbers are affected.",3/24/2016,"03/24/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73885,"Ongoing","Siemens Healthcare Diagnostics Inc.","101 Silvermine Rd",,"Brookfield","CT","06804-2047","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.","Z-1886-2016","Class II","Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2,  Device listing # D011374, All serial numbers and lots are affected.  The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use","1300","Discrepant patient results on Dimension Vista Intelligent Lab Systems.  Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.  ","06/01/2016",," All serial numbers are affected.",3/24/2016,"03/24/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73886,"Terminated","Siemens Medical Solutions USA, Inc.","685 E Middlefield Rd",,"Mountain View","CA","94043-4045","United States","Voluntary: Firm Initiated","Visit","Distributed in Germany, U.A.E., Hungary and Brazil.","Z-1572-2016","Class II","ACUSON X700 Ultrasound System with software version 1.0.04.  Model numbers:  10658844  ACUSON X700 Ultrasound System  10658846 - ACUSON X700 Ultrasound System (Russia)  10658845 - ACUSON X700 Ultrasound System (Korea)    Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.  The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.  ","4 ","Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to recover system operation.  ","04/27/2016","04/27/2016"," Material (System)      IVK Group                   Serial number:  10658844	              ACUSON X700	          356559  10658844	              ACUSON X700	          356733  10658844	              ACUSON X700	          356734  10658844	              ACUSON X700	          358714  ",9/5/2015,"09/05/2015",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73887,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",".","Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-1914-2016","Class II","VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD. ","VITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units","Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results. ","06/06/2016",," Software Version 3.2.2 & below; VITROS 5600 Serial Numbers J56000024 - J56002387; VITROS 5600 (Refurbished) US Serial Numbers: 56000186, 56000308, 56000315, 56000327, 56000339, 56000458, 56000559, 56000718, 56000727, 56000741, 56000747, 56000750, 56000786, 56000792, 56000824, 56001062, 56001235, 56001635, 56001641; Foreign Serial Numbers: 56000147, 56000200, 56000214, 56000245,56000283, 56000330, 56000331, 56000362, 56000377, 56000399, 56000413, 56000416, 56000428, 56000437, 56000438, 56000439, 56000459, 56000463, 56000464, 56000466, 56000515, 56000528, 56000537, 56000555, 56000560, 56000632, 56000642, 56000669, 56000680, 56000749, 56000867, 56001133, 56001135, 56001246, 56001461, 56001482, 56001487, 56001859.   Unique Device Identifier No. 10758750002740",4/6/2016,"04/06/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73887,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",".","Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.","Z-1913-2016","Class II","VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.","US: 218 units, Foreign: 587 units ","Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results. ","06/06/2016",," Software Version 3.2.2 & below; Serial Numbers J36000012 - J36000933.Unique Device Identifier No. 10758750002979, IVD.",4/6/2016,"04/06/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73888,"Ongoing","Health 4 Life, LLC","1345 Encinitas Blvd # 736",,"Encinitas","CA","92024-2845","United States","Voluntary: Firm Initiated","E-Mail","Nationwide U.S. distribution through online sales.    No foreign distribution.","F-1324-2016","Class I","Passion 4 Life  30 FL oz. Bottle","8,382 Bottles","Undeclared whey protein containing the allergens of milk and soy lecithin.","05/10/2016",," Lot #15093, 15217, 15249, 15248, 15401, 15442, 16010",4/15/2016,"04/15/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73889,"Ongoing","Bindi North America","507 Main St",".","Belleville","NJ","07109-3322","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL","F-0556-2017","Class II","Bindi USA Chocolate Gelato 1.24 Gal Container (4.8 L)    UPC 815073016564  ","177 tubs","Gelato may contain strands or strings of plastic or have a cracked lid.","12/05/2016",," 7607   Lot 6035 ",4/8/2016,"04/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73889,"Ongoing","Bindi North America","507 Main St",".","Belleville","NJ","07109-3322","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL","F-0555-2017","Class II","Bindi USA Vanilla Bean Gelato 1.24 Gal Container (4.8 L) UPC 815073016557  ","373 tubs","Gelato may contain strands or strings of plastic or have a cracked lid.","12/05/2016",," catalog 7606    Lot #s 6036 / 6040 / 6050",4/8/2016,"04/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73889,"Ongoing","Bindi North America","507 Main St",".","Belleville","NJ","07109-3322","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL","F-0557-2017","Class II","Bindi Amerana Cherry Grana Gelato 1.24 Gal Container (4.8L)  UPC 815073016588","3 Tubs","Gelato may contain strands or strings of plastic or have a cracked lid.","12/05/2016",," 7609    Lot 6026 ",4/8/2016,"04/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73889,"Ongoing","Bindi North America","507 Main St",".","Belleville","NJ","07109-3322","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL","F-0558-2017","Class II","Bindi Cappucino Gelato 1.24 Gal Container (4.8L)    UPC 815073016595","165 Tubs","Gelato may contain strands or strings of plastic or have a cracked lid.","12/05/2016",," 7610  Lot 6041 ",4/8/2016,"04/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73890,"Terminated","OneLegacy","221 S Figueroa St Ste 500",,"Los Angeles","CA","90012-2526","United States","Voluntary: Firm Initiated","Telephone","California","B-0542-16","Class II","Cornea","2 human corneas"," Human corneas, not tested appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.","05/24/2016","05/24/2016"," R160204341R; R160204341L ",3/1/2016,"03/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73891,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0500-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Blood products, which did not meet the acceptable product specifications, were distributed.","05/24/2016","05/24/2016"," W071216000973; ",3/14/2016,"03/14/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73891,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0501-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.","05/24/2016","05/24/2016"," W071216000973 (Part A); W071216000973(Part B) ",3/14/2016,"03/14/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73892,"Terminated","Arc Blood Services, New England Region","180 Rustcraft Rd Ste 115",,"Dedham","MA","02026-4551","United States","Voluntary: Firm Initiated","E-Mail","California","B-0502-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","05/24/2016","05/24/2016"," W200415205736; ",3/2/2016,"03/02/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2071-2016","Class II","Gastroscope  Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","9,669 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s FG-16V, FG-24V, FG-29V, EG-1540, EG-1580K, EG1840, EG-2540, EG-2940, EG-3840T, EG-3831T, EG-3870TK, EG-1870K, EG-2470K, EG-2530, EG-2730K, EG-2731, EG-2770K, EG-290KP, EG-2930K, EG-2931, EG-2931K, EG-2970K, EG-3430Z, EG-3470K, EG-3470ZK, EG-1690K, EG-2490K, EG-2790I, EG-2790K, EG27-I10, EG-2990I, EG-2990K, EG29-I10, EG-3490K and EG-3890TK",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2075-2016","Class II","Signmoidoscope  Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations","1,596 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s FS-34V, ES-3831, ES-3870K and ES-3840",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2069-2016","Class II","Confocal GI Scope  Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","17 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s EG-3870CIK, EC-3870CILK",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2067-2016","Class II","Choledochoscope  Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","50 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s FCP-8P and FCP-9P",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2079-2016","Class II","Esophagoscope  Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","405 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s EE-1540 and EE-1580k",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2073-2016","Class II","Laryngo Stroboscope  Product Usage	Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.    ","206 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #VNL-1570STK",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2072-2016","Class II","Intubation Scope  Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","1,220 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS and FI-9RBS",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2077-2016","Class II","Ultrasound Gastroscope  Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric ","819 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s EG-3630U, EG-3630UR, EG-3670URK, EG-3830UT, EG-3870UTK, FG-34UX, FG-36UX and FG-38UX",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2078-2016","Class II","Ureteroscope  Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.","32 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s FUR-9P and FUR-9RBS",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2066-2016","Class II","Choledocho-Nephroscope  Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","126 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s ECN-1530 and FCN-15X",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2080-2016","Class II","Small Bowel Scope  Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","96 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #VSB-3430",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2065-2016","Class II","Bronchoscope  Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","4,195 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s FB-10V, FB015BS, FB-15P, FB-15RBS, FB-15V, FB-18BS, FB-18P, FB-18RBS, FB-18V, FB-19TV, FB-8V, EB--1530T3, EB-1170K, EB01570K, EB-1575K, EB-1970K, EB-1970-TK and EB-1975K",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2070-2016","Class II","Cystoscope  Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","120 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s ECY-1530, ECY-1570K, FCY-15P2 and FCY-15RBS",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2076-2016","Class II","Ultrasound Bronchoscope  Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations","115 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #EB-1970UK",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2074-2016","Class II","Naso-Pharyngo-Laryngoscope  Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations","215 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s FNL-10RAP, FNL-13RAP, FNL-15RP3 and VNL-1530T",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73894,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam","Z-2068-2016","Class II","Colonoscope  Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.","12,412 units","Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.","06/28/2016",," Model #'s EC-3430L, EC-3430LK, EC-3470LK, EC-380LKP, EC-3830LK, EC-3930LZ, EC-3831L, EC-3832L, EC-3832LK, EC-3870LK, EC-3870LZK, EC-3872LK, FC-38LV, EC-3830TLK, EC-3832TL, EC-3870TLK, EC-3872TLK, EC-3440L, EC-3840K, EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-3890LI, EC-3890LK, EC-3890TLK and EC38-I10L",4/6/2016,"04/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73895,"Completed","Keystone Laboratories Inc","1103 Kansas St",,"Memphis","TN","38106-1913","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. Including: MD and NJ","D-0853-2016","Class II","BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only.  Distributed by KEYSTONE LABORATORIES, UPC 07059600430.","7 Cases of 12 Bottles","Microbial Contamination of Non-Sterile Products: Failed S.aureus test.","05/16/2016",," Lot #: 10AN5 ",4/4/2016,"04/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73896,"Ongoing","Lymol Medical","4 Plympton St",,"Woburn","MA","01801-2917","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0858-2016","Class II","Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only,  Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30  ","25,007 canisters","Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.","05/20/2016",," Lot #: 4L034, Exp. MAY 2017",4/28/2016,"04/28/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73897,"Ongoing","Royal Snacks Inc","27460 Avenue Scott Ste C",,"Valencia","CA","91355-3473","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, TX, CT, CO, GA, NY, CT    No foreign distribution.","F-1361-2016","Class II","Royal Snacks   Jalapeno Pistachio  Royal Size","367 cases","Undeclared Yellow #5 and Blue #1","05/17/2016",," 10-01-15 thru 3-10-16",4/18/2016,"04/18/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73898,"Terminated","WD IMPORT AND EXPORT INC.","4703 2nd Ave",,"Brooklyn","NY","11232-4218","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York City (NY)","F-1384-2016","Class I","Whole Dried Yellow Fish in bulk cardboard box, unlabeled, Product of China --- Fish measured 6.5 - 7.5 inches in length","2 cases","The product was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets. ","05/20/2016","05/20/2016"," Uncoded",4/4/2016,"04/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0940-2016","Class II","Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas","7 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0942-2016","Class II","Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","47 bags","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry.",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0929-2016","Class II","Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","22 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0944-2016","Class II","Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","84 bags","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry.",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0924-2016","Class II","Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","5 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0925-2016","Class II","Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","a) 10 bags, b) 23 bags, c) 9 bags, d) 6 bags","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry.",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0927-2016","Class II","Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","3 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0933-2016","Class II","Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","4 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0947-2016","Class II","Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","2 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0932-2016","Class II","Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","11 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0937-2016","Class II","Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","7 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0922-2016","Class II","Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","5 cassettes","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry.",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0918-2016","Class II","Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","32 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0919-2016","Class II","Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","16 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0946-2016","Class II","Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR ","54 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0920-2016","Class II","D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","6 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0936-2016","Class II","Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","1 bag","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry.",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0931-2016","Class II","Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","7 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0915-2016","Class II","Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, Arkansas","11 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0939-2016","Class II","TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas","86 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0945-2016","Class II","Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","88 bags","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0926-2016","Class II","Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","a) 16 bags and b) 18 bags","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0930-2016","Class II","Milrinone 200 mcg/mL in  a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","a) 15 bags, b) 15 bags, c) 15 bags, d) 4 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0923-2016","Class II","Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","3 cassettes","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0938-2016","Class II","TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas","7 bags","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry.",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0917-2016","Class II","Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","16 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0928-2016","Class II","Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","24 bags","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry.",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0921-2016","Class II","Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","14 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0916-2016","Class II","Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","a) 39 bags and b) 8 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0911-2016","Class II","0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","a) 6 bags b) 1 bag c) 2 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0948-2016","Class II","Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","11 bags","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry.",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0914-2016","Class II","Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","21 syringes","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0913-2016","Class II","70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","18 syringes","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0935-2016","Class II","Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","53 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0912-2016","Class II","1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","7 bags","Lack of Sterility Assurance.","05/29/2016",," All product remaining within expiry.",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0943-2016","Class II","Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","59 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0941-2016","Class II","Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","1 bag","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73899,"Ongoing","Baptist Health Medical Towers Pharmacy and Infusion Services","9601 Baptist Health Dr Ste 109",,"Little Rock","AR","72205-6323","United States","Voluntary: Firm Initiated","Telephone","Arkansas","D-0934-2016","Class II","Piperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR","14 bags","Lack of Sterility Assurance","05/29/2016",," All product remaining within expiry",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73901,"Terminated","Central Texas Regional Blood & Tissue Center","4300 N Lamar Blvd",,"Austin","TX","78756-3421","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0504-16","Class III","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.","05/24/2016","05/24/2016"," W221616350877; W221616350877; ",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73902,"Terminated","BPL Plasma, Inc.","2575 Sunset Dr",,"San Angelo","TX","76904-7606","United States","Voluntary: Firm Initiated","E-Mail","Israel","B-0505-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor for whom no documentation of an arm inspection and/or screening questions, was distributed.","05/24/2016","05/24/2016"," SA0252661; ",3/18/2016,"03/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73903,"Terminated","LifeShare Blood Centers","214 Doctor Michael Debakey Dr",,"Lake Charles","LA","70601-5953","United States","Voluntary: Firm Initiated","Letter","Louisiana","B-0472-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood Product collected from a donor who traveled to a malarial endemic area was distributed.","04/26/2016","04/26/2016"," W036515324622",4/13/2016,"04/13/2016",5/4/2016,"05/04/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73904,"Terminated","BPL Plasma, Inc.","2320 E Bell Rd Ste 101",,"Phoenix","AZ","85022-2902","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0473-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","05/02/2016","05/02/2016"," PH0059539",3/2/2016,"03/02/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73905,"Terminated","Blood Systems, Inc.  dba UBS - California","2223 Eastman Ave Ste A",,"Ventura","CA","93003-8050","United States","Voluntary: Firm Initiated","Telephone","California","B-0474-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","4 units","Apheresis products collected from donors taking Propecia and Accutane were distributed.","05/02/2016","05/02/2016"," W042216008002E (double collection); W042216008011C(double collection)",3/4/2016,"03/04/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73906,"Terminated","Central Texas Regional Blood & Tissue Center","4300 N Lamar Blvd",,"Austin","TX","78756-3421","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0475-16","Class III","Apheresis Red Blood Cells, Leukocytes Reduced","2","Apheresis red cells, not meeting product specifications, were distributed.","05/02/2016","05/02/2016"," W221616300718 (double collection)",3/1/2016,"03/01/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73907,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI","Z-1601-2016","Class II","Syngo Dynamics; Kinetdx Picture Archiving and Communications System","84 units","Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.","05/04/2016",," Model Numbers: 10091637, 10091673, 10091805, 10091807    Serial Numbers: 85021, 85040, 85042, 85045, 85047, 85057, 85079, 85080, 85081, 85086, 85090, 85115, 85143, 85145, 85146, 85147, 85149, 85157, 85167, 85168, 85170, 85172, 85177, 85178, 85185, 85186, 85189, 85191, 85234, 85235, 85239, 85281, 85307, 85309, 85322, 85325, 85326, 85329, 85335, 85338, 85350, 85353, 85354, 85368, 85370, 85374, 85377, 85380, 85385, 85387, 85401, 85418, 85421, 85422, 85427, 85435, 85442, 85447, 85462, 85467, 85468, 85469, 85470, 85473, 85481, 85482, 85484, 85859, 85860, 85866, 85867, 85871, 85872, 85873, 85874, 85875, 85876, 85880, 85883, 85884, 85893, 85896, 85910, 85918",4/14/2016,"04/14/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73908,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada","Z-1628-2016","Class II"," GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC.    Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.  ","630 units","Instructions for use  booklet may puncture the outer Tyvek lid.","05/09/2016",," SP15H05-1067842 thru SP15KI9-1099303",4/21/2016,"04/21/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73908,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada","Z-1629-2016","Class II","GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC    Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.  ","707 units","Instructions for use  booklet may puncture the outer Tyvek lid.","05/09/2016",," SP15H05-1067841 thru SP15L02-1102423",4/21/2016,"04/21/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73908,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada","Z-1630-2016","Class II"," GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC  Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.  ","288 units","Instructions for use  booklet may puncture the outer Tyvek lid.","05/09/2016",," SPI5El2-1049760 thru SPI5K10-1096019",4/21/2016,"04/21/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73908,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada","Z-1631-2016","Class II"," GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC    Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.  ","118 units","Instructions for use  booklet may puncture the outer Tyvek lid.","05/09/2016",," SPI5E12-1049765 thru SPl5Hl8-1071450",4/21/2016,"04/21/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73908,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide and Germany, Sweden, Netherlands, Israel, Denmark, United Kingdom, Canada","Z-1627-2016","Class II","GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC    Product Usage:  The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.  ","315 units","Instructions for use booklet may puncture the outer Tyvek lid.","05/09/2016",," SP15H05-1067843 thru SP15K05 -1094463",4/21/2016,"04/21/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73909,"Ongoing","VistaPharm, Inc.","7265 Ulmerton Rd",,"Largo","FL","33771-4809","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0838-2016","Class II","Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771    ","8,901 cases","Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage. ","05/04/2016",," Lot # 435200, EXP 01/18",4/18/2016,"04/18/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73910,"Ongoing","Liquid Assets Inc","1407 N 105th East Ave",,"Tulsa","OK","74116-1534","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC,  ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Australia, Puerto Rico","F-1406-2016","Class I","Life's Qik Fix 70 Plant Minerals Plus 80 Additional Nutrients 180 Vegetable Capsules Dietary Supplement Manufactured Exclusively For: MAGZUMA NUTRITION Overland Park, Kansas 66210 www.magzuma.com 1-888-306-8855 or 1-913-624-9676","393 bottles","Dietary Supplements contain undeclared milk and soy.","05/31/2016",," Lot Numbers: 16023",4/20/2016,"04/20/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73910,"Ongoing","Liquid Assets Inc","1407 N 105th East Ave",,"Tulsa","OK","74116-1534","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC,  ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Australia, Puerto Rico","F-1405-2016","Class I","Angel Wings Complete Daily Multi with 146 nutrients including Anti-aging and Superfruit Antioxidants and 75 Plant Derived Minerals 120 Capsules UPC: 0-16158-01225-3 Liquid Assets, Inc. Tulsa, OK 74116 1-888-497-4535 www.ExceptionalProducts.org; Magzuma Zuma Supreme Daily Wellness 147 Whole Food Nutrients Anti-aging and Superfruit Antioxidants 120 Vegetable Capsules Dietary Supplements, MagZuma, LLC. 7300 W. 110th St., Suite 700 Overland Park, Kansas 66210 TEL: 888.306.8855","3145 bottles","Dietary Supplements contain undeclared milk and soy.","05/31/2016",," Lot Numbers: 14656, 14657, 15109, 15489, 15488, 15616, and 16007",4/20/2016,"04/20/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0148-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0159-2017","Class II","     plastic bag with twist tie.",,"Undeclared wheat and milk (butter ingredient)","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0153-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat and milk (cheese ingredient)","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0154-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0152-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat and milk (cheese ingredient)","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0160-2017","Class II","     plastic bag with twist tie.",,"Undeclared wheat and milk (butter ingredient)","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0156-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0150-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0155-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat and milk (cheese ingredient)","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0149-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0158-2017","Class II","     plastic bag with twist tie.",,"Undeclared wheat and milk (butter ingredient)","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0161-2017","Class II","     plastic bag with twist tie.",,"Undeclared milk (butter ingredient)","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0157-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0162-2017","Class I","    This information was hand written on a business card, no separate ingredient statement.",,"Undeclared wheat, milk, and soy (Lecithin)","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73911,"Terminated","Union Bagel Shop","153 E Electric St",,"Union","OR","97883","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Products were only distributed to one retail store located in Grande, OR","F-0151-2017","Class II","    2 bagels per package - plastic bag with twist tie.",,"Undeclared wheat","10/14/2016","10/17/2016"," None",4/7/2016,"04/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73913,"Ongoing","Pfizer Inc.","235 East 42nd Street",,"New York","NY","10017-5703","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0857-2016","Class II","Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.","68, 214 bottles","Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. ","05/20/2016",," Lot #: M25569, Exp 08/18",4/28/2016,"04/28/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73914,"Ongoing","Sincere Orient Commercial Foods Corp.","15222 Valley Blvd",,"City of Industry","CA","91746-3323","United States","Voluntary: Firm Initiated","Telephone","CA, WA","F-1313-2016","Class II","Thin Egg Noodle (Mi Trung Ga), 5lbs, 8 units/case","1,248 packages (6,240 lbs)","Sincere Orient Food is recalling the Thin Egg Noodle (Mi Trung Ga) because it contains undeclared wheat.","05/04/2016",," no lot numbers",4/20/2016,"04/20/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73915,"Terminated","Ryszard Food Distributor, Inc. ","278 Boerum St",,"Brooklyn","NY","11206-3522","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Brooklyn, NY","F-2387-2016","Class I","Novus Snack brand Golden Raisins, Net 10 oz., Product of U.S.A. --- Firm on label: Packed for Ryszard food Distributor, Inc. ","10 - 10 oz. plastic packages (bags)","The product contained undeclared sulfites (1337.2 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets.","09/20/2016","09/20/2016"," Best Before: 1 July 2016",3/25/2016,"03/25/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1472-2016","Class II","Chocolate Chip, TranSmart, Frozen Pre-cut Cookie Dough, Net Weight 22.5 lbs (10.22 kgs).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000147540 and 1000147541, Material number: 10194869.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1481-2016","Class II","1 oz. Dutch Cupboard, Oatmeal Raisin Cookie Dough, Net Weight: 22.5 lbs (10.20 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000163574 and 1000149078, Material number: 10194763.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1448-2016","Class II","0.75 oz. TransSmart, Gourmet Mini Bites, Brownie Cookie Dough, Net Wt: 27 lbs (12.24 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000137168, Material number: 10194589.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1465-2016","Class II","TranSmart, Sugar Cookie, 240  1.5 oz. Cookies, Net Weight: 22.5 lbs/10.21 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000143901 and 1000143902, Material number; 10194682.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1461-2016","Class II","Dutch Cupboard, Sugar Cookie Dough, 360  1.1 ounce cookies, Net Weight: 24.75 lbs/11.24 kgs.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000147566, Material number: 10194637.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1466-2016","Class II","0.5 oz. TranSmart, Mini Chocolate Chip Cookies with M&Ms, Net Weight 22.5 lbs (10.20 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000148840, Material number: 10194581.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1454-2016","Class II","Macadamia Nut Cookie With White Drops, Frozen Pre-cut Cookie Dough, Net Weight: 23.44 lbs/10.64 kgs. And 24.61 lbs/1/16 kgs.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000148872 and 1000157698, Material number: 10194652 and Batch: 1000148838, Material number: 10194788. ",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1457-2016","Class II","TranSmart White Chunk Macadamia Nut, 168  2.5 oz. Cookies, Net Weight: 26.25 lbs 11.91 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000137295 and 1000137296, Material number: 10194792.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1479-2016","Class II","12 RND M.C. (No Trans), For Bake, Net Weight 46.2 lbs/20.96 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000145825, 1000149001 and 10000158800, Material number: 10194735.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1443-2016","Class II","TranSmart Gourmet Mini Bites Wedding Cookie, 576, .75oz cookies, Net Wt 27 lbs/12.26 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch:  1000153246, Material number; 10194595.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1450-2016","Class II","Cinnabon Cinnamon Chip, 3 oz. Cookie, Net Weight 23.43 lbs (10.63 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000161436, Material number: 10220716.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1468-2016","Class II","TranSmart, White Chocolate Chip Fudge Cookie, 240  1.5 oz. Cookies, Net Weight: 22.5 lbs/10.21 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000149077, Material number: 10194691.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1440-2016","Class II","TranSmart, Ginger Cookie, 300-1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg (Frozen).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000132843, Material number: 10194665",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1470-2016","Class II","TranSmart, Chocolate Chip Cookie, 240  1.5oz cookies, Net Weight 22.5 lbs/10.21 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000152940 and 10000149076, Material numbers: 10194679.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1449-2016","Class II","Cinnabon Caramel Pecan, 3 oz. Cookie, Net Weight 23.45 lbs. (10.63 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000161431, Material number: 10221564.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1463-2016","Class II","TranSmart, Sugar Cookie Dough, 576/0.75 ounce cookies, Net Weight 27 lbs/12.26 kgs and 96/4 ounce cookies, Net Weight 24 lbs/10.9 kgs.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000132842, Material number: 10194588 and Batch: 1000149081 Material number: 10205697.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1464-2016","Class II","0.5 oz. TranSmart, Mini Sugar Cookie Dough, Net Weight 22.5 lbs (10.20 kg). ","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000148870 and 1000151950, Material number: 10194582.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1459-2016","Class II","7 Eleven, Sugar Cookie (2.2 oz. Pucks), Net Weight 33 lbs (14.96 kg), Manufactured by; CSM Bakery, Tucker, GA 30084.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000156704, Material number: 10207880.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1446-2016","Class II","¿ Sheet Unbaked Message Cookie, 20/20 oz. Unbaked Chocolate Chip Cookies, Net Weight 25 lbs/11.34 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000148878, Material number: 10194712.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1475-2016","Class II","TranSmart, 12 Chocolate Chip Message Cookie, 24/24 ounce chocolate chip cookies in Bakeable Plastic Pans with Domes, Net Weight 36 lbs/16.33 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000147522 and 1000147528, Material number: 10194739.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1483-2016","Class II","Oatmeal Raisin, Frozen Pre-cut Cookie Dough, Net Weight 23.44 lbs/10.63 kgs and 24.61 lbs (11.16 kgs)","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000151632, Material number: 10194648 and Batch: 100014881, Material number: 10194785.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1480-2016","Class II","7 Eleven, Oatmeal Raisin Cookie (2.2 oz. Pucks)/ Net Weight 33 lbs (14.96 kg), Made in the USA By: CSM Bakery, Inc., Tucker, GA 30084.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000156710, Material number: 10207264",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1474-2016","Class II","FLIK, ZT Thin & Crispy Chocolate Chip Cookies, Contains 300 cookies weighing approximately 1.2 oz, Net Weight 22.5 lbs (10.2 kg), Manufactured for FLIK International, Rye Brook, NY 10573.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000149079 and 1000149080, Material number: 10203867.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1478-2016","Class II","Brill, New Cookie, Chocolate Chunk, No Thaw, 160-2.75 oz. Cookies, Net Weight 27.5 lbs. (12.47 kg), Produced for Chick-Fil-A, Inc., Manufactured by: CSM bakery Products NA, Inc., Tucker, GA 30084.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000148294, 100014511, 1000146517, 1000146515, 1000155869, 1000153626, 1000146520, 1000157617, 1000157620, 1000146526; Material number: 10205631.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1444-2016","Class II","7 Eleven, Chocolate Chunk Cookie (2.2 oz Pucks), Net Weight 33 lb (14.96 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000148837, Material number: 10194657.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1477-2016","Class II","Chocolate Chip Cookie, Net Weight: 21 lbs (9.53 kgs).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000148896, 1000152943 and 1000152942, Material number: 10194818.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1484-2016","Class II","TranSmart, 4 oz. Oatmeal Raisin Walnut Cookie Dough, Net Weight 24 lbs (10.88 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000142215 and 1000142210, Material number: 10194894.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1467-2016","Class II","0.5 oz. TranSmart, Mini Chocolate Chip Cookie Dough, Net Weight 22.5 lbs (10.20 kgs).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000164181, Material number: 10194580.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1460-2016","Class II","Sugar, Frozen Pre-cut Cookie Dough, Net Weight 24.61 lbs/11.16 kgs and 23.44 lbs/10.64 kgs.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000153180 and 1000147601, Material number: 10194787 and Batch: 1000146662, Material number: 10194650.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1469-2016","Class II","Chocolate Chip with Colored Candy Pieces, Frozen Pre-cut Cookie Dough, Net Weight; 24.61 lbs/11.17 kgs. and 23.44 lbs/10.64 kgs.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000147603, Material number: 10194789 and Batch: 1000132723, Material number: 10194651.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1476-2016","Class II","TranSmart, Brownie Milk Chocolate Chip Cookie, 180  1 ounce cookies, Net Weight: 11.25 lbs/5.10 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000127053 and 1000147523, Material number; 101946521.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1441-2016","Class II","Candy Frozen Cookie Pucks 0.75oz, Keep Frozen, Net Weight 27 lbs (12.24 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch 1000137860, Material number: 10209429.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1442-2016","Class II","ARBYS Salted Caramel Chocolate Cookie, Net Weight 22.96 lbs (10.41 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000137149, 1000137150 and 10001137151, Material number: 10217050.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1458-2016","Class II","4 oz. Macadamia Nut Cookie Dough, TranSmart, Net Weight 24 lbs/10.9 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000151865, 1000137318 and 1000137319, Material number: 10194892.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1482-2016","Class II","Oatmeal Raisin, TranSmart Frozen Pre-cut Cookie Dough, Contains Approx. 120 Cookies, Net Weight 22.5 lbs (10.22 kgs).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000147511, Material number; 10194870.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1473-2016","Class II","Chocolate Chip, Frozen Pre-cut Cookie Dough, Net Weight: 24.61 lbs/11.17 kgs and 23.44 lbs/10.63 kgs.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000149007, 1000152964, 1000152966 and 1000146704, Material number: 10194646 and   Batch: 1000152950, 1000132703, 1000147598, Material number: 10194783.  ",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1456-2016","Class II","Macadamia Nut Cookie with White Drops, TranSmart, Frozen Pre-cut Cookie Cough, Net Weight 22.5 lbs (10.22 kgs).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000148907 and 1000151964, Material number: 10194871.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1445-2016","Class II","4 oz. Cranberry Nut Crunch Cookie Dough, TransSmart, Net Weight 24 lbs (10.88 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000137350 and 1000137349, Material number: 10194891.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1447-2016","Class II","TransSmart, Brownie Cookie, 300  1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg.","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000147631, Material number: 10194666.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1471-2016","Class II","1.25 oz. TranSmart, Chocolate Chip Cookie Dough, Net Weight: 23.44 lbs. (10.63 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 10001372050, 1000146655 and 1000132697, Material number: 10194654.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1462-2016","Class II","TranSmart, 1.2 oz. Sugar Cookie, Net Weight: 22.5 lbs (10.2 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000147612, 1000147613 and 1000151895, Material number: 10194664.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73917,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.","F-1455-2016","Class II","2 oz. TranSmart, Macadamia White Chocolate Cookie Dough, Net Weight 30 lbs (13.6 kg).","34,525 total cases","Undeclared allergen; Peanut protein.","06/13/2016",," Batch: 1000132801, 1000148833 and 1000157662, Material number: 10184784.",4/19/2016,"04/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73918,"Ongoing","Medical Depot Inc.","99 Seaview Blvd Fl 2",,"Port Washington","NY","11050-4606","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2105-2016","Class II","Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case    Aid the user in walking while relieving weight from one foot or leg.","123,125 pairs","Tip crutch failure involving the bottom of the metal portion which comes in contact with ground","06/30/2016",," Item #: 1) RTL 10400, 2) RTL 10402",2/17/2016,"02/17/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73918,"Ongoing","Medical Depot Inc.","99 Seaview Blvd Fl 2",,"Port Washington","NY","11050-4606","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2104-2016","Class II","Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case    Aid the user in walking while relieving weight from one foot or leg.","123,125 pairs","Tip crutch failure involving the bottom of the metal portion which comes in contact with ground","06/30/2016",," Item #: 1) RTL 10400, 2) RTL 10402",2/17/2016,"02/17/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73918,"Ongoing","Medical Depot Inc.","99 Seaview Blvd Fl 2",,"Port Washington","NY","11050-4606","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2103-2016","Class II","Universal aluminum crutch, 1 pair per case    Aid the user in walking while relieving weight from one foot or leg.","123,125 pairs","Tip crutch failure involving the bottom of the metal portion which comes in contact with ground","06/30/2016",," Item #: RTL 10433",2/17/2016,"02/17/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73918,"Ongoing","Medical Depot Inc.","99 Seaview Blvd Fl 2",,"Port Washington","NY","11050-4606","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2101-2016","Class II","Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crutch, tall adult, 8 pairs per case","123,125 pairs","Tip crutch failure involving the bottom of the metal portion which comes in contact with ground","06/30/2016",," Item #.: 1) 10400-1, 2) 10400-8, 3) 10401-1, 4) 10401-8, 5) 10402-1 & 6) 10402-8",2/17/2016,"02/17/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73918,"Ongoing","Medical Depot Inc.","99 Seaview Blvd Fl 2",,"Port Washington","NY","11050-4606","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2102-2016","Class II","EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case","123,125 pairs","Tip crutch failure involving the bottom of the metal portion which comes in contact with ground","06/30/2016",," Item #: 1) 10430-1, 2) 10430-8, 3) 10431-1, 4) 10431-8, 5) 10432-1 & 6) 10432-8",2/17/2016,"02/17/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73918,"Ongoing","Medical Depot Inc.","99 Seaview Blvd Fl 2",,"Port Washington","NY","11050-4606","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2106-2016","Class II","Direct Supply aluminum crutch, adult, 1 pair per case    Aid the user in walking while relieving weight from one foot or leg.","123,125 pairs","Tip crutch failure involving the bottom of the metal portion which comes in contact with ground","06/30/2016",," Item #: DS 10400",2/17/2016,"02/17/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73919,"Terminated","Inova Health Care Services","45745 Nokes Blvd Ste 160",,"Sterling","VA","20166-2493","United States","Voluntary: Firm Initiated","FAX","Rhode Island","B-0479-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Red Blood Cell product collected from a donor who traveled to a malarial endemic area was distributed.","05/02/2016","05/02/2016"," W089815456883 ",4/13/2016,"04/13/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73920,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0481-16","Class II","Fresh Frozen Plasma","3 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","05/03/2016","05/03/2016"," W270115516623; W270111515288; W270111500845",3/4/2016,"03/04/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73920,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0483-16","Class II","Platelets","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","05/03/2016","05/03/2016"," W270110511080",3/4/2016,"03/04/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73920,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0482-16","Class II","Red Blood Cells, Leukocytes Reduced","4 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","05/03/2016","05/03/2016"," W270115516623; W270111515288; W270111500845; W270110511080 ",3/4/2016,"03/04/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73920,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0480-16","Class II","Pooled Platelets, Leukocytes Reduced","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","05/03/2016","05/03/2016"," W270115519747",3/4/2016,"03/04/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73921,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.","Z-1933-2016","Class II","Cholesterol, Catalog No. OSR6x16    Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.","43,877 units total (10,496 units in US)","Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.  ","06/08/2016",," All lots",4/13/2016,"04/13/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73921,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.","Z-1932-2016","Class II","Uric Acid, Catalog No. OSR6x98    Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.","59,401 units total (10,868 units in US)","Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.  ","06/08/2016",," All lots",4/13/2016,"04/13/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73921,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.","Z-1930-2016","Class II","Lipase, Catalog No. OSR6x30    Product Usage:  Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.  ","32,926 units total (6,041 units in US)","Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.  ","06/08/2016",," All lots",4/13/2016,"04/13/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73921,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.","Z-1934-2016","Class II","Triglyceride, Catalog No. OSR6x118    Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.","79,009 units total (21,215 units in US)","Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.  ","06/08/2016",," All lots",4/13/2016,"04/13/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73921,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",".","Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.","Z-1931-2016","Class II","Lactate, Catalog No. OSR6x93    Product Usage:  Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.    ","54,351 units total (31,612 units in US)","Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.  ","06/08/2016",," All lots",4/13/2016,"04/13/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73923,"Ongoing","Smiths Medical ASD, Inc.","1265 Grey Fox Rd",,"Saint Paul","MN","55112-6929","United States","Voluntary: Firm Initiated","Letter","US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE.    OUS:  UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND,  PANAMA, PORTUGAL, SAUDI ARABIA, SWEDEN, SINGAPORE, TAIWAN, VIET NAAM, SOUTH AFRICA.","Z-1831-2016","Class II"," must be removed to activate the Flow Stop.    However, after attaching the reservoir to the pump, the user can still remove the  reservoir from the pump and prime it by holding the Flow Stop in the open position.","13,696,830 units","Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.","05/27/2016",," Devices with an expiration date on or before March 2021",4/22/2016,"04/22/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73924,"Ongoing","Pronutri, LLC","17692 Flintstone Ln",,"Huntington Beach","CA","92647-6457","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, TX, OR, IA, MN, CO    No foreign distribution.","F-1404-2016","Class I","Pronutri  Re-VITA-lize  Tropical Orange Dietary Supplement  32 oz. ","356 bottles","Undeclared whey protein which contains the allergens milk and soy lecithin.","05/27/2016",," Lot #15554 ",4/18/2016,"04/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0050-2017","Class II","HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.","1916 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers:  151200003M, 151260128M, 151300005M, 151310094M, 151320134M, 151320143M, 151340107M, 151370002M, 151390005M, 151390142M, 151400005M, 151400095M, 151400136M, 151470008M, 151510002M, 151520080M, 151880214M, 151890257M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0062-2017","Class II","lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106.","499 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Number: 15113014M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0069-2017","Class II","lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.","3159 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15117053M, 15117054M, 15124056M, 15128001M, 15128002M, 15131021M, 15133067M, 15141028M, 15147089M, 15147090M, 151740185M, 151740188M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0040-2017","Class II","fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.","1561 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15103037M, 15117042M, 15126027M, 15127049M, 15131003M, 15119043M, 15138050M, 15141033M, 15142056M, 15146040M, 15149039M, 151890299M, 151900220M, 151930019M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0032-2017","Class II","Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.","210 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 151000045M, 15127040M, 15133026M, 15141029M, 151930078M, 15132103M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0066-2017","Class II","lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79","830 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15119047M, 15124043M, 151340072M, 15134037M, 15148042M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0042-2017","Class II","fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.","1735 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers:  15119048M, 15126024M, 15127055M, 15133037M, 15135039M, 15138039M, 15140022M, 15141026M, 15148023M, 15152075M, 151730221M, 151890289M, 151900214M, Exp between 07/15/15-10/12/15  ",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0037-2017","Class II","fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium,  Product code 2R3303.    ","53357 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers:  15119083M, 15119086M, 15133078M, 15134127M, 15135064M, 151380066M, 15138007M, 151380108M, 151380109M, 15138060M, 15138063M, 15138064M, 15138065M, 15140043M, 15140082M, 15140084M, 15142093M, 151450033M, 151460093M, 151460094M, 15147097M, 15149047M,  15149108M, 15149112M, 15149113M, 15152051M, 15152053M, 15160010C, 15161003C, 15161004C, 15161007C, 15161008C, 15163003C, 151650036C, 151660042C, 151660043C, 151670006C, 151670007C, 151670008C, 151680044C, 151720006C, 151720013M, 151720106M, 151730140M, 151730141M, 151730143M, 151740003C, 151740004C, 151740137M, 151750008C, 151760042C, 151790004C, 151790040C, 151880332M, 151890122M, 151890123M, 151900009M, 151900137M, 151900178M, 151900243M, 151930033M, 15100140M, 151020015M, 151020016M, 15103004M, 151030057M, 151030092M, 151170046M, 151170087M, 151170088M, 151170089M, 15120066M, 15120068M, 15124083M, 151260091M, 15127016M, 15127089M, 15127092M, 15127093M, 15128108M, 15128109M, 151310088M, 151310089M, 151310101M, 151310102M, 151310104M, 15132007C, 151320098M, 15133003C, 15133013C, 15135011C, 15138006C, 15139012C, 15141001C, 15142004C, 15142005C, 15147001C, 15147002C, 15147003C, 15147004C, 15147013C, 15147014C, 15149005C, 15152009C, 15154007C, 15155001C, 15155009C, 15156004C, 15157003C, 15159004C, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0036-2017","Class II","fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.","110 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15140057M, 15147053M, 15127066M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0034-2017","Class II","fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.","4347 syringes","Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers:  15100052M, 15103048M, 15104052M, 15118032M, 15127009M, 15127068M, 15134039M, 15135009M, 15135054M, 15140070M, 15147039M, 15148065M, 151900145M, 151930043M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0061-2017","Class II","lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104.","500 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15117146M, 15121045M, 15125052M, 15131008M, 15133051M, 15140028M, 15149043M, 151890293M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0079-2017","Class II","morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259.","21506 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15125021M, 15126043M, 15126064M, 15126065M, 15126066M, 15127091M, 15132014M, 15133011C, 15134006C, 15134007C, 15134062M, 15135063M, 15139087M, 15141002C, 15141040M, 15141041M, 15146081M, 15147036M, 15147037M, 15147122M, 15148003C, 15148012M, 15148119M, 15149003M, 15152004C, 15153006C, 15154002C, 15155007C, 15160009C, 151650003C 151660005C, 151660006C, 151670005C, 151720005C, 151720041C, 151730003M, 151730006C, 151730007C, 151730128M, 151740131M, 151740136M, 151750007C, 151790041C, 151930021M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0059-2017","Class II","lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.","3285 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15118068M, 15124072M. 15125066M, 15128033M, 15131001M, 15131017M, 15139035M, 15139080M, 15146036M, 15147054M, 15152078M, 151730126M, 151740218M, 151900292M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0054-2017","Class II","ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3320.","1500 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 151120100M, 15112020M, 15112094M, 15113012M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0078-2017","Class II","morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.","592 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15113049M, 15113050M, Exp between 07/15/15-10/12/15  ",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0048-2017","Class II","HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925.","240 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15147130S, 15180094S, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0043-2017","Class II","fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107.","10 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Number: 151900252M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0064-2017","Class II","lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391.","300 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Number: 15113065M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0047-2017","Class II","HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210.","399 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15135098S, 15146063S, 15154082S, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0035-2017","Class II","fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.","8955 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15118074M, 15120007M, 15124007M, 15127060M, 15132006M, 15132039M, 15138059M, 15139012M, 15139051M, 15140003M, 15141067M, 15146006M, 15148075M, 151730112M, 151730155M, 151740205M, 151880329M, 151930020M, 151930026M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0039-2017","Class II","fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.","1522 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers:  15100054M, 15117048M, 15127063M, 15128034M, 15128044M, 15132059M, 15134032M, 15147063M, 15148055M, 151890302M, 151900130M, 151900222M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0028-2017","Class II","Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.","10 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Number: 15195070E, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0060-2017","Class II","lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.","2961 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15118064M, 15119066M, 15119075M, 15124006M, 15133061M, 15133066M, 15134057M, 15140063M, 15149053M, 151720021M, 151880315M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0092-2017","Class II","lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.","499 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Number: 15112122M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0072-2017","Class II","methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.","7556 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15118069M, 15126004M, 151320095M, 15132023M, 15133005C, 15133011M, 15133032M, 15140003C, 15141005C, 15153010C, 151390098M, 15139065M, 15140074M, 151450122M, 15146010M, 15147052M, 15148046M, 15148058M, 15152062M,15160001C, 151680006C, 151720023M, 151720080M, 151730133M, 151740008C, 151740211M, 151800043C, 151880168M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0033-2017","Class II","fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40    ","50 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Number: 15141053M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0056-2017","Class II","ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product  code 2R3348.","12,173 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15117083M, 15117090M, 15118047M, 15121052M, 15124079M, 15126020M, 15127007M, 15127096M, 15133014M, 15133068M, 15134067M, 15139089M, 15140069M, 15141027M, 15141043M, 15142095M, 15146008M, 15149111M, 15149116M, 151730004M, 151730116M, 151880152M, 151890126M, 151930170M, 151940024M, 151940182M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0091-2017","Class II","lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.","4400 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15118063M, 15119033M, 15124035M, 15132062M, 15135014C, 15138006M, 15146004M, 15147009C, 15152042M, 15155003C, 15160004C, 151680013C, 151730130M, 151900142M, 151950033M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0090-2017","Class II","succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.","2495 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15112035M, 15112036M, 15113006M, 15113026M, 15113078M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0093-2017","Class I","fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.","500 syringes","Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.","10/12/2016",," Lot Number: 15149004M, Exp 08/27/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0081-2017","Class II","morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.","25 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot number: 15125033M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0038-2017","Class II","fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.","997 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15112083M, 15112129M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0077-2017","Class II","morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.","935 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15117038M, 151200111M, 15126052M, 15127038M, 15131015M, 15134028M, 15134031M, 15135049M, 151380104M, 15139033M, 15139063M, 151410121M, 15146038M, 15147041M, 15149045M, 15152036M, 151730212M, 151890291M, 151930131M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0065-2017","Class II","lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112.","6324 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15118067M, 15120045M, 15127005M, 15131002M, 15135005M, 15135046M, 15140001M, 15140045M, 15146007M, 15147070M, 15152052M, 151880331M, 151900241M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0051-2017","Class II","HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.","4860 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15121069M, 15124075M, 15126078M, 15138012M, 15138013M, 15148077M, 15149122M, 15150103M, 151740201M, 151880159M, 151890210M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0087-2017","Class II","PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.","2985 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15112107M, 15112110M, 15112113M, 15113025, 15113077M, 15113092M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0075-2017","Class II","midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.","26079 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 151170045M, 151170084M, 151170093M, 15117084M, 151180080M, 15118092M, 15118094M, 15119054M, 15120072M, 15121093M, 151240093M, 151240094M, 151240099M, 15124074M, 151250094M, 15126044M, 15126079M, 15126080M, 15127097M, 15127098M, 15128112M, 151310092M, 151310103M, 151310105M, 15131028M, 151320099M, 15133012M, 15133081M, 15134068M,15134069M, 151380068M, 151380106M,  151380112M, 151390138M, 15139090M, 15140088M, 15140089M, 15141045M, 15141074M, 15141075M, 151450030M, 151450032M, 151460097M, 15146083M, 15146087M, 15149001M, 15149005M, 15149118M, 15149119M, 15150104M, 15152056M, 151720012M,   151730078M, 151730138M, 151740019M, 151740141M, 151740143M, 151890127M, 151890128M, 151890305M, 151900021M, 151900022M, 151900140M, 151930073M, 151930171M, 151930173M, Exp between 07/15/15-10/12/15  ",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0057-2017","Class II","ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500.","54 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15117045M, 15120050M, 15131014M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0030-2017","Class II","ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a  syringe, For IV Use, Rx only, PharMEDium, Product code 2R3308.","1478 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15112085M, 15112087M, 15112090M, 15113020M, 15113100M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0045-2017","Class II","glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329.","17462 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15117086M, 15117087M, 15117088M, 15118090M, 15120069M, 15120070M, 15124086M, 15126074M, 15126075M, 15127031M, 15127095M,   15133009M, 15133079M, 15134011M, 15134022M, 15134065M, 15140004M, 15140046M, 15140086M, 15141022M, 15141023M, 15141042M, 15142094M, 15147098M, 15149114M, 15149115M, 151520082M, 151520100M, 151520101M, 151520102M, 15152054M, 151740174M, 151880153M, 151890124M, 151900020M, 151910018M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0067-2017","Class II","lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384.","512 syringes","Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15112074M, 15113030M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0074-2017","Class II","midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product Code 2R3351.","4058 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15124077M, 15126077M, 15128005M, 15131033M, 15133007C, 15133080M, 15135013C, 15138066M, 15139013C, 15141044M, 15154009C, 15160005C, 151740043C, 151800047C, 151900147M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0080-2017","Class II","morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.","545 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15118049M, 15126025M, 15131016M, 15133030M, 15139058M, 15140053M, 15142047M, 15146041M, 15147034M, 15149046M, 151720071M, 151880293M, 151930114M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0084-2017","Class II","neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551.","700 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 151890186M, 151900229M, 151900255M, 151930138M, 151940246M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0026-2017","Class II","atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.","5568 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15146082M, 15147001M, 15147099M, 15149110M, 15150028M, 15152055M, 151730002M, 151730129M, 151880317M, 151880330M, 151890300M, 151930022M, 151940213M, 151940288M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0041-2017","Class II","fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.","616 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers:  15103031M, 15127041M, 15139034M, 15140039M, 15141048M, 15147057M, 15147086M, 15148053M, 151880285M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0058-2017","Class II","labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.","969 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15112079M, 15112124M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0071-2017","Class II","methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6134.","200 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15149041M, 151720043M, 15100060M, 15127064M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0049-2017","Class II","HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.","350 syringes","Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15138094S, 15148074S, 15152062S, 15159110S, 15180117S, 15183118S, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0082-2017","Class II","neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.","21053 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15112030M, 15112033M, 15112034M, 15112099M, 15112101M, 15112103M, 15112105M, 15112108M, 15113001M, 15113002M, 15113003M, 15113007M, 15113032M, 15113033M, 15113075M, 15113076M, 15159002S, 15159003S, 15159004S, 15159006S, 15159007S, 15159009S, 15159011S, 15174213S, 15175035S, 15175036S,  15175037S, 15176015S, 15176016S, 15176017S, 15176018S, 15176020S, 15176021S, 15176022S, 15176024S, 15177011S, 15177012S, 15177013S, 15177016S, 15177017S, 15177018S, 15177019S, 15180245S, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0044-2017","Class II","glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.","16366 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15100141M, 15118066M, 15118083M, 15121090M, 15124001M, 15126042M, 15127036M, 15128030M, 15132065M, 15133010M, 15134007M, 15135010M, 15138062M, 15139002M, 15139003M, 15139052M, 15139053M, 15140083M, 15142002M, 15142090M, 15146084M, 15148044M, 15150014M, 15153002M, 151720016M, 151740133M, 151880151M, 151890120M, 151890239M, 151900019M, 151910015M, 151930042M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0085-2017","Class II","PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3376.","380 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15113035M, 15112047M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0088-2017","Class II","remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.","1623 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 151680012C, 151720013C, 151730179M, 151740029M, 151790014C, 151880319M, 151890297M, 151890318M, 151900127M, 151930081M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0025-2017","Class II","atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.","4407 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15146085M, 15147088M, 15149011M, 15149109M, 15150093M, 151730001M, 151740139M, 151900018M, 151910014M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0068-2017","Class II","lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80","1161 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers:  15121068M, 15128035M, 15134056M, 15148067M, 15152003M, 151890376M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0076-2017","Class II","morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017.","3270 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15121035M, 15125026M, 15126061M, 15132040M, 15133041M, 15139084M, 15147038M, 15148024M, 15152044M, 151740022M, 151900205M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0027-2017","Class II","Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.","660 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15194041E, 15195008E, 15195020E, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0073-2017","Class II","midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.","1700 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15124046M, 15125056M, 15127070M, 15127073M, 15138054M, 15147055M, 15149049M, 151880314M, 151890307M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0063-2017","Class II","lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.","5900 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot numbers: 15118046M, 15128003M, 15128111M, 15133006M, 15139004M, 15140015C, 15146086M, 15150029M, 15153004M, 151660012C, 151720052C, 151730131C, 151740007C, 151750019C, 151760011C, 151800048C,151880154M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0046-2017","Class II","glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340.","1494 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15112008M, 15112040M, 15113024M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0089-2017","Class II","rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.","6970 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 151120168M, 151120169M, 15112027M, 15112096M, 15113021M, 15113080M, 15113081M, 15113082M, 15113083M, 15113084M, 15113085M, 15113086M, 15113087M, 15113088M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0086-2017","Class II","PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3109.","498 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Number: 15112121M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0055-2017","Class II","ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330.","9101 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15118003M, 15119077M, 15121002M, 15125019M, 15126067M, 15132022M, 15132038M, 15134043M, 15139009M, 15140006M, 15141004M, 15141065M, 15148045M, 15148070M, 151730156M, 151890125M, 151890208M, 151900010M, 151900125M, 151930044M, 151940270M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0083-2017","Class II","neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.","250 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 151880279M, 151890275M, 151930119M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0053-2017","Class II","ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234.","25 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Number: 15112064M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0031-2017","Class II","ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347.  ","1545 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers:  15118028M, 15118062M, 15125027M, 15126055M, 15131013M, 15133028M, 15139046M, 15146033M, 15146062M, 151880294M, 151890279M, 151930127M, 151940261M, Exp between 07/15/15-10/12/15  ",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0070-2017","Class II","methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.","7006 syringes","Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15118004M, 15119082M, 15134004C, 15134006M, 15139004C, 15139011M, 15140071M, 15141001M, 15141129M, 15147012C, 15147030M, 15148004C, 15150021M, 15155002C, 15160002C, 15160006C, 151730013C, 151760016C, 151810002C, 151890129M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0052-2017","Class II","HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165","450 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers: 15133058M, 15140061M, 15147056M, 151880295M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73925,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0029-2017","Class II","ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301.","995 syringes","Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.","10/12/2016",," Lot Numbers:  15112081M, 15113016M, Exp between 07/15/15-10/12/15",7/17/2015,"07/17/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73926,"Terminated","LifeServe Blood Center","431 E Locust St",,"Des Moines","IA","50309-1909","United States","Voluntary: Firm Initiated","Telephone","New Jersey","B-0520-16","Class III","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood product, which did not meet acceptable product specifications, was distributed.","06/02/2016","06/02/2016"," W037916558044; ",3/9/2016,"03/09/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73927,"Terminated","BPL Plasma, Inc.","2631 Dunn Ave",,"Jacksonville","FL","32218-4656","United States","Voluntary: Firm Initiated","E-Mail","Belgium","B-0527-16","Class II","Source Plasma","2 units","Blood products, collected from an ineligible donor, were distributed. ","05/17/2016","05/17/2016"," JV0355868; JV0356249; ",3/21/2016,"03/21/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73928,"Terminated","BPL Plasma, Inc.","2631 Dunn Ave",,"Jacksonville","FL","32218-4656","United States","Voluntary: Firm Initiated","E-Mail","Belgium","B-0521-16","Class II","Source Plasma","1 unit","Blood product, collected from a donor who had been incarcerated, was distributed. ","05/24/2016","05/24/2016"," JV0356941; ",3/24/2016,"03/24/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73929,"Terminated","The Blood Alliance, Inc.","7595 Centurion Pkwy",,"Jacksonville","FL","32256-0518","United States","Voluntary: Firm Initiated","Telephone","Florida","B-0522-16","Class III","Red Blood Cells, Leukocytes Reduced, Irradiated","3 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.","05/24/2016","05/24/2016"," W118816530347; W118816250566; W118816560187; ",3/25/2016,"03/25/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73930,"Terminated","Talecris Plasma Resources, Inc.","3810 Barrancas Ave",,"Pensacola","FL","32507-3493","United States","Voluntary: Firm Initiated","Letter","North Carolina; New York","B-0523-16","Class III","Source Plasma","23 units","Blood products, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed.","05/24/2016","05/24/2016"," 5110328676; 5110329077; 5110329964; 5110331267; 5110331652; 5110332694; 5110332938; 5110334218; 5110334637; 5110343464; 5110335577; 5110344657; 5110336112; 5110336883; 5110337531; 5110338300; 5110345117; 5110338929; 5110339727; 5110340428; 5110341303; 5110342039; 5110342950; ",4/19/2016,"04/19/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73931,"Terminated","Talecris Plasma Resources","6582 University Ave NE",,"Fridley","MN","55432-4330","United States","Voluntary: Firm Initiated","Letter","North Carolina","B-0530-16","Class II","Source Plasma","19 units","Blood products, collected from an ineligible donor, were distributed. ","05/17/2016","05/17/2016"," 5090362457; 5090362207; 5090361646; 5090361374; 5090360719; 5090360452; 5090359936; 5090358371; 5090358031; 5090357463; 5090357101; 5090356492; 5090356122; 5090355312; 5090355015; 5090354356; 5090353854; 5090353124; 5090352692",4/19/2016,"04/19/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73932,"Terminated","Biomat USA, Inc.","1709 S Avondale St",,"Amarillo","TX","79106-4516","United States","Voluntary: Firm Initiated","Letter","North Carolina","B-0524-16","Class III","Source Plasma","34 units","Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.","06/02/2016","06/02/2016"," 3470178544; 3470179286; 3470181352; 3470182319; 3470182892; 3470183352; 3470184857; 3470178536; 3470181886; 3470178234; 3470182700; 3470181192; 3470181596; 3470176766; 3470184484; 3470178936; 3470177951; 3470183185; 3470184280; 3470184576; 3470184192; 3470181561; 3470179348; 3470183302; 3470179370; 3470182893; 3470182486; 3470181455; 3470182841; 3470180006; 3470181052; 3470181537; 3470184552; 3470181282; ",4/19/2016,"04/19/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73933,"Ongoing","Buell's Orchard","108 Crystal Pond Rd",,"Eastford","CT","06242-9730","United States","Voluntary: Firm Initiated","E-Mail","MA, PA","F-1364-2016","Class II","TRADER JOE'S Apple Cider, NOT FROM CONCENTRATE SHAKE WELL NO PRESERVATIVES 100% JUICE PASTEURIZED.  PERISHABLE, KEEP REFRIGERATED. NET 64 FL OZ (2 QT) 1.89 L. UPC: 0016 4580. ","2758","Patulin was found in the apple cider at 63.7 ppb.","05/17/2016",," SELL BY MAY 15",4/22/2016,"04/22/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73934,"Ongoing","UNFI","71 Stow Drive",,"Chesterfield","NH","03442","United States","Voluntary: Firm Initiated","Letter","NY, RI, ME, MA, VT, OH, MN, IN, KY, MO, ME, SD, CT, IA, NE, WI, NJ","F-1363-2016","Class II","COMMERCIAL WHEAT GERM 274000, 50.00 lbs. (22.68 kg); UPC Code: 0-26938-46535-3","32 bags","Product contains generic E. coli. ","05/17/2016",," Lot Codes: W121915, W012116, W122315  ",4/15/2016,"04/15/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73935,"Ongoing","Fresenius Kabi USA, LLC","3 Corporate Dr",,"Lake Zurich","IL","60047-8930","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1037-2016","Class II","Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37","69225 units","Presence of Particulate Matter: Glass particulate found in sterile injectable product","06/16/2016",," Lot #: 6111504, Exp 09/2019",4/25/2016,"04/25/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73936,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","E-Mail","distributed in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OR, PA, RI, SC, TN, UT, VT, VA, WA, WV, WI, and in British Columbia, Alberta, Manitoba, Saskatchewan of Canada.","F-1763-2016","Class I","Frozen Organic Premium Blend Vegetable Medley with Shelled Edamame, Organic by Nature brand, net wt. 5 lb.  The UPC is 8 46358 00065 7.      Product label bears cooking instructions and listed as:    MICROWAVE  1. Pour one quarter contents of bag into  a microwave safe dish with 1/4 cup water.  2. Cook covered on HIGH 3 minutes  3. Stir and continue cooking uncovered for 3 to 4 minutes or until heated through*  4. Season to taste and serve.    STOVE TOP    1. Pour one quarter contents of bag into saucepan with 1/2 cup water.  2. Heat to a boil over medium -high heat.  3. Stir, reduce heat to simmer and cover.  4. Maintain simmer, stirring occasionally, 10 to 12 minutes or until heated through*  5. Season to taste and serve    * For food safety and best product quality cook to a temperature of 160F.  Since microwave ovens may vary in power, these instructions are guidelines only.  Do not refreeze after thawing.","1791 cases","Organic Premium Blend Vegetable Medley with Shelled Edamame product is recalled due to a potential for contamination with Listeria monocytogenes.","07/20/2016",," Best By date: 021118",4/22/2016,"04/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73936,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","E-Mail","distributed in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OR, PA, RI, SC, TN, UT, VT, VA, WA, WV, WI, and in British Columbia, Alberta, Manitoba, Saskatchewan of Canada.","F-1762-2016","Class I","Frozen Organic Mixed Vegetables,  Wellsley Farms Organic brand, net wt. 4 lb. The UPC is 8 88670 01013 6.    Product label bears cooking instructions and listed as:    MICROWAVE  1. Pour one quarter contents of bag into  a microwave safe dish with 1/4 cup water.  2. Cook covered on HIGH 3 minutes  3. Stir and continue cooking uncovered for 3 to 4 minutes or until heated through*  4. Season to taste and serve.    STOVE TOP    1.  Pour one quarter contents of bag into saucepan with 1/2 cup water.  2. Heat to a boil over medium -high heat.  3. Stir, reduce heat to simmer and cover.  4. Maintain simmer, stirring occasionally, 10 to 12 minutes or until heated through*  5. Season to taste and serve    * For food safety and best product quality cook to a temperature of 160F.  Since microwave ovens may vary in power, these instructions are guidelines only.  Do not refreeze after thawing.","6083 cases total","Organic Organic Mixed Vegetables product is recalled due to a potential for contamination with Listeria monocytogenes.","07/20/2016",," Best By dates: 102517 ",4/22/2016,"04/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73936,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","E-Mail","distributed in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OR, PA, RI, SC, TN, UT, VT, VA, WA, WV, WI, and in British Columbia, Alberta, Manitoba, Saskatchewan of Canada.","F-1761-2016","Class I","Frozen Organic Super Sweet White Corn, Organic by Nature, net wt. 5 lb. The UPC is 8 46358 00064 0.    Frozen Organic Super Sweet White Corn, Organic by Nature brand, net wt. 4 lb. The UPC is 8 46358 00070 1.    Organic Super Sweet Yellow and White Cut Corn, Live Smart Schwan's brand, net wt. 16 oz.  The UPC is 0 07218 06043 3.    Frozen Organic White Sweet Corn, True Goodness by Meijer brand, net wt. 10 oz. The UPC is	7 13733 43098 2.    ************************************************************************  Swan's label bears cooking instructions as listed below:    MICROWAVE (1100 Watts):  Cook in microwave safe bowl, stirring halfway through cook time.  Whole bag,1/2 cup, 8-10 minutes  Half bag, 1/4 cup, 5-7 minutes.    STOVE TOP  1. Bring 1/2 to 1 inch of water to boil in medium saucepan.  2. Add desired amount of corn to water, bring to a second boil.  3. Reduce heat to Low and simmer 3-5 minutes or until tender.  drain      Meijer label bears preparation instructions and it is described below:    MICROWAVE. DO NOT MICROWAVE IN BAG.    1) PLACE corn and 1/2 cup water in microwave-safe bowl.  2) COVER and microwave on HIGH 4 1/2 to 5 1/2 minutes.  3) CHECK that vegetables are cooked thoroughly.  DRAIN","8453 cases","Organic White Sweet Corn is recalled due to a potential for contamination with Listeria monocytogenes.","07/20/2016",," Best By: 091317;  111917; 112117, and 2B5320 (packed on 11/16/15).",4/22/2016,"04/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73936,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","E-Mail","distributed in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OH, OR, PA, RI, SC, TN, UT, VT, VA, WA, WV, WI, and in British Columbia, Alberta, Manitoba, Saskatchewan of Canada.","F-1760-2016","Class I","Frozen Organic Premium Sweet Baby Peas, Organic by Nature brand, net wt. 5 lb.   The UPC is 8 46358 00063 3.    Frozen IQF Organic Premium Sweet Baby Peas, Organic by Nature brand, net wt. 4 lb. The UPC is 8 46358 00069 5.    Frozen Organic Premium Quality Sweet Peas, Organic by Nature brand (Canada); net wet 2.5 kg.  The UPC is 8 46358 00061 9.    Frozen Organic Petite Green Peas, True Goodness by Meijer brand, net wt. 10 oz.   The UPC is  7 13733 43099 9.      Frozen Organic Peas, Wellsley Farms Organic,  Net wt. 4 lb.  The UPC is 8 88670 00997 0.    *******************************************************************************************  Organic by Nature label bears cooking instructions and it is described below:    MICROWAVE  1. Pour one quarter contents of bags into microwave safe dish with 1/4 cup water.  2. Cook covered on HIGH 3 minutes  3. Stir and continue cooking uncovered for 3 to 4 minutes or until heated through*  4. Season to taste and serve.    STOVE TOP:  1. Pour one quarter contents of bag into saucepan with ¿ cup water.  2. Heat to a boil over medium-high heat.  3. Stir, reduce heat to simmer and cover.  4. Maintain simmer, stirring occasionally, 10 to 12 minutes or until heated through.*  5. Season to taste and serve.  Meijer label bears preparation instructions and it is described below:    MICROWAVE. DO NOT MICROWAVE IN BAG.    1) PLACE peas and 1/2 cup water in microwave-safe bowl.  2) COVER and microwave on HIGH 4 to 5 minutes.  3) CHECK that vegetables are cooked thoroughly.  DRAIN.    Wellsley Farms label bears cooking instructions and it is described below:    STOVE TOP:  1. Pour one quarter contents of bag into saucepan with ¿ cup water.  2. Heat to a boil over medium-high heat.  3. Stir, reduce heat to simmer and cover.  4. Maintain simmer, stirring occasionally, 10 to 12 minutes or until heated through.*  5. Season to taste and serve.    MICROWAVE:  1. Pour one quarter contents of bag into a microwave safe dish with 1/4 cup water.  2. Cook covered on HIGH 3 minutes.  3. Stir a","24,534 cases total","Frozen Organic Peas product is recalled due to a potential for contamination with Listeria monocytogenes.","07/20/2016",," Best By: 102217; 102517; 112617; 120317; 021018; 021518; 031618; and 031718.",4/22/2016,"04/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73937,"Ongoing","Nuvi Global Corporation","8423 Rochester Ave Ste 101",".","Rancho Cucamonga","CA","91730-3995","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, CO, FL, IA, ID, IL, IN, MD, MN, MO, MS, NH, NJ, NV, NY, OK, SC, TX, UT, WA    No foreign distribution.","F-1431-2016","Class I","Nuvi Global  StemVitae   Multivitamin  30oz.","273 bottles","Undeclared whey protein which contains the allergens of milk and soy lecithin.","06/09/2016",," Lot #15556",4/19/2016,"04/19/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73939,"Ongoing","Qtrade Teas And Herb","16205 Distribution Way",,"Cerritos","CA","90703-2329","United States","Voluntary: Firm Initiated","Letter","US: OR, MA, IA    OUS: New Zealand, Canada","F-1373-2016","Class II","Organic Green Tea Hojicha, Net 16 kgs,   (bulk product 16 kg boxes with inner liner)","1,022.281 lbs","QTrade Teas & Herbs is recalling Organic Green Tea Hojicha  because it has the potential to be contaminated with Salmonella.","05/19/2016",," D1-HOJI-1406-50",4/22/2016,"04/22/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73940,"Ongoing","Qtrade Teas And Herb","16205 Distribution Way",,"Cerritos","CA","90703-2329","United States","Voluntary: Firm Initiated","Letter","US: CA, IL, NJ    OUS: Canada","F-1375-2016","Class II","Organic Ginger Peach Iced Tea, 100x1oz box, item #60001","520 units","QTrade Teas & Herbs is recalling Organic Ginger Root Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella.","05/19/2016",," S379872-50",4/22/2016,"04/22/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73940,"Ongoing","Qtrade Teas And Herb","16205 Distribution Way",,"Cerritos","CA","90703-2329","United States","Voluntary: Firm Initiated","Letter","US: CA, IL, NJ    OUS: Canada","F-1374-2016","Class II","Organic Ginger Root Tea Bag Cut (TBC), 25 kgs","1,046 lbs","QTrade Teas & Herbs is recalling Organic Ginger Root Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella.","05/19/2016",," ZO-136T",4/22/2016,"04/22/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73940,"Ongoing","Qtrade Teas And Herb","16205 Distribution Way",,"Cerritos","CA","90703-2329","United States","Voluntary: Firm Initiated","Letter","US: CA, IL, NJ    OUS: Canada","F-1376-2016","Class II","Organic Coconut Chai Tea Bag Cut (TBC), Net: 25kg","2,564 lbs","QTrade Teas & Herbs is recalling Organic Ginger Root Tea Bag Cut (TBC) because it has the potential to be contaminated with Salmonella.","05/19/2016",," S381121S-20  ",4/22/2016,"04/22/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73942,"Terminated","Innovative Blood Resources","100 N 84th St",,"Lincoln","NE","68505-3101","United States","Voluntary: Firm Initiated","FAX","LA","B-0556-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.","06/02/2016","06/02/2016"," W087915901999",4/14/2016,"04/14/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73944,"Terminated","Naples Community Hospital Blood Bank","2157 Pine Ridge Rd",,"Naples","FL","34109-2033","United States","Voluntary: Firm Initiated","FAX","Florida","B-0506-16","Class III","Red Blood Cells","1 unit","Blood product, collected from a donor without documentation of a hematocrit test having been performed, was distributed.","05/24/2016","05/24/2016"," W3041160018413",2/23/2016,"02/23/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73945,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI","Z-1710-2016","Class II","3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile    Product Usage:  The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).  ","1274 units","The sterile packaging may be compromised.  A protective cap is to be secured on the tip of the drill bit.  If the protective cap is not secured, the drill bit may puncture the sterile barrier.  ","05/23/2016",," Catalog ID 03.010.100S  Lot # 5525872, 6153368, 6530901, 5548707, 6197315, 6581051  5575918, 6199232, 6676406, 5603463, 6231850, 6721724  5649117, 6256560, 6734876, 5668880, 6305842, 6808463  5724639, 6319050, 6831468, 5742276, 6320150, 6997294  5807341, 6343980, 7039877, 6012770, 6401819, 7052565  6045597, 6448707, 7081479, 6057914, 6472100, 7378832  6108342, 6501856, 7410311, 6142443, 6503351, 7466207  7554670, 7620971, 7675571, 7711694, 7801251, 7918026  9815103, 9828932, 9905850, 9939769, H033348  ",4/18/2016,"04/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73945,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI","Z-1709-2016","Class II","3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S    Product Usage:  Usage:  The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).  ","7363 units","The sterile packaging may be compromised.  A protective cap is to be secured on the tip of the drill bit.  If the protective cap is not secured, the drill bit may puncture the sterile barrier.  ","05/23/2016",," Catalog ID 03.010.060S  Lot # 5558809, 6204324, 6813586, 7648837, 5559839, 6214366, 6818438, 7648838, 5575915, 6235676, 6827807, 7657752, 5579717, 6240287, 6830470, 7657753, 5582298, 6247514, 6835634, 7660380, 5585788, 6249834, 6841962, 7661528  5594237, 6269336, 6851101, 7661529, 5594238, 6276953, 6857546, 7674414, 5616439, 6279756, 6860704, 7687319, 5633067, 6279757, 6870563, 7693164, 5656914, 6302746, 6873394, 7716604, 5672506, 6313568, 6873396, 7731690  5682043, 6313569, 6898040, 7739027, 5692087, 6325420, 6904377, 7753584, 5702206, 6331923, 6908328, 7766654, 5711966, 6334954, 6919278, 7774127, 5724637, 6339936, 6925232, 7774128, 5727691, 6348925, 6931055, 7794479  5732158, 6355191, 6939080, 7817283, 5741332, 6368986, 6949503, 7830606, 5748361, 6375334, 6961056, 7835732, 5760640, 6382329, 6967764, 7848333, 5772367, 6398746, 6975982, 7869029, 5780654, 6413506, 6984973, 7870629  5782800, 6420887, 6996252, 7894923, 5782801, 6433683, 7004816, 7899079, 5782802, 6433684, 7013143, 7903010, 5794181, 6438144, 7019693, 7908522, 5816780, 6449832, 7029024, 7918012, 5818769, 6458079, 7036198, 7919639  5818770, 6464443, 7052563, 7924989, 5829138, 6475737, 7064072, 7941743, 5847359, 6480417, 7070681, 7947278, 5860702, 6486376, 7084937, 7963626, 5861834, 6488940, 7275546, 7981633, 5861836, 6505811, 7304754, 7993351  5870708, 6509276, 7349355, 9808655, 6010554, 6528479, 7359254, 9820617, 6031951, 6540263, 7371663, 9825386, 6034093, 6549146, 7382623, 9826363, 6034128, 6557658, 7400014, 9831036, 6051790, 6563112, 7400015, 9841499  6052762, 6572199, 7400016, 9855040, 6055036, 6577880, 7416878, 9859105, 6066429, 6586607, 7422660, 9864677, 6069150, 6593553, 7441691, 9869742, 6069151, 6598206, 7444103, 9878216, 6074684, 6603184, 7460590, 9886333  6080184, 6610704, 7465210, 9904888, 6081960, 6621162, 7476937, 9911126, 6091446, 6636693, 7485616, 9915461, 6092777, 6655352, 7497778, 9924572, 6109266, 6674053, 7499940, 9932287, 6121870, 6686555, 7512119, 9939768  6124816, 6707678, 7520264, 9959608, 6130838, 6721722, 7533286, 9961574",4/18/2016,"04/18/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0526-2017","Class II","Copack Wht/Yelcupcakebase, 51.5#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000153956, 1000149827, 1000144312, 1000134437",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0510-2017","Class II","Yeast Roll Mix, 20#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000149823, 1000157034, 1000138943, 1000144299 ",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0517-2017","Class II","BM Westco 1440 Yst Rds Donut Base, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000149842",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0513-2017","Class II","7-Eleven Variety Cookie Base, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000151314, 1000157043, 1000151316, 1000144302, 1000129958",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0511-2017","Class II","BM Westco New Horizon Yrd Mix, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000157042, 1000153955, 1000134434",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0515-2017","Class II","Yeast Roll Mix 20# (Bromated Free)","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000157866, 1000154611, 1000144311, 1000138930, 1000153953, 1000149843, 1000134433",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0507-2017","Class II","Logans Rdhse Yeast Roll Mix, 21.5#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000162496, 1000162208, 1000157036, 1000153960, 1000149848, 1000162436, 1000144316, 1000138932",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0506-2017","Class II","BM Westco Sup-R-Roll Donut Mix, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000162202, 1000157048, 1000153947, 1000149825, 1000144301, 1000134442",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0525-2017","Class II","Copack Choccupcake Base 51.5#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000149833, 1000138926",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0505-2017","Class II","BM Westco Mster Mix Raised Donut Mix, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000157031, 1000149824, 1000144300, 1000153958, 1000134441, 1000138929, 1000129967",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0518-2017","Class II","11644 Ultra Rich Creme Cake Mix, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000149822, 1000134439",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0520-2017","Class II","38260 Cream Cake Mix, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000153948, 1000144297",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0521-2017","Class II","Pudding Cake Concentrate 30%, 50# bag","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000149826, 1000134448",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0508-2017","Class II","Buffets Corn Muffin Mix,  30# Bag","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000144298, 1000134430",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0516-2017","Class II","ZT Banana Bread Mix, 13.5#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000157044, 1000153946, 1000144321, 1000138912",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0514-2017","Class II","7-Eleven Spice Cookie Base, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000157047, 1000153957, 1000151313, 1000129959",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0509-2017","Class II","ZT Carrot Bread Mix, 13.5#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000134446",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0519-2017","Class II","BM Westco 1440 Raised Donut Mix, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000149829",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0524-2017","Class II","Brill Choco Cream Cake Base, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000129969",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0522-2017","Class II","Cinnabon Cinn Rl BS, 50# International","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000144318, 1000134444",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0523-2017","Class II","Brill White Crm Cake Mix, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000154798, 1000149831, 1000144315, 1000138934",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73946,"Ongoing","CSM Bakery Products NA","1912 Montreal Rd",,"Tucker","GA","30084-5201","United States","Voluntary: Firm Initiated","Letter","AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC, OH, OR, PA, SC, TN, TX,VA, WI, Santa Domingo, & Guam","F-0512-2017","Class II","7-Eleven Sugar Cookie Base, 50#","3,124,735 pounds total","Undeclared allergen; Peanut Protein","11/23/2016","."," Batch 1000162195, 1000157046, 1000153961, 1000149847,  1000134432, 1000129956",4/21/2016,"04/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73947,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US nationwide distribution to OH, FL, TN, MN, OH, NY, VA, and MN.","Z-1598-2016","Class II","MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table. ","8 systems","The docking station top cover of the removable patient table may contain a magnetic metal plate.  When docking/undocking the table, the magnetic top cover may become attracted to the magnet.","05/03/2016",," Model # 10432914 and 10432915  Serial Numbers: 42472, 42489, 42477, 46169, 46178, 46175, 42478, 42485",4/13/2016,"04/13/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73948,"Ongoing","Greatbatch Medical","2300 Berkshire Ln N",,"Plymouth","MN","55441-4575","United States","Voluntary: Firm Initiated","Letter","US: IN, MI, TX.  OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.","Z-1883-2016","Class II","Torque Limiting Screwdriver:    Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only.     PRECIMED, Non Sterile.    Zimmer,  Non Sterile, Rx Only.    Screwdriver:  Customer Number/Model:  804-03-038 T11623, T14001   T14001, MTO35173507   T14378, MTO375173506   T14379, MTO35173505   T14380, MTO35175303   T8127.    ","1110","Greatbatch Medical has initiated a global Field Recall  for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not  achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction  For Use (IFU) provided with the device.","06/01/2016",,"05.1587814  05.1438412  05.1521913  ",4/26/2016,"04/26/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73948,"Ongoing","Greatbatch Medical","2300 Berkshire Ln N",,"Plymouth","MN","55441-4575","United States","Voluntary: Firm Initiated","Letter","US: IN, MI, TX.  OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.","Z-1884-2016","Class II","Torque Limiting Adapter:  Torque Limiting Attachment, Non Sterile, Distributed by Zimmer.    PRECIMED, Torque Limiting Adaptor, Non Sterile..    Customer Number/Model:  00-2360-080-00   T10232,  T116245   T116245, TLA025-25   TLA025-25,  00-2360-080-05   T10233, MAC21003 T116430, TLA025-30 TLA025-30,  MAC21001   T112972, MAC21001   T13621, TLA025-20   TLA025-20.        ","5952","Greatbatch Medical has initiated a global Field Recall  for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not  achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction  For Use (IFU) provided with the device.","06/01/2016",," 1000207  1001049  1001048  1000698  1000582  1000582  1001334  1001334  1002457  1002456  1002974  1002640  1003175  1003174  1003223  1003223  1003224  1003225  1003548  1003766  1003908  1004435  1004485  1004349  1004903  1005099  1004347  1005530  1005772  1005900  1009013  1008458  1009195  1009195  1009197  1009014  1009198  1009196  1009698  1009199  1009699  1009200  1009700  1011763  1010602  1012455  1012490  1013172  1013173  1013415  1013416  1013921  1013922  1514611  1614605  1714700  1953758  1953809  1953810  2124866  2073128  2116179  2141896  1953758  2150164  2157328  2209891  2302780  2302777  2302781  2302788  2362691  2407040  2407047  2407040  2407040  2898285  2898285  2898289  2971943  2904251  2919512  2938191  2978582  1004138  1004139  1004413  1004578  1004577  1004580  1004579  1005899  1005817  1009701  2324706  2920624  3092836  3092836  1006939      FC-002  FC-002  1012458  6280900001    8027435  8027436  8027434    ",4/26/2016,"04/26/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73948,"Ongoing","Greatbatch Medical","2300 Berkshire Ln N",,"Plymouth","MN","55441-4575","United States","Voluntary: Firm Initiated","Letter","US: IN, MI, TX.  OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.","Z-1882-2016","Class II","Torque Limiting Handle:  PRECIMED, T-Handle Torque, Non Sterile.    Handle:  Customer Number/Model:  MCL120014   T14000,  TLT911-50-S20   TLT911-50-S20,   TLT911-15-S01   TLT911-15-S01,  TLTS0007-20-S19   TLTS0007-20-S19,   TLT911-35-S01   TLT911-35-S01.","2","Greatbatch Medical has initiated a global Field Recall  for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not  achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction  For Use (IFU) provided with the device.","06/01/2016",," 6307760001  ",4/26/2016,"04/26/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73949,"Ongoing","Accriva Diagnostics Inc., dba ITC, dba Accumetrics","6260 Sequence Dr",,"San Diego","CA","92121-4358","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; state:  VA.   Foreign distribution to the following; China, Italy, Germany.","Z-1720-2016","Class II","Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.","135 boxes","Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.","05/25/2016",," Lot #B6JCA012",4/22/2016,"04/22/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73951,"Ongoing","Immucor Inc","3130 Gateway Dr",,"Norcross","GA","30071-1106","United States","Voluntary: Firm Initiated","Telephone","AL, AZ, CA, CO, CT, FL, HI, IL, IN, LA, MD, MA, MO, NY, NC, OH, TN, TX, VT, WA","B-0510-16","Class III","Galileo Echo","47 instruments","Galileo Echo automated blood bank analyzer, with potentially incorrect Color Level settings, were identified and corrected. ","05/10/2016",," Catalog Number 0087000 - Echo SN M00382, M01783, M01779, M00404, M01493, M00893, M00259, M00130, M00214, M00292, M01181, M01237, M01081, M00681, M00325, M01051, M01240, M00786, M00781, M01289, M00320, M00242, M00362, M00687, M01618, M00723, M00554, M01080, M01313, M00121, M00865, M00762, M00960, M01290, M00559, M00490, M00872, M00449, M00544, M00800, M01108, M00929, M00989, M01688, M00611, M00543, M01208",3/21/2016,"03/21/2016",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73952,"Terminated","Gulf Coast Regional Blood Center","1400 La Concha Ln",".","Houston","TX","77054-1802","United States","Voluntary: Firm Initiated","FAX","TX; Korea, Republic Of(South)","B-0553-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","06/06/2016","06/06/2016"," W044615085043",4/19/2016,"04/19/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73952,"Terminated","Gulf Coast Regional Blood Center","1400 La Concha Ln",".","Houston","TX","77054-1802","United States","Voluntary: Firm Initiated","FAX","TX; Korea, Republic Of(South)","B-0554-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","06/06/2016","06/06/2016"," W044615395316",4/19/2016,"04/19/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73952,"Terminated","Gulf Coast Regional Blood Center","1400 La Concha Ln",".","Houston","TX","77054-1802","United States","Voluntary: Firm Initiated","FAX","TX; Korea, Republic Of(South)","B-0552-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","06/06/2016","06/06/2016"," W044615395316",4/19/2016,"04/19/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73954,"Terminated","OneBlood, Inc.","8669 Commodity Cir",".","Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","E-Mail","FL","B-0555-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.","06/06/2016","06/06/2016"," W036814130402",2/26/2016,"02/26/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73955,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","E-Mail","FL","B-0557-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","06/02/2016","06/02/2016"," W036815670281",2/16/2016,"02/16/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73956,"Ongoing","Sinco","750 Pleasant St",,"Belmont","MA","02478-1428","United States","Voluntary: Firm Initiated","E-Mail","Directly to: MN, VT, product was further distributed to Target Stores Nationwide.","F-1398-2016","Class II","archer farms Greek-Inspired Spinach & Feta Cheese ARTISAN PIZZA, NET WT 14.9 OZ (425g). UPC Code: 0-85239-30714-4. Pizza is frozen. ","13,152 pizzas","Consumer found a small piece of gray plastic in the pizza. ","05/24/2016",," BEST BY OCT 15, 2016  Batch Code: 5288 A2",4/22/2016,"04/22/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73957,"Ongoing","CSM Bakery Products","1 King Arthurs Ct",,"Sugar Land","TX","77478-3145","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US and Canada","F-1487-2016","Class II"," Single Layer Red Velvet Cake","2504.4 cases","Lab testing revealed the recalled product tested positive for trace amounts of peanuts.","06/13/2016",," Lot: 1000155263 and 1000150300",4/26/2016,"04/26/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",73958,"Ongoing","Private Label Cosmetics Corp","111e Trade Zone Ct",,"Ronkonkoma","NY","11779-7368","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide via Amazon Internet Sales","F-1668-2016","Class II","PEPPERMINT ESSENTIAL OIL repacked into the following:   1) Radha Peppermint Oil, 100% Pure & Natural Peppermint Essential Oil Premium Therapeutic Grade, 4 Fl oz (120 ml), UPC 0 784672901284, Distributed by Radha Beauty 651 Addison St. Berkeley, CA 94710,   2) MAJESTIC PURE COSMECEUTICALS Peppermint essential oil 100% Pure & Natural Therapeutic Grade, 4 FL. OZ (118ML), Distributed by Majestic Pure Cosmeceuticals San Diego, CA 92131,   3) BODY WONDERS 100% PURE Peppermint Therapeutic Grade Essential Oil, 4 fl oz (118 ml), UPC 8 19090016589, Manufactured for and Distributed by: Body Wonders NJ 07030,   4) PURE BODY NATURALS PEPPERMINT OIL 100% PURE AND NATURAL, Premium Quality Therapeutic Grade Undiluted Essential Oil, 4 FL OZ 120 ML, UPC 0 784672 901284, Distributed By: Pure Luxe LLC, Houston, TX 77008-3642,   5) ESSENTIAL OIL LABS PEPPERMINT OIL, 4 FL OZ (120 ml), Essential Oil Labs 8605 Santa Monica Blvd #64787 Los Angeles, CA 90069,   6) Essentially Kates Premium Peppermint Oil, 4 fl oz/120 ml, Imported from India, Bottled in the USA for Essentially Kates Greeley, CO 80634","33,950 units Total"," and contains undeclared Diethyl phthalate","07/13/2016",," all lots",4/13/2016,"04/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73959,"Ongoing","Draeger Medical, Inc.","3135 Quarry Rd",,"Telford","PA","18969-1042","United States","Voluntary: Firm Initiated","Letter","US nationwide distribution, including  Puerto Rico and Guam.","Z-1812-2016","Class II","Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles.   Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000).  Anesthesia Vaporizer","16078 units distributed within the United States","Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure.    Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended.  Updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.  ","05/25/2016",," Catolog Number M35500 (D-Vapor)  M36700 (D-Vapor 3000)  Distributed October 2004  April 2016",4/21/2016,"04/21/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1277-2016","Class II","Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02","10","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1304-2016","Class II","HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0813-68 ","670","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1266-2016","Class II","Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70","400","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1313-2016","Class II","Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71","400","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1336-2016","Class II","Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0961-72 ","2665","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1305-2016","Class II","HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67 ","560","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1259-2016","Class II","Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC 45183-0100-69","4050 syringes","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1341-2016","Class II","Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41","10","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1315-2016","Class II","Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02 ","215","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1288-2016","Class II","Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75","40","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1270-2016","Class II","Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01","105","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1311-2016","Class II","Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose,  250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02","250","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1281-2016","Class II","Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only,  Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78","25","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1278-2016","Class II","HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0190-78","4500","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1292-2016","Class II","Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68","20","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1273-2016","Class II","Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41","40","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1260-2016","Class II","Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0104-70","650 syringes","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1321-2016","Class II","Bupivacaine HCI 0.125% in 0.9% Sodium Chloride,  250 mL  lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC 45183-0909-02 ","55","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1442-2016","Class II","Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 500 mL  lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0993-03","50","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1290-2016","Class II","Provocholine pre-diluted in 0.9% Sodium Chloride Set II  syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80","142","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1316-2016","Class II","Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride,  50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41 ","300","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1343-2016","Class II","Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx  Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03","70","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1325-2016","Class II","HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68","90","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1291-2016","Class II","Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68","5","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1331-2016","Class II","Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03","129","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1268-2016","Class II","Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0146-47","12","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1284-2016","Class II","Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride  50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0504-41","10","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1330-2016","Class II","Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70","800","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1257-2016","Class II","Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0019-02","130 bags","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1318-2016","Class II","Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02","216","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1329-2016","Class II","Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0938-68","150","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1267-2016","Class II","Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67","40","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1307-2016","Class II","Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75 ","30","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1265-2016","Class II","Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride  10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72","280","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1298-2016","Class II","Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0766-03","468","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1335-2016","Class II","Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0960-72","1675","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1326-2016","Class II","HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0933-75","120","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1324-2016","Class II","Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72","2735","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1299-2016","Class II","Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04","384","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1297-2016","Class II","Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03","72","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1310-2016","Class II","Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77 ","100","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1337-2016","Class II","Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70 ","1500","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1280-2016","Class II","Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48","18","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1332-2016","Class II","Lidocaine 2%,  5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0946-70","50","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1301-2016","Class II","Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72","1200","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1272-2016","Class II","Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC # 45183-0174-02","24","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1293-2016","Class II","HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC  45183-0702-68","100","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1256-2016","Class II","Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72","2100 syringes","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1279-2016","Class II","Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48","1083","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1312-2016","Class II","Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride,  50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41 ","675","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1319-2016","Class II","Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48","870","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1302-2016","Class II","Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride,  50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41 ","10","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1285-2016","Class II","Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41","5","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1306-2016","Class II","Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02","50","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1276-2016","Class II","Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC 45183-0187-41","485","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1344-2016","Class II","Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride  250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02","595","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1282-2016","Class II","Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03","72","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1258-2016","Class II","Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only,   Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01","150 bags","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1264-2016","Class II","Propofol1% 10mg/mL injection,  20 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0119-73","2580","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1262-2016","Class II","Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48","12","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1320-2016","Class II","Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48","20","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1271-2016","Class II","Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02","40","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1294-2016","Class II","Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0709-78","600","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1308-2016","Class II","Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only,  Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77 ","260","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1300-2016","Class II","Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48 ","45","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1275-2016","Class II","Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41 ","725","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1328-2016","Class II","Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0935-67","340","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1289-2016","Class II","Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41","1450","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1274-2016","Class II","Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72","225","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1317-2016","Class II","Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41","45","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1309-2016","Class II","Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02","10","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1334-2016","Class II","Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69","2300","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1261-2016","Class II","Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72","1575","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1322-2016","Class II","Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72","2175","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1269-2016","Class II","Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0148-48","95","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1314-2016","Class II","Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48","75","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1283-2016","Class II","Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41","20","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1327-2016","Class II","Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,  NDC 45183-0934-70","800","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1338-2016","Class II","Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69","2000","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1286-2016","Class II","Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67","20","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1296-2016","Class II","Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia  bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0740-04 ","1809","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1323-2016","Class II","Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0925-41 ","175","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1263-2016","Class II","Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41","200","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1340-2016","Class II","Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72","275","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1287-2016","Class II","Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0603-78","200","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1303-2016","Class II","Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02","70","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1333-2016","Class II","Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC  45183-0955-70","1925","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1295-2016","Class II","Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03 ","384","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73960,"Ongoing","Pharmakon Pharmaceuticals, Inc. ","14450 Getz Rd",,"Noblesville","IN","46060-3303","United States","Voluntary: Firm Initiated","Press Release","Nationwide        VA/DOD: CA, KY, MD, NC, OK, TX, VA","D-1339-2016","Class II","Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0971-72","1200","Lack of Assurance of Sterility","07/11/2016",," All Sterile Compounded Products within Expiry",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73961,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:   AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania,  Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-1872-2016","Class II","Brilliance 64 Computed Tomography X-ray Systems    Product Usage:  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","158 units","The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.","05/31/2016",," Model No. 728231; S/N: 4001 5169 9056 9074 9099 9134 9251 9515 9529 9538 9541  9548 9549 9554 9559 9561 9573 9574 9600 9618 9625 9631  9638 9646 9653 9656 9659 9667 9670 9678 9686 9689 9703  9711 9738 9740 9755 9763 9782 9805 9811 9822 9833 9837  9838 9859 9862 9890 9898 9901 9909 9910 9917 9920 9922  9923 9927 9930 9933 9983 9989 9993 10012 10014 10021 10024  10042 10047 10050 10051 10077 10092 10099 10106 10150 10179 10180  10193 10206 10208 10213 10216 10250 10299 10302 10379 10394 10422  10446 10470 10514 10610 10671 10698 10743 29002 29014 29015 29056  29107 29115 90124 90154 91003 95022 95024 95130 95157 95191 95197  95213 95222 95236 95239 95244 95258 95261 95343 95349 95351 95364  95374 95387 95399 95409 95410 95439 95475 95496 95504 95507 95512  95524 95538 95551 95563 95614 95616 95668 95688 95691 95707 95811  122856 122863 122866 122877 122902 122921 122922 122953 123070 123092 123096  123116 123117 300062 95341A  ",4/8/2016,"04/08/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73961,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:   AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania,  Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-1875-2016","Class II","Ingenuity Computed Tomography X-ray Systems    Product Usage:  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","215 units ","The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.","05/31/2016",," Model No. 728326; S/N: 300142 30003 30005 30006 30007 30008 30009 30010 30011 30012 30013  30014 30015 30017 30018 30019 30020 30021 30022 30025 30026 30027  30028 30029 30030 30031 30032 30033 30034 30035 30036 30037 30038  30039 30040 30041 30042 30043 30044 30045 30046 30049 32083 32107  52060 300003 300004 300005 300010 300011 300012 300013 300014 300015 300016  300017 300018 300019 300020 300021 300022 300024 300025 300027 300028 300029  300030 300031 300032 300033 300034 300035 300036 300037 300038 300039 300040  300041 300042 300043 300044 300045 300047 300049 300050 300051 300052 300053  300054 300055 300056 300057 300058 300059 300060 300061 300062 300063 300064  300065 300066 300068 300069 300070 300071 300072 300073 300074 300075 300077  300078 300079 300080 300081 300082 300083 300084 300086 300087 300088 300089  300090 300091 300092 300093 300094 300095 300096 300097 300098 300099 300100  300101 300102 300103 300104 300105 300106 300107 300108 300109 300110 300111  300112 300113 300114 300115 300116 300117 300118 300119 300120 300121 300122  300123 300124 300125 300126 300127 300128 300129 300130 300131 300132 300133  300135 300136 300137 300138 300139 300140 300141 300143 300144 300145 300146  300147 300148 300149 300150 300151 300156 300157 300158 300159 300160 300161  300162 300163 300164 300165 300166 300200 300201 300202 300203 300204 300205  300206 300207 300208 300209 300210 300211 300212 310058 310144 320003 320205 333057 336061 336084 336121 941091 30004-1",4/8/2016,"04/08/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73961,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:   AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania,  Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-1874-2016","Class II","Ingenuity Core 128 Computed Tomography X-ray Systems    Product Usage:  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","424 Units","The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.","05/31/2016",," Model No. 728323; S/N: 320123 320240 30016 30023 30151 32000 32001 32008 32010 32012 32013  32015 32016 32018 32021 32024 32026 32028 32032 32033 32034 32036  32037 32041 32042 32043 32044 32046 32047 32048 32049 32050 32051  32052 32053 32054 32055 32056 32057 32058 32059 32060 32061 32062  32063 32064 32065 32067 32068 32069 32070 32071 32072 32073 32074  32075 32076 32077 32078 32079 32080 32081 32082 32084 32085 32086  32087 32088 32089 32090 32091 32092 32093 32094 32095 32096 32097  32098 32099 32100 32101 32102 32103 32104 32105 32106 32108 32109  32110 32111 32112 32113 32114 32115 32116 32117 32118 32119 32120  32121 32122 32123 32124 32125 32126 32127 32128 32129 32130 32131  32132 32133 32134 32135 32136 32137 32138 32139 32140 32141 32142  32143 32144 32145 32146 32147 32148 32149 32150 32151 32152 32153  32154 32155 32156 32157 32158 32159 32160 32161 32162 32163 32164  32165 32166 32167 32168 52023 52028 52049 52062 122928 320001 320002  320003 320005 320006 320008 320010 320018 320024 320026 320029 320030 320031  320033 320037 320054 320058 320059 320069 320073 320074 320078 320079 320081  320082 320083 320084 320088 320090 320092 320096 320099 320100 320101 320103  320107 320111 320114 320115 320119 320122 320125 320126 320128 320129 320131  320132 320133 320134 320138 320144 320146 320147 320200 320201 320202 320203  320204 320206 320207 320208 320209 320210 320211 320212 320213 320214 320215  320216 320217 320218 320219 320220 320221 320222 320223 320224 320225 320226  320227 320228 320229 320230 320231 320232 320233 320234 320235 320236 320237  320238 320239 320241 320242 320243 320245 320246 320247 320248 320250 320251  320252 320254 320255 320256 320257 320258 320260 320261 320262 320263 320264  320265 320266 320267 320268 320269 333047 336011 336012 336013 336015 336016  336017 336018 336023 336025 336027 336028 336029 336034 336040 336044 336046  336051 336059 336060 336064 336066 336067 336068 336069 336070 336071 336072  336073 336075 336076 336077 336078 336079 336080 336081 336082 3",4/8/2016,"04/08/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73961,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:   AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania,  Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-1873-2016","Class II","Ingenuity Core Computed Tomography X-ray Systems,       Product Usage:  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.","300 Units","The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.","05/31/2016",," Model No. 728321; S/N: 310135 310257 52035 333068 31001 33084 52000 52007 52008 52010 52012  52013 52014 52015 52018 52019 52020 52021 52022 52024 52025 52026  52027 52029 52030 52031 52032 52033 52034 52036 52037 52038 52039  52040 52041 52042 52043 52044 52045 52046 52047 52048 52050 52052  52053 52054 52055 52056 52057 52058 52059 52061 52063 52064 52065  52066 52067 52068 52069 52070 52071 52072 52075 52076 52077 52078  52079 52080 52081 132164 132465 300141 310001 310002 310003 310009 310017  310022 310023 310026 310032 310039 310042 310052 310054 310055 310059 310064  310069 310070 310071 310081 310087 310088 310090 310096 310098 310107 310111  310113 310119 310121 310129 310133 310134 310141 310143 310149 310151 310157  310159 310160 310170 310203 310204 310205 310206 310207 310208 310209 310210  310211 310212 310213 310214 310215 310216 310217 310218 310219 310220 310221  310222 310223 310224 310225 310226 310227 310228 310229 310230 310231 310232  310233 310234 310235 310236 310237 310238 310239 310240 310241 310242 310243  310245 310246 310247 310248 310249 310250 310252 310253 310254 310255 310256  310258 310259 310260 310261 310262 310263 310264 310265 310266 310267 310269  310270 310271 310272 310273 310274 310275 310276 310277 310278 310279 310280  310281 310282 310283 310284 310285 310286 310287 310288 310289 310290 310291  310292 310293 310294 310295 310296 310297 310299 310300 310301 310304 310308  333002 333004 333005 333009 333010 333014 333015 333018 333019 333021 333030  333031 333037 333042 333043 333044 333045 333046 333048 333049 333050 333051  333052 333053 333054 333055 333056 333059 333060 333061 333062 333063 333064  333065 333066 333067 333069 333070 333071 333072 333073 333074 333075 333076  333077 333078 333079 333080 333081 333082 333083 333085 333086 333087 333088  333089 333090 333091 333092 333093 333094 333095 333096 333097 333098 333099  333100 333101 333102 333103 333104 333105 333106 333107 333108 333109 333110  333111 333112 333113 333114 333115 333116 333117 333118 333",4/8/2016,"04/08/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73962,"Terminated","Misty Fjord Seafood LLC","160 W Chewuch Rd",,"Winthrop","WA","98862-9722","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","unknown at this time","F-0350-2017","Class II","Misty Fjord Lox, vacuum packed in 4 oz serving size packs.",,"Misty Fjord Seafoods LLC is recalling Lemon Pepper smoked salmon, Maple smoked salmon and Lox salmon due to the potential to be contaminated with Listeria Monocytogenes.","11/08/2016","11/08/2016"," 5626, 5638, and 5647",4/21/2016,"04/21/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73962,"Terminated","Misty Fjord Seafood LLC","160 W Chewuch Rd",,"Winthrop","WA","98862-9722","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","unknown at this time","F-0348-2017","Class II","Misty Fjord Lemon Pepper Smoked Salmon, vacuum sealed 6 oz plastic packs.",,"Misty Fjord Seafoods LLC is recalling Lemon Pepper smoked salmon, Maple smoked salmon and Lox salmon due to the potential to be contaminated with Listeria Monocytogenes.","11/08/2016","11/08/2016"," 5626, 5638, and 5647",4/21/2016,"04/21/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73962,"Terminated","Misty Fjord Seafood LLC","160 W Chewuch Rd",,"Winthrop","WA","98862-9722","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","unknown at this time","F-0349-2017","Class II","Misty Fjord Maple Smoked Salmon, vacuum sealed 6 oz plastic packs.",,"Misty Fjord Seafoods LLC is recalling Lemon Pepper smoked salmon, Maple smoked salmon and Lox salmon due to the potential to be contaminated with Listeria Monocytogenes.","11/08/2016","11/08/2016"," 5626, 5638, and 5647",4/21/2016,"04/21/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73963,"Terminated","Biomat USA, Inc.","6340 Gateway Dr",,"Indianapolis","IN","46254-2732","United States","Voluntary: Firm Initiated","Letter","North Carolina","B-0399-16","Class III","Source Plasma","2 units","Misbranded Source Plasma was distributed. ","05/26/2016","05/26/2016"," 3270379405; 3270379308; ",4/22/2016,"04/22/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73964,"Completed","Benson's Old Home Kitchens Bakery Division","134 Elder St",,"Bogart","GA","30622-1500","United States","Voluntary: Firm Initiated","E-Mail","AL, DE, FL, LA, NC, OK, SC, TN, TX","F-0538-2017","Class II","Winn Dixie 32 oz. Sour Cream Creme Cake","59,324  units total","Undeclared allergen; Peanut Protein","11/25/2016",," 16100, 16106",4/24/2016,"04/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73964,"Completed","Benson's Old Home Kitchens Bakery Division","134 Elder St",,"Bogart","GA","30622-1500","United States","Voluntary: Firm Initiated","E-Mail","AL, DE, FL, LA, NC, OK, SC, TN, TX","F-0533-2017","Class II","Old Home Kitchens, 14 oz. Sliced Lemon Creme Cake, Winn-Dixie, 14 oz. Sliced Lemon Creme Cake, Winn-Dixie, 32 oz. Sliced Lemon Creme Cake, and Winn Dixie, 32 oz. Lemon Creme Cake","59,324  units total","Undeclared allergen; Peanut Protein","11/25/2016",," Old Home Kitchens - 16104, 16098; Winn Dixie 16104, 16098, 16100, 16107",4/24/2016,"04/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73964,"Completed","Benson's Old Home Kitchens Bakery Division","134 Elder St",,"Bogart","GA","30622-1500","United States","Voluntary: Firm Initiated","E-Mail","AL, DE, FL, LA, NC, OK, SC, TN, TX","F-0534-2017","Class II","Old Home Kitchens, 14 oz. Strawberry Swirl Cream Cake","59,324  units total","Undeclared allergen; Peanut Protein","11/25/2016",," 16098",4/24/2016,"04/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73964,"Completed","Benson's Old Home Kitchens Bakery Division","134 Elder St",,"Bogart","GA","30622-1500","United States","Voluntary: Firm Initiated","E-Mail","AL, DE, FL, LA, NC, OK, SC, TN, TX","F-0539-2017","Class II","No Label Dutch Apple Creme Cake, 28 oz.","59,324  units total","Undeclared allergen; Peanut Protein","11/25/2016",," 16110",4/24/2016,"04/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73964,"Completed","Benson's Old Home Kitchens Bakery Division","134 Elder St",,"Bogart","GA","30622-1500","United States","Voluntary: Firm Initiated","E-Mail","AL, DE, FL, LA, NC, OK, SC, TN, TX","F-0537-2017","Class II","Winn Dixie 32 oz. Sock It To Me Creme Cake","59,324  units total","Undeclared allergen; Peanut Protein","11/25/2016",," 16106, 16107",4/24/2016,"04/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73964,"Completed","Benson's Old Home Kitchens Bakery Division","134 Elder St",,"Bogart","GA","30622-1500","United States","Voluntary: Firm Initiated","E-Mail","AL, DE, FL, LA, NC, OK, SC, TN, TX","F-0535-2017","Class II","Winn Dixie 32 oz. Cream Cheese Creme Cake","59,324  units total","Undeclared allergen; Peanut Protein","11/25/2016",," 16106",4/24/2016,"04/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73964,"Completed","Benson's Old Home Kitchens Bakery Division","134 Elder St",,"Bogart","GA","30622-1500","United States","Voluntary: Firm Initiated","E-Mail","AL, DE, FL, LA, NC, OK, SC, TN, TX","F-0536-2017","Class II","Winn Dixie 14 oz. Sliced Vanilla Cream Cake, Winn Dixie 32 oz. Vanilla Creme Cake, Old Home Kitchens, 14 oz.  Sliced Vanilla Cream Cake","59,324 units total","Undeclared allergen; Peanut Protein","11/25/2016",," Winn Dixie - 16111, 16104, 16106; Old Home Kitchens - 16104",4/24/2016,"04/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73965,"Completed","Glenn Wayne Wholseale Bakery Inc.","1800 Artic Ave",,"Bohemia","NY","11716-2443","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York State","F-0373-2017","Class I","7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY, NET WT. 4 OZ., UPC 052548558765; Manhattan UPC: 052548570644 ","1888 units","The finished cookie product may contain undeclared peanuts.","10/28/2016",," Best By Dates: Friday 0422, Saturday 0423, Sunday 0424 ",4/26/2016,"04/26/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73965,"Completed","Glenn Wayne Wholseale Bakery Inc.","1800 Artic Ave",,"Bohemia","NY","11716-2443","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York State","F-0372-2017","Class I","7-ELEVEN FRESH TO GO OATMEAL RAISIN COOKIE, NET WT. 4 OZ., UPC 052548558758; Manhattan UPC: 052548570651 ","3278 units","The finished cookie product may contain undeclared peanuts.","10/28/2016",," Best By Dates: Friday 0422, Saturday 0423, Sunday 0424 ",4/26/2016,"04/26/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73965,"Completed","Glenn Wayne Wholseale Bakery Inc.","1800 Artic Ave",,"Bohemia","NY","11716-2443","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New York State","F-0371-2017","Class I","7-ELEVEN FRESH TO GO CHOCOLATE CHUNK COOKIE, NET WT. 4 OZ., UPC 052548558741; Manhattan UPC: 052548570668 -- ","4486 units","The finished cookie product may contain undeclared peanuts.","10/28/2016",," Best By Dates: Friday 0422, Saturday 0423, Sunday 0424 ",4/26/2016,"04/26/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73966,"Ongoing","Riba Foods Inc","3735 Arc St",,"Houston","TX","77063-5235","United States","Voluntary: Firm Initiated","Letter","US","F-0379-2017","Class II","Frontera Texas Original Taco Skillet Sauce with mild red chile + cumin 8 oz. pouch","3888 cases","Product may have undeclared soy from soy sauce.","11/02/2016",," BEST BY: 13 APR17 and 15 APR17",4/26/2016,"04/26/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73967,"Ongoing","Spice Chain","9 Elkins Rd",,"E Brunswick","NJ","08816-2006","United States","Voluntary: Firm Initiated","Letter","NJ and SC","F-1527-2016","Class II","Rose Red Organic Ginger Steam Filter Bag & Organic Ground Ginger Steam packaged in a poly-lined corrugated carton; 40 lb case  bulk pack 40 lbs","5,240 pounds"," A positive result was discovered for Salmonella in Rose Red Filterbag Ginger and Organic Ground Ginger.    ","06/15/2016",," GN-FB-146-SO-IN-X40, Lot #MV23741-01 and GN-GD-000-SO-IN-X40, Lot #MV23741-01          Distribution dates 321/2016-3/23/2016",4/7/2016,"04/07/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73968,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY, IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.","Z-1706-2016","Class II","GE Healthcare, Discovery IGS 730.  Indicated for use in generating fluoroscopic and rotational images of human anatomy.","54","Potential non-recoverable loss of image acquisition.   The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure. ","05/23/2016",," Mfg Lot or Serial #	System ID  664365BU4	804828CATH4  669085BU3	573815D730  668484BU9	714FVDISC  672437BU1	775770CATHLAB3  0000HXF3001331	801714DIS730  00000632172BU3	203694IGS730  00000633128BU4	309624FT6  00000633831BU3	619532DISCOVERY  00000630288BU9	303426IR  0000HXF3001333	949250DISC730  00000637023BU3	214345IGS730  0000HXE9001300	650723SC1  00000646169BU3	330375HOR  00000638611BU4	414649DIS1  00000646917BU5	720854IGS730  00000614688BU0	610954OR1  00000622054BU5	423778DISC  646007BU5	206VMDISCOVERY1  00000637724BU6	281BAYIGS730  Not Avaialble	GON4345699  Not Avaialble	GON4110095  Not Avaialble	DZ1104VA03  00000661681BU7	030078RX05  00000651337BU8	190059RX30  00000659126BU7	210060RX14  0000HXE9001292	613722D730  00000650197BU7	082416040061  00000653093BU5	082416040069  00000668482BU3	082416040074  Not Avaialble	082416060019  00000653092BU7	082416100080  00000651999BU5	082416120043  Not Avaialble	082416200019  00000618688BU6	M54866AG1  00000614687BU2	A4185526  0000013A2A0001	M40480222  00000623224BU3	M4160476  00000663234BU3	M94838145  00000646918BU3	S41600101  00000650095BU3	HC4348XR11  00000671395BU2	HC4348XR14  00000660146BU2	HU1205VA03  00000627794BU1	IE1147VA01  00000672728BU3	B5120737  00000642198BU6	YV2000  BAPFI0033-0011	XV649425BU6  00000653091BU9	XVE14287001  Not Avaialble	SA2454VA01  00000615500BU6	0847160010  0000014A2A0010	AE1477VA01  Not Avaialble	GON4316421  00000642197BU8	10692VAS01  00000638812BU8	00169VAS01  Not Avaialble	00584VAS06  ",4/15/2016,"04/15/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73968,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY, IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.","Z-1707-2016","Class II","GE Healthcare, Discovery IGS 740.  Indicated for use in generating fluoroscopic and rotational images of human anatomy.","25","Potential non-recoverable loss of image acquisition.   The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure. ","05/23/2016",," Mfg Lot or Serial #	System ID  Mfg Lot or Serial #	System ID  664365BU4	804828CATH4  669085BU3	573815D730  668484BU9	714FVDISC  672437BU1	775770CATHLAB3  0000HXF3001331	801714DIS730  00000632172BU3	203694IGS730  00000633128BU4	309624FT6  00000633831BU3	619532DISCOVERY  00000630288BU9	303426IR  0000HXF3001333	949250DISC730  00000637023BU3	214345IGS730  0000HXE9001300	650723SC1  00000646169BU3	330375HOR  00000638611BU4	414649DIS1  00000646917BU5	720854IGS730  00000614688BU0	610954OR1  00000622054BU5	423778DISC  646007BU5	206VMDISCOVERY1  00000637724BU6	281BAYIGS730  Not Avaialble	GON4345699  Not Avaialble	GON4110095  Not Avaialble	DZ1104VA03  00000661681BU7	030078RX05  00000651337BU8	190059RX30  00000659126BU7	210060RX14  0000HXE9001292	613722D730  00000650197BU7	082416040061  00000653093BU5	082416040069  00000668482BU3	082416040074  Not Avaialble	082416060019  00000653092BU7	082416100080  00000651999BU5	082416120043  Not Avaialble	082416200019  00000618688BU6	M54866AG1  00000614687BU2	A4185526  0000013A2A0001	M40480222  00000623224BU3	M4160476  00000663234BU3	M94838145  00000646918BU3	S41600101  00000650095BU3	HC4348XR11  00000671395BU2	HC4348XR14  00000660146BU2	HU1205VA03  00000627794BU1	IE1147VA01  00000672728BU3	B5120737  00000642198BU6	YV2000  BAPFI0033-0011	XV649425BU6  00000653091BU9	XVE14287001  Not Avaialble	SA2454VA01  00000615500BU6	0847160010  0000014A2A0010	AE1477VA01  Not Avaialble	GON4316421  00000642197BU8	10692VAS01  00000638812BU8	00169VAS01  Not Avaialble	00584VAS06  ",4/15/2016,"04/15/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73970,"Ongoing","Vitalicious Acquisition","165-35 145th Dr",,"Jamaica","NY","11434-5108","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-0370-2017","Class I","VitaTops Apple Crumb, NET WT. 2 oz. (55g), packed in a clear plastic film and sold frozen in cases of 12 units, 24 units, or variety packs.  The affected lots were sold in case of 24 units per case.","145 cases (24 units per case)","The affected lots of VitaTops Apple Crumb contain undeclared milk.  ","10/28/2016",," Lots 16 075 C and 16 078 C (stamped on top of film)",4/21/2016,"04/21/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73971,"Terminated","OneBlood, Inc.","2315 Hypoluxo Rd",,"Lantana","FL","33462-3925","United States","Voluntary: Firm Initiated","FAX","Florida","B-0400-16","Class III","Apheresis Red Blood Cells, Leukocytes Reduced","1 unit","Apheresis Red Blood Cells, not meeting product specification, were distributed. ","05/26/2016","05/26/2016"," W036816237813; ",3/30/2016,"03/30/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73972,"Terminated","BPL Plasma, Inc.","701 2nd St SW",,"Albuquerque","NM","87102-4118","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0548-16","Class III","Source Plasma","1 unit","Blood product, collected from an ineligible donor, was distributed. ","05/26/2016","05/26/2016"," AB1548109; ",3/11/2016,"03/11/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73973,"Ongoing","Making It a Lifestyle","6202 Beechwood Dr",,"Corpus Christi","TX","78412-4744","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0220-2017","Class I","BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. ","1000 bottles","Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.","12/22/2016",," All lots",4/29/2016,"04/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73973,"Ongoing","Making It a Lifestyle","6202 Beechwood Dr",,"Corpus Christi","TX","78412-4744","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0221-2017","Class I","BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.","1000 bottles","Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.","12/22/2016",," All Lots",4/29/2016,"04/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73973,"Ongoing","Making It a Lifestyle","6202 Beechwood Dr",,"Corpus Christi","TX","78412-4744","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0222-2017","Class II","3rd DEGREE capsules, 60-count bottles,  Manufactured for: Making it A Lifestyle, L.L.C. ","1000 bottles","Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.","12/22/2016",," All lots",4/29/2016,"04/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73974,"Ongoing","GE Medical Systems, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to  AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM.","Z-1589-2016","Class II","GE, Revolution CT.  The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications","26 (US = 4;OUS = 22)","An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. ","04/29/2016",," Mfg Lot or Serial #	System ID  442706CN8	727398REVO  443227CN4	940898REVO  00000442994CN0	919684REVCT  443069cn0	404616CTR  00000442968CN4	83141966438  443342CN1	905521RCT1  00000444648CN0	82421100836  00000442479CN2	82421190324  00000443071CN6	82421300072  00000443308CN2	82421040370  00000444206CN7	82421160425  00000442792CN8	M5480791  00000443675CN4	410014CT04  00000443869CN3	A51773126  00000442785CN2	REV015  00000443501CN2	REV013  00000442940CN3	850210884  00000443590CN5	850210890  00000442289CN5	NO1031CT01  00000444156CN4	CT444156CN4  00000442748CN0	CT442748CN0  00000443952CN7	R002CT09  00000443540CN0	A201CT03  00000444038CN4	AE1015CT02  00000443409CN8	00145CTS01  00000443994CN9	00095CTS04  ",4/20/2016,"04/20/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73975,"Ongoing","Giant Eagle, Inc.","101 Kappa Dr",,"Pittsburgh","PA","15238-2809","United States","Voluntary: Firm Initiated","E-Mail","IN, OH, MD, PA, WV","F-1408-2016","Class I","Walnut Delights 6 Pack  Net Weight: 9 oz.  PLU #69690  UPC: 2 69690 20399 7  Giant Eagle, LLC, Pittsburgh, PA","288 units","Giant Eagle discovered that the scale label fails to declare the milk ingredient. The allergen statement does not declare the milk allergen.","05/31/2016",," All date codes",4/28/2016,"04/28/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73975,"Ongoing","Giant Eagle, Inc.","101 Kappa Dr",,"Pittsburgh","PA","15238-2809","United States","Voluntary: Firm Initiated","E-Mail","IN, OH, MD, PA, WV","F-1409-2016","Class I","Pecan Tassie - 6 Pack  PLU# 77997  Net Wt. 5 OZ.    Sell By (dates up to) May 03, 2016    Giant Eagle, Inc., Pittsburgh, PA    ","5165 units","Giant Eagle discovered that the scale label fails to declare the milk ingredient. The allergen statement does not declare the milk allergen.","05/31/2016",," All date codes",4/28/2016,"04/28/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73975,"Ongoing","Giant Eagle, Inc.","101 Kappa Dr",,"Pittsburgh","PA","15238-2809","United States","Voluntary: Firm Initiated","E-Mail","IN, OH, MD, PA, WV","F-1410-2016","Class I","Small Cookie Tray, PLU # 9793  Net Wt. 45 oz; . and  Medium Cookie Tray, PLU #9794  Net Wt 90 oz.;  and   Large Cookie Tray, PLU #9795  Net Wt. 144 OZ.    Sell by: (dates up to 5/4/2016)    Giant Eagle, Inc., Pittsburgh, PA","up to 38,879 units","Giant Eagle discovered that the ingredient statement for Pecan Tassies fails to declare the milk ingredient. The allergen statement does not declare the milk allergen.","05/31/2016",," All date codes",4/28/2016,"04/28/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73976,"Ongoing","Bakery Express of Southern California","1910 W. Malvern Ave",,"Fullerton","CA","92833","United States","Voluntary: Firm Initiated","E-Mail","U.S. distribution to the following; CA.  Products were distributed to two distribution centers for 7-Eleven and were further distributed to retail stores in Southern CA.    No foreign distribution.","F-1840-2016","Class I","7-ELEVEN  FRESH TO GO  CHOCOLATE CHUNK COOKIE  NET WT. 4.0 OZ  UPC: 052548558741","22,346","Undeclared peanuts","07/27/2016",," Best By:  0425  0424  0423  0422  0421  0420  0419  0418  0417  0416  0415  0414",4/23/2016,"04/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73976,"Ongoing","Bakery Express of Southern California","1910 W. Malvern Ave",,"Fullerton","CA","92833","United States","Voluntary: Firm Initiated","E-Mail","U.S. distribution to the following; CA.  Products were distributed to two distribution centers for 7-Eleven and were further distributed to retail stores in Southern CA.    No foreign distribution.","F-1841-2016","Class I","7-ELEVEN  FRESH TO GO  OATMEAL RAISIN COOKIE  NET WT. 4.0 OZ  UPC: 052548558758","11,017","Undeclared peanuts","07/27/2016",," Best By:  0425  0424  0423  0422  0421  0420  0419  0418  0417  0416  0415  0414",4/23/2016,"04/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73977,"Ongoing","Novarad Corporation","752 E 1180 S Ste 200",,"American Fork","UT","84003-3561","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.","Z-1613-2016","Class II","NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4.  Novarad Corporation ","2,386 ","The SUV values that are being calculated in the PET/CT fusion tool are incorrect.  ","05/06/2016",," Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4",11/16/2015,"11/16/2015",5/18/2016,"05/18/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73978,"Ongoing","Orthofix, Inc","3451 Plano Pkwy",,"Lewisville","TX","75056-9453","United States","Voluntary: Firm Initiated","Letter","KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA","Z-1881-2016","Class II","Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct.  Rx Only Provided non Sterile.","36 units","There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.","06/01/2016",," All lots",4/27/2016,"04/27/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73979,"Ongoing","Affymetrix Inc","26111 Miles Rd",,"Warrensville Heights","OH","44128-5933","United States","Voluntary: Firm Initiated","Letter","Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.","Z-1909-2016","Class III","CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software.  The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software:    MOD R LA, CytoScan¿ Dx Pre-PCR (-20¿C) MOD T E W, CytoScan¿ Dx Pre-PCR (2¿-8¿C) MOD F L H, CytoScan¿  Dx Post-PCR  (-20¿C)  MOD S AH W PB, CytoScan¿ Dx Post-PCR  (2¿-8¿C) MOD E PW, CytoScan¿  Dx Post-PCR (15¿- 30¿ C) CytoScan Dx WS A  CytoScan Dx WS B CytoScan¿ Dx Array kit, 6Pk  ChAS Dx Analysis Software and Browser    ","507 kits","During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.","06/02/2016",," 4044094 exp 6/10/17; 4044095 exp 6/10/17 ;4044148 exp 10/14/17 ;4044149 exp 10/14/17 ;4044150 exp 12/17/17; 4044151 exp 12/17/17 ; 4044160* exp 3/31/15 and 4244477* exp  12/31/15. *Expiry of initial commercial lots was 12 -18 months.",4/14/2016,"04/14/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73980,"Ongoing","World's Choice Products","9651 Airway Rd Ste E",,"San Diego","CA","92154-7914","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, TX, NV, NY, Puerto Rico    Foreign distribution to the following; Canada","F-1399-2016","Class I","Choice Products   Supreme Elixir  32oz.  ","3,911 bottles","Undeclared whey protein which contains milk and soy lecithin.","05/27/2016",," Lot #15094, 15258, 15310, 15483, 16053, 16091 ",4/27/2016,"04/27/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73980,"Ongoing","World's Choice Products","9651 Airway Rd Ste E",,"San Diego","CA","92154-7914","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, TX, NV, NY, Puerto Rico    Foreign distribution to the following; Canada","F-1400-2016","Class I","New Life  Nature's Blend   100% Multivitamin Juice  32oz.","610 bottles","Undeclared whey protein which contains milk and soy lecithin.","05/27/2016",," Lot #15104, 15326 ",4/27/2016,"04/27/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73980,"Ongoing","World's Choice Products","9651 Airway Rd Ste E",,"San Diego","CA","92154-7914","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, TX, NV, NY, Puerto Rico    Foreign distribution to the following; Canada","F-1401-2016","Class I","Choice Products.  Xtreme Fiber Detox  Net. Wt. 1lb  Net Wt. 8oz.","2,512 container","Undeclared whey protein which contains milk and soy lecithin.","05/27/2016",," Lot #15174, 15372, 15423, 15538, 16051 ",4/27/2016,"04/27/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1679-2016","Class II","Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length	00114205020  Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length	00114205036  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 24 mm Length	00114205124  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 28 mm Length	00114205128  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 30 mm Length	00114205130  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 38 mm Length	00114205138  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 48 mm Length	00114205148  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 65 mm Length	00114205165  MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 55 mm Length	00114605599  MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 60 mm Length	00114606099  MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, 32 mm Thread Length, 7.0 mm Diameter, 65 mm Length	00114606532  MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 65 mm Length	00114606599  Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 12 mm Length	00114205012  ","751","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOTS:  63290148  63295349  63290143  63295363  63290146  63296605  63295371  63295372  63308565  63308562  63303825  63259852  63295341  ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1683-2016","Class II","Hgp ii acetabular cup bone screw selftap 6.5x15mm	00662406515  Hgp ii acetabular cup bone screw selftap 6.5x20mm	00662406520  Hgp ii acetabular cup bone screw selftap 6.5x25mm	00662406525  Hgp ii acetabular cup bone screw selftap 6.5x35mm	00662406535  Hgp ii acetabular cup bone screw selftap 6.5x55mm	00662406550  Hgp ii acetabular cup bone screw selftap 6.5x60mm	00662406560  ","1199","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOTS:  63276979  63276976  63245682  63276975  63276977  63301523  63276980  63303436        ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1680-2016","Class II","Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length	47115504507  Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length	47115507507  Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length	47115509007  ","90","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOTS:  63303808  63292589  63292588  ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1684-2016","Class II","Trilogy self-tapping bone screw   Bone screw 4.5x25 selftap	00625004525  Bone screw 4.5x50 selftap	00625004550  Bone screw 6.5x15 selftap	00625006515  Bone screw 6.5x20 selftap	00625006520  Bone screw 6.5x25 selftap	00625006525  Bone screw 6.5x30 selftap	00625006530  ","3893","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOTS:  63284570  63284572  63284573  63187350  63225662  63272712  63296123  63301504  63204283  63209528  63259476  63257719  ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1675-2016","Class II","Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length	47493501801    ","200","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOT:  63297474  ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1676-2016","Class II","Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length  	47234702116  ","99","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOT:  63146423",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1678-2016","Class II","M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length	00225304542  M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length	00225307042  ","219","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOTS:  63295051  63293672  ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1681-2016","Class II","ITST   intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length	00225305745  ","50","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOT:  63275969  ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1677-2016","Class II","Zimmer Plates and Screws (ZPS)   4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 	47484001200  4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 	47484001400  4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 	47484001600  4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 	47484001800  4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 	47484002000  4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 	47484002200  4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 	47484002600  4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 	47484003001  4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 	47484003200  4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 	47484003600  4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 	47484004000  4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 	47484004500  4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 	47484005000  4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 	47484005500  4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 	47484006000  4.5 mm Cortical Screw SelfTapping, 16 mm Length 	47484501601  4.5 mm Cortical Screw SelfTapping, 18 mm Length 	47484501801  4.5 mm Cortical Screw Self-Tapping, 20 mm Length 	47484502001  4.5 mm Cortical Screw Self-Tapping, 22 mm Length 	47484502201  4.5 mm Cortical Screw SelfTapping, 24 mm Length 	47484502401  4.5 mm Cortical Screw SelfTapping, 26 mm Length 	47484502601  4.5 mm Cortical Screw SelfTapping, 28 mm Length 	47484502801  4.5 mm Cortical Screw SelfTapping, 34 mm Length 	47484503401  4.5 mm Cortical Screw SelfTapping, 38 mm Length 	47484503801  4.5 mm Cortical Screw SelfTapping, 40 mm Length 	47484504001  4.5 mm Cortical Screw SelfTapping, 42 mm Length 	47484504201  4.5 mm Cortical Screw SelfTapping, 54 mm Length 	47484505401  4.5 mm Cortical Screw Self-Tapping, 58 mm Length 	47484505801  4.5 mm Cortical Screw SelfTapping, 64 mm Length 	47484506401  4.5 mm Cortical Screw SelfTapping, 66 mm Length 	47484506601  4.5 mm Cortical Screw SelfTapping, 68 mm Length 	47484506801  4.5 mm Corti","3955","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOTS:  63303573  63282072  63303577  63303574  63296633  63295456  63296634  63198636  63295464  63296636  63296638  63301486  63301487  63301489  63296639  63248519  63298802  63298803  63287869  63248522  63317364  63317363  63248525  63298795  63320881  63287871  63317168  63248527  63317167  63287874  63248531  63248532  63248535  63248537  63293690  63293693  63293694  63305250  63298784  63284871  63298783  63249226  63305251  63312141  ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1682-2016","Class II","VersaFx Femoral Fixation System   Hex head compression screw 4.7  mm dia.  2 inch (51 mm) length	47116202400  ","50","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOT:  63290189    ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1673-2016","Class II","Zimmer Plates and Screws (ZPS)   3.5 mm Cortical Screw SelfTapping, 10 mm Length 	47483501001  3.5 mm Cortical Screw SelfTapping, 14 mm Length 	47483501401  3.5 mm Cortical Screw SelfTapping, 16 mm Length 	47483501601  3.5 mm Cortical Screw SelfTapping, 24 mm Length 	47483502401  3.5 mm Cortical Screw SelfTapping, 30 mm Length 	47483503001  3.5 mm Cortical Screw SelfTapping, 40 mm Length 	47483504001  3.5 mm Cortical Screw SelfTapping, 75 mm Length 	47483507501  ","794","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOTS:  63252354  63283819  63308551  63252355  63312340  63252350  63283820  63243831  ",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73981,"Ongoing","Zimmer Manufacturing B.V.","Turpeaux Industrial Park Rd 1 km 123.4",,"Mercedita","PR","00715","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.","Z-1674-2016","Class II","Zimmer Plates and Screws (ZPS)   2.7 mm Cortical Screw SelfTapping, 14 mm Length 	47482701401  ","100","A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. ","05/16/2016",," LOT:  63292596",5/4/2016,"05/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73982,"Ongoing","Bridgewell Resources LLC","12420 SE Carpenter Dr",,"Clackamas","OR","97015-9077","United States","Voluntary: Firm Initiated","Telephone","distributed in CA and WA","F-1411-2016","Class I",".","134/25 lbs. bags","Ivory Teff Flour, Bulk 25 lb. bags, is recalled due to a potential contamination with Salmonella.","05/31/2016",," 205782-1026S.  Expiration Date April 11, 2017  Plant Code: B9911",4/25/2016,"04/25/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73983,"Ongoing","Stryker Sustainability Solutions","1810 W Drake Dr",,"Tempe","AZ","85283-4327","United States","Voluntary: Firm Initiated","Letter","Distributed in the state of NY and the country of Canada.","Z-1708-2016","Class II","Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877.  Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.","18 devices","Mislabeled for size","05/23/2016",," Catalog Number: 401450  Lot Number: 2561683E  Expiration Date: 5/13/2017    Catalog Number: 401877  Lot Number: 2555866E  Expiration Date: 5/6/2017",4/28/2016,"04/28/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73984,"Ongoing","Volcano Corporation","2870 Kilgore Rd",,"Rancho Cordova","CA","95670-6133","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of:  Japan, South Africa, Germany, Sweden, Belgium, France, Italy, Spain, India, Russian Federation, Hungary, Turkey, Poland, Portugal, Costa Rica, Finland, Great Britain, Croatia, India, Chile, Thailand, Mauritius, Iraq, Denmark, Norway, Ireland, Netherlands, Bulgaria, Czech Republic, Luxembourg, UAE, Austria, Poland, Pakistan, Sri Lanka, Kazakhstan, Slovakia, Saudi Arabia, Unite  Arab Emirates, Egypt., Jordan, Kuwait, Lebanon, Bulgaria, Romania, Latvia, Lithuania, Bosnia and Herzegovina, Greece, Malta, Cyprus, Romania, Tunisia, Kenya, Algeria, Israel, Jordan, Hong Kong, Republic of Korea,  Malaysia, New Zealand, Venezuela, Brazil, Philippines, Australia, Taiwan, Peru, Singapore, Panama, Mexico, Argentina, Costa Rica, Dominican Republic, China, and Paraguay,","Z-1813-2016","Class II","Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits.    Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.","5875 (2685 in US; 3190 ROW)","Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected data from the hospital network and be forced to reboot","05/25/2016",," Systems with software version 3.2.x, 3.3,and 3.4 and v3.4 software kits.  Product Codes:  807300001-807300001-R, 804200001-E, 807300001-E,807400001, 804200001, 806300001,1807400001,804200015, 804200001-M, 807400001-R, 07300001-M, 807300015-J, 804200014-R,804200014, 807400010, 804200001-R, 806300001-R, 807300015-RF,804200001-E, 806300001-R, 806300026, 807300001-R, 806300007,807300015    Serial Numbers:  101951631001,05207007001,101950286001,05207131001,05627, 05206042001, 0520641200, 1101950547001, 101950181001, 05206363001, 101950277001, 101951298001, 05207035001,05339,101950590001, 05206734001,101950229001,05206884001,102120770001,101950240001,  101950843001,105206471001,101950244001,05206115001,05206046001  05660,05036,06804119001,05205021001,06802011001,101950285001  101950192001  06801062001  102500002001  05208721001  05208168001  101950619001  05320041001  101951238001  05206001001  05206188001  101951628001  05208457001  05028  101950239001  977299  GREG RAUCH  6942 E. HUNTING HOLLOW CT  101950614001  101951308001  05206726001  05208267001  101950671001  05208316001  05014  06802001001  06802003001  05208369001  05206949001  05208371001  06802004001  06802004001  101950678001  05206033001  06802202001  06802893001  101950045001  05303126001  06802035001  06801009001  101950178001  06801004001  06801019001  06801018001  06801063001  05304085001  05208185001  05304027001  06801731001  101950118001  101951303001  05206414001  05208001001  05031  05206441001  05656  05206054001  05206070001  06802200001  05206824001  05304084001  101950618001  05667  05208328001  101951633001  101950617001  05206062001  06801413001  101950204001  06801166001  102120066001  102120067001  102120003001  102120052001  06804578001  101950795001  102120939001  05343  05432  06801371001  06803918001  05530  05206682001  05206216001  05304091001  101951620001  05206063001  06801233001  101950084001  101950082001  05206479001  05682  101950235001  9775006804470001  05208621001  05304099001  102120618001  102120916001  06804520001  ",4/25/2016,"04/25/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73985,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2278-2016","Class II","Gastroscope    Product Usage:  Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.  ","10,074 units","Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.","07/22/2016",," Model #'s FG-16V, FG-24V, FG-29V, EE-1540, EE-1580K, EG-1540, EG-1580K, EG-1840, EG-2540, EG-2940, EG-3840T, EG-3831T, EG-3870TK, EG-1870K, EG-2470K, EG-2530, EG-2730K, EG-2731, EG-2770K, EG-290KP, EG-2930K, EG-2931, EG-2931K, EG-2970K, EG-3430Z, EG-3470K, EG-3470ZK, VSB-3430K, EG-1690K, EG-2490K, EG-2790I, EG-2790K, EG27-I10, EG-2990I, EG-2990K, EG29-I10, EG-3490K and EG-3890TK.",4/6/2016,"04/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73985,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2275-2016","Class II","Colonoscope    Product Usage:  Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.  ","12,412 units","Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.","07/22/2016",," EC-3430L, EC-3430LK, EC-3470LK, EC-380LKP, EC-3830LK, EC-3830LZ, EC-3831L, EC-3832L, EC-3832LK, EC-3870LK, EC-3870LZK, EC-3872LK, EC-3830TLK, EC-3832TL, EC-3870TLK, EC-3872TLK, EC-3440L, EC-3840L, EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-3890LI, EC-3890LK, EC-3890TLK, EC38-I10L and FC-38LV.",4/6/2016,"04/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73985,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2277-2016","Class II","Duodenoscope    Product Usage:  Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.  ","433 units","Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.","07/22/2016",," Model #'s FD-34V and ED-3490TK",4/6/2016,"04/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73985,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2280-2016","Class II","Signmoidoscope    Product Usage:  Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.    ",,"Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.","07/22/2016",," Model #'s FS-34V, ES-3831, ES-3870K and ES-3840",4/6/2016,"04/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73985,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2276-2016","Class II","Confocal GI Scope    Product Usage:  Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.      ","17 units","Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.","07/22/2016",," Model #'s EG-3870CIK and EC-3870CIK",4/6/2016,"04/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73985,"Ongoing","Pentax Medical Company","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2279-2016","Class II","Ultrasound Gastroscope    Product Usage:  Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.  ","819 units","Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.","07/22/2016",," Model #'s EG-3630U, FG-38UX, EG-3630UR, FG-34UX, FG-36UX, EG-3830UT, EG-3670URK and EG-3870UTK.",4/6/2016,"04/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73986,"Ongoing","B. Braun Medical, Inc.","901 Marcon Blvd",,"Allentown","PA","18109-9512","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AL, AR, AZ, BC, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN. TX, UT, VA, VT, WA, WI, WV and Puerto Rico","Z-1907-2016","Class II","Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve    Product Usage:    Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)  ","11,000 units available in commercial channels","BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units.  The tears have been identified in the blister package paper, where the unit label writing is located. ","06/02/2016",," Serial Numbers: 61342856, 61181826, 61200666, 61221679, 61250908, 61230098, 61259709, 61316886, 61325854, 61318424, 61321589, 61315864, 61187901, 61282829, 61247686, 61266076, 61277092  Product Catalog Number: 412023 and 412027 ",4/14/2016,"04/14/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73986,"Ongoing","B. Braun Medical, Inc.","901 Marcon Blvd",,"Allentown","PA","18109-9512","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AL, AR, AZ, BC, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN. TX, UT, VA, VT, WA, WI, WV and Puerto Rico","Z-1906-2016","Class II","Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve    Product Usage:  Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)  ","Approximately 11,000 units available in commercial channels","BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units.  The tears have been identified in the blister package paper, where the unit label writing is located. ","06/02/2016",," Serial Numbers: 61342856, 61181826, 61200666, 61221679, 61250908, 61230098, 61259709, 61316886, 61325854, 61318424, 61321589, 61315864, 61187901, 61282829, 61247686, 61266076, 61277092  Product Catalog Number: 412023 and 412027 ",4/14/2016,"04/14/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73987,"Terminated","Stanford Medical School Blood Center","3373 Hillview Ave",,"Palo Alto","CA","94304-1204","United States","Voluntary: Firm Initiated","FAX","Florida","B-0549-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from an ineligible donor, was distributed. ","05/26/2016","05/26/2016"," W070515316727; ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",73988,"Terminated","Virginia Blood Services","2825 Emerywood Pkwy",,"Richmond","VA","23294-3719","United States","Voluntary: Firm Initiated","FAX","Virginia","B-0550-16","Class II","Apheresis Platelets, Leukocytes Reduced","3 units","Plateletpheresis products, not meeting product specifications, were distributed. ","05/26/2016","05/26/2016"," W087616060031; W087616060031; W087616060031; ",3/15/2016,"03/15/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73989,"Ongoing","Biomerieux France Chemin De L'Or","Chemin De L'Orme",,"Marcy L'Etoile",,,"France","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AL, AZ, CA, FL, GA, IA, KS, KY, MA, MI, MN, NC, NE, NJ, NY, OH, SC, TX, VA and WV.","Z-2779-2016","Class III","VIDAS NT-pro-BNP    Product Usage:  VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.  ","229 kits","Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.","09/09/2016",," Reference number: 30449-01, Lot #1004474560.",4/15/2016,"04/15/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73990,"Completed","Harris Teeter","701 Crestdale Rd",,"Matthews","NC","28105-1700","United States","Voluntary: Firm Initiated","E-Mail","DE, DC, GA, MD, NC, SC & VA","F-1523-2016","Class II","12 Count Sugar Cookies, UPC 0007203695601, 12 Ct (Pack 25/12 Ct)","10571 Units","Undeclared allergen; Peanut Protein","06/14/2016",," UPC: 0007203695601 - Item # 955195",4/20/2016,"04/20/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73990,"Completed","Harris Teeter","701 Crestdale Rd",,"Matthews","NC","28105-1700","United States","Voluntary: Firm Initiated","E-Mail","DE, DC, GA, MD, NC, SC & VA","F-1520-2016","Class II","Gourmet Oatmeal Raisin Walnut Cookies, UPC 0007203695193, 4 Ct (Pack 24/4 Ct)","8487 Units","Undeclared allergen; Peanut Protein","06/14/2016",," UPC: 0007203695103 - Item # 932467",4/20/2016,"04/20/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73990,"Completed","Harris Teeter","701 Crestdale Rd",,"Matthews","NC","28105-1700","United States","Voluntary: Firm Initiated","E-Mail","DE, DC, GA, MD, NC, SC & VA","F-1519-2016","Class II","Gourmet White Chocolate Macadamia Cookies, UPC 0007203695132, 4 Ct (Pack 24/4 Ct)","8048 units","Undeclared allergen; Peanut Protein","06/14/2016",," UPC: 0007203695132 - Item # 932350",4/20/2016,"04/20/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73990,"Completed","Harris Teeter","701 Crestdale Rd",,"Matthews","NC","28105-1700","United States","Voluntary: Firm Initiated","E-Mail","DE, DC, GA, MD, NC, SC & VA","F-1522-2016","Class II","Gourmet Cranberry Crunch Cookies, UPC 0007203695600, 4 Ct (Pack 24/4 Ct)","8372 units","Undeclared allergen; Peanut Protein","06/14/2016",," UPC: 0007203695600 - Item # 932475",4/20/2016,"04/20/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73990,"Completed","Harris Teeter","701 Crestdale Rd",,"Matthews","NC","28105-1700","United States","Voluntary: Firm Initiated","E-Mail","DE, DC, GA, MD, NC, SC & VA","F-1521-2016","Class II","12 Inch Message Cookies, UPC 0007203695587, 1 Pk (Pack 24/1 Ct)","8797 Units","Undeclared allergen; Peanut Protein","06/14/2016",," UPC: 0007203695587 - Item # 927319",4/20/2016,"04/20/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",73992,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1033-2016","Class II","Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01",,"Presence of Particulate Matter: Cardboard","06/15/2016",," Lot #:565003A, Exp.01 Aug 2017",5/6/2016,"05/06/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73994,"Ongoing","Republic Of Tea","5 Hamilton Lndg Ste 100",,"Novato","CA","94949-8263","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US distribution only.","F-2003-2016","Class II","Organic Turmeric Ginger Spice of Life Green Tea;  Organic Blend of Tumeric, Spices, Natural Honey Flavor and Fine China Green Tea  50 CT Tin: Net Wt. 2.65 oz.. (75G)  UPC: 7-42676-40355-5.    The Republic of Tea","5017 tins ","Republic of Tea was notified by their supplier of a positive result for Salmonella in organic ginger that they  received and distributed. ","08/26/2016",," Best Sipped by March 23, 2018 ",4/29/2016,"04/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73994,"Ongoing","Republic Of Tea","5 Hamilton Lndg Ste 100",,"Novato","CA","94949-8263","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US distribution only.","F-2004-2016","Class II","The Republic of Tea - Organic Turmeric Ginger: Green Tea  Ingredients: Organic Turmeric, Organic Green Tea, Organic Ginger, Organic Cinnamon and Natural Honey Flavor    Packed in 250 CT Bulk Bag (375 g) and  and  50 count refill bag. (75 g)    UPC - 250 bulk bag: 7-42676-30655-9   UPC 50 CT refill: 7-42676-42155-9 .    The Republic of Tea","250 ct  bulk bags and 50refill packs.","Republic of Tea was notified by their supplier of a positive result for Salmonella in organic ginger that they  received and distributed. ","08/26/2016",," Best Sipped by March 23, 2018  and April 13, 2018",4/29/2016,"04/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73995,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted","Z-2841-2016","Class II","IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.  ","525 units","24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit. ","09/16/2016",," SMN Number:10381403  Lot: 411  Expired: 2016-04",4/15/2016,"04/15/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73996,"Ongoing","Patel Shippers Inc","18390 Sw 232nd St",,"Miami","FL","33170-5304","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, NY, & VA.","F-1413-2016","Class I","Fresh Long Chili Peppers, Raw,  10 lb box.  Imported from Dominican Republic.","47 boxes, 10 lbs each.","Product tested positive for Salmonella.","06/01/2016",," No lot codes used by recalling firm or grower",4/28/2016,"04/28/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73997,"Ongoing","Bakery Express of Central Florida, Inc.","1630 Prime Ct Ste 200",".","Orlando","FL","32809-7404","United States","Voluntary: Firm Initiated","E-Mail","Distributed throughout Florida only.","F-1429-2016","Class II","7-Eleven Fresh To Go Peanut Butter Cookie  Net Wt 4.0 oz  (114g).  Manufactured by Bakery Express in Orlando, FL.","3,355 packages","Undeclared peanut allergen","06/06/2016",," Lot Codes:  041916 through 042116;  UPC Code:  052548585570, expiration 4/24/2016. ",4/22/2016,"04/22/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",73997,"Ongoing","Bakery Express of Central Florida, Inc.","1630 Prime Ct Ste 200",".","Orlando","FL","32809-7404","United States","Voluntary: Firm Initiated","E-Mail","Distributed throughout Florida only.","F-1430-2016","Class II","7-Eleven Fresh To Go Sugar Cookie made with M&M (R) Chocolate Candy  Net Wt  4.0 oz  (114g). Manufactured by Bakery Express in Orlando, FL.","5,156 packages","Undeclared peanut allergen","06/06/2016",," Lot Codes:  041916 through 042116;  UPC Code:  052548558765, expiration 4/24/2016. ",4/22/2016,"04/22/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73998,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",".","Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","US, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colunbia, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay","Z-1940-2016","Class II","CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks","156,712 units","Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.  ","06/09/2016",," Lot Numbers:   1785989H  1785990H  1786004H  1786005H  1786006H  1786007H  1791520H  1791521H  1791522H  1791523H  1791524H  1791525H  1791526H  1791527H  1791528H  1791529H  1791845H  1791846H  1793690H  1793706H  1793707H  1793709H  1793710H  1793711H  1793712H  1793713H  1793714H  1793715H  1793716H  1794101H  1794102H  1794103H  1794104H  1794105H  1794106H  1794107H  1794108H  1794153H  1794154H  1794155H  1794156H  1794157H  1794158H  1794159H  1794160H  1794161H  1794162H  1794163H  1794164H  1794165H  1794166H  1794167H  1794168H  1794544H  1794545H  1794546H  1794547H  1794548H  1794549H  1794550H  1794551H  1794552H  1794553H  1794554H  1794555H  1794556H  1794557H  1794558H  1794559H  1794560H  1794561H  1794562H  1794563H  1794564H  1794565H  1822927H  1822928H  1822929H  1794169H  1794175H  1794176H  1794566H  1794567H  1794568H  1794569H  1794570H  1794571H  1794572H  1796505H  1796506H  1799220H  1799221H  1799222H  1799223H  1799224H  1799225H  1799226H  1799227H  1799228H  1799229H  1799230H  1799231H  1799232H  1799233H  1799248H  1799249H  1799250H  1799251H  1799252H  1799253H  1799254H  1799255H  1799256H  1799257H  1799259H  1799260H  1799297H  1799333H  1799334H  1799335H  1799336H  1799337H  1799338H  1799339H  1799340H  1799341H  1799342H  1799344H  1799345H  1799346H  1799347H  1799348H  1799349H  1799350H  1799351H  1799352H  1799353H  1799354H  1799355H  1799505H  1799506H  1799548H  1799583H  1799584H  1799585H  1799586H  1799587H  1799588H  1799589H  1799590H  1799591H  1799592H  1799593H  1799594H  1799595H  1799596H  1799597H  1799598H  1799599H  1799600H  1799601H  1799602H  1799603H  1799604H  1799605H  1799606H  1799607H  1799608H  1799609H  1799610H  1799611H  1799612H  1799613H  1799614H  1799615H  1799616H  1799838H  1801714H  1801716H  1801717H  1801720H  1801721H  1801723H  1801725H  1801726H  1802250H  1802251H  1802252H  1802253H  1802254H  1802296H  1802297H  1802298H  1802299H  1802300H  1802301H  1802307H  1802309H  1802310H  1802311H  1802314H  1802316H  1802317H ",4/28/2016,"04/28/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",73999,"Ongoing","Berchtold Corp.","1950 Hanahan Rd",".","Charleston","SC","29406-4878","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1925-2016","Class II","Surgical Table Cushion (HybriGel Pads)  HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.","227 units","The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-ray.","06/07/2016",," 141364, 141365, 141367, 141369, 142575, 142577, 142579, 142769, 142771, 142773, 142774, 142775, 143420, 144088, 144384, 144447, 145384, 145529, 145545, 145936, 146141, 146963, 147304, 147305, 147306",4/19/2016,"04/19/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74000,"Ongoing","O'Steen Meat Specialties, Inc.","2126 N Broadway Ave",,"Oklahoma City","OK","73103-4310","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, GA, LA, OH, PA, TX, VA","F-1412-2016","Class II","Code 2013 Spicy Mac & Cheese Bites Breaded Macaroni & Monterey Jack Cheese O 'Steen Meat Specialties Inc. 2126 N. Broadway Oklahoma City, OK 73103 Phone (405) 236-1952 KEEP FROZEN Net Weight 10 LBS.  UPC: 7-49616-02013-1","847 cases","Potential plastic inclusion.","06/01/2016",," Lot Number: APR 8 2016, APR 12 2016, APR 15 2016, APR 18 2016, APR 19 2016, APR 26 2016;  Item Code: 2013",4/29/2016,"04/29/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74001,"Ongoing","Kracker Enterprises, LLC","1100 Klein Rd","Suite 200","Plano","TX","75074-3782","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IA, IL, MD, MO, NY, RI, TX, WA, WI","F-0044-2017","Class III","Doctor Kracker Klassic 3 Seed Crispbreads Net Wt 7 oz (200g) in cardboard container.","9951 cases","Milk declared in the ingredient statement although the product does not contain milk.","10/07/2016",,"  Lot Number: 170189116054, 170111116060, 170114416067, 170114416074, 170117616074, 170120716082",4/29/2016,"04/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74001,"Ongoing","Kracker Enterprises, LLC","1100 Klein Rd","Suite 200","Plano","TX","75074-3782","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IA, IL, MD, MO, NY, RI, TX, WA, WI","F-0043-2017","Class II","Doctor Kracker Pumpkin Seed Cheddar Crispbreads Net Wt. 7 oz. (200g) in cardboard container.","7125 cases","Undeclared milk in the ingredient statement although the product name contains Cheddar.","10/07/2016",," UPC: 95538 00002, Lot Number: 170216316070, 170219216077, 170223616091, 170229216105, 170232816117",4/29/2016,"04/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74002,"Ongoing","Greiner Bio-One North America, Inc.","4238 Capital Dr",".","Monroe","NC","28110-7681","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico","Z-1923-2016","Class II","4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297  VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate","250,800 pieces (209 cases)","The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.","06/07/2016",," Lot A151137L",4/26/2016,"04/26/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74003,"Ongoing","Jacobsen Salt Co.","602 SE Salmon St",,"Portland","OR","97214-3443","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Mississippi","F-1397-2016","Class II",".","2400 units total","Corn Seasoning Salt Blue Cheese and Herb is recalled because the label declared blue cheese but milk is not declared.","05/24/2016",," Lot code: 89226039, 89226062, 89226081, 89226085;   Best Before (Month/Year): 12/2019 or 1/2020",4/27/2016,"04/27/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74004,"Ongoing","Natus Medical Incorporated","5900 1st Ave S",,"Seattle","WA","98108-3248","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in the US including AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WA DC,and WI and in Canada and Singapore.","Z-1878-2016","Class II","Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44.  Filter Catalogue Part Number: 54343, 54344, and 100105-01.","21 filters","The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.","06/01/2016",," Filter Serial Numbers: Filter SN: 2522893, 2522897, 2522898, 2522899, 2522900, 2522903, 2522914, 2522915, 2522916, 2522917, 2522918, 2522919, 2522920, 2522921, 2522922, 2522923, 2522924, 2522925, 2522926, 2522930, and 2522931.",4/22/2016,"04/22/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74005,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","Voluntary: Firm Initiated","Letter","US Distribution to WI and NV.","Z-1607-2016","Class II","Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B  This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.","3 units","Potential degradation of detector performance.","05/04/2016",," Serial No. 3BA1572002, 3BA1562001, 2881492002",4/24/2016,"04/24/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74006,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","4139 Carmichael Rd",,"Montgomery","AL","36106-2803","United States","Voluntary: Firm Initiated","FAX","Alabama","B-0508-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Plateletpheresis product, not meeting firm specifications, were distributed. ","05/05/2016","05/05/2016"," W115116097160G; ",4/12/2016,"04/12/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74007,"Terminated","American Red Cross Blood Services Tennessee Valley Region","2201 Charlotte Ave",,"Nashville","TN","37203-1817","United States","Voluntary: Firm Initiated","Letter","California","B-0509-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from an ineligible donor, was distributed. ","05/05/2016","05/05/2016"," W201915192634; ",3/17/2016,"03/17/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74009,"Ongoing","Ortho-Clinical Diagnostics","1000 Lee Road",,"Rochester","NY","14606","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:   AL, AR, AZ, CA, CT, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, WA, WV & Puerto Rico;** Foreign: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.","Z-2804-2016","Class III","The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876,  is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the determination of percent glycated hemoglobin (HbA1c) in human whole blood.","520 Units","There is an incorrect value (data/calibration mathematics) on ADDs.  This incorrect value will prevent a successful calibration of the assay.","09/14/2016",," Lot 3155  Product Codes: 6842906 & 6801876",4/19/2016,"04/19/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2613-2016","Class II","Shuttle¿ Select Slip-Cath  Catheter, Intravascular, Diagnostic  The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques","60,302","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog prefixes/suffixes SCBR5.5-/-SHTL  SCBR6.5-/-SHTL    Catalog/product number; Global/order number  SCBR5.5-35-125-P-NS-H1-SHTL	                     G31129  SCBR5.5-35-125-P-NS-JB1-SHTL	                     G31130  SCBR5.5-35-125-P-NS-JB2-SHTL	                     G36361  SCBR5.5-35-125-P-NS-MPA-SHTL	                     G23697  SCBR5.5-35-125-P-NS-SIM1-SHTL	G23699  SCBR5.5-35-125-P-NS-SIM2-SHTL	G36360  SCBR5.5-35-125-P-NS-VERT-SHTL	G23698  SCBR5.5-35-125-P-NS-VTK-SHTL	                      G36359  SCBR5.5-35-135-P-NS-ANG-SHTL	                      G48154  SCBR5.5-35-150-P-NS-0-SHTL	                      G23705  SCBR5.5-35-150-P-NS-ANG-SHTL 	G23704  SCBR5.5-35-75-P-NS-ANG-SHTL	                      G48152  SCBR6.5-35-125-P-NS-H1-SHTL	                      G31134  SCBR6.5-35-125-P-NS-JB1-SHTL	                     G31135  SCBR6.5-35-125-P-NS-JB2-SHTL	                     G36364  SCBR6.5-35-125-P-NS-SIM1-SHTL	G23701  SCBR6.5-35-125-P-NS-SIM2-SHTL	G36363  SCBR6.5-35-125-P-NS-VERT-SHTL	G23700  SCBR6.5-35-125-P-NS-VTK-SHTL            	G36362  ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2620-2016","Class II"," Access Nonvascular Introducer Set  Accessories, Catheter  Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures","148,334","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog prefixes / suffixes NPAS-/-SST    Catalog/product number; Global/order number  NPAS-100-HC-NT-U-SST	G52963  NPAS-100-HC-U-SST   	G52962  NPAS-101-HC-NT-U-SST	G23067  NPAS-101-HC-U-SST   	G23066  NPAS-104-HC-NT-JWG-U-SST	G52966  NPAS-104-HC-NT-U-SST	G52965  NPAS-104-HC-U-SST   	G52964  NPAS-105-HC-NT-U-SST	G52967  NPAS-108-HC-NT-U-SST	G25516  NPAS-120-HC-NT-U-SST	G25517  NSSW-4.0-18-NPAS-100-HC-SST	G34253      ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2617-2016","Class II","Kumpe Access Catheter  Cathether, Ureteral, General & Plastic Surgery  Used in combination with a HiWire¿, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment","26,076","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog/product number; Global/order number  023565-BT 	G18074  ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2618-2016","Class II","Liver Access and Biopsy Needle Set  Biopsy needle kit  Intended for use in obtaining liver histology samples via a jugular vein approach.","52,756","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog prefixes LABS    Catalog/product number; Global/order number  LABS-100   	G08283  LABS-200	                      G08284  LABS-200-CHP-A	G10590    ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2612-2016","Class II","Beacon¿ Tip Centimeter Sizing Catheter  Beacon¿ Tip White Vessel Sizing Catheter  Beacon¿ Tip Vessel Sizing Catheter    Catheter, Intravascular, Diagnostic  The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.","332,255","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog prefixes NR5.0    Catalog/product number; Global/order number  Centimeter Sizing:  NR5.0-35-70-P-10S-VCF-CSC-20	G31220  NR5.0-35-70-P-10S-PIG-CSC-20	G31215  NR5.0-35-70-P-10S-0-CSC-20	G31213  NR5.0-35-100-P-10S-VCF-CSC-20	G31221  NR5.0-35-100-P-10S-PIG-CSC-20	G31216  NR5.0-35-100-P-10S-0-CSC-20	G31214  White Vessel Sizing:  NR5.0-35-70-P-10S-PIG-WSC	G31224  NR5.0-35-70-P-10S-CFP-WSC	G31227  NR5.0-35-70-P-10S-0-WSC	G31228  NR5.0-35-65-P-6S-VCF-WSC	G31229  NR5.0-35-100-P-10S-PIG-WSC	G31226  Vessel Sizing:  NR5.0-35-90-P-10S-VCF-CAVA	G31233  NR5.0-35-90-P-10S-PIG-CAVA	G31231  NR5.0-35-70-P-10S-VCF-CAVA	G31232  NR5.0-35-70-P-10S-PIG-CAVA	G31230  ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2611-2016","Class II","Beacon¿ Tip Royal Flush¿ Plus High-Flow Catheter  Catheter, Intravascular, Diagnostic  The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.","532,395","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog prefixes HNR5.0    Catalog/product number; Global/order number  HNR5.0-35-100-P-10S-0	G09697  HNR5.0-35-100-P-10S-CFP	G11264  HNR5.0-35-100-P-10S-PIG	G09059  HNR5.0-35-100-P-8S-VCF	G31403  HNR5.0-35-100-P-NS-0	G10313  HNR5.0-35-100-ST-10S-0	G09565  HNR5.0-35-100-ST-10S-PIG	G09525  HNR5.0-35-110-P-10S-0	G11241  HNR5.0-35-110-P-10S-PIG	G11265  HNR5.0-35-65-P-8S-VCF	G12129  HNR5.0-35-70-P-10S-0	G09411  HNR5.0-35-70-P-10S-CFP	G11262  HNR5.0-35-70-P-10S-PIG	G08832  HNR5.0-35-70-P-10S-PIG-RICKETTS-081983	G11280  HNR5.0-35-70-P-4S-PED	G11281  HNR5.0-35-70-P-NS-0	                     G11959  HNR5.0-35-70-ST-10S-0	G09564  HNR5.0-35-70-ST-10S-PIG	G09050  HNR5.0-35-80-P-8S-NEFF-CANADA-082098	G11860  HNR5.0-35-90-P-10S-0	G09412  HNR5.0-35-90-P-10S-CFP	G11266  HNR5.0-35-90-P-10S-PIG	G09408  HNR5.0-35-90-P-10S-PIG-RICKETTS-081983	G11282  HNR5.0-35-90-P-6S-PED	G11729  HNR5.0-35-90-P-8S-VCF	G12799  HNR5.0-35-90-ST-10S-0	G11641  HNR5.0-35-90-ST-10S-PIG	G09197  HNR5.0-38-100-P-10S-0	G11267  HNR5.0-38-100-P-10S-CFP	G11268  HNR5.0-38-100-P-10S-PIG	G09285  HNR5.0-38-100-P-NS-0	G27874  HNR5.0-38-110-P-10S-0	G09461  HNR5.0-38-110-P-10S-PIG	G11269  HNR5.0-38-70-P-10S-0	G11270  HNR5.0-38-70-P-10S-CFP	G11271  HNR5.0-38-70-P-10S-PIG	G11272  HNR5.0-38-70-P-NS-0	                     G11289  HNR5.0-38-80-P-10S-OPC	G27877  HNR5.0-38-90-P-10S-0	G11273  HNR5.0-38-90-P-10S-CFP	G11274  HNR5.0-38-90-P-10S-PIG	G11275  ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2619-2016","Class II","Neff DAgostino Percutaneous Access Set  Accessories, Catheter  Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures","5,020","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog/product number; Global/order number  NPAS-100-DAgostino-B-050393          G08403        ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2616-2016","Class II","Haskal Transjugular Intrahepatic Portal Access Set  Introducer, catheter  Intended for transjugular liver access in diagnostic and interventional procedures.","12,595","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog/product number; Global/order number  HTPS-100	G36126  ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2614-2016","Class II","Slip-Cath¿ Beacon¿ Tip Catheter  Catheter, Intravascular, Diagnostic  The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.","298,340","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5    Catalog/product number; Global/order number  SCBR5.0-38-100-P-NS-0	G12005  SCBR5.0-38-100-P-NS-C2	G12008  SCBR5.0-38-100-P-NS-DAV	G11996  SCBR5.0-38-100-P-NS-H1	G11991  SCBR5.0-38-100-P-NS-HN4	G23693  SCBR5.0-38-100-P-NS-JB1	G11997  SCBR5.0-38-100-P-NS-JB2	G11998  SCBR5.0-38-100-P-NS-KMP	G28535  SCBR5.0-38-100-P-NS-MAN	G11999  SCBR5.0-38-100-P-NS-MPA	G12002  SCBR5.0-38-100-P-NS-NTR	G23695  SCBR5.0-38-100-P-NS-RVC	G43120  SCBR5.0-38-100-P-NS-SIM1	G12000  SCBR5.0-38-100-P-NS-SIM2	G11992  SCBR5.0-38-100-P-NS-SIM3	G12001  SCBR5.0-38-100-P-NS-TEGT	G23694  SCBR5.0-38-100-P-NS-VERT	G12007  SCBR5.0-38-100-P-NS-VTK	G13163  SCBR5.0-38-125-P-NS-0	G32366  SCBR5.0-38-125-P-NS-DAV	G13413  SCBR5.0-38-125-P-NS-H1	G23696  SCBR5.0-38-125-P-NS-JB1	G13530  SCBR5.0-38-125-P-NS-SIM1	G32369  SCBR5.0-38-125-P-NS-SIM2	G13200  SCBR5.0-38-125-P-NS-TEGT	G32367  SCBR5.0-38-125-P-NS-VERT	G12168  SCBR5.0-38-125-P-NS-VTK	G12082  SCBR5.0-38-40-P-NS-KMP	G11993  SCBR5.0-38-65-P-NS-0	G12009  SCBR5.0-38-65-P-NS-C1	G12003  SCBR5.0-38-65-P-NS-C2	G11994  SCBR5.0-38-65-P-NS-C3	G12004  SCBR5.0-38-65-P-NS-DAV	G23688  SCBR5.0-38-65-P-NS-H1	G13319  SCBR5.0-38-65-P-NS-KMP	G12156  SCBR5.0-38-65-P-NS-LEV1	G12798  SCBR5.0-38-65-P-NS-MPA	G23689  SCBR5.0-38-65-P-NS-RC2	G13272  SCBR5.0-38-65-P-NS-RDC	G13092  SCBR5.0-38-65-P-NS-RIM	G11995  SCBR5.0-38-65-P-NS-SIM1	G12716  SCBR5.0-38-65-P-NS-SIM2	G23691  SCBR5.0-38-65-P-NS-TC	G36320  SCBR5.0-38-65-P-NS-TC-BNK	G36322  SCBR5.0-38-65-P-NS-TEGT	G12179  SCBR5.0-38-80-P-NS-C2	G12006  SCBR5.0-38-80-P-NS-MPA	G23692  SCBR5.0-38-80-P-NS-RH	G36214  SCBR5.0-38-80-P-NS-VS	G13431  SCBR5.0-38-80-P-NS-VS1	G13432  SCBR5.0-38-80-P-NS-VS2	G13433  SCBR5.0-38-80-P-NS-VS3	G13434  SCBR5.5-35-60-P-NS-PATEL	G51570  SCBR6.5-35-60-P-NS-PATEL	G51571  ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2610-2016","Class II","Beacon¿ Tip Torcon NB¿ Advantage Catheter  Catheter, Intravascular, Diagnostic","2,662,505","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog prefixes HNBR5.0 and HNBR6.0    Catalog/product number; Global/order number  HNBR5.0-35-100-P-NS-0	G09916  HNBR5.0-35-100-P-NS-C1	G08623  HNBR5.0-35-100-P-NS-C2	G08796  HNBR5.0-35-100-P-NS-CANADA-041480	G12570  HNBR5.0-35-100-P-NS-DAV	G08699  HNBR5.0-35-100-P-NS-FC3	G11204  HNBR5.0-35-100-P-NS-H1	G08421  HNBR5.0-35-100-P-NS-H3	G08918  HNBR5.0-35-100-P-NS-HN1	G09741  HNBR5.0-35-100-P-NS-HN4	G08917  HNBR5.0-35-100-P-NS-HNK1	G27811  HNBR5.0-35-100-P-NS-JB1	G08472  HNBR5.0-35-100-P-NS-JB2	G08809  HNBR5.0-35-100-P-NS-JB3	G08577  HNBR5.0-35-100-P-NS-MAN	G08511  HNBR5.0-35-100-P-NS-MIK	G11652  HNBR5.0-35-100-P-NS-MPA	G11468  HNBR5.0-35-100-P-NS-SIM1	G08471  HNBR5.0-35-100-P-NS-SIM2	G08422  HNBR5.0-35-100-P-NS-SIM3	G08597  HNBR5.0-35-100-P-NS-VERT	G11483  HNBR5.0-35-100-P-NS-WAIKATO	G13803  HNBR5.0-35-100-P-NS-WNBG	G08805  HNBR5.0-35-125-P-NS-C2	G12899  HNBR5.0-35-125-P-NS-C-PS	G31970  HNBR5.0-35-125-P-NS-DAV	G11375  HNBR5.0-35-125-P-NS-H1	G13258  HNBR5.0-35-125-P-NS-SIM2	G11658  HNBR5.0-35-125-P-NS-VANSCHIE1	G35733  HNBR5.0-35-125-P-NS-VANSCHIE2	G35734  HNBR5.0-35-125-P-NS-VANSCHIE3	G35735  HNBR5.0-35-125-P-NS-VANSCHIE4	G35736  HNBR5.0-35-125-P-NS-VANSCHIE5	G35737  HNBR5.0-35-125-P-NS-VS1	G35974  HNBR5.0-35-125-P-NS-WAIKATO	G27813  HNBR5.0-35-40-P-NS-KMP	G09751  HNBR5.0-35-40-P-NS-TEGT	G13804  HNBR5.0-35-40-P-NS-VANSCHIE1	G31410  HNBR5.0-35-40-P-NS-VANSCHIE2	G31409  HNBR5.0-35-40-P-NS-VANSCHIE3	G31408  HNBR5.0-35-60-P-NS-BELL-1.5	G27815  HNBR5.0-35-65-P-NS-C1	G08441  HNBR5.0-35-65-P-NS-C2	G08442  HNBR5.0-35-65-P-NS-C3	G08443  HNBR5.0-35-65-P-NS-DAV	G11414  HNBR5.0-35-65-P-NS-KMP	G11458  HNBR5.0-35-65-P-NS-LEV1	G11459  HNBR5.0-35-65-P-NS-LEV2	G11460  HNBR5.0-35-65-P-NS-RC1	G08469  HNBR5.0-35-65-P-NS-RC2	G08470  HNBR5.0-35-65-P-NS-RDC	G08596  HNBR5.0-35-65-P-NS-RIM	G08444  HNBR5.0-35-65-P-NS-RLG	G11380  HNBR5.0-35-65-P-NS-SHK0.8	G32368  HNBR5.0-35-65-P-NS-SIM1	G09853  HNBR5.0-35-65-P-NS-SIM2	G11478  HNBR5.0-35-65-P-NS-VANSCHIE1	G13795  HNBR5.0-35-65-P-NS-VANSCHIE2	G13794  HNBR5.0-35-65-P-NS-VANSCHIE",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2621-2016","Class II","Selective Salpingography Catheter with Beacon¿ Tip  Cannula, Manipulator/ Injector, Uterine  Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.","7,819","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog/product number; Global/order number  J-SSG-504000	G17868    ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2623-2016","Class II","White Lumax¿ Guiding Coaxial Catheter  Catheter, Percutaneous  Intended for the delivery of angioplasty balloons and other types of interventional devices.","3,425","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog/product number; Global/order number  LMGRF-7.0C-80-MPA-PULM	G11164              ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2615-2016","Class II","FluoroSet¿ Radiographic Tubal Assessment Set  Cannula, Manipulator/ Injector, Uterine  Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for evaluation of tubal patency.","1,881","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog/product number; Global/order number  J-RTAS-100	G51608  ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74010,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter",", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.","Z-2622-2016","Class II","Transluminal Biliary Biopsy Forceps Set  Forceps, Biopsy, Non-Electric  Intended for access to and biopsy of tissue within the biliary ductal system","2,606","Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.","08/22/2016",," All Lots.  Catalog/product number; Global/order number  BBFS-100   	G26088            ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74011,"Ongoing","A-S Medication Solutions LLC.","2401 Commerce Dr",,"Libertyville","IL","60048-4464","United States","Voluntary: Firm Initiated","Telephone","Virginia","D-0839-2016","Class III","Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0","2730 bottles","Labeling: Not elsewhere classified - count on the label was incorrect.","05/05/2016",," Lot # 6050129, Exp 05/31/17",4/22/2016,"04/22/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74013,"Ongoing","Ziehm Imaging Inc","6280 Hazeltine National Dr Ste 100",,"Orlando","FL","32822-5114","United States","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.","Z-2640-2016","Class II","Ziehm Vision RFD Mot,  Mobile C-arm for Mobile Fluoroscopic Imaging","14 devices ","Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.","08/25/2016",," Serial #'s 20379, 20398, 20399, 20403, 20413, 20415, 20534, 20601, 20602, 20618, 20619, 20620, 20621, and 20720.",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74013,"Ongoing","Ziehm Imaging Inc","6280 Hazeltine National Dr Ste 100",,"Orlando","FL","32822-5114","United States","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.","Z-2644-2016","Class II","Ziehm Vision2,   Mobile C-arm for Mobile Fluoroscopic Imaging  ","2 devices","Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.","08/25/2016",," Serial #'s: 91760 and 91770. ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74013,"Ongoing","Ziehm Imaging Inc","6280 Hazeltine National Dr Ste 100",,"Orlando","FL","32822-5114","United States","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.","Z-2642-2016","Class II","Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging","1 device ","Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.","08/25/2016",," Serial # 10841.",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74013,"Ongoing","Ziehm Imaging Inc","6280 Hazeltine National Dr Ste 100",,"Orlando","FL","32822-5114","United States","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.","Z-2641-2016","Class II","Ziehm Vision RFD,  Mobile C-arm for Mobile Fluoroscopic Imaging ","2 devices ","Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.","08/25/2016",," Serial #'s 20719 and 20721.",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74013,"Ongoing","Ziehm Imaging Inc","6280 Hazeltine National Dr Ste 100",,"Orlando","FL","32822-5114","United States","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.","Z-2639-2016","Class II","Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging","31 devices ","Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.","08/25/2016",," Serial #'s 20628, 20657, 20658, 20659, 20660, 20671, 20672, 20678, 20679, 20680, 20681, 20682, 20683, 20684, 20685, 20686, 20687, 20712, 10713, 20714, 20715, 20717, 20718, 20722, 20723, 20724, 20725, 20726, 20772, 20793, and 20794. ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74013,"Ongoing","Ziehm Imaging Inc","6280 Hazeltine National Dr Ste 100",,"Orlando","FL","32822-5114","United States","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.","Z-2643-2016","Class II","Ziehm Solo,  Mobile C-arm for Mobile Fluoroscopic Imaging","12 devices","Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.","08/25/2016",," Serial #'s: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977. ",4/15/2016,"04/15/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74014,"Ongoing","Dessert Innovations II Candy Divison","25 Enterprise Blvd SW ","Ste A2","Atlanta","GA","30336-2131","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA & NC","F-1514-2016","Class II","White Cupcakes with Pink Icing, UPC #10074865110140 ","8,928 cases","Undeclared allergen; Peanut Protein","06/14/2016",," Pink Icing - Code D16-097 & D16-102",4/26/2016,"04/26/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74014,"Ongoing","Dessert Innovations II Candy Divison","25 Enterprise Blvd SW ","Ste A2","Atlanta","GA","30336-2131","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA & NC","F-1517-2016","Class II","White Cupcakes with Yellow Icing, UPC #10074865110157 ",,"Undeclared allergen; Peanut Protein","06/14/2016",," Yellow Icing - Code D16-095 & D-16-096",4/26/2016,"04/26/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74014,"Ongoing","Dessert Innovations II Candy Divison","25 Enterprise Blvd SW ","Ste A2","Atlanta","GA","30336-2131","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA & NC","F-1516-2016","Class II","White Cupcakes with Blue Icing, UPC #10074865110164 ",,"Undeclared allergen; Peanut Protein","06/14/2016",," Blue Icing - Code D16-097",4/26/2016,"04/26/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74014,"Ongoing","Dessert Innovations II Candy Divison","25 Enterprise Blvd SW ","Ste A2","Atlanta","GA","30336-2131","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA & NC","F-1515-2016","Class II","White Cupcakes with White Icing, UPC #10074865110102 ",,"Undeclared allergen; Peanut Protein","06/14/2016",," White Icing - Code D16-095",4/26/2016,"04/26/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74015,"Ongoing","Ceg Enterprises Llc","8096 Excelsior Blvd",,"Hopkins","MN","55343-3415","United States","Voluntary: Firm Initiated","Telephone","Nationwide Distribution through Tuesday Morning retail stores.","Z-2047-2016","Class II","Germ Terminator, Toothbrush Steam Sterilization for Oral Health.  Model GT100.  The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads.  Water is poured into a reservoir in the device's housing.  The steam cycle is followed by a drying cycle.  ","100,548 units","CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following issues:  UL label believed to be not genuine; discoloration of power cords (could indicate some degradation); reports of excessive heat.  ","06/23/2016",," Model GT100",4/5/2016,"04/05/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74016,"Completed","Eban Bakery Gluten Free Breads and Baked Goods LLC","5760 Westbourne Ave",,"Columbus","OH","43213-1400","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio","F-1591-2016","Class II"," .  The cookies are packaged 6 per container. The container is a plastic tub with lid and tamper proof band.","12 containers/6 cookies each"," portion  on the product label. ","06/28/2016",,,4/27/2016,"04/27/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1357-2016","Class II","Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd, Imported by Murray Int'l Trading Co., Inc. New York, NY 10013, UPC 7 67533 86115 6, remaining labeling contains Chinese characters.","17 boxes","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1352-2016","Class II","PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters.","Unknown","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1345-2016","Class II","PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters.","84 bottles","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1349-2016","Class II","CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters.","48 bottles","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1350-2016","Class II","Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.","96 bottles","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1356-2016","Class II","PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm containers within a box, PING ON OINTMENT CO LTD, PING ON OINTMENT INTERNATIONAL LTD, 149 Queen's Road West, Hong Kong, UPC 8 33679 00001 5, remaining labeling contains Chinese characters.","216 packets","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1353-2016","Class II","GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.","Unknown","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1351-2016","Class II","LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains Chinese characters.","178 boxes","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1358-2016","Class II","FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains Chinese characters.","97 boxes","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1348-2016","Class II","SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic of China, remaining labeling contains Chinese characters.","144 bottles","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1346-2016","Class II","ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, UPC 0 49987 01144 9, remaining labeling contains Chinese characters.","204 bottles","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1354-2016","Class II","WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.","Unknown","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1355-2016","Class II","FARSER KAI YEUNG PILL, packaged in a bottle within a box,  Made in The Peoples Republic of China, remaining labeling contains Chinese characters.","Unknown","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74017,"Ongoing","Murray International Trading Co., Inc.","908 Dean St",,"Brooklyn","NY","11238-3204","United States","Voluntary: Firm Initiated","Telephone","Nationwide and Puerto Rico","D-1347-2016","Class II","FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.","unknown","Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.","07/11/2016",," All lots",4/20/2016,"04/20/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74018,"Ongoing","Epimed International, Inc.","141 Sal Landrio Dr","Crossroads Business Park","Johnstown","NY","12095-3835","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : AL, AK, FL, IN, TN & TX","Z-0086-2017","Class II","15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415   Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia","576 units","There is a possibility that the needles may have the potential to skive a catheters outer coating.  If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.","10/31/2016",," 1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181)  2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445)  3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)",4/22/2016,"04/22/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1810-2016","Class I"," Cut Green Beans, Brand Overhill Farms, Net Wt 30 lb, UPC 0931140     Cut Green Beans, Brand Pantry Essentials, Net Wt 12 oz, UPC 2113015221  Cut Green Beans, Brand Pantry Essentials, Net Wt 32 oz, UPC 2113015155    Cut Green Beans, Brand Parade, Net Wt 16 oz, UPC 5070028672  Cut Green Beans, Brand Parade, Net Wt 32 oz, UPC 5070055810    Cut Green Beans, Brand Safeway Kitchens, Net Wt 16 oz, UPC 2113009151  Cut Green Beans, Brand Safeway Kitchens, Net Wt 32 oz, UPC 2113009083  Whole Petite Green Beans, Brand Safeway Kitchens, Net Wt 12 oz, UPC 2113009005    Cut Green Beans, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009151  Cut Green Beans, Brand Signature Kitchens, Net Wt 32 oz, UPC 2113009083  French Cut Green Beans, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009082  Whole Green Beans, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113024256  Whole Green Beans, Brand Signature Kitchens, Net Wt 12 oz, UPC 2113009005    Cut Green Beans, Brand The Inn, Net Wt 20 lb, UPC 8628920109  Whole Green Beans, Brand The Inn, Net Wt 2 lb, UPC 8628920112    Organic Whole Green Beans, Brand Trader Joe's, Net Wt 16 oz, UPC 00169219    Organic Cut Green Beans, Brand True Goodness, Net Wt 10 oz, UPC 1373343095    Cut Green Beans, Brand USDA, Net Wt 30 lb, UPC 203050004407    Cut Green Beans, Brand VIP, Net Wt 32 oz, UPC 7007701208    Organic Cut Green Beans, Brand Wild Oats, Net Wt 12 oz, UPC 4873700713     ***********BULK ","Retails = 33,759,454 lbs and BULK = 15,498,593 lbs.; BULK 1/2 inch green beans = 67,200 lbs.","Green Beans are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," Cut Green Beans have the code format 203017001168  08:29  Pantry Essentials Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Pantry Essentials Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Parade Cut Green Beans have the code format Best By: 122215 201250001108 15:23) Product of USA A  Parade Cut Green Beans have the code format Best By: 122215 20155000110815:23) Product of USA A  Safeway Kitchens Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Safeway Kitchens Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Safeway Kitchens Whole Petite Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens French Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Whole Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Whole Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  The Inn Cut Green Beans have the code format 202050001115  08:30  Trader Joe's Organic Whole Green Beans have the code format Lot 115 16 BF 22:58 C Product of USA  True Goodness Organic Cut Green Beans have the code format Best By: 042318 16:30 D Product of USA                                              USDA Cut Green Beans have the code format 203050004407 08:27  VIP Cut Green Beans have the code format 3756 107 16 08:27 A  USA/CANADA  Wild Oats Organic Cut Green Beans	 have the code format Best  By: 040918 15:15 A Product of USA                                              ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1809-2016","Class I","Organic Edamame, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000120  Organic Shelled Edamame, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000119  Organic Edamame, Brand Organic by Nature, Net Wt 8 oz, UPC 4635800073  Edamame, Brand Live Smart, Net Wt 6 oz, UPC 604369  Edamame, Brand O Organic, Net Wt 16 oz, UPC 7989340179  Edamame, Brand Signature Kitchens, Net Wt 48 oz, UPC 2113009197  Shelled Edamame, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009092  ","437,752 lbs","Edamame are recalled because they have the potential to be contaminated with Listeria monocytogenes.    Live Smart Edamame have the code format Product of USA 2B6101 02:11 B  O Organic Edamame have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Edamame have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Shelled Edamame have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  ","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Live Smart Edamame	6oz	604369	Product of USA                                                                       2B6101 02:11 B  O Organic Edamame	16oz	7989340179	Best Before: Oct 23 17 S3904 15:08                                  B Product of USA  Signature Kitchens Edamame	48oz	2113009197	Best Before: Oct 23 17 S3904 15:08                                  B Product of USA  Signature Kitchens Shelled Edamame	16oz	2113009092	Best Before: Oct 23 17 S3904 15:08                                  B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1817-2016","Class I","Pepper Strips, Brand Signature Kitchens, Net Wt 14 oz, UPC 2113009100  ","449,411 lbs","Pepper Strips are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Signature Kitchens Pepper Strips have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1811-2016","Class I","Cut Italian Beans, Brand Northwest Growers Select, Net Wt 20 lb, UPC 4635800031  Green Italian Beans, Brand Chef Maxwell, Net Wt 30 lb, UPC 3530295001      ***********BULK containers************    Italian Cut Beans, Brand JAG Foods/LA Foods, Net Wt 30 lb.    Italian Cut Beans, brand The Inn, Net wt. 20 lb.  ","Retail= 187,380 lbs. and BULK = 184,200 lbs.","Italian Beans are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Chef Maxwell Green Italian Beans have the code format Best By: 071616  203008009920   17:36  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1804-2016","Class I","Organic California Broccoli Florets, Brand Bybee Foods, Net Wt 4 lb, UPC 4635800050  Organic Broccoli Florets, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000117  Broccoli Cuts, Brand Northwest Growers Select, Net Wt 20 lb, UPC 4635800046  Organic California Broccoli Florets, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800060  Organic Broccoli Florettes, Trader Joe's, Net Wt 16 oz, UPC 00542784  Organic Broccoli Florets, Brand True Goodness, Net Wt 10 oz, UPC 1373343097  Organic Broccoli Florets, Brand Wild Oats, Net Wt 10 oz, UPC 4873700377  ","4,664,738 lbs","Broccoli are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Trader Joe's Organic Broccoli Florettes have the code format Lot 115 16 BF 22:58 C Product of USA    True Goodness Organic Broccoli Florets have the code format Best By: 042318 16:30 D Product of USA                                                Wild Oats Organic Broccoli Florets have the code format Best By: 040918 15:15 A Product of USA                                              ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1807-2016","Class I","Organic Multi-Colored Cauliflower Florets, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800076  ","15,984 lbs","Organic Multi-Colored Cauliflower Florets are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1802-2016","Class I","Organic Raspberries, Columbia River Organics, Net Wt 10 oz, UPC 5711000130  ","The firm has not distributed","Organic Raspberries are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1799-2016","Class I","Organic Sweet Cherries, brand Columbia River Organics, Net Wt 10 oz, UPC 5711000127  ","64,215 lbs","Organic Sweet Cherries are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1818-2016","Class I","Organic Steamers Sweet Potatoes, Brand Bybee Foods, Net Wt 12 oz, UPC 4635800052  Organic Sweet Potatoes, Brand Columbia River Organics, Net Wt 10 oz, UPC 4635800023  Organic Diced Sweet Potatoes, Brand Wild Oats, Net Wt 10 oz, UPC 4873700709    *******BULK containers***************    Sweet Potatoes, Brand CH Belt, Net Wt 1650  ","471,483 lbs","Organic Sweet Pototoes are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Wild Oats Organic Diced Sweet Potatoes have the code format Best  By: 040918 15:15 C Product of USA                                              ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1801-2016","Class I","Organic Peaches, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000129  Sliced Peaches, Brand O Organic, Net Wt 10 oz, UPC 7989340650  ","66,630 lbs","Organic Peaches are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Sliced Peaches have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1819-2016","Class I","Chopped Spinach, Brand Bybee Foods Northwest Growers Select, Net Wt 56 oz, UPC 4635800035    Organic Spinach, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000121    Chopped Spinach, Brand Earth's Pride Organics, Net Wt 3.5 lb, UPC 0000027771    Organic Chopped Spinach, Brand Wellsley Farms, Net Wt 4 lb, UPC 8867001013    Organic Chopped Spinach, Brand True Goodness, Net Wt 10 oz, UPC 1373343101    Organic Chopped Spinach, Brand Wild Oats, Net Wt 10 oz, UPC 4873700380  ","2,214,066 lbs","Spinach are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Earth's Pride Organics Chopped Spinach have the code format Best By: 041218 103 16 23:01 B Product of USA 726623001122  Wellsley Farms Organic Chopped Spinach have the code format Best By: 041218 103 16 23:01 B Product of USA 746700001137  True Goodness Organic Chopped Spinach have the code format Best By: 042318 16:30 D Product of USA                                              Wild Oats Organic Chopped Spinach have the code format Best By: 040918 15:15 D Product of USA                                              ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1814-2016","Class I","Baby Lima Beans, Brand Parade, Net Wt 16 oz, UPC 5070030670    Baby Lima Beans, Safeway Kitchens, Net Wt 20 oz, UPC 2113009144    Lima Beans, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009946  Lima Beans, Brand Signature Kitchens, Net Wt 20 oz, UPC 2113009944    Baby Lima Beans, Brand VIP, Net Wt 16 oz, UPC 7007701016    Baby Lima Beans, Brand Quirch, Net Wt 14 oz, UPC 6507260150  Baby Lima Beans, Brand Quirch, Net Wt 32 oz, UPC 6507260149  ","603,197 lbs","Lima Beans are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Parade Baby Lima Beans have the code format Best By: 122215 311200001108 15:23) Product of USA A  Signature Kitchens Lima Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Lima Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  VIP Baby Lima Beans have the code format 3756 107 16 08:27 A USA/CANADA  Quirch Baby Lima Beans have the code format Sell By: 012515  15:15 Product of USA A                                               Quirch Baby Lima Beans have the code format Sell By: 012515  15:15 Product of USA B                                                ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1800-2016","Class I","Organic Cranberries, Brand Columbia River Organics, Net Wt 10 oz, UPC 4635800026.  ","57,818 lbs","Organic Cranberries are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1820-2016","Class I","Brussels Sprouts, Brand O Organic, Net Wt 10 oz, UPC 7989340283  ","6,960 lbs","Brussels Sprouts are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Brussels Sprouts have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1813-2016","Class I","Organic Diced Leeks, Brand Organic by Nature, Net Wt 40 lb, UPC R01810D    *******BULK Containers*****************    Organic Leeks, Brand Pacific Foods, Net Wt. 40 lb","296,000 lbs","Organic Diced Leeks are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1808-2016","Class I"," Supersweet Cob Corn, Brand Northwest Growers Select, Net Wt 48 count, UPC 528628    Organic Super Sweet White Corn, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800070  Organic Super Sweet Whole Kernel Corn, Brand Organic by Nature, Net Wt 50 lb, UPC R03881  Org White Corn, Brand Organic by Nature, Net Wt 4 lb, UPC 4635800070  Organic White Corn, Brand Organic by Nature, Net Wt 5 lb, UPC 4635800064  Whole Kernel Sweet Corn, Brand Organic by Nature Organic, Net Wt 4 lb, UPC 4635800058    Cut Corn, Brand Chef Maxwell, Net Wt 20 lb, UPC 051849  Cut Corn, Brand Chef Maxwell, Net Wt 30 lb, UPC 3530295002    Cut Corn, Brand Correct Choice, Net Wt 30 lb, UPC 30CBE    Cut Corn, Brand Endico, Net Wt 20 lb, UPC 601459277304    Cut Corn, Brand Farmer's Bounty, Net Wt 20 lb, UPC 02300  Corn, Brand Farmer's Bounty, Net Wt 30 lb, UPC 5711000171    Cut Corn, Brand Fiesta Mart, Net Wt 16 oz, UPC 5102280003    Cut Corn, Brand The Inn, Net Wt 20 lb, UPC 8628920723    Organic Super Sweet Yellow and White Corn, Brand Live Smart, Net Wt 16 oz, UPC 604338  Super Sweet Cut Corn, Brand Live Smart, Net Wt 40 oz, UPC 603379    Cut Corn, Brand Parade, Net Wt 16 oz, UPC 5070030666  Cut Corn, Brand Parade, Net Wt 32 oz, UPC 5070007676    Golden Cut Corn, Brand O Organic, Net Wt 16 oz, UPC 7989340175  Org SS Corn, Brand O Organics, Net Wt 16 oz, UPC 7989340175    Super Sweet Corn, Brand Panda Express, Net Wt 20 lb, UPC 07913    Cut Corn, Brand Pantry Essentials, Net Wt 64 oz, UPC 2113015225    Super Sweet Corn, Brand Safeway Kitchens, Net Wt 12 oz, UPC 2113009065    Sweet Corn, Brand Signature Kitchens, Net Wt 12 oz, UPC 2113009065  White Sweet Corn, Brand Signature Kitchens, Net Wt 12 oz, UPC 2113009035  White Sweet Corn, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113024254  Whole Kernel Corn, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009152  Whole Kernel Corn, Brand Signature Kitchens, Net Wt 32 oz, UPC 2113009021    Organic Super Sweet Cut Corn, Brand Trader Joe's, Net Wt 16 oz, UPC 00299633    Cut Corn, Brand USDA, Net Wt 30","32,186,790 lbs","Corn are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Chef Maxwell Cut Corn have the code format Best By: 071616  102000009920  17:29    Chef Maxwell Cut Corn have the code format Best By: 071616  10300000992017:33    Correct Choice CutCorn	 have the code format 103000407766   08:26    Endico Cut Corn have the code format 102000007709  08:29    Farmer's Bounty Cut Corn have the code format 102000407721   08:26    Farmer's Bounty Corn have the code format 103000407721 08:30    Fiesta Mart Cut Corn have the code format Best By: 122215 101200201178 15:23 Product of USA A    The Inn Cut Corn have the code format 102000401115  08:29    Live Smart Organic Bi-color Corn have the code format Product of USA         2B6101 02:11 B    Live Smart Super Sweet Cut Corn have the code format Product of USA        2B6101 02:11 B    Parade Cut Corn have the code format Best By: 122215 10120020110815:23 Product of USA A    Parade Cut Corn have the code format Best By: 122215 101500201108 15:23 Product of USA A    O Organic Golden Cut Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    O Organics Org SS Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Panda Express Super Sweet Corn have the code format Use By: 021415 BF 16:20                                         Pantry Essentials Cut Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Safeway Kitchens Super Sweet Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Sweet Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens White Sweet Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens White Sweet Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Whole Kernel Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signatu",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1798-2016","Class I","Organic Blueberries, Brand Columbia River Organics, Net Wt. 10 oz, UPC 5711000125  Wild Blueberries, Brand O Organic, Net Wt. 10 oz, UPC 7989340654  ","167,678 lbs","Blueberries are recalls because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Wild Blueberries have the code format: Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1805-2016","Class I","Organic Butternut Squash, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000141  Organic Butternut Squash, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800075  Organic Butternut Squash, Brand Organic by Nature, Net Wt 2 kg, UPC 4635800067  Butternut Squash, Brand O Organic, Net Wt 10 oz, UPC 7989340281  Organic Diced Butternut Squash, Brand Wild Oats, Net Wt 10 oz, UPC 4873700710  ","727,463 lbs","Butternut Squash are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Butternut Squash have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Wild Oats Organic Diced Butternut Squash have the code format Best  By: 040918 15:15 B Product of USA                                              ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1806-2016","Class I","Diced Carrots, Brand Northwest Growers Select, Net Wt 20 lb, UPC 20100  Organic Diced Carrots, Brand Northwest Growers Select, Net Wt 50 lb, UPC 4635800019  Shoestring Carrots, Brand Northwest Growers Select, Net Wt 20 lb, UPC 4635800027  Organic Diced Carrots, Brand Organic by Nature , Net Wt 50 lb, UPC 20191  Carrots, Brand Chef Maxwell, Net Wt 30 lb, UPC 635302-5004  Diced Carrots, Brand Farmer's Bounty, Net Wt 50 lb, UPC 4635800029  Slice Carrots, Brand Farmer's Bounty, Net Wt 30 lb, UPC 463580008  Diced Carrots, Brand The Inn, Net Wt 20 lb, UPC	8628920742  Crinkle Cut Carrots, Brand Parade, Net Wt 16 oz, UP 5070030668  Crinkle Cut Carrots, Brand Safeway Kitchens, Net Wt 24 oz, UPC 2113009109  Crinkle Cut Carrots, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009945  Crinkle Cut Carrots, Brand Signature Kitchens, Net Wt 24 oz, UPC 2113009945    *******BULK containers***************    Organic Carrots, Brand Hain, Net Wt 1250 lb    Carrots, Brand MRB Foods Sources, Net Wt 50 lb    Organic Carrots, Brand Pacific Foods, Net Wt 50 lb  Organic Carrots, Brand Pacific Foods, Net Wt 1600 lb    Organic Carrots, Brand Primal Pet Food Inc, Net Wt 50 lb  Organic Carrots, Brand Primal Pet Food Inc, Net Wt 1500 lb  ","1,251,822 lbs","Carrots are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Chef Maxwell Carrots have the code format Best By: 071616  254000009920  17:40    Farmer's Bounty Diced Carrots have the code format 255020004421  08:37    Farmer's Bounty Slice Carrots have the code format 4635800008  08:37    The Inn Diced Carrots have the code format 252020001115 08:32    Parade Crinkle Cut Carrots have the code format Best By: 122215 251235001108 15:23 Product of USA A    Safeway Kitchens Crinkle Cut Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Crinkle Cut Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Crinkle Cut Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1815-2016","Class I","Organic Chopped Onions, Brand Bybee Foods, Net Wt 45 lb, UPC R02303    Organic Diced Onions, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000116    Diced Onions, Brand Northwest Grower's Select, Net Wt 45 lb, UPC 19190  Pearl Onions, Brand Northwest Growers Select, Net Wt 20 lb, UPC 22100    Organic Diced Onions, Brand Organic by Nature, Net Wt 45 lb, UPC AK#200064  Organic Diced Onions, Brand Organic by Nature, Net Wt 45 lb, UPC 202819    Raw Chopped Onions, Brand Farmer's Bounty, Net Wt 45 lb, UPC 26290     Chopped Onions, Brand Parade, Net Wt 12 oz, UPC 5070055791    Chopped Onion, Brand Signature Kitchens, Net Wt 12 oz, UPC 2113009049    Onion Cut, Brand Veggie Maria, Net Wt 500 g, UPC 543567006321    *******BULK containers***************    Organic Onions Diced, Brand Amy's, Net Wt 45 lb    Organic Onions Diced, Brand CH Belt, Net Wt 45    Organic Onions Diced, Brand Don Lee Farms, Net Wt 45    Organic Onions Diced, Happy Family/Nuture INC, Net Wt 1250    Organic Onions Diced, Brand Pacific Foods, Net Wt 45 lb  Organic Onions Diced, Pacific Foods, Net Wt 1250    Onions Diced, Brand Single Source, Net Wt 45 lb          ","6,689,779 lbs","Onions are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Farmer's Bounty Raw Chopped Onions have the code format 284523007721  08:36  Parade Chopped Onions have the code format Best By: 122215 281123001108 15:23) Product of USA A  Signature Kitchens Chopped Onion have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Veggie Maria Onion Cut have the code format 2016/01 20:55 B 103700201142    ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1812-2016","Class I","Organic Chopped Kale, Brand Bybee Foods, Net Wt 56 oz, UPC 4635800054  Organic Chopped Kale, Brand Organic by Nature, Net Wt 40 lb, UPC R02208  Chopped Kale, Brand O Organic, Net Wt 10 oz, UPC 7989340282  Organic Chopped Kale, Brand Wild Oats, Net Wt 10 oz, UPC 4873700379    *******BULK containers*****************    Organic Kale, Brand Pacific Foods, Net Wt. 40 lbs","401,928 lbs","Chopped Kale are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Chopped Kale have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Wild Oats Organic Chopped Kale have the code format Best By: 040918 15:15 C  Product of USA                                              ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1803-2016","Class I","Organic Strawberries, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000131","183,569 lbs","Organic Strawberries are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74019,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada & Japan.","F-1816-2016","Class I","Green Peas, Brand Bybee's Best, Net Wt 20 lb, UPC 4635800011  Green Peas, Brand Byee Foods, Net Wt 50 lb, UPC 155000007785CR  Organic Sweet Baby Peas, Brand Bybee Foods, Net Wt 5 lb, UPC 5711000145    Organic Petite Peas, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000109    Green Peas, Brand Northwest Growers Select, Net Wt 20 lb, UPC 5711000152  Green Peas, Brand Northwest Growers Select, Net Wt 55 lb, UPC 45721084  Organic Peas, Brand Northwest Growers Select, Net Wt 30 lb, UPC 5711000155    Organic Baby Peas, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800069  Organic Green Peas, Brand Organic by Nature, Net Wt 50 lb, UPC R01790  Organic Sweet Baby Peas, Brand Organic by Nature, Net Wt 5 lb, UPC 4635800063  Organic Sweet Peas, Brand Organic by Nature, Net Wt 2.5 kg, UPC 4635800061    Peas, Brand Chef Maxwell, Net Wt 20 lb, UPC 051849  Green Peas, Brand Chef Maxwell, Net Wt 30 lb, UPC 3530295003    Green Peas, Brand Correct Choice, Net Wt 30 lb, UPC 30PBE    Peas, Brand Earth's Pride Organics, Net Wt 5 lb, UPC 0000027772    Peas, Brand Endico, Net Wt 20 lb, UPC 7720    Green Peas, Brand Farmers Bounty, Net Wt 30 lb, UPC 5711000161  Green Peas, Brand Farmer's Bounty, Net Wt 50 lb, UPC 4635800028    Green Peas, Fiesta Mart, Net Wt 16 oz, UPC 5102280005    Green Peas, Brand The Inn, Net Wt 20 lb, UPC 8628920742    Green Peas, Brand Live Smart, Net Wt 40 oz, UPC 603546    Green Peas, Brand Parade, Net Wt 16 oz, UPC 5070031666  Green Peas, Brand Parade, Net Wt 32 oz, UPC 5070007682  Petite Green Peas, Brand Parade, Net Wt 16 oz, UPC 5070055804    Green Peas, Brand O Organic, Net Wt 16 oz, UPC 7989340174    Green Peas, Brand Pantry Essentials, Net Wt 64 oz, UPC 2113015226    Green Peas, Brand Safeway Kitchens, Net Wt 32 oz, UPC 2113009029  Green Peas, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009028  Green Peas, Brand Signature Kitchens, Net Wt 32 oz, UPC 2113009029  Green Peas (NO SALT ADDED), Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009031  Petite Green Peas, Brand Signature Kitchens, N","36,178,713 lbs","Peas are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Chef Maxwell Peas have the code format Best By: 071616  152000009920   17:31  Chef Maxwell Green Peas have the code format Best By: 071616  153000009920   17:37  Correct Choice Green Peas have the code format 153000007766  08:29  Earth's Pride Organics Peas have the code format Best By: 041218 103 16 23:01 B Product of USA 556700001122  Endico Peas have the code format 152000007709  08:31  Farmers Bounty Green Peas have the code format 152000007721   08:32  Farmer's Bounty Green Peas have the code format 155000007721  08:38  Fiesta Mart Green Peas	have the code format Best By: 122215 151200001178 15:23) Product of USA A  The Inn Green Peas have the code format 15200000111508:31  Live Smart Green Peas have the code format Product of USA 2B6101 02:11 B  Parade Green Peas have the code format Best By: 122215 151200001108 15:23) Product of USA A  Parade Green Peas have the code format Best By: 122215 151500001108 15:23) Product of USA A  Parade Petite Green Peas have the code format Best By: 122215 151210001108 15:23) Product of USA A  O Organic Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Pantry Essentials Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Safeway Kitchens Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Green Peas (NO SALT ADDED) have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Petite Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Petite Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Sugar Snap Peas hav",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2270-2016","Class I","2nd EXPANSION 5/31/2016   Navitas Naturals, Superfood CACAO, Tart Cranberry, cacao Nut Bar, 1.4  oz., UPC 11961-02026    Distributed by Navitas Naturals, Novato, CA  94948.","388 bars","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016      PLot#  80316055    ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2264-2016","Class I","2nd EXPANSION 5/31/2016    Product shipped OUS only.  Chili Limon Sunflower Kernel.  5 kg / 11 lb. box.   Product of USA, Manufactured by SunOpta, Crookston, MN","2nd EXPANSION 5/31/2016 8,266,463 lbs. total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016    PLot#:   8L5M16  ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2258-2016","Class I","1.  Roasted & Salted Sunflower Kernel, 0.7 oz plastic bag, Distributed by Newport Ingredients, Los Angeles, CA  90036;  2.  Planters Sunflower Kernels, Net Wt 3 oz. (85g) plastic bag;   3.  Dakota's Best! Biggy'z Roasted & Salted Kernels, Net Wt 16 oz (454g) plastic bag;  4.  Roasted & Salted Sunflower Kernels, 5 lbs (2.25 kgs) box, Manufactured by SunOpta, Crookston, MN;  5.  Roasted & Salted Sunflower Kernels, 25 lbs (11.34 kgs) poly lined paper bag, Manufactured by SunOpta, Crookston, MN;  6. Roasted & Salted SL-80 Sunflower Kernels, 45 lbs vacuum packed bag in box, Manufactured by SunOpta, Crookston, MN;   7.  Roasted & Salted Sunflower Kernel, 50 lbs. bag, Product of USA, Manufactured by SunOpta, Crookston, MN;   8.  Sunflower RAS Kernel WIP Bulk  2000 LB. poly lined-poly woven tote, Manufactured by SunOpta, Crookston, MN       EXPANDED 5/18/2016     Sunrich Naturals Roasted & Salted Sunflower Kernels Net Wt. 1 oz (28.4 g) plastic bag, Distributed by:  Sunrich Consumer Brands, Hope, MN  56046.      2nd EXPANSIN 5/31/2016  1.  Kar's Roasted and Salted sunflower kernels, Net Wt. 2.0 oz. (57g), UPC 77034-00989.  Kar's Nuts, Madison Heights, MI  48071.     2.  Spitz Salted Sunflower Kernels, 100g, UPC 69579-21000","422,900 lbs. total   EXPANDED 5/18/2016  2,905,875 lbs. total   2nd EXPANSION 5/31/2016 8,266,463 lbs total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.    2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 0.7 oz:  PLot # / Child Lot # / Expiration:    8B6M08/37260395112/2/8/2017  8B6M08/37260395160/2/8/2017  8B6M09/37260405015/2/9/2017  8B6M09/37260405061/2/9/2017  8B6M09/37260405152/2/9/2017  8B6M09/37260405188/2/9/2017  8B6M09/37260405239/2/9/2017  8B6M09/37260405298/2/9/2017  8B6M10/37260415024/2/10/2017  8B6M10/37260415081/2/10/2017  8B6M10/37260415172/2/10/2017  8B6M10/37260415217/2/10/2017  8B6M10/37260415294/2/10/2017  8B6M10/37260415333/2/10/2017  8B6M11/37260415332/2/10/2017  8B6M11/37260425046/2/11/2017  8B6M11/37260425150/2/11/2017  8B6M11/37260425178/2/11/2017  8B6M11/37260465039/2/15/2017  8B6M15/37260465085/2/15/2017  8B6M16/37260475028/2/16/2017  8B6M16/37260475172/2/16/2017  8B6M16/37260475250/2/16/2017  8B6M17/37260485115/2/17/2017  8B6M17/37260485227/2/17/2017  8B6M17/37260485268/2/17/2017  8B6M18/37260495027/2/18/2017  8B6M18/37260495065/2/18/2017  8B6M18/37260495142/2/18/2017  8B6M18/37260495170/2/18/2017    3.0 oz PLot # / Child Lot # / Expiration:    7065B3/37260465003/3/6/2017  7065B3/37260465007/3/6/2017  7065B3/37260465017/3/6/2017  7065A3/37260465028/3/6/2017  7065A3/37260465036/3/6/2017  7065A3/37260465050/3/6/2017  7065A3/37260465065/3/6/2017  7065C3/37260465099/3/6/2017  7065C3/37260465121/3/6/2017  7065C3/37260465164/3/6/2017  7066B3/37260475010/3/7/2017  7066B3/37260475039/3/7/2017  7066B3/37260475064/3/7/2017  7066B3/37260475083/3/7/2017  7066A3/37260475127/3/7/2017  7066A3/37260475161/3/7/2017  7066A3/37260475171/3/7/2017  7066A3/37260475185/3/7/2017  7066C3/37260475212/3/7/2017  7066C3/37260475218/3/7/2017  7066C3/37260475269/3/7/2017  7066C3/37260485003/3/7/2017  7067B3/37260485004/3/8/2017  7067B3/37260485033/3/8/2017  7067B3/37260485047/3/8/2017  7067B3/37260485078/3/8/2017  7067A3/37260485156/3/8/2017  7067A3/37260485182/3/8/2017  7067C3/37260485211/3/8/2017    16 oz.  PLot # / Child Lot # / Expiration:  02-08-17B2/37260395064/2/8/2017  FEB-11-17C2/37260425053/2/11/2017  FEB-11-17C2/37260425063/2/11/2017  FEB-11-17C2/37260425067/2/11/2017  FEB-11-17C2/37260425073/2/11/2017",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016","6M13 / 37261045105 / 7/12/16  8D6M13 / 37261045124 / 7/12/16  8D6M13 / 37261045125 / 7/12/16  8D6M13 / 37261045132 / 7/12/16  8D6M13 / 37261045134 / 7/12/16  8D6M13 / 37261045154 / 7/12/16  8D6M13 / 37261045156 / 7/12/16  8D6M13 / 37261045158 / 7/12/16  8D6M13 / 37261045172 / 7/12/16  8D6M13 / 37261045173 / 7/12/16  8D6M13 / 37261045174 / 7/12/16  8D6M13 / 37261045182 / 7/12/16  8D6M13 / 37261045183 / 7/12/16  8D6M13 / 37261045206 / 7/12/16  8D6M13 / 37261045211 / 7/12/16  8D6M13 / 37261045212 / 7/12/16  8D6M13 / 37261045213 / 7/12/16  8D6M13 / 37261045214 / 7/12/16  8D6M13 / 37261045231 / 7/12/16  8D6M13 / 37261045232 / 7/12/16  8D6M13 / 37261045254 / 7/12/16  8D6M13 / 37261045255 / 7/12/16  8D6M13 / 37261045256 / 7/12/16  8D6M13 / 37261045285 / 7/12/16  8D6M13 / 37261045286 / 7/12/16  8D6M13 / 37261045297 / 7/12/16  8D6M13 / 37261045299 / 7/12/16  8D6M13 / 37261055018 / 7/13/16  8D6M13 / 37261055019 / 7/13/16  8D6M14 / 37261055025 / 7/13/16  8D6M14 / 37261055026 / 7/13/16  8D6M14 / 37261055037 / 7/13/16  8D6M14 / 37261055038 / 7/13/16  8D6M14 / 37261055052 / 7/13/16  8D6M14 / 37261055053 / 7/13/16  8D6M14 / 37261055062 / 7/13/16  8D6M14 / 37261055063 / 7/13/16  8D6M14 / 37261055080 / 7/13/16  8D6M14 / 37261055081 / 7/13/16  8D6M14 / 37261055082 / 7/13/16  8D6M14 / 37261055097 / 7/13/16  8D6M14 / 37261055101 / 7/13/16  8D6M14 / 37261055102 / 7/13/16  8D6M14 / 37261055103 / 7/13/16  8D6M14 / 37261055135 / 7/13/16  8D6M14 / 37261055136 / 7/13/16  8D6M14 / 37261055137 / 7/13/16  8D6M14 / 37261055156 / 7/13/16  8D6M14 / 37261055162 / 7/13/16  8D6M14 / 37261055166 / 7/13/16  8D6M14 / 37261055167 / 7/13/16  8D6M14 / 37261055178 / 7/13/16  8D6M14 / 37261055179 / 7/13/16  8D6M14 / 37261055184 / 7/13/16  8D6M14 / 37261055189 / 7/13/16  8D6M14 / 37261055190 / 7/13/16  8D6M14 / 37261055195 / 7/13/16  8D6M14 / 37261055196 / 7/13/16  8D6M14 / 37261055219 / 7/13/16  8D6M14 / 37261055222 / 7/13/16  8D6M14 / 37261055223 / 7/13/16  8D6M14 / 37261055224 / 7/13/16  8D6M14 / 37261065002 / 7/14/16  8D6M14 / 37261065003 / 7/14/16 ",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2261-2016","Class I","EXPANDED 5/18/2016   DAKOTA STYLE Salted Caramel sunflower kernel 2000 lbs. Poly Lined - Poly Woven Tote, Product of USA, Manufactured by SunOpta, Crookston, MN","EXPANDED 5/18/2016    2,905,875 lbs. total.   2nd EXPANSION 5/31/2016 8,266,463 lbs. total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," EXPANDED 5/18/2016     PLot# / Child Lot# / Expiration  8C6M31 / 37260915128 / 6/29/16    2nd EXPANSION 5/31/2016  PLot#:  8F5M03, 8H5M12.",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2260-2016","Class I","DAKOTA STYLE SAVORY BACON sunflower kernel 2000 lbs. Poly Lined - Poly Woven Tote, Product of USA, Manufactured by SunOpta, Crookston, MN","422,900 lbs. total  EXPANDED 5/18/2016  2,905,875 lbs. total  2nd EXPANSION 5/31/2016  8,266,463 lbs. total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," PLot# / Child Lot# / Expiration    8B6M09 / 37260405180 / 5/3/2016  8B6M09 / 37260405181 / 5/3/2016    EXPANDED  5/18/2016   PLot# / Child Lot# / Expiration:  8D6M01 / 37260925033 / 6/30/16    2nd EXPANSION 5/31/2016  PLot#:  8F5M09, 8H5M12, 8I5M21, 8J5M27, 8A6M13.   ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2259-2016","Class I","1.  Roasted Not Salted Sunflower Kernel, 5 lbs (2.25 kgs) box, Manufactured by SunOpta, Crookston, MN;    2.  Roasted Not Salted Sunflower Kernels, 25 lbs (11.34 kgs) poly lined paper bag, Manufactured by SunOpta, Crookston, MN;   3. Roasted Not Salted SL-80 Sunflower Kernels, 45 lbs vacuum packed bag in box, Manufactured by SunOpta, Crookston, MN;    4.  Roasted Not Salted Sunflower Kernel, 50 lbs. bag, Product of USA, Manufactured by SunOpta, Crookston, MN;         EXPANDED 5/18/2016   Roasted Not Salted Sunflower Kernel, 2000 lbs. Poly Lined - Poly Woven Tote, Product of USA, Manufactured by SunOpta, Crookston, MN;  ","422,900 lbs. total   EXPANDED 5/18/2016  2,905,875 lbs. total   2nd EXPANSION 5/31/2016 8,266,463 lbs total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016.","09/15/2016",," 5 lb   PLot # / Child Lot # / Expiration:  8B6M02 / 37260335027 / 2/2/2017      25 lb   PLot # / Child Lot # / Expiration:    8B6M02 / 37260335021 / 4/26/2016        45 lb   PLot # / Child Lot # / Expiration:    8B6M02378737 / 37260325127 / 2/1/2017  8B6M02378737 / 37260325128 / 2/1/2017  8B6M02378737 / 37260325140 / 2/1/2017  8B6M02378737 / 37260325141 / 2/1/2017  8b6m01378108 / 37260325001 / 2/1/2017  8B6M01378108 / 37260325002 / 2/1/2017  8B6M01378108 / 37260325003 / 2/1/2017  8B6M03375785 / 37260345100 / 2/3/2017  8B6M03 / 37260325151 / 2/1/2017  8B6M02376004 / 37260325102 / 2/1/2017  8B6M02376004 / 37260325103 / 2/1/2017  8B6M02376004 / 37260325122 / 2/1/2017  8B6M02376004 / 37260325123 / 2/1/2017  8B6M08376004 / 37260395012 / 2/8/2017  8B6M08376004 / 37260395013 / 2/8/2017  8B6M08376004 / 37260395013/  2/8/2017  8B6M08376004 / 37260395014 / 2/8/2017  8B6M08376004 / 37260395015 / 2/8/2017  8B6M02377709 / 37260325004 / 2/1/2017  8B6M02377709 / 37260325005 / 2/1/2017  8B6M02377709 / 37260325007 / 2/1/2017  8B6M02377709 / 37260325008 / 2/1/2017  8B6M02377709 / 37260325009 / 2/1/2017  8B6M02377709 / 37260325013 / 2/1/2017  8B6M02377709 / 37260325014 / 2/1/2017  8B6M02377709 / 37260325022 / 2/1/2017  8B6M02377709 / 37260325026 / 2/1/2017  8B6M02377709 / 37260325043 / 2/1/2017  8B6M02377709 / 37260325044 / 2/1/2017  8B6M02377709 / 37260325045 / 2/1/2017  8B6M02377709 / 37260325061 / 2/1/2017  8B6M02377709 / 37260325062 / 2/1/2017  8B6M02377709 / 37260325076 / 2/1/2017  8B6M02377709 / 37260325081 / 2/1/2017  8B6M02377709 / 37260325086 / 2/1/2017  8B6M02377709 / 37260465026 / 2/15/2017      50 lb   PLot # / Child Lot # / Expiration:    8b6m02 / 37260335023 / 4/26/2016  8B6M02 / 37260335024 / 4/26/2016  8B6M02 / 37260335034 / 4/26/2016  8B6M02 / 37260335035 / 4/26/2016  8B6M02 / 37260335036 / 4/26/2016  8B6M02 / 37260335037 / 4/26/2016  8B6M08 / 37260395018 / 5/2/2016  8B6M08 / 37260395019 / 5/2/2016  8B6M08 / 37260395020 / 5/2/2016  8B6M08379415 / 37260395008 / 5/2/2016  8B6M08379415 / 37260395009 / 5/2/2016  8B",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2265-2016","Class I","2nd EXPANSION 5/31/2016   Product shipped OUS only.   Light Salt Sunflower Kernel, 5 kg / 11 lb. box.   Product of USA, Manufactured by SunOpta, Crookston, MN","2nd EXPANSION 5/31/2016 8,266,463 lbs. total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016    PLot#:   8L5M10  ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2269-2016","Class I","2nd EXPANSION 5/31/2016   Sunrich Naturals Chili Lime flavored Sunflower Kernels, packaged under the following sizes:  1.  Net Wt. 1 oz. plastic bag, UPC 10304-01214;    2.  Net Wt. 1.2 oz. (34g), UPC 10304-03214 .     Product of USA.   Distributed by Sunrich Consumer Brands, Hope, MN  56046","2nd EXPANSION 5/31/2016 8,266,463 lbs. total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016    1 oz. package PLot#:  34215155, 34215156, 34215159, 34215160, 34215166, 34215167.      1.2 oz. package PLot#:  34215168.    ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2266-2016","Class I","2nd EXPANSION 5/31/2016  Roasted No Salt Ranch Sunflower Kernel, 45 lb. box.   Product of USA, Manufactured by SunOpta, Crookston, MN","2nd EXPANSION 5/31/2016 8,266,463 lbs. total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016    PLot#:   8H5M25  ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2268-2016","Class I","2nd EXPANSION 5/31/2016  Product shipped OUS only.  Spitz Dill Pickle Sunflower Kernel, 100g plastic bag, UPC 69579-21001.   Product of USA, ","2nd EXPANSION 5/31/2016 8,266,463 lbs. total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016    PLot#:   07-09-16C2, 09-10-16B, 09-11-16A, 11-10-16B, 11-10-16C, 01-07-17A.  ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2272-2016","Class I","2nd EXPANSION 5/31/2016   Navitas Naturals, Superfood HEMP, Creamy Peanut, hemp Nut Bar, 1.4 oz., UPC 11961-02030    Distributed by Navitas Naturals, Novato, CA  94948.","366 bars","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016      PLot#  80316054    ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2273-2016","Class I","2nd EXPANSION 5/31/2016   Navitas Naturals, Superfood MACA, Sweet Maple maca Nut Bar, 1.4 oz., UPC 11961-02024    Distributed by Navitas Naturals, Novato, CA  94948.","343 bars","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016      PLot#  80316053    ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2267-2016","Class I","2nd EXPANSION 5/31/2016  Roasted No Salt Sweet Onion & White Cheddar Sunflower Kernel, 45 lb. box.   Product of USA, Manufactured by SunOpta, Crookston, MN","2nd EXPANSION 5/31/2016 8,266,463 lbs. total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016    PLot#:   8H5M26  ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2271-2016","Class I","2nd EXPANSION 5/31/2016   Navitas Naturals, Superfood GOJI, Tangy berry, acai Nut Bar, 1.4 oz., UPC 11961-02028    Distributed by Navitas Naturals, Novato, CA  94948.","380 bars","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016      PLot#  80316055    ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2262-2016","Class I","2nd EXPANSION 5/31/2016   Blazin Hot sunflower kernel 1.2 oz. plastic bag.   Product of USA, Manufactured by SunOpta, Crookston, MN","2nd EXPANSION 5/31/2016   8,266,463 lbs total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.       2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016    PLot#:  34215159, 34215160, 34215161, 34215170, 34215173, 34215174, 34215175, 34215176, 34215177, 34215180, 34215181.    ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74020,"Ongoing","SunOpta Food and Grain, Inc.","1220 Sunflower St",,"Crookston","MN","56716-2480","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI.  EXPANDED 5/18/2016  Additional states:  CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR     2nd EXPANSION 5/31/2016  Additional States:  MD, MT, OK, VA.  OUS to include:  Canada, GUATEMALA,  Great Britain, and Mexico.","F-2263-2016","Class I","2nd EXPANSION 5/31/2016   DAKOTA STYLE Ranch sunflower kernel 50 lb. plain bag.   Product of USA, Manufactured by SunOpta, Crookston, MN","2nd EXPANSION 5/31/2016 8,266,463 lbs total","SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes.      EXPANDED 5/18/2016    SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination.      2nd EXPANSION 5/31/2016  SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016","09/15/2016",," 2nd EXPANSION 5/31/2016    PLot#:  8K5M18.    ",5/2/2016,"05/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74021,"Ongoing","Mighty Leaf Tea","100 Smith Ranch Rd Ste 120",,"San Rafael","CA","94903-1979","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, NY, PA, GA, WA, ME, UT, CA, IL, MN, OR, MT, TX, NV, FL, CO, OR, NJ, SC,AZ, VA, CT, NC, WA, WI.","F-1383-2016","Class II","Mighty Leaf Tea Company Organic Ginger Peach Iced Tea;  100/1 oz. per case  Item number 60001.  UPC: 00656252600019","394 cases","Firm was notified by their supplier of Organic Ginger Peach tea that it has the potential to be contaminated with Salmonella.","05/20/2016",," Lot: S379872-50:  Best By: DEC2017.  ",4/27/2016,"04/27/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74022,"Ongoing","Brookshire Brothers LTD-Central Bakery Plant","2111 Spence St",,"Lufkin","TX","75904-1321","United States","Voluntary: Firm Initiated","Letter","TX and LA","F-1486-2016","Class II","Fresh Harvest Ice NET WT 8 LB and Fresh Harvest Ice NET WT 16 LB packaged in clear plastic bags","308,400 pounds","Foreign object found in bag of ice.","06/10/2016",," Julian Dates 0826 thru 1206",4/30/2016,"04/30/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74023,"Ongoing","Giant Eagle, Inc.","101 Kappa Dr",,"Pittsburgh","PA","15238-2809","United States","Voluntary: Firm Initiated","E-Mail","PA, OH, IN","F-1836-2016","Class I","Sunflower Seeds, PLU# 65167;   various weights; various sell by dates;  Market District;   Distributed by Giant Eagle, Pittsburgh, PA 15238","total for bulk and repacked containers (cannot be separated) 2197.53 lbs.","Giant Eagle supplier SunOpta has informed Giant Eagle of the expansion of their sunflower kernel recall due to possible Listeria monocytogenes contamination. Giant Eagle repacked the sunflower kernels under the Market District label, which were sold in the bulk section of 12 of its Market District stores. Giant Eagle has expanded their recall to include all lots of sunflower seeds","07/27/2016",," Sell by dates to 12/1/16",5/3/2016,"05/03/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74024,"Ongoing","Dough Masters Co Inc","23412 Dequindre Rd",".","Warren","MI","48091-1822","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan & Ohio only","F-1435-2016","Class II","7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY, 2 pieces, NET WT. 4 OZ. The affected cookies are packed in a clear, plastic film, two cookies per package.","1372 pieces","DOUGH MASTERS WHOLESALE BAKERY of Warren, MI. is recalling select 7-ELEVEN FRESH TO GO brand cookies because they may contain undeclared allergen peanuts resulting from a supplier's recall.","06/09/2016",," Best By dates codes: Friday 0422, Saturday 0423, Sunday 0424, Monday 0425 on the front label; UPC 052548558765 Manhattan UPC: 052548558765.",4/22/2016,"04/22/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74025,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Distributed in the US states of CA, GA, MN, and OH, and in the Netherlands.","Z-1814-2016","Class II","PerFuse Decompression Instrument PN: 800-0541, Lot:100650.  Designed to access the femoral head for decompression.","22","The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes. ","05/25/2016",," PerFuse Decompression Instrument PN: 800-0541, Lot:100650",4/11/2016,"04/11/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74026,"Ongoing","Werner Gourmet Meat Snacks, Inc.","2807 3rd St",".","Tillamook","OR","97141-2500","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, CA, CO, CT, ID, KS, MA, MN, MT, NJ, NM, NV, NY, OK, OR, SC, TX, VA, WA.","F-1418-2016","Class II",".","24,318/6 oz. packages and 252/2 oz. packages","Werner Brand Sweet Hot Crunch Mix is recalled because label declared butter, but milk is not declared.","06/03/2016",," Best By Jan. 29, 2017 or before",5/2/2016,"05/02/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74026,"Ongoing","Werner Gourmet Meat Snacks, Inc.","2807 3rd St",".","Tillamook","OR","97141-2500","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, CA, CO, CT, ID, KS, MA, MN, MT, NJ, NM, NV, NY, OK, OR, SC, TX, VA, WA.","F-1417-2016","Class II",".","360/2.25 oz. packages and 31,068/6oz. packages","Werner Brand Butter Toffee Peanuts are recalled because the labels declared butter, but milk is not declared.","06/03/2016",," Best By Jan. 29, 2017 or before",5/2/2016,"05/02/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74027,"Terminated","New York Blood Center, Inc.","1200 Prospect Ave",,"Westbury","NY","11590-2723","United States","Voluntary: Firm Initiated","Telephone","NY","B-0573-16","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","06/14/2016","06/14/2016"," W047016113272",4/14/2016,"04/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74028,"Terminated","Tissue Banks International - National","880 Harbour Way South Suite 100",,"Richmond","CA","94804","United States","Voluntary: Firm Initiated","E-Mail","New York; California","B-0507-16","Class II","Tendon","2 tendon allografts","Human tendon allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. ","05/05/2016","05/05/2016"," SF1507039001; SF1507039002; ",4/15/2016,"04/15/2016",5/11/2016,"05/11/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74029,"Terminated","South Bend Medical Foundation, Inc.","530 N Lafayette Blvd",,"South Bend","IN","46601-1004","United States","Voluntary: Firm Initiated","Letter","IN","B-0574-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.","06/14/2016","06/14/2016"," W045216000153",4/11/2016,"04/11/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74030,"Ongoing","GSK Consumer Healthcare","184 Liberty Corner Rd Ste 200",,"Warren","NJ","07059-6868","United States","Voluntary: Firm Initiated","Letter","US Nationwide","Z-2148-2016","Class III","Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)","1,440 cases ( 34, 560  retail - units )","Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market.","07/11/2016",," Shipper case lot #8008580, Retal Carton Lot #4543U8008580",4/25/2016,"04/25/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74031,"Ongoing","RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)","375 River Park Cir",,"Marquette","MI","49855-1781","United States","Voluntary: Firm Initiated","E-Mail","US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.","Z-1829-2016","Class II","Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve.  Spinal fixation device instrument.","17 devices","Potential for a product defect where the cannula may be obstructed.  This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.","05/26/2016",," Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve; Lot Number: 170684; Part Number: 26-COUNTER-T-XLINK",4/22/2016,"04/22/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74032,"Ongoing","Blue Bell Creameries, L.P.","1101 S Blue Bell Rd",,"Brenham","TX","77833-4413","United States","Voluntary: Firm Initiated","Press Release","Texas and Louisiana","F-1407-2016","Class II","BLUE BELL ICE CREAM Rocky Road pint ","23,973 pints","Product may have been mispackaged and contain undeclared wheat and soy.","05/31/2016",," Lot 022918576",5/3/2016,"05/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74033,"Ongoing","Brown & Haley Inc.","110 E 26th St",".","Tacoma","WA","98421-1109","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide","F-1425-2016","Class I","Mountain Thins Trail Mix flavor, packaged in a stand-up film pouch (resealable), net wt. 5.3 oz. The UPC is 0 41770 33370 7   ","70,352 units","Mountain Thins Trail Mix flavor, net wt. 5.3 oz., is recalled because it has the potential to be contaminated with Listeria monocytogenes","06/06/2016",," Lots O07O610, O07O620, Best by 3/7/2017  Lots O08O610, O08O620, Best by 3/8/2017  Lots O09O610, O09O620, Best by 3/9/2017  Lots O10O610, O10O620, Best by 3/10/2017  Lots O11O610, Best by 3/11/2017  Lots O16O610, Best by 3/16/2017  Lots W11W610, W11W620, Best by 4/11/2017  Lots W14W610, Best by 4/14/2017  Lots W15W610, Best by 4/15/2017  ",5/4/2016,"05/04/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74034,"Ongoing","Teleflex Medical","2917 Weck Dr",".","Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.","Z-1938-2016","Class II","Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated.    A tracheal tube is inserted into a patients mouth or nose for airway management.","6,390 ea.","The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube. ","06/09/2016",," Lot 73F1500606",5/5/2016,"05/05/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74035,"Ongoing","NatureBox, Inc.","100 Redwood Shores Pkwy Fl 2",,"Redwood City","CA","94065-1155","United States","Voluntary: Firm Initiated","E-Mail","Nationwide through direct purchase on web site.","F-0087-2017","Class I","Dark Cocoa Nom Noms  4.5oz. (128g)  UPC: 8 54557 00533 5  Lot 16083    Product is shipped directly to customers per individual order or to corporate customers in 20 x 4.5 oz. bags cases.    Ingredients:  Rolled Oats, Almonds. For address freshness (Grape juice, rice dextrin), honey, sugar, canola oil, dark chocolate flavored chips (sugar, vegetable far {palm, palm kernel}, cocoa processed with alkali, dry buttermilk, soy lecithin (an emulsifier), natural flavors, Cocoa Powder, Egg Whites, Unsweetened Chocolate, unsweetened coconut, Brown Rice Syrup, natural flavor, pumpkin seeds, cocoa processed with alkali, salt.    Contains: Tree nuts (almonds, coconut, Milk, Soy and Egg).    Packed in a facility that also processes tree nuts, peanuts, milk, wheat, egg and soy.    Distributed by Nature Box, San Carlos, CA  ","12,775  bags ","Firm was notified by third party warehouse that some Peanut Butter Nom Nom product was packaged in Dark Cocoa Nom Nom packaging and therefore did not declare peanuts in the ingredient or allergen information.","10/12/2016",," Lot 16083;  Best By 09/23/16",5/4/2016,"05/04/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74036,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and Internationally to Albania Austria  Belgium Bulgaria Burkina Faso Canada Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Polynesia Georgia Germany Great Britain Greece Guadeloupe Hungary  Iceland Italy Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Martinique Netherlands Norway Poland Portugal Romania Russian Federation Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey United Arab Emirates and Uzbekistan.","Z-2041-2016","Class II","Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin  For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems  Cat No. 02789602/SMN 1031 7708 (100 test)  Cat No. 02790309/SMN 10317709 (500 test)","SMN 10317708 = 16434 kits and SMN 10317709 = 16033 kits","Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin","06/20/2016",," All in date lots",5/2/2016,"05/02/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74037,"Completed","Wicker's Food Products Inc","501 Main St",,"Hornersville","MO","63855","United States","Voluntary: Firm Initiated","Telephone","Arkansas and Tennessee","F-1589-2016","Class II","Wicker's Black Label Steak Marinade, 16 Fl. Oz. (473.28 mL), Ingredients: Soy Sauce (Water, Salt, Hydrolyzed Soy Protein, Corn Syrup, Caramel Coloring), Vinegar, Herbs and Spices","68/12 bottles/cases","Steak marinade product contains undeclared wheat.","06/23/2016",," Best by: 10/26/20  Lot Number: 110265",4/21/2016,"04/21/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1827-2016","Class II","Various trauma and sports medicine instruments and implants.  Orthopedic manual surgical instrument.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  900728  900737  900738  900740  909836  110008343  110009769  231201303    Lot #'s  669220  625160  625180  679060  529190  585920  742460  751280  751290  751330  751400  751410  751420  751430  630570    ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1826-2016","Class II","Various trauma and sports medicine instruments and implants.  Spinal interlaminal fixation orthosis.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  904756    Lot #'s  625590    ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1825-2016","Class II","Various trauma and sports medicine instruments and implants.  Appliance, fixation, nail/blade/plate combination, multiple component.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  200185  200195  200200  16-235136    Lot #'s  711680  655630  691980  722690  692000  722670  744670    ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1816-2016","Class II","Various trauma and sports medicine instruments and implants.  cannula, surgical, general & plastic surgery and accessories",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  900360  900364  900360H  900360HI  900363H  900364I    Lot #'s  606770  343280  420090  742780  763750  742780  565910  343280  ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1817-2016","Class II","Various trauma and sports medicine instruments and implants.  Plate, fixation, bone.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  24616  131212112  131212113  131212114  131212116  131212118  131212216  131212218  131212220  131212222  131212224  131212316  131212318  131212320  131212322  856135016  856135018  856135020  856135022  856135024  856135026  856135028  856135030  856135034  856135036  856135038  856135040  856135042      Lot #'s  606160  729130  664900  752650  752660  664910  664930  752680  664950  752690  752720  664990  665020  665040  665060  665070  665090  665100  665120  665130  758430  758500  758520  758540  758550  758570  758670  758680  758700  758710  758720  758730  758740      ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1828-2016","Class II","Various trauma and sports medicine instruments and implants.  Fastener, fixation, nondegradable, soft tissue.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  904414  904723  904727  904754  904755  904781  904834  912029  912030  912031  912037  912046  912050  912057  912068  912069  912071  912073  912076  912077  912082  912091  916036  110003172  110003182  110005093  110005096  110005198  110005306  110005307  110016992  912036R  912036R  912037R  912040R  912141C    Lot #'s  625480  673840  763780  652380  652400  652420  652430  652440  656180  607100  563710  563720  625660  654830  654850  654870  649000  649010  649030  649040  649050  649060  649070  649080  649100  654420  654480  654490  654500  654590  654600  654610  654680  676910  676920  676930  677020  655030  530920  579450  579460  579480  579490  579500  579510  579520  579530  579540  649150  649160  655050  655100  677120  677130  677150  677160  677170  677180  649880  649930  649960  649990  677340  650010  650050  628350  677980  657260  657280  657290  722500  649490  649520  649550  649580  649600  649620  649630  655160  649830  649850  678220  678230  678260  678280  655220  664610  676800  676810  676940  676950  677480  ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1823-2016","Class II","Various trauma and sports medicine instruments and implants.  Screw, fixation, bone.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  HAA60-11030  HAA60-13030  HAA60-15040  HAA60-16040  HAA60-18040    Lot #'s  016150  016210  165130  016230  133890  181600  133970  134000  181620  ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1818-2016","Class II","Various trauma and sports medicine instruments and implants.  Arthroscope.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  908518  908520    Lot #'s  675890  579290  579300  ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1819-2016","Class II","Various trauma and sports medicine instruments and implants.  Rod, fixation, intramedullary and accessories.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  28234  28338  28811  28813  28821  29260  29822  805065080  14-400428  14-400436  14-405032  14-405040  14-440118  14-440121  14-441280      Lot #'s  590970  591080  591090  665210  692040  692250  692280  692290  695900  610470  665230  665240  692440  692450  692480  692620  692660  692670  692690  721680  721720  721730  729080  722730  621840  621860  678300  664740  664820  664870  664880  503760  503770  693840  ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1824-2016","Class II","Various trauma and sports medicine instruments and implants.  Passer.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  904051    Lot #'s  880370  673790  ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1815-2016","Class II","Various trauma and sports medicine instruments and implants.  guide, surgical, instrument",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  281001080  281001100  35-351208  35-351534  35-351564    Lot #'s  606200  606210  606220  614280  661690  661700  661660  755290  764390  764400  621850  ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1822-2016","Class II","Various trauma and sports medicine instruments and implants.  Pin, fixation, smooth.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  24415  24416  27914  27922  328010  14-401440  14-450360  14-450365  14-450380  14-450390  35-361681    Lot #'s  679900  693860  729090  722660  668350  591000  591010  591020  652700  745110  752860  728860  652650  664410  664440  606280    ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1821-2016","Class II","Various trauma and sports medicine instruments and implants.  Bit, drill.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  24445  27961  904301  904760  231201307    Lot #'s  693880  606180  614250  668360  625470  710630  710640  668330  ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74038,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.","Z-1820-2016","Class II","Various trauma and sports medicine instruments and implants.  Reamer.",,"Insufficient seal strength on sterile barrier packaging.  The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile.  If the product becomes non-sterile and is used or implanted, it may lead to an infection.","05/26/2016",," Part #'s  41009  110004188  110010579    Lot #'s  668490  756990  757010  757030  758180  ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74039,"Ongoing","Ohio Hickory Harvest Brand Products Inc.","90 Logan Pkwy",,"Akron","OH","44319-1177","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY.","F-0318-2017","Class I","Big Y cranberry nut trail mix in plastic tub NET WT 20 OZ (1 LB 4 OZ) 567g INGREDIENTS: CRANBERRIES***PEANUTS, PEANUT OIL, RAISINS, SUNFLOWER KERNELS, PEPITAS, WALNUTS. CONTAINS: PEANUTS, WALNUTS UPC 0 18894 00457 8 DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, ma 01104 ","155 cs/10/20 oz tubs","The firm was notified by their supplier that the products may be contaminated with Listeria monocytogenes..","12/10/2016",," Best By Date 02/09/17",5/4/2016,"05/04/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74039,"Ongoing","Ohio Hickory Harvest Brand Products Inc.","90 Logan Pkwy",,"Akron","OH","44319-1177","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY.","F-0317-2017","Class I","Club Chef Raisin Sunflower Mix 4.8 oz bag ","180 cases/60/4.8 oz bags","The firm was notified by their supplier that the products may be contaminated with Listeria monocytogenes..","12/10/2016",," Best By Dates 02/19/16, 02/22/16, 03/19/16, 03/21/16, 03/22/16, 03/30/16, 04/06/16 & 04/07/16.",5/4/2016,"05/04/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74039,"Ongoing","Ohio Hickory Harvest Brand Products Inc.","90 Logan Pkwy",,"Akron","OH","44319-1177","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY.","F-0319-2017","Class I","Hickory Harvest FOODS Rucker's Cajun Mix 25 lb. bag in a box  INGREDIENTS: Cajun Sesame Sticks***soybean oil***Sunflower Kernels, Hot & Spicy Peanuts***Contains: Peanut, Soy, Wheat. ","685/25 lb. bags in boxes","The firm was notified by their supplier that the products may be contaminated with Listeria monocytogenes..","12/10/2016",," Best if Used By: 110415, 021116, 031016, 042315, 070115, 080415, 080615, 082715, 090315, 092415, 100615, 120315;",5/4/2016,"05/04/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74039,"Ongoing","Ohio Hickory Harvest Brand Products Inc.","90 Logan Pkwy",,"Akron","OH","44319-1177","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY.","F-0316-2017","Class I","Hickory Harvest FOODS Sweet & Salty Trail Mix 25 lb. UPC 0-36232-00510-0, 4.5oz UPC 0-36232-06075-5.  INGREDIENTS: Peanuts, Raisins***Sunflower Kernel*** AKRON, OH 44319 UPC 0 36232 00510 0","713 cases/1/25 lb bag","The firm was notified by their supplier that the products may be contaminated with Listeria monocytogenes..","12/10/2016",," 25 lb box Best By Dates: 011516, 012016, 020216, 021116, 070815, 080515, 082615, 092315, 102115, 111215, 111815, 112015, 120215, 126115, 122115;  4.5oz Best By Dates: 010216, 042916, 050516, 052716, 071416, 071516, 080416, 101516, 111616;",5/4/2016,"05/04/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74039,"Ongoing","Ohio Hickory Harvest Brand Products Inc.","90 Logan Pkwy",,"Akron","OH","44319-1177","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY.","F-0314-2017","Class I","Roasted & Salted Sunflower Kernels under the following brand names: AMISH FARMS SALEM, OHIO 44460 5.5 oz plastic bag UPC 8 55993 20018 6, heinen's Warrensville Heights, OH 44128 NET WT 10 oz tub UPC 0 36232 07703 9, Hickory Harvest FOODS Akron, OH 44319 5 oz  plastic tube UPC 0 36232 07704 6, 7 oz plastic tube UPC 0 36232 07716 9, 10 oz plastic tub UPC 0 36232 07703 9 & 11 oz plastic tub UPC 0 36232 07702 2, IM Good 1.6 oz tube UPC 7 93724 80218 9, Liberty Candy & Nuts Inc .3 oz plastic tube UPC 6 08819 35672 3; Market Source 5 lb box, UPC 0 36232 07715 2; Raylicious 1.5 oz plastic tube UPC 8 55291 00192 8 & Sheetz Distribution Services, Claysburg, PA 19625 3.5 oz plastic bag UPC 7 59465 00784 9; SunOpta 50# bag; and Superior Brokerage 7oz. cup, UPC 8-10222-02129-1 and 9oz. rectangle container, UPC 8-10222-02022-5. INGREDIENTS: Sunflower Kernels, Sunflower Oil and/or Peanut Oil, with Citric Acid added as a Preservative, and Salt","4,642 Cases (various size and quantities per case) + 8/50 lb bags","The firm was notified by their supplier that the products may be contaminated with Listeria monocytogenes.","12/10/2016",," Amish Farms Roasted Salted Sunflower Kernel  Best By Date, 07/09/16, 08/12/16, 10/07/16, 11/25/16, 02/25/17 & 04/20/17.  Heinens Roasted Salted Sunflower Kernel  Best By Date, 02/25/16, 03/09/16, 03/24/16, 03/25/16, 03/29/16, 04/14/16, 05/24/16, 05/25/16, 05/29/16, 07/08/16, 08/18/16, 10/19/16 & 12/28/16;   Hickory Harvest Roasted Salted Sunflower Kernel Car Cup  Best By Dates, 10/28/16, 11/01/16, 11/16/16, 11/17/16, 11/25/16 & 12/29/16;   Hickory Harvest Roasted Salted Sunflower Kernel 5 oz:: Best By Dates, 03/03/16, 04/09/16, 04/23/16, 04/30/16, 05/27/16, 07/12/16, 08/03/16, 08/13/16, 10/12/16, 11/25/16, 12/28/16 & 12/29/16;   Hickory Harvest Roasted Salted Sunflower Kernel 10oz: Best By Date, 01/30/16, 03/09/16, 03/10/16, 03/25/16, 03/??/16, 04/22/16, 04/29/16, 05/04/16, 05/31/16, 06/02/16, 06/22/16, 06/23/16, 06/25/16, 07/08/16, 08/12/16, 08/18/16, 09/28/16, 10/19/16, 11/18/16, 12/25/16, 12/28/16, 01/07/17 & 01/08/17;   Hickory Harvest Roasted Salted Sunflower Kernel 11 oz: Best By Date, 01/29/16, 03/18/16, 05/31/16, 06/18/16, 08/18/16, 08/19/16, 10/27/16 & 01/11/17;   Hickory Harvest Roasted Salted Sunflower Kernel 25#: Best By Dates, 010416, 011816, 011916, 012516, 020116, 020816, 021516, 022116, 022216, 022315, 022916, 030816, 031416, 060815, 062215, 062315, 062915, 062916, 070615, 070816, 071315, 071915, 072015, 072016, 072115, 072116, 072315, 072316, 072915, 072916, 080215, 081616, 081715, 083115, 083116, 090315, 090815, 090816, 091415, 091416, 092115, 092116, 092117, 092815, 092816, 101215, 102715, 110215, 110315, 110915, 111615, 111815, 112315, 112316, 120415, 121415, 122115, 122815, 122915;   IM Good Roasted Salted Sunflower Kernel  Best By Date, 022617, 050316, 061116, 070716, 071716, 080716, 081316, 082716, 110816;  Liberty Roasted Salted Sunflower Kernel  Best By Dates, 011517, 021217, 030817, 030917, 041617, 071616, 071716, 071716, 081316, 091116, 102916, 120516, 120715;  Market Source Roasted Salted Sunflower Kernel  Best By Date, 011816, 021216, 030816, 040516, 070615, 072915, 082015, 090915",5/4/2016,"05/04/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74039,"Ongoing","Ohio Hickory Harvest Brand Products Inc.","90 Logan Pkwy",,"Akron","OH","44319-1177","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY.","F-0315-2017","Class I","Roasted No Salt Sunflower Kernel s under the following brand names: heinen's Warrensville Heights, OH 44128 NET WT. 10 oz (284g) UPC 0 36232 07707 7 & Hickory Harvest FOODS Akron, OH 44319 NET WT. 10 oz (284g) UPC 0 36232 07707 9; Sandridge Foods NET WT 4 OZ (113G), SunOpta 50 lb. bag, Superior Brokerage 9oz. rectangle container, UPC 8-10222-02140-6 ","1,305 cases (various size & quantities per case) + 8/50 lb bags","The firm was notified by their supplier that the products may be contaminated with Listeria monocytogenes..","12/10/2016",," Heinens Roasted No Salt Sunflower Kernel  Best By Dates, 020416, 021316, 022116, 032415, 032416, 052516, 062416, 070816, 081816, 100816, 101416;  Hickory Harvest Roasted No Salt Sunflower Kernel  Best By Dates, 022116, 030916, 032116, 032416, 032516, 042616, 042916, 060216, 061516, 070816, 071916, 091416, 101416;  Sandridge Foods Roasted No Salt Sunflower Kernel  Best By Date, 03/19/17  SunOpta Roasted No Salt Sunflower Kernel  Best By Date, 8B6M08  Superior Brokerage No Salt Sunflower Kernels Best By Dates 15246, 15265, 15281, 15295, 15315, 15317, 15320, 15322;",5/4/2016,"05/04/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74040,"Ongoing","The Kroger Co","1014 Vine St",,"Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, SC, TN, TX, UT, VA, WV & WY.","F-1414-2016","Class I","Kroger CRANBERRY DELIGHT TRAIL MIX NET WT 14 OZ  INGREDIENTS: DRIED CRANBERRIES ***ALMONDS, SUNFLOWER SEEDS*** UPC 0 11110 89869 2 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202","7,837 cs/6/14 oz bags","The firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.","06/01/2016",," Sell By: MAR0917, MAR1017, MAR1117 & APR1117.",5/3/2016,"05/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74040,"Ongoing","The Kroger Co","1014 Vine St",,"Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, SC, TN, TX, UT, VA, WV & WY.","F-1416-2016","Class I","Kroger SALTED SUNFLOWER KERNELS 6 oz (170g) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT. DISTRIBUTED BY THE KROGER CO CINCINNATI, OHIO 45202 UPC 0 11110 61877 1","5,574 cs/6/6 oz bags","The firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.","06/01/2016",," Sell By: DEC1116, DEC1316 & DEC1416.",5/3/2016,"05/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74040,"Ongoing","The Kroger Co","1014 Vine St",,"Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to the following states: AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, SC, TN, TX, UT, VA, WV & WY.","F-1415-2016","Class I","Kroger SALAD TOPPERS Roasted & Salted Sunflower Kernels NET WT 3.5 OZ (99G) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 02127 4 ","5,192 cs/9/3.5 oz bags","The firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.","06/01/2016",," Sell By: DEC0316 & DEC0416",5/3/2016,"05/03/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2441-2016","Class I","UPC 411014937907,	Fresh Finds Dried Tropical Mix, Best By/Date Code: 3/17/2017 .          ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/17/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2443-2016","Class I","UPC 639277187567,	Naturally Select Indulgent Trail Mix, Best By/Date Code: 3/24/2017 .        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/24/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2449-2016","Class I","UPC 075450040586 Hy-Vee Caramel Cashew Honey Crunch Trail Mix., Best By/Date Code:  4/5/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 4/5/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2436-2016","Class I","UPC 071725713124,	Amport Foods Chocolatey Nut Trail Mix, Best By/Date Code: 1/8/2017 .    UPC 639277431417,	Naturally Select Chocolate & Nut Trail Mix, Best By/Date Code: 3/23/2017 .        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 1/8/2017, 3/23/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2457-2016","Class I","UPC 071725728203 Nature's Harvest Sweet Nut & Berry Munch Trail Mix,  Best By/Date Code: 12/27/2016.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 12/27/2016",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2433-2016","Class I","UPC 041498205379,	Southern Grove Tuscan Trail Mix, Best By/Date Code: 4/28/2017 .  ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 4/28/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2426-2016","Class I","UPC 041498200190,	Southern Grove Adventure Trail Mix , Best By/Date Code: 3/28/2017.    ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/28/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2440-2016","Class I","UPC 071725748034,	Amport Foods Yogurt Almonds, Best By/Date Code: 1/8/2017 .          ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 1/8/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2419-2016","Class I","UPC 1373312032,  Meijer White Choc Chip Pretzel Bars, Best By/Date Code:  DEC 09 16.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: DEC 09 16",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2439-2016","Class I","UPC 071725711939,	Amport Foods Milk Chocolate Peanuts, Best By/Date Code: 1/7/2017 .            ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 1/7/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2434-2016","Class I","UPC 071725241412,	Amport Foods Sunflower Seeds Roasted, Best By/Date Code: 11/26/2016 .    UPC 071725241504,	Amport Foods Sunflower Seeds Roasted, Best By/Date Code: 12/2/2016,12/25/2016, 12/11/2016  .      UPC 071725748003,	Amport Foods Sunflower Seeds Roasted & Unsalted, Best By/Date Code: 12/3/2016,1/6/2017  .    UPC ,071725748003, 	American Importing Company. Inc., Roasted No Salt Seeds , Best By/Date Code: 1/6/2017.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 11/26/2016 , 12/2/2016,12/25/2016, 12/11/2016, 12/3/2016,1/6/2017 .",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2454-2016","Class I","UPC 071715727510 Nature's Harvest Sunflower Kernels Honey Roasted., Best By/Date Code:  12/20/2016, 1/21/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 12/20/2016, 1/21/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2411-2016","Class I","UPC 070038614142, 	Best Choice Mountain Trail Mix,  Best By/Date Code: 3/14/2017.    UPC 041498148447, Southern Grove Mountain Trail Mix, Best by Date Code: 4/4/2017, 4/26/2017.    UPC 075450016796, 	Hy-Vee Mountain Mix Trail Mix,  Best By/Date Code: 4/5/2017, 4/15/2017.    UPC 075450040739, 	Hy-Vee Mountain Trail Mix,  Best By/Date Code: 3/23/2017.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/14/2017, 4/4/2017,  4/5/2017, 4/15/2017, 4/26/2017, 3/23/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2407-2016","Class I","UPC 041498114749,	Southern Grove  Dry Roasted No Salt Almond,  Best By/Date Code	3/4/2017.  ",,"TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/4/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2430-2016","Class I","UPC 041498132248,	Southern Grove Oven Roasted Almonds with Sea Salt, Best By/Date Code: 3/16/2017.    UPC 041498132248,	Southern Grove  Dry Roasted Sea Salt Almond,  Best By/Date Code	3/4/2017.    UPC 071725728791,	Nature's Harvest Almond Dry Roasted Sea Salted,  Best By/Date Code	3/16/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/16/2017, 3/4/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2421-2016","Class I","UPC 1373312015,  Meijer Peanut Butter Dark Chocolate Protein Bars,Best By/Date Code:  DEC 05 16,  JAN 04 17.    UPC 3225108607, Family Gourmet Peanut Butter Dark Chocolate Protein ,Bars Best By/Date Code: JAN 04 17.    UPC 3680039453,	Food Club Peanut Butter Dark Chocolate Protein Bars,Best By/Date Code: DEC 05 16, JAN 04 17.    UPC 4130304540,	Essential Everyday Peanut Butter Dark Chocolate Protein Bars,  Best By/Date Code:	DEC 05 16, JAN 04 17.    UPC 5042847944 , Gold Emblem Peanut Butter Dark Chocolate Protein Bars ,Best By/Date Code:  DEC 05 16, JAN 04 17, JAN 05 17.    UPC 7003863811, Best Choice Peanut Butter Dark Chocolate Protein Bars,Best By/Date Code: DEC 05 16,  JAN 04 17.    UPC 7025322720, Our Family Peanut Butter Dark Chocolate Protein Bars,Best By/Date Code: DEC 05 16, JAN 04 17.    UPC 7078447478,  Tops Peanut Butter Dark Chocolate Protein Bars, Best By/Date Code: JAN 04 17.    UPC 7874203428,  Great Value Peanut Butter Dark Chocolate Protein Bars, Best By/Date Code: 12 05 16, 12 06 16, 01 05 17, 01 06 17.    UPC 7989380098,  Eating Right (Lucerne) Peanut Butter Dark Chocolate Protein Bars, Best By/Date Code: DEC 05 16, JAN 05 17.          ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code:  DEC 05 16,  JAN 04 17, JAN 05 17, 12 05 16, 12 06 16, 01 05 17, 01 06 17.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2417-2016","Class I","UPC 1373312016,	Meijer Peanut Almond Dark Chocolate Protein Bars, Best By/Date Code:	DEC 07 16.    UPC 1373312016,	Meijer Peanut Almond Dark Chocolate Protein Bars Best By/Date Code:	JAN 07 17    UPC 4130304541,	Essential Everyday Peanut Almond Dark Chocolate Protein Bar, Best By/Date Code:	DEC 07 16.    UPC 7003863812,	Best Choice Peanut Almond Dark Chocolate Protein Bars, Best By/Date Code:	DEC 07 16, JAN 07 17.      UPC 7025322722,	Our Family Peanut Almond Dark Chocolate Protein Bars Best By/Date Code:	DEC 07 16.    UPC 7874203429,	Great Value Peanut Almond Dark Chocolate Protein Bars, Best By/Date Code: 12 06 16, 12 07 16, 01 06 17.    UPC 7989380097,	Eating Right (Lucerne) Peanut Almond Dark Chocolate Protein Bars, Best By/Date Code:	DEC 07 16, JAN 07 17.    UPC 1121302629   Spartan Peanut Almond Dark Chocolate Protein Bars Best By/Date Dec 07 16.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: DEC 07 16, JAN 07 17, 12 06 16, 12 07 16, 01 06 17.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2427-2016","Class I","UPC 041498131500,	Southern Grove Chopped Walnuts , Best By/Date Code: 3/22/2017.    ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code:3/22/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2459-2016","Class I","UPC 041498200183 Southern Grove Unwind Trail Mix,  Best By/Date Code: 3/28/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/28/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2456-2016","Class I","UPC 071725749314 Nature's Harvest Dark Chocolate Covered Cashews,  Best By/Date Code: 1/6/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 1/6/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2412-2016","Class I","UPC 071725728166, 	Natures Harvest Afternoon Snack Blend, Best By/Date Code: 11/28/2016.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code:11/28/2016",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2428-2016","Class I","UPC 041498160982,	Southern Grove Cranberry & Nut Trail Mix , Best By/Date Code: 3/24/2017, 4/15/2017    UPC071725706133,  Amport Foods Cranberry Nut Trail Mix, , Best By/Date Code: 3/18/2017, 4/14/2017.  ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/24/2017,4/15/2017,  3/18/2017, 4/14/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2446-2016","Class I","UPC 071725750167 Clover Valley Chocolatey Peanut Butter Trail Mix., Best By/Date Code:  3/25/2017 .        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/25/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2406-2016","Class I","UPC 071725750198, Natures Harvest  Whole Almonds,  Best By/Date Code: 	3/3/2017  UPC 071725750266,	Natures Harvest  Slivered Almond,  Best By/Date Code: 	3/3/2017  UPC 071725750259,	Natures Harvest Sliced Almonds, Best By/Date Code: 	3/4/2017    UPC 041498121686, Southern Grove Sliced Almonds, Best By/Date Code:3/21/2017","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/3/2017, 3/4/2017, 3/21/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2409-2016","Class I","UPC 071725728074, 	Natures Harvest Sunflower Kernels Ranch Flavored,  Best By/Date Code: 3/1/2017, 3/31/2017, 4/27/2017.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/1/2017, 3/31/2017, 4/27/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2452-2016","Class I","UPC 049022846524 Nice! Peanut Lovers Trail Mix., Best By/Date Code:  4/19/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 4/19/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2408-2016","Class I","UPC 071725750211,  Natures Harvest Pecans, Best By/Date Code :   3 /4/2017","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/4/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2423-2016","Class I","UPC 7003860349,  Best Choice Trail Mix Fruit and Nut Bars Best By/Date Code: JAN 04 17.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: JAN 04 17",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2437-2016","Class I","UPC 071725712387,	Amport Foods Dark Chocolate Almond, Best By/Date Code: 1/7/2017 .          ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 1/7/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2438-2016","Class I","UPC 071725711854,	Amport Foods Dark Chocolate Cranberry Trail Mix, Best By/Date Code: 1/2/2017 .    UPC 075450041354,	Hy-Vee Dark Chocolate Cranberry Trail Mix, Best By/Date Code: 4/14/2017 .    UPC 071725749062,	Nature's Harvest Dark Chocolate Cranberry Trail Mix, Best By/Date Code: 3/28/2017.              ",,"TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 1/2/2017, 4/14/2017, 3/28/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2444-2016","Class I","UPC 639277286208	Salted Sunflower Seeds in Shell distributed by Greenbrier International, Inc., Best By/Date Code:2/25/2017,  2/28/2017,3/17/2017, 3/21/2017, 4/13/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 2/25/2017,   2/28/2017,3/17/2017, 3/21/2017,4/13/2017 .",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2450-2016","Class I","UPC 049022880641 Delish Blueberry Nut Blend Premium Trail Mix., Best By/Date Code:  3/17/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/17/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2420-2016","Class I","UPC 049022832275, 	Nice Sunflower Seeds Salted in Shell, Best By/Date Code: 3/4/2017, 4/15/2017.    ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code:3/4/2017, 4/15/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2455-2016","Class I","UPC 071725728166 Nature's Harvest Afternoon Trail Mix., Best By/Date Code: 1/14/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 1/14/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2431-2016","Class I","UPC 041498211004,	Southern Grove PB & Pretzel Trail Mix, Best By/Date Code: 3/28/2017,4/5/2017 .  ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code:  3/28/2017,4/5/2017 .",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2435-2016","Class I","UPC 071725741042,	Amport Foods Trail Mix Raisin & Nut, Best By/Date Code: 4/4/2017 .    UPC 071725714688,	Amport Foods Trail Mix Raisin & Nut, Best By/Date Code: 1/14/2017 .        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 4/4/2017, 1/14/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2416-2016","Class I","UPC 1115099114	Roundy Peanut Butter Dark Chocolate Bars, 	Best By/Date Code: DEC 05 16, JAN 04 17.  ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: DEC 05 16, JAN 04 17.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2424-2016","Class I","UPC 2113028372,  Signature Kitchen Peanut Chocolate Chunk Bars , Best By/Date Code: Dec 09 16.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: Dec 09 16",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2432-2016","Class I","UPC 041498206765,	Southern Grove Roasted & Unsalted Sunflower Kernels, Best By/Date Code: 4/28/2016, 3/1/2017, 3/14/2017,3/28/2017 .      UPC 071725727503,	Nature's Harvest Sunflower Kernels Roasted & Unsalted, Best By/Date Code: 11/25/2016, 11/26/2016, 12/4/2016, 12/18/2016, 12/23/2016, 1/2/2017, 1/14/2017, 1/15/2017.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code:   4/28/2016, 3/1/2017, 3/14/2017,3/28/2017,   11/25/2016, 11/26/2016, 12/4/2016, 12/18/2016, 12/23/2016, 1/2/2017, 1/14/2017, 1/15/2017. ",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2448-2016","Class I","UPC 075450041101Hy-Vee Santa Fe Trail Mix., Best By/Date Code:  3/31/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/31/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2425-2016","Class I","UPC  071725748010,	Sunflower Seeds Roasted and Salted, Best By/Date Code: 11/27/2016.    UPC  007172524140,	Amport Roasted and Salted Sunflower Seeds, Best By/Date Code:11/26/2016.    639277348319,Naturally Select  Roasted and Salted Sunflower Seed, Best By/Date Code: 3/1/2017.    UPC  071725241351,	Amport Foods Sunflower Seeds Roasted & Salted, Best By/Date Code:12/3/2016,12/26/2016, 12/12/2016 .    UPC 071725748010,	Amport Foods Sunflower Seeds Roasted & Salted, Best By/Date Code:12/31/2016,12/26/2016, 1/14/2017 .    UPC 071725241405,	Amport Foods Sunflower Seeds Roasted & Salted, Best By/Date Code:1/7/2017 .        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 11/26/2016, 11/27/2016, .1/7/2017, 1/14/2017, 3/1/17, 12/31/2016, 12/26/2016, 12/12/2016, 12/3/2016.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2445-2016","Class I","UPC 032251046506 Family Gourmet Tropical Mix., Best By/Date Code:  3/16/2017 .        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/16/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2414-2016","Class I","UPC 071725711533,	Natures Harvest Southwest Trail MixBest By/Date Code:	11/28/2016,12/27/2016,12/30/2016,  1/17/2017 .    UPC 708615110434,	K&G Southwest Trail MixBest By/Date Code: 11/28/2016.  ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code:11/28/2016,12/27/2016,12/30/2016,  1/17/2017 .  ",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2415-2016","Class I","UPC 1115029456,	Roundy Sweet and Salty Almond Chewy Bars, Best By/Date Code:	DEC 08 16.    UPC 1116103436,	ShurFine Sweet and Salty Almond Chewy Bars, Best By/Date Code:	DEC 08 16.    UPC 1373312025,	Meijer Sweet and Salty Almond Bars, Best By/Date Code:	DEC 07 16, DEC 08 16.    UPC 1540016425,	Western Family Sweet and Salty Almond Bars,Best By/Date Code :	DEC 07 16.    UPC 2113028352,	Signature Kitchen Sweet & Salty Almond Bars, Best By/Date Code:  	Dec 08 16.    UPC 3680017921	Food Club Sweet and Salty Almond Bars, Best By/Date Code:  	DEC 07 16, DEC 08 16.    UPC 4130300139	Essential Everyday Sweet and Salty Almond Bars, Best By/Date Code:	DEC 08 16.    UPC 7025322712	Our Family Sweet and Salty Almond Bars, Best By/Date Code:	DEC 08 16.    UPC 7078447470	Tops Sweet and Salty Almond Bars, Best By/Date Code:	DEC 07 16.    UPC 7874207499.	Great Value Sweet & Salty Almond Bars, Best By/Date Code:	12 08 16, 	12 09 16.    UPC 8826749280	FoodHold Sweet and Salty Almond Bars,Best By/Date Code	DEC 07 16.    UPC 1121306657       Spartan Sweet and Salty Almond Bars, Best By/Date Dec 08 16.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: DEC 07 16, DEC 08 16, 12 08 16, 12 09 16.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2410-2016","Class I","UPC 070038638285,  Best Choice Dark Chocolate Cranberry,  Best By/Date Code: 3/14/2017","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/14/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2418-2016","Class I","UPC 1373312031,  Meijer Peanut Chocolate chunk Pretzel Bars, Best By/Date Code: DEC 09 16.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: DEC 09 16",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2429-2016","Class I","UPC 041498177829,	Southern Grove Nuts, Seeds & Raisins Trail Mix , Best By/Date Code: 3/23/2017, 4/13/2017.  ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/23/2017, 4/13/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2458-2016","Class I","UPC 041498202057 Southern Grove Sunny Cranberry Trail Mix,  Best By/Date Code: 3/28/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/28/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2405-2016","Class I","Sunflower Kernels packaged in the following brands and sizes:      UPC 041498206680, Southern Grove Roasted and Salted Sunflower Kernels,   Best by/Date: 3/1/2017, 3/2/2017, 2/28/2017, 3/15/2017,3/28/2017, 4/29/2017 .    UPC 071725727497, Natures Harvest Roasted and Salted Sunflower Kernels, Best by/Date: 11/25/2016, 12/4/2016, 3/1/2017, 12/19/2016,12/20/2016, 12/25/2016, 1/2/2017,  1/3/2017, 1/16/2017, 1/20/17 .    USPC 883967300013,	Smart Sense Roasted and Salted Sunflower Kernels, Best by/Date: 3/4/2017.    USPC 050428353240,	Gold Emblem Roasted and Salted Sunflower Kernels, Best by/Date: 11/27/2016, 1/14/2017.    USPC 883967300013,	Smart Sense Roasted Salted Sunflower Kernels, Best by/Date: 3/16/2017.                          ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code:      11/25/2016, 11/27/2016, 12/19/2016,12/4/2016, 12/20/2016, 12/25/2016, 1/2/2017,  1/3/2017, 1/14/2017, 1/16/2017, 1/20/2017,    2/28/2017, 3/1/2017,  3/2/2017,3/4/2017, 3/15/2017, 3/16/2017,3/28/2017,  4/29/2017.        ",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2442-2016","Class I","UPC 639277431455,	Naturally Select Fruit & Nut Trail Mix, Best By/Date Code: 3/15/2017 .        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/15/2017",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2413-2016","Class I","UPC 071725714688, 	Raisin and Nut Trail Mix, Best By/Date Code:11/28/2016.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code:11/28/2016",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2447-2016","Class I","UPC 075450040593 Hy-Vee Berry Trail Mix., Best By/Date Code:  3/19/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/19/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2453-2016","Class I","UPC 049022880627 Delish Almond Berry Pistachio Premium Trail Mix., Best By/Date Code:  3/18/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/18/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2451-2016","Class I","UPC 049022880634 Delish Tropical Blend Premium Trail Mix., Best By/Date Code:  3/17/2017.        ","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: 3/17/2017.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74041,"Ongoing","Treehouse Foods","2021 Spring Rd Ste 600",,"Oak Brook","IL","60523-1860","United States","Voluntary: Firm Initiated","Telephone","US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.","F-2422-2016","Class I","UPC 4130300137,  Essential Everyday Trail Mix Bars, Best By/Date Code: JAN 04 17.","92,865 cases for all products","TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.","09/30/2016",," Best By/Date Code: JAN 04 17.",5/3/2016,"05/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74042,"Ongoing","Tasty Toppings Inc","11285 158th St","PO Box 728 ","Duncan","NE","68634","United States","Voluntary: Firm Initiated","Press Release","Coverage is predominately the Midwest, specifically Nebraska, Iowa, Kansas, Colorado and South Dakota.  Smaller concentration of stores in ND, WY, UT, OK, TX, MN and WI.","F-0324-2017","Class III","Dorothy Lynch Homestyle 8 oz., 16 oz., and 32 oz. bottles (12/case) and 128 oz. bottles (4/case)   ","3617 12-8oz. bottle cases, 27218 12-16oz. bottle cases, 22241 12-32oz. bottle cases, and 9082 4-gallon cases","The firm issued a press release on May 6, 2016, which encouraged consumers with affected bottles to return the product to the store for a refund.  The recall will extend through the wholesale and retail distribution chain via scripted phone notification.  The firm has informed distributors/retails to remove the product from shelves and track by using the best by date and sku.  Products should be destroyed.  The information has been posted on the firm website.","11/04/2016",,"Gallons with Best By dates between 6/16/16 and 10/11/16 are recalled.  ",5/6/2016,"05/06/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74043,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom","Z-2261-2016","Class II","Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.","18,366 cases","An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.","07/22/2016",," All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58740, 58741, 58742, 58749, 58750, 58753, 58754",6/23/2016,"06/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74043,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom","Z-2263-2016","Class II","Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL","18,474 case","An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.","07/22/2016",," All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 66617, 66622, 66632, 66642, 69616, 69621, 69631, and 69641",6/23/2016,"06/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74043,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom","Z-2257-2016","Class II","AUTOCOMP6 XPS High Speed Compounder REF 58810 ","16 devices","An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.","07/22/2016",," 000001, 003002, 003003, 003004, 003005, 003006, 003007, 003008, 003009, 003010, 003011, 003012, 003013, 003014, 003015, 003016, 003017, 003018, 003019, 003020, 003023, 003024, 003025, 003026, 003027, 003028, 003029, 003030, 003031, 003036, 003037, 003038, 003039, 003040, 003041, 003042, 003043, 003044, 003045, 003046, 003047, 003048, 003049, 003050, 003051, 003052, 003053, 003054, 003055, 003056, 003057",6/23/2016,"06/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74043,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom","Z-2259-2016","Class II","AUTOCOMP6 High Speed Compounder ","323","An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.","07/22/2016",," 1006, 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1021, 1022, 1023, 1024, 1025, 1026, 1027, 1028, 1029, 1030, 1031, 1032, 1033, 1034, 1035, 1036, 1037, 1038, 1039, 1040, 1041, 1042, 1043, 1044, 1045, 1046, 1047, 1048, 1049, 1050, 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1092, 1093, 1094, 1095, 1096, 1097, 1098, 1099, 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1111, 1112, 1113, 1114, 1115, 1116, 1117, 1118, 1119, 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1147, 1148, 1149, 1150, 1151, 1152, 1153, 1154, 1155, 1156, 1157, 1158, 1159, 1160, 1161, 1162, 1163, 1164, 1165, 1166, 1167, 1168, 1169, 1170, 1171, 1172, 1173, 1174, 1175, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027, 2028, 2029, 2030, 2031, 2032, 2033, 2034, 2035, 2036, 2037, 2038, 2039, 2040, 2041, 2042, 2043, 2044, 2045, 2046, 2047, 2048, 2049, 2050, 2051, 2052, 2053, 2054, 2055, 2056, 2057, 2058, 2059, 2060, 2061, 2062, 2063, 2064, 2065, 2066, 2067, 2068, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2088, 2089, 2090, 2091, 2092, 2093, 2094, 2095, 2096, 2097, 2098, 2099, 2100, 2101, 2102, 2103, 2104, 2105, 2106, 2107, 2108, 2109, 2110, 2111, 2112, 2113, 2114, 2115, 2116, 2117, 2118, 2119, 2120, 2121, 2122, 2123, 2124, 2125, 2126, 2127, 2128, 2129, 2130, 2131, 2132, 2133, 2134, 2135, 2136, 2137, 2138, 2139, 2140, 2141, 2142, 2143, 2144, 2145, 2146, 2147, 2148, 2149, 2150, 2151, 2152, 2153, 2154, 2155, 2156, 2157, 2158, 2159, 2160, 2161, 2162, 2163",6/23/2016,"06/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74043,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom","Z-2264-2016","Class II","Container fill and transfer sets, 250 mL and 500 mL, .    .","1,350 cases","An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.","07/22/2016",," All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 66505 and 66510",6/23/2016,"06/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74043,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom","Z-2262-2016","Class II","Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL ","3,829 cases","An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.","07/22/2016",," All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58733 and 58734",6/23/2016,"06/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74043,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom","Z-2260-2016","Class II","Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL. ","137,598 cases","An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.","07/22/2016",," All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58781, 58785, 62005, 62010, 62015, 62025, 62030, 62035, 64005, 64010, 64015, 64025, 64030, 64035, 64781, 65005, 65010, 65015, 65025, 65030, 65035, 66005, 66010, 66015, 66020, 66025, 66030, 66035, 66305, 66310, 66315, 66325, 66330, 66335, 66705, 66710, 66715, 66725, 66730, 66735, 66910, 66915, 66925, 66930, 66935, 67005, 67010, 67015, 67025, 67030, 67035, 69005, 69010, 69015, 69025, 69030, 69035",6/23/2016,"06/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74043,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom","Z-2258-2016","Class II","AUTOCOMP6 XP High Speed Compounder REF 58810 ","93 devices","An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.","07/22/2016",," 0001, 0002, 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0022, 0023, 0024, 0025, 0026, 0027, 0028, 0029, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0037, 0038, 0039, 0040, 0041, 0042, 0043, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0056, 0057, 0058, 0059, 0060, 0061, 0062, 0063, 0064, 0065, 0066, 0067, 0068, 0069, 0070, 0071, 0072, 0073, 0074, 0075, 0076, 0077, 0078, 0079, 0080, 0081, 0082, 0083, 0084, 0085, 0086, 0087, 0088, 0089, 0090, 0091, 0092, 0093, 0094, 0095, 0096, 0097, 0098, and 0099",6/23/2016,"06/23/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74044,"Ongoing","Novo Nordisk Inc","1100 Campus Rd",".","Princeton","NJ","08540-6650","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0956-2016","Class II","Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only,  Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21 ","723 pens"," step","06/06/2016",," Lot Number FC70222",4/27/2016,"04/27/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74045,"Ongoing","Excelsior Medical Corp","1933 Heck Ave",,"Neptune","NJ","07753-4428","United States","Voluntary: Firm Initiated","Letter","US Nationwide distribution.","Z-1989-2016","Class II","Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe).  For flushing of IV catheters and IV tubing only.  ","184,500","Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.","06/14/2016",," Product Code, Lot number, Expiration date.    513604	3123326	7/1/2016  E0500-55	3123349	7/1/2016  513602	3126577	8/1/2017  ",4/28/2016,"04/28/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74046,"Ongoing","Genzyme Corporation / Genzyme Biosurgery","1125 Pleasantview Ter",,"Ridgefield","NJ","07657-2310","United States","Voluntary: Firm Initiated","Letter","MI, PA & NJ","D-1029-2016","Class III","Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only,  Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1","2350 vials","Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.","06/10/2016",,"  Lot #: 61R1001, Exp. 12/2016",4/27/2016,"04/27/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74047,"Terminated","Blood Systems, Inc. DBA United Blood Services","1503 Bertrand Dr",,"Lafayette","LA","70506-3049","United States","Voluntary: Firm Initiated","FAX","Mississippi","B-0526-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, for which donor suitability was not adequately determined, was distributed.","05/19/2016","05/19/2016"," W041616001588H",3/28/2016,"03/28/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74048,"Terminated","San Diego Blood Bank","3636 Gateway Center Ave Ste 100",,"San Diego","CA","92102-4508","United States","Voluntary: Firm Initiated","Telephone","California","B-0531-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor for whom donor suitability was inadequately determined, was distributed.","05/19/2016","05/19/2016"," W044216508668",3/18/2016,"03/18/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74049,"Terminated","Altru Health Systems, Inc.","1200 S Columbia Rd",,"Grand Forks","ND","58201-4036","United States","Voluntary: Firm Initiated","Telephone","Venezuela","B-0543-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, for which donor suitability was not adequately determined, was distributed.","05/26/2016","05/26/2016"," W066616000168",4/25/2016,"04/25/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74050,"Terminated","American National Red Cross","3747 Euclid Ave",,"Cleveland","OH","44115-2501","United States","Voluntary: Firm Initiated","Telephone","OH","B-0576-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","5 units","Blood products, mislabeled and/ or missing labeling  information, were distributed. ","06/14/2016","06/14/2016"," W203816331486- part 1; W203816331486-part 2; W203816332780; W203816352543; W203816352550",3/16/2016,"03/16/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74051,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0525-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Platelet product, not prepared in accordance with specifications, was distributed.","05/19/2016","05/19/2016"," W071216001159 ",4/4/2016,"04/04/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74052,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0532-16","Class III","Apheresis Fresh Frozen Plasma, Irradiated","4 units","Blood products, in which labels applied to blood units or products incorrect or missing information, were distributed.","06/13/2016","06/13/2016"," W071215007188; W071215007208; W071215007208; W071215007208; ",4/11/2016,"04/11/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74053,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.","Z-1919-2016","Class II","1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System.  1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.    Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.","19 units","Labeling errors.  The outer packge label expiration date may exceed the expiration date of the subcomponents.  ","06/07/2016",," Catalog #  851.690.01S, Lot # 6904416, 6904418, 7672126",5/2/2016,"05/02/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74053,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.","Z-1918-2016","Class II","1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System.    1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.    Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.","22 units","Labeling errors.  The outer packge label expiration date may exceed the expiration date of the subcomponents.  ","06/07/2016",," Catalog # 851.689.01S, Lot # 7672066 and 7672089",5/2/2016,"05/02/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74053,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.","Z-1920-2016","Class II","1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System.  1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.    Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.","14 units","Labeling errors.  The outer packge label expiration date may exceed the expiration date of the subcomponents.  ","06/07/2016",," Catalog # 851.691.01S, Lot # 6123191, 6913455, 7540885",5/2/2016,"05/02/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1404-2016","Class II","2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48	  ","85 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K8892	,	Lot Number	160560168M	,	Exp. Date	5/17/2016	;  Service Code	2K8892	,	Lot Number	160810001M	,	Exp. Date	6/10/2016	;  Service Code	2K8219	,	Lot Number	160530297M	,	Exp. Date	5/23/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1363-2016","Class II","0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994	, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83	  ","15 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number: 160700041M; Exp. Date 6/8/2016	  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1429-2016","Class II","5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141","445 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8477	,	Lot Number	160400137M	,	Exp. Date	5/10/2016	;  Service Code	2H8477	,	Lot Number	160450131M	,	Exp. Date	5/15/2016	;  Service Code	2H8477	,	Lot Number	160470138M	,	Exp. Date	5/17/2016	;  Service Code	2H8477	,	Lot Number	160480132M	,	Exp. Date	5/18/2016	;  Service Code	2H8477	,	Lot Number	160550129M	,	Exp. Date	5/25/2016	;  Service Code	2H8477	,	Lot Number	160610059M	,	Exp. Date	5/30/2016	;  Service Code	2H8477	,	Lot Number	160620029M	,	Exp. Date	5/31/2016	;  Service Code	2H8477	,	Lot Number	160680044M	,	Exp. Date	6/6/2016	;  Service Code	2H8477	,	Lot Number	160750038M	,	Exp. Date	6/13/2016	;  Service Code	2H8477	,	Lot Number	160760128M	,	Exp. Date	6/14/2016	;  Service Code	2H8477	,	Lot Number	160820118M	,	Exp. Date	6/21/2016	;  Service Code	2H8477	,	Lot Number	160830037M	,	Exp. Date	6/22/2016	;  Service Code	2H8477	,	Lot Number	160890044M	,	Exp. Date	6/27/2016	;  Service Code	2H8477	,	Lot Number	160900040M	,	Exp. Date	6/28/2016	;  Service Code	2H8477	,	Lot Number	160960037M	,	Exp. Date	7/4/2016	;  Service Code	2H8477	,	Lot Number	160970136M	,	Exp. Date	7/6/2016	;  Service Code	2K8477	,	Lot Number	160520174M	,	Exp. Date	5/22/2016	;  Service Code	2K8477	,	Lot Number	160890053M	,	Exp. Date	6/27/2016	;  Service Code	2K8477	,	Lot Number	160940139M	,	Exp. Date	7/3/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1403-2016","Class II","2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50	  ","105 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160890247M	,	Exp. Date	6/28/2016	;  Lot Number	160380151M	,	Exp. Date	5/8/2016	;  Lot Number	160490238M	,	Exp. Date	5/19/2016	;  Lot Number	160550208M	,	Exp. Date	5/25/2016	;  Lot Number	160610062M	,	Exp. Date	5/30/2016	;  Lot Number	160630184M	,	Exp. Date	6/2/2016	;  Lot Number	160700191M	,	Exp. Date	6/9/2016	;  Lot Number	160750045M	,	Exp. Date	6/13/2016	;  Lot Number	160770156M	,	Exp. Date	6/16/2016	;  Lot Number	160910163M	,	Exp. Date	6/30/2016	;  Lot Number	160810279M	,	Exp. Date	6/20/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1420-2016","Class II","4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection,  Service Code 2T8214, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC	 61553-214-48	","936 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K8130	,	Lot Number	160450167M	,	Exp. Date	5/9/2016	;  Service Code	2K8130	,	Lot Number	160460113M	,	Exp. Date	5/10/2016	;  Service Code	2K8130	,	Lot Number	160490184M	,	Exp. Date	5/13/2016	;  Service Code	2K8130	,	Lot Number	160540122M	,	Exp. Date	5/17/2016	;  Service Code	2K8130	,	Lot Number	160590163M	,	Exp. Date	5/23/2016	;  Service Code	2K8130	,	Lot Number	160610226M	,	Exp. Date	5/25/2016	;  Service Code	2K8130	,	Lot Number	160630185M	,	Exp. Date	5/27/2016	;  Service Code	2K8130	,	Lot Number	160670242M	,	Exp. Date	5/31/2016	;  Service Code	2K8130	,	Lot Number	160680239M	,	Exp. Date	6/1/2016	;  Service Code	2K8130	,	Lot Number	160730147M	,	Exp. Date	6/6/2016	;  Service Code	2K8130	,	Lot Number	160750140M	,	Exp. Date	6/8/2016	;  Service Code	2K8130	,	Lot Number	160770169M	,	Exp. Date	6/10/2016	;  Service Code	2K8130	,	Lot Number	160820223M	,	Exp. Date	6/15/2016	;  Service Code	2K8130	,	Lot Number	160840161M	,	Exp. Date	6/17/2016	;  Service Code	2K8130	,	Lot Number	160850004M	,	Exp. Date	6/17/2016	;  Service Code	2K8130	,	Lot Number	160960163M	,	Exp. Date	6/29/2016	;  Service Code	2K8214	,	Lot Number	160480213M	,	Exp. Date	5/18/2016	;  Service Code	2K8214	,	Lot Number	160490043C	,	Exp. Date	5/19/2016	;  Service Code	2K8214	,	Lot Number	160660037M	,	Exp. Date	6/4/2016	;  Service Code	2K8214	,	Lot Number	160680039M	,	Exp. Date	6/6/2016	;  Service Code	2K8214	,	Lot Number	160700003M	,	Exp. Date	6/8/2016	;  Service Code	2K8214	,	Lot Number	160770051M	,	Exp. Date	6/15/2016	;  Service Code	2K8214	,	Lot Number	160840167M	,	Exp. Date	6/23/2016	;  Service Code	2K8214	,	Lot Number	160900176M	,	Exp. Date	6/29/2016	;  Service Code	2K9130	,	Lot Number	160470154M	,	Exp. Date	5/17/2016	;  Service Code	2K9130	,	Lot Number	160520171M	,	Exp. Date	5/22/2016	;  Service Code	2K9130	,	Lot Number	160670175M	,	Exp. Date	6/6/2016	;  Service Code	2K9130	,	Lot Number	160870068M	,	Exp. Date	6/25/2016	;  Service Code	2T8214	,	Lot Number	160480151M	,	Exp. Date	5/9/2016	;  Service Code	2T8214	,	Lot Number	160490007M	,	Exp. D",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1428-2016","Class II","5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61		","115 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160380152M	,	Exp. Date	5/8/2016	;  Lot Number	160400233M	,	Exp. Date	5/10/2016	;  Lot Number	160540186M	,	Exp. Date	5/24/2016	;  Lot Number	160660046M	,	Exp. Date	6/4/2016	;  Lot Number	160730154M	,	Exp. Date	6/12/2016	;  Lot Number	160750176M	,	Exp. Date	6/14/2016	;  Lot Number	160760046M	,	Exp. Date	6/14/2016	;  Lot Number	160800066M	,	Exp. Date	6/18/2016	;  Lot Number	160820111M	,	Exp. Date	6/20/2016	;  Lot Number	160960039M	,	Exp. Date	7/4/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1434-2016","Class II","8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50	","650 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160390094M	,	Exp. Date	5/9/2016	;  Lot Number	160450111M	,	Exp. Date	5/15/2016	;  Lot Number	160520101M	,	Exp. Date	5/22/2016	;  Lot Number	160550109M	,	Exp. Date	5/25/2016	;  Lot Number	160610124M	,	Exp. Date	5/31/2016	;  Lot Number	160620115M	,	Exp. Date	6/1/2016	;  Lot Number	160670036M	,	Exp. Date	6/5/2016	;  Lot Number	160680038M	,	Exp. Date	6/7/2016	;  Lot Number	160690110M	,	Exp. Date	6/7/2016	;  Lot Number	160740117M	,	Exp. Date	6/12/2016	;  Lot Number	160760109M	,	Exp. Date	6/15/2016	;  Lot Number	160820103M	,	Exp. Date	6/21/2016	;  Lot Number	160830107M	,	Exp. Date	6/22/2016	;  Lot Number	160900032M	,	Exp. Date	6/29/2016	;  Lot Number	160970021M	,	Exp. Date	7/6/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1433-2016","Class II","6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86","79 syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160450146M	,	Exp. Date	5/14/2016	;  Lot Number	160520168M	,	Exp. Date	5/22/2016	;  Lot Number	160620181M	,	Exp. Date	6/1/2016	;  Lot Number	160760038M	,	Exp. Date	6/14/2016	;  Lot Number	160900172M	,	Exp. Date	6/29/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1423-2016","Class II","5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride    Service Code	2K8135	,	NDC	61553-135-48	,	100 ml in 150 ml Baxter Intravia Bag 	;  Service Code	2K8136	,	NDC	61553-136-02	,	250 ml in 250 ml Baxter Intravia Bag 	;  Service Code	2K8447	,	NDC	61553-447-25	,	500 ml in 500 ml Baxter Intravia Bag 	;  Service Code	2K9135	,	NDC	61553-135-10	,	350 ml in 500 ml Baxter Intravia Bag 	;  Service Code	2K9915	,	NDC	61553-915-97	,	250 ml in 250 ml Baxter Intravia Bag 	;  Service Code	4J8136	,	NDC	61553-136-97	,	250 ml in 250 ml Baxter Intravia Bag 	;  Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141,","3,474 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8136	,	Lot Number	160390196M	,	Exp. Date	5/9/2016	;  Service Code	2H8136	,	Lot Number	160400231M	,	Exp. Date	5/10/2016	;  Service Code	2H8136	,	Lot Number	160410114M	,	Exp. Date	5/11/2016	;  Service Code	2H8136	,	Lot Number	160460187M	,	Exp. Date	5/16/2016	;  Service Code	2H8136	,	Lot Number	160490237M	,	Exp. Date	5/19/2016	;  Service Code	2H8136	,	Lot Number	160520172M	,	Exp. Date	5/22/2016	;  Service Code	2H8136	,	Lot Number	160530288M	,	Exp. Date	5/23/2016	;  Service Code	2H8136	,	Lot Number	160600186M	,	Exp. Date	5/30/2016	;  Service Code	2H8136	,	Lot Number	160630207M	,	Exp. Date	6/2/2016	;  Service Code	2H8136	,	Lot Number	160670243M	,	Exp. Date	6/6/2016	;  Service Code	2H8136	,	Lot Number	160730070M	,	Exp. Date	6/11/2016	;  Service Code	2H8136	,	Lot Number	160740213M	,	Exp. Date	6/13/2016	;  Service Code	2H8136	,	Lot Number	160810151M	,	Exp. Date	6/20/2016	;  Service Code	2H8136	,	Lot Number	160830114M	,	Exp. Date	6/22/2016	;  Service Code	2H8136	,	Lot Number	160880266M	,	Exp. Date	6/27/2016	;  Service Code	2H8136	,	Lot Number	160950223M	,	Exp. Date	7/4/2016	;  Service Code	2H8136	,	Lot Number	160960179M	,	Exp. Date	7/5/2016	;  Service Code	2H8136	,	Lot Number	161080119M	,	Exp. Date	7/17/2016	;  Service Code	2K8135	,	Lot Number	160390318M	,	Exp. Date	5/9/2016	;  Service Code	2K8135	,	Lot Number	160450256M	,	Exp. Date	5/15/2016	;  Service Code	2K8135	,	Lot Number	160520144M	,	Exp. Date	5/22/2016	;  Service Code	2K8135	,	Lot Number	160660248M	,	Exp. Date	6/5/2016	;  Service Code	2K8135	,	Lot Number	160730089M	,	Exp. Date	6/12/2016	;  Service Code	2K8135	,	Lot Number	160840235M	,	Exp. Date	6/23/2016	;  Service Code	2K8135	,	Lot Number	160950175M	,	Exp. Date	7/4/2016	;  Service Code	2K8136	,	Lot Number	160470209M	,	Exp. Date	5/11/2016	;  Service Code	2K8136	,	Lot Number	160490159M	,	Exp. Date	5/13/2016	;  Service Code	2K8136	,	Lot Number	160560128M	,	Exp. Date	5/20/2016	;  Service Code	2K8136	,	Lot Number	160600250M	,	Exp. Date	5/24/2016	;  Service Code	2K8136	,	Lot Number	160660268M	,	Exp. ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1360-2016","Class II","0.03% Bupivacaine HCl (Preservative Free) in  Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11	  ","177 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot # 160410097M; Exp. 05/16	  Lot # 160420107M; Exp. 05/16	  Lot # 160460117M; Exp. 05/16	  Lot # 160530133M; Exp. 05/16  Lot # 160540206M; Exp. 05/16	  Lot # 160570008M; Exp. 05/16		  Lot # 160670132M; Exp. 06/16		  Lot # 160700001C; Exp. 06/16  Lot # 160770020C; Exp. 06/16  Lot # 160900103C; Exp. 06/16  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1372-2016","Class II","0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141","866 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2N1488	,	Lot Number	160520176M	,	Exp. Date	5/22/2016	;  Service Code	2N1488	,	Lot Number	160600059M	,	Exp. Date	5/30/2016	;  Service Code	2N1488	,	Lot Number	160970115M	,	Exp. Date	7/5/2016	;  Service Code	2N1489	,	Lot Number	160490027C	,	Exp. Date	5/19/2016	;  Service Code	2N1489	,	Lot Number	160560032C	,	Exp. Date	5/26/2016	;  Service Code	2N1489	,	Lot Number	160620024C	,	Exp. Date	6/1/2016	;  Service Code	2N1489	,	Lot Number	160630029C	,	Exp. Date	6/2/2016	;  Service Code	2N1489	,	Lot Number	160670059C	,	Exp. Date	6/6/2016	;  Service Code	2N1489	,	Lot Number	160700047C	,	Exp. Date	6/9/2016	;  Service Code	2N1489	,	Lot Number	160730025C	,	Exp. Date	6/12/2016	;  Service Code	2N1489	,	Lot Number	160810057C	,	Exp. Date	6/20/2016	;  Service Code	2R3332-5	,	Lot Number	160420156M	,	Exp. Date	5/11/2016	;  Service Code	2R3332-5	,	Lot Number	160470152M	,	Exp. Date	5/16/2016	;  Service Code	2R3332-5	,	Lot Number	160620035M	,	Exp. Date	5/31/2016	;  Service Code	2R3332-5	,	Lot Number	160770159M	,	Exp. Date	6/16/2016	;  Service Code	2R3332-5	,	Lot Number	160830044M	,	Exp. Date	6/21/2016	;  Service Code	2R3332-5	,	Lot Number	160970032M	,	Exp. Date	7/5/2016	;  Service Code	3332NO	,	Lot Number	160380115M	,	Exp. Date	5/7/2016	;  Service Code	3332NO	,	Lot Number	160420112M	,	Exp. Date	5/11/2016	;  Service Code	3332NO	,	Lot Number	160540138M	,	Exp. Date	5/24/2016	;  Service Code	3332NO	,	Lot Number	160660215M	,	Exp. Date	6/5/2016	;  Service Code	3332NO	,	Lot Number	160690125M	,	Exp. Date	6/7/2016	;  Service Code	3332NO	,	Lot Number	160750228M	,	Exp. Date	6/14/2016	;  Service Code	3332NO	,	Lot Number	160900145M	,	Exp. Date	6/28/2016	;  Service Code	3332NO	,	Lot Number	160950153M	,	Exp. Date	7/4/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1365-2016","Class II","0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141	","8,581 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2C8192	,	Lot Number	160830033M	,	Exp. Date	5/7/2016	;  Service Code	2H8192	,	Lot Number	160380144M	,	Exp. Date	5/8/2016	;  Service Code	2H8192	,	Lot Number	160480178M	,	Exp. Date	5/18/2016	;  Service Code	2H8192	,	Lot Number	160610225M	,	Exp. Date	5/31/2016	;  Service Code	2H8192	,	Lot Number	160690186M	,	Exp. Date	6/8/2016	;  Service Code	2H8192	,	Lot Number	160730071M	,	Exp. Date	6/12/2016	;  Service Code	2H8192	,	Lot Number	160760041M	,	Exp. Date	6/14/2016	;  Service Code	2H8192	,	Lot Number	160820212M	,	Exp. Date	6/21/2016	;  Service Code	2H8192	,	Lot Number	160880171M	,	Exp. Date	6/27/2016	;  Service Code	2H8192	,	Lot Number	160940141M	,	Exp. Date	7/3/2016	;  Service Code	2H8192	,	Lot Number	160950053M	,	Exp. Date	7/3/2016	;  Service Code	2H8194	,	Lot Number	160410184M	,	Exp. Date	5/11/2016	;  Service Code	2H8194	,	Lot Number	160540217M	,	Exp. Date	5/24/2016	;  Service Code	2H8194	,	Lot Number	160550223M	,	Exp. Date	5/25/2016	;  Service Code	2H8194	,	Lot Number	160590170M	,	Exp. Date	5/29/2016	;  Service Code	2H8194	,	Lot Number	160630202M	,	Exp. Date	6/2/2016	;  Service Code	2H8194	,	Lot Number	160660049M	,	Exp. Date	6/4/2016	;  Service Code	2H8194	,	Lot Number	160740150M	,	Exp. Date	6/13/2016	;  Service Code	2H8194	,	Lot Number	160750224M	,	Exp. Date	6/14/2016	;  Service Code	2H8194	,	Lot Number	160760187M	,	Exp. Date	6/15/2016	;  Service Code	2H8194	,	Lot Number	160810145M	,	Exp. Date	6/19/2016	;  Service Code	2H8194	,	Lot Number	160840152M	,	Exp. Date	6/23/2016	;  Service Code	2H8194	,	Lot Number	160870050M	,	Exp. Date	6/25/2016	;  Service Code	2H8194	,	Lot Number	160880248M	,	Exp. Date	6/27/2016	;  Service Code	2H8194	,	Lot Number	160900001M	,	Exp. Date	6/28/2016	;  Service Code	2H8194	,	Lot Number	160910151M	,	Exp. Date	6/30/2016	;  Service Code	2H8194	,	Lot Number	160950209M	,	Exp. Date	7/4/2016	;  Service Code	2H8194	,	Lot Number	160960222M	,	Exp. Date	7/5/2016	;  Service Code	2H8194	,	Lot Number	161080218M	,	Exp. Date	7/17/2016	;  Service Code	2K8117	,	Lot Number	160390199M	,	Exp. D",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1430-2016","Class II","5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54		","90 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160730064M	,	Exp. Date	6/2/2016	;  Lot Number	160800057M	,	Exp. Date	6/9/2016	;  Lot Number	160820113M	,	Exp. Date	6/11/2016	;  Lot Number	160960142M	,	Exp. Date	6/26/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1378-2016","Class II","10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,	  NDC 61553-143-50		      ","65 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8143	,	Lot Number	160830115M	,	Exp. Date	6/22/2016	;  Service Code	2H8143	,	Lot Number	160910155M	,	Exp. Date	6/30/2016	;  Service Code	2K8448	,	Lot Number	160480205M	,	Exp. Date	5/12/2016	;  Service Code	2K8448	,	Lot Number	160610064M	,	Exp. Date	5/24/2016	;  Service Code	2K8448	,	Lot Number	160760042M	,	Exp. Date	6/9/2016	;  Service Code	2K8448	,	Lot Number	160890047M	,	Exp. Date	6/22/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1388-2016","Class II","16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96	","230 BD syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160410126M	,	Exp. Date	5/10/2016	;  Lot Number	160450114M	,	Exp. Date	5/14/2016	;  Lot Number	160460158M	,	Exp. Date	5/15/2016	;  Lot Number	160670040M	,	Exp. Date	6/5/2016	;  Lot Number	160730148M	,	Exp. Date	6/12/2016	;  Lot Number	160840112M	,	Exp. Date	6/22/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1375-2016","Class II","1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95 ","1,527 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K9998	,	Lot Number	160460135M	,	Exp. Date	5/10/2016	;  Service Code	2K9998	,	Lot Number	160530146M	,	Exp. Date	5/17/2016	;  Service Code	2K9998	,	Lot Number	160590137M	,	Exp. Date	5/23/2016	;  Service Code	2K9998	,	Lot Number	160660221M	,	Exp. Date	5/30/2016	;  Service Code	2K9998	,	Lot Number	160730163M	,	Exp. Date	6/6/2016	;  Service Code	2K9998	,	Lot Number	160870147M	,	Exp. Date	6/20/2016	;  Service Code	2K9998	,	Lot Number	160880265M	,	Exp. Date	6/21/2016	;  Service Code	2K9998	,	Lot Number	160940206M	,	Exp. Date	6/27/2016	;  Service Code	2K9998	,	Lot Number	161080210M	,	Exp. Date	7/11/2016	;  Service Code	2T8998	,	Lot Number	160460267M	,	Exp. Date	5/7/2016	;  Service Code	2T8998	,	Lot Number	160470042M	,	Exp. Date	5/8/2016	;  Service Code	2T8998	,	Lot Number	160530034M	,	Exp. Date	5/14/2016	;  Service Code	2T8998	,	Lot Number	160610043M	,	Exp. Date	5/22/2016	;  Service Code	2T8998	,	Lot Number	160640008M	,	Exp. Date	5/24/2016	;  Service Code	2T8998	,	Lot Number	160690011C	,	Exp. Date	5/30/2016	;  Service Code	2T8998	,	Lot Number	160690012C	,	Exp. Date	5/30/2016	;  Service Code	2T8998	,	Lot Number	160740064C	,	Exp. Date	6/4/2016	;  Service Code	2T8998	,	Lot Number	160810066C	,	Exp. Date	6/11/2016	;  Service Code	2T8998	,	Lot Number	160840030C	,	Exp. Date	6/14/2016	;  Service Code	2T8998	,	Lot Number	160880042C	,	Exp. Date	6/18/2016	;  Service Code	2T8998	,	Lot Number	160880043C	,	Exp. Date	6/18/2016	;  Service Code	2T8998	,	Lot Number	160910014C	,	Exp. Date	6/21/2016	;  Service Code	2T8998	,	Lot Number	160910015C	,	Exp. Date	6/21/2016	;  Service Code	2T8998	,	Lot Number	160950071C	,	Exp. Date	6/25/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1413-2016","Class II","3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,  250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97	  ","700 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160420248M	,	Exp. Date	5/6/2016	;  Lot Number	160490250M	,	Exp. Date	5/13/2016	;  Lot Number	160600329M	,	Exp. Date	5/24/2016	;  Lot Number	160620002M	,	Exp. Date	5/25/2016	;  Lot Number	160660181M	,	Exp. Date	5/30/2016	;  Lot Number	160760025M	,	Exp. Date	6/9/2016	;  Lot Number	160870159M	,	Exp. Date	6/20/2016	;  Lot Number	160940170M	,	Exp. Date	6/27/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1380-2016","Class II","10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02	",,"Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160460189M	,	Exp. Date	5/10/2016	;  Lot Number	160480179M	,	Exp. Date	5/12/2016	;  Lot Number	160520105M	,	Exp. Date	5/15/2016	;  Lot Number	160530291M	,	Exp. Date	5/17/2016	;  Lot Number	160540130M	,	Exp. Date	5/17/2016	;  Lot Number	160550186M	,	Exp. Date	5/19/2016	;  Lot Number	160560087M	,	Exp. Date	5/19/2016	;  Lot Number	160590074M	,	Exp. Date	5/23/2016	;  Lot Number	160620037M	,	Exp. Date	5/25/2016	;  Lot Number	160630028M	,	Exp. Date	5/26/2016	;  Lot Number	160660039M	,	Exp. Date	5/29/2016	;  Lot Number	160730059M	,	Exp. Date	6/6/2016	;  Lot Number	160740234M	,	Exp. Date	6/7/2016	;  Lot Number	160800073M	,	Exp. Date	6/12/2016	;  Lot Number	160820049M	,	Exp. Date	6/14/2016	;  Lot Number	160890045M	,	Exp. Date	6/21/2016	;  Lot Number	160970197M	,	Exp. Date	6/30/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1414-2016","Class II","3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag  Service Code 2H8262 (NDC 61553-262-50),  250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141		","345 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8180	,	Lot Number	160450152M	,	Exp. Date	5/11/2016	;  Service Code	2H8180	,	Lot Number	160830040M	,	Exp. Date	6/17/2016	;  Service Code	2H8262	,	Lot Number	160380102M	,	Exp. Date	5/8/2016	;  Service Code	2H8262	,	Lot Number	160750131M	,	Exp. Date	6/14/2016	;  Service Code	2H8262	,	Lot Number	161080121M	,	Exp. Date	7/17/2016	;  Service Code	2K8180	,	Lot Number	160460038C	,	Exp. Date	5/10/2016	;  Service Code	2K8180	,	Lot Number	160480026C	,	Exp. Date	5/12/2016	;  Service Code	2K8180	,	Lot Number	160550022C	,	Exp. Date	5/19/2016	;  Service Code	2K8180	,	Lot Number	160620021C	,	Exp. Date	5/26/2016	;  Service Code	2K8180	,	Lot Number	160680038C	,	Exp. Date	6/1/2016	;  Service Code	2K8180	,	Lot Number	160760022C	,	Exp. Date	6/9/2016	;  Service Code	2K8180	,	Lot Number	160770042C	,	Exp. Date	6/10/2016	;  Service Code	2K8180	,	Lot Number	160830034C	,	Exp. Date	6/16/2016	;  Service Code	2K8180	,	Lot Number	160900094C	,	Exp. Date	6/23/2016	;  Service Code	2K8180	,	Lot Number	160940033C	,	Exp. Date	6/27/2016	;  Service Code	2K8180	,	Lot Number	160970035C	,	Exp. Date	6/30/2016	;  Service Code	2K8905	,	Lot Number	160810187M	,	Exp. Date	6/11/2016	;  Service Code	2K8905	,	Lot Number	160890186M	,	Exp. Date	6/18/2016	;  Service Code	2K8975	,	Lot Number	160550132M	,	Exp. Date	5/15/2016	;  Service Code	2K8975	,	Lot Number	160610229M	,	Exp. Date	5/22/2016	;  Service Code	2K8975	,	Lot Number	160770165M	,	Exp. Date	6/7/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1425-206","Class II","5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257,  Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20	","2,713 syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8138	,	Lot Number	160410192M	,	Exp. Date	5/11/2016	;  Service Code	2H8138	,	Lot Number	160600314M	,	Exp. Date	5/30/2016	;  Service Code	2H8138	,	Lot Number	160690002M	,	Exp. Date	6/7/2016	;  Service Code	2H8138	,	Lot Number	160690191M	,	Exp. Date	6/8/2016	;  Service Code	2H8138	,	Lot Number	160740233M	,	Exp. Date	6/13/2016	;  Service Code	2H8138	,	Lot Number	160760163M	,	Exp. Date	6/14/2016	;  Service Code	2H8138	,	Lot Number	160830226M	,	Exp. Date	6/22/2016	;  Service Code	2H8138	,	Lot Number	160890256M	,	Exp. Date	6/28/2016	;  Service Code	2H8138	,	Lot Number	160940138M	,	Exp. Date	7/3/2016	;  Service Code	2H8138	,	Lot Number	160960197M	,	Exp. Date	7/5/2016	;  Service Code	2H8138	,	Lot Number	161080219M	,	Exp. Date	7/17/2016	;  Service Code	2K8138	,	Lot Number	160450061M	,	Exp. Date	5/9/2016	;  Service Code	2K8138	,	Lot Number	160470232M	,	Exp. Date	5/11/2016	;  Service Code	2K8138	,	Lot Number	160480268M	,	Exp. Date	5/12/2016	;  Service Code	2K8138	,	Lot Number	160590083M	,	Exp. Date	5/23/2016	;  Service Code	2K8138	,	Lot Number	160630170M	,	Exp. Date	5/27/2016	;  Service Code	2K8138	,	Lot Number	160690170M	,	Exp. Date	6/2/2016	;  Service Code	2K8138	,	Lot Number	160700150M	,	Exp. Date	6/3/2016	;  Service Code	2K8138	,	Lot Number	160770283M	,	Exp. Date	6/10/2016	;  Service Code	2K8138	,	Lot Number	160840146M	,	Exp. Date	6/17/2016	;  Service Code	2K8138	,	Lot Number	160910269M	,	Exp. Date	6/24/2016	;  Service Code	2K8138	,	Lot Number	161080325M	,	Exp. Date	7/11/2016	;  Service Code	2K8807	,	Lot Number	160490044C	,	Exp. Date	5/10/2016	;  Service Code	2K8807	,	Lot Number	160630012C	,	Exp. Date	5/24/2016	;  Service Code	2K8807	,	Lot Number	160700033C	,	Exp. Date	5/31/2016	;  Service Code	2K8807	,	Lot Number	160970033C	,	Exp. Date	6/27/2016	;  Service Code	2K8872	,	Lot Number	160600059C	,	Exp. Date	5/21/2016	;  Service Code	2K8872	,	Lot Number	160630026C	,	Exp. Date	5/24/2016	;  Service Code	2K8872	,	Lot Number	160660158M	,	Exp. Date	5/27/2016	;  Service Code	2K8872	,	Lot Number	160740036M	,	Exp.",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1400-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98","480 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160480033C	,	Exp. Date	5/12/2016	;  Lot Number	160520027C	,	Exp. Date	5/16/2016	;  Lot Number	160610040C	,	Exp. Date	5/25/2016	;  Lot Number	160750051C	,	Exp. Date	6/8/2016	;  Lot Number	160800038C	,	Exp. Date	6/13/2016	;  Lot Number	160880045C	,	Exp. Date	6/21/2016	;  Lot Number	160940037C	,	Exp. Date	6/27/2016	;  Lot Number	160960035C	,	Exp. Date	6/29/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1382-2016","Class II","10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27	    ","740 BD syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160380150M	,	Exp. Date	5/7/2016	;  Lot Number	160420180M	,	Exp. Date	5/11/2016	;  Lot Number	160450106M	,	Exp. Date	5/14/2016	;  Lot Number	160480109M	,	Exp. Date	5/17/2016	;  Lot Number	160660210M	,	Exp. Date	6/5/2016	;  Lot Number	160700121M	,	Exp. Date	6/8/2016	;  Lot Number	160770215M	,	Exp. Date	6/16/2016	;  Lot Number	160820099M	,	Exp. Date	6/20/2016	;  Lot Number	160880167M	,	Exp. Date	6/26/2016	;  Lot Number	161080045M	,	Exp. Date	7/16/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1389-2016","Class II","2 mcg/mL Fentanyl Citrate and  0.25% Bupivacaine HCl (Preservative Free)  in 0.9% Sodium Chloride,	 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48  ","425 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160390174M	,	Exp. Date	5/9/2016	;  Lot Number	160400196M	,	Exp. Date	5/10/2016	;  Lot Number	160470128M	,	Exp. Date	5/17/2016	;  Lot Number	160530287M	,	Exp. Date	5/23/2016	;  Lot Number	160540190M	,	Exp. Date	5/24/2016	;  Lot Number	160590168M	,	Exp. Date	5/29/2016	;  Lot Number	160610129M	,	Exp. Date	5/31/2016	;  Lot Number	160680254M	,	Exp. Date	6/7/2016	;  Lot Number	160700199M	,	Exp. Date	6/9/2016	;  Lot Number	160750132M	,	Exp. Date	6/14/2016	;  Lot Number	160770177M	,	Exp. Date	6/16/2016	;  Lot Number	160810292M	,	Exp. Date	6/20/2016	;  Lot Number	160820115M	,	Exp. Date	6/21/2016	;  Lot Number	160840157M	,	Exp. Date	6/23/2016	;  Lot Number	160880249M	,	Exp. Date	6/27/2016	;  Lot Number	160890261M	,	Exp. Date	6/28/2016	;  Lot Number	160940057M	,	Exp. Date	7/2/2016	;  Lot Number	160960151M	,	Exp. Date	7/5/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1392-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141		  ","950 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K9226	,	Lot Number	160450145M	,	Exp. Date	5/9/2016	;  Service Code	2K9226	,	Lot Number	160530166M	,	Exp. Date	5/17/2016	;  Service Code	2K9226	,	Lot Number	160560080M	,	Exp. Date	5/19/2016	;  Service Code	2K9226	,	Lot Number	160670164M	,	Exp. Date	5/31/2016	;  Service Code	2K9226	,	Lot Number	160730130M	,	Exp. Date	6/6/2016	;  Service Code	2K9226	,	Lot Number	160770032M	,	Exp. Date	6/10/2016	;  Service Code	2K9226	,	Lot Number	160810035M	,	Exp. Date	6/13/2016	;  Service Code	2K9226	,	Lot Number	160820135M	,	Exp. Date	6/15/2016	;  Service Code	2K9226	,	Lot Number	160870152M	,	Exp. Date	6/20/2016	;  Service Code	2K9226	,	Lot Number	160890036M	,	Exp. Date	6/22/2016	;  Service Code	2K9226	,	Lot Number	160950040M	,	Exp. Date	6/27/2016	;  Service Code	2K9294	,	Lot Number	160400210M	,	Exp. Date	5/10/2016	;  Service Code	2K9294	,	Lot Number	160700164M	,	Exp. Date	6/9/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1418-2016","Class II","4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08),   Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141	","455 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8126	,	Lot Number	161080146M	,	Exp. Date	7/17/2016	;  Service Code	2K8127	,	Lot Number	160460115M	,	Exp. Date	5/10/2016	;  Service Code	2K8127	,	Lot Number	160560222M	,	Exp. Date	5/20/2016	;  Service Code	2K8127	,	Lot Number	160610209M	,	Exp. Date	5/25/2016	;  Service Code	2K8127	,	Lot Number	160620148M	,	Exp. Date	5/26/2016	;  Service Code	2K8127	,	Lot Number	160660062M	,	Exp. Date	5/29/2016	;  Service Code	2K8127	,	Lot Number	160680154M	,	Exp. Date	6/1/2016	;  Service Code	2K8127	,	Lot Number	160690126M	,	Exp. Date	6/2/2016	;  Service Code	2K8127	,	Lot Number	160740153M	,	Exp. Date	6/7/2016	;  Service Code	2K8127	,	Lot Number	160800064M	,	Exp. Date	6/12/2016	;  Service Code	2K8127	,	Lot Number	160810161M	,	Exp. Date	6/14/2016	;  Service Code	2K8127	,	Lot Number	160880187M	,	Exp. Date	6/21/2016	;  Service Code	2K8127	,	Lot Number	160950226M	,	Exp. Date	6/28/2016	;  Service Code	2K8127	,	Lot Number	160960154M	,	Exp. Date	6/29/2016	;  Service Code	2K8211	,	Lot Number	160530215M	,	Exp. Date	5/23/2016	;  Service Code	2K8211	,	Lot Number	160590067M	,	Exp. Date	5/29/2016	;  Service Code	2K8211	,	Lot Number	160750033M	,	Exp. Date	6/13/2016	;  Service Code	2K8211	,	Lot Number	160880261M	,	Exp. Date	6/27/2016	;  Service Code	2K8211	,	Lot Number	160910039M	,	Exp. Date	6/29/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1412-2016","Class II","20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48	","555 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K8158	,	Lot Number	160380113M	,	Exp. Date	5/8/2016	;  Service Code	2K8158	,	Lot Number	160410115M	,	Exp. Date	5/11/2016	;  Service Code	2K8158	,	Lot Number	160420111M	,	Exp. Date	5/12/2016	;  Service Code	2K8158	,	Lot Number	160450184M	,	Exp. Date	5/15/2016	;  Service Code	2K8158	,	Lot Number	160520106M	,	Exp. Date	5/21/2016	;  Service Code	2K8158	,	Lot Number	160530143M	,	Exp. Date	5/23/2016	;  Service Code	2K8158	,	Lot Number	160550124M	,	Exp. Date	5/25/2016	;  Service Code	2K8158	,	Lot Number	160560211M	,	Exp. Date	5/26/2016	;  Service Code	2K8158	,	Lot Number	160600195M	,	Exp. Date	5/30/2016	;  Service Code	2K8158	,	Lot Number	160620137M	,	Exp. Date	6/1/2016	;  Service Code	2K8158	,	Lot Number	160690124M	,	Exp. Date	6/7/2016	;  Service Code	2K8158	,	Lot Number	160730219M	,	Exp. Date	6/12/2016	;  Service Code	2K8158	,	Lot Number	160740084C	,	Exp. Date	6/14/2016	;  Service Code	2K8158	,	Lot Number	160770123M	,	Exp. Date	6/16/2016	;  Service Code	2K8158	,	Lot Number	160840027M	,	Exp. Date	6/22/2016	;  Service Code	2K8158	,	Lot Number	160870228M	,	Exp. Date	6/26/2016	;  Service Code	2K8158	,	Lot Number	160910212M	,	Exp. Date	6/30/2016	;  Service Code	2K8158	,	Lot Number	161080220M	,	Exp. Date	7/17/2016	;  Service Code	2K8495	,	Lot Number	160420155M	,	Exp. Date	5/12/2016	;  Service Code	2K8495	,	Lot Number	160490122M	,	Exp. Date	5/19/2016	;  Service Code	2K8913	,	Lot Number	160940019C	,	Exp. Date	5/10/2016	;  Service Code	2K8913	,	Lot Number	160960022C	,	Exp. Date	5/12/2016	;  Service Code	2K8913	,	Lot Number	160970021C	,	Exp. Date	5/13/2016	;  Service Code	2K8947	,	Lot Number	160970025C	,	Exp. Date	5/17/2016	;  Service Code	2K8986	,	Lot Number	160910040M	,	Exp. Date	5/11/2016	;  Service Code	2T6622	,	Lot Number	160950152M	,	Exp. Date	5/10/2016	;  Service Code	2K8495	,	Lot Number	160520175M	,	Exp. Date	5/22/2016	;  Service Code	2K8495	,	Lot Number	160530128M	,	Exp. Date	5/23/2016	;  Service Code	2K8495	,	Lot Number	160540117M	,	Exp. Date	5/24/2016	;  Service Code	2K8495	,	Lot Number	160550130M	,	",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1424-2016","Class II","5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141  ","562 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8287	,	Lot Number	160390110M	,	Exp. Date	5/9/2016	;  Service Code	2H8287	,	Lot Number	160450123M	,	Exp. Date	5/15/2016	;  Service Code	2H8287	,	Lot Number	160470115M	,	Exp. Date	5/17/2016	;  Service Code	2H8287	,	Lot Number	160600178M	,	Exp. Date	5/30/2016	;  Service Code	2H8287	,	Lot Number	160750128M	,	Exp. Date	6/14/2016	;  Service Code	2H8287	,	Lot Number	160800058M	,	Exp. Date	6/18/2016	;  Service Code	2H8287	,	Lot Number	160820110M	,	Exp. Date	6/20/2016	;  Service Code	2H8287	,	Lot Number	160960130M	,	Exp. Date	7/5/2016	;  Service Code	2H8287	,	Lot Number	160970119M	,	Exp. Date	7/6/2016	;  Service Code	2K8287	,	Lot Number	160530140M	,	Exp. Date	5/17/2016	;  Service Code	2K8287	,	Lot Number	160630194M	,	Exp. Date	5/27/2016	;  Service Code	2K8287	,	Lot Number	160680251M	,	Exp. Date	6/1/2016	;  Service Code	2K8287	,	Lot Number	160760045M	,	Exp. Date	6/8/2016	;  Service Code	2K8287	,	Lot Number	160770044M	,	Exp. Date	6/9/2016	;  Service Code	2K8287	,	Lot Number	160770117M	,	Exp. Date	6/10/2016	;  Service Code	2K8287	,	Lot Number	160940055M	,	Exp. Date	6/26/2016	;  Service Code	2K8287	,	Lot Number	160960048M	,	Exp. Date	6/28/2016	;  Service Code	2K8811	,	Lot Number	160490167M	,	Exp. Date	5/9/2016	;  Service Code	2K8811	,	Lot Number	160530310M	,	Exp. Date	5/14/2016	;  Service Code	2K8811	,	Lot Number	160600078M	,	Exp. Date	5/20/2016	;  Service Code	2K8811	,	Lot Number	160630029M	,	Exp. Date	5/23/2016	;  Service Code	2K8811	,	Lot Number	160670255M	,	Exp. Date	5/28/2016	;  Service Code	2K8811	,	Lot Number	160750239M	,	Exp. Date	6/5/2016	;  Service Code	2K8811	,	Lot Number	160810296M	,	Exp. Date	6/11/2016	;  Service Code	2K8811	,	Lot Number	160950247M	,	Exp. Date	6/25/2016	;  Service Code	2K8873	,	Lot Number	160680043C	,	Exp. Date	5/29/2016	;  Service Code	2K8873	,	Lot Number	160840036C	,	Exp. Date	6/14/2016	;  Service Code	2K8873	,	Lot Number	160870015C	,	Exp. Date	6/17/2016	;  Service Code	2K8873	,	Lot Number	160960052C	,	Exp. Date	6/26/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1394-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141	","1,280 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K8176	,	Lot Number	160460099M	,	Exp. Date	5/10/2016	;  Service Code	2K8176	,	Lot Number	160480269M	,	Exp. Date	5/12/2016	;  Service Code	2K8176	,	Lot Number	160560160M	,	Exp. Date	5/20/2016	;  Service Code	2K8176	,	Lot Number	160630171M	,	Exp. Date	5/27/2016	;  Service Code	2K8176	,	Lot Number	160690141M	,	Exp. Date	6/2/2016	;  Service Code	2K8176	,	Lot Number	160740128M	,	Exp. Date	6/7/2016	;  Service Code	2K8176	,	Lot Number	160750247M	,	Exp. Date	6/8/2016	;  Service Code	2K8176	,	Lot Number	160810137M	,	Exp. Date	6/14/2016	;  Service Code	2K8176	,	Lot Number	160870187M	,	Exp. Date	6/20/2016	;  Service Code	2K8176	,	Lot Number	160940253M	,	Exp. Date	6/27/2016	;  Service Code	2K8176	,	Lot Number	161080131M	,	Exp. Date	7/11/2016	;  Service Code	2K8871	,	Lot Number	160480223M	,	Exp. Date	5/8/2016	;  Service Code	2K8871	,	Lot Number	160670054C	,	Exp. Date	5/28/2016	;  Service Code	2K8871	,	Lot Number	160870033C	,	Exp. Date	6/17/2016	;  Service Code	2K8967	,	Lot Number	16092001C	,	Exp. Date	6/21/2016	;  Service Code	2T8871	,	Lot Number	160970026M	,	Exp. Date	5/7/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1387-2016","Class II","10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02	,	  ","1,277 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K8482	,	Lot Number	160400113M	,	Exp. Date	5/10/2016	;  Service Code	2K8482	,	Lot Number	160460097M	,	Exp. Date	5/16/2016	;  Service Code	2K8482	,	Lot Number	160470229M	,	Exp. Date	5/17/2016	;  Service Code	2K8482	,	Lot Number	160530109M	,	Exp. Date	5/23/2016	;  Service Code	2K8482	,	Lot Number	160630133M	,	Exp. Date	6/2/2016	;  Service Code	2K8482	,	Lot Number	160670166M	,	Exp. Date	6/6/2016	;  Service Code	2K8482	,	Lot Number	160680146M	,	Exp. Date	6/7/2016	;  Service Code	2K8482	,	Lot Number	160750150M	,	Exp. Date	6/14/2016	;  Service Code	2K8482	,	Lot Number	160810139M	,	Exp. Date	6/20/2016	;  Service Code	2K8482	,	Lot Number	160910246M	,	Exp. Date	6/30/2016	;  Service Code	2K8482	,	Lot Number	160960036C	,	Exp. Date	7/5/2016	;  Service Code	2K8482	,	Lot Number	160970147M	,	Exp. Date	7/6/2016	;  Service Code	2K8482	,	Lot Number	161080277M	,	Exp. Date	7/17/2016	;  Service Code	2K8908	,	Lot Number	160940041C	,	Exp. Date	5/10/2016	;  Service Code	2K8908	,	Lot Number	160950030C	,	Exp. Date	5/11/2016	;  Service Code	2T6482	,	Lot Number	160560209M	,	Exp. Date	5/26/2016	;  Service Code	2T6482	,	Lot Number	160590158M	,	Exp. Date	5/29/2016	;  Service Code	2T6482	,	Lot Number	160750214M	,	Exp. Date	6/14/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1415-2016","Class II","3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag,   Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141		","1,470 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8239	,	Lot Number	160400232M	,	Exp. Date	5/10/2016	;  Service Code	2H8239	,	Lot Number	160630193M	,	Exp. Date	6/2/2016	;  Service Code	2K8239	,	Lot Number	160520143M	,	Exp. Date	5/16/2016	;  Service Code	2K8239	,	Lot Number	160530306M	,	Exp. Date	5/17/2016	;  Service Code	2K8239	,	Lot Number	160610250M	,	Exp. Date	5/25/2016	;  Service Code	2K8239	,	Lot Number	160630167M	,	Exp. Date	5/27/2016	;  Service Code	2K8239	,	Lot Number	160680214M	,	Exp. Date	6/1/2016	;  Service Code	2K8239	,	Lot Number	160750241M	,	Exp. Date	6/8/2016	;  Service Code	2K8239	,	Lot Number	160820181M	,	Exp. Date	6/15/2016	;  Service Code	2K8239	,	Lot Number	160840225M	,	Exp. Date	6/17/2016	;  Service Code	2K8239	,	Lot Number	160900186M	,	Exp. Date	6/23/2016	;  Service Code	2K8239	,	Lot Number	160940234M	,	Exp. Date	6/27/2016	;  Service Code	2K8239	,	Lot Number	161080183M	,	Exp. Date	7/11/2016	;  Service Code	2K8284	,	Lot Number	160470223M	,	Exp. Date	5/17/2016	;  Service Code	2K8284	,	Lot Number	160520118M	,	Exp. Date	5/22/2016	;  Service Code	2K8284	,	Lot Number	160610207M	,	Exp. Date	5/31/2016	;  Service Code	2K8284	,	Lot Number	160620153M	,	Exp. Date	6/1/2016	;  Service Code	2K8284	,	Lot Number	160750236M	,	Exp. Date	6/14/2016	;  Service Code	2K8284	,	Lot Number	160770226M	,	Exp. Date	6/16/2016	;  Service Code	2K8284	,	Lot Number	160840209M	,	Exp. Date	6/23/2016	;  Service Code	2K8284	,	Lot Number	160910218M	,	Exp. Date	6/30/2016	;  Service Code	2K8284	,	Lot Number	160960157M	,	Exp. Date	7/5/2016	;  Service Code	2K8284	,	Lot Number	161080227M	,	Exp. Date	7/17/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1398-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48","940 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160380168M	,	Exp. Date	5/8/2016	;  Lot Number	160410137M	,	Exp. Date	5/11/2016	;  Lot Number	160460150M	,	Exp. Date	5/16/2016	;  Lot Number	160530279M	,	Exp. Date	5/23/2016	;  Lot Number	160590185M	,	Exp. Date	5/29/2016	;  Lot Number	160630160M	,	Exp. Date	6/2/2016	;  Lot Number	160680179M	,	Exp. Date	6/7/2016	;  Lot Number	160730238M	,	Exp. Date	6/12/2016	;  Lot Number	160840215M	,	Exp. Date	6/23/2016	;  Lot Number	160880193M	,	Exp. Date	6/27/2016	;  Lot Number	160890187M	,	Exp. Date	6/28/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1386-2016","Class II","10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02	,	  ","1,234 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8481	,	Lot Number	160460180M	,	Exp. Date	5/16/2016	;  Service Code	2H8481	,	Lot Number	160540181M	,	Exp. Date	5/24/2016	;  Service Code	2H8481	,	Lot Number	160830170M	,	Exp. Date	6/22/2016	;  Service Code	2K8481	,	Lot Number	160380110M	,	Exp. Date	5/8/2016	;  Service Code	2K8481	,	Lot Number	160390206M	,	Exp. Date	5/9/2016	;  Service Code	2K8481	,	Lot Number	160400241M	,	Exp. Date	5/10/2016	;  Service Code	2K8481	,	Lot Number	160410170M	,	Exp. Date	5/11/2016	;  Service Code	2K8481	,	Lot Number	160450130M	,	Exp. Date	5/15/2016	;  Service Code	2K8481	,	Lot Number	160480181M	,	Exp. Date	5/18/2016	;  Service Code	2K8481	,	Lot Number	160520033M	,	Exp. Date	5/22/2016	;  Service Code	2K8481	,	Lot Number	160530127M	,	Exp. Date	5/23/2016	;  Service Code	2K8481	,	Lot Number	160540137M	,	Exp. Date	5/24/2016	;  Service Code	2K8481	,	Lot Number	160560212M	,	Exp. Date	5/26/2016	;  Service Code	2K8481	,	Lot Number	160600294M	,	Exp. Date	5/30/2016	;  Service Code	2K8481	,	Lot Number	160610237M	,	Exp. Date	5/31/2016	;  Service Code	2K8481	,	Lot Number	160630118M	,	Exp. Date	6/2/2016	;  Service Code	2K8481	,	Lot Number	160660175M	,	Exp. Date	6/5/2016	;  Service Code	2K8481	,	Lot Number	160670245M	,	Exp. Date	6/6/2016	;  Service Code	2K8481	,	Lot Number	160730063M	,	Exp. Date	6/12/2016	;  Service Code	2K8481	,	Lot Number	160770227M	,	Exp. Date	6/16/2016	;  Service Code	2K8481	,	Lot Number	160840171M	,	Exp. Date	6/23/2016	;  Service Code	2K8481	,	Lot Number	160870146M	,	Exp. Date	6/26/2016	;  Service Code	2K8481	,	Lot Number	160910219M	,	Exp. Date	6/30/2016	;  Service Code	2K8481	,	Lot Number	160940163M	,	Exp. Date	7/3/2016	;  Service Code	2K8481	,	Lot Number	160970137M	,	Exp. Date	7/6/2016	;  Service Code	2K8481	,	Lot Number	161080124M	,	Exp. Date	7/17/2016	;  Service Code	2K8909	,	Lot Number	160910236M	,	Exp. Date	5/7/2016	;  Service Code	2K8909	,	Lot Number	160950070C	,	Exp. Date	5/11/2016	;  Service Code	2K8909	,	Lot Number	161080282M	,	Exp. Date	5/24/2016	;  Service Code	2K8911	,	Lot Number	160970035M	,	Exp. ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1419-2016","Class II","4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride	50 mL in 60 mL Monoject Syringe,   Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48	","3,828 syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8267	,	Lot Number	160630024M	,	Exp. Date	5/28/2016	;  Service Code	2K8128	,	Lot Number	160490252M	,	Exp. Date	5/13/2016	;  Service Code	2K8128	,	Lot Number	160530274M	,	Exp. Date	5/17/2016	;  Service Code	2K8128	,	Lot Number	160600213M	,	Exp. Date	5/24/2016	;  Service Code	2K8128	,	Lot Number	160660184M	,	Exp. Date	5/30/2016	;  Service Code	2K8128	,	Lot Number	160730236M	,	Exp. Date	6/6/2016	;  Service Code	2K8128	,	Lot Number	160810218M	,	Exp. Date	6/14/2016	;  Service Code	2K8128	,	Lot Number	160820186M	,	Exp. Date	6/15/2016	;  Service Code	2K8128	,	Lot Number	160940172M	,	Exp. Date	6/27/2016	;  Service Code	2K8267	,	Lot Number	160450259M	,	Exp. Date	5/15/2016	;  Service Code	2K8267	,	Lot Number	160540156M	,	Exp. Date	5/24/2016	;  Service Code	2K8267	,	Lot Number	160600323M	,	Exp. Date	5/30/2016	;  Service Code	2K8267	,	Lot Number	160660257M	,	Exp. Date	6/5/2016	;  Service Code	2K8267	,	Lot Number	160730258M	,	Exp. Date	6/12/2016	;  Service Code	2K8267	,	Lot Number	160770130M	,	Exp. Date	6/16/2016	;  Service Code	2K8267	,	Lot Number	160840132M	,	Exp. Date	6/23/2016	;  Service Code	2K8267	,	Lot Number	160900007M	,	Exp. Date	6/28/2016	;  Service Code	2K8267	,	Lot Number	160970143M	,	Exp. Date	7/6/2016	;  Service Code	2K8267	,	Lot Number	161080249M	,	Exp. Date	7/17/2016	;  Service Code	2K8638	,	Lot Number	160410229M	,	Exp. Date	5/11/2016	;  Service Code	2K8638	,	Lot Number	160420200M	,	Exp. Date	5/12/2016	;  Service Code	2K8638	,	Lot Number	160460214M	,	Exp. Date	5/16/2016	;  Service Code	2K8638	,	Lot Number	160480210M	,	Exp. Date	5/17/2016	;  Service Code	2K8638	,	Lot Number	160490254M	,	Exp. Date	5/19/2016	;  Service Code	2K8638	,	Lot Number	160490255M	,	Exp. Date	5/19/2016	;  Service Code	2K8638	,	Lot Number	160520127M	,	Exp. Date	5/22/2016	;  Service Code	2K8638	,	Lot Number	160600310M	,	Exp. Date	5/30/2016	;  Service Code	2K8638	,	Lot Number	160630164M	,	Exp. Date	6/2/2016	;  Service Code	2K8638	,	Lot Number	160670272M	,	Exp. Date	6/6/2016	;  Service Code	2K8638	,	Lot Number	160750259M	,	Ex",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1393-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141		,	  ","1,476 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8296	,	Lot Number	160420192M	,	Exp. Date	5/8/2016	;  Service Code	2H8296	,	Lot Number	160450199M	,	Exp. Date	5/11/2016	;  Service Code	2H8296	,	Lot Number	160490146M	,	Exp. Date	5/15/2016	;  Service Code	2H8296	,	Lot Number	160590180M	,	Exp. Date	5/25/2016	;  Service Code	2H8296	,	Lot Number	160660231M	,	Exp. Date	6/1/2016	;  Service Code	2H8296	,	Lot Number	160700136M	,	Exp. Date	6/5/2016	;  Service Code	2H8296	,	Lot Number	160770233M	,	Exp. Date	6/12/2016	;  Service Code	2H8296	,	Lot Number	160820140M	,	Exp. Date	6/17/2016	;  Service Code	2H8296	,	Lot Number	160880282M	,	Exp. Date	6/23/2016	;  Service Code	2H8296	,	Lot Number	160910131M	,	Exp. Date	6/26/2016	;  Service Code	2H8296	,	Lot Number	160970117M	,	Exp. Date	7/1/2016	;  Service Code	2H8296	,	Lot Number	161080157M	,	Exp. Date	7/13/2016	;  Service Code	2K8296	,	Lot Number	160420191M	,	Exp. Date	5/12/2016	;  Service Code	2K8296	,	Lot Number	160480230M	,	Exp. Date	5/18/2016	;  Service Code	2K8296	,	Lot Number	160540227M	,	Exp. Date	5/24/2016	;  Service Code	2K8296	,	Lot Number	160610205M	,	Exp. Date	5/31/2016	;  Service Code	2K8296	,	Lot Number	160670249M	,	Exp. Date	6/6/2016	;  Service Code	2K8296	,	Lot Number	160830181M	,	Exp. Date	6/22/2016	;  Service Code	2K8296	,	Lot Number	160840213M	,	Exp. Date	6/23/2016	;  Service Code	2T6296	,	Lot Number	160450196M	,	Exp. Date	5/15/2016	;  Service Code	2T6296	,	Lot Number	160530159M	,	Exp. Date	5/23/2016	;  Service Code	2T6296	,	Lot Number	160690195M	,	Exp. Date	6/8/2016	;  Service Code	2T6296	,	Lot Number	160750219M	,	Exp. Date	6/14/2016	;  Service Code	2T6296	,	Lot Number	160810166M	,	Exp. Date	6/20/2016	;  Service Code	2T6296	,	Lot Number	160880176M	,	Exp. Date	6/26/2016	;  Service Code	2T6296	,	Lot Number	160940048M	,	Exp. Date	7/2/2016	;  Service Code	2T6296	,	Lot Number	160970123M	,	Exp. Date	7/5/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1384-2016","Class II","10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20			  	  ","1,577 BD syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2T6733	,	Lot Number	160560088M	,	Exp. Date	5/25/2016	;  Service Code	2T6733	,	Lot Number	160590097M	,	Exp. Date	5/28/2016	;  Service Code	2T6733	,	Lot Number	160610032M	,	Exp. Date	5/31/2016	;  Service Code	2T6733	,	Lot Number	160630191M	,	Exp. Date	6/2/2016	;  Service Code	2T6733	,	Lot Number	160740251M	,	Exp. Date	6/13/2016	;  Service Code	2T6733	,	Lot Number	160890051M	,	Exp. Date	6/27/2016	;  Service Code	2T6733	,	Lot Number	160910161M	,	Exp. Date	6/29/2016	;  Service Code	2K8478	,	Lot Number	160380039M	,	Exp. Date	5/8/2016	;  Service Code	2K8478	,	Lot Number	160410139M	,	Exp. Date	5/11/2016	;  Service Code	2K8478	,	Lot Number	160450247M	,	Exp. Date	5/15/2016	;  Service Code	2K8478	,	Lot Number	160540145M	,	Exp. Date	5/24/2016	;  Service Code	2K8478	,	Lot Number	160610157M	,	Exp. Date	5/31/2016	;  Service Code	2K8478	,	Lot Number	160660142M	,	Exp. Date	6/5/2016	;  Service Code	2K8478	,	Lot Number	160730262M	,	Exp. Date	6/12/2016	;  Service Code	2K8478	,	Lot Number	160770247M	,	Exp. Date	6/16/2016	;  Service Code	2K8478	,	Lot Number	160810195M	,	Exp. Date	6/20/2016	;  Service Code	2K8478	,	Lot Number	160890161M	,	Exp. Date	6/28/2016	;  Service Code	2K8478	,	Lot Number	160910234M	,	Exp. Date	6/30/2016	;  Service Code	2K8478	,	Lot Number	160940235M	,	Exp. Date	7/3/2016	;  Service Code	2T8478	,	Lot Number	160910132M	,	Exp. Date	5/7/2016	;  Service Code	2T8478	,	Lot Number	160940032C	,	Exp. Date	5/10/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1361-2016","Class II","0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54		,	","80 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot # 160420165M; Exp. 05/16	  Lot # 160540128M; Exp. 05/16	  Lot # 160630117M; Exp. 06/16	  Lot # 160770157M; Exp. 06/16	  Lot # 160870055M; Exp. 06/16	  Lot # 160890153M; Exp. 06/16  Lot # 160950340M; Exp. 07/16",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1416-2016","Class II","3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette,    Service Code 2K8837 (NDC 61553-837-48), Service Code	2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Code 2K8976 (NDC 61553-976-48), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141	","5,727 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	3V8708	,	Lot Number	160410168M	,	Exp. Date	5/11/2016	;  Service Code	3V8708	,	Lot Number	160600286M	,	Exp. Date	5/30/2016	;  Service Code	3V8708	,	Lot Number	160810284M	,	Exp. Date	6/20/2016	;  Service Code	3V8708	,	Lot Number	160820091M	,	Exp. Date	6/20/2016	;  Service Code	2H8285	,	Lot Number	160470170M	,	Exp. Date	5/13/2016	;  Service Code	2H8285	,	Lot Number	160530182M	,	Exp. Date	5/19/2016	;  Service Code	2H8285	,	Lot Number	160600296M	,	Exp. Date	5/26/2016	;  Service Code	2H8285	,	Lot Number	160670185M	,	Exp. Date	6/2/2016	;  Service Code	2H8285	,	Lot Number	160740253M	,	Exp. Date	6/9/2016	;  Service Code	2H8285	,	Lot Number	160820206M	,	Exp. Date	6/17/2016	;  Service Code	2H8285	,	Lot Number	160880254M	,	Exp. Date	6/23/2016	;  Service Code	2H8285	,	Lot Number	160910152M	,	Exp. Date	6/26/2016	;  Service Code	2K8237	,	Lot Number	160400261M	,	Exp. Date	5/10/2016	;  Service Code	2K8237	,	Lot Number	160450263M	,	Exp. Date	5/15/2016	;  Service Code	2K8237	,	Lot Number	160540239M	,	Exp. Date	5/24/2016	;  Service Code	2K8237	,	Lot Number	160620203M	,	Exp. Date	6/1/2016	;  Service Code	2K8237	,	Lot Number	160700152M	,	Exp. Date	6/9/2016	;  Service Code	2K8237	,	Lot Number	160730269M	,	Exp. Date	6/12/2016	;  Service Code	2K8237	,	Lot Number	160760207M	,	Exp. Date	6/15/2016	;  Service Code	2K8237	,	Lot Number	160810315M	,	Exp. Date	6/20/2016	;  Service Code	2K8237	,	Lot Number	160870248M	,	Exp. Date	6/26/2016	;  Service Code	2K8237	,	Lot Number	160940250M	,	Exp. Date	7/3/2016	;  Service Code	2K8237	,	Lot Number	160970220M	,	Exp. Date	7/6/2016	;  Service Code	2K8643	,	Lot Number	160420245M	,	Exp. Date	5/12/2016	;  Service Code	2K8643	,	Lot Number	160470238M	,	Exp. Date	5/17/2016	;  Service Code	2K8643	,	Lot Number	160480261M	,	Exp. Date	5/18/2016	;  Service Code	2K8643	,	Lot Number	160600351M	,	Exp. Date	5/30/2016	;  Service Code	2K8643	,	Lot Number	160700177M	,	Exp. Date	6/9/2016	;  Service Code	2K8643	,	Lot Number	160770260M	,	Exp. Date	6/16/2016	;  Service Code	2K8643	,	Lot Number	160870191M	,	Exp.",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1371-2016","Class II","0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette,  Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52","325 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number 160960175M; Exp. Date 5/6/2016	  Lot Number 160970036M; Exp. Date 5/7/2016	  Lot Number 161080071M; Exp. Date 5/18/2016	  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1373-2016","Class II","1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175	  Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48","40 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160630037M	,	Exp. Date	5/23/2016	;  Lot Number	160640007M	,	Exp. Date	5/24/2016	;  Lot Number	160700207M	,	Exp. Date	5/31/2016	;  Lot Number	160730149M	,	Exp. Date	6/3/2016	;  Lot Number	160830163M	,	Exp. Date	6/12/2016	;  Lot Number	160880258M	,	Exp. Date	6/18/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1427-2016","Class II","5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 100 mL in 100 mL Smiths Medical Cassette, Service Code 2T8200, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-200-52		","45 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160500008M	,	Exp. Date	5/10/2016	;  Lot Number	160940038C	,	Exp. Date	6/24/2016	;  Lot Number	160970126M	,	Exp. Date	6/27/2016	;  Lot Number	161080140M	,	Exp. Date	7/8/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1383-2016","Class II","10 mcg/mL HYDROmorphone HCl  and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17	","55 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160470116M	,	Exp. Date	5/17/2016	;  Lot Number	160490123M	,	Exp. Date	5/19/2016	;  Lot Number	160800048M	,	Exp. Date	6/18/2016	;  Lot Number	160890060M	,	Exp. Date	6/27/2016	;  Lot Number	160940050M	,	Exp. Date	7/2/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1405-2016","Class II","2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37),  200 ml in 250 ml Baxter Intravia Bag 	;  Service Code 2K8464 (NDC 61553-464-61), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141		  ","2,006 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8255	,	Lot Number	160550161M	,	Exp. Date	5/11/2016	;  Service Code	2H8255	,	Lot Number	160620170M	,	Exp. Date	5/18/2016	;  Service Code	2H8255	,	Lot Number	160760132M	,	Exp. Date	6/1/2016	;  Service Code	2H8255	,	Lot Number	160830148M	,	Exp. Date	6/8/2016	;  Service Code	2H8255	,	Lot Number	160900158M	,	Exp. Date	6/15/2016	;  Service Code	2H8255	,	Lot Number	160970139M	,	Exp. Date	6/22/2016	;  Service Code	2K8255	,	Lot Number	160490046C	,	Exp. Date	5/13/2016	;  Service Code	2K8255	,	Lot Number	160620032C	,	Exp. Date	5/26/2016	;  Service Code	2K8255	,	Lot Number	160770046C	,	Exp. Date	6/10/2016	;  Service Code	2K8464	,	Lot Number	160420154M	,	Exp. Date	5/6/2016	;  Service Code	2K8464	,	Lot Number	160530249M	,	Exp. Date	5/17/2016	;  Service Code	2K8464	,	Lot Number	160540207M	,	Exp. Date	5/18/2016	;  Service Code	2K8464	,	Lot Number	160660045M	,	Exp. Date	5/29/2016	;  Service Code	2K8464	,	Lot Number	160730092M	,	Exp. Date	6/6/2016	;  Service Code	2K8464	,	Lot Number	160840137M	,	Exp. Date	6/17/2016	;  Service Code	2K8464	,	Lot Number	160910145M	,	Exp. Date	6/24/2016	;  Service Code	2T8255	,	Lot Number	160480271M	,	Exp. Date	5/9/2016	;  Service Code	2T8255	,	Lot Number	160530302M	,	Exp. Date	5/14/2016	;  Service Code	2T8255	,	Lot Number	160600047C	,	Exp. Date	5/21/2016	;  Service Code	2T8255	,	Lot Number	160610032C	,	Exp. Date	5/22/2016	;  Service Code	2T8255	,	Lot Number	160700030C	,	Exp. Date	5/30/2016	;  Service Code	2T8255	,	Lot Number	160700031C	,	Exp. Date	5/31/2016	;  Service Code	2T8255	,	Lot Number	160740060C	,	Exp. Date	6/4/2016	;  Service Code	2T8255	,	Lot Number	160770034C	,	Exp. Date	6/7/2016	;  Service Code	2T8255	,	Lot Number	160830059C	,	Exp. Date	6/13/2016	;  Service Code	2T8255	,	Lot Number	160880040C	,	Exp. Date	6/18/2016	;  Service Code	2T8255	,	Lot Number	160880041C	,	Exp. Date	6/18/2016	;  Service Code	2T8255	,	Lot Number	160940029C	,	Exp. Date	6/24/2016	;  Service Code	2T8255	,	Lot Number	160950051C	,	Exp. Date	6/25/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1362-2016","Class II","0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC	61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL White Smiths Medical Cassette (NDC 615530-933-11) f) 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141	;    			  	  ","2,194 bags and cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8197	,	Lot Number	160730048M	,	Exp. Date	6/12/2016	;  Service Code	2H8197	,	Lot Number	160840111M	,	Exp. Date	6/22/2016	;  Service Code	2H8197	,	Lot Number	160870066M	,	Exp. Date	6/25/2016	;  Service Code	2H8197	,	Lot Number	160880208M	,	Exp. Date	6/27/2016	;  Service Code	2H8197	,	Lot Number	160910038M	,	Exp. Date	6/29/2016	;  Service Code	2K8189	,	Lot Number	160730049M	,	Exp. Date	6/11/2016	;  Service Code	2K8189	,	Lot Number	160810152M	,	Exp. Date	6/20/2016	;  Service Code	2K8189	,	Lot Number	160820330M	,	Exp. Date	6/21/2016	;  Service Code	2K8189	,	Lot Number	160940135M	,	Exp. Date	7/3/2016	;  Service Code	2K8189	,	Lot Number	160960178M	,	Exp. Date	7/5/2016	;  Service Code	2K8189	,	Lot Number	160970201M	,	Exp. Date	7/6/2016	;  Service Code	2K8197	,	Lot Number	160660178M	,	Exp. Date	6/5/2016	;  Service Code	2K8197	,	Lot Number	160670161M	,	Exp. Date	6/6/2016	;  Service Code	2K8197	,	Lot Number	160730253M	,	Exp. Date	6/12/2016	;  Lot # 160770186M; Exp. 06/16	  Lot # 160810189M; Exp. 06/16	  Lot # 160840050M; Exp. 06/16	  Lot # 160890231M; Exp. 06/16   Lot # 160910228M; Exp. 06/16  Lot # 160560020M; Exp. 05/16	  Lot # 160610020C; Exp. 05/16	  Lot # 160630014C; Exp. 06/16	  Lot # 160660007C; Exp. 06/16	  Lot # 160670052C; Exp. 06/16	  Lot # 160680067C; Exp. 06/16  Lot # 160740037C; Exp. 06/16	  Lot # 160740038C; Exp. 06/16	  Lot # 160810067C; Exp. 06/16  Lot # 160840174M; Exp. 06/16	  Lot # 160880157M; Exp. 06/16  Lot # 169000103M; Exp. 06/16	  Lot # 160600222M; Exp. 05/16	  Lot # 160740168M; Exp. 05/16	  Lot # 160810051C ;Exp. 05/16  Lot # 160830031C; Exp. 06/16  Lot # 160880019C; Exp. 06/16  Lot # 160880175M; Exp. 06/16  Lot # 160950002C; Exp. 06/16	  Lot # 160960172M; Exp. 07/16  Lot # 160950133M; Exp. 07/16",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1391-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95","17,990 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K9966	,	Lot Number	160390021M	,	Exp. Date	5/9/2016	;  Service Code	2K9966	,	Lot Number	160450151M	,	Exp. Date	5/15/2016	;  Service Code	2K9966	,	Lot Number	160610223M	,	Exp. Date	5/31/2016	;  Service Code	2K9966	,	Lot Number	160660080M	,	Exp. Date	6/5/2016	;  Service Code	2K9966	,	Lot Number	160880210M	,	Exp. Date	6/27/2016	;  Service Code	2K9966	,	Lot Number	160890277M	,	Exp. Date	6/28/2016	;  Service Code	2K9966	,	Lot Number	160910004M	,	Exp. Date	6/29/2016	;  Service Code	3V8709	,	Lot Number	160550119M	,	Exp. Date	5/19/2016	;  Service Code	3V8709	,	Lot Number	160630116M	,	Exp. Date	5/27/2016	;  Service Code	3V8709	,	Lot Number	160750050M	,	Exp. Date	6/7/2016	;  Service Code	3V8709	,	Lot Number	160890054M	,	Exp. Date	6/21/2016	;  Service Code	3V8724	,	Lot Number	160390325M	,	Exp. Date	5/9/2016	;  Service Code	3V8724	,	Lot Number	160600304M	,	Exp. Date	5/30/2016	;  Service Code	3V8724	,	Lot Number	160770031M	,	Exp. Date	6/15/2016	;  Service Code	3V8724	,	Lot Number	160880271M	,	Exp. Date	6/27/2016	;  Service Code	2H8129	,	Lot Number	160540238M	,	Exp. Date	5/20/2016	;  Service Code	2H8129	,	Lot Number	160590104M	,	Exp. Date	5/25/2016	;  Service Code	2H8129	,	Lot Number	160660247M	,	Exp. Date	6/1/2016	;  Service Code	2H8129	,	Lot Number	160730274M	,	Exp. Date	6/8/2016	;  Service Code	2H8129	,	Lot Number	160810226M	,	Exp. Date	6/16/2016	;  Service Code	2H8129	,	Lot Number	160840032M	,	Exp. Date	6/19/2016	;  Service Code	2H8129	,	Lot Number	160940173M	,	Exp. Date	6/29/2016	;  Service Code	2H8129	,	Lot Number	161080115M	,	Exp. Date	7/13/2016	;  Service Code	2H8132	,	Lot Number	160390248M	,	Exp. Date	5/9/2016	;  Service Code	2H8132	,	Lot Number	160460217M	,	Exp. Date	5/16/2016	;  Service Code	2H8132	,	Lot Number	160490227M	,	Exp. Date	5/19/2016	;  Service Code	2H8132	,	Lot Number	160530175M	,	Exp. Date	5/23/2016	;  Service Code	2H8132	,	Lot Number	160600229M	,	Exp. Date	5/30/2016	;  Service Code	2H8132	,	Lot Number	160660244M	,	Exp. Date	6/5/2016	;  Service Code	2H8132	,	Lot Number	160700169M	,	Exp. ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1369-2016","Class II","0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95	","140 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number: 160970109M, Exp. Date 5/7/2016	    ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1368-2016","Class II","0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; ,	Service Code	2H8120	,	NDC	61553-120-50	,	250 ml in 250 ml Hospira LifeCare Bag 	;  ,	Service Code	2H8243	,	NDC	61553-243-54	,	200 ml in 250 ml Hospira LifeCare Bag 	;  ,	Service Code	2K8120	,	NDC	61553-120-09	,	400 ml in 500 ml Baxter Intravia Bag 	;  ,	Service Code	2K8243	,	NDC	61553-243-37	,	200 ml in 250 ml Baxter Intravia Bag 	;  ,	Service Code	2K9120	,	NDC	61553-120-03	,	500 ml in 500 ml Baxter Intravia Bag 	;  ,	Service Code	2N1120	,	NDC	61553-120-84	,	400 ml in 500 ml Baxter Intravia Bag 	;  ,	Service Code	2N9619	,	NDC	61553-619-97	,	250 ml in 250 ml Baxter Intravia Bag   	;  Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141	","2,874 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8120	,	Lot Number	160380137M	,	Exp. Date	5/8/2016	;  Service Code	2H8120	,	Lot Number	160420181M	,	Exp. Date	5/12/2016	;  Service Code	2H8120	,	Lot Number	160450166M	,	Exp. Date	5/15/2016	;  Service Code	2H8120	,	Lot Number	160460209M	,	Exp. Date	5/16/2016	;  Service Code	2H8120	,	Lot Number	160600277M	,	Exp. Date	5/30/2016	;  Service Code	2H8120	,	Lot Number	160610057M	,	Exp. Date	5/30/2016	;  Service Code	2H8120	,	Lot Number	160610224M	,	Exp. Date	5/31/2016	;  Service Code	2H8120	,	Lot Number	160680153M	,	Exp. Date	6/7/2016	;  Service Code	2H8120	,	Lot Number	160810219M	,	Exp. Date	6/20/2016	;  Service Code	2H8120	,	Lot Number	160910124M	,	Exp. Date	6/29/2016	;  Service Code	2H8120	,	Lot Number	160960220M	,	Exp. Date	7/5/2016	;  Service Code	2H8243	,	Lot Number	160530200M	,	Exp. Date	5/9/2016	;  Service Code	2H8243	,	Lot Number	160600047M	,	Exp. Date	5/16/2016	;  Service Code	2H8243	,	Lot Number	160670033M	,	Exp. Date	5/22/2016	;  Service Code	2H8243	,	Lot Number	160810051M	,	Exp. Date	6/5/2016	;  Service Code	2H8243	,	Lot Number	160880267M	,	Exp. Date	6/13/2016	;  Service Code	2H8243	,	Lot Number	160910035M	,	Exp. Date	6/15/2016	;  Service Code	2H8243	,	Lot Number	160950059M	,	Exp. Date	6/19/2016	;  Service Code	2K8120	,	Lot Number	160480190M	,	Exp. Date	5/18/2016	;  Service Code	2K8120	,	Lot Number	160550194M	,	Exp. Date	5/25/2016	;  Service Code	2K8120	,	Lot Number	160940060M	,	Exp. Date	7/2/2016	;  Service Code	2K8243	,	Lot Number	160410183M	,	Exp. Date	5/11/2016	;  Service Code	2K8243	,	Lot Number	160420152M	,	Exp. Date	5/12/2016	;  Service Code	2K8243	,	Lot Number	160460131M	,	Exp. Date	5/16/2016	;  Service Code	2K8243	,	Lot Number	160490239M	,	Exp. Date	5/19/2016	;  Service Code	2K8243	,	Lot Number	160520184M	,	Exp. Date	5/22/2016	;  Service Code	2K8243	,	Lot Number	160550125M	,	Exp. Date	5/25/2016	;  Service Code	2K8243	,	Lot Number	160590160M	,	Exp. Date	5/29/2016	;  Service Code	2K8243	,	Lot Number	160600171M	,	Exp. Date	5/30/2016	;  Service Code	2K8243	,	Lot Number	160610227M	,	Exp",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1396-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;    Service Code	2H8125	,	NDC	61553-125-52	,	100 ml in 100 ml Hospira LifeCare Bag 	;  Service Code	2H8204	,	NDC	61553-204-54	,	200 ml in 250 ml Hospira LifeCare Bag 	;  Service Code	2H8205	,	NDC	61553-205-50	,	250 ml in 250 ml Hospira LifeCare Bag 	;  Service Code	2K8104	,	NDC	61553-104-03	,	500 ml in 500 ml Baxter Intravia Bag 	;  Service Code	2K8124	,	NDC	61553-124-48	,	100 ml in 150 ml Baxter Intravia Bag 	;  Service Code	2K8204	,	NDC	61553-204-37	,	200 ml in 250 ml Baxter Intravia Bag 	;  Service Code	2K8205	,	NDC	61553-205-02	,	250 ml in 250 ml Baxter Intravia Bag 	;  Service Code	2K8443	,	NDC	61553-443-47	,	150 ml in 150 ml Baxter Intravia Bag 	;  Service Code	2K8491	,	NDC	61553-491-30	,	125 ml in 150 ml Baxter Intravia Bag 	;  Service Code	2K9491	,	NDC	61553-491-96	,	100 ml in 150 ml Baxter Intravia Bag 	;  Service Code	2K9802	,	NDC	61553-802-96	,	100 ml in 150 ml Baxter Intravia Bag 	;  Service Code	4J8205	,	NDC	61553-205-97	,	250 ml in 250 ml Baxter Intravia Bag 	;    Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141	","97,716 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	3V8705	,	Lot Number	160380161M	,	Exp. Date	5/8/2016	;  Service Code	3V8705	,	Lot Number	160400200M	,	Exp. Date	5/10/2016	;  Service Code	3V8705	,	Lot Number	160460205M	,	Exp. Date	5/15/2016	;  Service Code	3V8705	,	Lot Number	160530278M	,	Exp. Date	5/23/2016	;  Service Code	3V8705	,	Lot Number	160610204M	,	Exp. Date	5/31/2016	;  Service Code	3V8705	,	Lot Number	160630155M	,	Exp. Date	6/2/2016	;  Service Code	3V8705	,	Lot Number	160700159M	,	Exp. Date	6/9/2016	;  Service Code	3V8705	,	Lot Number	160770234M	,	Exp. Date	6/16/2016	;  Service Code	3V8705	,	Lot Number	160800199M	,	Exp. Date	6/19/2016	;  Service Code	3V8705	,	Lot Number	160840217M	,	Exp. Date	6/23/2016	;  Service Code	3V8705	,	Lot Number	161080171M	,	Exp. Date	7/17/2016	;  Service Code	3V8707	,	Lot Number	160460233M	,	Exp. Date	5/10/2016	;  Service Code	3V8707	,	Lot Number	160530170M	,	Exp. Date	5/17/2016	;  Service Code	3V8707	,	Lot Number	160660139M	,	Exp. Date	5/30/2016	;  Service Code	3V8707	,	Lot Number	160670160M	,	Exp. Date	5/31/2016	;  Service Code	3V8707	,	Lot Number	160730245M	,	Exp. Date	6/6/2016	;  Service Code	3V8707	,	Lot Number	160810188M	,	Exp. Date	6/14/2016	;  Service Code	3V8707	,	Lot Number	160880197M	,	Exp. Date	6/21/2016	;  Service Code	3V8707	,	Lot Number	160940223M	,	Exp. Date	6/27/2016	;  Service Code	3V8707	,	Lot Number	160960010M	,	Exp. Date	6/28/2016	;  Service Code	2C8124	,	Lot Number	160870072M	,	Exp. Date	5/11/2016	;  Service Code	2C8124	,	Lot Number	160960047M	,	Exp. Date	5/20/2016	;  Service Code	2C8205	,	Lot Number	160810170M	,	Exp. Date	5/6/2016	;  Service Code	2C8205	,	Lot Number	160890184M	,	Exp. Date	5/14/2016	;  Service Code	2C8205	,	Lot Number	160910167M	,	Exp. Date	5/15/2016	;  Service Code	2C8205	,	Lot Number	160970129M	,	Exp. Date	5/21/2016	;  Service Code	2H8125	,	Lot Number	160420030M	,	Exp. Date	5/8/2016	;  Service Code	2H8125	,	Lot Number	160450359M	,	Exp. Date	5/11/2016	;  Service Code	2H8125	,	Lot Number	160460339M	,	Exp. Date	5/12/2016	;  Service Code	2H8125	,	Lot Number	160490036M	,	Exp",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016"," Code	2K8870	,	Lot Number	160950031C	,	Exp. Date	6/24/2016	;  Service Code	2K8870	,	Lot Number	160950039M	,	Exp. Date	6/25/2016	;  Service Code	2K8870	,	Lot Number	160950085M	,	Exp. Date	6/25/2016	;  Service Code	2K8870	,	Lot Number	160950103C	,	Exp. Date	6/25/2016	;  Service Code	2K8870	,	Lot Number	160950312M	,	Exp. Date	6/25/2016	;  Service Code	2K8870	,	Lot Number	160960073C	,	Exp. Date	6/26/2016	;  Service Code	2K8870	,	Lot Number	160960075C	,	Exp. Date	6/26/2016	;  Service Code	2K8870	,	Lot Number	160970067C	,	Exp. Date	6/27/2016	;  Service Code	2K9491	,	Lot Number	160530138M	,	Exp. Date	5/17/2016	;  Service Code	2K9491	,	Lot Number	160600182M	,	Exp. Date	5/24/2016	;  Service Code	2K9491	,	Lot Number	160750223M	,	Exp. Date	6/8/2016	;  Service Code	2K9491	,	Lot Number	160880029M	,	Exp. Date	6/20/2016	;  Service Code	2K9491	,	Lot Number	160960187M	,	Exp. Date	6/29/2016	;  Service Code	2K9802	,	Lot Number	160460029C	,	Exp. Date	5/16/2016	;  Service Code	2K9802	,	Lot Number	160530044C	,	Exp. Date	5/23/2016	;  Service Code	2K9802	,	Lot Number	160620030C	,	Exp. Date	6/1/2016	;  Service Code	2K9802	,	Lot Number	160740049C	,	Exp. Date	6/13/2016	;  Service Code	2K9802	,	Lot Number	160810058C	,	Exp. Date	6/20/2016	;  Service Code	2K9802	,	Lot Number	160880023C	,	Exp. Date	6/27/2016	;  Service Code	2K9802	,	Lot Number	160950044C	,	Exp. Date	7/4/2016	;  Service Code	2P6491	,	Lot Number	160470222M	,	Exp. Date	5/17/2016	;  Service Code	2P6491	,	Lot Number	160690031M	,	Exp. Date	6/7/2016	;  Service Code	2P6491	,	Lot Number	160820226M	,	Exp. Date	6/21/2016	;  Service Code	2P6491	,	Lot Number	160870171M	,	Exp. Date	6/26/2016	;  Service Code	2P6491	,	Lot Number	160890218M	,	Exp. Date	6/27/2016	;  Service Code	2P6491	,	Lot Number	160960035M	,	Exp. Date	7/4/2016	;  Service Code	2T6124	,	Lot Number	160390194M	,	Exp. Date	5/9/2016	;  Service Code	2T6124	,	Lot Number	160630152M	,	Exp. Date	6/2/2016	;  Service Code	2T6124	,	Lot Number	160670178M	,	Exp. Date	6/5/2016	;  Service Code	2T6124	,	Lot Number	160880206M	,	Exp. Date	6/2",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1370-2016","Class II","0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50","10 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number 161080149M; Exp. Date 5/18/2016	      ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1410-2016","Class II","20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8494, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-494-61","25 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160530134M	,	Exp. Date	5/23/2016	;  Lot Number	160630039M	,	Exp. Date	6/1/2016	;  Lot Number	160900044M	,	Exp. Date	6/28/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1381-2016","Class II","10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141		    ","600 Monoject Syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2T6014	,	Lot Number	160390220M	,	Exp. Date	5/9/2016	;  Service Code	2T6014	,	Lot Number	160700029M	,	Exp. Date	6/8/2016	;  Service Code	2T6636	,	Lot Number	160380145M	,	Exp. Date	5/7/2016	;  Service Code	2T6636	,	Lot Number	160390003M	,	Exp. Date	5/8/2016	;  Service Code	2T6636	,	Lot Number	160460177M	,	Exp. Date	5/15/2016	;  Service Code	2T6636	,	Lot Number	160490165M	,	Exp. Date	5/18/2016	;  Service Code	2T6636	,	Lot Number	160550201M	,	Exp. Date	5/24/2016	;  Service Code	2T6636	,	Lot Number	160670237M	,	Exp. Date	6/6/2016	;  Service Code	2T6636	,	Lot Number	160680008M	,	Exp. Date	6/6/2016	;  Service Code	2T6636	,	Lot Number	160700023M	,	Exp. Date	6/8/2016	;  Service Code	2T6636	,	Lot Number	160710003M	,	Exp. Date	6/9/2016	;  Service Code	2T6636	,	Lot Number	160740258M	,	Exp. Date	6/13/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1408-2016","Class II","20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8146, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-189-48	  ","10 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot # 160630032M; Exp. 6/1/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1364-2016","Class II","0.1% Bupivacaine HCl (Preservative Free)  in 0.9% Sodium Chloride,   Service Code 2K8195, 	100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag  NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag,  Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,","4,081 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K8195	,	Lot Number	160390084M	,	Exp. Date	5/9/2016	;  Service Code	2K8195	,	Lot Number	160530298M	,	Exp. Date	5/23/2016	;  Service Code	2K8195	,	Lot Number	160540203M	,	Exp. Date	5/24/2016	;  Service Code	2K8195	,	Lot Number	160550182M	,	Exp. Date	5/25/2016	;  Service Code	2K8195	,	Lot Number	160590153M	,	Exp. Date	5/29/2016	;  Service Code	2K8195	,	Lot Number	160660150M	,	Exp. Date	6/5/2016	;  Service Code	2K8195	,	Lot Number	160740115M	,	Exp. Date	6/12/2016	;  Service Code	2K8195	,	Lot Number	160810295M	,	Exp. Date	6/20/2016	;  Service Code	2K8195	,	Lot Number	160820217M	,	Exp. Date	6/21/2016	;  Service Code	2K8195	,	Lot Number	160830164M	,	Exp. Date	6/21/2016	;  Service Code	2K8195	,	Lot Number	160950236M	,	Exp. Date	7/4/2016	;  Service Code	2K8195	,	Lot Number	160970203M	,	Exp. Date	7/6/2016	;  Service Code	2H8266	,	Lot Number	160410177M	,	Exp. Date	5/11/2016	;  Service Code	2H8266	,	Lot Number	160600056M	,	Exp. Date	5/29/2016	;  Service Code	2H8266	,	Lot Number	160740185M	,	Exp. Date	6/13/2016	;  Service Code	2H8266	,	Lot Number	160830175M	,	Exp. Date	6/22/2016	;  Service Code	2H8266	,	Lot Number	160950218M	,	Exp. Date	7/4/2016	;  Service Code	2H8272	,	Lot Number	160450150M	,	Exp. Date	5/15/2016	;  Service Code	2H8272	,	Lot Number	160600070M	,	Exp. Date	5/29/2016	;  Service Code	2H8272	,	Lot Number	160900043M	,	Exp. Date	6/28/2016	;  Service Code	2K8115	,	Lot Number	160530135M	,	Exp. Date	5/23/2016	;  Service Code	2K8115	,	Lot Number	160740158M	,	Exp. Date	6/13/2016	;  Service Code	2K8115	,	Lot Number	160940047M	,	Exp. Date	7/2/2016	;  Service Code	2K8115	,	Lot Number	160950158M	,	Exp. Date	7/4/2016	;  Service Code	2K8216	,	Lot Number	160390353M	,	Exp. Date	5/9/2016	;  Service Code	2K8216	,	Lot Number	160470237M	,	Exp. Date	5/17/2016	;  Service Code	2K8216	,	Lot Number	160480276M	,	Exp. Date	5/18/2016	;  Service Code	2K8216	,	Lot Number	160540026M	,	Exp. Date	5/24/2016	;  Service Code	2K8216	,	Lot Number	160610271M	,	Exp. Date	5/31/2016	;  Service Code	2K8216	,	Lot Number	160730105M	,	Exp. ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1421-2016","Class II","5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48		","2,256 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160460023M	,	Exp. Date	5/7/2016	;  Lot Number	160460024M	,	Exp. Date	5/7/2016	;  Lot Number	160460025M	,	Exp. Date	5/7/2016	;  Lot Number	160460328M	,	Exp. Date	5/7/2016	;  Lot Number	160540052M	,	Exp. Date	5/15/2016	;  Lot Number	160600338M	,	Exp. Date	5/21/2016	;  Lot Number	160600339M	,	Exp. Date	5/21/2016	;  Lot Number	160600340M	,	Exp. Date	5/21/2016	;  Lot Number	160600341M	,	Exp. Date	5/21/2016	;  Lot Number	160680065C	,	Exp. Date	5/29/2016	;  Lot Number	160750039C	,	Exp. Date	6/5/2016	;  Lot Number	160750040C	,	Exp. Date	6/5/2016	;  Lot Number	160750041C	,	Exp. Date	6/5/2016	;  Lot Number	160770040C	,	Exp. Date	6/7/2016	;  Lot Number	160880030C	,	Exp. Date	6/18/2016	;  Lot Number	160880031C	,	Exp. Date	6/18/2016	;  Lot Number	160880032C	,	Exp. Date	6/17/2016	;  Lot Number	160880033C	,	Exp. Date	6/18/2016	;  Lot Number	160880034C	,	Exp. Date	6/18/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1409-2016","Class II","20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12","435 Monoject Syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K8157	,	Lot Number	160420116M	,	Exp. Date	5/12/2016	;  Service Code	2K8157	,	Lot Number	160540135M	,	Exp. Date	5/24/2016	;  Service Code	2K8157	,	Lot Number	160630121M	,	Exp. Date	6/2/2016	;  Service Code	2K8157	,	Lot Number	160730218M	,	Exp. Date	6/12/2016	;  Service Code	2K8157	,	Lot Number	160760126M	,	Exp. Date	6/14/2016	;  Service Code	2K8157	,	Lot Number	160770152M	,	Exp. Date	6/16/2016	;  Service Code	2K8157	,	Lot Number	160810169M	,	Exp. Date	6/20/2016	;  Service Code	2K8157	,	Lot Number	160840206M	,	Exp. Date	6/23/2016	;  Service Code	2K8157	,	Lot Number	160940210M	,	Exp. Date	7/3/2016	;  Service Code	2T6620	,	Lot Number	160900133M	,	Exp. Date	5/6/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1395-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201	,	NDC	61553-201-58	,	200 ml in 250 ml Cormix Bag 	;  Service Code	2H8131	,	NDC	61553-131-50	,	250 ml in 250 ml Hospira LifeCare Bag 	;  Service Code	2H8201	,	NDC	61553-201-54	,	200 ml in 250 ml Hospira LifeCare Bag 	;  Service Code	2K8122	,	NDC	61553-122-48	,	100 ml in 100 ml Baxter APII Bag 	;  Service Code	2K8123	,	NDC	61553-123-48	,	100 ml in 150 ml Baxter Intravia Bag 	;  Service Code	2K8131	,	NDC	61553-131-02	,	250 ml in 250 ml Baxter Intravia Bag 	;  Service Code	2K8201	,	NDC	61553-201-37	,	200 ml in 250 ml Baxter Intravia Bag 	;  Service Code	2K8442	,	NDC	61553-442-30	,	125 ml in 150 ml Baxter Intravia Bag 	;  Service Code	2K8490	,	NDC	61553-490-47150 ml in 150 ml Baxter Intravia Bag, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141	","43,589 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	3V8701	,	Lot Number	160390095M	,	Exp. Date	5/9/2016	;  Service Code	3V8701	,	Lot Number	160480198M	,	Exp. Date	5/18/2016	;  Service Code	3V8701	,	Lot Number	160540108M	,	Exp. Date	5/24/2016	;  Service Code	3V8701	,	Lot Number	160690111M	,	Exp. Date	6/8/2016	;  Service Code	3V8701	,	Lot Number	160740250M	,	Exp. Date	6/13/2016	;  Service Code	3V8701	,	Lot Number	160820104M	,	Exp. Date	6/21/2016	;  Service Code	3V8701	,	Lot Number	160900119M	,	Exp. Date	6/28/2016	;  Service Code	3V8701	,	Lot Number	160970024M	,	Exp. Date	7/5/2016	;  Service Code	3V8703	,	Lot Number	160420127M	,	Exp. Date	5/6/2016	;  Service Code	3V8703	,	Lot Number	160460220M	,	Exp. Date	5/10/2016	;  Service Code	3V8703	,	Lot Number	160530317M	,	Exp. Date	5/17/2016	;  Service Code	3V8703	,	Lot Number	160540155M	,	Exp. Date	5/18/2016	;  Service Code	3V8703	,	Lot Number	160630132M	,	Exp. Date	5/27/2016	;  Service Code	3V8703	,	Lot Number	160660018C	,	Exp. Date	5/30/2016	;  Service Code	3V8703	,	Lot Number	160660249M	,	Exp. Date	5/30/2016	;  Service Code	3V8703	,	Lot Number	160750261M	,	Exp. Date	6/8/2016	;  Service Code	3V8703	,	Lot Number	160800218M	,	Exp. Date	6/13/2016	;  Service Code	3V8703	,	Lot Number	160910144M	,	Exp. Date	6/24/2016	;  Service Code	3V8703	,	Lot Number	160940249M	,	Exp. Date	6/27/2016	;  Service Code	3V8703	,	Lot Number	161080258M	,	Exp. Date	7/11/2016	;  Service Code	2C8201	,	Lot Number	160960246M	,	Exp. Date	5/21/2016	;  Service Code	2H8122	,	Lot Number	160400260M	,	Exp. Date	5/6/2016	;  Service Code	2H8122	,	Lot Number	160460244M	,	Exp. Date	5/12/2016	;  Service Code	2H8122	,	Lot Number	160530172M	,	Exp. Date	5/19/2016	;  Service Code	2H8122	,	Lot Number	160600231M	,	Exp. Date	5/26/2016	;  Service Code	2H8122	,	Lot Number	160610162M	,	Exp. Date	5/27/2016	;  Service Code	2H8122	,	Lot Number	160660246M	,	Exp. Date	6/1/2016	;  Service Code	2H8122	,	Lot Number	160680217M	,	Exp. Date	6/3/2016	;  Service Code	2H8122	,	Lot Number	160770255M	,	Exp. Date	6/12/2016	;  Service Code	2H8122	,	Lot Number	160800216M	,	Exp. ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1399-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.162% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free flow-flow protection, Service Code 2T8229, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-229-97		","21 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot #160960135M; Exp. Date 5/6/2016	  Lot #161080053M; Exp. Date 5/17/2016	  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1426-2016","Class II","5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141","3,927 syringes ","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8139	,	Lot Number	160420171M	,	Exp. Date	5/12/2016	;  Service Code	2H8139	,	Lot Number	160460111M	,	Exp. Date	5/16/2016	;  Service Code	2H8139	,	Lot Number	160490001M	,	Exp. Date	5/18/2016	;  Service Code	2H8139	,	Lot Number	160530289M	,	Exp. Date	5/23/2016	;  Service Code	2H8139	,	Lot Number	160560215M	,	Exp. Date	5/26/2016	;  Service Code	2H8139	,	Lot Number	160590055M	,	Exp. Date	5/29/2016	;  Service Code	2H8139	,	Lot Number	160600232M	,	Exp. Date	5/30/2016	;  Service Code	2H8139	,	Lot Number	160610189M	,	Exp. Date	5/31/2016	;  Service Code	2H8139	,	Lot Number	160670159M	,	Exp. Date	6/6/2016	;  Service Code	2H8139	,	Lot Number	160740151M	,	Exp. Date	6/13/2016	;  Service Code	2H8139	,	Lot Number	160770172M	,	Exp. Date	6/16/2016	;  Service Code	2H8139	,	Lot Number	160800069M	,	Exp. Date	6/18/2016	;  Service Code	2H8139	,	Lot Number	160810208M	,	Exp. Date	6/20/2016	;  Service Code	2H8139	,	Lot Number	160900168M	,	Exp. Date	6/29/2016	;  Service Code	2H8139	,	Lot Number	160960158M	,	Exp. Date	7/5/2016	;  Service Code	2H8139	,	Lot Number	161080229M	,	Exp. Date	7/17/2016	;  Service Code	2H8140	,	Lot Number	160450212M	,	Exp. Date	5/11/2016	;  Service Code	2H8140	,	Lot Number	160550237M	,	Exp. Date	5/21/2016	;  Service Code	2H8140	,	Lot Number	160660222M	,	Exp. Date	6/1/2016	;  Service Code	2H8140	,	Lot Number	160670248M	,	Exp. Date	6/2/2016	;  Service Code	2H8140	,	Lot Number	160700215M	,	Exp. Date	6/5/2016	;  Service Code	2H8140	,	Lot Number	160870227M	,	Exp. Date	6/22/2016	;  Service Code	2H8140	,	Lot Number	160880150M	,	Exp. Date	6/23/2016	;  Service Code	2H8140	,	Lot Number	160940208M	,	Exp. Date	6/29/2016	;  Service Code	2H8140	,	Lot Number	161080214M	,	Exp. Date	7/13/2016	;  Service Code	2K8139	,	Lot Number	160450047M	,	Exp. Date	5/9/2016	;  Service Code	2K8139	,	Lot Number	160590188M	,	Exp. Date	5/23/2016	;  Service Code	2K8139	,	Lot Number	160610248M	,	Exp. Date	5/25/2016	;  Service Code	2K8139	,	Lot Number	160730263M	,	Exp. Date	6/6/2016	;  Service Code	2K8139	,	Lot Number	160770133M	,	Exp.",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1402-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141		,	","95 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8103	,	Lot Number	160450153M	,	Exp. Date	5/11/2016	;  Service Code	2K8444	,	Lot Number	160490047C	,	Exp. Date	5/13/2016	;  Service Code	2K8444	,	Lot Number	160540031C	,	Exp. Date	5/18/2016	;  Service Code	2K8444	,	Lot Number	160610039C	,	Exp. Date	5/25/2016	;  Service Code	2K8444	,	Lot Number	160730032C	,	Exp. Date	6/6/2016	;  Service Code	2K8444	,	Lot Number	160760038C	,	Exp. Date	6/9/2016	;  Service Code	2K8444	,	Lot Number	160800049C	,	Exp. Date	6/13/2016	;  Service Code	2K8444	,	Lot Number	160960053C	,	Exp. Date	6/29/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1422-2016","Class II","5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50	,","655 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2H8256	,	Lot Number	160410124M	,	Exp. Date	5/11/2016	;  Service Code	2H8256	,	Lot Number	160560146M	,	Exp. Date	5/26/2016	;  Service Code	2H8256	,	Lot Number	160590041M	,	Exp. Date	5/29/2016	;  Service Code	2H8256	,	Lot Number	160690131M	,	Exp. Date	6/8/2016	;  Service Code	2H8256	,	Lot Number	160900157M	,	Exp. Date	6/29/2016	;  Service Code	2K8254	,	Lot Number	160390176M	,	Exp. Date	5/9/2016	;  Service Code	2K8254	,	Lot Number	160410129M	,	Exp. Date	5/11/2016	;  Service Code	2K8254	,	Lot Number	160460130M	,	Exp. Date	5/16/2016	;  Service Code	2K8254	,	Lot Number	160530293M	,	Exp. Date	5/23/2016	;  Service Code	2K8254	,	Lot Number	160590075M	,	Exp. Date	5/29/2016	;  Service Code	2K8254	,	Lot Number	160600187M	,	Exp. Date	5/30/2016	;  Service Code	2K8254	,	Lot Number	160610002M	,	Exp. Date	5/30/2016	;  Service Code	2K8254	,	Lot Number	160680155M	,	Exp. Date	6/6/2016	;  Service Code	2K8254	,	Lot Number	160760125M	,	Exp. Date	6/14/2016	;  Service Code	2K8254	,	Lot Number	160880192M	,	Exp. Date	6/27/2016	;  Service Code	2K8254	,	Lot Number	160890178M	,	Exp. Date	6/28/2016	;  Service Code	2K8256	,	Lot Number	160480195M	,	Exp. Date	5/12/2016	;  Service Code	2K8256	,	Lot Number	160530189M	,	Exp. Date	5/17/2016	;  Service Code	2K8256	,	Lot Number	160560081M	,	Exp. Date	5/19/2016	;  Service Code	2K8256	,	Lot Number	160590069M	,	Exp. Date	5/23/2016	;  Service Code	2K8256	,	Lot Number	160660151M	,	Exp. Date	5/30/2016	;  Service Code	2K8256	,	Lot Number	160680250M	,	Exp. Date	6/1/2016	;  Service Code	2K8256	,	Lot Number	160880025M	,	Exp. Date	6/20/2016	;  Service Code	2K8256	,	Lot Number	160950047M	,	Exp. Date	6/27/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1397-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141		  ","250 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160470226M	,	Exp. Date	5/11/2016	;  Lot Number	160540237M	,	Exp. Date	5/18/2016	;  Lot Number	160600045M	,	Exp. Date	5/23/2016	;  Lot Number	160750052M	,	Exp. Date	6/7/2016	;  Lot Number	160950043M	,	Exp. Date	6/27/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1379-2016","Class II","10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52	      ","750 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160460017C	,	Exp. Date	5/12/2016	;  Lot Number	160600019C	,	Exp. Date	5/26/2016	;  Lot Number	160670016C	,	Exp. Date	6/2/2016	;  Lot Number	160740027C	,	Exp. Date	6/9/2016	;  Lot Number	160810024C	,	Exp. Date	6/16/2016	;  Lot Number	160880005C	,	Exp. Date	6/23/2016	;  Lot Number	160950036M	,	Exp. Date	6/29/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1374-2016","Class II","1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95    ","361 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160460204M	,	Exp. Date	5/10/2016	;  Lot Number	160560170M	,	Exp. Date	5/20/2016	;  Lot Number	160700007M	,	Exp. Date	6/2/2016	;  Lot Number	160810176M	,	Exp. Date	6/14/2016	;  Lot Number	160830325M	,	Exp. Date	6/16/2016	;  Lot Number	160880270M	,	Exp. Date	6/21/2016	;  Lot Number	160890245M	,	Exp. Date	6/22/2016	;  Lot Number	160900144M	,	Exp. Date	6/23/2016	;  Lot Number	160950241M	,	Exp. Date	6/28/2016	;  Lot Number	161080135M	,	Exp. Date	7/11/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1431-2016","Class II","5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20	","5 syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160540183M	,	Exp. Date	5/23/2016  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1367-2016","Class II","0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag,  Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,		;","355 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K8119	,	Lot Number	160480208M	,	Exp. Date	5/18/2016	;  Service Code	2K8119	,	Lot Number	160490134M	,	Exp. Date	5/19/2016	;  Service Code	2K8119	,	Lot Number	160520129M	,	Exp. Date	5/22/2016	;  Service Code	2K8119	,	Lot Number	160530167M	,	Exp. Date	5/23/2016	;  Service Code	2K8119	,	Lot Number	160700126M	,	Exp. Date	6/8/2016	;  Service Code	2K8119	,	Lot Number	160740148M	,	Exp. Date	6/13/2016	;  Service Code	2K8119	,	Lot Number	160750046M	,	Exp. Date	6/13/2016	;  Service Code	2K8119	,	Lot Number	160820124M	,	Exp. Date	6/21/2016	;  Service Code	2K8171	,	Lot Number	160880264M	,	Exp. Date	6/27/2016	;  Service Code	2K8217	,	Lot Number	160380114M	,	Exp. Date	5/8/2016	;  Service Code	2K8217	,	Lot Number	160410116M	,	Exp. Date	5/11/2016	;  Service Code	2K8217	,	Lot Number	160480128M	,	Exp. Date	5/18/2016	;  Service Code	2K8217	,	Lot Number	160540123M	,	Exp. Date	5/23/2016	;  Service Code	2K8217	,	Lot Number	160600196M	,	Exp. Date	5/30/2016	;  Service Code	2K8217	,	Lot Number	160730054M	,	Exp. Date	6/12/2016	;  Service Code	2K8217	,	Lot Number	160740245M	,	Exp. Date	6/13/2016	;  Service Code	2K8217	,	Lot Number	160750048M	,	Exp. Date	6/13/2016	;  Service Code	2K8217	,	Lot Number	160840149M	,	Exp. Date	6/23/2016	;  Service Code	2K8217	,	Lot Number	160900131M	,	Exp. Date	6/29/2016	;  Service Code	2K8217	,	Lot Number	160960139M	,	Exp. Date	7/5/2016	;  Service Code	2K8463	,	Lot Number	160400227M	,	Exp. Date	5/10/2016	;  Service Code	2K8463	,	Lot Number	160630030M	,	Exp. Date	6/1/2016	;  Service Code	2K8463	,	Lot Number	160890243M	,	Exp. Date	6/28/2016	;  Service Code	2K8463	,	Lot Number	160970195M	,	Exp. Date	7/6/2016	;  Service Code	2K8931	,	Lot Number	160970018C	,	Exp. Date	5/7/2016	;  Service Code	2N1119	,	Lot Number	160490041C	,	Exp. Date	5/19/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1377-2016","Class II","1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232,  (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection  Service Code 2T8878 	100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52),  Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141	    ","384 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2T8232	,	Lot Number	160970019C	,	Exp. Date	5/7/2016	;  Service Code	2T8878	,	Lot Number	160450193M	,	Exp. Date	5/6/2016	;  Service Code	2T8878	,	Lot Number	160470227M	,	Exp. Date	5/8/2016	;  Service Code	2T8878	,	Lot Number	160590187M	,	Exp. Date	5/19/2016	;  Service Code	2T8878	,	Lot Number	160630026M	,	Exp. Date	5/23/2016	;  Service Code	2T8878	,	Lot Number	160700162M	,	Exp. Date	5/31/2016	;  Service Code	2T8878	,	Lot Number	160710004M	,	Exp. Date	5/31/2016	;  Service Code	2T8878	,	Lot Number	160740228M	,	Exp. Date	6/4/2016	;  Service Code	2T8878	,	Lot Number	160750111M	,	Exp. Date	6/4/2016	;  Service Code	2T8878	,	Lot Number	160900226M	,	Exp. Date	6/20/2016	;  Service Code	2T8878	,	Lot Number	161080176M	,	Exp. Date	7/8/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1432-2016","Class II","6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86	","180 syringes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160480035C	,	Exp. Date	5/18/2016	;  Lot Number	160560026C	,	Exp. Date	5/26/2016	;  Lot Number	160620029C	,	Exp. Date	6/1/2016	;  Lot Number	160630001C	,	Exp. Date	6/1/2016	;  Lot Number	160810283M	,	Exp. Date	6/20/2016	;  Lot Number	160880013C	,	Exp. Date	6/27/2016	;  Lot Number	160890043C	,	Exp. Date	6/28/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1366-2016","Class II","0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217,  Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50","315 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160380121M	,	Exp. Date	5/7/2016	;  Lot Number	160420113M	,	Exp. Date	5/11/2016	;  Lot Number	160450116M	,	Exp. Date	5/15/2016	;  Lot Number	160470127M	,	Exp. Date	5/16/2016	;  Lot Number	160480136M	,	Exp. Date	5/18/2016	;  Lot Number	160490132M	,	Exp. Date	5/18/2016	;  Lot Number	160520114M	,	Exp. Date	5/21/2016	;  Lot Number	160530129M	,	Exp. Date	5/23/2016	;  Lot Number	160590138M	,	Exp. Date	5/29/2016	;  Lot Number	160600038C	,	Exp. Date	5/30/2016	;  Lot Number	160620018C	,	Exp. Date	6/1/2016	;  Lot Number	160700020C	,	Exp. Date	6/9/2016	;  Lot Number	160740044C	,	Exp. Date	6/13/2016	;  Lot Number	160750033C	,	Exp. Date	6/14/2016	;  Lot Number	160760051C	,	Exp. Date	6/15/2016	;  Lot Number	160770024C	,	Exp. Date	6/16/2016	;  Lot Number	160810053C	,	Exp. Date	6/20/2016	;  Lot Number	160820033C	,	Exp. Date	6/21/2016	;  Lot Number	160880014C	,	Exp. Date	6/27/2016	;  Lot Number	160940015C	,	Exp. Date	7/2/2016	;  Lot Number	160950034C	,	Exp. Date	7/4/2016	;  Lot Number	160960019C	,	Exp. Date	7/5/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1390-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50	,	  ","60 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160390213M	,	Exp. Date	5/9/2016	;  Lot Number	160420162M	,	Exp. Date	5/12/2016	;  Lot Number	160480197M	,	Exp. Date	5/18/2016	;  Lot Number	160600057M	,	Exp. Date	5/29/2016	;  Lot Number	161080145M	,	Exp. Date	7/17/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1411-2016","Class II","20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96		  ","212 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160600315M	,	Exp. Date	5/7/2016	;  Lot Number	160670256M	,	Exp. Date	5/14/2016	;  Lot Number	160730057M	,	Exp. Date	5/20/2016	;  Lot Number	160740144M	,	Exp. Date	5/20/2016	;  Lot Number	160800152M	,	Exp. Date	5/27/2016	;  Lot Number	160900142M	,	Exp. Date	6/5/2016	;  Lot Number	160910123M	,	Exp. Date	6/6/2016	;  Lot Number	160940037M	,	Exp. Date	6/9/2016	;  Lot Number	161080048M	,	Exp. Date	6/24/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1376-2016","Class II","1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52    ","25 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot # 160970162M; Exp. Date 5/7/2016	    ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1417-2016","Class II","3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30	","1,015 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160390336M	,	Exp. Date	5/9/2016	;  Lot Number	160530318M	,	Exp. Date	5/23/2016	;  Lot Number	160600347M	,	Exp. Date	5/30/2016	;  Lot Number	160750243M	,	Exp. Date	6/14/2016	;  Lot Number	160760164M	,	Exp. Date	6/14/2016	;  Lot Number	160830228M	,	Exp. Date	6/22/2016	;  Lot Number	160890224M	,	Exp. Date	6/28/2016	;  Lot Number	160960242M	,	Exp. Date	7/5/2016	;  Lot Number	160970140M	,	Exp. Date	7/6/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1401-2016","Class II","2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02	","90 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160420104M	,	Exp. Date	5/6/2016	;  Lot Number	160450187M	,	Exp. Date	5/9/2016	;  Lot Number	160530126M	,	Exp. Date	5/17/2016	;  Lot Number	160680200M	,	Exp. Date	6/1/2016	;  Lot Number	160730047M	,	Exp. Date	6/5/2016	;  Lot Number	160750130M	,	Exp. Date	6/8/2016	;  Lot Number	160830227M	,	Exp. Date	6/16/2016	;  Lot Number	160870077M	,	Exp. Date	6/19/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1385-2016","Class II","10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50		","30 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot # 160890042M; Exp. Date 5/13/2016	  Lot # 160960052M; Exp. Date 5/20/2016	  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1407-2016","Class II","2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02	  ","380 bags","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Lot Number	160530277M	,	Exp. Date	5/17/2016	;  Lot Number	160610199M	,	Exp. Date	5/25/2016	;  Lot Number	160660176M	,	Exp. Date	5/30/2016	;  Lot Number	160690200M	,	Exp. Date	6/2/2016	;  Lot Number	160770187M	,	Exp. Date	6/10/2016	;  Lot Number	160890268M	,	Exp. Date	6/22/2016	;  Lot Number	160960227M	,	Exp. Date	6/29/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74057,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1406-2016","Class II","2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0972-48				  ","220 Medical Cassettes","Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.","07/16/2016",," Service Code	2K8210	,	Lot Number	160390175M	,	Exp. Date	5/9/2016	;  Service Code	2K8210	,	Lot Number	160400226M	,	Exp. Date	5/10/2016	;  Service Code	2K8210	,	Lot Number	160520170M	,	Exp. Date	5/22/2016	;  Service Code	2K8210	,	Lot Number	160590066M	,	Exp. Date	5/29/2016	;  Service Code	2K8210	,	Lot Number	160670046M	,	Exp. Date	6/5/2016	;  Service Code	2K8210	,	Lot Number	160680006M	,	Exp. Date	6/6/2016	;  Service Code	2K8210	,	Lot Number	160700027M	,	Exp. Date	6/8/2016	;  Service Code	2K8210	,	Lot Number	160730069M	,	Exp. Date	6/11/2016	;  Service Code	2K8210	,	Lot Number	160880217M	,	Exp. Date	6/27/2016	;  Service Code	2K8972	,	Lot Number	160450177M	,	Exp. Date	5/6/2016	;  Service Code	2K8972	,	Lot Number	160460196M	,	Exp. Date	5/7/2016	;  Service Code	2K8972	,	Lot Number	160600082M	,	Exp. Date	5/20/2016	;  Service Code	2K8972	,	Lot Number	160670061C	,	Exp. Date	5/28/2016	;  Service Code	2K8972	,	Lot Number	160740067C	,	Exp. Date	6/4/2016	;  Service Code	2K8972	,	Lot Number	160810085C	,	Exp. Date	6/11/2016	;  Service Code	2K8972	,	Lot Number	160950188M	,	Exp. Date	6/25/2016	;  ",5/5/2016,"05/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74058,"Ongoing","Bickel's Snack Foods Inc","1120 Zinns Quarry Rd",,"York","PA","17404-3533","United States","Voluntary: Firm Initiated","Telephone","Alabama, Arkansas, Colorado, Delaware, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Wisconsin, and West Virginia  Per Dutch Valley Distributors.","F-1557-2016","Class I","Golden Gourmet Snacks Veggie Chips;  Net Wt. 12 OZ;  Bickel's Snack Foods, Inc., York, PA 17404  Lot codes: 26SEP16 Z4D1 and 26SEP16 Z5D1","201 cases 10 bags/case - 2010 bags.","Golden Gourmet Veggie Chips are being recalled due to an undeclared milk allergen. Ranch Flavored Veggie Chips, which contain a milk ingredient, were packed in plain veggie chip bags. ","06/20/2016",," Lot codes: 26SEP16 Z4D1 and 26SEP16 Z5D1",5/4/2016,"05/04/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74059,"Ongoing","Medtronic Neuromodulation","7000 Central Ave",".","Minneapolis","MN","55421-1241","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution","Z-1926-2016","Class II","Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators.    Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.","60,941","Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge session was found to be key factor.","06/07/2016",," All lot/serial numbers are affected for both Model numbers 37714 and 97714.",5/3/2016,"05/03/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74060,"Ongoing","Manna Pro Corp","707 Spirit 40 Park Dr Ste 150",,"Chesterfield","MO","63005-1137","United States","Voluntary: Firm Initiated","Telephone","Shipped to distribution centers in California and subsequently to retail stores in CA, HI, NV, and OR.","V-0013-2017","Class I","MannaPro Chick Starter Medicated, Amprolium 113.5 g/ton, UPC 0 95668 10555 6, packaged in 25 lb woven plastic bags.  Manufactured by MannaPro Products LLC. St. Louis, MO","292 25# bags","Product contains excessive levels of salt.","10/21/2016",," MADE 11/23/15 WP-2",4/8/2016,"04/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74061,"Ongoing","CMP Industries, Llc","413 N Pearl St",,"Albany","NY","12207-1311","United States","Voluntary: Firm Initiated","Letter","Domestic - MI, MN, NJ, NM, NY & PA; International - Canada","Z-2098-2016","Class II","IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface  ","77 units Total","Possible presence of foreign material (rust).","06/29/2016",," Lot Number: 79943  Expiration Date: March 2021",4/28/2016,"04/28/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74061,"Ongoing","CMP Industries, Llc","413 N Pearl St",,"Albany","NY","12207-1311","United States","Voluntary: Firm Initiated","Letter","Domestic - MI, MN, NJ, NM, NY & PA; International - Canada","Z-2097-2016","Class II","IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450;  Indicated for relining a denture surface.","77 units Total","Possible presence of foreign material (rust).","06/29/2016",," Lot Number: 79943  Expiration Date: March 2021",4/28/2016,"04/28/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74062,"Ongoing","Pita Pal Foods LP","3100 Canal St",,"Houston","TX","77003-1602","United States","Voluntary: Firm Initiated","Press Release","AZ, CA, FL, GA, MI, NY, OK, TX","F-1585-2016","Class I","Pita Pal Chipotle Quinoa & Black Beans Superfood Mild Net Wt 28 oz (1.75 LBS) 793g Keep Refrigerated UPC: 8-50157-00017-6 www.pitapal.com Pita Pal Foods, LP. Houston, TX 7703","48 cases","Product may be contaminated with Listeria monocytogenes.","06/27/2016",," Expiration Date or Use/Freeze by dates through June 13, 2016.",5/5/2016,"05/05/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74062,"Ongoing","Pita Pal Foods LP","3100 Canal St",,"Houston","TX","77003-1602","United States","Voluntary: Firm Initiated","Press Release","AZ, CA, FL, GA, MI, NY, OK, TX","F-1583-2016","Class I","Pita Pal Mediterranean Three Bean Net Wt. 8 oz. (226g) UPC: 8-50157-0007-7 Keep Refrigerated Pita Pal Foods, LP Houston, TX 7003 www.pitapal.com; Pita Pal Mediterranean Three Bean Salad UPC: 8-50157-00048-0 Keep Refrigerated Net Wt: 24 oz.; Pita Pal Mediterranean Three Bean Salad UPC: 8-50157-00084-8 Keep Refrigerated Net Weight: 4 lbs","560 cases","Product may be contaminated with Listeria monocytogenes.","06/27/2016",," Expiration Date or Use/Freeze by dates through June 13, 2016.",5/5/2016,"05/05/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74062,"Ongoing","Pita Pal Foods LP","3100 Canal St",,"Houston","TX","77003-1602","United States","Voluntary: Firm Initiated","Press Release","AZ, CA, FL, GA, MI, NY, OK, TX","F-1582-2016","Class I","Hightower Corn Relish UPC: 8-51570-00386-7 5 pound plastic containers Manufactured By Pita Pal Foods Keep Refrigerated","18 cases","Product may be contaminated with Listeria monocytogenes.","06/27/2016",," Expiration Date or Use/Freeze by dates through June 13, 2016.",5/5/2016,"05/05/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74062,"Ongoing","Pita Pal Foods LP","3100 Canal St",,"Houston","TX","77003-1602","United States","Voluntary: Firm Initiated","Press Release","AZ, CA, FL, GA, MI, NY, OK, TX","F-1584-2016","Class I","Pita Pal Texas Caviar Net Wt. 8 oz. (226g) UPC: 8-50157-0006-0 Keep Refrigerated Pita Pal Foods, LP. Houston, TX 77003 www.pitapal.com; Pita Pal Texas Caviar UPC: 8-50157-00086-2 Keep Refrigerated Net Weight: 4.5 lbs; ","715 cases","Product may be contaminated with Listeria monocytogenes.","06/27/2016",," Expiration Date or Use/Freeze by dates through June 13, 2016.",5/5/2016,"05/05/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74063,"Ongoing","Creative Snacks Co., LLC","241 Burgess Rd Ste B",,"Greensboro","NC","27409-9333","United States","Voluntary: Firm Initiated","Telephone","CA, CT, DE, GA, IN, ME, MA, MN, NJ, NY, NC, SC, TX, UT","F-1863-2016","Class I"," Fresh Market Healthy Snackin, 25 lb. bulk, UPC n/a                             ","79 cases","Potential presence of Listeria Monocytogenes","08/03/2016",," Code 1203032216, 1224032916",5/5/2016,"05/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74063,"Ongoing","Creative Snacks Co., LLC","241 Burgess Rd Ste B",,"Greensboro","NC","27409-9333","United States","Voluntary: Firm Initiated","Telephone","CA, CT, DE, GA, IN, ME, MA, MN, NJ, NY, NC, SC, TX, UT","F-1867-2016","Class I","Creative Snacks Co. Roasted, Salted Sunflower Seeds, 10 lb. bulk, UPC 816512013892; Plentiful Planet Roasted, Salted Sunflower Seeds, 10 lb. bulk, UPC 077420000873; Creative Snacks Co. Roasted, Salted Sunflower Seeds, 9 oz. cup, UPC 816512011218                   ","1386 cases","Potential presence of Listeria Monocytogenes","08/03/2016",," Creative Snacks 10 lb. bulk  4861031816, 4881032916, 4903033116, 4936041316; Plentiful Planet 10 lb. bulk  4869031816, 4927041116, 4964041916, 61268; Creative Snacks 9 oz. cup  2684030716, 2742032216, 2801033116, 2885041516, 2857041216, 61247",5/5/2016,"05/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74063,"Ongoing","Creative Snacks Co., LLC","241 Burgess Rd Ste B",,"Greensboro","NC","27409-9333","United States","Voluntary: Firm Initiated","Telephone","CA, CT, DE, GA, IN, ME, MA, MN, NJ, NY, NC, SC, TX, UT","F-1864-2016","Class I","Plentiful Planet Heart Smart Mix, 25 lb. bulk, UPC 030684710285; Publishers Clearing House Heart Smart Mix 8 oz. bag, UPC n/a; Creative Snacks Co. Heart Smart 3.5 oz. Snack Bags, UPC 816512012130; Creative Snacks Co. Heart Smart 9.5 oz. cup, UPC 855983002066; Creative Snacks Co. Heart Smart Mix 10 lb. bulk, UPC 816512013014                             ","5,448 cases ","Potential presence of Listeria Monocytogenes","08/03/2016",," Plentiful Planet 25 lb. bulk  1224032916, 1156030316, 1204032216; Publishers Clearing 8 oz.  6710041216, 61185; Creative Snacks 3.5 oz.  6620030316, 6627030916, 6640031516, 6656032416, 6673033016, 6697040516, 6733041816, 61313, 61201, 61357; 9.5 oz. cup  2674030316, 2764032416, 2819040516, 2886041516, 61188, 61162, 61242, 61324; 10 lb. bulk  1183031416, 4869032116, 4894033016, 61181   ",5/5/2016,"05/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74063,"Ongoing","Creative Snacks Co., LLC","241 Burgess Rd Ste B",,"Greensboro","NC","27409-9333","United States","Voluntary: Firm Initiated","Telephone","CA, CT, DE, GA, IN, ME, MA, MN, NJ, NY, NC, SC, TX, UT","F-1868-2016","Class I","Creative Snacks Co. Hold the Salt!, 10 lb. bulk, UPC 816512011201; Creative Snacks Co. Hold the Salt!, 8.5 oz. cup, UPC 816512011034                   ","110 cases","Potential presence of Listeria Monocytogenes","08/03/2016",," Creative Snacks 10 lb. bulk 1296041516; Creative Snacks 8.5 oz. cup 2934041916",5/5/2016,"05/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74063,"Ongoing","Creative Snacks Co., LLC","241 Burgess Rd Ste B",,"Greensboro","NC","27409-9333","United States","Voluntary: Firm Initiated","Telephone","CA, CT, DE, GA, IN, ME, MA, MN, NJ, NY, NC, SC, TX, UT","F-1862-2016","Class I","Creative Snacks Brain Food, 3.5 oz. Snack Bag, UPC 816512015124, 10 lb. Bulk, UPC 816512013021, 9.5 oz. cup, UPC 855983002073; Fresh Market Brain Food, 25 lb. Bulk, UPC N/A, 9.5 oz. cup, UPC 737094218270,                                ","5,480 cases","Potential presence of Listeria Monocytogenes","08/03/2016",," Creative Snacks Co. Snack Bag  6625030816, 6641031516, 6659032416, 6680033116, 6698040516, 61316, 61352; Creative Snacks Co. 10 lb. bulk  1180031016, 4870032116, 4895033016, 4910040416, 1285041316, 61331; Fresh Market 25 lb. bulk  1180031016, 1205032216, 1242033116, 1285041316, 61240; Fresh Market 9.5 oz. cup -  3067030916; Creative Snack Co. 9.5 oz. cup  26750303156, 2704031016, 2711031416, 2766032416, 2816040416, 29120401716, 61313, 61247 ",5/5/2016,"05/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74063,"Ongoing","Creative Snacks Co., LLC","241 Burgess Rd Ste B",,"Greensboro","NC","27409-9333","United States","Voluntary: Firm Initiated","Telephone","CA, CT, DE, GA, IN, ME, MA, MN, NJ, NY, NC, SC, TX, UT","F-1865-2016","Class I","Creative Snacks Co. Roasted, No Salt Sunflower Seeds, 9 oz. cup, UPC 816512011294; 10 lb. bulk, UPC 816512011423; Plentiful Planet Roasted, No Salt Sunflower Seeds, 25 lb. bulk, UPC 07742417794; 10 lb. bulk, UPC 077420000880                         ","383 cases","Potential presence of Listeria Monocytogenes","08/03/2016",," Creative Snacks Co. 9 oz. cup  2741032216, 2818040516, 2855041116, 2884041516; Creative Snacks Co. 10 lb. bulk  4900033116; Plentiful Planet 25 lb. bulk  4891032916, 4926041116; Plentiful Planet 10 lb. bulk - 4963041916, 61268",5/5/2016,"05/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74063,"Ongoing","Creative Snacks Co., LLC","241 Burgess Rd Ste B",,"Greensboro","NC","27409-9333","United States","Voluntary: Firm Initiated","Telephone","CA, CT, DE, GA, IN, ME, MA, MN, NJ, NY, NC, SC, TX, UT","F-1866-2016","Class I","Creative Snacks Co. Sunny Day Splendor, 10 lb. bulk, UPC 816512014653; Creative Snacks Co. Sunny Day Splendor 10 oz. cup, UPC 816512010983                      ","90 cases","Potential presence of Listeria Monocytogenes","08/03/2016",," Creative Snacks 10 lb. bulk 1192031716; Creative Snacks 10 oz. cup 2930041916",5/5/2016,"05/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74064,"Completed","Invivo Corporation","3545 SW 47th Ave",,"Gainesville","FL","32608-7691","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI","Z-2688-2016","Class II","Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems. ","3","A diode was inadvertently not assembled  into the system, which may result in coil overheating","08/30/2016",," Model #: 9896-032-14382; Serial #: 13 (production order 301128446), 14 (production order 301153586), and 15 (production order 301153587).",5/6/2016,"05/06/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74065,"Ongoing","Pulmuone Foods Usa","2315 Moore Ave",".","Fullerton","CA","92833-2510","United States","Voluntary: Firm Initiated","Letter","US: WA, NJ, MD, CA, IL, GA, TX,     Canada.","F-1370-2016","Class I","Noodles with Fire-roasted Black Bean Sauce, 23.3oz, UPC 7 53214 30021 2, Food Item No. 30021, Pack Size: 16.","6,957 cases","Pulmuone Foods is recalling noodles because it contains undeclared milk.","06/09/2016",," Affected Lot Numbers (Best By Dates):  5/14/2016, 5/29/2016, 6/8/2016, 7/4/2016, 8/9/2016, 8/16/2016, 8/17/2016, 9/11/2016",5/5/2016,"05/05/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74065,"Ongoing","Pulmuone Foods Usa","2315 Moore Ave",".","Fullerton","CA","92833-2510","United States","Voluntary: Firm Initiated","Letter","US: WA, NJ, MD, CA, IL, GA, TX,     Canada.","F-1368-2016","Class I","Korean Noodles in a Savory Black Bean Sauce, 46.6oz, UPC 7-53214-73298-3, Food Item No. 1027557, Pack Size: 8.","10,129 cases","Pulmuone Foods is recalling noodles because it contains undeclared milk.","06/09/2016",," Affected Lot Numbers (Best By Dates):  6/2/2016, 6/21/2016, 8/16/2016, 8/21/2016, 9/17/2016, 9/30/2016, 10/11/2016, 10/25/2016, 11/1/2016, 11/6/2016, 11/22/2016",5/5/2016,"05/05/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74065,"Ongoing","Pulmuone Foods Usa","2315 Moore Ave",".","Fullerton","CA","92833-2510","United States","Voluntary: Firm Initiated","Letter","US: WA, NJ, MD, CA, IL, GA, TX,     Canada.","F-1369-2016","Class I","Noodles with Beijing Style Black Bean Sauce, 23.3oz, UPC 7 53214 30024 3, Food Item No. 30024, Pack Size: 16.","2,203 cases","Pulmuone Foods is recalling noodles because it contains undeclared milk.","06/09/2016",," Affected Lot Numbers (Best By Dates):  5/14/2016, 6/4/2016, 7/16/2016, 7/26/2016, 8/20/2016.",5/5/2016,"05/05/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74066,"Ongoing","Club Chef LLC","3776 Lake Park Drive",".","Covington","KY","41017-9826","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was shipped to GA & IN","F-0589-2017","Class I","Club Chef Broccoli & Raisin Salad Kits, in 7.625 lb cases, containing 1bag (4.8 oz) of Raisin Sunflower Mix per case.","5,090 cases","The firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.","12/06/2016",," Item #48001; Case Lot # 6127KT5 Use By: MAY-16-16; Packaging Lot #16089 3/29/16 & Lot number: 16123 Pack on date 4/28/16",5/5/2016,"05/05/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74067,"Ongoing","Staar Surgical Co.","1911 Walker Ave",,"Monrovia","CA","91016-4846","United States","Voluntary: Firm Initiated","Letter","US","Z-1964-2016","Class II","STAAR AQ Cartridge-FP,  guide and delivery system for Intraocular lenses.","2,612 units","The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).","06/14/2016",," 1281706, 1282812",5/2/2016,"05/02/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74068,"Ongoing","Sandoz, Inc","506 Carnegie Ctr Ste 400",,"Princeton","NJ","08540-6243","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1046-2016","Class III","Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz  Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01 ",,"Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.","06/20/2016",," Lot #:  EN0389, EP0473, Exp. 8/2016 ; FA4834, FN2602, Exp. 2/2017; FW3646 , Exp.11/2017",5/2/2016,"05/02/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74068,"Ongoing","Sandoz, Inc","506 Carnegie Ctr Ste 400",,"Princeton","NJ","08540-6243","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1045-2016","Class III","Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz  Inc.,  Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01     ","78,606 bottles ","Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.","06/20/2016",," Lot #s: EN3846, Exp 08/2016; FA4809, Exp 2/2017, FW3654 , Exp11/2017     ",5/2/2016,"05/02/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74069,"Ongoing","Simply Delicious Inc.","6325 Gunpark Dr",,"Boulder","CO","80301-3592","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide CA, CO, ID, MD, MN, OR, TN, TX, and WA.  No foreign or military/govt/VA consignees.","F-1403-2016","Class II","Bobo's Oat Bars, Gluten Free, Lemon Poppyseed, Net Weight 3 oz (85g), packaged in clear plastic, 12 bars per sleeve, also sold as individual units. Manufactured by Simply Delicious, Inc. ","142 Cases","Simply Delicious is recalling Lemon Poppyseed bars because they were mispackaged with Coconut bars.","05/26/2016",," Lot Number: MR0203 Best Buy: 11/02/2016",5/5/2016,"05/05/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74070,"Terminated","Stryker Corporation","5900 Optical Ct",".","San Jose","CA","95138-1400","United States","Voluntary: Firm Initiated","Other","GA, UT, MD, NJ, MT","Z-1910-2016","Class II","Stryker FlowPort II Adapter: Model number: 00CAT00778   The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.","21 units","Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction","06/03/2016","06/03/2016"," Lot Numbers Affected: 13604",5/4/2016,"05/04/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74071,"Ongoing","ConAgra Foods Inc","1 Conagra Dr",,"Omaha","NE","68102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AZ, CA, CO, FL, HI, IA, ID, IL, LA, MD, MN, NJ, NV, OH, OK, PA, TX, UT, VA, and WI and in the following countries: Canada, Columbia, Japan, and Panama.","F-2279-2016","Class I","Watts Brothers Farms Organic Super Sweet Corn (Yellow/Gold), net wt. 5 lbs., item V5398, UPC 681241153986.    Trader Joe's Organic Super Sweet Cut Corn, net wt. 16 oz., item 5474, UPC 0029 9633.    *********NICHIREI BRANDS ARE NOT DISTRIBUTED IN THE US*****    Nichirei Organic Super Sweet Cut Corn, item V5599, UPC 4 902130 363610  Nichirei Value + Organic Super Sweet Cut Corn, item V5801, UPC 4 949486 327026  ","805,616 lbs. Expanded quantity: 334,318 lbs.","Organic Super Sweet Corn (Yellow/Gold) and Organic Super Sweet Cut Corn are recalled due to the potential to be contaminated with Listeria monocytogenes. ","09/15/2016",," Watts Brothers Farms Organic Super Sweet Corn (Yellow/Gold) CODES:    Best Before 03/18/17	6180 03 18 17 HH:MM  Best Before 04/09/17	6180 04 09 17 HH:MM  Best Before 04/13/17	6180 04 13 17 HH:MM  Best Before 04/14/17	6180 04 14 17 HH:MM  Best Before 04/29/17	6180 04 29 17 HH:MM  Best Before 05/18/17	6180 05 18 17 HH:MM  Best Before 05/19/17	6180 05 19 17 HH:MM  Best Before 05/28/17	6180 05 28 17 HH:MM  Best Before 06/12/17	6180 06 12 17 HH:MM    expanded codes:    Best Before 08/07/17	6180 08 07 17 HH:MM   Best Before 09/01/17	6180 09 01 17 HH:MM   Best Before 09/02/17	6180 09 02 17 HH:MM     ***********************************************************************************  Trader Joe's Organic Super Sweet Cut Corn CODES    6180 03237HH  6180 03247HH  6180 06287HH  6180 06297HH  6180 06307HH  6180 07137HH  6180 08117HH  6180 08127HH  6180 08137HH      ************codes for NICHIREI brand*************  2017.1.1/KH4	  2017.2.17/KH4	  2017.2.18/KH4	  2016.12.28/KH4	    expanded code: 2016.12.29/KH4",5/5/2016,"05/05/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74071,"Ongoing","ConAgra Foods Inc","1 Conagra Dr",,"Omaha","NE","68102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AZ, CA, CO, FL, HI, IA, ID, IL, LA, MD, MN, NJ, NV, OH, OK, PA, TX, UT, VA, and WI and in the following countries: Canada, Columbia, Japan, and Panama.","F-2278-2016","Class I","Watts Brothers Farms Organic Mixed Vegetables, UPC 681241053484.    ************Foodservice Products********************    Watts Tote 4-Way Mixed Vegetables, item 3902  Watts Brothers 5 Way Mixed Vegetables, item V5173  Watts Brothers 4 Way Mixed Vegetables, item V5218  Watts Brothers 5 Way Mixed Vegetables, item V5246  Watts Brothers 4 Way Mixed Vegetables, item V5412    Sc 3623  12/40 oz  5-Way Mixed Vegetables, item V5359  Sc 2975  1/30#    5-Way Mixed Vegetables, item V5363  Sr 4493  12/40 oz  5-Way Mixed Vegetables, item V5370  Sr 2991  1/30#    5-Way Mixed Vegetables, item V5374    Alasko   6/2Kg    4-Way Mixed Vegetables, item V5448  Alasko   6/2Kg    4-Way Mixed Vegetables, item V5453      *********NICHIREI BRANDS ARE NOT DISTRIBUTED IN THE US*****    Nichirei Organic Mixed Vegetables, item V5600, UPC 4 902130 363641.  Nichirei Value + Organic Mixed Vegetables, item V5803, UPC 	4 949486 327019  ","7,543,480 lbs. - expanded recall 2,962,179 lbs.","Organic Mixed Vegetables are recalled due to the potential to be contaminated with Listeria monocytogenes.  ","09/15/2016",," Additional codes recalled on 7/28/16    Best Before 01/08/17	6180 01 08 17 HH:MM   Best Before 01/09/17	6180 01 09 17 HH:MM   Best Before 02/02/17	6180 02 02 17 HH:MM   Best Before 02/11/17	6180 02 11 17 HH:MM   Best Before 02/26/17	6180 02 26 17 HH:MM   Best Before 03/04/17	6180 03 04 17 HH:MM   Best Before 03/05/17	6180 03 05 17 HH:MM   Best Before 03/23/17	6180 03 23 17 HH:MM   Best Before 06/29/17	6180 06 29 17 HH:MM   Best Before 06/30/17	6180 06 30 17 HH:MM   Best Before 07/23/17	6180 07 23 17 HH:MM   Best Before 07/24/17	6180 07 24 17 HH:MM   Best Before 08/10/17	6180 08 10 17 HH:MM   Best Before 08/31/17	6180 08 31 17 HH:MM   Best Before 09/04/17	6180 09 04 17 HH:MM   Best Before 09/23/17	6180 09 23 17 HH:MM   Best Before 09/24/17	6180 09 24 17 HH:MM   Best Before 09/25/17	6180 09 25 17 HH:MM   Best Before 10/01/17	6180 10 01 17 HH:MM   Best Before 10/02/17	6180 10 02 17 HH:MM   Best Before 10/14/17	6180 10 14 17 HH:MM   Best Before 12/09/17	6180 12 09 17 HH:MM   Best Before 12/10/17	6180 12 10 17 HH:MM   Best Before 01/13/18	6180 01 13 18 HH:MM   Best Before 01/15/18	6180 01 15 18 HH:MM   Best Before 02/03/18	6180 02 03 18 HH:MM     ********************************************************************  Best Before 09/30/16	6180 09 30 16 HH:MM  Best Before 10/01/16	6180 10 01 16 HH:MM  Best Before 10/16/16	6180 10 16 16 HH:MM  Best Before 12/03/16	6180 12 03 16 HH:MM  Best Before 12/11/16	6180 12 11 16 HH:MM  Best Before 12/12/16	6180 12 12 16 HH:MM  Best Before 12/16/16	6180 12 16 16 HH:MM  Best Before 12/17/16	6180 12 17 16 HH:MM  Best Before 01/20/17	6180 01 20 17 HH:MM  Best Before 01/21/17	6180 01 21 17 HH:MM  Best Before 02/03/17	6180 02 03 17 HH:MM  Best Before 02/12/17	6180 02 12 17 HH:MM  Best Before 02/26/17	6180 02 26 17 HH:MM  Best Before 03/31/17	6180 03 31 17 HH:MM  Best Before 04/17/17	6180 04 17 17 HH:MM  Best Before 04/24/17	6180 04 24 17 HH:MM  Best Before 04/25/17	6180 04 25 17 HH:MM  Best Before 05/08/17	6180 05 08 17 HH:MM  Best Before 05/12/17	6180 05 12 17 HH:MM  Best Before 05/2",5/5/2016,"05/05/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74071,"Ongoing","ConAgra Foods Inc","1 Conagra Dr",,"Omaha","NE","68102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AZ, CA, CO, FL, HI, IA, ID, IL, LA, MD, MN, NJ, NV, OH, OK, PA, TX, UT, VA, and WI and in the following countries: Canada, Columbia, Japan, and Panama.","F-2280-2016","Class I","Watts Brothers Farms Organic Peas, net wt. 5 lbs., item V5402, UPC 681241 054023.    Nichirei item below is not distributed in the US:    Nichirei Value + Organic Green Peas, item V5802, UPC 4 949486 327033 ","1,165,775 lbs. Expanded quantity: 656,120 lbs.","Organic Peas are recalled due to the potential to be contaminated with Listeria monocytogenes.  ","09/15/2016",," expanded codes recalled on 7/28/16    Best Before 10/23/16	6180 10 23 16 HH:MM  Best Before 10/24/16	6180 10 24 16 HH:MM  Best Before 10/30/16	6180 10 30 16 HH:MM  Best Before 05/18/17	6180 05 18 17 HH:MM   Best Before 05/27/17	6180 05 27 17 HH:MM   Best Before 05/28/17	6180 05 28 17 HH:MM     ******************************************************************************************    Best Before 11/23/16 6180 11 23 16 HH:MM  Best Before 11/24/16 6180 11 24 16 HH:MM  Best Before 11/25/16 6180 11 25 16 HH:MM  Best Before 11/26/16 6180 11 26 16 HH:MM  Best Before 12/01/16 6180 12 01 16 HH:MM  Best Before 04/24/17 6180 04 24 17 HH:MM  Best Before 10/21/17 6180 10 21 17 HH:MM  Best Before 01/22/18 6180 01 22 16 HH:MM  Best Before 01/23/18 6180 01 23 16 HH:MM  Best Before 01/24/18 6180 01 24 16 HH:MM    Code for Nichirei brand  2017.5.18./KH4  ",5/5/2016,"05/05/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74071,"Ongoing","ConAgra Foods Inc","1 Conagra Dr",,"Omaha","NE","68102","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AZ, CA, CO, FL, HI, IA, ID, IL, LA, MD, MN, NJ, NV, OH, OK, PA, TX, UT, VA, and WI and in the following countries: Canada, Columbia, Japan, and Panama.","F-2281-2016","Class I","Green Beans -FoodService packages      827200Pu Tote Green Bean Cut Usa, Item no. 3883;  Watts Brothers Cut Green Beans, item no. V5180;  Sc 5197  12/2#  Cut Green Beans, item no. V5403;  Sr 3064  1/30# cut Green Beans, item no. V5405.  ","3,256,852 lbs.","Cut Green Beans are recalled due to the potential to be contaminated with Listeria monocytogenes.  ","09/15/2016",," Produced after May 1, 2014  best before date after April 26, 2016  ",5/5/2016,"05/05/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74072,"Ongoing","Twin City Foods Inc","10120 269th Place NW",,"Stanwood","WA","98292-4736","United States","Voluntary: Firm Initiated","E-Mail","distributed in California, Texas and Washington","F-1669-2016","Class I","Central Markets Organics Green Peas, frozen, net wt. 16 oz. UPC 4122010240    Central Markets Organics Green Peas, frozen,  net wt. 12 oz. UPC 4122081674","2664 cases","Central Market Organic Peas recalled due to the potential for these products to be contaminated with Listeria monocytogenes. ","07/13/2016",," Best Used By DEC.09.2017  Best Used By JAN.08.2018  ",5/5/2016,"05/05/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74072,"Ongoing","Twin City Foods Inc","10120 269th Place NW",,"Stanwood","WA","98292-4736","United States","Voluntary: Firm Initiated","E-Mail","distributed in California, Texas and Washington","F-1670-2016","Class I","Central Markets Organics Mixed Vegetables, frozen, net wt. 16 oz. UPC 4122010249  		  HEB Organics Mixed Vegetables, frozen, net wt. 16 oz. UPC 4122004013  		  Sweetfrost Mixed Vegetables, frozen, net wt. 16 oz. UPC 7307381875    Woodstock Organic Mixed Vegetables, net wt. UPC 10 oz. UPC 4256300160  ","9738 cases","Organics Mixed Vegetables are recalled due to the potential for these products to be contaminated with Listeria monocytogenes. ","07/13/2016",," Central Markets Organics Mixed Vegetables: Best Used By DEC.05.2017 and Best Used By JAN.11.2018.    HEB Organics Mixed Vegetables: Best Used By MAR.04.2018 and Best Used By MAR.25.2018.    Woodstock Organic Mixed Vegetables: Best Used By JAN.11.2018.    Sweetfrost Mixed Vegetables: 20886  ",5/5/2016,"05/05/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2363-2016","Class II","TAI PEI GARDEN VEGETABLE RICE, Net Wt. 18oz (510g), 8/18 oz. pails, Product # 82070","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2366-2016","Class II","VIP-CORN CUT, Net Wt. 32 oz (2lbs) 907g, 12/32 oz., 12/16 oz., Product # 7007701048, 7007701248","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2362-2016","Class II","MOLLYS KITCHEN BATTERED VEGETABLE STICKS, 6/2 lb. bags, Product # 673692","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2376-2016","Class II","Molly's Kitchen Battered Green Beans, 6/2 lb. bags., Product # 671850","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," limited to date code 0945280 on the master case",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2358-2016","Class II","WAHOO-BATTERED VEGGIE FRIES, 6/2 lb. bags, Product # 229650","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2375-2016","Class II","Toasted Onion Battered Green Beans, Net Wt. 12lb (5.44kg), 6/2 lb. bags., Product # 275720","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," limited to date code 0945280 on the master case",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2370-2016","Class II","VIP-STEAMWORKS ORGANIC MIXED VEGEGETABLES, 6 pk./24 oz., Product # 7007706476","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2373-2016","Class II","OLD PARK SOUTHWEST VEGETABLE SPRING ROLL, 162 ct./1.5 oz., Product # 56857","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2374-2016","Class II","1.  AJINOMOTO VEGETABLE FRIED RICE, Net Wt. 27 lb (9 ct./3 lb. bags.), 12.25 kg, Net Wt. 27lb (12.24kg), 9/3 lb. bags., Product # 5650053, 5650273    2.  MINH brand 4 ct./3 lb. bags;    3.  JADE MOUNTAIN brand, 4 ct./3 lb. bags;    4.  FIRST STREET brand, 16 oz (1lb) 454g, 12/1 lb. bags;    5.  Hy Vee brand, 16oz (1lb) 454g, 12/1 lb. bags.","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2371-2016","Class II","VIP-STEAMWORKS SWEET CUT CORN, 12 pk./12 oz., Product # 7007706548","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2360-2016","Class II","BATTERED SWEET CORN NUGGET, 6/2 lb. bags, Product # 241550, 672685","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2361-2016","Class II","SPICY BREADED CORN NUGGET w/JALAPENO, 6/2 lb. bags, Product # 241720, 864964","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2359-2016","Class II","Battered Corn Nugget, Net Wt. 32oz (2lbs) 907g, 6/2lb bags, 4/3lb bags, Product #241120, 241620.    UPC: 10050650024115","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2367-2016","Class II","VIP-QP PETITE PEAS, 12/16 oz., Product # 7007701065","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2372-2016","Class II","VIP-STEAMWORKS MIX VEGETABLES, 12 pk./12 oz., Product # 7007706576","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2368-2016","Class II","VIP-STEAMWORKS ORGANIC SWEET CORN, 6 pk./24 oz., Product # 7007706448","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2364-2016","Class II","TAI PEI PDQ SHRIMP FRIED RICE, Net Wt. 12 oz (340g), 9/12 oz. pails, Product # 82072","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2365-2016","Class II","TAI PEI SHRIMP FRIED RICE, 8/12 oz. pails, Product # 7007700806","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74073,"Terminated","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","U.S.","F-2369-2016","Class II","VIP-STEAMWORKS ORGANIC PEAS, 6 pk./24 oz., Product # 7007706464","1,915,263 cases Total","Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes. ","09/22/2016","09/23/2016"," all lots",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74074,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0533-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","06/17/2016","06/17/2016"," W069116108089; ",4/4/2016,"04/04/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74075,"Terminated","LifeShare Blood Centers","214 Doctor Michael Debakey Dr",,"Lake Charles","LA","70601-5953","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0575-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","06/14/2016","06/14/2016"," W036513150914",3/9/2016,"03/09/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74076,"Terminated","LifeShare Blood Centers","214 Doctor Michael Debakey Dr",,"Lake Charles","LA","70601-5953","United States","Voluntary: Firm Initiated","Letter","Louisiana","B-0534-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. ","06/13/2016","06/13/2016"," W036515323349; ",3/11/2016,"03/11/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74077,"Terminated","Central Texas Regional Blood & Tissue Center","4300 N Lamar Blvd",,"Austin","TX","78756-3421","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0535-16","Class II","Apheresis Platelets, Leukocytes Reduced","4 units","Blood products, which did not meet the acceptable product specifications, were distributed.","06/13/2016","06/13/2016"," W221615618291; W221616600335; W221616600335; W221616600335; ",3/18/2016,"03/18/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74078,"Ongoing","Ergoactives, Llc","20725 NE 16th Ave Ste A26",,"Miami","FL","33179-2132","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WA; and, the countries of Ecuador & Venezuela.","Z-2137-2016","Class II","HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.","278 units","Products are marketed without a cleared 510k. ","07/06/2016","."," All lots; UPC: 862821000030.",1/19/2016,"01/19/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74079,"Ongoing","Integra York PA, Inc","589 Davies Dr",,"York","PA","17402-8630","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution. US nationwide, Mexico, and Korea.","Z-1841-2016","Class II","Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.","678 Chisel Blade Holders","One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.  ","05/31/2016",," Catalogue No. 4-405, Lot # 97327",3/11/2016,"03/11/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74080,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US nationwide distribution.","Z-1912-2016","Class II","DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument.  Part number 351.43  ","244 units","Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions.  The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points.  This could potentially be reproduced during use and reprocessing.","06/06/2016",," Catalog ID # 351.43  Lot numbers: XXX5071, 3945479, 4738380, XXX5072, 3997000, 4816738, XXX5073,   3996999, 4816739, A3CN449, 3997338, 4441056, 3007721, 4326050, 5407442, 3148892, 4307973, 5582819, 3175916, 4387338, 5722664, 3175202, 4441055, 5813837, 3175201, 4441079, 5786778, 3921562, 4559672, 5800844, 3928332, 4561383, 5903413, 3935789, 4619549, 5910995.",5/2/2016,"05/02/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74081,"Completed","Tucker Milling LLC","85 Signal Point Dr",,"Guntersville","AL","35976-8031","United States","Voluntary: Firm Initiated","Letter","AL, FL, GA, TN, MS","V-522-2016","Class II","ALL STOCK TASTY 10%, A TEXTURED SWEET FEED FOR CATTLE AND HORSES, NET WT. 50 LBS (22.68 KG), MANUFACTURED BY TUCKER MILLING, LLC","1,135.7 tons","The firm received a small number of reports of  choking in horses.","09/21/2016",," serial numbers:  131833, 131838, 131894, 131844, 131968, 131946, 132004, 132082, 132103, 132143, 132139, 132189, 132230, 132236, 132243, 132278, 132283, 132323, 132311, 132366, 132285, 132428, 132497, 132456, 132533, 132549, 132517, 132601, 132510, 132592, 132709, 132728, 132714",4/25/2016,"04/25/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74082,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed to one customer: Colorado","Z-1949-2016","Class II","LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.","6 units","Product incorrectly packaged.  The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect.  The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur. ","06/10/2016",," Lot Number 9890811, Catalog ID 02.110.115S",5/2/2016,"05/02/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74083,"Ongoing","Philips Healthcare","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","USA (nationwide) Distribution to the states of :   ( DuraDiagnost) to the states of :  OH, CA, WA and NE.    (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.","Z-1696-2016","Class II","Philips Healthcare DuraDiagnost stationary X-ray system","5","The detector may signal that it is ready for acquisition  when it actually is not, resulting in failure to properly acquire the X-ray image.","06/03/2016",," software version - 4.0.2,  4.0.3, 4.0.4 into 4.0.5",11/10/2015,"11/10/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74083,"Ongoing","Philips Healthcare","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","USA (nationwide) Distribution to the states of :   ( DuraDiagnost) to the states of :  OH, CA, WA and NE.    (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.","Z-1695-2016","Class II","Philips Healthcare DigitalDiagnost stationary X-ray system","160","The detector may signal that it is ready for acquisition  when it actually is not, resulting in failure to properly acquire the X-ray image.","06/03/2016",," software version - 4.0.4,  4.1.2,  4.1.3.",11/10/2015,"11/10/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74084,"Ongoing","Arthrex, Inc.","1370 Creekside Blvd",,"Naples","FL","34108-1945","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.","Z-1959-2016","Class II","BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.","138 total products","Potential for polystyrene particulate presence.","06/14/2016",," Catalog #: AR-8948W-1655; Batch #: 10019147; Unique Device Identifier: 00888867202726. ",4/22/2016,"04/22/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74084,"Ongoing","Arthrex, Inc.","1370 Creekside Blvd",,"Naples","FL","34108-1945","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.","Z-1960-2016","Class II","BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.","138 total products","Potential for polystyrene particulate presence.","06/14/2016",," Catalog #: AR-8948W-1665; Batch #: 10020489; Unique Device Identifier: 00888867202726. ",4/22/2016,"04/22/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74084,"Ongoing","Arthrex, Inc.","1370 Creekside Blvd",,"Naples","FL","34108-1945","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.","Z-1962-2016","Class II","BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.","138 products total","Potential for polystyrene particulate presence.","06/14/2016",," Catalog #: AR-8948W-2055; Batch #: 10019817; Unique Device Identifier: 00888867202740. ",4/22/2016,"04/22/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74084,"Ongoing","Arthrex, Inc.","1370 Creekside Blvd",,"Naples","FL","34108-1945","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.","Z-1963-2016","Class II","BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.","138 total products","Potential for polystyrene particulate presence.","06/14/2016",," Catalog #: AR-8948W-2065; Batch #: 10019150; Unique Device Identifier: 00888867202757. ",4/22/2016,"04/22/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74084,"Ongoing","Arthrex, Inc.","1370 Creekside Blvd",,"Naples","FL","34108-1945","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.","Z-1961-2016","Class II","BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.","138 total products","Potential for polystyrene particulate presence.","06/14/2016",," Catalog #: AR-8948W-2045; Batch #: 10019148; Unique Device Identifier: 00888867202733. ",4/22/2016,"04/22/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74084,"Ongoing","Arthrex, Inc.","1370 Creekside Blvd",,"Naples","FL","34108-1945","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.","Z-1958-2016","Class II","BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.","138 total products","Potential for polystyrene particulate presence.","06/14/2016",," Catalog #: AR-8948W-1645; Batch #: 10019815 & 10031866; Unique Device Identifier: 00888867202702.",4/22/2016,"04/22/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74086,"Ongoing","KVK-Tech, Inc.","110 Terry Dr",,"Newtown","PA","18940-3427","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1057-2016","Class III","Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03","9360 bottles of lot # 12825A and 7284 bottles of lot # 12937A","Discoloration: presence of scuffing marks on tablets. ","06/28/2016",," Lot #: 12825 A, 12937A, Exp 8/18",5/5/2016,"05/05/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74087,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan","Z-1705-2016","Class II","iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.","20","If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.","05/23/2016",," Software iGUIDE 2.1 and 2.2",5/12/2016,"05/12/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74088,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",,"Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to Publix retail stores in AL, FL, GA, NC, SC, & TN","F-1518-2016","Class I","Publix Deli, Wheatberry Salad,  sold in 3.5 oz clamshell, 1 lb Grab and Go kit, and Chef Select custom order behind the deli counter.  Received at retail store as a 12.75 lbs kit.  Ingredients are combined at retail store.  Manufactured for Publix Supermarkets in Lakeland, FL","1,559 kits","Potential contamination with Listeria monocytogenes.","06/14/2016",," All lot codes, all expiration dates.  last ship date 04/30/2016.",5/5/2016,"05/05/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2349-2016","Class I","Walnuts Halves & Pieces Net Wt. 2.5 lbs  Distributed by Woodstock Farms Mfg. Edison, NJ 08817 Product of USA ",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Best by 3/16/17 Lot 16076  Best by 04/11/17 Lot 16102",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2351-2016","Class I","Nature's Promise Cranberry Trail Mix Net Wt. 12 oz Distributed by Foodhold USA LLC Landover, MD 20785  Product of USA UPC 688267066122",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Best by 09/17/16 lot 16082, 16099 &16117",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2350-2016","Class I","Nature's Promise Walnuts Halves &  Pieces Net Wt. 7 oz   Product of USA UPC 688267144042",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Best by 4/19/17 Lot Code 16110   Best by 04/02/17  Lot Code 16093",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2347-2016","Class I","Woodstock Cape Cod Cranberry Mix Net Wt. 10 oz.  Distributed by Woodstock 313 Iron Horse Way Providence RI 02908 USA UPC 042563008772",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Best by 9/17/16 Lot numbers 16079, 16091, 16098  Best by 11/30/16 Lot number 16126",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2348-2016","Class I","Woodfield Farms Walnuts Halves & Pieces Net Wt. 2.5 lbs  Distributed by Woodstock Farms Mfg. Edison, NJ 08817 UPC 075239001944  Product of USA ",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Best by 04/21/17 Lot 16112",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2352-2016","Class I","Market Basket Walnuts Raw Net Wt. 7 oz Distributed by Demoulas Supermarkets, Inc. Tewksbury, MA 01876     UPC 049705408094",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Best by 04/14/17 Lot  Code 16105  Best by 03/23/17 Lot  Code 16083",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2346-2016","Class I","Woodstock Farms Mfg. Cape Cod Cranberry Mix Net Wt. 25 Lbs.  Distributed by Woodstock Farms Mfg. Edison, NJ 08817  UPC C250575","107 cases","Walnut pieces may be contaminated with Listeria monoctyogenes which was determined through Third Party Sampling.","09/19/2016",," Lot #16109, #16097  Best by 09/17/16    ",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2355-2016","Class I","Woodstock Farms Mfg. Cranberry Nut Seed Mix Net Wt. 25 Lbs. Packed by by Woodstock Farms Mfg. Edison, NJ 08817   UPC 7523914090",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Best by 12/15/16 Lot Code 16074  Best by 01/05/17 Lot  Code 16091  ",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2353-2016","Class I","Market Basket Cape Cod Cranberry Trail Mix  Net Wt. 10 oz (284 g) Distributed by Demoulas Supermarkets, Inc. Tewksbury, MA 01876 UPC 049705408322",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Best by 09/17/16 Lot  Code 16106  ",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2354-2016","Class I","Walnut Combo Halves & Pieces, 25 lbs      Label not available as per firm.",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Lot #5278",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74089,"Ongoing","United Natural Trading","96 Executive Ave",,"Edison","NJ","08817-6016","United States","Voluntary: Firm Initiated","Telephone","nationwide","F-2356-2016","Class I","Woodstock Walnuts Halves & Pieces Net Wt. 6 oz. Distributed by Woodstock 313 Iron Horse Way Providence, RI 02908 USA   UPC 042563008604",,"Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.","09/19/2016",," Best by 4/01/17 Lot 16092   Best by 4/15/17  Lot  16106",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74091,"Ongoing","El Gordo Spices, LLC","10203 Corkwood Place","Suite 115","Dallas","TX","75238-1200","United States","Voluntary: Firm Initiated","Letter","Texas, Oklahoma, Louisiana","F-1759-2016","Class I","Morelos Ground Dried Shrimp Net. Wt. 3 oz.; 1 oz.; El Gordo Ground Dried Shrimp Net. Wt. 3 oz.; La Azteca Ground Dried Shrimp Net. wt. 3 oz. all packaged in cellophane bags","4764 units","Product is being recalled due to the failure of declaration of sulfites on the label.","07/20/2016",," UPC codes: 1826703047, 1826706047, 1826708047",5/6/2016,"05/06/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74091,"Ongoing","El Gordo Spices, LLC","10203 Corkwood Place","Suite 115","Dallas","TX","75238-1200","United States","Voluntary: Firm Initiated","Letter","Texas, Oklahoma, Louisiana","F-1758-2016","Class I","Morelos Whole Dried Shrimp Net. Wt. 1 oz.; El Gordo Whole Dried Shrimp Net. Wt. 1 oz.; La Azteca Whole Dried Shrimp Net. Wt. 1 oz. all packaged in cellophane bags","2988 units","Product is being recalled due to the failure of declaration of sulfites on the label.","07/20/2016",," UPC codes: 1826703021, 1826706021, 1826708021",5/6/2016,"05/06/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74093,"Ongoing","Schulze & Burch Biscuit Co","1133 W 35th St",".","Chicago","IL","60609-1447","United States","Voluntary: Firm Initiated","Telephone","The firm shipped the product to 10 customers. All customers were Aldi distribution centers.","F-1422-2016","Class I","Aldi's Millville protein chew bars, dark chocolate peanut butter packaged 5 bars to a box in a yellow and brown box with brown and white lettering. ","467,964 cartons, 5 bars per carton","A supplier of one of the ingredients in the protein chewy bars informed firm of Listeria Monocytogenes positive. ","06/03/2016",," i.	JAN 01 17 2T1  ii.	JAN 02 17 1T1  iii.	JAN 15 17 1T1   iv.	JAN 15 17 2T1   ",5/3/2016,"05/03/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74093,"Ongoing","Schulze & Burch Biscuit Co","1133 W 35th St",".","Chicago","IL","60609-1447","United States","Voluntary: Firm Initiated","Telephone","The firm shipped the product to 10 customers. All customers were Aldi distribution centers.","F-1421-2016","Class I","Aldi's Millville protein chew bars, peanut, dark chocolate & almond packaged 5 bars per box in a yellow and brown box with brown and white lettering. ","467,964 cartons, 5 bars per carton","A supplier of one of the ingredients in the protein chewy bars informed firm of Listeria Monocytogenes positive. ","06/03/2016",," i.	DEC 04 16 1T1  ii.	DEC 04 16 2T1  iii.	DEC 18 16 1t1  iv.	DEC 18 16 2T1  v.	DEC 31 16 2T1  vi.	JAN 01 17 1T1  vii.	JAN 01 17 2T1   viii.	JAN 14 17 1T1  ix.	JAN 14 17 2T1   x.	JAN 15 17 1T1  xi.	JAN 20 17 2T1  xii.	JAN 21 17 1T1  ",5/3/2016,"05/03/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74094,"Completed","Roche Molecular Systems, Inc.","1080 US Highway 202 S",,"Branchburg","NJ","08876-3733","United States","Voluntary: Firm Initiated","Telephone","Distributed in NC and WA.","Z-2216-2016","Class II","cobas¿ Liat¿ Analyzer","2","Device was released with default pcal/gain settings for  photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.","07/15/2016",," US-IVD: M1-E-00383 & M1-E-00434",5/9/2016,"05/09/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74095,"Ongoing","Lets Talk Health Inc","3441 Main St Ste 104",,"Chula Vista","CA","91911-5828","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; CA, VA, MO, AR, KY, LA, OR, OH, NY, MT, MN, CO, IL, WV, UT, SD, PA, TX, NE, FL, KS, AZ, MA, IA, MD, NJ, CT, WI, TN, MI, VA, OK, WA, HI, PR.     Foreign distribution to the following; Canada, Finland, Australia, Sweden, Hong Kong, Poland, Lebanon","F-1561-2016","Class I","Let's Talk Health  Aqua Vitae Multi-Vitamin  32oz.      UPC #91131181096","451 units","Undeclared whey protein which contains milk and soy lecithin.","06/17/2016",," Lot #15258, 15483 & 16091",5/9/2016,"05/09/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74095,"Ongoing","Lets Talk Health Inc","3441 Main St Ste 104",,"Chula Vista","CA","91911-5828","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; CA, VA, MO, AR, KY, LA, OR, OH, NY, MT, MN, CO, IL, WV, UT, SD, PA, TX, NE, FL, KS, AZ, MA, IA, MD, NJ, CT, WI, TN, MI, VA, OK, WA, HI, PR.     Foreign distribution to the following; Canada, Finland, Australia, Sweden, Hong Kong, Poland, Lebanon","F-1563-2016","Class I","Let's Talk Health  Tox Elim Liquid  32oz.      UPC #91131181119","75 units","Undeclared whey protein which contains milk and soy lecithin.","06/17/2016",," Lot #15425",5/9/2016,"05/09/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74095,"Ongoing","Lets Talk Health Inc","3441 Main St Ste 104",,"Chula Vista","CA","91911-5828","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; CA, VA, MO, AR, KY, LA, OR, OH, NY, MT, MN, CO, IL, WV, UT, SD, PA, TX, NE, FL, KS, AZ, MA, IA, MD, NJ, CT, WI, TN, MI, VA, OK, WA, HI, PR.     Foreign distribution to the following; Canada, Finland, Australia, Sweden, Hong Kong, Poland, Lebanon","F-1560-2016","Class I","Let's Talk Health  Energizer Drink Mix Pomegranate  0.3oz     UPC #91131180525","500 units","Undeclared whey protein which contains milk and soy lecithin.","06/17/2016",," Lot #14594 & #15432  ",5/9/2016,"05/09/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74095,"Ongoing","Lets Talk Health Inc","3441 Main St Ste 104",,"Chula Vista","CA","91911-5828","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; CA, VA, MO, AR, KY, LA, OR, OH, NY, MT, MN, CO, IL, WV, UT, SD, PA, TX, NE, FL, KS, AZ, MA, IA, MD, NJ, CT, WI, TN, MI, VA, OK, WA, HI, PR.     Foreign distribution to the following; Canada, Finland, Australia, Sweden, Hong Kong, Poland, Lebanon","F-1558-2016","Class I","Let's Talk Health  Energizer Drink Mix Citrus  0.3oz     UPC #91131180631","500 units","Undeclared whey protein which contains milk and soy lecithin.","06/17/2016",," Lot #14593 & #15431  ",5/9/2016,"05/09/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74095,"Ongoing","Lets Talk Health Inc","3441 Main St Ste 104",,"Chula Vista","CA","91911-5828","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; CA, VA, MO, AR, KY, LA, OR, OH, NY, MT, MN, CO, IL, WV, UT, SD, PA, TX, NE, FL, KS, AZ, MA, IA, MD, NJ, CT, WI, TN, MI, VA, OK, WA, HI, PR.     Foreign distribution to the following; Canada, Finland, Australia, Sweden, Hong Kong, Poland, Lebanon","F-1562-2016","Class I","Let's Talk Health  Agua Vitae Kids Multi-Vitamin Liquid  16 oz.      UPC #91131180280","200 units","Undeclared whey protein which contains milk and soy lecithin.","06/17/2016",," Lot #15193  ",5/9/2016,"05/09/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74095,"Ongoing","Lets Talk Health Inc","3441 Main St Ste 104",,"Chula Vista","CA","91911-5828","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; CA, VA, MO, AR, KY, LA, OR, OH, NY, MT, MN, CO, IL, WV, UT, SD, PA, TX, NE, FL, KS, AZ, MA, IA, MD, NJ, CT, WI, TN, MI, VA, OK, WA, HI, PR.     Foreign distribution to the following; Canada, Finland, Australia, Sweden, Hong Kong, Poland, Lebanon","F-1559-2016","Class I","Let's Talk Health  Energizer Drink Mix Strawberry/Banana  0.3oz     UPC #91131180624","500 units","Undeclared whey protein which contains milk and soy lecithin.","06/17/2016",," Lot #14592 & #15411  ",5/9/2016,"05/09/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74096,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.","Z-1672-2016","Class II","Visualase Cooled Laser Applicator System (VCLAS). The VCLAS  system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS).      The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.","120","Potential for  the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.","05/16/2016",," All lot numbers manufactured by BioTex are affected for Model Numbers:   T03: 001-4003 - VCLAS 001-4003 .4mm CORE FIBER 3mm TIP  T10: 001-4000 - VCLAS 001-4000 .4mm CORE FIBER 10mm TIP  T15: 001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP  ",5/9/2016,"05/09/2016",5/25/2016,"05/25/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74097,"Ongoing","Cordis Corporation","14201 Nw 60th Ave",,"Miami Lakes","FL","33014-2802","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.","Z-1946-2016","Class II","Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)","4,400 units in US and 3,100 units in Foreign Countries","Inability to deploy the stent or partial stent deployment.","06/10/2016",," Catalog Number:  PC0520RXC, Lot Numbers: 17298513, 17340803;  Catalog Number:  PC0530RXC, Lot Numbers: 17283329, 17286330, 17333401 and 17376719; Catalog Number:  PC0540RXC, Lot Numbers: 17295225 , 17312647, 17337070 and 17366679; Catalog Number:  PC0620RXC, Lot Numbers:  17256203, 17264566, 17282136 and 17382573; Catalog Number:  PC0630RXC, Lot Numbers: 17255095, 17264568, 17287132, 17294353, 17306044, 17308314, 17328366, 17337071, 17364507, 17388949 and 17392573;  Catalog Number:  PC0640RXC, Lot Numbers: 17249849, 17264995, 17283330, 17296211, 17331381, 17356085, 17364567, 17370803 and 17392574; Catalog Number:  PC0720RXC, Lot Numbers: 17249850 and 17260987; Catalog Number: PC0730RXC, Lot Numbers: 17256214, 17264569, 17276754, 17290641, 17322268,17332269, 17341779, 17347010,  17357107, 17361603, 17381650 and 17386230;     Catalog Number:  PC0740RXC, Lot Numbers: 17250948, 17253599, 17264571, 17282140, 17287345, 17295226, 17308316, 17322270, 17325372, 17331383, 17335082, 17344455, 17351475, 17361605, 17371407 and  17378613;  Catalog Number:  PC0820RXC, Lot Numbers: 17260988 and 17347026;  Catalog Number: PC0830RXC, Lot Numbers: 17250952,   17256217, 17259977, 17265886, 17270630, 17280875, 17291876, 17294239, 17323767, 17328144, 17335802, 17340809,17349810, 17357109, 17360669,  17364569, 17369477,17376721, 17379881, 17381652 and 17388950;     Catalog Number:  PC0840RXC, Lot Numbers:  17247325, 17251834, 17259051, 17264572, 17276782, 17287346, 17296212, 17306048,17321489,    17325375, 17328145,17335084, 17335085, 17346758, 17346759, 17349811,    17356086,  17360672, 17364570, 17370806 and 17379882;   Catalog Number:  PC0920RXC, Lot Numbers:  17269319 and  17388951;  Catalog Number:  PC0930RXC, Lot Numbers: 17251837,  17274483,  17290643, 17298514, 17312648, 17313248, 17349018 , 17357110, 17361606, 17366682 and 17393271;     Catalog Number:  PC0940RXC, Lot Number: 17260989, 17264998, 17270632, 17272818, 17280877, 17307877, 17312649, 17319031, 17319032, 17329303,  17339531, 17349019, 17354593, 17386232, 17387886",5/4/2016,"05/04/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74097,"Ongoing","Cordis Corporation","14201 Nw 60th Ave",,"Miami Lakes","FL","33014-2802","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.","Z-1947-2016","Class II","Cordis PRECISE (R)  RX Nitinol Stent System (Biliary)","4,400 units in US; 3,100 units to Foreign Countries","Inability to deploy the stent or partial stent deployment.","06/10/2016",," Catalog Number:  P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number:  17241838; Catalog Number: P07030RXB, Lot Number : 17291878;  Catalog Number: P07040RXB, Lot Number:  17291879;  Catalog Number: P06040RXB, Lot Number:  17415243.",5/4/2016,"05/04/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74098,"Ongoing","Rucker's Wholesale & Service Co., Inc.","PO Box 277",".","Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","Shipped to bass pro shops across the united states. See attachment in email for a list of consignees.","F-1428-2016","Class I"," packaged in a clear 3 oz plastic bag with attached green and orange label with yellow and black writing. item number: 7339, UPC # 752545073390. ","672 bags, 3 oz per bag ","Ingredient in the trail mix, may be contaminated with Listeria  Monocytogenes","06/03/2016",," best by codes 031417 & 041817",5/6/2016,"05/06/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74099,"Ongoing","Akorn, Inc.","1925 W Field Ct Ste 300",,"Lake Forest","IL","60045-4862","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-0949-2016","Class II","Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12","57,920 bottles","Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability","05/29/2016",," Lot# 5A17A, Expiry 06/16  Lot# 5K21A, Expiry 03/17  Lot# 6A08A, Expiry 06/17",5/17/2016,"05/17/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74100,"Ongoing","Stahlbush Island Farms, Inc.","3122 Se Stahlbush Island Rd",,"Corvallis","OR","97333-2709","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in IL, PA, RI, and WA and in Canada","F-2284-2016","Class I","IQF Green Beans, packed in a 10 oz. (US) and a 283 g (Canadian) kraft paper bag with food grade liner, 12 bags to a case. The UPC code 6 38882 00053 7.      The cooking instructions on the label is read:    How To Prepare    Stovetop: Place frozen green beans into a small amount of boiling water. Cover, steam for 3 to 5 minutes or until tender. Drain and season to taste.    Microwave: Place frozen green beans into a covered microwave- safe dish. Add 1/2 cup water and a spoonful of butter (optional) and cook on high for 3 to 5 minutes, stirring occasionally. Drain and season to taste.","9,264 cases","Stahlbush IQF Green Beans are recalled due to the potential to be contaminated with Listeria monocytogenes.  ","09/16/2016",," Lot numbers and Best By Dates:  #16034001, with a best buy code date of 02/03/18.  #15097001, with a best buy code date of 04/07/17.  #14328001, with a best buy code date of 12/2016.  #15362001, with a best buy code date of 12/28/17.  #14310002, with a best buy code date of 11/06/16.  ",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74101,"Ongoing","Rucker's Makin Batch Candies, Inc. ","777 East State St. ",,"Bridgeport","IL","62417","United States","Voluntary: Firm Initiated","E-Mail","The firm shipped to one direct account.","F-2378-2016","Class I",". Dollywood sweet and salty trail mix packaged in an 11 oz clear plastic bag with a grey sticker label containing red lettering. UPC 490000503272","240 bags, 11 oz per bag. ","Sunflower kernels received from the supplier and subsequently used in the trail mix bag may be contaminated with Listeria Monocytogenes.   ","09/17/2016",," Best by dates of 11-22-2016 and 1-6-2017",5/6/2016,"05/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74102,"Ongoing","Norpac Foods, Inc. (Plant #8)","3305 25th St Se",,"Salem","OR","97302-1135","United States","Voluntary: Firm Initiated","E-Mail","distributed in Alaska, California, Hawaii, Idaho, Montana, Nevada, Oregon, Washington and Guam.","F-1615-2016","Class I","Natural Directions Organic Mixed Vegetables, frozen, net wt. 12 oz. UPC 0 15400 19672 7    ","1850 cases","Organic Mixed Vegetables are recalled because they have the potential to be contaminated with Listeria monocytogenes.  ","07/06/2016","."," Use by/Sell By dates/ Codes    USE BY 06 2017 / MFG 06 16 2015	code 5J5 16X8 HH:MM.  USE BY 02 2018 / MFG 02 16 2016	code 5F6 16X8 HH:MM.  USE BY 04 2018 / MFG 04 19 2016	code 5H6 19X8 HH:MM.     ",5/9/2016,"05/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74102,"Ongoing","Norpac Foods, Inc. (Plant #8)","3305 25th St Se",,"Salem","OR","97302-1135","United States","Voluntary: Firm Initiated","E-Mail","distributed in Alaska, California, Hawaii, Idaho, Montana, Nevada, Oregon, Washington and Guam.","F-1616-2016","Class I","Natural Directions Organic Green Peas, frozen, net wt. 12 oz. UPC 0 15400 19670 3","417 cases","Natural Directions Organic Green Peas are recalled because they have the potential to be contaminated with Listeria monocytogenes.  ","07/06/2016","."," Use by/Sell By dates/ Codes    USE BY 03 2018 / MFG 03 21 2016	code 5G6 21X8 HH:MM.  USE BY 04 2018 / MFG 04 11 2016	code 5H6 11X8 HH:MM.  USE BY 04 2018 / MFG 04 12 2016	code 5H6 12X8 HH:MM.    ",5/9/2016,"05/09/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74104,"Terminated","American National Red Cross","995 E Broad St","Central Ohio Region","Columbus","OH","43205-1322","United States","Voluntary: Firm Initiated","Telephone","Ohio","B-0519-16","Class III","Apheresis Fresh Frozen Plasma","1 unit","Blood product, in which labels applied to blood unit or product incorrect or missing information, was distributed.","06/23/2016","06/23/2016"," W201316819401; ",4/1/2016,"04/01/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74105,"Ongoing","Harris Teeter Distribution Ctr","200 Distribution Dr",,"Greensboro","NC","27410-6202","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","DC, DE, FL, MD, NC, SC and VA.","F-1838-2016","Class I","Harris Teeter Organics Mixed Vegetables, 16oz bags (product labeling not available).","1,152 cases (12/16oz bags per case)","Potential contamination with Listeria monocytogenes.","07/28/2016",," UPC 72036 76393 Sell by Sep 30 17 SBCF",5/6/2016,"05/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74105,"Ongoing","Harris Teeter Distribution Ctr","200 Distribution Dr",,"Greensboro","NC","27410-6202","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","DC, DE, FL, MD, NC, SC and VA.","F-1839-2016","Class I","Harris Teeter Organics Corn, 16oz bags (product labeling not available).","603 cases (12/16oz bags per case)","Potential contamination with Listeria monocytogenes.","07/28/2016",," UPC 72036 76395 Sell by Oct 01 17 SBBF",5/6/2016,"05/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74106,"Ongoing","Sedecal USA, Inc.","230 Lexington Dr",".","Buffalo Grove","IL","60089-6930","United States","Voluntary: Firm Initiated","Letter","US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ, GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN, CT, ID, MI, AR and KS.","Z-1691-2016","Class II","Sedecal SA Mobile Diagnost w DR x-ray system","US - 145"," was selected and is displayed in the generator control area of the Eleva User Interface. ","06/03/2016",," System Code 712001",3/23/2015,"03/23/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74107,"Ongoing","Hill-Rom, Inc.","1069 State Road 46 E",".","Batesville","IN","47006-7520","United States","Voluntary: Firm Initiated","Letter","Worldwide and US Nationwide Distribution   AE, AO, AR , AT , AU , AZ , BD , BE , BG , BH , BM , BN , BR , CA , CH , CL , CN , CO , CS , CZ , DE , DK , EG , ES , FI , FR , GB , GR , HK , HR , HU , ID , IE , IL , IN , IR , IS , IT , JO , JP , KR , KW , LB , LI , LK , LT , LU , LV , LY , MA , MT , MX , MY , NL , NO , NZ , OM , PH , PK , PL , PT , QA , RO , RS , RU, SA , SE , SG , SI , SK , SY , TH , TN , TR , TW , UA , US , UY  and  ZA.","Z-1916-2016","Class II"," 600 QRH    Component of Liko Lifts    Product  Usage:  Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).  ","163,561 ","The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use.   If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient.","06/06/2016",," 600 QRH	3156086  ",3/8/2016,"03/08/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74108,"Ongoing","The Kroger Co","1014 Vine St",,"Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: AL, AR, GA, IL, IN, KS, KY, MI, MO, MS, NC, NE, OH, SC, TN, TX, VA & WV.","F-2306-2016","Class I","Kroger Broccoli Raisin Salad, INGREDIENTS: Broccoli, dressing***sugar,. contains less than 2% sunflower seeds, golden raisins, raisins, lime juice, xanthan gum. DIST BY THE KROGER COMPANY CINCINNATI, OHIO 45202 UPC  002871 58200 0.","3,214 cases ","Firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.","09/30/2016",," All codes",5/6/2016,"05/06/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74109,"Ongoing","World Class Distribution, Inc.","1510 Cargo Court",,"Minooka","IL","60447","United States","Voluntary: Firm Initiated","Telephone","Distributed to 1 Distributor and 58 retailers in IL, IN, IA, KS, KY, MI, MN, MO, NE, OH, and WI.","F-2195-2016","Class I"," packaged in a clear plastic 10 oz container with yellow sticker and green lettering. ","3,763 units, 10 oz per unit ","The Kale in the salad, tested plosive for salmonella per an FDA sample. ","09/14/2016",," Use by 5/5/ 2016 through 5/14/2016",5/9/2016,"05/09/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74110,"Ongoing","The Kroger Co","1014 Vine St",,"Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, OR, SC, TN, TX, UT, VA, WA, WV & WY.","F-1592-2016","Class I","simple truth organic Mixed Vegetables NET WT 10 OZ (283g) KEEP FROZEN INGREDIENTS: ORGANIC CARROTS, ORGANIC CORN ORGANIC PEAS, GREEN BEANS.","2,447 cs/12/10 oz bags","The firm was notified by their supplier that the product maybe contaminated with Listeria monocytogenes.","06/28/2016",," Sell by: Dec 2016, Jan 2017",5/6/2016,"05/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1894-2016","Class I","TCA Board, 16542A  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1888-2016","Class I","AVEA  Comprehensive ventilator, 17310-xx  (xx = 0 - 14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1899-2016","Class I","AVEA GDE upgrade kit, 12284-PMN  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1896-2016","Class I","Gas Delivery Engine (GDE), 16650A  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1897-2016","Class I","Gas Delivery Engine (GDE)-refurbished, R16650A  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1889-2016","Class I","AVEA Standard ventilator, 17311-xx  (xx = 0 - 14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1898-2016","Class I","AVEA GDE/UIM upgrade kit, 12283-PMN  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1891-2016","Class I","AVEA  Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1892-2016","Class I","AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1890-2016","Class I","AVEA Standard with Compressor ventilator, 17312-xx  (xx = 0 - 14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1893-2016","Class I","AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74111,"Ongoing","Carefusion 211 Inc dba Carefusion","22745 Savi Ranch Pkwy",,"Yorba Linda","CA","92887-4668","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.","Z-1895-2016","Class I","Gas Delivery Engine (GDE)-1st Generation, 16222-001-99  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.","922 units total (501 units in US) ","CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). ","06/13/2016",," n/a",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0698-2017","Class I","SUNSHINE CRANBERRY DELIGHT sold under the following labels: 1) Wegmans square tub SUNSHINE CRANBERRY DELIGHT, 20 oz, shipped 12 packs per case, 2) 15 LBS ALPINE VALLEY SUNSHINE CRANBERRY DELIGHT, shipped 1 per case, 3) SUNSHINE CRANBERRY DELITE, NET WT 4.5 OZ (127g) shipped 6 packs per case, 4) SUNSHINE CRANBERRY DELIGHT, NET WT 20 OZ (1 LB 4 OZ) 566 g, 5) STEWART'S SUNSHINE CRANBERRY DELITE, NET WT 5 oz (141g), shipped 18 packs per case, 6) Cranberry Almond Trail Mix, NET WT 13 OZ (368g), packed 12 per case","5,429 cases total","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," 1) BEST BY 12/15/16, 1/7/17 & 2/9/17  2) Lot Code BD 161021 and BD 161261  3) BEST BY 2/10/17  4) BEST IF SOLD BY: JAN 18 17  5) BEST BY 02/28/17  6) BEST BY 03/04/16-02/28/17",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0696-2017","Class I","ROASTED & SALTED SUNFLOWER KERNELS sold under the following labels: 1) ROASTED & SALTED SUNFLOWER KERNELS, 10.25 oz, shipped 12 packs per case, 2) Tops square tub ROASTED & SALTED SUNFLOWER KERNELS, 10.25 oz, shipped 12 packs per case, 3) EARTH FARE ROASTED & SALTED SUNFLOWER KERNELS, NET WT 16 OZ (1 LB) 453g, shipped 6 per case","800 cases total","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," 1) BEST BY 03/24/17  2) BEST BY 01/28/17  3) BEST BY 06/04/16 to 05/31/17",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0701-2017","Class I","Flave! SUNFLOWER SEEDS, NET WT 7.5OZ (212g), shipped 12 packs per case","1,308 cases total","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," Best By 4/20/17",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0699-2017","Class I","Flave! TROPICAL TRAIL MIX, NET WT 8OZ (226g), shipped 12 packs per case","953 cases total","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," Best By 4/20/17 ",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0695-2017","Class I","Yogurt Trail Mix under the following labels: 1) 15 LB ALPINE VALLEY YOGURT FRUIT/NUT MIX, packed as 1 per case, 2) Alpine Valley Yogurt Trail Mix, 4oz, 3) GONZO YOGURT FRUIT & NUT MIX, NET WT 5 OZ (141g), shipped 6 per case","1,973 cases","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," 1) Best By Dates between 02/04/16-01/31/17  2) lot code: BD 161261  3) lot codes: 14161021, 1460691, 14153551, 14152752 & 14152171",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0697-2017","Class I","ROASTED & UNSALTED SUNFLOWER KERNELS sold under the following labels: 1) ROASTED & UNSALTED SUNFLOWER KERNELS, 10.25 oz, shipped 12 packs per case, 2) Tops square tub ROASTED & UNSALTED SUNFLOWER KERNELS, 10.25 oz, shipped 12 packs per case, 3) EARTH FARE ROASTED & UNSALTED SUNFLOWER KERNELS, NET WT 16 OZ (1 LB) 453g, shipped 6 per case","782 cases total","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," 1) BEST BY 03/23/17, 3/30/17, & 5/3/17  2) BEST By 3/30/17 & 5/3/17  3) BEST By 06/04/16 - 05/31/17",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0702-2017","Class I","Flave! BEACH RETREAT TRAIL MIX, Net Wt. 18.5 OZ (1 LB 2.5 OZ) 524g, packed 12 per case","423 cases","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," Best By 06/04/16 to 05/31/17",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0700-2017","Class I","Oriental Snack Mix under the following labels: 1) Flave! ORIENTAL MIX, NET WT 6OZ (170g), shipped 12 packs per case, 2) Alpine Valley Oriental Snack Mix, 4oz 3) 15 LB Bulk ALPINE VALLEY ORIENTAL DELIGHT MIX, shipped 1 per case","1,810 cases total","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," 1) Best By 3/10/17 & 4/21/17   2) Best By 02/04/16 - 01/31/17  3) No Codes",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0703-2017","Class I","Flave! HIKERS HAVEN TRAIL MIX, Net Wt. 21.5 OZ (1 LB 5.5 OZ) 609g, packed 12 per case","989 cases","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," Best By 06/04/16 to 05/31/17",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74112,"Ongoing","First Source Llc","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN, LA, MA, MD, MI, NJ, NY, PA,VA, WV & SC via retail stores","F-0694-2017","Class I","FITNESS MIX sold under the following labels: 1) 15 LBS ALPINE VALLEY FITNESS MIX, packed as 1 per case, 2) Wegmans square tub FITNESS MIX, 20 oz, packed as 12 per case, Flave! FITNESS MIX, NET WT 8OZ (226g), packed as 12 per case, 4) FITNESS MIX, NET WT 5 OZ (141g), shipped 6 packs per case & 5) fitness MIX, NET WT. 10 OZ. (283 G), packed 12 per case.","4,886 cases total","Product has the potential to be contaminated with Listeria monocytogenes","12/12/2016",," 1) lot code: BD 161021  2) Best By 12/24/16  3) Best By 4/20/17 & 5/02/17  4) Best By 1/07/17  5) Lot Codes 14152401 & 14152751",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74113,"Ongoing","Immuno-Mycologics, Inc","2700 Technology Pl",,"Norman","OK","73071-1127","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.","Z-2040-2016","Class II","Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150  The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis","467 units","The device was found to have bacterial contamination.","06/20/2016",," Lot 111WH3",5/9/2016,"05/09/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74114,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.","Z-1965-2016","Class II","TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws    The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.","71 units","As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth Gauges from prior lot numbers manufactured before Integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge.  The number should be 4, it is 6.   3) The space / holder ","06/14/2016",," Lot UP15H2, Lot UP09D3, Lot UP07E2",5/10/2016,"05/10/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74115,"Ongoing","Dakota Style, Inc","One Chip Road",,"Clark","SD","57225","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, NE, NH, NY, OH, OR, PA, SD, TX, UT, VA, WI.","F-1567-2016","Class I","Dakota Style Roasted & Salted Sunflower Kernels, Net Wt. 3.5 oz. plastic bag.  UPC 84872-20172","88,000 lbs.","Dakota Style Foods is recalling certain Sunflower Kernel products because they may be contaminated with Listeria monocytogenes.  ","06/22/2016",," Lots:  8B6M02 and 8B6M09  Expiration dates:  February 1, 2017 through March 21, 2017",5/5/2016,"05/05/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74115,"Ongoing","Dakota Style, Inc","One Chip Road",,"Clark","SD","57225","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, NE, NH, NY, OH, OR, PA, SD, TX, UT, VA, WI.","F-1568-2016","Class I","Savory Bacon Sunflower Kernels, Net Wt. 4 oz and 8 oz.","88,000 lbs.","Dakota Style Foods is recalling certain Sunflower Kernel products because they may be contaminated with Listeria monocytogenes.  ","06/22/2016",," Lots:  8B6M02 and 8B6M09  Expiration dates:  February 1, 2017 through March 21, 2017",5/5/2016,"05/05/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74116,"Ongoing","Charlie's Specialties, Inc.","2500 Freedland Rd",,"Hermitage","PA","16148-9022","United States","Voluntary: Firm Initiated","E-Mail","OH","F-2307-2016","Class II","Four Seasons Pecan Tarts;   202 4T0867 ; Sel By: 09/10/2016, 09/15/15, 10/13/16,10/28/16; and   12/10/15, 12/15/15, 01/13/16, 01/28/16 (lot numbers).     180 Pieces; Weight 8#;   Packed exclusively for International Market Brands, Cleveland, Ohio  44146.    ","48 cases - 180 count","bulk, food service, Four Season Pecan Tarts contain undeclared milk.","09/30/2016",," Lot #s: 12/10/15, 12/15/15, 01/13/16, 01/28/16.   ",5/10/2016,"05/10/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74118,"Ongoing","Pearson Foods Inc.","1024 Ken O Sha Ind Park Dr Se",,"Grand Rapids","MI","49508-8217","United States","Voluntary: Firm Initiated","E-Mail","Domestic Only: IL, MI, WI    No Foreign or VA/DOD","F-2012-2016","Class I","Nappa Shredded 2/5 lb, packaged in plastic, keep refrigerated","59 lbs","Pearson Foods Corporation is voluntarily recalling a limited number of packaged Kale products because they may be contaminated with Salmonella.","08/29/2016",," Nappa Shredded (3/8 inch)  2/5 lb, packaged in plastic, keep refrigerated; Manufactured on 04/26/16, Use by Date of 5/6/16 and 5/7/16 Tracking Code 643",5/9/2016,"05/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74118,"Ongoing","Pearson Foods Inc.","1024 Ken O Sha Ind Park Dr Se",,"Grand Rapids","MI","49508-8217","United States","Voluntary: Firm Initiated","E-Mail","Domestic Only: IL, MI, WI    No Foreign or VA/DOD","F-2011-2016","Class I","Kale, 4/ 1 lb, & 1 /2 lb shredded packaged in plastic, keep refrigerated","64 lbs & 73 lbs","Pearson Foods Corporation is voluntarily recalling a limited number of packaged Kale products because they may be contaminated with Salmonella.","08/29/2016",," Kale, 4/1 lb shredded packaged in plastic, Use by date May 8th, 2016; manufactured on 04/26/2016; and RC Kale (3/8 inch) 1/2 lb shredded,  Manufactured on 04/26/16, Use by of 05/07/16, tracking code 643",5/9/2016,"05/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74120,"Terminated","Central Texas Regional Blood & Tissue Center","4300 N Lamar Blvd",,"Austin","TX","78756-3421","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0536-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","4 units","Apheresis products, for which quality control testing for residual white blood cell count was not performed, were distributed.","05/26/2016","05/26/2016"," W221616301402 (double collection); W221616301391(double collection) ",4/1/2016,"04/01/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74121,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","1212 E California Rd",,"Fort Wayne","IN","46825-5812","United States","Voluntary: Firm Initiated","Telephone","Indiana","B-0537-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","05/24/2016","05/24/2016"," W203815276720",3/12/2016,"03/12/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74122,"Terminated","Michigan Blood","13400 Stark Rd",,"Livonia","MI","48150-1547","United States","Voluntary: Firm Initiated","Telephone","MI","B-0572-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, altered in a manner that possibly compromised sterility, was distributed.","06/14/2016","06/14/2016"," W120616003297",3/28/2016,"03/28/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2230-2016","Class I","Kroger(R) VEGETABLE SOUP MIX, NET WT 12 OZ. (340g), DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202, UPC 1111089790","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," BEST IF USED BY: May 2017 through Aug 2017, Feb 2016 through Sept 2016, Oct 2017; with Mfg Code ### # K # #",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2229-2016","Class I","Frozen peas and carrots labeled as:    1) Kroger(R) Peas & Carrots, NET WT 12 OZ. (340g), DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202, UPC 1111089741      2) Pictsweet(R) Peas & Carrots, NET WT 12 OZ. (340g), DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38305, UPC 7056096287      ","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," 1) UPC 1111089741  BEST IF USED BY: Jan 2016 through Apr 2016; with Mfg Code ### # K # #    2) UPC 7056096287  BEST IF USED BY: Aug 4 2016, Oct 10 2016; with Mfg Code ### # K # #",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2231-2016","Class I","Pictsweet(R) Summer Blend, NET WT. 24 OZ., 1 LB. 8 OZ. (680g), DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38305, UPC 7056095975","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," BEST IF USED BY: Sep 9 2016, Sep 10 2016, Oct 10 2016, Nov 13 2016, Nov 14 2016, Dec 4 2016, Dec 5 2016, Jan 11 2017, Jan 12 2017 ,Jan 7 2018, Feb 10 2018; with Mfg Code ### # K # #",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2225-2016","Class I","Frozen green peas labeled as:    1. Kroger(R) Green Peas, NET WT 32 OZ (2 LB) 907g, UPC 1111081918  BEST IF USED BY: Jan 2016 through Mar 2016; with Mfg Code ### # K # #    2. p$$t(TM) Green Peas, NET WT 16 OZ (1 LB) 453g, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202, UPC 1111082603  BEST IF USED BY: Feb 2016 through Mar 2016; with Mfg Code ### # K # #    3. Kroger(R) Green Peas, NET WT 12 OZ. (340g), DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202, UPC 1111089736  BEST IF USED BY: Jan 2016 through Apr 2016; with Mfg Code ### # K # #    4. Pictsweet(R) Green Peas Family Size, NET WT. 28 OZ., 1 LB. 12 OZ. (794g), UPC 7056090056  BEST IF USED BY: Jul 20 2016, Aug 10 2016, Aug 20 2016, Sep 16 2016, Sep 21 2016; with Mfg Code ### # K # #    5. Pictsweet(R) Green Peas Family Size, NET WT. 24 OZ., 1 LB. 8 OZ. (680g), UPC 7056090093  BEST IF USED BY: Aug 20 2016, Sep 10 2016; with Mfg Code ### # K # #    ","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," 1. UPC 1111081918  BEST IF USED BY: Jan 2016 through Mar 2016; with Mfg Code ### # K # #    2. UPC 1111082603  BEST IF USED BY: Feb 2016 through Mar 2016; with Mfg Code ### # K # #    3. UPC 1111089736  BEST IF USED BY: Jan 2016 through Apr 2016; with Mfg Code ### # K # #    4. UPC 7056090056  BEST IF USED BY: Jul 20 2016, Aug 10 2016, Aug 20 2016, Sep 16 2016, Sep 21 2016; with Mfg Code ### # K # #    5. UPC 7056090093  BEST IF USED BY: Aug 20 2016, Sep 10 2016; with Mfg Code ### # K # #  ",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2227-2016","Class I","Frozen mixed vegetables labeled as:  1. p$$t(TM) Mixed Vegetables, NET WT 16 OZ (1 LB) 453g, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202, UPC 1111082605  BEST IF USED BY: Jan 2016 through Oct 2017; with Mfg Code ### # K # #    2. Pictsweet(R) Mixed Vegetable Family Size, NET WT. 24 OZ., 1 LB. 8 OZ. (680g), UPC 7056095011  BEST IF USED BY: Jul 22 2016, Aug 13 2016, Aug 17 2016, Sep 10 2016, Sep 11 2016, Sep 19 2016, Sep 26 2016, Oct 8 2016, Oct 9 2016, Oct 20 2016, Oct 21 2016, Oct 29 2016, Nov 7 2016, Nov 8 2016, Nov 18 2016, Nov 19 2016, Dec 8 2016, Dec 9 2016, Jan 4 2017, Jan 5 2017, Jan 12 2017, Jan 13 2017, Jan 21 2017, Jan 27 2017, Jan 28 2017, Feb 25 2017, Feb 26 2017, Nov 10 2017, Nov 17 2017, Jan 5 2018, Jan 12 2018, Mar 3 2018; with Mfg Code ### # K # #    3. Pictsweet(R) Mixed Vegetable Family Size, NET WT. 28 OZ., 1 LB. 12 OZ. (794g), UPC 7056095077  BEST IF USED BY: Jul 14 2016, Jul 30 2016, Aug 6 2016, Sep 5 2016, Sep 7 2016, Sep 8 2016, Sep 10 2016, Sep 16 2016, Sep 26 2016, Sep 27 2016, Oct 7 2016, Oct 12 2016, Oct 13 2016, Oct 21 2016, Nov 4 2016, Nov 6 2016, Nov 7 2016, Nov 23 2016, Dec 6 2016, Dec 7 2016, Dec 15 2016, Jan 4 2017, Jan 5 2017, Jan 7 2017, Jan 29 2017, Feb 5 2017, Feb 6 2017, Feb 23 2017, Feb 24 2017, Feb 25 2017; with Mfg Code ### # K # #    4. Pictsweet(R) Mixed Vegetables, NET WT 12 OZ. (340g), DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38305, UPC 7056095088  BEST IF USED BY: Aug 4 2016, Aug 6 2016, Sep 10 2016, Sep 16 2016, Oct 15 2016, Oct 16 2016, Nov 3 2016, Dec 5 2016, Dec 26 2016, Feb 19 2017, Feb 20 2017, Mar 22 2017, Mar 23 2017, Nov 4 2017, Nov 16 2017, Mar 12 2018, Mar 17 2018; with Mfg Code ### # K # #  ","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," 1. UPC 1111082605  BEST IF USED BY: Jan 2016 through Oct 2017; with Mfg Code ### # K # #    2. UPC 7056095011  BEST IF USED BY: Jul 22 2016, Aug 13 2016, Aug 17 2016, Sep 10 2016, Sep 11 2016, Sep 19 2016, Sep 26 2016, Oct 8 2016, Oct 9 2016, Oct 20 2016, Oct 21 2016, Oct 29 2016, Nov 7 2016, Nov 8 2016, Nov 18 2016, Nov 19 2016, Dec 8 2016, Dec 9 2016, Jan 4 2017, Jan 5 2017, Jan 12 2017, Jan 13 2017, Jan 21 2017, Jan 27 2017, Jan 28 2017, Feb 25 2017, Feb 26 2017, Nov 10 2017, Nov 17 2017, Jan 5 2018, Jan 12 2018, Mar 3 2018; with Mfg Code ### # K # #    3. UPC 7056095077  BEST IF USED BY: Jul 14 2016, Jul 30 2016, Aug 6 2016, Sep 5 2016, Sep 7 2016, Sep 8 2016, Sep 10 2016, Sep 16 2016, Sep 26 2016, Sep 27 2016, Oct 7 2016, Oct 12 2016, Oct 13 2016, Oct 21 2016, Nov 4 2016, Nov 6 2016, Nov 7 2016, Nov 23 2016, Dec 6 2016, Dec 7 2016, Dec 15 2016, Jan 4 2017, Jan 5 2017, Jan 7 2017, Jan 29 2017, Feb 5 2017, Feb 6 2017, Feb 23 2017, Feb 24 2017, Feb 25 2017; with Mfg Code ### # K # #    4. UPC 7056095088  BEST IF USED BY: Aug 4 2016, Aug 6 2016, Sep 10 2016, Sep 16 2016, Oct 15 2016, Oct 16 2016, Nov 3 2016, Dec 5 2016, Dec 26 2016, Feb 19 2017, Feb 20 2017, Mar 22 2017, Mar 23 2017, Nov 4 2017, Nov 16 2017, Mar 12 2018, Mar 17 2018; with Mfg Code ### # K # #  ",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2224-2016","Class I","Frozen cut green beans labeled as:  1. Kroger(R) Cut Green Beans, NET WT 32 OZ (2 LB) 907g, UPC1111081914  BEST IF USED BY: Feb 2016 through Oct 2017; with Mfg Code ### # K # #  6 units per case    2. Kroger(R) Cut Green Beans, NET WT 12 OZ. (340g), DISTRIBUTED BY THE KROGER CO.,CINCINNATI, OH 45202, UPC 1111089730  BEST IF USED BY: Jan 2016 through Oct 2017; with Mfg Code ### # K # #  12 units per case    3. Pictsweet(R) Cut Green Beans Family Size, NET WT. 28 OZ., 1 LB. 12 OZ. (794g), UPC 7056084323  BEST IF USED BY: Sep 7 2016, Oct 27 2016, Dec 1 2016, Jan 3 2017, Jan 4 2017; with Mfg Code ### # K # #  6 units per case      4. Pictsweet(R) Cut Green Beans, NET WT 12 OZ. (340g), DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38305, UPC 7056084394  BEST IF USED BY: Aug 4 2016, Aug 6 2016, Nov 4 2016, Dec 5 2016, Nov 3 2017, Nov 16 2017, Jan 13 2018, Mar 24 2018; with Mfg Code ### # K # #  7 units per case  ","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," 1. UPC1111081914  BEST IF USED BY: Feb 2016 through Oct 2017; with Mfg Code ### # K # #    2.UPC 1111089730  BEST IF USED BY: Jan 2016 through Oct 2017; with Mfg Code ### # K # #     3. UPC 7056084323  BEST IF USED BY: Sep 7 2016, Oct 27 2016, Dec 1 2016, Jan 3 2017, Jan 4 2017; with Mfg Code ### # K # #    4. UPC 7056084394  BEST IF USED BY: Aug 4 2016, Aug 6 2016, Nov 4 2016, Dec 5 2016, Nov 3 2017, Nov 16 2017, Jan 13 2018, Mar 24 2018; with Mfg Code ### # K # #  ",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2228-2016","Class I","Kroger(R) Mixed Vegetable Meal Ready Sides, (1) NET WT 5 LB (2.26kg),  UPC 1111089406 and (2) NET WT 12 OZ. (340g), UPC 1111089735,   DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202,  ","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," (1) UPC 1111089406  BEST IF USED BY: Jan 2016 through May 2016; with Mfg Code ### # K # #    (2) UPC 1111089735  BEST IF USED BY: Jan 2016 through Oct 2017; with Mfg Code ### # K # #  ",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2235-2016","Class I","Pictsweet(R) Steam'able Cut Green Beans, NET WT 10 OZ. (283g), DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38305, UPC 7056097916","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," BEST IF USED BY: Jul 30 2016, Aug 11 2016, Sep 26 2016, Sep 27 2016, Nov 13 2017, Jan 7 2018, Jan 24 2018, Feb 18 2018, Mar 10 2018; with Mfg Code ### # K # #",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2233-2016","Class I","Pictsweet(R) Steam'able Green Peas, NET WT 12 OZ. (340g), DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38305, UPC 7056097901","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," BEST IF USED BY: Jun 27 2016, Jul 5 2016, Jul 30 2016, Aug 1 2016, Aug 11 2016, Aug 13 2016, Sep 2 2016, Sep 13 2016, Mar 10 2018; with Mfg Code ### # K # #",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2232-2016","Class I","Pictsweet(R) Seasoned Summer Vegetables, NET WT 12 OZ. (340g), DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38305, UPC 7056097622","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," BEST IF USED BY: Aug 3 2016, Aug 5 2016, Nov 9 2016, Nov 10 2016; with Mfg Code ### # K # #",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2234-2016","Class I","Pictsweet(R) Steam'able Mixed Vegetables, NET WT 10 OZ. (283g), DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38305, UPC 7056097911","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," BEST IF USED BY: Jul 4 2016, Jul 5 2016, Aug 1 2016, Aug 3 2016, Aug 6 2016, Aug 10 2016, Aug 11 2016, Aug 12 2016, Sep 5 2016, Sep 6 2016, Sep 15 2016, Sep 27 2016, Sep 28 2016, Oct 13 2016, Oct 14 2016, Nov 2 2016, Nov 5 2016, Nov 14 2016, Nov 15 2016, Nov 16 2016, Dec 15 2016, Dec 16 2016, Jan 29 2017, Jan 30 2017, Feb 5 2017, Feb 6 2017, Feb 25 2017, Feb 26 2017, Nov 8 2017, Nov 17 2017, Jan 7 2018, Jan 10 2018, Jan 24 2018, Feb 4 2018, Feb 8 2018, Mar 1 2018, Mar 7 2018, Mar 17 2018, Mar 18 2018; with Mfg Code ### # K # #",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74123,"Ongoing","The Pictsweet Company","#10  Pictsweet Drive",,"Bells","TN","38006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-2226-2016","Class I","Kroger(R) Mixed Vegetables Meal Ready Sides, NET WT 32 OZ (2 LB) 907g, UPC 1111081934","871,952 Cases Total","Possible Listeria Monocytogenes contamination in bulk vegetables supplied by CRF Frozen Foods, LLC used in manufacturing several Pictsweet products.","09/14/2016",," BEST IF USED BY: Jan 2016 through Aug 2017; with Mfg Code ### # K # #",5/6/2016,"05/06/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74125,"Ongoing","Apatech Limited","370 Centennial Ave",".","Elstree",,,"United Kingdom","Voluntary: Firm Initiated","Letter","Worldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, Taiwan, and New Zealand.","Z-1922-2016","Class II","Actifuse ABX/Actifuse MIS System     A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. ","11696 units","Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.","06/07/2016",," Product Code: 506005078050  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078051  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078052  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078058  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078060  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078070  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078072  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017  ",8/18/2015,"08/18/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74126,"Ongoing","Allergan Sales, LLC","8301 Mars Dr",,"Waco","TX","76712-6578","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1064-2016","Class II","Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612    ","17802 units","Failed Content Uniformity Specifications.","07/06/2016","."," Lot #: a) 84172, b) 84173, Exp FEB/2017  ",5/10/2016,"05/10/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74126,"Ongoing","Allergan Sales, LLC","8301 Mars Dr",,"Waco","TX","76712-6578","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1065-2016","Class II","Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g,  sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159    ",,"Failed Content Uniformity Specifications.","07/06/2016","."," Lot #: 84126, Exp FEB/2017  ",5/10/2016,"05/10/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74127,"Ongoing","Elanco Animal","250 Innovation Way",,"Greenfield","IN","46140","United States","Voluntary: Firm Initiated","Letter","CA, ID, MN, NY, PA, SD, TX, WI.  No international.","V-0016-2017","Class II","Posilac¿: Sometribove Zinc Suspension    Description  Sterile, prolonged-release injectable formulation of a recombinant DNA derived  bovine somatotropin analog in single-dose syringes each containing  500 mg of sometribove zinc suspension.    Pre-Filled Sterile Syringe  500 mg / dose  2mI Pre-filled sterile syringe packaged in 100 count cartons  OTC","114,500","Syringes appear to be more brittle than the previous syringes, which may result in cracks in the barrel of the syringe.  A cracked syringe barrel has the potential to impact the sterility of the product. Considering the indications of the product, it is assessed that the involved batch of the product has the potential to pose a microbial risk in the target animals. If there is a contamination, possible injection site abscess may result. If the infection spreads from local site, fever or upper respiratory or gastro intestinal infections could occur.","11/18/2016","."," Batch C554686  expiration date of Oct 2019",3/31/2016,"03/31/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74128,"Ongoing","Skytron, Div. The KMW Group, Inc","5085 Corporate Exchange Blvd SE",,"Grand Rapids","MI","49512-5515","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.","Z-1844-2016","Class II","EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide   General Purpose Surgical Table    Skytron EZ Slide Operating Table  General Purpose Surgical Table","27","The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.      ","05/31/2016",," Model number 3502.  All units.  Units entered commercial distribution between April 30, 2014 and July 24, 2014",4/6/2016,"04/06/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74129,"Ongoing","Wegmans Food Markets, Inc.","1500 Brooks Ave",,"Rochester","NY","14624","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ, NY, MA, MD, PA & VA thru Wegmans Food Markets","F-1625-2016","Class I","Wegmans Chocolate Chip Brownie, 32 oz., UPC#7789098948","7 units","Undeclared milk allergen","07/07/2016","."," All Codes, Best-Before Date: Within Expiry",5/10/2016,"05/10/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74129,"Ongoing","Wegmans Food Markets, Inc.","1500 Brooks Ave",,"Rochester","NY","14624","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ, NY, MA, MD, PA & VA thru Wegmans Food Markets","F-1626-2016","Class I","Wegmans Chocolate Chip Brownie, 2 pack, UPC#7789098966","40 units","Undeclared milk allergen","07/07/2016","."," All Codes, Best-Before Date: Within Expiry",5/10/2016,"05/10/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74129,"Ongoing","Wegmans Food Markets, Inc.","1500 Brooks Ave",,"Rochester","NY","14624","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ, NY, MA, MD, PA & VA thru Wegmans Food Markets","F-1624-2016","Class I","Wegmans Brownie with Icing, Pan, 16 oz., UPC#7789082502","280 units","Undeclared milk allergen","07/07/2016","."," All Codes, Best-Before Date: Within Expiry",5/10/2016,"05/10/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74129,"Ongoing","Wegmans Food Markets, Inc.","1500 Brooks Ave",,"Rochester","NY","14624","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ, NY, MA, MD, PA & VA thru Wegmans Food Markets","F-1627-2016","Class I","Frozen Round Brownie CC#016969 -  is not a retail item but instead is a component to the other items.","11,436 units","Undeclared milk allergen","07/07/2016","."," All Codes",5/10/2016,"05/10/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74129,"Ongoing","Wegmans Food Markets, Inc.","1500 Brooks Ave",,"Rochester","NY","14624","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ, NY, MA, MD, PA & VA thru Wegmans Food Markets","F-1623-2016","Class I","Wegmans Brownie with Icing and Walnuts, Pan, 16 oz., UPC#7789037092","51 units","Undeclared milk allergen","07/07/2016","."," All Codes, Best-Before Date: Within Expiry",5/10/2016,"05/10/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74129,"Ongoing","Wegmans Food Markets, Inc.","1500 Brooks Ave",,"Rochester","NY","14624","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ, NY, MA, MD, PA & VA thru Wegmans Food Markets","F-1621-2016","Class I","Wegmans Fudgy & Chewy Brownies with Chocolate Chips 14 oz.,  UPC#7789032990","2,664 units","Undeclared milk allergen","07/07/2016","."," All Codes, Best-Before Date: Within Expiry",5/10/2016,"05/10/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74129,"Ongoing","Wegmans Food Markets, Inc.","1500 Brooks Ave",,"Rochester","NY","14624","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ, NY, MA, MD, PA & VA thru Wegmans Food Markets","F-1622-2016","Class I","Wegmans Fudgy & Chewy Brownies with Walnuts 14 oz.,  UPC#7789075773","2,045 units","Undeclared milk allergen","07/07/2016","."," All Codes, Best-Before Date: Within Expiry",5/10/2016,"05/10/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74131,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-2382-2016","Class II","Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body. ","57 Units","Software issues found in  v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.","08/10/2016",," Brilliance iCT SP Model No. 728311   S/N:200107,200003,200011,200009,200017,200074,200022,200013,200027,200049,200032,  200030,200043,200040,200038,200047,200051,200044,200063,200061,200068,200067,  200089,200088,200092,200093,200101,200097,200100,200105,200109,200121,200204,  200111,200117,200127,200131,200200,200205,200138,200202,200201,200203,200209,  200210,200206,200208,200207,200211,200019,200015,200029,200024,200023,200025,  200026,200041,200086,200102,200213	  ",4/29/2016,"04/29/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74131,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-2380-2016","Class II","Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.","150","Software issues found in software versions  v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.","08/10/2016",," Model No. 728231, Brilliance 64 CT S/N:  9099,9134,9251,9515,9646,9822,9898,9983,10099,10180,10206,10208,91003,95130,95157,95387,95504,4001,9056,9074,9529   9538,9549,9554,9573,9574,9618,9625,9638,9653,9656, 9659,9667,9670,9686,9689,9703,9738,9740,9755,9782,9811,  9833,9837,9838,9859,9862,9901,9909,9910,9917,9920,9923,9927,9930,9933,9989,9993,10021,10024,10042,10047,10050,,  10051,10077,10092,10106,10150,10193,10213,	10250,10299,10379,10394,10422,10671,10698  29002,29014,29056,29107,29115,90124,90154,95022,95024,95191,95197,95222,95236,95258,95261,95351,95364,95399,95410,95475,95496,95507,95512,95524,95551,95563,95614,95616,	  95668,95688,95691,95707,95811,95341A,9541,9548,9559,9561,9600,9631,9678,9711,9763,9805, 9890, 9922, 10012, 10014, 10179,10216,10302,10446,10470,10514,10610,10743,95239,95244,95343,95349,95374,95409,95439	95538,  300062,122921,123092,123096,123116,123117,29015,5169,  9367,9640,9997,123029		    ",4/29/2016,"04/29/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74131,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-2383-2016","Class II","Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. ","276 Units","Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.  ","08/10/2016",," Ingenuity Core Model No. 728321  S/N:31001	52030	52031	52044	52050	310292	333064	52000	52012	52015	52018  52020	52022	52063	310001	310022	310023	310026	310032	310039	310096	310105  310133	310135	310157	310160	310209	310210	310211	310212	310213	310214	310215  310216	310217	310218	310219	310220	310221	310222	310223	310224	310225	310226  310227	310228	310229	310230	310231	310232	310233	310234	310236	310237	310238  310239	310240	310241	310242	310243	310245	310246	310247	310248	310249	310250  310252	310253	310254	310255	310256	310257	310258	310259	310260	310261	310262  310263	310264	310265	310266	310267	310269	310270	310271	310272	310273	310274  310275	310276	310277	310278	310279	310280	310281	310282	310283	310284	310285  310287	310288	310289	310290	310291	333002	333005	333010	333015	333018	333021  333042	333043	333051	333060	333061	333106	333107	333108	333109	333110	333112  333114	333115	333116	333117	333121	52035	333068	33084	52007	52008	52010  52013	52014	52019	52021	52024	52025	52026	52027	52029	52032	52033  52034	52036	52037	52038	52039	52040	52041	52042	52043	52045	52046  52047	52048	52052	52053	52054	52055	52056	52057	52058	52059	52061  52064	52065	52067	52068	52069	52070	52071	52072	52075	52076	52077  52078	52079	132164	132465	310002	310003	310009	310017	310042	310052	310054  310055	310059	310064	310069	310070	310071	310081	310087	310088	310090	310098  310107	310111	310113	310119	310121	310129	310134	310141	310143	310149	310151  310159	310170	310203	310204	310205	310206	310207	310208	310235	310293	310294  310295	310296	310297	310299	310300	310301	310304	310308	333009	333014	333019  333030	333031	333037	333044	333045	333046	333048	333049	333050	333052	333053  333054	333055	333056	333059	333062	333063	333065	333066	333067	333069	333070  333071	333072	333073	333074	333075	333076	333077	333078	333079	333080	333081  333082	333083	333085	333086	333087	333088	333089	333090	333091	333092	333093  333094	333095	333096	333097	333098	333099	333100	333101	333102	333103	333104  333105	333122	333123	333124	52004	52073	52",4/29/2016,"04/29/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74131,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-2385-2016","Class II","Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.","205 Units","Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.  ","08/10/2016",," Ingenuity CT Model No. 728326  S/N:300004	30003	30005	30006	30007	30008	30009	30010	30011	30012	30013  30014	30015	30017	30018	30019	30020	30021	30022	30025	30026	30027  30028	30029	30030	30031	30032	30033	30034	30036	30037	30038	30039  30040	30041	30042	30043	30044	30045	30046	32083	300015	300033	300037  300038	300045	300054	300057	300066	300068	300072	300081	300082	300084	300089  300091	300107	300109	300120	300122	300141	300142	300149	300150	300156	300157  300207	300208	300209	300210	300211	30004-132107	52060	300003	300005	300010  300011	300012	300013	300014	300016	300017	300018	300019	300020	300021	300022  300024	300025	300027	300028	300029	300030	300031	300032	300034	300035	300036  300039	300040	300041	300042	300043	300044	300047	300049	300050	300051	300052  300053	300055	300056	300058	300059	300060	300061	300062	300063	300064	300065  300069	300070	300071	300073	300074	300075	300077	300078	300079	300080	300083  300086	300087	300088	300090	300092	300093	300094	300095	300096	300097	300098  300099	300100	300101	300102	300103	300104	300105	300106	300108	300110	300111  300112	300113	300114	300115	300116	300117	300118	300119	300121	300123	300124  300125	300126	300127	300128	300129	300130	300131	300132	300133	300135	300136  300137	300138	300139	300140	300143	300144	300145	300147	300148	300151	300158  300159	300160	300161	300162	300163	300164	300165	300166	300200	300201	300202  310058	310144	333057	336061	336084	336121	30047	52051	300213	300214	300216  300217	600023	600047											        ",4/29/2016,"04/29/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74131,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-2384-2016","Class II","Ingenuity Core128  Model No. 728323; To produce cross-sectional images of the body.","380 Units","Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.  ","08/10/2016",," Ingenuity Core128 Model No. 728323  S/N:30023	30151	32000	32001	32008	32061	32065	32067	32076	32162	52023  52028	52049	336177	30016	32012	32042	32044	32057	32068	32069	32100  32106	32138	32139	32140	32141	32142	32143	32144	32145	32146	32147  32148	32149	32150	32151	32152	32153	32154	32155	32156	32157	32158  32159	32160	32161	32163	32164	32165	32166	32167	320001	320003	320006  320008	320010	320024	320026	320029	320031	320037	320054	320078	320090	320092  320107	320202	320224	320225	320226	320227	320228	320229	320230	320231	320232  320233	320234	320235	320236	320238	320239	320240	320241	320242	320243	320245  320246	320247	320248	320250	320251	320252	320254	320255	320256	320258	336011  336012	336015	336016	336018	336025	336027	336028	336029	336034	336040	336044  336068	336072	336076	336092	336100	336102	336104	336142	336148	336149	336150  336151	336152	336153	336154	336155	336156	336157	336158	336159	336160	336161  336162	336163	336164	336166	336167	336168	336170	336171	336172	336173	336174  336175	336176	336178	336180	336181	336182	336183	336184	336185	336186	336188  336190	336192	336193	336194	32010	32013	32015	32016	32018	32021	32024  32026	32028	32032	32033	32034	32036	32037	32041	32043	32046	32047  32048	32049	32050	32051	32052	32053	32054	32055	32056	32058	32059  32060	32062	32063	32064	32070	32071	32072	32073	32074	32075	32077  32078	32079	32080	32081	32082	32084	32085	32086	32087	32088	32089  32090	32091	32092	32093	32094	32095	32096	32097	32098	32099	32101  32102	32103	32104	32105	32108	32109	32110	32111	32112	32113	32114  32115	32116	32117	32118	32119	32120	32121	32122	32123	32124	32125  32126	32127	32128	32129	32130	32131	32132	32133	32134	32135	32136  32137	32168	320002	320005	320018	320030	320033	320058	320059	320069	320073  320074	320079	320081	320082	320083	320084	320088	320096	320099	320100	320101  320103	320111	320114	320115	320119	320122	320123	320125	320126	320128	320129  320131	320132	320133	320134	320138	320144	320146	320147	320200	320201	320203  320204	320222	320223	320237	320260	320261	3202",4/29/2016,"04/29/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74131,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY.    Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.","Z-2381-2016","Class II","Brilliance iCT,  Model No. 728306; To produce cross-sectional images of the body. ","335 Units","Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.","08/10/2016",," Brilliance iCT Model No. 728306  S/N:85071	85072	100150	100349	100695	100715	100716	100719	100721	100723	100724  100725	100726	100727	100728	100105	100123	100130	100132	100141	100146	100159  100328	100375	100378	100473	100700	100703	100709	100710	100711	100712	100713  100717	100720	100162	85003	85004	85010	85012	85013	85014	85015	85016  85017	85018	85019	85020	85021	85022	85023	85024	85025	85026	85027  85028	85029	85030	85031	85032	85033	85034	85035	85036	85037	85038  85039	85040	85041	85042	85043	85044	85045	85046	85047	85048	85049  85050	85051	85052	85053	85054	85055	85056	85057	85058	85059	85060  85061	85062	85063	85064	85065	85066	85067	85068	85069	85070	100016  100018	100019	100022	100024	100025	100037	100038	100040	100044	100048	100049  100050	100051	100053	100054	100058	100062	100064	100065	100070	100072	100082  100084	100091	100093	100094	100099	100101	100103	100111	100113	100114	100115  100119	100122	100125	100131	100133	100134	100135	100140	100144	100149	100153  100161	100165	100169	100170	100178	100180	100181	100184	100185	100190	100191  100192	100193	100195	100200	100214	100215	100217	100221	100222	100228	100231  100236	100243	100244	100247	100260	100270	100271	100273	100274	100278	100280  100281	100289	100299	100302	100304	100308	100309	100310	100314	100318	100325  100329	100331	100335	100343	100346	100350	100351	100356	100360	100365	100368  100370	100372	100373	100374	100393	100396	100398	100399	100400	100402	100405  100406	100408	100411	100416	100423	100436	100441	100446	100449	100450	100452  100453	100454	100458	100461	100462	100463	100464	100465	100466	100469	100472  100483	100490	100491	100493	100494	100498	100503	100506	100507	100508	100509  100511	100512	100513	100517	100518	100520	100521	100522	100600	100601	100602  100603	100604	100605	100606	100607	100608	100609	100610	100611	100612	100613  100614	100615	100616	100617	100618	100619	100620	100621	100622	100623	100624  100625	100626	100627	100628	100629	100630	100631	100632	100633	100634	100635  100636	100637	100638	100639	100640	100641	1",4/29/2016,"04/29/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74132,"Ongoing","POPSALOT, LLC","7723 Somerset Blvd",,"Paramount","CA","90723-4104","United States","Voluntary: Firm Initiated","E-Mail","U.S. distribution to the following; CA    No foreign distribution.","F-2285-2016","Class II","Popsalot  Moroccan Mystique   3.5 oz","165 cases","Gluten levels above regulatory threshold.","09/16/2016",," 2250,6020",5/5/2016,"05/05/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1783-2016","Class I","Big House Blend, brand Bybee's, frozen, net wt. 30lb. UPC AZ#85    Best Mixed Vegetables, brand Bybee's, frozen, net wt. 20lb. UPC 4635800014    California Blend, brand Chef Maxwell, frozen, net wt. 20lb. UPC 063027    Raw Mixed Vegetables, brand Chef Maxwell, frozen, net wt. 30lb. UPC 63530295005    4 Way, brand E. Boyd, frozen, net wt. 55lb. UPC --    4 Way, brand E. Boyd, frozen, net wt. 1600lb. UPC --    Potato 3 Way, brand E. Boyd, frozen, net wt. 30lb. UPC --    Mixed Vegetables, brand Farmer's Bounty, frozen, net wt. 20lb. UPC 02300    Mixed Vegetables, brand Farmer's Bounty, frozen, net wt. 30lb. UPC 4635800003    4 Way, brand JAG Foods/LA Foods, frozen, net wt. 30lb. UPC --    Mixed Vegetables, brand Life Foods, frozen, net wt. 1kg. UPC 903392007687    Mixed Vegetables, brand McCain, frozen, net wt. 500g. UPC 991438945222    Mixed Vegetables, brand McCain, frozen, net wt. 1kg. UPC 991438945123    Mixed Vegetables, brand McCain YGC, frozen, net wt. 1kg. UPC 991438945383    Mixed Vegetables, brand Northwest Growers Select, frozen, net wt. 20lb. UPC 4635800044    4 Way, brand Single Source, frozen, net wt. 30lb. UPC --    4-Way Mixed Vegetables, brand The Inn, frozen, net wt. 20lb. UPC 8628920720    5-Way Mixed Vegetables, brand The Inn, frozen, net wt. 20lb. UPC 8628920744    The ingredients statement declares: Mixed Vegetables.","3193736 lbs.","Mixed Vegetables are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code formats:     Chef Maxwell California Blend has the code format Best By: 071616  352000009920  17:28                          Chef Maxwell Raw Mixed Vegetables has the code format Best By: 071616 403000009920  17:39    Farmer's Bounty Mixed Vegetables has the code format 402000007721  08:29    Farmer's Bounty Mixed Vegetables has the code format 403000007721  08:33    Life Foods Mixed Vegetables has the code format Use By: 20160924 351900007716 16:20 Product of USA A    McCain Mixed Vegetables has the code format Use By: 20160924 353400001189 16:20 Product of USA B    McCain Mixed Vegetables has the code format Use By: 20160924 351900007789 16:20 Product of USA A    McCain YGC Mixed Vegetables has the code format Use By: 20160924 351900007732 16:20 Product of USA A    The Inn 4-way Mixed Vegetables has the code format 402000001115 08:33    The Inn 5-way Mixed Vegetables has the code format 45200000111508:34  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1775-2016","Class I","Supreme Bean & Carrot Blend, brand VIP, frozen, net wt. 14oz. UPC 7007705002    The ingredient statement declares: Beans and Carrots. ","198923 lbs.","Bean & Carrot blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:                                        3756 107 16 08:27 A USA/CANADA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1776-2016","Class I","Organic Mixed Vegetables with Shelled Edamame, brand Bybee Foods, frozen, net wt. 5lb. UPC 4635800001    Organic Vegetable Medley, brand Live Smart, frozen, net wt. 16oz. UPC 604345    Organic Vegetable medley With Shelled Edamame, brand Organic by Nature, frozen, net wt. 5lb. UPC 4635800065    The ingredients statement declares: Beans, Carrots, Corn, Peas, and Edamame. ","11051858 lbs.","Beans, Carrots, Corn, Peas, and Edamame mixes are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:                                        Live Smart Organic Vegetable Medley has the code format Product of USA 2B6101 02:11 B  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1792-2016","Class I","Garden Blend Vegetables, brand O Organic, frozen, net wt. 16oz. UPC 7989310100    The ingredients statement declares: Broccoli, Carrots, Corn, and Soybeans. ","3936 lbs.","Garden Blend Vegetables is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1787-2016","Class I","Mini Bow Tie Pasta and Vegetable Blend, brand Live Smart, frozen, net wt. 32oz. UPC 603232    The ingredients statement declares: Mini Bow Tie Pasta, Corn, Carrots, Peas, and Peppers.","271200 lbs.","Mini Bow Tie Pasta and Vegetable Blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     Product of USA 2B6101 02:11 B  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1786-2016","Class I","Stew Vegetables, brand Signature Kitchens, frozen, net wt. 16oz. UPC 2113009947    The ingredients statement declares: Carrots, Celery, Onions, and Potatoes.   ","Firm did not provide.","Stew Vegetables are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1781-2016","Class I","Organic Gardener's Blend, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000114    Mixed Vegetable Blend, brand O Organic, frozen, net wt. 16oz. UPC 7989340182    Vegetable Blend, brand Pantry Essentials, frozen, net wt. 32oz. UPC 2113015151    Vegetable Blend, brand Pantry Essentials, frozen, net wt. 64oz. UPC 2113015227    Organic Vegetable Medley, brand Organic by Nature, frozen, net wt. 5lb. UPC 4635800066    Organic Vegetable Medley, brand Organic by Nature, frozen, net wt. 2.5kg. UPC 4635800062    Organic Mixed Vegetables, brand Bybee Foods, frozen, net wt. 5lb. UPC 4635800051    Organic Mixed Vegetables, brand Bybee Foods, frozen, net wt. 4lb. UPC 4635800053    Mixed Vegetables, brand Endico, frozen, net wt. 40oz. UPC 0145916610    Mixed Vegetables, brand Great Value, frozen, net wt. 12oz. UPC 7874205334    Mixed Vegetables, brand Great Value, frozen, net wt. 26oz. UPC 7874210907    Steamable Mixed Vegetables, brand Great Value, frozen, net wt. 12oz. UPC 7874208026    Mixed Vegetables, brand James Farm, frozen, net wt. 40oz. UPC 6069501542    Mixed Vegetables, brand Safeway Kitchens, frozen, net wt. 16oz. UPC 2113009153    Seamed Mixed Vegetables, brand Season's Choice, frozen, net wt. 12oz. UPC 4149820284    Mixed Vegetables (4-way), brand Signature Kitchens, frozen, net wt. 16oz. UPC 2113009153    Organic Mixed Vegetables, brand Simply Nature, frozen, net wt. 16oz. UPC 4149829655    Organic Mixed Vegetables, brand True Goodness, frozen, net wt. 10oz. UPC 1373343096    Organic Mixed Vegetables, brand Wellsley Farms, frozen, net wt. 4lb. UPC 8867000997    Organic Mixed Vegetables, brand Wild Oats, frozen, net wt. 12oz. UPC 4873700715    Org 4way, brand O Organics, frozen, net wt. 16oz. UPC 7989340182    Organic Foursome, brand Trader Joe's, frozen, net wt. 16oz. UPC 00959902    The ingredients statement declares: Beans, Carrots, Corn, and Peas.","1639160 lbs.","Beans, Carrots, Corn, and Peas mixes are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code formats:     O Organic Mixed Vegetable Blend has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Pantry Essentials Vegetable Blend has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Pantry Essentials Vegetable Blend has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Endico Mixed Vegetables has the code format Sell By: 012515  15:15 Product of USA C                                                  Great Value Mixed Vegetables has the code format Best If Used By: 042318 B 23:02 Product of USA    Great Value MIxed Vegetables has the code format Best If Used By: 042318 C 23:02 Product of USA    Great Value Steamable Mixed Vegetables has the code format Best If Used By: 042318 A 23:02 Product of USA    James Farm Mixed Vegetables has the code format Sell By: 012515  15:15 Product of USA D                                                  Safeway Kitchens Mixed Vegetables has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Season's Choice Steamed Mixed Vegetables has the code format Best Before: 032518 B 15:15 Product of USA                                                Signature Kitchens Mixed Vegetables (4-way) has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Simpy Nature Organic Mixed Vegetables has the code format Sell By: 012515 15:15 Product of USA D                                                  True Goodness Organic Mixed Vegetables has the code format Best By: 042318 16:30 D Product of USA                                                Wellsley Farms Organic Mixed Vegetables has the code format Best By: 041218 103 16 23:01 B Product of USA 556700001137    Wild Oats Organic Mixed Vegetables has the code format Best By: 040918 15:15 D Product of USA                                                O Organics Org 4way has the code format Best Before: Oct 2",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1782-2016","Class I","Stir Fry Vegetable, brand Signature Kitchens, frozen, net. wt. 16oz. UPC 2113009077    Stir Fry Vegetable, brand Signature Kitchens, frozen, net wt. 32oz. UPC 2113009186    The ingredients statement declares: Beans, Broccoli, Carrots, Celery, Onions, Peas, Peppers, and Water Chestnuts. ","Firm did not provide.","Stir Fry Vegetable is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code formats:     Signature Kitchens Stir Fry Vegetable has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Stir Fry Vegetable has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1777-2016","Class I","Organic Peas & Pearl Onions, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000113    The ingredients statement declares: Peas and Pearl Onions. ","Firm did not provide.","Organic Peas & Pearl Onions are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:                                        Live Smart Organic Vegetable Medley has the code format Product of USA 2B6101 02:11 B  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1773-2016","Class I","Peas & Carrots, brand Bybee's Best, frozen, net wt. 20lb. UPC 4635800013    Peas & Carrots, brand Chef Maxwell, frozen, net wt. 30lb. UPC 98020    Carrots and Peas, brand CH Belt, frozen, net wt. 20lb. UPC --    Organic Peas & Carrots, brand Columbia River Organics, frozen, net wt.10oz. UPC 5711000112    Peas and Carrots, brand Emerald Farms, frozen, net wt. 40oz. UPC 3765403673    Peas and Carrots, brand Endico, frozen, net wt.	20lb. UPC 7730    Peas and Carrots, brand Endico, frozen, net wt.	40oz. UPC 0145916730    Peas & Carrots, brand Farmer's Bounty, frozen, net wt. 30lb. UPC 4635800002    Peas & Carrots, brand Fiesta Mart, frozen, net wt. 16oz. UPC 5102280007    Peas & Carrots, brand Great Value, frozen, net wt. 12oz. UPC 7874205335    Peas & Carrots, brand James Farm, frozen, net wt. 40oz. UPC 6069501001    Peas and Carrots, brand JAG Foods/LA Foods, frozen, net wt. 30lb. UPC --    Peas & Carrots, brand Northwest Growers Select, frozen, net wt. 20lb. UPC 14100    Carrots & Peas, brand Panda Express, frozen, net wt. 20lb. UPC 10882210001309    Peas and Dice Carrots, brand Parade, frozen, net wt. 16oz. UPC 5070031831    Peas & Carrots, brand Quirch, frozen, net wt. 14oz. UPC 6507260152    Peas & Carrots, brand Quirch, frozen, net wt. 32oz. UPC 6507260151    Green Peas & Diced Carrots, brand Safeway Kitchens, frozen, net wt. 12oz. UPC 2113009182    Peas & Carrots, brand Signature Kitchens, frozen, net wt. 12oz. UPC 2113009182    Peas & Carrots, brand Signature Kitchens, frozen, net wt. 16oz. UPC 2113009154    Peas & Carrots, brand Signature Kitchens, frozen, net wt. 32oz. UPC 2113009033    Peas & Carrots, brand The Inn, frozen, net wt. 20lb. UPC 8628920749    Organic Peas & Shoestring Carrots, brand True Goodness, frozen, net wt.10oz.  UPC 0882077972    Peas & Carrots, brand VIP, frozen, net wt. 16oz. UPC 7007701068    The ingredients statement declares: Peas and Carrots. ","4015345 lbs.","Peas & Carrots are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have code formats:                                        Chef Maxwell Peas & Carrots have the code format Best By: 071616  303000009920   17:38    Emerald Farms Peas and Carrots have the code format Sell By: 012515 15:15 Product of USA C                                                Endico Peas and Carrots have the code format 302000007709 08:32    Endico Peas and Carrots have the code format Sell By: 012515 15:15 Product of USA D                                                  Farmer's Bounty Peas & Carrots have the code format 303000007721  08:34    Fiesta Mart Peas & Carrots have the code format Best By: 122215 301200001178 15:23 Product of USA A    Great Value Peas & Carrots have the code format Best If Used By: 042318 C 23:02 Product of USA    James Farm Peas & Carrots have the code format Sell By: 012515  15:15 Product of USA E                                                 Panda Express Carrots & Peas have the code format Use By: 021415 BF 16:20                                         Parade Peas and Dice Carrots have the code format Best By: 122215 3011200001108 15:23 Product of USA A    Quirch Peas & Carrots have the code format Sell By: 012515 15:15 Product of USA A                                                 Quirch Peas & Carrots have the code format Sell By: 012515  15:15 Product of USA B                                                  Safeway Kitchens Green Peas & Diced Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Peas & Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Peas & Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Peas & Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    The Inn Peas & Carrots have the code format 302000001115  08:35    True Goodness Organic Pe",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1789-2016","Class I","Supreme Garden Stir-Fry, brand VIP, frozen, net wt. 14oz. UPC 7007705010    The ingredients statement declares: Beans, Broccoli, Mushrooms, Onions, and Peppers. ","Will be provided. ","Supreme Garden Stir-Fry is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     3756 107 16 08:27 A USA/CANADA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1795-2016","Class I","Supreme Healthy Garden Blend, brand VIP, frozen, net wt. 14oz. UPC 7007705011    The ingredients statement declares: Broccoli, Carrots, Soybeans, Squash, and Zucchini. ","216699 lbs.","Supreme Healthy Garden Blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     3756 107 16 08:27 A USA/CANADA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1771-2016","Class I","Mix Vegetables, brand JFDA (label in Japanese), frozen, net wt. 1 kg., UPC 991438945321    Mixed Vegetables, brand Mountain Mist, frozen, net wt. 1 kg., UPC 4635800055    The ingredients statement declares: Carrots, Corn, and Peas. ","158.4 lbs.","Mixed Vegetables (contains Carrots, Corn, and Peas) are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    These products have a code format:     JFDA Mix Vegetables have the code format Use By: 20160924 351900007731 16:20 Product of USA A  Mountain Mist Mixed Vegetables have the code format Use By: 20150512 351900007738 16:20 Product of USA D  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1791-2016","Class I","Harvest Vegetable Blend, brand Signature Kitchens, frozen, net wt. 12oz. UPC 2113024259    The ingredients statement declares: Broccoli, Carrots, Cauliflower, Corn, and Peppers. ","4671 lbs.","Harvest Vegetable Blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1790-2016","Class I","Supreme Fiesta Blend, brand VIP, frozen, net wt. 14oz. UPC 7007705009    The ingredients statement declares: Black Beans, Corn, Onions, and Peppers.","Firm did not provide.","Supreme Fiesta Blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     3756 107 16 08:27 A USA/CANADA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1780-2016","Class I","Organic Root Medley, brand Organic by Nature, frozen, net wt. 16oz. UPC 4635800074    The ingredients statement declares: Carrots, Parsnips, and Potatoes.","34992 lbs.","Organic Root Medley is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1793-2016","Class I","Organic Garden Stir Fry	, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000124    The ingredients statement declares: Broccoli, Carrots, Onions, Peppers, and Zucchini. ","60240 lbs.","Organic Garden Stir Fry is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1785-2016","Class I","Organic California Harvest, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000122    The ingredients statement declares: Broccoli, Carrots, Cauliflower, and Zucchini. ","69045 lbs.","Organic California Harvest is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1772-2016","Class I","Broccoli & Cauliflower, brand Wild Oats Organic, frozen, net wt. 10 oz., UPC 4873700711    The ingredients statement declares: Broccoli and Cauliflower.","41296 lbs.","Broccoli & Cauliflower are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has a code format: Best  By: 040918 15:15 B  Product of USA                                             ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1774-2016","Class I","Asparagus, Corn & Carrots Blend, brand Signature Kitchens, frozen, net wt. 12oz. UPC 2113009181    The ingredients statement declares: Asparagus, Corn, and Carrots. ","4824 lbs.","Asparagus, Corn, & Carrots are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:                                        Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1788-2016","Class I","Organic Stir-Fry, brand Kirkland Signature, frozen, net wt. 4lb. UPC 9661910114    The ingredients statement declares: Beans, Broccoli, Carrots, Mushrooms, Onions, and Peppers. ","1148592 lbs.","Organic Stir Fry is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     Best  By: 040918 15:15 B USA/Holland/Ecuador Certified Organic By WSDA                                              ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1784-2016","Class I","Mixed Vegetable, brand Emerald Farms, frozen, net wt. 40oz. UPC 3765403670    Mixed Vegetables, brand Fiesta Mart, frozen, net wt. 16oz. UPC 5102280006    Mixed Vegetables, brand Parade, frozen, net wt. 16oz. UPC 5070030675    Mixed Vegetables, brand Parade, frozen, net wt. 32oz. UPC 5070055832    Mixed Vegetables, brand Quirch, frozen, net wt. 14oz. UPC 6507260130    Mixed Vegetables, brand Quirch, frozen, net wt. 32oz. UPC 6507260129    Mixed Vegetables,brand Safeway Kitchens, frozen, net wt. 32oz. UPC 2113009042    Mixed Vegetables (4-way), brand Signature Kitchens, frozen, net wt. 32oz. UPC 2113009042    Mixed Vegetables (5-way), brand Signature Kitchens, frozen, net wt. 32oz. UPC 2113009042    Mixed Vegetables (5-way), brand Signature Kitchens, frozen, net wt. 12oz. UPC 2113024258    Mixed Vegetables, brand VIP, frozen, net wt. 16oz. UPC 7007701076    Mixed Vegetables, brand VIP, frozen, net wt. 32oz. UPC 7007701276    The ingredients statement declares: Beans, Carrots, Corn, and Lima Beans.","4250756 lbs.","Mixed Vegetables are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code formats:     Emerald Farms Mixed Vegetables has the code format Sell By: 012515  15:15 Product of USA E                                                 Fiesta Mart Mixed Vegetables has the code format Best By: 122215 451200001178 15:23) Product of USA A    Parade Mixed Vegetables has the code format Best By: 122215 45150000110815:23) Product of USA A    Parade Mixed Vegetables has the code format Best By: 122215 451200001108 15:23) Product of USA A    Quirch Mixed Vegetables has the code format Sell By: 012515 15:15 Product of USA E                                                 Quirch Mixed Vegetables has the code format Sell By: 012515 15:15 Product of USA A                                                  Safeway Kitchens Mixed Vegetables has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Mixed Vegetables (4-way) has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Mixed Vegetables (5-way) has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Mixed Vegetables (5-way) has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    VIP Mixed Vegetables has the code format 3756 107 16 08:27 A USA/CANADA    VIP Mixed Vegetables has the code format 3756 107 16 08:27 A USA/CANADA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1797-2016","Class I","Organic Broccoli & Cheddar Cheese, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000140    The ingredients statement declares: Broccoli and Cheddar Cheese. ","Firm did not provide. ","Organic Broccoli & Cheddar Cheese is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1794-2016","Class I","Supreme Stir-Fry Sensation, brand VIP, frozen, net wt. 14oz. UPC 7007705027    The ingredients statement declares: Broccoli, Carrots, Peas, Soybeans, and Water Chestnuts. ","Firm did not provide.","Supreme Stir-Fry Sensation is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     3756 107 16 08:27 A USA/CANADA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1796-2016","Class I","Organic Potato Medley, brand Columbia River Organics, frozen, net wt. 10oz. UPC 4635800025    The ingredients statement declares: Yukon Gold Potatoes, Red Potatoes, Russet Potatoes, Sea Salt, Black Pepper, Garlic Powder, and Canola Oil.","Firm did not provide.","Organic Potato Medley is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1778-2016","Class I","Red, Green and Yellow Pepper Strips, brand Safeway Kitchens, frozen, net wt. 14oz., UPC 2113009100    The ingredients statement declares: Red, Green, and Yellow Pepper Strips. ","449411 lbs.","Red, Green, and Yellow Pepper Strips are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:                                        Best Before: Oct 23 17 S3904 15:08 B Product of USA  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74133,"Ongoing","CRF Frozen Foods, LLC","1825 N Commercial Ave",,"Pasco","WA","99301-9533","United States","Voluntary: Firm Initiated","Press Release","US nationwide and in Canada and Japan","F-1779-2016","Class I","Organic Steamers Roasted Red Potato & Vegetable Medley, brand Bybee Foods, frozen, net wt.12oz. UPC 4635800041    Roasted Red Potatoes and Vegetable Medley, brand Earth's Pride Organics, frozen, net wt. 12oz. UPC 00000229244    Organic Roasted Red Potato & Vegetable Medley, brand Wellsley Farms, frozen, net wt. 4lb., UPC 8867001014    Organic Bounty Blend, brand Columbia River Organics, frozen, net wt. 10oz. UPC 4635800024    The ingredients statement declares: Beans, Mushrooms, Peppers, and Potatoes.","643930 lbs.","Potoatoes, Beans, Peppers, and Mushrooms mixes are recalled because they have the potential to be contaminated with Listeria monocytogenes.","07/26/2016",," All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code format:                                        Earth's Pride Organics Roasted Red Potatoes and Vegetable Medley has the code format Best By: 041218 103 16 23:01 B Product of USA 743829001122    Wellsley Farms Organic Roasted Red Potato & Vegetable Medley has the code format Best By: 041218 103 16 23:01 B Product of USA 176700401137  ",5/2/2016,"05/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74134,"Ongoing","Vending Nut Co Inc","2222 Montgomery St",,"Fort Worth","TX","76107-4519","United States","Voluntary: Firm Initiated","Letter","Texas","F-1570-2016","Class I","NUTS Vending Nut Co. 2222 Montgomery St. Ft. Worth, TX 76107 817-737-3071 www.vendingnut.com Sunflower Seeds Roasted & No Salt Net Wt. (160 oz) 10lb UPC: 0-98301-00006-5 in cardboard container.","35,000 pounds","Product has the potential to be contaminated with Listeria monocytogenes.","06/22/2016",," Lot: 8B6M02, Pack Date: 02/24/16-05/02/16",5/5/2016,"05/05/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74134,"Ongoing","Vending Nut Co Inc","2222 Montgomery St",,"Fort Worth","TX","76107-4519","United States","Voluntary: Firm Initiated","Letter","Texas","F-1569-2016","Class I","NUTS Sunflower Seeds Roasted & Salted Vending Nut Co. Fort Worth, Texas 76107 Net Wt. 16 oz. (1 LB.) 454g packaged in plastic bags","12,000 pounds","Product has the potential to be contaminated with Listeria monocytogenes.","06/22/2016",," Lot: 8B6M02, Pack Date: 02/24/16-05/02/16",5/5/2016,"05/05/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74135,"Ongoing","Profarma Distributors LLC","4751 Poth Rd",,"Columbus","OH","43213-1331","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1042-2016","Class II","VERMOX Tablets 500 mg, 1-count box, UPC 501109900596","254 boxes (254 tablets)","CGMP Deviations","06/17/2016",," Lot # UJE 040; Exp. 02/17 ",5/11/2016,"05/11/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74135,"Ongoing","Profarma Distributors LLC","4751 Poth Rd",,"Columbus","OH","43213-1331","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1043-2016","Class II","1% Clotrimazol cream, 30 mg tube,  UPC 501318644335","79 boxes (79 tubes)","CGMP Deviations","06/17/2016",," Lot # GRU1390; Exp. 08/17",5/11/2016,"05/11/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74135,"Ongoing","Profarma Distributors LLC","4751 Poth Rd",,"Columbus","OH","43213-1331","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1040-2016","Class II","tabcin NOCHE; Capsules,12-count box, UPC 501008485033","31 boxes ( 372 capsules)","CGMP Deviations","06/17/2016",," Lot # X223FS; Exp. 11/17 ",5/11/2016,"05/11/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74135,"Ongoing","Profarma Distributors LLC","4751 Poth Rd",,"Columbus","OH","43213-1331","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1039-2016","Class II","tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057","42 boxes (504 capsules)","CGMP Deviations","06/17/2016",," Lot # 224TS; Exp.  02/17",5/11/2016,"05/11/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74135,"Ongoing","Profarma Distributors LLC","4751 Poth Rd",,"Columbus","OH","43213-1331","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1041-2016","Class II","VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619","163 boxes (978 tablets)","CGMP Deviations","06/17/2016",," Lot # UPE187; Exp. 08/17",5/11/2016,"05/11/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74136,"Ongoing","Sandridge Food Corporation","133 Commerce Dr",,"Medina","OH","44256-1333","United States","Voluntary: Firm Initiated","Letter","Product was shipped to FL & GA","F-1750-2016","Class I","Crunchy Wheatberry Salad Kit 12.75 LB (5.78kg) ***SUNFLOWER SEED POUCH: INGREDIENTS SUNFLOWER KERNELS (Sunflower Kernels, Canola and/or Peanut oil and/or Sunflower Oil Citric Acid)  Manufactured by Sandridge Food Corporation, Medina, Ohio 44256","1,559 cs/1/4 oz bags of sunflower kernels","The firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.","07/19/2016",," Item K340718Lot # 052816, Use By Date 2016-05-28; Lot # 052816, Use By Date 2016-05-28; Lot # 052816, Use By Date 2016-05-28; Lot # 060816, Use By Date 2016-06-08;  Lot # 052116, Use By Date 2016-05-21; Lot # 060116, Use By Date 2016-06-01; Lot # 060816, Use By Date 2016-06-08; Lot # 052116, Use By Date 2016-05-21; Lot # 060416, Use By Date 2016-06-04 & Lot # 052116, Use By Date 2016-05-21.",5/4/2016,"05/04/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74137,"Ongoing","Mccall Farms Inc","6615 S Irby St",,"Effingham","SC","29541-3577","United States","Voluntary: Firm Initiated","E-Mail","SC","F-1597-2016","Class I","Piggly Wiggly, Yellow Cut Corn, Net Wt 32oz (2 lbs), 907g bags, Distributed by Piggly Wiggly LLC, Keene, NH 03431.","336 cases","Possible Listeria monocytogenes contamination.","06/30/2016",," CORN0J14FXHA,	UPC 4129075181",5/9/2016,"05/09/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74138,"Ongoing","Bayer Health Care LLC","4207 Michigan Avenue Rd NE",".","Cleveland","TN","37323-5505","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0977-2016","Class II","Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762","37,512 bottles","Labeling; Product Contains Undeclared API (Oxybenzone)","06/09/2016",," CV006V9, 2/2018",5/10/2016,"05/10/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74139,"Ongoing","Baxter Healthcare Corp","21026 Alexander Ct",,"Hayward","CA","94545-1234","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.","Z-1838-2016","Class II","COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.","274 units","Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.","05/31/2016",," HA160136",5/12/2016,"05/12/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74139,"Ongoing","Baxter Healthcare Corp","21026 Alexander Ct",,"Hayward","CA","94545-1234","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.","Z-1840-2016","Class II","COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072;  For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.","6,128 units","Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.","05/31/2016",," HA151038, HA151220, HA151037, HA151028, HA160114, HA160115, HA160222",5/12/2016,"05/12/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74139,"Ongoing","Baxter Healthcare Corp","21026 Alexander Ct",,"Hayward","CA","94545-1234","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.","Z-1839-2016","Class II","COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071;  For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.","6,804 units","Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.","05/31/2016",," HA160151, HA151205, HA151036, HA151035, HA160229",5/12/2016,"05/12/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74140,"Ongoing","Integrated Science Systems Inc","1215 George C Wilson Dr Unit A4",".","Augusta","GA","30909-5700","United States","Voluntary: Firm Initiated","E-Mail","Nationwide distribution to CA only.","Z-1911-2016","Class II","Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T   The product is used as an aid in the identification of Staphylococcus aureus from Culture","2625 kits","Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.","06/03/2016",," Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043",2/19/2016,"02/19/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74141,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",".","Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Press Release","Distributed to the following states: AL, FL, GA, NC, SC, TN","F-1427-2016","Class I","Publix Cranberry Nut & Seed Mix, 7.05 ounce plastic container.  Manufactured by Publix Supermarkets in Lakeland, FL.","1,278 cases, 8 containers per case.","Possible contamination of Listeria monocytogenes.","06/03/2016",," Lot codes 16074, 16091",5/10/2016,"05/10/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74142,"Ongoing","CareFusion 303, Inc.","10020 Pacific Mesa Blvd",,"San Diego","CA","92121-4386","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and in Canada.","Z-2064-2016","Class II","Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19;  Central programming, monitoring and power supply component for the Alaris System.","69,693 units","A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. ","06/28/2016",," Serial no.  14566816  14566942  14566976  14567039  14567041  14567050  14567060  14567079  14567084  14567085  14567126  14567131  14567132  14567144  14412839  14509419  14509442  14509601  14510079  14510087  14517114  14517126  14517135  14517137  14517139  14517179  14517183  14517186  14517193  14517202  14517205  14517208  14517214  14517218  14517220  14517246  14517250  14517253  14517254  14517256  14517257  14517259  14517260  14517282  14517286  14517287  14517296  14517297  14517301  14517303  14517305  14517309  14517310  14517312  14517314  14517315  14517316  14517318  14517319  14517323  14517324  14517326  14517327  14517336  14517337  14517339  14517341  14517345  14517346  14517351  14517356  14517359  14517360  14517362  14517363  14517364  14517369  14517372  14517373  14517378  14517381  14517383  14517388  14517389  14517391  14517393  14517396  14517400  14517401  14517402  14517403  14517409  14517415  14517417  14517418  14517421  14517424  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"Food",74143,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","Other","Nationwide throughout the US","F-1757-2016","Class I","Whole Foods Market Korean BBQ Sauce NET WT 12 OZ (340g) packaged in a glass bottle","8604 units","Undeclared peanut and coconut.","07/20/2016",," UPC 9948244812; Best By OCT 19/17",5/11/2016,"05/11/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74144,"Ongoing","SOS Telecom Inc.","20228 45th Ave",,"Bayside","NY","11361-2540","United States","Voluntary: Firm Initiated","Press Release","NY","D-0103-2017","Class I","Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.    ",,"Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements","10/14/2016",," Lot: 7788965; Best use by: 10/15/2018",5/12/2016,"05/12/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74144,"Ongoing","SOS Telecom Inc.","20228 45th Ave",,"Bayside","NY","11361-2540","United States","Voluntary: Firm Initiated","Press Release","NY","D-0102-2017","Class I","Ninja-X, 4200 mg, 1 capsule per pack,  24 single packs per box.    ",,"Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements","10/14/2016",," Lot: 7920888; Best Use by: 6/31/2018",5/12/2016,"05/12/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74144,"Ongoing","SOS Telecom Inc.","20228 45th Ave",,"Bayside","NY","11361-2540","United States","Voluntary: Firm Initiated","Press Release","NY","D-0104-2017","Class I","Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.    ",,"Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements","10/14/2016",," Lot: 7920499; Best use by: 10/15/2016",5/12/2016,"05/12/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74144,"Ongoing","SOS Telecom Inc.","20228 45th Ave",,"Bayside","NY","11361-2540","United States","Voluntary: Firm Initiated","Press Release","NY","D-0101-2017","Class I","Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box",,"Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements","10/14/2016",," Lot No: 9236999; Best use by: 12/16/2016",5/12/2016,"05/12/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74145,"Ongoing","Hmshost","6600 Rockledge Dr",,"Bethesda","MD","20817-1806","United States","Voluntary: Firm Initiated","Telephone","HMSHost received a total of 1,275 pounds of product under the lot codes that are recalled which were distributed to 34 customers in total. Distribution is only for US and to HMSHost Airports & Travel Plazas Concepts/Stores. No Foreign Country was affected.","F-2153-2016","Class I","Woodstock Cape Cod Cranberry Mix, 25lbs.  Item #250575    The product  also goes by the following trades names:    1). 1897 Cape Cod Cranberry Mix 7oz  2). Ciao Cape Cod Cranberry Mix 7oz  3). Farmers Market Cape Cod Cranberry Mix 7oz  4). Grounded In Cape Cod Cranberry Mix 7oz  5). La Tapenade Cape Cod Cranberry Mix 7oz  6). Marche Cape Cod Cranberry Mix 7oz  7). MKT Cape Cod Cranberry Mix 7oz  8). Pronto Cape Cod Cranberry Mix 7oz  9). PZA Cape Cod Cranberry Mix 7oz  10). The Local Cape Cod Cranberry Mix 7oz  11). Urban Market Cape Cod Cranberry Mix 7oz  12) Fresh Attraction Cape Cod Cranberry Mix 7oz","Total of 1,275 pounds ","Woodstock Farms informed HMSHost of their  recall.   HMSHost purchase bulk snacks from Woodstock Farms , has discovered during their routine testing that the walnuts used in the recalled items/products may have the presence of Listeria  Monocytogenes.  HMSHost repackaged the bulk snack under several private label brands to sell to the consumer.  HMSHost is initiating a precautionary voluntary recall.  ","09/19/2016",," Lot #16097, Best By 09/17/16 & Lot #16109, Best By 09/17/16  UPC# 2050000142000 for all labels.",5/9/2016,"05/09/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74146,"Ongoing","The Aloe Source","3101 Technology Dr Ste 135",,"Plano","TX","75074-3728","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1053-2016","Class II","aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA  Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc.,  the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089","577 (212 1 fl oz.. plastic bottles, 167 8 fl oz. plastic bottles, 198 8 fl oz. plastic tubes)","CGMP Deviations","06/26/2016",," Lot # 1407012; Exp. 03/17",5/11/2016,"05/11/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74147,"Ongoing","Montero Farms","2501 W Military Hwy","Ste D11, C1, C2, C3","Mcallen","TX","78503-8955","United States","Voluntary: Firm Initiated","Telephone","TX, IN","F-1587-2016","Class I","Productos Del Campo Castillo Chile Habanero (Fresh Habanero Peppers)","154 boxes each containing 8 lbs of product  for a total of 1,232 lbs.","Potential to be contaminated with Salmonella.","06/27/2016",," Lot Number 41142 and Lot Number 41143 is printed on top of the cartons of recalled products",5/11/2016,"05/11/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74148,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",".","Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI;     Foreign: Australia, New Zealand, Korea,  Austria, Belgium, Germany, Italy, France, Luxembourg, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Arab Emirates.","Z-1917-2016","Class II","Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.","10,256"," Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants. ","06/07/2016",," Part Number, Lot Number, Date of Manufacture:   42509909210,	63138589,	07/28/2015;  42509909210,	63097616,	06/10/2015;  00590708181,	56595825,	04/20/2015;  00590708185,	56610423,	03/12/2015;  00590708176,	56595826,	03/04/2015;  00590708179,	56595827,	03/04/2015;  00590708180,	56595828,	03/04/2015;  00590708181,	56595824,	03/02/2015;  00590708178,	56595692,	02/17/2015;  00590708176,	56595691,	02/16/2015;  00590708177,	56595801,	02/16/2015;  00590708180,	56595694,	02/04/2015;  00590708179,	56595693,	01/29/2015;  00590708181,	56595642,	01/20/2015;  00590708177,	56595625,	01/06/2015;  42539807902,	62906456,	12/14/2014;  00590708178,	56595569,	12/12/2014;  42539808802,	62885379,	11/22/2014;  42539807102,	62885377,	11/21/2014;  42539806702,	62885376,	11/20/2014;  42539806701,	62885375,	11/18/2014;  42539808801,	62863647,	10/29/2014;  42539802000,	62854350,	10/16/2014;  42539808802,	62849167,	10/14/2014;  42539806702,	62849168,	10/13/2014;  42539807502,	62839311,	10/08/2014;  42539807101,	62833614,	10/07/2014;  42539802000,	62844358,	10/07/2014;  42539808301,	62839310,	10/04/2014;  42539806401,	62833616,	10/03/2014;  42539807101,	62839312,	10/03/2014;  42539800500,	62844377,	09/30/2014;  42539802000,	62827692,	09/29/2014;  42539807901,	62831188,	09/25/2014;  42539808301,	62833610,	09/25/2014;  00590708176,	56595440,	09/25/2014;  42539806401,	62837612,	09/24/2014;  42539807502,	62833612,	09/24/2014;  00590708179,	56595441,	09/24/2014;  00590708180,	56595442,	09/24/2014;  42539807501,	62831191,	09/22/2014;  00590708181,	56595443,	09/18/2014;  42539807501,	62827408,	09/15/2014;  42539807901,	62827407,	09/15/2014;  42509909210,	62817496,	09/08/2014;  42539806402,	62817469,	09/03/2014;  42539808302,	62817467,	09/03/2014;  42539807902,	62817468,	09/02/2014;  42539806701,	62813822,	08/24/2014;  00590708177,	56595435,	08/05/2014;  42539802000,	62769875,	08/03/2014;  42539800500,	62779559,	07/30/2014;  42539800100,	62779557,	07/29/2014;  42539800700,	62769874,	07/28/2014;  42539800100,	62769871,	07/27/2014;  42539800500,	627",5/11/2016,"05/11/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74149,"Ongoing","Philips Healthcare","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.","Z-1715-2016","Class II","Philips Healthcare Brilliance iCT SP  Computed Tomography X-Ray System","US-423","Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm ","06/06/2016",," Software v. 4.13,  4.14 and 4.15.",9/6/2015,"09/06/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74149,"Ongoing","Philips Healthcare","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.","Z-1716-2016","Class II","Philips Healthcare Ingenuity Core Computed Tomography X-Ray System","US-423","Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm ","06/06/2016",," Software v. 4.13,  4.14 and 4.15.",9/6/2015,"09/06/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74149,"Ongoing","Philips Healthcare","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.","Z-1714-2016","Class II","Philips Healthcare Brilliance iCT Computed Tomography X-Ray System","US-423","Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm ","06/06/2016",," Software v. 4.13,  4.14 and 4.15.",9/6/2015,"09/06/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74149,"Ongoing","Philips Healthcare","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.","Z-1713-2016","Class II","Philips Healthcare Brilliance 64 Computed Tomography X-Ray System","US - 423 ","Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm ","06/06/2016",," Software v. 4.13,  4.14 and 4.15.",9/6/2015,"09/06/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74149,"Ongoing","Philips Healthcare","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.","Z-1717-2016","Class II","Philips Healthcare Ingenuity CT Computed Tomography X-Ray System","US-423","Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm ","06/06/2016",," Software v. 4.13,  4.14 and 4.15.",9/6/2015,"09/06/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74149,"Ongoing","Philips Healthcare","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.","Z-1719-2016","Class II","Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System","US - 423","Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm ","06/06/2016",," Software v. 4.13,  4.14 and 4.15.",9/6/2015,"09/06/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74149,"Ongoing","Philips Healthcare","3000 Minuteman Rd",".","Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.","Z-1718-2016","Class II","Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System","US - 423","Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm ","06/06/2016",," Software v. 4.13,  4.14 and 4.15.",9/6/2015,"09/06/2015",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74150,"Terminated","LifeShare Blood Centers","8910 Linwood Ave",,"Shreveport","LA","71106-6508","United States","Voluntary: Firm Initiated","Telephone","Louisiana","B-0561-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Blood products, which did not meet the acceptable product specifications for release, were distributed.","06/13/2016","06/13/2016"," W036516369068; W036516369068; ",3/23/2016,"03/23/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74151,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","FAX","Florida","B-0562-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.","06/13/2016","06/13/2016"," W036814418286; W036814418286; ",4/18/2016,"04/18/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74152,"Terminated","American Red Cross Blood Services","209 Farmington Ave",,"Farmington","CT","06032-1955","United States","Voluntary: Firm Initiated","FAX","Connecticut","B-0563-16","Class III","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.","06/13/2016","06/13/2016"," W2033163332071; W2033163332072; ",3/23/2016,"03/23/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74153,"Ongoing","Medtronic Navigation, Inc.-Littleton","300 Foster Street",,"Littleton","MA","01460-2017","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2082-2016","Class II","Medtronic 0-arm Imaging mobile x-ray system.    Model Numbers - B1-700-00027,    B1-700-00028      ","US - 581","It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.","07/06/2016","."," Model No. BI-700-00027 and BT-700-00028",3/17/2016,"03/17/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74154,"Ongoing","Roche Molecular Systems, Inc.","1080 US Highway 202 S",,"Branchburg","NJ","08876-3733","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.","Z-2203-2016","Class III","cobas¿ Liat Influenza A/B Quality Control Kit;  For use with  cobas¿ Liat Influenza A/B Assay.","194 distributed kits","Kit labeled with the incorrect expiration date. ","07/13/2016",," Lot Numbers:  51222E, 60121H, 60201D, and 60229F",5/17/2016,"05/17/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74155,"Ongoing","Virbac AH, Inc","3200 Meacham Blvd",,"Fort Worth","TX","76137-4611","United States","Voluntary: Firm Initiated","Telephone","Product was distributed to CA, FL, MI, MO, MN, OR, PA, and WI.  There was no foreign/military/government distribution.","V-0007-2017","Class II","easOtic (hydrocortisone aceponate 1.11 mg / miconazole nitrate 15.1 mg / gentamicin sulfate 1.5 mg/ml) suspension for dogs packaged in 10 mL size canister, 1 canister per carton, Net Contents 10 mL, NDC 51311-360-10. NADA 141-330. The responsible firm name on the label is Virbac Animal Health, Fort Worth, TX 76137.","53,196 canisters","Out of specification result for gentamicin sulfate at 18-month stability time-point.","10/11/2016",," Lot: 140729; Exp. Date 30Jun2016",5/12/2016,"05/12/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74156,"Ongoing","Miami Fat Supply, Inc","1510 Max Hooks Rd Ste F",,"Groveland","FL","34736-8032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, and VA; and, the country of Dominican Republic.","Z-1957-2016","Class II","The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile.     Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.","443 units","During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.","06/13/2016",," Lots 1165 and 1271.",4/21/2016,"04/21/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74157,"Ongoing","Carfagnas Inc","3518 Johnny Appleseed Ct",,"Columbus","OH","43231-4985","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio only","F-2014-2016","Class II","Carfagnas Mild Chili Ready Sauce in 32 oz. glass jars.","1,640 jars ","Acidified process not on file with the FDA","08/29/2016",," Manufacturing code: 50340   ",5/3/2016,"05/03/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74157,"Ongoing","Carfagnas Inc","3518 Johnny Appleseed Ct",,"Columbus","OH","43231-4985","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Ohio only","F-2015-2016","Class II","Carfagnas Spicy Chili Ready Sauce in 32 oz. glass jars. ","735 jars","Acidified process not on file with the FDA","08/29/2016",," Manufacturing code: 50341",5/3/2016,"05/03/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74158,"Ongoing","Medtronic Navigation, Inc.-Littleton","300 Foster Street",,"Littleton","MA","01460-2017","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2083-2016","Class II","Medtronic Navigation O-arm 02 surgical x-ray imaging system","US - 63","Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered  gaps in compliance with the requirements for information to be provided  to users in 21CFR part 1 020.30(h). ","07/06/2016","."," model number BT-700-02000",3/17/2016,"03/17/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74159,"Ongoing","Food Gusto, Inc.","810 E 27th St",,"Paterson","NJ","07513-1215","United States","Voluntary: Firm Initiated","Telephone","CT, MA and NY","F-0189-2017","Class I","Birdy 3 in 1 Robusta Coffea Mix, 445.5 g in a red sealed plastic bag, Product of Thailand, UPC 8850250007425","30 cartons","Birdy 3 in 1 Coffee Mix (Robusta) may contain undeclared milk allergen and the nutritional labeling is unclear.","10/19/2016",," Lot #D092121515",5/10/2016,"05/10/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74161,"Ongoing","Frozen Inc.","4004 Grape St",".","Denver","CO","80216-4512","United States","Voluntary: Firm Initiated","Telephone","One consignee in Colorado. No foreign or VA/govt/military consignees.","F-1437-2016","Class II","24 oz RM German Choc. Dessert Bar Cake. Net Wt: 24 oz, K Dairy, UPC 752716883308, Vollmer's Bakery - 4004 Grape Street - Denver, CO - 303-388-8393. Packaging: Plastic Container, 8 per case, Keep frozen, refrigerate after opening.","175 cases","Frozen Inc is recalling 24 oz RM German Chocolate Dessert Bar Cake because it does not list pecans. ","06/08/2016",," Lot 8430 and UPC (752716883308 )",5/9/2016,"05/09/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74162,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN","Z-0072-2017","Class II","ADVIA Centaur XPT Immunoassay System","292 units Total (3 domestically & 289 internationally)","The ADVIA Centaur¿ XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily.  Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results.  Systems running in a language other than English are not impacted.","10/12/2016",," None",4/28/2016,"04/28/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74163,"Ongoing","Fresh Express Incorporated","900 E Blanco Rd",,"Salinas","CA","93901-4419","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","PA","F-1485-2016","Class I","The Farmers Market, Chopped Asian, Chopped Lettuce Blend, Roasted Chicken, Cherry Infused Cranberries & Almond Crunch, Square Noodles and Sesame Ginger Dressing, Net Wt. 6.25 oz. (177g), packed in clear rigid plastic containers, Fresh Express Incorporated, P.O. Box 80599, Salinas, CA 93912.","3 Cases x 6 bowls of 6.25 oz. each","Undeclared allergens; wheat, soy and tree nuts (almonds).","06/10/2016",," Product Code: G126B22, Use By May 20.",5/12/2016,"05/12/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74164,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cyprus, Czech Republic, Ecuador Egypt, Estonia, France, Germany, Greece, Hong Kong, India, Indonesia, Iran,  Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Morocco, Nabibia, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka,Sweden, Switzerland, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Zimbabwe","Z-1879-2016","Class II","Monaco RTP System    Product Usage:  The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.  ","1401 units"," (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.","06/02/2016",," Monaco versions 5.10.00 and higher",5/18/2016,"05/18/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74165,"Terminated","BPL Plasma","301 W Main St",,"Carbondale","IL","62901-2901","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0564-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","06/13/2016","06/13/2016"," CD0494574; ",4/2/2016,"04/02/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74166,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","FAX","Florida","B-0565-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Blood product,s which did not meet the acceptable product specifications, were distributed.","06/23/2016","06/23/2016"," W036816080719; W036816080719; ",4/20/2016,"04/20/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74167,"Terminated","BPL Plasma, Inc. ","3744 Blanding Blvd",,"Jacksonville","FL","32210-5243","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0551-16","Class II","Source Plasma","18 units","Plasma products, for which donor eligibility determinations were inadequately performed, were distributed.","05/31/2016","05/31/2016"," JK0697757; JK0698124; JK0681845; JK0684216; JK0685625; JK0686028; JK0687334; JK0687621; JK0688916; JK0689298; JK0693804; JK0694450; JK0695094; JK0695688; JK0696470; JK0696889; JK0699037; JK0702069",4/9/2016,"04/09/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74169,"Terminated","The Blood Center","2609 Canal St",".","New Orleans","LA","70119-6456","United States","Voluntary: Firm Initiated","Telephone","Louisiana","B-0568-16","Class II","Red Blood Cells","1 unit","Blood product, collected from a donor who disclosed travel history to a malarial endemic area, was distributed.","06/03/2016","06/03/2016"," W067116005724",4/8/2016,"04/08/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74170,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",".","Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Domestic only:   AL  AR  CA  FL  GA  IL  IN  KS  KY  MD  MI  MO  NC  NM  OH  OK  SC  TN  TX  VA  WA  WI","Z-1939-2016","Class II","Maestro Air Motor  Pneumatic cranial drill motor.   The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system.  The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories.","189","Due to the buildup of grease within the hose and motor, there is an increased likelihood that the product may require  multiple attempts to start. In addition, there is a possibility that the grease may migrate into the attachment end of the  motor.  Risk to Health:  Although there have been no reported incidents, there is a negligible possibility that the orange grease may leak from  the attachme","06/09/2016",," Model Number:  5407-200-000  S/N:  1522406703 1522406713 1522406733 1522406743 1522406753 1522406763 1522406773 1522406793  1522406803 1522406813 1522406833 1522406843 1522406853 1522406863 1522406873 1522406883  1522406893 1522406903 1522406923 1523018583 1523018603 1523018623 1523018633 1523018683  1523018713 1523018723 1523018733 1523018743 1523018773 1523018783 1523018813 1523018823  1523018833 1523018843 1523018853 1523018863 1523018873 1523018883 1523018893 1523018903  1523018913 1523601703 1523601723 1523601733 1523601743 1523601763 1523601773 1523601783  1523601793 1523601813 1523601823 1523601833 1523601843 1523601863 1523601873 1523601883  1523601893 1523601903 1523601913 1523601923 1523601933 1523601943 1523904263 1523904273  1523904283 1523904293 1523904303 1523904313 1523904333 1523904343 1523904353 1523904363  1523904373 1523904383 1523904393 1523904403 1523904413 1523904423 1523904433 1523904443  1523904453 1523904463 1523904473 1523904493 1523904503 1523904513 1523904523 1523904543  1523906203 1523906213 1523906223 1523906233 1523906243 1523906253 1523906263 1523906273  1523906283 1526102833 1526102843 1526102853 1526102863 1526102873 1526102893 1526102903  1526102913 1526102923 1526102933 1526102943 1526102953 1526102963 1526102973 1526102983  1526102993 1526103003 1526103013 1526103023 1526103033 1526103043 1526103053 1526804843  1526804853 1526804863 1526804873 1526804883 1526804903 1526804933 1526804953 1526804993  1526805003 1526805013 1526805023 1526805033 1526902093 1526902103 1526902113 1526902133  1528503293 1528503303 1528503313 1528503323 1528503333 1528503393 1528503433 1528503453  1528503463 1528503473 1528503483 1528503583 1528503623 1528503633 1528503643 1528503653  1528503663 1528503683 1528503693 1528503713 1528503793 1528503803 1528503823 1528503833  1528503843 1528503853 1528503863 1528503873 1528503883 1535100493 1535100523 1535100553  1535100563 1535100573 1535100613 1535100623 1535100633 1535100653 1535100663 1535100673  1535502623 1535502663 1535502693 1535602023 1535602",4/28/2016,"04/28/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74171,"Ongoing","B. Braun Medical, Inc.","901 Marcon Blvd",,"Allentown","PA","18109-9512","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: Canada.","Z-1703-2016","Class II","WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734.    Usage: Infusion of solution/medication into implanted intravascular ports.","5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]","Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.  ","05/20/2016",," Catalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.  ",4/26/2016,"04/26/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74172,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada...","Z-1943-2016","Class II","Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S  Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.","2812 units","DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.  ","06/09/2016",," Catalog ID 07.704.003S, 07.704.005S and 07.704.010S  Lot Numbers: DSC1679, DSC3869, DSC7712, DSC8448, DSC9141, DSD0256, DSD2012, DSD2506, DSD3236, DSC1747, DSC1748, DSC2468, DSC3590, DSC3874, DSC6847, DSC7713, DSC8449, DSC9067, DSC9142, DSD0257, DSD0919, DSD2013, DSD2380, DSD3237. DSC1676, DSC2469, DSC3591, DSC3879, DSC8441, DSC9143, DSD0055, DSD0466, DSD1956, DSD2381",5/11/2016,"05/11/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74172,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada...","Z-1944-2016","Class II","Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S  Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.","2098 units","DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.  ","06/09/2016",," Catalog ID 07.704.003S, 07.704.005S and 07.704.010S  Lot Numbers: DSC1679, DSC3869, DSC7712, DSC8448, DSC9141, DSD0256, DSD2012, DSD2506, DSD3236, DSC1747, DSC1748, DSC2468, DSC3590, DSC3874, DSC6847, DSC7713, DSC8449, DSC9067, DSC9142, DSD0257, DSD0919, DSD2013, DSD2380, DSD3237. DSC1676, DSC2469, DSC3591, DSC3879, DSC8441, DSC9143, DSD0055, DSD0466, DSD1956, DSD2381",5/11/2016,"05/11/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74172,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",".","West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada...","Z-1942-2016","Class II","Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S  Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.","1246 units ","DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.  ","06/09/2016",," Catalog ID 07.704.003S, 07.704.005S and 07.704.010S  Lot Numbers: DSC1679, DSC3869, DSC7712, DSC8448, DSC9141, DSD0256, DSD2012, DSC1747, DSC1748, DSC2468, DSC3590, DSC3874, DSC6847, DSC7713, DSC8449, DSC9067, DSC9142, DSD0257, DSD0919, DSD2013,   DSC1676, DSC2469, DSC3591, DSC3879, DSC8441, DSC9143, DSD0055, DSD0466, DSD1956, DSD2381",5/11/2016,"05/11/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74173,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","E-Mail","NC and PA","Z-2086-2016","Class II","Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248","12 units","As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly.  The labeling incorrectly reflects the material as Cobalt Chromium instead of Titanium.","06/29/2016",," Cat No. 10207205, Lot: QJ0248",4/29/2016,"04/29/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74175,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","Tennessee; Virginia; Georgia","B-0629-16","Class III","Red Blood Cells, Leukocytes Reduced","10 units","Blood products, collected in blood bags that had exceeded the manufacturer's instructions for use, were distributed.  ","06/22/2016","06/22/2016"," W043216016448; W043216016421; W043216013192; W043216018812; W043216018833; W043216013196; W043216018984; W043216018811; W043216013163; W043216016459; ",4/9/2016,"04/09/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74176,"Ongoing","Medical Components, Inc dba MedComp","1499 Delp Dr",".","Harleysville","PA","19438-2936","United States","Voluntary: Firm Initiated","Letter","US Distributed to: FL, TX, NC","Z-1924-2016","Class II","Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490    Product Usage:  The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.  ","VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).","This recall has been initiated due to the product labeled with the incorrect expiration date. ","06/07/2016",," Catalog Numbers/Lot Numbers/Exp. Date/UDI Number:  VS203 Lot # MBZX140 exp. date 01/18/2021 UDI# 884908105209  VS303 Lot # MBZL450 exp. date 11/14/2020 UDI# 884908105216  VS303 Lot # MBZV930 exp. date 11/01/2021 UDI# 884908105216  VS303 Lot # MBZZ490 exp. date 01/28/2021 UDI# 884908105216",5/5/2016,"05/05/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74177,"Ongoing","Ballester Hermanos, Inc.","Carr. 869 #3 West Gate Industrial Park","Bo. Palmas","Catano","PR","00962","United States","Voluntary: Firm Initiated","E-Mail","Puerto Rico only.","F-0003-2017","Class II",".","166 CASES","Product label states name and ingredients as Octopus and real content is Squid.    ","10/03/2016",," Unknown ",5/12/2016,"05/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74177,"Ongoing","Ballester Hermanos, Inc.","Carr. 869 #3 West Gate Industrial Park","Bo. Palmas","Catano","PR","00962","United States","Voluntary: Firm Initiated","E-Mail","Puerto Rico only.","F-0004-2017","Class II",".","145 CASES","Product label states name and ingredients as Octopus and real content is Squid.    ","10/03/2016",," Unknown ",5/12/2016,"05/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74177,"Ongoing","Ballester Hermanos, Inc.","Carr. 869 #3 West Gate Industrial Park","Bo. Palmas","Catano","PR","00962","United States","Voluntary: Firm Initiated","E-Mail","Puerto Rico only.","F-0001-2017","Class II",".","5,286 CASES","Product label states name and ingredients as Octopus and real content is Squid.    ","10/03/2016",," Unknown ",5/12/2016,"05/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74177,"Ongoing","Ballester Hermanos, Inc.","Carr. 869 #3 West Gate Industrial Park","Bo. Palmas","Catano","PR","00962","United States","Voluntary: Firm Initiated","E-Mail","Puerto Rico only.","F-0002-2017","Class II",".","495 CASES","Product label states name and ingredients as Octopus and real content is Squid.    ","10/03/2016",," Unknown ",5/12/2016,"05/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74178,"Ongoing","Leica Biosystems Richmond Inc.","5205 Route 12",,"Richmond","IL","60071","United States","Voluntary: Firm Initiated","Letter","U.S. consignees: Nationwide; Foreign Consignees: China, Japan, Russia, Italy and England.","Z-1948-2016","Class III","Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.     This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.","33 systems","An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. ","06/10/2016",," Serial #            System  300139           23ADMWS  300157           23ADMWS  300154           23ADMR  300153           23ADMR  300152           23ADMWS  300133           23ADMR  300132          23ADMR  300131          23ASLOMWS  300160          23ADMWS  300127          23AUWS  300128          23ASlDMWS  300151          23ADMR  300150          23ASlDMWS  300155         23ASLDMWS  300159         23ASLOMWS  300129         23ADMR  300156         23ADMWS  300140         23ASLDMWS  300149         23ADMR  300148         23ADMR  300147         23AOMR  300146         23ADMR  300145         23ADMR          300144        23ADMR          300130        23ADMWS   300134        23ASLDMWS  300142         23ASLDMWS  300138         23ASLDMWS  300135         23ADMWS  300136         23ASLDMWS  ",5/6/2016,"05/06/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74179,"Ongoing","Cell Marque Corporation","6600 Sierra College Blvd",,"Rocklin","CA","95677-4306","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.","Z-2038-2016","Class II","SIOOA I (EP I84) Rabbit Monoclonal Antibody;  Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361.  Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.","23 units","Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.","06/17/2016",," Lot codes:  1335409A  1335409D  1335409B  1335409E  1335409C  1335409F.",5/10/2016,"05/10/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74180,"Ongoing","Teva North America","425 Privet Rd",,"Horsham","PA","19044-1220","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0868-2016","Class II","Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454    ","546 bags","Lack of Assurance of Sterility:  Due to potential for leaking bags.  ","05/24/2016",," Lot # 2520715,  Exp Date: 7/17  ",4/27/2016,"04/27/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74181,"Ongoing","Karlsburger Foods, Inc.","3236 Chelsea Rd W",".","Monticello","MN","55362-4667","United States","Voluntary: Firm Initiated","Telephone","US: FL, IL, KS, MI, MN, MO, NE, ND, PA, SD, WI.","F-1423-2016","Class II","Karlsburger, Mesquite Seasoning Mix & Marinade, Item 46402, Net WT 2 lbs in plastic shaker jars.","256 units","Karlsburger Foods Inc., is recalling 2 lb containers of Mesquite Seasoning Mix because it contains  an undeclared allergen, soy.  Product not sold to retail.","06/03/2016",," All lot numbers.    4102901, 5042901,5092901,6040601",5/10/2016,"05/10/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1649-2016","Class I","Dr. Praeger's California Veggie Burger (Vegan), 4 oz., 10 lbs  (4.54 kg), Best if used by: May-16-2018, UPC (01)0 0080868 97010 3, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","4,355 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BG-03A    VBIN4-C  Case code: T16AJ-04A Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16CE-03B Retail unit code: T16CE Best by: 2/24/2018  Case code: H16BF-03C Retail unit code: H16BF Best by: 3/15/2018  Case code: H16CD-02B Retail unit code: H16CD Best by: 3/23/2018  Case code: H16CE-01A Retail unit code: H16CE Best by: 3/24/2018  Case code: R16AF-03A Retail unit code: R16AF Best by: 4/05/2018  Case code: R16CB-01A Retail unit code: R16CB Best by: 4/21/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1645-2016","Class I","Dr. Praeger's California Veggie Burger Sliders (Vegan), 1.5 oz., 10 lbs. (4.54 kg), Best if used by: May-17-2018, UPC (01) 0 0080868 01015, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","2,757 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BH-02A    VBIN-SL  Case code: T16AJ-04C Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16CE-03D Retail unit code: T16CE Best by: 2/24/2018  Case code: T16CE-03G Retail unit code: T16CE Best by: 2/24/2018  Case code: R16BJ-03A Retail unit code: R16BJ Best by: 4/19/2018  Case code: R16BJ-03B Retail unit code: R16BJ Best by: 4/19/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1639-2016","Class I","Dr. Praeger's Black Bean Burger (Vegetarian), 4.25 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06619, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","54","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-22B    SVB-SWIN4  Case code:H16AI-05A Retail unit code: H16AI Best by: 3/08/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1641-2016","Class I","Dr. Praeger's Black Bean Slider, 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06615, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","64 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-26A    VBBINSL165I  Case code: N16CB-05A Retail unit code: N16CB Best by: 1/21/2018  Case code: H16AI-08A Retail unit code: H16AI Best by: 3/08/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1644-2016","Class I","Dr. Praeger's California Veggie Balls (Vegan), 1 oz., 10 lbs. (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 01310, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","553 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-25B    VBBIN  Case code: H16CB-02B Retail unit code: H16CB Best by: 3/21/2018  Case code: H16CB-02D Retail unit code: H16CB Best by: 3/21/2018  Case code: H16CB-02C Retail unit code: H16CB Best by: 3/21/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1632-2016","Class I","Dr. Praeger's Sensible Foods Organic Harvest Veggie Burgers, 10 x 1.36kg, (48 oz. (3 lbs)),  Best if used by: May -16-2017, Distributed by: Costco Wholesale UK Ltd,  UPC 0 8086830110 6","1,452 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BG-02B    LCOVB-R10-UK  Case code: W14BB-01A Retail unit code: W14BB Best by: 12/11/2015  Case code: R15CA-02A Retail unit code: R15CA Best by: 4/20/2016  Case code: F15CG-04A Retail unit code: F15CG Best by: 5/26/2016",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1640-2016","Class I","Dr. Praeger's Black Bean Burger (CN Labeled) (Vegetarian), 3.3 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06616, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","400 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-23A    SVB-SWIN33-CN  Case code:H16AI-06A Retail unit code: H16AI Best by: 3/08/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1630-2016","Class I","Dr. Praeger's Purely Sensible Foods Jumbo California Veggie Burger (Vegan), 5.5 oz., 10 lbs (4.54.kg), Best if used by: May 17, 2018, UPC (01) 00080868 01011, Dr. Praegers Sensible Foods, Elmwood Park, NJ 07407","6,501 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BH-02B    JVBIN  Case code: T16CE-03E Retail unit code: T16CE Best by: 2/24/2018  Case code: H16BF-03A Retail unit code: H16BF Best by: 3/15/2018  Case code: R16AF-03D Retail unit code: R16AF Best by: 4/05/2018  Case code: R16AG-02A Retail unit code: R16AG Best by: 4/06/2018  Case code: R16AG-02B Retail unit code: R16AG Best by: 4/06/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1637-2016","Class I","Dr. Praeger's California Veggie Burgers, 12 x 11 oz. (312g)/box, Best if used by: May-16-2018, UPC 0 0080868 000010 7, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","1,639 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BG-03C    VB12  Case code: N16CH-01A Retail unit code: N16CH Best by: 1/27/2018  Case code: N16CH-01Z Retail unit code: N16CH Best by: 1/27/2018  Case code: T16AD-01A Retail unit code: T16AD Best by: 2/03/2018  Case code: T16AD-01Z Retail unit code: T16AD Best by: 2/03/2018  Case code: T16AJ-02B Retail unit code: T16AJ Best by: 2/09/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1652-2016","Class I","Dr. Praeger's Black Bean Veggie Burger, 12 x 10 oz. (283 g)/box, Best if used by: May-12-2018, UPC 0 80868 06019 4, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","422 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-21A    SVB-BB12  Case code: N16CH-04A Retail unit code: N16CH Best by: 1/27/2018  Case code: N16CH-04Z Retail unit code: N16CH Best by: 1/27/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1647-2016","Class I","Dr. Praeger's California Veggie Burgers, 6 x 10 oz. (238g)/box, Best if used by: May-10-2018, UPC (01) 6 0080868 00010 9, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","25,444 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BA-01B    VBCA06  Case code: T16BI-02A Retail unit code: T16BI Best by: 2/18/2018  Case code: R16BD-01A Retail unit code: R16BD Best by: 4/13/2018  Case code: H16AI-04A Retail unit code: H16AI Best by: 3/08/2018  Case code: H16CD-02A Retail unit code: H16CD Best by: 3/23/2018  Case code: T16AJ-02C Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16CD-02A Retail unit code: T16CD Best by: 2/23/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1635-2016","Class I","Trader Joe's Quinoa Cowboy Veggie Burger, 26 x 12 oz. (340g)/box, Best if used by: May-12-2018, UPC 0053 2761, Dist. & Sold Exclusively By: Trader Joe's, Monrovia CA 91016","13,156 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-01A    TJQCB26  Case code: N16CI-02A Retail unit code: N16CI Best by: 1/28/2018  Case code: N16CI-02B Retail unit code: N16CI Best by: 1/28/2018  Case code: N16CI-02D Retail unit code: N16CI Best by: 1/28/2018  Case code: T16AE-01A Retail unit code: T16AE Best by: 2/04/2018  Case code: T16BB-01A Retail unit code: T16BB Best by: 2/11/2018  Case code: T16CF-01A Retail unit code: T16CF Best by: 2/25/2018  Case code: H16AE-01A Retail unit code: H16AE Best by: 3/04/2018  Case code: H16BA-02A Retail unit code: H16BA Best by: 3/10/2018  Case code: H16BH-01A Retail unit code: H16BH Best by: 3/17/2018  Case code: H16BA-02C Retail unit code: H16BA Best by: 3/10/2018  Case code: R16AG-01A Retail unit code: R16AG Best by: 4/06/2018  Case code: R16AG-01B Retail unit code: R16AG Best by: 4/06/2018  Case code: R16CA-06A Retail unit code: R16CA Best by: 4/20/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1642-2016","Class I","Dr. Praeger's Bombay Veggie Burgers, 6 x 10 oz. (283g)/box, Best if used by: May-12-2018, UPC (01) 6 0080868 000050 5, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","1,122 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-27A    VBBY06  Case code: N16CH-02B Retail unit code: N16CH Best by: 1/27/2018  Case code: N16CH-02A Retail unit code: N16CH Best by: 1/27/2018  Case code: N16CH Retail unit code: N16CH Best by: 1/27/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1646-2016","Class I","Dr. Praeger's California Veggie Burgers, 26 x 10 oz./box, Best if used by: May-18-2018, UPC 0 80868 00010, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","9,679 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BI-01A    VB26  Case code: N16CH-01B Retail unit code: N16CH Best by: 1/27/2018  Case code: T16AD-01B Retail unit code: T16AD Best by: 2/03/2018  Case code: T16AJ-02A Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16BI-02B Retail unit code: T16BI Best by: 2/18/2018  Case code: T16BI-02D Retail unit code: T16BI Best by: 2/18/2018  Case code: T16CD-02B Retail unit code: T16CD Best by: 2/23/2018  Case code: T16CE-03A Retail unit code: T16CE Best by: 2/24/2018  Case code: H16AI-04B Retail unit code: H16AI Best by: 3/08/2018  Case code: H16AJ-01A Retail unit code: H16AJ Best by: 3/09/2018  Case code: H16BG-02A Retail unit code: H16BG Best by: 3/16/2018  Case code: H16BG-02N Retail unit code: H16BG Best by: 3/16/2018  Case code: H16DA-01A Retail unit code: H16DA Best by: 3/30/2018  Case code: R16AH-01A Retail unit code: R16AH Best by: 4/07/2018  Case code: R16BD-01B Retail unit code: R16BD Best by: 4/13/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1651-2016","Class I","Dr. Praeger's GF California Veggie Burger, 4 oz., 10 lbs  (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 01060, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","320 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-20A    GLVBIN4  Case code: H16CJ-01A Retail unit code: H16CJ Best by: 3/29/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1636-2016","Class I","Ungar's Veggie Balls (Vegan), 1 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC 0 0080868 81310 3, Ungar's Food Products, Elmwood Park, NJ 07407","176 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-25A    UVBBIN  Case code: H16CB-02A Retail unit code: H16CB Best by: 3/21/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1643-2016","Class I","Dr. Praeger's Tex Mex Veggie Burgers, 6 x 10 oz. (283g)/box, Best if used by: Jan -4-2018, UPC (01) 6 0080868 00048 , Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","1,284 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #N16AE-11R    VBTM06  Case code: H16AI-03A Retail unit code: H16AI  Best by: 3/08/2018  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1650-2016","Class I","Dr. Praeger's Chipotle Black Bean Burger, 4.25 oz., 10 lbs  (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06621 9, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","151 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-24A    SVB-CBBIN425  Case code: H16AI-07A Retail unit code: H16AI Best by: 3/08/2018  Case code: H16AI-07B Retail unit code: H16AI Best by: 3/08/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1648-2016","Class I","Dr. Praeger's California Veggie Burger (Vegan), 4 oz., 10 lbs  (4.54 kg), Best if used by: May-16-2018, UPC (01)0 0080868 01010 6, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","4,376 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BG-03B    VBIN4  Case code: T16AJ-04A Retail unit code: T16AJ Best by: 2/09/2018  Case code: T16CE-03C Retail unit code: T16CE Best by: 2/24/2018  Case code: H16BF-03B Retail unit code: H16BF Best by: 3/15/2018  Case code: H16BF-03D Retail unit code: H16BF Best by: 3/15/2018  Case code: H16CE-01B Retail unit code: H16CE Best by: 3/24/2018  Case code: R16AF-03B Retail unit code: R16AF Best by: 4/05/2018  Case code: R16AF-03E Retail unit code: R16AF Best by: 4/05/2018  Case code: R16CB-01B Retail unit code: R16CB Best by: 4/21/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1633-2016","Class I","Aldi California/Black Bean Veggie Burgers, Net 15.0 lbs, 24 x 10 oz (284g)/box, Sale By: May -09-2018","1,548 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Item #47198    AL-47198-R24    Case code: ALDI-04A Retail unit code: H16CE Best by: 3/24/2018  Case code: ALDI-04B Retail unit code: H16CE Best by: 3/24/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1631-2016","Class I","Dr. Praeger's Purely Sensible Foods Organic Harvest Veggie Burgers, 10 x 48 oz (1.36kg), Best if used by: May 16, 2017, UPC 0 8086830110 5, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","5,517 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BG-02A    LCOVB-R10  Case code: L14CG-03A Retail unit code: L14CG Best by: 11/26/2015  Case code: L14CG-03B Retail unit code: L14CG Best by: 11/26/2015  Case code: W14BB-01B Retail unit code: W14BB Best by: 12/11/2015  Case code: N15CC-03A Retail unit code: N15CC Best by: 1/22/2016  Case code: F15CG-04B Retail unit code: F15CG Best by: 5/26/2016  Case code: F15CG-04C Retail unit code: F15CG Best by: 5/26/2016  Case code: V15AG-02A Retail unit code: V15AG Best by: 7/06/2016  Case code: G15BA-02A Retail unit code: G15BA Best by: 8/10/2016  Case code: E15CG-03A Retail unit code: E15CG Best by: 10/26/2016  Case code: L15AC-03A Retail unit code: L15AC Best by: 11/02/2016  Case code: L15CD-01A Retail unit code: L15CD Best by: 11/23/2016  Case code: L15CD-01B Retail unit code: L15CD Best by: 11/23/2016  Case code: H16CI-02A Retail unit code: H16CI Best by: 3/28/2017",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1634-2016","Class I","Aldi Kale Burger, Net 18.75 lbs, 30 x 10 oz (284 grams), Sell By: May -17-2018","1,871 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Item #50206    AL-50206-R30  Case code: H16AH-02A Retail unit code: H16AH Best by: 3/07/2018  Case code: H16AH-02B Retail unit code: H16AH Best by: 3/07/2018  Case code: H16CC-01A Retail unit code: H16CC Best by: 3/22/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74182,"Ongoing","Dr. Praeger'S Sensible Foods","9 Boumar Pl",,"Elmwood Park","NJ","07407-2615","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Foreign","F-1638-2016","Class I","Dr. Praeger's Black Bean Burger (Vegetarian), 3.3 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06617, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407","2,716 cases","Dr. Praeger's Sensible Food/Ungar's Food Products is voluntarily recalling various not-ready-to eat frozen products because they may be contaminated with Listeria monocytogenes. ","07/08/2016",," Lot #F16BC-22A    SVB-SWIN33  Case code: N16CI-03A Retail unit code: N16CI Best by: 1/28/2018  Case code: F16AE-03C Retail unit code: F16AE Best by: 5/04/2018",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74183,"Ongoing","Coca-Cola Company  (The)","1 Coca Cola Plz Nw",,"Atlanta","GA","30313-2420","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, OR, & WA","F-2642-2016","Class II","Sprite Zero, 12 oz. can/12 pack, UPC 049000037111; Sprite, 12 oz. can/6 pack, UPC N/A; Sprite, 12 oz. can/12 pack, UPC 049000028928; Sprite, 12 oz. can/20 pack, UPC 049000014655","14,168 cases total"," sound. Recall initiated on 4/29/16.","09/30/2016",," Date Code/Lot Code - UPC 049000037111 - AUG1516TRC; UPC N/A - JAN0917TRC; UPC 049000028928 - JAN0917TRC; UPC 049000014655 - JAN0917TRC",4/29/2016,"04/29/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74183,"Ongoing","Coca-Cola Company  (The)","1 Coca Cola Plz Nw",,"Atlanta","GA","30313-2420","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, OR, & WA","F-2643-2016","Class II","Diet Dr Pepper, 12 oz. can/24 pack, UPC 078000083132; Diet Dr Pepper, 12 oz. can/6 pack, UPC N/A; Diet Dr Pepper, 12 oz. can/20 pack, UPC 078000083095; Dr Pepper, 12 oz. can/6 pack, UPC N/A; Dr Pepper , 12 oz. can/ 20 pack, UPC 078000082098; Dr Pepper 12 oz. can/ 12 pack, UPC 078000082166; Dr Pepper, 12 oz. can/24 pack, UPC 078000082135","14,168 cases total"," sound. Recall initiated on 4/29/16.","09/30/2016",," Date Code/Lot Code - UPC 078000083132 - JUL1116TRD; UPC N/A - JUL1116TRC & JUL116TRC; UPC 078000083095 - JUL1116TRC; UPC N/A - JAN0917TRD; UPC 078000082098 - JAN0917TRD; UPC 078000082166 - JAN0917TRD & JAN0917TRE; UPC 078000082135 - JAN0917TRD",4/29/2016,"04/29/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74183,"Ongoing","Coca-Cola Company  (The)","1 Coca Cola Plz Nw",,"Atlanta","GA","30313-2420","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, OR, & WA","F-2641-2016","Class II","Coca-Cola, 16 fl. oz. can/12 pack, UPC 049000054318; Coca-Cola, 12 oz. can/12 pack, UPC 049000028904; Coca-Cola Zero, 12 oz. can/12 pack, UPC 049000042559; Diet Coke, 12 oz. can/24 pack, UPC 049000010633; Diet Coke, 12 oz. can/12 pack, UPC 049000028911; Cherry Coke, 12 oz. can/12 pack, UPC 049000031034","14,168 cases total"," sound. Recall initiated on 4/29/16.","09/30/2016",," Date Code/Lot Code - UPC 049000053418 - JAN0217 VJ E; UPC 049000028904 - JAN0917TRE; UPC 049000042559 - AUG1516TRD; UPC 049000010633 - JUL1116TRE; UPC 049000028911 - JUL1116TRB; UPC049000031034 - JAN0917TRD ",4/29/2016,"04/29/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74184,"Terminated","Blood Centers of the Pacific - Irwin Center","270 Masonic Ave",,"San Francisco","CA","94118-4496","United States","Voluntary: Firm Initiated","Telephone","California","B-0538-16","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood product, collected from a donor who lived with an individual who had Hepatitis B, was distributed.","05/24/2016","05/24/2016"," W117016013288Q",3/31/2016,"03/31/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74185,"Terminated","HCSC-Blood Center dba as Miller-Keystone Blood Center ","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0539-16","Class III","Red Blood Cells, Leukocytes Reduced","2 units","Mislabeled blood products were distributed.","05/26/2016","05/26/2016"," W050916006688; W050916006990",3/21/2016,"03/21/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74185,"Terminated","HCSC-Blood Center dba as Miller-Keystone Blood Center ","1465 Valley Center Pkwy",,"Bethlehem","PA","18017-2265","United States","Voluntary: Firm Initiated","Telephone","Pennsylvania","B-0540-16","Class III","Red Blood Cells","3 units","Mislabeled blood products were distributed.","05/26/2016","05/26/2016"," W050916006912; W050916003527; W050916005771",3/21/2016,"03/21/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74186,"Terminated","CSL Plasma Inc","10970 New Halls Ferry Rd",,"Saint Louis","MO","63136-4433","United States","Voluntary: Firm Initiated","Other","Illinois; California","B-0541-16","Class II","Source Plasma","16 units","Blood products, collected from a donor who received a piercing within one year of donation, were distributed.","05/24/2016","05/24/2016"," 10700602811; 10700498460; 10700460147; 10700551890; 10700539904; 10700439380; 10700599990; 10700586196; 10700409923; 10700395517; 10700393950; 10700208072; 10700140290; 10700125031; 10700311150; 10700116670",3/4/2016,"03/04/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1007-2016","Class II","QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02172016:86@12, Exp.05/18/2016; Lot #: 04012016:22@4, Exp.06/30/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0997-2016","Class II","MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01182016:46@7, Exp.04/17/2016; Lot #: 02192016    60@29, Exp. 05/19/2016; Lot #: 04082016:83@53; Exp.  07/11/2016; Lot #: 04202016:61@66, Exp.07/19/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0999-2016","Class II","METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02022016 : 72@19, Exp. 07/13/2016; Lot #: 02092016:  09@23, Exp. 08/08/2016; Lot #: 02262016:14@7, Exp.       08/27/2016; Lot #:03022016: 60@23, Exp. 08/21/2016; Lot #:   03012016:54@20, Exp.08/24/2016; Lot #: 03212016:   35@49, Exp. 09/17/2016; Lot #: 04142016: 15@2, Exp.     10/11/2016; Lot #: 04212016: 69@19, Exp.10/19/2016.   ",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0981-2016","Class II","ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 03302016:68@10, Exp.06/28/2016; Lot #: 03082016:83@38, Exp.   06/06/2016; Lot #:02172016:37@51, Exp. 5/17/2016; Lot #: 2102016:80@55, Exp.5/30/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1010-2016","Class II","SUPER TRI-MIX #4, packaged in 5mL vials, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 03022016:16@45, Exp. 06/01/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0982-2016","Class II","ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy   Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02022016:85@22 , Exp.05/03/2016; Lot #: 02242016:50@16, Exp.  06/12/2016; Lot #:03102016:30@65, Exp. 06/12/2016; Lot #: 3172016:14@19, Exp. 06/15/2016; Lot #: 04122016:20@2 , Exp. 07/11/2016; Lot #: 04212016:84@1, Exp. 07/20/2016.  ",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1021-2016","Class II","TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01072016:16@30, Exp. 04/06/2016; Lot #: 01132016 :    34@42, Exp. 04/12/2016; Lot #: 03082016:02@13, Exp. 06/06/2016; Lot #: 03302016:      46@39, Exp. 06/30/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0996-2016","Class II","M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 03222016:11@22, Exp. 09/20/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1020-2016","Class II","TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 12302015:53@18, Exp.04/29/2016; Lot #: 03142016:67@53, Exp. 06/12/2016; Lot #: 03302016:   43@38, Exp. 06/28/2016; Lot #: 03/292016:   30@23, Exp. 06/29/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1006-2016","Class II","QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01292016:04@9, Exp.07/27/2016; Lot #: 04082016:   84@17, Exp. 10/09/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0998-2016","Class II","M.l.C./B5/B6  25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121",,"Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01272016:00@24, Exp.03/28/2016; Lot #: 03292016:   96@35, Exp. 05/24/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1017-2016","Class II","TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 11162016:19@6, Exp.02/15/2016.  ",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1012-2016","Class II","TESTOSTERONE CYPIONATE  10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02032016: 60@27, Exp. 05/03/2016; Lot #: 02222016:   29@62, Exp. 05/22/2016; Lot #: 03072016:87@66, Exp.06/06/2016; Lot #: 4152016:34@39, Exp. 07/18/2016; Lot #: 04282016:06@14, Exp. 07/27/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1009-2016","Class II","SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01062016:29@49, Exp.04/06/2016; Lot #: 02032016:   30@5, Exp.05/03/2016; Lot #: 03312016:91@17; Exp.  06/29/2016; Lot #: 03302016:17@40, Exp. 06/30/2016; Lot 4132016:46@20, Exp. 07/12/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1002-2016","Class II","METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01262016:86@2, Exp. 07/30/2016; 02222016:31@27, Exp. 08/20/2016; Lot #: 03022016:1@47, Exp. 08/29/2016; Lot #: 03032016:26@ 1, Exp. 08/30/2016; Lot #: 04122016: 84@227, Exp.10/15/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1016-2016","Class II","TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02292016:67@10, Exp. 05/29/2016; Lot #: 03022016:   98@43, Exp.05/31/2016; Lot #: 03162016:25@32, Exp. 06/14/2016; Lot #: 03302016:36@36, Exp.06/30/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0990-2016","Class II","HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 03012016:82@33, Exp. 05/30/2016; Lot #: 03012016:65@41, Exp.  06/16/2016; Lot #: 04142016:89@48, Exp. 07/12/2016; Lot #: 04142016:  28@49, Exp. 07/17/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0986-2016","Class II","GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02222016:97@38, Exp.05/24/2016; Lot #: 03032016:27@26 , Exp. 06/26/2016; Lot #: 4272016:60@37, Exp. 07/26/2016; Lot #: 01132016:18@44, Exp. 02/03/2016; Lot #: 01132016:74 @17, Exp. 03/04/2016; Lot #: 01132016:90@9, Exp. 03/04/2016; Lot #: 02222016:34@23, Exp. 04/03/2016; Lot #: 04282016:79@45, Exp. 06/27/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0985-2016","Class II","GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01182016:29@27 , Exp. 02/01/2016; Lot #: 030720 1631@50, Exp. 03/21/2016; Lot #: 03232016:83@6, Exp   04/06/2016; Lot #: 03282016:43@11, Exp. 04/11/2016; Lot #: 04192016:43@16, Exp. 05/03/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0978-2016","Class II","17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 units (total all products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 04262016: 87@3, Exp. 07/26/2016; Lot #:  03102016:72@38 , Exp. 06/08/2016; Lot #: 12222015:88@23, Exp. 03/22/2016; Lot #: 02022016:73@27, Exp.  05/03/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0993-2016","Class II","L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01272016:54@25, Exp.02/27/2016; Lot #: 03292016:   62@36 , Exp.04/29/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0988-2016","Class II","1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01072016:  23@28, Exp. 04/06/2016; Lot #: 01082016:  27@1, Exp. 04/07/2016; Lot #:02012016:20@39, Exp. 05/01/2016; Lot #: 02022016:07@7, Exp.05/02/2016; Lot #: 02152016:29@50, Exp. 05/15/2016; Lot #: 02292016: 40@24, Exp.05/29/2016; Lot #: 02292016: 12@42 , Exp.05/29/2016; Lot #: 03042016:96@9, Exp.06/02/2016; Lot #: 03082016:59@34, Exp.06/08/2016  03142016:65@58, Exp.06/12/2016; Lot #: 03212016: 66@2, Exp.06/19/2016; Lot #: 03022016:50@38, Exp.06/23/2016; Lot #: 03302016: 93@11, Exp.      06/28/2016; Lot #: 04062016:79@22, Exp.07/07/2016; Lot #: 04122016    38@58, Exp.07/12/2016; Lot #: 04152016: 87@1, Exp. 07/14/2016; Lot #:  04152016:12@12, Exp. 07/14/2016; Lot #: 04222016: 55@27, Exp.07/21/2016    ",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1013-2016","Class II","TESTOSTERONE CYPIONATE  150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01042016:26@3, Exp.04/03/2016; Lot #: 01072016: 10@15, Exp.04/06/2016; Lot #: 02032016:41@16, Exp. 05/03/2016; Lot #: 03152016: 62@44, Exp.06/15/2016; Lot #: 04292016:35@11, Exp. 07/31/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1014-2016","Class II","TESTOSTERONE CYPIONATE  175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02172016:12@37, Exp. 05/18/2016; Lot #: 03182016:    88@13, Exp. 06/16/2016; Lot #: 04202016:35@14, Exp.   07/19/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1008-2016","Class II","QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02052016:96@38, Exp.05/09/2016; Lot #: 04052016:  39@6, Exp. 07/04/2016; Lot #: 04132016:79@19, Lot #:   07/13/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1019-2016","Class II","TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 03022016:16@45, Exp. 06/01/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0994-2016","Class II","M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01042016: 45@46, Exp. 07/02/2016; Lot #:01112016:   87@46, Exp. 07/10/2016; Lot #:01112016:78@63, Exp.   07/10/2016; Lot #: 01272016:81@30, Exp.07/25/2016; Lot #: 02102016:89@2, Exp. 08/08/2016; 02162016:25@57, Exp.08/14/2016; 02262016:33@54, Exp.08/24/2016; Lot #: 03092016:64@51, Exp.09/07/2016; Lot #: 04142016:01@45, Exp.10/11/2016  04142016:17@37, Exp.10/15/2016; 04282016:72@48, Exp.10/29/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1024-2016","Class II","VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01052016:13@44, Exp.03/07/2016; Lot #: 01052016:    06@43, Exp. 04/13/2016; Lot #: 04052016:84@24; Exp. 06/06/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1023-2016","Class II","VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01120J67: 6@22, Exp. 04/12/2016; Lot #: 021820J6 : 52@39, Exp.04/18/2016; Lot #: 02262016: 89@3, Exp. 04/26/2016; Lot #: 03082016 : 76@46   06/06/2016;03022016:61@8, Exp. 06/08/2016; 032120 16:49@65, Exp.06/21/2016; 01152016:48@14, Exp. 04/19/2016; 03032016:74@52, Exp. 05/02/2016; 03242016:68@13, Exp. 06/27/2016; 04142016:00@50, Exp.  06/13/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0989-2016","Class II","1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 032520164: 7@1, Exp 06/23/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1022-2016","Class II","VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01182016:09@28, Exp. 02/01/2016; Lot #: 03072016:50@49, Exp. 03/21/2016; Lot #: 03232016: 79@7, Exp. 04/06/2016; Lot #:03282016:15@10, Exp. 04/11/2016; Lot #: 04192016:35@14, Exp.07/19/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1001-2016","Class II","METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01262016:77@53, Exp. 04/25/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0980-2016","Class II","ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 03252016:11 @26, Exp. 05/07/2016; Lot #: 04042016:28 @39, Exp.  05/06/2016; Lot #: 02102016:00 @22, Exp. 03/24/2016; Lot #:02112016:08 @13, Exp. 03/16/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0995-2016","Class II","M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01222016:57@21, Exp.03/33/2016; Lot #: 01222016:   78@51, Exp.04/25/2016; Lot #: 01272016:51@23, Exp.  03/27/2016; Lot #: 02292016:71@13, Exp. 04/29/2016; Lot #: 03022016:46@14, Exp. 06/22/2016; Lot #:04252016:20@62, Exp.06/24/2016; Lot #: 04262016:18@11, Exp.06/25/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1005-2016","Class II","PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01252016:44@43, Exp. 07/26/2016.   ",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1027-2016","Class II","ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY;  30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","916 total units","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01042016:74@36, Exp. 07/03/2016; Lot #: 01052016:14@12, Exp.06/18/2016; Lot #: 01272016:70@17, Exp. 07/25/2016; Lot #:02222016:62@12, Exp.08/24/2016; Lot #:03212016:57@30, Exp.    09/17/2016; Lot #: 04182016:42@44, Exp.10/16/2016; Lot #:05012016:18@29, Exp.11/01/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0991-2016","Class II","Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01222016:81@52, Exp. 03/25/2016; Lot #:03042016: 23@29, Exp.05/22/2016; Lot #:03212016:35@53, Exp.    05/22/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0987-2016","Class II","GLUTATHIONE 200MG/ML, packaged in 5mL vials,   Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02232016: 64@43, Exp. 05/24/2016; Lot #: 03142016: 70@16,Exp. 06/14/2016; Lot #: 04182016:17@15, Exp.07/17/2016; Lot #: 04182016:64@12, Exp. 07/18/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1028-2016","Class II","ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","916 total units","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02102016:22@57, Exp. 08/08/2016; Lot #: 02292016:59@55 ,Exp.   08/28/2016; Lot #: 03072016:68@7, Exp. 09/03/2016; Lot #: 4052016:41@56, Exp. 10/04/2016; Lot #: 04192016:41@34, Exp.10/16/2016.     ",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1025-2016","Class II","QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 011520J6:90@35, Exp.04/17/2016; Lot #: 04282016:23@31, Exp.08/01/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0992-2016","Class II","LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 03142016:25@14, Exp. 04/15/2016; Lot #: 04182016:  22@14, Exp. 05/18/2016; Lot #: 04182016: 67@16, Exp. 05/19/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1004-2016","Class II","PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01282016:60@3, Exp.04/28/2016; Lot #: 02242016:  90@20, Exp.05/24/2016; Lot #: 02222016:06@67, Exp.  05/24/2016; Lot #: 03082016:81@21, Exp.06/06/2016; Lot #: 03162016:  62@1, Exp. 06/14/2016.   ",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1000-2016","Class II","METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01062016: 32@16, Exp.04/06/2016; Lot #: 01252016:   96@51, Exp. 07/23/2016; Lot #: 03302016: 68@42, Exp.  09/25/2016; Lot #: 04042016:11@27, Exp.10/02/2016; Lot #: 04122016: 90@15, Exp. 10/09/2016  04202016:57@13, Exp.10/22/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1018-2016","Class II","TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02162016:54@17, Exp. 05/17/2016; Lot #: 03232016:   19@8, Exp. 06/20/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0984-2016","Class II","ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02162016:85@45, Exp. 5/17/2016; Lot #:03092016:30@19, Exp. 06/07/2016; Lot #: 01282016:77@25, Exp.05/03/2016; Lot #: 3112016:98@21, Exp. 06/13/2016; Lot #:03242016:52@22, Exp. 06/27/2016; Lot #: 04122016:15@50, Exp. 7/11/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1015-2016","Class II","TESTOSTERONE CYPIONATE  200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01142016:19@26, Exp. 04/14/2016; Lot #: 02032016:23@32, Exp.    05/05/2016, Lot #: 02092016:17@9, Exp.06/10/2016; Lot #: 04262016:    11@16, Exp. 07/27/2016; Lot #: 01112016:65@70, Exp.04/10/2016; Lot #:   01202016:57@46, Exp.04/19/2016; 01212016:08@34, Exp. 04/28/2016; Lot:   02082016:08@27, Exp.05/08/2016; Lot #: 02222016:82@50, Exp.05/22/2016  03142016:75@24, Exp. 06/14/2016; Lot #: 03212016:07@73, Exp. 06/26/2016  03232016:47@23, Exp. 06/28/2016; Lot #: 04062016:96@28, Exp. 07/06/2016  04132016:@46 , Exp. 07/13/2016; Lot #: 04192016:92@1, Exp.07/19/2016  04272016:63@11, Exp.07/26/2016.    ",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1003-2016","Class II","MYERS' COCKTAIL, packaged in 37 mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01112016:29@20, Exp. 01/19/2016; Lot #:01202016:  85@9, Exp. 01/27/2016; Lot #: 01222016: 56@17, Exp. 01/29/2016; Lot #: 01222016:36@49, Exp.02/02/2016; Lot #: 01262016:72@12, Exp.02/02/2016; Lot #: 01262016: 56@58, Exp.02/03/2016; Lot #: 02052016:89@26, Exp.03/02/2016; Lot #: 02112016:55@39, Exp.03/03/2016; Lot #: 02102016:  95@17, Exp. 03/08/2016; Lot #: 02222016:39@46, Exp. 03/15/2016; Lot #: 04222016:40@48, Exp.03/16/2016; Lot #: 02262016:53@13, Exp.03/24/2016; Lot #: 03072016:  01@14, Exp. 03/29/2016; Lot #: 03082016:40@11, Exp.03/30/2016; Lot #: 3012016:90@30, Exp.04/07/2016; Lot #: 03012016:78@13, Exp.04/18/2016; Lot #: 03222016:  19@17     04/13/2016; Lot #: 0331201661@40, Exp.04/21/2016; Lot #: 04132016:89@17, Exp.  05/06/2016; Lot #: 04272016:35@45, Exp. 05/20/2016; Lot #: 04292016:70@27, Exp.05/23/2016.        ",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0979-2016","Class II","ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 01252016:40@31, Exp. 04/27/2016; Lot #: 03072016:78@19, Exp. 06/6/2016; Lot #: 02222016:71@35, Exp. 05/27/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1026-2016","Class II","CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","916 total ","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #:01082016:75@3, Exp.07/06/2016; Lot #:01282016:72@10, Exp. 07/27/2016; Lot #: 02012016:74@35, Exp. 07/31/2016; Lot #:02102016:40@16, Exp.08/09/2016; Lot #: 02242016:73@41, Exp.  08/23/2016; Lot #: 03102016:64@53, Exp.09/07/2016; Lot #:04052016:70@16  Exp. 10/02/2016; Lot #: 04222016:85@37, Exp.10/22/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-0983-2016","Class II","ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 04112016:76@67, Exp.07/12/2016",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74187,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",".","Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV","D-1011-2016","Class II","TESTOSTERONE CYPIONATE  100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121","869 Units (Total All Products)","Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.","06/09/2016",," Lot #: 02042016: 80@58, Exp.05/04/2016; Lot #: 02222016:88@11, Exp.05/23/2016; Lot #: 03282016:42@5, Exp. 06/26/2016; Lot #: 03292016:29@1, Exp.06/27/2016; Lot #: 03222016:22@19, Exp. 06/28/2016; Lot #: 04202016:46@30, Exp.07/19/2016.",5/17/2016,"05/17/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74188,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","E-Mail","Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.","Z-1837-2016","Class II","SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380.  The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted during a surgical procedure.","46,191 boxes total - both sizes","Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula  lumen when insufflation is connected during a surgical procedure.","05/27/2016",," All lots",5/9/2016,"05/09/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74188,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","E-Mail","Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.","Z-1836-2016","Class II","SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361.  The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.","46, 191 boxes - total both sizes","Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula  lumen when insufflation is connected during a surgical procedure.","05/27/2016",," All lots",5/9/2016,"05/09/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74189,"Ongoing","Ellipse A/S","Agern Alle 11",".","Horsholm",,,"Denmark","Voluntary: Firm Initiated","Letter","Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.","Z-1697-2016","Class II","Ellipse ND: YAG Laser applicator for Ellipse Multiflex    Medical Laser Products.","US - 14","Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.","06/09/2016",," All serial numbers",5/5/2016,"05/05/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74189,"Ongoing","Ellipse A/S","Agern Alle 11",".","Horsholm",,,"Denmark","Voluntary: Firm Initiated","Letter","Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.","Z-1698-2016","Class II","Ellipse ND: YAG Laser applicator for Ellipse Nordlys system    Medical Laser Products.","US - 25","Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.","06/09/2016",," All serial numbers",5/5/2016,"05/05/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74190,"Ongoing","Medical Vision Ab","Haestholmsvaegen 32",,"Nacka",,,"Sweden","Voluntary: Firm Initiated","Letter","Distributed to the US, to the states of NH, OK, AL, PA, IL, MA, TX, MI, NC, CA, MN, CT, GA, NY, WI, KY, OH, VA, AL, NJ, TN, SD, and IN.","Z-2705-2016","Class II","Double Pump RF Patient Cassette; Product Number: 72204055.    Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.","3,295 devices","Sterility of device may be compromised due to sterile package breakage. ","08/30/2016",," All lot numbers of Double Pump RF Patient Cassettes delivered to the US,   Batch numbers: 13I03, 14A01, 14A06, 14A09, 14A10, 14B03, 14B09, 14C06, 14C10, 14D07, 14D11, 14E06, 14E10, 14F01, 14F02, 14F03, 14F04, 14F10, 14F11, 14G07, 14H02, 14H04, 14H08, 14H09, 14J01, 14J02, and 14J03.",5/10/2016,"05/10/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74191,"Completed","Nico Corp.","250 E 96th St Ste 125",,"Indianapolis","IN","46240-3872","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.","Z-2045-2016","Class II","Myriad handpiece  Tissue morcellator","63 units","This recall has been initiated due to a defective component within the handpiece which will  cause the handpiece to fail. The failure will result in the inability to cut tissue with the  handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad  handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.","06/21/2016",," 13ga, 13cm Myriad Handpiece  Part number: NN-8004  Lots 1444664 and 1508994",2/24/2014,"02/24/2014",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2006-2016","Class II","Biograph 16 TruePoint TV, Material Number 10249556  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","36 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  72405,72408,72409,72411,72412,72413,72415,72416,72423,72430,72438,72439,72446,72447,72449,72451,72452,72454,72456,72458,72462,72463,72469,72473,72478,72482,72483,72488,72490,72500,72506,72507,72508,72510,72516,72536  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2034-2016","Class II","Biograph mCT-X 3R, MATERIAL NUMBER 10248673    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","22 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1002,1003,1004,1005,1006,1007,11009,11010,11011,11012,11008,11013,11015,11019,11017,11018,11020,31021,31022,31023,11014,1001  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2021-2016","Class II","BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","28 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  11001,11002,11003,11004,11005,11007,11006,11008,11009,11010,11011,11012,11013,11014,11015,11016,11017,11018,11019,11020,11021,11023,11022,11024,11026,11027,11025,11030  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2033-2016","Class II","Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","127 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1013,11055,1005,1006,1004,1011,1003,1002,1008,1009,1010,11022,11028,1012,1016,1017,1019,11020,1007,11023,11024,11025,11026,11029,11030,11032,11033,11056,1018,11036,1014,11038,11039,11027,11049,11057,11040,11041,11042,11043,11031,11035,11044,11045,11034,11046,11047,11048,11037,11050,11051,11052,11053,11054,11058,11059,11060,11061,11062,11063,11064,11065,11067,11068,11069,11070,11071,11072,11074,11073,11075,11076,11066,11077,1001,11078,11079,11081,11083,11084,11082,11086,11087,11088,11080,11090,11091,11092,11094,11093,11096,21097,11095,21098,11089,21100,31110,21101,21102,21103,21099,21105,31106,11015,21104,31107,31108,31109,31111,31112,31113,31114,31124,31115,31117,31118,31119,31120,31121,90001,31122,31125,31126,1015,31116,31123,31127  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2005-2016","Class II","Biograph mCT-X 4R, MATERIAL NUMBER 10248670    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","83 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers: 1002,1003,1001,1004,1005,1006,1008,1009,1010,1007,1011,11013,11014,11015,11016,11017,11018,11020,11012,11019,11021,11022,11023,11026,11025,11024,11027,11044,11029,11028,11030,11031,11032,11033,11034,11037,11036,11038,11040,11042,11039,11035,11045,11046,11041,11047,11048,  11049,11050,11051,11052,11054,11055,11056,11043,11058,11059,11057,11061,11060,11062,11063,11064,11065,11066,11067,11068,11069,11070,21071,21073,21072,21074,31075,31076,31077,31083,31079,31080,31081,31082,31078,40001091760  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2019-2016","Class II","BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","2 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers: 1007,1008",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2023-2016","Class II","BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","9 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  11004,11001,11002,11003,11005,11006,11007,11008,11009",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2018-2016","Class II","BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","4 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1001,1003,1010,11012",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2024-2016","Class II","BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","12 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:    11001,11002,11003,11006,11004,11007,11008,11009,11005,11010,11011,11012",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2011-2016","Class II","Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","1 unit","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Number 45646",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2030-2016","Class II","Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","47 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:    1002,1004,1006,1007,1005,1010,1013,1016,1017,11018,11019,11031,1012,11020,1014,11026,11022,  1015,11024,11025,11023,11027,11028,11030,11032,11038,11033,11034,11036,11039,11037,11040,  11041,11044,11042,21045,21048,31047,31049,11029,1008,1009,1011,11021,11033,11035,31046  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2035-2016","Class II","SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","4 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1002,1001,11003,11004",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2012-2016","Class II","BIOGRAPH 6 TruePoint, Material Number 10097289    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","102 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1003,1004,1009,1013,1016,1028,1031,1032,1033,1036,1037,1038,1040,1042,1052,1059,1066,1070,1083,1095,44983,45511,45514,45519,45523,45530,45531,45535,45537,45538,45540,45542,45543,45550,45551,45567,45568,45569,45570,45571,45573,45575,45577,45578,45579,45581,45583,45588,45593,45595,45599,45602,45603,45604,45607,45609,45610,45611,45613,45614,45618,45619,45620,45621,45623,45624,45625,45627,45628,45629,45630,45631,45633,45635,45636,45637,45638,45639,45640,45642,45643,45644,45645,45648,45649,45650,45651,45652,45653,45654,45655,45657,45658,45659,45661,45662,45663,45664,45666,45701,45702,45703   ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2008-2016","Class II","BIOGRAPH 40 TruePoint, Material Number 10097303	  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","48 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:   1003,1004,1005,1006,1009,1011,1012,1013,1014,1015,1016,1017,1018,1019,1020,1022,1023,1024,1028,1029,1030,1031,1032,1033,1034,1035,1036,1037,1039,1041,1042,1043,1044,1045,1046,1047,1049,1050,1051,1052,1053,1054,11055,11056,11059,11060,11061,11063  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2036-2016","Class II","SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","2 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1001,1002",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2026-2016","Class II","BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","2 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  11001,11002",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2013-2016","Class II","BIOGRAPH 64 - 3 Ring, Material Number 08727450    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","15 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1001,1002,1003,1004,1007,1010,1012,1013,1014,1015,1016,1017,1018,1019,1022",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2031-2016","Class II","Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.  ","100 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1024,1001,1002,1003,1005,1006,1007,1008,1009,1011,1012,1013,1004,1014,1017,1018,1019,1020,1022,1010,1023,11034,1016,1015,1025,11026,11029,11028,11030,11031,11035,11032,11033,11027,11036,11037,11039,11038,11040,11043,11044,11045,11046,11083,11047,11041,11042,11049,11051,11050,11053,11054,11055,11056,11057,11058,11059,11076,11060,11061,11062,11063,11064,11052,11065,11048,11074,11069,11067,11068,11070,11072,11075,11073,11066,11077,11078,11071,11080,11081,11082,11084,21085,21086,21087,21088,21089,21090,21091,31092,21093,31094,31095,31097,31096,31099,91001,31100,1021,31098  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2010-2016","Class II","BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","1 unit","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Number 1001",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2009-2016","Class II","BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","46 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1001,1002,1003,1004,1005,1006,1007,1008,1009,1010,1011,1012,1013,1014,1015,1016,1017,1018,1019,1021,1022,1023,1024,1025,1026,1027,1028,1029,1031,1033,1034,1035,1037,1038,1040,1042,1043,1044,1045,1046,1047,1048,1049,1050,1051,1053  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2029-2016","Class II","BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","5 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  31001,31002,31003,31004,60001",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2017-2016","Class II","Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","2 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  72418,72428",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2032-2016","Class II","Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","51 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1003,1004,1005,1006,1007,11009,11010,11011,11012,11013,11014,11023,11015,11016,11017,11018,11019,11020,11021,11022,11025,11028,11029,11027,31042,11024,11026,11033,11032,21034,31037,31040,21035,11031,11030,21036,31038,31039,31046,31041,31043,31045,31047,31048,31044,31049,  31050,31051,31054,1008,31053  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2028-2016","Class II","BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","143 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:    11001,11002,11005,11006,11007,11009,11012,11013,11014,11015,11003,11017,11019,11020,11010,11022,11008,11004,11024,11040,11026,11027,11028,11018,11023,11029,11021,11041,11032,11034,11035,11030,11036,11037,11038,11039,11025,11045,21084,11042,11046,11049,21063,11043,11050,  11031,11033,21052,21054,21053,21056,21057,21058,21059,21060,21061,21062,21065,21066,21067,11044,21068,11047,21071,21072,21073,21069,21075,21076,21077,21055,21078,21081,21080,21051,21082,21064,21070,21074,21086,21087,21079,21085,21083,21126,21090,21091,21092,21095,21093,  21094,21088,21098,21096,21100,21097,21101,21103,21104,21105,21106,21107,21110,21111,21109,21112,21115,21099,21136,21117,21118,21120,21122,21123,21102,21125,21116,21127,21128,21119,21114,21108,21131,21134,21135,21113,21137,21130,21138,21124,21121,21129,21142,21141,21144,  21149,21150,11011,11016,21089,21143,21145,21148  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2014-2016","Class II","BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","16 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1021,1024,1027,1029,1030,1031,1032,1033,1034,1037,11044,11045,11046,11047,11048,11049",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2007-2016","Class II","BIOGRAPH 40 - 3 Ring, Material Number 10097233  The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","5 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1001,1004,1009,1012,1014",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2020-2016","Class II","BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","9 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:    11001,11002,11003,11004,11005,11006,11007,11009,59001",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2027-2016","Class II","BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","13 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers;   11001,11002,11003,11004,11005,11006,11007,11008,11009,11011,11010,11013,11012",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2037-2016","Class II","Biograph 16 TruePoint, MATERIAL NUMBER 10249555    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","63 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:    72402,72404,72407,72414,72419,72420,72421,72427,72429,72431,72433,72434,72435,72436,72437,72440,72441,72443,72444,72445,72448,72450,72453,72455,72457,72459,72460,72461,72464,72465,72466,72468,72471,72472,72475,72476,72477,72481,72486,72487,72489,72491,72492,72494,72495,  72496,72497,72499,72501,72502,72503,72504,72505,72512,72515,72521,72523,72526,72528,72530,72531,72535,72537  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2025-2016","Class II","BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","25 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  11002,11003,11004,11001,11005,11006,11008,11009,11007,11010,11011,11012,11014,11015,11013,11017,11016,11021,11018,11019,11025,11023,11022,60001,11026  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2022-2016","Class II","BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","3 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  11001,11002,11003",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2016-2016","Class II","BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.",,"Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1001,1004,1015,1020,1024,1035,1042,44889,44977,45502,45509,45516,45518,45520,45522,45525,45527,45528,45532,45533,45539,45544,45547,45549,45554,45556,45560,45564,45574,45586,45587,45590,45600,45612,45615,45656,45660  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74192,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2015-2016","Class II","BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302    The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.","49 units","Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. ","06/21/2016",," Serial Numbers:  1002,1003,1004,1005,1006,1007,1008,1011,1013,1014,1015,1016,1017,1019,1020,1021,1022,1023,1024,1025,1028,1029,1030,1031,1032,1033,1034,1036,1037,1038,1039,1041,1042,1043,1045,1046,1048,1049,1050,1051,1052,1054,1055,11057,11059,11060,11061,11063,58004  ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74194,"Ongoing","Nostrum Laboratories, Inc.","705 E Mulberry St",,"Bryan","OH","43506-1432","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1030-2016","Class II","Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32  ","2839 bottles","Failed Dissolution Specifications","06/14/2016",," BZP0093A, BZP0094A, BZP0095A, BZP0096A, BZP0097A, Exp 02/2017  ",5/23/2016,"05/23/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74196,"Ongoing","GE Healthcare, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, IN, KS, NE, NY,NC, OH, OR, PA, TN, TX, UT, A, WA, WI; and countries of: Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Mexico, New Zealand, Norway, Peru, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.","Z-1915-2016","Class II","GE Revolution CT    The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. ","197 (US = 68; OUS = 129)","GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie","06/06/2016",," 	  Mfg Lot or Serial #	System ID  00000437624CN0	N/A  00000439694CN1	N/A  00000439777CN4	N/A  00000439930CN9	N/A  00000441224CN3	203688ERREV1  00000441575CN8	N/A  00000441624CN4	N/A  00000441648CN3	N/A  00000441916CN4	469841REVO  00000442032CN9	N/A  00000442124CN4	N/A  00000442219CN2	N/A  00000442443CN8	N/A  00000443993CN1	N/A  00000444530CN0	N/A  00000445085CN4	N/A  00000438756CN9	309655REVCT  00000439113CN2	212241REVCT  00000439205CN6	415476MCT3  00000439287CN4	415476MCT2  00000439836CN8	215662CTREV  00000440713CN6	815226RVCT  00000441459CN5	206320REV  00000441716CN8	808522RCT  00000442228CN3	281274REV  00000442994CN0	919684REVCT  00000443379CN3	608263REVCT  00000443664CN8	409772CT7  00000443900CN6	402481BEREVCT  00000444165CN5	AM14CFI65  00000444175CN4	801507REV  00000444253CN9	704384REV  00000444745CN4	808KMCCT  00000444872CN6	316268REVCT  00000445059CN9	310222REVO  438369CN1	206598REV1  438902CN9	801662REV1  439823CN6	408356RV1  439835CN0	503216SREV  441040cn3	215952CTREV  441064CN3	256HHRCT1  441066CN8	414805REVCT  441262CN3	RMHCTREV  441990CN9	206598ERREV  442592CN2	205699CTREV  442706CN8	727398REVO  443069CN0	404616CTR  443227CN4	940898REVO  443327CN2	858824REVCT  444398CN2	731541REVCT  444409CN7	386REVCT3  444840CN3	760940REVCT  444913CN8	206288SCREV  00000437624CN0	786596WKRIVO  00000439777CN4	703698REVOCT  00000439930CN9	715847RCT1  00000442124CN4	408498RV2  443327CN2	858824REVCT  00000441624CN4	217876REVO1  00000445085CN4	713792ACT35  00000441575CN8	847437ACT7  442032CN9	512DELLCT  00000442994CN0	N/A  3993CN1	972566OPREVO  445084CN7	708216CTREV  442592CN2	AM13KPM21  444165CN5	317338STVREVO  444970CN8	630527REVO  00000436942CN7	83119511730  00000439799CN8	83119074723  00000441381CN1	83130644883  00000441694CN7	83132979115  00000442968CN4	83141966438  00000439505CN9	190059CT06  00000440315CN0	220078CT04  00000441578CN2	030355CT07  00000441683CN0	CT441683CN0  00000443038CN5	CT443038CN5  00000445060CN7	204787RCT1  00000437410CN4	519646REVO1  440051CN1	E416249CT1  441839CN8	E416249CTE  442044CN4	403944",5/9/2016,"05/09/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74197,"Ongoing","FSC Laboratories, Inc","6000 Fairview Rd Ste 600",,"Charlotte","NC","28210-2201","United States","Voluntary: Firm Initiated","Letter","US Nationwide distribution.","Z-1995-2016","Class II","Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).","1435 units","Product had torn/loose seal around the mouthpiece.","06/15/2016",," Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01",5/16/2016,"05/16/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74198,"Ongoing","Physio-Control, Inc.","11811 Willows Rd NE",,"Redmond","WA","98052-2003","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and countries of: Argentina, Austria, Australia, Bahamas, Bangladesh, Belgium, Brazil, Brunei Darussalami, Canada, Chile, China, Croatia, Cyprus. Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore,  Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan (Province of China), Turkey, United Arab Emirates, United Kingdom, New Caledonia, and New Zealand,.","Z-2100-2016","Class II","LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable.    LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.","25178 units (10,418 in US and 14,760 outside US)","LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. ","06/29/2016",," ********Serial numbers of devices distributed in the US ***********    42871736, 42871737, 42871738, 42871748, 42871751, 42871754, 42871756, 42871761, 42871763, 42871771, 42897196, 42897198, 42897203, 42897205, 42897206, 42897207, 42897208, 42897210, 42897211, 42897212, 42897215, 42897216, 42897217, 42897218, 42897221, 42897222, 42897227, 42897228, 42897235, 42897236, 42897237, 42897238, 42897239, 42897240, 42897244, 42897246, 42897247, 42897248, 42897252, 42897255, 42897256, 42897258, 42897260, 42897264, 42897265, 42897291, 42897295, 42897296, 42897297, 42897298, 42897299, 42897304, 42897305, 42897306, 42897308, 42897309, 42897310, 42897311, 42897312, 42897313, 42897314, 42897317, 42897318, 42897319, 42897322, 42897323, 42897324, 42897325, 42897326, 42897329, 42897335, 42897336, 42897345, 42897346, 42897347, 42897348, 42897349, 42897350, 42897351, 42897354, 42897355, 42897356, 42897357, 42897358, 42897361, 42897364, 42897365, 42897366, 42897367, 42897368, 42897369, 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"Biologics",74199,"Terminated","Central Texas Regional Blood & Tissue Center","4300 N Lamar Blvd",".","Austin","TX","78756-3421","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0558-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Platelet products, labeled as leukoreduced, which did not meet leukoreduction criteria, were distributed.","06/07/2016","06/07/2016"," W221615619178 (Double collection)",4/4/2016,"04/04/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74200,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",".","Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","FAX","Colorado","B-0571-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who did not meet eligibility criteria, was distributed.","06/07/2016","06/07/2016"," W036216744687",4/12/2016,"04/12/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74201,"Terminated","Eversight Illinois, Bloomington","301  S  Prospect Rd Ste 2",,"Bloomington","IL","61704-4908","United States","Voluntary: Firm Initiated","E-Mail","Michigan; Illinois","B-0547-16","Class II","Cornea","2 human corneas","Human Corneas, recovered from a donor who was not properly evaluated for hemo-dilution, were distributed.","05/26/2016","05/26/2016"," W403715000018V0005000;   W403715000018V0006000  ",4/11/2016,"04/11/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74202,"Terminated","Community Blood Center Of Gtr KC","4040 Main St",,"Kansas City","MO","64111-2308","United States","Voluntary: Firm Initiated","FAX","New York","B-0597-16","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from a donor who disclosed travel history to a malarial endemic area, were distributed.","06/14/2016","06/14/2016"," W045015019836; W045015043526 ",5/3/2016,"05/03/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1551-2016","Class I","chocolate covered pretzels","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1545-2016","Class I","Rice Krispcicles","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1537-2016","Class I","sugar free milk chocolate cashew cluster","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1538-2016","Class I","MS molded chocolate","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1546-2016","Class I","Pralines","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared tree nuts, milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1533-2016","Class I","white and dark chocolate pecan krispie clusters","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1554-2016","Class I","turtle brownies","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, tree nuts, and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1549-2016","Class I","Oreos (chocolate coated)","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1550-2016","Class I","chocolate covered Twinkies","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1540-2016","Class I","pecan fudge","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1542-2016","Class I","sea salt caramel fudge","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1541-2016","Class I","peanut butter fudge","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1544-2016","Class I","sugar free salt water taffy","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and eggs","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1531-2016","Class I","white and dark chocolate cashew turtles and tortoises","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1553-2016","Class I","caramel cake","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1535-2016","Class I","white and dark chocolate cashew clusters","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1532-2016","Class I","white and dark chocolate pecan turtles and tortoises","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1534-2016","Class I","white and dark chocolate peanut clusters","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1548-2016","Class I","White Trash","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1536-2016","Class I","sugar free milk chocolate peanut cluster","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1547-2016","Class I","Cocoons","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared tree nuts, milk, wheat, and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1555-2016","Class I","praline cookies","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, tree nuts, and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1543-2016","Class I","salt water taffy ","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1556-2016","Class II","The Caramel Factory (TM) Caramel Icing, NET WT. 22OZ, 1 LB. 6OZ. (622 grams) and 2.5 GAL bucket","74.5 cases of 16 units and 26 buckets","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1552-2016","Class I","caramel sugar cookies","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74205,"Ongoing","The Caramel Factory, LLC.","127 Lakewood Dr",,"Batesville","MS","38606-3011","United States","Voluntary: Firm Initiated","Letter","Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.","F-1539-2016","Class I","fudge","unknown","Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)","06/17/2016",," None",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74206,"Ongoing","Zimmer Gmbh","Sulzer Allee 8",,"Winterthur",,,"Switzerland","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.","Z-2003-2016","Class II","Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0.  The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning.  The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.","177","In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery,  increasing the infection risk or second use of anesthesia necessary.","06/16/2016",," Item Number: 01.04227.005  Lot Numbers:  2792457  2794578  2812029  2817212  2844463  2794576  2794579  2815118  2817213  2847568  2794577  2794580  2815119  2832862",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74207,"Ongoing","Stryker Medical Division of Stryker Corporation","3800 E Centre Ave",,"Portage","MI","49002-5826","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide) and the countries of Australia, Canada, Hong Kong, Spain, Switzerland, and United Kingdom.","Z-1990-2016","Class II"," are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments. ","770 ","Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either the battery was placed into the cot or shortly after placing the battery into the cot. In addition to the alleged smoking, one of the reports had also noted that when the user attempted to lower the cot (prior to the alleged smoking) the device went into high speed retract and then a few moments later i","06/14/2016",," Model numbers:  6506-000-000,  6516-000-000,   6550-000-000    Serial Numbers  150740131  150740132  150740133  150740134  150740135  150740136  150740137  150740138  150740289  150740290  150740291  150740292  150740293  150740294  150740295  150740296  150740297  150740298  150740299  150740550  150740551  150740552  150740553  150740554  150740555  150740556  150740557  150740558  150740559  150740560  150740561  150740562  150740563  150740564  150740565  150740566  150740567  150740568  150740569  150740570  150740587  150740588  150740589  150740590  150740591  150740592  150839490  150840425  150840426  150840427  150840428  150840429  150840430  150840431  150840432  150840433  150840434  150840435  150840436  150840437  150840438  150840439  150840440  150840441  150840442  150840443  150840444  150840445  150840446  150840447  150840448  150840449  150840450  150840493  150840495  150840496  150840497  150840498  150840499  150840550  150840551  150840552  150840553  150840554  150840555  150840556  150840557  150840558  150840559  150840560  150840561  150840562  150840563  150840564  150840565  150840566  150840567  150840568  150840569  150840570  150840571  150840572  150840573  150840574  150840575  150840576  150840750  150840751  150840752  150840773  150840774  150840775  150840776  150840777  150840778  150840779  150840780  150840781  150840782  150840783  150840784  150840805  150840806  150840807  150840808  150840809  150840810  150840811  150840812  150840813  150840814  150840815  150840816  150840817  150840818  150840819  150840820  150840821  150840822  150840823  150840824  150840825  150840832  150840833  150840834  150840835  150840836  150840837  150840838  150840839  150840840  150840841  150840842  150840843  150840844  150840845  150840846  150840847  150840848  150840849  150840850  150840879  150840880  150840881  150840882  150840883  150840884  150840885  150840886  150840887  150840888  150840889  150840890  150840891  150840892  150840893  150840894  150840895  1508408",5/5/2016,"05/05/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74208,"Ongoing","Implant Direct Sybron Manufacturing, LLC","3050 E Hillcrest Dr",,"Westlake Village","CA","91362-3171","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - U.S. Nationwide in the states of OR, NE, VA, FL, MO, WA, TX and the countries of CZ, GB, NL, MF, DK, IT, IE, DE","Z-2046-2016","Class II","6534-08N InterActive¿ Implant Open-Tray Transfer Narrow  Part Number: 6534-08N     Product Usage:  Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impression material prior to delivery to the laboratory technician.  ","48","The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression.  This discrepancy may lead to the possibility of an oversized crown fabrication.","06/23/2016",," Lot #71664",5/19/2016,"05/19/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74209,"Ongoing","Galderma Laboratories, L.P.","14501 N Freeway Tx",,"Fort Worth","TX","76177","United States","Voluntary: Firm Initiated","Letter","U.S. Nationwide","D-1031-2016","Class III","Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only.  Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.","71,340 Bottles","Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.","06/14/2016",," Lot #: 1496059A, Expiry: 08/31/2017; Lot #: AD9848A, Expiry: 11/30/2017",5/19/2016,"05/19/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74210,"Ongoing","The Quaker Oats Company","555 W Monroe St",,"Chicago","IL","60661-3605","United States","Voluntary: Firm Initiated","Press Release","Product was distributed to 40 different customers in 87 different U.S. locations. See attached spreadshett for a customer list.","F-1666-2016","Class I","Quaker Quinoa Granola Bars, yogurt, fruit and nut flavor  packaged in a multi colored box with brown lettering. 5, 1.23 oz bars per box. ","970 cases, 12 units per case, 5 bars per unit","Sunflower kernels used in Quinoa bars are contaminated with Listeria Monocytogenes. ","07/11/2016",," best before date October 10, 2016 and October 11, 2016",5/16/2016,"05/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74210,"Ongoing","The Quaker Oats Company","555 W Monroe St",,"Chicago","IL","60661-3605","United States","Voluntary: Firm Initiated","Press Release","Product was distributed to 40 different customers in 87 different U.S. locations. See attached spreadshett for a customer list.","F-1665-2016","Class I","Quaker Quinoa Granola Bars, Chocolate Nut Medley packaged in a multi colored box with brown lettering. 5, 1.23 oz bars per box. ","470 cases, 12 units per case, 5 bars per unit. ","Sunflower kernels used in Quinoa bars are contaminated with Listeria Monocytogenes. ","07/11/2016",," best before date October 16, 2016 and October 17, 2016",5/16/2016,"05/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74211,"Ongoing","One Lambda Inc","21001 Kittridge St",".","Canoga Park","CA","91303-2801","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; GA, AZ, MA, CA, CO, WA, NY, MI, TX, ME, LA, PA, FL, MS, TN, KY, NC, OH, WV, OR, WI, IL, VT, DC, MI, KS. MO, NJ, OK, RI, AL, CT,    Foreign distribution to the following; Canada, Argentina, Bosnia, Brazil, Bulgaria, Chile, China, Costa Rica, Cypris, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Jorda, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Pakistan, Panama, Peru, Philippines, Poland, Qatar, Romania, Russiam Saudi Arabia, Serbia, Singapore, Slovakia, Sri Lanka, Thailand, Trinidad, Turkey, UAE, United Kingdom, Uruguay, Vietnam","B-0569-16","Class II"," Gold SSP  Catalog Identification: 54010D, 54310D, 54340D, 54350D, 54360D, 541100D","9356 test kits","HLA test kits, which may be associated with false negative reactions, were distributed. ","06/09/2016",," Lot #22  Batches:  63056, 1608939, 1608858, 1472871, 1385981, 1256853    Lot #38  Batches: 1649364, 1608950, 1608870, 1568517, 1472869, 1428080, 1391657, 1360419, 1306788, 1249868    Lot #36  Batches: 69962, 1649370, 1624938, 1615269, 1608938, 1608849, 1544261, 1472866, 1441214, 1399473, 1357615, 1304515, 1255129    Lot #29  Batches: 75232, 1608960, 1608890, 1589667, 645, 646, 647, 1508463, 1465433, 1428078, 1395129, 1362561, 1306794, 1293558, 1247232    Lot #8  Batches: 1608856, 1441210    Lot #12  Batches: 68764, 1648453, 1615252, 1608903, 1608823, 1544269, 1446993, 1395079, 1303557",5/6/2016,"05/06/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74211,"Ongoing","One Lambda Inc","21001 Kittridge St",".","Canoga Park","CA","91303-2801","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; GA, AZ, MA, CA, CO, WA, NY, MI, TX, ME, LA, PA, FL, MS, TN, KY, NC, OH, WV, OR, WI, IL, VT, DC, MI, KS. MO, NJ, OK, RI, AL, CT,    Foreign distribution to the following; Canada, Argentina, Bosnia, Brazil, Bulgaria, Chile, China, Costa Rica, Cypris, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Jorda, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Pakistan, Panama, Peru, Philippines, Poland, Qatar, Romania, Russiam Saudi Arabia, Serbia, Singapore, Slovakia, Sri Lanka, Thailand, Trinidad, Turkey, UAE, United Kingdom, Uruguay, Vietnam","B-0570-16","Class II","UniTray SSP HLA Typing Kits    Catalog Identification: 7860010, 7860110, 7800010, 7800110, 7810010, 7810110, 7850010, 7850110, 470802, 470812, 4729010, 4729110","3977 test kits","HLA test kits, which may be associated with false negative reactions, were distributed. ","06/09/2016",," Lot #22  Batches: 1649631, 1608916, 1465419, 1256848    Lot #38  Batches: 1608926, 1608825, 1472876, 1409795, 1322136, 1221266    Lot #36  Batches: 1608914, 1544275, 1409794, 1316325    Lot #29  Batches:  1608868, 1544273, 1472861, 1414737, 1255127    Lot #8  Batches: 1649580, 1608863, 1491675, 1221254    Lot #12   Batches: 1608873, 1580702, 1467113, 1306793",5/6/2016,"05/06/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74213,"Completed","Materialise USA LLC","44650 Helm Ct",".","Plymouth","MI","48170-6061","United States","Voluntary: Firm Initiated","E-Mail","One consignee, Indiana.","Z-1941-2016","Class II","Signature TKA GDE/MDL Set 04-05    Patient-specific surgical guide and instrument set.","1","A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case.  If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used. ","06/09/2016",," Lot #154970",5/3/2016,"05/03/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74214,"Ongoing","Tarrier Foods Corp","2700 International St",,"Columbus","OH","43228-4640","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR,GA, IA, KY, MI, MN, NY, OH, PA, TN and  VA.","F-2384-2016","Class I",,"1561/10 lbs. bags and 94/25 lbs. bags","The firm was notified by their supplier that the products may be contaminated with Listeria monocytogenes.","09/22/2016",," Item 0540/ 10lbs:   LOT NO  054008816 use by 7/26/2016, LOT NO  054009816 use by 8/5/2016, and LOT NO  054013316 use by 9/9/2016 .     Item 0545/25 lbs:  LOT NO 054508816 use by 7/26/2016,  LOT NO 054509816 use by 8/5/2016, LOT NO 054511916 use by 8/26/2016, LOT NO 054512616 use by 9/2/2016 , and LOT NO 054513216 use by 9/8/2016.",5/19/2016,"05/19/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74215,"Ongoing","GE Healthcare, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI.      OUS:  Argentina  Australia  Austria  Brazil  Canada  Chile  Colombia  Denmark  Egypt  Finland  France  Germany  Greece  Hong Kong  Iceland  Italy  Japan  Korea (Republic of)  Kuwait  Malaysia  Netherlands  Norway  Peru  Poland  Portugal  Russia  Singapore  South Africa  Spain  Sweden  Switzerland  Ukraine  United Arab Emirates  United Kingdom","Z-1927-2016","Class II","MSK 1.5T Extreme MR Scanner, a diagnostic imaging device","97","The gas venting may not occur properly.  A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.","06/08/2016",," Mfg Lot or Serial #	System ID  0001072011-001	708216MR3  0001082010-001	AIC202  0001272010-001	RADNETMR1656  0002032011-001	407333EXTMR  0003072010-001	702254LVRMR  0003242009-001	JCI178  0004012010-001	201487ONI  0005152009-001	ZPR2185  0005262010-001	CALPAC003  0006012008-001	MHMH162  0006082010-001	SPRUCEEXT  0006182010-001	205930MR3  0007142009-001	POA187  0009142010-001	6150  0009172009-001	RADNETMR1641  0010182010-001	305CMI2  0011292010-001	513636EXTMR  0012052010-001	713791BONIMR  0012162008-001	HCH170  0012182008-001	916734EXMR  0007152011-001	MREQUINE3  SM12062013-002	718518MR430S  0008152010-001	0910272074  0008142012-001	AP4502MR01  0004082010-001	MR04082010  0005072010-001	MR05072010  0007082010-001	MR07082010  0007092010-001	MR07092010  0011242009-001	MR11242009  0012142009-001	MR12142009  0012152009-001	MR12152009  0003292011-001	EG1252MR02  0004192011-001	EG1524MR01  SM02042013-001	607849MR01  SM04292013-001	PC0127MR04  SM05062013-001	533398MR01  SM06092014-002	419793MR01  SM06182013-001	PC4318MR03  SM07182014-005	115530MR01  SM08152013-001	123701MR01  SM09132012-003	PC9982MR01  SM12122013-001	123955MR01  0001022012-001	PC0362MR03  0001152012-001	414456MR01  0001182010-001	PC7485MR01  0003012010-001	PY4178MR02  0003142012-007	761131MR01  0005132011-001	PC3756MR01  0006042009-001	PC5454MR01  0006062009-001	HC9457MR01  0006142012-001	805467MR01  0006212012-001	CC3829MR01  0006282012-010	PC0573MR03  0006302011-001	PC0075MR04  0007172012-001	654076MR01  0007232012-001	PC4712MR01  0007252012-001	PC1820MR01  0007272010-001	HC4201MR01  0008022011-001	PC3814MR03  0008142011-001	440719MR01  0009072009-001	PC8854MR01  0009092011-001	PC6543MR01  0009132010-001	PC1345MR01  0009172011-001	743862MR01  0010082010-001	TP0008MR03  0010082011-001	PKOB02MR05  0010172011-002	125995MR02  0011162010-001	126538MR02  0011202011-001	PC4529MR02  0012102011-001	788048MR01  SM02142014-001	123959MR01  SM07142014-002	PC4616MR01  0001182011-001	H10634MR11  0009062011-001	A5992702  0003302011-001	0834270017  0002182011-001	O",5/9/2016,"05/09/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74215,"Ongoing","GE Healthcare, LLC","3000 N Grandview Blvd",".","Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI.      OUS:  Argentina  Australia  Austria  Brazil  Canada  Chile  Colombia  Denmark  Egypt  Finland  France  Germany  Greece  Hong Kong  Iceland  Italy  Japan  Korea (Republic of)  Kuwait  Malaysia  Netherlands  Norway  Peru  Poland  Portugal  Russia  Singapore  South Africa  Spain  Sweden  Switzerland  Ukraine  United Arab Emirates  United Kingdom","Z-1928-2016","Class II","Optima 1.5T MR430s MR Scanner, a diagnostic imaging device","101","The gas venting may not occur properly.  A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.","06/08/2016",," 0001272012-001	615VEMR  0003062012-008	605328SMR15  0012102012-001	SMRDEMO01  0005162012-003	801243MR2  SM05132013-001	970879MR430  SM10172011-004	509482MR3  SM06142013-001	641428ONI  SM10302012-006	ARIA430S  SM06272013-006	207OA430MR  SM11262012-007	USOTCSMR  SM07082013-012	719766SMR  0SM5312013-001	760725MR1  SM08152013-002	703805ONIMR4  SM11252013-001	310665MR  0000SM09202013	208557MR2  SM05212013-004	VAD430  SM11132012-002	856581MR430  SM12172012-001	303577MR2  0001212012-001	786308MR1  0012222011-001	973586MR  0006012011-001	SINAI601  0007132011-001	516482MR430  0012042011-001	MKMG430S  0 02162012-001	805679ONI  0012142011-001	215DOY430S  0006112012-004	360786ONIMR  0003062012-007	212288ONI  0010272011-009	513636NICMR  0003282012-001	518453MR2  0002112012-001	803434ONI  Missing_SN_GON4194272	402EXTMR  SM03132014-002	H430SMR  SM05142014-006	520VAONIMR  SM07182014-009	352376ONI1  SM11062012-001	MRSM11062012001  0002022012-001	0910272081  0004212012-001	514697ONI  SM01232014-003	SM01232014-003  SM05192014-003	MRSM05192014003  0005252012-002	MRMEDSMR3  SM02252014-003	082427010079  SM03292014-007	082427020055  SM05272014-007	082427020060  SM09202013-017	082427040145  0SM0225013-004	082427030080  SM06202013-002	MRSM06182013002  SM01202014-014	DK1000MR04  SM10242013-002	DK1075MR01  0000DK1030MR03	DK1030MR03  0012132011-001	DK1068MR01  0001192012-001	FI1378MR01  0011052011-002	FI1006MR02  SM01102014-001	M24070304  SM01152013-001	L1650217  SM03052014-004	M176430610  SM04152014-001	M5817305  SM04292014-002	M2862820  SM07182014-014	M172471308  SM08152013-003	M4215583  SM12192013-003	M219000205  SM02042014-003	D4185525  SM07182014-008	0828270040  0002042012-001	IS1019MR01  SM10122012-003	A5177233  SM12102012-003	A287971801  0007172011-001	A127292410  0009242011-001	A5725513  SM02132014-001	OM0005  SM03202014-001	OM0004  SM11122013-007	OM0003  SM12202013-001	OM0100  0005102012-004	OM0001  0008022012-003	OM0002  0007302012-008	0850270400  SM07182014-012	KW1019MR04  SM07182014-013	KW1001MR05  0005152012-004	DRD0120  SM",5/9/2016,"05/09/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74216,"Ongoing","Papa John's Salads and Produce, Inc.","859 S 86th Ave",,"Tolleson","AZ","85353-9268","United States","Voluntary: Firm Initiated","Press Release","AZ, CA, ID, MT, ND, NM, OR, WY.","F-1524-2016","Class I","(Albertsons/Safeway/Basha Hometown Grocers) Oriental Salad with Sesame Ginger Dressing, Net Wt.10 oz.(284g), 24 pieces per case, UPC 78279602691; (Food 4 Less) Oriental Salad with Sesame Ginger Dressing, Net Wt. 13 oz. (369 g), UPC 78277602840","886 units total","Papa John's Salad and Produce is voluntarily recalling Oriental Salad with Sesame Ginger Dressing due to possible Listeria monocytogenes contamination. ","06/17/2016",," Albertsons/Safeway/Food 4 Less Sell by dates: 5/18, 5/19, 5/20, 5/21, 5/22, 5/23, 5/24, 5/25.     Basha's Sell By dates: 5/18, 5/19, 5/20, 5/21, 5/22, 5/23, 5/24.   ",5/21/2016,"05/21/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74217,"Terminated","American Red Cross Blood Services","4050 Lindell Blvd",,"Saint Louis","MO","63108-3202","United States","Voluntary: Firm Initiated","Telephone","MO","B-0620-16","Class II","Apheresis Platelets, Leukocytes Reduced","3 units","Blood products, which did not meet the acceptable product specifications, were distributed.","06/23/2016","06/23/2016"," W201116878200-part 1; W201116878200-part 2; W201116878200-part 3 ",4/4/2016,"04/04/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74218,"Terminated","Michigan Blood","1036 Fuller Ave Ne","PO Box 1704","Grand Rapids","MI","49503-1304","United States","Voluntary: Firm Initiated","Telephone","MI","B-0616-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, possibly contaminated with air, was distributed.","06/23/2016","06/23/2016"," W120616040735",3/31/2016,"03/31/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74219,"Ongoing","Ultimate Nutrition, Inc.","21 Hyde Rd",,"Farmington","CT","06032-2801","United States","Voluntary: Firm Initiated","Press Release","The recalled Amino Gold was distributed nationwide through distributors, stores, and web sites.  The product was sold direct to distributors in CA, NC, ID, PA, CT.","F-1769-2016","Class I","ULTIMATE NUTRITION AMINO GOLD TABLETS SUPER WHEY FORMULA Dietary Supplement 1000 mg 250 capsules; UPC: 099071 00120 7","less than 1000 of all/lots products involved in this recall","Product contains undeclared milk. ","09/13/2016",," Lot/Unit Numbers: 405138",5/20/2016,"05/20/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74219,"Ongoing","Ultimate Nutrition, Inc.","21 Hyde Rd",,"Farmington","CT","06032-2801","United States","Voluntary: Firm Initiated","Press Release","The recalled Amino Gold was distributed nationwide through distributors, stores, and web sites.  The product was sold direct to distributors in CA, NC, ID, PA, CT.","F-1768-2016","Class I","ULTIMATE NUTRITION AMINO GOLD TABLETS SUPER WHEY FORMULA Dietary Supplement 1500 mg 325 tablets","less than 1000 of all/lots products involved in this recall","Product contains undeclared milk. ","09/13/2016",," Lot/Unit Numbers: 403122, 508080, 604166",5/20/2016,"05/20/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74219,"Ongoing","Ultimate Nutrition, Inc.","21 Hyde Rd",,"Farmington","CT","06032-2801","United States","Voluntary: Firm Initiated","Press Release","The recalled Amino Gold was distributed nationwide through distributors, stores, and web sites.  The product was sold direct to distributors in CA, NC, ID, PA, CT.","F-1770-2016","Class I","ULTIMATE NUTRITION AMINO GOLD CAPSULES SUPER WHEY FORMULA Dietary Supplement, 1000 mg, 250 tablets; UPC: 0 99071 00140 5","less than 1000 of all/lots products involved in this recall","Product contains undeclared milk. ","09/13/2016",," Lot/Unit Numbers: 406001, 407067, 602230",5/20/2016,"05/20/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74220,"Ongoing","Dr. Reddy's Laboratories, Inc.","107 College Rd E",,"Princeton","NJ","08540-6623","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1058-2016","Class III","CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC,  Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523","84,240 bottles","Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.","06/30/2016",," Lot # 79405008A, 79405008B, 79405008C, Exp 05/2017",4/22/2016,"04/22/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74221,"Ongoing","Roche Molecular Systems, Inc.","1080 US Highway 202 S",,"Branchburg","NJ","08876-3733","United States","Voluntary: Firm Initiated","Letter","Foriegn Distribution       Austria, Belgium, Croatia, Czech  Republic, Denmark, France, Germany,  Greece, Hungary , Italy, Lithuania,  Luxembourg, Netherlands, Norway, Poland,  Romania, Slovakia, Slovenia, Spain,  Switzerland, Turkey, United Kingdom  cfDNA: Austria, Belgium, Croatia, Czech  Republic, Denmark, France, Germany,  Greece, Hungary , Italy, Lithuania,  Luxembourg, Netherlands, Poland,  Romania, Slovakia, Slovenia, Spain,  Switzerland, Turkey, United Kingdom","Z-2254-2016","Class II","cobas EGFR Mutation Test V2  Materials number   CE-IVD: EGFR v2: 07248563190  cfDNA: 07247737190    Device Identifier:  EGFR v2.0: 00875197005448  cfDNA: 00875197005424    Product Usage:  A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).  ","735 devices EGFR; 509 devices cfDNA"," (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit. ","07/21/2016",," Lot W08792, Lot W11783, Lot W11438, Lot W14903, Lot W05108. Lot W11435, Lot W12238",4/5/2016,"04/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74222,"Completed","MicroAire Surgical Instruments, LLC","3590 Grand Forks Blvd",,"Charlottesville","VA","22911-9006","United States","Voluntary: Firm Initiated","Letter","The product was distributed in the United States and Sweden","Z-2294-2016","Class II","Endotine Transbleph 3.5 (CFD-080-0167)","29","MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).","07/27/2016",," Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373",5/6/2016,"05/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74223,"Ongoing","Valeant Pharmaceuticals North America LLC","400 Somerset Corporate Blvd",,"Bridgewater","NJ","08807-2867","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1032-2016","Class III","Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ  08807, UPC 0 00950 86006 8.","3827 bottles","Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.","06/15/2016",," Lot #'s P0230-022R, P0230-023R, Exp 06/17",5/23/2016,"05/23/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74224,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA","Z-2084-2016","Class II","K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System   The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws","182 units","The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.","06/28/2016",," Lot 237830TE",5/20/2016,"05/20/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74225,"Ongoing","Datascope Corporation","15 Law Dr",".","Fairfield","NJ","07004-0011","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-1935-2016","Class II","MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿    MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿      MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿    MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA","31,030 units (US); 15,604 units (OUS)","It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the  STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).","06/08/2016",," (PN 0684-00-0294-01U)  (PN 0684-00-0294-02U)  (PN 0684-00-0295-01U)  (PN 0684-00-0295-02U)  (PN 0684-00-0296-01U)",5/13/2016,"05/13/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74226,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Distributed to Columbia and the following US states: AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI","Z-2049-2016","Class II","PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy","10,054 units","Presence of leaks near top of the PrismaSate bags","06/24/2016",," Listing #D051124, Unique Device Identifier #07332414037048, Product code #105351. Lot code (Exp date): 1000123133 (02/28/2017), 1000128162 (04/30/2017), 1000128163 (04/30/2017), 1000128164 (04/30/2017).",5/23/2016,"05/23/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74227,"Ongoing","C.J. Dannemiller Company, Inc.","5300 S Hametown Road",,"Norton","OH","44203-6126","United States","Voluntary: Firm Initiated","Letter","AR, CO, FL, IA, IN, KY, MI, NY, OH, PA, SD, VA, WI and WV.","F-1697-2016","Class I","    ","823 boxes /30 lbs cases SALTED and 253 boxes/30 lbs cases NO SALT","Firm recalling under directions from their Supplier, due to possible risk of product containing Listera monocytogenes. ","07/15/2016",," The following codes were recalled on May 20th, 2016 with an updated/corrected letter on 6/2/16: Sunflower kernels roasted and salted:  30 lbs cardboard box with  MFG  DATES 02/29/16, 03/21/16, 03/28/16, 04/11/16 04/18/16 and 04/25/16.    The following codes were recalled on June 6th, 2016 as part of the expanded Sun opta recall:   30 lbs cardboard boxes of Sunflower kernels roasted and salted: Lot # 15202 through Lot #16060.    30 lbs cardboard boxes of Sunflower kernels roasted and no salt: Lot # 15202 through Lot #16060.",5/20/2016,"05/20/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74227,"Ongoing","C.J. Dannemiller Company, Inc.","5300 S Hametown Road",,"Norton","OH","44203-6126","United States","Voluntary: Firm Initiated","Letter","AR, CO, FL, IA, IN, KY, MI, NY, OH, PA, SD, VA, WI and WV.","F-1698-2016","Class I",,"823 boxes /30 lbs cases SALTED and 253 boxes/30 lbs cases NO SALT","Firm recalling under directions from their Supplier, due to possible risk of product containing Listera monocytogenes. ","07/15/2016",," The following codes were recalled on June 6th, 2016 as part of the expanded Sun opta recall:       30 lbs cardboard boxes of Sunflower kernels roasted, no salt: Lot # 15165 through Lot #16060.",5/20/2016,"05/20/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74229,"Ongoing","CarboFix Orthopedics, Ltd.","11 Ha, Hoslim St.",,"Herzliya",,,"Israel","Voluntary: Firm Initiated","Letter","AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA","Z-1991-2016","Class II","Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.","638","Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.","06/14/2016",," Catalog Number PFT912250 - Lot Number QTN90712, QTN02700, QTN61401, QTN02785A, QTN61402, QTN83201B, QTN61402A, QTN43801, QTN43801A, QTN43801B, QTN83201C, QTN04161A",5/10/2016,"05/10/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74230,"Ongoing","SSC- Surgical Specialties Corporation","9993 Marconi Dr",,"San Diego","CA","92154-7271","United States","Voluntary: Firm Initiated","Letter","TX, ME, MA, MI, OH, KS, MN, KS, TN, GA","Z-2042-2016","Class II","/15cm 9-0 USP, Product No. J2558N","36 boxes (432 units)","/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.","06/21/2016",," MAPX540",5/20/2016,"05/20/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74231,"Ongoing","Woodland Foods","3751 Sunset Ave",,"Waukegan","IL","60087-3213","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. food distributors located in CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,	MD, MI, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, WA and WI.","F-0730-2017","Class I",".    ","9 lbs (2 cases of 4.5 lbs)","Sunflower seeds purchased from SunOpta that are potentially contaminated with Listeria. ","12/22/2016",," 901485      ",5/19/2016,"05/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74231,"Ongoing","Woodland Foods","3751 Sunset Ave",,"Waukegan","IL","60087-3213","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. food distributors located in CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,	MD, MI, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, WA and WI.","F-0731-2017","Class I",".    ","7,900 lbs","Sunflower seeds purchased from SunOpta that are potentially contaminated with Listeria. ","12/22/2016",," 911850, 912057, 919308, 923918, 924146      ",5/19/2016,"05/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74231,"Ongoing","Woodland Foods","3751 Sunset Ave",,"Waukegan","IL","60087-3213","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. food distributors located in CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,	MD, MI, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, WA and WI.","F-0727-2017","Class I",". Product was packaged into 5 lb boxes.    ","299 lbs","Sunflower seeds purchased from SunOpta that are potentially contaminated with Listeria. ","12/22/2016",," 911763",5/19/2016,"05/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74231,"Ongoing","Woodland Foods","3751 Sunset Ave",,"Waukegan","IL","60087-3213","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. food distributors located in CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,	MD, MI, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, WA and WI.","F-0728-2017","Class I",". Product was packaged into 5 lb boxes.    ","25 lb.","Sunflower seeds purchased from SunOpta that are potentially contaminated with Listeria. ","12/22/2016",," 928560",5/19/2016,"05/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74231,"Ongoing","Woodland Foods","3751 Sunset Ave",,"Waukegan","IL","60087-3213","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. food distributors located in CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,	MD, MI, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, WA and WI.","F-0726-2017","Class I",". Product was packaged into 5 & 40 lb boxes.    ","450 lbs ","Sunflower seeds purchased from SunOpta that are potentially contaminated with Listeria. ","12/22/2016",," 803161, 803267, 810659, 811261, 811968, 812184, 813248, 818596, 818609, 818831, 818835, 820864, 821464, 821942, 822822, 823127, 825272, 829957, 831153, 831208, 832302, 832333, 837294, 837418, 837948, 839501, 840679, 841703, 842199, 846295, 846719, 847622, 847667, 847996, 848076, 848543, 850351, 850482, 853129,  53219, 853660, 854564, 854819, 854952, 856220, 859143, 861308, 861317, 861330, 863136, 863480, 865800, 869126, 870330, 870856, 870858, 871378, 872209, 872656, 873594, 875371, 876890, 878087, 878599, 879461,879502, 879723, 880059, 882735, 883863, 884793, 885161, 885808, 886621, 888017, 889942, 892173, 892796 , 897844, 898192, 899938, 902047, 903199, 903256, 903710, 904858, 905300, 905438, 906149, 906796, 909449, 916925, 923185, 923187, 924114, 924560, 924609, 925480, 926637 and 928131. ",5/19/2016,"05/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74231,"Ongoing","Woodland Foods","3751 Sunset Ave",,"Waukegan","IL","60087-3213","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. food distributors located in CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,	MD, MI, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, WA and WI.","F-0729-2017","Class I",".    ","960 lbs ","Sunflower seeds purchased from SunOpta that are potentially contaminated with Listeria. ","12/22/2016",," Firm's product code N34B lot code L902095       ",5/19/2016,"05/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74232,"Ongoing","Silva International Inc.","523 N Ash St",,"Momence","IL","60954-1335","United States","Voluntary: Firm Initiated","Letter","Product was shipped to locations in TX, OH, IL, CT, AL, FL, WI, CO and New Zealand","F-1667-2016","Class II","Zesty Nacho Spice Blend (containing dehydrated chipotle powder) from Silva International packaged in a 50 lb. poly-lined cardboard box. ","10,000 lbs","Samples of dehydrated chipotle powder came back positive for gluten, possibly from wheat. Potential presence of wheat was not disclosed on label.","07/14/2016",," 042916CL01-50",5/19/2016,"05/19/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74232,"Ongoing","Silva International Inc.","523 N Ash St",,"Momence","IL","60954-1335","United States","Voluntary: Firm Initiated","Letter","Product was shipped to locations in TX, OH, IL, CT, AL, FL, WI, CO and New Zealand","F-1590-2016","Class II","Dehydrated chipotle powder from Silva International packaged in a 50 lb. poly-lined cardboard box. ","2,908 lbs lbs. ","Samples of dehydrated chipotle powder came back positive for gluten, possibly from wheat. Potential presence of wheat was not disclosed on label.","07/14/2016",," 120815369-50, 020516690-50",5/19/2016,"05/19/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74233,"Ongoing","Zydus Pharmaceuticals USA Inc","73 Route 31 N",,"Pennington","NJ","08534-3601","United States","Voluntary: Firm Initiated","Letter","US Nationwide","D-1491-2016","Class II","Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06","14,808 bottles","Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.","09/02/2016",," Lot # MP993, Exp10/16; MR2704, Exp 02/17;  MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17",5/9/2016,"05/09/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74234,"Completed","Medtest Holdings, Inc.","5449 Research Dr",,"Canton","MI","48188-2261","United States","Voluntary: Firm Initiated","E-Mail","MI, MN, NJ, IL, NY.  US Only.","Z-2063-2016","Class II","Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.","13","Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.  The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples.  The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1.  Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.","06/28/2016",," Model: H7575-57  Lot: 416703  Expiration date: 2016-01",4/3/2015,"04/03/2015",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74235,"Terminated","Delta Blood Bank","65 N Commerce St",,"Stockton","CA","95202-2318","United States","Voluntary: Firm Initiated","FAX","CA","B-0622-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.","07/08/2016","07/08/2016"," W128716450468",4/22/2016,"04/22/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74236,"Terminated","ARUP Laboratories, Inc.","9786 S. Sandy Parkway",,"Sandy","UT","84070-2565","United States","Voluntary: Firm Initiated","Telephone","UT","B-0621-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.","07/08/2016","07/08/2016"," W158016300364",4/7/2016,"04/07/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74237,"Terminated","American National Red Cross Great Lakes Region","1800 E Grand River Ave",,"Lansing","MI","48912-2305","United States","Voluntary: Firm Initiated","Other","California","B-0544-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","05/26/2016","05/26/2016"," W201815289426",3/22/2016,"03/22/2016",6/1/2016,"06/01/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74238,"Terminated","CSL Behring GmbH","Emil-von-Behring-Str. 76",".","Marburg",,,"Germany","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0566-16","Class III","Prothrombin Complex Concentrate (Human)","2 lots","Two batches of Prothrombin Complex Concentrate (Human), not meeting incoming material specifications, were distributed.   ","06/03/2016","06/03/2016"," C6460111A; C6760111A",3/18/2016,"03/18/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74239,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  China and Malaysia.","Z-1998-2016","Class II","Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672    Product Usage:  The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.  ","2 units","The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.","06/15/2016",," Serial Numbers:  31125,31126",4/25/2016,"04/25/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74239,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  China and Malaysia.","Z-2000-2016","Class II","BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958    Product Usage:  The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.  ","1 unit","The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.","06/15/2016",," Serial Number 11022",4/25/2016,"04/25/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74239,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  China and Malaysia.","Z-1999-2016","Class II","BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956    Product Usage:  The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.  ","1 unit","The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.","06/15/2016",," Serial Number 11009",4/25/2016,"04/25/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74239,"Ongoing","Siemens Medical Solutions USA Inc.","810 Innovation Dr",,"Knoxville","TN","37932-2562","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  China and Malaysia.","Z-1997-2016","Class II","BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786    Product Usage:  The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.  ","1 unit","The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.","06/15/2016",," Serial Number 21139",4/25/2016,"04/25/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0654-2017","Class I","Nacho and Salsa with Milk, Item # 61619          ","108 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #: 6134   Best Used By: 9/10/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0640-2017","Class I","Frosted Flakes w/Cheese Stick Meal Break, Item #61438","32 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 6075, 2) 6112  Best Used By: 1) 9/14/16, 2) 9/19/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0645-2017","Class I","Cheese Stick Marinara Sauce Red Vegetable, Item # 61418","2,559 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5338, 2) 6007, 3) 6011, 4) 6028, 5) 6047, 6) 6057, 7) 6077, 8) 6082, 9) 6112, 10) 6127, 11) 6130  Best Used By: 1) 7/11/16, 2) 7/28/16, 3) 8/12/16, 4) 8/12/16, 5) 10/1/16, 6) 10/1/16, 7) 10/4/16, 8) 10/4/16, 9) 10/4/16 & 12/9/16, 10) 10/30/16, 11) 10/30/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0652-2017","Class I","Hummus with Milk, Item # 61617        ","288 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 6091 & 2) 6130    Best Used By: 1) 12/7/16 & 12/9/16,  2) 12/10/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0646-2017","Class I","Pasadena Chili Lime Dippers, Item # 6142000294  ","1,068 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5363, 2) 6048, 3) 6070  Best Used By: 1) 8/17/16, 2) 10/22/16, 3) 10/23/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0642-2017","Class I","PBJ w/Milk Meal Break, Item #61602","360 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 6090, 6091 & 6125  Best Used By: 1/11/17",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0644-2017","Class I","BBQ Chicken w/Milk Meal Break, Item #61605","324 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 6042, 6091, 6092, 2) 6125  Best Used By: 1) 1/25/17, 2) 2/9/17",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0643-2017","Class I","Tuna Salad w/Milk Meal Break, Item #61603","360 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 6091, 2) 6126  Best Used By: 1) 1/25/17, 2) 2/9/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0635-2017","Class I","Cheese Stick w/Beef Stick Meal Break, Item #61406","7,275 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5310, 2) 5337, 3) 6005, 4) 6007, 5) 6025, 6) 6035, 7) 6036, 8) 6052, 9) 6053, 10) 6055, 11) 6061, 12) 6069, 13) 6078, 14) 6111, 15) 6117, 16) 6118, 17) 6124, 18) 6129, 19) 6131, 20) 6133, 21) 6138, 22) 6140, 23) 6190, 24) 6111  Best Used By: 1) 5/15/16, 2) 7/11/16, 3) 8/27/16, 4) 7/11/16, 5) 8/27/16, 6) 8/27/16, 7) 9/16/16, 8) 10/1/16, 9) 10/1/16, 10) 10/1/16, 11) 10/1/2016 & 10/5/16, 12) 11/7/16, 13) 11/11/16, 14) 11/15/16, 15) 9/2/16, 16) 10/5/16, 17) 9/2/16 & 12/10/16, 18) 12/10/16, 19) 9/11/16, 20) 5/11/16 & 9/11/16, 21) 12/14/16, 22) 10/4/16, 23) 10/4/16, 24) 11/15/16     ",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0647-2017","Class I","PB&J, Item # 61402    ","1,548 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 6043, 2) 6049, 3) 6099, 4) 6130, 5) 6134  Best Used By:  1) 11/24/16, 2) 12/8/16 & 2/18/16, 3) 10/4/16, 1/11/2017 & 11/11/17, 4) 10/30/16, 5) 9/10/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0651-2017","Class I","Cheese Cup w/Milk, Item # 61610        ","288 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 6092 & 2) 6127  Best Used By: 1) 1/25/17 & 2) 10/30/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0641-2017","Class I","Cinnamon Pop Tarts Meal Break, Item #61439","512 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 6062, 2) 6075, 3) 6098, 4) 6112, 5) 6132  Best Used By: 1) 11/2/16, 2) 11/7/16, 3) 12/10/16, 4) 12/10/16 & 12/16/16, 5) 9/11/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0649-2017","Class I","Hummus Meal Breaks, Item # 61417      ","3,679 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5328, 2) 6004, 3) 6011, 4) 6026, 5) 6041, 6) 6054, 7) 6069, 8) 6082, 9) 6083, 10) 6137  Best Used By: 1) 10/23/16, 2) 11/3/16, 3) 11/16/16, 4) 11/12/16, 11/17/16 & 1/11/17, 5) 11/24/16, 6) 12/8/16, 7) 12/9/16, 8) 1/19/17, 9) 1/25/16 & 1/25/17, 10) 12/14/16        ",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0636-2017","Class I","Cheese Sauce Meal Break, Item #61410","2,352 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5338, 2) 6005, 3) 6021, 4) 6042, 5) 6047, 6) 6074, 7) 6081, 8) 6126, 9) 6130, 10) 6137  Best Used By: 1) 10/23/16, 2) 11/5/16, 3) 5/27/16 & 11/17/16, 4) 12/7/16, 5) 12/7/16 & 12/17/16, 6) 12/6/16 & 12/9/16, 7) 1/22/16, 8) 3/1/17, 9) 12/1/16, 10) 12/14/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0638-2017","Class I","Lime Bean Dippers Meal Break, Item #61420","1,068 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5363, 2) 6052, 3) 6054, 4) 6056, 5) 6074, 6) 6078, 7) 6082, 8) 6112, 9) 6134, 10) 6137  Best Used By: 1) 10/22/16, 2) 10/23/16, 3) 10/22/16, 4) 10/23/16, 5) 10/23/16, 6) 10/23/16, 7) 10/23/16, 8) 10/26/16, 9) 9/10/16, 10) 10/26/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0639-2017","Class I","Cheese Cup Meal Break, Item #61430","1,930 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5322, 2) 5328, 3) 5351, 4) 6025, 5) 6028, 6) 6039, 7) 6070, 8) 6090, 9) 6116, 10) 6132, 11) 6138  Best Used By: 1) 8/26/16, 2) 8/27/16, 3) 5/25/16 & 10/7/16, 4) 11/17/16, 5) 10/9/16, 6) 10/9/16, 11/17/16 & 12/9/16, 7) 12/9/16, 8) 12/9/16 & 1/15/17, 9) 1/15/16, 10) 9/11/16, 11) 12/15/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0650-2017","Class I","Beef & Cheese Stick w/ Vegetable Juice, Item # 61426        ","1,418 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5363, 2) 6025, 3) 6061, 4) 6075    Best Used By: 1) 7/11/16, 2) 9/16/16, 3) 10/5/16, 4) 11/7/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0637-2017","Class I","Salsa / Nachos Meal with Red Vegetable, Item # 61419    ","108 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5322, 2) 6004, 3) 6039, 4) 6046, 5) 6057, 6) 6074, 7) 6090, 8) 6116, 9) 6124, 10) 6127, 11) 6130, 12) 6137, 13) 6146, 14) 6639, 15) 6646  Best Used By: 1) 5/21/16, 2) 7/8/16, 3) 7/17/16 & 9/16/16, 4) 9/22/16, 5) 9/2/16 & 9/22/16, 6) 10/28/16, 7) 12/1/16, 8) 12/1/16 & 12/16/16, 9) 12/1/16, 10) 10/30/16, 11) 12/1/16, 12) 12/1/16 & 12/14/16, 13) 9/22/16, 14) 7/17/16, 15) 9/22/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0653-2017","Class I","Cheese Stick & Marinara with Milk, Item # 61618          ","288 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 6091, 2) 6092, 3) 6130  Best Used By: 1) 11/11/16,  2) 11/11/16, 3) 12/10/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74240,"Ongoing","E S Foods","20 Crossways Park Dr N Ste 100",".","Woodbury","NY","11797-2007","United States","Voluntary: Firm Initiated","E-Mail","CA, KS, KY, TN, TX, UT, VA, WA and Wi to foodservice distributors, food banks and school meal programs","F-0648-2017","Class I","Chicken/BBQ, Item # 61405    ","1,886 cases","A potential for Listeria monocytogenes contamination was verified by the sunflower kernel raw material supplier.","12/08/2016",," Lot #'s: 1) 5321, 2) 5327, 3) 6006, 4) 6048, 5) 6078, 6) 6118, 7) 6127, 8) 6139   Best Used By: 1) 10/21/16 , 2) 10/21/16, 3) 11/16/16, 4) 12/18/16, 5) 12/16/16 & 1/22/17, 6) 1/22/17, 7) 12/16/16, 8) 12/16/16",5/19/2016,"05/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74241,"Ongoing","Fresenius Medical Care Renal Therapies Group, LLC","920 Winter St",,"Waltham","MA","02451-1521","United States","Voluntary: Firm Initiated","Letter","Distributed US (nationwide)","Z-2044-2016","Class II","Crit Line in a Clip (CLiC). CliC P/N: CL 10041001  CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment.  Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows:  Model:   190895  2008T GEN 2 BIBAG w/o CDX  190713  2008T Hemodialysis SYS with CDX  190858  2008T Hemodialysis System w/o CDX  190766  2008T Hemodialysis System  w/o CDX        ","875 units","Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.","06/21/2016",," S/N:  1C01M140014  1C01M140015  1C01M140020  1C01M140046  1C01M140050  1C01M140055  1C01M140063  1C01M140071  1C01M140075  1C01M140090  1C31M140024  1C31M140025  1C31M140026  1C31M140027  1C31M140028  1C31M140036  1C31M140037  1C31M140058  1C32M140015  1C32M140018  1C32M140019  1C32M140049  1C32M140050  1C32M140051  1C32M140061  1C40M140081  1C40M140086  1C40M140087  1C40M140088  1C41M140001  1C41M140002  1C41M140005  1C41M140085  1C41M140086  1C41M140110  1C41M140117  1C41M140118  1C41M140123  1C41M140124  1C41M140146  1C41M140163  1C41M140180  1C41M140186  1C41M140196  1C41M140215  1C41M140217  1C41M140223  1C41M140236  1C41M140247  1C41M140252  1C41M140257  1C41M140277  1C41M140282  1C41M140285  1C41M140288  1C41M140291  1C41M140306  1C41M140307  1C41M140308  1C41M140312  1C41M140318  1C42M140011  1C42M140012  1C42M140026  1C42M140040  1C42M140044  1C42M140051  1C42M140058  1C42M140061  1C42M140070  1C42M140078  1C42M140081  1C42M140086  1C42M140091  1C42M140120  1C42M140124  1C42M140125  1C42M140127  1C42M140155  1C42M140163  1C42M140198  1C42M140227  1C42M140270  1C43M140006  1C43M140007  1C43M140028  1C43M140042  1C43M140043  1C43M140049  1C43M140050  1C43M140055  1C43M140058  1C43M140099  1C43M140104  1C43M140109  1C43M140122  1C43M140123  1C43M140124  1C43M140126  1C43M140127  1C43M140169  1C43M140170  1C43M140172  1C43M140173  1C43M140175  1C43M140176  1C43M140189  1C43M140197  1C43M140199  1C43M140201  1C43M140202  1C43M140203  1C43M140209  1C43M140230  1C43M140231  1C43M140233  1C43M140234  1C43M140248  1C43M140251  1C43M140252  1C43M140253  1C43M140254  1C43M140258  1C43M140261  1C43M140263  1C43M140265  1C43M140266  1C43M140270  1C43M140278  1C43M140279  1C43M140282  1C43M140286  1C43M140287  1C43M140290  1C43M140294  1C43M140295  1C43M140298  1C43M140300  1C43M140301  1C43M140302  1C43M140306  1C43M140310  1C43M140313  1C43M140314  1C43M140332  1C43M140333  1C43M140360  1C43M140390  1C43M140392  1C43M140409  1C43M140422  1C43M140424  1C44M140001  1C44M140002  1C44M140005  1C44M140011  1C44M14001",5/24/2016,"05/24/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74242,"Completed","Unomedical As","Aholmvej 1  3 Osted",,"Roskilde",,,"Denmark","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, IN, PA, and Internationally  to Canada, Korea, and Japan.","Z-0359-2017","Class II","  The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin","9,782,880 units","Tubing detachment","11/03/2016",," 5031734, 5034234, 5034311, 5035640, 5036333, 5037019, 5037922, 5037923, 5039570, 5040033, 5040162, 5040476, 5041194, 5043391, 5043392, 5046554, 5047941, 5048106, 5048106, 5049985, 5051351, 5052913, 5053724, 5054982, 5056181, 5056651, 5057784, 5059432, 5059299, 5059931, 5064182, 5064183, 5064848, 5064849, 5066434, 5066634, 5967602, 5067603, 5076272, 5032622, 5032758, 5034233, 5034310, 5035639, 5037920, 5037921, 5037930, 5039572, 5040161, 5043390, 5046552, 5048407, 5050059, 5051349, 5051349, 5066394, 5067601, 5075676, 5032623, 5038026, 5038063, 5038064, 5038065, 5040032,  5040475, 5049408, 5042573, 5044092, 5048408, 5049833, 5051350, 5052912, 5053723, 5057783, 5058431, 5059298, 5061640, 5070165, 5072741, 5031735, 5031736, 5032662, 5032663, 5034236, 5035643. 5035644, 5037021, 5038839, 5039986, 5039987, 5040035, 5040163, 5042478, 5042575, 5042576, 5042714, 5042715, 5043393, 5046462, 5046463, 5046558, 5047107, 5047491, 5047942, 5047943, 5050056, 5050057, 5051352, 5051353, 5051354, 5057791, 5058433, 5059933, 5061646, 5061670, 5061967, 5063527, 5063528, 5063628, 5066395, 5067505, 5067604, 5067605, 5070166, 5070833, 5070834, 5072351, 5030865, 5031737, 5031738, 5032665, 5032670, 5032671, 5032759, 5032760, 5033423, 5033424, 5034312, 5034313, 5034314, 5034315, 5034316, 5036334, 5038842, 5038843, 5039574, 5039988, 5039989, 5039990, 5039991, 5039992, 5039993, 5040164, 5040165, 5041846, 5041847, 5041848, 5041855, 5041856, 5042469, 5042470, 5042471, 5042549, 5042550, 5042592, 5042593, 5043394, 5043395, 5043396, 5043397, 5043398, 5043399, 5043400, 5042548, 5046464, 5046465, 5046560, 5046561, 5046562, 5046563, 5047497, 5047498, 5048108, 5048409, 5048410, 5049133, 5049134, 5049568, 5049569, 5049570, 5050058, 5051355, 5051356, 5051357, 5051358, 5052914, 5053725, 5053726, 5054287, 5054288, 5055346, 5055347, 5055389, 5055390, 5055391, 5059936, 5056165, 5056167, 5056174, 5057107, 5057108, 5057785, 5057786, 5058434, 5058435, 5058436, 5059300, 5059301, 5059302, 5059934, 5059935, 5059937, 5060839, 5060840, 5060841, 5061641, 5063529, ",11/7/2014,"11/07/2014",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74242,"Completed","Unomedical As","Aholmvej 1  3 Osted",,"Roskilde",,,"Denmark","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, IN, PA, and Internationally  to Canada, Korea, and Japan.","Z-0355-2017","Class II","  The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin","1,295,515 units","Tubing detachment","11/03/2016",," 5021247, 5021251, 5021253, 5029813, 5031819, 5031820, 5031821, 5031822, 5031823, 5032577, 5032578, 5033752, 5033753, 5033754, 5033755, 5034062, 5034063, 5034064, 5034199, 5034200, 5035085, 5035086, 5035098, 5035099, 5035100, 5037024, 5037025, 5038106, 5038107, 5038108, 5038109, 5038110, 5040382, 5040939, 5040940, 5040941, 5040942, 5040943, 5040944, 5040945, 5040946, 5041053, 5041054, 5041055, 5041056, 5041057, 5043820, 5044874, 5044875, 5044876, 5044877, 5044878, 5044879, 5044880, 5044881, 5044882, 5047110, 5047111, 5047112, 5047113, 5047115, 5047116, 5047117, 5047118, 5047119, 5047121, 5051915, 5053663, 5053664, 5053665, 5053666, 5053667, 5053668, 5053669, 5053670, 5054453, 5054455, 5054456, 5054457, 5054458, 5054459, 5054460, 5054467, 5056817, 5056855, 5056856, 5056857, 5058622, 5058632, 5058636, 5058638, 5058639, 5058640, 5058641, 5058642, 5058735, 5060034, 5060036, 5060037, 5060038, 5060042, 5062768, 5062779, 5062781, 5062782, 5062783, 5062796, 5062814, 5062815, 5065701, 5066393, 5066981, 5066984, 5066992, 5067121, 5067122, 5067123, 5067124, 5067126, 5067127, 5067128, 5067129, 5067130, 5067131, 5067132, 5067133, 5067134, 5067137, 5070832, 5071891, 5071892, 5075507, 5075508, 5075510, 5075533, 5076039, 5077501, 5035530, 5035531, 5035532, 5054472, 5054473, 5054474, 5054479, 5054480, 5063759, 5063760, 5063761   ",11/7/2014,"11/07/2014",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74242,"Completed","Unomedical As","Aholmvej 1  3 Osted",,"Roskilde",,,"Denmark","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, IN, PA, and Internationally  to Canada, Korea, and Japan.","Z-0358-2017","Class II","Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1  The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin","22,114 units","Tubing detachment","11/03/2016",," 5048997, 5048998, 5048999, 5052118, 5052332, 5052333, 5052334, 5063721, 5066962, 5066963, 5066964",11/7/2014,"11/07/2014",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74242,"Completed","Unomedical As","Aholmvej 1  3 Osted",,"Roskilde",,,"Denmark","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, IN, PA, and Internationally  to Canada, Korea, and Japan.","Z-0360-2017","Class II",", Paradigm  The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin","4,748,000 units","Tubing detachment","11/03/2016",," 5038783, 5040464, 5042582, 5042584, 5043414, 5043415, 5046638, 5046639, 5047168, 5049122, 5052903, 5052904, 5056680, 5057219, 5057241, 5057953, 5060205, 5061496, 5063694, 5064402, 5068516, 5068555, 5071403, 5072333, 5073682, 5075554, 5076349, 5043121, 5044843, 5057215, 5064141, 5068515, 5035649, 5035690, 5039578, 5039579, 5039580, 5039581, 5040158, 5040159, 5040465, 5040466, 5040467, 5040468, 5042578, 5042580, 5042581, 5043094, 5043095, 5043100, 5043106, 5043387, 5043417, 5043418, 5043419, 5046393, 5046395, 5046396, 5046640, 5046641, 5047170, 5047171, 5047510, 5047511, 5047580, 5047581, 5047582, 5049123, 5050034, 5050035, 5050036, 5051560, 5051561, 5051562, 5052905, 5052906, 5053786, 5053787, 5053788, 5054558, 5054559, 5055496, 5055497, 5056681, 5056682, 5057047, 5057221, 5057226, 5057231, 5057232, 5057242, 5057243, 5057251, 5057954, 5057955, 5060206, 5060207, 5060208, 5060946, 5060947, 5060948, 5060949, 5060988, 5060989, 5063695, 5063696, 5064142, 5064143, 5064144, 5064145, 5065089, 5065090, 5065106, 5066445, 5066513, 5066514, 5066524, 5067182, 5067183, 5067587, 5067589, 5067590, 5068518, 5068520, 5068522, 5070664, 5072716, 5072717, 5075402, 5075403, 5075555, 5075556, 5075557, 5076350, 5077461, 5077462, 5078949, 5053658, 5064299, 5032640, 5039582, 5039589, 5040469, 5041195, 5043329, 5043420, 5043421, 5046397, 5047172, 5047175, 5047583, 5049124, 5050037, 5051563, 5052907, 5053661, 5056683, 5057244, 5058702, 5058704, 5059523, 5059551, 5059552, 5060209, 5060950, 5061497, 5063697, 5064403, 5066515, 5067184, 5067592, 5068528, 5071405, 5072347, 5072718, 5075404, 5075558, 5077463, 5038779, 5032646, 5040470, 5040471, 5041196, 5043112, 5043114, 5043422, 5043423, 5044841, 5047177, 5047584, 5050038, 5051564, 5052908, 5055463, 5055465, 5056684, 5057245, 5060210, 5060951, 5060952, 5060990, 5067185, 5067593, 5068526, 5070666, 5071406, 5072719, 5075405, 5077464, 5078950, 5057216, 5032652, 5040472, 5040473, 5043117, 5043425, 5043426, 5043427, 5046644, 5046645, 5047179, 5049125, 5053789, 5055498, 5058706, 5058708, 5059553, 5",11/7/2014,"11/07/2014",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74242,"Completed","Unomedical As","Aholmvej 1  3 Osted",,"Roskilde",,,"Denmark","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, IN, PA, and Internationally  to Canada, Korea, and Japan.","Z-0356-2017","Class II","  The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin","664,000 units","Tubing detachment","11/03/2016",," 5031810, 5034061, 5034232, 5035097, 5036348, 5038182, 5038183, 5038184, 5038185, 5038186, 5038187, 5038188, 5040990, 5040991, 5040992, 5041073, 5041074, 5045147, 5045148, 5047241, 5047242, 5047243, 5047245, 5048097, 5053689, 5054465, 5054466, 5054550, 5054553, 5054554, 5057103, 5057104, 5057105, 5057106, 5058633, 5058637, 5058731, 5058732, 5058733, 5058734, 5062769, 5062770, 5062780, 5062811, 5062812, 5062813, 5066512, 5066999, 5067219, 5067220, 5067221, 5067222, 5067223, 5067224, 5067225, 5067226, 5067574, 5068464, 5068465, 5071889, 5073670, 5073671, 5075505, 5075509, 5076078, 5054475, 5054476, 5054477, 5054478, 5063762, 5063763  ",11/7/2014,"11/07/2014",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74242,"Completed","Unomedical As","Aholmvej 1  3 Osted",,"Roskilde",,,"Denmark","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, IN, PA, and Internationally  to Canada, Korea, and Japan.","Z-0357-2017","Class II","AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs  The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin","653,280 units","Tubing detachment","11/03/2016",," 5032433, 5033654, 5037164, 5040419, 5044362, 5046682, 5051308, 5053298, 5058508, 5061927, 5062202, 5065546, 5069297, 5072252, 5075118, 5044359, 5053289, 5061929, 5032436, 5033657, 5037159, 5040420, 5044355, 5046683, 5051309, 5053299, 5058501, 5061928, 5062205, 5065539, 5069295, 5072249, 5032442, 5033662, 5037162, 5040424, 5044361, 5051304, 5053292, 5058505, 5061931, 5061933, 5062208, 5032438, 5037160, 5044360, 5051310, 5053300, 5062211, 5069296, 5072253, 5032439, 5032440, 5033659, 5033660, 5037161, 5040422, 5044365, 5046684, 5051303, 5053297, 5058503, 5061939, 5062212, 5065550, 5065551, 5069298, 5072250, 5075121, 5032441, 5033661, 5037167, 5040423, 5044366, 5046681, 5051311, 5053293, 5058504, 5061930, 5065552, 5069301, 5072254, 5033658, 5044363, 5062206, 5062207, 5065540, 5065541, 5065542, 5069302, 5072251  ",11/7/2014,"11/07/2014",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1903-2016","Class I","Integrated Food Service  Turkey Sausage & Cheese Bagel Thin Sandwich  Code #809013",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1911-2016","Class I","Integrated Food Service  Low Sodium, Reduced Fat   Chili Cheese Dog  Chicken Hot Dog with Chili & Cheese on a Whole Grain Hot Dog Bun  Code #C95200/952000  ",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1900-2016","Class I","Integrated Food Service  All American Cheese Burger  Beef Patty and Cheese on a Whole Grain Bun  Code #471007/C47107-CH",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1909-2016","Class I","Integrated Food Service  Chicken Hot Dog   on a Whole Grain Bun  Code #941500",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1908-2016","Class I","Integrated Food Service  Bean & Cheese Chalupa-Bulk  Code #C82705/827005",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1913-2016","Class I","Integrated Food Service  Beef Sausage Sandwich  Beef Sausage Patty on a Whole Grain Hawaiian Bun  Code #990018  ",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1893-2016","Class I","Integrated Food Service  Turkey Breast & Cheese Sandwich  on a Whole Grain Ciabatta Roll  Code #C16006/160006",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1886-2016","Class I","Integrated Food Service  Turkey Ham & Cheese Sandwich   on a Whole Grain Knot Roll  Code #130008/C13008",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1912-2016","Class I","Integrated Food Service  Original Wienerschnitzel  Chili Cheese Dog  All Meat Hot Dog with Chili & Cheese on a Whole Grain Hot Dog  Code #C96100/960000  ",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1892-2016","Class I","Integrated Food Service  Turkey Breast & Cheese Sandwich  on a Whole Grain French Roll  Code #C16001/160001",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1907-2016","Class I","Integrated Food Service  Chicken Little Sliders-Wrapped  Code #809050",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1877-2016","Class I","Cafe Favorites  Turkey Ham & Cheese Deli Flatz  Code #C22148/22148",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1887-2016","Class I","Integrated Food Service  Turkey Ham & Cheese Sandwich   on a Whole Grain Hawaiian Bun  Code #130018/C13018",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1878-2016","Class I","Integrated Food Service  Turkey Ham & Cheese Sandwich  Code #C13001/130001",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1888-2016","Class I","Integrated Food Service  Submarine on a French Roll  Turkey Bolo, Turkey Salami and Cheese on a Whole Grain French Roll  Code #C14001/140001",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1883-2016","Class I","Cafe Favorites  Cold Cut Combo on a Whole Grain Knot Roll  Code #C02372/02372",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1891-2016","Class I","Integrated Food Service  Turkey Breast Combo on a Whole Grain Knot Roll  Code #C15008/150008",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1881-2016","Class I","Cafe Favorites  Oven Roasted Turkey Breast & Cheese Melt on Knot Roll  Code #C02272/02272",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1894-2016","Class I","Cafe Favorites  Oven Roasted Turkey Breast & Cheese Deli Flatz-IW  Code #C22348/22348",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1890-2016","Class I","Integrated Food Service  Submarine Sandwich on a Whole Grain Ciabatta Roll  Code #C14006/140006",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1896-2016","Class I","Integrated Food Service  Chicken Patty Sandwich  Chicken Patty on a Whole Grain Bun  Code #400003",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1882-2016","Class I","Cafe Favorites  Oven Roasted Turkey Breast Sub  Code #C02284/02284",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1905-2016","Class I","Integrated Food Service  Chicken Double Dogs  on Whole Grain Buns  Code #809021",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1885-2016","Class I","Integrated Food Service  Turkey Bologna & Cheese Sandwich  Turkey Bologna on a whole Grain French Roll  Code #C12001/120001",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1889-2016","Class I","Integrated Food Service  Italian Submarine Sandwich  Code #C140004/C14004",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1902-2016","Class I","Cafe Favorites  Turkey Sausage & Cheese Sunrise Twist  Code #C52140/52140",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1906-2016","Class I","Integrated Food Service  Chili Cheese Dog  on Whole Grain Buns  Code #809022",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1876-2016","Class I","Cafe Favorites  Turkey Ham, Egg & Cheese Sunrise Twist  Code #C51140/51140",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1899-2016","Class I","Integrated Food Service  Cheeseburger Sliders  Mini Slider Beef Patty and Cheese on a Whole Grain Bun  Code #470220/C47220-CH",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1901-2016","Class I","Integrated Food Service  Teriyaki Burger  Beef Patty on a Whole Grain Hawaiian Bun  Code #C48008",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1879-2016","Class I","Cafe Favorites  Turkey Ham & Cheese Melt on a Knot Roll  Code #C02172/02172",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1884-2016","Class I"," Super Sub on a Whole Grain Hoagie-IW  Code #C02384/02384",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1914-2016","Class I","Integrated Food Service  Egg & Cheese Bagel Thin Sandwich  Code #C38004/380004  ",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1910-2016","Class I","Integrated Food Service  Chili Cheese Dog  Whole Grain Hot Dog Bun, Chicken Frank, Chili Sauce and Reduced Sodium Reduced Fat American Cheese  Code #C95150/951500  ",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1897-2016","Class I","Integrated Food Service  BBQ Rib Sandwich  BBQ Rib Beef Patty on a Whole Grain Roll  Code #460007",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1898-2016","Class I","Integrated Food Service  All America Burger  Beef Patty on a Whole Grain Bun  Code #470007",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1895-2016","Class I","Cafe Favorites  Italian Deli Flatz  Code #C22548/22548",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1880-2016","Class I","Cafe Favorites  Turkey Ham & Cheese Submarine  Code #C02184/02184",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74243,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.     No foreign distribution.","F-1904-2016","Class I","Integrated Food Service  Beef Sausage & Cheese on a Mini Bagel  Code #809016/C80916-CH  Code #C80916",,"Potential Listeria monocytogenes contamination.","08/05/2016",," Lot #040115-050616",5/23/2016,"05/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74244,"Ongoing","Troyer Cheese Inc","6597 CR 625",,"Millersburg","OH","44654-9274","United States","Voluntary: Firm Initiated","Telephone","Prodeuct was shipped to the following states: AL, AR, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NJ, OH, OK, PA, SC, TN, TX, UT, VA, WI & WV.","F-0708-2017","Class I","BACKROAD COUNTRY WALNUTS HALVES & PIECES, Net Wt. 6 oz (170g)   Product Code 15318 BEST IF USED BY 05/2017","24 cs/12/6 oz bags","The product has been recalled because it has the potential to be contaminated with Listeria monocytogenes.","12/14/2016",," Product Code 15318 BEST IF USED BY 05/2017",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74244,"Ongoing","Troyer Cheese Inc","6597 CR 625",,"Millersburg","OH","44654-9274","United States","Voluntary: Firm Initiated","Telephone","Prodeuct was shipped to the following states: AL, AR, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NJ, OH, OK, PA, SC, TN, TX, UT, VA, WI & WV.","F-0705-2017","Class I","BACKROAD COUNTRY CRANBERRY NUT DELIGHT MIX, Net Wt. 9 oz (256g)   Product Code 15359 BEST IF USED BY 05/2017","31 cs/12/9 oz bags","The product has been recalled because it has the potential to be contaminated with Listeria monocytogenes.","12/14/2016",," Product Code 15359 BEST IF USED BY 05/2017",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74244,"Ongoing","Troyer Cheese Inc","6597 CR 625",,"Millersburg","OH","44654-9274","United States","Voluntary: Firm Initiated","Telephone","Prodeuct was shipped to the following states: AL, AR, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NJ, OH, OK, PA, SC, TN, TX, UT, VA, WI & WV.","F-0706-2017","Class I","BACKROAD COUNTRY HONEY ISLAND CRUNCH MIX ,Net Wt. 9 oz (256g)   Product Code 15356 BEST IF USED BY 05/2017","37 cs/12/9 oz bags","The product has been recalled because it has the potential to be contaminated with Listeria monocytogenes.","12/14/2016",," Product Code 15356 BEST IF USED BY 05/2017",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74244,"Ongoing","Troyer Cheese Inc","6597 CR 625",,"Millersburg","OH","44654-9274","United States","Voluntary: Firm Initiated","Telephone","Prodeuct was shipped to the following states: AL, AR, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NJ, OH, OK, PA, SC, TN, TX, UT, VA, WI & WV.","F-0707-2017","Class I","BACKROAD COUNTRY PEANUT BUTTER PRETZELS, Net Wt. 7 oz (198g)  Product Code 15372 BEST IF USED BY 05/2017","71 cs/12/7 oz bags","The product has been recalled because it has the potential to be contaminated with Listeria monocytogenes.","12/14/2016",," Product Code 15372 BEST IF USED BY 05/2017",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74244,"Ongoing","Troyer Cheese Inc","6597 CR 625",,"Millersburg","OH","44654-9274","United States","Voluntary: Firm Initiated","Telephone","Prodeuct was shipped to the following states: AL, AR, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NJ, OH, OK, PA, SC, TN, TX, UT, VA, WI & WV.","F-0709-2017","Class I","BACKROAD COUNTRY ROASTED AND SALTED SUNFLOWER SEEDS ,Net Wt. 30 lb bag, UPC 1 13671 02091 5   Product Code 15318 BEST IF USED BY 05/2017","65/30 lb bags","The product has been recalled because it has the potential to be contaminated with Listeria monocytogenes.","12/14/2016",," Product Code 15318 BEST IF USED BY 05/2017",5/23/2016,"05/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74245,"Ongoing","Leica Biosystems Richmond Inc.","5205 Route 12",,"Richmond","IL","60071","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution. US nationwide; Portugal, Spain, Thailand,  Italy, China, Romania, Egypt,  India, France,  Hungary, Mexico, Germany, Norway,  Turkey,  Pakistan, Malaysia, UK, Luxembourg, Israel, Canada, Switzerland, Taiwan, South Africa, Saudi Arabia, Korea, Singapore and Japan.","Z-2039-2016","Class III","CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.","283 systems","Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed.   These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.","06/20/2016",," System	23CAP001KXX001 with Serial Number 201021, System 23CAP001KXX001 with Serial Number 201020, System 23CAP001KXX001 with Serial Number	200994, System 23CAP001KFX001 with Serial Number	200752, System 23GSLXXXKFXUPG with Serial Number 201013, System 23GSLXXXKFXUPG with Serial Number 201050, System	23CAP007FXX001 with Serial Number	200930, System	 23CAP002KFX001 with Serial Number	201000, System 23CAP001KXX001	  with Serial Number	200969, System 23CAP001KFX001	with Serial Number 200942, System	23GSL120KFX001 with Serial Number	200910, System 23CAP001FXX001	  with Serial Number	200710, System	23GSLXXXKFXUPG		 with Serial Number	200890, System 23GSL120KFX001		 with Serial Number	201001System	 23CAP002FXX001		 with Serial Number	200889, System	23GSLXXXKFXUPG with Serial Number	201087, System	23CUP003CVX720		 with Serial Number 201086, System	23GSL10XKXX001		 with Serial Number	201085, System 23REV001XXX001	  with Serial Number	201084, System	23REV001XXX001		 with Serial Number	201083, System	23REV001XXX001		 with Serial Number 201082, System	23REV001XXX001		 with Serial Number	201081, System	23REV001XXX001		 with Serial Number	201080, System 23REV001XXX001	  with Serial Number	201079, System	23REV001XXX001		 with Serial Number	201078, System	23REV001XXX001		 with Serial Number 201077, System	23REV001XXX001		 with Serial Number	201076, System	23CUP001CVX720		 with Serial Number	201056  System 	23CUP001CVMV4		 with Serial Number	200921, System	23CUP001CVX720	 with Serial Number	200920, System	23CAP001FXX001		 with Serial Number	201004, System	23CUP001CVX720		 with Serial Number	200922, System	23CUP003CVX720		 with Serial Number	200749, System	23CUP001CVX720		 with Serial Number	200748, System	23CUP001CVX720	 with Serial Number	200747, System	23CUP001CVX720		 with Serial Number	200996, System	23CUP003CVX720		 with Serial Number	200980, System	23REV000KXX001		 with Serial Number	200973, System	23REV000KXX001		 with Serial Number	200972, System	23REV000KXX001	 with Serial Number	200971, System	23CW4000UP002		 with S",5/2/2016,"05/02/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74246,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","424 S Mesa Hills Dr",".","El Paso","TX","79912-5441","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0559-16","Class III"," Pooled Cryoprecipitated AHF","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","06/03/2016","06/03/2016"," W0411150461440 ",4/18/2016,"04/18/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74247,"Terminated","American National Red Cross Southeastern Michigan Region","100 Mack Ave",,"Detroit","MI","48201-2416","United States","Voluntary: Firm Initiated","FAX","Michigan","B-0560-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Apheresis product, for which the residual white blood cell count testing was not performed, was distributed.","05/31/2016","05/31/2016"," W20131581458400",2/11/2016,"02/11/2016",6/8/2016,"06/08/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74249,"Ongoing","Amerx Health Care Corp.","1300 S Highland Ave",,"Clearwater","FL","33756-6519","United States","Voluntary: Firm Initiated","E-Mail","AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska.   Bahrain & Colombia.","Z-2249-2016","Class II","Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. ","6,993 Units","Product did not meet specifications for Zinc Acetate (OOS).","07/20/2016",," Lot # 668",5/20/2016,"05/20/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74250,"Ongoing","Nu Life Market LLC","1202 E 5th St",,"Scott City","KS","67871-4155","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed to CA, IL, and MI. There was no foreign/military/government distribution.","F-1927-2016","Class I","Sun Life Natural Sunflower Spread in clear plastic jar with brown plastic lid, Net Wt. 12 oz., UPC 855881003370. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.","128 jars (96 lbs.)","Product manufactured with roasted sunflower kernels which may be contaminated with Listeria monocytogenes.","08/15/2016",," lot 5266A1, best by 6/17/2016;  and lot 5315A1, best by 8/5/2016",5/19/2016,"05/19/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74250,"Ongoing","Nu Life Market LLC","1202 E 5th St",,"Scott City","KS","67871-4155","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed to CA, IL, and MI. There was no foreign/military/government distribution.","F-1926-2016","Class I","Sun Life Enjoy Life Sunflower Spread, Net Wt.. 40 lbs (18.18 kg).  The responsible name on the label is Nu Life Market, LLC, Scott City, KS.","87,840 lbs.","Product manufactured with roasted sunflower kernels which may be contaminated with Listeria monocytogenes.","08/15/2016",," lot 5216E1, exp. date 5/4/2016;  lot 5217E1, exp. date 5/5/2016;  lot 5218E1, exp. date 5/6/2016;  lot 5222E1, exp. date 5/10/2016;  lot 5309E1, exp. date 8/5/2016;  lot 5313E1, exp. date 8/9/2016;  lot 5338E1, exp. date 9/4/2016;  lot 5342E1, exp. date 9/8/2016;  lot 5343E1, exp. date 9/9/2016;  lot 5344E1, exp. date 9/10/2016;  lot 6062E1, exp. date 12/2/2016;  lot 6063E1, exp. date 12/3/2016;  lot 6064E1, exp. date 12/4/2016;  lot 6067E1, exp. date 12/7/2016;  lot 6077E1, exp. date 12/17/2016;  lot 6103E1, exp. date 1/12/2017;  lot 6104E1, exp. date 1/13/2017;  lot 6105E1, exp. date 1/14/2017;  and lot 6106E1, exp. date 1/15/2017",5/19/2016,"05/19/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74250,"Ongoing","Nu Life Market LLC","1202 E 5th St",,"Scott City","KS","67871-4155","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed to CA, IL, and MI. There was no foreign/military/government distribution.","F-1928-2016","Class I","Sun Life Natural Sunflower Spread with Maple in clear plastic jar with brown plastic lid, Net Wt. 12 oz.., UPC 855881003370. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.","61 jars (45.75 lbs.)","Product manufactured with roasted sunflower kernels which may be contaminated with Listeria monocytogenes.","08/15/2016",," lot 5225B1, best by 5/13/2016;  ",5/19/2016,"05/19/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74250,"Ongoing","Nu Life Market LLC","1202 E 5th St",,"Scott City","KS","67871-4155","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed to CA, IL, and MI. There was no foreign/military/government distribution.","F-1929-2016","Class I","Sun Life Natural Sunflower Spread with Chocolate in clear plastic jar with brown plastic lid, Net Wt. 12 oz.., UPC 855881003370. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.","109 jars (81.75 lbs.)","Product manufactured with roasted sunflower kernels which may be contaminated with Listeria monocytogenes.","08/15/2016",," lot 5246C1, best by 5/28/2016;  ",5/19/2016,"05/19/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74250,"Ongoing","Nu Life Market LLC","1202 E 5th St",,"Scott City","KS","67871-4155","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed to CA, IL, and MI. There was no foreign/military/government distribution.","F-1925-2016","Class I","Sun Life Natural Sunflower Kernel Paste, Net Wt. 40 lbs (18.18 kg) buckets and 450 lbs. (204.12 kg) barrels.  The responsible name on the label is Nu Life Market, LLC, Scott City, KS.","70,670 lbs.","Product manufactured with roasted sunflower kernels which may be contaminated with Listeria monocytogenes.","08/15/2016",," lot 5280D1, exp. 7/7/2016;  lot 5281D1, exp. 7/8/2016;  lot 5282D1, exp. 7/9/2016;  lot 5285D1, exp. 7/12/2016;  lot 5351D1, exp. 9/17/2016;  lot 5352D1, exp. 9/18/2016;  lot 5355D1, exp. 9/21/2016;  lot 5356D1, exp. 9/22/2016;   lot 6082D1, exp: 12/22/2016;  lot 6076D1, exp: 12/16/2016;  lot 6111D1, exp:  4/20/2017;  lot 6112D1, exp:  4/21/2017;  lot 6113D1, exp:  4/22/2017; and  lot 6116D1, exp:  4/25/2017",5/19/2016,"05/19/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74251,"Ongoing","Virtus Pharmaceuticals, Llc","2649 Causeway Center Dr",,"Tampa","FL","33619-6102","United States","Voluntary: Firm Initiated","E-Mail","Nationwide & Puerto Rico.","D-1044-2016","Class III","Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10","24,614 bottles","Chemical Contamination: Bottles may contain broken dessicants","06/20/2016",,"  Lot #: 638J011A",5/13/2016,"05/13/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74252,"Ongoing","Merz North America, Inc.","6501 Six Forks Rd",,"Raleigh","NC","27615-6515","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT and WA.","Z-2607-2016","Class II","Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics.    Product Usage:  RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.  ","1,591 units","Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.","08/19/2016",," Model number: 8063M0K1, Lot #100088744.",5/20/2016,"05/20/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74253,"Ongoing","West-Ward Columbus Inc","1809 Wilson Rd",,"Columbus","OH","43228-9579","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1441-2016","Class III","Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41","1,182 bottles","Failed Impurities/Degradation Specification; 9 month stability","07/14/2016",," Lot #560185A; Exp. 6/30/2017",5/19/2016,"05/19/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74254,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",,"Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV only","V-0001-2017","Class II","APOMORPHINE HCL (VET) 3MG/ML INJECTABLE  Sterile Glass Vials - 5ML  Refrigerated  Well Care Compounding Pharmacy  Las Vegas, NV",,"Firm is performing a recall on all unexpired sterile compounded products due to concerns of lack of sterility assurance. ","10/04/2016",," Lot Code/ Expiry Date  01282016:87@46 05/01/2016;  04012016:92@26 07/02/2016;",5/17/2016,"05/17/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74254,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",,"Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV only","V-0003-2017","Class II","CYCLOSPORINE (A) (VET) 2% OIL OPTH SOLUTION (15mL)  Room Temp  Well Care Compounding Pharmacy  Las Vegas, NV",,"Firm is performing a recall on all unexpired sterile compounded products due to concerns of lack of sterility assurance. ","10/04/2016",," Lot Code/ Expiry Date  12242015:73@5 07/27/2016;   01292016:20@4 07/27/2016;   01292016:20@4 07/27/2016",5/17/2016,"05/17/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74254,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",,"Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV only","V-0002-2017","Class II","CYCLOSPORINE (A) (VET) 1% OIL OPTH Soln  15 mL  Sterile Droptainer  Room Temp  Well Care Compounding Pharmacy  Las Vegas, NV",,"Firm is performing a recall on all unexpired sterile compounded products due to concerns of lack of sterility assurance. ","10/04/2016",," Lot Code/ Expiry Date  02042016:52@15 05/04/2016;   02082016:44@20 05/08/2016;   02222016:67@18 05/22/2016;   02242016:53@45 05/24/2016;   04122016:56@48 07/11/2016;   04282016:66@27 07/27/2016",5/17/2016,"05/17/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74254,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",,"Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV only","V-0004-2017","Class II","CYCLOSPORINE (PF) l% OPTH SUSP (15 mL)   Sterile Droptainer  Room Temp  Well Care Compounding Pharmacy  Las Vegas, NV",,"Firm is performing a recall on all unexpired sterile compounded products due to concerns of lack of sterility assurance. ","10/04/2016",," Lot Code/ Expiry Date   01222016:24@42   02/05/2016;    01262016:51@7     02/09/2016;    01272016:66@40   02/10/2016;    02052016:45@1     02/19/2016;    02152016:78@49   02/29/2016;    04272016:37@17   05/16/2016",5/17/2016,"05/17/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74254,"Ongoing","Well Care Compounding Pharmacy","3430 E Tropicana Ave Ste 9",,"Las Vegas","NV","89121-7345","United States","Voluntary: Firm Initiated","Press Release","NV only","V-0005-2017","Class II","TACROLIMUS OPTH (AQ) 0.02 SOLUTION  Sterile Dropper  Refrigerated  Well Care Compounding Pharmacy  Las Vegas, NV",,"Firm is performing a recall on all unexpired sterile compounded products due to concerns of lack of sterility assurance. ","10/04/2016",," Lot Code/ Expiry Date  01042016:13@5    04/03/2016;   01182016:39@34  04/17/2016;   01262016 :62@48 04/26/2016;   01272016:71@3    04/26/2016;   02232016:42@35  05/23/2016;   03012016: 13@5   04/03/2016;   03072016: 16@43  06/05/2016;   03152016:20@68   06/13/2016;   03242016:92@3     06/22/2016;   04072016:17@9    07/06/2016",5/17/2016,"05/17/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74255,"Ongoing","EN-R-G Foods, Inc.","2620 Copper Ridge Frontage Unit H",,"Steamboat Springs","CO","80487-5007","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and foreign.  No VA/govt/military consignees.","F-0530-2017","Class II"," Protein Chews Raspberry,1.8oz, film package, 12 packets per box.","103,354","EN-R-G Foods is recalling Cherry Lime Protein Chews, Raspberry Protein Chews, Juneberry Protein Chews due to complaints of nausea and/ or vomiting after consumption.","11/23/2016","."," Lot 02149",5/24/2016,"05/24/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74255,"Ongoing","EN-R-G Foods, Inc.","2620 Copper Ridge Frontage Unit H",,"Steamboat Springs","CO","80487-5007","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and foreign.  No VA/govt/military consignees.","F-0531-2017","Class II"," Protein Chews Juneberry,1.8oz, film package, 12 packets per box.","40,079","EN-R-G Foods is recalling Cherry Lime Protein Chews, Raspberry Protein Chews, Juneberry Protein Chews due to complaints of nausea and/ or vomiting after consumption.","11/23/2016","."," Lot 02146",5/24/2016,"05/24/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74255,"Ongoing","EN-R-G Foods, Inc.","2620 Copper Ridge Frontage Unit H",,"Steamboat Springs","CO","80487-5007","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide and foreign.  No VA/govt/military consignees.","F-0529-2017","Class II"," Protein Chews Cherry Lime,1.8oz, film package, 12 packets per box.","72,240 units","EN-R-G Foods is recalling Cherry Lime Protein Chews, Raspberry Protein Chews, Juneberry Protein Chews due to complaints of nausea and/ or vomiting after consumption.","11/23/2016","."," Lot 02152",5/24/2016,"05/24/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74256,"Completed","Blue Buffalo Company","11 River Rd",,"Wilton","CT","06897-6010","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide  Canada","V-518-2016","Class II","Blue Buffalo Life Protection Formula Fish & Sweet Potato Recipe for Dogs, 30 lb bag.    UPC Code:	859610000326	     ",,"Product is contaminated with mold","09/20/2016",," Best by Date April 11, 2017 AH  2A 12:08  14:00",5/26/2016,"05/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74257,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0587-16","Class II","Fresh Frozen Plasma","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","06/23/2016","06/23/2016"," W270113590555; ",5/2/2016,"05/02/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74257,"Terminated","Central Pennsylvania Blood Bank","8167 Adams Dr",,"Hummelstown","PA","17036-8625","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0586-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","06/23/2016","06/23/2016"," W270113590555; ",5/2/2016,"05/02/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74259,"Terminated","American Red Cross Blood Services","3838 Dewey Ave",,"Omaha","NE","68105-1148","United States","Voluntary: Firm Initiated","Telephone","Minnesota","B-0589-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood product, which did not meet the acceptable product specification, was distributed.","06/23/2016","06/23/2016"," W200916866096; ",4/28/2016,"04/28/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74260,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","Switzerland; California","B-0614-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","06/23/2016","06/23/2016"," W333615127417; ",4/14/2016,"04/14/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74260,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","Switzerland; California","B-0615-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","06/23/2016","06/23/2016"," W333616006552; ",4/14/2016,"04/14/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74261,"Terminated","BPL Plasma, Inc.","2575 Sunset Dr",,"San Angelo","TX","76904-7606","United States","Voluntary: Firm Initiated","E-Mail","Israel","B-0590-16","Class II","Source Plasma","3 units","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.","06/23/2016","06/23/2016"," SA0262671; SA0262988; SA0263718; ",4/13/2016,"04/13/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74262,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Canada, Bermuda, Bahamas, Gaum, US Virgin Islands, Mariana Islands","F-1751-2016","Class I","Kashi Chewy Trail Mix Granola Bars  1.2 oz individual bar  6 count retail carton (7.4 oz.), 12 carton per case;  35 count club store carton (42 oz.), 1 carton per case;  12 count food service carton (14.4 oz.), 6 carton per case ",,"Product contains sunflower seeds potentially contaminated with Listeria monocytogenes.  Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. ","07/19/2016",," UPC  6 count retail: 18627 03000;  35 count club store: 18627 10302;  12 count food service: 18627 37948  individual bar: 18627 03200    Better If Used Before Date/Best If Used By Date:   MAR 01 2017 or earlier",5/31/2016,"05/31/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74262,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Canada, Bermuda, Bahamas, Gaum, US Virgin Islands, Mariana Islands","F-1756-2016","Class I","Kashi Whole Grain Bars    35 g individual bar, 18 count retail carton (630 g), 6 cartons per case",,"Product contains sunflower seeds potentially contaminated with Listeria monocytogenes.  Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. ","07/19/2016",," 18 count retail carton  UPC 0 18627 50406 1      Better If Used Before Date/Best If Used By Date:  2016 SE 11 EX  2016 NO 30 EX        ",5/31/2016,"05/31/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74262,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Canada, Bermuda, Bahamas, Gaum, US Virgin Islands, Mariana Islands","F-1752-2016","Class I","Kashi GOLEAN Honey Pecan Baklava Bars  1.59 oz. individual bar  5 count retail carton (7.95 oz.), 6 cartons per case;  8 count carton (12.72 oz.);  12 count food service carton (19 oz.), 1 carton per case",,"Product contains sunflower seeds potentially contaminated with Listeria monocytogenes.  Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. ","07/19/2016",," UPC  5 count retail: 18627 10474;  8 count: 18627 10514  12 count food service: 18627 10471  individual bar: 1862710472    Better If Used Before Date/Best If Used By Date:  Jul 21 2016; Aug 07 2016; Sep 13 2016; Sep 22 2016; Oct 20 2016",5/31/2016,"05/31/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74262,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Canada, Bermuda, Bahamas, Gaum, US Virgin Islands, Mariana Islands","F-1753-2016","Class I","Bear Naked Soft Baked Granola, Cinnamon + Sunflower Butter  11 oz. retail unit, 6 count carton, 1 cartons per case;  26 oz. club store retail unit, 1 count carton, 1 carton per case;  1.2 oz. food service sample unit, 50 count carton, 1 carton per case",,"Product contains sunflower seeds potentially contaminated with Listeria monocytogenes.  Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. ","07/19/2016",," 11 oz. retail unit   UPC 84623 10163  Better If Used Before Date/Best If Used By Date:  AUG 13 2016 to JAN 11 2017     26 oz. club store retail unit   UPC 84623 10173  Better If Used Before Date/Best If Used By Date:  DEC 24 2016 to JAN 13 2017    1.2 oz. Food service sample unit  UPC 84623 10179  Better If Used Before Date/Best If Used By Date:  DEC 02 2016; DEC 03 2016  ",5/31/2016,"05/31/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74262,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Canada, Bermuda, Bahamas, Gaum, US Virgin Islands, Mariana Islands","F-1755-2016","Class I","Kashi Whole Grain Trail Mix Bars   35 g individual bar, 6 count retail carton (210 g), 12 cartons per case",,"Product contains sunflower seeds potentially contaminated with Listeria monocytogenes.  Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. ","07/19/2016",," 6 count retail carton  UPC 18627 43610  individual bar  UPC 18627 43611    Better If Used Before Date/Best If Used By Date:  2017 JA 04 RE  2017 JA 05 RE  2017 JA 06 RE  2017 FE 10 RE      ",5/31/2016,"05/31/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74262,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Canada, Bermuda, Bahamas, Gaum, US Virgin Islands, Mariana Islands","F-1754-2016","Class I","Bear Naked Soft Baked Granola, Pepita + Hemp + Sunflower Butter  10.5 oz. retail unit, 6 count carton, 1 cartons per case;  ",,"Product contains sunflower seeds potentially contaminated with Listeria monocytogenes.  Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. ","07/19/2016",," UPC 84623 10168  Better If Used Before Date/Best If Used By Date:  OCT 14 2016 to DEC 04 2016    ",5/31/2016,"05/31/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74263,"Ongoing","Musculoskeletal Transplant Foundation, Inc.","125 May St Ste 300",,"Edison","NJ","08837-3264","United States","Voluntary: Firm Initiated","Letter","nationwide","Z-2004-2016","Class II","Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.","114 units","AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.","07/07/2016","."," Serial  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  04314046801122  ",4/21/2016,"04/21/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74264,"Completed","Steris Corporation","5960 Heisley Rd",,"Mentor","OH","44060-1834","United States","Voluntary: Firm Initiated","Letter","AL;AK, AZ; AR; CA; CO; CT; DC; FL; GA; IL; IN; IA; NY; NJ; NC; OH; OK; OR; PA; PR; SC; TX; UT and  VA.   Foreign accounts: Canada; France; Korea; Panama; Qatar and Thailand.","Z-2248-2016","Class II","OT1000 Series Orthopedic Surgical Tables","148 ","STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.","07/20/2016",," OT1000, OT1100, and OT1200 Orthopedic Surgical Table",5/23/2016,"05/23/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74265,"Ongoing","Brainlab AG","Kapellenstr. 12",".","Feldkirchen",,,"Germany","Voluntary: Firm Initiated","Letter","Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.","Z-1929-2016","Class II"," ExacTrac Vero is a Patient Positioning System for Radiation therapy.","27 Systems","Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5","06/08/2016",," Potentially affected is ExacTrac Vero version 3.5 (including all subversions). Serial numbers/lot numbers are not applicable for a software version.    Model/catalogue numbers:     20892 EXACTRAC VERO SOFTWARE 3.5  20892A EXACTRAC VERO SOFTWARE 3.5.1  20892B EXACTRAC VERO SOFTWARE 3.5.2  20892C EXACTRAC VERO SOFTWARE 3.5.3  20893 VERO INFRARED POSITIONING/MONITORING SW  46213 EXACTRAC VERO SW UPDATE 3.5 TO 3.5.1  46214 EXACTRAC VERO UPGRADE KIT 3.2 to 3.5 FOC  46215 EXACTRAC VERO UPGRADE KIT 3.1 TO 3.5 FOC  46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3  46228 EXACTRAC VERO 3.5 ROW  46238 EXACTRAC VERO 3.5 JAPAN",5/4/2016,"05/04/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74266,"Terminated","BPL Plasma, Inc.","1400 S Interstate 35",,"San Marcos","TX","78666-6007","United States","Voluntary: Firm Initiated","E-Mail","NC","B-0619-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","07/08/2016","07/08/2016"," SS0490186",4/19/2016,"04/19/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74267,"Terminated","LifeServe Blood Center","431 E Locust St",,"Des Moines","IA","50309-1909","United States","Voluntary: Firm Initiated","Telephone","NB","B-0618-16","Class III","Platelet Pheresis, Leukocytes Reduced, Irradiated","1 unit","Platelet, labeled with an incorrect volume, was distributed.","07/08/2016","07/08/2016"," W037916559443 ",4/18/2016,"04/18/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74268,"Terminated","BPL Plasma, Inc.","2320 E Bell Rd Ste 101",,"Phoenix","AZ","85022-2991","United States","Voluntary: Firm Initiated","E-Mail","KY","B-0617-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","07/08/2016","07/08/2016"," PH0062418",4/5/2016,"04/05/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74269,"Ongoing","Coca-Cola Company  (The)","1 Coca Cola Plz Nw",".","Atlanta","GA","30313-2420","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, CA, IL, IN, IA, MA, MN, NJ, NY, NC,  PA, RI, UT, VA, WA and WI.","F-1436-2016","Class II","Honest Kids-Super Fruit Punch, Organic Juice Drink, 59 fluid oz. bottle, 006 57622 41273 7, Honest Tea, Inc., 4827 Bethesda Ave., Bethesda, MD 20814.","1,164 cases/ 8 bottles per case","The label does not list apple juice ingredient present in the beverage.","06/08/2016",," Date Codes: APR2317BAC1 and APR2317BAD1",5/23/2016,"05/23/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74270,"Ongoing","Par Pharmaceutical","6 Ram Ridge Rd",,"Chestnut Ridge","NY","10977-6713","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico.","D-1038-2016","Class III","Pramipexole Dihydrochloride Extended Release  Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11","12,535 bottles","Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.","06/16/2016",," Lot #s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017",5/28/2016,"05/28/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74271,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.","Z-2090-2016","Class II","LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.","12 units","The surface inside of the femoral component, where cement is applied for adhesion, is below specification.","06/29/2016",," Lot codes:  15LM08792,15LM15638,15LM15639,15MM03011,15MM03012,15MM03014,15MM09814",5/26/2016,"05/26/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74271,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.","Z-2094-2016","Class II","LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.","10 units","The surface inside of the femoral component, where cement is applied for adhesion, is below specification.","06/29/2016",," Lot codes:  15KM09184,15LM08835,15LM08837,15LM08839,15LM08840",5/26/2016,"05/26/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74271,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.","Z-2095-2016","Class II","LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.","97 units","The surface inside of the femoral component, where cement is applied for adhesion, is below specification.","06/29/2016",," Lot codes:  15JM04561,15JM04570,15JM04589,15KM08936,15KM08937,15KM08940,15KM08942,15KM08948,15KM08949,15KM09010,15KM09011,15KM09013,15KM09014,15KM09015,15KM09016,15LM09119,15LM09122,15LM09123,15LM09124,15LM12483,15LM12484,15LM12486,15LM12488,15LM15652,15MM09829,15MM09833,16AM12222,16AM12224,16AM12235,16AM12237,16AM12240,16AM12243,16AM12255,16AM12268",5/26/2016,"05/26/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74271,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.","Z-2092-2016","Class II","LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.","33 units","The surface inside of the femoral component, where cement is applied for adhesion, is below specification.","06/29/2016",," Lot codes:  15KM09161,15KM09163,15KM09175,15KM17714,15KM17800,15KM17806,15KM17809,15KM17817,15LM01258,15LM01259,15LM01260,15LM01261,15LM08803,15LM08816,15LM08820,15LM08821,71421375,15KM09183",5/26/2016,"05/26/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74271,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.","Z-2093-2016","Class II","LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.","16 units","The surface inside of the femoral component, where cement is applied for adhesion, is below specification.","06/29/2016",," Lot codes:  15KM20807,15KM20808,15KM20811,15KM20812,15LM08258,15LM12482,15MM03005,15MM03007",5/26/2016,"05/26/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74271,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.","Z-2091-2016","Class II","LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.","3 units","The surface inside of the femoral component, where cement is applied for adhesion, is below specification.","06/29/2016",," Lot Code:  15LM08798",5/26/2016,"05/26/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74273,"Ongoing","ZYTO Technologies, Inc.","387 S 520 W Ste 200",,"Lindon","UT","84042-1961","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and other foreign consignees. No VA/govt/military.","Z-2121-2016","Class II","The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).","1252 total ","ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance. ","07/01/2016","."," Not Applicable.",11/23/2015,"11/23/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74273,"Ongoing","ZYTO Technologies, Inc.","387 S 520 W Ste 200",,"Lindon","UT","84042-1961","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and other foreign consignees. No VA/govt/military.","Z-2120-2016","Class II","The ZYTO Tower is the input device to program the software with various virtual items. ","1252 total ","ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance. ","07/01/2016","."," Serial Number		  TI2001-TI2003		  TI2021-TI2076		  TI2081-TI2092		  TI2095-TI2104		  TI2105-TI2113		  TI2114-TI2127		  TI2128-TI2138		  TI2139-TI2150		  TI2151-TI2158		  TI2159-TI2211		  TI2212-TI2213		  TI2214-TI2215		  Tl2216		  TI2217-TI2239		  TI2240-TI2279		  Tl2280-Tl2304		  TI2305-TI2314		  Tl2315-Tl2328		  Tl2331		  0114TPN12332-0114TPN12347		  0114TPN12348-0114TPN12372		  0114TPN12373-0114TPN12393		  0114DPN00000-0114DPN00017		  0114TPN12394-0114TPN12401		  0114TPN12402-0114TPN12407		  0114TPN12408-0114TPN12409		  0114TPN12410-0114TPN12414		  0114TPN12415-0114TPN12416		  0115DPN00000-0115DPN00008		  1501TPN00000-1501TPN00003		  1501TPN00004-1501TPN00008		  1501TPN00009-1501TPN00010		  1501TPN00011-1501TPN00018		  1501TPN00019-1501TPN00020		  1502TPN00000-1502TPN00007		  1503TPN00000-1503TPN00007		  1503TPN00008-1503TPN00035		  1503TPN00036-1503TPN00040		  1505TPN00000-1505TPN00002		  1505TPN00003-1505TPN00021		  1506TPN00000-1506TPN00002		  1506TPN00003-1506TPN00005		  1507TPNOOOOO		  1507TPN00001-1507TPN00002		  1507TPN00003-1507TPN00017		  1508TPN00000-1508TPN00004		  1509TPN00000-1509TPN00009		  1509TPN00010-1509TPN00019		",11/23/2015,"11/23/2015",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74274,"Ongoing","Sid Wainer And Son","2301 Purchase St",,"New Bedford","MA","02746-1686","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CT, DC, MA, ME, NC, NH, NJ, NY, PA, RI, TX,VT","F-1613-2016","Class I","Domaine de Provence La Cucina Tart Shells  Produced Exclusively for Sid Wainer& Son, New Bedford, MA  UPC Code: 708152149119  Item Number: 149110","117 cases (252 pieces box)","Product contains undeclared allergen, eggs.","07/05/2016","."," All product",5/27/2016,"05/27/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74274,"Ongoing","Sid Wainer And Son","2301 Purchase St",,"New Bedford","MA","02746-1686","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, CT, DC, MA, ME, NC, NH, NJ, NY, PA, RI, TX,VT","F-1614-2016","Class II","¿ Cone Tart Shells    Produced Exclusively for Sid Wainer & Son, New Bedford, MA  UPC Code: 708152316856    Item Number: 316850    ","166 cases (308 pieces per box)","Product contains undeclared allergen, coconut.","07/05/2016","."," All product",5/27/2016,"05/27/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74275,"Ongoing","Medtronic Sofamor Danek Usa, Inc - Dallas Distribution","4620 N Beach St",,"Haltom City","TX","76137-3219","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT.","Z-2085-2016","Class II","Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.","368 devices","Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.","06/28/2016",," All Serial Numbers.",5/13/2016,"05/13/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74276,"Ongoing","Ev3, Inc.","4600 Nathan Ln N",,"Plymouth","MN","55442-2890","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to LA and WI.","Z-2048-2016","Class II"," over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency","2"," Self-expanding Peripheral Stent Systems, model PRB35-08-040-  080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a  6x40x120mm device as indicated by both the inner pouch and device labels. This potential issue is limited to  two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed.  This does not affect any other Medtronic product or implantable devices.","06/23/2016",," lot: A164580",5/23/2016,"05/23/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74277,"Ongoing","Chelsea Food Service Division of United Airlines","27280 E 75th Ave",,"Denver","CO","80249-6375","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to one store in Colordo.  No foreign, VA/govt/military consignees.","F-2236-2016","Class I","Cookies and Cream, Produced for King Soopers, 6.6 oz. Packaged: Plastic clam shell, Individual unit, King Soopers, Denver CO","216 units","Product label does not declare the allergen, eggs.","09/15/2016",," Sell by 05/21/16",5/19/2016,"05/19/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74278,"Terminated","OneBlood, Inc.","10100 Dr Martin Luther King Jr St N",,"St Petersburg","FL","33716-3806","United States","Voluntary: Firm Initiated","Telephone","FL","B-0645-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.","07/08/2016","07/08/2016"," W036816052788-part 1; W036816052788-part 2 ",5/11/2016,"05/11/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74279,"Terminated","BPL Plasma","301 W Main St",,"Carbondale","IL","62901-2901","United States","Voluntary: Firm Initiated","E-Mail","NC","B-0644-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.","07/08/2016","07/08/2016"," CD0511233",4/2/2016,"04/02/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74280,"Ongoing","Siemens Healthcare Diagnostics Inc.","101 Silvermine Rd",,"Brookfield","CT","06804-2047","United States","Voluntary: Firm Initiated","Letter","Nationwide: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV.","Z-2087-2016","Class II","Hettich Centrifuge Modules:  StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836)  Aptio Centrifuge Module (10703032 or 10713761)  FlexLab High Throughput Centrifuge Module (11171747)  FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.","487 ","Premature bucket failures ","06/29/2016",," All serial numbers are affected.",5/11/2016,"05/11/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74281,"Ongoing","Sweet Earth Inc.","3080 Hilltop Road",,"Moss Landing","CA","95039","United States","Voluntary: Firm Initiated","Press Release","FL, TX, OH, IN, OR, CA, WA, WI.","F-1526-2016","Class I","Big Sur Breakfast Burrito;  A delicious blend of roasted potatoes & red peppers, smoked  seitan and seasoned tofu.  Net Wt. 7.0 oz. (198 g).    Ingredients: Filling: Russet Potatoes, tofu (water, soybeans, Calcium sulfate, Calcium chloride, Sweet Earth Traditional Seitan (water, wheat gluten, soy sauce (water soybeans,  wheat,  salt, alcohol), ginger, garlic, lemon, roasted red peppers, yellow onions, canola oil,  nutritional yeast, sea salt,  natural hickory smoke,  turmeric and spices.  Wrap - ,water. unbleached white flour , Non GMO expeller, pressed canola oil, salt, baking powder (sodium bicarbonate, sodium acid  pyrophosphate, potato starch), yeast, citric acid.    Contains, Soy, wheat.    UPC - 7 oz. unit: #016741111127;  UPC - 12-pack case: #016741111134    Sweet Earth Natural Foods, Moss Landing, CA 95039.","1214 cases (12x7oz units per case)","Packaging error where a small quantity of Sana Cruz Burritos were packaged in Big Sur Burrito pouches and do not properly declare milk as an ingredient or allergen.","06/18/2016",," Lot 6090  Best By 3/30/2017",5/27/2016,"05/27/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74282,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Other","US Distribution to Illinois","Z-2081-2016","Class II","CENTURION Vision System","1 unit","The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.","06/28/2016",," Serial Number 1601444801X",5/24/2016,"05/24/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74283,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD,  TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-2153-2016","Class II","6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.","19,497,844 units in total","Labeling does not match the cleared indications for use in the United States and Canada.","07/11/2016",," Many affected part numbers",2/16/2016,"02/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74283,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD,  TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-2156-2016","Class II","4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.","19,497,844 units in total","Labeling does not match the cleared indications for use in the United States and Canada.","07/11/2016",," Many affected part numbers",2/16/2016,"02/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74283,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD,  TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-2157-2016","Class II","4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.","19,497,844 units in total","Labeling does not match the cleared indications for use in the United States and Canada.","07/11/2016",," Many affected part numbers",2/16/2016,"02/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74283,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD,  TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-2152-2016","Class II","6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.","19,497,844 units in total","Labeling does not match the cleared indications for use in the United States and Canada.","07/11/2016",," Many affected part numbers",2/16/2016,"02/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74283,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD,  TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-2155-2016","Class II","4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.","19,497,844 units in total","Labeling does not match the cleared indications for use in the United States and Canada.","07/11/2016",," Many affected part numbers",2/16/2016,"02/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74283,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD,  TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-2154-2016","Class II","7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.","19,497,844 units in total","Labeling does not match the cleared indications for use in the United States and Canada.","07/11/2016",," Many affected part numbers",2/16/2016,"02/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74283,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD,  TN, TX, UT, VA, VT, WA, WI, WV, and WY.","Z-2158-2016","Class II","3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone    Product Usage:  Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.  ","19,497,844 units in total","Labeling does not match the cleared indications for use in the United States and Canada.","07/11/2016",," Many affected part numbers",2/16/2016,"02/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74284,"Ongoing","WHOLE FOODS MARKET","2520 Glendale Blvd",,"Los Angeles","CA","90039-3220","United States","Voluntary: Firm Initiated","E-Mail","U.S. distirbution to CA only (Los Angeles).    No foreign distribution.","F-1691-2016","Class I","White Kimchi","4lbs.","Undeclared fish, shellfish, and/or tree nuts.","07/15/2016",," Offered between 05/25-27/2016",5/27/2016,"05/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74284,"Ongoing","WHOLE FOODS MARKET","2520 Glendale Blvd",,"Los Angeles","CA","90039-3220","United States","Voluntary: Firm Initiated","E-Mail","U.S. distirbution to CA only (Los Angeles).    No foreign distribution.","F-1689-2016","Class I","Spicy Kimchi","4lbs","Undeclared fish, shellfish, and/or tree nuts.","07/15/2016",," Offered between 05/25-27/2016",5/27/2016,"05/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74284,"Ongoing","WHOLE FOODS MARKET","2520 Glendale Blvd",,"Los Angeles","CA","90039-3220","United States","Voluntary: Firm Initiated","E-Mail","U.S. distirbution to CA only (Los Angeles).    No foreign distribution.","F-1690-2016","Class I","Kimchi Fried Rice","4lbs","Undeclared fish, shellfish, and/or tree nuts.","07/15/2016",," Offered between 05/25-27/2016",5/27/2016,"05/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74284,"Ongoing","WHOLE FOODS MARKET","2520 Glendale Blvd",,"Los Angeles","CA","90039-3220","United States","Voluntary: Firm Initiated","E-Mail","U.S. distirbution to CA only (Los Angeles).    No foreign distribution.","F-1692-2016","Class I","Kimchi Guacamole  Item Number 20185700000 ","17lbs.","Undeclared fish, shellfish, and/or tree nuts.","07/15/2016",," Item Number 20185700000   Sell-by Dates of May 29 to May 31 ",5/27/2016,"05/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2213-2016","Class I","2 lb Gold Medal All Purpose Flour     Case UPC	000-16000-10720  Package UPC	000-16000-10710  Recalled Better If Used By Dates	25MAY2017KC, 26MAY2017KC, 27MAY2017KC, 28MAY2017KC, 29MAY2017KC, 30MAY2017KC, 31MAY2017KC, 01JUN2017KC, 02JUN2017KC, and 03JUN2017KC    Expanded recall: 15MAY2017KC through 24MAY2017KC, 04JUN2017KC, 05JUN2017KC, 11JUN2017KC, 12JUN2017KC, 13JUN2017KC, 14JUN2017KC    Expanded recall #2: 7-25-16  Recalled Better if Used by Dates	18JUN2017KC, 01AUG2017KC, 13AUG2017KC through 21AUG2017KC    10 lb Gold Medal All Purpose Flour	   Case UPC	000-16000-12410  Package UPC	000-16000-10410  Recalled Better If Used By Dates	02JUN2017KC,  03JUN2017KC    Expanded Recall: 16MAY2017KC through 20MAY2017KC, 05JUN2017KC  Expanded Recall: 7-25-16  Recalled Better if Used by Dates	18JUN2017KC, 01AUG2017KC.    5 lb Gold Medal All Purpose Flour	   Case UPC	000-16000-12610  Package UPC	000-16000-10610  Recalled Better If Used By Dates	25MAY2017KC, 27MAY2017KC, 28MAY2017KC, 29MAY2017KC, 30MAY2017KC, 31MAY2017KC, 01JUN2017KC, 03JUN2017KC, 04JUN2017KC, 05JUN2017KC, 11JUN2017KC, 12JUN2017KC, 13JUN2017KC, 14JUN2017KC    Expanded Recall: 15MAY2017KC through 24MAY2017KC.    Expanded Recall #2: 7-25-16  Recalled Better if Used by Dates	18JUN2017KC, 01AUG2017KC, 13AUG2017KC through 21AUG2017KC      10 lb Gold Medal All Purpose Flour- Banded Pack   Case UPC	000-16000-21294  Package UPC	000-16000-10410  Recalled Better If Used By Dates	03JUN2017KC, 04JUN2017KC, 05JUN2017KC.    25 lb Jetro Lenz Best All Purpose Flour  Unit UPC	60695-00295  Code Dates/Production Dates	16NOV2015KC, 17NOV2015KC   Expanded: 13NOV2015KC, 14NOV2015KC, 04DEC2015KC  	   50 lb Jetro Chef's Quality All Purpose Flour  Unit UPC	60695-02575  Code Dates/Production Dates	19NOV5KC  Expanded: 07NOV2015KC, 04NOV2015KC, 05NOV2015KC, 02DEC2015KC    Expanded Recall: 4.25lb Gold Medal All Purpose Flour	  Package UPC 000-16000-12670, Case UPC 100-16000-12670, Recalled Better if Used by Dates	21MAY2017KC, 03JUN2017KC.    Expanded Recall #2 7-25-16  Recalled Better ","614,478 total units for all product","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," Recalled Better If Used By Dates	25MAY2017KC, 26MAY2017KC, 27MAY2017KC, 28MAY2017KC, 29MAY2017KC, 30MAY2017KC, 31MAY2017KC, 01JUN2017KC, 02JUN2017KC, and 03JUN2017KC,   04JUN2017KC, 05JUN2017KC, 16NOV2015KC, 17NOV2015KC, 19NOV5KC, .    Expanded recall: 15MAY2017KC through 24MAY2017KC, 04JUN2017KC, 05JUN2017KC, 11JUN2017KC, 12JUN2017KC, 13JUN2017KC, 14JUN2017KC,  03JUN2017KC.  12NOV2015KC, 13NO19NOV5KC, 18NOV2015KC, 25NOV2015KC, 04DEC2015KC, 07NOV2015KC, 14NOV2015KC, 15NOV2015KC,  04NOV2015KC, 05NOV2015KC, 02DEC2015KC    Expanded recall #2: 7-25-16  Recalled Better if Used by Dates	18JUN2017KC, 01AUG2017KC, 13AUG2017KC through 21AUG2017KC    Expanded Recall: 7-25-16  Recalled Better if Used by Dates	18JUN2017KC, 01AUG2017KC.    Expanded Recall #2: 7-25-16  Recalled Better if Used by Dates	18JUN2017KC, 01AUG2017KC, 13AUG2017KC through 21AUG2017KC.    Expanded Recall #2 7-25-16  Recalled Better if Used by Dates	01AUG2017KC, 19AUG2017KC, 20AUG2017KC, 21AUG2017KC.    ",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2214-2016","Class I","2 lb Gold Medal Self Rising Flour    Case UPC	000-16000-10730  Package UPC	000-16000-11710  Recalled Better If Used By Dates	23AUG2016KC  Expanded: 	  09AUG2016KC, 10AUG2016KC, 16AUG2016KC, 17AUG2016KC, 06SEP2016KC, 07SEP2016KC    Expanded Recall: 5 lb Gold Medal Self Rising Flour	  Package UPC 000-16000-11610  Recalled Better if Used by Dates	10AUG2016KC, 11AUG2016KC    Expanded Recall #2 7-25-16  Recalled Better if Used by Dates	27OCT2016KC","614,478 total units for all product","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," 23AUG2016KC    Expanded Recall: 09AUG2016KC, 10AUG2016KC, 16AUG2016KC, 17AUG2016KC, 06SEP2016KC, 07SEP2016KC, 11AUG2016KC.    Expanded Recall #2 7-25-16  Recalled Better if Used by Dates	27OCT2016KC    ",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2216-2016","Class I","13.5 ounce Gold Medal Wondra   Case UPC	000-16000-42476  Package UPC	000-16000-18980  Recalled Better If Used By Dates	25FEB2017PK, 26FEB2017PK, 27FEB2017PK, 02MAR2017PK, 03MAR2017PK, 04MAR2017PK, and 30MAR2017PK.  Expanded Recall:   Recalled Better if Used by Dates	23FEB2017KC, 24FEB2017KC  Expanded Recall #2: 7-25-16  Recalled Better if Used by Dates	14MAY2017PK    5 lb Safeway Signature Kitchens All Purpose Flour Enriched Bleached  Note:  Case uses BB (Best By) format, but consumer unit uses BIUB (Better/Best If Used By).  Case UPC	100-21130-53001  Package UPC	000-21130-53001  Recalled BIUB	MAY 28 17    50 lb Gold Medal Hotel & Restaurant Bakers All-Purpose Enriched Flour Bleached       Unit UPC	100-16000-14314  Code Dates/Production Dates	19NOV5KC    Expanded: 08NOV2015KC, 09NOV2015KC, 25NOV2015KC, 02DEC2015KC, 03DEC2015KC.   	   25 lb Gold Medal Hotel & Restaurant Bakers All-Purpose Enriched Flour Bleached  Unit UPC	100-16000-14317  Code Dates/Production Dates	15NOV2015KC, 16NOV2015KC, 17NOV2015KC, 18NOV2015KC, 19NOV2015KC, 20NOV2015KC,   21NOV2015KC.    Expanded: 12NOV2015KC, 13NOV2015KC, 22NOV2015KC, 25NOV2015KC, 01DEC2015KC, 02DEC2015KC, 03DEC2015KC, 04DEC2015KC, 11NOV2015KC.    25 lb Pillsbury Hotel & Restaurant All Purpose Bleached Enriched  Unit UPC	100-18000-32666  Code Dates/Production Dates	16NOV2015KC   	   50 lb Pillsbury Hotel & Restaurant All Purpose Bleached Enriched  Unit UPC	100-18000-32679  Code Dates/Production Dates	17NOV5KC      Expanded Recall: 2 lb Signature Kitchens All Purpose Flour Enriched Bleached  Package UPC 000-21130-53000, Case UPC 100-21130-53000,  Recalled Better if Used by Dates	BB MAY 27 2017    Expanded Recall #2 7-25-16.  Recalled Better if Used by Dates	BB 15 AUG 2017, BB 16 AUG 2017    Expanded Recall:   10 lb Gold Medal H&R All Purpose Bleached Enriched Flour,   Unit UPC	100-16000-14473,   Code Dates/Production Dates	04NOV2015KC, 05NOV2015KC, 10NOV2015KC, 11NOV2015KC.    Expanded Recall:   25 lb Medallion All Purpose Flour Bleached Enriched Flour  Unit UPC	100-16000","614,478 total units for all product","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," Recalled Better If Used By Dates	25FEB2017PK, 26FEB2017PK, 27FEB2017PK, 02MAR2017PK, 03MAR2017PK,  04MAR2017PK, 30MAR2017PK, MAY 28 17,  04NOV2015KC, 05NOV2015KC,  10NOV2015KC , 11NOV2015KC,15NOV2015 TO 19NOV2015KC,  20NOV2015KC, 21NOV2015KC.    	   Expanded Recall: 23FEB2017PK, 24FEB2017PK, MAY 27 2017,   12NOV2015KC, 13NOV2015KC, 22NOV2015KC, 25NOV2015KC, 01DEC2015KC, 02DEC2015KC, 03DEC2015KC, 04DEC2015KC, 08NOV2015KC, 19NOV2015KC, 11NOV2015KC, 14NOV2015KC,  07NOV2015KC, 09NOV2015KC.     Expanded Recall #2: 7-25-2016  Recalled Better if Used by Dates	14MAY2017PK    Expanded Recall #2 7-25-16.  Recalled Better if Used by Dates	BB 15 AUG 2017, BB 16 AUG 2017  ",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2212-2016","Class I","25 lb  Uncle Julios Tortilla Flour Bleached, Malted, Enriched  Unit UPC	100-16000-50257  Code Dates/Production Dates	18NOV2015KC, 19NOV2015KC    ","614,478 total units for all product","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," 18NOV2015KC, 19NOV2015KC",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2219-2016","Class I","25lb New Yung Wah Diamond Brand Hotel & Restaurant Enriched Bromated Bleached Flour  Unit UPC	100-16000-50875  Code Dates/Production Dates	15NOV2015KC  ","614,478 total units for all product","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," 15NOV2015KC  ",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2221-2016","Class I","Expanded Recall:    50 lb Wondra Enriched Unmalted Flour	  Unit UPC	100-16000-54380  Code Dates/Production Dates	04NOV2015KC, 05NOV2015KC  	  ","614,478 for all products","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," Expanded Recall: 04NOV2015KC, 05NOV2015KC       	   ",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2215-2016","Class I","5 lb Gold Medal Unbleached Flour	     Case UPC	000-16000-12690  Package UPC	000-16000-19610  Recalled Better If Used By Dates	25MAY2017KC, 27MAY2017KC, 03JUN2017KC, 04JUN2017KC    Expanded Recall: 19MAY2017KC through 24MAY2017KC, 11JUN2017KC, 12JUN2017KC    Expanded Recall #2 7-25-16.  Recalled Better if Used by Dates	01AUG2017KC, 14AUG2017KC, 15AUG2017KC, 16AUG2017KC, 17AUG2017KC, 19AUG2017KC, 20AUG2017KC      Expanded Recall:   50 lb Gold Medal H&R All Purpose Unbleached Flour  Unit UPC	100-16000-14439  Code Dates/Production Dates	05NOV2015KC, 16NOV2015KC, 17NOV2015KC, 04DEC2015KC  ","614,478 total units for all product","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," 25MAY2017KC, 27MAY2017KC, 03JUN2017KC, 04JUN2017KC      Expanded Recall: 19MAY2017KC through 24MAY2017KC, 11JUN2017KC, 12JUN2017KC, 05NOV2015KC, 16NOV2015KC, 17NOV2015KC, 04DEC2015KC    Expanded Recall #2 7-25-16.  Recalled Better if Used by Dates	01AUG2017KC, 14AUG2017KC, 15AUG2017KC, 16AUG2017KC, 17AUG2017KC, 19AUG2017KC, 20AUG2017KC",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2217-2016","Class I","5 lb Safeway Signature Kitchens Unbleached Flour All Purpose Enriched  Note:  Case uses BB (Best By) format, but consumer unit uses BIUB (Better/Best If Used By).  Case UPC	100-21130-53022  Package UPC	000-21130-53022  Recalled BIUB	MAY 27 17    Expanded Recall #2 7-25-16  Recalled Better if Used by Dates	BB 01 AUG 2017.      25lb Gold Medal Hotel & Restaurant Bakers All Purpose Enriched Flour Unbleached  Unit UPC	100-16000-14438  Code Dates/Production Dates	18NOV2015KC    ","614,478 total units for all product","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," MAY 27 17, 18NOV2015KC    Expanded Recall #2 7-25-16  Recalled Better if Used by Dates	BB 01 AUG 2017.",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2220-2016","Class I","50lb Sysco Classic  Hotel & Restaurant Flour Bleached Enriched Malted  Unit UPC	34730-23936  Code Dates/Production Dates	17NOV5KC, 18NOV5KC   	   25lb Sysco All-Purpose Hotel & Restaurant Flour Bleached Enriched Malted  Unit UPC	34730-23957  Code Dates/Production Dates	20NOV5KC, 21NOV5KC    25lb  Sysco All-Purpose Hotel & Restaurant Flour Bleached Enriched Malted  Unit UPC	34730-23958  Code Dates/Production Dates	20NOV2015KC, 21NOV2015KC   	   ","614,478 total units for all product","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," 17NOV5KC, 18NOV5KC, 20NOV5KC, 21NOV5KC       	   ",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74285,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD.       OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.","F-2218-2016","Class I","25 lb Gold Medal Hotel & Restaurant Bakers Self-Rising Enriched Flour Bleached  Unit UPC	100-16000-14318  Code Dates/Production Dates	16NOV2015KC, 02DEC2015KC, 03DEC2015KC.","614,478 total units for all product","General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour.  To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.","09/14/2016",," 16NOV2015KC, 02DEC2015KC, 03DEC2015KC.",5/31/2016,"05/31/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74286,"Ongoing","Colonia Care Pharmacy","515 Inman Ave Ste A",,"Colonia","NJ","07067-1114","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ and NY","D-0209-2017","Class II","C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067    ",,"Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.","12/22/2016",," All lots with Use by Date of 5/22/2016 to 8/31/2016                ",7/28/2016,"07/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74286,"Ongoing","Colonia Care Pharmacy","515 Inman Ave Ste A",,"Colonia","NJ","07067-1114","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ and NY","D-0208-2017","Class II","C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067    ","ALL","Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.","12/22/2016",," All lots with Use by Date of 5/22/2016 to 8/31/2016",7/28/2016,"07/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2114-2016","Class II","Hostess Ding Dongs, chocolate cake with creamy filing, packaged in 10-ct multi-packs of individual cakes, net wt. 12.70oz (360 g), UPC 888109110611; and 6-ct. single serving fun size snack packs, individual pack net wt. 2.55 oz (72 g), UPC 888109010027.  The responsible firm name on the label is Hostess Brands LLC, Kansas City, MO 64141.  ","1,803,126 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," batch and best buy date per UPC:  UPC 888109110611:  D032924000,  Best by 6/2/2016;  D033024000, Best by 6/3/2016;  D040424000, Best by 6/8/2016;  D040524000, Best by 6/9/2016;  D040624000, Best by 6/10/2016;  D041124000, Best by 6/15/2016;  D041224000, Best by 6/16/2016;  D041324000, Best by 7/6/2016; and     UPC 88109010027:    D032924000,  Best by 6/2/2016;  D040424000, Best by 6/8/2016;  D041124000, Best by 6/15/2016;  ",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2115-2016","Class II","Iced Devil's Food cake with creamy filling, packaged as Hostess Zingers in 10-ct multi-packs of individual cakes, net wt. 12.70oz (360 g), UPC 888109110581; 6-ct. single serving fun size snack packs, individual pack net wt. 2.55 oz (72 g), UPC 888109010027;with the responsible firm name on the label is Hostess Brands LLC, Kansas City, MO 64141; and Dolly Zingers in 6-ct. single serving packs, 3 cakes per pack net wt. 3.81 oz. (108g), the responsible name on the label is Hostess Brands, LLC, Kansas City, MO 64141  ","653,724 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," batch and best buy date per UPC:  UPC 888109110581:    D040124000, best by 6/5/2016;  D040824000, best by 6/12/2016;  D040924000, best by 6/13/2016; and    UPC 88810930036/888109010058/888109000202/888109000356:    D040124000, best by 6/5/2016;  D040824000, best by 6/12/2016;  D040924000, best by 6/13/2016;",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2119-2016","Class II","Hostess Donettes Powdered Mini Donuts, packaged in 9ct and 6-20ct bags of mini donuts, net wt. 10.5oz, UPC 888109150044; packaged in 9ct bag of mini donuts, net wt. 13.16oz, UPC 888109110246; packaged in 6ct single serve packages, net wt. 3oz, UPC 888109050047; the most responsible firm on the label is Hostess Brands, LLC, Kansas City, MO 64141","1,294,627 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," batch and best by date per UPC code:    UPC 888109110246:  D031921000, best by 5/23/2016  D032021000, best by 5/24/2016  D032121000, best by 5/25/2016  D040821000, best by 6/12/2016    UPC 888109150044:  D031821000, best by 5/22/2016  D031821001, best by 6/8/2016  D031824000, best by 6/8/2016  D031921000, best by 5/23/2016  D031921001, best by 6/8/2016  D040221000, best by 6/6/2016  D040821000, best by 6/12/2016  D032121000, best by 5/25/2016    UPC 888109050047:  D031821000, best by 5/22/2016  D031921000, best by 5/23/2016  D040221000, best by 6/6/2016  D040821000, best by 6/12/2016",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2116-2016","Class II","Iced Vanilla cake with creamy filling, packaged as Hostess Zingers Vanilla in 10-ct multi-packs of individual cakes, net wt. 12.70oz (360 g), UPC 888109110598; 6-ct. single serving fun size snack packs, 3 cakes per pack net wt. 3.81 oz. (108g), UPC 888109010119 and 888109300029; with the responsible firm name on the label is Hostess Brands LLC, Kansas City, MO 64141; and Dolly Zingers in 6-ct. single serving packs, 3 cakes per pack net wt. 3.81 oz. (108g), the responsible name on the label is Hostess Brands, LLC, Kansas City, MO 64141.  ","1,008,996 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," batch and best buy date per UPC:   UPC 888109110598:    D033124000, best by 6/4/2016;  D040124000, best by  6/5/2016;  D040724000, best by  6/11/2016;  D041424000, best by  6/18/2016;  D041524000, best by  6/19/2016; and     UPC 888109300029/888109010119:    D033124000, best by 6/4/2016;  D040124000, best by  6/5/2016;  D040724000, best by  6/11/2016;  D040824000, best by  6/12/2016;  D041524000, best by  6/19/2016",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2121-2016","Class II","Crunch Mini Donuts, packaged in 6-14-ct and 9-14-ct bags of mini donuts as Hostess Donettes Crunch Mini Donuts, net wt. 9.5oz, UPC 888109110642; packaged in 9-17-ct bags of mini donuts as Hostess Donettes Crunch Mini Donuts, net wt. 10.5oz, UPC 888109110659; packaged in 6ct single serving packages as Hostess Donettes Crunch Mini Donuts, net wt. 4oz, UPC 888109050054; packaged in 6ct single serving packages as Dolly Madison Crunch Mini Donuts, net wt. 4oz, UPC 888109300081; the most responsible firm name on the label is Hostess Brands, LLC, Kansas City, MO 64141","761,335 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," batch and best by date per UPC code:    UPC 888109300081:  D031921000, best by 5/23/2016    UPC 888109050054:  D031921000, best by 5/23/2016  D032021000, best by 5/24/2016  D040221000, best by 6/6/2016    UPC 888109110659:  D041324000, best by 6/17/2016    UPC 888109110642:  D031924000, best by 5/23/2016  D032524000, best by 5/29/2016  D032624000, best by 5/30/2016  D041424000, best by 6/18/2016  D041524000, best by 6/19/2016  D031824000, best by 5/22/2016  D032024000, best by 5/24/2016  D032424000, best by 5/28/2016",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2120-2016","Class II","Hostess Donettes Double Chocolate Mini Donuts, packaged in 9-ct bags of mini donuts, net wt. 11.25 oz, UPC 888109150037, the most responsible firm name on the label is Hostess Brands, LLC in Kansas City,MO 64141.","95,769 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," UPC 888109150037:    D040221000, best by 6/6/2016  D040821000, best by 6/12/2016",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2118-2016","Class II","Chocolate Frosted Mini Donuts, packaged in 6-20ct and 9ct bags of mini donuts as Hostess Donettes Frosted Mini Donuts, net wt. 11.25oz, UPC 888109150020; packaged in 9ct bags of mini donuts as Hostess Donettes Frosted Mini Donuts, net wt. 14.07oz, UPC 888109110239; packaged in 6ct single serve packages as Dolly Madison Chocolate Mini Donuts, net wt. 3oz, UPC 888109300067; packaged in 6ct single serve packages as Hostess Donettes Frosted Mini Donuts, net wt. 3oz, UPC 888109050023; the most responsible firm name on the label is Hostess Brands, LLC, Kansas City, MO 64141","1,426,814 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," batch and best by dates per UPC code:    UPC 888109110239:  D032021000, best by 5/24/2016  D032121000, best by 5/25/2016    UPC 888109300067:  D032121000, best by 5/25/2016    UPC 888109050023:  D032121000, best by 5/25/2016    UPC 888109150020:  D031821000, best by 5/22/2016  D031821001, best by 6/22/2016  D031824001, best by 6/29/2016  D031921000, best by 5/23/2016  D031924000, best by 6/29/2016  D032021000, best by 5/24/2016  D032024000, best by 6/29/2016  D041124000, best by 6/15/2016  D041224000, best by 6/16/2016  D031824000, best by 5/22/2016  D032124000, best by 5/25/2016  D032224000, best by 5/26/2016  D032324000, best by 5/27/2016  D032424000, best by 5/28/2016  D032424001, best by 6/22/2016  D032524000, best by 6/22/2016  D032524001, best by 6/22/2016  D032624001, best by 6/22/2016  D032824000, best by 6/1/2016  D032924000, best by 6/2/2016  D040821000, best by 6/12/2016  D041224000, best by 6/16/2016  D041324000, best by 6/17/2016  D041324001, best by 6/29/2016  D041424000, best by 6/29/2016  D032121000, best by 5/25/2016",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2117-2016","Class II","Iced Raspberry cake with creamy filling, packaged as Hostess Zingers Raspberry in 10-ct multi-packs of individual cakes, net wt. 13.40oz (360 g), UPC 888109110604; 6-ct. single serving fun size snack packs, 3 cakes per pack net wt. 4.02oz. (108g), UPC 888109010089; with the responsible firm name on the label is Hostess Brands LLC, Kansas City, MO 64141.","553,056 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," batch and best by date per UPC:     UPC 888109110604:     D040924000, best by 6/13/2016;   D041024000, best by 6/14/2016;   D041524000, best by 6/19/2016;   D041624000, best by 6/20/2016;   D040924000 (frozen), best by N/A;   D041524000 (frozen), best by N/A     UPC 888109010089:     D041024000, best by 6/14/2016;   D041524000, best by 6/19/2016;   D041624000, best by 6/20/2016;   D040924000 (frozen), best by N/A;   D041024000 (frozen), best by N/A;   D041524000 (frozen), best by N/A.",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2113-2016","Class II","Hostess Chocodile Twinkies, chocolate covered sponge cake with creamy filling, packaged in 9-ct multi-packs of individual cakes, net wt. 13.02 oz (396 g), UPC 888109110499; and 6-ct. single serving fun size snack packs, individual pack net wt. 2.89 oz (82 g), UPC 888109010492.  The responsible firm name on the label is Hostess Brands LLC, Kansas City, MO 64141.  ","591,609 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," batch and best buy date per UPC:  UPC 888109110499:  D033124000	6/4/2016  D040624000	6/10/2016  D040724000	6/11/2016  D041324000	6/17/2016  D041424000	7/6/2016    UPC 888109010492:    D033124000	6/4/2016  D040624000	6/10/2016  D041324000	6/17/2016  D041424000	6/18/2016  D040724000	6/11/2016  ",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2122-2016","Class II","Hostess Donettes Glazed Mini Donuts, packaged in 9-17-ct and 6-17-ct bags of mini donuts, net wt. 10.50oz, UPC 888109110659;the most responsible firm name on the label is Hostess Brands, LLC, Kansas City, MO 64141.","505,704 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," UPC 888109110659    D032124000, best by 5/25/2016  D032824000, best by 6/1/2016  D032924000, best by 6/2/2016  D041124000, best by 6/15/2016  D041224000, best by 6/16/2016  D032224000, best by 5/26/2016  D032324000, best by 5/27/2016  D032424000, best by 5/28/2016  D041324000, best by 6/17/2016  D041424000, best by 6/18/2016",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74287,"Ongoing","Hostess Brands, LLC","1 E Armour Blvd",,"Kansas City","MO","64111-1201","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide distribution.  No foreign or military/government distribution.","F-2123-2016","Class II","Hostess Donettes Maple Glazed Mini Donuts, packaged in 9-17-ct bagsof mini donuts, net wt. 10.50oz, UPC 888109111243; the most responsible firm name on the label is Hostess Brands LLC, Kansas City, MO 64141.","26,289 units","Product is manufactured with flour known to contain peanut allergen and is not labeled to contain peanuts.","09/13/2016",," UPC code 888109111243: D032424000, best by 5/28/2016",6/3/2016,"06/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74288,"Terminated","Department of Army William Beaumont Army Medical Center","5005 N Piedras St",,"El Paso","TX","79920-5001","United States","Voluntary: Firm Initiated","FAX","New York; New Jersey","B-0607-16","Class II","Red Blood Cells","2 units","Blood products, collected from ineligible donors, were distributed. ","06/21/2016","06/21/2016"," W012713001734; W012713002867",5/12/2016,"05/12/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74288,"Terminated","Department of Army William Beaumont Army Medical Center","5005 N Piedras St",,"El Paso","TX","79920-5001","United States","Voluntary: Firm Initiated","FAX","New York; New Jersey","B-0609-16","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood products, collected from ineligible donors, were distributed. ","06/21/2016","06/21/2016"," W012714005260",5/12/2016,"05/12/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74288,"Terminated","Department of Army William Beaumont Army Medical Center","5005 N Piedras St",,"El Paso","TX","79920-5001","United States","Voluntary: Firm Initiated","FAX","New York; New Jersey","B-0608-16","Class III","Blood and Blood Products for Reprocessing","2 units","Blood products, collected from ineligible donors, were distributed. ","06/21/2016","06/21/2016"," W012713001734; W012713002867",5/12/2016,"05/12/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74289,"Terminated","DCI Plasma Center Of Duluth, LLC","1720 W Superior St",,"Duluth","MN","55806-2137","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0606-16","Class III","Source Plasma","1 unit","Source Plasma, collected from an ineligible donor, was distributed. ","06/21/2016","06/21/2016"," DU0891799",4/30/2016,"04/30/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74290,"Terminated","Hoxworth Blood Center","PO Box 67005","3130 Highland Ave Ml#0055","Cincinnati","OH","45267-0001","United States","Voluntary: Firm Initiated","Letter","Ohio","B-0610-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Red Blood Cells, lacking proper labeling, were distributed. ","06/21/2016","06/21/2016"," W037716002359",5/19/2016,"05/19/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74291,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","Alabama; Puerto Rico; Tennessee; Virginia; Georgia","B-0602-16","Class II","Red Blood Cells, Leukocytes Reduced","264 units","Blood products, collected in a manner with a potential for air contamination, were distributed.  ","06/14/2016","06/14/2016"," W043216012026; W043216012027; W043216012046; W043216018303; W043216022210; W043216026204; W043216012023; W043216012025; W043216012048; W043216012050; W043216013235; W043216023000; W043216012130; W043216012041; W043216020808; W043216012058; W043216012083; W043216020837; W043216021589; W043216021600; W043216015642; W043216026330; W043216026334; W043216018265; W043216026286; W043216023908; W043216026205; W043216012146; W043216016331; W043216013239; W043216018285; W043216018244; W043216012022; W043216013209; W043216012131; W043216012137; W043216019751; W043216017079; W043216012100; W043216026252; W043216012168; W043216015681; W043216015720; W043216018203; W043216020855; W043216012101; W043216015607; W043216026306; W043216020836; W043216020882; W043216012092; W043216012107; W043216012111; W043216012115; W043216015627; W043216015675; W043216015722; W043216015774; W043216015798; W043216012072; W043216026236; W043216012109; W043216015623; W043216020817; W043216015754, W043216012190, W043216026304, W043216015767, W043216018290, W043216015773, W043216015777, W043216018266, W043216018267, W043216011718, W043216015772, W043216026254, W043216026281, W043216018262, W043216018294, W043216018297, W043216026219, W043216026220, W043216026221, W043216012113, W043216015613, W043216012145, W043216026310, W043216020816, W043216015661, W043216018240, W043216011717, W043216018300, W043216012055, W043216012095, W043216012134, W043216012135, W043216012138, W043216015641, W043216015657, W043216018268, W043216018293, W043216012047, W043216012052, W043216012037, W043216012066, W043216015723, W043216015786, W043216012022, W043216012049, W043216012051, W043216012065, W043216026245, W043216012094, W043216015698, W043216018205, W043215105414, W043215105415, W043215105422, W043215105423, W043216012112, W043216015603, W043216015610, W043216012098, W043216026336, W043216015714, W043216012062, W043216012059, W043216012188, W043216015631, W043216020802, W043216012099, W043216015755, W043216018284, W043216009999, W043216012105, W043216026269, W043",4/14/2016,"04/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74291,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","Alabama; Puerto Rico; Tennessee; Virginia; Georgia","B-0601-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","55 units","Blood products, collected in a manner with a potential for air contamination, were distributed.  ","06/14/2016","06/14/2016"," W043216012171; W043216012171; W043216012167; W043216015677; W043216012197; W043215105418; W043215105418; W043216015604; W043216012144; W043216012080, W043216012080, W043216012067, W043216015677, W043216012067, W043216012197, W043216022202, W043216012197, W043216012191, W043216026249, W043216026249, W043216012191, W043216026234, W043216026262, W043216026234, W043216026262, W043216012173, W043216012173, W043215105451, W043215105450, W043215105450, W043216012108, W043216015665, W043216012108, W043216015665, W043215105452, W043216018305, W043216012144, W043216018305, W043216015677, W043216022202, W043215105452, W043216015606, W043216015606, W043216015789, W043216015795, W043216018245, W043216015789, W043216015795, W043216018245, W043216015633, W043216015682, W043216015685, W043216015633, W043216015682, W043216015685",4/14/2016,"04/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74291,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","Alabama; Puerto Rico; Tennessee; Virginia; Georgia","B-0604-16","Class II","Plasma Frozen, Cryoprecipitate Reduced ","6 units","Blood products, collected in a manner with a potential for air contamination, were distributed.  ","06/14/2016","06/14/2016"," W043216000554, W043215045467, W043215030392,  W043215030397, W043215030400, W043215034872  ",4/14/2016,"04/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74291,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","Alabama; Puerto Rico; Tennessee; Virginia; Georgia","B-0600-16","Class II","Plasma Frozen within 24 hours (FP24)","324 units","Blood products, collected in a manner with a potential for air contamination, were distributed.  ","06/14/2016","06/14/2016"," W043215086193; W043215061490; W043215072787; W043216009952; W043216012003; W043215055683; W043216012079; W043216012130; W043216015659; W043216008641; W043216018204; W043216015790; W043215112715; W043215045499; W043215072644; W043215052635; W043215039758; W043215045406; W043216002631; W043215104362; W043215034909; W043215090336; W043215090340; W043215027731; W043215030590; W043216015715; W043215077217; W043216000413, W043216000529, W043215072635, W043215039800, W043215045439, W043215045440, W043215061444, W043215061456, W043215052751, W043215034937, W043215034938, W043216006443, W043216006444, W043216006451, W043215099758, W043216006500, W043216006505, W043215068967, W043215072689, W043215090337, W043215090352, W043215068992, W043215054418, W043215077344, W043215084257, W043215025483, W043215107355, W043215068822, W043215068824, W043215072794, W043216009981, W043216012009, W043215107395, W043215039735, W043215061584, W043215055676, W043216012060, W043215085412, W043215055698, W043216002707, W043215104369, W043215104373, W043216006440, W043216006448, W043215110132, W043215110139, W043215112802, W043216004459, W043215068938, W043215072661, W043215097735, W043215086190, W043215086195, W043215090350, W043215084251, W043215054450, W043215027751, W043215027759, W043215025475, W043215025481, W043215034063, W043215099626, W043215042274, W043215086014, W043215072798, W043215047813, W043215049992, W043215107392, W043216022210, W043215039764, W043215085405, W043215054571, W043215055692, W043215055708, W043216012134, W043216012194, W043215107310, W043216015714, W043215110117, W043215110125, W043215110136, W043215107391, W043215047814, W043215086073, W043216011122, W043215072686, W043215027712, W043215027733, W043215068833, W043215047916, W043215068911, W043215045457, W043215097751, W043216006441, W043216006442, W043215039683, W043215072692, W043215077355, W043215084252, W043215054454, W043215107319, W043215064826, W043215030281, W043215055796, W043215061525, W043215025476, W043216000433, W043216015636, W043216006467, W043",4/14/2016,"04/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74291,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","Alabama; Puerto Rico; Tennessee; Virginia; Georgia","B-0603-16","Class II","Cryoprecipitated AHF","8 units","Blood products, collected in a manner with a potential for air contamination, were distributed.  ","06/14/2016","06/14/2016"," W043216012149, W043215112205, W043215030400, W043216002704, W043216000584, W043215105578, W043215112630, W043215112631  ",4/14/2016,"04/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74291,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","Alabama; Puerto Rico; Tennessee; Virginia; Georgia","B-0605-16","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated ","10 units","Blood products, collected in a manner with a potential for air contamination, were distributed.  ","06/14/2016","06/14/2016"," W043215107325, W043216018310, W043216015775, W043216009867, W043215099794, W043216009996,   W043216012028, W043216015666, W043216012057,   W043216012143  ",4/14/2016,"04/14/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74292,"Terminated","Blood Bank of Alaska, Inc.","1215 Airport Heights Drive",,"Anchorage","AK","99508","United States","Voluntary: Firm Initiated","FAX","Alaska","B-0611-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Low platelet yield pheresis product was distributed. ","06/21/2016","06/21/2016"," W066515423820",5/17/2016,"05/17/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74295,"Ongoing","Hologic, Inc","250 Campus Dr",,"Marlborough","MA","01752-3020","United States","Voluntary: Firm Initiated","Letter","US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY   OUS: United Arab Emirates, Australia, Argentina, Belgium, Canada, Switzerland, Chile, Colombia, Germany, Denmark, France, Great Britain, Hong Kong, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Qatar, Singapore, Thailand, Taiwan, United States, and South Africa.","Z-2239-2016","Class II","ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.","16,870","Cracks ATEC Canister Lids.","07/19/2016",," Lot Number: 2150013 and 20150014",5/31/2016,"05/31/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74296,"Completed","Invivo Corporation","12151 Research Pkwy Ste 200",,"Orlando","FL","32826-3286","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Australia,  Austria, Denmark, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and England","Z-2867-2016","Class II","Philips Expression Information Portal (IP5) Model 865471.   The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.","639 units","Frozen Display Numerics and Disabled Menu Keys after extended run time.  This customer notification was sent August 22, 2014.","09/21/2016",," Serial numbers US23200121, US23200122, US23200123, US23200124, US23200125, US23200126, US23200127, US23200128, US23200129, US23200130, US23200131, US23200132, US23200133, US23200134, US23200135, US23200136, US23200137, US23200138, US23200139, US23200140, US23200141, US23200142, US23200143, US23200144, US23200145, US23200146, US23200147, US23200148, US23200149, US23200150, US23200151, US23200152, US23200153, US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200, US23200201, US23200202, US23200203, US23200204, US23200205, US23200206, US23200207, US23200208, US23200209, US23200210, US23200211, US23200212, US23200213, US23200214, US23200215, US23200216, US23200217, US23200218, US23200219, US23200220, US23200221, US23200222, US23200223, US23200224, US23200225, US23200226, US23200227, US23200228, US23200229, US23200230, US23200231, US23200232, US23200233, US23200234, US23200235, US23200236, US23200237, US23200238, US23200239, US23200240, US23200241, US23200242, US23200243, US23200244, US23200245, US23200246, US23200247, US23200248, US23200249, US23200250, US23200251, US23200252, US23200253, US23200254, US23200255, US23200256, US23200258, US23200259, US23200260, US23200261, US23200262, US23200263, US23200264, US23200265, US23200266, US23200267, US23200268, US23200269, US23200270, US23200271, US23200272, US23200273, US23200274, US23200275, US23200276, US23200277, US23200278, US23200279, US23200280, US23200281, US23200282, US23200283, US23200284, US23200285, US23200286, US23200287, US23200288, US23200289, US23200290, US23200291, US23200292, US23200293, US23200294, US23200295, US23200296, U",9/14/2014,"09/14/2014",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74297,"Ongoing","Devicor Medical Products Inc","300 E Business Way Fl 5",,"Cincinnati","OH","45241-2384","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AL,  AR, CA,  CT,  DC,  FL,  GA,  IL, KS, KY, LA,  MA,  MD,  ME,  MI, MN, MS, NC,  NJ,  NY, OH, PA,  SC, TN, WA and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.","Z-2211-2016","Class II","Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815.  Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile.    Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.","F11537107D1 = 360; F11536423D1 = 80; F11537109D1 = 360","A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.  ","07/14/2016",," MST1009 - Lot F11537107D1 Exp. Date 9-Sept, 2018;  MST0815  Lot F11536423D1 Exp. Date 8-Sept, 2018; and, MST1009 Lot F11537109D1 Exp. Date 10-Sept, 2018.  ",5/19/2016,"05/19/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74298,"Ongoing","Galliker Dairy Co.","143 Donald Ln",,"Johnstown","PA","15904-2829","United States","Voluntary: Firm Initiated","Letter","PA, NJ, MD","F-0683-2017","Class II","Galliker's Lemon Iced Tea Flavored, 1 GAL and  Galliker's Lemon Flavored Iced Tea, 1/2 GAL    ","2851 gallon jugs","The products were labeled as pasteurized, but there was no  legal documentation (pasteurization chart) to back the claim.  No other test was available to back the claim.  ","12/09/2016",," Sell By: July 28 16",5/17/2016,"05/17/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74299,"Completed","Pharmedium Services, LLC","150 N Field Dr Ste 350",".","Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","Telephone","NY","D-0976-2016","Class II","Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN  38141, NDC 61553-836-11, Service Code 2K5836.","240 bags","Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.","06/09/2016",," Lot# 161300033M, Exp 07/26/16",5/16/2016,"05/16/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74300,"Ongoing","Covidien, LLC","540 Oakmead Pkwy",,"Sunnyvale","CA","94085-4022","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.","Z-2122-2016","Class II","Covidien Cytosponge Cell Collection Kit.  Contains Cytosponge Cell Collection Device, Specimen Jar with preservative.   Item code CYTO-KIT-R    Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.","620 total units (260 US; 360 OUS)","Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.","07/05/2016","."," Item Code: CYTO-KIT-R;  Lot numbers: 3441120915, 3441102015",6/6/2016,"06/06/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74300,"Ongoing","Covidien, LLC","540 Oakmead Pkwy",,"Sunnyvale","CA","94085-4022","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.","Z-2123-2016","Class II","Covidien Cytosponge Cell Collection Device.  Item code CYTO-101-01.    Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.","620 total units (260 US; 360 OUS)","Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.","07/05/2016","."," Item Code: CYTO-101-01.  Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.",6/6/2016,"06/06/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74301,"Ongoing","Stryker Sustainability Solutions","1810 W Drake Dr",,"Tempe","AZ","85283-4327","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA.","Z-2096-2016","Class I","AngioDynamics Soft Vu Omni Flush Angiographic Catheter  Model Number: 10732203","167","Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.","07/21/2016",," Item          Lot            Manufacturing  Number    Number    Date        Expiration Date  10732203 119965U 11/7/2003 N/A  10732203 158623U 12/2/2003 N/A  10732203 175183U 3/22/2005 N/A  10732203 179688U 10/29/2004 N/A  10732203 191185U 12/5/2004 N/A  10732203 210813U 7/1/2005    N/A  10732203 225911U 10/27/2005 N/A  10732203 225918U 10/19/2005 N/A  10732203 225919U 10/17/2005 N/A  10732203 8248U      1/31/2006 N/A  10732203 253202U  2/23/2006 N/A  10732203 277726U  7/21/2006 N/A  10732203 302844U  12/14/2006 N/A  10732203 309329U  11/16/2006 N/A  10732203 325680U 12/30/2006 N/A  10732203 343908U 8/2/2008 N/A  10732203 352756U 8/11/2008 N/A  10732203 352761U 9/3/2008 N/A  10732203 359352U 2/6/2008 N/A  10732203 363987U 5/17/2008 N/A  10732203 366572U 10/18/2008 N/A  10732203 369818U 9/27/2008 N/A  10732203 375883U 9/20/2008 N/A  10732203 772102U 8/5/2004 N/A  10732203 773196U 12/18/2004 N/A  10732203 773216U 1/6/2005 N/A  10732203 775985U 3/16/2005 N/A  10732203 7710750U 8/3/2006 N/A",6/1/2016,"06/01/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74302,"Ongoing","Sunrise Foods Inc","3120 Valleyview Dr",,"Columbus","OH","43204-2023","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, IL, IN, KY, MI, MN, MS, NJ, NY, OH, PA & VA.","F-2206-2016","Class II","National Food Group Bourbon Sauce 5.25 lb plastic bag Ingredients: Sugar, Oyster Flavored Sauce***All purpose Flour White Bleached Enriched***Dried Yeast. Contains: (Wheat) FOR INSTITUTIONAL USE ONLY Prepared for: National Food Group, Novi MI UPC 8 12177 01154 9","234 boxes/2/5.25 lb bags","The firm was notified by their supplier that the flour used in their products may be contaminated with E. Coli.","09/14/2016",,"  NFG: 605158, Item # 47-0057 Lot Dates: 2/24/2016, 5/9/2016",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74302,"Ongoing","Sunrise Foods Inc","3120 Valleyview Dr",,"Columbus","OH","43204-2023","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, IL, IN, KY, MI, MN, MS, NJ, NY, OH, PA & VA.","F-2205-2016","Class II","Jump Dark Teriyaki Sauce .5 gallon plastic bag Ingredients: WATER, SUGAR, SOY SAUCE***ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat) FOR INSTITUTIONAL USE ONLY Prepared for Jump International HIllard, Ohio 43026 UPC 8 56460 00114 5","2,507 boxes/4/.5 gallon bags","The firm was notified by their supplier that the flour used in their products may be contaminated with E. Coli.","09/14/2016",," J14-2019-2, Item # 36-1875  Lot Dates 1/8/2016, 1/15/2016, 1/18/2016, 1/22/2016, 1/26/2016, 2/1/2016, 2/8/2016, 2/29/2016, 3/30/2016, 4/7/2016, 4/11/2016, 4/27/2016, 5/5/2016",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74302,"Ongoing","Sunrise Foods Inc","3120 Valleyview Dr",,"Columbus","OH","43204-2023","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, IL, IN, KY, MI, MN, MS, NJ, NY, OH, PA & VA.","F-2207-2016","Class II","Sunrise Foods Pre-Thickened Spicy General Tso Sauce 5 lb plastic bag Ingredients: WATER, SOY SAUCE***SOYBEAN OIL, SWEET RICE***ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat) FOR INSTITUTIONAL USE ONLY SUNRISE FOODS, INC. COLS, OHIO 43204  UPC 8 12177 01053 5","299 boxes/8/5 lb bags","The firm was notified by their supplier that the flour used in their products may be contaminated with E. Coli.","09/14/2016",," Item # 59-1011 Lot Dates: 1/5/2016, 1/13/2016 & 1/27/2016.",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74302,"Ongoing","Sunrise Foods Inc","3120 Valleyview Dr",,"Columbus","OH","43204-2023","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, IL, IN, KY, MI, MN, MS, NJ, NY, OH, PA & VA.","F-2204-2016","Class II","Jump Dark Stir Fry Sauce .5 gallon plastic bag Ingredients: WATER, SOY SAUCE***OYSTER FLAVORED SAUCE***MUSHROOM SOY SAUCE***SOYBEAN OIL***ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat). FOR INSTITUTIONAL USE ONLY JUMP PROPRIETARY PRODUCT Prepared for: Jump International Hillard, Ohio 43026 UPC 8 56460 00116 9","711 boxes/4/.5 gallon bags","The firm was notified by their supplier that the flour used in their products may be contaminated with E. Coli.","09/14/2016",," J14-0409-2, Item # 36-1595-N Lot Dates: 1/4/2016, 1/21/2016, 1/26/2016, 2/3/2016, 2/10/2016, 4/26/2016",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74302,"Ongoing","Sunrise Foods Inc","3120 Valleyview Dr",,"Columbus","OH","43204-2023","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AL, AR, AZ, CA, CO, IL, IN, KY, MI, MN, MS, NJ, NY, OH, PA & VA.","F-2203-2016","Class II","China Garden Bourbon Sauce (for Chicken) 5.25 lb plastic bag  Ingredients: SUGAR, OYSTER FLAVORED SAUCE***SWEET RICE, WATER, ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat). FOR INSTITUTIONAL USE ONLY SUNRISE FOODS, INC. COLS, OHIO 43204","27 boxes/2/5.25 lb bags","The firm was notified by their supplier that the flour used in their products may be contaminated with E. Coli.","09/14/2016",," Item # 34-1100 Lot Dates: 4/8/2016",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74303,"Terminated","LifeSouth Community Blood Centers, Inc.","1221 NW 13th St",,"Gainesville","FL","32601-4111","United States","Voluntary: Firm Initiated","FAX","Florida","B-0592-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood product, with an unacceptable pH, was distributed. ","06/23/2016","06/23/2016"," W1151160548961; ",4/25/2016,"04/25/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74304,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Kentucky","B-0593-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.","06/23/2016","06/23/2016"," W039515032830; ",4/12/2016,"04/12/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1606-2016","Class II","Soft Whole Wheat Flour, Bulk","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: Lot codes: 21-031616-01, 21-031616-01, 21-031716-01, 21-032416-01, 21-032416-01, 21-032516-01, 21-032516-01, 21-032816-01, 21-032916-01, 21-032916-01, 21-033016-01, 21-033016-01, 21-033116-01, 21-040516-01, 21-040616-01, 21-040716-01, 21-040816-01, 21-041216-01, 21-041316-01, 21-041516-01, 21-031416-01, 21-031516-01, 21-031516-01, 21-031716-01, 21-031716-01, 21-032116-01, 21-032116-01, 21-032316-01, 21-032316-01, 21-032416-01, 21-032816-01, 21-033016-01, 21-040616-01, 21-040816-01, 21-040816-01, 21-041116-01, 21-041116-01, 21-041316-01, 21-031616-01, 21-031416-01, 21-031416-02, 21-031416-03, 21-031416-04, 21-031416-01, 21-031516-02, 21-031516-01, 21-031516-03, 21-031516-04, 21-031616-01, 21-031616-02, 21-031616-03 ,21-031516-01 ,21-031716-01, 21-031716-02, 21-031716-03, 21-031716-01, 21-031716-01, 21-031816-01, 21-031816-01, 21-031816-01, 21-031816-02, 21-031916-01, 21-031916-02, 21-031916-01, 21-031916-01, 21-032016-01, 21-032016-02, 21-032016-03, 21-032016-01, 21-032116-01, 21-032116-02, 21-032116-03, 21-032116-01, 21-032116-01, 21-032216-01, 21-032216-02, 21-032216-03, 21-032216-01, 21-032316-01, 21-032316-02, 21-032316-03, 21-032316-01, 21-032416-01, 21-032416-02, 21-032416-03, 21-032416-01, 21-032416-02, 21-032816-01, 21-032919-01, 21-032916-01, 21-033016-01, 21-033016-02, 21-033016-01, 21-033016-01, 21-033016-01, 21-033116-01, 21-033116-02, 21-033116-03, 21-033116-01, 21-040116-01, 21-040116-01, 21-040116-02, 21-040116-03, 21-040116-01, 21-040216-01, 21-040216-02, 21-040216-03, 21-040216-01, 21-040216-04, 21-040116-01, 21-040216-01, 21-040216-01, 21-040316-01, 21-040316-02, 21-040316-03, 21-040316-01, 21-040416-01, 21-040416-02, 21-040416-03, 21-040416-01, 21-040516-01, 21-040516-02, 21-040516-03, 21-040516-04, 21-040516-01, 21-040616-01, 21-040616-02, 21-040616-03, 21-040616-04, 21-040616-01, 21-040616-01, 21-040716-01, 21-040716-02, 21-040716-03, 21-040716-04, 21-040716-01, 21-040816-01, 21-040816, 21-040816-02, 21-040816-03, 21-040916-01, 21-040916-02, 21-040916-03, 21-040916-01, 21-041016-01, 2",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1599-2016","Class II","Kraft Cake Flour (110760), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1019050, Lot code: 69-21-032316.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1611-2016","Class II","Cookie/Cracker Flour, EN, BL  C, Bulk","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1012000,  Lot codes: 21-031616-01, 21-031816-01, 21-032316-01, 21-032516-01, 21-033016-01, 21-040116, 21-040516-01, 21-040716-01, 21-041216-01, 21-041416-01, 21-041816-01, 21-042016-01, 21-042216-01, 21-042616-01, 21-042816-01 and 21-042916-01.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1600-2016","Class II","Kraft Cake Flour (110760), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1019050, Lot code: 69-21-032316.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1605-2016","Class II","Pastry Flour (BRMOO20, M1633, 825, R000110690), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1030050, Lot codes: 486-21-040116, 50-21-040716, 100-21-020216, 100-21-020216, 48-21-020216, 850-21-032216, 100-21-033016, 100-21-033016, 100-21-033016, 100-21-031116 and 5-21-040716.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1601-2016","Class II","Bojangles Chicken Breading Flour (12248), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 3019050, Lot codes: 229-21-030910, 401-21-031616, 581-21-031816, 760-21-032416, 850-21-032916, 62-21-032916, 221-21-041116, 244-21-041316 and 412-21-041916.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1609-2016","Class II","Soft Wheat Flour  EN BL M  Bulk","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1533000, Lot Code: 21-032316-01, 21-040116-01, 21-041416-01, 21-041516-01, 21-041816-01, 21-041916-01, 21-042116 and 21-042216-01.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1602-2016","Class II","Donut Flour, Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1014050, Lot codes: 79-21-030216, 101-21-032816, 79-21-030216, 101-21-032816, 765-21-032116, 69-21-032316, 70-21-032516, 58-21-032516, 50-21-040216, 229-21-030910, 401-21-031616, 581-21-031816, 760-21-032416, 850-21-032916, 62-21-032916, 221-21-041116, 244-21-041316, 412-21-041916, 21-031616-01, 21-031616-01, 21-031716-01, 21-032416-01, 21-032416-01, 21-032516-01, 21-032516-01, 21-032816-01, 21-032916-01, 21-032916-01, 21-033016-01, 21-033016-01, 21-033116-01, 21-040516-01, 21-040616-01, 21-040716-01, 21-040816-01, 21-041216-01, 21-041316-01, 21-041516-01, 21-031416-01, 21-031516-01, 21-031516-01, 21-031716-01, 21-031716-01, 21-032116-01, 21-032116-01, 21-032316-01, 21-032316-01, 21-032416-01, 21-032816-01, 21-033016-01, 21-040616-01, 21-040816-01, 21-040816-01, 21-041116-01, 21-041116-01, 21-041316-01, 21-031616-01, 21-032116-01, 21-032416-01, 21-040616-01, 21-041116-01, 21-041516-01, 21-042516-01, 21-041616-01, 21-042216, 21-042616-01, 21-031616-01, 21-031716-01, 21-031616-01, 21-031816-01, 21-031716-01, 21-031916-01, 21-032116-01, 21-032216-01, 21-031816-01, 21-031816-01, 21-032116-01, 21-032516-01, 21-032216-01, 21-032316-01, 21-032616-01, 21-032816-01, 21-032916-01, 21-032516-01, 21-032516-01, 21-032816-01, 21-033016-01, 21-033016-01, 21-033116-01, 21-040216-01, 21-040216-02, 21-040416-01, 21-040516-01, 21-040116, 21-040616-01, 21-040516-01, 21-040716-01, 21-040616-01, 21-040716-01, 21-040816-01, 21-041116, 21-041216-01, 21-041416-01, 21-041516, 21-041816-01, 21-042016-01, 21-042116, 21-042216-01, 21-042516-01, 21-042616-01, 21-042616-01, 21-042716, 21-042816-01, and 21-042916-01 and 21-042916-01.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1598-2016","Class II","Craft Cake Flour (M4138), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.","279,514 CWTS(bulk measure/1 CWT equals 100 lbs.  e.g. 500 CWTS = 50,000 LBS).","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1524050, Lot codes: 416-21-020916, 450-21-041216, 57-21-033016, 100-21-020216, 400-21-031116, 527-21-031116, 504-21-040116, 150-21-033016, 587-21-041416.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1612-2016","Class II","Cookie/Cracker Flour, EN, C- Bulk","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," Code: SKU: 1523000, Lot codes: 21-031716-01, 21-031816-01, 21-032916-01, 21-033016-01, 21-040116-01, 21-040216-01 and 21-040416-01.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1603-2016","Class II","Graham, Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 4006050, Lot codes: 765-21-032116, 70-21-032516, 58-21-032516, 50-21-040216, 58-21-032516 and 50-21-040216.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1607-2016","Class II","Soft Wheat Flour EN  Bulk","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1034000, Lot Codes: 21-031716-01, 21-032416-01, 21-032516-01, 21-032916-01, 21-031616-01, 21-033016-01, 21-040516-01, 21-040616-01, 21-040716-01, 21-040816-01, 21-041216-01, 21-032416-01, 21-031416-01, 21-031416-02, 21-031416-03, 21-031416-04, 21-031516-02, 21-031516-01, 21-031516-03, 21-031516-04, 21-031616-01, 21-031616-02, 21-031616-03, 21-031716-01, 21-031816-01, 21-031816-02, 21-031916-01, 21-031916-02, 21-031916-01, 21-032016-01, 21-032016-02, 21-032016-03, 21-032116-01, 21-032116-02, 21-032116-03, 21-032116-01, 21-032216-01, 21-032216-02, 21-032216-03, 21-032216-01, 21-032316-01, 21-032316-02, 21-032316-03, 21-032416-01, 21-032416-02, 21-032416-03, 21-032416-01, 21-032416-02, 21-032919-01, , 21-032916-01, 21-033016-01, 21-033016-02, 21-033016-01, 21-033116-01, 21-033116-03, 21-040116-01, 21-040116-02, 21-040116-03, 21-040216-01, 21-040216-02, 21-033116-03, 21-040216-04, 21-040116-01, 21-040216-01, 21-040316-01, 21-040316-03, 21-040416-01, 21-040416-02, 21-040416-03, 21-040516-01, 21-040516-02, 21-040516-03, 21-040516-04, 21-040616-01, 21-040616-02, 21-040616-03, 21-040616-04, 21-040616-01, 21-040716-01, 21-040716-02, 21-040716-03, 21-040716-04, 21-040816-01, 21-040816-02, 21-040816-03, 21-040916-01, 21-040916-02, 21-040916-03, 21-041016-01, 21-041016-02, 21-041016-03, 21-041116-01, 21-041116-02, 21-041116-03, 21-041216-01, 21-041216-02, 21-041216-03, 21-041216-01, 21-041316-01, 21-041316-02, 21-041016-01, 21-041316-04, 21-041316-01, 21-041416-01, 21-041416-02, 21-041416-03, 21-041416-01, 21-041516-01, 21-041516-02, 21-041516-03, 21-041616-01, 21-041616-02, 21-041516-01, 21-041716-01, , 21-041716-02, 21-041816-01, 21-041816-02, 21-041816-03, 21-041816-01, 21-041916-01, 21-041916-02, 21-041916-03, 21-041916-01, 21-042016-01, 21-042016-02, 21-042016-03, 21-042016-04, 21-042116-01, 21-042116, 21-042116-03, 21-042116-04, 21-042116-01, 21-042216-01, 21-042216-02, 21-042216-03, 21-042216-04, 21-042316-01, 21-042316-02, 21-042316-03, 21-042216-01, 21-042316-01, 21-042416-01, 21-042416-02, 21-042416-03, 21",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1610-2016","Class II","SOFT WHOLE WHEAT FLOUR  BULK","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 4011000, Lot Code: 21-031616-01, 21-032116-01, 21-032416-01, 21-040616-01, 21-041116-01, 21-041516-01, 21-042516-01, 21-031416-01, 21-031516-01, 21-031716-01, 21-031816-01, 21-031916-01, 21-032016-01, 21-032116-01, 21-032316-01, 21-032816-01, 21-032916-01, 21-032916-02, 21-033016-01, 21-033116-01, 21-040116-01, 21-040216-01, 21-040316-01, 21-030416-01, 21-040416-02, 21-040516-01, 21-040616-01, 21-040716-01, 21-040816, 21-040916-01, 21-041016-01, 21-041116-01, 21-041116-01, 21-041216-01, 21-041416-01, 21-041516-01, 21-041716-01, 21-041716-02, 21-041816-01, 21-041916-01, 21-042016-01, 21-042116, 21-042216, 21-042316-01, 21-042416-01, 21-042516-01, 21-042916-01 and  21-043016-01.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1608-2016","Class II","Soft Wheat Flour-EN BL C-LVL 4.7  Bulk","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1526000, Lot Code: 21-031616-01, 21-032416-01, 21-032516-01, 21-032816-01, 21-032916-01, 21-033016-01, 21-033116-01, 21-041516-01, 21-031416-01, 21-031516-01, 21-031716-01, 21-032116-01, 21-032316-01, 21-032416-01, 21-032816-01, 21-033016-01, 21-040816-01, 21-041116-01, 21-041316-01, 21-042216 and 21-042616-01.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74305,"Ongoing","Grain Craft, Inc.","201 W Main St Ste 203",,"Chattanooga","TN","37408-1137","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL, GA, LA, MI, MO, NC, NJ, TN and TX.","F-1604-2016","Class II","Unenriched Pastry Flour, (M1613, R100258001), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.","279,514 CWTS","Possible Peanut Protein contamination.","07/06/2016","."," SKU: 1031050, Lot codes: 434-21-030816, 400-21-033016, 243-21-042616, 100-21-020216, 200-21-030316, 52-21-033016, 96-21-032216, 600-21-040716 and 13-21-040716.",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74306,"Ongoing","Dean Foods, Inc.","2711 N Haskell Ave","Suite 3400","Dallas","TX","75204-2911","United States","Voluntary: Firm Initiated","Press Release","ID, OR, WY, UT","F-2603-2016","Class II","Meadow Gold Dairy Pure Fresh Half & Half One Quart (946 mL)","1206 containers","Insufficient pasteurization.","09/23/2016",," SELL BY 16-05 06-17-19 CK-D _ _:_ _ LK UPC: 4190007913 ",6/1/2016,"06/01/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74306,"Ongoing","Dean Foods, Inc.","2711 N Haskell Ave","Suite 3400","Dallas","TX","75204-2911","United States","Voluntary: Firm Initiated","Press Release","ID, OR, WY, UT","F-2605-2016","Class II","Old Style Meadow Gold Heavy Whipping Cream Grade A Pint (473 mL) in waxed cardboard container","60 containers","Insufficient pasteurization.","09/23/2016",," SELL BY 16-05 06-24-16 CK-D _ _:_ _ LK, UPC: 1570013313",6/1/2016,"06/01/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74306,"Ongoing","Dean Foods, Inc.","2711 N Haskell Ave","Suite 3400","Dallas","TX","75204-2911","United States","Voluntary: Firm Initiated","Press Release","ID, OR, WY, UT","F-2604-2016","Class II","Meadow Gold Dairy Pure Fresh Heavy Whipping Cream One Gallon (3.78L) in plastic one gallon container; Fresh Meadow Gold Dairy Pure Heavy Whipping Cream Half Pint (236 mL) in waxed cardboard carton; Meadow Gold Dairy Pure Fresh Heavy Whipping Cream One Quart (946mL) in waxed cardboard carton.","590 containers","Insufficient pasteurization.","09/23/2016",," 1 gallon: 16-05 6-24-16 _ _:_ _ CK-D DL, UPC: 1570016615;  Half pint: SELL BY 16-05 06-24-16 CK-D _ _:_ _ LK, UPC: 1570010018; Quart: SELL BY 16-05 06-24-16 CK-D _ _:_ _, UPC: 1570013210",6/1/2016,"06/01/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74307,"Ongoing","Navitas, LLC.","15 Pamaron Way",,"Novato","CA","94949-6231","United States","Voluntary: Firm Initiated","Press Release","NY, NH, CT, PA, GA, FL, IN, IA, WI, TX, CA, WA, CO, OR, DC, ME, MD, UT, SC, MI, and one consignee in Canada","F-1687-2016","Class I","Navitas Naturals Superfood Goji bar:  Tangy berry, Acai, Nut Bar  Net WT. 1.4 oz/40 G.  Gluten free., non GMO.    Ingredients: Organic roasted cashew, almond, honey, crisp brown rice, evaporated cane sugar, roasted sunflower seed, tapioca syrup, dried blueberry (blueberry, apple juice concentrate, sunflower oil), cacao nib, quinoa crisp, dried goji berry, pomegranate powder, acai powder, blueberry flavor, non-soy glycerin, citric acid.  Allergen information: contains tree nuts (cashews & almonds)    Distributed by Navitas Naturals, Novato, CA.","3,275 caddies of 12 bars","Firm was notified by manufacturer that four varieties of   their Superfood bars were made using sunflower seeds under recall for Listeria Monocytogenes.","07/15/2016",," Lot 0476; Best Before Mar 2017.",6/2/2016,"06/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74307,"Ongoing","Navitas, LLC.","15 Pamaron Way",,"Novato","CA","94949-6231","United States","Voluntary: Firm Initiated","Press Release","NY, NH, CT, PA, GA, FL, IN, IA, WI, TX, CA, WA, CO, OR, DC, ME, MD, UT, SC, MI, and one consignee in Canada","F-1686-2016","Class I","Navitas Naturals Superfood Cacao bar:  Tart Cranberry, Cacao, Nut Bar  Net WT. 1.4 oz/40 G.  Gluten free.    Ingredients:     Distributed by Navitas Naturals, Novato, CA.","3,269 caddies of 12 bars","Firm was notified by manufacturer that four varieties of   their Superfood bars were made using sunflower seeds under recall for Listeria Monocytogenes.","07/15/2016",," Lot 0476; Best Before Mar 2017.",6/2/2016,"06/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74307,"Ongoing","Navitas, LLC.","15 Pamaron Way",,"Novato","CA","94949-6231","United States","Voluntary: Firm Initiated","Press Release","NY, NH, CT, PA, GA, FL, IN, IA, WI, TX, CA, WA, CO, OR, DC, ME, MD, UT, SC, MI, and one consignee in Canada","F-1685-2016","Class I","Navitas Naturals Superfood Hemp bar:  Creamy Peanut, Hemp, Nut Bar.  Net Wt. 1.4 oz/40 G.  Gluten free.    Ingredients: Organic Roasted Cashews, Almonds Honey, Evaporated Cane Sugar, Crisp Brown rice, roasted peanuts, tapioca syrup, roasted sunflower seeds, quinoa crisp, almond butter, toasted hemp seed, sea salt, not-soy glycerin, organic flavor.  Allergen information: Contains Peanuts & Tress nuts (Cashews and Almonds).    Distributed by Navitas Naturals, Novato, CA.","3.221 caddies of 12 bars","Firm was notified by manufacturer that four varieties of   their Superfood bars were made using sunflower seeds under recall for Listeria Monocytogenes.","07/15/2016",," Lot 0466; Best Before Mar 2017.",6/2/2016,"06/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74307,"Ongoing","Navitas, LLC.","15 Pamaron Way",,"Novato","CA","94949-6231","United States","Voluntary: Firm Initiated","Press Release","NY, NH, CT, PA, GA, FL, IN, IA, WI, TX, CA, WA, CO, OR, DC, ME, MD, UT, SC, MI, and one consignee in Canada","F-1688-2016","Class I","Navitas Naturals Superfood Maca bar:  Sweet Maple, Maca, Nut Bar  Net WT. 1.4 oz/40 G.  Gluten free.    Ingredients:   Distributed by Navitas Naturals, Novato, CA.","3,316 caddies of 12 bars","Firm was notified by manufacturer that four varieties of   their Superfood bars were made using sunflower seeds under recall for Listeria Monocytogenes.","07/15/2016",," Lot 0466; Best Before Mar 2017.",6/2/2016,"06/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74308,"Ongoing","DeVilbiss Healthcare LLC","100 Devilbiss Dr",,"Somerset","PA","15501-2125","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC","Z-2246-2016","Class II","DeVilbiss Model 7305P-D Powered Suction Unit","48 units","A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.","07/20/2016",," Serial numbers: PD465146 - PD465193",5/23/2016,"05/23/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74309,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of MD, MN, MS and the countries of Australia, Austria, Bangladesh, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guadeloupe, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Republic Korea, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E, United Kingdom & Vietnam.","Z-2256-2016","Class II","ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979).     Product Usage:  This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.  ","446 units Total (3 domestically & 443 internationally)","Eight (8) issues were identified which may affect the results generated by the system software version.","07/21/2016",," none",5/26/2016,"05/26/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74310,"Ongoing","Clif Bar And Company","1451 66th St",,"Emeryville","CA","94608-1004","United States","Voluntary: Firm Initiated","Press Release","US and Canada","F-1694-2016","Class I","CLIF BAR Sierra Trail Mix  energy bar, 68 g bar  UPC: 7-22252-16105-5;  6 and 12 count packages, mini pack sizes-150 count Sample only. No UPC.    INGREDIENTS: Organic Brown Rice Syrup, Organic Rolled Oats, Organic Raisins, Organic Peanuts, Soy Protein Isolate, Rice Flour, Organic Cane Syrup, Organic Peanut Butter, Organic Roasted Soybeans, Organic Oat Fiber, Dried Cane Syrup, Organic Soy Flour, Unsweetened Chocolate¿¿, Pumpkin Seeds, Sunflower Seeds, Organic Date Paste, Sea Salt, Cocoa Butter¿¿, Natural Flavors, Barley Malt Extract, Sunflower Oil, Vanilla Extract, Soy Lecithin, Mixed Tocopherols (Antioxidant).    ClifBar & Company, Emeryville, CA","approximately 1,973,133 packaging units total, all varieties","Firm was notified by supplier of sunflower kernels that they may be contaminated with Listeria monocytogenes.","07/15/2016",," All pack configurations with best by date ranges starting 05JUN16 through 24MAR17",6/2/2016,"06/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74310,"Ongoing","Clif Bar And Company","1451 66th St",,"Emeryville","CA","94608-1004","United States","Voluntary: Firm Initiated","Press Release","US and Canada","F-1696-2016","Class I","CLIF BAR Sierra Trail Mix/ Melange Montagnard Sierra;  68 g bar; 12 ct packages  UPC: 7-22252-12115-8  Canadian distribution only.    INGREDIENTS: BROWN RICE SYRUP*, SOY RICE CRISPS (SOY PROTEIN ISOLATE, RICE FLOUR, BARLEY MALT EXTRACT), ROLLED OATS*, RAISINS*, PEANUTS*, CHOCOLATE CHIPS (DRIED CANE SYRUP, UNSWEETENED CHOCOLATE!, COCOA BUBUTTERSOY LECITHIN, VANILLA EXTRACT), ROASTED SOYBEANS*, CANE SYRUP*, PEANUT BUTTER*, SOY FLOUR*, OAT HULL FIBRE*, SUNFLOWER SEEDS, PUMPKIN SEEDS, DATE PASTE*, MILLED FLAXSEED*, SEA SALT, NATURAL FLAVOURS, TOCOPHEROLS. VITAMINS & MINERALS: POTASSIUM CITRATE, DICALCIUM PHOSPHATE, MAGNESIUM OXIDE, ASCORBIC ACID, DL-ALPHA TOCOPHERYL ACETATE, ZINC CITRATE, MANGANESE GLUCONATE, NIACINAMIDE, BIOTIN, COPPER GLUCONATE, IRON, BETA-CAROTENE, RETINYL PALMITATE, D-CALCIUM PANTOTHENATE, SODIUM SELENITE, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE MONONITRATE, ERGOCALCIFEROL, CHROMIUM CHLORIDE, SODIUM MOLYBDATE, POTASSIUM IODIDE, CYANOCOBALAMIN. CONTAINS PEANUTS, SOY, BARLEY, AND OATS. MAY CONTAIN TRACES OF TRITICALE, WHEAT, MILK, RYE, AND TREE NUTS. *ORGANIC   INGR¿DIENTS : SIROP DE RIZ BRUN*, P¿PITES DE RIZ ET SOJA (ISOLAT DE PROT¿INES DE SOJA, FARINE DE RIZ, EXTRAIT DE MALT DORGE), FLOCONS DAVOINE*, RAISINS SECS*, ARACHIDES*, BRISURES DE CHOCOLAT (SIROP DE CANNE D¿SHYDRAT¿, CHOCOLAT NON SUCR¿!, BEURRE DE CACAO!, L¿CITHINE DE SOJA, EXTRAIT DE VANILLE),  F¿VES DE SOJA GRILL¿ES*, SIROP DE CANNE*, BEURRE DARACHIDE*, FARINE DE SOJA*, FIBRE DE BALLES DAVOINE*, GRAINES DE TOURNESOL, GRAINES DE CITROUILLE, P¿TE DE DATES*, GRAINES DE LIN MOULUES*, SEL MARIN, AR¿MES NATURELS, TOCOPH¿ROLS. VITAMINES ET MIN¿RAUX : CITRATE DE POTASSIUM, PHOSPHATE  DICALCIQUE, OXYDE DE MAGN¿SIUM, ACIDE ASCORBIQUE, AC¿TATE DE DL-ALPHA TOCOPH¿RYLE, CITRATE DE ZINC, GLUCONATE DE MANGAN¿SE, NIACINAMIDE, BIOTINE, B¿TA-CAROT¿NE, PALMITATE DE R¿TINYLE, GLUCONATE DE CUIVRE, FER, D-PANTOTH¿NATE DE CALCIUM, S¿L¿NITE DE SODIUM, ACIDE FOLIQUE, CHLORHYDRATE DE  PYRIDOXINE, RIBOFLAVINE, MONONITRATE DE THIAMINE, ERGOCA","approximately 1,973,133 packing units total, all varieties.","Firm was notified by supplier of sunflower kernels that they may be contaminated with Listeria monocytogenes.","07/15/2016",," Expiry 2016JN06 to 2017FE23",6/2/2016,"06/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74310,"Ongoing","Clif Bar And Company","1451 66th St",,"Emeryville","CA","94608-1004","United States","Voluntary: Firm Initiated","Press Release","US and Canada","F-1693-2016","Class I","CLIF BAR Nuts & Seeds energy bar, 68 g bar.  Almonds, Peanuts, Pumpkin Seeds  UPC: 7-22252-16101-7;  12 count and 6 count packages      INGREDIENTS: Organic Brown Rice Syrup, Organic Rolled Oats, Soy Protein Isolate, Sunflower Seeds, Organic Almonds, Organic Cane Syrup, Organic Peanut Butter, Rice Flour, Organic Roasted Soybeans, Organic Pumpkin Seeds, Organic Sunflower Seed Butter, Organic Soy Flour, Organic Oat Fiber, Natural Flavors, Sea Salt, Sunflower Oil, Barley Malt Extract, Mixed Tocopherols (Antioxidant).    ClifBar & Company, Emeryville, CA","approximately 1,973,133 packaging units total, all varieties","Firm was notified by supplier of sunflower kernels that they may be contaminated with Listeria monocytogenes.","07/15/2016",," All pack configurations with best by date ranges starting 08JUN16 through 21JAN17",6/2/2016,"06/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74310,"Ongoing","Clif Bar And Company","1451 66th St",,"Emeryville","CA","94608-1004","United States","Voluntary: Firm Initiated","Press Release","US and Canada","F-1695-2016","Class I","CLIF BAR Mojo Mountain Mix trail bar, 45 g bar  UPC: 7-22252-10561-5;  12 count packages;    INGREDIENTS: Organic Brown Rice Syrup, Soy Rice Crisps (Soy Protein Isolate, Organic Rice Flour, Calcium Carbonate), Organic Peanuts, Organic Raisins, Almonds, Organic Chocolate Chips (Organic Dried  Cane Syrup, Organic Unsweetened Chocolate, Organic Cocoa Butter, Organic Soy Lecithin, Organic Vanilla Extract), Organic Pretzels (Organic Wheat Flour, Salt, Organic Canola Oil, Organic Malt), Organic Peanut Butter, Organic Roasted Soybeans, Pumpkin Seeds, Roasted Sunflower Seeds (Sunflower Seeds, Sunflower Oil), Organic Oat Syrup Solids, Vegetable Glycerin, Organic Sunflower Oil, Sea Salt, Organic Gum Arabic, Mixed Tocopherols (Antioxidant).       ClifBar & Company, Emeryville, CA","approximately 1,973,133 packaging units total, all varieties.","Firm was notified by supplier of sunflower kernels that they may be contaminated with Listeria monocytogenes.","07/15/2016",," All pack configurations with best by date ranges starting 16JUN16 through 02FEB17",6/2/2016,"06/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74311,"Ongoing","Custom Ultrasonics, Inc.","144 Railroad Dr",,"Ivyland","PA","18974-1449","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY  OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.","Z-2130-2016","Class II","The System 83 Plus, Endoscope Washer/Disinfector  Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.","2,345 units","To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.  ","07/06/2016","."," All serial numbers",5/6/2016,"05/06/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74312,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to the states of :  AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA,  PR, RI, SC, SD, TN,TX, UT, VA, VT, WA, WI, WV, WY    Foreign:None    VA/DOD: See list below","Z-2304-2016","Class II","ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P)    The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.","53,897 Units distributed","Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer.  ","08/01/2016",," 04491050190  ONLINE TDM Vancomycin 100 tests  05108420190  ONLINE TDM Vancomycin 200 tests  04642490190  Hitachi Vancomycin (Modular P)  04642481190  Hitachi Vancomycin (917, MOD P)",5/26/2016,"05/26/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74313,"Ongoing","Ach Food Companies Inc","7171 Goodlett Farms Pkwy",,"Cordova","TN","38016-4909","United States","Voluntary: Firm Initiated","Letter","Nationwide and in the Domincan Republic.  No government or military distribution.","F-1853-2016","Class I","Salad topping labeled under the following brand names:   (Product 1) Durkee Salad Topping in plastic bottle, Net Wt. 6.75 oz (192 g), packed in cases of 12. UPC 047600091366. The responsible firm name on the label is ACH Food Companies, Inc. Memphis, TN; (Product 2) Hy-Vee Garden Style Salad Topping in plastic bottle, Net Wt. 6.75 oz (192 g), packed in cases of 12.  UPC 036800173224. The responsible firm name on the label is Hy-Vee Inc.; (Product 3) Food Club Salad Topping in plastic bottle, Net Wt. 6.75 oz (192 g), packed in cases of 12. UPC 075450047554. The responsible firm name on the label is Topco Associates LLC, Skokie, IL.","111,564 6.75oz bottles distributed","Product manufactured with ingredient which may be contaminated with Listeria monocytogenes.","08/02/2016",," (Product 1) Best by dates JUL 20 17, JUL 21 17, AUG 18 17, AUG 19 17, OCT 05 17, NOV 17 17, NOV 22 17, and FEB 09 18; (Product 2) Lot codes: 232A5 B, 238A5 B, 239A5 C, 279A5 C, 327A5 B, 327A5 C, 041A6 C, 042A6 B, and 111A6 B; and (Product 3) Best by dates JUL 21 17, OCT 05 17, NOV 17 17, and APR 20 18.",6/2/2016,"06/02/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74314,"Ongoing","Aidarex Pharmaceuticals LLC","595 N Smith Ave Ste B",,"Corona","CA","92880-6920","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1061-2016","Class III","Ciprofloxacin OPTH 0.3%  SOL, generic for: Ciloxan, Rx Only,  2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01  ","599 bottles","Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.","06/30/2016",," Lot # : a) 44704-1, 44899-1, 45153-1, 45387-1 Exp. 10/2016, 45449-1, 45801-1, 47647-1,  Exp. 02/2017    b) 40990-1 Exp: 05/2016, 45960-1 Exp. 08/2016, 45316-1, 45961-1 Exp. 09/2016  ",6/1/2016,"06/01/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74315,"Ongoing","Aidarex Pharmaceuticals LLC","595 N Smith Ave Ste B",".","Corona","CA","92880-6920","United States","Voluntary: Firm Initiated","FAX","U.S. including: CA, ND, PA, TN","D-0975-2016","Class II","CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only.  MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.","292 Bottles","Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.","06/08/2016",," Lot #: 45335-1, Expiry: 2017/02; Lot #: 46807-1, Expiry: 2017/01; Lot #:  44359-1, Expiry: 2017/02; Lot #: 44395-1, Expiry: 2017/02; Lot #:  44693-1, Expiry: 2017/02; Lot #: 44694-1, Expiry: 2017/02; Lot #: 43707-1, Expiry: 2017/03; Lot #: 47697-1, Expiry: 2017/03; Lot #: 48605-1, Expiry: 2017/03; Lot #: 48659-1, Expiry: 2017/03; Lot #: 47772-1, Expiry: 2017/05; Lot #: 48271-1, Expiry: 2017/05.",6/1/2016,"06/01/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74316,"Ongoing","Aidarex Pharmaceuticals LLC","595 N Smith Ave Ste B",".","Corona","CA","92880-6920","United States","Voluntary: Firm Initiated","FAX","IN, GA","D-0974-2016","Class III","CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01  ","10","CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.","06/07/2016",," Lot#: 47312-1, Exp 01/2018",6/1/2016,"06/01/2016",6/15/2016,"06/15/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74317,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribuiton to OK, ME, NY, & Hawaii.","Z-2128-2016","Class II","Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18.  Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.","14","Labeled with the incorrect Global Trade Item Number (GTIN).  The GTIN on the label identifies the devices as another.","07/05/2016","."," Catalog #: 160-33-18; Serial#: 4300062, 4300063; Exp Date: 02/27/2021. Catalog #: 160-33-18; Serial#:4325742, 4325743, 4325744, 4325745, 4325746, 4325747, 4325748, 4325749, 4325750, 4325751, 4325752, 4325753; Exp Date: 03/17/2021. ",5/26/2016,"05/26/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74317,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribuiton to OK, ME, NY, & Hawaii.","Z-2127-2016","Class II","Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17.  Product Usage	Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.    ","8 units","Labeled with the incorrect Global Trade Item Number (GTIN).  The GTIN on the label identifies the devices as another.","07/05/2016","."," Catalog #: 160-33-17; Serial#: 4192419, 4192420; Exp Date: 11/28/2020. Catalog #: 160-33-17; Serial#: 4223628, 4223629, 4223630, 4223631, 4223632, 4223633; Exp Date: 01/02/2021. ",5/26/2016,"05/26/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74318,"Ongoing","Riba Foods Inc","3735 Arc St",,"Houston","TX","77063-5235","United States","Voluntary: Firm Initiated","Press Release","Texas","F-1596-2016","Class II","Bayou Brothers Creole Sauce NET WT 33OZ. (2 LBS 1 OZ) 936g packaged in a glass jar","4,048 cases","Product contains undeclared fish.","06/30/2016",," Best By: 23MAR17, 09JUN17, 21AUG17, 15SEP17, 13OCT17, 05NOV17, 17NOV17, 02DEC17, 13JAN18, 22JAN18, 10MAR18, 12APR18, 18MAY18  ",6/3/2016,"06/03/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74319,"Ongoing","Lyne Laboratories, Inc.","10 Burke Dr",,"Brockton","MA","02301-5505","United States","Voluntary: Firm Initiated","Letter","NJ","D-1062-2016","Class III","Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48","12,215 Bottles shipped to Rising Pharmaceuticals","Subpotency: product assayed and found OOS for cyproheptadine","07/05/2016","."," Lot #: CR1603, Exp 12/17",6/7/2016,"06/07/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0029-2017","Class II","Zenostar MT Color B4 60ml, art. no. 681058.   Product Usage:  For coloring dental porcelain    ","7 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U38887, exp date: Sep 16 2017",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0037-2017","Class II","Zenostar MT Color Impulse orange, art. no. 681168.      Product Usage:  For coloring dental porcelain  ","5 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U44402, expiration date: Oct 19 2017; V01767, expiration date:  Jan 18 2018; U52968, expiration date: Jan 18 2018; U53010, expiration date: Nov 16 2017; and U38982, expiration date: Sep 17 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0035-2017","Class II","Zenostar MT Color D3 60ml, art. no. 681064.     Product Usage:  For coloring dental porcelain  ","18 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U38639, exp date: Sep 15 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0025-2017","Class II","Zenostar MT Color A4 60ml, art. no. 681054.     Product Usage:  For coloring dental porcelain  ","11 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U38746, exp date: Sep 15 2017",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0019-2017","Class II","Zenostar MT Color Impulse grey, art. no. 681167    Product Usage:  For coloring dental porcelain  ","60 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U52159, exp date: Mar 30 2018; U52107, exp date: Nov 16 2017; U44397, exp date: Oct 19 2017; and U39255, exp date: Sep 20 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0022-2017","Class II","Zenostar MT Color A2 60ml, art. no. 681051.     Product Usage:  For coloring dental porcelain    ","72 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U51512, exp date: Nov 10 2017; U44051, exp date: Oct 19 2017; U43988, exp date: Nov 2 2017; U43931, exp date: Nov 2 2017; and U39054 exp date: Sep 17 2017  ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0033-2017","Class II","Zenostar MT Color C4 60ml, art. no. 681062.      Product Usage:  For coloring dental porcelain  ","10 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U38677, exp date: Sep 15 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0031-2017","Class II","Zenostar MT Color C2 60ml art. no. 681060.     Product Usage:  For coloring dental porcelain    ","19 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U44095, exp date: Oct 19 2017 and U38600, exp date: Sep 15 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0020-2017","Class II","Zenostar MT Color Impulse violet, art. no. 681166    Product Usage:  For coloring dental porcelain      ","25 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U49960, Exp. date: Nov 2 2017; U44396, exp. date: Oct 19 2017; and U38897, exp date: Sep 16 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0017-2017","Class II","Zenostar MT Color Impulse blue, Art. no. 681165    Product Usage:  For coloring dental porcelain  ","79 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U54839, expiration date: Jan 25 2018; Lot No: U51735, expiration date: Nov 11 2017; Lot No: U49940, expiration date: Nov 2 2017; Lot No: U44391, expiration date: Oct 19 2017 and Lot No: U39253, expiration date: Sep 20 2017",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0023-2017","Class II","Zenostar MT Color A3 60ml, art. no. 681052.      Product Usage:  For coloring dental porcelain  ","42 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U49683, exp date: Nov 2 2017; U49656, exp date: Nov 2 2017; and U39116, exp date: Sep 17 2017",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0032-2017","Class II","Zenostar MT Color C3 60ml, art. no. 681061.   Product Usage:  For coloring dental porcelain  ","13 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U38627, exp date: Sep 15 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0030-2017","Class II","Zenostar MT Color C1 60ml, art. no. 681059.     Product Usage:  For coloring dental porcelain  ","37 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U51611, exp date: Nov 11 2017; U50758, exp date: Nov 5 2017; U43929, exp date: Nov 5 2017; and U38834, exp date: Sep 16 2017  ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0034-2017","Class II","Zenostar MT Color D2 60ml, art. no. 681063.     Product Usage:  For coloring dental porcelain  ","40 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U43930, exp date: Nov 2 2017 and U39238, exp date: Sep 20 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0021-2017","Class II","Zenostar MT Color A1 60ml, art. no. 681050,     Product Usage:  For coloring dental porcelain    ","94 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U51483, exp date: Nov 10 2017; U43963, exp date: Nov 2 2017; U43927, exp. date: Nov 2 2017; and U38867, exp date: Sep 16 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0028-2017","Class II","Zenostar MT Color B3 60ml, art. no. 681057.     Product Usage:  For coloring dental porcelain    ","27 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U38751, exp date: Sep 15 2017",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0036-2017","Class II","Zenostar MT Color D4 60ml, art. no. 681065.     Product Usage:  For coloring dental porcelain  ","9 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U38680, exp date: Sep 15 2017    ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0026-2017","Class II","Zenostar MT Color B1 60ml, art. no. 681055.     Product Usage:  For coloring dental porcelain  ","43 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U49851, exp date: Nov 2 2017; U49838, exp date: Nov 2 2017; and U39117, Sep 17 2017  ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0024-2017","Class II","Zenostar MT Color A3.5 60ml, art. no. 681053.     Product Usage:  For coloring dental porcelain  ","17 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U49659, exp date: Nov 2 2017; U43928, exp date: Oct 19 2017; and U38672, exp date: Sep 15 2017",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0018-2017","Class II","Zenostar MT Color Impulse brown, art. no. 681169    Product Usage:  For coloring dental porcelain  ","11 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U44405, expiration date: Oct 19 2017; U39262, expiration date: Sep 20 2017     ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74320,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.","Z-0027-2017","Class II","Zenostar MT Color B2 60ml, art. no. 681056.      Product Usage:  For coloring dental porcelain      ","15 units","The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.","10/04/2016",," Lot No: U39398, exp date: Sep 21 2017  ",5/27/2016,"05/27/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74321,"Terminated","NatureBox, Inc.","100 Redwood Shores Pkwy Fl 2",,"Redwood City","CA","94065-1155","United States","Voluntary: Firm Initiated","E-Mail","Nationwide directly to consumers through online purchase.","F-1565-2016","Class I","SunOpta Country Ranch Sunflower Kernels- 45lbs case    6075 lbs received (35 cases)  ","1305 lbs. (29 cases)","Firm was notified by supplier of sunflower seeds that they are being recalled due to Listeria Monocytogenes.","06/18/2016","07/07/2016"," not provided",6/3/2016,"06/03/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74321,"Terminated","NatureBox, Inc.","100 Redwood Shores Pkwy Fl 2",,"Redwood City","CA","94065-1155","United States","Voluntary: Firm Initiated","E-Mail","Nationwide directly to consumers through online purchase.","F-1564-2016","Class I","NatureBox Cheddar and Onion Sunflower kernels:   5 oz. (142g) customer stand up pouch.  UPC: 8 54557 00531 1    Ingredients: Non GMO Sunflower kernels, Sunflower Oil, Sweet Onion and White Cheddar Seasoning Blend (cane sugar, onion and garlic powder, cheddar cheese powder {cheddar cheese (pasteurized milk, cheese cultures, salt, enzymes), buttermilk, whey, salt, disodium phosphate}, salt, natural flavors, lactic acid, spices, silicon dioxide (to prevent caking).  Contains: Milk.      Distributed by NatureBox, San Carlos, CA 94070      ","22,231 x 5 oz. pouches.","Firm was notified by supplier of sunflower seeds that they are being recalled due to Listeria Monocytogenes.","06/18/2016","07/07/2016"," Lot 8H5M26:  Best Before dates: 03/29/16, 04/27/16, 05/09/16, 05/18/16, 06/10/16, 07/11/16, 07/19/16, 08/15/16, 08/26/16, 09/17/16.",6/3/2016,"06/03/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74321,"Terminated","NatureBox, Inc.","100 Redwood Shores Pkwy Fl 2",,"Redwood City","CA","94065-1155","United States","Voluntary: Firm Initiated","E-Mail","Nationwide directly to consumers through online purchase.","F-1525-2016","Class I","NatureBox Country Ranch Sunflower kernels;   5 oz. (142g) customer stand up pouch.  UPC: 8 52523 00535 8    Ingredients: Sunflower kernels, Sunflower Oil, Buttermilk Powder, Salt, Rice Syrup Solids, Onion and Garlic, Sour Cream Powder (cultured milk, nonfat milk), Tomato Powder, Cheese Powder (cheddar cheese, cultures pasteurized milk, salt, enzymes), Torula Yeast, natural Flavors, Corn Flour, Citric Acid, Parsley. Green Bell Pepper Powder, Silicon Dioxide.  Contains: Milk.    Distributed by NatureBox, San Carlos, CA 94070      ","14, 941 x 5 oz. pouches.","Firm was notified by supplier of sunflower seeds that they are being recalled due to Listeria Monocytogenes.","06/18/2016","07/07/2016"," Lot 8H5M25;  Best Before Dates: 05/18/16, 06/10/16, 08/25/16,5/9/16, 7/15/16.",6/3/2016,"06/03/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74322,"Terminated","United Blood Services","6220 E Oak St",,"Scottsdale","AZ","85257-1101","United States","Voluntary: Firm Initiated","FAX","Arizona","B-0594-16","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.","06/23/2016","06/23/2016"," W041016046862S; W041016043575G; ",4/22/2016,"04/22/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74323,"Terminated","Plasma Biological Services Inc","4798 Summer Ave",,"Memphis","TN","38122-4732","United States","Voluntary: Firm Initiated","E-Mail","NC","B-0643-16","Class III","Source Plasma","14 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","07/08/2016","07/08/2016"," 15MEMF8887; 15MEMF8746; 15MEMF7378; 15MEMF7134; 15MEME7118; 15MEME5488; 15MEME4133; 15MEME3753; 15MEME3480; 15MEMD2775; 15MEMD1207; 15MEMC9178; 15MEMC6850; 15MEMC6110",1/14/2016,"01/14/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74324,"Ongoing","The Quaker Oats Company","555 W Monroe St",,"Chicago","IL","60661-3605","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to multiple locations within the U.S. (nationwide): No foreign consignees.","F-0047-2017","Class I","Quaker Quinoa Granola Bars, chocolate nut medley packaged in a multi colored box with brown lettering. Wrapper UPC: 000 30000 00243 8","77,448 cases, 12 units per case, 5 bars per unit. ","SunOpta expanded their recall of listeria Monocytogenes in sunflower kernels. These sunflower kernels were used in the manufacturing of quinoa bars at the quaker oats company. ","10/07/2016",," Best by dates: all dats prior to November 15, 2016 (NOV 15 16 K)",6/2/2016,"06/02/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74324,"Ongoing","The Quaker Oats Company","555 W Monroe St",,"Chicago","IL","60661-3605","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to multiple locations within the U.S. (nationwide): No foreign consignees.","F-0048-2017","Class I","Quaker quinoa granola bars, yogurt fruit and nut flavor packaged in a multi colored box with brown lettering. Wrapper UPC: 000 30000 00195 0","106, 436 cases, 12 units per case, 5 bars per unit. ","SunOpta expanded their recall of listeria Monocytogenes in sunflower kernels. These sunflower kernels were used in the manufacturing of quinoa bars at the quaker oats company. ","10/07/2016",," Best by dates: all dats prior to November 15, 2016 (NOV 15 16 K)",6/2/2016,"06/02/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74325,"Ongoing","Dr. Reddy's Laboratories, Inc.","107 College Rd E",,"Princeton","NJ","08540-6623","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1063-2016","Class III","Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01","9,330 bottles","Failed impurities/degradation: out of specification result for impurity secorapamycin.","07/05/2016","."," Lot # H400044, H400045 , Exp 07/16; H400048, Exp 08/16; H400055, Exp 10/16; H400070, H400071, H400073 and H400074, Exp 11/16",6/3/2016,"06/03/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74326,"Ongoing","Sandoz Inc","100 College Rd W",,"Princeton","NJ","08540-6604","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1036-2016","Class III","Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only,  Manufactured by Sandoz  Inc., Princeton, NJ 08540, NDC 0185-0630-01","3,048 bottles ( 304,800 tablets)","Labeling: Incorrect or Missing Package Insert","06/16/2016",," Lot # FC1960; Exp.: 02/18",5/25/2016,"05/25/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74327,"Ongoing","Tradewind Foods de Puerto Rico Inc.","Urb. Industrial Luchetti",,"Bayamon","PR","00961","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic: Puerto Rico and US Virgin Islands (St. Croix and St. John); International: St. Marteen, Anguila, Tortola, Curacao, and Aruba.","F-2602-2016","Class III",,"297 cases/12 jars per case","Goya Honey with Comb product tested by FDA showed presence of 2, 6 Dichlorobenzamide which is not EPA registered for use in honey.","09/23/2016",," 15173",6/7/2016,"06/07/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74328,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",,"Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to the following states: AL, FL, GA, NC, SC, TN.","F-2196-2016","Class I","Publix Nuts, Seeds and Raisins Mix in the following sizes: 16.2 oz. Plastic Clamshell Box, 5.06 oz. Plastic Go-cup and 25 lbs. Bags    				 ","9,873 retail containers (16.2 oz)  total, 552 bulk/25 lb bags (used for 5.6 oz cup size)","May contain Listeria monocytogenes","09/14/2016",," 16.2 oz. UPC # 000-41415-08886 / Lots # All Date Lots,  5.06 oz. UPC # 002-25143-00000 / Lots # All Date Lots and  25 lbs.   UPC # 004-00002-10396 / Lots # All Date Lots.",6/1/2016,"06/01/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74329,"Ongoing","Lifeline First Aid LLC","26200 SW 95th Ave Ste 302",,"Wilsonville","OR","97070-8204","United States","Voluntary: Firm Initiated","Letter","Distributed in AZ,  CA,  CO,  FL,  GA,  IL,  KY,  MD,  MN,  MO,  MT,  NE,  NJ,  NY,  OK,  OR,  PA,  SC,  TN,  UT,  VA,  WA,  WA,  and WI.  Also distributed in New Zealand.","Z-2132-2016","Class II","Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6.    Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline.    UPC Red color kit:  845174005464;   UPC Lime color kit:  845174005594;   UPC Purple color:  845174005600;   UPC of master case of 6 845174005471 (2 each color)    Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453    ","3572 units of item #4042; 29,088 units of item #4043; 1,248 units of item #4037","First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use. ","07/06/2016","."," item #4042 and item #4043 have the expiration date: 11/30/2017.    Item #4037 has the following lots and expiration dates:  Lot #	Expiration Date  101483;	3/15  101546;	6/15  101682;	7/15  101804;	1/16  101812;	1/16  102032;	5/16  102109;	5/16  102098;	5/17  102130;	5/16  102296;	10/16  102317;	10/16  102295;	10/16  102372;	1/17  102638;	1/17  102694;	8/17  ",5/16/2016,"05/16/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74329,"Ongoing","Lifeline First Aid LLC","26200 SW 95th Ave Ste 302",,"Wilsonville","OR","97070-8204","United States","Voluntary: Firm Initiated","Letter","Distributed in AZ,  CA,  CO,  FL,  GA,  IL,  KY,  MD,  MN,  MO,  MT,  NE,  NJ,  NY,  OK,  OR,  PA,  SC,  TN,  UT,  VA,  WA,  WA,  and WI.  Also distributed in New Zealand.","Z-2133-2016","Class II","5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.        ","2975 kits","Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use. ","07/06/2016","."," Exp Dates/Lot #  Jan-16; 14181  Nov-16; 15077  Nov-16; 15097  Mar-17; 15278  Oct-17; 16068  ",5/16/2016,"05/16/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74330,"Ongoing","Natures One Inc","8754 Cotter St",,"Lewis Center","OH","43035-7104","United States","Voluntary: Firm Initiated","Press Release","Product was shipped to the following states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI AND WY and the District of Columbia.     Product was also shipped to Canada.","F-0167-2017","Class II","Nature's One, Organic PediaSmart¿ Dairy Vanilla complete nutrition beverage for kids 1 to 13 years NET WT 12.7 oz (360 G) can Contains: milk, soy & coconut UPC 7 16514 88101 0 Manufactured for: Natures One, 8754 Cotter Street, Lewis Center, OH 43035","5,336 cs/6/12.7 oz canisters + 5/12.7 oz canisters","The firm received complaints that the wrong size scoop was in the product canister.  Use of this scoop would only yield 60% nutrition instead of 100% nutrition.","10/18/2016",," Lot #'s: 3141515 PDV 5357 Exp Date 1 DEC 2017; 3151515 PDV 5357 Exp Date 1 DEC 2017 & 3151515 PDV 5360 Exp Date 1 DEC 2017",6/4/2016,"06/04/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74331,"Ongoing","The Hain Celestial Group, Inc. - Worldwide HQ","1111 Marcus Ave",,"New Hyde Park","NY","11042-1221","United States","Voluntary: Firm Initiated","Press Release","Products were distributed across the United States and Mexico.  The products also were available for purchase on the internet.","F-1845-2016","Class I","MaraNatha¿ All Natural Sunflower Seed Butter, NET WT 12 OZ (340g)., UPC 0 51651-09367 5","14,533 cases (12/12oz)","A potential for Listeria monocytogenes contamination was verified by the sunflower seed raw material supplier.","07/28/2016",," Use By 28JUL16 thru 05DEC16",6/3/2016,"06/03/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74332,"Terminated","United Blood Services","6220 E Oak St",,"Scottsdale","AZ","85257-1101","United States","Voluntary: Firm Initiated","FAX","Arizona; Switzerland","B-0577-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor with a history of Viral Hepatitis, were distributed.","06/10/2016","06/10/2016"," W041015193104J",4/20/2016,"04/20/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74332,"Terminated","United Blood Services","6220 E Oak St",,"Scottsdale","AZ","85257-1101","United States","Voluntary: Firm Initiated","FAX","Arizona; Switzerland","B-0578-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from a donor with a history of Viral Hepatitis, were distributed.","06/10/2016","06/10/2016"," W0410151926488",4/20/2016,"04/20/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74333,"Terminated","United Blood Services","6220 E Oak St",,"Scottsdale","AZ","85257-1101","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0659-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.","07/18/2016","07/18/2016"," W0410160137247",4/26/2016,"04/26/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74334,"Terminated","South Texas Blood & Tissue Center","6211 W Interstate 10",,"San Antonio","TX","78201-2023","United States","Voluntary: Firm Initiated","FAX","Texas","B-0612-16","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from an ineligible donor, were distributed. ","06/21/2016","06/21/2016"," W140915094872 (double collection)",5/24/2016,"05/24/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74335,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0579-16","Class II","Apheresis Platelets, Irradiated","1 unit","Apheresis Platelet products for which pH testing was invalid, were distributed.","06/10/2016","06/10/2016"," W071216015029 ",5/4/2016,"05/04/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74335,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0580-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Apheresis Platelet products for which pH testing was invalid, were distributed.","06/10/2016","06/10/2016"," W071216015031; W071216015029 ",5/4/2016,"05/04/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74335,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Letter","Tennessee","B-0581-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","3 units","Apheresis Platelet products for which pH testing was invalid, were distributed.","06/10/2016","06/10/2016"," W071216015031 (double collection); W071216015029 ",5/4/2016,"05/04/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74336,"Terminated","American National Red Cross (the)","825 John St",,"West Henrietta","NY","14586-9790","United States","Voluntary: Firm Initiated","Telephone","Maryland","B-0582-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Apheresis products, in which quality control for residual WBC count was not performed, were distributed.","06/10/2016","06/10/2016"," W200116845735 (double collection)",4/26/2016,"04/26/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74337,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","E-Mail","FL","B-0658-16","Class II","Blood and Blood Products for Reprocessing","3 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","07/18/2016","07/18/2016"," W036815048870; W036814208143; 1253210 ",5/2/2016,"05/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74338,"Completed","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Telephone","Tennessee","B-0623-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from an unsuitable donor due to a donor screening deviation, was distributed.  ","06/22/2016","06/22/2016"," W071216007407",4/25/2016,"04/25/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74339,"Ongoing","Virtus Pharmaceuticals, Llc","2649 Causeway Center Dr",,"Tampa","FL","33619-6102","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1048-2016","Class III","VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30","1,586 bottles","Defective delivery system: Softgel capsules are leaking.","06/22/2016",," Lot # 21601142 Exp 12/17",5/16/2016,"05/16/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1719-2016","Class I","Triple Chocolate Bar 6x5, UPC: 637480035408, Case UPC: 637480034005.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","784 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K61182, Best By 4/27/2017",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1714-2016","Class I","Chocolate Chip Granola Bar 6x6, UPC: 637480046060, Case UPC: 637480046657.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage",,"Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K53152, Best By 11/11/2016; Lot K53162, Best By 11/12/2016; Lot K53172, Best By 11/13/2016",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1710-2016","Class I","Day Break Cranberry Almond Bar 6x5, UPC: 637480055062, Case UPC: 637480059060.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","112,531 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K52702, Best By 9/27/2016; Lot K52712, Best By 9/28/2016; Lot K52722, Best By 9/29/2016; Lot K52924, Best By 10/19/2016; Lot K52934, Best By 10/20/2016; Lot K52944, Best By 10/21/2016; Lot K53432, Best By 12/9/2016; Lot K53442, Best By 12/10/2016; Lot K53452, Best By 12/11/2016; Lot K60562, Best By 2/25/2017; Lot K60882, Best By 3/28/2017; Lot K60892, Best By 3/29/2017; Lot K60902, Best By 3/30/2017; Lot K61162, Best By 4/25/2017; Lot K61172, Best By 4/26/2017; ",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1720-2016","Class I","Chocolate Peanut Butter Pretzel Bar 6x5, UPC: 637480022774, Case UPC: 00637480025577.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","536 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K61233, Best By 5/2/2017",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1718-2016","Class I","Cashew Trail Mix Bar 6x5, UPC: 637480025850, Case UPC: 637480029858.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","3,719 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K53524, Best By 12/18/2016",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1712-2016","Class I","Strawberry Almond Bar 6x5, UPC: 637480025904, Case UPC: 637480029902.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","10,742 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K53102, Best By 11/6/2016; Lot K53132, Best By 11/9/2016",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1715-2016","Class I","Day Break Peanut Butter Fudge Crisp Bar 6x5, UPC: 637480055024, Case UPC: 637480059022.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","19,913 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K52732, Best By 9/30/2016; Lot K52742, Best By 10/1/2016; Lot K61192, Best By 4/29/2017; Lot K61202, Best By 4/30/2017",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1716-2016","Class I","Day Break Chocolate Hazelnut Bar 6x5, UPC: 637480055321, Case UPC: 637480059534.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","17,033 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K52964, Best By 10/23/2016; Lot K53504, Best By 12/16/2016; Lot K53514, Best By 12/17/2016; Lot K53524, Best By 12/18/2016",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1713-2016","Class I","Blueberry Greek Yogurt Bar 6x5, UPC: 637480025669, Case UPC: 637480020053.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","27,534 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K52944, Best By 10/21/2016; Lot K52954, Best By 10/22/2016; Lot K53142, Best By 11/10/2016; Lot K60902, Best By 3/30/2017; Lot K60912, Best By 3/31/2017; Lot K60922, Best By 4/1/2017",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1717-2016","Class I","Caramel Double Chocolate Crunch Bar 6x5, UPC: 637480035057, Case UPC: 637480039055.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","12,222 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K53494, Best By 12/15/2016; Lot K53504, Best By 12/16/2016",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74340,"Ongoing","Atkins Nutritionals, Inc.","1050 17th St Ste 1500",,"Denver","CO","80265-2078","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. Canadian and foreign consignees. No VA/govt/military.","F-1711-2016","Class I","Cinnamon Bun Crisp Bar 6x5, UPC: 637480059251, Case UPC: 637480005906.  Packaging: Outer paper carton containing individually wrapped bars, Ambient Storage","9,782 cases","Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.","07/18/2016",," Lot K53484, Best By 12/14/2016",6/3/2016,"06/03/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74341,"Ongoing","Datascope Corporation","15 Law Dr",,"Fairfield","NJ","07004-0011","United States","Voluntary: Firm Initiated","Letter","US in the state of GA","Z-2002-2016","Class II","Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage:  The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours  ","17 units","Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.","06/15/2016",," Lot/batch No: 3000003260, Part number 701050175",5/9/2016,"05/09/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74342,"Ongoing","Frito-Lay, Inc","7701 Legacy Dr",,"Plano","TX","75024-4099","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US","F-1829-2106","Class II","20 count Baked & Popped Mix packaged as 20 single flexible plastic bags","990,080 units","Potential to contain undeclared peanuts.","07/26/2016",," in the second and third position (example : x32xxxxxx)",6/6/2016,"06/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74342,"Ongoing","Frito-Lay, Inc","7701 Legacy Dr",,"Plano","TX","75024-4099","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US","F-1831-2016","Class II","32 count Fun Times mix packaged as 32 single flexible plastic bags","905,598 units","Potential to contain undeclared peanuts.","07/26/2016",," in the second and third position (example : x32xxxxxx)",6/6/2016,"06/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74342,"Ongoing","Frito-Lay, Inc","7701 Legacy Dr",,"Plano","TX","75024-4099","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US","F-1828-2016","Class II","Rold Gold Honey Wheat Braided 10 oz. packaged in flexible plastic bag.","64,992 units","Potential to contain undeclared peanuts.","07/26/2016",," in the second and third position (example : x32xxxxxx)",6/6/2016,"06/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74342,"Ongoing","Frito-Lay, Inc","7701 Legacy Dr",,"Plano","TX","75024-4099","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US","F-1830-2016","Class II","20 count SunChips & Rold Gold Mix packaged as 20 single flexible plastic bags","259,128 units","Potential to contain undeclared peanuts.","07/26/2016",," in the second and third position (example : x32xxxxxx)",6/6/2016,"06/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74342,"Ongoing","Frito-Lay, Inc","7701 Legacy Dr",,"Plano","TX","75024-4099","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US","F-1833-2016","Class II","30 count Home Town Favorite Variety Pack packaged as 30 single flexible plastic bags","94,336 units","Potential to contain undeclared peanuts.","07/26/2016",," in the second and third position (example : x32xxxxxx)",6/6/2016,"06/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74342,"Ongoing","Frito-Lay, Inc","7701 Legacy Dr",,"Plano","TX","75024-4099","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US","F-1832-2016","Class II","30 count Baked and Popped Variety Pack packaged as 30 single flexible plastic bags","217,248 units","Potential to contain undeclared peanuts.","07/26/2016",," in the second and third position (example : x32xxxxxx)",6/6/2016,"06/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74342,"Ongoing","Frito-Lay, Inc","7701 Legacy Dr",,"Plano","TX","75024-4099","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US","F-1827-2016","Class II","Rold Gold Tiny Twists 1 oz., 2 oz., 16 oz., and 20 1/2 oz.; Rold Gold Original Pretzel Thins 4 oz. and 16 oz.; Rold Gold Sticks 16 oz. packaged in flexible plastic bags.","1,066,918 units","Potential to contain undeclared peanuts.","07/26/2016",," in the second and third position (example : x32xxxxxx)",6/6/2016,"06/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74344,"Ongoing","Medtronic Inc., Cardiac Rhythm and Heart Failure","8200 Coral Sea St NE",,"Mounds View","MN","55112-4391","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution to Austria, Belgium, China , Czech Republic , Denmark , Finland , France,  Germany, Hong Kong, India , Ireland , Israel, Italy , Malaysia, Netherlands, Norway, Poland, Portugal , Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.","Z-2125-2016","Class II"," Patient Monitor, Model 24950, Rx Only.  The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.","262"," Network. While the transmission appears successful to the patient, the transmitted data, including CareAlerts, are not visible to the clinic.","07/05/2016","."," Serial #'s:     YDM001132A YDM091046A YDM230250A YDM287007A YDM316478A YDM338461A YDM001745A YDM092101A YDM230251A YDM287161A YDM319952A YDM338462A YDM002664A YDM096286A YDM230252A YDM287223A YDM320649A YDM338463A YDM002701A YDM100162A YDM230254A YDM287345A YDM320877A YDM338577A YDM003337A YDM102883A YDM230265A YDM287370A YDM321013A YDM339781A  YDM004445A YDM102905A YDM231186A YDM287388A YDM321225A YDM339914A YDM004921A YDM110112A YDM231295A YDM287416A YDM334335A YDM340510A YDM005795A YDM127412A YDM231296A YDM287421A YDM335349A YDM340704A YDM010849A YDM127843A YDM234714A YDM287435A YDM335397A YDM358237A YDM010853A YDM128264A YDM240991A YDM289828A YDM335518A YDM359331A  YDM011147A YDM141892A YDM241982A YDM289829A YDM335520A YDM359860A YDM011149A YDM144415A YDM242216A YDM291918A YDM335555A YDM362795A YDM011272A YDM150513A YDM242217A YDM291922A YDM336083A YDM363407A YDM012137A YDM150765A YDM252868A YDM291931A YDM336111A YDM366123A YDM013030A YDM150783A YDM253726A YDM292587A YDM336391A YDM366134A  YDM015178A YDM150795A YDM261210A YDM292592A YDM336411A YDM366212A YDM015183A YDM150796A YDM265729A YDM292634A YDM336426A YDM367410A YDM015353A YDM150864A YDM266233A YDM295750A YDM336434A YDM368670A YDM020290A YDM157438A YDM266778A YDM297528A YDM336461A YDM369861A YDM020298A YDM157859A YDM267760A YDM298219A YDM336479A YDM369882A  YDM022307A YDM167864A YDM267780A YDM302707A YDM336759A YDM369923A YDM023936A YDM179487A YDM268447A YDM303547A YDM336846A YDM369928A YDM032480A YDM182698A YDM272202A YDM303555A YDM337081A YDM369939A YDM033976A YDM183406A YDM272660A YDM304176A YDM337083A YDM370040A YDM037712A YDM184560A YDM274102A YDM304209A YDM337439A YDM371430A  YDM037957A YDM184823A YDM274701A YDM315137A YDM337452A YDM371639A YDM042190A YDM186805A YDM278813A YDM315420A YDM337535A YDM371740A YDM042952A YDM194474A YDM279279A YDM315576A YDM337635A YDM371746A YDM043309A YDM194904A YDM279482A YDM315625A YDM337947A YDM371866A YDM050840A YDM195374A YDM279555A YDM315642A YDM337949A YDM371913A  YDM051330A YDM196814A YDM280192A YDM315743",5/26/2016,"05/26/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74345,"Ongoing","Herr Foods, Inc.","273 Old Baltimore Pike",,"Nottingham","PA","19362-0300","United States","Voluntary: Firm Initiated","Visit","Nationwide","F-1700-2016","Class I","Waffle Works Double Chocolate Waffle Sandwich Snacks  Net Wt. 4 OZ..  Distributed By: Herr Foods, Inc., Nottingham, PA 19363.  June0616 through February0117","84,528 packages","Packaging failed to declare the milk ingredient (whey powder) in  the ingredient statement. The allergen statement listed Wheat and Soy Ingredients, but did not include Milk Ingredients (whey powder).","07/15/2016",," June0616 through February0117",6/6/2016,"06/06/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74346,"Ongoing","ORTHO-CLINICAL DIAGNOSTICS","FELINDRE MEADOWS",,"Bridgend",,,"United Kingdom","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution","Z-2145-2016","Class III","VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators.     For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.","US: Lot 6471 - 282, Lot 6480 - 344","Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product. ","07/08/2016",," Lots 6471 (expiry date 19-Jul-2016), 6480 (expiry date 23-Aug-2016)",5/9/2016,"05/09/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74347,"Terminated","Blood Systems, Inc.  dba UBS - California","2223 Eastman Ave Ste A",,"Ventura","CA","93003-8050","United States","Voluntary: Firm Initiated","Telephone","TN, NV","B-0670-16","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.","07/18/2016","07/18/2016"," W041916004753U; W0419160092240 ",4/22/2016,"04/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74348,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","Letter","New York; New Jersey; California","B-0663-16","Class II","Cryoprecipitated AHF","1 unit","Blood products, collected from an ineligible donor, were distributed. ","07/21/2016","07/21/2016"," W047015406887; ",5/18/2016,"05/18/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74348,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","Letter","New York; New Jersey; California","B-0661-16","Class II","Red Blood Cells, Leukocytes Reduced","3 units","Blood products, collected from an ineligible donor, were distributed. ","07/21/2016","07/21/2016"," W04701549568; W047016054955; W047015383193; ",5/18/2016,"05/18/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74348,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","Letter","New York; New Jersey; California","B-0662-16","Class II","Blood and Blood Products for Reprocessing","2 units","Blood products, collected from an ineligible donor, were distributed. ","07/21/2016","07/21/2016"," W047016054955; W047015383193; ",5/18/2016,"05/18/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74348,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","Letter","New York; New Jersey; California","B-0660-16","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood products, collected from an ineligible donor, were distributed. ","07/21/2016","07/21/2016"," W04701549568; ",5/18/2016,"05/18/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74349,"Terminated","New York Blood Center, Inc.","1200 Prospect Ave",,"Westbury","NY","11590-2723","United States","Voluntary: Firm Initiated","Telephone","New York","B-0624-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","2 units","Platelet products, labeled as leukoreduced but were not tested for WBCs, were distributed.","06/28/2016","06/28/2016"," W047016131856 (Double collection)",5/19/2016,"05/19/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74350,"Terminated","San Diego Blood Bank","3636 Gateway Center Ave Ste 100",,"San Diego","CA","92102-4508","United States","Voluntary: Firm Initiated","Telephone","California","B-0596-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Apheresis products, which were not filtered according to specifications, were distributed.","06/21/2016","06/21/2016"," W044216521642 (double collection)",4/15/2016,"04/15/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74351,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0583-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor who received a piercing within one year of donation, were distributed.","06/14/2016","06/14/2016"," W069116112715",5/16/2016,"05/16/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74351,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0584-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor who received a piercing within one year of donation, were distributed.","06/14/2016","06/14/2016"," W069116112715 ",5/16/2016,"05/16/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74352,"Ongoing","Brown & Haley Inc.","110 E 26th St",,"Tacoma","WA","98421-1109","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AL, AR, AZ, CA, FL, FL, HI, IL, MN, MO, NJ, NV, PA, RI, TX, UT, VA, WA and in Singapore and Taiwan","F-1699-2016","Class I","Mountain Thins Trail Mix flavor, packaged in a stand-up film pouch (resealable), net wt. 5.3 oz. The UPC is 0 41770 33370 7","6743 pouches","One additional lot of Mountain Thins Trail Mix flavor, net wt. 5.3 oz., is recalled because it has the potential to be contaminated with Listeria monocytogenes.","07/15/2016",," lot O03O610, Best by Date: 03MAR17 (3/3/2017)",6/1/2016,"06/01/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74353,"Ongoing","The Hershey Company","100 Crystal A Dr",,"Hershey","PA","17033-9524","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide","F-0352-2017","Class I","SOFiT Protein Plus Sunflower Seeds Sea Salt; Seeds covered by a crunchy protein shell:  NET WT. 1 OZ.","4656 units","The Hershey Company has issued a voluntary recall of three products sold under the SoFit brand after a supplier who provides sunflower seeds for the products expanded its recall on June 1.    Products have the potential to be contaminated with Listeria monocytogenes. ","11/10/2016",," Best Before dates, Consumer Unit Code: 10 2016, 72H; 10 2016, 72J; 02 2017, 79P; 03 2017, 82F; 03 2017, 82G; 03 2017, 82K;   03 2017, 82L  ",6/4/2016,"06/04/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74353,"Ongoing","The Hershey Company","100 Crystal A Dr",,"Hershey","PA","17033-9524","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide","F-0354-2017","Class I","SOFiT Protein Plus Pumpkin Seeds Sesame Garlic, Seeds covered by a crunchy protein shell:  NET WT. 1 OZ.","12,804 units","The Hershey Company has issued a voluntary recall of three products sold under the SoFit brand after a supplier who provides sunflower seeds for the products expanded its recall on June 1.     Products have the potential to be contaminated with Listeria monocytogenes.","11/10/2016",," Best Before dates, Consumer Unit Code: 11 2017, 73B; 11 2017, 73C; 03 2017, 81P; 03 2017, 81R.",6/4/2016,"06/04/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74353,"Ongoing","The Hershey Company","100 Crystal A Dr",,"Hershey","PA","17033-9524","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide","F-0353-2017","Class I","SOFiT Protein Plus Almonds Jalapeno Garlic, whole almonds covered by a crunchy protein shell:  NET WT. 1 OZ.","12192 units","The Hershey Company has issued a voluntary recall of three products sold under the SoFit brand after a supplier who provides sunflower seeds for the products expanded its recall on June 1.    Products have the potential to be contaminated with Listeria monocytogenes.  ","11/10/2016",," Best Before dates, Consumer Unit Code: 10 2017, 72R; 11 2017, 73A; 02 2017, 79R; 03 2017, 82C; 03 2017, 82D",6/4/2016,"06/04/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74354,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","Z-2143-2016","Class III","enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD","US: 30 units","If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?.¿ The difference in terminology exists for US Markets only. ","07/08/2016",," Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; Serial Numbers/J Numbers: JIM341866, JIM341820, JIM341679, JIM341352, JIM343421, JIM341174, JIM336745, JIM340667, JIM338283,   JIM-341592, JIM336957, JIM341996, JIM342334, JIM343694, JIM336855,   JIM334236, JIM341415, JIM341392, JIM336481, JIM340934, JIM336167,   JIM342249, JIM338290, JIM341750, JIM341426, JIM334986, JIM334527,   JIM340024, JIM341021, JIM340658  ",5/16/2016,"05/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74355,"Ongoing","Ortho-Clinical Diagnostics","513 Technology Blvd",,"Rochester","NY","14626-3601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide in the countries of Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland and Venezuela.","Z-2273-2016","Class II","VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack     Product Usage:  For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).  ","US: 27,625 sales units; Foreign: 4757 sales units","Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System.  An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.","07/22/2016",," Lots #s: 0329-0528-8193 (exp. 05/01/2017), 0329-0528-8892 (exp. 06/01/2017), 0329-0528-8192 (exp. 05/01/2017), 0329-0528-8902 (exp. 06/01/2017), 0329-0528-8226 (exp. 05/01/2017), 0329-0528-8928 (exp. 07/01/2017),   0329-0528-8227 (exp. 05/01/2017), 0329-0528-9000 (exp. 07/01/2017), 0329-0528-8359 (exp. 05/01/2017), 0329-0528-8927 (exp. 07/01/2017), 0329-0528-8361 (exp. 05/01/2017), 0329-0528-8965 (exp. 07/01/2017), 0329-0528-8360 (exp. 05/01/2017), 0329-0528-8966 (exp. 07/01/2017),   0329-0528-8324 (exp. 05/01/2017), 0329-0528-9167 (exp. 07/01/2017), 0329-0528-8323 (exp. 05/01/2017), 0329-0528-9171 (exp. 07/01/2017), 0329-0528-8325 (exp. 05/01/2017), 0329-0528-9196 (exp. 07/01/2017), 0329-0528-6999 (exp. 03/01/2017), 0329-0528-9172 (exp. 07/01/2017), 0329-0528-7000 (exp. 03/01/2017), 0329-0528-9177 (exp. 07/01/2017), 0329-0528-6998 (exp. 03/01/2017), 0329-0528-9265 (exp. 07/01/2017), 0329-0528-8903 (exp. 06/01/2017), 0329-0528-9176 (exp. 07/01/2017), 0329-0528-8901 (exp. 06/01/2017), 0329-0528-9264 (exp. 07/01/2017), 0329-0528-8893 (exp. 06/01/2017), 0329-0528-9368 (exp. 07/01/2017), 0329-0528-8891 (exp. 06/01/2017), 0329-0528-9369 (exp. 07/01/2017). ",5/18/2016,"05/18/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74356,"Ongoing","Hardy Diagnostics","1430 W McCoy Ln",,"Santa Maria","CA","93455-1005","United States","Voluntary: Firm Initiated","Telephone","U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.","Z-2146-2016","Class II","QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80.    Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide. ","25","Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.","07/08/2016",," All units manufactured between October 2014 and May 2016.",5/24/2016,"05/24/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74358,"Terminated","Blood Centers of the Pacific - Irwin Center","270 Masonic Ave",,"San Francisco","CA","94118-4496","United States","Voluntary: Firm Initiated","Telephone","California","B-0595-16","Class III","Plasma Frozen within 24 hours (FP24)","1 unit","Misbranded blood product was distributed.","06/21/2016","06/21/2016"," W117016003042S",4/25/2016,"04/25/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74359,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","1001 N Lincoln Blvd",,"Oklahoma City","OK","73104-3299","United States","Voluntary: Firm Initiated","FAX","Oklahoma","B-0585-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Apheresis products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","06/14/2016","06/14/2016"," W091015256994 (double collection)",4/28/2016,"04/28/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74360,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin","B-0598-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom eligibility was inadequately determined, were distributed.","06/14/2016","06/14/2016"," W036316381236",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74360,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin","B-0599-16","Class II","Fresh Frozen Plasma","1 unit","Blood products, collected from a donor for whom eligibility was inadequately determined, were distributed.","06/14/2016","06/14/2016"," W036316381236",5/17/2016,"05/17/2016",6/22/2016,"06/22/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74361,"Ongoing","Attix Pharmaceuticals Inc","481 University Ave Unit 502",,"Toronto",,,"Canada","Voluntary: Firm Initiated","Telephone","CO","D-1047-2016","Class III","Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada",,"cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration","06/21/2016",," Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017",5/18/2016,"05/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74362,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution: in the states of MA, CA, IL, TN, IL","Z-2136-2016","Class II","ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER.    Product Usage:  Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatible medications, central venous pressure monitoring, lack of usable peripheral IV sites, replacement of multiple peripheral sites for IV access and injection of contrast media.  ","1, 170 units","Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.  ","07/06/2016","."," Device Listing # D040746, FDA Product Code FOZ, Product Code: ASK-45854-PUC, ASK-45854-PSFM, ASK-42854-PCSM and ASK-42854-PBW4  Lot # 23F15F1786, 23F15F1862, 23F15G0818, 23F15J0162, 23F15H0460, 23F15F0943, 23F15G0729, 23F15J1084",6/2/2016,"06/02/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74363,"Ongoing","Ortho-Clinical Diagnostics","1000 Lee Road",,"Rochester","NY","14606","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to  Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and   Venezuela.","Z-2119-2016","Class III","VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics   For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.","US: 1517; Foreign: 842","Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.","07/01/2016","."," Lots 2915 (exp. December 2016) and 1995 (exp. July 2016)",5/24/2016,"05/24/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74364,"Ongoing","Rucker's Makin Batch Candies, Inc. ","777 East State St. ",,"Bridgeport","IL","62417","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm shipped this product to one retail facility. The retail facility is Dollywood Theme Park, 1130 Wagner Drive, Sevierville, TN 37862. No foreign Consignees.","F-2222-2016","Class I",". UPC code 4 9000 503302","389 bags, 9 ounces per bag","Cajun Mix containing sunflower kernels are contaminated with Listeria Monocytogenes per the supplier SunOpta. ","09/14/2016",," best by codes ranging 1/23/2016 to 11/11/16",6/7/2016,"06/07/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74366,"Ongoing","ORTHO-CLINICAL DIAGNOSTICS","FELINDRE MEADOWS",,"Bridgend",,,"United Kingdom","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda","Z-2302-2016","Class II","VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code  874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics,    For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.","US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda","Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack.","07/29/2016",," Lot Numbers:1836, 1840, 1845, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1968, 1978, 1988, 1998",6/2/2016,"06/02/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",74367,"Ongoing","Arbonne International","9400 Jeronimo Rd",,"Irvine","CA","92618-1907","United States","Voluntary: Firm Initiated","Letter","Arbonne manufactures and/or distributes cosmetic products, including It's A Fine Line Liquid Eye Liner in the US. It's A Fine Line Liquid Eye Liner is sold via the Arbonne website, www.arbonne.com. Independent Consultants who market the Arbonne eye liner product direct consumers to purchase the product online, as well. Arbonne subsidiaries, Arbonne Europe SarL, Arbonne UK Ltd., and Arbonne International Distribution, Inc., have also distributed It's A Fine Line Liquid Eye Liner in Canada, the United Kingdom, Poland, and Australia.    This product was not sold under a government contract and was not sold to any federal, state, or local agency involved in the school lunch program.","F-1931-2016","Class II","Arbor (Brown) Liquid Eyeliner, Catalog SKU#6736, Product Code: 80000073","3,818 units","Arbonne is recalling Eclipse (Black) & Arbor (Brown) liquid eyeliner due to Staphylococcus saprophyticus, Staphylococcus lentus, and Staphylococcus xylosis.","08/16/2016",," Lot No. 1196, 3535, 3555",6/2/2016,"06/02/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",74367,"Ongoing","Arbonne International","9400 Jeronimo Rd",,"Irvine","CA","92618-1907","United States","Voluntary: Firm Initiated","Letter","Arbonne manufactures and/or distributes cosmetic products, including It's A Fine Line Liquid Eye Liner in the US. It's A Fine Line Liquid Eye Liner is sold via the Arbonne website, www.arbonne.com. Independent Consultants who market the Arbonne eye liner product direct consumers to purchase the product online, as well. Arbonne subsidiaries, Arbonne Europe SarL, Arbonne UK Ltd., and Arbonne International Distribution, Inc., have also distributed It's A Fine Line Liquid Eye Liner in Canada, the United Kingdom, Poland, and Australia.    This product was not sold under a government contract and was not sold to any federal, state, or local agency involved in the school lunch program.","F-1930-2016","Class II","Eclipse (Black) Liquid Eyeliner, Catalog SKU#6735, Product code: 80000072","14,837 units","Arbonne is recalling Eclipse (Black) & Arbor (Brown) liquid eyeliner due to Staphylococcus saprophyticus, Staphylococcus lentus, and Staphylococcus xylosis.","08/16/2016",," Lot No. 0206, 0216, 0256, 0256 (a), 0266, 1266, 3565, 3575",6/2/2016,"06/02/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74368,"Ongoing","Amd-Ritmed,  Inc.","295 Fire Tower Dr",".","Tonawanda","NY","14150-5833","United States","Voluntary: Firm Initiated","E-Mail","NY, MA, VA, TN","Z-0727-2017","Class II"," (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile   -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150","US: 216 cases (200 dressings per case) ","The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.  ","12/08/2016",," Lot 68408, expiration date 2018¿05",6/8/2016,"06/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74369,"Terminated","DCI Plasma Center Of Duluth, LLC","1720 W Superior St",,"Duluth","MN","55806-2137","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0628-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor for whom suitability to donate was inadequately determined, was distributed.","06/22/2016","06/22/2016"," DU0876506",5/16/2016,"05/16/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74370,"Terminated","American National Red Cross, Penn Jersey Region","700 Spring Garden St",,"Philadelphia","PA","19123-3508","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0630-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor for whom eligibility was inadequately determined, was distributed.","06/28/2016","06/28/2016"," W202216607071",4/29/2016,"04/29/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74371,"Ongoing","Windy Acres Candy & Nut, Outlet Inc.","6805 W State Route 73",,"Wilmington","OH","45177-8949","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: IN, KY & OH.","F-1855-2016","Class I","ROAST, NO SALT SUNFLOWER SEEDS sold under the following brands: Jungle Jim  16oz (453G) INGREDIENTS: SUNFLOWER SEEDS ROASTED IN SUNFLOWER AND OR PEANUT OIL UPC 0 82987 05874 8 & Windy Acres 8 OZ (22  G) UPC 0 82987 30172 1 & 5 lb plastic bag WILMINGTON, OH 45177 ","9cs/12/16 oz tubs + 3 cs/12/80 bags + 6 cs/1/5lb box","The firm was notified by their supplier that the Sunflower kernels they received may be contaminated with Listeria monocytogenes.","08/01/2016",," Jungle Jim Item #05874 EXP DATE: 05/2017  Windy Acres Item #30172 LOT# 051016-342 EXP DATE 03/2017  Windy Acres Item #30172B5 PACK DATES 2/19/16 - 05/12/16",5/24/2016,"05/24/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74371,"Ongoing","Windy Acres Candy & Nut, Outlet Inc.","6805 W State Route 73",,"Wilmington","OH","45177-8949","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: IN, KY & OH.","F-1856-2016","Class I","Windy Acres FRUITY TRAIL MIX Roasted Peanuts, Pineapple, Papaya, Raisins & Almonds 7 OZ (198 G) UPC 0 82987 02016 5 WILMINGTON, OH 45177 1-937-382-8057","79 cs/12/7 oz bags","The firm was notified by their supplier that the Sunflower kernels they received may be contaminated with Listeria monocytogenes.","08/01/2016",," Item #02016 LOT# 022916-137 EXP DATE: 11/2016",5/24/2016,"05/24/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74372,"Ongoing","Fujifilm Medical Systems U.S.A., Inc.","419 West Ave",,"Stamford","CT","06902-6343","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, FL,  KS, NE, NY, and PA.","Z-2043-2016","Class II","Fujifilm Synapse PACS software version 4.4.000,  Fujifilm Synapse PACS software version 4.4.001,  Fujifilm Synapse PACS software version 4.4.004,  Fujifilm Synapse PACS software version 4.4.010 and  Fujifilm Synapse PACS software version 4.4.020    FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an  off-the-shelf PC networked with Fuji Synapse PACS.    ","27 units"," message displays instead","06/21/2016",," Software version:  4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020",5/10/2016,"05/10/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74373,"Ongoing","Sagent Pharmaceuticals Inc","1901 N Roselle Rd Ste 700",,"Schaumburg","IL","60195-3194","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1450-2016","Class II","Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69","3990 vials","Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.","07/28/2016",," Lot #: OXT515, Exp. July 2017",6/13/2016,"06/13/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74374,"Ongoing","CH Guenther & Sons, Inc","129 E Guenther",,"San Antonio","TX","78204-1402","United States","Voluntary: Firm Initiated","Telephone","Products was distributed to the southern midwest and central south including the states of AR, OK, IA, IL, KS, MO, and TX.","F-1918-2016","Class II","Williams Chipotle Chili Seasoning, Net Wt. 1 1/8 OZ. (32 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches.","547/24/1.13 OZ/pouches/cases","Chili and taco seasoning products contain an ingredient which was recalled for potentially containing undeclared wheat allergen. Testing revealed the presence of gluten. Wheat is not declared on the label.","08/09/2016",," BETTER BY 12/27/17",6/8/2016,"06/08/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74374,"Ongoing","CH Guenther & Sons, Inc","129 E Guenther",,"San Antonio","TX","78204-1402","United States","Voluntary: Firm Initiated","Telephone","Products was distributed to the southern midwest and central south including the states of AR, OK, IA, IL, KS, MO, and TX.","F-1919-2016","Class II","Williams Chipotle Taco Seasoning, Net Wt. 1 1/4 OZ. (35.4 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches.","702/24/1.25 OZ/pouches/cases","Chili and taco seasoning products contain an ingredient which was recalled for potentially containing undeclared wheat allergen. Testing revealed the presence of gluten. Wheat is not declared on the label.","08/09/2016",," BETTER BY 01/27/18; BETTER BY 04/11/18",6/8/2016,"06/08/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74375,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","70 retail stores nationwide. Product was also shipped to canada firms. please see attached spread sheet for a full list of customers.","F-1743-2016","Class I","SWEET N SALTY MIX 7.5 oz. packaged in a clear plastic bag with brown and purple label with the UPC 052545013397","1,344 bags","Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta. ","07/19/2016",," best by date 062216 to 041817",6/8/2016,"06/08/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74375,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","70 retail stores nationwide. Product was also shipped to canada firms. please see attached spread sheet for a full list of customers.","F-1747-2016","Class I"," UPC 752545073390","20,184 bags","Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta. ","07/19/2016",," best by date 062216 to 041817",6/8/2016,"06/08/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74375,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","70 retail stores nationwide. Product was also shipped to canada firms. please see attached spread sheet for a full list of customers.","F-1740-2016","Class I","Cajun Hot Mix 6 OZ. packaged in clear plastic bags with sticker label. This product has multiple brands. All brands are under the same UPC 052545002681. Brand names include Big R. Stores, Bomgaar's, C-A-L Ranch Store's, Coastal, Family Choice, Fin Feather Furn Outfitter's, Gebos, Sportman's warehouse, theisen's, ","3,915 bags","Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta. ","07/19/2016",," best by dates  071316  to  051617",6/8/2016,"06/08/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74375,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","70 retail stores nationwide. Product was also shipped to canada firms. please see attached spread sheet for a full list of customers.","F-1745-2016","Class I","SWEET N SALTY 10 OZ packaged in a clear plastic bag with sticky label under the UPC code 052545023396 and several brands including BIG R STORE'S, FAMILY CHOICE, FARM & HOME SUPPLY, JAYS SPORTING GOODS","1,032 bags","Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta. ","07/19/2016",," best by date 062216 to 041817",6/8/2016,"06/08/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74375,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","70 retail stores nationwide. Product was also shipped to canada firms. please see attached spread sheet for a full list of customers.","F-1741-2016","Class I","Cajun hot mix 6 OZ Family Choice Brand, packaged in a clear plastic bag with brown and blue sticky labile. UPC 052545012680","4,671 bags","Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta. ","07/19/2016",," Best by 071316  to  051617",6/8/2016,"06/08/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74375,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","70 retail stores nationwide. Product was also shipped to canada firms. please see attached spread sheet for a full list of customers.","F-1744-2016","Class I","CAJUN HOT MIX 8 OZ. packaged in a clear plastic bag with sticky label under the UPC number 052545022689, and several brand names, including ATWOOD'S RANCH & HOME, BASS PRO SHOP'S UNCLE BUCK'S, BIG R STORE'S, CABELA'S CLASSIC'S, CABELA'S OUTFITTER CLASSIC, FARM & HOME SUPPLY, F & S TRADING, JAYS SPORTING GOODS, MOO'D FOOD /MURDOCHS, and RURAL KING","24,112 bags","Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta. ","07/19/2016",," best by date 071316  to  051617",6/8/2016,"06/08/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74375,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","70 retail stores nationwide. Product was also shipped to canada firms. please see attached spread sheet for a full list of customers.","F-1746-2016","Class I"," UPC code 752545070894","15,312 bags","Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta. ","07/19/2016",," best by date 071316  to  022917",6/8/2016,"06/08/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74375,"Ongoing","Rucker's Wholesale & Service Co., Inc.","777th & State",,"Bridgeport","IL","62417-0277","United States","Voluntary: Firm Initiated","E-Mail","70 retail stores nationwide. Product was also shipped to canada firms. please see attached spread sheet for a full list of customers.","F-1742-2016","Class I","SWEET N SALTY 7.5 OZ.packaged in a clear plastic bag with white sticky label. The product is under UPC code 052545003398 and includes the brand names Big R Store's, Coastal, and Fin feather Fur Outfitter's.","504 bags","Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta. ","07/19/2016",," best by date 062216 to 020117",6/8/2016,"06/08/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74376,"Ongoing","Taylor Fresh Foods Inc","911 Blanco Cir Ste B",,"Salinas","CA","93901-4449","United States","Voluntary: Firm Initiated","Letter","MS,. IN, KY, GA, OH, VA, TN.","F-0080-2017","Class II","Taylor Farms Cranberry Walnut Salad;  Salad kit for one:  Baby Lettuce Blend, Feta Cheese, Flat Bread Chips, Dried cranberries and Walnuts and Raspberry Vinaigrette dressing.    Distributed by: Taylor Farms Inc., Salinas, CA.","518 cases","Some packages of Taylor Farms Cranberry Walnut Salad kits may have the incorrect back label with ingredients for Taylor Farms Spinach Salad with Bacon and not properly declare walnuts or wheat.  The Walnuts are clearly visible through the packaging.","10/11/2016",," Use thru 06/14/2016;  TFT 152 B",6/9/2016,"06/09/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74377,"Ongoing","Fal Foods Usa","2420 49th St",,"Astoria","NY","11103-1017","United States","Voluntary: Firm Initiated","Press Release","New York, New Jersey, Pennsylvania","F-1843-2016","Class I",".","43 boxes (6 x 4pk: 1032 bars)","The lot contains undeclared milk allergen which was confirmed by FDA sampling and analysis.","07/28/2016",," Lot 15226, BEST BY date 021317",6/9/2016,"06/09/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74378,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","US Distribution including Puerto Rico and to the states of : AK, AZ, CA, FL, GA, IL, IN, LA, MD, MI, MO, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and to the countries of :  Canada, Denmark, Finland, Germany, Israel, Japan, Netherlands, Norway, Sweden, United Kingdom","Z-2052-2016","Class II","MOSAIQ Oncology Information System","69","It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.","06/27/2016",," Versions 2.62 and higher",6/17/2016,"06/17/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74379,"Ongoing","Haemonetics Corporation","400 Wood Rd",,"Braintree","MA","02184-2412","United States","Voluntary: Firm Initiated","Letter","AZ, CA, FL, LA. OH, NV,NY, SD, TX","B-0709-16","Class II","Haemonetics Leukotrap RC System with RC2D Filter  Haemonetics Anticoagulant Citrate Phosphate Triple Dextrose (CP2D & Additive Solution 3 (AS-3), 500 ml  Reorder # 129-63"," 393,786  units","All lots of Haemonetics Corporation Leukotrap RC System with RC2D Filter (Re-Order Numbers 129-62 & 129-63) with reports of higher than expected residual white blood cells, were distributed. ","08/25/2016",," Lots  distributed between April 14, 2016 and June 17, 2016.  Product Code:  192-63     (Lot Numbers):  1556476  1556477  1556538  1656043  1656044  1656045  1656046  1656047  1656048  1656049  1656077  1656079  1656080  1656081  1656082  1656083  1656084  1656085  1656086  1656087  1656089  1656090  1656091  1656093  1656094  1656104  1656105  1656106  1656134  1656138  1656139  1656140  1656149  1656150  1656170  1656171  1656173  ",6/8/2016,"06/08/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74379,"Ongoing","Haemonetics Corporation","400 Wood Rd",,"Braintree","MA","02184-2412","United States","Voluntary: Firm Initiated","Letter","AZ, CA, FL, LA. OH, NV,NY, SD, TX","B-0708-16","Class II","Haemonetics Leukotrap RC System with RC2D Filter  Anticoagulant Citrate Phosphate Double Dextrose (CP2D & Additive Solution 3 (AS-3), 500 ml  Reorder #129-62 "," 57,186 units","All lots of Haemonetics Corporation Leukotrap RC System with RC2D Filter (Re-Order Numbers 129-62 & 129-63) with reports of higher than expected residual white blood cells, were distributed. ","08/25/2016",," Lots  distributed between April 14, 2016 and June 17, 2016.  Product Code:  192-62 (Lot Numbers):  1656039  1656076  1656153  1656177  1656178  1656179  ",6/8/2016,"06/08/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74380,"Ongoing","Garden-Fresh Foods, Inc.","726 S 12th St",,"Milwaukee","WI","53204-1211","United States","Voluntary: Firm Initiated","Telephone","US:  MI, WI, IL","F-1765-2016","Class I","Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in  Garden Fresh Foods Cool Breeze Health SALD Kit #2052, Net WT 7.06 lbs, 3.20 kg. 0 01 11596 72052 1.","126 kits & 126 sunflower kernel packages. ","Garden Fresh Foods Inc. is recalling 4oz individual packages of sunflower kernels that were included in   three of their salad kits.  The kernels were distributed by Eillien's Candies whose ingredient supplier, SunOpta, has stated may be contaminated with Listeria monocytogenes.  There have been no reported illnesses to date.","07/21/2016",," Use-By-Dates, which were 5/28, 5/30, 5/31 and 6/4.  ",5/24/2016,"05/24/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74380,"Ongoing","Garden-Fresh Foods, Inc.","726 S 12th St",,"Milwaukee","WI","53204-1211","United States","Voluntary: Firm Initiated","Telephone","US:  MI, WI, IL","F-1767-2016","Class I","Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in Garden Fresh Foods,  Cool Breeze Salad Kit  #2092, Net Wt 6.75 lbs 3,06 kg, 0 01 11596 72092 7.","221 kits containing 2 individually sealed sumflower kernels/kit  for a total of 442 packages","Garden Fresh Foods Inc. is recalling 4oz individual packages of sunflower kernels that were included in   three of their salad kits.  The kernels were distributed by Eillien's Candies whose ingredient supplier, SunOpta, has stated may be contaminated with Listeria monocytogenes.  There have been no reported illnesses to date.","07/21/2016",," Use-By-Dates,  5/25, 5/26, 6/1, 6/3, 6/8, 6/12. 6/16, 6/19 and 6/22.",5/24/2016,"05/24/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74380,"Ongoing","Garden-Fresh Foods, Inc.","726 S 12th St",,"Milwaukee","WI","53204-1211","United States","Voluntary: Firm Initiated","Telephone","US:  MI, WI, IL","F-1766-2016","Class I","Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in Garden Fresh Foods  Broccoli Raisin Salad Kit #2081, Net Wt 3.38 lbs, 1.53 kg, 0 00 11596 42081 3.","13 kits and 13 packages of sumflower kernels.","Garden Fresh Foods Inc. is recalling 4oz individual packages of sunflower kernels that were included in   three of their salad kits.  The kernels were distributed by Eillien's Candies whose ingredient supplier, SunOpta, has stated may be contaminated with Listeria monocytogenes.  There have been no reported illnesses to date.","07/21/2016",," Use-By-Dates, which were 5/28, 5/30 and 6/4. ",5/24/2016,"05/24/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74382,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","FAX","Tennessee","B-0631-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","07/08/2016","07/08/2016"," W043214053527; W043214053527; ",5/27/2016,"05/27/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74385,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Iowa","B-0632-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, in which routine resting and/or performed, interpreted or documented incorrectly, was distributed.","07/08/2016","07/08/2016"," W038313311747; ",5/25/2016,"05/25/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74386,"Terminated","American National Red Cross","River Valley Region","520 E Chestnut St","Louisville","KY","40202-1602","United States","Voluntary: Firm Initiated","E-Mail","California","B-0633-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","07/08/2016","07/08/2016"," W202415275244; ",1/22/2016,"01/22/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2312-2016","Class I","BLAIN'S FARM & FLEET TRAIL MIX 12 OZ (340 g), UPC 034952814392, Item # 609594.  7/13/16, 6/1/16, 4/28/16, 3/10/16, 8/19/16    BULK - TRAIL MIX  25#	412965, Item # 412965.  12/2/16, 1/11/17, 2/22/16, 4/7/16, 5/18/16, 7/16/16,8/18/16.    EILLIEN'S TRAIL MIX 22 OZ ( 1 lb 6 oz)  (624 g), UPC 034952562613, Item # 303420.  10/27/16, 12/2/16, 1/13/17,1/28/17,2/19/16, 4/15/16, 4/30/16, 3/26/16, 3/3/16,   4/6/16, 5/6/16, 5/17/16, 6/1/16, 6/28/16, 7/21/16, 8/10/16, 9/15/16.      EILLIEN'S TRAIL MIX TRAY          14 OZ, UPC 034952572902, Item # 204545.  6/28/16, 8/10/16, 9/1/16, 9/10/16 ,10/11/16, 11/3/16, 2/18/16, 4/16/16, 5/18/16,  6/1/16, 5/9/16, 11/21/15, 11/1/15, 1/6/16, 2/4/16, 1/13/16, 12/10/15.      MILL'S FLEET FARM TRAIL MIX , 24 OZ ( 1 lb 8 oz) ( 680 g), UPC 034952360752, Item #677492.  10/7/16, 11/15/16, 12/23/16, 1/28/17, 6/21/16, 3/17/16, 4/9/16, 2/12/16, 5/6/16, 7/29/16.      ROYAL SNACKS TRAIL MIX, POUCH BAG, NET WT.  13 OZ (369 g), UPC 034952571523, Item # 119479.  10/19/16, 11/11/16, 11/16/16, 12/2/16, 1/5/17, 2/3/17, 4/29/16, 7/28/16, 3/4/16,  8/24/16, 2/14/16, 6/18/16, 3/22/16,4/8/16.    URGE TRAIL MIX ,   3.5OZ (99 G),  UPC 039779010538, Item # 618165.  10/11/16, 10/11/16, 10/19/16, 1/12/17, 6/10/16, 4/9/16, 3/5/16, 7/7/16, 2/29/16,  6/8/16, 6/2/16, 7/22/16, 8/25/16, 2/11/16  ","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best  By Date: 7/13/16, 6/1/16, 4/28/16, 3/10/16, 8/19/16.  12/2/16, 1/11/17, 2/22/16, 4/7/16, 5/18/16, 7/16/16, 8/18/16.  10/27/16, 12/2/16, 1/13/17, 1/28/17, 2/19/16, 4/15/16, 4/30/16, 3/26/16, 3/3/16,   4/6/16, 5/6/16, 5/17/16, 6/1/16, 6/28/16, 7/21/16, 8/10/16, 9/15/16.  6/28/16, 8/10/16, 9/1/16, 9/10/16, 10/11/16, 11/3/16, 2/18/16, 4/16/16, 5/18/16,  5/9/16, 11/21/15, 11/1/15, 1/6/16,2/4/16,1/13/16, 12/10/15.  10/7/16, 11/15/16, 12/23/16, 1/28/17, 6/21/16, 3/17/16, 4/9/16, 2/12/16, 5/6/16,  7/29/16.  10/19/16, 11/11/16, 11/16/16, 1/5/17, 2/3/17, 4/29/16, 7/28/16, 3/4/16,   8/24/16, 2/14/16, 6/18/16, 3/22/16, 4/8/16.  10/11/16, 1/12/17, 6/10/16, 3/5/16, 7/7/16, 2/29/16, 6/8/16,   6/2/16, 7/22/16, 8/25/16, 2/11/16.  ",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2317-2016","Class I","Mae's Corner Store,  DELUX PARTY TRAY. 24.5 OZ(1 lb 8.5 oz) 695 g. UPC  034952415490. Iterm # 610907.    Item #512236, WIP EIL CRAN SESAME KERN MX25#, 512236.  6/21/16, 8/11/16","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best By Date: 5/11/16, 3/24/16, 3/23/16, 4/15/16.  6/21/16, 8/11/16",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2309-2016","Class I","BLAIN'S FARM & FLEET ROASTED/UNSALTED SUNFLOWER KERNEL 16 OZ, 1 LB (454 g), UPC  034952820881, Item # 699009.  10/11/16, 11/22/16, 12/30/16, 1/25/17, 2/22/16, 6/15/16, 9/16/16, 3/3/16, 5/17/16,  7/7/16, 4/20/16, 8/4/16.      BULK - ROASTED/UNSALTED  SUNFLOWER KERNELS 50#, 404129    EILLIEN'S 14 OZ  (397 g), ROASTED /UNSALTED SUNFLOWER KERNEL, UPC 034952563658, Item # 304287.  12/30/16, 1/25/17, 2/28/16, 4/29/16, 5/24/16, 7/7/16, 8/24/16.      EILLIEN'S R/N/S SUNFLOWER KERN 12 OZ (240 g), UPC 034952571134, Item # 128587.  12/17/16.    Item # 800315: 9/22/16, 10/19/16, 11/22/16, 12/15/16, 12/30/16, 1/5/17, 1/20/17,   1/25/17, 1/27/17, 2/4/17, 5/18/16, 2/28/16, 3/24/16, 5/20/16, 2/7/16, 3/23/16, 5/13/16,  4/1/16, 8/30/16, 3/3/16, 4/6/16, 6/1/16, 6/28/16, 2/20/16, 6/22/16, 9/21/16, 5/5/16,  6/8/16, 8/20/16, 8/5/16, 7/17/16, 7/20/16.      EILLIEN'S R/N/S SUNFLOWER KERN 7 OZ (198 g), UPC 034952575798, Item # 800107.  1/13/17, 1/14/17, 2/9/17, 3/5/16, 6/22/16, 2/8/16.    EILLIEN'S ROASTED UNSALTED SUNFLOWER KERN TRAY 13 OZ (369 g), UPC 034952572728, Item # 204347.    7/7/16, 7/26/16, 8/22/16, 9/9/16, 9/30/16, 10/21/16, 11/9/16, 3/10/16, 1/15/16, 2/13/16, 11/21/15, 6/14/16, 1/20/16, 12/9/15, 4/19/16, 12/29/15, 12/29/15,  11/6/15, 12/18/15, 5/17/16.    MILL'S FLEET FARM ROASTED UNSALTED SUNFLOWER KERNEL 16 OZ (1 LB), UPC 034952363838, Item # 600353.  10/26/16, 12/1/16, 1/25/17, 5/18/16, 2/7/16; 4/2/16, 7/9/16, 9/14/16, 2/20/16,  5/10/16, 8/20/16.      PIGGLY WIGGLY ROASTED UNSALTED SUNFLOWER KERNELS   13 OZ (369 G), UPC 034952574166, Item # 669796.  10/5/16, 10/26/16, 11/22/16, 12/8/16, 12/31/16, 1/12/17, 2/9/17, 2/13/16, 2/28/16,  4/2/16, 6/24/16, 9/4/16, 3/9/16, 4/24/16.      ROYAL POUCH BAG ROASTED UNSALTED SUNFLOWER KERNELS 11 OZ (312 G), UPC 034952571349, Item # 119586.  11/2/16, 11/24/16, 12/28/16, 1/20/17,2/12/17, 5/20/16, 2/15/16, 9/2/16, 4/6/16,  8/6/16, 5/5/16, 7/12/16, 9/18/16, 2/6/16, 3/10/16, 3/18/16.    Item #117739, 760 CT 12 OZ SUNFLOWER KERNEL, UPC 34952136166.  1/20/17, 1/25/17, 1/27/17, 2/4/17.  ","10/22/16","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best  By Date: 10/11/16, 11/22/16, 12/30/16, 1/25/17, 2/22/16, 6/15/16, 9/16/16, 3/3/16, 5/17/16,  7/7/16, 4/20/16, 8/4/16.    12/30/16, 1/25/17, 2/28/16, 4/29/16, 5/24/16, 7/7/16, 8/24/16.    12/17/16.    9/22/16, 10/19/16, 11/22/16, 12/15/16, 12/30/16, 1/5/17, 1/20/17,   1/25/17, 1/27/17, 2/4/17, 5/18/16, 2/28/16, 3/24/16, 5/20/16, 2/7/16, 3/23/16, 5/13/16,  4/1/16, 8/30/16, 3/3/16, 4/6/16, 6/1/16, 6/28/16, 2/20/16, 6/22/16, 9/21/16, 5/5/16,  6/8/16, 8/20/16, 8/5/16, 7/17/16, 7/20/16.      1/13/17, 1/14/17, 2/9/17, 3/5/16, 6/22/16, 2/8/16.    7/7/16, 7/26/16, 8/22/16, 9/9/16, 9/30/16, 10/21/16, 11/9/16, 3/10/16, 1/15/16, 2/13/16, 11/21/15, 6/14/16, 1/20/16, 12/9/15, 4/19/16, 12/29/15, 12/29/15,  11/6/15, 12/18/15, 5/17/16.    10/26/16, 12/1/16, 1/25/17, 5/18/16, 2/7/16; 4/2/16, 7/9/16, 9/14/16, 2/20/16,  5/10/16, 8/20/16.      10/5/16, 10/26/16, 11/22/16, 12/8/16, 12/31/16, 1/12/17, 2/9/17, 2/13/16, 2/28/16,  4/2/16, 6/24/16, 9/4/16, 3/9/16, 4/24/16.      11/2/16, 11/24/16, 12/28/16, 1/20/17,2/12/17, 5/20/16, 2/15/16, 9/2/16, 4/6/16,  8/6/16, 5/5/16, 7/12/16, 9/18/16, 2/6/16, 3/10/16, 3/18/16.    1/20/17, 1/25/17, 1/27/17, 2/4/17.",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2311-2016","Class I","BLAIN'S FARM & FLEET SUNFLOWER KERNEL 2 OZ (57 g), UPC	034952818949, Item # 670547.  10/5/16, 11/25/16, 3/3/16, 5/6/16, 7/23/16, 3/10/16.    BLAIN'S FARM & FLEET SUNFLOWER KERNELS 16 OZ , 1 lb(454 g), UPC 034952813661, Item # 637413.  10/4/16, 10/18/16, 10/19/16, 11/22/16, 12/1/16, 12/30/16, 1/13/17, 1/18/17, 1/20/17,  2/4/17, 2/22/16, 9/1/16, 2/28/16, 6/15/16, 6/15/16, 8/9/16, 7/6/16, 9/14/16, 5/24/16,  2/20/16, 4/20/16, 5/5/16, 7/19/16, 3/29/16.      EILLIEN'S 10 OZ (284 g) SUNFLOWER KERNELS, UPC 034952131581, Item 202358.  9/29/16, 11/10/16, 12/9/16, 1/4/17, 2/5/17, 6/21/16, 2/15/16, 3/19/16, 4/9/16, 4/15/16,  5/13/16, 5/27/16, 9/2/16.    EILLIEN'S 12 OZ (340 g) SUNFLOWER KERNELS, UPC 034952571103, Item # 128884.  10/28/16, 6/3/16, 9/16/16.  Item # 800323: 9/22/16, 10/4/16, 10/19/16, 10/27/16, 11/22/16, 12/1/16, 12/15/16,  12/30/16, 1/5/17, 1/20/17, 1/25/17, 2/4/17, 5/18/16, 5/18/16, 9/1/16, 2/28/16, 3/24/16,  3/24/16, 3/30/16, 5/20/16, 2/7/16, 8/30/16, 3/3/16, 4/6/16, 6/1/16, 2/20/16, 6/22/16,  6/22/16, 8/3/16, 5/5/16, 6/8/16, 6/29/16, 7/19/16, 8/5/16, 8/21/16, 7/20/16,    EILLIEN'S 14 OZ (397 g), SUNFLOWER KERNELS, UPC 034952563481, Item # 304907.  9/29/16, 10/4/16, 10/4/16, 10/27/16, 12/1/16, 12/15/16, 1/25/17, 2/13/16, 9/1/16,   2/28/16, 3/30/16, 7/14/16, 6/11/16, 4/30/16, 3/3/16, 5/24/16, 2/20/16, 4/20/16, 4/28/16, 6/22/16, 6/22/16, 7/23/16, 8/3/16.  Item #: 1/13/17, 2/15/16.    EILLIEN'S SUNFLOWER KERNEL TRAY   13 OZ (369 g), UPC 034952572711, Item # 204339.  6/29/16, 7/18/16, 8/10/16, 8/23/16, 9/9/16, 9/30/16, 9/30/16,10/19/16,11/9/16,  11/10/16,4/16/16,1/29/16,3/11/16,1/15/16,1/1/16,11/21/15, 6/16/16, 1/20/16,12/9/15,   6/9/16, 11/8/15, 5/17/16, 5/17/16, 4/8/16.    EILLIEN'S SUNFLOWER KERNELS        4 OZ (113 g), UPC	034952006094, Item # 200188.  10/20/16, 10/26/16, 12/3/16, 12/31/16, 1/27/17, 2/9/17, 2/16/17, 7/16/16, 2/5/16,  5/11/16, 2/7/16, 3/4/16, 3/17/16, 3/23/16, 4/2/16, 4/14/16, 5/19/16, 5/28/16, 6/11/16,  6/24/16, 7/6/16, 7/9/16, 9/4/16.    HOLIDAY SNACKTIME SUNFLOWER KERNEL   12 OZ (340 g)","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best  By Date: 10/5/16, 11/25/16, 3/3/16, 5/6/16, 7/23/16, 3/10/16.    10/4/16, 10/18/16, 10/19/16, 11/22/16, 12/1/16, 12/30/16, 1/13/17, 1/18/17, 1/20/17,  2/4/17, 2/22/16, 9/1/16, 2/28/16, 6/15/16, 6/15/16, 8/9/16, 7/6/16, 9/14/16, 5/24/16,  2/20/16, 4/20/16, 5/5/16, 7/19/16, 3/29/16.    9/29/16, 11/10/16, 12/9/16, 1/4/17, 2/5/17, 6/21/16, 2/15/16, 3/19/16, 4/9/16, 4/15/16,  5/13/16, 5/27/16, 9/2/16.    10/28/16, 6/3/16, 9/16/16.  800323: 9/22/16, 10/4/16, 10/19/16, 10/27/16, 11/22/16, 12/1/16, 12/15/16,  12/30/16, 1/5/17, 1/20/17, 1/25/17, 2/4/17, 5/18/16, 5/18/16, 9/1/16, 2/28/16, 3/24/16,  3/24/16, 3/30/16, 5/20/16, 2/7/16, 8/30/16, 3/3/16, 4/6/16, 6/1/16, 2/20/16, 6/22/16,  6/22/16, 8/3/16, 5/5/16, 6/8/16, 6/29/16, 7/19/16, 8/5/16, 8/21/16, 7/20/16,    9/29/16, 10/4/16, 10/4/16, 10/27/16, 12/1/16, 12/15/16, 1/25/17, 2/13/16, 9/1/16,   2/28/16, 3/30/16, 7/14/16, 6/11/16, 4/30/16, 3/3/16, 5/24/16, 2/20/16, 4/20/16, 4/28/16, 6/22/16, 6/22/16, 7/23/16, 8/3/16.  Item #: 1/13/17, 2/15/16.    6/29/16, 7/18/16, 8/10/16, 8/23/16, 9/9/16, 9/30/16, 9/30/16,10/19/16,11/9/16,  11/10/16,4/16/16,1/29/16,3/11/16,1/15/16,1/1/16,11/21/15, 6/16/16, 1/20/16,12/9/15,   6/9/16, 11/8/15, 5/17/16, 5/17/16, 4/8/16.    10/20/16, 10/26/16, 12/3/16, 12/31/16, 1/27/17, 2/9/17, 2/16/17, 7/16/16, 2/5/16,  5/11/16, 2/7/16, 3/4/16, 3/17/16, 3/23/16, 4/2/16, 4/14/16, 5/19/16, 5/28/16, 6/11/16,  6/24/16, 7/6/16, 7/9/16, 9/4/16.    11/17/16, 11/18/16, 12/10/16, 12/28/16, 12/30/16, 12/31/16, 12/31/16, 1/25/17,  2/22/16, 2/28/16, 3/17/16, 4/15/16, 2/12/16, 9/14/16, 3/26/16, 3/3/16, 5/24/16,   2/20/16, 7/12/16, 2/8/16.    10/11/16, 10/11/16, 12/1/16, 12/8/16, 12/15/16, 12/15/16, 12/30/16, 1/6/17, 2/16/17,  5/18/16, 9/1/16, 8/9/16, 8/9/16, 4/2/16, 2/15/16, 3/5/16, 3/26/16, 2/20/16, 5/5/16,  5/7/16, 6/8/16, 6/29/16, 7/19/16.    11/17/16, 1/20/17, 2/16/17, 4/1/16, 4/30/16, 6/17/16, 8/13/16.    10/11/16, 10/18/16, 12/2/16, 1/12/17, 2/22/16, 2/22/16, 7/16/16, 3/17/16, 6/17/16,  5/1/16, 6/3/16, 7/7/16, 2/29/16, 7/29/16, 6/8/16, 8/20/16, 2/8/16, 2/",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2316-2016","Class I","HOLIDAY PANTRY, RAISIN & NUT , NET WT. 9 OZ(255 G),   UPC:  041282995424, Item # 130476.","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best By Date:    10/21/16  11/15/16  1/18/17  1/26/17  2/13/16  2/19/16  2/5/16  3/17/16  3/2/16  3/8/16  4/20/16  4/22/16  5/13/16  5/27/16  7/2/16  7/1/16  11/29/16  12/2/16  ",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2313-2016","Class I","BULK - ROASTED  & SALTED SUNFLOWER KERNELS 50#,   UPC: 034952142440. No CODE.    EILLIEN'S ROASTED & SALTED SUNFLOWER KERN 7 OZ (198 g) ,   UPC 034952575576 Item 800139.    PIGGLY WIGGLY ROASTED &SALTED  SUNFLOWER KERNELS   13 OZ(369 g), UPC 034952574159 Item # 669788..    Royal Snacks, Roasted & Salted Sunflower Kernels, Net WT 11 oz (312 g), UPC: 034952571356.    PIGGLY WIGGLY, Roasted & Salted  SUNFLOWER KERNEL , 14 OZ(397 g).   UPC: 034952580945, Item # 691378.    PIGGLY WIGGLY , Roasted & Salted SUNFLOWER KERNELS,  4 OZ(113 g), UPC: 034952579864, Item # 623645..    ","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best By Date:     1/1/17, 1/21/17, 2/10/17,  1/13/17, 2/4/17, 2/16/17, 2/9/17,1/18/17,  2/11/17, 2/12/17, 1/19/17.    2/7/16, 2/6/16, 2/21/16, 2/14/16,  2/20/16, 2/21/16, 3/24/16, 3/4/16, 3/9/16,   4/22/16, 4/24/16,   4/13/16, 4/15/16,  4/6/16,4/20/16,   4/10/16, 5/1/16,  5/5/16, 5/11/16,   5/14/16,,, 5/26/16, 6/11/16,6/24/16,  6/29/16,  7/1/16, , 7/6/16, 8/17/16,8/9/16,  8/21/16   9/2/16,  9/4/16, 9/3/16, , 9/8/16, , 9/18/16,  9/29/16,  10/7/16, 10/18/16, 10/27/16, 11/15/16, 11/8/16, 11/22/16,11/24/16, 12/18/16,  12/1/16,12/16/16,   , 12/23/16, 12/8/16,  12/1/16,12/23/16 .   ",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2322-2016","Class I","Item # 413674, WIP SPORTSMAN MIX 25#, UPC 120046901.  ( this item goes into making many items listed)  9/28/16, 11/18/16, 12/16/16, 12/22/16, 1/26/17, 2/17/17, 9/1/16, 2/5/16, 2/28/16,   3/24/16, 3/30/16, 3/30/16, 4/29/16, 6/15/16, 7/14/16.  ",,"Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best  By Date 9/28/16, 11/18/16, 12/16/16, 12/22/16, 1/26/17, 2/17/17, 9/1/16, 2/5/16, 2/28/16,   3/24/16, 3/30/16, 3/30/16, 4/29/16, 6/15/16, 7/14/16.  ",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2314-2016","Class I","FIGI'S HOT & SPICY CAJUN SNACK MIX, 16 OZ (453 G),   UPC 609883  Item # 609883.","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best By Date:  12/3/16  7/14/16  6/17/16  3/26/16  5/7/16  8/23/16  ",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2308-2016","Class I","BLAIN'S FARM & FLEET, The BIG  GAME PARTY TRAY B 25 OZ, UPC 034952822434, Item # 612547.  7/15/16, 6/17/16.","62,229 cases for total products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best  By Date: 7/15/16, 6/17/16",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2315-2016","Class I","FIGI'S NATURES MIX, PO# 00460590, 012-0022-901, 15071. 20#, UPC # 680223.","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best By Date:   9/22/16  11/9/16  11/24/16  1/5/17  1/26/17  4/7/16  5/11/16  6/25/16  7/28/16  8/9/16  ",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2320-2016","Class I","Mae's Corner Market, Sedona Mix,  14 OZ (397 g),   UPC 034952415230, Item # 610587.","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best By Date: 11/15/16, 4/30/16/ 4/27/16.",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2321-2016","Class I","Eillien's Cranberry Sesame Sunflower Kernel Mix, Net WT 14 oz (397 g), UPC 034952586572, Item # 698274.  10/22/16.    Item #512236, WIP EIL CRAN SESAME KERN MX25#, 512236.  6/21/16, 8/11/16  ","62,229 cases for total products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best  By Date 10/22/16, 6/21/16, 8/11/16  ",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2318-2016","Class I","Mae's Corner Market, FIJI MIX,  14 OZ(397 g) ,   UPC 034952415247, Item # 610611.","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best By Date: 8/18/16, 4/40/16, 4/27/16.",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2319-2016","Class I","Mae's  Corner Market,  HOLIDAY PARTY TRAY MIX  31.4.5OZ( 1 lb 15.5 oz) 838 g, UPC 034952410549, Item # 681080.","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best By Date: 5/5/16, 4/13/16,  4/14/16, 4/20/16, 4/21/16, 3/21/16. ",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74387,"Ongoing","Eillien's Candies, Inc.","1301 Waube Ln",,"Green Bay","WI","54304-5655","United States","Voluntary: Firm Initiated","Letter","IL, IA, MI, MN, NY, ND, OK, SD, TX, WI.","F-2310-2016","Class I","BLAIN'S FARM & FLEET SPORTSMAN'S MIX 1.75OZ (50 g), UPC 034952818956, Item # 670554.  10/19/16, 2/21/16, 7/1/16, 8/10/16, 4/16/16.  BLAIN'S FARM & FLEET SPORTSMAN'S MIX  7 -1.75OZ, UPC # 34952850871, Item # 698712 : 2/5/16, 3/8/16, 4/7/16, 4/17/16, 7/6/16, 8/3/16.    BLAIN'S FARM & FLEET SPORTSMAN MIX 12 OZ (340 g), UPC 034952814460, Item # 648212.  9/23/16, 12/1/16, 12/1/16, 12/24/16, 1/25/17, 6/15/16, 7/14/16, 2/7/16, 3/4/16,  8/10/16, 4/17/16, 4/21/16, 5/26/16.    BLAIN'S FARM & FLEET SPORTSMAN MIX JAR 38 OZ, 2 lbs 2 oz (1077 g), UPC 034952820386, Item # 68768.  12/17/16, 12/23/16, 2/9/17, 2/16/17, 4/7/16, 2/5/16, 3/24/16    BULK - SPORTSMAN MIX 25#	413674    EILLIEN'S SPORTSMAN MIX  22 OZ	, 1 lb 6 oz ( 624 g), UPC 034952577365, Item # 306753.  10/25/16, 12/7/16, 1/18/17, 1/18/17, 5/18/16, 7/13/16, 7/1/16, 4/23/16, 6/14/16,  2/12/16, 3/26/16, 2/29/16, 5/4/16, 5/25/16, 7/29/16, 7/29/16, 9/3/16, 9/21/16,  Item # 414458: 7/13/16.    EILLIEN'S SPORTSMAN MIX 4 OZ (113 g), UPC  034952575705, Item # 800195.  11/23/16, 11/23/16, 6/21/16, 6/21/16, 3/17/16, 9/8/16.    EILLIEN'S SPORTSMAN MIX TRAY      15 OZ, UPC 034952572926, Item #204560.  6/29/16, 7/21/16, 8/18/16, 9/2/16, 9/18/16, 10/12/16, 10/26/16, 11/11/16, 11/5/15,  12/30/15, 4/14/16, 2/11/16, 4/28/16, 12/4/15, 6/4/16, 2/24/16, 11/14/15, 1/13/16,  1/16/16, 5/25/16.    HOLIDAY SNACKTIME SPORTSMAN MIX  11 OZ (312 g), UPC 041282995318, Item# 130443.  10/27/16, 12/14/16, 12/31/16, 1/19/17, 1/25/17, 5/28/16, 2/12/16, 3/5/16, 3/3/16,  2/29/16, 7/19/16, 4/27/16, 2/6/16, 3/18/16.      MILL'S FLEET FARM SPORTSMAN MIX        24 OZ , 1 lb 8 oz(680 g), UPC 034952362763, Item # 696831.  10/13/16, 11/15/16, 12/21/16, 1/21/17, 7/9/16, 4/1/16, 2/1/16, 4/23/16, 2/12/16,  9/14/16, 3/3/16, 7/29/16, 5/7/16, 4/13/16, 3/2/16, 6/2/16, 6/16/16, 7/12/16, 9/9/16.    MILL'S FLEET FARM SPORTSMAN MIX       32 OZ, 2 lbs  (907 g), UPC 034952361766, Item # 678318.  10/20/16, 10/20/16, 11/17/16, 12/28/16, 1/25/17, 2/13/17, 2/5/16, 3/30/16, 7/14/16,  6/25/16, 3/4/16, 5/13/16, 6/17/16, 2/12/16,","62,229 cases total for all products.","Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.","09/16/2016",," Best  By Date: 10/19/16, 2/21/16, 7/1/16, 8/10/16, 4/16/16.  2/5/16, 3/8/16, 4/7/16, 4/17/16, 7/6/16, 8/3/16  9/23/16, 12/1/16, 12/1/16, 12/24/16, 1/25/17, 6/15/16, 7/14/16, 2/7/16, 3/4/16,  8/10/16, 4/17/16, 4/21/16, 5/26/16.    12/17/16, 12/23/16, 2/9/17, 2/16/17, 4/7/16, 2/5/16, 3/24/16    10/25/16, 12/7/16, 1/18/17, 1/18/17, 5/18/16, 7/13/16, 7/1/16, 4/23/16, 6/14/16,  2/12/16, 3/26/16, 2/29/16, 5/4/16, 5/25/16, 7/29/16, 7/29/16, 9/3/16, 9/21/16,  414458: 7/13/16.    EILLIEN'S SPORTSMAN MIX 4 OZ	034952575705, Item # 800195.  11/23/16, 11/23/16, 6/21/16, 6/21/16, 3/17/16, 9/8/16.      6/29/16, 7/21/16, 8/18/16, 9/2/16, 9/18/16, 10/12/16, 10/26/16, 11/11/16, 11/5/15,  12/30/15, 4/14/16, 2/11/16, 4/28/16, 12/4/15, 6/4/16, 2/24/16, 11/14/15, 1/13/16,  1/16/16, 5/25/16.    10/27/16, 12/14/16, 12/31/16, 1/19/17, 1/25/17, 5/28/16, 2/12/16, 3/5/16, 3/3/16,  2/29/16, 7/19/16, 4/27/16, 2/6/16, 3/18/16.      10/13/16, 11/15/16, 12/21/16, 1/21/17, 7/9/16, 4/1/16, 2/1/16, 4/23/16, 2/12/16,  9/14/16, 3/3/16, 7/29/16, 5/7/16, 4/13/16, 3/2/16, 6/2/16, 6/16/16, 7/12/16, 9/9/16.    10/20/16, 10/20/16, 11/17/16, 12/28/16, 1/25/17, 2/13/17, 2/5/16, 3/30/16, 7/14/16,  6/25/16, 3/4/16, 5/13/16, 6/17/16, 2/12/16, 6/28/16, 6/28/16, 4/27/16, 3/29/16,  4/21/16, 3/1/16.    12/2/16, 1/18/17, 8/18/16, 3/4/16, 6/11/16, 2/1/16, 4/23/16, 6/14/16.    4/27/16.    9/23/16, 1/27/17, 3/9/16.  9/23/16, 1/18/17, 1/27/17, 7/1/16, 8/10/16, 2/29/16, 5/4/16,3/9/16,    8/11/16, 8/24/16, 9/18/16, 9/18/16, 10/18/16, 11/12/16, 1/7/16, 11/28/15, 12/30/15,  5/6/16, 1/28/16, 2/4/16, 2/5/16, 4/5/16, 11/8/15, 6/18/16, 5/25/16, 12/10/15.    11/11/16, 12/17/16, 12/28/16, 2/3/17, 2/17/17, 2/5/16, 8/11/16, 4/1/16, 5/5/16,  2/14/16, 9/9/16, 3/10/16, 3/18/16, 6/18/16.    12/21/16, 2/13/17, 7/14/16, 5/13/16, 3/5/16.    11/15/16, 5/18/16, 2/12/16, 7/5/16, 8/5/16.    8/16/16, 2/4/17,    10/25/16, 12/1/16, 12/8/16, 3/26/16, 8/30/16.    4/7/16  ",5/23/2016,"05/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74388,"Ongoing","Schulze & Burch Biscuit Co","1133 W 35th St",,"Chicago","IL","60609-1447","United States","Voluntary: Firm Initiated","Telephone","The product was shipped to Aldi Inc. , 1200 Kirk Road, Batavia, IL 60510 from there it is further shipped to distribution centers andd then to Aldi stores. no product was distributed to foreign firms.","F-2082-2016","Class I","Aldi's Millville protein chew bars, dark chocolate peanut butter packaged 5 bars to a box in a yellow and brown box with brown and white lettering.","64,955 cases (or) 779,460 cartons,  12 Cartons per case","A supplier of one of the ingredients in the protein chewy bars informed firm of Listeria Monocytogenes positive.","09/02/2016",," i.	SEP14162T1  ii.	OCT14161T1  iii.	OCT14162T1  iv.	OCT18162T1  v.	OCT19161T1  vi.	OCT19162T1  vii.	OCT28161T1  viii.	OCT28162T1  ix.	NOV08161T1  x.	NOV08162T1  xi.	JAN01172T1  xii.	JAN02171T1  xiii.	JAN15171T1   xiv.	JAN15172T1   ",6/1/2016,"06/01/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74388,"Ongoing","Schulze & Burch Biscuit Co","1133 W 35th St",,"Chicago","IL","60609-1447","United States","Voluntary: Firm Initiated","Telephone","The product was shipped to Aldi Inc. , 1200 Kirk Road, Batavia, IL 60510 from there it is further shipped to distribution centers andd then to Aldi stores. no product was distributed to foreign firms.","F-2083-2016","Class I","Aldi's Millville protein chew bars, peanut, dark chocolate & almond packaged 5 bars per box in a yellow and brown box with brown and white lettering.","64,955 cases (or) 779,460 cartons,  12 Cartons per case","A supplier of one of the ingredients in the protein chewy bars informed firm of Listeria Monocytogenes positive.","09/02/2016",," i.	OCT14162T1  ii.	OCT15161T1  iii.	OCT15162T1   iv.	OCT28162T1   v.	OCT29161T1   vi.	OCT29162T1   vii.	NOV08162T1   viii.	NOV09161T1  ix.	DEC04161T1  x.	DEC04162T1  xi.	DEC18161T1  xii.	DEC18162T1  xiii.	DEC31162T1  xiv.	JAN01171T1  xv.	JAN01172T1   xvi.	JAN14171T1  xvii.	JAN14172T1   xviii.	JAN15171T1  xix.	JAN20172T1  xx.	JAN21171T1  ",6/1/2016,"06/01/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74389,"Ongoing","Terumo Cardiovascular Systems Corporation","6200 Jackson Rd",,"Ann Arbor","MI","48103","United States","Voluntary: Firm Initiated","Letter","Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,    VA, WA, WI, WV, WY     Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic,              Ecuador, El Salvador, England, Finland, France, Germany  Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel,   Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia  Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea,            Spain, Sweden, Switzerland, Taiwan,                Thailand, Turkey, United Arab Emirates , Uruguay ,                     Venezuela, Vietnam","Z-2207-2016","Class II"," Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.  The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).The system has the capacity to circulate water at a rate of up to  6.5 gal.min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels.    Product Usage:  HX2 Temperature Management Systems is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.  ","6412 units","Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor  no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. ","07/14/2016",," Temperature Management Systems, P/N 809810, Catalog Number 809810",6/8/2016,"06/08/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74389,"Ongoing","Terumo Cardiovascular Systems Corporation","6200 Jackson Rd",,"Ann Arbor","MI","48103","United States","Voluntary: Firm Initiated","Letter","Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,    VA, WA, WI, WV, WY     Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic,              Ecuador, El Salvador, England, Finland, France, Germany  Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel,   Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia  Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea,            Spain, Sweden, Switzerland, Taiwan,                Thailand, Turkey, United Arab Emirates , Uruguay ,                     Venezuela, Vietnam","Z-2208-2016","Class II","Sarns TCM;     The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for cardioplegia, freeze water for an ice  supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature.    Product Usage:  The Sarns TCM is indicated for controlling and monitoring patient temperature.  ","6412 units","Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor  no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. ","07/14/2016",," The Sarns Temperature Control and Monitor unit (TCM), PIN 15747, Catalog Number 15747",6/8/2016,"06/08/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74389,"Ongoing","Terumo Cardiovascular Systems Corporation","6200 Jackson Rd",,"Ann Arbor","MI","48103","United States","Voluntary: Firm Initiated","Letter","Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,    VA, WA, WI, WV, WY     Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic,              Ecuador, El Salvador, England, Finland, France, Germany  Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel,   Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia  Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea,            Spain, Sweden, Switzerland, Taiwan,                Thailand, Turkey, United Arab Emirates , Uruguay ,                     Venezuela, Vietnam","Z-2209-2016","Class II","Sarns TCM II;     The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an  extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood  temperature.    Product Usage:  The Sarns TCM II is indicated for controlling and monitoring patient temperature.  ","6412 units","Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor  no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. ","07/14/2016",," The Sarns Temperature Control and Monitor unit (TCM), TCM II TUV, 115V (P/N 4415),  TCM II TUV, 220V (P/N 4416),  TCM II, with Cardioplegia, 11 OV/60Hz (P/N 164925)  TCM II, without Cardioplegia, 110V/60Hz (P/N 164930)  TCM II, with Cardioplegia, 220V/50Hz (P/N 164935)  TCM II, without Cardioplegia, 220V/50Hz (P/N 164940)",6/8/2016,"06/08/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74389,"Ongoing","Terumo Cardiovascular Systems Corporation","6200 Jackson Rd",,"Ann Arbor","MI","48103","United States","Voluntary: Firm Initiated","Letter","Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,    VA, WA, WI, WV, WY     Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic,              Ecuador, El Salvador, England, Finland, France, Germany  Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel,   Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia  Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea,            Spain, Sweden, Switzerland, Taiwan,                Thailand, Turkey, United Arab Emirates , Uruguay ,                     Venezuela, Vietnam","Z-2210-2016","Class II","Preamendments device-Sarns  Dual Cooler-Heater.      The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000  pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures.    Product Usage:  The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in open-heart surgery.  ","6412 units","Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor  no longer selling the Inter chlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. ","07/14/2016",," The Sarns Dual Cooler-Heater ; Dual Cooler Heater 115V/60Hz (P/N 11160);  Dual Cooler Heater 220V/50Hz (P/N 4332);  Dual Cooler Heater 1 OOV/60Hz (P/N 14114);  Dual Cooler Heater 1 OOV/50Hz (PIN 13460)",6/8/2016,"06/08/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74390,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD,  MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI","Z-2088-2016","Class II","Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173, ","74 systems","Software error in previous software versions in which two references for the same image may exist in the database.","06/29/2016",," Serial Numbers: 100389, 100198, 100258, 100259, 100538, 100133, 100213, 100214, 100031, 100484, 100362, 100233, 100140, 100141, 100142, 100143, 100144, 100416, 100105, 100106, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100457, 100245, 100447, 100364, 100314, 100298, 100299, 100386, 100139, 100027, 100300, 100197, 100025, 100084  100186, 100189, 100190, 100191, 100192, 100195, 100196, 100033, 100306, 100307, 100232, 100256, 100199, 100188, 100194, 100257, 100425, 100029, 100253, 100132, 100247, 100248, 100434, 100491, 100495, 100221, 100212",5/9/2016,"05/09/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74391,"Ongoing","Esaote S.p.A.","Via Di Caciolle,15",,"Firenze",,,"Italy","Voluntary: Firm Initiated","Letter","Domestic: FL, TX, OH, MN, NV;   Foreign: No customers in Canada;  No VA/DOD.","Z-2124-2016","Class II","Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)","11 USA;  29 OUS","The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table.  Additionally, a weight limit is added to the patient seat for weight-bearing examinations. ","07/05/2016","."," Item No., Unit Description and Serial No.s:  101002000,	UNIT, G-SCAN BRIO,	05202;  101002000,	UNIT, G-SCAN BRIO,	05203;  101002000,	UNIT,  G-SCAN BRIO 2.1A;	05205;  101002000,	UNIT, G-SCAN BRIO 2.1A,	05207;  101002000	UNIT, G-SCAN BRIO 2.1A,	05208;  101002000	UNIT, G-SCAN BRIO 2.1A,	05209;  101002000	UNIT, G-SCAN BRIO 2.1A,	05210;  101002000	UNIT, G-SCAN BRIO 2.1A,	05211;  101002000	UNIT,  G-SCAN BRIO 2.1A,	05305;  101002000	UNIT,  G-SCAN BRIO 2.1A,	05308  ",6/6/2016,"06/06/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74392,"Ongoing","Post Consumer Brands","20802 Kensington Blvd",,"Lakeville","MN","55044-8052","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","nationwide.  OUS to include:  Bahamas, Bermuda, Cambodia, Costa Rica, Dominican Republic, El Salvador, Honduras, Jamaica, Netherlands Antilles, Panama, Singapore, Trinidad and Tobago, Vietnam","F-2382-2016","Class I","Post Great Grains Protein Blend, Honey, oats & seeds cereal.  Net Wt. 13.5 oz (382 g) carton with plastic liner.  UPC 84912-00456.  Post Foods LLC, 1 Upper Pond Road, Parsippany, NJ  07054","73,025 cases","Post Great Grains Protein Blend - honey oats & seeds cereal is being recalled because it contains sunflower seeds that have the potential to be contaminated with Listeria monocytogenes.","09/19/2016",," Best When Used By:  AUG 1416, AUG1516, AUG1616, AUG1716, NOV0916, NOV1016, NOV1116, NOV1216, FEB1817, FEB1917",6/3/2016,"06/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74393,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution and to the countries of : Algeria, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Ghana, Gibraltar, Greece, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom,  Uruguay, Venezuela, Viet Nam, Zambia, Zimbabwe","Z-2108-2016","Class II","Access Free T3 Assay, Ref No. A13422    The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.","205,744 kits total (13,358 kits in US)","Demonstrate an upward shift in patient results.","06/30/2016",," 524087  526807  528874  529913  530102  531647  532473  534080  534081  534336  535481  570090  570116  570222  570236  570239  570245  570246  622173  622174  671016  671025  671033",6/8/2016,"06/08/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0343-2017","Class II","Muscle Milk Pro Series 40 14 oz;, 40 g protein  Crushin' Cookies.    UPC (case): 8-76063-00293-6;    UPC (unit): 8-76063-00283-7","21614 cases of 12 x 14 oz. units","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood Lot numbers:E15336, A16023, F16107.  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0344-2017","Class II","Muscle Milk Pro Series 40, 14 oz.. 40 g protein;  Knock Out Chocolate    UPC (case):  8-76063-00290-5;    UPC (unit):  8-76063-00280-6","16082 cases of 12 x 14 oz. units","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood Lot numbers: A15354, B15355, E16024, F16025, A16056, A16096, B16097, A16111, D16142, E16143, E16155, F16156, E15356, G16094, H16095, A16117.",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0337-2017","Class II","Muscle Milk 14 oz, 25 g protein  Cookies N Cr¿me.    UPC (case): 8-76063-00224-0;    UPC (unit):  8-76063-00204-2","42498 cases of 12 units per case","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers:D15336, A1601, F16103, D16106, E16107, E16128,  B16154, B16011, D16102, E16103, D16158.  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0336-2017","Class II","Muscle Milk 14 oz  Chocolate, 25 g protein.    UPC (case):  8-76063-00221-9;    UPC (unit):  8-76063-00201-1","130840 cases shipped 12 x 14 oz. units","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers: C15355,D16024,E16052,F16053,C16097,D16098,  E16099,J16108, K16109, G16156, H16156, D15355, B16057, A15340, B15341, C15341 ,E16093, F16094, B16117, C16118, I16129, J16130, A16138, K16130, L16131.",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0331-2017","Class II","FitPro Go! 14oz, 35 g protein   Chocolate Chip Cookies    UPC(Case): 8-5418200338-6;    UPC Unit: 8-5418200325-6","8915 cases of 12 x 14 oz.","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers: A16019, B16020, E16113, F16114    ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0345-2017","Class II","Muscle Milk Pro Series 40 14 oz., 40 g protein;  Going Bananas    UPC (case):  8-76063-00294-3;    UPC (unit):  8-76063-00284-4","35734 cases shipped, 12 x 14 oz. per case","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood Lot numbers: G15351, B16023, C16024, B16051, H16104  F16128.  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0340-2017","Class II","Muscle Milk 14 oz. 25 g protein  Caramel Kick    UPC (case): 8-76063-00214-1;    UPC (unit):  8-76063-00219-6","3578 Units","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood Lot numbers: G16025  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0342-2017","Class II","Muscle Milk 10 oz. 18 g protein.  Sold in 4 packs  Vanilla Creme    UPC (case): 8-76063-00272-1;    UPC (unit): 8-76063-00262-2","4780 cases - 6 x four packs per case","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," Unknown",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0338-2017","Class II","Muscle Milk 14 oz., 25 g protein  Strawberry;    UPC (case): 8-76063-00229-5;    UPC (unit):  8-76063-00209-7","12522 Units","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers: C16011, D16012, C16051, I15352, I16104, F16136  A16137.  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0333-2017","Class II","Muscle Milk Pro Series 40 14 oz.;  40 g protein  Intense Vanilla    UPC Case: 8-76063-00291-2;    UPC Unit: 8-76063-00281-3","21561 cases shipped; 12 x 14 oz. units per case","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers: C15336, C15350, C16009 D16010, B16046, C16061, A16101, B16102, A16105, A16126, B16127,  A16153, A16154.                    ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0335-2017","Class II","Muscle Milk  Caf¿ Latte   Caf¿ Latte, 414 mL    UPC (case):  8-76063-00215-8;    UPC (unit):  8-76063-00210-3","13988 cases, 12 units per case","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers: F15336, D16052.  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0330-2017","Class II","FitPro Go! 14oz   Chocolate; 35 g protein    UPC Case: 8-5418200328-7;    UPC Unit: 8-5418200324-9","14831cases - 12 x 14 oz. units per case","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers: C16020, D16113.  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0341-2017","Class II","Muscle Milk 10 oz. 18 grams protein. Sold in 4 packs  Chocolate;    UPC (case):  8-76063-00271-4;    UPC (unit):  8-76063-00261-5","7216 cases - 24 units per case - six-4 packs","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," BB JAN2317 0601",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0334-2017","Class II","Muscle Milk, 14oz ; 40 g protein  Banana;    UPC (case): 8-76063-00223-3    UPC (unit): 8-76063-00203-5","1015450 cases - 12 x 14 oz. units","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numers: D15350, E15351, F15351, H15351, A16047, B16048, A16049, A16050, A16051, H15351, F15351, A16047, B16048, G16104, H16107, I16108, E16136.            ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0329-2017","Class II","FitPro Go! 14oz   Strawberry;  35g protein    UPC (Case): 8-5418200329-4;    UPC (Individual): 8-5418200326-3","14024 cases shipped, 12 x 14 oz. containers","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers: C16019, C16113.    ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0346-2017","Class II","Muscle Milk 100 Calorie 14 oz  Chocolate     UPC (case):  8-76063-00575-3;    UPC (unit):  8-76063-00565-4","14,534cases, 12 x 14 oz.  units","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers: B15363, B15361, C15362, A15363, D16118  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0339-2017","Class II","Muscle Milk 14 oz, 25 g protein.  Vanilla Creme    UPC (case):  8-76063-00222-6;    UPC (unit):  8-76063-00202-8","132597 cases; 12 x 14 oz. containers","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood lot numbers: A15335, B15336, A16008, B16009, B16042, C16043  A16046, A16059, A16060, B16061, B16105, C16106, C16127, D16128  A16157, B16158, B15350, C16046, A15349, C16102, C16135, D16136  C16158  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74394,"Ongoing","H.P. Hood, LLC","8340 Belvedere Ave",,"Sacramento","CA","95826-5902","United States","Voluntary: Firm Initiated","Telephone","USA, Canada, Australia and south Africa","F-0332-2017","Class II","FitPro Go! 14oz , 35 g protein  Vanilla;    UPC (case) : 8-5418200327-0;     UPC (unit): 8-5418200325-6","15457 cases, 12 x 14 oz. containers","Products recalled due to premature spoilage (swelled containers & foul odor). ","11/07/2016",," HP Hood Lot numbers: A16018, B16019, A16112.  ",6/9/2016,"06/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74395,"Ongoing","Siemens Medical Solutions USA, Inc.","2501 Barrington Rd",,"Hoffman Estates","IL","60192-2061","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (Nationwide) including states of: District of Columbia and Puerto Rico and countries of: Algeria, Argentina, Austria, Australia, Bangladesh, Bahrain, Belarus, Belgium, Brazil, Cameroon, Canada, Chile, China, Colombia, Congo-The Democratic Republic of the, Costa Rica,  Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Great Britain, India, Iran, Ireland, Israel, Italy,  Japan, Kazakhstan, Korea, Kuwait, Lebanon, Mauritius, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Serbia (Republic of Serbia), South Africa, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, United Arab Emirates, Uzbekistan, Viet nam, and Yemen.","Z-2758-2016","Class II","e.cam and Symbia E gamma camera systems with patient beds    To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. ","5451",,"09/08/2016",," Model numbers 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324119, 7324135, 7324143, 7324150, 7760809, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823961, 7823979, 10151531, 10151532, 10275879, 10413009, 10520745.    Serial numbers:  2005003	,  5130	,  1176	,  1180	,  1161	,  1169	,  1162	,  1163	,  1165	,  1166	,  1172	,  2025	,  2052	,  7595	,  RC524	,  RC495	,  8515	,  1198	,  1202	,  10016	,  5563	,  5556	,  7588	,  8757	,  10342	,  11371	,  11666	,  5560	,  7507	,  7596	,  10345	,  11674	,  1210	,  1211	,  1005	,  1156	,  1261	,  5562	,  5538	,  5555	,  10348	,  11372	,  1155	,  4019	,  8545	,  8756	,  9241	,  9235	,  9238	,  10351	,  10346	,  10350	,  11370	,  1262	,  1028	,  1358	,  4112	,  7509	,  7606	,  7599	,  8760	,  8758	,  1209	,  1208	,  1032	,  7600	,  8759	,  9173	,  9245	,  1213	,  5561	,  5514	,  7608	,  8761	,  1212	,  1359	,  1075	,  4117	,  7605	,  8763	,  8767	,  9240	,  9243	,  10356	,  10354	,  11667	,  1010	,  1360	,  7607	,  10359	,  1007	,  1158	,  1159	,  1263	,  7072	,  4114	,  4116	,  9239	,  9242	,  9248	,  11067	,  11680	,  3028	,  11679	,  1071	,  3006	,  1146	,  1160	,  1264	,  1361	,  1174	,  8547	,  8769	,  8770	,  10358	,  10353	,  10062	,  5141	,  11373	,  1049	,  1161	,  5626	,  1112	,  70017	,  2090	,  4118	,  4119	,  4120	,  7602	,  7610	,  7611	,  8773	,  8548	,  8766	,  9251	,  9246	,  591	,  10357	,  1051	,  6006	,  8732	,  8755	,  8771	,  8517	,  9247	,  8520	,  11719	,  1292	,  5024	,  5167	,  5025	,  5567	,  5108	,  5031	,  7616	,  9253	,  9252	,  9038	,  1068	,  11672	,  11675	,  1347	,  4121	,  5573	,  5502	,  7615	,  7617	,  8781	,  11002	,  10362	,  11001	,  1265	,  4022	,  5127	,  5136	,  5160	,  5170	,  5110	,  5131	,  5147	,  5116	,  5104	,  5557	,  5570	,  7618	,  10361	,  1145	,  1266	,  1240	,  1365	,  7038	,  2100	,  2096	,  4023	,  5575	,  9254	,  11004	,  5	,  11375	,  11123	,  1014	,  1366	,  2098	,  8503	,  8782	,  8778	,  8779	,  9255	,  9263	,  9018	,  11006	,  11374	,  1",8/5/2016,"08/05/2016",9/14/2016,"09/14/2016"," 10059	,  11346	,  11345	,  11348	,  11660	,  1194	,  11785	,  1147	,  4082	,  4083	,  4086	,  4016	,  9212	,  584	,  10317	,  10320	,  10321	,  11065	,  11347	,  11066	,  71102	,  1039	,  11764	,  1255	,  1351	,  1026	,  2075	,  2023	,  4084	,  8728	,  8727	,  8520	,  556	,  10322	,  10318	,  10324	,  590	,  1342	,  1043	,  1338	,  1349	,  11491	,  2074	,  4049	,  8736	,  8543	,  8731	,  9220	,  8519	,  10323	,  10328	,  10327	,  1343	,  1149	,  1252	,  2076	,  5547	,  7573	,  7576	,  7584	,  8735	,  8701	,  9219	,  11656	,  11669	,  11717	,  1179	,  7579	,  8739	,  8733	,  8521	,  11351	,  11676	,  8022	,  1199	,  1192	,  1353	,  5112	,  5553	,  7581	,  7582	,  10332	,  11349	,  11677	,  1200	,  7197	,  1177	,  1181	,  1183	,  1257	,  1150	,  1151	,  9223	,  9214	,  10325	,  10326	,  10331	,  11352	,  11354	,  1004	,  1178	,  1180	,  4038	,  3062	,  2080	,  9224	,  10329	,  10334	,  11355	,  11357	,  1344	,  1044	,  1040	,  1041	,  1371	,  1150	,  1258	,  4047	,  70003	,  1133	,  4095	,  4018	,  8740	,  8743	,  9221	,  10337	,  10333	,  10061	,  11356	,  1047	,  11142	,  11786	,  1256	,  1260	,  1357	,  1354	,  1176	,  1139	,  2079	,  4098	,  7587	,  8730	,  8741	,  9225	,  10338	,  10330	,  10339	,  1148	,  1152	,  2081	,  5551	,  5512	,  5513	,  8746	,  8744	,  9226	,  9231	,  11671	,  11678	,  1003	,  1005	,  1201	,  1203	,  1045	,  10086	,  8745	,  8748	,  9227	,  9230	,  9234	,  9037	,  11358	,  11359	,  1341	,  1070	,  1046	,  1356	,  70035	,  4096	,  4017	,  5559	,  7590	,  8747	,  10336	,  1204	,  1141	,  4097	,  4100	,  10341	,  9017	,  10312	,  10343	,  11360	,  11361	,  1195	,  1196	,  1207	,  1153	,  1154	,  1241	,  2028	,  1341	,  1027	,  1142	,  9007	,  9228	,  10340	,  10344	,  11362	,  11363	,  1259	,  9232	,  7589	,  7592	,  8754	,  8750	,  11365	,  11673	,  11681	,  1206	,  2018	,  11109	,  11794	,  11368	,  11369	,  11366	,  1205	,  11367	,  4107	,  9036	,  9233	.",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74396,"Ongoing","Crescent Specialty Foods Inc","12432 Highway 99","Suites 82 & 83","Everett","WA","98204-5547","United States","Voluntary: Firm Initiated","Telephone","distributed in Oregon and Washington","F-1708-2016","Class I",".","Approximately 1165/6 oz. Packages","Product has the potential to be contaminated with Salmonella.","07/18/2016",," no codes, no best by or expiration dates",6/10/2016,"06/10/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74397,"Ongoing","X Spine Systems Inc","452 Alexandersville Rd",,"Miamisburg","OH","45342-3658","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV.    Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.","Z-0125-2017","Class II","Calix P PEEK Lumbar System, PLIF Trial","1504 units","The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.","10/18/2016",," Size, 22mm x 10mm x 6mm, Part #:, X034-0970, Lot #:, 015857-6-1, 021425, 025070, 28221, 31896, 656802; Size, 22mm x 10mm x 7mm, Part #:, X034-0971, Lot #:, 015857-6-1, 021425, 025070, 28221, 31896, 656802; Size, 22mm x 10mm x 8mm, Part #:, X034-0972, Lot #:, 015857-7-1, 021426, 025071, 28224, 656803; Size, 22mm x 10mm x 9mm, Part #:, X034-0973, Lot #:, 015857-8-1, 021427, 025072, 28225, 28225R, 656804; Size, 22mm x 10mm x 10mm , Part #:, X034-0974, Lot #:, 015857-9-1, 021428, 025073, 28226, 656805; Size, 22mm x 10mm x 11mm, Part #:, X034-0975, Lot #:, 015857-10-1, 021429, 025074, 28227, 656806; Size, 22mm x 10mm x 12mm, Part #:, X034-0976, Lot #:, 015857-11-1, 021430, 025075, 28228, 656807; Size, 22mm x 10mm x 13mm, Part #:, X034-0977, Lot #:, 015857-12-1, 021432, 025076, 28229, 656808; Size, 22mm x 10mm x 14mm, Part #:, X034-0978, Lot #:, 015857-13-1,021433, 025077,125077, 28230, 656809; Size, 22mm x 10mm x 15mm, Part #:, X034-0979, Lot #:, 656810, 015857-13, 21434, 25078, 28231; Size, 22mm x 10mm x 16mm, Part #:, X034-0980, Lot #:, 015857-15-1, 015857-16-1, 021435, 021436, 025079, 28232, 656811; Size, 26mm x 10mm x 6mm, Part #:, X034-1050, Lot #:, 015857-15-1, 015857-16-1, 021435, 021436, 025079, 28232, 656811; Size, 26mm x 10mm x 8mm, Part #:, X034-1052, Lot #:, 015857-19-1, 021439, 025081, 10346, 26234, 28234, 656813, 656813R; Size, 26mm x 10mm x 9mm, Part #:, X034-1053, Lot #:, 10121, 11947; Size, 26mm x 10mm x 10mm, Part #:, X034-1054, Lot #:, 015857-20-1, 021440, 025082, 28235, 656814; Size, 26mm x 10mm x 11mm, Part #:, X034-1055, Lot #:, 10124, 11948; Size, 26mm x 10mm x 12mm, Part #:, X034-1056, Lot #:, 015857-21-1, 021441, 025083, 28236, 656815; Size, 26mm x 10mm x 13mm, Part #:, X034-1057, Lot #:, 10125, 11949 & Size, 26mm x 10mm x 14mm, Part #:, X034-1058, Lot #:, 021443, 015857-22-1, 015857-23-1, 021442, 021443, 025084, 28237, 656816.",5/17/2016,"05/17/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74397,"Ongoing","X Spine Systems Inc","452 Alexandersville Rd",,"Miamisburg","OH","45342-3658","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV.    Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.","Z-0126-2017","Class II","Calix T PEEK Lumbar System, TLIF Rasp ","195 units","The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.","10/18/2016",," Size, 28mm x 10mm x 6mm, Part #:, X034-0360, Lot #:, 23515, 23516, 24295, 24836, 24836s1, 24836S2, 657001, 760913 & Size, 28mm x 10mm x 10mm, Part #:, X034-0364, Lot #:, 23517, 23518, 24296, 24837, 657002, 760914.",5/17/2016,"05/17/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74397,"Ongoing","X Spine Systems Inc","452 Alexandersville Rd",,"Miamisburg","OH","45342-3658","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV.    Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.","Z-0127-2017","Class II","Calix T PEEK Lumbar System, TLIF Trial","1186 units","The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.","10/18/2016",," Size, 28mm x 10mm x 6mm, Part #:, X034-0340, Lot #:, 118501, 23502, 23503, 24284, 24291, 24825, 24825s1, 24825S2, 760902;  Size, 28mm x 10mm x 7mm, Part #:, X034-0341, Lot #:, 118502, 23504, 24285, 24826, 24826S1, 24826S2, 760903; Size, 28mm x 10mm x 8mm, Part #:, X034-0342, Lot #:, 118503, 23505, 24286, 24827, 24827S1, 24827S2, 760904; Size, 28mm x 10mm x 9mm, Part #:, X034-0343, Lot #:, 118504, 23506, 24287, 24828, 24828S1, 24828S2, 760905; Size, 28mm x 10mm x 10mm, Part #:, X034-0344, Lot #:, 118505, 23507, 24288, 24829, 24829S1, 24829S2, 760906; Size, 28mm x 10mm x 11mm, Part #:, X034-0345, Lot #:, 118506, 23508, 24289, 24830, 24830S1, 24830S2, 760907; Size, 28mm x 10mm x 12mm, Part #:, X034-0346, Lot #:, 118507, 23509, 24290, 24831, 24831S1, 24831s2, 760908; Size, 28mm x 10mm x 13mm, Part #:, X034-0347, Lot #:, 118508, 23510, 24291, 24832, 24832s1, 24832S2, 760909; Size, 28mm x 10mm x 14mm, Part #:, X034-0348, Lot #:, 118509, 23511, 24292, 24833, 760910; Size, 28mm x 10mm x 15mm, Part #:, X034-0349, Lot #:, 118510, 23512, 24293, 24293-R, 24834, 760911 & Size, 28mm x 10mm x 16mm, Part #:, X034-0350, Lot #:, 118511, 23513, 23514, 24294, 24835, 24835S1, 24835S2, 32513, 760912.",5/17/2016,"05/17/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74397,"Ongoing","X Spine Systems Inc","452 Alexandersville Rd",,"Miamisburg","OH","45342-3658","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV.    Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.","Z-0124-2017","Class II","Calix P PEEK Lumbar System, PLIF Rasp","182 units","The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.","10/18/2016",," Size, 22mm x 10mm x 6mm, Part #:, X034-0990, Lot #:, 015641-2-1, 015641-2-1R, 015857-24-1, 020316, 020329, 020746, 19894, UP1009, UPI002, UPI005, UPI008 & Size, 22mm x 10mm x 10mm, Part #:, X034-0994, Lot #:, 015641-3-1, 015641-3-1R,015857-25-1, 020317, 020330, 020747, UPI001, UPI004, UPI007.",5/17/2016,"05/17/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74398,"Ongoing","Taylor's Candy, Inc.","4855 W 115th St",,"Alsip","IL","60803-2864","United States","Voluntary: Firm Initiated","E-Mail","The firm shipped to 28 U. S. consignees. No foreign consignees. See attached spreadsheet in email.","F-1837-2016","Class I",". UPC code 091976440075 ","22 cases, 12 packages per case, 5.5 oz per package  ","SunOpta has expanded their voluntary recall of Sunflower Kernels due to the potential presence of Listeria monocytogenes. ","07/27/2016",," Manufacturer Date 1 1036",6/6/2016,"06/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74399,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1359-2016","Class II","Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only,  Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32","373,850 tubes","Crystallization: Product contains particulate identified to be crystallized active ingredient.","07/12/2016",," Lot #: 52610LL, Exp. 01 OCT 2016;  Lot #: 57660LL, Exp. 01 MAR 2017",6/23/2016,"06/23/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2070-2016","Class II","Nature Made(R) Super B-Complex, KEY B VITAMINS + VITAMIN C, 140 count, UPC 0-31604-02727-8          ","78642 units","Specific lots of Nature Made(R) product may have possible Staphylococcus aureus contamination. ","09/02/2016",," Lot No. 1173779, exp. JUL 2017",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2076-2016","Class II","Nature Made(R) D3 1000IU, 300 count, UPC 0-31604-02683-7  ","91329 units","Specific lots of Nature Made(R) Vitamin D tablets may exceed specifications for yeast/mold.  ","09/02/2016",," Lot Nos.:  1140172, exp. SEPT 2017; 1175637, exp. JUL 2018; 1176756, exp. JUL 2018",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2072-2016","Class II","Super B-Complex, KEY B VITAMINS + VITAMIN C, 360 count, UPC 0-31604-02729-2            ","134,028 units","Lot No. 1173146, exp. JUL 2017 of Nature Made(R) product may have possible Staphylococcus aureus contamination. Salmonella.  Lot No 1204001, exp. MAR 2018 of Nature Made(R) product may have possible contamination.","09/02/2016",," Lot Nos.:  1173146, exp. JUL 2017; 1204001, exp. MAR 2018",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2075-2016","Class II","Nature Made(R) D3 1000IU, 100 count, UPC 0-31604-01870-2    ","161507 units","Specific lots of Nature Made(R) Vitamin D tablets may exceed specifications for yeast/mold.  ","09/02/2016",," Lot Nos.:  1147550, exp. Sept 2017; 1174782,  exp. JUL 2018; 1176755, exp. JUL2018",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2066-2016","Class II","Nature Made(R) adult gummies Multi, 150 count, UPC 0-31604-04172-4  ","6132 units","Specific lots of Nature Made(R) product may have possible Salmonella contamination. ","09/02/2016",," Lot Nos.: 1196071, AUG 2017; exp. 1205052, exp. OCT 2017",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2067-2016","Class II","Nature Made(R) Multi + Omega-3, 150 count, UPC 0-31604-04173-1    ","10836 units","Specific lots of Nature Made(R) product may have possible Salmonella contamination. ","09/02/2016",," Lot No. 1173600, exp. JAN 2017",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2073-2016","Class II","Nature Made(R) adult gummies Hair.Skin.Nails, 90 count, UPC 0-31604-04016-1      ","14604 units","Specific lots of Nature Made(R) adult gummies Hair.Skin.Nails may exceed specifications total viable plate count. ","09/02/2016",," Lot No. 1198437, exp. SEPT 2017",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2074-2016","Class II","Nature Made(R) adult gummies Hair.Skin.Nails, 150 count, UPC 0-31604-04132-8-1    ","11136 units","Specific lots of Nature Made(R) adult gummies Hair.Skin.Nails may exceed specifications total viable plate count. ","09/02/2016",," Lot No. 1198438, exp. SEPT 2017",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2077-2016","Class II","Nature Made(R) D3 1000IU, 125 count, UPC 0-31604-02793-3  ","23865 units","Specific lots of Nature Made(R) Vitamin D tablets may exceed specifications for yeast/mold.  ","09/02/2016",," Lot No. 1147978, exp. SEPT 2017",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2065-2016","Class II","Nature Made(R) adult gummies Multi, 90 count, UPC 0-31604-02841-1","2076 units","Specific lots of Nature Made(R) product may have possible Salmonella contamination. ","09/02/2016",," Lot No. 1196066, exp. AUG 2017",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2068-2016","Class II","Nature Made(R) adult gummies Multi for Her plus Omega-3, 100 count, UPC 0-31604-04236-3      ","6792 units","Specific lots of Nature Made(R) product may have possible Salmonella contamination. ","09/02/2016",," Lot No. 1196048, exp. AUG 2017",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2078-2016","Class II","Nature Made(R) D3 1000IU, 350 count, UPC 0-31604-04070-3  ","30480 units","Specific lots of Nature Made(R) Vitamin D tablets may exceed specifications for yeast/mold.  ","09/02/2016",," Lot No. 1177557, exp. SEPT 2017",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2069-2016","Class II","Nature Made(R) adult gummies Multi for Her plus Omega-3, 150 count, UPC 0-31604-04275-2        ","15504 units","Specific lots of Nature Made(R) product may have possible Salmonella contamination. ","09/02/2016",," Lot No. 1196050, exp. AUG 2017  ",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74400,"Ongoing","Pharmavite","8510 Balboa Blvd Ste 100",,"Northridge","CA","91325-3581","United States","Voluntary: Firm Initiated","E-Mail","nationwide","F-2071-2016","Class II","Nature Made(R) Super B-Complex, KEY B VITAMINS + VITAMIN C, 460 count, UPC 0-31604-02728-5          ","70,540 units","Lot No. 1170987, exp. JUL 2017 of Nature Made(R) product may have possible Staphylococcus aureus contamination. Lot No1204735, exp. MAR 2018 of Nature Made(R) product may have possible Salmonella contamination. ","09/02/2016",," Lot Nos.:  1170987, exp. JUL 2017; 1204735, exp. MAR 2018",6/6/2016,"06/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74402,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Products were sold in the following states: AL, AR, CA, FL, GA, IL, IN, MS, NC, ND, NJ, NV, NY, OH, PA, SC, TN & VA.    Products were also shipped to the following countries: Albania, ALGERIA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Cape Verde, Chile, China, Colombia, Congo, Democratic, Costa Rica, Cyprus, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, India, INDONESIA, Ireland, Italy, Japan, Jordan, Latvia, Lebanon, Libyan Arab Jamahiri, Lithuania, Malawi, Mali, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Nigeria, Oman, Palestine, Paraguay, Philippines, Poland, Romania, Russia, Senegal, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Kingdom, Venezuela, Viet Nam & Zambia.","Z-2346-2016","Class II","MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.","899 units","The following issues have been found in MX 16-slice systems with software version 1.1.4.21426:    1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patients images before pasting, a previous patients images may be present in the clipboard and be copied onto the film of the current patient.      2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started.    3. If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function","08/05/2016",," Model No. 728131, S/N:   EP16E090001	EP16E090002	EP16E090003	EP16E090004	EP16E090006		EP16E090007	EP16E090008	EP16E090009	EP16E090010	EP16E090011	EP16E090012	EP16E090013	EP16E090014	EP16E090015	EP16E100001	EP16E100002	EP16E100003	EP16E100004	EP16E100005	EP16E100006	EP16E100007	EP16E100008	EP16E100009	EP16E100010	EP16E100011	EP16E100012	EP16E100013	EP16E100014	EP16E100015	EP16E100016	EP16E100017	EP16E100018	EP16E100019	EP16E100020	EP16E100021	EP16E100022	EP16E100023	EP16E100024	EP16E100025	EP16E100026	EP16E100027	EP16E100028	EP16E100029	EP16E100030	EP16E100031	EP16E100032	EP16E100033	EP16E100034	EP16E100035	EP16E100036	EP16E100037	EP16E100038	EP16E100039	EP16E100041	EP16E100042	EP16E100043	EP16E100044	EP16E100045	EP16E100046	EP16E100047	EP16E100048	EP16E100049	EP16E100050	EP16E100051	EP16E100052	EP16E100053	EP16E100054	EP16E100055	EP16E100056	EP16E100057	EP16E100058	EP16E100059	EP16E100060	EP16E100061	EP16E100062	EP16E100063	EP16E100067	EP16E100069	EP16E100070	EP16E100071	EP16E100072	EP16E100073	EP16E100074	EP16E100075	EP16E100076	EP16E100077	EP16E100078	EP16E100079	EP16E100080	EP16E100081	EP16E100082	EP16E100083	EP16E100084	EP16E100085	EP16E100086	EP16E100087	EP16E100088	EP16E100089	EP16E100090	EP16E100091	EP16E100092	EP16E100093	EP16E100094	EP16E100095	EP16E100096	EP16E100097	EP16E100098	EP16E100099	EP16E100100	EP16E100101	EP16E100102	EP16E100103	EP16E100104	EP16E100105	EP16E100106	EP16E100107	EP16E100108	EP16E100109	EP16E100110	EP16E100111	EP16E100112	EP16E100113	EP16E110001	EP16E110002	EP16E110003	EP16E110004	EP16E110005	EP16E110006	EP16E110007	EP16E110008	EP16E110009	EP16E110010	EP16E110011	EP16E110012	EP16E110013	EP16E110014	EP16E110015	EP16E110016	EP16E110017	EP16E110018	EP16E110019	EP16E110020	EP16E110021	EP16E110022	EP16E110023	EP16E110024	EP16E110025	EP16E110026	EP16E110027	EP16E110028	EP16E110029	EP16E110030	EP16E110031	EP16E110032	EP16E110033	EP16E110034	EP16E110035	EP16E110036	EP16E110037	EP16E110038	EP16E110039	EP16E110040	EP16E110041	EP16E110042	EP16E110043	EP16E110044	EP16E110045	EP16E110046	EP",4/20/2016,"04/20/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74402,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Products were sold in the following states: AL, AR, CA, FL, GA, IL, IN, MS, NC, ND, NJ, NV, NY, OH, PA, SC, TN & VA.    Products were also shipped to the following countries: Albania, ALGERIA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Cape Verde, Chile, China, Colombia, Congo, Democratic, Costa Rica, Cyprus, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, India, INDONESIA, Ireland, Italy, Japan, Jordan, Latvia, Lebanon, Libyan Arab Jamahiri, Lithuania, Malawi, Mali, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Nigeria, Oman, Palestine, Paraguay, Philippines, Poland, Romania, Russia, Senegal, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Kingdom, Venezuela, Viet Nam & Zambia.","Z-2347-2016","Class II","MX 16-slice SKD whole body computed tomography X-ray system.  Imaging diagnostic tool.","80 units","The following issues have been found in MX 16-slice systems with software version 1.1.4.21426:    1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patients images before pasting, a previous patients images may be present in the clipboard and be copied onto the film of the current patient.      2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started.    3. If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function","08/05/2016",," Model No. 728132; S/N:   EP16ER100003, EP16ER100004, EP16ER100005, EP16ER100007, EP16ER100008, EP16ER110003, EP16ER110004, EP16ER110005, EP16ER110006, EP16ER110007, EP16ER110008, EP16ER110009, EP16ER110010, EP16ER110011, EP16ER110012, EP16ER110013, EP16ER110014, EP16ER110015, EP16ER110016, EP16ER110017, EP16ER110018, EP16ER110019, EP16ER110020, EP16ER110021, EP16ER110022, EP16ER110023, EP16ER110024, EP16ER120001, EP16ER120002, EP16ER120003, EP16ER120004, EP16ER120005, EP16ER120006, EP16ER120007, EP16ER120008, EP16ER120010, EP16ER120012, EP16ER120015, EP16ER120016, EP16ER120017, EP16ER120018, EP16ER130001, EP16ER130002, EP16ER130005, EP16ER130006, EP16ER130007, EP16ER130008, EP16ER130009, EP16ER130010, EP16ER130011, EP16ER130012, EP16ER130013, EP16ER130014, EP16ER130015, EP16ER130016, EP16ER130018, EP16ER130025, EP16ER130026, EP16ER130029, EP16ER130033,  EP16ER130034, EP16EB150009 & EP16EB150014.    Model No.728135; S/N:   EP16E120009, EP16E120011, EP16E120013, EP16ER130003, EP16ER130004, EP16ER130017, EP16ER130019, EP16ER130020, EP16ER130021, EP16ER130022, EP16ER130023, EP16ER130024, EP16ER130027, EP16ER130028, EP16ER130030, EP16ER130031 & EP16ER130032.",4/20/2016,"04/20/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74403,"Ongoing","Stanmore Implants Worldwide Ltd.","210 Centennial Avenue Centennial Park","Centennial Park","Borehamwood",,,"United Kingdom","Voluntary: Firm Initiated","Letter","Directly distributed to TX, further distributed to AL and MS","Z-2553-2016","Class II","METS SMILES Total Knee Replacement","3 units","The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation.","08/17/2016",," Catalogue Numbers: mkfp/Std5 and mkfp/Std10  Batch Numbers: B4311 and B5470",5/31/2016,"05/31/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74404,"Ongoing","Martinez Imports, LLC","190 Passaic St",,"Passaic","NJ","07055-6416","United States","Voluntary: Firm Initiated","Telephone","NY","F-1671-2016","Class II","Los Mart Chicharrin Rueda, 1 lb, Packaged & Distributed by Martinez Imports, 1 Market St. Bldg. #6, Passaic, NJ 07055","14 cases total","NYSDAM sampled this product and sampling analysis revealed it contained undeclared Yellow #6.","07/18/2016",," No Codes",4/27/2016,"04/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74404,"Ongoing","Martinez Imports, LLC","190 Passaic St",,"Passaic","NJ","07055-6416","United States","Voluntary: Firm Initiated","Telephone","NY","F-1672-2016","Class II","Los Mart Chicharrin Cuadro, 1 lb., Packaged & Distributed by Martinez Imports, 1 Market St, Bldg #6, Passaic, NJ 07055","14 cases total","NYSDAM sampled this product and sampling analysis revealed it contained undeclared Yellow #6.","07/18/2016",," No Codes",4/27/2016,"04/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74404,"Ongoing","Martinez Imports, LLC","190 Passaic St",,"Passaic","NJ","07055-6416","United States","Voluntary: Firm Initiated","Telephone","NY","F-1674-2016","Class II","Los Mart Chicharrin Lagrima (Palmex Rotini), 1 lb., Package & Distributed by Martinez Imports, 1 Market St., Bldg #6, Passaic, NJ 07055","14 cases total","NYSDAM sampled this product and sampling analysis revealed it contained undeclared Yellow #6.","07/18/2016",," No Codes",4/27/2016,"04/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74404,"Ongoing","Martinez Imports, LLC","190 Passaic St",,"Passaic","NJ","07055-6416","United States","Voluntary: Firm Initiated","Telephone","NY","F-1675-2016","Class II","Botanas Los Mart Velitas Candies, 10 pieces, Packaged & Distributed by: Martinez Imports, 190 Passaic St. Passaic, NJ, UPC 1 82729302105","14 cases total","NYSDAM sampled 5 products and they were found to contain undeclared colors, Blue #1, Red #3, Red #40, Yellow #5 and Yellow #6.","07/18/2016",," No Codes",4/27/2016,"04/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74404,"Ongoing","Martinez Imports, LLC","190 Passaic St",,"Passaic","NJ","07055-6416","United States","Voluntary: Firm Initiated","Telephone","NY","F-1673-2016","Class II","Los Mart Palmex Tornillo (Wheat Flour Snack), 1 lb., Packaged & Distributed by Martinez Imports, 1 Market St., Bldg #6, Passaic, NJ 07055","14 cases total","NYSDAM sampled this product and sampling analysis revealed it contained undeclared Yellow #6.","07/18/2016",," No Codes",4/27/2016,"04/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74405,"Terminated","Michigan Blood","1036 Fuller Ave Ne","PO Box 1704","Grand Rapids","MI","49503-1304","United States","Voluntary: Firm Initiated","FAX","Michigan","B-0634-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.","07/08/2016","07/08/2016"," W120616040258; ",4/13/2016,"04/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74406,"Terminated","North Carolina Eye Bank, Inc. (The)","3900 Westpoint Blvd Ste F",,"Winston Salem","NC","27103-6798","United States","Voluntary: Firm Initiated","Telephone","South Carolina","B-0613-16","Class III","Cornea","1 human cornea","Human cornea, recovered without verifying supplies and reagents met specifications for use, and was distributed.","06/21/2016","06/21/2016"," DM03871601; ",2/18/2016,"02/18/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1733-2016","Class II","Famous Amos  Cookies Chocolate Chip, 12 ct., 12.4 oz.; and 2.7 oz. cup                                       ","24,350 cases; and 2.7 oz. cup cases: 19,141cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 7667754103, RETAIL UPC: 7667754104; CASE & Consumer Unit BIUB DATES: JAN 11 17 thru JAN 13 17     2.7 oz. cup CASE UPC: 7667710032, RETAIL UPC:7667710033;  CASE & Consumer Unit BIUB DATES: DEC 11 16; DEC 14 16 thru DEC 15 16                   ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1723-2016","Class II","Keebler Frozen Graham Snacks Cinnamon, 4 ct., 12.7 oz. ; and cups 2.2 oz. 10 ct., and cups 2.2 oz. 8 ct.        ","15,380 cases; cups 2.2 oz. 13,530 cases and 5,222 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3010010954; RETAIL UPC: 3010010955; CASE & Consumer Unit BIUB DATES: JAN 05 17;  JAN 20 17  thru JAN 21 17 ; and    CASE UPCs: 3010010947 & 3010011218; RETAIL UPC: 3010010957; CASE & Consumer Unit BIUB DATES:JAN 01 17         ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1739-2016","Class II","Keebler Gripz Chips D 325 ct Bulk, .9 oz.                                                                ","7,959 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 110055186; RETAIL UPC: 300031,   ; CASE and Consumer Unit BIUB DATE: JAN 08 17        CASE & Consumer Unit BIUB DATES: JUN 01 16                         ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1730-2016","Class II","Keebler Grahams Crackers Honey 200 CT, 2-pk, 0.49 oz., and 30 CT 5.33 oz.,10 Lb. cases                                     ","200 CT: 28,940 cases; 30 CT: 9,498 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC 2-pk 200 CT: 3010038406;   CASE UPC 30 CT: 3010020248, CASE & Consumer Unit BIUB DATES: DEC 31 16 thru JAN 02 17; and DEC 31 16 thru JAN 03 17                  ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1732-2016","Class II","Keebler Mini Sandies Shortbread cookies, 100 ct., 1.0 oz.                                       ","988 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3010073969; RETAIL UPC: 3010073970;  CASE & Consumer Unit BIUB DATES: DEC 30 16                   ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1737-2016","Class II","Keebler Animal Totes, bulk tote 400 lb.                                                       ","45 totes, 400 lb","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3010049509    CASE & Consumer Unit BIUB DATES: JUN 01 16                         ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1738-2016","Class II","Keebler 5 Flavor Mod                                                           ","26 cases ","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3010011315; CASE BIUB DATE: WJ11156A4061        CASE & Consumer Unit BIUB DATES: JUN 01 16                         ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1729-2016","Class II","Keebler Cookie Dough Minis, 150 ct., 2.5 oz.                                  ","17 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 170002873, RETAIL UPC: 3010010902, CASE & Consumer Unit BIUB DATES: Jan 02 17               ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F1734-2016","Class II","Keebler Graham Crumbs, 160 oz. , 400 oz.                                            ","2,239 cases, and 888 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," 160 oz. CASE UPC: 3010015347; and 400 oz. CASE UPC: 3010016154;  CASE & Consumer Unit BIUB DATES: DEC 31 16                       ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1726-2016","Class II","Murray Ginger Snaps Old Fashioned Ginger Cookies, 12 ct., 16 oz.                     ","24,974 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE  UPC: 8201199597; RETAIL UPC: 8201110007; CASE & Consumer Unit BIUB DATES: JAN 01 17;   JAN 04 17         ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1736-2016","Class II","Gripz Variety On the Go Pack, 14 pack, 12.6 oz.                                                   ","7,959 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3010010524, RETAIL UPC: 3010010525,    CASE & Consumer Unit BIUB DATES: DEC 09 16 thru DEC 11 16                        ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1735-2016","Class II","Premium Whole Chocolate Cremes 25 lb                                               ","10 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3010045953;   CASE & Consumer Unit BIUB DATES: JAN 01 17                         ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1725-2016","Class II","Keebler Animals Crackers; 10 ct., 2.4 oz.                 ","28,233 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3010010849, RETAIL UPC: 3010010850; CASE & Consumer Unit BIUB DATES: DEC 19 16  thru JAN 04 17      ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1722-2016","Class II","Kellogg's Special K Mini Brownies Fudge, 6 ct, 4.44 oz.     ","9,375 cases + 1,079 cases (Export)","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3800076433;EXPORT UPC: 3800012637; RETAIL UPC:  3800076434; CASE & Consumer Unit BIUB DATES: JAN 03 2017      ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1721-2016","Class II","Kellogg's Special K Mini Brownies Blondie, 6 ct, 4.44 oz.     ","26,035 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3800073818; RETAIL UPC: 3800073819; CASE & Consumer Unit BIUB DATES: JAN 01 2017 thru JAN 02 2017     ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1724-2016","Class II","Keebler E. L. Fudge Double Stuffed Sandwich Cookies, 12 ct., 12 oz.             ","38,369 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 3010019546; RETAIL UPC: 3010020363; CASE & Consumer Unit BIUB DATES: JAN 06 2017 thru JAN 08 2017     ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1728-2016","Class II","Mother's Double Chocolate Chip Minis Cookies, 12 ct., 12 oz.                         ","3,246 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASEUPC: 2780010011, RETAIL UPC: 2780010012; CASE & Consumer Unit BIUB DATES: Jan 05 17           ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1727-2016","Class II","Famous Amos Cookies Double Chocolate Chip, 12 ct., 12.4 oz.                         ","3,863 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 7667710059, RETAIL UPC: 7667710060; CASE & Consumer Unit BIUB DATES: JAN 04 17 thru Jan 05 17           ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74407,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Press Release","Domestic: AL; AR; AZ; CA; CO; CT; FL; GA; HI; IA ; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; PR, SC; SD; TN; TX; UT; VA; WA; WI; WV    Foreign: Bermuda, Singapore, Malaysia    VA/DOD: See below","F-1731-2016","Class II","Famous Amos Cookies Chocolate Chip Pecan, 12 ct., 12 .4 oz.                                       ","11,246 cases","Kellogg Company initiated a voluntary recall of multiple snack food items because of the potential for undeclared allergen peanut due to a supplier's recall of flour.","07/19/2016",," CASE UPC: 7667754105; RETAIL UPC: 7667754107  , CASE & Consumer Unit BIUB DATES: JAN 14 17                  ",6/13/2016,"06/13/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74408,"Ongoing","Dako North America Inc.","1170 Mark Ave",,"Carpinteria","CA","93013-2918","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia,  Qatar, Romania, Serbia, Sweden, and Turkey.","Z-2099-2016","Class II","Dako HER2 CISH pharmDx Kit, product code: SK 109    Product Usage:  For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.  ","31 kits","An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.","06/29/2016",," 20031683",6/10/2016,"06/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74409,"Ongoing","Simple Health LLC","1308 N Patt St",,"Anaheim","CA","92801-2551","United States","Voluntary: Firm Initiated","Press Release","US: CA, CO, FL, GA, ID, IL, IN, LA, NJ, NY, NC, NV, OR, PA, SC, TX, TN, UT, WA","F-1749-2016","Class I","Tosi Cappuccino Crunch Cashew SuperBites, 12 bars per pack, Net Wt. 2.6 ounces, UPC 755918046113","559 boxes (6708 pcs) total","Simple Health LLC is recalling Tosi Cappuccino Almond SuperBites and Tosi Cappuccino Crunch Cashew SuperBites because they have undeclared milk and soy. ","07/19/2016",," 05052016  05212016  05272016  05272016  06102016  06172016  06242016  07212016  08052016  08262016  09092016  09302016  10042016  10142016  10142016  11072016  12162016  02112017  02292017  03242017",6/10/2016,"06/10/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74409,"Ongoing","Simple Health LLC","1308 N Patt St",,"Anaheim","CA","92801-2551","United States","Voluntary: Firm Initiated","Press Release","US: CA, CO, FL, GA, ID, IL, IN, LA, NJ, NY, NC, NV, OR, PA, SC, TX, TN, UT, WA","F-1748-2016","Class I","Tosi Cappuccino Crunch Almond SuperBites, 12 bars per pack, Net Wt. 2.6 ounces, UPC 755918046106","559 boxes (6708 pcs) total","Simple Health LLC is recalling Tosi Cappuccino Almond SuperBites and Tosi Cappuccino Crunch Cashew SuperBites because they have undeclared milk and soy. ","07/19/2016",," 05052016  05212016  05272016  05272016  06102016  06172016  06242016  07212016  08052016  08262016  09092016  10042016  10142016  10142016  11072016  12162016  02112017  02292017  03242017",6/10/2016,"06/10/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74411,"Ongoing","Big L Brands Inc DBA molly&drew The Beer Bread Company","1314 Early St",,"Sac City","IA","50583-1524","United States","Voluntary: Firm Initiated","Telephone","Product was distributed one consignee in Tennessee","F-2202-2016","Class I","molly&drew The Beer Bread Company, Beer Bread Mix, NET WT. 19.75 OZ, UPC 8 55290 00300 8, molly & drew Sac City, IA. Packed in paper bags.","6000 bags","The product contains an ingredient that is being recalled by the ingredient supplier. The ingredient is potentially contaminated with E. coli O121. Recall was started on 6/14/16.","09/14/2016",," Lot # L1215A, L1215B, L1215C, BEST BY:01/2018",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74413,"Ongoing","Parker Products, Inc.","2737 Tillar St",,"Fort Worth","TX","76107-1395","United States","Voluntary: Firm Initiated","E-Mail","OH, CA","F-1764-2016","Class II","3015 Choco Praline Graham Blend Net Weight: 25 lbs/11.34 kgs","725 cases","Undeclared peanuts","07/21/2016",," Lot Number: 16123 Exp. 02/02/2017, 16140 Exp. 02/19/2017  Note: If product is not coded, beginning and ending production date of each product involved in the recall.",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74414,"Ongoing","Phibro Animal Health Corporation","300 Frank W Burr Blvd Ste 21",,"Teaneck","NJ","07666-6704","United States","Voluntary: Firm Initiated","Letter","CA and MN","V-0006-2017","Class II","Neo-Terramycin 100/100D (neomycin-oxytetracycline), Type A Medicated Article Antibiotic, Net Weight 50 lb (22.7 kg), packaged in a Multi-wall bag, Phibro Animal Health Corporation, NDC #66104-8851-0","49 bags (A40870006NK) and 55 bags (A40900007)","Out of Specification for Neo Terramycin 100/100 D Type A Medicated Article.","10/07/2016",," Lot numbers A40870006NK and A40900007NK",5/26/2016,"05/26/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74415,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to  AK,AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, and WY","Z-2214-2016","Class II","Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument  Part Number ID 03.037.017, Class I exempt   Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850; 9340629; 9351396; 9554329; 9604307; 9347642; 9428332; 9533341; 9661610; 9339162; 9439269; 9574931; 9734868; 9347641; 9485532; 9569618; 9704087; 9351397; 9485534; 9569617; 9734876; 9359540; 9494322; 9590744; 9661608; 9359339; 9501935; 9590747; 9371095; 9505477; 9604306  These devices are specific to the Trochanteric Fixation Nail Advanced (TFNA) system. The TFNA Proximal Femoral Nailing System is for the treatment of intramedullary fixation of proximal femoral fractures","2,064 units","DePuy Synthes is initiating a voluntary medical device recall due to Blade/Screw Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the TFNA aiming arm properly, which may cause surgical delay.","07/15/2016",," Catalog ID: 03.037.017  Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850; 9340629; 9351396; 9554329; 9604307; 9347642; 9428332; 9533341; 9661610; 9339162; 9439269; 9574931; 9734868; 9347641; 9485532; 9569618; 9704087; 9351397; 9485534; 9569617; 9734876; 9359540; 9494322; 9590744; 9661608; 9359339; 9501935; 9590747; 9371095; 9505477; 9604306    Manufactured Date : 30Jul2014 -01Jul2015  ",6/7/2016,"06/07/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2195-2016","Class II","Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","34 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2191-2016","Class II","Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","18 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2199-2016","Class II","Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","19 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2192-2016","Class II","Part # SD313.012,  Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg	7/18/2007-8/2/2007    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","18 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part # SD313.012,  Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg	7/18/2007-8/2/2007",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2198-2016","Class II","Part # 313.232,  2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","36 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part # 313.232,  2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2194-2016","Class II","Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","75 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2196-2016","Class II","Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg.  2/12/2002-5/23/2005    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.    		","383 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg.  2/12/2002-5/23/2005  		",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2197-2016","Class II","Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","79 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2193-2016","Class II","Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098	    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","29 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098	  ",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2189-2016","Class II","Screwdriver Blade, Handle, Drill Bit,  Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short	Lot # 5053859    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","50 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part Number: 313.945, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short, Lot # 5053859, mfg. 7/28/2005, No Expiration Date product provided  Non Sterile",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74416,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.","Z-2190-2016","Class II","Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005    Product Usage:  The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.  ","26 units","DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.  ","07/12/2016",," Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005",5/31/2016,"05/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2170-2016","Class II","COMBOS SNACKS PIZZERIA PRETZEL - 15 OZ -Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419780473","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 613FBALB01  613FCALB01      Best before 4/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2173-2016","Class II","COMBOS SWEET AND SALTY CARAMEL CREME PRETZEL Net Wt. 6.0 oz (170.1g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA   UPC 41419780879","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 613GBALB01  613GCALB01    best by 4/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2174-2016","Class II","COMBOS SNACKS PIZZERIA PRETZEL Net Wt. 1.80 oz. (51 g)   Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA   UPC 41419714751","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 613FBALB01  613FCALB01  613GAALB01  614DCALB01      best by 4/1/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2171-2016","Class II","COMBOS SNACKS CHEDDAR CHEESE PRETZEL - 15 OZ -  Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA  UPC 41419780480","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 613EAALB01  613EBALB01  614FAALB01  614FBALB01    3/2017  4/2017      Best before 4/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2179-2016","Class II","COMBOS PIZZERIA PRETZEL - Net Wt. 1.80 OZ (51 g)   Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA  UPC 41419714751","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 613GAALB01  613GBALB01  614DCALB01  614EAALB01  614EBALB01  614ECALB01          best by 4/1/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2168-2016","Class II","COMBOS PEPPERONI CRACKER - Net Wt. 1.70 oz. (48.2 g)  Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA   UPC 41419420089","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 614BAALB01  614BBALB01  614BCALB01  614CAALB01        Best before 4/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2166-2016","Class II","COMBOS PIZZERIA PRETZEL - Net Wt. 6.30 Oz. (178.6 g)  Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA  UPC 41419420065","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 613FBALB01  613FCALB01  613GAALB01  613GBALB01  614DCALB01  614EAALB01  614EBALB01  614ECALB01      Best before 4/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2165-2016","Class II","COMBOS CHEDDAR CHEESE PRETZEL Net Wt. 6.30 oz (178.6 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA   UPC 41419420058","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 613EAALB01  613EBALB01  613ECALB01  613FAALB01  613FBALB01  614FAALB01  614FBALB01  614FCALB01      Best before 3/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2176-2016","Class II","COMBOS SNACKS CHEDDAR CHEESE PRETZEL - Net Wt. 1.80 OZ (51 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA 41419714713","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 613ECALB01  613FAALB01  613FBALB01  614FAALB01  614FBALB01  614FCALB01        best by 4/1/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2167-2016","Class II","COMBOS CHEDDAR CHEESE CRACKER - Net Wt. 6.30 oz (178.6 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC  USPC 41419420072","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 614AAALB01  614ABALB01  614ACALB01  614BAALB01        Best before 4/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2180-2016","Class II","COMBOS SNACKS CHEDDAR CHEESE PRETZEL - Net Wt.  1.70 OZ (51 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA  UPC 41419714744","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 614AAALB01  614ABALB01  614ACALB01  614BAALB01      best by 4/1/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2177-2016","Class II","COMBOS PEPPERONI PIZZA CRACKER - Net Wt. 1.70 OZ (48.2 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA   UPC 41419714737","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 614BAALB01  614BBALB01  614BCALB01        best by 4/1/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2175-2016","Class II","COMBOS  SNACK BUFFALO BLUE CHEESE PRETZEL - Net Wt. 1.80 (51 g)  oz  Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA   UPC 41419474303","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 614CAALB01  614CBALB01  614CCALB01  614DAALB01        best by 4/1/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2172-2016","Class II","COMBOS SNACKS CHEDDAR CHEESE CRACKER - 15 OZ   Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA  UPC 41419780497","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 614AAALB01  614ABALB01  614ACALB01    4/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2178-2016","Class II","COMBOS SNACKS CHEDDAR CHEESE CRACKER - Net. Wt. 1.70 oz (48.2g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA   UPC 41419714744","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 614AAALB01  614ABALB01  614ACALB01  614BAALB01        best by 4/1/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74417,"Ongoing","Mars Chocolate North America","700 High St",,"Hackettstown","NJ","07840-1502","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide; Foreign","F-2169-2016","Class II","COMBOS BUFFALO BLUE CHEESE PRETZEL Net Wt.6.30 oz (178.6 g)Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA   UPC 4141420119","183,678 cases (total)","Mars Chocolate North America is recalling select Combos due to the potential for undeclared peanut residue.","09/15/2016",," 614CAALB01  614CBALB01  614CCALB01  614DAALB01  614DBALB01        Best before 4/2017",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74418,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","USA Distribution to the states of : AK,AL,AR,AZ,CA,CH,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,ON,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI, & WV","Z-2138-2016","Class II","Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue","6,255  units ","DePuy Synthes is voluntarily initiating a recall  due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.  ","07/07/2016","."," Lot Numbers: 1749148, 1896349, 3057585, 3126474, 3277587, 3527962, 3666979, 3723149, 3754359, 3754360, 3800237, 3800239, 3825498, 4182364, 4182365, 4184238, 4184239, 4184240, 4184241, 4186156, 4186158, 4186159, 4201866, 4201867, 4201868, 4205288, 4872583, 4894156, 4894157, 4931671, 4931672, 4931673, 4952212, 4992237, 4992836, 5004334, 5083067, 5106349, 5115240, 5115241, 5127039, 5153048, 5153049, 5328496, 5337095, 5339819, 5344347, 5369177, 5391267, 5404749, 5450581, 5485082, 5510560, 5510561, 5510562, 5510563, 5510564, 5510565, 5583188, 7554579, 7554580, 7559611, 7559614, 7571578, 7571579, 7580696, 7583500, 7596250, 7780217, 7784418, 7784419, 7875460, 7923388, 7949747, 7992504, 8024598, 8060315. 8155523, 8203696, 8226175, 8238466, 8292917,8312365,8348012,8377148,8504955,8612171,8688476,8701156,8711152,8743078,8743084  8756426, 8756427, 8834945,8840904,8948836,8948838,9079710,9079712,9079716,9172619,9172621,9237247  9361663, 9361665, 9432606, 9432608, 9494467, 9494469, 9608863, 9647283, 9665152, 9671639, 9715870, 9720837, 9720840, 9783567, 9783570,. 9788216, 9801777, 9810012, 9823178, 9829378, 9836403, 9836404, 9836405, 9896775, 9913152  Part Numbers: 482.823, Device Listing Number: D194880",5/31/2016,"05/31/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74419,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.","Z-2582-2016","Class II","TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. ","182 units","DePuy Synthes is voluntarily initiating a recall  due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.  ","08/17/2016",," Part #487.963, Lot # A4JX956; 4038561; 4091230; 4281408; 4294703; 4454536; 4475459; 5041111; 5041112; 5414450; 5414451; 5505099; 5505140; 5621104; 5621108; 5621109; 5621110; 6291848; 6879052; 7626782; 7865438; 9890200; mfg. 09JUN1999 -26APR2016, Exp.  22MAR2020-26APR2036",5/23/2016,"05/23/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74419,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.","Z-2585-2016","Class II","TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. ","274 units","DePuy Synthes is voluntarily initiating a recall  due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.  ","08/17/2016",," Part # 487.974, Lot# A4JY041; 3949739; 4038565; 4044599; 4091233; 4600267; 4744818; 4745317; 4873173; 4873174; 5202231; 5202232; 5202233; 5202234; 5298113; 5304974; 5354033; 5469087; 5820678; 5860826; 6044556; 6199927; 6778533; 6877042; 6983832; 7492522; 7880980; 7931712; 9885355, mfg. date 11JUN1999 -21DEC2015, exp. date 20JUL2019-21DEC2035",5/23/2016,"05/23/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74419,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.","Z-2586-2016","Class II","TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. ","599 units","DePuy Synthes is voluntarily initiating a recall  due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.  ","08/17/2016",," Part #487.975, Lot# A4JV281; 3959732; 3959733; 4038566; 4044600; 4095085; 4418691; 4479352; 4597089; 4767010; 4851967; 4851968; 5277361; 5346057; 5419963; 5433149; 5445352; 5445632; 5445638; 5785469; 5785471; 5828442; 5828447; 5847302; 5847357; 5883452; 6107608; 6107609; 6107614; 6107615; 6141641; 6141642; 6164420; 6164421; 6819614; 7489031; 7537257; 7865426; 7935481; A4JY058, mfg. date 14MAY1999 - 22APR2015, exp. date 06OCT2019-22APR2035",5/23/2016,"05/23/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74419,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.","Z-2581-2016","Class II","TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. ","90 units","DePuy Synthes is voluntarily initiating a recall  due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.  ","08/17/2016",," Part # 487.962,  Lot # A4JY080; 4042146; 4042147; 4365410; 4548558; 4664392; 5041113; 5041114; 5041162; 5071337; 5229307; 5414447; 5414448; 5414449; 5422905; 5621082; 5621083; 5621088; 5696010; 6164423; 6164425; 6164555; 6171239; 6171240; 6397761; 7537258; 7927945, mfg date 09JUN1999 -30JUN2015, exp date 22MAR2020-30JUN2035",5/23/2016,"05/23/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74419,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.","Z-2584-2016","Class II","TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. ","259 units","DePuy Synthes is voluntarily initiating a recall  due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.  ","08/17/2016",," Part # 487.965,  Lot # A4JV312; 3959731; 3988317; 4038563; 4091229; 4095071; 4375627; 4375628; 4375629; 4407383; 4420112; 4435710; 4664397; 4664398; 4746860; 5021031; 5143278; 5175697; 5282148; 5321401; 5321402; 5321404; 5332086; 5332087; 5391281; 5391293; 5505151; 5505153; 5559857; 5559858; 5559859; 5621131; 5621132; 5621145; 5621150; 5621166; 5841367; 5857578; 5859707; 5859708; 5859710; 5859711; 6130707; 6130708; 6287524; 6287525; 6538904; 6551654; 6720329; 7458399; 7865439; 9916673; A4JX605, mfg. date 14MAY1999 - 27APR2016, exp. date 24SEP2019-27APR2036",5/23/2016,"05/23/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74419,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.","Z-2583-2016","Class II","TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. ","413 units","DePuy Synthes is voluntarily initiating a recall  due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.  ","08/17/2016",," Part #487.964, Lot # A4JV280; 4038562; 4091232; 4095219; 4454474; 4485940; 4538241; 5021030; 5041163; 5051836; 5140379; 5175699; 5292906; 5321397; 5321398; 5321399; 5332085; 5391292; 5505143; 5505144; 5505147; 5559642; 5559649; 5559854; 5559855; 5559856; 5621111; 5621115; 5621126; 5621127; 5621128; 5621130; 5868674; 6250788; 6250789; 6250793; 6397763; 6538895; 6551653; 6720328; 6932326; 7489023; 7489024; 7609552; A4JY067, Mfg date 17MAY1999 - 04SEP2014, Exp. date 22MAR2020-04SEP2034",5/23/2016,"05/23/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74420,"Ongoing","Frito-Lay, Inc","7701 Legacy Dr",,"Plano","TX","75024-4099","United States","Voluntary: Firm Initiated","Press Release","GA, KY, NC, SC, TN, VA, WV","F-1842-2016","Class I","Doritos Spicy Sweet Chili Flavored tortilla chips in 3 1/8 ounce bags","1656 packages","Undeclared Milk","07/28/2016",," Guaranteed Fresh Date: August 9, UPC code: 28400-42119, Manufacturing Code: 2711 152 05, 2712 152 05",6/15/2016,"06/15/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74421,"Terminated","Van Vogt Creations","50 Hutchens Hill Rd",,"Pomeroy","WA","99347-9655","United States","Voluntary: Firm Initiated","Other","Firm's retail store located in WA","F-2201-2016","Class II","Mill House Salad Dressing & Gourmet Sauce 12 FL OZ Plastic Bottles    Ingredients: canola oil, garlic, lemon juice, water, salt, pepper."," 26 - 12 fl. oz. bottles","Van Vogt Creations is recalling Mill House Salad Dressing & Gourmet Sauce due to undeclared sulfites.","09/14/2016","09/14/2016"," 0416161 Best By: 4/16/17",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74422,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Distributed to: CA,NY,TX,OH,CO,NY,TX,CA,NE,NJ,TX,FL,IL,TX,MO,CA,PA,FL,NJ,MO,ND","Z-2107-2016","Class II","SYNGO Breast Care,  visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.","29 units","Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior:   1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to read.  2) The facility name and address are not shown per default (in the current software versions this information is displayed only when the reader chooses an appropriate image text display mode).  ","06/30/2016",," Device Model # 10496180    Serial Numbers: 221176,130159,130773,100641,100642,100643,100644,100645,100811,100812,100813,100814,221129,130326,221192,130201,220930,130438,102113,130635,130377,130125,130546,130322,101309,101503,220743,102013,130575",6/6/2016,"06/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74423,"Ongoing","Prinston Pharmaceutical Inc","2002 Eastpark Blvd",,"Cranbury","NJ","08512-3514","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1049-2016","Class III","Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ  08512, NDC 43547-331-09.","60 bottles (5 cases)","Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.","06/23/2016",," Lot #: 327B16002, Exp 12/17",5/30/2016,"05/30/2016",6/29/2016,"06/29/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2176-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 3MM X 6CM  MODEL Number:M0035443060      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035443060:    Lot Number/Expiration Date:  18826753	31-Jan-19  18826606	31-Jan-19  18794421	31-Jan-19  18777349	31-Dec-18  18750808	31-Dec-18  18754448	31-Dec-18  18760112	31-Dec-18  18491003	31-Jul-18  18443198	30-Jun-18  18827047	31-Jan-19  18816704	31-Jan-19  18776301	31-Dec-18  18750603	31-Dec-18  18491065	31-Jul-18  18442058	30-Jun-18  18808498	31-Jan-19  18783540	31-Jan-19  18764659	31-Dec-18  18750193	31-Dec-18  18708724	30-Nov-18  18491096	31-Jul-18  18443258	30-Jun-18  18443228	30-Jun-18  18393950	31-May-18  18817367	31-Jan-19  18782584	31-Jan-19  18755514	31-Dec-18  18703469	30-Nov-18  18443018	30-Jun-18  18442958	30-Jun-18  18442538	30-Jun-18  18441728	30-Jun-18  18436622	30-Jun-18  18827341	31-Jan-19  18809086	31-Jan-19  18809674	31-Jan-19  18765615	31-Dec-18  18750398	31-Dec-18  18471007	31-Jul-18  18490724	31-Jul-18  18818030	31-Jan-19  18760113	31-Dec-18  18708786	30-Nov-18  18490972	31-Jul-18  18442508	30-Jun-18  18442268	30-Jun-18  18827194	31-Jan-19  18703264	30-Nov-18  18490910	31-Jul-18  18442568	30-Jun-18  18827488	31-Jan-19  18826900	31-Jan-19  18808792	31-Jan-19  18443048	30-Jun-18  19013252	30-Apr-19  19000510	30-Apr-19  18951824	31-Mar-19  18853836	28-Feb-19  19028176	30-Apr-19  18990655	30-Apr-19  19041022	31-May-19  19040295	31-May-19  19000572	30-Apr-19  18960708	31-Mar-19  18902391	28-Feb-19  19013163	30-Apr-19  19066272	31-May-19  19063700	31-May-19  18975258	30-Apr-19  18974821	30-Apr-19  18905927	31-Mar-19  19028296	30-Apr-19  19013074	30-Apr-19  18952060	31-Mar-19  18951116	31-Mar-19  18905896	28-Feb-19  18901749	28-Feb-19  18990624	30-Apr-19  18952296	31-Mar-19  19028056	30-Apr-19  19012985	30-Apr-19  18975695	30-Apr-19  18943458	31-Mar-19  18926529	31-Mar-19  18903033	28-Feb-19  19027936	30-Apr-19  19039567	31-May-19  19000541	30-Apr-19  18960301	31-Mar-19  18951588	31-Mar-19  18943981	31-Mar-19  18883033	28-Feb-19  18925429	31-Mar-19  18944504	31-Mar-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2168-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 1.5 MM X 1 CM  MODEL Number:M0035431510    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035431510;    Lot Number/Expiration Date:  18581295	30-Sep-18  18800256	31-Jan-19  18775373	31-Dec-18  18744204	30-Nov-18  18812788	31-Jan-19  18607578	30-Sep-18  18602655	30-Sep-18  19003141	30-Apr-19  18935435	31-Mar-19  18923481	31-Mar-19  18953907	31-Mar-19  18883412	28-Feb-19  18852906	28-Feb-19  19056331	31-May-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2172-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 2MM X 3CM  MODEL Number:M0035442030      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035442030:    Lot Number/Expiration Date:  18824618	31-Jan-19  18789433	31-Jan-19  18789313	31-Jan-19  18567759	31-Aug-18  18809910	31-Jan-19  18758958	31-Dec-18  18727834	30-Nov-18  18643654	31-Oct-18  18583601	31-Aug-18  18516768	31-Jul-18  18440858	30-Jun-18  18824978	31-Jan-19  18770574	31-Dec-18  18679027	30-Nov-18  18654466	31-Oct-18  18554671	31-Aug-18  18727594	30-Nov-18  18702335	30-Nov-18  18679058	30-Nov-18  18554733	31-Aug-18  18583632	30-Sep-18  18824858	31-Jan-19  18816099	31-Jan-19  18789193	31-Jan-19  18770164	31-Dec-18  18721125	30-Nov-18  18667475	31-Oct-18  18470167	31-Jul-18  18440828	30-Jun-18  18770369	31-Dec-18  18758838	31-Dec-18  18740007	31-Dec-18  18654404	31-Oct-18  18515390	31-Jul-18  18824738	31-Jan-19  18789553	31-Jan-19  18727714	30-Nov-18  18567790	31-Aug-18  18489524	31-Jul-18  18462508	30-Jun-18  18434346	30-Jun-18  18810270	31-Jan-19  18810150	31-Jan-19  18810030	31-Jan-19  18816010	31-Jan-19  18740154	31-Dec-18  18715530	30-Nov-18  18702304	30-Nov-18  18654497	31-Oct-18  18437093	30-Jun-18  18437033	30-Jun-18  18992597	30-Apr-19  19071307	31-May-19  18946838	31-Mar-19  18897907	28-Feb-19  18869664	28-Feb-19  18847712	31-Jan-19  18992628	30-Apr-19  19045040	31-May-19  19044951	31-May-19  19071071	31-May-19  19014571	30-Apr-19  18933425	31-Mar-19  18933692	31-Mar-19  18947016	31-Mar-19  18897814	28-Feb-19  18869810	28-Feb-19  18881694	28-Feb-19  19054629	31-May-19  19054753	31-May-19  19014726	30-Apr-19  18869869	31-Mar-19  18881787	28-Feb-19  18848068	31-Jan-19  19044862	31-May-19  19014602	30-Apr-19  18976136	30-Apr-19  18961238	31-Mar-19  18911301	28-Feb-19  18933603	31-Mar-19  19045129	31-May-19  19014664	30-Apr-19  18961118	31-Mar-19  18947105	31-Mar-19  18946927	31-Mar-19  18897876	28-Feb-19  18869748	28-Feb-19  18881725	28-Feb-19  18992659	30-Apr-19  19054691	31-May-19  19030837	30-Apr-19  19054815	31-May-19  19065247	31-May-19  19071543	31-May-19  19014633	30-Apr-19  18976225	30-Apr-19  18976047	30-Apr-19  18911332	28-Feb-19  18869954	28-Feb-19  18881",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2173-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 2MM X 4CM  MODEL Number:M0035442040      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035442040:    Lot Number/Expiration Date:  18824889	31-Jan-19  18789584	31-Jan-19  18715147	30-Nov-18  18654621	31-Oct-18  18583663	31-Aug-18  18779217	31-Dec-18  18771773	31-Dec-18  18758989	31-Dec-18  18715561	30-Nov-18  18567945	31-Aug-18  18583694	30-Sep-18  18489927	31-Jul-18  18456251	30-Jun-18  18456101	30-Jun-18  18779279	31-Dec-18  18789344	31-Jan-19  18771711	31-Dec-18  18715383	30-Nov-18  18679151	30-Nov-18  18568131	31-Aug-18  18470407	30-Jun-18  18818239	31-Jan-19  18810301	31-Jan-19  18721156	30-Nov-18  18702459	30-Nov-18  18521395	31-Jul-18  18824769	31-Jan-19  18779248	31-Dec-18  18702490	30-Nov-18  18654590	31-Oct-18  18436562	30-Jun-18  18825009	31-Jan-19  18818208	31-Jan-19  18810061	31-Jan-19  18702552	30-Nov-18  18741929	30-Nov-18  18667537	31-Oct-18  18567883	31-Aug-18  18456191	30-Jun-18  18440768	30-Jun-18  18824649	31-Jan-19  18810181	31-Jan-19  18809941	31-Jan-19  18758869	31-Dec-18  18741991	30-Nov-18  18741898	30-Nov-18  18568007	31-Aug-18  18470287	30-Jun-18  18440708	30-Jun-18  18393710	31-May-18  18818177	31-Jan-19  18789464	31-Jan-19  18759109	31-Dec-18  18727865	30-Nov-18  18727745	30-Nov-18  18727625	30-Nov-18  18679089	30-Nov-18  18679120	30-Nov-18  18654528	31-Oct-18  18643778	31-Oct-18  18567914	31-Aug-18  18583725	30-Sep-18  18489834	31-Jul-18  19029955	30-Apr-19  19054722	31-May-19  19029924	30-Apr-19  19045373	31-May-19  19045249	31-May-19  19014943	30-Apr-19  18881427	28-Feb-19  18881017	28-Feb-19  18990009	30-Apr-19  19014850	30-Apr-19  18950447	31-Mar-19  18881632	28-Feb-19  18932694	31-Mar-19  18946218	31-Mar-19  19054784	31-May-19  19045404	31-May-19  19065216	31-May-19  18977548	30-Apr-19  18977459	30-Apr-19  18977370	30-Apr-19  18932725	31-Mar-19  19054660	31-May-19  19014757	30-Apr-19  18896432	28-Feb-19  18847681	31-Jan-19  19071276	31-May-19  19071040	31-May-19  19071512	31-May-19  19014881	30-Apr-19  19014819	30-Apr-19  18961269	31-Mar-19  18950385	31-Mar-19  19045342	31-May-19  18932663	31-Mar-19  18932632	31-Mar-19  18896699	28-Feb-19  18896",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2164-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 1.5 MM X 4 CM  MODEL Number:M0035421540    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035421540    Lot Number/Expiration Date:  18808912	31-Jan-19  18741434	31-Dec-18  18714072	30-Nov-18  18677229	30-Nov-18  18625483	31-Oct-18  18625541	31-Oct-18  18642784	31-Oct-18  18633921	31-Oct-18  18598299	30-Sep-18  18590470	30-Sep-18  18542363	31-Aug-18  18420011	31-May-18  18419897	31-May-18  18833256	28-Feb-19  18808618	31-Jan-19  18787244	31-Jan-19  18677171	30-Nov-18  18524564	31-Jul-18  18524622	31-Jul-18  18832645	31-Jan-19  18768683	31-Dec-18  18756119	31-Dec-18  18725503	30-Nov-18  18666721	31-Oct-18  18642842	31-Oct-18  18642668	31-Oct-18  18598183	30-Sep-18  18590528	30-Sep-18  18578953	30-Sep-18  18406806	31-May-18  18809794	31-Jan-19  18787859	31-Jan-19  18755053	31-Dec-18  18741144	31-Dec-18  18701144	30-Nov-18  18590586	30-Sep-18  18579069	30-Sep-18  18549270	31-Aug-18  18420182	31-May-18  18420239	31-May-18  18809206	31-Jan-19  18817972	28-Feb-19  18701318	30-Nov-18  18677113	30-Nov-18  18488340	31-Jul-18  18598125	30-Sep-18  18542305	31-Aug-18  18787449	31-Jan-19  18714246	30-Nov-18  18625599	31-Oct-18  18634037	31-Oct-18  18598241	30-Sep-18  18559192	31-Aug-18  18832034	31-Jan-19  18817309	28-Feb-19  18787654	31-Jan-19  18768041	31-Dec-18  18701260	30-Nov-18  18809500	31-Jan-19  18701202	30-Nov-18  18677287	30-Nov-18  18642726	31-Oct-18  18590412	30-Sep-18  18559250	31-Aug-18  19080127	31-May-19  19010580	30-Apr-19  18931017	31-Mar-19  18885811	28-Feb-19  18846227	28-Feb-19  19026877	30-Apr-19  19025829	30-Apr-19  19043083	31-May-19  18974705	30-Apr-19  18957691	31-Mar-19  18911592	31-Mar-19  18845848	28-Feb-19  19049933	31-May-19  18998580	30-Apr-19  18853712	28-Feb-19  18887225	28-Feb-19  19080305	31-May-19  19026353	30-Apr-19  18998638	30-Apr-19  18975142	30-Apr-19  18956531	31-Mar-19  19079949	31-May-19  18964774	31-Mar-19  19042039	30-Apr-19  19010180	30-Apr-19  18963382	31-Mar-19  18912801	31-Mar-19  18911995	31-Mar-19  18846606	28-Feb-19  18963846	31-Mar-19  18930672	31-Mar-19  18899164	28-Feb-19  18912398	31-Mar-19  18974268	30-Apr-19  18987031	30-Apr-19  190509",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2165-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 1 MM X 1 CM  MODEL Number:M0035431010    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035431010      Lot Number/Expiration Date:  18784731	31-Jan-19  18767279	31-Dec-18  18685490	30-Nov-18  18592036	30-Sep-18  18818328	31-Jan-19  18723284	30-Nov-18  18630215	31-Oct-18  18601959	30-Sep-18  18414374	31-May-18  18748453	31-Dec-18  18730570	30-Nov-18  18606940	30-Sep-18  18403443	31-May-18  18818502	31-Jan-19  18796245	31-Jan-19  18627513	31-Oct-18  18601901	30-Sep-18  18581353	30-Sep-18  18484777	31-Jul-18  18818676	31-Jan-19  18777759	31-Dec-18  18484661	31-Jul-18  18429414	30-Jun-18  18801963	31-Jan-19  18803278	31-Jan-19  18786355	31-Jan-19  18776711	31-Dec-18  18767778	31-Dec-18  18723052	30-Nov-18  18539797	31-Aug-18  18417674	31-May-18  18831860	31-Jan-19  18818850	31-Jan-19  18739085	30-Nov-18  18833082	31-Jan-19  18748163	31-Dec-18  18738163	30-Nov-18  18602017	30-Sep-18  18581469	31-Aug-18  18543905	31-Aug-18  18450658	30-Jun-18  19002735	30-Apr-19  18941882	31-Mar-19  18941418	31-Mar-19  18930269	31-Mar-19  18894264	28-Feb-19  18893885	28-Feb-19  18885637	28-Feb-19  18957343	31-Mar-19  18956763	31-Mar-19  18940954	31-Mar-19  18857373	28-Feb-19  18975521	30-Apr-19  18975084	30-Apr-19  18847507	28-Feb-19  18930614	31-Mar-19  18847275	31-Jan-19  19002909	30-Apr-19  18929924	31-Mar-19  18847333	31-Jan-19  19062880	31-May-19  19002851	30-Apr-19  19002677	30-Apr-19  18974210	30-Apr-19  18930959	31-Mar-19  18906932	31-Mar-19  19046992	31-May-19  19002793	30-Apr-19  18893506	28-Feb-19  18887051	28-Feb-19  18847391	28-Feb-19  18984787	30-Apr-19  19037618	31-May-19  19064752	31-May-19  18894643	28-Feb-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2181-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 2MM X 6CM  MODEL Number:M0035452060            Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035452060;    Lot Number/Expiration Date:  18777380	31-Dec-18  18538894	31-Aug-18  18726354	30-Nov-18  18830541	31-Jan-19  18802659	31-Jan-19  18776332	31-Dec-18  18499021	31-Jul-18  18743910	30-Nov-18  18725944	30-Nov-18  18454649	30-Jun-18  18794568	31-Jan-19  18538832	31-Aug-18  18829512	31-Jan-19  18801344	31-Jan-19  18709049	30-Nov-18  18693095	30-Nov-18  18499207	31-Jul-18  19032899	30-Apr-19  19047487	31-May-19  18852469	28-Feb-19  18954631	31-Mar-19  18906669	28-Feb-19  18877336	28-Feb-19  19037939	31-May-19  18973118	30-Apr-19  18899998	28-Feb-19  18900840	28-Feb-19  19046456	31-May-19  18972772	30-Apr-19  18955537	31-Mar-19  19005724	30-Apr-19  18935230	31-Mar-19  18925282	31-Mar-19  18876468	28-Feb-19  19032992	30-Apr-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2167-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 1 MM X 3 CM  MODEL Number:M0035431030        Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035431030;    Lot Number/Expiration Date:  18801491	31-Jan-19  18757273	31-Dec-18  18709428	30-Nov-18  18602133	30-Sep-18  18523870	31-Jul-18  18802806	31-Jan-19  18664601	31-Oct-18  18569137	31-Aug-18  18517839	31-Jul-18  18486090	31-Jul-18  18842022	31-Jan-19  18651923	31-Oct-18  18651865	31-Oct-18  18607288	30-Sep-18  18518071	31-Jul-18  18774611	31-Dec-18  18762227	31-Dec-18  18637042	31-Oct-18  18564861	31-Aug-18  18843756	28-Feb-19  18842889	31-Jan-19  18781019	31-Jan-19  18651981	31-Oct-18  18546861	31-Aug-18  18447942	30-Jun-18  18830688	31-Jan-19  18815198	31-Jan-19  18814328	31-Jan-19  18736978	30-Nov-18  18592210	30-Sep-18  18517955	31-Jul-18  18414488	31-May-18  18829659	31-Jan-19  18583312	31-Aug-18  18984903	30-Apr-19  19050397	31-May-19  18883354	28-Feb-19  18911821	31-Mar-19  19041285	30-Apr-19  18944244	31-Mar-19  18922785	31-Mar-19  18902333	28-Feb-19  18911418	31-Mar-19  18857263	28-Feb-19  18973207	30-Apr-19  19041807	30-Apr-19  19065916	31-May-19  19063344	31-May-19  18901691	28-Feb-19  19074243	31-May-19  19049355	31-May-19  19042329	31-May-19  19005113	30-Apr-19  18944767	31-Mar-19  18973553	30-Apr-19  18943198	31-Mar-19  18943721	31-Mar-19  19042851	31-May-19  18855184	28-Feb-19  19048313	31-May-19  18972861	30-Apr-19  18953849	31-Mar-19  18912224	31-Mar-19  19005171	30-Apr-19  18902975	28-Feb-19  18912627	31-Mar-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2169-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 1.5 MM X 2 CM  MODEL Number:M0035431520      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035431520:    Lot Number/Expiration Date:  18784673	31-Jan-19  18723226	30-Nov-18  18686302	30-Nov-18  18637332	31-Oct-18  18627687	31-Oct-18  18569824	31-Aug-18  18453278	30-Jun-18  18391505	31-May-18  18769932	31-Dec-18  18735994	30-Nov-18  18710356	30-Nov-18  18652851	31-Oct-18  18801847	31-Jan-19  18755945	31-Dec-18  18602481	30-Sep-18  18832966	28-Feb-19  18843005	28-Feb-19  18630099	31-Oct-18  18510994	31-Jul-18  18495363	31-Jul-18  18484141	31-Jul-18  18803162	31-Jan-19  18786297	31-Jan-19  18754879	31-Dec-18  18734778	30-Nov-18  18602423	30-Sep-18  18585290	31-Aug-18  18450430	30-Jun-18  18769816	31-Dec-18  18785485	31-Jan-19  18637274	31-Oct-18  18511110	31-Jul-18  18465901	30-Jun-18  18769700	31-Dec-18  18746995	31-Dec-18  18725103	30-Nov-18  18694228	30-Nov-18  18686012	30-Nov-18  18665561	31-Oct-18  18607752	30-Sep-18  18449575	30-Jun-18  18832355	28-Feb-19  18831744	31-Jan-19  18842138	28-Feb-19  18732878	30-Nov-18  18637216	31-Oct-18  18584252	31-Aug-18  18569882	31-Aug-18  18569766	31-Aug-18  18523410	31-Jul-18  19033487	30-Apr-19  18984845	30-Apr-19  18972140	30-Apr-19  18861952	28-Feb-19  18878607	28-Feb-19  19063170	31-May-19  18923191	31-Mar-19  18897527	28-Feb-19  18897185	28-Feb-19  18910290	31-Mar-19  19032199	30-Apr-19  19002213	30-Apr-19  19002155	30-Apr-19  18950942	31-Mar-19  18897698	28-Feb-19  18858983	28-Feb-19  19031329	30-Apr-19  19031909	30-Apr-19  19002271	30-Apr-19  18951058	31-Mar-19  18950884	31-Mar-19  18896843	28-Feb-19  18897014	28-Feb-19  18879010	28-Feb-19  18909942	31-Mar-19  18910638	31-Mar-19  18843872	28-Feb-19  19031619	30-Apr-19  19002329	30-Apr-19  18878204	28-Feb-19  18886556	28-Feb-19  18938172	31-Mar-19  18939594	31-Mar-19  18951000	31-Mar-19  18897356	28-Feb-19  18885142	28-Feb-19  18971589	30-Apr-19  18950826	31-Mar-19  18860449	28-Feb-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2160-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 1 MM X 2 CM  MODEL Number: M0035421020    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035421020:  Lot Number/Expiration Date:  18825272	31-Jan-19  18811666	31-Jan-19  18819711	31-Jan-19  18790659	31-Jan-19  18701550	30-Nov-18  18628881	31-Oct-18  18598937	30-Sep-18  18562915	31-Aug-18  18582507	30-Sep-18  18582275	31-Aug-18  18819885	31-Jan-19  18811840	31-Jan-19  18742370	30-Nov-18  18714594	30-Nov-18  18723922	30-Nov-18  18701782	30-Nov-18  18701608	30-Nov-18  18677925	30-Nov-18  18657200	31-Oct-18  18667185	31-Oct-18  18667069	31-Oct-18  18647521	31-Oct-18  18599227	30-Sep-18  18582565	30-Sep-18  18553961	31-Aug-18  18790775	31-Jan-19  18790543	31-Jan-19  18742602	31-Dec-18  18647347	31-Oct-18  18604218	30-Sep-18  18585521	31-Aug-18  18515100	31-Jul-18  18825330	31-Jan-19  18790717	31-Jan-19  18723864	30-Nov-18  18742428	31-Dec-18  18714478	30-Nov-18  18729520	30-Nov-18  18677693	30-Nov-18  18657142	31-Oct-18  18638318	31-Oct-18  18647405	31-Oct-18  18604160	30-Sep-18  18825156	31-Jan-19  18825214	31-Jan-19  18819827	31-Jan-19  18811724	31-Jan-19  18729346	30-Nov-18  18701724	30-Nov-18  18657316	31-Oct-18  18623511	30-Nov-18  18647463	31-Oct-18  18599053	30-Sep-18  18591050	30-Sep-18  18534835	31-Aug-18  18819769	31-Jan-19  18811608	31-Jan-19  18825098	31-Jan-19  18759488	31-Dec-18  18701434	30-Nov-18  18667011	31-Oct-18  18628939	31-Oct-18  18598879	30-Sep-18  18591108	30-Sep-18  18562741	31-Aug-18  18534777	31-Aug-18  18790485	31-Jan-19  18701492	30-Nov-18  18666953	31-Oct-18  18638260	31-Oct-18  18598995	30-Sep-18  18599111	30-Sep-18  18554135	31-Aug-18  18515042	31-Jul-18  18469498	31-Jul-18  18447937	30-Jun-18  18811550	31-Jan-19  18790601	31-Jan-19  18677809	30-Nov-18  18591166	30-Sep-18  18590992	30-Sep-18  18582449	30-Sep-18  18582391	31-Aug-18  18582333	31-Aug-18  18554019	31-Aug-18  18515274	31-Jul-18  18488746	31-Jul-18  18965760	31-Mar-19  19030868	30-Apr-19  19030690	30-Apr-19  19044166	31-May-19  18977312	30-Apr-19  19071102	31-May-19  19013933	30-Apr-19  19071338	31-May-19  18977223	30-Apr-19  18946958	31-Mar-19  18896552	28-Feb-19  18916270	31-Mar-19  1908288",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2166-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 1 MM X 2 CM  MODEL Number:M0035431020      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035431020;    Lot Number/Expiration Date:  18785369	31-Jan-19  18741318	30-Nov-18  18719333	30-Nov-18  18583254	30-Sep-18  18557530	31-Aug-18  18429528	30-Jun-18  18818792	31-Jan-19  18801607	31-Jan-19  18772009	31-Dec-18  18771835	31-Dec-18  18758722	31-Dec-18  18748395	31-Dec-18  18740448	30-Nov-18  18709718	30-Nov-18  18725975	30-Nov-18  18726385	30-Nov-18  18544137	31-Aug-18  18517433	31-Jul-18  18447952	30-Jun-18  18818618	31-Jan-19  18818444	31-Jan-19  18740738	30-Nov-18  18544079	31-Aug-18  18510936	31-Jul-18  18824386	31-Jan-19  18784557	31-Jan-19  18772067	31-Dec-18  18741608	31-Dec-18  18686476	30-Nov-18  18568905	31-Aug-18  18517549	31-Jul-18  18824444	28-Feb-19  18824502	31-Jan-19  18818270	31-Jan-19  18758107	31-Dec-18  18726180	30-Nov-18  18686650	30-Nov-18  18664543	31-Oct-18  18647231	31-Oct-18  18647173	31-Oct-18  18568963	31-Aug-18  18458590	30-Jun-18  18391277	31-May-18  18824328	31-Jan-19  18802922	31-Jan-19  18748105	31-Dec-18  18647115	31-Oct-18  18568847	31-Aug-18  18557472	31-Aug-18  18786181	31-Jan-19  18772183	31-Dec-18  18686534	30-Nov-18  18585000	31-Aug-18  18584194	31-Aug-18  18582103	30-Sep-18  18582045	30-Sep-18  18557356	31-Aug-18  18510878	31-Jul-18  18523236	31-Jul-18  18772125	31-Dec-18  18686418	30-Nov-18  18647289	31-Oct-18  18452822	30-Jun-18  18450373	30-Jun-18  19033545	30-Apr-19  19004591	30-Apr-19  19004475	30-Apr-19  19004417	30-Apr-19  18927253	31-Mar-19  18915458	31-Mar-19  18915748	31-Mar-19  18915574	31-Mar-19  18915516	31-Mar-19  18845790	28-Feb-19  19052916	31-May-19  18976256	30-Apr-19  18976844	30-Apr-19  18976550	30-Apr-19  18895388	28-Feb-19  18895098	28-Feb-19  19031967	30-Apr-19  18976403	30-Apr-19  19063228	31-May-19  18941012	31-Mar-19  18957807	31-Mar-19  18896258	28-Feb-19  18865965	28-Feb-19  18885463	28-Feb-19  18845411	28-Feb-19  18984961	30-Apr-19  19032257	30-Apr-19  19031387	30-Apr-19  18928771	31-Mar-19  18928012	31-Mar-19  18846169	31-Jan-19  18866197	28-Feb-19  18846548	28-Feb-19  19052595	31-May-19  18957227	31-Mar-19  18956",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2163-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 1.5 MM X 3 CM  MODEL Number: M0035421530    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035421530    Lot Number/Expiration Date:  18576579	31-Aug-18  18825794	31-Jan-19  18759372	31-Dec-18  18769642	31-Dec-18  18759430	31-Dec-18  18742312	30-Nov-18  18730158	30-Nov-18  18700332	30-Nov-18  18666315	31-Oct-18  18642494	31-Oct-18  18598589	30-Sep-18  18598705	30-Sep-18  18590702	30-Sep-18  18571949	31-Aug-18  18576695	30-Sep-18  18542073	31-Aug-18  18553555	31-Aug-18  18461134	30-Jun-18  18487818	31-Jul-18  18482418	31-Jul-18  18455339	30-Jun-18  18790369	31-Jan-19  18790079	31-Jan-19  18759314	31-Dec-18  18700274	30-Nov-18  18700158	30-Nov-18  18676997	30-Nov-18  18676591	30-Nov-18  18642436	31-Oct-18  18620147	30-Sep-18  18633863	31-Oct-18  18473146	30-Jun-18  18482417	31-Jul-18  18473260	30-Jun-18  18433320	30-Jun-18  18419555	31-May-18  18406749	31-May-18  18398515	31-May-18  18811376	31-Jan-19  18825968	31-Jan-19  18816588	31-Jan-19  18790427	31-Jan-19  18790253	31-Jan-19  18700448	30-Nov-18  18629577	31-Oct-18  18660541	31-Oct-18  18642610	31-Oct-18  18590760	30-Sep-18  18571717	31-Aug-18  18455453	30-Jun-18  18811260	31-Jan-19  18811202	31-Jan-19  18811144	31-Jan-19  18790137	31-Jan-19  18769874	31-Dec-18  18769990	31-Dec-18  18742196	31-Dec-18  18742080	30-Nov-18  18598763	30-Sep-18  18590644	30-Sep-18  18571601	31-Aug-18  18524506	31-Jul-18  18433263	30-Jun-18  18817914	31-Jan-19  18811434	31-Jan-19  18660773	31-Oct-18  18642320	31-Oct-18  18642262	31-Oct-18  18553671	31-Aug-18  18811086	31-Jan-19  18714014	30-Nov-18  18676707	30-Nov-18  18666373	31-Oct-18  18666257	31-Oct-18  18620205	30-Sep-18  18619915	30-Sep-18  18461647	30-Jun-18  18433149	30-Jun-18  18826490	31-Jan-19  18826142	31-Jan-19  18825446	31-Jan-19  18817251	31-Jan-19  18790021	31-Jan-19  18776885	31-Dec-18  18742022	30-Nov-18  18730042	30-Nov-18  18676649	30-Nov-18  18660599	31-Oct-18  18619857	30-Sep-18  18629635	31-Oct-18  18590818	30-Sep-18  18571427	31-Aug-18  18541957	31-Aug-18  18391790	30-Apr-18  18398230	31-May-18  18826316	31-Jan-19  18825620	31-Jan-19  18811318	31-Jan-19  18714188	30-Nov-18  187002",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2185-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 3MM X 4CM  MODEL Number:M0035453040      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035453040;    Lot Number/Expiration Date:  18603553	30-Sep-18  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2177-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 3.5 MM X 6CM  MODEL Number:M0035443560      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035443560:    Lot Number/Expiration Date:  18736425	31-Dec-18  18521457	31-Jul-18  18838703	31-Jan-19  18703233	30-Nov-18  18443288	30-Jun-18  18735209	30-Nov-18  18659056	31-Oct-18  18781251	31-Jan-19  18801665	31-Jan-19  18747459	31-Dec-18  18802980	31-Jan-19  18659087	31-Oct-18  18649087	31-Oct-18  18536525	31-Aug-18  19046694	31-May-19  19047725	31-May-19  18875709	28-Feb-19  18987089	30-Apr-19  19006438	30-Apr-19  18959391	31-Mar-19  18936943	31-Mar-19  19022830	30-Apr-19  18984771	30-Apr-19  18922696	31-Mar-19  18898321	28-Feb-19  19061363	31-May-19  18853805	28-Feb-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2183-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 2.5MM X 4CM  MODEL Number:M0035452540      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035452540;    Lot Number/Expiration Date:  18440351	30-Jun-18  18539018	31-Aug-18  18439805	30-Jun-18  18519562	31-Jul-18  18468754	30-Jun-18  18922401	31-Mar-19  19060307	31-May-19  18970593	30-Apr-19  18898116	28-Feb-19  19034354	31-May-19  18875384	28-Feb-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2174-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 2.5 MM X 4CM  MODEL Number:M0035442540      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035442540:    Lot Number/Expiration Date:  18820098	31-Jan-19  18819974	31-Jan-19  18809411	31-Jan-19  18809117	31-Jan-19  18768594	31-Dec-18  18736394	30-Nov-18  18654342	31-Oct-18  18554516	31-Aug-18  18489245	31-Jul-18  18416403	31-May-18  18393530	30-Apr-18  18820005	31-Jan-19  18778602	31-Dec-18  18735178	30-Nov-18  18760121	31-Dec-18  18583787	30-Sep-18  18583880	30-Sep-18  18778397	31-Dec-18  18778807	31-Dec-18  18760123	31-Dec-18  18469927	31-Jul-18  18455711	30-Jun-18  18441368	30-Jun-18  18820036	31-Jan-19  18809705	31-Jan-19  18760120	31-Dec-18  18654156	31-Oct-18  18606693	30-Sep-18  18521064	31-Jul-18  18808823	31-Jan-19  18808529	31-Jan-19  18787828	31-Jan-19  18758428	31-Dec-18  18654187	31-Oct-18  18654280	31-Oct-18  18583942	30-Sep-18  18521126	31-Jul-18  18469957	31-Jul-18  18831210	31-Jan-19  18758018	31-Dec-18  18654125	31-Oct-18  18521095	31-Jul-18  18462388	30-Jun-18  18456041	30-Jun-18  18455861	30-Jun-18  18830181	31-Jan-19  18820067	31-Jan-19  18787623	31-Jan-19  18787213	31-Jan-19  18654249	31-Oct-18  18606631	30-Sep-18  18606600	30-Sep-18  18819943	31-Jan-19  18787418	31-Jan-19  18768273	31-Dec-18  18767952	31-Dec-18  18654373	31-Oct-18  18654311	31-Oct-18  18554485	31-Aug-18  18489183	31-Jul-18  18462418	30-Jun-18  18455921	30-Jun-18  18441488	30-Jun-18  18441458	30-Jun-18  18416223	31-May-18  19052974	31-May-19  19052653	31-May-19  19043872	31-May-19  19013488	30-Apr-19  19069385	31-May-19  18943892	31-Mar-19  18913849	28-Feb-19  19068743	31-May-19  18976461	30-Apr-19  18893796	28-Feb-19  18894175	28-Feb-19  18870346	28-Feb-19  18885258	28-Feb-19  18992380	30-Apr-19  19028025	30-Apr-19  19080185	31-May-19  19052011	31-May-19  18960332	31-Mar-19  18998928	30-Apr-19  19013666	30-Apr-19  18870085	28-Feb-19  18951913	31-Mar-19  18944415	31-Mar-19  18944938	31-Mar-19  18914375	31-Mar-19  18913323	28-Feb-19  19028265	30-Apr-19  19028145	30-Apr-19  19043694	31-May-19  19069064	31-May-19  19013844	30-Apr-19  18951441	31-Mar-19  18929003	31-Mar-19  18913586	28-Feb-19  18870",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2170-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 1.5 MM X 3 CM  MODEL Number:M0035431530      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035431530:    Lot Number/Expiration Date:  18758254	31-Dec-18  18685258	30-Nov-18  18651285	31-Oct-18  18637564	31-Oct-18  18426876	31-May-18  18802748	31-Jan-19  18758459	31-Dec-18  18709486	30-Nov-18  18637506	31-Oct-18  18551662	31-Aug-18  18551894	31-Aug-18  18551778	31-Aug-18  18503529	31-Jul-18  18466471	30-Jun-18  18841964	31-Jan-19  18829601	31-Jan-19  18758049	31-Dec-18  18767569	31-Dec-18  18685548	30-Nov-18  18651227	31-Oct-18  18551604	31-Aug-18  18830630	31-Jan-19  18843698	28-Feb-19  18842831	31-Jan-19  18637390	31-Oct-18  18592500	30-Sep-18  18557240	31-Aug-18  18627281	31-Oct-18  18776363	31-Dec-18  18767070	31-Dec-18  18732530	30-Nov-18  18551836	31-Aug-18  18453506	30-Jun-18  18815140	31-Jan-19  18814270	31-Jan-19  18780961	31-Jan-19  18766571	31-Dec-18  18637448	31-Oct-18  18522949	31-Jul-18  18518477	31-Jul-18  18801433	31-Jan-19  18777411	31-Dec-18  18735646	31-Dec-18  18734430	30-Nov-18  18685838	31-Oct-18  18722263	30-Nov-18  18458818	30-Jun-18  18402198	31-May-18  19049471	31-May-19  19005345	30-Apr-19  18975463	30-Apr-19  18895272	28-Feb-19  18985193	30-Apr-19  19005403	30-Apr-19  19060071	31-May-19  18974589	30-Apr-19  18944128	31-Mar-19  18943082	31-Mar-19  19032025	30-Apr-19  18950234	31-Mar-19  18862184	28-Feb-19  18860682	28-Feb-19  18877220	28-Feb-19  19031155	30-Apr-19  18949886	31-Mar-19  18949712	31-Mar-19  18896142	28-Feb-19  18895852	28-Feb-19  18859219	28-Feb-19  18889081	28-Feb-19  19031445	30-Apr-19  18928887	31-Mar-19  18928128	31-Mar-19  19005287	30-Apr-19  18974152	30-Apr-19  18950060	31-Mar-19  18944651	31-Mar-19  18888559	28-Feb-19  19031735	30-Apr-19  19050513	31-May-19  18975026	30-Apr-19  18888037	28-Feb-19  18943605	31-Mar-19  18927369	31-Mar-19  18894982	28-Feb-19  18876352	28-Feb-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2179-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 2MM X 3CM  MODEL Number:M0035452030          Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number::M0035452030;    Lot Number/Expiration Date:  19032837	30-Apr-19  19034203	31-May-19  18953644	31-Mar-19  19032930	30-Apr-19  18986505	30-Apr-19  18922370	31-Mar-19  18987445	30-Apr-19  18972051	30-Apr-19  18971500	30-Apr-19  18905990	31-Mar-19  19060369	31-May-19.    ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2162-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 1.5 MM X 2 CM  MODEL Number: M0035421520    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035421520:  Lot Number/Expiration Date:  18571775	31-Aug-18  18826432	31-Jan-19  18820709	31-Jan-19  18810506	31-Jan-19  18771506	31-Dec-18  18742834	31-Dec-18  18641914	31-Oct-18  18660947	31-Oct-18  18432978	30-Jun-18  18825388	31-Jan-19  18810970	31-Jan-19  18820593	31-Jan-19  18758780	31-Dec-18  18789731	31-Jan-19  18742776	31-Dec-18  18721938	30-Nov-18  18676533	30-Nov-18  18633805	31-Oct-18  18641972	31-Oct-18  18825910	31-Jan-19  18826258	31-Jan-19  18701086	30-Nov-18  18742718	31-Dec-18  18676359	30-Nov-18  18700796	30-Nov-18  18666663	31-Oct-18  18625251	31-Oct-18  18642030	31-Oct-18  18598415	30-Sep-18  18534255	31-Aug-18  18821173	28-Feb-19  18810390	31-Jan-19  18789847	31-Jan-19  18789673	31-Jan-19  18758370	31-Dec-18  18728186	30-Nov-18  18700680	30-Nov-18  18625135	30-Sep-18  18576927	30-Sep-18  18534545	31-Aug-18  18487470	31-Jul-18  18460621	30-Jun-18  18826084	31-Jan-19  18825736	31-Jan-19  18825562	31-Jan-19  18810738	31-Jan-19  18820941	31-Jan-19  18820825	31-Jan-19  18778633	31-Dec-18  18742950	31-Dec-18  18714130	30-Nov-18  18666489	31-Oct-18  18625193	30-Sep-18  18629461	31-Oct-18  18590180	30-Sep-18  18562973	31-Aug-18  18534023	31-Aug-18  18563089	31-Aug-18  18406635	31-May-18  18642088	31-Oct-18  18810622	31-Jan-19  18778428	31-Dec-18  18789963	31-Jan-19  18771622	31-Dec-18  18722727	30-Nov-18  18701028	30-Nov-18  18648913	31-Oct-18  18666547	31-Oct-18  18590354	30-Sep-18  18563263	31-Aug-18  18821057	31-Jan-19  18771042	31-Dec-18  18742660	31-Dec-18  18700970	30-Nov-18  18660831	31-Oct-18  18563321	31-Aug-18  18582739	30-Sep-18  18559308	31-Aug-18  18482415	30-Jun-18  18439457	30-Jun-18  18789905	31-Jan-19  18810854	31-Jan-19  18820477	31-Jan-19  18789789	31-Jan-19  18758575	31-Dec-18  18742892	30-Nov-18  18700912	30-Nov-18  18700622	30-Nov-18  18660889	31-Oct-18  18642146	31-Oct-18  18641856	31-Oct-18  18563147	31-Aug-18  18439343	30-Jun-18  18397945	31-May-18  19055171	31-May-19  19028965	30-Apr-19  19028733	30-Apr-19  18991622	30-Apr-19  19070054	31-May-19  1906982",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2184-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 3MM X 4CM  MODEL Number:M0035452560    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035452560;    Lot Number/Expiration Date:  18426504	31-May-18  18780350	31-Jan-19  18426444	31-May-18  18532556	31-Aug-18  18794332	31-Jan-19  18830452	31-Jan-19  19036717	31-May-19  19005693	30-Apr-19  19060276	31-May-19  18939358	31-Mar-19  19056621	31-May-19  19037970	31-May-19  18971989	30-Apr-19  18906402	28-Feb-19  18953265	31-Mar-19  18897969	28-Feb-19  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2171-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 1.5 MM X 4 CM  MODEL Number:M0035431540    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035431540:    Lot Number/Expiration Date:  18843121	28-Feb-19  18842254	28-Feb-19  18752256	31-Dec-18  18637622	31-Oct-18  18531974	31-Aug-18  18450202	30-Jun-18  18765704	31-Dec-18  18749439	31-Dec-18  18748627	31-Dec-18  18546175	31-Aug-18  18546117	31-Aug-18  18556378	31-Aug-18  18538344	31-Aug-18  18749033	31-Dec-18  18602307	30-Sep-18  18532032	31-Jul-18  18802864	31-Jan-19  18797083	31-Jan-19  18794216	31-Jan-19  18812672	31-Jan-19  18637738	31-Oct-18  18607230	31-Oct-18  18637680	31-Oct-18  18449404	30-Jun-18  18794100	31-Jan-19  18776421	31-Dec-18  18602365	30-Sep-18  18581643	30-Sep-18  18801549	31-Jan-19  18737036	31-Dec-18  18602249	30-Sep-18  18486380	31-Jul-18  18486322	31-Jul-18  19086644	31-May-19  18941592	31-Mar-19  19086586	31-May-19  18973495	30-Apr-19  19004069	30-Apr-19  18859100	28-Feb-19  18972803	30-Apr-19  19056273	31-May-19  19062764	31-May-19  19003895	30-Apr-19  18973149	30-Apr-19  18956009	31-Mar-19  18893301	28-Feb-19  18894059	28-Feb-19  18860564	28-Feb-19  19003547	30-Apr-19  18955103	31-Mar-19  18942056	31-Mar-19  18886614	28-Feb-19  18894438	28-Feb-19  18941128	31-Mar-19  19083403	31-May-19  18862068	28-Feb-19  18885200	28-Feb-19  19003721	30-Apr-19  19064636	31-May-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2175-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 3MM X 4CM  MODEL Number:M0035443040      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035443040 :    Lot Number/Expiration Date:  18442838	30-Jun-18  18442388	30-Jun-18  18490600	31-Jul-18  18831276	31-Jan-19  18760116	31-Dec-18  18760119	31-Dec-18  18584035	30-Sep-18  18470827	31-Jul-18  18442358	30-Jun-18  18830247	31-Jan-19  18470767	30-Jun-18  18470857	31-Jul-18  18800019	31-Jan-19  18760117	31-Dec-18  18568317	31-Aug-18  18462748	30-Jun-18  18443108	30-Jun-18  18442178	30-Jun-18  18568224	31-Aug-18  18490538	31-Jul-18  18462838	30-Jun-18  18568193	31-Aug-18  18584004	30-Sep-18  18490662	31-Jul-18  18442688	30-Jun-18  19066241	31-May-19  19035290	31-May-19  18902944	28-Feb-19  18877825	28-Feb-19  18973721	30-Apr-19  18846664	31-Jan-19  19081717	31-May-19  19026562	30-Apr-19  18973029	30-Apr-19  18876957	28-Feb-19  18905865	28-Feb-19  19027086	30-Apr-19  19080897	31-May-19  19063669	31-May-19  18845906	31-Jan-19  18845527	31-Jan-19  19026038	30-Apr-19  18902302	28-Feb-19  18846285	31-Jan-19  19081102	31-May-19  18901660	28-Feb-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2182-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 2.5MM X 3CM  MODEL Number:M0035452530      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035452530;    Lot Number/Expiration Date:  18538956	31-Aug-18  18538925	31-Aug-18  18439775	30-Jun-18.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2186-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 3MM X 6CM  MODEL Number:M0035453060      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035453060;    Lot Number/Expiration Date:  18499486	31-Jul-18  18603584	30-Sep-18  19086497	31-May-19.",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2178-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 2MM X 2CM  MODEL Number:M0035452020        Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035452020:    Lot Number/Expiration Date:  19056683	31-May-19  19060338	31-May-19  18985514	30-Apr-19  19034323	31-May-19  18970562	30-Apr-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2161-2016","Class II","Target Detachable Coils:  TARGET 360 NANO 1 MM X 3 CM  MODEL Number: M0035421030    Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number: M0035421030:  Lot Number/Expiration Date:  18604566	30-Sep-18  18488920	31-Jul-18  18807744	31-Jan-19  18807570	31-Jan-19  18677403	31-Oct-18  18666895	31-Oct-18  18654009	31-Oct-18  18647637	31-Oct-18  18629287	31-Oct-18  18542421	31-Aug-18  18554251	31-Aug-18  18469669	30-Jun-18  18462274	30-Jun-18  18462217	30-Jun-18  18393386	30-Apr-18  18814099	31-Jan-19  18788265	31-Jan-19  18769352	31-Dec-18  18714536	30-Nov-18  18701840	30-Nov-18  18677577	30-Nov-18  18677461	30-Nov-18  18629171	31-Oct-18  18604508	30-Sep-18  18582681	30-Sep-18  18535009	31-Aug-18  18426357	30-Jun-18  18714768	30-Nov-18  18714652	30-Nov-18  18629229	31-Oct-18  18554193	31-Aug-18  18701898	30-Nov-18  18730274	30-Nov-18  18677519	30-Nov-18  18653835	31-Oct-18  18831481	31-Jan-19  18769468	31-Dec-18  18714304	30-Nov-18  18807918	31-Jan-19  18714420	30-Nov-18  18654067	31-Oct-18  18638376	31-Oct-18  18590876	30-Sep-18  18604450	30-Sep-18  18488978	31-Jul-18  18469612	30-Jun-18  18831539	31-Jan-19  18788439	31-Jan-19  18736862	31-Dec-18  18736746	30-Nov-18  18666837	31-Oct-18  18666779	31-Oct-18  18653893	31-Oct-18  18604392	30-Sep-18  18542479	31-Aug-18  18931539	31-Mar-19  18901428	28-Feb-19  19048197	31-May-19  18945290	31-Mar-19  18931771	31-Mar-19  18846927	31-Jan-19  18909826	31-Mar-19  18887689	28-Feb-19  18887573	28-Feb-19  18847159	28-Feb-19  18976078	30-Apr-19  19025545	30-Apr-19  19043431	31-May-19  18975900	30-Apr-19  18975989	30-Apr-19  19067208	31-May-19  18954139	31-Mar-19  18961180	31-Mar-19  18961060	31-Mar-19  18945174	31-Mar-19  18931307	31-Mar-19  18847043	31-Jan-19  19025429	30-Apr-19  19048139	31-May-19  18945406	31-Mar-19  18901486	28-Feb-19  18909768	28-Feb-19  19043373	31-May-19  19012218	30-Apr-19  19012392	30-Apr-19  18976167	30-Apr-19  18854389	28-Feb-19  19012044	30-Apr-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2187-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 3MM X 8CM  MODEL Number:M0035453080      Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035453080;    Lot Number/Expiration Date:  18459616	30-Jun-18  18532587	31-Aug-18  18837651	31-Jan-19  18827994	31-Jan-19  18906549	31-Mar-19  18985483	30-Apr-19  18935083	31-Mar-19  18984769	30-Apr-19  19056652	31-May-19  19034292	31-May-19  18875473	28-Feb-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74425,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.","Z-2180-2016","Class II","Target Detachable Coils:  TARGET HELICAL NANO 2MM X 4CM    MODEL Number:M0035452040            Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.  ","45,302 (8,188 in the U.S.) - total, all model numbers","Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended  stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.","07/11/2016",," MODEL Number:M0035452040;    Lot Number/Expiration Date:  18760131	31-Dec-18  18760129	31-Dec-18  18832208	31-Jan-19  18832819	31-Jan-19  18831597	31-Jan-19  18760132	31-Dec-18  18760130	31-Dec-18  18852438	28-Feb-19  18905625	31-Mar-19  18939389	31-Mar-19  19032961	30-Apr-19  19032868	30-Apr-19  19037908	31-May-19  18900809	28-Feb-19  18906580	28-Feb-19  18987592	30-Apr-19  19036655	31-May-19  18971469	30-Apr-19  18986652	30-Apr-19  18875322	28-Feb-19  19047456	31-May-19  18972020	30-Apr-19  18899967	28-Feb-19.  ",6/6/2016,"06/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74426,"Ongoing","Gasco Industrial","3 Calle A","Rincon Industrial Park","Gurabo","PR","00778-2037","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico and Saint Berthelemy","F-2138-2016","Class II",".","3079 units","Undeclared wheat in the soy sauce products. Recall started on 6/15/16. ","09/13/2016",," Lots # 16051201 (exp.5/11/18), 16021501 (exp. 2/2/18), 15102901 (exp. 10/29/17), 15082601 (exp. 8/26/17), 15072801 (exp. 7/28/17), 15042301(exp. 4/23/17), 14120901 (exp. 12/9/16), and 14070801 (exp. 7/8/16)",6/15/2016,"06/15/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74426,"Ongoing","Gasco Industrial","3 Calle A","Rincon Industrial Park","Gurabo","PR","00778-2037","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico and Saint Berthelemy","F-2139-2016","Class II",".","154 units","Undeclared wheat in the soy sauce products. Recall started on 6/15/16. ","09/13/2016",," Lots # 15091601 (exp. 9/16/17), 15072801 (exp. 7/28/17), 15042301 (exp. 4/23/17)",6/15/2016,"06/15/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74426,"Ongoing","Gasco Industrial","3 Calle A","Rincon Industrial Park","Gurabo","PR","00778-2037","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Puerto Rico and Saint Berthelemy","F-2137-2016","Class II",".","1146 units","Undeclared wheat in the soy sauce products. Recall started on 6/15/16. ","09/13/2016",," Lots #16011901 (exp. 1/18-18), 15091601 (exp. 9/16/17), 15072801 (exp. 7/28/17), 15042301 (exp. 4/23/17)",6/15/2016,"06/15/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74427,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX","Z-2117-2016","Class II","Ingenuity Core-Computed Tomography X-ray system    Product Usage:  The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.","18","Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images.  A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.         ","06/30/2016",," Ingenuity Core,System Code #728321, Serial numbers:  310101, 310102, 310103, 310104, 310105, 310106, 310108, 310109, 310112, 310115, 310137, 333006, 333008, 333011, 333012, 333013, 333016, 333017, 333023",4/1/2016,"04/01/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74427,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX","Z-2116-2016","Class II","Brilliance 64, Computed Tomography X-ray system    Product Usage:  The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes","94","Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images.  A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.         ","06/30/2016",," Brilliance 64: System Code #728231 Serial  numbers:  9847, 9936, 9937, 9963, 10067, 10146, 10155, 10181, 10184, 10189, 10191, 10216, 10240, 10292, 10768, 10769, 10770, 10771, 10772, 10773, 10774, 10776, 10777, 10778, 10779, 10780, 10781, 10782, 10783, 10784, 10785, 10786, 10787, 10788, 10789, 10790, 10791, 10794, 10804, 10807, 29026, 29048, 29065, 29081, 29118, 29151, 91003, 95116, 95142, 95523, 95571, 95660, 95838, 95839, 95840, 95841, 95842, 95843, 95845, 95846, 95847, 95848, 95849, 95850, 95851, 95852, 95853, 95854, 95855, 95856, 95857, 95858, 95863, 95866, 95870, 95871, 95872, 95873, 95877, 95882, 95884, 95885, 95886, 95888, 95889, 95890, 95891, 95892, 95893, 95895, 95896, 95897, 95939, 6000861, 9208A, 9081",4/1/2016,"04/01/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74427,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX","Z-2118-2016","Class II","Ingenuity Core 128-Computed Tomography X-ray system    Product Usage:  The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes..  ","19","Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images.  A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.         ","06/30/2016",," Ingenuity Core128:System Code #728323, Serial numbers:  320001, 320016, 320076, 320077, 320080, 320085, 320086, 320087, 320088, 320089, 320091, 320113, 336001, 336002, 336003, 336006, 336007, 336008, 336009, 336010, 336014",4/1/2016,"04/01/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74428,"Ongoing","Armour Eckrich Meats Llc","4225 Naperville Rd",,"Lisle","IL","60532-3656","United States","Voluntary: Firm Initiated","Letter","Cases were distributed nationwide.  No government or military distribution.","F-1846-2016","Class II","Armour Snackmaker Keebler Animals Crackers, Chocolate Icing with Natural and Artificial Flavors, Plain Icing which are packaged in 2.7oz packages; Unit UPC code 2781500240 .  There are 18 packages to a case, Case SKU 2781500240. The responsible firm name on the label is Armour-Eckrich Meats LLC, Cincinnati, OH 45240.","5403 cases / 18 packages per case","Product contains an ingredient which is being recalled from their supplier due to the potential of low levels of peanut residue.","07/28/2016",," lot 1011072916, sell by 7/29/16; lot 1011080516, sell by 08/05/16; lot 1011081816, sell by 08/18/16; lot 1011082516, sell by 08/25/16; and lot 1011083016, sell by 08/30/2016.",6/15/2016,"06/15/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74429,"Ongoing","Sustainable Community Development LLC dba SCD Probiotics","1327 E 9th St",,"Kansas City","MO","64106-1718","United States","Voluntary: Firm Initiated","Letter","Distributed to NM, KS, HI, MI, CA, and Hong Kong.  No government or military distribution.","F-1848-2016","Class II","Xtra Immunity Brown Rice Antioxidant Probiotic Extract, a liquid packaged in a 500mL bottle.  UPC 184368000114. The responsible firm name on the label is SCD Probiotics, Kansas City, MO 64106.","3940 bottles","The product is a dietary supplement with drug claims, making the product misbranded.","07/28/2016",," Lot RX14092-01F, Exp. 6/12/2016; Lot RX15295-02A, Exp. 10/2/2016; Lot RX14295-02B, Exp. 11/30/2016; Lot RX14295-02C, Exp. 12/21/2016; and Lot RX15078-01A, Exp. 2/25/2017",6/17/2016,"06/17/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74430,"Ongoing","Bounce Life Style HQ","1000 NW Wall St Ste 220",,"Bend","OR","97703-2258","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide in the US and in Australia, Canada, and United Kingdom.","F-2402-2016","Class I","US - Bounce Apple Cinnamon Protein Punch Energy Balls (old name), net wt. 1.48 oz. (42g).  Product UPC Codes are 852949003723 (individual packs) and 852949003730 (12-unit boxes).    US - Bounce Apple Cinnamon Protein Energy Balls (new name), net wt. 1.48 oz. (42g). Product UPC codes are 852949003723 (individual packs) and 852949003730 (12-unit boxes).      Australia - Bounce Energy Ball Apple Cinnamon Protein Punch, individual pack has a net wt. 42g and UPC 19335805000374 and 40 pc. jar has UPC 9335805000469.    Canada - Bounce Energy Ball Apple & Cinnamon Protein Punch, net wt. 42g, individual pack has UPC 852949003471.    United Kingdom- Bounce Energy Ball Apple Cinnamon Protein Punch -  individual pack has a net wt. 42g.  The 60 pieces bulk pack has UPC 9335805000841;the 40 pieces jar has UPC 9335805000469; the 30 pieces tub has UPC 19335805000435; Other indiviual balls has UPCs 9335805000360; 9335805001060; 9335805001152; and 9335805000308.         .","2450 cases in US; 223,252 loose packs in UK; 83,338 loose packs in Australia; 15,900 units in Canada ","Apple Cinnamon Protein Punch Energy Ball product is recalled because it has the potential to be contaminated with Listeria monocytogenes.  This product contains sunflower kernels that were recalled by supplier SunOpta.","09/27/2016",," Best by Dates of product distributed in the US:    Apple Cinnamon Protein Punch Energy Balls have the Best Before Dates 04SEP16 and 12NOV16.    Apple Cinnamon Protein Energy Balls have Best Before Dates: 23 DEC16, 10 JAN17, 22 FEB17, and 31MAR17.    ***************************************************************************************  Best by Dates of product distributed in Australia    B.B. 04SEP16 F5 3085  B.B. 16SEP16 F5 3205  B.B. 12DEC16 F5 0436  B.B. 25JAN17 F6 0856  B.B. 22FEB17 F6 1136  B.B. 06MAR17 F6 1276    *************************************************************************************  Best by Dates of product distributed in Canada    B.B. 29OCT16 F6 3635  B.B. 10JAN17 F6 0706  B.B. 25JAN17 F6 0856  B.B. 05FEB17 F5 0966  B.B. 22FEB17 F6 1136  B.B. 06MAR17 F6 1276  B.B. 12MAR17 F6 1336   B.B. 31MAR17 F5 1516    ***************************************************************************************  Best by Dates of product distributed in United Kingdom    B.B. L 28AUG16  B.B. L 11SEP16 F5 3155  B.B. L 07OCT16 F6 3415  B.B. L 21OCT16 F5 3545/3555  B.B. L 08NOV16 F5 0086  B.B. L 21NOV16 F5 0216  B.B. L 01DEC16 F5 0316  B.B. L 02JAN17 F6 0626  B.B. L 30JAN17 F5 0906  B.B. L 14FEB17 F6 1056  B.B. L 14FEB17 F6 1056  B.B. L 02MAR17 F6 1236  B.B. L 12MAR17 F6 1336   ",6/8/2016,"06/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74430,"Ongoing","Bounce Life Style HQ","1000 NW Wall St Ste 220",,"Bend","OR","97703-2258","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide in the US and in Australia, Canada, and United Kingdom.","F-2404-2016","Class I","Bounce Energy Ball Cashew & Pecan Vitality Lift, each loose unit has net wt 42 gram.    The bulk pack (contains 60 pieces) has UPC 9335805000872 and 9335805000308.  The jar (contains 40 pieces) has UPC 9335805000254.    Bounce Energy Ball Cashew & Pecan Vitality Lift unit has UPC 9335805000094 (61,764 balls); 9335805001077 (7,200 balls); and 9335805000049 (257 balls).  ","80,701 loose bars distributed in UK","Bounce Energy Ball Cashew & Pecan Vitality Lift is recalled because it has the potential to be contaminated with Listeria monocytogenes.  This product contains sunflower kernels that were recalled by supplier SunOpta.","09/27/2016",," Best By dates codes    B.B. L 29AUG16 F5 3025    B.B. L 19SEP16 F5 3225    B.B. L 07OCT16 F5 3415  B.B. L 22OCT16 F6 3565    B.B. L 05NOV16 F6 0056  B.B. L 22NOV16 F 0226    B.B. L 03DEC16 F5 0346  B.B. L 16DEC16 F5 0476    B.B. L 02JAN17 F6 0626  B.B. L 29JAN17 F6 0896    B.B. L 14FEB17 F6 1056  B.B. L 15FEB17 F6 1056  ",6/8/2016,"06/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74430,"Ongoing","Bounce Life Style HQ","1000 NW Wall St Ste 220",,"Bend","OR","97703-2258","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide in the US and in Australia, Canada, and United Kingdom.","F-2403-2016","Class I","Australia -Cashew Cinnamon - Caf¿ Bounce, each bulk bag contains 60 pieces, and has UPC 29335805000494","4428 bags","Cashew Cinnamon - Caf¿ Bounce is recalled because it has the potential to be contaminated with Listeria monocytogenes.  This product contains sunflower kernels that were recalled by supplier SunOpta.","09/27/2016",," B.B. 09DEC16 F5 0406  B.B. 05MAR17 F6 1266  ",6/8/2016,"06/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74431,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0625-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","06/28/2016","06/28/2016"," W069115110337",5/20/2016,"05/20/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74431,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0626-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","06/28/2016","06/28/2016"," W069115110337",5/20/2016,"05/20/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74432,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",,"Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0627-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, for which donor suitability was inadequately determined, was distributed.","06/28/2016","06/28/2016"," W036215565534",5/6/2016,"05/06/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74433,"Terminated","Our Lady Of The Lake Hospital Inc","Attn: Blood Bank","5000 Hennessy Blvd","Baton Rouge","LA","70808-4375","United States","Voluntary: Firm Initiated","FAX","Louisiana","B-0637-16","Class III","Red Blood Cells, Leukocytes Reduced",,"Blood product, collected from a donor who tested positive for the antibody to Hepatitis B core Antigen on more than one occasion, was distributed.","06/30/2016","06/30/2016"," W1657130023031",6/9/2016,"06/09/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74434,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Telephone","Tennessee","B-0638-16","Class III"," Pooled Cryoprecipitated AHF","2 units"," Pooled Cryoprecipitated AHF products, identified as unsuitable due to a component preparation deviation, were distributed.","06/28/2016","06/28/2016"," W071216000102; W071216000106",5/3/2016,"05/03/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74435,"Terminated","Plasma Biological Services Inc","2562 Frayser Blvd",,"Memphis","TN","38127-5829","United States","Voluntary: Firm Initiated","E-Mail","California","B-0641-16","Class II","Source Plasma","1 unit","Plasma product, collected from a donor who received a tattoo within 12 months of donating, was distributed.","06/28/2016","06/28/2016"," 16MTNA3091",3/28/2016,"03/28/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74436,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated","Letter","Nationwide to AL, AZ, CA, FL, IL, KS, MA, MD, MS,NJ, OH, PA, TN, TX, UT, and WA. No foreign/VA/govt/military.","Z-2219-2016","Class II","The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.","2482 units","WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).","07/18/2016",," TR1041, TR1043, TR1044, TR1047, TR1049, TR1051, TR1053, TR1054, TR1055, TR1056, TR1058, TR1059, TR1060, TR1061, TR1062, TR1063, TR1064, TR1065, TR1066, TR1067, TR1068, TR1069, TR1070, TR1071, TR1072, TR1073, TR1074, TR1077, TR1078, TR1079, TR1080, TR1081, TR1082, TR1083, TR1084, TR1085, TR1086, TR1087, TR1088, TR1089, TR1090, TR1091, TR1093, TR1094, TR1095, TR1096, TR1097, TR1099, TR1100, TR1101, TR1102, TR1105, TR1106, TR1107, TR1109, TR1110, TR1111, TR1113, TR1114, TR1115, TR1116, TR1117, TR1118, TR1120, TR1121, TR1122, TR1123, TR1124, TR1125, TR1126, TR1127, TR1128, TR1129R, TR1131, TR1132, TR1133, TR1134, TR1136, TR1137, TR1138, TR1141, TR1142, TR1143, TR1144, TR1145, TR1146, TR1147, TR1148, TR1149, TR1150, TR1151, TR1154, TR1156, TR1157, TR1158, TR1159, TR1160, TR1161, TR1163, TR1164, TR1165, TR1166, TR1167, TR1168, TR1169, TR1170, TR1171, TR1172, TR1173, TR1174, TR1175, TR1176, TR1177, TR1178, TR1179, TR1180, TR1182, TR1183, TR1184, TR1185, TR1186, TR1187, TR1190, TR1191, TR1192, TR1193, TR1194, TR1195, TR1197, TR1198, TR1200, TR1201, TR1202, TR1203, TR1204, TR1205, TR1206, TR1207, TR1208, TR1209, TR1210, TR1211, TR1212, TR1213, TR1216, TR1218, TR1219, TR1220, TR1222, TR1223, TR1224, TR1226, TR1227, TR1228, TR1229, TR1230, TR1234, TR1235, TR1236, TR1238, TR1239, TR1240, TR1241, TR1243, TR1246, TR1247, TR1248, TR1249, TR1250, TR1251, TR1252, TR1252R, TR1253, TR1254, TR1255, TR1256, TR1257, TR1258, TR1261, TR1263, TR1264, TR1266, TR1269, TR1270, TR1271, TR1272, TR1273, TR1274, TR1275, TR1276, TR1277, TR1278, TR1279, TR1280, TR1281, TR1282, TR1283, TR1284, TR1285, TR1286, TR1287, TR1288, TR1289, TR1290, TR1291, TR1292, TR1293, TR1294, TR1295, TR1296, TR1297, TR1298, TR1299, TR1300, TR1301, TR1302, TR1303, TR1304, TR1305, TR1306, TR1307, TR1308, TR1309, TR1310, TR1311, TR1312, TR1313, TR1314, TR1315, TR1317, TR1318, TR1319, TR1320, TR1321R, TR1322, TR1323, TR1324, TR1325, TR1326, TR1327, TR1328, TR1329, TR1330, TR1332, TR1335, TR1336, TR1339, TR1341, TR1342, TR1344R, TR1346, TR1347, TR1348, TR1349, TR1351, ",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74436,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated","Letter","Nationwide to AL, AZ, CA, FL, IL, KS, MA, MD, MS,NJ, OH, PA, TN, TX, UT, and WA. No foreign/VA/govt/military.","Z-2220-2016","Class II","The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.","2966 units","WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).","07/18/2016",," PCF15045R, PFA13002, PFA13005, PFA13006, PFA13007, PFA13008, PFA13009, PFA13010, PFA13011, PFA13012, PFA13013, PFA13014, PFA13015, PFA13016, PFA13017, PFA13018, PFA13019, PFA13020, PFA13021, PFA13022, PFA13023, PFA13024, PFA13025, PFA13026, PFA13027, PFA13028, PFA13029, PFA13030, PFA13031, PFA13032, PFA13033, PFA13034, PFA13035, PFA13036, PFA13037, PFA13038, PFA13039, PFA13040, PFA13041, PFA13042, PFA13043, PFA13044, PFA13045, PFA13046, PFA13047, PFA13048, PFA13049, PFA13050, PFA14001, PFA14002, PFA14003, PFA14004, PFA14005, PFA14006, PFA14007, PFA14008, PFA14009, PFA14010, PFA14011, PFA14012, PFA14013, PFA14014, PFA14015, PFA14016, PFA14017, PFA14018, PFA14019, PFA14020, PFA14021, PFA14022, PFA14023, PFA14024, PFA14025, PFA14026, PFA14027, PFA14028, PFA14029, PFA14030, PFA14031, PFA14032, PFA14034, PFA14035, PFA14036, PFA14037, PFA14038, PFA14039, PFA14040, PFA14041, PFA14042, PFA14043, PFA14044, PFA14045, PFA14046, PFA14047, PFA14048, PFA14049, PFA14050, PFA14051, PFA14052, PFA14053, PFA14054, PFA14055, PFA14056, PFA14057, PFA14058, PFA14059, PFA14060, PFA15001, PFA15002, PFA15003, PFA15004, PFA15005, PFA15006, PFA15007, PFA15008, PFA15009, PFA15010, PFA15011, PFA15012, PFA15013, PFA15014, PFA15015, PFA15016, PFA15017, PFA15018, PFA15019, PFA15020, PFA15021, PFA15022, PFA15023, PFA15024, PFA15025, PFA15026, PFA15027R, PFA15028, PFA15029, PFA15030, PFA15031, PFA15032, PFA15033, PFA15035, PFA15036, PFA15037, PFA15038, PFA15039, PFA15041, PFA15043, PFA15044, PFA15045, PFA15046, PFA15047, PFA15050R, PFA15051, PFA15052, PFA15053, PFA15054, PFA15055, PFA15056, PFA15057, PFA15058, PFA15059, PFA15060, PFA15061, PFA15062, PFA15063, PFA15064, PFA15065, PFA15066, PFA15067, PFA15068, PFA15069, PFA15070, PFA15071, PFA15072, PFA15073, PFA15074, PFA15075, PFA15076, PFA15077, PFA15078, PFA15079, PFA15080, PFA15081, PFA15082, PFA15083, PFA15084, PFA15085, PFA15086, PFA15087, PFA15088, PFA15089, PFA15090, PFA15091, PFA15092, PFA15093, PFA15094, PFA15095, PFA15096, PFA15097, PFA15098, PFA15099, PFA15100, PFB13001, PFB13002, P",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2235-2016","Class II","T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","1147 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300828. Lot Number: 1406166, 1406167, 1406168, 1406169, 1407507, 1408134",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2227-2016","Class II","T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","304 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300576. Lot Number: 1407016, 1410164D, 1411070D, 1501024D, 1503091D, 1506091D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2226-2016","Class II"," 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","679 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300206. Lot Number: 1406087, 1407505, 1409132D, 1409133D, 1412060D, 1503090D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2234-2016","Class II","T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","270 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300692. Lot Number: 1407023, 1409042D, 1410166D, 1411072D, 1412062D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2228-2016","Class II","T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","58 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300577. Lot Number: 1407025",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2225-2016","Class II"," 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","7529 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300204. Lot Number: 1406006, 1406008, 1406170, 1406171, 1406172, 1406173, 1406174, 1407125, 1407126, 1407127, 1407128, 1407129, 1408076, 1408077, 1409038D, 1409039D, 1409040D, 1410074D, 1410075D, 1410076D, 1410077D, 1411066D, 1411067D, 1412003D, 1412004D, 1412006D, 1412007D, 1501054D, 1501055D, 1501056D, 1501057D, 1501058D, 1502023D, 1502025D, 1502033D, 1503051D, 1503053D, 1506055D, 1506057D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2229-2016","Class II"," IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","1323 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300642. Lot Number: 1406088, 1406163, 1406164, 1406165, 1409041D, 1409134D, 1410165D, 1506065D, 1508008D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2224-2016","Class II"," 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","3342 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300198. Lot Number: 1406083, 1406084, 1406085, 1406086, 1407014, 1407015, 1407118, 1407119, 1408129, 1408130, 1410072D, 1410073D, 1412059D, 1501062D, 1501106D, 1503048D, 1503049D, 1506064D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2232-2016","Class II","T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","383 total cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300649. Lot Number: 1412061D, 1503069D, 1505046D, 1506087D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2231-2016","Class II","T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","2198 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300644. Lot Number: 1406019, 1406020, 1407020, 1407021, 1407022, 1407120, 1407121, 1408133, 1501111D, 1506067D, 1507020D, 1507060D, 1508073D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2233-2016","Class II","T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","295 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300650. Lot Number: 1412070D, 1502055D, 1503039D, 1505047D, 1506051D, 1506052D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2221-2016","Class II"," Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","37 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-204840. Lot Number: 1504031D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2223-2016","Class II"," 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","2757 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300197. Lot Number: 1406082, 1407122, 1408126, 1408128, 1410078D, 1410079D, 1410080D, 1410081D, 1410082D, 1411025D, 1411026D, 1501022D, 1501109D, 1503083D, 1507012D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2230-2016","Class II","T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","1857 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300643. Lot Number: 1406089, 1407017, 1407018, 1407019, 1407506, 1408132, 1412071D, 1412114D, 1501110D, 1503055D, 1506066D, 1508007D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74437,"Ongoing","WalkMed Infusion, LLC","6555 S Kenton St Ste 304",,"Englewood","CO","80111-6838","United States","Voluntary: Firm Initiated",,"US Nationwide Distribution in the states of AL, AZ, CA, FL, IL, MA, MS, NJ, NV, NY, OH, PA, TN, UT, and WA.","Z-2222-2016","Class II"," 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case.    Product Usage:  Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.  ","2453 cases","WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets. ","07/18/2016",," Product Number: 020-300188. Lot Number: 1407012, 1407013, 1407504, 1408125, 1410069D, 1410070D, 1410071D, 1411106D, 1412002D, 1412113D, 1503120D, 1506053D, 1507011D",6/14/2016,"06/14/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74438,"Completed","Lactalis American Group, Inc.","2376 S Park Ave",,"Buffalo","NY","14220-2670","United States","Voluntary: Firm Initiated","E-Mail","OR, GA, CO, AZ, IN, WA","F-2039-2016","Class II","PRESIDENT brand Authentic Pub Cheese SPREADABLE CHEESE, Cheddar & Porter Ale, Net Wt. 8 oz. (226g), UPC 070153229047 --- Dist. by Lactalis American Group, Inc. Buffalo, NY 14220 --- The product is manufactured approximately every 5 weeks (from 11/02/2015 to 04/06/2016).","17,856 - 8 oz. tubs","The product contains undeclared wheat from ingredient used in production.","09/01/2016",," Codes: MAY2516R, JUN1716R, JUL1516R ",5/25/2016,"05/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74439,"Ongoing","Baked in the Sun Corporation","2560 Progress St",,"Vista","CA","92081-8465","United States","Voluntary: Firm Initiated","Letter","US: CA, NV","F-1678-2016","Class II","Baked in the Sun 4 Pack Smore's Muffin, Wholesale item (food service), not labeled for individual retail sale.    4 pcs/carton","1848 pcs","Baked in the Sun is recalling Smores Muffin because it may contain undeclared peanut residual.","07/14/2016",," Date: 5/25/2016 to 6/14/2016  ",6/14/2016,"06/14/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74440,"Ongoing","HELLOFRESH","1025 Post N Paddock St",,"Grand Prairie","TX","75050-1140","United States","Voluntary: Firm Initiated","E-Mail","AL, AR, AZ, CO, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, ND, NE, NM, OH, OK, SD, TN, TX, WI, WV, WY","F-1935-2016","Class I","Nir's Lamb-Stuffed Zucchini with Spiced Lentil Stew","1,258 pounds","Possible contamination with Listeria monocytogenes","08/16/2016",," No expiration date or lot numbers are assigned.",6/14/2016,"06/14/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74440,"Ongoing","HELLOFRESH","1025 Post N Paddock St",,"Grand Prairie","TX","75050-1140","United States","Voluntary: Firm Initiated","E-Mail","AL, AR, AZ, CO, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, ND, NE, NM, OH, OK, SD, TN, TX, WI, WV, WY","F-1934-2016","Class I","Seared Steak with Spring Veggie Succotash and Mint-Chive Pesto","8,032 pounds","Possible contamination with Listeria monocytogenes","08/16/2016",," No expiration date or lot numbers are assigned.",6/14/2016,"06/14/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74440,"Ongoing","HELLOFRESH","1025 Post N Paddock St",,"Grand Prairie","TX","75050-1140","United States","Voluntary: Firm Initiated","E-Mail","AL, AR, AZ, CO, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, ND, NE, NM, OH, OK, SD, TN, TX, WI, WV, WY","F-1932-2016","Class I","Summer Vegetable Salad with Seared Chicken, Garlic Croutons, and Mustard-Chive Vinaigrette","6,469 pounds","Possible contamination with Listeria monocytogenes","08/16/2016",," No expiration date or lot numbers are assigned.",6/14/2016,"06/14/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74440,"Ongoing","HELLOFRESH","1025 Post N Paddock St",,"Grand Prairie","TX","75050-1140","United States","Voluntary: Firm Initiated","E-Mail","AL, AR, AZ, CO, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, ND, NE, NM, OH, OK, SD, TN, TX, WI, WV, WY","F-1933-2016","Class I","Lemony Pan-Seared Chicken with Pesto Potato Salad and Peas","10,019 pounds","Possible contamination with Listeria monocytogenes","08/16/2016",," No expiration date or lot numbers are assigned.",6/14/2016,"06/14/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74441,"Ongoing","National Frozen Foods Corporation","14406 Rd 3 NE",,"Moses Lake","WA","98837","United States","Voluntary: Firm Initiated","Telephone","Distributed nationwide in the US and also in Canada and Japan","F-2199-2016","Class II","Not Ready to Eat, IQF Sysco Classic Peas & Onions, NFFC item number 74865-12430.  Products' labels contains Cooking Instructions. Net Weight 2.5 lbs.  CASE UPC 100074865 124307  "," 11,160 lbs","Not Ready To Eat IQF Sysco Classic Peas & Onions are recalled because they have a potential to be contaminated with Listeria monocytogenes.","09/14/2016",," Code printed on case: BEST BY 04/18 NF2 6D27J1N 70086   ",6/13/2016,"06/13/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74441,"Ongoing","National Frozen Foods Corporation","14406 Rd 3 NE",,"Moses Lake","WA","98837","United States","Voluntary: Firm Initiated","Telephone","Distributed nationwide in the US and also in Canada and Japan","F-2197-2016","Class II","Not Ready to Eat, IQF green peas.  Products' labels contains Cooking Instructions.  Products are sold under various brands and various net weight.    Bountiful Harvest Green Peas, item #  22486-11904, case UPC & label UPC 30822486119042  and 2248611904, net wt. 12/2.5 LB      C&W Early Harvest Petite Peas, item # 70332-00159, case UPC & label UPC 10070332001591 and 7033200159, net wt. 12/16 oz.    C&W Petite Peas, item # 70332-00158, case UPC & label UPC 10070332001584 and 7033200158, net wt. 12/16 OZ    Crown Point  Green Peas, item # CNP99-11239, case UPC & label UPC 10813973017008, net wt. 20 LB    Crown Point Peas, item # CNP99-11240, case UPC & label UPC 10813973016902, net wt. 12/2.5 LB    Early Dawn Green Peas, item # ERDEX-8M445, case UPC & label ERDEX-8M445 and 7437331521, net wt. 24/500 G     Early Dawn Green Peas, item # ERDEX-8M540, case UPC & label UPC 7437331523, net wt. 6/2 KG     Evergreen Green Peas, item # EVGEX-20440, case UPC & label UPC 4940507000126, net wt 12/1 KG    Festival Green Peas, item # FECEX-2K440, case UPC & label UPC 4967777006016, net wt 12/1 KG     Field Fresh Peas, item #	64775-17440, case UPC & label UPC 6477517440, net wt. 20 LB      First Street Green Peas, item # 41512-08202, case UPC & label UPC 4151208202 and 4151208201, net wt. 12/2.5 LB    First Street Green Peas, item # 41512-12135, case UPC & label UPC 4151212135 and 4151212134, net wt. 12/12 OZ      Foodtown Peas, item # 11153-34628, case UPC & label UPC 11153 34628 and 11153 34628, net wt. 12/40 OZ    Frost Sweet Green Peas, item # FRS99-10002, net wt. 12/2.5 LB      Great Value Sweet Peas, item # 78742-05336, case UPC & label UPC 10078742053360 and 7874205336, net wt. 12/12 OZ      Great Value Sweet Peas, item # 78742-05336-1, case UPC & label UPC 30078742053364 and 7874205336, net wt 10/12 OZ      Great Value Sweet Peas, item # 78742-10912-1, case UPC & label UPC 30078742109122 and 7874210912, net wt. 5/26 OZ    Green Peas, item # 72608-22036, net wt. 55 LB  Green Peas, item # BOYEX-1K025, net wt. 25 KG   Gree"," 2,849,270 lbs","Not Ready To Eat IQF green peas are recalled because they have a potential to be contaminated with Listeria monocytogenes.","09/14/2016",," Codes printed on poly bags:    PRINTED ON POLY  6E11B1N  6E11C1N  6E11D1N  6E11E1N  BEST BY MAR-23-18 KA31  BEST BY MAR-23-18 KA32  BEST BY MAR-23-18 KA33  BEST BY MAR-28-18 KA31  BEST BY MAR-28-18 KA32  BEST BY MAR-28-18 KA33  BEST BY MAR-29-18 KA31  BEST BY MAR-29-18 KA32  BEST BY MAR-29-18 KA33  BEST BY MAR-07-18 KA32  BEST BY MAR-07-18 KA33  BEST BY MAR-17-18 KA31  BEST BY MAR-17-18 KA32  BEST BY MAR-17-18 KA33  BEST BY MAR-29-18 KA31  BEST BY MAR-29-18 KA32  BEST BY MAR-29-18 KA33  BEST BY MAR-28-18 KA33    6C23E1N  6C23F1N  PRO 25.02.2016   EXP 25.02.2018  6B25B1N  PRO 26.02.2016  EXP 26.02.2018 6B26F1N  2018.02.25    LOT.6B25F1N                 2018.02.25    LOT.6B25G1N   2018.03.03    LOT.6C03B1N      2018.03.03    LOT.6C03C1N  2018.02.25    LOT.6B25G1N   2018.03.21    LOT.6C21C1N  2018.03.21    LOT.6C21D1N  2018.03.21    LOT.6C21E1N   2017.11.04  5L04D1N                                             2017.11.04 5L04E1N                               2018.02.25 6B25C1N  2018.02.25 6B25D1N  2018.02.25 6B25D1N  2018.03.21  6C21F1N                                             2018.03.21  6C21F1N                                           BEST BY JUN 02 17      5M02C1N  BEST BY JUN 02 17      5M02D1N  BEST BY NOV 11 17     6E11E1N    BEST BY NOV 11 17     6E11F1N    BEST BY NOV 11 17     6E11G1N    BEST BY NOV 11 17     6E11H1N    BEST BY OCT 28 17 6D28B3N        BEST BY OCT 28 17 6D28C3N            MAR 26 18 NFF3  5G15C1N  5G15D1N   5G15E1N  5G15F1N  6A22C1N  6A22D1N  6A22E1N  6A23B1N  6A23C1N  6A23D1N  BEST BY 03 02 17 5J02A3N  BEST BY 03 02 17 5J02B3N  BEST BY 03 02 17 5J02C3N  BEST BY 03 02 17 5J02D3N  BEST BY 03 02 17 5J02E3N  BEST BY 03 02 17 5J02F3N  BEST IF USED BY 08 06 17 6B06B3N  BEST IF USED BY 08 06 17 6B06C3N  BEST IF USED BY 08 06 17 6B06D3N  BEST IF USED BY 08 06 17 6B06E3N  BEST IF USED BY 08 06 17 6B06F3N  BEST IF USED BY 08 06 17 6B06G3N  BEST IF USED BY 08 06 17 6B06H3N  BEST IF USED BY 10 14 17 6D14F3N   BEST IF USED BY 10 14 17 6D14G3N   BEST IF USED BY 10 14 17 6D14H3N   BEST IF USED BY 1",6/13/2016,"06/13/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74441,"Ongoing","National Frozen Foods Corporation","14406 Rd 3 NE",,"Moses Lake","WA","98837","United States","Voluntary: Firm Initiated","Telephone","Distributed nationwide in the US and also in Canada and Japan","F-2198-2016","Class II","Not Ready to Eat, IQF Mixed Vegetables.  Products' labels contains Cooking Instructions. Products are sold under various brands and various net weight.         Heinz Mixed Vegetables	02521-39698	14902521396989	4902521396982	12/1 KG   Heinz Mixed Vegetables	02521-39698	14902521396989	4902521396982	12/1 KG   Heinz Mixed Vegetables	02521-39698	14902521396989	4902521396982	12/1 KG   Heinz Mixed Vegetables	02521-39698	14902521396989	4902521396982	12/1 KG   Heinz Mixed Vegetables	02521-39698	14902521396989	4902521396982	12/1 KG  Bountiful Harvest 5 Way Mixed Veg	22486-11912	00822486119126	N/A	30 LB  Festival Mixed Vegetables	FECEX-2K688	N/A	4967777005019	12/1 KG   Festival Mixed Vegetables	FECEX-2K688	N/A	4967777005019	12/1 KG   Garden Fresh Mixed Vegetables	64775-37371	10064775373711	N/A	30 LB   Garden Fresh Mixed Vegetables	64775-37371	10064775373711	N/A	30 LB   Garden Fresh Mixed Vegetables	64775-47370	10064775473701	N/A	20 LB  Garden Fresh Mixed Vegetables	64775-47370	10064775473701	N/A	20 LB  Great Value Mixed Vegetables	78742-05334-1	30078742053340	7874205334	10/12 OZ  Great Value Mixed Vegetables	78742-05334-1	30078742053340	7874205334	10/12 OZ  Great Value Mixed Vegetables	78742-05334-1	30078742053340	7874205334	10/12 OZ  Great Value Mixed Vegetables	78742-05334-1	30078742053340	7874205334	10/12 OZ  Great Value Mixed Vegetables	78742-05334-1	30078742053340	7874205334	10/12 OZ  Great Value Mixed Vegetables	78742-05334-1	30078742053340	7874205334	10/12 OZ  Great Value Mixed Vegetables	78742-05334-1	30078742053340	7874205334	10/12 OZ  Great Value Mixed Vegetables	78742-05334-1	30078742053340	7874205334	10/12 OZ  Great Value Mixed Vegetables	78742-05334-1	30078742053340	7874205334	10/12 OZ  Great Value Mixed Vegetables	78742-10907-1	30078742109078	7874210907	5/26 OZ  Great Value Mixed Vegetables	78742-10907-1	30078742109078	7874210907	5/26 OZ  Great Value Mixed Vegetables	78742-10907-1	30078742109078	7874210907	5/26 OZ  Great Value Mixed Vegetables	78742-10907-1	30078742109078	7874210907	5/26 OZ  Great Value Mix"," 1,894,013 lbs","Not Ready To Eat IQF Mixed Vegetables are recalled because they have a potential to be contaminated with Listeria monocytogenes.","09/14/2016",," PRINTED ON POLY    2017.09.23   6C23D1N  2017.09.23   6C23E1N  2017.09.23   6C23F1N  2017.09.23   6C23G1N  2017.09.23   6C23H1N  2017.11.03 5L03D1N  2018.03.29 6C29H1N    BEST IF USED BY 07 06 17 6A06B3N  BEST IF USED BY 07 06 17 6A06C3N  BEST IF USED BY 07 06 17 6A06D3N  BEST IF USED BY 07 06 17 6A06F3N  BEST IF USED BY 07 06 17 6A06G3N  BEST IF USED BY 07 06 17 6A06H3N  BEST IF USED BY 07 06 17 6A06J3N  BEST IF USED BY 07 06 17 6A06K3N  BEST IF USED BY 07 06 17 6A06L3N  BEST IF USED BY 07 18 17 6A18B3N  BEST IF USED BY 07 18 17 6A18C3N  BEST IF USED BY 07 18 17 6A18D3N  BEST IF USED BY 07 18 17 6A18E3N  BEST IF USED BY 07 18 17 6A18F3N  BEST IF USED BY 07 18 17 6A18G3N  BEST IF USED BY 07 18 17 6A18H3N  BEST IF USED BY 07 18 17 6A18J3N  BEST IF USED BY 07 18 17 6A18K3N  BEST IF USED BY 07 18 17 6A18L3N  BEST IF USED BY 07 20 17 6A20B3N  BEST IF USED BY 07 20 17 6A20C3N  BEST IF USED BY 07 20 17 6A20D3N  BEST IF USED BY 07 20 17 6A20E3N  BEST IF USED BY 07 20 17 6A20F3N  BEST IF USED BY 07 20 17 6A20G3N  BEST IF USED BY 07 20 17 6A20H3N  BEST IF USED BY 07 20 17 6A20J3N  BEST IF USED BY 07 20 17 6A20K3N  BEST IF USED BY 07 20 17 6A20L3N  BEST IF USED BY 07 27 17 6A27B3N  BEST IF USED BY 07 27 17 6A27C3N  BEST IF USED BY 07 27 17 6A27D3N  BEST IF USED BY 07 27 17 6A27E3N  BEST IF USED BY 07 27 17 6A27F3N  BEST IF USED BY 07 27 17 6A27G3N  BEST IF USED BY 07 27 17 6A27H3N  BEST IF USED BY 07 27 17 6A27J3N  BEST IF USED BY 07 27 17 6A27K3N  BEST IF USED BY 07 27 17 6A27L3N  BEST IF USED BY 07 27 17 6A27M3N  BEST IF USED BY 09 28 17 6C28B3N  BEST IF USED BY 09 28 17 6C28C3N  BEST IF USED BY 09 28 17 6C28D3N  BEST IF USED BY 10 04 17 6D04C3N  BEST IF USED BY 10 04 17 6D04D3N  BEST IF USED BY 10 04 17 6D04E3N  BEST IF USED BY 10 04 17 6D04F3N  BEST IF USED BY 10 06 17 6D06A3N  BEST IF USED BY 10 06 17 6D06B3N  BEST IF USED BY 10 06 17 6D06C3N  BEST IF USED BY 10 06 17 6D06D3N  BEST IF USED BY 10 06 17 6D06E3N  BEST IF USED BY 10 06 17 6D06F3N  BEST IF USED BY 10 06 17 6D06G3N  BEST IF USED BY 10 06 17 6D06H3N  BES",6/13/2016,"06/13/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74441,"Ongoing","National Frozen Foods Corporation","14406 Rd 3 NE",,"Moses Lake","WA","98837","United States","Voluntary: Firm Initiated","Telephone","Distributed nationwide in the US and also in Canada and Japan","F-2200-2016","Class II","Not Ready to Eat, IQF Peas and Carrots. Products' labels contains Cooking Instructions.       Bountiful Harvest Peas & Carrots, item # 22486-11902, case & label UPC 30822486119028, Net wt. 12/2.5 LB    Bountiful Harvest Peas & Carrots,  item # 22486-11913, case & label UPC 00822486119133, Net wt. 30 LB      C.H. Belt's Worlds Finest Peas & Carrots, item # WFN99-12490, case & label UPC 0088240000268, net wt. 20 LB    Crown Point Peas & Carrots, item # CNP99-11241, case & label UPC 10813973016083, net wt. 20 LB    James Farm Peas & Carrots, item # 60695-01001, case & label UPC 760695010011 and 6069501001, net wt. 12/2.5 LB    Maplewood Peas & Carrots, item # 15429-23600, case & label UPC 81542923600, net wt. 12/2 LB    Restaurant Saver Peas & Carrots, item # 60695-00353, case & label UPC 760695003532, net wt. 20 LB    Smart Source Peas & Carrots, item # 22486-11916, case & label UPC 30822486116165, net wt. 12/2.5 LB    Sysco Classic Peas & Carrots, item # 74865-07850, case & label UPC 10074865078501 and 7486507850, net wt. 12/2.5 LB      Sysco Classic Peas & Carrots, item # 74865-66491, case & label UPC  00074865664912, net wt. 30 LB    Sysco Reliance Peas & Carrots, item # 74865-65716, case & label UPC 00074865657167, net wt. 30 LB    Valamont Peas & Carrots, item # 72608-12490, case & label UPC 00072608124907, net wt. 20 LB    ","approximately 665,858 lbs.","Not Ready To Eat IQF Peas and Carrots are recalled because they have a potential to be contaminated with Listeria monocytogenes.","09/14/2016",," PRINTED ON CASE	PRINTED ON POLY    6E23G1N 70476	66E23G1N  6A30E1N 68868	  6A30F1N 68868	  5L05H1N  67648	  6C24H1N  69598	  6C02H1N   69292 	6C02H1N   6C02J1N   69292 	6C02J1N   6E03B1N  70171 	6E03B1N   6E03C1N  70171 	6E03C1N   6E03D1N  70171 	6E03D1N   6E03E1N  70171 	6E03E1N   6E03F1N  70171 	6E03F1N   6D30J1N  70142	6D30J1N  5M11H1N   68088	  5M11J1N   68088 	  6B18H1N 69139	  BEST BY 01/18 NF2  6A19H1N 68667  	  BEST BY 01/18 NF2  6A19J1N 68667  	  BEST BY 01/18 NF2  6A23B1N 68750 	  BEST BY 01/18 NF2  6A23C1N 68750 	  BEST BY 01/18 NF2  6A23D1N 68750 	  BEST BY 01/18 NF2  6A23E1N 68750 	  BEST BY 01/18 NF2  6A23F1N 68750 	  BEST BY 01/18 NF2  6A23G1N 68750 	  BEST BY 01/18 NF2  6A23J1N 68750 	  BEST BY 01/18 NF2  6A23J1N 68750 	  BEST BY 01/18 NF2 6C17J1N  69529	  BEST BY 10/17 NF2 5K21F1N  67434	  BEST BY 10/17 NF2 5K21G1N  67434	  BEST BY 10/17 NF2 5K21H1N  67434	  BEST BY 04/18 NF2 6D01C1N 69711	  BEST BY 04/18 NF2 6D01D1N 69711 	  BEST BY 04/18 NF2 6D01E1N 69711USA	  BEST BY 04/18 NF2 6D01F1N 69711	  6B03G1N  68924 	  6B03H1N  68924 	  6B03H1N  68924 	  6B03H1N  68924 	  ",6/13/2016,"06/13/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74442,"Ongoing","GE Healthcare, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","US: AK, AZ, CA, COM, CT , DC, FL, GA, GU, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH,OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY.      OUS:  Algeria  Argentina  Australia  Austria  Bahrain  Belarus  Belgium  Bermuda  Brazil  Bulgaria  Canada  China  Egypt  France  Germany  Hungary  India  Indonesia  Ireland  Italy  Japan  Kazakhstan  Korea (Republic of)  Kuwait  Lebanon  Mexico  Netherlands  New Zealand  Poland  Qatar  Romania  Russia  Russian Federation  Saudi Arabia  Singapore  Spain  Sweden  Switzerland  Taiwan  Thailand  Turkey  United Arab Emirates  United Kingdom  Uruguay","Z-2131-2016","Class II","GE Healthcare, Discovery MR750w","471 (184 US; 287 OUS)","GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w.    A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.  No injury has been reported to GE as a result of this issue.","07/06/2016","."," 	  Mfg Lot or Serial #	System ID  00001250FMM03D	9075653T  00001308FMM00B	602863MR  Missing_SN_GON4205067	480342MR3  00001134FMM10E	928348MR  00001140FMM0FX	RADNETMR597  N/A	530CHI750W  N/A	858824MR1  00000000UA0083	408356MR1  00001204FMM058	RADNETMR599  00000000UA0262	949760MR3  00000308185MR8	510449MR750W  00000000UA0075	619543HDMR4  00000000UA0118	858622HDMR1  00001204FMM052	415CB3TW  00001309FMM08B	RADNETMR613  00001307FMM09Y	415UCBHMR3  1-4G33-86	805739MR3  310871MR9	310264MR2  309905MR8	RADNETMR621  00001204FMM04G	559734VIMR1  000005373011-3	RADNETMR598  N/A	720848MR4  N/A	720848MR3  311108MR5	303492MR  00001118FMM0WE	303604MR2  00001309FMM09E	720854MR  00000000UA0472	719365MR  Missing_SN_GON4077136	303837MR2  309815MR9	970624MR1  310950MR1	860446MR750W  00001251FMM00R	202966MR3TW  Missing_SN_GON4231312	561955MR1  00001309FMM097	386FNSBMR3T  00001308FMM042	954355MR750W  1309FMM09F	904483MR3T  00000000UA0465	305665MR750W  00001204FMM057	305461MR1  00001140FMM0FG	407SMSLMR1  00001147FMM0E5	386FHPCMR3T  00001223FMM08M	561844MR1  N/A	706787750DV  00001236FMM04Y	912819MR  00001301FMM043	671NAVYMR  00001234FMM0KL	671FHPMR750W  310330MR6	808HRAEMR750W  00001204FMM055	808545MR  00001250FMM035	808YMMR  00000306104MR1	808873MR750W  1-4GFG-928	319335MR2  310776MR0	773665SJMR2  PG75W1600017MR	312702MR750  00001250FMM02E	217876DMH3T  N/A	847316MR3T  00000305089MR5	708346MR3  00000307816MR9	708346MR4  310973MR3	309655IMRI  00001309FMM094	309655MR750W  N/A	815968MR  00001203FMM0VP	815395MR2  00000306062MR1	847872ZMR2  00000309665MR8	317887MR3  00001308FMM03T	317865MR4  00001308FMM006	913322MISHMRW  310253MR0	859334MR  00001221FMM06J	270798MR2  1406NMM0C2	318443MR2  00000307418MR4	225763MR2  00001236FMM051	337289MR1  1236FMM04H	337943MR1  00001251FMM01F	BRIGHAM750WMR1  00001227FMM011	BOSTONMEDMR1  MISSING_SN_GON#4350388	508746MR3  00001250FMM03C	VAWESTROX750W  00001309FMM085	410328MR3T  00001204FMM04U	RADNETMR1652  00000306342MR7	RADNETMR1651  00001203FMM0W2	RADNETMR1635  00000303329MR7	RADNETMR1629  223355	3014643TMR ",6/8/2016,"06/08/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74443,"Ongoing","Zupan Enterprises, Inc.","7223 Ne Hazel Dell Ave",,"Vancouver","WA","98665-8320","United States","Voluntary: Firm Initiated","E-Mail","distributed in Oregon.","F-1854-2016","Class I","Macaroni Salad with Cheddar Cheese is packaged in a plastic bag, each case contains 2/5 lbs. bags. The label listed item #23070 and the UPC 8 87241 80712 0.    The product was also sold both in Zupans Markets service deli salad case, sized to order, and available in prepacked round plastic containers (8, 12 & 16 oz.) in its Grab & Go area. Scale label on bottom of the product container reads Macaroni Salad with Cheddar Cheese with code 394.","93 cases (2/5 lbs. bags per case)","Macaroni Salad with Cheddar Cheese is recalled due to the potential to be contaminated with Listeria monocytogenes.  This product contains affected green peas that were recalled by National Frozen Foods Company.","08/02/2016",," Use By Dates from 04/15/16 to 06/23/16",6/15/2016,"06/15/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74444,"Terminated","The Blood Alliance, Inc.","7595 Centurion Pkwy",,"Jacksonville","FL","32256-0518","United States","Voluntary: Firm Initiated","FAX","Florida","B-0640-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who was not deferred after testing reactive for anti-HTLV, was distributed.","06/30/2016","06/30/2016"," W118815201192 ",6/9/2016,"06/09/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74445,"Ongoing","Cardiovascular Systems Inc","1225 Old Hwy 8 NW",,"Saint Paul","MN","55112-6416","United States","Voluntary: Firm Initiated","Letter","US Nationwide distribution.","Z-2051-2016","Class II","ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box.  For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360.  Cardiovascular.","190 units (38 - 5 pack shelf cartons)","The pouch label was missing the use by date (UBD) of 2018-04.","06/27/2016",," Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.",6/13/2016,"06/13/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74446,"Ongoing","Magic Seasoning Blends, LLC","720 Distributors Row",,"Harahan","LA","70123-3208","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1684-2016","Class II","TASTE BUDS SEASONED FLOUR, ITEM# ZEAON1040, NET WT. 40 LBS.","5120 lbs","There is a potential presence of peanut protein in certain lots of milled flour which was used in custom seasoned flour blends.","07/14/2016",," 6096707, 6120701",5/25/2016,"05/25/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74446,"Ongoing","Magic Seasoning Blends, LLC","720 Distributors Row",,"Harahan","LA","70123-3208","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1679-2016","Class II","ONION BREADER, NET WEIGHT 25 lbs, MFG FOR: LEE ROY SELMONS, TAMPA, FL  33609","9900 lbs","There is a potential presence of peanut protein in certain lots of milled flour which was used in custom seasoned flour blends.","07/14/2016",," 6120403, 6126705, 6131704",5/25/2016,"05/25/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74446,"Ongoing","Magic Seasoning Blends, LLC","720 Distributors Row",,"Harahan","LA","70123-3208","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1682-2016","Class II","OUTBACK STEAKHOUSE  COMPLETE BREADING MIX, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA  70123","3322 lbs ","There is a potential presence of peanut protein in certain lots of milled flour which was used in custom seasoned flour blends.","07/14/2016",," 6084713, 6084714, 6084718, 6084719, 6088702, 6088703, 6088704, 6088705, 6088706, 6084715, 6084703, 6084704, 6084705, 6084706, 6084707, 6084708, 6084709, 6084710, 6095715, 6095716, 6095717, 6095720, 6095718, 6095719, 6096701, 6096702, 6096703, 6096704, 6102722, 6106713, 6106714, 6106715, 6106716, 6106717, 6106718, 6106719, 6109701, 6109702, 6109703, 6109704, 6109705, 6109706, 6109707, 6109708, 6109709, 6109710, 6109712, 6109713, 6109714, 6109715, 6109716, 6109717, 6109718, 6110701,   6110702, 6110703, 6110704, 6110705, 6110706, 6110707, 6110708, 6110709, 6110710,   6110712, 6110711, 6110713, 6110714, 6110715, 6110716, 6110717, 6110718, 6110719, 6112701, 6112702, 6112703, 6112704, 6112705, 6112706, 6112707, 6112708, 6112709, 6112710 ",5/25/2016,"05/25/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74446,"Ongoing","Magic Seasoning Blends, LLC","720 Distributors Row",,"Harahan","LA","70123-3208","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1680-2016","Class II","OUTBACK STEAKHOUSE  OSI Mama's Batter, Qty 40lbs, NET WEIGHT 40 lbs, MFG FOR: OSI, TAMPA, FL  33609    ","18720 lbs","There is a potential presence of peanut protein in certain lots of milled flour which was used in custom seasoned flour blends.","07/14/2016",," 6104402, 6104403, 6118705, 6118706, 6118707",5/25/2016,"05/25/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74446,"Ongoing","Magic Seasoning Blends, LLC","720 Distributors Row",,"Harahan","LA","70123-3208","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1683-2016","Class II","WOW 101 TENDER BATTER, NET WT. 25 lbs, ITEM #: WOW101TNBT025  ","325 lbs","There is a potential presence of peanut protein in certain lots of milled flour which was used in custom seasoned flour blends.","07/14/2016",," 6126704",5/25/2016,"05/25/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74446,"Ongoing","Magic Seasoning Blends, LLC","720 Distributors Row",,"Harahan","LA","70123-3208","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1681-2016","Class II","OUTBACK STEAKHOUSE  CRAWFISH/CHICKEN/CALAMARI BREADER, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA  70123","3320 lbs","There is a potential presence of peanut protein in certain lots of milled flour which was used in custom seasoned flour blends.","07/14/2016",," 6120701",5/25/2016,"05/25/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74447,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Distribution to states of: GA and FL; and country of: Switzerland.","Z-2253-2016","Class II","Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A)    Use for cutting and shaping bone including bones of the cranium and spine.","18","The graphics at the attachment interface indicating locked and unlocked position are reversed.","07/21/2016",," Lot #'s: H29309439804, H44310033104, K09311396703, and K09311396704.",6/15/2016,"06/15/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74448,"Ongoing","Tippin's Gourmet Pies, LLC","5051 Speaker Rd",,"Kansas City","KS","66106-1043","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Recalled product was distributed to Kansas, Missouri, Texas, Oklahoma, Arizona, Wisconsin, and Illinois.  There was no government or military distribution.","F-1995-2016","Class II","Tippins Mini Key Lime Base packaged in ?.  UPC code is 680816000106. Packaged in 30 pie bases per case.  Shipped frozen. Net wt. 11oz each.","32 cases of pie bases","Product was manufactured with an ingredient which has the potential to contain low levels of peanut residue.","08/26/2016",," Lot number: 05-03-16",6/17/2016,"06/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74448,"Ongoing","Tippin's Gourmet Pies, LLC","5051 Speaker Rd",,"Kansas City","KS","66106-1043","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Recalled product was distributed to Kansas, Missouri, Texas, Oklahoma, Arizona, Wisconsin, and Illinois.  There was no government or military distribution.","F-1992-2016","Class II"," Cream Cheese Base packaged in ?.  UPC code is 680816002711. Packaged in 18 pie bases per case.  Shipped frozen.","60 cases of pie bases","Product was manufactured with an ingredient which has the potential to contain low levels of peanut residue.","08/26/2016",," Lot number: 04-22-16",6/17/2016,"06/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74448,"Ongoing","Tippin's Gourmet Pies, LLC","5051 Speaker Rd",,"Kansas City","KS","66106-1043","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Recalled product was distributed to Kansas, Missouri, Texas, Oklahoma, Arizona, Wisconsin, and Illinois.  There was no government or military distribution.","F-1993-2016","Class II"," Keylime Base packaged in ?.  UPC code is 680816000205. Packaged in 18 pie bases per case.  Shipped frozen. Net wt. 31oz each.","60 cases of pie bases","Product was manufactured with an ingredient which has the potential to contain low levels of peanut residue.","08/26/2016",," Lot numbers: 04-25-16, and 06-01-16.",6/17/2016,"06/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74448,"Ongoing","Tippin's Gourmet Pies, LLC","5051 Speaker Rd",,"Kansas City","KS","66106-1043","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Recalled product was distributed to Kansas, Missouri, Texas, Oklahoma, Arizona, Wisconsin, and Illinois.  There was no government or military distribution.","F-1991-2016","Class II"," Key Lime Pie packaged in aluminum pie plates with plastic covers.  The responsible firm listed on the label is TGP, LLC Kansas City, KS 66106.  UPC code is 680816050057. Packaged in 8 pies per case.  Shipped frozen.","1137 cases of pies","Product with was manufactured with an ingredient which has the potential to contain low levels of peanut residue.","08/26/2016",," Lot numbers: 04-18-16, 04-21-16, 04-25-16, 04-26-16, 04-27-16, 05-03-16, 05-04-16, 05-05-16, 05-11-16, 05-17-16, and 05-31-2016.",6/17/2016,"06/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74448,"Ongoing","Tippin's Gourmet Pies, LLC","5051 Speaker Rd",,"Kansas City","KS","66106-1043","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Recalled product was distributed to Kansas, Missouri, Texas, Oklahoma, Arizona, Wisconsin, and Illinois.  There was no government or military distribution.","F-1994-2016","Class II"," Key Lime Base packaged in ?.  UPC code is 680816001851. Packaged in 12 pie bases per case.  Shipped frozen. Net wt. 21oz each.","30 cases of pie bases","Product was manufactured with an ingredient which has the potential to contain low levels of peanut residue.","08/26/2016",," Lot numbers: 05-03-16, and 06-01-16.",6/17/2016,"06/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74449,"Ongoing","Smith & Nephew, Inc.","130 & 120 Forbes Blvd",,"Mansfield","MA","02048","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide,  AT, AU, DE, FR, GB, JP, PT, and RU.","Z-2218-2016","Class II","Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for arthroscopic use.","563","The device could be subject to breaches of its sterile packaging.","07/18/2016",," Batch numbers: 50412843, 50477278, 50527184",6/15/2016,"06/15/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74450,"Terminated","Green Cuisine, Inc.","2021 1st St",,"San Fernando","CA","91340-2611","United States","Voluntary: Firm Initiated","Telephone","US: CA, NV, and AZ","F-0692-2017","Class I","Pesto Pasta Salad with Arugula, Net Wt. 16oz, UPC 857898004333","202 units","Green Cuisine is recalling Pesto Pasta Salad with Arugula because it may be contaminated with Listeria monocytogenes. ","12/09/2016","12/12/2016"," Lot code: 06/20 ",6/16/2016,"06/16/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74451,"Ongoing","Essential Foods Inc. dba Globespun Gourmet","520 South Massachusetts St.",,"Seattle","WA","98134","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Oregon and Washington","F-2091-2016","Class I","Globespun Gourmet Thai, net wt. 8 oz, plastic wrapped.  UPC 32328 00405.","251 wraps (total)","Globespun Gourmet Thai 8 oz wrap is recalled because an ingredient (peas) has the potential to be contaminated with Listeria monocytogenes.","09/16/2016",," best by dates: 06 17, 06 20, and 06 24 ",6/15/2016,"06/15/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74451,"Ongoing","Essential Foods Inc. dba Globespun Gourmet","520 South Massachusetts St.",,"Seattle","WA","98134","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Oregon and Washington","F-2092-2016","Class I","Globespun Gourmet Coconut Curry, net wt. 8 oz, plastic wrapped.  UPC 32328 00210","251 wraps (total)","Globespun Gourmet Coconut Curry 8 oz wrap is recalled because an ingredient (peas) has the potential to be contaminated with Listeria monocytogenes.","09/16/2016",," best by dates: 06 17, 06 20, and 06 24 ",6/15/2016,"06/15/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74451,"Ongoing","Essential Foods Inc. dba Globespun Gourmet","520 South Massachusetts St.",,"Seattle","WA","98134","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Oregon and Washington","F-2094-2016","Class I","Globespun Gourmet Dolma La- Tibetan potato, net wt. 8 oz., plastic wrapped.  UPC 32328 00503.","251 wraps (total)","Globespun Gourmet Dolma La 8 oz wrap is recalled because an ingredient (peas) has the potential to be contaminated with Listeria monocytogenes.","09/16/2016",," best by dates: 06 17, 06 20, and 06 24 ",6/15/2016,"06/15/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74451,"Ongoing","Essential Foods Inc. dba Globespun Gourmet","520 South Massachusetts St.",,"Seattle","WA","98134","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Oregon and Washington","F-2093-2016","Class I","Globespun Gourmet Tandoori- flavors of India, net wt. 8 oz., plastic wrapped. UPC 32328 00211.","251 wraps (total)","Globespun Gourmet Tandoori 8 oz wrap is recalled because an ingredient (peas) has the potential to be contaminated with Listeria monocytogenes.","09/16/2016",," best by dates: 06 17, 06 20, and 06 24 ",6/15/2016,"06/15/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74452,"Ongoing","Tosoh Bioscience, Inc.","6000 Shoreline Ct Ste 101",,"South San Francisco","CA","94080-7606","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.","Z-2282-2016","Class III","Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package.       The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.","41 single sets of Progesterone 3 calibrators ","Instructions For Use had incorrect lot number and calibrator values","07/25/2016",," Catalog Number 02534001 (One set of Calibrators US)    Lot G13C303 (only those received/repackaged in the US)",6/7/2016,"06/07/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74453,"Ongoing","Spartan Stores","850 76th St Sw",,"Byron Center","MI","49315-8510","United States","Voluntary: Firm Initiated","E-Mail","Domestic: MI    Foreign: None  VA/DOD: None","F-1850-2016","Class II","Cherry Cheesecake, 5 oz. ","1617 units","SpartanNash Company initiated a voluntary recall of Cherry, Strawberry, and Blueberry Cheesecakes with a sell by date of 06/06/2016 to 06/21/2016, due to the potential for undeclared allergen peanut residue resulting from a supplier's recall of graham cracker crumbs.","07/29/2016",," #595, UPC #0-11213-03462, Sell By 6/6/2016 to 6/21/2016 - Cherry",6/14/2016,"06/14/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74453,"Ongoing","Spartan Stores","850 76th St Sw",,"Byron Center","MI","49315-8510","United States","Voluntary: Firm Initiated","E-Mail","Domestic: MI    Foreign: None  VA/DOD: None","F-1852-2016","Class II","Blueberry Cheesecake, 5 oz. ","1396 units","SpartanNash Company initiated a voluntary recall of Cherry, Strawberry, and Blueberry Cheesecakes with a sell by date of 06/06/2016 to 06/21/2016, due to the potential for undeclared allergen peanut residue resulting from a supplier's recall of graham cracker crumbs.","07/29/2016",," #597, UPC #0-11213-03464, Sell By 6/6/2016 to 6/21/2016 - Blueberry",6/14/2016,"06/14/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74453,"Ongoing","Spartan Stores","850 76th St Sw",,"Byron Center","MI","49315-8510","United States","Voluntary: Firm Initiated","E-Mail","Domestic: MI    Foreign: None  VA/DOD: None","F-1851-2016","Class II","Strawberry Cheesecake, 5 oz. ","1592 units","SpartanNash Company initiated a voluntary recall of Cherry, Strawberry, and Blueberry Cheesecakes with a sell by date of 06/06/2016 to 06/21/2016, due to the potential for undeclared allergen peanut residue resulting from a supplier's recall of graham cracker crumbs.","07/29/2016",," #596, UPC #0-11213-03463, Sell By 6/6/2016 to 6/21/2016 - Strawberry",6/14/2016,"06/14/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74454,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2135-2016","Class II","MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System    Product Usage:  Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performance, we are crossing over to Toshibas new 3T Conform Technology. Vantage Titan 3T features a patient aperture of 71 cm and Pianissimo noise reduction technology. It comes with a new, fully functional, state-of-the-art interface designed for ease of use.  ","33 units","A potential problem associated to the gradient  coil (ASGC) in the Titan 3T MRI System.","07/06/2016","."," A5A1082001  A5B1182002  A5B1192003  A5B1192004  A5B11Y2005  A5B11Y2006  A5B11Z2007  A5C1212008  A5C1212009  A5C1222010  A5C1232011  A5C1252012  A5C1262013  A5C1282014  A5C1292015  A5C12X2016  A5C12Y2017  A5C12Z2018  A5D1312019  A5D1322020  A5D1362021  A5D1392023  A5D13X2024  A5D13Y2025  A5D13Y2026  A5D13Z2027  A5C1412028  A5C1422029  A5D1492030  A5D14X2031  A5D14X2032  A5E1522033  A5F1592035  A5D1372022  A5P1562034",4/14/2016,"04/14/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74455,"Terminated","Five Star Gourmet Foods, Inc.","3880 Ebony St",,"Ontario","CA","91761-1500","United States","Voluntary: Firm Initiated","E-Mail","U.S. distribution to the following; CA.  No foregin distribution.","F-0684-2017","Class I","Five Star Gourmet Foods  Energizer Box  Item Code: FG10144","9186 cases","Potential Listeria monocytogenes contamination.","12/09/2016","12/21/2016"," Lot Numbers:  11216  11116  11316  11716  11116  11316  11716  11916  12016  12016  12416  11916  12416  12616  12516  12616  12716  12416  12516  ",6/2/2016,"06/02/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74456,"Ongoing","GMJ Natural Products, Inc.","2101 W Crescent Ave Ste G",,"Anaheim","CA","92801-3806","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA.    No foreign distribution.","F-2383-2016","Class I","Jugo Moringa Plus Antiox  32 oz    Distributed By:   GMJ Natural Products  Anaheim, CA 92801    UPC Code: 14465 77631","1668 bottles","Undeclared whey protein which contains the allergens of milk and soy lecithin.","09/19/2016",," Lot # 15094,15258,15310,16053, 16091",5/10/2016,"05/10/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74457,"Ongoing","Annona Company, LLC","444 S Cedros Ave","Ste. 175","Solana Beach","CA","92075-1980","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; WA, FL, MI, NY, CA, WI, OH, TX, PA, NC, MO, IN, KY, DE, CO.    Foreign distribution to the following; Cayman Islands.","F-2223-2016","Class I","Earnest Eats Chewy Granola Dark Chocolate Almond  UPC 891048001636  5-1.2 oz (35g) BARS NET WT 6.2 oz (175g)    Distributed by Earnest Eats Solana Beach, CA 92075","304 master cases ( 5 bars per carton, 12 cartons per case, total 18,240 bars)","Potential Listeria monocytogenes contamination.","09/14/2016",," Lot Code: B.B. 29APR17 F3 0606",6/17/2016,"06/17/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74458,"Ongoing","Fresh Express Incorpated","4757 The Grove Dr",,"Windermere","FL","34786-8426","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AR, DC, DE, FL, GA, IA, IL, KY, KS, LA, MD, MI, MO, MS, NC, OH, OK, PA, SC, TN, TX, VA, WI and WV.","F-0763-2017","Class II","Fresh Express Kit Caesar salad, Net Wt. 7.6 oz. (215g), Fresh Express Incorporated, 550 S. Caldwell St. Charlotte, NC 28202, packed in clear flexible plastic bags. Product Code: G163B13A","2449 Cases x 6 bags of 7.6 oz each = 14,694 of 7.6 oz bags.","The condiment kits in some Caesar Salad bags contain undeclared allergens: tree nuts (walnuts).","12/16/2016",," Use-By-Date 6/26/2016",6/17/2016,"06/17/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74459,"Terminated","BPL Plasma, Inc.","2631 Dunn Ave",,"Jacksonville","FL","32218-4656","United States","Voluntary: Firm Initiated","E-Mail","Belgium","B-0642-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.","07/08/2016","07/08/2016"," JV0335466",1/6/2016,"01/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74460,"Terminated","BPL Plasma","301 W Main St",,"Carbondale","IL","62901-2901","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0635-16","Class III","Source Plasma","1 unit","Blood product, in which donor screening/donor record incomplete or incorrect, was distributed.","07/08/2016","07/08/2016"," CD0487672; ",6/10/2016,"06/10/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74461,"Terminated","BPL Plasma, Inc.","5252 E Fowler Ave",,"Temple Terrace","FL","33617-2147","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0636-16","Class III","Source Plasma","1 unit","Blood product, in which donor screening/donor record incomplete or incorrect, was distributed.","07/08/2016","07/08/2016"," TT0560542; ",6/10/2016,"06/10/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74463,"Terminated","BPL Plasma, Inc","1250 S Plaza Way Ste C",,"Flagstaff","AZ","86001-6101","United States","Voluntary: Firm Initiated","E-Mail","Kentucky","B-0639-16","Class III","Source Plasma","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","06/28/2016","06/28/2016"," FS0352204",6/17/2016,"06/17/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74464,"Ongoing","Medtronic Navigation","Kochav Yokneam","1 Hamelacha St.","Yokne'am Ilit",,,"Israel","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide.","Z-2129-2016","Class II","PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller    Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician. ","52","Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because of misplaced ground pins which may cause electrical shock to the user.","07/06/2016","."," Model No. 506A0107-01 & 506A0107-02 - Warning Lamps Control Box; 504A0276-01, 504A0277-01& 504A0278-01 - Warning Lamps Control Box Cables; 506A0297-01 & 506A0298-01 - Thermoflex Chiller",6/20/2016,"06/20/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74465,"Ongoing","Carefusion 2200 Inc","75 N Fairway Dr",,"Vernon Hills","IL","60061-1845","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.","Z-2212-2016","Class I","DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code:  C16.    Designed to retract or elevate organs and tissue to provide better visualization access.","10","BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs ","07/22/2016",," Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code:  C16",7/1/2016,"07/01/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1253-2016","Class II","ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY   ","500 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151217-38,	BUD: 06/14/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1245-2016","Class II","TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY   ","150 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160119-12,	BUD: 07/17/16.  b) Lot #: 160119-12,	BUD: 07/17/16.  c) Lot #: 160119-12,	BUD: 07/17/16.  d) Lot #: 160119-12,	BUD: 07/17/16.  e) Lot #: 160119-12,	BUD: 07/17/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1214-2016","Class II","METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY   ","8020 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151218-30,	BUD: 06/15/16;  Lot #: 151221-70,	BUD: 06/18/16.  b) Lot #: 151221-78,	BUD: 06/18/16;  Lot #: 160217-40,	BUD: 08/15/16.  c) Lot #: 151221-78,	BUD: 06/18/16;  Lot #: 160217-40,	BUD: 08/15/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1249-2016","Class II","TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY   ","2000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160125-14,	BUD: 07/23/16;  Lot #: 160315-12,	BUD: 09/11/16.  b) Lot #: 160125-14,	BUD: 07/23/16;  Lot #: 160315-12,	BUD: 09/11/16.",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1242-2016","Class II","TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY   ","8000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #151210-5,	BUD: 06/07/16;  Lot #160204-31,	BUD: 08/02/16;  Lot #160107-8,	BUD: 07/05/16;  Lot #160303-47,	BUD: 08/30/16.  b) Lot #151210-5,	BUD: 06/07/16;  Lot #160107-8,	BUD: 07/05/16;  Lot #160204-31,	BUD: 08/02/16;  Lot #160303-47,	BUD: 08/30/16.  c) Lot #151207-8,	BUD: 06/04/16;  Lot #160303-47,	BUD: 08/30/16;  Lot #151210-5,	BUD: 06/07/16;  Lot #160107-8,	BUD: 07/05/16;  Lot #160204-31,	BUD: 08/02/16;  Lot #160106-34,	BUD: 07/04/16;  Lot#160208-22,	BUD: 08/06/16.  d) Lot #151210-5,	BUD: 06/07/16;  Lot #160107-8,	BUD: 07/05/16;  Lot #160204-31,	BUD: 08/02/16;  Lot #160303-47,	BUD: 08/30/16.  e) Lot #151210-5,	BUD: 06/07/16;  Lot #160107-8,	BUD: 07/05/16;  Lot #160204-31,	BUD:  08/02/16;  Lot #160303-47,	BUD: 08/30/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1192-2016","Class II","HYDROXY B12 1000MCG/ML   W/PRES (BENZALKONIUM 0.01%), 10ML Vials, MEDAUS PHARMACY   ","7000 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151221-56,	BUD: 06/18/16;  Lot #: 160203-23,	BUD: 08/01/16;  Lot #: 160218-45,	BUD: 08/16/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1172-2016","Class II","B-COMPLEX 50 IN NACL 0.9% (PF)  B1-50MG, B2-5-PO4-5MG, B3-50MG,  B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY   		","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160218-57,	BUD: 08/16/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1241-2016","Class II","TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY   ","500 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160115-17,	BUD: 07/13/16.  b) Lot #: 160115-17,	BUD: 07/13/16.  c) Lot #: 160115-17,	BUD: 07/13/16.  d) Lot #: 160115-17,	BUD: 07/13/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1184-2016","Class II","FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY   ","250 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151214-62,	BUD: 06/11/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1201-2016","Class II","LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","7000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160107-37,	BUD: 07/5/16;  Lot #: 160303-67,	BUD: 07/31/16.  b) Lot #: 160107-37,	BUD: 07/5/16;  Lot #: 160303-67,	BUD: 07/31/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1216-2016","Class II","METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY   ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160118-31,	BUD: 07/16/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1188-2016","Class II","HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY   ","500 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151230-23,	BUD: 06/27/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1176-2016","Class II","CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY   ","8500 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot # : 151123-11,              BUD: 05/21/16;  Lot #: 160105-24,	BUD: 07/03/16;  Lot #: 160118-7,	BUD: 07/16/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1250-2016","Class II","ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY   ","500 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160120-57,	BUD: 07/18/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1189-2016","Class II","HYDROGEN PEROXIDE 3% (PF), 5ML Vials, MEDAUS PHARMACY   ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160112-35,	BUD: 07/10/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1168-2016","Class II","B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY 	  ","380 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160115-3,	BUD: 06/11/16;  Lot #: 160202-10,	BUD: 06/11/16;  Lot #: 160204-43,	BUD: 06/11/16;  Lot #: 160223-3,	BUD: 06/11/16;  Lot #: 160307-26,	BUD: 06/11/16;  Lot #: 160309-1,	BUD: 06/11/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1197-2016","Class II","L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY   ","500 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160203-41,	BUD: 08/01/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1181-2016","Class II","DMSO 99.9 (PF), In a)  5ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","2218 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151217-2,	BUD: 05/30/16;  Lot #: 160115-6,	BUD: 05/30/16;  Lot #: 160303-8,	BUD: 08/30/16;  Lot #: 160303-10,	BUD: 08/30/16.  b) Lot #: 151203-37,	BUD: 05/30/16;  Lot #: 151203-72,	BUD: 05/30/16;  Lot #: 151209-7,	BUD: 05/30/16;  Lot #: 151209-8,	BUD: 05/30/16;  Lot #: 151209-9,	BUD: 05/30/16;  Lot #: 151209-10,	BUD: 05/30/16;  Lot #: 151209-11,	BUD: 05/30/16;  Lot #: 151209-13,	BUD: 05/30/16;  Lot #: 151209-14,	BUD: 05/30/16;  Lot #: 160104-31,	BUD: 05/30/16;  Lot #: 160113-77,	BUD: 05/30/16;  Lot #: 151218-7,	BUD: 06/15/16;  Lot #: 151218-8,	BUD: 06/15/16;  Lot #: 160113-78,	BUD: 07/11/16;  Lot #: 160113-4,	BUD: 07/11/16;  Lot #: 160122-10,	BUD: 07/20/16;  Lot #: 160201-6,	BUD: 07/30/16;  Lot #: 160201-7,	BUD: 07/30/16;  Lot #: 160204-9,	BUD: 08/02/16;  Lot #: 160208-5,	BUD: 08/06/16;  Lot #: 160208-6,	BUD: 08/06/16;  Lot #: 160210-65,	BUD: 08/08/16;	  Lot #: 160210-66,	BUD: 08/08/16;  Lot #: 160210-67,	BUD: 08/08/16;  Lot #: 160210-68,	BUD: 08/08/16;  Lot #: 160210-69,	BUD: 08/08/16;  Lot #: 160303-12,	BUD: 08/30/16;  Lot #: 160303-13,	BUD: 08/30/16;  Lot #: 160309-2,	BUD: 09/05/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1196-2016","Class II","L-CARNITINE 250MG/ML (PF), 10ML Vials, MEDAUS PHARMACY   ","2250 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151123-72,             BUD: 05/21/16;  Lot #: 151124-33,              BUD: 05/22/16;  Lot #: 151217-18,	BUD: 06/14/16;  Lot #: 151217-22,	BUD: 06/14/16;  Lot #: 151221-3,	BUD: 06/18/16;  Lot #: 160303-64,	BUD: 08/30/16      ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1169-2016","Class II","B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML,   2ML Vials, MEDAUS PHARMACY     ","60 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151229-15,	BUD: 06/26/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1206-2016","Class II","LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%)  ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","2000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160208-41,	BUD: 07/31/16.  b) Lot #: 160208-41,	BUD: 07/31/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1218-2016","Class II","METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY   ","600 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151123-25,	BUD: 05/21/16;  Lot #: 160126-12,	BUD: 07/24/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1254-2016","Class II","HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY   ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160111-62,	BUD: 07/09/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1236-2016","Class III","PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY   ","4000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151220-6,	BUD: 06/17/16,  Lot #: 160225-7,	BUD: 08/23/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1239-2016","Class II","TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY   ","5500 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151202-54,	BUD: 05/30/16;  Lot #: 160308-31,	BUD: 09/04/16.  b) Lot #: 151202-54,	BUD: 05/30/16;  Lot #: 160308-31,	BUD: 09/04/16.  c) Lot #: 151202-54,	BUD: 05/30/16;  Lot #: 160308-31,	BUD: 09/04/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1180-2016","Class II","DMPS 50MG/ML (PF), 5ML Vials,  MEDAUS PHARMACY   ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151216-33,	BUD: 06/13/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1208-2016","Class II","LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%)  B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","7000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151228-58,	BUD: 05/26/16;  Lot #: 160203-6,	BUD: 07/31/16.  b) Lot #: 151228-58,	BUD: 05/26/16;  Lot #: 160203-6,	BUD: 07/31/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1190-2016","Class II","HYDROXY B12 5MG/ML W/PRES  (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY   ","210 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160202-12,	BUD: 07/11/16;  Lot #: 160204-10,	BUD: 07/11/16;  Lot #: 160210-70,	BUD: 07/11/16;  Lot #: 160215-11,	BUD: 07/11/16;  Lot #: 160222-17,	BUD: 07/11/16;  Lot #: 160223-64,	BUD: 07/11/16;  Lot #: 160224-67,	BUD: 07/11/16;  Lot #: 160307-28,	BUD: 07/11/16;  Lot #: 160308-1,	BUD: 07/11/16;  Lot #: 160309-3,	BUD: 07/11/16    ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1187-2016","Class II","GERMANIUM SESO 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY   ","49 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151229-21,	BUD: 06/26/16;  Lot #: 151229-25,	BUD: 06/26/16;  Lot #: 151229-31,	BUD: 06/26/16;  Lot #: 160126-14,	BUD: 07/24/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1227-2016","Class II","MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY   ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151209-24,	BUD: 06/06/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1230-2016","Class II","NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY   ","400 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160203-18,	BUD: 08/01/16.  b) Lot #: 160203-18,	BUD: 08/01/16.  c) Lot #: 160203-18,	BUD: 08/01/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1178-2016","Class II","DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY ","3500 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151217-31,	BUD: 06/14/16.  b) Lot #: 151217-31,	BUD: 06/14/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1248-2016","Class II","TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY     ","85 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160215-23,	BUD: 08/13/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1182-2016","Class II","EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY   ","24000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151202-45,	BUD: 05/30/16;  Lot #: 160105-38,	BUD: 07/03/16;  Lot #: 160114-20,	BUD: 07/12/16;  Lot #: 160217-28,	BUD: 08/15/16      ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1205-2016","Class II","LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY   ","65 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160209-36,	BUD: 07/31/16.  b) Lot #: 151202-20,	BUD: 05/26/16;  Lot #: 151214-49,	BUD: 05/26/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1251-2016","Class II","ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY   ","2000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151203-53;	BUD: 05/31/16;  Lot #: 151217-38;	BUD: 06/14/16;  Lot #: 160208-36;	BUD: 08/06/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1234-2016","Class II","PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY  		      ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160104-67,	BUD: 07/02/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1243-2016","Class II","TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY   ","20 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160302-71,	BUD: 08/29/16.  b) Lot #: 151207-8,	BUD: 06/04/16;  Lot #: 160106-34,	BUD: 07/04/16;  Lot #: 160208-22,	BUD: 08/16/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1173-2016","Class II","B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY   		","4000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151220-4,	BUD: 06/17/16;  Lot #: 160216-31,	BUD: 08/14/16    ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1229-2016","Class II","NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials,  b) 50ML Vials, and c) 100ML Vials,  MEDAUS PHARMACY   ","358000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151201-30,	BUD: 05/29/16;  Lot #: 151209-26,	BUD: 06/06/16;  Lot #: 151216-63,	BUD: 06/13/16;  Lot #: 151231-11,	BUD: 06/28/16;  Lot #: 160105-4,	BUD: 07/03/16;  Lot #: 160125-41,	BUD: 07/23/16;  Lot #: 160211-20,	BUD: 08/09/16.  b) Lot #: 151201-30,	BUD: 05/29/16;  Lot #: 151209-26,	BUD: 06/06/16;  Lot #: 151216-63,	BUD: 06/13/16;  Lot #: 151231-11,	BUD: 06/28/16;  Lot #: 160105-4,	BUD: 07/03/16;  Lot #: 160125-41,	BUD: 07/23/16;  Lot #: 160511-20,	BUD: 08/09/16.  c) Lot #: 151201-30,	BUD: 05/29/16;  Lot #: 151209-26,	BUD: 06/06/16;  Lot #: 151216-63,	BUD: 06/13/16;  Lot #: 151231-11,	BUD: 06/28/16;  Lot #: 160105-4,	BUD: 07/03/16;  Lot #: 160125-41,	BUD: 07/23/16;  Lot #: 160511-20,	BUD: 08/09/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1213-2016","Class II","MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY   ","3000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160115-24,	BUD: 07/13/16;  Lot #: 160302-61,	BUD: 08/29/16.  b) Lot #: 160115-24,	BUD: 07/13/16;  Lot #: 160302-61,	BUD: 08/29/16.",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1177-2016","Class II","CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY","506 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151207-10,	BUD: 06/04/16;  Lot #: 151222-18,	BUD: 06/19/16;  Lot #: 151222-20,	BUD: 06/19/16;  Lot #: 160210-47,	BUD: 08/29/16;  Lot #: 160210-49,	BUD: 08/29/16;  Lot #: 160215-20,	BUD: 08/13/16;  Lot #: 160302-45,	BUD: 08/29/16;  Lot #: 160302-56,	BUD: 08/29/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1219-2016","Class II","METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY   ","331 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160201-11,	BUD: 07/11/16;  Lot #: 160215-13,	BUD: 07/11/16;  Lot #: 160309-4,	BUD: 07/11/16.  b) Lot #: 160315-1,	BUD: 07/11/16;  Lot #: 160201-11,	BUD: 07/11/16;  Lot #: 160210-71,	BUD: 07/11/16;  Lot #: 160309-4,	BUD: 07/11/16.  c) Lot #: 160125-17,	BUD: 07/11/16;  Lot #: 160210-35,	BUD: 07/11/16;  Lot #: 160222-20,	BUD: 07/11/16;  Lot #: 160204-46,	BUD: 07/11/16;  Lot #: 160307-25,	BUD: 07/11/16.",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1202-2016","Class II","LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%)  ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML;  5ML Vials, MEDAUS PHARMACY     ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160203-2,     BUD: 07/31/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1167-2016","Class II","B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY 		  	  ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151228-28,	BUD: 06/25/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1221-2016","Class II","M.I.C./B-COMPLEX (PF)  B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML Vials, MEDAUS PHARMACY   ","3000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151220-5,	BUD: 05/26/16;  Lot #: 160127-25,	BUD: 07/25/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1247-2016","Class II","THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%),  5ML Vials, MEDAUS PHARMACY   ","213 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160129-2,	BUD: 06/07/16;  Lot #: 160201-10,	BUD: 06/07/16;  Lot #: 160222-19,	BUD: 06/07/16;  Lot #: 160215-12,	BUD: 06/07/16;  Lot #: 160315-2,	BUD: 06/07/16    ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1183-2016","Class II","ESTRADIOLVAL 3MG/TEST CYP 35MG/  TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY     ","10 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151218-14,	BUD: 06/15/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1195-2106","Class II","L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY   ","2000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160303-62,	BUD: 08/30/16    ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1179-2016","Class II","DEXPANTHENOL 250MG/ML W/PRES.  (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY   ","1110 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160204-45,	BUD: 06/14/16;  Lot #: 160210-38,	BUD: 06/14/16;  Lot #: 160215-9,	BUD: 06/14/16;  Lot #: 160222-16,	BUD: 06/14/16;  Lot #: 160223-6,	BUD: 06/14/16;  Lot #: 160229-74,	BUD: 06/14/16;  Lot #: 160302-31,	BUD: 06/14/16;  Lot #: 160307-27,	BUD: 06/14/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1203-2016","Class II","LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG, METHIONINE 12.5 MG, INOSITOL 25 MG, CHOLINE CL-25 MG, LIDCAINE 10 MG/ML, 2ML Vials, MEDAUS PHARMACY   ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151130-85,	BUD:  05/26/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1171-2016","Class II","B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","955 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151222-11,	BUD: 05/28/16;  Lot #: 151224-5,	BUD: 05/28/16;  Lot #: 160111-1,	BUD: 05/28/16;  Lot #: 160119-3,	BUD: 05/28/16;  Lot #: 160119-64,	BUD: 05/28/16;  Lot #: 160217-10,	BUD: 05/28/16;  Lot #: 160307-22,	BUD: 05/28/16.  b) Lot #: 151223-30,	BUD: 05/28/16;  Lot #: 151224-2,	BUD: 05/28/16;  Lot #: 160111-1,	BUD: 05/28/16;  Lot #: 160112-2,	BUD: 05/28/16;  Lot #: 160118-2,	BUD: 05/28/16;  Lot #: 160119-64,	BUD: 05/28/16;  Lot #: 160125-1,	BUD: 05/28/16;  Lot #: 160208-4,	BUD: 05/28/16;  Lot #: 160210-64,	BUD: 05/28/16;  Lot #: 160215-6,	BUD: 05/28/16;  Lot #: 160222-14,	BUD: 05/28/16;  Lot #: 160307-22,	BUD: 05/28/16;  Lot #: 160307-23,	BUD: 06/11/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1217-2016","Class II","METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY   ","2000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151218-28,	BUD: 06/15/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1207-2016","Class II","LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%)  ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","4000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151210-40,	BUD: 05/26/16;  Lot #: 160229-60,	BUD: 07/31/16.  b) Lot #: 151210-40,	BUD: 05/26/16;  Lot #: 160229-60,	BUD: 07/31/16.",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1212-2016","Class II","MANGANESE CHL 0.1MG/ML PF,  10ML Vials, MEDAUS PHARMACY   ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151214-64, BUD: 5/31/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1200-2016","Class II","LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY   ","147 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151203-48,	BUD: 05/31/16;  Lot #: 151204-9,	BUD: 06/01/16;  Lot #: 151218-20,	BUD: 06/15/16;  Lot #: 160125-23,	BUD: 07/23/16;  Lot #: 160125-24,	BUD: 07/23/16;  Lot #: 160125-25,	BUD: 07/23/16;  Lot #: 160127-6,	BUD: 07/25/16;  Lot #: 160302-76,	BUD: 08/29/16;  Lot #: 160302-77,	BUD: 08/29/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1237-2016","Class II","RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY   ","35 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151123-74,	BUD: 05/21/16;  Lot #: 160315-10,	BUD: 09/11/16.  b) Lot #: 160204-21,	BUD: 08/02/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1220-2016","Class II","M.I.C. 25/50/50 (PF)  METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2ML Vials, MEDAUS PHARMACY   ","187 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151130-48,	BUD: 05/26/16;  Lot #: 151215-7,	BUD: 05/26/16;  Lot #: 151216-12,	BUD: 05/26/16;  Lot #: 160106-27,	BUD: 05/26/16;  Lot #: 160113-38,	BUD: 07/11/16;  Lot #: 160223-33,	BUD: 07/31/16;  Lot #: 160307-36,	BUD: 07/31/16;  Lot #: 160307-52,	BUD: 07/31/16;  Lot #: 160308-5,	BUD: 07/31/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1228-2016","Class II","NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials,  b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY   ","157,500 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151217-47,	BUD: 06/14/16;  Lot #: 160112-51,	BUD: 07/10/16;  Lot #: 160127-43,	BUD: 07/25/16;  Lot #: 160218-8,	BUD: 08/16/16;  Lot #: 151211-26,	BUD: 06/08/16.  b) Lot #: 151211-26,	BUD: 06/08/16;  Lot #: 151217-47,	BUD: 06/14/16;  Lot #: 160112-51,	BUD: 07/10/16;  Lot #: 160127-43,	BUD: 07/25/16;  Lot #: 160218-8,	BUD: 08/16/16.  c) Lot #: 151211-26,	BUD: 06/08/16;  Lot #: 160112-51,	BUD: 07/10/16;  Lot #: 160127-43,	BUD: 07/25/16;  Lot #: 151217-47,	BUD: 06/14/16;  Lot #: 160218-8,	BUD: 08/16/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1211-216","Class II","MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","5000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160203-19,	BUD: 08/01/16;  Lot #: 160222-60,	BUD: 08/20/16.  b) Lot #: 160203-19,	BUD: 08/01/16;  Lot #: 160222-60,	BUD: 08/20/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1175-2016","Class II","B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY   ","370 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151228-62,	BUD: 06/25/16.  b) Lot #: 160111-2,	BUD: 06/11/16;  Lot #: 160113-3,	BUD: 06/11/16;  Lot #: 160113-76,	BUD: 06/11/16;  Lot #: 160118-1,	BUD: 06/11/16;  Lot #: 160119-2,	BUD: 06/11/16;  Lot #: 160119-65,	BUD: 06/11/16;  Lot #: 160122-9,	BUD: 06/11/16;  Lot #: 160128-10,	BUD: 06/11/16;  Lot #: 160202-65,	BUD: 06/11/16;  Lot #: 160204-44,	BUD: 06/11/16;  Lot #: 160217-54,	BUD: 06/11/16;  Lot #: 160223-5,	BUD: 06/11/16;  Lot #: 160224-66,	BUD: 06/11/16;  Lot #: 160229-23,	BUD: 06/11/16;  Lot #: 160315-3,	BUD: 06/11/16.  c) Lot #: 160118-1,	BUD: 06/11/16;  Lot #: 160127-2,	BUD: 06/11/16;  Lot #: 160210-37,	BUD: 06/11/16;  Lot #: 160223-5,	BUD: 06/11/16;  Lot #: 160310-14,	BUD: 06/11/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1210-2016","Class II","LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%)  ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, In a) 5ML Vials  and b) 10ML Vials, MEDAUS PHARMACY   ","14000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160104-40,	BUD: 05/26/16;  Lot #: 160209-28,	BUD: 07/31/16.  b) Lot #: 160104-40,	BUD: 05/26/16;  Lot #: 160209-28,	BUD: 07/31/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1238-2016","Class II","SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY   ","884 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151130-35,	BUD: 05/21/16;	  Lot #: 151202-28,	BUD: 05/21/16;	  Lot #: 151223-68,	BUD: 05/21/16;	  Lot #: 151216-20,	BUD: 05/21/16;	  Lot #: 151123-77,	BUD: 05/21/16;	  Lot #: 151204-22,	BUD: 05/21/16;	  Lot #: 160111-30,	BUD: 05/21/16;	  Lot #: 160112-27,	BUD: 05/21/16;	  Lot #: 160120-8,	BUD: 05/21/16;  Lot #: 160118-12,	BUD: 05/21/16;	  Lot #: 160119-20,	BUD: 05/21/16;	  Lot #: 160202-37,	BUD: 05/21/16;	  Lot #: 160208-61,	BUD: 05/21/16;	  Lot #: 160208-62,	BUD: 05/21/16;  Lot #: 160216-37,	BUD: 08/14/16;  Lot #: 160216-38,	BUD: 08/14/16;  Lot #: 160216-35,	BUD: 08/14/16;  Lot #: 160216-40,	BUD: 08/14/16;  Lot #: 160223-27,	BUD: 08/14/16;  Lot #: 160229-43,	BUD: 08/14/16;  Lot #: 160303-22,	BUD: 08/14/16;  Lot #: 160309-17,	BUD: 08/14/16  	  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1226-2016","Class II","MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY   ","21000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151130-64,	BUD: 05/28/16,  Lot #: 151228-22,	BUD: 06/25/16,  Lot #: 160210-29,	BUD: 08/08/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1252-2016","Class II","ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY   ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151217-12,     BUD: 06/14/16 ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1224-2016","Class II","M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%)  METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","500 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160107-17,	BUD: 07/05/16.  b) Lot #: 160107-17,	BUD: 07/05/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1185-2016","Class II","FOLIC ACID 10MG/ML W/PRES.  (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY   ","500 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160215-30,	BUD: 08/13/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1240-2016","Class II","TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY   ","10 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160315-4,	BUD: 05/30/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1233-2016","Class II","PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY   ","60 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160308-3,	BUD: 09/04/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1193-2016","Class II","HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY   ","300 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160104-64,	BUD: 07/02/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1231-2016","Class II","NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY   ","104 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160204-29,	BUD: 08/02/16.  b) Lot #: 151123-73,	BUD: 05/21/16;  Lot #: 151124-42,	BUD: 05/22/16;  Lot #: 151201-20,	BUD: 05/29/16;	  Lot #: 151215-10,	BUD: 06/12/16;  Lot #: 160229-46,	BUD: 07/17/16;  Lot #: 160202-33,	BUD: 07/31/16.  c) Lot #: 160315-9,                BUD: 09/11/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1215-2016","Class II","METHYL B12 1000MCG/ML/PYRIDOXINE 100MG  W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","20 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160222-85,	BUD: 07/05/16.  b) Lot #: 160222-85,	BUD: 07/05/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1222-2016","Class II","M.I.C B-COMPLEX PREMIX W/HYDROXY B12  W/PRES. (BENZALKONIUM 0.01%)  HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG,  B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG,  METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY   ","110 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160229-24,	BUD: 07/25/16,  Lot #: 160315-5,	BUD: 07/25/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1170-2016","Class II","B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY   ","4000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151130-66,	BUD: 05/28/16;  Lot #: 160222-51,	BUD: 08/20/16.  b) Lot #: 151130-60,	BUD: 05/28/16;  Lot #: 160222-51,	BUD: 08/20/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1204-2016","Class II","LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","155 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 151203-50,	BUD: 05/26/16;  Lot #: 160128-34,	BUD: 07/26/16;  Lot #: 160229-51,	BUD: 07/31/16.  b) Lot #: 151204-10,	BUD: 05/26/16;  Lot #: 151204-19,	BUD: 05/26/16.    ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1191-2016","Class II","HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY   ","800 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160119-8,	BUD: 07/17/16;  Lot #: 160204-30,	BUD: 08/02/16.  b) Lot #: 160119-8,	BUD: 07/17/16;  Lot #: 160204-30,	BUD: 08/02/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1235-2016","Class II","PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY   ","2000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160126-20,	BUD: 07/24/16.  b) Lot #: 160126-20,	BUD: 07/24/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1223-2016","Class II","M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%)  B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG;  CYANO B12 100MCG; CHOLINE CHL-50MG;  INOSITOL-25MG;METHIONINE 12.5MG/ML, 5ML Vials, MEDAUS PHARMACY   ","1430 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160119-59;	BUD: 05/26/16,  Lot #: 151228-72;	BUD: 05/26/16,  Lot #: 160127-4;	BUD: 05/26/16,  Lot #: 160201-13;	BUD: 05/26/16,  Lot #: 160202-13;	BUD: 05/26/16,  Lot #: 160204-11;	BUD: 05/26/16,  Lot #: 160202-66;	BUD: 06/11/16,  Lot #: 160307-31;	BUD: 06/11/16,  Lot #: 160224-68;	BUD: 06/11/16,  Lot #: 160205-8;	BUD: 06/11/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1199-2016","Class II","L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY   ","55 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160308-2,      BUD: 09/04/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1232-2016","Class II","PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY   ","1500 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160112-47,	BUD: 07/10/16;  Lot #: 160225-9,	BUD: 08/23/16.  b) Lot #: 160112-47,	BUD: 07/10/16;  Lot #: 160225-9,	BUD: 08/23/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1194-2016","Class II","L-CARNITINE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY   ","1400 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151123-18,             BUD: 05/21/16;  Lot #: 151124-39,            BUD: 05/22/16;  Lot #: 160203-42,             BUD: 08/01/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1246-2016","Class II","THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY   ","1000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151210-17,	BUD: 06/07/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1225-2016","Class II","M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials, MEDAUS PHARMACY   ","2000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151223-63,	BUD: 05/26/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1174-2016","Class II","B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY   ","62 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," a) Lot #: 160209-24,	BUD: 05/28/16.  b) Lot #: 160106-12,	BUD: 05/28/16;  Lot #: 160222-70,	BUD: 05/28/16.  c) Lot #: 160129-9,	BUD: 05/28/16;  Lot #: 160202-16,	BUD: 05/28/16.  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1244-2016","Class II","TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY ","13 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160115-20,	BUD: 07/13/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1198-2016","Class II","L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials,  MEDAUS PHARMACY   ","5000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160222-28,             BUD: 05/22/16;  Lot #: 160302-63,	BUD: 05/31/16",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1186-2106","Class II","GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY   ","110 mL  in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 160315-14,	BUD: 09/11/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74466,"Ongoing","Medaus, Inc.","6801 Cahaba Valley Rd Ste 116",,"Birmingham","AL","35242-9609","United States","Voluntary: Firm Initiated","E-Mail","U.S. Nationwide, Japan, and New Zealand.","D-1209-2016","Class II","LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%)  ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG,INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, 5ML Vials,  MEDAUS PHARMACY  ","4000 mL in Vials","Lack of Assurance of Sterility","07/08/2016",," Lot #: 151210-46,	BUD: 06/07/16;  Lot #: 160208-50,	BUD: 07/31/16  ",5/13/2016,"05/13/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74467,"Ongoing","S-L Snacks NC, LLC","8600 South Blvd",,"Charlotte","NC","28273-6925","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, NC, OH, OK PA, SC, TN, TX, VA, WV & WI","F-1849-2016","Class II","Lance Oyster Crackers, Dist. by Snyder's-Lance, Inc., Charlotte, NC 28277","8,728 cases","May contain low levels of peanut residue.","07/29/2016",," 23 JUL 16, 30 JUL 16 and 13 AUG 16",6/15/2016,"06/15/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74468,"Ongoing","CSL Behring GmbH","Emil-von-Behring-Str. 76",,"Marburg",,,"Germany","Voluntary: Firm Initiated","Letter","Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV","Z-2241-2016","Class II","Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.:  D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.","898 units","Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days.  A maximum bias of -37% was observed.  ","07/19/2016",," Lot Number 15243MA	Mfg Date: 08/31/2015	Exp Date: 05/31/2016  Lot Number 15243MB	Mfg Datge: 08/31/2015 Exp Date: 05/31/2016  ",5/17/2016,"05/17/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74469,"Ongoing","Draeger Medical, Inc.","3135 Quarry Rd",,"Telford","PA","18969-1042","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI.","Z-2215-2016","Class I","Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964    The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators. ","42,922 units worldwide (US distribution 1,530)","Isolated episodes of leakage at the check valve were found","08/04/2016",," Catalog Number: 5704964",5/31/2016,"05/31/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74470,"Ongoing","Gardner Pie Company","191 Logan Pkwy",,"Akron","OH","44319-1188","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The state of Ohio only","F-2244-2016","Class II","Product is a 32-ounce Key Lime pie sold at the firm's retail outlet only. Pie is packed in a cardboard carton with an aluminum pie pan and a plastic dome lid. Retail pie is not labeled. Customers are provided the flavor of pie they select for purchase.  ","163 individual pies","The firm was notified by their supplier of graham cracker crumbs that the flour used to manufacture the crumbs was potentially contaminated with peanut residue. The graham cracker crumbs are used in the production of key lime pie, and cheesecake. The crumbs are used to make the bottom crust of pie and cheesecake.","09/15/2016",," No codes on pies. ",6/17/2016,"06/17/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74470,"Ongoing","Gardner Pie Company","191 Logan Pkwy",,"Akron","OH","44319-1188","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The state of Ohio only","F-2245-2016","Class II"," cheesecake packed in a cardboard carton in an aluminum pie pan with a plastic dome lid.   Pies for further distribution are packed in a master case, 8 units per case. The brand name on the case is Gardner Pie Company Akron, OH. The ingredient statement and coding information are printed on the master case.  ","600 individual cheesecakes sold to one distributor & 509 indivudal cheese cakes sold through the firm's retail outlet. Total is 1,109 cheesecakes. ","The firm was notified by their supplier of graham cracker crumbs that the flour used to manufacture the crumbs was potentially contaminated with peanut residue. The graham cracker crumbs are used in the production of key lime pie, and cheesecake. The crumbs are used to make the bottom crust of pie and cheesecake.","09/15/2016",," 06/07/16. Codes are printed on master carton sold through one distributor.     ",6/17/2016,"06/17/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74471,"Completed","Old World Spices & Seasonings Inc","5320 College Blvd",,"Overland Park","KS","66211-1621","United States","Voluntary: Firm Initiated","Letter","Product was distributed in Missouri and Minnesota.  No government or military distribution.","F-2331-2016","Class III","EAT Barbeque Zero to Hero, a Sweet Rub, packaged in 6.5oz bottles (mislabeled).  The responsible firm named on the label is Pellet Envy, LLC in Kansas City, USA.  UPC code is 859849005024.  The correct label should read 6.7oz.  Bottles are packed in cases of 6.","93 - 6.5oz bottles ","Some bottles of barbeque seasoning without a statement noting the product contains MSG (monosodium glutamate).","09/16/2016",," Lot 005316, exp. is N/A.",6/21/2016,"06/21/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74473,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","FDA Mandated","Letter","US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.","Z-2188-2016","Class II","Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System    ","23","During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.","07/18/2016",," Model Number - XIDF-AWS801",2/24/2016,"02/24/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74476,"Ongoing","Dutch Treat Salads Inc.","3255 Production Ct",,"Zeeland","MI","49464-8581","United States","Voluntary: Firm Initiated","E-Mail","MI only","F-2357-2016","Class I","Sweet Pea Pasta Salad  10 lb cardboard case (2, 5lb plastic bags), 2 lb rigid plastic container, 14 oz. rigid plastic container  Keep Refrigerated  ","3107 lbs","Product has potential of being contaminated with Listeria monocytogenes. ","09/16/2016",," Use by dates through July 1, 2016",6/17/2016,"06/17/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74477,"Ongoing","NeoCoil, LLC","N27W23910 Paul Rd Ste A",,"Pewaukee","WI","53072-6204","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.","Z-2312-2016","Class II","3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A.  The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.    To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.","39 (11 US, 28 OUS)","There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.","08/01/2016",,"    046-4-0012  046-4-0013  046-4-0014  046-4-0015  046-4-0016  046-4-0017  046-4-0018  046-4-0019  046-4-0020  046-4-0021  046-4-0022  046-4-0023  046-4-0024  046-4-0025  046-4-0026  046-4-0027  046-4-0028  046-4-0029  046-4-0030  046-4-0031  046-4-0032  046-4-0033  046-4-0034  046-4-0035  046-4-0036  046-4-0037  046-4-0038  046-4-0039  046-4-0040  046-4-0041  046-4-0042  046-4-0043  046-4-0044  046-4-0045  046-4-0046  046-4-0047  046-4-0048  046-4-0049  046-4-0050  ",6/17/2016,"06/17/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Fire & Brimstone Net Wt. 16 Fl. Oz., UPC code 602573053102, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared fish. Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Bournero Net Wt. 16 Fl. Oz., UPC code 837654919101, exp 12-31-2016, no lot code. Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared fish. Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Orange Jalapeno-Glaze Net Wt. 16 Fl. Oz., UPC code 837654919033, exp 12-31-2016, no lot code. Product contains butter. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared milk protein. Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Carolina Gold Net Wt. 16 Fl. Oz., UPC code 837654919095, exp 12-31-2016, no lot code.  Product contains butter. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared milk protein.  Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Original Net Wt. 16 Fl. Oz., UPC code 837654919064, exp 12-31-2016, no lot code. Product contains anchovies and butter. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared fish and milk protein on product labeled to contain worcestshire sauce and butter.  Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Mild Net Wt. 16 Fl. Oz., UPC code 837654919002, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared fish. Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Sweety Que Net Wt. 16 Fl. Oz., UPC code 837654919163, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared fish. Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Apple Net Wt. 16 Fl. Oz., UPC code 837654919040, exp 12-31-2016, no lot code.  Product contains anchovies. The most responsible firm on the label is www.NormsGourmet.com, Manufactured & Distributed in Omaha, NE.","Unknown, total of approximately 110 cases total distributed","Undeclared fish .Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Apricot-Chipotle Net Wt. 16 Fl. Oz., UPC code 837654919088, exp 12-31-2016, no lot code. Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared fish.Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Medium Net Wt. 16 Fl. Oz., UPC code 837654919019, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared fish. Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Hot Net Wt. 16 Fl. Oz., UPC code 837654919026, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.","Unknown.  A total of approximately 110 cases were distributed.","Undeclared fish.  Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74478,"Terminated","Norm's Gourmet Sauces & Blends","105 S 14th St",,"Fort Calhoun","NE","68023-3530","United States","Voluntary: Firm Initiated","Visit","Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.",,"Class II","Norm's Gourmet Sauces & Blends Apple Net Wt. 16 Fl. Oz., UPC code 837654919040, exp 12-31-2016, no lot code.  Product contains anchovies. The most responsible firm on the label is www.NormsGourmet.com, Manufactured & Distributed in Omaha, NE.","Unknown, total of approximately 110 cases total distributed","Undeclared fish .Products were also produced without a filed scheduled process.","09/23/2016","09/23/2016"," There is no lot or batch code.  Exp is 12-31-2016.",6/10/2016,"06/10/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74480,"Terminated","Inova Health Care Services","45745 Nokes Blvd Ste 160",,"Sterling","VA","20166-2493","United States","Voluntary: Firm Initiated","Letter","Virginia","B-0646-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.","08/08/2016","08/08/2016"," W089816451108; ",6/9/2016,"06/09/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74481,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0648-16","Class III","Blood and Blood Products for Reprocessing","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","08/08/2016","08/08/2016"," W069115148284; W069116111233; ",5/20/2016,"05/20/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74481,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0647-16","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","08/08/2016","08/08/2016"," W069115148284; W069116111233; ",5/20/2016,"05/20/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74482,"Terminated","Blood Bank Of Delmarva, Inc","100 Hygeia Dr",,"Newark","DE","19713-2047","United States","Voluntary: Firm Initiated","Telephone","Delaware","B-0649-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, manufactured without additive solution, was distributed.","08/08/2016","08/08/2016"," W036915222776; ",12/7/2015,"12/07/2015",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74483,"Ongoing","Marin Food Specialties Inc","14800 Byron Highway",,"Byron","CA","94514","United States","Voluntary: Firm Initiated","Press Release","CA, NV, OR and WA","F-1870-2016","Class I","Raw Macadamias, 6 oz. clear plastic tubs, NET WT (170g)    Whole Foods:    Distributed by Whole Foods Market, Emeryville, CA:  Ingredients: Macadamia Nuts; contains tree nuts.  Product of Malawi:  UPC: 9 99482 00132 5    ","240 cases (12 units per case)","IEH sample of Whole Foods Raw Macadamia nuts had a positive result for Salmonella.","08/04/2016",," Best By dated 8/21/16 - 11/6/16",6/21/2016,"06/21/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74484,"Ongoing","Encore Medical, Lp","9800 Metric Blvd",,"Austin","TX","78758-5445","United States","Voluntary: Firm Initiated","Letter","CO, ID, TX","Z-2242-2016","Class II","MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636","14 (7 sets)","Reported failure of the instrument.  The retaining ring component of a neck trial became disassembled from the body of the neck. ","07/19/2016",," Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901",6/21/2016,"06/21/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74485,"Ongoing","Honey Bunchie, LLC","1820 Industrial Cir Unit E",,"Longmont","CO","80501-6524","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No foreign/govt/VA/military consignees.","F-1871-2016","Class I","Honey Bunchies Gourmet Honey Bars, 1.9 oz. snack bar containing honey, sunflower kernels, peanuts and pecans. Packaging:  Box containing 20 individual bars in plastic wrappers. Manufactured by:  Honey Bunchie, LLC, Longmont, CO. Individual Bar UPC 8 66192 00010 1; Box of 20 Bars UPC 8 66192 00011 8.","45, 960 bars","Honey Bunchie, LLC is initiating a voluntary recall of a limited number of Honey Bunchies Gourmet Honey Bars that contain SunOpta sunflower kernels that have the potential of contamination with Listeria monocytogenes.","08/04/2016",," Lot	Production Date	Best Buy Date  D4	7/27/2015		12/27/2015  E4	7/28/2015		12/28/2015  F4	8/03/2015		1/03/2016  G4	8/04/2015		1/04/2016  H4	8/10/2015		1/10/2016  I4	8/18/2015		1/18/2016  J4	8/24/2015		1/24/2016  K4	8/26/2015		1/26/2016  L4	8/31/2015		1/31/2016  M4	9/07/2015		4/07/2016  N4	9/14/2015		4/14/2016  O4	9/21/2015		4/21/2016  P4	9/22/2015		4/22/2016  Q4	9/28/2015		4/28/2016  R4	10/05/2015		5/05/2016  S4	10/05/2015		8/05/2016  T4	10/12/2015		5/12/2016  U4	10/12/2015		8/12/2016  V4	10/19/2015		8/19/2016  W4	10/20/2015		8/20/2016	  X4	10/26/2015		8/26/2016  Y4	11/03/2015		9/03/2016  Z4	11/09/2015		9/09/2016  A5	11/16/2015		9/16/2016  B5	11/23/2015		9/23/2016  C5	11/30/2015		9/30/2016  D5	12/07/2015		10/07/2016  E5	12/14/2015		10/14/2016  F5	12/21/2015		10/21/2016  G5	12/28/2015		10/28/2016  ",5/31/2016,"05/31/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74486,"Completed","Nobel Biocare Usa Llc","22715/22725 Savi Ranch Pkwy",,"Yorba Linda","CA","92887","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil    Non US: Taiwan, SC","Z-2237-2016","Class II","Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105  Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.","53 units total (33 units in US)","Incorrect top label on an implant package.","07/19/2016",," 13030677",6/22/2016,"06/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74487,"Ongoing","One Lambda Inc","21001 Kittridge St",,"Canoga Park","CA","91303-2801","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; OH, IL, NY, MD, MA, CA.    Foreign distribution to the following; Japan and Israel.","B-0650-16","Class II"," Allele Specific HLA Class I DNA Typing Tray  A*31  Catalog ID: SSPR1-31","10 test kits; 1 Lot","HLA test kits, which may be associated with false negative reactions, were distributed. ","06/30/2016",," Lot Number: 003  Batches: 101734",6/8/2016,"06/08/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74488,"Ongoing","ErgoSafe Products, LLC (DBA) Prism Medical","10888 Metro Ct",,"Maryland Heights","MO","63043-2413","United States","Voluntary: Firm Initiated","Letter","Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea","Z-0728-2017","Class II","Carry bar which is an accessory to a lift used for patients in hospitals and other facilities.  Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.","not greater than 17,964 units","The black plastic puck on the carry bar is breaking resulting in potential for patient harm.","12/09/2016",," There are no lot numbers, serial numbers, or UPC codes, only the model numbers.    Model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.",8/30/2016,"08/30/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74489,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","US distribution in the states of TN and KY.","Z-2201-2016","Class II","Femoral Arterial Line  Catheterization Kit with Sharps Safety Features  510K 810675, product code DQX, Device Listing D025180  Material ASK-04018-VUH    Product Usage:  The Arrow arterial catheterization device permits access to the peripheral arterial circulation.  ","50 units in total","Labeling error.  Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.","07/12/2016",," Lot/Batch Numbers: 23F14M0829, 23F14M0986",6/2/2016,"06/02/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74489,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","US distribution in the states of TN and KY.","Z-2202-2016","Class II","Femoral Arterial Line  Catheterization Kit with Sharps Safety Features  510K 810675, product code DQX, Device Listing D025180  Material ASK-04018-VUH    Product Usage:  The Arrow arterial catheterization device permits access to the peripheral arterial circulation.  ","50 units in total","Labeling error.  Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.","07/12/2016",," Lot/Batch Numbers: 23F14M0829, 23F14M0986",6/2/2016,"06/02/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74490,"Ongoing","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.","Z-2147-2016","Class II","AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8)    Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.","5740","Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified.  The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.","07/08/2016",," Lots: 1505600017 ; 1505600018 ; 1506500005 ; 1509200078 ; 1513100112 ; 1513900027 ; 1513900028 ; 1514700045 ; 1516600192 ; 1516800126 ; 1517800004 ; 1519500037 ; 1520100049 ; 1520100050 ; 1520900031 ; 1520900033 ; 1521600126 ; 1523000093 ; 1523600120 ; 1525100023 ; 1525800026 ; 1526500032 ; 1526500033 ; 1526500034 ; 1526500072 ; 1527200050 ; 1527200051 ; 1527200052 ; 1527800163 ; 1529300026 ; 1529300027 ; 1529300028 ; 1533500033 ; 1534200034 ; 1601900027 ; 1601900028 ; ",6/22/2016,"06/22/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74491,"Ongoing","Greenland Trading Corp","238 Pennsylvania Ave",,"Paterson","NJ","07503-2121","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, FL, MA, NJ, NY, PA and TN","F-1924-2016","Class I","Al Rasheed Sardine Item #4017  Label not available - NYSDAM sampling.","106 cases (24 packages each)","Greenland Trading Corporation is recalling Al Rasheed Sardines due to potential C. botulinum contamination.","08/15/2016",," 03/2017",6/17/2016,"06/17/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74492,"Ongoing","Wm Bolthouse Farms Inc","7200 E Brundage Ln",,"Bakersfield","CA","93307-3016","United States","Voluntary: Firm Initiated","Press Release","Nationwide,and   Canada,   Jamaica  Puerto Rico  Tahiti  Anguilla  Antigua  Aruba  Barbados  St. Maarten   St. Thomas  Qatar  Lebanon  UAE   Bahrain  Oman  Kuwait  Saudi Arabia  Cayman Islands  Guam  Hong Kong  American Samoa","F-1701-2016","Class II","Bolthouse Farms Chocolate Protein Plus:  22 g protein per bottle + 21 vitamins & minerals.  Packaged in 11 oz./325 mL - item number PPC3BF9;   15.2 oz/450 mL I item number: PPC4BF6;- US; PPC4BC6 - Canada;   32 oz./946 mL; item number PPCQBF6 - US, PPCQBC6 - Canada:                     Selling Unit UPC                            Case GTIN  11 oz.       0-71464-01868-9                          1-00-71464-01868-6;  15.2 oz.    0-71464-30650-2                          1-00-71464-30603-5 - US;                    0-71464-30650-2                          1-00-71464-30603-5 - Canada;  32 oz         0-71464-30651-9                          1-00-71464-30602-8 - US;                     0-71464-30651-9                          1-00-71464-30602-8 - Canada    Bolthouse Juice Products, LLC, Bakersfield, CA 93307","3,814,275 units; 624,148 cases - total all varieties","Bolthouse Farms is recalling  8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.","07/15/2016",," 11 oz; Best By : 7/3/16 and 7/23/16 and 7/24/16 and 8/18/16 and 8/19/16;   All Production Times;   Lot numbers:   BV116D04A2PP090  BV316D04A2PP090  BV216D24A2PP090  BV316D24A2PP090  BV316D25A2PP090  BV316E20A2PP090  BV316E21A2PP090.    15.2 oz. - Best By: 6/19/16 and 6/21/16 and 6/22/16 and 7/12/16 and 7/21/16, 7/22/16 and 8/9/16 and 8/10/16 and 8/12/16 and 8/13/16 and 8/17/16 and 8/22/16 and 8/23/16 and 8/30/16 and 8/31/16;   All Production Times;  Lot numbers: BV216C23A2PP090  BV316C21A2PP090  BV316C23A2PP090  BV316C24A2PP090  BV116D13A2PP090  BV116D23A2PP090  BV116E15A2PP090  BV116E25A2PP090  BV116F05A2PP065  BV116F06A2PP065  BV216D22A2PP090  BV216E14A2PP090  BV216E15A2PP090  BV216E25A2PP090  BV216F05A2PP065  BV216F16A2PP075  BV316D13A2PP090  BV316D22A2PP090  BV316D23A2PP090  BV316E14A2PP090  BV316E15A2PP090  BV316E24A2PP090  BV316E25A2PP090  BV316F05A2PP065  BV316F06A2PP065  BV316F13A2PP065  BV316F16A2PP075  BV316F17A2PP075.  15.2 oz. Canada: Best By : 7/21/16 and 8/20/16 and 9/18/16;   All Production Times;  Lot numbers:   BV116C23A2PP120  BV216D22A2PP120  BV216E21A2PP120;    32 oz. - Best By : 7/11/16 and 7/12/16 and 7/24/16 and 7/25/16 and 7/26/16 and 8/10/16 and 8/17/16 and  8/24/16; All Production Times  Lots:  BV116D12A2PP090  BV116D25A2PP090  BV116D26A2PP090  BV116D27A2PP090  BV116E12A2PP090  BV116E26A2PP090  BV116F13A2PP065  BV216D12A2PP090  BV216D25A2PP090  32 0z. Canada - Best By : 8/23/16 and 9/23/16 and 10/12/16; All Production Times.  Lots :  BV116D25A2PP120  BV216D25A2PP120  BV316E26A2PP120  BV316F14A2PP120  BV316F14A2PP120R.          ",6/22/2016,"06/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74492,"Ongoing","Wm Bolthouse Farms Inc","7200 E Brundage Ln",,"Bakersfield","CA","93307-3016","United States","Voluntary: Firm Initiated","Press Release","Nationwide,and   Canada,   Jamaica  Puerto Rico  Tahiti  Anguilla  Antigua  Aruba  Barbados  St. Maarten   St. Thomas  Qatar  Lebanon  UAE   Bahrain  Oman  Kuwait  Saudi Arabia  Cayman Islands  Guam  Hong Kong  American Samoa","F-1705-2016","Class II","Bolthouse Farms Strawberry Protein Plus:  30 g protein per bottle + 21 vitamins & minerals.  Packaged in 15.2 oz/450 mL  item number: PPCN4BF6;    32 oz/946 mL. - item number PPSWQBF6                     Selling Unit UPC                            Case GTIN  15.2 oz.   0-71464-01890-0                           1-00-71464-01890-7;  32 oz.      0-71464-01891-7                            1-00-71464-01891-4;    Bolthouse Juice Products, LLC, Bakersfield, CA 93307","3,814,275 units; 624,148 cases - all varieties","Bolthouse Farms is recalling  8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.","07/15/2016",," 15.2 oz -  Best By : 6/23/16 and 8/16/16 and 9/15/16; All Production Times.   Lots:    BV216C25A2PP090  BV216E21A2PP090  BV316F17A2PP090.    32 oz.- Best By : 9/12/16; All Production Times;  Lots:  BV116F14A2PP090  BV316F14A2PP090.       ",6/22/2016,"06/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74492,"Ongoing","Wm Bolthouse Farms Inc","7200 E Brundage Ln",,"Bakersfield","CA","93307-3016","United States","Voluntary: Firm Initiated","Press Release","Nationwide,and   Canada,   Jamaica  Puerto Rico  Tahiti  Anguilla  Antigua  Aruba  Barbados  St. Maarten   St. Thomas  Qatar  Lebanon  UAE   Bahrain  Oman  Kuwait  Saudi Arabia  Cayman Islands  Guam  Hong Kong  American Samoa","F-1704-2016","Class II","Bolthouse Farms Coconut Protein Plus:  30 g protein per bottle + 21 vitamins & minerals.  Packaged in 15.2 oz/450 mL  item number: PPCN4BF6;                       Selling Unit UPC                            Case GTIN  15.2 oz.   0-71464-01892-4                           1-00-71464-01892-1;                       Bolthouse Juice Products, LLC, Bakersfield, CA 93307","3,814,275 units; 624,148 cases","Bolthouse Farms is recalling  8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.","07/15/2016",," 15.2 oz - Best By : 8/19/16 and 8/20/16 and 9/15/16; All Production Times.   Lots:  BV116F17A2PP090  BV216E21A2PP090  BV316E21A2PP090  BV316E22A2PP090.  ",6/22/2016,"06/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74492,"Ongoing","Wm Bolthouse Farms Inc","7200 E Brundage Ln",,"Bakersfield","CA","93307-3016","United States","Voluntary: Firm Initiated","Press Release","Nationwide,and   Canada,   Jamaica  Puerto Rico  Tahiti  Anguilla  Antigua  Aruba  Barbados  St. Maarten   St. Thomas  Qatar  Lebanon  UAE   Bahrain  Oman  Kuwait  Saudi Arabia  Cayman Islands  Guam  Hong Kong  American Samoa","F-1702-2016","Class II","Bolthouse Farms Vanilla Bean Protein Plus:  30 g protein per bottle + 21 vitamins & minerals.  Packaged in 11 oz./325 mL - item number PPV3BF9;   15.2 oz/450 mL  item number: PPV4BF6;- US;    32 oz./946 mL; item number PPVQBF6 - US, PPVQBC6 - Canada:                     Selling Unit UPC                            Case GTIN  11 oz.      0-71464-01867-2                          1-00-71464-01867-9;  15.2 oz.   0-71464-01639-5                          1-00-71464-01639-2;   32 oz       0-71464-01640-1                          1-00-71464-01640-8 US;                    0-71464-01640-1                          1-00-71464-01640-8 - Canada  .  Bolthouse Juice Products, LLC, Bakersfield, CA 93307","3,814,275 units; 624,148 cases - all varieties","Bolthouse Farms is recalling  8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.","07/15/2016",," 11 oz; Best By : 7/24/16 and 8/18/16; All Production Times;  Lots:  BV116D25A2PP090  BV216E20A2PP090  BV316D25A2PP090  BV316E20A2PP090;    15.2 oz -  Best By : 6/22/16 and 6/23/16 and 7/12/16 and 7/21/16 and 8/11/16 and 8/12/16 and 8/22/16 and 9/9/16 and 9/10/16; All Production Times.   Lots:  BV116C25A2PP090  BV216C24A2PP090  BV316C24A2PP090  BV316C25A2PP090  BV116D13A2PP090  BV116D22A2PP090  BV116E14A2PP090  BV216D13A2PP090  BV216D22A2PP090  BV216E13A2PP090R  BV216E14A2PP090  BV216E24A2PP090  BV216F11A2PP090  BV316D22A2PP090  BV316E13A2PP090  BV316E13A2PP090  BV316E14A2PP090  BV316E24A2PP090  BV316F11A2PP090  BV316F12A2PP090;    32 oz. US - Best By : 7/10/16 and 7/11/16 and 8/3/16 and 8/9/16 and 9/13/16,   All Production Times;  Lots:  BV116E05A2PP090  BV116E11A2PP090  BV216D11A2PP090  BV216E05A2PP090  BV216E11A2PP090  BV216F14A2PP090  BV316D11A2PP090  BV316D12A2PP090  BV316F14A2PP090.    32 oz. Canada: Best By : 7/10/16 and 8/24/16 and 9/12/16; ,  All Production Times;  Lots :  BV116D11A2PP090  BV216D11A2PP090  BV216E26A2PP090  BV216F14A2PP090.    ",6/22/2016,"06/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74492,"Ongoing","Wm Bolthouse Farms Inc","7200 E Brundage Ln",,"Bakersfield","CA","93307-3016","United States","Voluntary: Firm Initiated","Press Release","Nationwide,and   Canada,   Jamaica  Puerto Rico  Tahiti  Anguilla  Antigua  Aruba  Barbados  St. Maarten   St. Thomas  Qatar  Lebanon  UAE   Bahrain  Oman  Kuwait  Saudi Arabia  Cayman Islands  Guam  Hong Kong  American Samoa","F-1703-2016","Class II","Bolthouse Farms Coffee Protein Plus:  30 g protein per bottle + 21 vitamins & minerals.  Packaged in 11 oz./325 mL - item number PPJ3BF9;   15.2 oz/450 mL  item number: PPJ4BF6;    32 oz./946 mL; item number PPJQBF6:                     Selling Unit UPC                            Case GTIN  11 oz.       0-71464-01869-6                          1-00-71464-01869-3;  15.2 oz.   0-71464-01627-2                           1-00-71464-01627-9;   32 oz       0-71464-01628-9                           1-00-71464-01628-6;                      Bolthouse Juice Products, LLC, Bakersfield, CA 93307","3,814,275 units; 624,148 cases - all varieties","Bolthouse Farms is recalling  8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.","07/15/2016",," 11 oz; - Best By: 7/7/16 and 7/23/16  and 8/19/16;   All Production Times;  Lots:            BV116D24A2PP090  BV116E21A2PP090  BV216D24A2PP090  BV316D08A2PP090;    15.2 oz -  Best By : 6/23/16 and 7/20/16 and 7/21/16 and 8/11/16 and 8/22/16 and 9/10/16; All Production Times.   Lots:  BV216C25A2PP090  BV116D21A2PP090  BV116E13A2PP090  BV116E24A2PP090  BV216D21A2PP090  BV216E13A2PP090  BV216E24A2PP090  BV216F12A2PP090  BV316D21A2PP090  BV316D22A2PP090  BV316E13A2PP090  BV316F12A2PP090;    32 oz. US - Best By: 7/11/16 and 7/26/16 and 8/10/16 and 9/12/16,   All Production Times;  Lots:  BV116D12A2PP090  BV116D27A2PP090  BV116F14A2PP090  BV216D27A2PP090  BV216E12A2PP090  BV316D12A2PP090  BV316E12A2PP090.        ",6/22/2016,"06/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74492,"Ongoing","Wm Bolthouse Farms Inc","7200 E Brundage Ln",,"Bakersfield","CA","93307-3016","United States","Voluntary: Firm Initiated","Press Release","Nationwide,and   Canada,   Jamaica  Puerto Rico  Tahiti  Anguilla  Antigua  Aruba  Barbados  St. Maarten   St. Thomas  Qatar  Lebanon  UAE   Bahrain  Oman  Kuwait  Saudi Arabia  Cayman Islands  Guam  Hong Kong  American Samoa","F-1706-2016","Class II","Bolthouse Farms Banana Honey Almond Butter Protein Plus:  30 g protein per bottle + 21 vitamins & minerals.  Packaged in 11 oz/450 mL  item number: PPH3BF9;    15.0 oz/946 mL. - item number PPH4BF6;                     Selling Unit UPC                            Case GTIN  11 oz.      0-71464-01918-1                           1-00-71464-01918-8  15.2 oz.   0-71464-01893-1                           1-00-71464-01893-8;    Bolthouse Juice Products, LLC, Bakersfield, CA 93307.","1,377,483 units; 226,477 cases","Bolthouse Farms is recalling  8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.","07/15/2016",," 11 oz -  Best By : 7/3/16 and 7/4/16 and  7/13/16 and 7/14/16 and 8/20/16 and 8/21/16 and 9/15/16; All Production Times.   Lots:  BV216D04A2PP090  BV216D14A2PP090  BV216E22A2PP090  BV216F17A2PP090  BV316D04A2PP090  BV316D05A2PP090  BV316D14A2PP090  BV316D15A2PP090;    15.2 oz.- Best By : 6/23/16 and 8/20/16 and 9/15/16 ; All Production Times;  Lots:  BV116F17A2PP090  BV216C25A2PP090  BV216E22A2PP090  BV216F17A2PP090  BV316C25A2PP090.       ",6/22/2016,"06/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74492,"Ongoing","Wm Bolthouse Farms Inc","7200 E Brundage Ln",,"Bakersfield","CA","93307-3016","United States","Voluntary: Firm Initiated","Press Release","Nationwide,and   Canada,   Jamaica  Puerto Rico  Tahiti  Anguilla  Antigua  Aruba  Barbados  St. Maarten   St. Thomas  Qatar  Lebanon  UAE   Bahrain  Oman  Kuwait  Saudi Arabia  Cayman Islands  Guam  Hong Kong  American Samoa","F-1707-2016","Class II","Bolthouse Farms Mocha Cappuccino Perfectly Protein :   30 g protein per bottle + 21 vitamins & minerals.  Packaged in 15.2 oz/946 mL.- item number MC4BF6 - US and MC4BC6 - Canada;  32 oz./946 mL  item number: MCQBF6 - US; MCQBC6 - Canada                     Selling Unit UPC                            Case GTIN  15.2 oz.   0-71464-30050-0                           1-00-71464-30003-3 - US                   0-71464-30050-0                           1-00-71464-30003-3 - Canada      32 oz.       0-71464-30051-7                          1-00-71464-30002-6 - US                    0-71464-30051-7                          1-00-71464-30002-6 - Canada                              Bolthouse Juice Products, LLC, Bakersfield, CA 93307.","3,814,275 units; 624,148 cases","Bolthouse Farms is recalling  8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.","07/15/2016",," 15.2 oz - US.- Best By: 9/2/16  ; All Production Times;  Lots:       BV216F04A2MC090       BV316E04A2MC090.    15.2 oz - Canada - Best By: 9/2/16; All Production times:  Lots:  BV116F04A2MC090  BV216F04A2MC090.    32 oz - US - Best By: 8/2/16 and 8/3/16; All Production Times;  Lots:       BV116E04A2MC090      BV216E04A2MC090      BV316E04A2MC090;    32 oz. - Canada - Best By: 8/2/16; All Production Times;  Lots:  BV116E04A2MC090  BV216E04A2MC090                     ",6/22/2016,"06/22/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74493,"Ongoing","Meduri Farms Inc","12375 Smithfield Rd",,"Dallas","OR","97338-9587","United States","Voluntary: Firm Initiated","Telephone","distributed in CA, CO, ID, MD, OR, TX and WA and in Australia, Canada, China, Great Britain, Hong Kong, and India.","F-1861-2016","Class I","Meduri Farms Dried Blueberries/Sugar Infused, Catalog  #s: 080282, 08028X, 08028, 080281, 08127X.  Product is packaged in a BULK corrugated box with food grade plastic liner, net weight 10 lbs., 20 lbs., and 25 lbs. ","146,468 lbs.","Meduri Farms Dried Blueberries/Sugar Infused product is recalled due to a potential contamination with peanut protein.  The firm found half of a peanut while packaging dried blueberries product.","08/01/2016",," Batch/ Lot numbers:    065781/ 20238065781  065791/ 21034065791  065781/ 21344065781  065781/ 21352065781  065778/ 21371065778  065781/ 21387065781  065810/ 21405065810  065802/ 21406065802  065802/ 21420065802  065827/ 21421065827  065802/ 21425065802  065810/ 21426065810  065810/ 21448065810  065802/ 21451065802  065791/ 21455065791  065827/ 21467065827  065827/ 21469065827  065810/ 21476065810  065802/ 21498065802  ",6/20/2016,"06/20/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74497,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1494-2016","Class II","ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).    ","1,299 bags","CGMP Deviations","09/07/2016",," All lots within Expiry. Lot # 4720915, 6790315, 6800315, 6810315, 6820315",6/16/2016,"06/16/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74497,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1495-2016","Class II","Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC#  0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)      ","92,480 containers","CGMP Deviations","09/07/2016",," All Lots Within Expiry  ",6/16/2016,"06/16/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74497,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1497-2016","Class II","Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454  NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)    ","13,223 vials","CGMP Deviations","09/07/2016",," All Lots Within Expiry  Lot # 2930614, 2940614, 2950614",6/16/2016,"06/16/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74497,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1496-2016","Class II","Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.    ","14,661 vials","CGMP Deviations","09/07/2016",," All Lots Within Expiry  Lot# 2710715, 2720715, 2730715, 3110715, 3120715",6/16/2016,"06/16/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74500,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV),  Sweden, South Africa,  Chile, Australia,  New Zealand,  Canada,  United Kingdom, Switzerland, Colombia,  and Poland.","Z-2281-2016","Class II","Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm.  Non Sterile    Catalog Numbers 2199-2022, 2199-2028 and 2199-2032.    For use in total hip arthroplasty.","1,864 units","Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.","07/25/2016",," Catalog Nos. 2199-2022, 2199-2028 and 2199-2032  All lots manufactured from May 30, 2012",6/3/2016,"06/03/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74502,"Ongoing","Teva North America","425 Privet Rd",,"Horsham","PA","19044-1220","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1455-2016","Class II","Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16","8,052 bottles","Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. ","08/09/2016",," Lot # 95113, exp 01/2017",6/22/2016,"06/22/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74503,"Ongoing","Immune Tree, Inc (formerly ITG, Inc.)","Ste. 100","14512 S. Centerpoint Way","Bluffdale","UT","84065","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, worldwide.  No military/govt/VA consignees.","F-2333-2016","Class II","Colostrum6 Powder (6.5 oz) Item No. 9902;  Sold under the following brands: Immune Tree, Surthrival, HealthWorks (Not purchased since 3/18/15). Packaged in HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle","2654 containers","Immune Tree is recalling certain Immune Tree; Health Works; Immune Pro6; Good For You and Surthrival brand colostrum products due to undeclared milk allergen.","09/16/2016",," Lot #9902-014, 9902-032, 9902-042, 9902-052, 9902-062, 9902-063 9902-075, 9902-076, 9902-083, 9902-088, 9902-089, 9902-103, 9902-104, 9902-111, 9902-126, 9902-131, 9902-132, 9902-138",6/6/2016,"06/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74503,"Ongoing","Immune Tree, Inc (formerly ITG, Inc.)","Ste. 100","14512 S. Centerpoint Way","Bluffdale","UT","84065","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, worldwide.  No military/govt/VA consignees.","F-2336-2016","Class II","Colostrum6 Powder (2.5 oz), Item No. 9915, Sold under brand Immune Tree (discontinued), Packaged using HDPE White bottle","222 bottles","Immune Tree is recalling certain Immune Tree; Health Works; Immune Pro6; Good For You and Surthrival brand colostrum products due to undeclared milk allergen.","09/16/2016",," Lot #9915-012, 9915-028, 9915-042, 9915-095, 9915-110, 9915-111",6/6/2016,"06/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74503,"Ongoing","Immune Tree, Inc (formerly ITG, Inc.)","Ste. 100","14512 S. Centerpoint Way","Bluffdale","UT","84065","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, worldwide.  No military/govt/VA consignees.","F-2335-2016","Class II","Colostrum6 Powder Kilo (35.3 oz); Item No. 9903; Brand Name Immune Tree, Surthrival, Packaged using HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle","1608 bottles","Immune Tree is recalling certain Immune Tree; Health Works; Immune Pro6; Good For You and Surthrival brand colostrum products due to undeclared milk allergen.","09/16/2016",," Lot #9903-014, 9903-021, 9903-047, 9903-049, 9903-055, 9903-060, 9903-062, 9903-063, 9903-068, 9903-069, 9903-077 ",6/6/2016,"06/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74503,"Ongoing","Immune Tree, Inc (formerly ITG, Inc.)","Ste. 100","14512 S. Centerpoint Way","Bluffdale","UT","84065","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, worldwide.  No military/govt/VA consignees.","F-2334-2016","Class II","LeptiTrim6 Vanilla Shake Item No. 9907; 860 g. Brand Immune Tree; Packaged using HDPE White bottle","513 bottles","Immune Tree is recalling certain Immune Tree; Health Works; Immune Pro6; Good For You and Surthrival brand colostrum products due to undeclared milk allergen.","09/16/2016",," Lot #031016-01, 9907-071, 9907-074, 9907-075, 9907-105, 9907-123",6/6/2016,"06/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74503,"Ongoing","Immune Tree, Inc (formerly ITG, Inc.)","Ste. 100","14512 S. Centerpoint Way","Bluffdale","UT","84065","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, worldwide.  No military/govt/VA consignees.","F-2332-2016","Class II","Colostrum6 Capsules 500mg, Item No 9901, 180 ct.  Sold under the brands: Immune Tree, Immune Pro-6 (Not purchased since 8/25/2014), Surthrival, Good For You Canada. Packaged using HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle","6258 bottles","Immune Tree is recalling certain Immune Tree; Health Works; Immune Pro6; Good For You and Surthrival brand colostrum products due to undeclared milk allergen.","09/16/2016",," Lot #24610, 24628, 041416-01, 050416-01",6/6/2016,"06/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74505,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Letter","US","Z-2269-2016","Class III","Proadvantage Mono Rapid Test Cassette, Catalog No. P080016   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.",,"The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.","07/22/2016",," all lots are affected",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74505,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Letter","US","Z-2271-2016","Class III","Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.",,"The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.","07/22/2016",," all lots are affected",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74505,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Letter","US","Z-2267-2016","Class III","Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.",,"The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.","07/22/2016",," all lots are affected",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74505,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Letter","US","Z-2266-2016","Class III","Cardinal Health Mono Rapid Test, Catalog No. B1077-28,   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes. ",,"The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.","07/22/2016",," all lots are affected",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74505,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Letter","US","Z-2270-2016","Class III","Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.",,"The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.","07/22/2016",," all lots are affected",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74505,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Letter","US","Z-2265-2016","Class III","Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404.  Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.   ",,"The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.","07/22/2016",," all lots are affected",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74505,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Letter","US","Z-2268-2016","Class III","Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.  ",,"The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.","07/22/2016",," all lots are affected",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74507,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","Worldwide distribution to Belgium, China, Egypt, Germany, India, Korea, Republic of, Myanmar, Nigeria, Peru, Russian Federation, Rwanda, Singapore, Spain, Sweden, Taiwan, Thailand, and United Kingdom","Z-2109-2016","Class II","Big Bore Oncology tomography X-ray system scanner, model number 728243.   The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes","47 units","Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel. ","06/30/2016",," Big Bore Oncology System Code 728243; Serial numbers:	  75002, 75003, 75004, 75005, 75006, 75007, 75008, 75009, 75010, 75011, 75012, 75014, 75015, 75016, 75017, 75018, 75019, 75020, 75021, 75022, 75023, 75024, 75025, 75026, 75030, 75032, 75035, 75036, 75037, 75040, 75042, 75044, 75047, 75048, 75049, 75051, 75053, 75060, 75064, 75100, 75102, 75104, 75105, 750111, 750114  ",6/14/2016,"06/14/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74507,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","Worldwide distribution to Belgium, China, Egypt, Germany, India, Korea, Republic of, Myanmar, Nigeria, Peru, Russian Federation, Rwanda, Singapore, Spain, Sweden, Taiwan, Thailand, and United Kingdom","Z-2110-2016","Class II","Big Bore Radiology tomography X-ray system scanner, model number 728244.   The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. ","89","Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel. ","06/30/2016",," Big Bore Radiology System Code 728244; Serial numbers  75033, 75110  ",6/14/2016,"06/14/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74508,"Ongoing","CareFusion 303, Inc.","10020 Pacific Mesa Blvd",,"San Diego","CA","92121-4386","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.","Z-2879-2016","Class II","Alaris Syringe Module Model 8110 with software version 9.15    The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.","12,000 units","A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.  ","09/23/2016",," Software version 9.15",8/8/2016,"08/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74509,"Ongoing","Teva North America","425 Privet Rd",,"Horsham","PA","19044-1220","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1449-2016","Class III","Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.","14, 370 units","Failed Tablet/Capsule Specifications","07/27/2016",," Lot #: 02D163, Exp. 9/2017",5/18/2016,"05/18/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74510,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","E-Mail","Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA.  There was no government/military/foreign distribution.","Z-2159-2016","Class II","Merge OfficePACS software.  The firm name on the label is Merge Healthcare, Heartland, WI.","49 sites have the affected software","Potential data loss occurs as a result of product archiving not working properly.","07/11/2016",," Version 3.4",1/31/2016,"01/31/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74511,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.","Z-2111-2016","Class II","Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional  images of the body.","3 units","Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel.  ","06/30/2016",," 921216",6/21/2016,"06/21/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74511,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.","Z-2112-2016","Class II","Brilliance iCT model #728306; Intended to produce cross- sectional  images of the body.  ","1 unit","Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack. ","06/30/2016",," 911162",6/21/2016,"06/21/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74511,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.","Z-2115-2016","Class II","Ingenuity Core, model # 728326; Intended to produce cross- sectional  images of the body.","1 unit","Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel. ","06/30/2016",," 901510",6/21/2016,"06/21/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74511,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.","Z-2114-2016","Class II","Ingenuity Core 128, model #728323; Intended to produce cross- sectional  images of the body.","14 units","Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel. ","06/30/2016",," 901469, 901479, 901487, 901491, 901497, 901502, 901508, 901515, 901517, 901518, 901520, 901530, 901533, 921223    ",6/21/2016,"06/21/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74511,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.","Z-2113-2016","Class II","Ingenuity Flex, model # 728317; Intended to produce cross- sectional  images of the body. ","10 units","Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel. ","06/30/2016",," 901475, 901476, 901495, 901505, 901509, 901513, 901529, 901532, 901539, 901541",6/21/2016,"06/21/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74513,"Ongoing","Bayer Healthcare","1 Bayer Dr",,"Indianola","PA","15051-9702","United States","Voluntary: Firm Initiated","Letter","Worldwide and the US state of NEW YORK","Z-2244-2016","Class II","Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit    Usage:  The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.  ","42 units","Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.","07/19/2016",," Catalog numbers: MRXP 200  Serial numbers: 100009, 100011, 100019, 100020, 100022, 100026, 100027, 100028, 100036, 100047, 100065, 100066, 100069, 100074, 100075, 100085, 100090, 100091, 100096, 100097, 100098, 100099, 100100, 100101, 100103, 100104, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100118, 100119, 100129, 100152, 100155, 100161, 100166",6/9/2016,"06/09/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74514,"Ongoing","Teva North America","425 Privet Rd",,"Horsham","PA","19044-1220","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1451-2016","Class III","mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA  92618, NDC 0703-4685-01.","2,506 vials","Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.","07/28/2016",," Lot # 31318659B, Exp 02/17",5/31/2016,"05/31/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74515,"Ongoing","Karl Storz Endoscopy","2151 E Grand Ave",,"El Segundo","CA","90245-5017","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution to the states of : IL, NM, TX, MD, TN, PA, FL, KY, MO, NY, MN, DC, MA, WI, CT, MI, ID, CO, GA, NJ and AR., and to the countries of : Argentina, Australia, Belgium, Bulgaria, China, Germany, Finland, Great Britain, India, Italy and Japan.","Z-2134-2016","Class II","Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope     ","619 units total (90 units in US)","Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinocope and an electro-surgery generator (ESG).","07/06/2016","."," NT743473-P  NT743472-P  NT742840-P  XU738911-P  YU741045-P  XU738248-P  WU737260-P  PV715203-P  PV715207-P  NT742829-P  XU738899-P  WU737275-P  YV724235-P  WU737269-P  WU737268-P  VU736411-P  XU738901-P  XU738910-P  ZU742677-P  YU741050-P  VU736405-P  TU733422-P  TU733419-P  SU733063-P  VU736390-P  VU736386-P  UU734392-P  RV716122-P  OT744400-P  NT743287-P  OT744395-P  NU727551-P  NU727552-P  NU727706-P  TU734218-P  TU734217-P  NT742846-P  YU741046-P  OU728667-P  TU733735-P  VU736388-P  NT742848-P  NT742838-P  OU728672-P  OU728427-P  WU737813-P  OU729135-P  OU728431-P  OU728430-P  WU737805-P  ZU742670-P  ZU742671-P  YU741049-P  YU740475-P  ZU742681-P  RV716116-P  SU733055-P  SU733057-P  SU733059-P  SU733060-P  TU733418-P  TU733420-P  TU733421-P  TU733423-P  TU733424-P  TU733425-P  TU733427-P  WU737810-P  XU738914-P  YU740004-P  YU740471-P  YU740479-P  YU740480-P  YU741036-P  NV711744-P  PV715216-P  OU728670-P  NU726430-P  OT744399-P  OT744389-P  OT744386-P  YU739999-P  YU740003-P  YU740005-P  UU734395-P  YV724443-P  YV724442-P  YV724440-P  YV724438-P  YV724245-P  ",6/20/2016,"06/20/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74516,"Ongoing","Deli-Food Chili & Spice LLC","6850 Mcnutt Rd","Ste 100","Anthony","NM","88021-9241","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","2 consignees in Maryland and Ohio. No Canadian/foreign/VA/govt/military.","F-1872-2016","Class I","Deli-Food Ancho Chile Powder 50 lb corrugated boxes x 45 each.","2,250 lbs","Deli-Food Chili & Spice LLC announces a voluntary field action for Ancho Chile Powder due to positive testing for Salmonella. ","08/04/2016",," Lot #: C-01772-16069",6/10/2016,"06/10/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74517,"Ongoing","Inner Health Group, Inc dba Michael's Naturopathic Programs","6003 Randolph Blvd.",,"San Antonio","TX","78233","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-1869-2016","Class I","Michael's Naturopathic Programs Cholesterol Metabolism Factors 270 count, 180 count, and 90 count tablets packaged in plastic bottles","18,375 units","May contain undeclared milk (in the form of calcium caseinate) and soy.","08/03/2016",," Lot numbers: 1307013, 1310060, 1402177, 1405356, 1408114, 1410186, 1501476, 1505367, 1510296, 1602062",6/23/2016,"06/23/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74518,"Ongoing","Radagast Pet Food, Inc.","3617 SE 17th Ave",,"Portland","OR","97202-3831","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide except HI and MS and in Canada","V-535-2016","Class I","Frozen Rad Cat Raw Diet Free-Range Turkey,  8 oz, UPC 851536001005.  Frozen Rad Cat Raw Diet Free-Range Turkey, 16oz, UPC 851536001012.   Frozen Rad Cat Raw Diet Free-Range Turkey, 24oz, UPC 851536001029.   ","3889 containers total.","Frozen Rad Cat Raw Diet Free-Range Turkey product is recalled due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes.","09/30/2016",," Lot Code 62372, Best By Date: 01/21/2017        ",6/22/2016,"06/22/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74518,"Ongoing","Radagast Pet Food, Inc.","3617 SE 17th Ave",,"Portland","OR","97202-3831","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide except HI and MS and in Canada","V-534-2016","Class I","Frozen Rad Cat Raw Diet Free-Range Chicken, 8 oz, UPC 851536001036.  Frozen Rad Cat Raw Diet Free-Range Chicken, 16oz, UPC 851536001043.   Frozen Rad Cat Raw Diet Free-Range Chicken, 24oz, UPC 851536001050.   Frozen Rad Cat Raw Diet Free-Range Chicken, 1oz samples.","2869 containers total and 540/1 oz. sample cups","Frozen Rad Cat Raw Diet Free-Range Chicken product is recalled due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes.","09/30/2016",," Lot code 62416, Best By Date: 03/14/2017         ",6/22/2016,"06/22/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74518,"Ongoing","Radagast Pet Food, Inc.","3617 SE 17th Ave",,"Portland","OR","97202-3831","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed nationwide except HI and MS and in Canada","V-533-2016","Class I","Frozen Rad Cat Raw Diet Grass-Fed Beef, 8 oz, UPC 851536001241.  Frozen Rad Cat Raw Diet Grass-Fed Beef, 16oz, UPC 851536001258.   Frozen Rad Cat Raw Diet Grass-Fed Beef, 24oz, UPC 851536001265.   Frozen Rad Cat Raw Diet Grass-Fed Beef, 1oz samples.","7739 containers total and 3600/1 oz. sample cups","Frozen Rad Cat Raw Diet Grass-Fed Beef product is recalled due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes.","09/30/2016",," Lot  62361, best by date 1/8/2017  Lot  62384, best by date  2/6/2017          ",6/22/2016,"06/22/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74519,"Ongoing","Stratus Pharmaceuticals Inc","12379 SW 130th St",,"Miami","FL","33186-6208","United States","Voluntary: Firm Initiated","Letter","Nationwide and PR","D-1464-2016","Class III","Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz  (142 g) and b) 9.0 oz  (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ.  Distributed by Stratus Pharmaceuticals Inc., Miami, FL.","a) 12,345 tubes; b) 8,578 tubes","Crystallization; Complaints that cream appears to have crystallized","08/23/2016",," a) Lot (Exp): 8020 (02/17), 8096 (07/18), 8125 (08/18), 8169 (10/18).  NDC 58980-680-50    b) Lot (Exp): 8020 (02/17), 8125 (08/18), 8170 (10/18). NDC 58980-680-90",5/26/2016,"05/26/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74520,"Ongoing","Ab Sciex","500 Old Connecticut Path",,"Framingham","MA","01701-4574","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally to   Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,","Z-2526-2016","Class II"," LC/MS/MS System. In-Vitro Diagnostic  Instrument Part Number (REF): 5024501  3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.","124 units","MultiQuant MD software where under certain conditions a user  can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.","08/12/2016",," Software Version:  MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software ",6/16/2016,"06/16/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74520,"Ongoing","Ab Sciex","500 Old Connecticut Path",,"Framingham","MA","01701-4574","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally to   Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,","Z-2527-2016","Class II","AB SCIEX 3200MD QTRAP¿ LC/MS/MS System  Mass Spectrometer  for In-Vitro Diagnostic Use.  Instrument Part Number (REF): 5024500  3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.","2 units","MultiQuant MD software where under certain conditions a user  can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.","08/12/2016",," Software Version:  MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software ",6/16/2016,"06/16/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74520,"Ongoing","Ab Sciex","500 Old Connecticut Path",,"Framingham","MA","01701-4574","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally to   Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,","Z-2529-2016","Class II","AB SCIEX QTRAP¿ 4500MD LC/MS/MS System  Mass Spectrometer  for In-Vitro Diagnostic Use.  Instrument Part Number (REF): 5031231  3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.","28 units","MultiQuant MD software where under certain conditions a user  can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.","08/12/2016",," Software Version:  MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software ",6/16/2016,"06/16/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74520,"Ongoing","Ab Sciex","500 Old Connecticut Path",,"Framingham","MA","01701-4574","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally to   Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,","Z-2528-2016","Class II","AB SCIEX Triple Quad 4500MD LC/MS/MS System.  Mass Spectrometer  for In-Vitro Diagnostic Use.  Instrument Part Number (REF): 5031257  3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.","121 units","MultiQuant MD software where under certain conditions a user  can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.","08/12/2016",," Software Version:  MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software ",6/16/2016,"06/16/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74521,"Ongoing","The Father's Table, LLC","2100 Country Club Rd",,"Sanford","FL","32771-4051","United States","Voluntary: Firm Initiated","E-Mail","In process.","F-1825-2016","Class II","GFS Sea Salt Caramel Cheesecake, 68 oz, 14 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.","76 cases (304 cakes)","Undeclared allergen- peanut protein.","07/22/2016",," Item #: 51633, Package/Case # (exp date): 1221642/05-01-17 (05/01/17).",6/20/2016,"06/20/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74521,"Ongoing","The Father's Table, LLC","2100 Country Club Rd",,"Sanford","FL","32771-4051","United States","Voluntary: Firm Initiated","E-Mail","In process.","F-1823-2016","Class II","GFS Fruit Swirl Variety Cheesecake, 68 oz, 12 cut.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.","63 cases (252 cakes)","Undeclared allergen- peanut protein.","07/22/2016",," Item #: 75667, Package/Case # (exp date): 1121642/04-21-17 (04/21/17).",6/20/2016,"06/20/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74521,"Ongoing","The Father's Table, LLC","2100 Country Club Rd",,"Sanford","FL","32771-4051","United States","Voluntary: Firm Initiated","E-Mail","In process.","F-1824-2016","Class II","GFS Raspberry Lemonade Cheesecake, 68 oz, 14 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.","432 cases (1,728 cakes)","Undeclared allergen- peanut protein.","07/22/2016",," Item #: 59121, Package/Case # (exp date): 1141641/04-23-17 (04/23/17), 1221642/05-01-17 (05/01/17).",6/20/2016,"06/20/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74521,"Ongoing","The Father's Table, LLC","2100 Country Club Rd",,"Sanford","FL","32771-4051","United States","Voluntary: Firm Initiated","E-Mail","In process.","F-1821-2016","Class II","GFS Creamy Indulgence NY Style Cheesecake, 68 oz, 12 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.","959 cases (3,836 cakes)","Undeclared allergen- peanut protein.","07/22/2016",," Item # 75662, Package/Case # (exp date): 1011641/04-10-17 (04/10/2017), 1061642/04-15-17 (04/15/17), 1121641/04-21-17 (0421/17), 1231642/05-02-17 (05/02/17).",6/20/2016,"06/20/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74521,"Ongoing","The Father's Table, LLC","2100 Country Club Rd",,"Sanford","FL","32771-4051","United States","Voluntary: Firm Initiated","E-Mail","In process.","F-1826-2016","Class II","GFS Brownie Cheesecake, 54 oz, 12 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.","156 cases (624 cakes)","Undeclared allergen- peanut protein.","07/22/2016",," Item #: 75664, Package/Case # (exp date): 1231642/05-02-17 (05/02/17).",6/20/2016,"06/20/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74521,"Ongoing","The Father's Table, LLC","2100 Country Club Rd",,"Sanford","FL","32771-4051","United States","Voluntary: Firm Initiated","E-Mail","In process.","F-1822-2016","Class II","GFS Triple White Chocolate Cheesecake, 68 oz, 14 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.","413 cases (1,652 cakes)","Undeclared allergen- peanut protein.","07/22/2016",," Item #: 59122, Package/Case # (exp date): 1101642/04-19-17 (04/19/17), 1211642/04-30-17 (04/30/17).",6/20/2016,"06/20/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74522,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","E-Mail","The software was distributed nationwide to medical facilities.  There was no government/military/foreign distribution.","Z-2144-2016","Class II","Merge OfficePACS software.  The firm name on the label is Merge Healthcare, Hartland, WI.  OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.","216 sites have the affected software","Potential data loss occurs as a result of the software archiving not working properly. ","07/08/2016",," Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2",1/30/2016,"01/30/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74523,"Ongoing","Draeger Medical, Inc.","3135 Quarry Rd",,"Telford","PA","18969-1042","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including Puerto Rico and the states of  AK,AL,AR,CA,CO,CT,DE,FL,GA,HI,IA,IL,IN,KS,KY,LA,MA,MD,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TS,TX,UT,VA,WA,WI,WV, and WY.","Z-2295-2016","Class II","Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled.    Product Usage:  Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer bassinet during normal and intensive care - For infant re-warming and compensation of heat loss - For thermal stabilizing of infants with mattress heater (Babytherm 8010 only) - For gentle warming therapy using the combination of radiant and mattress heater - Cooling infants with fever (temperature of mattress below infant body temperature, Babytherm 8010 only) - With adjustable bed tilt for treatment of infants in Trendelenburg and reverse Trendelenburg position - For weaning infants from incubators - For O2 and nebulizer therapy (with appropriate accessories) - For lowering an infant s bilirubin levels when using the phototherapy option  ","1,599 units","Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.","07/28/2016",," Serial Numbers: ARLN-xxxx to ASFE-xxxx  Catalog Numbers: FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004)   ",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74524,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Distributed to:               CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA","Z-2298-2016","Class II","Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.","1,004 units","Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on  a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot  334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control  Levels and patient samples.","07/28/2016",," Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324  Syva¿ EMIT¿ 2000 Theophylline - kit lot G3",6/17/2016,"06/17/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74524,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Distributed to:               CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA","Z-2299-2016","Class II","ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems.  Copies of IFUs included in submission.      ","658 units","Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on  a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot  334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control  Levels and patient samples","07/28/2016",," ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent - SMN# 10377503, Lot # 334018",6/17/2016,"06/17/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74525,"Ongoing","Fujifilm Medical Systems U.S.A., Inc.","419 West Ave",,"Stamford","CT","06902-6343","United States","Voluntary: Firm Initiated","Letter","US Distribution to: NC and HI.","Z-2690-2016","Class II","FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY)    The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.","2 Units","If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.","08/30/2016",," 26330437 and 17230408  ",6/9/2016,"06/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74527,"Terminated","Prime Time International","86705 Avenue 54 Ste A",,"Coachella","CA","92236-3814","United States","Voluntary: Firm Initiated","Letter","US: CA","F-0476-2017","Class I","PRIME TIME Cucumbers, 1 & 1/9 BUSHEL CARTON, 25kg per carton, TAG ID# 10173318, 10173319, 10173320, 10173322.","168 cartons","Sun and Sands Enterprise dba Prime Time International is recalling cucumber bushels (Lot 10-1461) because they have the potential to be contaminated with Salmonella.","11/17/2016","11/17/2016"," 10-1461",6/23/2016,"06/23/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74528,"Ongoing","Citra Labs LLC.","55 Messina Dr",,"Braintree","MA","02184-6783","United States","Voluntary: Firm Initiated","Letter","Nationwide","B-0730-16","Class II","Citra Labs triCitrasol, Anticoagulant Sodium Citrate Concentrate, 46.7% Trisodium Citrate, 30 mL  P/N 6030-10 bottles/case  P/N 6032-12 bottles/case  ","4,436 bottles","Citra Lab's ACD-A and tri-Citrasol anticoagulants, both manufactured in glass containers which may contain a defect and compromise sterility of the products, were distributed. ","08/29/2016",," PN6030 Lot Numbers:  G32E  G32K  15C02A  15C02B    PN6032; Lot Number G32H",6/29/2016,"06/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74528,"Ongoing","Citra Labs LLC.","55 Messina Dr",,"Braintree","MA","02184-6783","United States","Voluntary: Firm Initiated","Letter","Nationwide","B-0729-16","Class II","ACD-A, Anticoagulant Citrate Dextrose Solution, Solution A, USP, 30 mL.   Packaged under the following labels:  P/N: 9332 labeled for Biomet  P/N: 9335 labeled for Cytomedix  P/N: 9338 la bled for SpineSmith   P/N: 9350 Citra label","127,640 bottles","Citra Lab's ACD-A and tri-Citrasol anticoagulants, both manufactured in glass containers which may contain a defect and compromise sterility of the products, were distributed. ","08/29/2016",," PN9332 Lot Numbers:  E32H  E32N  E35K  E35L  F31E  F31M  F32J  F32K  E36A  E36N  F34J  F34N  F35H  F35K  F33H  F33K  F37A  F37E  F38J  F38N  F39J  F39L  G33H  G33J  G31E  G31K  G34F  G34N  G35L  G35N  G36E  G36N  G37J  G37H  G38N  G38K  A41E  A41H  A45H  A45K  A46L  A46M  A47J  A47K  A48C  A48N  14L02A  14L02B  15D01A  15D01B  15E01A  15E01B  15E02A  15F01A  15F01B  15F03A  15F03B    PN9335:    Lot Numbers:  E34K  E34N  A42H  A43K  15E02B    PN9338:    Lot Numbers:  F310N  F310J  A42K  A43H    PN9350:    Lot Number:  14L02C",6/29/2016,"06/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74529,"Ongoing","Moller Vital","Hadelandsvegen 2","P.o. Box 408","Gjovik",,,"Norway","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide)  and Internationally to SZ, TR, BE, CH, DE, DK, ES, FI, FR, GB, IS LV, NL, NO, SE, SI, AU, CN, IL, JP, NZ, IN, QA, PE, AE","Z-2291-2016","Class II","Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion  Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various situations. The coupling that holds the suspension is fixed to the lifting belt by a bolt through an aluminum housing. The bolt is hold in place by a rubber cap secured with a small screw. The other end of the lifting belt is fixed to the lifting drum on the motor. The design is identical on both Air 205 and Air 300 in all variants","516 units (374 US)","Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing. ","07/26/2016",," 45638  45639  45640  45641  45642  45643  45644  45645  45646  45647  45869  46381  46851  46852  46853  46854  46855  46856  46857  46858  46859  46860  46861  46862  46863  46864  46865  46866  46867  46868  46870  46872  46873  46874  46875  46876  46877  46878  46879  46880  46881  46882  46883  46884  46885  46886  46887  46888  46889  46890  46891  46892  46893  46894  46895  46896  46897  46898  46899  46900  46901  46902  46903  46904  46911  46912  46913  46914  46915  46916  46917  46918  46919  46920  46921  46922  46923  46924  46925  46926  46927  46928  46929  46930  46931  46935  46936  46937  46938  46939  46940  46941  46942  46943  46944  46945  46946  46947  46948  46949  46950  48210  48211  48212  48213  48214  48215  48216  48217  48218  48219  48220  48221  48222  48223  48224  48225  48226  48227  48228  48229  48230  48231  48232  51766  51767  51768  51769  51770  51771  51772  51773  51774  51775  51776  51777  51778  51779  51780  51781  51782  51783  51784  51785  51786  51787  51788  51789  51790  51791  51792  51793  51794  51795  53158  53159  53160  53161  53162  53163  53164  53165  53166  53167  53168  53172  53173  53174  53175  53176  53177  53178  53179  53180  53181  53182  53409  53410  53411  53412  53430  53566  53603  53604  53605  53618  53619  54378  54379  54380  54381  54382  54383  54384  54385  54386  54387  54388  54389  54390  54391  54392  54393  54394  54395  54396  54397  54398  54399  54400  54401  54402  54403  54404  54405  54406  54407  54636  56381  56382  56383  56384  56385  56386  58001  58002  58003  58004  58005  58006  58152  58153  58154  58155  58156  58157  58158  58159  58160  58963  58964  58965  58966  58967  58968  58969  58970  58971  58972  58973  58974  59671  59672  59673  59674  59675  59676  59677  59678  59679  59680  59681  59682  59683  59684  59685  59686  59687  59688  59689  59690  59691  59692  59693  59694  59695  59696  59697  59698  59699  59700  59701  59702  59703  59704  59705  59706  59707  59708  59709  59710  59711  ",6/24/2016,"06/24/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74530,"Ongoing","Kill Cliff","143 Mystic Pl Ne",,"Atlanta","GA","30342-2520","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AR, AZ, CA, CT, DE, FL, GA, ID, IL, IN, IIO, KS, KY, LA, MA, MD, ME, MI, MS, MO, NC, ND, NH, NJ, NM, NY, NV, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WI and WY; International accounts: Europe and the Pacific.","F-2246-2016","Class II","KC (Kill Cliff) Strawberries & Cream Protein Bars, 2.1oz (60g) individually wrapped bar (in cases of 12-2.1 oz (60g) bars).","43,788 bars","Product may contain mold. Recall started on 6/21/16","09/15/2016",," UPC code 896743002124, Use by Date: 16July2016.",6/21/2016,"06/21/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74531,"Ongoing","Nature's Harmony LLC","1984 Bakers Ferry Rd",,"Elberton","GA","30635-5949","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","GA","F-1857-2016","Class I","Cherokee Rose Hand Made cheese, Produced by Natures Harmony in Berton, GA 30635.","7 units weighing a total of 92 pounds","Product was found to be contaminated with Salmonella. Product was distributed to food service established only.","08/01/2016",," Lot number: 022916.",6/21/2016,"06/21/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74532,"Ongoing","Valeant Pharmaceuticals North America LLC","400 Somerset Corporate Blvd",,"Bridgewater","NJ","08807-2867","United States","Voluntary: Firm Initiated","Letter","US Nationwide","D-1059-2016","Class III","SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.","958 Bottles","Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis. ","06/30/2016",," Lot #: 2555979, Expiry: 09/2016.",6/10/2016,"06/10/2016",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74533,"Ongoing","Danville Materials, Inc.","3420 Fostoria Way Ste A200",,"San Ramon","CA","94583-1327","United States","Voluntary: Firm Initiated","Letter","US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.","Z-2530-2016","Class II","Perioscopy Sheath:  Part number: 1008;        The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).  ","~ 2123 units","The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date.  Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim. ","08/12/2016",," Part number 1008:  Lot numbers:  1133; 1135; 1136; 1137; 1138; 1163; 1171; 1172; 1173;   1174; 1175; 1218; 1240; 1243; 1258; 1264; 1264-1;    1275; 1276; 1277; 1311; 1314; 1315; 1325; 1326.  ",6/24/2016,"06/24/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74534,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, U.A.E.,  Algeria,  Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Canada, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland,   Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Namibia, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.","Z-2525-2016","Class II","Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument  that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP.  SMN: 10444834, 10453531","977 units","Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.","08/11/2016",," All software versions and serial numbers",6/22/2016,"06/22/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74535,"Ongoing","Mondelez International","200 Deforest Ave",,"East Hanover","NJ","07936-2833","United States","Voluntary: Firm Initiated","Press Release","Nationwide","F-1970-2016","Class II","Nabisco Honey Maid Teddy Grahams Cinnamon  Cubs Graham Snacks Net Wt .5 oz (14g) Distributed by Mondelez Global LL East Hanover, NJ 07936 USA  UPC 019320016769      ","544 cases (150 units per case)","Teddy Graham Cub Snacks were produced using Grain Craft Flour containing peanut residue.","08/24/2016",," 11 Oct 16 - 12 Oct 16  (top of package)",6/23/2016,"06/23/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74536,"Ongoing","Land O Lakes Purina LLC","1080 County Road F W",,"Shoreview","MN","55126-2910","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH, PA","V-539-2016","Class I","Product is in a White and Green 50lb. paper bag, PURINA LAMB GROWER B30 MEDICATED Type C Medicated Feed COMPLETE FEED FOR GROWER SHEEP. 30.00 g/ton Lasalocid. Manufactured by Purina Animal Nutrition LLC.","508  50 lb. bags","Elevated levels of copper","09/30/2016",," Lot Number: 6May06WCH2  Item No. 1850500-206  Product Code:  L329  ",6/24/2016,"06/24/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74537,"Ongoing","Becton, Dickinson and Company, BD Biosciences","2350 Qume Dr",,"San Jose","CA","95131-1812","United States","Voluntary: Firm Initiated","Letter","USA Distribution to the states of : NC, WA, WI, NJ, PR, MD, NY, MA, CA, NY , MD, KY, IN, VA, SD, PA, OH, AR, AZ  and Foreign to : Canada, Belgium and Chile","Z-2252-2016","Class II","BD Trucount Tubes:   Catalog number: 340334      Hematology:  BD Trucount tubes are used for determining absolute counts of leucocytes in blood.","328 US, 516 International","One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.  ","07/21/2016",," Catalog 340334, Lot ;6083708  (embossing ID of (160216T3)",6/24/2016,"06/24/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74538,"Ongoing","Creative Snacks Co., LLC","241 Burgess Rd Ste B",,"Greensboro","NC","27409-9333","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","DE and GA.","F-1858-2016","Class I","The Fresh Market, Smoked Supreme Nut Mix, Net Wt. 12.3 oz. (349g), Distributed by: The Fresh Market, Inc., Greensboro, NC 27408, packed in clear plastic package.","2,604/12.3oz. packages","Undeclared allergen: Peanuts and soy.","08/01/2016",," Best by Date 01/29/2017",6/23/2016,"06/23/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74539,"Completed","Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1054-2016","Class II","Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS ","39 vials","Lack of Assurance of Sterility:  Aluminum crimps do not fully seal the rubber stopper to the vials.","06/28/2016",," Lot#: 389279, Use by 09-09-16",6/10/2015,"06/10/2015",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74539,"Completed","Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1055-2016","Class II","Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS ","9 Vials","Lack of Assurance of Sterility:  Aluminum crimps do not fully seal the rubber stopper to the vials.","06/28/2016",," Lot#: 395575, Use by 07-27-2016",6/10/2015,"06/10/2015",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74539,"Completed","Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1056-2016","Class II","Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS ","54 vials","Lack of Assurance of Sterility:  Aluminum crimps do not fully seal the rubber stopper to the vials.","06/28/2016",," Lot#: 391462, Use by 10-06-2016",6/10/2015,"06/10/2015",7/6/2016,"07/06/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74540,"Ongoing","Teva North America","425 Privet Rd",,"Horsham","PA","19044-1220","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1470-2016","Class II","Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76","53,328 bottles","Superpotent drug: Out of specification test result for assay during stability testing.","08/24/2016",," Lot # 35434158A, Exp 6/17",6/24/2016,"06/24/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74541,"Ongoing","Sanwa International Wholesale Foods, LLC","2621 E Hillsborough Ave",,"Tampa","FL","33610-4409","United States","Voluntary: Firm Initiated","Other","FL.","F-1997-2016","Class I","Organic Hot Finger Peppers (Florida), sold  in 0.5-1 lb plastic bags.  Each case will hold approximately 15-20 bags.  ","300 pounds total, approximately 15-20 cases.","Tested positive for Salmonella.","08/29/2016",," Lot # 2168.",6/29/2016,"06/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74542,"Ongoing","Olympus Corporation of the Americas","3500 Corporate Pkwy","PO Box 610","Center Valley","PA","18034-0610","United States","Voluntary: Firm Initiated","Letter","Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY","Z-0138-2017","Class II","OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector","2, 686 units","New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes. ","10/19/2016",," Model: OER-Pro, All serial numbers affected",6/23/2016,"06/23/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74543,"Ongoing","Natural Formulas","2125 American Ave",,"Hayward","CA","94545-1803","United States","Voluntary: Firm Initiated","Letter","US and Mexico, Finland, Estonia, Japan, Italy, Finland, Japan, South Africa.","F-2154-2016","Class I","NeolifeBar: Fruit & Nuts;  10 g Protein; 5 g Fiber. 320 mg Omega-3s.  Net Wt. 1.6 oz. (45 g). Product is sold as a package of 15 bars:    Distributed by GNLD International, LLC, Fremont, CA.  Not sold in retail stores","309 cases in US, 4384  cases foreign distribution ","Product was manufactured with Sunflower Kernels provided by SunOpta, which are under recall for possible contamination with Listeria Monocytogenes.","09/23/2016",," Lot 3285A, (US and foreign distribution)  Best By 12/2016 and lot  3425A  and 0476A (foreign distribution only.",6/23/2016,"06/23/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74545,"Ongoing","Medtronic Neuromodulation","7000 Central Ave",,"Minneapolis","MN","55421-1241","United States","Voluntary: Firm Initiated","Letter","US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.","Z-2602-2016","Class II","Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).  ","70","Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers.  During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.","08/19/2016",," lots: VA15GPJ, VA15K3N, VA15K7K",6/10/2016,"06/10/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74546,"Ongoing","AC Culinary Group LLC","760 19th St Ste.5",,"Catano","PR","00962","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-1847-2016","Class II","    Product presentations: 12oz and 32oz","2892 units","Undeclared food allergen FD&C Yellow #6.  ","07/28/2016",," 12 oz presentation: LOT: 28J, EXP: 12/16  32 oz presentation: LOT: 31R JN, EXP: 09/16",6/30/2016,"06/30/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74547,"Ongoing","Parker Medical","5085 Weeping Willow Cir",,"Highlands Ranch","CO","80130-4485","United States","Voluntary: Firm Initiated","Telephone","US Nationwide Distribution in the states of  KY, MO, FL, TN, and TX.","Z-2243-2016","Class II","Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box.    Product Usage:  The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.  ","5,500 units","Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use. ","07/19/2016",," Model Number: H-PFTVPU-60; H-PFTVPU-65; H-PFTVPU-70; H-PFTVPU-75; H-PFTVPU-80; H-PFTVPU-85; H-PFTVPU-90; H-PFTVVC-60; H-PFTVVC-65; H-PFTVVC-70; H-PFTVVC-75; H-PFTVVC-80; H-PFTVVC-85; H-PFTVVC-90    Lot Numbers: 1512TVC2029I through 1512TVC2029O (I, J, K, L, M, N, O);  1602TVC0226I through 1602TVC2226O (I, J, K, L, M, N, O); 1602TVU0226I through 1602TVU0226O (I, J, K, L, M, N,O); 1512TVU2029I through 1512TVU2029O (I, J, K, L, M, N,O)",6/2/2016,"06/02/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74548,"Ongoing","Zimmer Gmbh","Sulzer Allee 8",,"Winterthur",,,"Switzerland","Voluntary: Firm Initiated","Letter","Domestic: CO, IL	    Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan,                          Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong,                   Philippines, Iran, Brazil, Turkey, United Arab Emirates  (UAE), Uruguay","Z-2324-2016","Class II","V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.","169","Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.","08/02/2016",," Part No.: 502015640; Lot Numbers:27374, 104547/188A9",6/27/2016,"06/27/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74548,"Ongoing","Zimmer Gmbh","Sulzer Allee 8",,"Winterthur",,,"Switzerland","Voluntary: Firm Initiated","Letter","Domestic: CO, IL	    Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan,                          Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong,                   Philippines, Iran, Brazil, Turkey, United Arab Emirates  (UAE), Uruguay","Z-2323-2016","Class II","V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.","169","Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.","08/02/2016",," Part No.: 502015635; Lot Numbers:9721/188D11",6/27/2016,"06/27/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74548,"Ongoing","Zimmer Gmbh","Sulzer Allee 8",,"Winterthur",,,"Switzerland","Voluntary: Firm Initiated","Letter","Domestic: CO, IL	    Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan,                          Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong,                   Philippines, Iran, Brazil, Turkey, United Arab Emirates  (UAE), Uruguay","Z-2322-2016","Class II","TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.","169","Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.","08/02/2016",," Part No.: 502015629; Lot Numbers: 7975/188D10,  10409/188A12,  10408/188A12",6/27/2016,"06/27/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74548,"Ongoing","Zimmer Gmbh","Sulzer Allee 8",,"Winterthur",,,"Switzerland","Voluntary: Firm Initiated","Letter","Domestic: CO, IL	    Foreign: Argentina, Costa Rica, India, Malta, Japan, Philippines, Vietnam, Portugal, Dominican Republic, Argentina, Australia, Russia, Saudi Arabia, Ireland, Ecuador, China, Singapore, Indonesia, Canada, Mexico, South Korea , Spain, Netherlands, Sweden, Malaysia, New Zealand, Switzerland, El Salvador, England, Norway, Finland, Venezuela, Taiwan, Italy, Colombia, Greece, Thailand, France, Israel, Jamaica, Japan,                          Jordan, Germany, Korea, Lebanon, Belgium, Hong Kong,                   Philippines, Iran, Brazil, Turkey, United Arab Emirates  (UAE), Uruguay","Z-2321-2016","Class II","TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.","169","Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.","08/02/2016",," Part No.: 502015621; Lot Numbers: 8695/188B11,  8916/188B11,  9555/188D11,  10413/311A12,  11137/188B12",6/27/2016,"06/27/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74549,"Ongoing","Spacelabs Healthcare Inc","35301 SE Center St",,"Snoqualmie","WA","98065-9216","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA Distribution and to the countries of :  AFGHANISTAN, ARGENTINA, AUSTRALIA, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GUATEMALA, HONG KONG, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JORDAN, KUWAIT, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, PAKISTAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, Slovakia, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and URUGUAY.","Z-2343-2016","Class II","91496 Ultraview SL Command Module, Options A, B, C, and I.    Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP.    Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP.    Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP.    Option I: SpO2, Temperature x2, & adult/neonate NIBP.  ","1990 modules and 117 PCBAs & valves distributed in the US; 832 modules and 366 PCBAs & valves distributed outside the US","The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data.","08/04/2016",," Manifold Lot Codes: 128280, 129420, 129940, or 155640.",7/1/2016,"07/01/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74550,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Letter","Nationwide and CANADA","B-0686-16","Class III","ORTHO ProVue Analyzers; Product Code MTS213784; Unique Device Identifier (GTIN) 10758750006014","23 analyzers","ORTHO ProVue Analyzers,  with suboptimal reference images and/or  Brillo values outside of specification, were distributed. ","08/18/2016",," 0571281329, 0572472508, 0570003672, 0572082120, 0572082116, 0570003722, 0570003667, 0570004176, 0570004178, 0570003448, 0572462492, 0570003949, 0571211256, 0571561601, 0571711749, 0572072109, 0570004392, 0572802838, 0573493185, 0572622654, 0572362397, 0573493183, 0572522557",6/14/2016,"06/14/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74552,"Ongoing","Medtronic Neuromodulation","7000 Central Ave",,"Minneapolis","MN","55421-1241","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution.","Z-2645-2016","Class II","DBS Pocket Adaptor, Model 64001 and Model 64002.    The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.","7,542 in the US and 12,999 outside the US.","Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.","08/24/2016",," Notification is not lot specific.",6/23/2016,"06/23/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74553,"Ongoing","Halyard Health, Inc","5405 Windward Pkwy",,"Alpharetta","GA","30004-3894","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and  TX, and the country of Canada.","Z-2391-2016","Class II","Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue. ","51 kits","Mismatch between the length of the RF electrode (probe) and the cannula (introducer),","08/11/2016",," Lot Number M5264D205",6/16/2016,"06/16/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74554,"Ongoing","GE Inspection Technologies, LP","50 Industrial Park Rd",,"Lewistown","PA","17044-9312","United States","FDA Mandated","Letter","US Distribution to the states of : FL, TN, and TX.","Z-2236-2016","Class II","GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems.    A microfocus CT system used primarily for 3D metrology and analysis. ","4","Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system.  The identified cause was insufficient attachment of shielding in the door.  Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard. ","07/22/2016",," SN - PA2384",3/2/2016,"03/02/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74555,"Ongoing","Eastland Food Corporation","8305 Stayton Dr Ste C",,"Jessup","MD","20794-3008","United States","Voluntary: Firm Initiated","Other","The cases in the lot were distributed to retailers in Connecticut, Illinois, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, West Virginia.","F-2024-2016","Class I","Euro Custard Cake, Plastic wrapped cardboard container (Net Wt. 7.20 oz.)","a single lot (310 Cases)","The New York Department of Agriculture and Markets tested the Euro Custard Cake an detected that the product contained milk.  The label did not declare milk and list it as an allergen on the label. Eastland Food Corporation became aware of these results on June 21 when FDA visited it facility.   Eastland Food Corporation performed an investigation into the matter and determine late on June 22 that a single lot (310 cases) of product was missing this information.     To this point no adverse incidents have been reported due to the mislabeling.  Health risk assessment, people who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the affected Euro Custard Cakes under the mistaken assumption that it does not contain milk.  ","08/31/2016",," Item Code: 240304; Best Before 5/25/2017",6/23/2016,"06/23/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74556,"Ongoing","Novarad Corporation","752 E 1180 S Ste 200",,"American Fork","UT","84003-3561","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution including US nationwide. No Canadian distribution.","Z-2151-2016","Class II","NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) ","2695","Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.","07/11/2016",," All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0",5/9/2013,"05/09/2013",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74557,"Ongoing","Richard-Allan Scientific Company","4481 Campus Dr",,"Kalamazoo","MI","49008-2590","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of FL, PA, NY, MD, CA, and  AZ.","Z-2351-2016","Class II","Richard Allan Scientific 10% Neutral Buffered Formalin,  Part Number: 53901 and 561201  Item 53901 90ml bottle, 125 per case;  Item 561201 120ml bottle, 75 per case.","18 cases","potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown  whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the  outcome would be risk of false positive or false negative test results which may lead to serious  injury. There is the possibility the patient may need to be re-biopsied.","08/05/2016",," Item 53901, Lot 371348, exp date 01APR2020;  Item 561201, Lot 371355, exp date 01APR2020 ",6/13/2016,"06/13/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74558,"Ongoing","Golden State Medical Supply Inc.","5187 Camino Ruiz",,"Camarillo","CA","93012-8601","United States","Voluntary: Firm Initiated","Letter","Nationwide. No foreign distribution.","D-1255-2016","Class III","DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10","2077 bottles","Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018","07/11/2016",," Lot# GS011709, GS012352",6/28/2016,"06/28/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74559,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Affected geographies: United Arab Emirates, Curacao, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Brunei, Canada, Switzerland, Colombia, Costa Rica, Czech Republic, Germany, Ecuador, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Ireland, India, Iraq, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Macao, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, China, United States of America (including Puerto Rico), Viet Nam, Mayotte, South Africa.","Z-2247-2016","Class II","The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.","4,221 units total (2,033 units in US)",,"07/20/2016",," All",6/27/2016,"06/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74560,"Ongoing","CHG Hospital Beds Inc","153 Towerline Place",,"London",,,"Canada","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of:  AK , AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and country of: Canada","Z-2332-2016","Class II","Spirit Select Bed, A-C Powered Hospital Bed","4,308 units total","Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause the bed to unexpectedly lower resulting in patient injury. ","08/03/2016",," Model Numbers: 5700, Spirit Select Bed  (manufactured between November 1, 2014  January 13, 2016); Serial Numbers:029481  029482  029483  029484  029485  029486  029487  029488  029489  029490  029491  029492  029493  029494  029495  029496  029497  029498  029499  029500  029501  029502  029503  029504  029505  029506  029507  029508  029509  029510  029511  029512  029513  029514  029515  029516  029517  029518  029519  029520  029521  029522  029523  029524  029525  029526  029527  029528  029529  029530  029531  029532  029543  029544  029545  029546  029547  029548  029549  029550  029551  029552  029553  029554  029555  029556  029557  029565  029566  029567  029568  029569  029570  029571  029572  029573  029574  029575  029576  029577  029578  029579  029580  029581  029582  029583  029584  029585  029586  029587  029588  029589  029590  029591  029592  029593  029594  029595  029596  029597  029598  029599  029600  029601  029602  029603  029604  029605  029606  029607  029608  029609  029610  029611  029612  029613  029614  029615  029616  029617  029618  029619  029620  029621  029622  029623  029624  029625  029626  029627  029628  029629  029630  029631  029632  029633  029634  029635  029636  029637  029638  029660  029661  029662  029663  029664  029665  029666  029667  029668  029669  029670  029671  029672  029673  029674  029675  029676  029677  029678  029679  029680  029681  029682  029683  029684  029685  029686  029687  029688  029689  029690  029691  029692  029693  029694  029695  029696  029697  029698  029699  029700  029701  029702  029703  029704  029705  029706  029709  029710  029711  029712  029713  029714  029715  029716  029717  029718  029719  029720  029721  029722  029723  029724  029725  029726  029727  029728  029729  029730  029731  029732  029733  029734  029735  029736  029737  029738  029739  029740  029741  029742  029743  029744  029745  029746  029747  029748  029749  029750  029751  029752  029753  029754  029755  029756  029757  029758  029759  029760  029812  0",6/28/2016,"06/28/2016",8/10/2016,"08/10/2016","97                     032098                     032099                     032100                     032101                     032102                     032103                     032104                     032105                     032106                     032107                     032108                     032109                     032110                     032111                     032112                     032113                     032114                     032115                     032116                     032117                     032118                     032119                     032120                     032121                     032122                     032123                     032124                     032125                     032126                     032127                     032128                     032129                     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032204                     032205                     032206                     032207                     032208                     032209                  ","                    033505                     033506                     033507                     033508                     033509                     033510                     033511                     033512                     033513                     033514                     033515                     033516                     033517                     033518                     033519                     033520                     033521                     033522                     033523                     033524                     033525                     033526                     033527                     033528                     033529                     033530                     033531                     033532                     033533                     033534                     033535                     033536                     033537                     033538                     033539                     033540                     033541                     033542                     033543                     033544                     033545                     033546                     033547                     033548                     033549                     033550                     033551                     033552                     033553                     033554                     033555                     033556                     033557                     033558                     033559                     033560                     033561                     033562                     033563                     033564                     033565                     033566                     033567                     033568                     033569                     033570                     033571                     033572                     033573                     033574                     033575                     033576                     033577                     033578                     033579                     ","                 035772                     035773                     035774                     035775                     035797                     035798                     035799                     035800                     035801                     035802                     035803                     035804                     035805                     035806                     035807                     035808                     035809                     035810                     035811                     035812                     035813                     035814                     035815                     035816                     035817                     035818                     035819                     035820                     035821                     035822                     035823                     035824                     035825                     035826                     035827                     035828                     035829                     035830                     035831                     035832                     035833                     035834                     035835                     035836                     035837                     035838                     035839                     035840                     035841                     035842                     035843                     035844                     035845                     035846                     035847                     035848                     035849                     035850                     035851                     035852                     035853                     035854                     035855                     035856                     035857                     035858                     035859                     035860                     035861                     035862                     035863                     035864                     035865                     035866                     035867                     035",,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74560,"Ongoing","CHG Hospital Beds Inc","153 Towerline Place",,"London",,,"Canada","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including states of:  AK , AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and country of: Canada","Z-2331-2016","Class II","Spirit Plus Bed, A-C Powered Hospital Bed  ","4,308 units total","Stryker Medical is initiating a voluntary recall of the Spirit Select and Spirit Plus A-C powered hospital beds due to reports of hi-lo actuators broken at the mount ends, which could cause the bed to unexpectedly lower resulting in patient injury. ","08/03/2016",," Model Numbers: 5600, Spirit Plus Bed  (manufactured between November 1, 2014  January 13, 2016); Serial Numbers: Serial Number  029481  029482  029483  029484  029485  029486  029487  029488  029489  029490  029491  029492  029493  029494  029495  029496  029497  029498  029499  029500  029501  029502  029503  029504  029505  029506  029507  029508  029509  029510  029511  029512  029513  029514  029515  029516  029517  029518  029519  029520  029521  029522  029523  029524  029525  029526  029527  029528  029529  029530  029531  029532  029543  029544  029545  029546  029547  029548  029549  029550  029551  029552  029553  029554  029555  029556  029557  029565  029566  029567  029568  029569  029570  029571  029572  029573  029574  029575  029576  029577  029578  029579  029580  029581  029582  029583  029584  029585  029586  029587  029588  029589  029590  029591  029592  029593  029594  029595  029596  029597  029598  029599  029600  029601  029602  029603  029604  029605  029606  029607  029608  029609  029610  029611  029612  029613  029614  029615  029616  029617  029618  029619  029620  029621  029622  029623  029624  029625  029626  029627  029628  029629  029630  029631  029632  029633  029634  029635  029636  029637  029638  029660  029661  029662  029663  029664  029665  029666  029667  029668  029669  029670  029671  029672  029673  029674  029675  029676  029677  029678  029679  029680  029681  029682  029683  029684  029685  029686  029687  029688  029689  029690  029691  029692  029693  029694  029695  029696  029697  029698  029699  029700  029701  029702  029703  029704  029705  029706  029709  029710  029711  029712  029713  029714  029715  029716  029717  029718  029719  029720  029721  029722  029723  029724  029725  029726  029727  029728  029729  029730  029731  029732  029733  029734  029735  029736  029737  029738  029739  029740  029741  029742  029743  029744  029745  029746  029747  029748  029749  029750  029751  029752  029753  029754  029755  029756  029757  029758  029759  029",6/28/2016,"06/28/2016",8/10/2016,"08/10/2016","          032097                     032098                     032099                     032100                     032101                     032102                     032103                     032104                     032105                     032106                     032107                     032108                     032109                     032110                     032111                     032112                     032113                     032114                     032115                     032116                     032117                     032118                     032119                     032120                     032121                     032122                     032123                     032124                     032125                     032126                     032127                     032128                     032129                     032131                     032132                     032133                     032134                     032135                     032136                     032137                     032138                     032139                     032140                     032141                     032142                     032143                     032144                     032145                     032146                     032147                     032148                     032149                     032150                     032151                     032152                     032153                     032190                     032191                     032192                     032193                     032194                     032195                     032196                     032197                     032198                     032199                     032200                     032201                     032202                     032203                     032204                     032205                     032206                     032207                     032208                     032209    ","       033504                     033505                     033506                     033507                     033508                     033509                     033510                     033511                     033512                     033513                     033514                     033515                     033516                     033517                     033518                     033519                     033520                     033521                     033522                     033523                     033524                     033525                     033526                     033527                     033528                     033529                     033530                     033531                     033532                     033533                     033534                     033535                     033536                     033537                     033538                     033539                     033540                     033541                     033542                     033543                     033544                     033545                     033546                     033547                     033548                     033549                     033550                     033551                     033552                     033553                     033554                     033555                     033556                     033557                     033558                     033559                     033560                     033561                     033562                     033563                     033564                     033565                     033566                     033567                     033568                     033569                     033570                     033571                     033572                     033573                     033574                     033575                     033576                     033577                     033578                     033579       ","    035771                     035772                     035773                     035774                     035775                     035797                     035798                     035799                     035800                     035801                     035802                     035803                     035804                     035805                     035806                     035807                     035808                     035809                     035810                     035811                     035812                     035813                     035814                     035815                     035816                     035817                     035818                     035819                     035820                     035821                     035822                     035823                     035824                     035825                     035826                     035827                     035828                     035829                     035830                     035831                     035832                     035833                     035834                     035835                     035836                     035837                     035838                     035839                     035840                     035841                     035842                     035843                     035844                     035845                     035846                     035847                     035848                     035849                     035850                     035851                     035852                     035853                     035854                     035855                     035856                     035857                     035858                     035859                     035860                     035861                     035862                     035863                     035864                     035865                     035866                     035867          ",,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74561,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US (nationwide), Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and United Kingdom","Z-2537-2016","Class I","Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177.    Used with vascular catheter.    Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.","8,750 devices were distributed in commerce","Potential coating contamination with glass particles. ","08/25/2016",," Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177.      Lot numbers 6911522, 6911523, 6911524, 6911526, 6911527, 6911528, 6911529, 6911530, 6911533, 6911535, 6911545, 6911549, 6911551, 6911552, 6919676, 6919678, 6919680, 6935843, 6935844, 6935846, 6935848, 6935849, 6935850, 6935851, 6935852, 6935853, 6935855, 6948854, 6948855, 6948856, 6948857, 6948858, 6948860, 6948861, 6948862, 6955228, 6955229, 6955230, 6955231, 6955232, 6955233, 6955234, 6955235, 6955236, 6955237, 6961752, 6961753, 6961754, 6961755, 6961756, 6961757, 6961758, 6961759, 6961760, 6961761, 6965235, 6965236, 6965237, 6965238, 6965240, 6965469, 6965625, 6965626, 6968777, 6968779, 6975365, 6975367, 6975368, 6981022, 6981026, 6981346, 6981347, 6981349, 6981351, 6986896, 6986897, 6986898, 6988487, 6988488, 6992197, 6992198, 6995077, 6995078, 6995080, 6995082, 6995083, 6997860, 6999759, 6999760, 7000724, 7000725, 7000726, 7000727, 7000730, 7000732, 7000733, 7000735, 7012526, 7012527, 7012528, 7012529, 7012530, 7012840, 7015853, 7015854, 7015855, 7015856, 7015857, 7015897, 7015898, 7015899, 7016252, 7016253, 7019017, 7019018, 7019019, 7019020, 7019022, 7019025, 7019027, 7019491, 7019492, 7019493, 7019494, 7021222, 7021223, 7021224, 7021225, 7021226, 7021227, 7022591, 6948855X, 6955234X, NS6911520, NS6935845, NS6935847, NS6935854, NS6948859, NS6965239, NS6968778, NS6975369, NS6981025, NS6995079, NS6999757, NS6999758, NS6999761, NS7000728, NS7012841, NS7019023, NS7019024, and NS7019495. ",6/24/2016,"06/24/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74562,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA, IL, SD  Foreign: Canada, Netherlands","Z-2205-2016","Class II","6.0mm Round Fluted Bur, Super Long","25","Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.","07/14/2016",," 5190-010-060  Lot Numbers 15231017, 16033017, 16066017",6/16/2016,"06/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74562,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA, IL, SD  Foreign: Canada, Netherlands","Z-2204-2016","Class II","5.0mm Round Fluted Bur, Super Long","25","Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.","07/14/2016",," 5190-010-050  5.0mm Round Fluted Bur, Super Long , Lot Number: 15322017",6/16/2016,"06/16/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74563,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2286-2016","Class II","AnastoCiip Universal Clip Remover (6 Pack}   REF# 4001-00     The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.    ","40 units (6-Pack)","US marketing brochure for the AnastoClip AC Closure  System states that the Anastoclip catalog numbers  can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.","07/25/2016",," Lot Numbers:  ANR1064¿  ANR1066¿  ANR1068¿  ANR1069¿  ",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74563,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2283-2016","Class II","Anastoclip AC 8cm 35 Clips (1 Each} Medium  REF # 4000-06    The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.","256 units","US marketing brochure for the AnastoClip AC Closure  System states that the Anastoclip catalog numbers  can be used for dura closure, but the catalog numbers are only  intended for cardiovascular use","07/25/2016",," Lot Numbers:  ANC1532¿  ANC1577¿  ANC1643¿  ANC1647¿  ANC1673¿  ANC2007¿  ANC2025¿  ANC2027¿  ANC2031¿  ANC2032¿  ANC2037¿  ",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74563,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2284-2016","Class II","AnastoClip AC 8cm 35 Clips (1 Each} Large  REF # 4000-07     The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.","471 units","US marketing brochure for the AnastoClip AC Closure  System states that the Anastoclip catalog numbers  can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.","07/25/2016",," Lot Numbers:  ANC1549¿  ANC1612¿  ANC1678¿  ANC1679¿  ANC1682¿  ANC2001¿  ANC2008¿  ANC2009¿  ANC2013¿  ANC2015¿  ANC2016¿  ANC2017¿  ANC2018¿  ANC2019¿  ANC2020¿  ANC2021¿  ",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74563,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2288-2016","Class II","AnastoCiip Universal Clip Remover (6 Pack}  REF# e4001-00     The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.","55 units (6 pack)","US marketing brochure for the AnastoClip AC Closure  System states that the Anastoclip catalog numbers  can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.","07/25/2016",," Lot Numbers:  ANR1067¿  ANR1072¿  ANR1073¿  ANR1074¿  ",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74563,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2285-2016","Class II","Anasto AC Closure System and Anasto Universal Clip Remover-   Anasto AC 8cm 25 Clips (1 Each}  X-Large   REF # 4000-08    The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.","170 units","US marketing brochure for the AnastoClip AC Closure  System states that the Anastoclip catalog numbers  can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.","07/25/2016",," Lot Numbers:  ANC1487¿  ANC1665¿  ANC1672¿  ANC1683¿  ANC2002¿  ANC2003¿  ANC2010¿  ANC2011¿  ",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74563,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2289-2016","Class II","AnastoCiip Universal Clip Remover (1Each}  REF# e4001-04    The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.","20 units","US marketing brochure for the AnastoClip AC Closure  System states that the Anastoclip catalog numbers  can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.","07/25/2016",," Lot Numbers:  ANR1067¿  ANR1073¿  ",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74563,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2287-2016","Class II"," AnastoCiip Universal Clip Remover (1Each}  REF# 4001-04     The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.","39 units","US marketing brochure for the AnastoClip AC Closure  System states that the Anastoclip catalog numbers  can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.","07/25/2016",," Lot Numbers:  ANR1055¿  ANR1058¿  ANR1061¿  ANR1062¿  ANR1063¿  ANR1064¿  ANR1065¿  ANR1066¿  ANR1069¿  ",6/22/2016,"06/22/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74564,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA","Z-2601-2016","Class III","Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A  The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili","76","Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States","08/19/2016",," Software Version 2.2A",7/5/2016,"07/05/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74565,"Ongoing","Mentor Texas, LP.","3025 Skyway Cir N",,"Irving","TX","75038-3524","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.","Z-2326-2016","Class II","Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.  ","35 units","The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.","08/03/2016",," 7316994",7/1/2016,"07/01/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74566,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Press Release","US: All states in USA including PUERTO RICO, VIRGIN ISLANDS  except AK, SD & WV.    OUS: ARUBA, BARBADOS, TRINIDAD & TOBAGO, CURACAO, BERMUDA,  CHILE JAMAICA, SINGAPORE, FRENCH POLYNESIA, HONG KONG.","F-2002-2016","Class I","Nature Valley Protein Chewy Bars,  Peanut, Almond, & Dark Chocolate,   Carton UPC  000-16000-45724,  Case UPC 100-16000-45724, 5 bars/carton,   , 5-1.42 OZ (40g)BARS, NET WT 7.1 OZ (201g).  ","762,319 cases and 1544 pallets for all products.","General Mills announced  a voluntary U.S. recall of multiple skus of Nature Valley Protein Chewy Bars and Nature Valley Simple Nut Bars.  The recall is being issued in association with the expanded recall of sunflower kernels from SunOpta due to the potential presence of Listeria monocytogenes.","08/31/2016",," All date codes within shelf life.    BIUB 29MAR2016HN through BIUB 18JAN2017HN ",6/2/2016,"06/02/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74566,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Press Release","US: All states in USA including PUERTO RICO, VIRGIN ISLANDS  except AK, SD & WV.    OUS: ARUBA, BARBADOS, TRINIDAD & TOBAGO, CURACAO, BERMUDA,  CHILE JAMAICA, SINGAPORE, FRENCH POLYNESIA, HONG KONG.","F-2001-2016","Class I","Nature Valley Protein Chewy Bars, Honey, Peanut & Almond with Pumpkin Seeds, Carton UPC 000-16000-47196, Case UPC 100-16000-47196, 5 bars/carton, 5-1.42 OZ (40 g)BARS, NET WT 7.1 OZ (201 g).  ","762,319 cases and 1544 pallets for all products.","General Mills announced  a voluntary U.S. recall of multiple skus of Nature Valley Protein Chewy Bars and Nature Valley Simple Nut Bars.  The recall is being issued in association with the expanded recall of sunflower kernels from SunOpta due to the potential presence of Listeria monocytogenes.","08/31/2016",," All date codes within shelf life.  BIUB 29MAR2016HN through BIUB 18JAN2017HN",6/2/2016,"06/02/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74566,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Press Release","US: All states in USA including PUERTO RICO, VIRGIN ISLANDS  except AK, SD & WV.    OUS: ARUBA, BARBADOS, TRINIDAD & TOBAGO, CURACAO, BERMUDA,  CHILE JAMAICA, SINGAPORE, FRENCH POLYNESIA, HONG KONG.","F-1999-2016","Class I","Nature Valley Simple Nut Bars,  Almond, Cashew & Sea Salt,  Carton UPC 000-16000-46474, Case UPC 100-16000-46474, 	4 bars/carton, 4 1.17 OZ (33 g) BARS, NET WT 4.68 OZ (132 g).      Nature Valley Simple Nut Bars,  Almond, Cashew & Sea Salt, Carton UPC 000-16000-41301, Case UPC 000-16000-47734,	25 bars/carton.   ","762,319 cases and 1544 pallets for all products.","General Mills announced  a voluntary U.S. recall of multiple skus of Nature Valley Protein Chewy Bars and Nature Valley Simple Nut Bars.  The recall is being issued in association with the expanded recall of sunflower kernels from SunOpta due to the potential presence of Listeria monocytogenes.","08/31/2016",," All date codes within shelf life.  BIUB 24MAR2016JA through BIUB 17DEC2016JA.",6/2/2016,"06/02/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74566,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Press Release","US: All states in USA including PUERTO RICO, VIRGIN ISLANDS  except AK, SD & WV.    OUS: ARUBA, BARBADOS, TRINIDAD & TOBAGO, CURACAO, BERMUDA,  CHILE JAMAICA, SINGAPORE, FRENCH POLYNESIA, HONG KONG.","F-2000-2016","Class I","Nature Valley Simple Nut Bars , Roasted Peanut & Honey, Carton UPC 000-16000-46475, Case UPC 100-16000-46475, 4 - 1.17 OZ (33 g) BARS,  NET WT 4.68 OZ (132 g), 4 bars/carton.      Nature Valley Simple Nut Bars,  Roasted Peanut & Honey.   Carton UPC 000-16000-41308, Case UPC 100-16000-41308,  16 bars/carton, 16 -1.17 OZ (33 g) BARS, NET WT 1 LB 2.72 OZ (18.72 OZ) 530 g.       ","762,319 cases and 1544 pallets for all products.","General Mills announced  a voluntary U.S. recall of multiple skus of Nature Valley Protein Chewy Bars and Nature Valley Simple Nut Bars.  The recall is being issued in association with the expanded recall of sunflower kernels from SunOpta due to the potential presence of Listeria monocytogenes.","08/31/2016",," All date codes within shelf life.  BIUB 24MAR2016JA through BIUB 17DEC2016JA.  ",6/2/2016,"06/02/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74567,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide (including Puerto Rico) and the countries of: Australia, Canada, Colombia, Germany, Guatemala, Netherlands, Singapore, Tunisia, , Spain","Z-2274-2016","Class II","Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA.    Product Usage:  For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only.  ","62 units total (33 units in US)","A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.","07/22/2016",," AFB13H005, AFB13H008, AFB13H012, AFB13K002, AFB13K005, AFB13K008, AFB13J002, AFB13J003, AFB13J004, AFB13J005, AFB13J007, AFB15J001, AFB15C010, AFB13K009, AFB14H001, AFB15C008, AFB15C003, AFB15C005, AFB15C004, AFB15C006, AFB14H005, AFB14H003, AFB13K004, AFB13K006, AFB13K007, AFB13J008, AFB13K001, AFB13J006, AFB13J010, AFB13H013, AFB13H009, AFB13H003, AFB13H004",2/5/2016,"02/05/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74568,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide (including Guam and Puerto Rico),   and Internationally  to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Zambia, Zimbabwe.","Z-2310-2016","Class II","AU5800 Chemistry Analyzers, Reference No. A98352  The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.","2,130 units total (588 units in US)","Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.","08/01/2016",," 1040016",7/30/2015,"07/30/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74568,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide (including Guam and Puerto Rico),   and Internationally  to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Zambia, Zimbabwe.","Z-2308-2016","Class II","AU480 Chemistry Analyzers, Reference No. B28624  The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.","3,355 units total (617 units in US)","Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.","08/01/2016",," 1030647",7/30/2015,"07/30/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74568,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide (including Guam and Puerto Rico),   and Internationally  to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Zambia, Zimbabwe.","Z-2309-2016","Class II","AU680 Chemistry Analyzers, Reference No. B04779  The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.","3,084 units total (713 units in US)"," Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.","08/01/2016",," 1030834",7/30/2015,"07/30/2015",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74569,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- United Arab Emirates, Angola, Australia, Belgium, Bulgaria, Canada, Switzerland, China, Colombia, Costa Rica , Czech Republic, Germany, Denmark, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Mexico, Malaysia, Namibia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russian Federation, Rwanda, Saudi Arabia, Sweden, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, US (including Puerto Rico), Vietnam, South Africa, and Zimbabwe.","Z-2272-2016","Class II","UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems    The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System.     Catalog No.  UniCel DxC 800 Synchron Clinical Systems  UniCel DxC 600 Synchron Clinical Systems  UniCel DxC 600i Synchron Access Integrated Clinical Systems  UniCel DxC 880i Synchron Access Integrated Clinical Systems  UniCel DxC 660i Synchron Access Integrated Clinical Systems    Product Labeling Reference No. A93719    For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.","3,540 units total (1,067 units in US)","Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.","07/22/2016",," Up to and including 6133",4/22/2014,"04/22/2014",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74570,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","North Carolina; Indiana; Illinois; California","B-0652-16","Class III"," Pooled Cryoprecipitated AHF","6 units","Blood products, collected from two donors who tested positive for the antibody to Hepatitis B core Antigen on more than one occasion, were distributed.","07/12/2016","07/12/2016"," W040715144711; W040712321368; W040711324581; W040709322494; W040709320873; W040714326833",5/6/2016,"05/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74570,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","North Carolina; Indiana; Illinois; California","B-0651-16","Class III","Apheresis Red Blood Cells, Leukocytes Reduced","6 units","Blood products, collected from two donors who tested positive for the antibody to Hepatitis B core Antigen on more than one occasion, were distributed.","07/12/2016","07/12/2016"," W040715125068 (double collection); W040714590355 (double collection); W040712432592 (double collection)",5/6/2016,"05/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74570,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","North Carolina; Indiana; Illinois; California","B-0653-16","Class III","Red Blood Cells, Leukocytes Reduced","19 units","Blood products, collected from two donors who tested positive for the antibody to Hepatitis B core Antigen on more than one occasion, were distributed.","07/12/2016","07/12/2016"," W040715141120; W040714432489; W040713531199; W040713611059; W040713231819; W040712530020; W040711632989; W040711536920; W040711439793; W040710131001; W040710456275; W040709530681; W040709332547; W040709130806; W040715242185; W040715157643; W040714456313; W040712238194; W040712230027",5/6/2016,"05/06/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74571,"Ongoing","Gilbert Foods Inc.","7251 Standard Dr",,"Hanover","MD","21076-1322","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed through Amazon Fresh in the Bellevue, Washington area. Shelf life of the product is 7 days and the last affected lot expires on 06/20/16.  There is an estimate of less than 2 edible cases of product left out in the public. This is based upon the expiration date of the last lot produced. The last lot produced had an expiration date of 06/20/16.    Product is shipped directly to the consumers home.    There are no government or military accounts associated with this product.    This product had one direct account by way of Amazon Fresh. Amazon Fresh phone number is (866) 380-0525.","F-2274-2016","Class I","Brand Name: Evies Cheddar Potato Macaroni Salad   Net Weight: 6 oz. container  Units per package: 1   Units per case: 6 containers per case  Package Type: clear plastic container  ","27 Cases","Gilbert Foods Inc. t/a Hearn-Kirkwood  is initiating a voluntary recall of Evies Cheddar Potato Macaroni Salad. The co-packer of the product, Marys Harvest Fresh Foods, notified us that the peas that were used in Evies Cheddar Potato Macaroni Salad are a part of National Frozen Foods Corporations voluntary recall. Because potentially contaminated peas were used in the Evies Cheddar Potato Macaroni Salad, there is the risk that the entire container of Evies Cheddar Potato Macaroni Salad could be contaminated with Listeria monocytogenes.         Listeria monocytogenes, is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.  There have been no reported illnesses or complaints attributed to the recalled items to date.Product is shipped directly to the consumer through Amazon Fresh.  ","09/16/2016",," Use by dates of 04/15/16 to 06/20/16.    UPC # 6637511772  ",6/22/2016,"06/22/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74572,"Ongoing","Figi's, Inc","3200 S Central Ave",,"Marshfield","WI","54449","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, FL, GA,  IL, KY, LA, MI, MN, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WV.","F-2276-2016","Class I","Snack Shoppe, 16 OZ Hot & Spicy Cajun Snack Mix in a foil bag that is contained in a tin box. The foil bags are marked with the lot number. ","31 lbs","Figi's Companies, Inc is recalling 2 products that are related to the SunOpta sunflower kernel recall, because they have the potential to be contaminated with Listeria monocytogenes. ","09/19/2016",," HD116063 16OZHSMIX",6/24/2016,"06/24/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74572,"Ongoing","Figi's, Inc","3200 S Central Ave",,"Marshfield","WI","54449","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, FL, GA,  IL, KY, LA, MI, MN, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WV.","F-2277-2016","Class I","Figi's Gifts in Good Taste, 16 OZ  (453.60 g) Nature's Mix in a plastic bag that is a red circular tin container.     Nature's Mix is packaged in a plastic bulk bag with approximately 8-12 ounces o product.  ","2212.75 lbs","Figi's Companies, Inc is recalling 2 products that are related to the SunOpta sunflower kernel recall, because they have the potential to be contaminated with Listeria monocytogenes. ","09/19/2016",," not available",6/24/2016,"06/24/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74576,"Ongoing","Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally  to Australia, The Netherlands, and Japan","Z-2240-2016","Class II","TSP Hip Fracture Plating System  device, fixation, proximal femoral, implant  The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies","5458 units","The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.   ","07/19/2016",," All Lots.    Part Number / Description:    14-451002  130 DEG 2-HOLE LEFT NECK FX  14-451004  130 DEG 4-HOLE LEFT NECK FX  14-451070  7.5MM TELESCOPE LAG SCR 70MM  14-451075  7.5MM TELESCOPE LAG SCR 75MM  14-451080  7.5MM TELESCOPE LAG SCR 80MM  14-451085  7.5MM TELESCOPE LAG SCR 85MM  14-451090  7.5MM TELESCOPE LAG SCR 90MM  14-451095  7.5MM TELESCOPE LAG SCR 95MM  14-451100  7.5MM TELESCOPE LAG SCR 100MM  14-451102  130 DEG 2-HOLE RIGHT NECK FX  14-451104  130 DEG 4-HOLE RIGHT NECK FX  14-451105  7.5MM TELESCOPE LAG SCR 105MM  14-451110  7.5MM TELESCOPE LAG SCR 110MM  14-451115  7.5MM TELESCOPE LAG SCR 115MM  14-451120  7.5MM TELESCOPE LAG SCR 120MM  14-451125  7.5MM TELESCOPE LAG SCR 125MM  14-451130  7.5MM TELESCOPE LAG SCR 130MM  14-451500  ANGLE GUIDE 130 DEG  14-451502  GUIDE WIRE 3.0MM  14-451503  GUIDE PIN DRIVER 3.0MM  14-451504  TARGETING GUIDE 130 DEG LEFT  14-451505  TARGETING GUIDE 130 DEG RIGHT  14-451509  JIG ATTACHMENT DRIVER 3.5MM  14-451510  NON-LOCK GUIDE SLEEVE 7.5MM  14-451511  LOCKING GUIDE SLEEVE 7.5MM  14-451512  ENTRY TROCAR 7.5 MM  14-451513  DRILL BIT 3.0MM  14-451525  GUIDE WIRE DEPTH GAUGE 3.0MM  14-451526  STEP DRILL CANNULATED 7.5MM  14-451527  STEP DRILL NON-CANN 7.5MM  14-451528  TSP HIP FX TAP 7.5MM  14-451529  HEX DRIVER NECK SLEEVE 5.0MM  14-451530  DRIVER CONNECTOR SHAFT 5.0MM  14-451531  HEX DRIVER NECK SHAFT 3.5MM  14-451532  INSERTER LIMITED COLLAPSE  14-451533  DEPTH GAUGE LIMITED COLLAPSE  14-451535  SCREW GUIDE SLEEVE 4.5MM  14-451536  TROCAR 4.5MM SCREW  14-451537  DRILL GUIDE LOCKING 3.5MM  14-451538  DRILL GUIDE NON-LOCK 3.5MM  14-451539  DRILL BIT 3.5MM  14-451540  SCREW DEPTH GAUGE 4.5MM  14-451541  SCREW DEPTH GAUGE HOOK 4.5MM  14-451542  TSP HIP FX CORTICAL TAP 4.5MM  14-451543  DRIVER 5.0 HEX/3.5 HEXALOBE  14-451544  CONNECTOR SHAFT 4.5MM SCREW  14-451546  T HANDLE W/ HUDSON  14-451550  IMPACTION HANDLE  14-451551  IMPACTION GUIDE PAD  14-451552  IMPACTION PLATE PAD  14-451554  GUIDE WIRE ALIGNMENT ARM  14-451560  GUIDE WIRE PUSHER 2.8MM  14-451561  GUIDE WI",6/10/2016,"06/10/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74577,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The medical facilities who currently have the affected versions are located nationwide.  There was government distribution but no military or foreign distribution.","Z-2341-2016","Class II","Merge HEMO software.  ","37 ","The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7","08/04/2016",," Software versions 8.10, 9.10, 9.20.",7/2/2012,"07/02/2012",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74579,"Terminated","Rex Hospital, Inc.","2709 Blue Ridge Rd Ste 150",,"Raleigh","NC","27607-6493","United States","Voluntary: Firm Initiated","Telephone","North Carolina","B-0674-16","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.","08/08/2016","08/08/2016"," W044716154946; ",6/21/2016,"06/21/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74580,"Terminated","American Red Cross Blood Services","209 Farmington Ave",,"Farmington","CT","06032-1955","United States","Voluntary: Firm Initiated","Other","California","B-0675-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, was distributed.","08/08/2016","08/08/2016"," W203315198008; ",5/24/2016,"05/24/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74581,"Ongoing","Invacare Corporation","1 Invacare Way",,"Elyria","OH","44035-4190","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC,  TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.","Z-2365-2016","Class II"," Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.","395 units","The rear gradation scale was screen printed upside down on the flowmeter gauge.","08/08/2016",," Serial numbers for Model IRCPF16AW:     16CF024370, 16CF024373, 16CF024376, 16CF024379, 16CF024382,16CF024368,16CF024369, 16CF024371,16CF024372, 16CF024374,16CF024375, 16CF024377,16CF024378, 16CF024380,16CF024381, 16CF037743.      ",6/21/2016,"06/21/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74581,"Ongoing","Invacare Corporation","1 Invacare Way",,"Elyria","OH","44035-4190","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC,  TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.","Z-2364-2016","Class II","lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton.  The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.","395 ","The rear gradation scale was screen printed upside down on the flowmeter gauge.","08/08/2016",," Serial numbers for Model IRCPF16:	    16BF023724, 16BF023729, 16BF023734, 16BF023739, 16BF023744,16BF023720, 16BF023725, 16BF023730, 16BF023735, 16BF023740, 16BF023745,16BF023721, 16BF023726, 16BF023731, 16BF023736, 16BF023741, 16BF023746,16BF023722, 16BF023727, 16BF023732, 16BF023737, 16BF023742, 16BF023747,16BF023723, 16BF023728, 16BF023733, 16BF023738, 16BF023743, 16BF023748,16BF023749, 16BF030593, 16CF015205, 16CF019539, 16CF026064, 16CF030100,16BF023750, 16BF030594, 16CF015206, 16CF019540, 16CF026065, 16CF030101,16BF023751, 16CF016169, 16CF015207, 16CF019541, 16CF026066, 16CF030102,16BF023752, 16CF016170, 16CF015208, 16CF019542, 16CF026067, 16CF030103,16BF023753, 16CF016171, 16CF015209, 16CF019543, 16CF026068,16CF030104,16BF023754, 16CF016172, 16CF015210, 16CF019544, 16CF026069, 16CF030105,16BF023755, 16CF016173, 16CFOI5211, 16CF019545, 16CF026070, 16CF030106,16BF025606, 16CF016174, 16CF015212, 16CF019546, 16CF026071, 16CF030107,16BF025607, 16CF016175, 16CFOI5213, 16CF019547, 16CF026072, 16CF030108,16BF025608, 16CF016176, 16CF015214, 16CF019548, I6CF026073, 16CF030109,16BF025609, 16CF016177, 16CF015215, 16CF019549, l6CF026074, 16CF030110,16BF025610, 16CF016178, 16CF015216, l6CF019550, l6CF026075, 16CF0301ll,16BF025611, 16CF016179, 16CF018612, 16CF019551, 16CF026076, 16CF030112,16BF025612, 16CF016180, 16CF018613, 16CF019552, l6CF026077, 16CF030113,16BF025613, 16CF016181, 16CF018614, 16CF019553, 16CF026078, 16CF030114,16BF025614, 16CF016182, 16CF018615, 16CF019554, 16CF026079, 16CF030115,16BF025615, 16CF016183, 16CF018616, 16CF019555, 16CF026080, l6CF030116,16BF025616, 16CF016184, 16CF018617, 16CF019556, 16CF026081, 16CF030117,16BF025617, 16CF016185, 16CF018618, 16CF019557, 16CF026082, 16CF030118,16BF025618, 16CF016186, 16CF018619, 16CF019558, 16CF026083, 16CF030119,16BF025619, 16CF016187, 16CFOI8620, 16CF019559, 16CF026084, 16CF030120,16BF025620, 16CF016188, 16CF018621, 16CF019560, 16CF026085, 16CF030121,16BF025621, 16CF016189, 16CF018622, 16CF019561, 16CF026086, 16CF030122,16BF025622, 16CF016190, 16CF018",6/21/2016,"06/21/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74582,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.","Z-2536-2016","Class II","Stryker AutoPlex System.  Model Numbers  0607-687-000, 0605-887-000, 0605-687-000, and  0605-683-000.  For bone cement.    Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly into a fracture site using the cement injector and introducer needle combination.","4,841 boxes (9,682 units)","The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle.  Potential for delay in surgery if additional cement needs to be prepared for the injection procedure.","08/15/2016",," Model Number(s):  0607-687-000  0605-887-000  0605-687-000  0605-683-000    0607-687-000  Lot numbers: 16021012, 16027022, 16049012, 16061012,  16092012, 16107012, 16022012, 16028012, 16049022, 16063012, 16098012,  16109012, 16025012, 16028022, 16049032, 16063022, 16100012, 16109022,  16025022, 16033012, 16053012, 16070012, 16104012, 16113022, 16026012,  16041012, 16056012, 16070022, 16104022, 16113032, 16026022, 16048012,  16056022, 16074012, 16105012, 16118012, 16027012, 16048022, 16060012,  16088012, 16106012, 16118022  0605-887-000  Lot numbers: 16041012, 16040012, 16050012, 16057012,  16069012, 16078012, 16104012, 16112012, 16124012  0605-687-000  Lot numbers: 16041012, 16047012, 16111012  0605-683-000  Lot numbers: 16071012",6/14/2016,"06/14/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74583,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.","Z-2296-2016","Class II","Integra External Fixation System Rocker Bottom Model # 12225400.    For use in the treatment of bone conditions amenable to treatment by the use of external fixation.","27 units","The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.","07/27/2016",," Lot # PN625.",7/1/2016,"07/01/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74584,"Ongoing","Aspen Surgical Puerto Rico Corp.","Rd 183 Km 20.3",,"Las Piedras","PR","00771","United States","Voluntary: Firm Initiated","Letter","US distribution only.","Z-2755-2016","Class II","    Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.","6,000 pieces","After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B.","09/08/2016",," LOT 0088464",6/27/2016,"06/27/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74585,"Ongoing","Varian Medical Systems, Inc.","911 Hansen Way",,"Palo Alto","CA","94304-1028","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.","Z-2149-2016","Class II","Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE;    Radiology: The AlignRT Plus system is indicated for use to position  and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.","166 OSMS in US, 23 OSMO - International, ","Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].","07/11/2016",," TrueBeam version 2.0/2.5 with any version OSMS.    OSMA serial numbers:  HOM0084  HOM0176  HOM0368  HOM0003  HOM0004  HOM0005  HOM0006  HOM0008  HOM0009  HOM0010  HOM0011  HOM0012  HOM0015  HOM0016  HOM0017  HOM0018  HOM0019  HOM0020  HOM0021  HOM0022  HOM0023  HOM0024  HOM0025  HOM0026  HOM0027  HOM0028  HOM0029  HOM0030  HOM0031  HOM0032  HOM0033  HOM0034  HOM0035  HOM0036  HOM0037  HOM0071  HOM0072  HOM0073  HOM0074  HOM0075  HOM0076  HOM0077  HOM0078  HOM0079  HOM0080  HOM0081  HOM0082  HOM0083  HOM0084  HOM0085  HOM0086  HOM0087  HOM0088  HOM0089  HOM0090  HOM0091  HOM0095  HOM0096  HOM0097  HOM0098  HOM0099  HOM0100  HOM0101  HOM0102  HOM0103  HOM0107  HOM0108  HOM0109  HOM0110  HOM0111  HOM0113  HOM0114  HOM0115  HOM0116  HOM0117  HOM0118  HOM0125  HOM0126  HOM0127  HOM0128  HOM0129  HOM0170  HOM0171  HOM0172  HOM0173  HOM0174  HOM0175  HOM0176  HOM0177  HOM0178  HOM0179  HOM0180  HOM0181  HOM0182  HOM0183  HOM0184  HOM0185  HOM0186  HOM0187  HOM0188  HOM0189  HOM0190  HOM0191  HOM0304  HOM0305  HOM0306  HOM0307  HOM0308  HOM0309  HOM0310  HOM0311  HOM0312  HOM0313  HOM0314  HOM0315  HOM0316  HOM0317  HOM0318  HOM0319  HOM0320  HOM0321  HOM0322  HOM0323  HOM0324  HOM0329  HOM0330  HOM0331  HOM0332  HOM0333  HOM0334  HOM0335  HOM0336  HOM0337  HOM0338  HOM0339  HOM0340  HOM0341  HOM0342  HOM0347  HOM0348  HOM0349  HOM0350  HOM0351  HOM0352  HOM0353  HOM0354  HOM0356  HOM0357  HOM0358  HOM0359  HOM0360  HOM0361  HOM0362  HOM0363  HOM0364  HOM0365  HOM0366  HOM0367  HOM0368  HOM0369  HOM0370  HOM0371  HOM0372  HOM0373  HOM0374  HOM0381  HOM0382  HOM0383  HOM0386  HOM0387  HOM0388  HOM0389  HOM0390  HOM0391  HOM0392  HOM0393  HOM0394  HOM0395  HOM0396  HOM0403  HOM0404  HOM0405  HOM0406  HOM0409  HOM0410  HOM0411  HOM0412  HOM0413  HOM0414  HOM0415  HOM0416  HOM0420  HOM0421  HOM0422  HOM0424  HOM0440  HOM0441  HOM0442  HOM0444  HOM0445  HOM0447  HOM0448  HOM0454  HOM0457  HOMWMZ1.    ",6/23/2016,"06/23/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74585,"Ongoing","Varian Medical Systems, Inc.","911 Hansen Way",,"Palo Alto","CA","94304-1028","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.","Z-2150-2016","Class II","Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE;    Radiology: The AlignRT Plus system is indicated for use to position  and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.","21 AlignRT Plus in US, 1 International.","Varian Medical Systems has received reports that unintended changes were made to planned couch  parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user  sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical  Surface Monitoring System [OSMS].","07/11/2016",," TrueBeam version 2.0/2.5 with any version OSMS.    AlignRT Serial Numbers:  247-0200  247-0209  248-0013  248-0057  248-0070  249-0057  249-0066  249-0163  249-0164  249-0195  249-0226  249-0274  249-0050  249-0286  249-0277  248-0044  249-0227  247-0208  249-0047  247-0218  248-0050  248-0043  248-0048  249-0293  249-0155.  ",6/23/2016,"06/23/2016",7/20/2016,"07/20/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74586,"Ongoing","New American Food Products, LLC.","983 Riverside Dr",,"Methuen","MA","01844-6703","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","New England","F-1859-2016","Class I","Cumberland Farms Farmhouse Premium Chocolate Treats - Sea Salt Carmel Delights, 3 oz. bag","1100 cases (12/case)","Product contains peanuts undeclared allergen","08/01/2016",," Use by Date: 2017-05-25 ",7/1/2016,"07/01/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74587,"Ongoing","Natus Medical Incorporated","5900 1st Ave S",,"Seattle","WA","98108-3248","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution and to the countries of : including American Samoa and Guam, and in the following countries:  Albania, Argentina, Australia, Austria, Bangladesh, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, Indonesia, Iraq, Israel, Italy, Korea, Kuwait, Latvia, Malaysia, Mongolia, Namibia, Netherlands, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Virgin Islands (British).","Z-0770-2017","Class II","Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia.    006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad  006254 neoBLUE blanket LED Light Box  006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad  007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR  007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR  007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK  007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK  007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS  007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS","2619 units (1925 units in the US and 694 units OUTSIDE the US)","neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box.","12/15/2016",," ************SERIAL NUMBERS OF UNITS DISTRIBUTED TO US GOVERMENT ACCOUNTS    000089, 000104, 000128, 001342, 001364, 001367, 001371, 001372, 001373, 001374, 001375, 001376, 001377, 001391, 001392, 001393, 001394, 001441, 001442, 001455, 001456, 001463, 001495, 001496, 001497, 001878, 001893, 001912, 001915, 001992, 001993, 002040, 002041, 002165, 002166, 002167, 002168, 002289, 002290, 002291, 002292, 002320, 002462, 002463, 002762, 002763, 002766, 002860, 002870, 002873, 002888, 003594, 003595, 003600, 003604, 003632, 003633, and 003893.    ***********SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US    ..000284, ..000287, ..000297, ..000299, ..000310, ..000324, ..000328, ..000365, .000301, .000313, .000321, .000322, .000323, .000352, .000415, .000419, .000420, .000426, .000427, .000435, .000445, .000449, .000467, .000483, .000508, .000518, .000523, .000531, .000541, .000581, .000651, .000670, .000695, .000696, .000697, .000698, 000030, 000031, 000032, 000033, 000035, 000036, 000039, 000041, 000042, 000043, 000044, 000046, 000048, 000050, 000051, 000052, 000053, 000056, 000062, 000070, 000076, 000081, 000082, 000085, 000086, 000087, 000088, 000093, 000094, 000139, 000140, 000143, 000144, 000146, 000162, 000163, 000164, 000166, 000167, 000170, 000180, 000181, 000187, 000189, 000190, 000193, 000195, 000202, 000205, 000208, 000215, 000218, 000221, 000223, 000234, 000235, 000238, 000240, 000242, 000243, 000244, 000245, 000246, 000248, 000249, 000250, 000253, 000254, 000255, 000257, 000263, 000275, 000276, 000281, 000290, 000291, 000292, 000293, 000303, 000317, 000320, 000325, 000332, 000333, 000335, 000336, 000340, 000343, 000344, 000345, 000349, 000350, 000351, 000352, 000353, 000354, 000366, 000411, 000414, 000417, 000418, 000422, 000424, 000425, 000428, 000430, 000432, 000436, 000441, 000442, 000443, 000446, 000452, 000453, 000454, 000456, 000457, 000458, 000459, 000460, 000462, 000469, 000472, 000475, 000477, 000479, 000483, 000489, 000493, 000495, 000499, 000500, 000502, 000511, 000516, 000522, 000528, 000530, 0",10/28/2016,"10/28/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74588,"Ongoing","Dream Body Weight Loss","2330 S Belt Line Rd",,"Grand Prairie","TX","75051-4151","United States","Voluntary: Firm Initiated","Press Release","United States","D-0106-2017","Class II","Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle","Unknown","Marketed without an approved NDA/ANDA: Undeclared sibutramine.","10/19/2016",," All lots.",7/1/2016,"07/01/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74588,"Ongoing","Dream Body Weight Loss","2330 S Belt Line Rd",,"Grand Prairie","TX","75051-4151","United States","Voluntary: Firm Initiated","Press Release","United States","D-0108-2017","Class II","Dream Body Advanced 400 mg 30 capsules in brown foil packets.","Unknown","Marketed without an approved NDA/ANDA: Undeclared sibutramine.","10/19/2016",," All lots.",7/1/2016,"07/01/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74588,"Ongoing","Dream Body Weight Loss","2330 S Belt Line Rd",,"Grand Prairie","TX","75051-4151","United States","Voluntary: Firm Initiated","Press Release","United States","D-0107-2017","Class II","Dream Body 450 mg 30 capsules in a plastic screw on top bottle","Unknown","Marketed without an approved NDA/ANDA: Undeclared sibutramine.","10/19/2016",," All lots.",7/1/2016,"07/01/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74589,"Ongoing","Maglio & Co Ready Fresh","4287 N Port Washington Rd",,"Glendale","WI","53212","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Il, WI, NE, MO, MI, MN .","F-1921-2016","Class I","Raw Refrigerated  Cucumbers, 11/9 bushel, 6 count, 12 count, 24 count, in corrugated cardboard cases, Southern Valley Produce Lot 16300705.      (The product was either distributed in original container or were repackaged). ","2150 pounds","A sample of raw cucumbers tested positive for Salmonella spp. ","08/11/2016",,"	X0882849  ",6/30/2016,"06/30/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74590,"Completed","US Endoscopy Group Inc","5976 Heisley Rd",,"Mentor","OH","44060-1873","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of :  OH, OR, WA  and Internationally to the country of Italy.","Z-0289-2017","Class II","Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060    A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes","36 units","US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed.  The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components.  All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.  ","10/19/2016",," Model #: 00711819; Lot 1520268",5/18/2016,"05/18/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74591,"Ongoing","Vital Care Compounder, LLC","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1166-2016","Class II","TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS","13 units","Lack of Assurance of Sterility:  Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.","07/07/2016","."," Lot#:382331, Use by 12-11-16",6/29/2016,"06/29/2016",7/13/2016,"07/13/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0026-2017","Class II","Metrix 600ML Blood Donor Bag, Part # 7070, non-sterile, not for human use, packed individually in polybags, 125 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","500 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 7070-27871",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0018-2017","Class II","Metrix Bleeding Bag, Part # 2150, non-sterile, not for human use, packed in 200 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","83120 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 2150-27894, 2150-27971, 2150-28085, 2150-28086, 2150-28200, 2150-28201, 2150-28206B, 2150-28206, 2150-28207, 2150-28208, and 2150-28209  (Lots 2150-28202 and 2150-28460 were not distributed and remain in quarantine at firm's facility)",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0027-2017","Class II","Metrix 2L Blood Donor Bag with Needle, Part # 7310, non-sterile, not for human use, packed individually in polybags, 100 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","500 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 7310-27972",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0024-2017","Class II","Metrix 1L Defibro Bag, Part # 4770, non-sterile, not for human use, packed in 60 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","8400 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 4770-A1719   (Lots 4770-A1720, 4770-A1721, and 4770-A1722 are quarantined at the firm)",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0022-2017","Class II","Metrix Donor Goat Set, Part # 3120, non-sterile, not for human use, packed in 25 per polybag, 200 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","10000 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 3120-27940 (Lot 3120-28392 was scrapped by the firm)",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0025-2017","Class II","Metrix 12Gauge Donor Set, Part # 5350, non-sterile, not for human use, packed in 25 per polybag, 200 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","5000 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 5350-28017, 5350-28018, and 5350-28101  (Lot 5350-28399 is quarantined at the firm)",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0017-2017","Class II","Metrix Bleeding Bag 15 G Needle, Part # 2000, non-sterile, not for human use, packed in 200 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","2145 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot 2000-28212",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0020-2017","Class II","Metrix 1L Defibro Bag, Part # 2560, non-sterile, not for human use, packed in 60 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","2400 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 2560-27720",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0023-2017","Class II","Metrix Bleeding Bag 12G Inner Seal, Part # 4630, non-sterile, not for human use, packed in 150 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","10186 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 4630-27915 and 4630-28166",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0021-2017","Class II","Metrix Donor Set W/15 Gauge Needle, Part # 3080, non-sterile, not for human use, packed in 25 per polybag, 400 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","4800 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 3080-27804, 3080-27805, 3080-27984, and 30801-27985 (Lot 3080-28292 was scrapped by the firm)",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74592,"Ongoing","The Metrix Company","4400 Chavenelle Rd",,"Dubuque","IA","52002-2655","United States","Voluntary: Firm Initiated","Letter","Distributed throughout the US, Canada, and New Zealand.","V-0019-2017","Class II","Metrix Bleeding Bag 15G Needle, Part # 2210, non-sterile, not for human use, packed in 200 units per case. The responsible firm name on the label is The Metrix Company, Dubuque, IA 52002.","2085 units","The hub of the needle on affected products may contain aluminum flakes.","11/22/2016","."," Lot numbers: 2210-28019",7/7/2016,"07/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74593,"Ongoing","Olympus Scientific Solutions Americas","48 Woerd Ave",,"Waltham","MA","02453-3824","United States","FDA Mandated","Letter","Nationwide Distribution.","Z-2255-2016","Class II","Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence.     Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.     ","2, 210 units distributed in the USA","Trigger lock option does not always prevent x-ray generation.  Specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the trigger is pulled.  The correction is via repair by a software update.","07/29/2016",," All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher",6/22/2016,"06/22/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",74594,"Ongoing","NOW Foods","395 Glen Ellyn Rd",,"Bloomingdale","IL","60108-2176","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to 25 retail stores domestically and 1 medical facility. The product was also distributed to Ioannina, Greece and Garthabae, Iceland.","F-1990-2016","Class II",". The package is a white 5 oz box with grey and purple lettering. ","130 tubes , 4 oz per tube ","Rejuvenating Clay Masks Total Viable Count (TVC) test result exceeded specification; microorganisms were identified as Saccharomyces cerevisiae and Streptococcus sanguinis.","08/26/2016",," NOW Product #: 8024  NOW Lot#: 1958257  NOW Batch #: 575948  Contract Mfg. Lot#: 25483",7/1/2016,"07/01/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74595,"Ongoing","Nidek Inc","47651 Westinghouse Dr",,"Fremont","CA","94539-7474","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.","Z-2587-2016","Class II","OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier.    Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.  ","17","Nidek Inc. received information from our manufacturer NIDEK CO.  Japan that the shown axial  lengths were much shorter at AL-Scan measurement.","08/17/2016",," OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier.  Serial numbers: 220005, 220006, 220008, 220009, 220013, 220017, 220018, 220019, 220020, 220021, 220023, 220025, 220026, 220031, 220032, 220033, 220036.  ",7/1/2016,"07/01/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74596,"Ongoing","Sunrise Medical (US) LLC","2842 N Business Park Ave",,"Fresno","CA","93727-1328","United States","Voluntary: Firm Initiated","Letter","US and Mexico, Japan,  Chile, Kuwait, Columbia, Hong Kong,   China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles,  British Virgin Islands,","Z-2290-2016","Class II","Quickie Q7 wheelchair. Model EIR4    Physical Medicine.  The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.","12,142 devices in US, 1,710 devices internationally.","There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing  causing the backrest to detach from the chair frame.","07/25/2016",," Model EIR 4  13,000 + serial numbers. RES would not accept this number. Please see spreadsheet provided in documents.R4-007239 to R4-022394.  Serial number range: ",7/1/2016,"07/01/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74597,"Ongoing","Mister Cookie Face Corporation","1989 Rutgers University Blvd",,"Lakewood","NJ","08701-4538","United States","Voluntary: Firm Initiated","Press Release","IL, NC and OH","F-1915-2016","Class II","cones, 32 oz. box, Manufactured by Mister Cookie Face LLC, Lakeland, NJ and Distributed by Aldi, Batavia, IL 60510, UPC 041498191962","2,880 boxes"," Ice Cream Cones are being recalled because they may contain peanuts which are not declared on the allergen statement.","08/06/2016",," N/A",6/30/2016,"06/30/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74598,"Completed","RL Schreiber Inc","710 Hendrickson Dr",,"Lebanon","KY","40033-8148","United States","Voluntary: Firm Initiated","E-Mail","Product was shipped to FL only.","F-0673-2017","Class I","R.L. SCHREIBER Demi-Glace Brown Sauce Mix 18 oz (510 G)white plastic bag INGREDIENTS: Enriched Bleached Wheat Flour***CONTAINS: Wheat, Soy, Milk  Produced in a facility with Egg","30/18-oz plastic bags","Product was manufactured using flour potentially contaminated with E. coli.","12/09/2016",," Product code: CFDEMIGB  1470; Lot #6-098-158723.",7/5/2016,"07/05/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74599,"Ongoing","AccessClosure, Inc., A Cardinal Health Company","5452 Betsy Ross Dr",,"Santa Clara","CA","95054-1101","United States","Voluntary: Firm Initiated","Letter","US in the states of CA, and MS.","Z-2329-2016","Class II","6F/7F MynxGrip Vascular Closure Device;  Product Model MX6721,    Product Usage:  The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.  ","55 units","A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.","08/03/2016",," Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016",7/13/2016,"07/13/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74600,"Ongoing","Branan Medical Corporation","140 Technology Dr Ste 400",,"Irvine","CA","92618-2426","United States","Voluntary: Firm Initiated","Letter","US Nationwide distribution in the states of: TN, NC, FL, and PA","Z-2311-2016","Class III","AmediCheck Instant Test Cup, Part No. C-C0501A-3A    Product Usage:  The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA  ","96 units","Branan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error. ","08/01/2016",," T0858",7/5/2016,"07/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74601,"Ongoing","Club Chef LLC","3776 Lake Park Drive",,"Covington","KY","41017-9826","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: IA, IL, IN, KY, MI, MN, MO, NC, NE, NJ, OH, PA, SC, TN, VA, WI & WV.","F-1860-2016","Class I","Diced and sliced  yellow onions. 2.5 lb & 5 lb clear plastic bags","4,445 cases","The firm was notified by a customer that the whole uncut product test positive for Listeria","08/01/2016",," Use By date 6/8/16, 6/9/16, 6/10/16, 6/11/16, 6/12/16, 6/13/16 & 6/14/16 and Julian dates: 150, 151, 153 & 154",6/7/2016,"06/07/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2558-2016","Class II","Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM  Item Code: E258128  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","3530","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  211742X through 60870082X",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2564-2016","Class II","Valleylab  Laparoscopic Wire J-Hook Electrode 36CM  Item Code: E277236  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","85630","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  210110X through 61250197X		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2554-2016","Class II","Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes  Item Code: E253028  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","13420","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  210141X through 61220104X",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2568-2016","Class II","Valleylab Laparoscopic Straight Spatula Electrode 28CM	  Item Code: E278028  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","6720","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  212060X through 60520072X		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2578-2016","Class II","Valleylab Laparoscopic Cylindrical Tip Electrode 28CM  Item Code:  E278628  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable",,"Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  213786X through 61220121X		  		  		  		  		  		  		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2560-2016","Class II","Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm  Item Code: E258328  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","2920","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  210556X through 60520063X		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2575-2016","Class II","Valleylab Laparoscopic Wire L-Hook Electrode Retractable	  Item Code: E2783R36ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","50055","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  208908X through 61220113X		  		  		  		  		  		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2566-2016","Class II","Valleylab Laparoscopic Wire J-Hook Electrode 45CM	  Item Code: E277345  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","24870","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  210409X through 61220133X		    		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2563-2016","Class II","Valleylab Laparoscopic Curved Spatula Electrode 45CM  Item Code: E277145  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","6381","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  209505X through 61220130X		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2557-2016","Class II","Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM  Item Code: E258028  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","6769","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  210573X through 60870080X",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2556-2016","Class II","  Item Code: E25306  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","19200","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  210286X through 61220102X",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2562-2016","Class II","Valleylab Laparoscopic Curved Spatula Electrode 36CM  Item Code: E277136  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","161940","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  210654X through 61380120X		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2573-2016","Class II","Valleylab Laparoscopic Wire L-Hook Electrode 28CM  Item Code: E278328  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","42900","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  209965X through 60870090X		  		  		  		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2570-2016","Class II","Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM	  Item Code: E2781R28ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable",,"Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  209358X through 60870083X		  		  		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2577-2016","Class II","Valleylab Laparoscopic Flat L-Hook Electrode Retractable	  Item Code:  E2784R28ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable  ","3470","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  209503X through 60870086X		  		  		  		  		  		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2574-2016","Class II","Valleylab Laparoscopic Wire L-Hook Electrode Retractable  Item Code: E2783R28ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","63320","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  209284X through 60870084X		  		  		  		  		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2565-2016","Class II","Valleylab Laparoscopic Wire J-Hook Electrode 36CM  Item Code: E277336  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","349629","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  00378X through 61220135X		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2559-2016","Class II","Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM  Item Code: E258228  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","210 ","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  216416X through 60080002X",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2561-2016","Class II","Valleylab Laparoscopic Straight Spatula Electrode 36C	  Item Code: E277036  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","13516","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  215084X through 61220127X		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2576-2016","Class II","Valleylab Laparoscopic Flat L-Hook Electrode 28cm	  Item Code: E278428  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","332","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  209220X through 52140033X		  		  		  		  		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2567-2016","Class II","Valleylab Laparoscopic Flat L-Hook Electrode 36CM	  Item Code: E277436  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","119770","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  210652X through 61390114X		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2571-2016","Class II","Valleylab Laparoscopic Wire J-Hook Electrode 28CM	  Item Code: E278228  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable",,"Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  209822X through 61220117X		    		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2555-2016","Class II","  Item Code: E25303  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable","19200","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  210286X through 61220102X",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2572-2016","Class II","Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM  Item Code: E2782R28ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable    ","1440","Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  213559X through 60520066X		  		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74602,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,","Z-2569-2016","Class II","Valleylab Laparoscopic Curved Spatula Electrode 28CM	  Item Code: E278128  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable",,"Potential for compromise of the package resulting in a breach of the sterile barrier","08/17/2016",," Affected Lot Range:  209716X through 61220115X		  		  		  		  		  ",7/8/2016,"07/08/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74603,"Ongoing","Isomeric Pharmacy Solution, LLC","2401 S Foothill Dr",,"Salt Lake City","UT","84109-1479","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.","D-1480-2016","Class II","Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL  Injection,  10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,  ","274  multdose vials","Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.","09/02/2016",," Lots# 03045 and 03046; Exp. 10/16",6/29/2016,"06/29/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74604,"Completed","Centurion Medical Products Corporation","100 Centurion Way",,"Williamston","MI","48895-9086","United States","Voluntary: Firm Initiated","Letter","KS, IN, IA, KY, MT, SD","Z-2250-2016","Class II","Convenience Kits from Centurion that  contain a Medtronic/Covidien Light Glove  ED SUTURE KIT  VAGINAL DELIVERY TRAY  ENDOSCOPY TRAY  MINOR BASIN SET  LAPAROSCOPIC BASIN TRAY  ","483","Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic.  According to the notice received from Medtronic, the recall was initiated  because some light covers may have splits or holes, which may result in the transfer of  microorganisms from the light handle into the patient wound.","07/20/2016",," Code	Lot #	                     Description	                                         exp date  SUT18365	2012070350	ED SUTURE KIT	                     Sep-14  MNS6710	2012070990	VAGINAL DELIVERY TRAY	Jan-15  MNS6710	2012082090	VAGINAL DELIVERY TRAY	Feb-15  MNS6710	2012092490	VAGINAL DELIVERY TRAY	Apr-15  MNS6710	2012120390	VAGINAL DELIVERY TRAY	Apr-15  MNS4635	2012081390	ENDOSCOPY TRAY	                     Feb-15  OR1640	2012040990	MINOR BASIN SET	                     Jan-15  OR1640	2012123190	MINOR BASIN SET	                     Apr-15  OR1575	2012071690	LAPAROSCOPIC BASIN TRAY	Nov-14  OR1575	2012091090	LAPAROSCOPIC BASIN TRAY	Feb-15  OR1575	2013010490	LAPAROSCOPIC BASIN TRAY	Apr-15  ",4/29/2015,"04/29/2015",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74605,"Ongoing","Let's Talk Health, Inc.","2411 Fenton St Ste 102",,"Chula Vista","CA","91914-3517","United States","Voluntary: Firm Initiated","E-Mail","Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines","D-1452-2016","Class II","Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.","417 bottles","Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.","07/29/2016",," Lot #15522",7/5/2016,"07/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74607,"Ongoing","Vision RT Ltd","Dove House, Arcadia Avenue",,"London",,,"United Kingdom","Voluntary: Firm Initiated","E-Mail","Product distributed in US.    The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom.    No product was distributed to US government accounts.","Z-2667-2016","Class II","AlignRT¿ Plus [private label-OSMS] K123371:  The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. ","47","Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS].  1. CRM 3194, No Serious Injury, No MDR, Aware date:  Dec 11, 2015    2. CRM 3321, No Patient Involved, No MDR, Aware date:  Jan 19, 2016  3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016	  No patient harm was reported in any of these cases.  ","08/25/2016",," Serial Number of the device(s) distributed  248-016  248-021  248-022  248-030  248-038  248-041  248-063  248-064  249-1514  249-1516  248-071  249-0239  248-073  248-080  248-084  249-0043  249-0055  249-0056  249-0058  249-0069  249-0130  249-0137  249-1509  249-0141  249-0275  249-0152  249-0162  249-0169  249-0251  249-0253  249-0254  249-0288  249-1503  249-1512  249-1518  249-TBD  249-0061  249-0131  249-0256  249-0289  249-0290  249-TBD  248-083  249-0273  249-0276  249-1500  249-1519  ",6/30/2016,"06/30/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74607,"Ongoing","Vision RT Ltd","Dove House, Arcadia Avenue",,"London",,,"United Kingdom","Voluntary: Firm Initiated","E-Mail","Product distributed in US.    The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom.    No product was distributed to US government accounts.","Z-2668-2016","Class II"," Radiotherapy Delivery System, K140528.  The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.","47","Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS].  1. CRM 3194, No Serious Injury, No MDR, Aware date:  Dec 11, 2015    2. CRM 3321, No Patient Involved, No MDR, Aware date:  Jan 19, 2016  3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016	  No patient harm was reported in any of these cases.  ","08/25/2016",," Serial Number of the device(s) distributed  248-016  248-021  248-022  248-030  248-038  248-041  248-063  248-064  249-1514  249-1516  248-071  249-0239  248-073  248-080  248-084  249-0043  249-0055  249-0056  249-0058  249-0069  249-0130  249-0137  249-1509  249-0141  249-0275  249-0152  249-0162  249-0169  249-0251  249-0253  249-0254  249-0288  249-1503  249-1512  249-1518  249-TBD  249-0061  249-0131  249-0256  249-0289  249-0290  249-TBD  248-083  249-0273  249-0276  249-1500  249-1519  ",6/30/2016,"06/30/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74608,"Ongoing","Dako  Denmark A/S","Produktionsvej 42",,"Glostrup",,,"Denmark","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, Canada, and Colombia.","Z-2330-2016","Class II","EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004.    Intended for use in immunohistochemistry together with Autostainer Link Instruments.","147 kits","The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1.","08/03/2016",," K8002 Lot no: 10112879  K8004 Lot no: 10111463",7/6/2016,"07/06/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74609,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland","Z-2345-2016","Class III","Medivance ArcticGel Neonatal Pad    The pad is designed to fit into an incubator and provide whole body cooling for patients.","64","An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.","08/05/2016",," Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822 ",6/30/2016,"06/30/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74610,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.","Z-2333-2016","Class III","SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization  The product is a urine collection system that includes a STATLOCK Foley Stabilization Device","530 units","Labeling problem","08/03/2016",," Lot Number NGZG1722",6/29/2016,"06/29/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74611,"Ongoing","H & E Trading Inc","514 Eugene Way",,"Wyckoff","NJ","07481-2102","United States","Voluntary: Firm Initiated","Telephone","GA, MA, MD, NJ, NY, PA and VA","F-1937-2016","Class II","Haitai Matdongsan Peanuts Crunch Snack, Net Wt. 11.49 oz. (325gr), Imported and Distributed by: Haitai, Inc, 7227 Telegraph Road, Montebello, CA 90640 - H & E Trading Inc, 514 Eugene Way, Wyckoff, NJ 07481, UPC 8 801019606786","3,115 cases","Haiati Matdongsan Peanut Crunch Snack, 80g and 325g, plastic flex bag is being recalled because it contains Soy Lecithin and this was not listed on the finished product labeling.","08/18/2016",," Expiration dates: 9/29/2016, 1/13/2017, 2/7/2017, 3/1/2017  and 3/8/2017 ",5/13/2016,"05/13/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74612,"Ongoing","Giant Eagle, Inc.","101 Kappa Dr",,"Pittsburgh","PA","15238-2809","United States","Voluntary: Firm Initiated","E-Mail","IN, OH, PA, WV","F-0681-2017","Class II","Clear plastic cup labeled as:  The Farmers Market Buffalo Hot Peanuts; Net Wt. 5 oz.; UPC 3003499846; Best By 10/25/2016","248 units","Farmer's Market Buffalo Hot Peanuts contained undeclared cashews and wheat. Labeling error at manufacturer found Farmer's Market Trail Mix labeled as Farmer's Market Buffalo Hot Peanuts.","12/09/2016",,"  Best By 10/25/2016",5/16/2016,"05/16/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74613,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution","Z-2743-2016","Class II","Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment  The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptures: Acute rupture of the Achill tendon(<10 days); Rupture located between 2 and 8 cm above calcaneum; Open or closed ruptures","6,729 units","Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles Tendon Suture System Achillon.","09/07/2016",," Model #'s 19700 and 19700ND",6/17/2016,"06/17/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74614,"Ongoing","Circulatory Technology Inc","21 Singworth St",,"Oyster Bay","NY","11771-3703","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.","Z-0057-2017","Class III"," ID tubing, ITEM BB14, STERILE,    Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump. ","958 units","Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.","10/07/2016",," Lot Numbers: R19229, 015323, 014882, 014602 & 014601",7/1/2016,"07/01/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74615,"Ongoing","Hill-Rom, Inc.","1069 State Road 46 E",,"Batesville","IN","47006-7520","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of: Canada, AUSTRALIA, CHINA, HONG KONG, THAILAND, POLAND, RUSSIAN FEDERATION, SLOVENIA, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, ICELAND, IRELAND, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY,  SPAIN, SWITZERLAND, and UNITED KINGDOM.","Z-2376-2016","Class II","Volker 2080, 2082, S 280 and S 282 series beds with lateral release button.  A/C Powered Adjustable Hospital Bed    Product Usage:  Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.      ","24262","The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm.  To date there has been one report of a related injury.  ","08/09/2016",," All beds (serial numbers) in the 2080, 2082, S 280 and S 282 series are affected by this field action except for those without siderails. The models are as follows: 2080, 2082, 2080 C, 2080 E, 2080 FS, 2080 K, 2080 LP, 2080 MA, 2080 MB, 2080 S, 2080 SL, 2080 SONDER, 2082 SONDER, S280, S280 SONDER, S282, S282 SONDER. ",6/14/2016,"06/14/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74616,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Nationwide, Canada, Algeria  Argentina  Australia  Austria  Bahrain  Bangladesh  Belgium  Brazil  Brunei Darussalam  Bulgaria  CHILE  China  Colombia  Croatia  Cuba  Cyprus  Czech Republic  Denmark  Dominican Republic  Ecuador  Egypt  Finland  France  French Polynesia  Georgia  Germany  Greece  Honduras  Hong Kong  Hungary  Iceland  India  Indonesia  Iran  Ireland  Israel  Italy  Japan  Jordan  Kazakhstan  Kenya  Korea, Republic of  Lebanon  Lithuania  Macedonia  Malaysia  Malta  Mexico  Morocco  Myanmar  Nepal  Netherlands  New Caledonia  Norway  Oman  Pakistan  Palestine, State of  PERU  Philippines  Poland  Portugal  Qatar  R¿union  Romania  RUSSIAN FEDERAT  Russian Federation  Saudi Arabia  Singapore  Slovakia  South Africa  Spain  Sri Lanka  Sweden  Switzerland  Taiwan  Tanzania  Thailand  Tunisia  Turkey  Ukraine  United Arab Emirates  United Kingdom  Uruguay  Uzbekistan  Viet Nam","Z-2670-2016","Class II","UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table,  722034; UNIQ FD20 OR Table,  722035; UNIQ FD20/20,  722038;  UNIQ FD20/20 biplane OR Table,  722039; UNIQ FD20/15,  722058; UNIQ FD20/15 OR Table 722059  ","1536 devices (includes both Allura and UNIQ)","Increase in the failure rate of certain low-voltage DC power supplies (DCPS) ","08/26/2016",," UNIQ with release R1.0",7/7/2016,"07/07/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74616,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Nationwide, Canada, Algeria  Argentina  Australia  Austria  Bahrain  Bangladesh  Belgium  Brazil  Brunei Darussalam  Bulgaria  CHILE  China  Colombia  Croatia  Cuba  Cyprus  Czech Republic  Denmark  Dominican Republic  Ecuador  Egypt  Finland  France  French Polynesia  Georgia  Germany  Greece  Honduras  Hong Kong  Hungary  Iceland  India  Indonesia  Iran  Ireland  Israel  Italy  Japan  Jordan  Kazakhstan  Kenya  Korea, Republic of  Lebanon  Lithuania  Macedonia  Malaysia  Malta  Mexico  Morocco  Myanmar  Nepal  Netherlands  New Caledonia  Norway  Oman  Pakistan  Palestine, State of  PERU  Philippines  Poland  Portugal  Qatar  R¿union  Romania  RUSSIAN FEDERAT  Russian Federation  Saudi Arabia  Singapore  Slovakia  South Africa  Spain  Sri Lanka  Sweden  Switzerland  Taiwan  Tanzania  Thailand  Tunisia  Turkey  Ukraine  United Arab Emirates  United Kingdom  Uruguay  Uzbekistan  Viet Nam","Z-2669-2016","Class II","Allura Xper with release R8.2: Allura Xper FD10,  722026; Allura Xper FD10/10,  722027; Allura Xper FD20,  722028; Allura Xper FD20/10 biplane,  722029;  Allura Xper FD10 OR Table,  722033; Allura Xper FD10/10 OR Table,  722034;  Allura Xper FD20 OR Table,  722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR Table,  722039; Allura Xper FD20/15,  722058; Allura Xper FD20/15 OR Table,  722059  ","1536 devices (includes both Allura and UNIQ)","Increase in the failure rate of certain low-voltage DC power supplies (DCPS) ","08/26/2016",," Allura Xper with release R8.2,",7/7/2016,"07/07/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74617,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR","Z-2297-2016","Class II","SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew  Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.","185 units","The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.","07/28/2016",," Lot Number 16AM14274",7/6/2016,"07/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74618,"Ongoing","RAYSEARCH LABORATORIES AB","Sveavaegen 9",,"Stockholm",,,"Sweden","Voluntary: Firm Initiated","E-Mail","California, Connecticut, Delaware, Florida, Hawaii, Maine, Missouri, New York, Ohio, Texas and Washington","Z-2206-2016","Class II","RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 --- Radiation Therapy Treatment Planning System --- designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions.  ","US: 170 units","An issue was found with the evaluation of biological clinical goals in RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5. Biological clinical goals for an adapted plan based on another planning CT than the original planning CT will show incorrect values. -- To the best of the firm's knowledge, the issue has not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect plan evaluation during treatment planning.  ","07/15/2016",," Software build numbers: 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 and 5.0.2.35",7/1/2016,"07/01/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74619,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT","Z-2390-2016","Class II","Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile,    Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants","47 units","It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.","08/11/2016",," Catalog No: I-K3254TA00  Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994",6/23/2016,"06/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74620,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution -- AR, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TX, and UT.","Z-2245-2016","Class II","Syngo.via, picture archiving and communications system software controlled.    Intended to be used for viewing, manipulation, communication, and storage of medical images.","50 units","Incorrect values for the volume calculation.  Software update VB30B via Update Instructions SY018/16/P to resolve software errors.  ","07/19/2016",," 310289,130542,130322,310149,130325,221063,310168,101762,221048,221096,220783,310195,130451,400031,130292,310114,220846,130269,130163,130402,130826,221051,102336,310282,220888,10007,221052,221049,130518,221002,221091,220915,130520,130472,100469,310249,130122,100013,130378,310188,102453,310079,310080,130240,130382,220985,310171,220879,220995, and 310268.",6/23/2016,"06/23/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74621,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-1947-2016","Class II",,"2652 units"," (Codfish Fritter Mix).","08/18/2016",," TBD",7/5/2016,"07/05/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74622,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",,"Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.","Z-2373-2016","Class II","OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing #  B106952.  One step polishing system for all common dental composites and amalgam. ","US: 86 units total","After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away.  OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected. ","08/09/2016",," REF/Product ID 634459: Lot UL0843;   REF/Product ID 634458: Lot VL0704;   REF/Product ID 634464: Lot VL0705.  ",7/11/2016,"07/11/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74623,"Ongoing","Allergan Sales, LLC","8301 Mars Dr",,"Waco","TX","76712-6578","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0099-2017","Class II","TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.","25,247 tubes (19,499 30 gram/ 5,748 100 gram)","Failed Content Uniformity Specifications","10/13/2016",," a) Lot# 82579; Exp. 10/16  b) Lot:# 85088 Exp. 05/17",6/30/2016,"06/30/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74623,"Ongoing","Allergan Sales, LLC","8301 Mars Dr",,"Waco","TX","76712-6578","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0100-2017","Class II","TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.","17,112 tubes","Failed Content Uniformity Specifications","10/13/2016",," Lot # 85037; Exp 05/17  Lot # 82583; Exp 10/16",6/30/2016,"06/30/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74624,"Ongoing","Implant Direct Sybron Manufacturing, LLC","3050 E Hillcrest Dr",,"Westlake Village","CA","91362-3171","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK.    Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.","Z-2320-2016","Class II","RePlant¿ Angled Abutment  Part Number 6050-52-60","205","Issue with design specification; oversized condition.","08/02/2016",," Lot #50174, 39799, 49364",7/5/2016,"07/05/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74625,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide including Puerto Rico, and outside the US to include:  Australia, Austria, Finland, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, United Kingdom.","Z-2533-2016","Class II","Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes:   1 cm x 6 cm, product code VG0106N,   0.8 cm x 8 cm, product code VG0108N,   1 cm x 10 cm, product code VG0110N, and   2 cm x 9 cm, product code VG0209N.    VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde.  Sterilized using aseptic processing techniques.  The pericardium is procured from cattle originating in the United States.  VASC-Guard is chemically sterilized using ethanol and propylene oxide.    ","32,763 eaches","Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch.  Baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention.  One report involved a case with a fatal outcome.","08/12/2016",," Product Code VG0106N, Lot #:  SP16A04-1108933, SP16A11-1111696, SP16A12-1111933, SP16A12-1111938, SP16A12-1111942, SP16A12-1111947, SP16A27-1116312, SP16A29-1116884, SP16B04-1118465, SP16B08-1119650, SP16B12-1121361, SP16B22-1123979, SP16B24-1124658, SP16C01-1126439, SP16C01-1126508, SP16C07-1128790, SP16C08-1129067, SP16C09-1129905, SP16C10-1130129, SP16C10-1130134, SP16C23-1134739, SP16C28-1136324, SP16C28-1136332, SP16D06-1139370, SP16D13-1141301, SP16D19-1142941, SP16D20-1143649, SP16D20-1143655, SP16D21-1143852, SP16D28-1146476, SP16E04-1148533, SP16E04-1148534, SP16E19-1152299, SP16E24-1153675, SP16F01-1155425, SP16F01-1155678, SP16F01-1155682, SP16F01-1155685.      Product Code VG0108N, Lot #:  SP16A04-1108941, SP16A04-1108956, SP16A04-1108974, SP16A06-1110391, SP16A12-1111872, SP16A12-1111952, SP16A14-1112703, SP16A14-1112720, SP16A18-1113372, SP16A19-1114051, SP16A19-1114056, SP16A21-1114800, SP16A21-1114802, SP16A21-1114805, SP16B04-1118471, SP16B04-1118475, SP16B05-1119212, SP16B05-1119217, SP16B08-1119654, SP16B08-1119720, SP16B12-1121365, SP16B12-1121366, SP16B19-1123365, SP16B22-1123983, SP16B25-1125254, SP16B25-1125260, SP16B25-1125268, SP16C01-1126459, SP16C07-1128755, SP16C08-1129301, SP16C10-1130184, SP16C10-1130191, SP16C10-1130200, SP16C10-1130208, SP16C10-1130219, SP16C10-1130227, SP16C16-1132096, SP16C18-1133115, SP16C18-1133138, SP16C18-1133148, SP16C18-1133152, SP16C18-1133155, SP16C18-1133157, SP16C21-1133807, SP16C22-1134481, SP16C24-1135156, SP16C28-1136307, SP16C28-1136436, SP16D01-1137764, SP16D04-1138414, SP16D04-1138417, SP16D12-1140707, SP16D12-1140708, SP16D19-1142958, SP16D19-1142967, SP16D21-1143872, SP16D21-1143878, SP16D28-1146462, SP16D28-1146466, SP16D28-1146471, SP16E04-1148520, SP16E04-1148522, SP16E04-1148549, SP16E05-1148667, SP16E11-1150104, SP16E11-1150110, SP16E11-1150115, SP16E11-1150174, SP16E19-1152326, SP16E19-1152330, SP16E19-1152335, SP16E24-1153278, SP16E24-1153280, SP16E26-1154142, SP16E26-1154146, SP16E27-1154532, SP16E27-1154534, SP16F01-1155407, SP16F07",6/24/2016,"06/24/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74626,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Letter","USA:  CA, CO, CT, FL, IN, IA, MD, NH, NY, TX, WA, WI.","F-2038-2016","Class I","Case: Beyond Meat Vegetarian Indian Curry with Beyond Chicken, GMI Item # 46671000, Frozen. Net WT 5 lbs (2.2 KG) 8 - 10 oz (263 g).     Individual items: 21 Grams of Plant Protein, Vegetarian Indian Curry with Beyond Chicken, Net WT 10 oz (263 g), UPC is 000-16000-46671 , Keep Frozen.","1826 cases","General Mills today announced a voluntary recall of a limited quantity of frozen Beyond Meat Vegetarian Indian Curry with Beyond Chicken.   The recall is being issued as a precaution after the producer of frozen peas used as an ingredient in this product issued a national recall for the potential presence of Listeria monocytogenes. ","08/31/2016",," 10NOV2016 NL	16NOV2016 NL	25NOV2016 NL  12NOV2016 NL	20NOV2016 NL	  15NOV2016 NL	24NOV2016 NL	  ",6/30/2016,"06/30/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74627,"Ongoing","Natus Medical Incorporated","5900 1st Ave S",,"Seattle","WA","98108-3248","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : AL, CA, FL, IL, IN, KY, LA, MA, MS, NJ, NY, OK, PA, SC and VA,  and Internationally to Pakistan.","Z-0056-2017","Class II","The Medix NatalCare LX Intensive Care Incubator.  Neonatal incubator.  Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.    ","104 units","NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate.  There were several complaints of wheels bending out of alignment.","10/07/2016",," 5045, 5046, 5047, 5048, 5051, 5053, 5056, 5057, 5096, 5097,  5128, 5129, 5130, 5131, 5132, 5133, 5134, 5135, 5136, 5138,  5139, 5209, 5210, 5211, 5212, 5213, 5214, 5219, 5220, 5221,  5222, 5223, 5224, 5225, 5226, 5227, 5228, 5248, 5249, 5250,  5251, 5252, 5253, 5254, 5255, 5256, 5257, 5276, 5277, 5278,  5279, 5280, 5281, 5282, 5283, 5284, 5285, 5286, 5287, 5288,  5289, 8290, 5291, 5292, 5293, 5294, 5322, 5323, 5324, 5325,  5326, 5327, 5328, 5329, 5330, 5331, 5332, 5333, 5334, 5335,  5336, 5337, 5383, 5385, 5388, 5389, 5504, 5505, 5506, 5507,  5508, 5509, 5510, 5511, 5543, 5544, 5545, 5546, 5547, 5548,  5549, 5550, 5551, and 5552.",8/25/2016,"08/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74630,"Ongoing","The Kroger Co","1014 Vine St",,"Cincinnati","OH","45202-1141","United States","Voluntary: Firm Initiated","Letter","Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, MI, MO, MT, MS, NC, NE, NM, NV, OH, OR, SC, TN, UT, VA, WA, WV & WY.","F-1873-2016","Class II","Kroger DELUXE ICE CREAM S'MORES 48 FL OZ (1.5 QT) 1.4 ML INGREDIENTS: ICE CREAM***GRAHAM COOKIES***CHOCOLATE CHUNKS***CONTAINS: MILK, SOY, WHEAT, COCONUT. UPC 0 11110 01399 6 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202","4,158 cs/6/48 oz cartons","The firm was notified that the product was manufactured with an ingredient that may contain low levels of peanut reside which is not declared in the ingredient statement.","08/04/2016",," Sell By May 20 17 & Sell By May 23 17",6/15/2016,"06/15/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74633,"Ongoing","Coca-Cola Company  (The)","1 Coca Cola Plz Nw",,"Atlanta","GA","30313-2420","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, CT, DE, FL, GA, IO, IL, IN, ME, MI, MN, MS, NC, NH, NJ, NY, PA, TN, TX, VA, WA, and WI.","F-2395-2016","Class II","Huberts Lemonade Watermelon, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.","53, 823 cases (12/16oz. glass bottles per case)","The product may contain foreign material (glass) in some bottles.","09/20/2016",," Date Codes: D1627UB and D1628UB",7/1/2016,"07/01/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74633,"Ongoing","Coca-Cola Company  (The)","1 Coca Cola Plz Nw",,"Atlanta","GA","30313-2420","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, CT, DE, FL, GA, IO, IL, IN, ME, MI, MN, MS, NC, NH, NJ, NY, PA, TN, TX, VA, WA, and WI.","F-2396-2016","Class II","Huberts Lemonade Blackberry, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.","53, 823 cases (12/16oz. glass bottles per case)","The product may contain foreign material (glass) in some bottles.","09/20/2016",," Date Codes: D1628UB.",7/1/2016,"07/01/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74633,"Ongoing","Coca-Cola Company  (The)","1 Coca Cola Plz Nw",,"Atlanta","GA","30313-2420","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, CT, DE, FL, GA, IO, IL, IN, ME, MI, MN, MS, NC, NH, NJ, NY, PA, TN, TX, VA, WA, and WI.","F-2394-2016","Class II","Huberts Lemonade Strawberry, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.","53, 823 cases (12/16oz. glass bottles per case)","The product may contain foreign material (glass) in some bottles.","09/20/2016",," Date Codes: D1626UB and D1627UB",7/1/2016,"07/01/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74633,"Ongoing","Coca-Cola Company  (The)","1 Coca Cola Plz Nw",,"Atlanta","GA","30313-2420","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, CT, DE, FL, GA, IO, IL, IN, ME, MI, MN, MS, NC, NH, NJ, NY, PA, TN, TX, VA, WA, and WI.","F-2397-2016","Class II","Huberts Original Lemonade, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.","53, 823 cases (12/16oz. glass bottles per case)","The product may contain foreign material (glass) in some bottles.","09/20/2016",," Date Code: D1626UB",7/1/2016,"07/01/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74634,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide","Z-2377-2016","Class II","Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S    Product Usage:  Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.  ","12,469 units","Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.","08/09/2016",," Catalog No. 6541-4-808  Lot Nos.: SB1K14, SB1K14A, SB1K14A1, SB1K14P, SB1K15, SB1K15A, SB1K15A1, SB1K15A2, SB1M25, SB1M25A, SB1M25A1, SB1M25A2, SB1M25A2X1, SB1N02, SB1N02A, SB1N02A1, SB1N02A2, SB1N02A3, SB1N02X1, SB1T05, SB1T05A, SB1T05A1, SB1T05AX1, SB1T05AX2, SB1T05KSB1V01, SB1V01K, SB1V01L, SB1V01X1, SB1V01X2, SB1V01X3, SB1W14, SB1W14K, SB1W14X1, SB2T19, SB2T19A, SB2T19D, SB2T19DX1, SB2T19DX2, SB2T19J, SB2T19K, SB2T19KX1, SB2T19KX2, SBT19X3, SB2V87, SB2V87A, SB2V87J, SB2V87JX1, SB2V87K, SB2V87X, SB2V87X1, SB2W23, SB2W23G, SB2W23X, SB2W23X1, SB3A20, SB3A20A, SB3A21, SB3A21D, SB3A21M, SB3A21X, SB3A22, SB3A22A1, SB3A22X1, SB3A55, SB3A55A, SB3A55A2, SB3A55AX1, SB3A55M, SB3A55X1, SB3H25, SB3H25D, SB3H25G, SB3H25X1, SB3H26, SB3H26D, SB3H26DX1, SB3H26X2, SB3K09, SB3K09X1, SB3K10, SB3K10L, SB3K10M, SB3K10MX1, SB3K10X1, SB3L19, SB3L19D, SB3L19K, SB3L19L, SB3L19P, SB3L19P1, SB3L20, SB3L20K, SB3L45, SB3L45A, SB3L45A1, SB3L45A2, SB3L45D, SB3L45DX1, SB3L45L, SB3L45T, SB3M17, SB3M17A, SB3M17K, SB3M17M, SB3M18, SB3M18A, SB3M18AX1, SB3M18D, SB3M18M, SB3M18R, SB3M19, SB3M19A, SB3M19A1, SB3M19S, SB3M19T, SB3M19W, SB3N46, SB3N46D, SB3N46P, SB3N46X1, SB4C12, SB4C12X1, SB4C37, SB4C37X1, SB4C38, SB4C38A, SB4C38D, SB4E18, SB4E181, SB4E181X1, SB4E18A, SB4E18D, SB4E18T, SB4H79, SB4H79A, SB4H79M, SB4L05, SB4L05A, SB4N17, SB4N17E, SB4N17M, SB4N17M1, SB4N18, SB4N18A, SB4N18A1, SB4N18D, SB4N18M, SB4N18T, SB4S01, SB4S01D, SB4S01J, SB4V07, SB4V07L, SB4V07M, SB4V07MM, SB5A02, SB5A02A, SB5A02A1, SB5A55",6/23/2016,"06/23/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74635,"Ongoing","Newly Weds Foods Inc","2501 N Keeler Ave",,"Chicago","IL","60639-2131","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-1922-2016","Class I","Bulk flour bland breader packaged into 15, 30, and 50 lb bags or boxes. ","260, 145 lbs","Flour contaminated with E. coli O121 was used in the manufacuring of flour based blends. ","08/15/2016",,"  B# 50368, 08NOV5KC,   CD012716B  CD013016C  CD121815C  CH010316W,010, 012  CH010316W001, 003  CH010316W002, 004  CH010316W005,006, 007, 008  CH010316W009  CH010316W011  CH010316W013  CH010416W001, 002  CH010416W003, 004, 005, 006, 008  CH010416W007  CH010416W009, 010  CH010416W011  CH010416W012  CH010616W001, 002, 003, 012, 013, 014  CH010616W004, 005  CH010616W005, 016  CH010616W006, 010  CH010616W007  CH010616W008, 011  CH010616W009  CH010616W015  CH010716W, 017, 018, 019, 020, 021  CH010716W021  CH010716W021, 022  CH010716W023  CH010716W024  CH122015B001  CH122315A001, 002, 004  CH122315A003, 005, 006  E5L150059  E6A060061  MS010716L  MS011416  MS122015L  MS769638  SE012016A001-002  SE012616C001  SE012616C001  SE020616C001-003  SE020616C004-005  SE021716D001  SE021716D001-002  SE022316D001-002  SE112115C003  SE112515C001  SE112615C002-004  SE120215D001-003  WN010716D001  WN010716D001, 011-014, 016 - 018  WN010716D002-010, 015  WN010916E001-002  CH121015M001",7/5/2016,"07/05/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74636,"Ongoing","Zimmer Surgical Inc","200 W Ohio Ave",,"Dover","OH","44622-9642","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.","Z-2338-2016","Class II","Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00.     Width plate is packaged inside of a padded-foam corrugate box.  A product label is applied to the lid of the box.  The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.    The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.","60 units","The surface coating applied to the device is blistering, peeling and discoloring after usage over time","08/04/2016",," Lot # 61999884, Serial # N/A  Lot # 62267513, Serial # N/A  Lot # 62635782, Serial # N/A  ",7/4/2016,"07/04/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74636,"Ongoing","Zimmer Surgical Inc","200 W Ohio Ave",,"Dover","OH","44622-9642","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.","Z-2334-2016","Class II","Zimmer¿ Air Dermatome II Handpiece,  item number 00-8851-001-00.    The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box.  An operating manual is packed with the handpiece between the top foam pad and box lid.  A product label is applied to the lid of the box.  The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.    The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.","630 units","The surface coating applied to the device is blistering, peeling and discoloring after usage over time","08/04/2016",," Lot # 61977101, Serial # 500001  500019  Lot # 61980678, Serial # 500021  500040  Lot # 61989398, Serial # 500081  500090  Lot # 62008619, Serial # 500091  500110  Lot # 62083340, Serial # 500151  500170  Lot # 62096333, Serial # 500171  500190  Lot # 62122378, Serial # 500191  500210  Lot # 62191658, Serial # 500211  500230  Lot # 62191665, Serial # 500231  500250  Lot # 62220857, Serial # 500251  500270  Lot # 62220882, Serial # 500291  500310  Lot # 62244236, Serial # 500331  500350  Lot # 62266024, Serial # 500351  500371  Lot # 62267510, Serial # 500372  500391  Lot # 62267596, Serial # 500452  500471  Lot # 62289834, Serial # 500412  500431  Lot # 62309628, Serial # 500472  500491  Lot # 62309698, Serial # 500512  500531  Lot # 62369392, Serial # 500532  500551  Lot # 62374685, Serial # 500552  500571  Lot # 62374721, Serial # 500592  500611  Lot # 62393971, Serial # 500632  500651  Lot # 62394012, Serial # 500652  500671  Lot # 62454338, Serial # 500692  500711  Lot # 62476761, Serial # 500712  500731  Lot # 62494048, Serial # 500732  500751  Lot # 62494086, Serial # 500752  500771  Lot # 62525837, Serial # 500772  500791  Lot # 62554526, Serial # 500792  500811  Lot # 62578715, Serial # 500812  500831  Lot # 62578759, Serial # 500832  500851  Lot # 62635778, Serial # 500852  500871  ",7/4/2016,"07/04/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74636,"Ongoing","Zimmer Surgical Inc","200 W Ohio Ave",,"Dover","OH","44622-9642","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.","Z-2335-2016","Class II","Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01.    The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box.  An operating manual is packed with the handpiece between the top foam pad and box lid.  A product label is applied to the lid of the box.  The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.    The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.","220 units","The surface coating applied to the device is blistering, peeling and discoloring after usage over time","08/04/2016",," Lot # 61987607, Serial # 500041  500060  Lot # 61989397, Serial # 500061  500080   Lot # 62007988, Serial # 500111  500130  Lot # 62008620, Serial # 500131  500150  Lot # 62244213, Serial # 500311  500330  Lot # 62267555, Serial # 500392  500411  Lot # 62289845, Serial # 500432  500451  Lot # 62309684, Serial # 500492  500511  Lot # 62374706, Serial # 500572  500591  Lot # 62393940, Serial # 500612  500631  Lot # 62415890, Serial # 500672  500691  ",7/4/2016,"07/04/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74636,"Ongoing","Zimmer Surgical Inc","200 W Ohio Ave",,"Dover","OH","44622-9642","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.","Z-2340-2016","Class II","Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box.  A product label is applied to the lid of the box.  The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.    The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.","110 units","The surface coating applied to the device is blistering, peeling and discoloring after usage over time","08/04/2016",," Lot # 61999890, Serial # N/A  Lot # 62267474, Serial # N/A  Lot # 62339193, Serial # N/A  Lot # 62561320, Serial # N/A   Lot # 62662647, Serial # N/A  ",7/4/2016,"07/04/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74636,"Ongoing","Zimmer Surgical Inc","200 W Ohio Ave",,"Dover","OH","44622-9642","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.","Z-2339-2016","Class II","Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box.  A product label is applied to the lid of the box.  The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.    The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.","90 units","The surface coating applied to the device is blistering, peeling and discoloring after usage over time","08/04/2016",," Lot # 61999886, Serial # N/A  Lot # 62267473, Serial # N/A  Lot # 62339165, Serial # N/A  Lot # 62606085, Serial # N/A  ",7/4/2016,"07/04/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74636,"Ongoing","Zimmer Surgical Inc","200 W Ohio Ave",,"Dover","OH","44622-9642","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.","Z-2337-2016","Class II","Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box.  A product label is applied to the lid of the box.  The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.    The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.","90 units","The surface coating applied to the device is blistering, peeling and discoloring after usage over time","08/04/2016",," Lot # 61999885, Serial # N/A  Lot # 62267472, Serial # N/A  Lot # 62339198, Serial # N/A  Lot # 62629006, Serial # N/A  ",7/4/2016,"07/04/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74636,"Ongoing","Zimmer Surgical Inc","200 W Ohio Ave",,"Dover","OH","44622-9642","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.","Z-2336-2016","Class II","Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 .    Width plates is packaged inside of a padded-foam corrugate box.  A product label is applied to the lid of the box.  The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.    The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.","70 units","The surface coating applied to the device is blistering, peeling and discoloring after usage over time","08/04/2016",," Lot # 61999883, Serial # N/A  Lot # 62243337, Serial # N/A  Lot # 62282028, Serial # N/A  Lot # 62393990, Serial # N/A  ",7/4/2016,"07/04/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74637,"Ongoing","BEST THERATRONICS LTD.","413 MARCH ROAD",,"KANATA",,,"Canada","FDA Mandated","Letter","Nationwide","Z-2251-2016","Class II","Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.  ","128","It was discovered that both the new device and the predicate device failed to comply with performance standard.","07/22/2016",," All Raycell units with serial #'s 5000 and higher.    ",5/6/2016,"05/06/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74638,"Ongoing","Hydroblend Inc ","1801 N Elder St",,"Nampa","ID","83687-3079","United States","Voluntary: Firm Initiated","E-Mail","distributed in WA.","F-1874-2016","Class III","Tortilla Crusted Crumb is a breading system, product Item Key N21997-B.  It composed of flour and other food grade ingredients.  Product is bagged in 25 lbs. multiwalled polylined paper bags. ","2575 lbs.","Tortilla Crusted Crumb is recalled due to a potential to be contaminated with E. coli O121.  ","08/04/2016",," Lot# 0016335",7/6/2016,"07/06/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74638,"Terminated","Hydroblend Inc ","1801 N Elder St",,"Nampa","ID","83687-3079","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in WA.","F-1874-2016","Class I","Tortilla Crusted Crumb is a breading system. Product Item Key N21997-B.  It composed of flour and other food grade ingredients.  Product is bagged in 25 lbs. multiwalled polylined paper bags. ","2575 lbs.","Tortilla Crusted Crumb is recalled due to a potential to be contaminated with E. coli O121.  ","08/15/2016","08/15/2016"," Lot# 0016335",7/6/2016,"07/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74639,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Netherlands, Canada, Japan, Switzerland, and United Kingdom","Z-2238-2016","Class II"," system.","3,163","A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be  more susceptible to breakages.  Risk to Health:  Injury to critical soft tissue requiring surgical intervention may occur.","07/19/2016",," Lot numbers:  15077027, 15077067, 15077097, 15078087, 15105017, 15108017, 15108047, 15108077, 15108087, 15108097, 15146017, 15146027, 15146037, 15146047",6/24/2016,"06/24/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74640,"Ongoing","Montana Flour & Grains, Inc","275 Mt Hwy 223",,"Fort Benton","MT","59442","United States","Voluntary: Firm Initiated","Telephone","distributed nationwide and also sold to internet customers from the company website: montanaflour.com","F-1948-2016","Class II","100% Organic Spelt Grain,  packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.","35,650 lbs.","Organic Spelt Grain is recalled because label does not declare wheat.","08/19/2016",," codes:    JG107-16  JG139-16  JGCD032-16  JGCD219-15  JGCD260-15  JGCD319-15  ",7/8/2016,"07/08/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74640,"Ongoing","Montana Flour & Grains, Inc","275 Mt Hwy 223",,"Fort Benton","MT","59442","United States","Voluntary: Firm Initiated","Telephone","distributed nationwide and also sold to internet customers from the company website: montanaflour.com","F-1949-2016","Class II","100% Organic Spelt Flour,  packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.","12,910 lbs.","Organic Spelt Flour is recalled because label does not declare wheat.","08/19/2016",," lot codes:    SPFGD26099F  SPFGC26096F  SPFGC26033F  SPFGC20646F  SPFGC20626F  SPFDA56099F  SPFDA56089F  SPFDA26048F  SPFCA56032F  SPFBA56160F  SPFBA55365F  ",7/8/2016,"07/08/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74640,"Ongoing","Montana Flour & Grains, Inc","275 Mt Hwy 223",,"Fort Benton","MT","59442","United States","Voluntary: Firm Initiated","Telephone","distributed nationwide and also sold to internet customers from the company website: montanaflour.com","F-1950-2016","Class II","100% Organic Unbleached White Flour,  packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.","121,325 lbs.","Organic Unbleached White Flour is recalled because label does not declare wheat.","08/19/2016",," codes:    UWFAA55317F  UWFAA55317F  UWFAA56043F  UWFAA56112F  UWFGC26033F  UWFGC26096F  UWFGC26112F  UWFGD16043F  UWFGD26112F  ",7/8/2016,"07/08/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74644,"Terminated","BPL Plasma, Inc.","2309A E Nettleton Ave",,"Jonesboro","AR","72401-4510","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0677-16","Class III","Source Plasma","1 unit","Blood product, in which donor screening/donor record incomplete or incorrect, was distributed.","08/08/2016","08/08/2016"," JB0497247; ",6/21/2016,"06/21/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74645,"Terminated","DCI Biologicals Greenville, Inc","2727 E 10th St",,"Greenville","NC","27858-3127","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0678-16","Class III","Source Plasma","1 unit","Blood product, in which quality control and distribution of product did not meet specifications, was distributed.","08/08/2016","08/08/2016"," GL0669927; ",7/5/2016,"07/05/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74646,"Completed","Southeastern Mills Custom Seasoning Solutions","333 Old Lindale Rd SE",,"Rome","GA","30161-6769","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","VA","F-2283-2016","Class II","Tortilla Encrusted Breader for Tilapia, Net Wt. 40 lbs, Sm# 1000323591, MFG For High Liner Foods, Newport News, VA 23603.","87/40 lb. Bags (3480 Pounds)","Product was manufactured with flour recalled by General Mills due to Ecoli contaminated.","09/15/2016",," Item #100032591, Lot # 1061674",7/7/2016,"07/07/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74647,"Ongoing","Carefusion 2200 Inc","75 N Fairway Dr",,"Vernon Hills","IL","60061-1845","United States","Voluntary: Firm Initiated","Letter","Illinois","Z-2846-2016","Class II","Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2","544 (2/PACKS)","The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect.    The PINK/RED Oxygen Delivery Module, 7700RAW, is intended to be used within the PINK/RED Pouch of the BROSELOW pediatric safety system.    Three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the PINK/RED Oxygen Delivery Module, 7700RAW, are affected by this voluntary Field Safety Corrective Action.","09/20/2016",," Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 914867 of the 2/PACK (7700RAW2). Expiration Date JAN 2021.",6/29/2016,"06/29/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74647,"Ongoing","Carefusion 2200 Inc","75 N Fairway Dr",,"Vernon Hills","IL","60061-1845","United States","Voluntary: Firm Initiated","Letter","Illinois","Z-2847-2016","Class II","Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD","50 units","The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect.    The PINK/RED Oxygen Delivery Module, 7700RAW, is intended to be used within the PINK/RED Pouch of the BROSELOW pediatric safety system.    Three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the PINK/RED Oxygen Delivery Module, 7700RAW, are affected by this voluntary Field Safety Corrective Action.","09/20/2016",," Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 916714 of the Broselow Complete Set of Colored Pouches, Product Code 7730MOD. Expiration Date MAR 2018.",6/29/2016,"06/29/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74648,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution --  USA, New Zealand, and United Kingdom.","Z-2301-2016","Class II","Merge PACS software.  The firm name on the label is Merge Healthcare, Hartland, WI.     Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.","109 sites have the affected versions","Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. ","07/29/2016",," Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.",1/30/2016,"01/30/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74649,"Ongoing","Innovision A/S","Skovvaenget 2",,"Glamsbjerg",,,"Denmark","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, to Massachusetts and Washington, DC; and, the countries of Canada, Germany, and United Kingdom.","Z-2769-2016","Class II","Innocor Cardiopulmonary Exercise and Lung Function Testing System      Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.","8","The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer.    The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use.    The replacement is intended to prevent risk of electric shock.","09/08/2016",," Ref. INN00400, Serial no. 1551369, 1540362, 1540363, and 1536361.",5/13/2016,"05/13/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0203-2017","Class I","FE RedBell Pepper, Product Code 22760.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","400 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot:  31645, 31643",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0207-2017","Class I","FE Maple, Product Code 27128.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","32,750 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot:  31552, 31939, 31969",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0196-2017","Class I","FE RedBell Pepper 339, Product Code 22339.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","6,000 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot codes:  31476, 31802",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0206-2017","Class I","FE Bacon, Product Code 24117.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","500 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot:  31769",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0193-2017","Class I","FE Bacon 286, Product Code 22286.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","400 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot 31790",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0195-2017","Class I","FE Green Bell Pepper 338, Product Code 22338.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","300 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot 31483",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0202-2017","Class I","FE Green Bell Pepper, Product Code 22733.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","1.500 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lots:  31624, 31978",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0200-2017","Class I","FE Jalapeno 709, Product Code 22709.  50 lb corrugated case with polyliner.  Manufactured by:  Quali Tech, 318 Hazel tine Drive, Chasma, MN  55318 USA","3,200 lbs.","Quali Tech has been notified by a supplier that they received material with the potential presence of E. coli O 121 bacteria.  ","10/19/2016",," Lots:  31504, 31756",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0199-2017","Class I","FE Red Bell Pepper, Product Code 22708.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","4,150 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lots:  31755, 32072",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0208-2017","Class I","PE Blueberry, Product Code 27136.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","176,900 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot:  31591, 31779, 31960",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0194-2017","Class I","FE Jalapeno 321A, Product Code 22321A.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","2,350 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lots:  31664, 31794, 31930",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0201-2017","Class I","FE Rainbow Blend 714, Product Code 22714.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","67,500 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lots:  31584, 31665, 31841, 31842",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0197-2017","Class I","FE Spinach 352, Product Code 22352.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","4,950 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lots:  31679, 31991",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0191-2017","Class I","FI Dry Blueberry / Strawberry Blend, Product Code 21585.  40 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","40,080 lbs","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot:  31800",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0205-2017","Class I","FE Rainbow Blend, Product Code 22795.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","1,400 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot:  31950",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0204-2017","Class I","FE Bacon, Product Code 22763.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","50 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot:  31750",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0192-2017","Class I","FE Carrot 281, Product Code 22281.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","40,150 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lot:  31717, 31832",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74650,"Ongoing","QualiTech, Inc","318 Lake Hazeltine Dr",,"Chaska","MN","55318-1034","United States","Voluntary: Firm Initiated","E-Mail","AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA.  Outside the US to include:  Canada.","F-0198-2017","Class I","FE Cheddar Cheese, Product Code 22518.  50 lb corrugated case with polyliner.  Manufactured by:  QualiTech, 318 Hazeltine Drive, Chaska, MN  55318 USA","7,050 lbs.","QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.  ","10/19/2016",," Lots:  31541, 31823, 31667, 31861",7/5/2016,"07/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74651,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.","Z-2303-2016","Class II","Merge PACS software.  The firm name on the label is Merge Healthcare, Hartland, Wisconsin.    Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. ","208 sites have the affected versions ","A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.","07/29/2016",," Versions: V6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6.0, 6.6.1, 6.6.1.1, 6.6.2",1/30/2016,"01/30/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74652,"Ongoing","Carestream Health Inc","150 Verona St",,"Rochester","NY","14608-1733","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.","Z-2217-2016","Class II","Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog  Number 1738822 --- Common Name: Touch Ultrasound    Diagnostic ultrasound imaging or fluid flow analysis of the human body","7 Units (US: 5 units,  OUS: 2 units)","A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated.  For example, measurement results of the anatomy may appear enlarged or distended when it actually is not.","07/18/2016",," Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043      ",7/8/2016,"07/08/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74653,"Ongoing","Northern Tier Bakery (dba\ Super Mom's)","625 2nd St",,"St Paul Park","MN","55071-1807","United States","Voluntary: Firm Initiated","E-Mail","WI, NC, WA","F-1967-2016","Class II","The Cheese & Berries Danish was labeled Pleasant Hill Ovens, Cheese Danish, Artificial Flavored, Net WT 5.0 OZ (142 g), UPC 7 63913 13003 4.","840 cases (12 count)","Northern Tier Bakery LLC is recalling Pleasant Hill Ovens Cheese & Berries Danish  pastries  for possible mislabeling and undeclared colors Blue #1 and Red #40. ","08/23/2016",," 097/16",6/22/2016,"06/22/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74654,"Ongoing","Sysmex America Inc","577 Aptakisic Rd",,"Lincolnshire","IL","60069-4325","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic.","Z-2770-2016","Class II","Fluorocell PLT reagent, Catalog #CD994563  Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers","3868 units"," message with asterisks beside the results indicating the data is unreliable. In rare instances, platelet flags may be absent. The PLT-I counts are unaffected.    The PLT-F is a reflex test used to confirm PLT-I results due to flagging or low values. As such, the likely impact to patient results is low. Affected results display a discrepancy between the PLT-I and PLT-F, with lower than expected PLT-F results that do not match the patient's clinical picture.","09/09/2016",," Lot number A5053, Expiration date 12/21/2016  Lot number A5054, Expiration date 12/21/2016  Lot number A5041, Expiration date 9/2/2016  Lot number A5042, Expiration date 9/2/2016  Lot number A5044, Expiration date 10/2/2016  Lot number A5046, Expiration date 11/9/2016  Lot number A5047, Expiration date 11/17/2016  Lot number A5048, Expiration date 11/17/2016  Lot number A5049, Expiration date 11/26/2016  Lot number A5050, Expiration date 11/26/2016  Lot number A5055, Expiration date 12/24/2016  ",7/1/2016,"07/01/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74655,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL,AZ,CA,CO,IA,IL,MA,MD,MI,MN,MO,NE,NJ,NY,OH,OR,PA,RI,TX,VA,WA,WI,WV","Z-2344-2016","Class II","Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled  Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255  Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.","51 units","Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup. ","08/05/2016",," Serial Numbers: 121185,147996,121169,105032,109190,109191,109197,109198,125100,158225,161021,154847,124083,123050,109187,124102,121167,125021,121163,117125,148001,158234,148010,158229,121171, 109183,109181,131101,158226,109194,117124,158244,109179,158238,109188,121179,137714,121168,158246,161022,121175,121173,154859,109186,158230,123046,158227,109189,123052,105029,105030",7/7/2016,"07/07/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74656,"Ongoing","Richard Wolf Medical Instruments Corp.","353 Corporate Woods Pkwy",,"Vernon Hills","IL","60061-3110","United States","Voluntary: Firm Initiated","Letter","U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.","Z-2608-2016","Class II","Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.","Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces","The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the  impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients. ","08/19/2016",," Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922",5/19/2016,"05/19/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74657,"Ongoing","Newly Weds Foods Inc","2501 N Keeler Ave",,"Chicago","IL","60639-2131","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2208-2016","Class I"," packaged in 25, 35, and 50 lb. bags. ","56,164.5 lbs. "," blends at Newly Weds Foods. Recall started on 7/7/16.","09/14/2016",," B50233  B50233  B50233  A95814  A95814  A95814  A95814  A95814  B50233  B50233  B50233  B50233  B50233  B50233  B50233  B50233  B50233  B50233  B50233  B50233  B50233  B50233  A96037  A96037  B50690  B50690  B57595  A95658  B5AHG5  B57411  B5AHG5  A97575  A58887  A92337  ",7/7/2016,"07/07/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74657,"Ongoing","Newly Weds Foods Inc","2501 N Keeler Ave",,"Chicago","IL","60639-2131","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2209-2016","Class I","Bulk packaged flour based tortilla bits packaged in 45.5 lb. bags. ","Unknown"," blends at Newly Weds Foods. Recall started on 7/7/16.","09/14/2016",," G65314  G65314  ",7/7/2016,"07/07/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74659,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","FAX","Texas; Kentucky","B-0664-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","07/17/2016","07/17/2016"," W0352140328573 ",7/5/2016,"07/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74659,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","FAX","Texas; Kentucky","B-0666-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","07/17/2016","07/17/2016"," W0352140328573 ",7/5/2016,"07/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74659,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","FAX","Texas; Kentucky","B-0665-16","Class II","Platelets","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","07/17/2016","07/17/2016"," W0352140328573 ",7/5/2016,"07/05/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74660,"Terminated","LifeSouth Community Blood Centers, Inc.","4039 W Newberry Rd",,"Gainesville","FL","32607-2342","United States","Voluntary: Firm Initiated","FAX","Florida","B-0657-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Mislabeled blood product was distributed.","07/17/2016","07/17/2016"," W115116112491S",6/30/2016,"06/30/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74661,"Terminated","Delta Blood Bank","65 N Commerce St",,"Stockton","CA","95202-2318","United States","Voluntary: Firm Initiated","FAX","California","B-0668-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.","07/17/2016","07/17/2016"," W128716460067",6/6/2016,"06/06/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74662,"Terminated","Blood Bank Of Delmarva, Inc","100 Hygeia Dr",,"Newark","DE","19713-2047","United States","Voluntary: Firm Initiated","Letter","Delaware","B-0669-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, which failed to meet the minimum specifications for red blood cell percent recovery, was distributed.","07/17/2016","07/17/2016"," W036916401521",6/27/2016,"06/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74663,"Ongoing","Bard Peripheral Vascular Inc","1625 W 3rd St",,"Tempe","AZ","85281-2438","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO.    Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.","Z-2547-2016","Class II","Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product    Part Number C1816B  The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.","1250 units","May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.","08/16/2016",," Lot Number: REZK0479",7/6/2016,"07/06/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74664,"Ongoing","Medline Industries Inc","1 Medline Pl",,"Mundelein","IL","60060-4485","United States","Voluntary: Firm Initiated","Letter","Continental U.S.","Z-2404-2016","Class II","Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.","903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)","There is 5 mL printed next to the increment on the medicine cups instead of 10 mL.    The cup has the correct mL markings for the other gradations, but sequentially, the markings are listed as 2.5 mL, 5 mL, 7.5 mL, and 5 mL.","08/11/2016",," Lot Numbers 122211502  122212515",5/11/2016,"05/11/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74665,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.","Z-2359-2016","Class I","Alere INRatio2 Replacement Monitor (Home)  Model Number: 0200457    Product Usage:  Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿2 PT/INR Home Monitoring System is not intended to be used for screening purposes.  ",,"Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.","08/19/2016",," All Lots  All Serial Numbers",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74665,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.","Z-2358-2016","Class I","Alere INRatio2 PT/INR Home Monitoring System  Model Number: 0200432, 0200433    Product Usage:  Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿2 PT/INR Home Monitoring System is not intended to be used for screening purposes.  ",,"Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.","08/19/2016",," All Lots  All Serial Numbers",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74665,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.","Z-2354-2016","Class I","Alere INRatio PT/INR System Professional  Model Numbers: 0100004    Product Usage:  Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use): The Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio ¿ 2 Monitor and INRatio¿ 2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio¿ 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿ 2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes.  ",,"Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere  INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.","08/19/2016",," All Lots  All Serial Numbers",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74665,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.","Z-2362-2016","Class I","Alere INRatio/ INRatio2 PT/INR Test Strips  Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7    Product Usage:  The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for use outside the body (in vitro diagnostic use). The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is not intended to be used for screening purposes.  ",,"Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Strips. This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere  INRatio¿/INRatio¿2 PT/INR System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.","08/19/2016",," All Lots  All Serial Numbers",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74665,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.","Z-2356-2016","Class I","Alere INRatio Replacement Monitor  Model Number: 0100137     Usage:  The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.  ",,"Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.","08/19/2016",," All Lots  All Serial Numbers",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74665,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.","Z-2357-2016","Class I","Alere INRatio2 PT/INR Professional Testing System  Model Number: 0200431    Product Usage:  The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.  ",,"Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.","08/19/2016",," All Lots  All Serial Numbers",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74665,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.","Z-2360-2016","Class I","Alere INRatio2 PT/INR Professional Monitoring System  Model Number: 55128A    Product Usage:  The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for use outside the body (in vitro diagnostic use). The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is not intended to be used for screening purposes.  ",,"Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.","08/19/2016",," All Lots  All Serial Numbers",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74665,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.","Z-2355-2016","Class I","INRatio Prothrombin Time (PT) Monitoring System  Model Number: 0100007     Product Usage:  The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that cause coagulation to begin. The test strip area on the test strip is separated into three channels, each of which contains electrodes for detection of the blood clot. One channel contains the reagents to perform the Prothrombin time test on the blood sample. The other two channels contain the reagents. to perfom the Prothrombin time test on the blood sample. The other two channels contain the reagents to run control tests. No external quality control test are required for the INRatio System. The meter monitors the reactions, and calculates the PT and INR for the blood sample, which are reported on the display. If the control results are not within a set range, it indicates a problem with the test and an error message is reported on the display instead of a result.    ",,"Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere  INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.","08/19/2016",," All Lots  All Serial Numbers",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74665,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Press Release","Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.","Z-2361-2016","Class I","Alere INRatio PT/INR Test Strips  Model Number: 0100071, 0100139    Product Usage:  The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.  ",,"Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.","08/19/2016",," All Lots  All Serial Numbers",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74666,"Ongoing","Nakanishi Inc.","700","Shimohinata","Kanuma",,,"Japan","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Illinois, Florida and Georgia.","Z-2672-2016","Class II","Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150).   The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).","30719 units","Through an error, the labeling failed to include the symbol or other text indicating that the  diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only.    This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.","08/26/2016",," Waiting for clarification from the firm.",7/8/2016,"07/08/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74666,"Ongoing","Nakanishi Inc.","700","Shimohinata","Kanuma",,,"Japan","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Illinois, Florida and Georgia.","Z-2674-2016","Class II","Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico)  The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.","4284 units","Through an error, the labeling failed to include the symbol or other text indicating that the  diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only.    This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.","08/26/2016",," Waiting for clarification from the firm.",7/8/2016,"07/08/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74666,"Ongoing","Nakanishi Inc.","700","Shimohinata","Kanuma",,,"Japan","Voluntary: Firm Initiated","Letter","Nationwide Distribution to Illinois, Florida and Georgia.","Z-2673-2016","Class II","Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light)  The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus lift, and implant preparation.","2574 units","Through an error, the labeling failed to include the symbol or other text indicating that the  diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only.    This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.","08/26/2016",," Waiting for clarification from the firm.",7/8/2016,"07/08/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74667,"Ongoing","Bakery Express - Mid Atlantic, Inc.","4711 Hollins Ferry Rd Ste 100",,"Baltimore","MD","21227-4630","United States","Voluntary: Firm Initiated","E-Mail","Fresh products are delivered daily through a daily distribution network. Shelf life and date of expiration indicated above.","F-2064-2016","Class II","7-Eleven, Fresh To Go, 	Walnut Fudge Brownie   Net weight: 	3.8 Ounces, Number of units per package: One  Shelf life: Three Days   Expiration date: 0708   (July 8, 2016)    ","1461 Packets of Walnut Fudge Brownies were ordered and shipped to the customer through a distribution network that supplies 7-Eleven convenience store","Bakery Express Mid Atlantic, Inc.  is recalling the 7-Eleven, Fresh To Go, Walnut Fudge Brownie products because of an undeclared walnut allergen.   An incorrect chocolate cookie label was placed on the retail packets of walnut fudge brownies. ","09/02/2016",," CODE:      Expiration/use by dates:	 best by Friday 0708    Customer product code number: 172697    UPC Number for Brownie: 0 52548 56393 6  ",7/6/2016,"07/06/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74668,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom","Z-2293-2016","Class II","MOSAIQ Oncology Information System","383","It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order. ","07/27/2016",," Versions 2.50.05 and higher",7/15/2016,"07/15/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74669,"Completed","Teleflex Medical","3015 Carrington Mill Blvd",,"Morrisville","NC","27560-5437","United States","Voluntary: Firm Initiated","Letter","USA Distribution to the states of :AL, AZ, CA, CT, FL, IL, KY, MD, MI, MN, NM, NY, NC, OR, PA, SC, TX, VA, WA, WI,  and Internationally to Canada","Z-2327-2016","Class II","Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile.    The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable","8,220 ea.","The manufacturing and expiration dates are not printed on the blister pack label.","08/03/2016",," Lot/Serial Number 01J1200435",8/8/2013,"08/08/2013",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74670,"Ongoing","Procesadora de Frutos y Vegetales del Caribe","Calle Club Rotario 24, Madre Vieja Sur",,"San Cristobal",,,"Dominican Republic (the)","Voluntary: Firm Initiated","Letter","U.S. consignees -     New York, United States.    No U.S. Government Agency consignees    No Foreign consignees     Please note: The firm ceased further distribution of the product(s) on   06/20/2015","F-1923-2016","Class II","Coconut milk , 13.5 fld oz, can, 214x406  3 pieces steel tins ,24 tins per case.  Refrigerate after opening.","1650 cases 24/13.5fld oz ","Procesadora de Frutos y Vegetales del Caribe SRL,  Calle Club Rotario 24, Madre Vieja Sur, San Crist¿bal, Dominican Republic   has initiated a voluntary recall due to an undeterminable number of lots of coconut milk that were thermally under processed.  ","08/12/2016",," Lots involved are 32 ,35, 37,41,43,47,39, 53 and 57. All these lots expire on May of 2018. The UPC code that identifies the P.A Coconut milk is: 7189123232406",6/13/2016,"06/13/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74672,"Ongoing","TYRX Inc.","1 Deerpark Dr Ste G",,"Monmouth Junction","NJ","08852-1920","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2540-2016","Class II","TRYX Absorbable Antibacterial Envelope    Product Usage:  Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)  ","2993 units","TRYX products are being recalled since the processes of  spaying, welding, drying oven and polymer were not adequately validated.","08/15/2016",," model number   CMRM6122     lot number  16E03727  16E05728    model number   CMRM6133    lot number   16E02726  16E06729  ",6/29/2016,"06/29/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74672,"Ongoing","TYRX Inc.","1 Deerpark Dr Ste G",,"Monmouth Junction","NJ","08852-1920","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2541-2016","Class II","TRYX Neuro Absorbable Antibacterial Envelope    Product Usage:  Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)  ","194 units","TRYX products are being recalled since the processes of  spaying, welding, drying oven and polymer were not adequately validated.","08/15/2016",," model number    NMRM6122     lot number    16E03727  16E05728    model number    NMRM6133    lot number    16E02726  16E09730  ",6/29/2016,"06/29/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74672,"Ongoing","TYRX Inc.","1 Deerpark Dr Ste G",,"Monmouth Junction","NJ","08852-1920","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2539-2016","Class II","TRYX Antibacterial Envelope Rx Only    Product Usage:  Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)  ","3460 units","TRYX products are being recalled since the processes of  spaying, welding, drying oven and polymer were not adequately validated.","08/15/2016",," model number   CMRM3122    lot number     15F30614  15F30614-A  15H10630  15K29659  16B05695    model number CMRM3133    lot number     15F18607  15G14620  15J29647  16C03706  ",6/29/2016,"06/29/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74674,"Terminated","American National Red Cross (The) - North Central Region","100 Robert St S",,"Saint Paul","MN","55107-1411","United States","Voluntary: Firm Initiated","E-Mail","MN","B-0721-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Blood products, with incomplete documentation of the irradiation process, were distributed. ","08/29/2016","08/29/2016"," W2009168612302",6/2/2016,"06/02/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74675,"Terminated","United Blood Services","6220 E Oak St",,"Scottsdale","AZ","85257-1101","United States","Voluntary: Firm Initiated","FAX","Arizona","B-0673-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Apheresis products, collected from an unsuitable donor due to a donor screening deviation, were distributed. ","07/28/2016","07/28/2016"," W0410160662680 (double collection) ",5/21/2016,"05/21/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74681,"Ongoing","Teleflex Medical","3015 Carrington Mill Blvd",,"Morrisville","NC","27560-5437","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of FL, KS and  WV.","Z-2374-2016","Class II","Servo Humidifier 163, Model 01-06-8125-8, REF 6419365    Product Usage:  A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.  ","2,700 ea.","Cracks may occur at the 15mm and 22mm ISO female connector.","08/09/2016",," Lots 201450, 201451, 201452, 201504",12/3/2015,"12/03/2015",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74682,"Ongoing","Baptista's Bakery, Inc","4625 W Oakwood Park Dr",,"Franklin","WI","53132-8872","United States","Voluntary: Firm Initiated","Telephone","AZ, CA, IL, IN, MN, OH, PA and WI.  Outside the US to include:  Canada","F-1920-2016","Class II","Snack Factory Original Pretzel Crisps, Thin, Crunchy Pretzel Crackers.    Made in a facility that processes Milk and Soy.  Distributed by:  Snack Factory, PO Box 6917, Hanover, PA  17331    Sold in the following sizes and UPC codes:    12 ct / 116 oz.      Net Wt 26 oz (l lb 10 oz.) 737g, UPC 49508-00692,   Net. Wt. 30 oz. (1 lb. 14 oz.) 850 g, UPC 49508-25040    ","31,760 units","Baptista's Bakery is recalling The Snack Factory 30 oz. Original Pretzel Crisps due to undeclared milk, because it may contain seasoned pretzel crisps which utilize dairy in their topical seasoning application.","08/11/2016",," 16 oz.:  Item Code 110608, Lot Code:  BB070165A 03, Best By Date 07-01-17;     26 oz.:  Item Code 110692, Lot Code:  BB070162A 03, Best By Date 07-01-17;     30 oz.:  Item Code 108105, Best By Date 07-01-17.",7/8/2016,"07/08/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74683,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA","Z-2538-2016","Class II","Weck EFx Classic Fascial Closure System, Rx Only, Sterile,    The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery","45","Incorrect expiration date was printed on the product label.","08/15/2016",," Product Code EFXCT1 - Lot/Batch Nos. ML-000342, ML-000343, ML-000344, ML-000348, ML-000349; Product Code EFXSP1 - Lot/Batch Nos. ML-000345, ML-000347 ",3/24/2016,"03/24/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2055-2016","Class II",,"749 boxes of 12 (16 oz) canister ea.","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 15238, 15267, 15280, 15306, 15309, 16021, 16062, and 16112",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2058-2016","Class II",,"202 boxes of 12 (16 oz) canister ea.","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 15258 and 15348",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2061-2016","Class II",,"153 boxes of (16 oz) canister ea.","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 16147 and 16180",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2054-2016","Class II",,"502 boxes of 12 (16 oz) canister ea.","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 15253, 15323, 16014, and 16131    ",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2059-2016","Class II",,"163 boxes of 12 (16 oz) canister each","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 15280 and 16118",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2063-2016","Class II",,"513 boxes of 12 (6 oz) pouches each","Undeclared allergen: Soy lethicin","09/02/2016",," Lot: 15316, 15338, 15342, and 16047",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2057-2016","Class II",,"239 boxes of 12 (16 oz) canister ea.","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 15280, 15238, 16014, and 16147",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2056-2016","Class II",,"150 boxes of 12 (16 oz) canister ea.","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 15349 and 16162",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2053-2016","Class II",,"616 boxes of 12 (16 oz) ea.","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 15246, 15280, 16014, 16033, 16131, and 16163",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2060-2016","Class II",,"440 boxes of 24 (11 oz) bags each","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 15217, 15230, 15271, and 15343",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74684,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","Letter","Puerto Rico only.","F-2062-2016","Class II",,"239 boxes of 24 (12oz) bags each","Undeclared allergen: Soy lethicin","09/02/2016",," Lots: 15274, 16124, and 16146",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74685,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","FDA Mandated","Letter","US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.","Z-2682-2016","Class II","Philips DuraDiagnost stationary X-ray system","15",", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)]. ","09/01/2016",," SN:  140054  140059  150013  150014  150039  150041  150042  150052  150053  150055  150056  150059  150061  150091  150093",9/17/2015,"09/17/2015",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0119-2017","Class II","COZY SHRIMP, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","111 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K363, Lot/Julian Code: PM15M18 / 15352.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0126-2017","Class II","ROASTED VEGETABLE, 200 CT, TART Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","59 cases/82 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K7051, Lot/Julian Code: PM15M03 / 15337 and PM15M04 / 15338.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0145-2017","Class II","MOZZARELLA CALZONE, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","23 cases/7 cases (100 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K8871, Lot/Julian Code: PM15M08 / 15342.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0123-2017","Class II","MINI CLASSIC FRENCH QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","84 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K462, Lot/Julian Code: PM15M10 / 15344.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0139-2017","Class II","CRAB CAKES, 1.25 OZ, 112 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","54 cases (112 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K8036, Lot/Julian Code: PM15M16 / 15350.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0135-2017","Class II","WILD MUSHROOM IN PHYLLO, 100 CT and 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","10 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K751, Lot/Julian Code: PM16A13 / 16013 and Item number: K7515, Lot/Julian Code: PM15M16 / 15350..",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0122-2017","Class II","MINI FLORENTINE QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","113 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K460, Lot/Julian Code: PM16A15 / 16015.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0125-2017","Class II","MINI MUSHROOM QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","119 cases/50 cases (200 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K468, Lot/Julian Code: PM15M16 / 15350.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0130-2017","Class II","APPLE EMPANADA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","63 cases (100 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K7165, Lot/Julian Code: PM15M14 / 15348.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0136-2017","Class II","MINI DEEP DISH MUSHROOM PIZZA, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","176 cases/115 cases (200 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K7954, Lot/Julian Code: PM15M18 / 15352 and PM15M17 / 15351.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0142-2017","Class II","MINI VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","152 cases/114 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K8661, Lot/Julian Code: PM15M18 / 15352 and PM15M17 / 15351.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0131-2017","Class II","SHRIMP EMPANADA Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","26 cases (100 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K718, Lot/Julian Code: PM15M18 / 15352.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0120-2017","Class II","PANANG SHRIMP, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","107 cases (100 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K3634, Lot/Julian Code: PM15M22 / 15356.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0143-2017","Class II","MINI VEGETABLE EGGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","106 cases (200 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K8662, Lot/Julian Code: PM15M10 / 15344.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0132-2017","Class II","VEGETABLE SAMOSA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","73 cases/205 cases (100 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K7195, Lot/Julian Code: PM15M16 / 15350.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0121-2017","Class II","MAC & CHEESE POPPERS, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","76 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K418, Lot/Julian Code: PM15M09 / 15343",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0128-2017","Class II","MUSHROOM TART, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","86 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K707, Lot/Julian Code: PM15M18 / 15352..",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0124-2017","Class II","MINI CHEESE QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","377 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K467, Lot/Julian Code: PM15M16 / 15350.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0134-2017","Class II","FOUR CHEESE PUFF, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260","28 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K7234, Lot/Julian Code: PM16A13 / 16013.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0129-2017","Class II","VEGETABLE EMPANADA, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","192 cases (100 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K716, Lot/Julian Code: PM15M22 / 15356",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0127-2017","Class II","LOBSTER POT PIE, 180 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","23 cases (180 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K7059, Lot/Julian Code: PM16A15 / 16015.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0141-2017","Class II","VEGETABLE SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","197 cases/152 cases/225 cases/66 cases/26 cases (200 units per case)","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K866, Lot/Julian Code: PM15M18 / 15352, PM15M08 / 15342, PM16A13 / 16013 and PM16A14 / 16014.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0133-2017","Class II","SWEET POTATO PUFF, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","57 cases (200 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K7210, Lot/Julian Code: PM16A18 / 16018",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0144-2017","Class II","SHRIMP SPRINGROLL, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","52 cases (200 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K867, Lot/Julian Code: PM15M10 / 15344.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0138-2017","Class II","CRAB CAKES, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","235 cases/ (200 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K802, Lot/Julian Code: PM15M03 / 15337.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0137-2017","Class II","COCONUT SHRIMP, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","205 cases/162 cases (100 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K800, Lot/Julian Code: PM16A12 / 16012 and PM15M18 / 15352.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74686,"Ongoing","Kabobs Inc","5423 N Lake Dr",,"Lake City","GA","30260-3534","United States","Voluntary: Firm Initiated","E-Mail","AR, CA, CO, CT, FL, GA, IL,IN, IO, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OK, OH, OR, PA, TN, TX WA, and WI.","F-0140-2017","Class II","COCONUT LOBSTER TAIL, 100 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.","80 cases (100 units per case).","Product was manufactured with flour recalled due to E. coli O121 contamination.","10/18/2016",," Item number: K8073, Lot/Julian Code: PM15M18 / 15352.",7/6/2016,"07/06/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74687,"Ongoing","Zimmer Biomet Spine, Inc","310 Interlocken Pkwy","Suite 120","Broomfield","CO","80021-3479","United States","Voluntary: Firm Initiated","Other","Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.","Z-2397-2016","Class II","Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.  ","5","Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.","08/11/2016",," Lot Numbers: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351.",6/30/2016,"06/30/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74687,"Ongoing","Zimmer Biomet Spine, Inc","310 Interlocken Pkwy","Suite 120","Broomfield","CO","80021-3479","United States","Voluntary: Firm Initiated","Other","Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.","Z-2398-2016","Class II","Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.  ","5","Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.","08/11/2016",," Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.",6/30/2016,"06/30/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74688,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Missouri","B-0672-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.","07/21/2016","07/21/2016"," W333616011980",6/23/2016,"06/23/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74690,"Ongoing","Kerry, Inc","3400 Millington Rd",,"Beloit","WI","53511-9554","United States","Voluntary: Firm Initiated","Letter","FL  IL  KS  MI  MN  MO  NJ  OK  TX  CANADA","F-1916-2016","Class II","Golden Dipt¿ Jalape¿o Breader is in a white 10 pound bag with the UPC number 763089721548 and Item Number: G5620.690.","553 units","Kerry Inc. was notified by our supplier that two of their products, a red bell pepper nugget and a jalapeno nugget, were made with a small percentage of affected flour which was recalled by General Mills because it may be contaminated with E. coli O121.","08/15/2016",," lots 0414647003 and 0513647003. ",7/11/2016,"07/11/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74690,"Ongoing","Kerry, Inc","3400 Millington Rd",,"Beloit","WI","53511-9554","United States","Voluntary: Firm Initiated","Letter","FL  IL  KS  MI  MN  MO  NJ  OK  TX  CANADA","F-1917-2016","Class I","SOUTHWEST BREADER G2293  25 LB BAG  POLY BAG  ITEM G2293.43","2892 units","Kerry Inc. was notified by our supplier that two of their products, a red bell pepper nugget and a jalapeno nugget, were made with a small percentage of affected flour which was recalled by General Mills because it may be contaminated with E. coli O121.","08/15/2016",," Lots:  0610616109  0520616109  0513616104  0408616105",7/11/2016,"07/11/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74691,"Ongoing","B-K Medical A/S","Mileparken 34",,"Herlev",,,"Denmark","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to TX, FL, and MA.  Internationally to Australia","Z-2325-2016","Class II","BK Medical ApS Ultrasound System Scanner bk2300 -  Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2.  The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN","6","In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be  unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of  the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the  software.","08/03/2016",," Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277",6/28/2016,"06/28/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74692,"Ongoing","ICC/Marie Callender's Products","491 W San Carlos St",,"San Jose","CA","95110-2632","United States","Voluntary: Firm Initiated","Press Release","AZ, CA, TX, UT, WA","F-2323-2016","Class I","Marie Callender's Cheese Biscuit, Restaurant Style;  Packaged in 7 oz. and 14 oz. Stand-up pouches.  UPC - 7 oz. 075968-14015-0, Item number 14015D;  UPC 14 oz. 075968-170110-9, Item number 17011","7 oz. - 4569 cases (12 x 7 oz. per case); 14 oz. - 90 cases (12 x 14 oz. per case)","Firm was notified by supplier that flour used as an ingredient in the cheese biscuit mix has been recalled because it may be contaminated with E-Coli.","09/16/2016",," 7 oz., Item number 14015D;  Lot Codes 6-082-01  - Best by  5/17/17 and lot 6-082-01, Best by 3/22/17;  14 oz. item number 17011; lot code 6-169-05; Best Buy Date of 6/17/17.",7/13/2016,"07/13/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74693,"Ongoing","Zimmer Gmbh","Sulzer Allee 8",,"Winterthur",,,"Switzerland","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OH and NM","Z-2292-2016","Class II"," Avenir Moller Stems are for cementless use only.","2","Product mix-up.    The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice versa.  Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.  ","07/26/2016",," Item Name: Avenir M¿ller Stem 4 Standard  Item Number: 01.06010.004  Lot Number: 4022860    Item Name: Avenir M¿ller Stem 6 Lateral  Item Number: 01.06010.106  Lot Number: 4023094",6/30/2016,"06/30/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74694,"Ongoing","Sun Pharmaceutical Industries, Inc.","270 Prospect Plains Rd",,"Cranbury","NJ","08512-3605","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1504-2016","Class III","Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u.  29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512        ","4,656 HDPE bottles","Failed Impurities/Degradation Specifications","09/16/2016",," Lot #: AVF0246/A,  AVF0247/B,  AVF0246/B,  AVF0246/C; Exp. 02/17   ",6/27/2016,"06/27/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74694,"Ongoing","Sun Pharmaceutical Industries, Inc.","270 Prospect Plains Rd",,"Cranbury","NJ","08512-3605","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1505-2016","Class III","Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only,  Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u.  29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512              ","2,952 HDPE bottles","Failed Impurities/Degradation Specifications","09/16/2016",," Lot #: AVF0254/C, AVF0254/B, AVF0254/C; Exp. 02/17    ",6/27/2016,"06/27/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74694,"Ongoing","Sun Pharmaceutical Industries, Inc.","270 Prospect Plains Rd",,"Cranbury","NJ","08512-3605","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1506-2016","Class III","Carvediol Tablets, USP, 12.5  mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u.  29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512              ","612 HDPE bottles","Failed Impurities/Degradation Specifications","09/16/2016",," Lot #: AVF0256/A , AVF0256/B, AVF0256/C; Exp. 02/17  ",6/27/2016,"06/27/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74694,"Ongoing","Sun Pharmaceutical Industries, Inc.","270 Prospect Plains Rd",,"Cranbury","NJ","08512-3605","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1507-2016","Class III","Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u.  29 Hungary,  Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512              ","3,889 HDPE bottles","Failed Impurities/Degradation Specifications","09/16/2016",," Lot # AVF0258/A, AVF0258/B, AVF0258/C, AVF0259/A, AVF0259/C; Exp. 02/17        ",6/27/2016,"06/27/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74695,"Ongoing","Ajinomoto Windsor Inc., Golden Tiger Plant","6717 S Alameda St",,"Los Angeles","CA","90001-2123","United States","Voluntary: Firm Initiated","Letter","US: AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, MA, MI, MN, MO, MT, MX, NE, NV, NY, OH, OR, PA, TN, TX, WA, WI, WV","F-2275-2016","Class II","Molly's Kitchen Hotzzarella Cheese Sticks, 12 lbs., Item No. 582648;  Fred's Hotzzarella Cheese Sticks, 12lbs., Item No. 0204320.","2,962 cases","Ajinomoto Windsor is recalling Cheese Sticks because it may be contaminated with E. coli O121.","09/15/2016",," 0986121, 0986158",7/14/2016,"07/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74696,"Ongoing","Sun Pharmaceutical Industries, Inc.","270 Prospect Plains Rd",,"Cranbury","NJ","08512-3605","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1446-2016","Class III"," buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc.   Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC  47335-737-86","16,085 bottles","Failed Dissolution Specifications","07/20/2016",," Lot JKN3477A, exp 07/2016",6/27/2016,"06/27/2016",7/27/2016,"07/27/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74697,"Ongoing","Monogram Appetizers, Inc","1424 Post Rd",,"Plover","WI","54467-2627","United States","Voluntary: Firm Initiated","Telephone","Nationwide -    US: Distributors IL, TX, OR, GA, OH.    US: Retail CA, DE, IL, KS, LA, MN, MT, ND, OH, TX, VT, WA.","F-2377-2016","Class I","Poppers brand Mozzarella Cheese Sticks Net Wt. 32 oz. (2 lb) 970 g.  Keep Frozen.  Cook Thoroughly.  UPC 46704-88920.  Distributed by:  Heinz","5980 cases","Monogram Appetizers is recalling Poppers Brand Mozzarella Cheese Sticks because they may contain undeclared egg.","09/20/2016",," Code:  Line 1 / Line 2:    Best By 03/28/2017 / KA5M14 A HH:MM  Best By 05/28/2017 / KA6B18 A HH:MM  Best By 09/28/2017 / KA6F08 A HH:MM",7/14/2016,"07/14/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74699,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Mississippi","B-0680-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Apheresis product, collected from a donor with a HTLV repeatedly reactive donation was distributed.","08/05/2016","08/05/2016"," W069116131515",6/2/2016,"06/02/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74700,"Ongoing","Teva North America","425 Privet Rd",,"Horsham","PA","19044-1220","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1453-2016","Class III","Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA  19044; By: 3M Drug Delivery Systems, Northridge, CA  91324; NDC 59310-206-08.  ","193,320 canisters","Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.     ","08/02/2016",," Lot # 150328, Exp 10/17",7/15/2016,"07/15/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74701,"Ongoing","Ethicon Endo-Surgery Inc","4545 Creek Rd",,"Blue Ash","OH","45242-2803","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada.","Z-0295-2017","Class II","Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM.  The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses","105","Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.","10/20/2016",,"  N91L48, N91L49, N91R40, N91R41, N91U0W, N91U0X",7/15/2016,"07/15/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74701,"Ongoing","Ethicon Endo-Surgery Inc","4545 Creek Rd",,"Blue Ash","OH","45242-2803","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada.","Z-0296-2017","Class II","Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM  The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses","213","Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.","10/20/2016",," N91L2N, N91L2P, N91N1J, N91N1K, N91L0T, N91L0U, N91N29,   N91N2G, N91R8X, N91R8Y. ",7/15/2016,"07/15/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74702,"Ongoing","Actavis Inc","400 Interpace Pkwy",,"Parsippany","NJ","07054-1120","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1457-2016","Class II","Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH  45237, NDC 00591-0900-30  NDC 00591-0900-30","167,152 bottles","Failed dissolution specifications: Glipizide 2.5 mg ER  Tablets exceeded  dissolution specification rates for the 10 hour testing point.","08/15/2016",," Lot # 3132593, 3132594, 3134420, 3134421,3134422, Exp. 02/17  ",6/30/2016,"06/30/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74703,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: All states in USA including  PR, GUAM, VIRGIN ISLANDS, except RI, SD, & WV.    OUS: CANADA, Aruba, Bahamas, Barbados, Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Guyana, Honduras, Jamaica, KLN  Maldives, MEXICO, Nicaragua, Northern Mariana Islands, Pakistan, Palestine  Panama, Papua New Guinea, Saint Lucia, Trinidad and Tobago.","F-2287-2016","Class I","Betty Crocker Delights Super Moist Carrot Cake Mix, NET WT 15.25 OZ (432 g), Package UPC 1 00 16000 40987 0, Carton UPC: 000-16000-40987 0.  	    ","156,370 cases & 466 pallets total for all products","Three flavors of Betty Crocker cake mix are being recalled by General Mills because of possible contamination with E. coli O121 associated with Gold Medal Flour recall.","09/15/2016",," Better if Used By dates: 12APR2017, 13APR2017, 14APR2017, 28MAY2017, 29MAY2017, 30MAY2017, 07JUL2017, 08JUL2017",7/11/2016,"07/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74703,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: All states in USA including  PR, GUAM, VIRGIN ISLANDS, except RI, SD, & WV.    OUS: CANADA, Aruba, Bahamas, Barbados, Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Guyana, Honduras, Jamaica, KLN  Maldives, MEXICO, Nicaragua, Northern Mariana Islands, Pakistan, Palestine  Panama, Papua New Guinea, Saint Lucia, Trinidad and Tobago.","F-2289-2016","Class I","Betty Crocker Super Moist Rainbow Bit Cake Mix,432 g,  Package UPC, 1 00 65633 46589 0, Carton UPC 000-65633-46589.    ","156,370 cases & 466 pallets total for all products","Three flavors of Betty Crocker cake mix are being recalled by General Mills because of possible contamination with E. coli O121 associated with Gold Medal Flour recall.","09/15/2016",," Better if Used by Dates 27AL2017, 08JN2017, 09JN2017  ",7/11/2016,"07/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74703,"Ongoing","General Mills, Inc","1 General Mills Blvd",,"Minneapolis","MN","55426-1347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US: All states in USA including  PR, GUAM, VIRGIN ISLANDS, except RI, SD, & WV.    OUS: CANADA, Aruba, Bahamas, Barbados, Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Guyana, Honduras, Jamaica, KLN  Maldives, MEXICO, Nicaragua, Northern Mariana Islands, Pakistan, Palestine  Panama, Papua New Guinea, Saint Lucia, Trinidad and Tobago.","F-2288-2016","Class I","Betty Crocker Delights Super Moist Party Rainbow Chip Cake Mix,   NET WT 15.25 OZ (432 g), Package, UPC package 1 00 16000 40997 9, Carton UPC: 000-16000-40997. 	  		  ","156,370 cases & 466 pallets total for all products","Three flavors of Betty Crocker cake mix are being recalled by General Mills because of possible contamination with E. coli O121 associated with Gold Medal Flour recall.","09/15/2016",," Better if Used By dates: 25MAR2017, 28MAR2017, 27APR2017, 28APR2017, 23MAY2017, 24MAY2017, 25MAY2017	  		  ",7/11/2016,"07/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74704,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","800 Macarthur Blvd",,"Mahwah","NJ","07430-2001","United States","Voluntary: Firm Initiated","Letter","Nationwide, Canada","Z-2549-2016","Class II","Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.","360 units","Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.","08/16/2016",," 100-00080-00 - Dyrline II Water Trap, Adult  115-020919-00- CO2 Module with Accessory Kit, Adult and Pediatric    Lot #1534, 1537, 1538, 1541, 1545, 1547, 1548, 1602, and 1606    ",6/23/2016,"06/23/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74705,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","Letter","US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.","Z-2349-2016","Class II","STAPLER 30, IS4000, model number 470430;    Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of  anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.","2065  total","An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a  Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend","08/05/2016",," All",7/14/2016,"07/14/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74705,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","Letter","US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.","Z-2350-2016","Class II","CURVED-TIP STAPLER 30,IS4000, model number  470530;    Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of  anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.","2065  total","An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a  Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend","08/05/2016",," All",7/14/2016,"07/14/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74705,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","Letter","US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.","Z-2348-2016","Class II","STAPLER 45, IS4000, model number 470298    Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection  and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).","2065 total","An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a  Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend","08/05/2016",," All",7/14/2016,"07/14/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74706,"Ongoing","Cardinal Health","1300 Waukegan Rd",,"Waukegan","IL","60085-6724","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Canada.","Z-2713-2016","Class II","The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.","Lot #884993 -16,000 units, Lot #903136 -1,900 units and Lot #903137 - 300 units.","Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has identified a potential customer/user safety risk associated with the missing locking clasp component.","09/01/2016",," Three (3) total lots (lot #884993, lot #903136 & lot #903137).",6/27/2016,"06/27/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74707,"Ongoing","Hospira Inc.","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units.  30 units returned by customer and destroyed internally.","D-1500-2016","Class II","DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20","24000 vials","Discoloration: Firm received complaints of product discoloration and particulates.","09/14/2016",," Lot #: 52175DD, Exp 01 Oct 2016",8/15/2016,"08/15/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74708,"Terminated","Northwest Farm Food Cooperative","1370 S Anacortes St",,"Burlington","WA","98233-3038","United States","Voluntary: Firm Initiated","Telephone","distributed on OR and WA","V-0043-2017","Class I","raw frozen ground spent hen. Product is sold in 50 lbs block.","45,000 lbs ","raw frozen ground spent hen is recalled due to a potential contamination with Clostridium botulinum.","12/21/2016","12/21/2016"," Lot numbers 02-24-16-c and 03-04-16-c",7/12/2016,"07/12/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74708,"Terminated","Northwest Farm Food Cooperative","1370 S Anacortes St",,"Burlington","WA","98233-3038","United States","Voluntary: Firm Initiated","Telephone","distributed on OR and WA","V-0044-2017","Class I","Raw frozen mixed feed containing ground spent hen. Product is sold in 50 lbs. block or 1000# totes","1450 lbs.","Mixed feed containing ground spent hen are recalled due to a potential contamination with Clostridium botulinum.","12/21/2016","12/21/2016"," Lot numbers 02-24-16-c and 03-04-16-c",7/12/2016,"07/12/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74709,"Ongoing","Top Taste, Inc","206 4th St W",,"Finley","ND","58230","United States","Voluntary: Firm Initiated","E-Mail","Distribution was made to MN, ND, and NE.","F-2601-2016","Class I","Frozen cinnamon rolls packaged under the following labels:    (1) Fetting's Cinnamon Rolls, packaged in 15-oz. plastic bags, 8 rolls per bag, 15 bags per case, product #79211, UPC #075812792115.  The firm name on the label is Top Taste, Inc., Finley, ND; and    (2) Abby's Bakery Homestyle Cinnamon Rolls, packaged in 23-oz. plastic bags, 12 rolls per bag, 12 bags per case, product #93599, UPC 74073093599.  The firm name on the label is Abby's Bakery, Wadena, MN.  ","2,500 cases (Fettings-1,898 cases and Abby's-602 cases)"," information.","09/23/2016",,"  Fetting's brand:  .416001 , 816003 exp 7/6/2016, 816004 exp7/6/2016, 2716002 exp 7/25/16 , 7416015 exp 9/10/2016, 7616010 exp 9/12/16, 8216015 , 10216011 exp 10/8/16, 13816009 exp 11/13/16, 16216009 12/7/16, and 18716007 exp 11/1/16;    Abby's brand:  416002 exp 7/2/16, 416003 exp 7/2/16, 416004 exp 7/2/16, 416006 exp 7/2/16, 1816013 exp 7/16/2016, 1816014 exp 7/30/16, 1816015 exp 7/30/16, 2716004 exp 7/25/16, 2716005 exp 7/25/16, 2716006 exp 7/25/16, 10216008 exp 10/8/16, 10216009 exp 10/8/16, 10216010 exp 10/8/16, 12416010 exp 11/5/16, 12416011 exp 11/5/16, 12416012 exp 11/5/16, 14616013 exp 11/23/16, 14616014 exp 11/23/16, 14616015 exp 11/23/16, 14616016 exp 11/23/16, 14616017 exp 11/23/17, 17216009 exp 12/17/16, 17216010 exp 12/17/16, 17216011 exp 12/17/16, 17216012 exp 12/17/16, 17216013 exp 12/17/16, 18716002 exp1/1/17, 18716003 exp 1/1/17, and 18716004 exp 1/1/17  ",7/15/2016,"07/15/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74710,"Ongoing","Ecolab Inc","370 Wabasha St N",,"Saint Paul","MN","55102-1323","United States","Voluntary: Firm Initiated","Letter","US: OH, NY, CA, MN.","Z-2744-2016","Class II","Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203.  Sterile EO.  Microtek Medical, Inc., Columbus, MS  39702.","6750 eaches (675 cases)","Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.","09/07/2016",," RBA202 Lot numbers:  D111574, D111654, D111724, D111864, D112024, D112094, D112224, D120164, D120454, D120544, D121144, D121314, D121674, D121944, D122204, D122554, D122854, D123324, D130354, D130454, D130914, D131704, D131994, D132464, D132974, D140834, D141204, D141774, D142244, D150404, D151334, D151464, D152304, D152364, D152454, D153084, D153204, D153494, D160544.      RBA203 Lot numbers:  D122194, D122354",7/14/2016,"07/14/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74711,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Illinois; Switzerland","B-0682-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, in which donor suitability was inadequately determined, were distributed.","07/28/2016","07/28/2016"," W036315027256",6/16/2016,"06/16/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74711,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Illinois; Switzerland","B-0681-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, in which donor suitability was inadequately determined, were distributed.","07/28/2016","07/28/2016"," W036315027256",6/16/2016,"06/16/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74712,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.","Z-2831-2016","Class II","Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.","274 units","During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.","09/15/2016",," Device Listing No.: D022515. CatalogNo.: MV39016. Lot No.: P1007642, P1007465, P1007466, P1007643, P1007641, P1007640, P1007468, P1007467. Exp Date: 08/01/2016.",7/11/2016,"07/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74712,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.","Z-2830-2016","Class II","Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.","274 units","During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.","09/15/2016",," Device Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637, P1007638, P1007461. Exp Date: 08/01/2016.",7/11/2016,"07/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74713,"Ongoing","Actavis Inc","400 Interpace Pkwy",,"Parsippany","NJ","07054-1120","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1448-2016","Class II","Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA   NDC 45963-304-09","8,062 units","Failed Dissolution Specifications","07/26/2016",," Lot #: 3803J141, Exp. 7/2016    ",7/11/2016,"07/11/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74714,"Ongoing","Hitachi Medical Systems America Inc","1959 Summit Commerce Park",,"Twinsburg","OH","44087-2371","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.","Z-2392-2016","Class II","Hitachi Scenaria Computed Tomography System  Hitachi Medical Systems America, Twinsburg, OH 44087","33 units","The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.","08/11/2016",," Serial #'s: S5002-S5014; S5017-S5038",6/30/2015,"06/30/2015",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74715,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.","Z-2315-2016","Class II","S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.      Product Usage:  The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.","27  in total","Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.","08/02/2016",," Model Number 9733986 . All lot numbers manufactured by Medtronic Navigation are affected. ",7/18/2016,"07/18/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74715,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.","Z-2316-2016","Class II","Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.     Product Usage:  The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. ","27  in total","Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.","08/02/2016",," Model Number 9733686-02. All lot numbers manufactured by Medtronic Navigation are affected. ",7/18/2016,"07/18/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74715,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.","Z-2314-2016","Class II","FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.      Product Usage:  The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.","27  in total","Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.","08/02/2016",," Model Number 9733986-02 . All lot numbers manufactured by Medtronic Navigation are affected. ",7/18/2016,"07/18/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74715,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.","Z-2313-2016","Class II","Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.      Product Usage:  The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.  ","27  in total","Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.","08/02/2016",," Model Number 9733763. All lot numbers manufactured by Medtronic Navigation are affected. ",7/18/2016,"07/18/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74715,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.","Z-2317-2016","Class II","Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.      Product Usage:  The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.","27  in total","Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.","08/02/2016",," Model Number 9733467. All lot numbers manufactured by Medtronic Navigation are affected. ",7/18/2016,"07/18/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74715,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.","Z-2318-2016","Class II","MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.      Product Usage:  The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.","27  in total","Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.","08/02/2016",," Model Number 9730888. All lot numbers manufactured by Medtronic Navigation are affected. ",7/18/2016,"07/18/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74715,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.","Z-2319-2016","Class II","MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.      Product Usage:  The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.","27  in total","Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.","08/02/2016",," Model Number 9730889. All lot numbers manufactured by Medtronic Navigation are affected. ",7/18/2016,"07/18/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74716,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WV,WY, Puerto Rico and Guam","Z-2393-2016","Class II","AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic  AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.","11,111 worldwide, 3,187 in the USA","The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system. ","08/11/2016",," Model Numbers:10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355, 5904433, 5904441, 5904466, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728350, 7728392    ",7/13/2016,"07/13/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74716,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WV,WY, Puerto Rico and Guam","Z-2395-2016","Class II","ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM,  interventional fluoroscopic x-ray system22    AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.","11,111, worldwide and 3,187 in the USA","The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system. ","08/11/2016",," Model Numbers:10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355, 5904433, 5904441, 5904466, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728350, 7728392    ",7/13/2016,"07/13/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74716,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WV,WY, Puerto Rico and Guam","Z-2394-2016","Class II","ARTIS ZEE AND ZEEGO, system, x-ray, angiographic  AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.","11,111 worldwide, 3,187 in the USA","The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system. ","08/11/2016",," Model Numbers:10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355, 5904433, 5904441, 5904466, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728350, 7728392    ",7/13/2016,"07/13/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74717,"Ongoing","ConAgra Frozen Foods, Inc","3100 East Main St, Hwy 64 East",,"Russellville","AR","72802","United States","Voluntary: Firm Initiated","Press Release","Product was distributed to distributors in the following US state: AL, AZ, FL, GA, LA, MA, MD, ME, MS, NC, NM, NY, OR, PA, SC, TX, VA, and WA.  No foreign or military/government distribution.","F-2087-2016","Class II","PF Chang's Home Menu Brand Shrimp Lo Mein, UPC 3100067005, 22 oz bag, 4 bags per case, ConAgra Foods, Omaha, NE 68102","2,969/4/22 OZ/bags/cases","Metal fragments were discovered in an raw ingredient used in the manufacture of frozen meal products","09/07/2016",," Lot number 5006616700, best by 6/10/2017",7/16/2016,"07/16/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74718,"Ongoing","McCain Foods USA","2275 Cabot Dr",,"Lisle","IL","60532-3653","United States","Voluntary: Firm Initiated","Letter","Nationwide. There are no foreign consignees.","F-2098-2016","Class II","Fire roasted Poblano & Jalapeno popper bites packaged in a white box with black lettering. The product is labeled in part: Canchor Poppers Fire Roasted  & Jalapeno popper bites, 2-4 lbs. ","1, 947 cases (2, 4lb boxes per case)","Firm used Flour from General Mills that has been contaminated with E. Coli O121. ","09/08/2016",," 30011027",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74718,"Ongoing","McCain Foods USA","2275 Cabot Dr",,"Lisle","IL","60532-3653","United States","Voluntary: Firm Initiated","Letter","Nationwide. There are no foreign consignees.","F-2097-2016","Class II","Breaded stuffed Jalapenos poppers labeled in part: Anchor breaded Fiesta Bold Poppers, breaded stuffed jalapenos, keep frozen. The product is packaged in a green 4 lb. box with white, green and orange lettering. ","555 cases ( 2, 4 lb. boxes per case)","Firm used Flour from General Mills that has been contaminated with E. Coli O121. ","09/08/2016",," 30010718  ",7/12/2016,"07/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74719,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, and WA.","Z-2389-2016","Class II","Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices    The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm Titanium LCP Distal Radius Plate System - Titanium LCP Compact Distal Radius System - 2.4 mm Titanium LCP Radial Head Plate Set - Titanium Modular Mini Fragment LCP System - 2.4 mm Titanium Variable Angle LCP Distal Radius System - 2.7 mm/3.5 mm Titanium Distal Fibula Plate System","41 units","It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft.  This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.","08/11/2016",," Lot Number: 9942217  Part Number: 412.812",6/28/2016,"06/28/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74720,"Ongoing","Hospira Inc.","275 N Field Dr",".","Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","US and Puerto Rico","D-0169-2017","Class III","5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01","287,200  2 mL ampules","Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.  ","12/06/2016",," Lot # 34-547-DK, 34-548-DK, Exp. 10/16,   Lot # 39-372-DK, Exp. 03/17     Lot Number may be followed by numbers from 01 to 99",6/29/2016,"06/29/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74722,"Ongoing","Anthogyr","2237 Avenue Andre Lasquin",,"Sallanches",,,"France","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution to sates of: NC, NY, and OR.","Z-2753-2016","Class II","Axiom REG implants Sterile    The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.","111 units","Following a FDA inspection showing that the firm failed to validate the design and process of its implants.","09/08/2016",," Code OP34080 Size 03.4 x 8.0   Code OP34100 Size 03.4 x 10.0  Code OP34120 Size 03.4 x 12.0  Code OP34140 Size 03.4 x 14.0  Code OP34160 Size 03.4 x 16.0  Code OP34180 Size 03.4 x 18.0  Code OP40060 Size 04.0 x 6.5  Code OP40080 Size 04.0 x 8.0  Code OP40100 Size 04.0 x 10.0  Code OP40120 Size 04.0 x 12.0  Code OP40140 Size 04.0 x 14.0  Code OP40160 Size 04.0 x 16.0  Code OP40180 Size 04.0 x 18.0  Code OP46060 Size 04.6 x 6.5  Code OP46080 Size 04.6 x 8.0  Code OP46100 Size 04.6 x 10  Code OP46120 Size 04.6 x 12  Code OP46140 Size 04.6 x 14  Code OP52060 Size 05.2 x 6.5  Code OP52080 Size 05.2 x 8.0  Code OP52100 Size 05.2 x 10.0  Code OP52120 Size 05.2 x 12.0  Code OP52140 Size 05.2 x 14.0  ",6/20/2016,"06/20/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74722,"Ongoing","Anthogyr","2237 Avenue Andre Lasquin",,"Sallanches",,,"France","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution to sates of: NC, NY, and OR.","Z-2754-2016","Class II","Axiom 2.8 implants  Sterile    The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.","10 units","Following a FDA inspection showing that the firm failed to validate the design and process of its implants.","09/08/2016",," Code OP28100 Size 02.8 x 10.0  Code OP28120 Size 02.8 x 12.0  Code OP28140 Size 02.8 x 14.0",6/20/2016,"06/20/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74723,"Ongoing","The Harvard Drug Group","31778 Enterprise Dr",,"Livonia","MI","48150-1960","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0022-2017","Class I","Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85","153,432 bottles","Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia","10/12/2016",," 20351407, 20351408, exp 09/16; 20351409, exp 11/16; 20351410, exp 12/16; 20351501, 20351502, exp 01/17; 20351503, exp 03/17; 20351504, exp 04/17; 20351505, exp 05/17; 20351506, 20351507, exp 06/17; 20351508, exp 07/17, 20351509, 20351510, exp 10/17; 20351511, 20351512, 20351513, exp 11/17; 20351601, exp 01/18; 20351602, exp 02/18; 20351603, exp 03/18; 20351604, 20351605, exp 04/18",7/15/2016,"07/15/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74724,"Ongoing","Topcon Medical Laser Systems, Inc","3130 Coronado Dr",,"Santa Clara","CA","95054-3205","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Japan, Netherlands, Algeria, Australia, Brazil, Chile, China, France, Guatemala, Hong Kong, Italy, New Zealand, Pakistan, Philippines, Singapore, Taiwan, and United Kingdom.","Z-2405-2016","Class II","    Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed  conventionally."," 205 units (21 in US, 184 OUS)","Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process.  This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode.  ","08/11/2016",," Model PASCAL Synthesis (532/577).  Serial numbers:  United States:  79056215  79064615  77055414  79065715  79088615  79088415  79063115  79081015  79095816  79085715  77050213  77050313  77052113  77052913  79088916  79081615  77051913  77052313  77053113  79071415  79073815  77053613  79081515.  ROW:  79087915  79073715  79074915  79075415  79075515  79076315      79076515      79076715  79076915      77055714      79050314  79050614      79050714  79050914  79051114  79051214  79051414  79051714  79052114  79052214  79052314  79052714  79052814  79052914  79053014  79053214  79053314  79054014  79054114  79054214  79054414  79054714  79054814  79055014  79055314  79055414  79055715  79057915  79058015  79058115  79058215  79059715  79059815  79064315  79065115  79065215  79065415  79065915  79067515  79067615  79067715  79068015  79068115  79068715  79069915  79070515  79071115  79072415  79072615  79072715  79072815  79072915  79073215  79073315  79073615  79077415  79077915  79078015  79079515  79082115  79084815  79086815  79086915  79087615  79088315  79089116  79090316  79090516  79090616  79093816  79094416  79095416  79095516  79074015  79074315  79074515  77052613  78051014  78051414  78051514  79051914  79053514  79053614  79053814  79053914  79054914  79056615  79057015  79057115  79057315  79057615  79058515  79060015  79060115  79060215  79060315  79060415  79060515  79060915  79061015  79061115  79061215  79061315  79061415  79061715  79062115  79062515  79062615  79062715  79062815        79063315        79063815        79063915  79064115  79064515  79064815  79065015  79065515  79066315  79066415  79066515  79066915  79068315  79068415  79068815  79070315  79070715  79070815  79070915  79071315  79071815  79072015      79080815  79080915      79081115  79082715  79082915  79083015  79084215  79085015  79087015  79087115  79093416  77055113  77055213  79068615  79069815  79091916  77055914  77053913  77054013  77054113  77054213  77054313  79077315  79091116  77055514  79058615  79059415  790",7/15/2016,"07/15/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74725,"Ongoing","Medicap Pharmacy","2790 W Cherry Ln Ste 100",,"Meridian","ID","83642-1102","United States","Voluntary: Firm Initiated","Letter","ID","D-1447-2016","Class II","Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID  83642, NDC 99999-9996-94.","1 bottle","Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.","07/22/2016",," Lot #: 05092016@19, Beyond Use Date: 06/08/16; Discard After 09/01/2017.",7/7/2016,"07/07/2016",8/3/2016,"08/03/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74726,"Terminated","Theo Chocolate Inc","3400 Phinney Ave N",,"Seattle","WA","98103-8624","United States","Voluntary: Firm Initiated","Press Release","distributed in AZ, CA, CO, CT, FL, GA, IA, ID, MI, MT, ND, NH, NJ, NY, OR, PA, TX, WA, and WI.","F-2142-2016","Class I","Theo Chocolate Salted Almond 70% Dark Chocolate bars are wrapped in a white paper envelope, weighs 3 oz., UPC is 8 74492 00170 4, and stored at room temperature","undetermined amount of Salted Almond 70% Dark Chocolate bars ","The Salted Almond 70% Dark Chocolate bars are recalled due to undeclared milk","09/13/2016","09/20/2016"," lot 3037431 and the expiration date 05/2017.",7/18/2016,"07/18/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74727,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","E-Mail","US distribution to state of: CA.","Z-2792-2016","Class II","Femoral Nail, A/R T2 Femur 011x280 mm    T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fractures proximal to a total knee arthroplasty, (8) Fractures distal to a hip joint and (9) Non-unions and malunions","1 unit in total","Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.","09/13/2016",," Catalog number 18251032S and Lot Code K288335",6/30/2016,"06/30/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74727,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","E-Mail","US distribution to state of: CA.","Z-2791-2016","Class II","Supracondylar Nail T2 SCN 09x300 mm    T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions","1 unit in total","Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.","09/13/2016",," Catalog number 18220930S and Lot Code K836729",6/30/2016,"06/30/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74728,"Terminated","Big Y Foods, Inc.","151 Cottage St",,"Springfield","MA","01104-3288","United States","Voluntary: Firm Initiated","E-Mail","CT, MA","F-2243-2016","Class I","Fresh Cucumbers   GROWN & PACKED  BY  ZACHARY  R HEIKEN PILESGROVE, N.J. 08098 856-297-5183   UPC Code: 4062  Item Number: 14138    ","31 cases","Product contaminated with Salmonella","09/15/2016","09/15/2016"," All lot codes",7/14/2016,"07/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74729,"Ongoing","Trophy Nut Co Inc","320 N 2nd St",,"Tipp City","OH","45371","United States","Voluntary: Firm Initiated","Letter","Product was shipped to MI.","F-2242-2016","Class I","Honey Peanuts Net Wt. 25 lbs (11.360g) Ing:peanuts, seasoning***honey, wheat starch***Allergen Statement: Contains peanuts and wheat. Manufactured on equipment that processes and packages peanuts and other tree nuts.May contain trace amounts of other nuts. UPC 0 74249 29186 4 Mfg. By: Trophy Nut Co. Tipp City, OH 48371","420 cases/25 lb each","The firm was notified by their customer that the product contained undeclared pecans.","09/17/2016",," MAY 27 2016",7/19/2016,"07/19/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74730,"Ongoing","Taro Pharmaceuticals U.S.A., Inc.","3 Skyline Dr",,"Hawthorne","NY","10532-2174","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0134-2017","Class III","Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC,  STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC ","17,100 kits","Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.","11/10/2016",," Lot #: E601, E602, E603, E604, E608, E609 - Exp. September 2017; E610  E611, Exp. October 2017   ",5/26/2016,"05/26/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74731,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia,  Czech Republic,  Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.","Z-2307-2016","Class II","MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036","993 total","The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag","08/01/2016",," All serial numbers.    708032 System Serial numbers 100, 198, 354, 104, 367, 68, 428, 183, 414, 355, 289, 32, 269, 361, 160, 423, 50, 56, 205, 350, 71, 208, 254, 108, 222, 286, 257, 253, 327, 128, 125, 40, 265, 174, 164, 214, 411, 263, 178, 103, 394, 425, 374, 284, 229, 79, 37, 11, 312, 116, 226, 296, 44, 49, 219, 207, 227, 154, 317, 18, 87, 406, 88, 244, 233, 315, 376, 288, 112, 402, 206, 261, 215, 31, 422, 344, 338, 342, 339, 384, 12, 136, 415, 416, 137, 228, 46, 126, 276, 280, 51, 193, 54, 232, 140, 20, 270, 121, 25, 59, 60, 48, 21, 28, 196, 199, 380, 316, 159, 153, 172, 14, 62, 216, 75, 282, 294, 340, 102, 76, 64, 13, 231, 106, 305, 372, 366, 364, 77, 189, 24, 279, 166, 221, 349, 72, 42, 424, 0, 80, 217, 43, 213, 197, 413, 145, 318, 210, 341, 111, 343, 55, 292, 241, 151, 246, 0, 110, 29, 141, 362, 35, 143, 236, 278, 99, 133, 365, 85, 267, 132, 134, 163, 127, 266, 412, 142, 144, 293, 358, 399, 303, 308, 238, 239, 287, 243, 74, 310, 34, 345, 39, 69, 409, 162, 240, 281, 368, 382, 357, 277, 26, 165, 224, 170, 171, 392, 237, 119, 30, 396, 36, 38, 211, 255, 53, 146, 188, 404, 41, 81, 256, 16, 130, 184, 115, 107, 247, 275, 373, 169, 192,   248, 388, 389, 147, 352, 397, 417, 209, 98, 245, 92, 203, 314, 297, 290, 353, 383, 86, 309, 363, 251, 235, 379, 129, 225, 260, 405, 90, 84, 249, 139, 120, 329, 161, 218, 201, 347, 66, 283, 122, 33, 113, 114, 268, 180, 181, 182, 105, 298, 299, 109, 124, 295, 258, 194, 73, 57, 91, 369, 259, 403, 152, 138, 400, 93, 157, 118, 89, 15, 220, 212, 401, 61, 67, 135, 47, 148, 65, 264, 346, 173, 407, 123, 375, 291, 52, 393, 306, 307, 398, 190.    708036 System serial numbers  19, 40, 21, 8, 9, 16, 45, 11, 17, 14, 30, 31, 32, 48, 12, 50, 4, 15, 25, 13, 18, 42, 46, 41, 36, 35, 37, 47, 27, 43, 10, 5, 7, 24, 34, 29, 26.",7/19/2016,"07/19/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74731,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia,  Czech Republic,  Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.","Z-2305-2016","Class II","MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.","993 total","The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag","08/01/2016",," All serial numbers.   708034 System serial numbers  6, 264, 112, 106, 233, 136, 31, 83, 224, 144, 71, 123, 5, 249, 134, 103, 266, 97, 132, 61, 19, 82, 196, 3, 12, 39, 244, 197, 119, 204, 75, 151, 69, 70, 37, 115, 55, 200, 180, 175, 78, 93, 234, 130, 142, 53, 113, 65, 27, 242, 202, 14, 208, 247, 261, 225, 28, 11, 110, 25, 128, 171, 81, 237, 211, 54, 76, 163, 207, 216, 122, 135, 205, 63, 238, 254, 262, 72, 1, 206, 187, 52, 143, 154, 155, 156, 73, 150, 98, 248, 80, 22, 133, 209, 167, 265, 105, 217, 79, NTS0427, 129, 13, 15, 16, 17, 18, 24, 84, 146, 41, 190, 10, 194, 125, 268, 177, 109, 42, 43, 44, 172, 213, 181, 212, 189, 26, 95, 9, 4, 117, 251, 2, 48, 183, 157, 245, 116, 62, 56, 160, 152, 127, 94, 174, 176, 259, 50, 58, 51, 277, 68, 159, 77, 40, 199, 253, 114  257, 246, 23, 147, 162, 29, 66, 47, 179, 221, 126, 195, 220, 161, 46, 182, 278, 138, 222, 269, 36, 96, 201, 137, 223, 228, 219, 60, 272, 111, 35, 85, 186, 38, 120, 170, 185, 32, 64, 30, 100, 101, 104, 235, 34, 148, 149, 67, 118, 121, 241, 210, 191, 255, 168, 273, 33, 240, 131, 88, 8, 193.    708037 System Serial numbers  48, 85, 17, 53, 2, 125, 170, 180, 157, 33, 49, 200, 18, 84, 216, 36, 116, 234, 201, 135, 236, 39, 96, 34, 19, 54, 132, 5, 154, 83, 151, 29, 21, 110, 175, 228, 183, 20, 4, 91, 69, 44, 205, 89, 164, 240, 165, 13, 51, 121, 174, 120, 43, 160, 185, 171, 23, 209, 95, 144, 50, 141, 156, 80, 94, 150, 190, 41, 10, 113, 93, 98, 196, 38, 64, 86, 72, 73, 230, 56, 22, 140, 181, 192, 37, 12, 191, 195, 155, 221, 182, 133, 246, 149, 169, 61, 62, 100, 101, 102, 103, 219, 226, 227, 46, 97, 99, 55, 3, 7, 8, 63, 233, 106, 114, 206, 207, 108, 213, 32, 163, 24, 92, 176, 212, 179, 14, 193, 214, 6, 30, 173, 222, 146, 115, 90, 177, 59, 25, 189, 118, 218, 153, 107, 161, 31, 27, 112, 42, 104  76, 26, 217, 35, 124, 139, 15, 66, 241, 245, 40, 239, 123, 58, 88, 172, 129, 81, 136, 159, 244, 238, 82, 65, 249, 70, 142, 188, 178, 158, 128, 117, 148, 45, 203, 79, 229, 199, 119, 126, 152, 71, 52, 60, 197, 198, 87, 105.     708038 System serial numbers 158, 146, 196, 164, 37",7/19/2016,"07/19/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74731,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia,  Czech Republic,  Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.","Z-2306-2016","Class II","UroDiagnost; x-ray system. Product Code: 708033","993 total","The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag","08/01/2016",," All serial numbers.    708033 System serial numbers  1, 17, 15, 4, 3, 7, 18, 21, 8, 13, 14, 11, 5, 16, 2.",7/19/2016,"07/19/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74732,"Ongoing","T2 Biosystems Inc","101 Hartwell Ave",,"Lexington","MA","02421-3125","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.","Z-2795-2016","Class II","T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base).    A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens.","6,864","Elevated levels of invalid results.","09/14/2016",," Lot Numbers:   000048532541  000048730657  000049837721  000050205643  000050205642  000050205641  000050205644  000051259462  000051269868  000051807669  000051989614  000052596978",7/7/2016,"07/07/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74733,"Ongoing","Faribault Foods, Inc","128 15th St NW",,"Faribault","MN","55021-3037","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, CO, IA, IL, MD, MI, MN, MO, ND, NE, OH, PA, TX","F-2385-2016","Class II","No-Salt-Added Black Beans, 15 oz. (425 g), packaged under the following brands:  1.  HEB, UPC 41220-91262;     2.  Kuner's UPC  72273-13613.  Distributed by Kuner-Empson, Division of Faribault Foods, Inc., 128 NW 18th Street, Faribault, MN  55021;     3.  Mrs. Grimes, UPC  71891-47607.  Distributed by:  Mrs. Grimes, Division of Faribault Foods, Inc., 128 NW 18th Street, Faribault, MN  55021;    4.  HyVee, UPC 75450-10519.  Distributed by Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA  50266;      5.  LaPreferida, UPC 71524-01769.  LaPreferida, Inc. Chicago, IL;    6.  Sprout's Farmers Market, UPC 74875-00724.  Manufactured exclusively for:  Sprouts Farmers Market, Phoenix, Arizona  8502;     7.  Our Family, UPC 70253-26394.  Distributed Y:  Nash Finch Company, Minneapolis, MN  55435","10,040 cases","Faribault Foods is recalling 15 oz.No-Salt-Added Black Beans due to potential presence of plastic and/or metal pieces.","09/23/2016",," Best By 04 APR 2019 258F2 095 16 XXXX",7/15/2016,"07/15/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74734,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand.  There was no military or government distribution.","Z-2532-2016","Class II","iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks. ","146 sites may have the affected version for both products","Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.","08/12/2016",," iConnect Access V4.0 or earlier with any version of Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and earlier.",1/30/2016,"01/30/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74734,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand.  There was no military or government distribution.","Z-2531-2016","Class II","iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.","146 sites potentially have the affected versions for both products","Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.","08/12/2016",," iConnect Access V4.0 or earlier with any version of Merge PACS and iConnect Access V4.1 with Merge PACS V6.5.4 or earlier",1/30/2016,"01/30/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74735,"Terminated","Gourmet Foods, Inc.","2557 Barrington Ct",,"Hayward","CA","94545-1174","United States","Voluntary: Firm Initiated","Letter","CA - Bay area and to one firm warehouse in HI but product was not further distributed.","F-0174-2017","Class II","Stretched Coconut Shrimp             Pack Size: 180 ea. per case  UPC: 22102-03        Keep Frozen:  Gourmet Foods, Hayward, CA   ","58 cases (180 per case)","Food products were manufactured using flour that has been recalled by General Mills due to potential    E-coli contamination.","10/18/2016","10/18/2016"," Lot codes 362, 380, 399 .",7/19/2016,"07/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74735,"Terminated","Gourmet Foods, Inc.","2557 Barrington Ct",,"Hayward","CA","94545-1174","United States","Voluntary: Firm Initiated","Letter","CA - Bay area and to one firm warehouse in HI but product was not further distributed.","F-0175-2017","Class II","Shrimp Coconut Brochette             Pack Size: 156 ea. per case  UPC: 23811-03        Keep Frozen:  Gourmet Foods, Hayward, CA   ","15 cases (156 pieces per case)","Food products were manufactured using flour that has been recalled by General Mills due to potential    E-coli contamination.","10/18/2016","10/18/2016"," Lot codes 374, 403",7/19/2016,"07/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74735,"Terminated","Gourmet Foods, Inc.","2557 Barrington Ct",,"Hayward","CA","94545-1174","United States","Voluntary: Firm Initiated","Letter","CA - Bay area and to one firm warehouse in HI but product was not further distributed.","F-0170-2017","Class II","Artichoke Bottom Ratatouille             Pack Size: 240 ea. per case         UPC: 18010-03        Keep Frozen:  Gourmet Foods, Hayward, CA   ","8 cases (240 pieces per case)","Food products were manufactured using flour that has been recalled by General Mills due to potential    E-coli contamination.","10/18/2016","10/18/2016"," Lot codes 129",7/19/2016,"07/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74735,"Terminated","Gourmet Foods, Inc.","2557 Barrington Ct",,"Hayward","CA","94545-1174","United States","Voluntary: Firm Initiated","Letter","CA - Bay area and to one firm warehouse in HI but product was not further distributed.","F-0176-2017","Class II","Shrimp 21/25 Coconut Butterfly             Pack Size: 200 ea. per case         UPC: 23502-03        Keep Frozen:  Gourmet Foods, Hayward, CA   ","32 cases (200 pieces per case)","Food products were manufactured using flour that has been recalled by General Mills due to potential    E-coli contamination.","10/18/2016","10/18/2016"," Lot codes 383, 397",7/19/2016,"07/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74735,"Terminated","Gourmet Foods, Inc.","2557 Barrington Ct",,"Hayward","CA","94545-1174","United States","Voluntary: Firm Initiated","Letter","CA - Bay area and to one firm warehouse in HI but product was not further distributed.","F-0169-2017","Class II","Artichoke Heart Breaded with Goat and Cheddar Cheese :             Pack Size: 240 ea. per case;  UPC: 13014-03       Keep Frozen:  Gourmet Foods, Hayward, CA   ","25 cases (240 pieces per case)","Food products were manufactured using flour that has been recalled by General Mills due to potential    E-coli contamination.","10/18/2016","10/18/2016"," Lot codes 124, 125.",7/19/2016,"07/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74735,"Terminated","Gourmet Foods, Inc.","2557 Barrington Ct",,"Hayward","CA","94545-1174","United States","Voluntary: Firm Initiated","Letter","CA - Bay area and to one firm warehouse in HI but product was not further distributed.","F-0172-2017","Class II","   Strudel Wild Mushroom             Pack Size: 240 ea. per case    UPC: 17338-03  Keep Frozen:  Gourmet Foods, Hayward, CA   ","16 cases (240 pieces per case)","Food products were manufactured using flour that has been recalled by General Mills due to potential    E-coli contamination.","10/18/2016","10/18/2016"," Lot codes 119, 214,",7/19/2016,"07/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74735,"Terminated","Gourmet Foods, Inc.","2557 Barrington Ct",,"Hayward","CA","94545-1174","United States","Voluntary: Firm Initiated","Letter","CA - Bay area and to one firm warehouse in HI but product was not further distributed.","F-0173-2017","Class II","Breaded Cheese Ravioli             Pack Size: 1 oz. ea. 15 lb. per case  UPC: 18890-03        Keep Frozen:  Gourmet Foods, Hayward, CA   ","6 cases","Food products were manufactured using flour that has been recalled by General Mills due to potential    E-coli contamination.","10/18/2016","10/18/2016"," Lot codes 364 .",7/19/2016,"07/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74735,"Terminated","Gourmet Foods, Inc.","2557 Barrington Ct",,"Hayward","CA","94545-1174","United States","Voluntary: Firm Initiated","Letter","CA - Bay area and to one firm warehouse in HI but product was not further distributed.","F-0171-2017","Class II","  Artichoke Heart with Boursin Mousse Breaded             Pack Size: 200 ea. per case         UPC: 11784-03        Keep Frozen:  Gourmet Foods, Hayward, CA   ","39 cases (200 pieces per case)","Food products were manufactured using flour that has been recalled by General Mills due to potential    E-coli contamination.","10/18/2016","10/18/2016"," Lot codes 190, 191, 215",7/19/2016,"07/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74736,"Ongoing","Resmed Corporation","9001 Spectrum Center Blvd",,"San Diego","CA","92123-1438","United States","Voluntary: Firm Initiated","Letter","US nationwide distribution","Z-2550-2016","Class II","Quattro Air FFM MED  AMER, Product Code: 62702,  full face mask for use with active-exhaust-valve ventilators","42 units","Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.","08/16/2016",," Lot 1142623 ",7/12/2016,"07/12/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74737,"Ongoing","American National Mfg Inc","252 Mariah Cir",,"Corona","CA","92879-1751","United States","Voluntary: Firm Initiated","Letter","Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.","Z-2605-2016","Class II","Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000.    Use with alternating pressure air flotation mattress.","31 units","The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required.","08/19/2016",," Serial No. 9500051 sequential to 9500300.",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74739,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","District of Columbia; Wisconsin; Switzerland","B-0700-16","Class II","Cryoprecipitated AHF","1 unit","Blood products, collected from an ineligible donor, were distributed. ","08/15/2016","08/15/2016"," W036315414781; ",6/17/2016,"06/17/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74739,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","District of Columbia; Wisconsin; Switzerland","B-0698-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from an ineligible donor, were distributed. ","08/15/2016","08/15/2016"," W036315414781; ",6/17/2016,"06/17/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74739,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","District of Columbia; Wisconsin; Switzerland","B-0699-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from an ineligible donor, were distributed. ","08/15/2016","08/15/2016"," W036315414781; ",6/17/2016,"06/17/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74740,"Terminated","Crown Peak Industries, LLC","8455 N 90th St",,"Scottsdale","AZ","85258-4476","United States","Voluntary: Firm Initiated","Visit","Arizona and Vermont","B-0685-16","Class III","Amniotic membrane","29 tissue allografts","Amniotic Membranes were not made available for distribution in accordance with current Good Tissue Practice.  ","08/03/2016","08/03/2016"," Allograft Ids 15001440001 thru 15001440029",5/26/2016,"05/26/2016",8/10/2016,"08/10/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74743,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide","Z-2396-2016","Class II","Orthopedic manual surgical instrument    Usage:  Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.  ","241 units","Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.","08/11/2016",," Catalog No. 0930-9-003",7/1/2016,"07/01/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74744,"Ongoing","Exact-Rx Inc","105 Baylis Rd",,"Melville","NY","11747-3833","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1465-2016","Class III","Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY ","6,310 tubes Total (3,224 tubes/5 oz & 3,086 tubes/9oz)","Crystallization; complaints received by the manufacturer of crystals forming in product","08/23/2016",," Lot #'s: a) 8160, b) 8160  Exp Date: 9/2018",6/2/2016,"06/02/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74745,"Ongoing","Talon Compounding Pharmacy","2950 Thousand Oaks Dr Ste 25",,"San Antonio","TX","78247-3347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1463-2016","Class II","Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy,  San Antonio, TX 78247","500 vials","Lack of Assurance of Sterility","08/22/2016",," Lot numbers: 01082016:58  01082016:58  01082016:58  01082016:58  01082016:58  01082016:58  01082016:58  01082016:58  01202016:78  01202016:78  01202016:78  01202016:78  01202016:78  01202016:78  01202016:78  01202016:78  01202016:78  01202016:78  01202016:78  01202016:78  01202016:78  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02012016:61  02052016:52  02012016:61  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  02052016:52  03042016:55  03042016:55  03042016:55  03042016:55  03042016:55  03042016:55  03042016:55  03042016:55  03042016:55  03042016:55  03102016:77  03042016:55  03092016:75  03092016:75  03092016:75  03092016:75  03092016:75  03092016:75  03092016:75  03092016:75  03212016:63  03092016:75  03092016:75  03092016:75  03092016:75  03092016:75  03092016:75  03092016:75  03092016:75  03092016:75  03222016:00  03222016:00  03222016:00  03222016:00  03222016:00  03292016:85  03292016:85  03222016:00  03292016:85  03292016:85  03222016:00  03222016:00  03292016:85  03222016:00  03222016:00  03222016:00  03222016:00  03222016:00  03302016:74  03222016:00  04012016:65  03302016:74  04012016:65  04012016:65  04012016:65  04012016:65  04012016:65  03302016:74  03302016:74  04012016:65  03302016:74  04012016:65  04012016:65  04012016:65  03302016:74  04012016:65  03302016:74  04012016:65  04012016:65  04072016:14  04012016:65  04012016:65  04012016:65  04012016:65  04112016:60  04062016:57  04062016:57  04062016:57  04062016:57  03302016:74  04062016:57  03302016:74  04042016:09  04062016:57  04062016:57  04042016:09  04042016:09  04062016:57  04012016:65  04042016:09  04042016:09  04012016:65  04062016:57  04062016:57  04062016:57  04062016:57  04012016:65  04012016:65  04012016:65  04062016:57  04062016:57  040",7/19/2016,"07/19/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74745,"Ongoing","Talon Compounding Pharmacy","2950 Thousand Oaks Dr Ste 25",,"San Antonio","TX","78247-3347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-1462-2016","Class II","Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu,  (m) 20,000 iu with B12, 10 mL sterile, depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy,  San Antonio, TX 78247"," 6,500 vials","Lack of Assurance of Sterility","08/22/2016",," Lot numbers: 12312015:45  12222015:91  01152016:91  01152016:91  01152016:91  01152016:91  01152016:91  12232015:37  12232015:37  12232015:37  12012015:03  01152016:91  12232015:37  12232015:37  12232015:37  01152016:91  01152016:91  01152016:91  01152016:91  01152016:91  01152016:91  01152016:91  01152016:41  01152016:91  01152016:91  01152016:41  01152016:91  01152016:91  01152016:41  01152016:91  01152016:41  01152016:41  01152016:91  01152016:41  01152016:41  01152016:41  01152016:41  01152016:41  01152016:41  01152016:41  01152016:41  01112016:51  01112016:51  01112016:51  01112016:51  01152016:41  01112016:51  01112016:51  01112016:51  01112016:51  01112016:51  01112016:51  01132016:48  01112016:51  01132016:48  01132016:48  01052016:83  12012015:94  01152016:41  01152016:41  01152016:41  01152016:kjb  01152016:kjb  01152016:kjb  01152016:kjb  12072015:24  01192016:45  01192016:45  01192016:45  01192016:11  01192016:11  01192016:45  01192016:11  01192016:45  01192016:11  01192016:45  01192016:45  01192016:11  01192016:11  01192016:45  01192016:11  01192016:50  01192016:11  01192016:50  01192016:11  01192016:50  01192016:11  12282015:71  01192016:11  12232015:94  12282015:71  01192016:50  01192016:50  12282015:71  01192016:66  12012015:94  12012015:94  01132016:48  01152016:kjb  12012015:94  12232015:37  12232015:37  12232015:37  01132016:48  01152016:kjb  01132016:48  01152016:kjb  01192016:77  01152016:kjb  12232015:37  01132016:48  12232015:37  11252015:17  12232015:37  01192016:77  01142016:25  01152016:kjb  01132016:48  01132016:48  01142016:25  01152016:kjb  01142016:25  12282015:71  01152016:kjb  01142016:25  01152016:kjb  01152016:kjb  01152016:kjb  01152016:kjb  01182016:95  01182016:95  01182016:95  01182016:95  01182016:95  01182016:95  01182016:95  01182016:95  01182016:95  01182016:95  01182016:95  01182016:95  01182016:95  01212016:DS  01182016:95  01182016:95  01182016:95  01182016:95  01192016:RP  01192016:RP  01192016:RP  01192016:77  01192016:RP  01192016:RP  01192016:RP  01192016:RP  0",7/19/2016,"07/19/2016",8/31/2016,"08/31/2016","016:37  02242016:16  02232016:37  02232016:37  02232016:37  02232016:37  02232016:37  02232016:37  02232016:37  02232016:37  02232016:37  02232016:37  03032016:68  03032016:68  02052016:53  02192016:91  02192016:91  02052016:53  02052016:53  02192016:91  02052016:53  02052016:53  02192016:91  03032016:58  03032016:58  03032016:58  02232016:58  02232016:58  02232016:58  03032016:68  02172016:39  02192016:39  02242016:81  02192016:39  02192016:39  02192016:39  02192016:39  02192016:39  02192016:39  03032016:68  03032016:68  03032016:68  03042016:03  03042016:03  03042016:03  03032016:68  03032016:68  03032016:68  02242016:81  03032016:68  02242016:81  03032016:68  03032016:68  03022016:32  02242016:81  03032016:68  03022016:32  03032016:68  03032016:68  03032016:68  02242016:81  03032016:68  02242016:81  03032016:68  03032016:68  03032016:68  03032016:68  02242016:81  02102016:69  02242016:81  02242016:81  03042016:03  03042016:03  03022016:32  03022016:32  03042016:03  02242016:81  02242016:81  02242016:81  02242016:81  02242016:81  02242016:81  02012016:30  02242016:09  02192016:39  02192016:39  02192016:39  02242016:09  03022016:80  03042016:03  03042016:03  03042016:03  03042016:03  03042016:03  03042016:03  03042016:03  03042016:03  03072016:14  03042016:03  03072016:14  01282016:94  12312015:45  03072016:14  02192016:39  02192016:39  02192016:39  02192016:39  02242016:09  02192016:39  02192016:39  02192016:39  02242016:09  03022016:32  03022016:32  03072016:14  02242016:09  11252015:17  03022016:32  02242016:09  02242016:09  02242016:09  03032016:58  03032016:58  03022016:32  02242016:09  02242016:09  03022016:80  03022016:32  03022016:80  02242016:09  02242016:09  02242016:09  02152016:43  02242016:09  02242016:09  03022016:80  03022016:80  02242016:08  02242016:08  02242016:08  03022016:32  03022016:32  02242016:08  02242016:08  02242016:08  02242016:08  03022016:32  03022016:32  02242016:08  03022016:32  02242016:08  02242016:08  02242016:08  02242016:08  02242016:08  02242016:08  02242016:08  03022016:","016:49  04192016:29  04192016:29  04192016:29  04192016:29  04192016:29  04192016:29  04112016:76  04192016:49  04192016:29  04192016:29  04192016:29  04182016:49  04192016:29  04192016:29  04192016:49  03222016:93  03222016:93  04192016:49  04192016:49  04192016:49  04052016:89  04192016:29  04072016:68  04052016:89  04072016:68  04072016:68  04062016:23  04072016:68  04072016:68  04072016:68  04072016:68  04072016:68  04072016:68  04072016:68  04062016:23  04122016:97  04072016:68  04122016:97  04122016:97  04122016:97  04122016:97  04122016:97  04122016:97  04122016:97  04122016:97  04122016:97  04062016:23  04122016:97  04062016:23  04122016:97  04122016:97  04062016:23  04122016:97  04122016:97  04062016:23  04122016:97  04122016:97  04072016:68  04122016:97  04122016:97  04122016:97  04072016:68  04122016:97  04072016:68  04122016:97  04192016:29  04122016:97  04122016:97  04262016:95  04192016:29  04192016:49  04192016:29  04192016:49  04192016:29  04192016:29  04192016:49  04202016:25  04202016:25  04202016:25  04202016:25  04202016:25  04202016:25  04202016:25  04062016:87  04202016:25  04262016:95  04262016:95  04262016:95  04262016:95  04262016:95  04262016:95  04202016:25  04202016:25  04202016:25  04122016:37  04202016:25  04202016:25  04062016:87  04202016:25  04152016:02  04202016:25  04212016:04  04212016:04  04212016:04  04202016:11  04212016:04  04202016:11  04212016:04  04192016:29  04202016:11  04212016:04  04202016:11  04212016:04  04202016:11  04212016:04  04202016:11  04202016:11  04212016:04  04212016:04  04212016:04  04212016:04  04212016:04  04212016:04  04212016:42  04212016:42  04212016:42  04212016:42  04212016:42  04212016:42  04202016:11  04122016:37  04212016:04  04122016:37  04112016:76  04212016:04  04202016:11  04212016:42  04202016:11  04212016:04  04202016:11  04202016:11  04222016:44  04222016:44  04222016:44  04222016:44  04222016:44  04222016:44  04202016:11  04222016:44  04202016:11  04202016:11  04222016:44  04222016:44  04222016:44  04222016:44  04222016:44  04222016:","16:53  06142016:17  06142016:17  06132016:53  06142016:17  06132016:53  06142016:17  06142016:17  06142016:17  06142016:17  06142016:17  06142016:17  06132016:53  06132016:53  06142016:17  06142016:17  06142016:17  06132016:53  05042016:78  06142016:55  05042016:78  05042016:78  05042016:78  05042016:78  06132016:44  06132016:44  05172016:31  06022016:85  06022016:85  06022016:85  06132016:53  06142016:55  06152016:77  06152016:77  06142016:55  06142016:55  05042016:78  06142016:55  06022016:66  06022016:66  06022016:66  06022016:66  06022016:66  06022016:66  06142016:55  06022016:66  06142016:55  06152016:77  06152016:77  06152016:77  06152016:77  06152016:77  06152016:77  06132016:53  06132016:53  06132016:53  06152016:77  06152016:77  06152016:20  06142016:55  06142016:55  06032016:05  06152016:77  06132016:53  06132016:53  06142016:55  06152016:77  06152016:20  06152016:77  06152016:77  06022016:24  06032016:32  06022016:85  06032016:76  06022016:24  06022016:24  06022016:24  06142016:55  05102016:62  06132016:44  06132016:44  05102016:62  06132016:44  05102016:62  05102016:62  06142016:55  06022016:47  06132016:44  06152016:20  06142016:55  06132016:44  06212016:22  06212016:22  06132016:44  06132016:44  06152016:77  06142016:55  06212016:54  06142016:55  06152016:77  06142016:55  06142016:55  06032016:32  06152016:77  06032016:32  06032016:32  06212016:57  06152016:33  06152016:33  06152016:33  06152016:33  06162016:90  06212016:57  06152016:33  06132016:44  06152016:33  06132016:44  06152016:77  06152016:33  06152016:77  06152016:20  06162016:50  06162016:50  06152016:20  06162016:50  06162016:50  06152016:20  06162016:50  06162016:50  06162016:50  06152016:20  06162016:50  06152016:20  06172016:67  06162016:50  06162016:50  06152016:20  06172016:67  06152016:20  06162016:50  06152016:20  06162016:50  06172016:67  06162016:50  06172016:67  06152016:20  06162016:50  06172016:67  06162016:43  06162016:50  06172016:67  06172016:67  06172016:67  06172016:67  06172016:67  06172016:67  06172016:67  06172016:6",,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74746,"Ongoing","Clinique International","767 5th Ave",,"New York","NY","10153-0023","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1474-2016","Class III","CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)","1,771,244 bottles for all shades","Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.","08/26/2016",," all lots",5/17/2016,"05/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74746,"Ongoing","Clinique International","767 5th Ave",,"New York","NY","10153-0023","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1478-2016","Class III","CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)","1,771,244 bottles for all shades","Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.","08/26/2016",," all lots",5/17/2016,"05/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74746,"Ongoing","Clinique International","767 5th Ave",,"New York","NY","10153-0023","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1473-2016","Class III","CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)","1,771,244 bottles for all shades","Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.","08/26/2016",," all lots",5/17/2016,"05/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74746,"Ongoing","Clinique International","767 5th Ave",,"New York","NY","10153-0023","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1476-2016","Class III","CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N)","1,771,244 bottles for all shades","Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.","08/26/2016",," all lots",5/17/2016,"05/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74746,"Ongoing","Clinique International","767 5th Ave",,"New York","NY","10153-0023","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1475-2016","Class III","CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)","1,771,244 bottles for all shades","Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.","08/26/2016",," all lots",5/17/2016,"05/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74746,"Ongoing","Clinique International","767 5th Ave",,"New York","NY","10153-0023","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1477-2016","Class III","CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)","1,771,244 bottles for all shades","Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.","08/26/2016",," all lots",5/17/2016,"05/17/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74747,"Ongoing","Agave Dream","4823 Oakwood Ave",,"La Canada","CA","91011-2541","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, OR, IL, SC, IN.  No foreign distribution.","F-1969-2016","Class I","Agave Dream Cappuccino Ice Cream  Pint  UPC code: 899349002048  ","396 cases","Potential Listeria monocytogenes contamination.","08/23/2016",," Best By 07/04/17",7/19/2016,"07/19/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74748,"Ongoing","Krispak Inc","3883 Swank Dr Se",,"Grand Rapids","MI","49512-3968","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic only: MI, OH, PA, MA, FL    Foreign: None  VA/DOD: None","F-2193-2016","Class I","GFS Honey Roasted Peanuts, 38 oz PET (Polyethylene terephthalate) plastic jar marked with lot number 176-16 stamped above the UPC code 093901252562 and GFS reorder number","756 PET jars  sellable units","Krispak, Inc. of Grand Rapids, MI, is recalling a small quantity of Honey Roasted Peanuts packed under the GFS label because they may contain undeclared allergen tree nuts, pecans following a supplier's recall.","09/23/2016",," GFS Honey Roasted Peanuts, 38 oz PET (Polyethylene terephthalate) plastic jar marked with lot number 176-16 stamped above the UPC code 093901252562 and GFS reorder number.",7/19/2016,"07/19/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74750,"Ongoing","RAYSEARCH LABORATORIES AB","Sveavaegen 9",,"Stockholm",,,"Sweden","Voluntary: Firm Initiated","Letter","AZ, CA, FL, MT, NC NY, TX, OH & WA","Z-0079-2017","Class II","Radiation Therapy Treatment Planning System, Model 5.0","491 units (187 domestically & 304 internationally)","For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose.  The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.","10/13/2016",," 5.0.0.37, 5.0.1.11 and 5.0.2.35",5/30/2016,"05/30/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74751,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-2328-2016","Class II","IntelliVue Patient Monitor    Product Usage:  The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.  ","50,495","If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.","08/03/2016",," Serial Numbers listed for US/VA/DOD Consignees.  For OUS serial numbers, plesae refer to customer list.   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DE35120491  DE35120492  DE35120493  DE35120494  DE35120495  DE35120496  DE35120497  DE35120498  DE35120499  DE35120501  DE35120502  DE35120503  DE35120504  DE35120505  DE35120506  DE35120507  DE35120508  DE35120509  DE35120510  DE35120511  DE35120514  DE35120515  DE35120516  DE35120517  DE35120518  DE35120519  DE35120520  DE35120521  DE35120522  DE35120523  DE35120524  DE35120525  DE35120526  DE35120527  DE35120528  DE35120529  DE35120530  DE35120531  DE35120532  DE35120533  DE35120534  DE35120535  DE35120536  DE35120537  DE35120538  DE35120539  DE35120540  DE35120541  DE35120542  DE35120543  DE35120544  DE35120545  DE35120546  DE35120547  DE35120548  DE35120549  DE35120550  DE35120551  DE35120552  DE35120553  DE35120554  DE35120555  DE35120556  DE35120557  DE35127022  DE35127023  DE35127024  DE35126986  DE35126987  DE35126989  DE35126993  DE35126994  DE35126996  DE35126997  DE35126999  DE35127000  DE35127001  DE35127002  DE3512",7/26/2016,"07/26/2016",8/10/2016,"08/10/2016","E35136511  DE35136512  DE35136513  DE35136515  DE35136516  DE35136517  DE35136518  DE35136520  DE35136521  DE35136522  DE35136523  DE35136557  DE35108958  DE35108959  DE35108960  DE35108961  DE35124154  DE35125580  DE35125581  DE35125582  DE35125583  DE35125584  DE35125585  DE35125586  DE35125587  DE35126160  DE35126161  DE35126163  DE35126164  DE35126165  DE35126166  DE35126173  DE35126174  DE35126175  DE35126176  DE35126177  DE35121399  DE35121383  DE35121384  DE35121385  DE35121386  DE35121387  DE35121388  DE34100673  DE35108251  DE35108254  DE35108255  DE35108259  DE35108260  DE35108266  DE35134046  DE35134047  DE35134049  DE35134050  DE35134051  DE35134052  DE35134054  DE35134055  DE35134058  DE35134059  DE35134061  DE35134062  DE35134063  DE35134065  DE35134066  DE35134067  DE35134068  DE35134077  DE35134132  DE35134019  DE35134020  DE35148460  DE35148461  DE35148462  DE35148463  DE35148464  DE35148465  DE35148466  DE35148467  DE35148468  DE35148469  DE35148471  DE35148473  DE35148474  DE35148475  DE35148483  DE35148488  DE35148513  DE35130944  DE35130946  DE35130947  DE35131034  DE35102877  DE35102878  DE35102879  DE35102880  DE35102881  DE35102883  DE35102884  DE35102885  DE35102886  DE35102887  DE35102888  DE35102889  DE35102890  DE35102891  DE35102892  DE35102893  DE35137215  DE35137216  DE35137217  DE35137218  DE35137219  DE35137220  DE35137221  DE35137222  DE35137224  DE35137225  DE35137227  DE35137229  DE35137230  DE35137231  DE35137234  DE35137248  DE35137249  DE35137250  DE35137252  DE35137268  DE35137293  DE35137295  DE35137296  DE35137298  DE35137299  DE35137300  DE35137301  DE35137302  DE35137303  DE35137304  DE35137305  DE35137306  DE35141680  DE35141681  DE35141682  DE35152962  DE35152963  DE35113243  DE35113244  DE35113245  DE35113246  DE35113247  DE35113250  DE35106101  DE35136095  DE35136096  DE35136097  DE35136098  DE35132508  DE35132509  DE35136099  DE35136101  DE35136102  DE35123563  DE35123564  DE35123565  DE35123566  DE35123567  DE35123568  DE35123569  DE35123570  DE35123574  DE3512","E35148208  DE35148210  DE35148211  DE35148218  DE35148219  DE35148220  DE35148221  DE35148222  DE35148223  DE35148224  DE35148225  DE35148226  DE35148227  DE35148269  DE35147190  DE35147192  DE35147193  DE35147194  DE35147195  DE35147196  DE35147197  DE35147198  DE35147199  DE35147201  DE35147202  DE35147203  DE35147204  DE35147205  DE35147212  DE35121598  DE35121599  DE35121600  DE35121601  DE35121602  DE35121603  DE35121604  DE35121605  DE35121607  DE35121608  DE35121609  DE35128811  DE35146424  DE35146425  DE35146427  DE35146470  DE35146457  DE35146458  DE35146459  DE35146460  DE35146461  DE35146462  DE35146463  DE35146464  DE35146465  DE35146466  DE35146467  DE35146468  DE35146471  DE35146472  DE35146473  DE35146474  DE35146480  DE35146481  DE35146482  DE35146483  DE35146486  DE35146487  DE35146488  DE35146492  DE35138587  DE35138582  DE35138583  DE35138584  DE35138585  DE35138586  DE35103483  DE35103484  DE35104506  DE35104518  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DE35142072  DE35142073  DE35142074  DE35142076  DE35142077  DE35142078  DE35142081  DE35142093  DE35140856  DE35140857  DE35140859  DE35140860  DE35140861  DE35140862  DE35140863  DE35140864  DE35140865  DE35140866  DE35140867  DE35140892  DE35134903  DE35112378  DE35112379  DE35112381  DE35112393  DE35112382  DE35112697  DE35112698  DE35112024  DE35112026  DE35112027  DE35112028  DE35112030  DE35112031  DE35112033  DE35112034  DE35112035  DE35112036  DE35112037  DE35112039  DE35112040  DE35112041  DE35112042  DE35112043  DE35112044  DE35112045  DE35112046  DE35112047  DE35112048  DE35112050  DE35112051  DE35112053  DE35112054  DE35112055  DE35112058  DE35112069  DE35112678  DE35112680  DE35112682  DE35112683  DE35112686  DE35112688  DE35112689  DE35112691  DE35112694  DE35112695  DE35112696  DE35112699  DE35113420  DE35113421  DE35113422  DE35114552  DE35111656  DE35111657  DE35111658  DE35111659  DE35111660  DE35111661  DE35111662  DE35111663  DE35111665  DE35111666  DE35111667  DE35111668  DE35111690  DE35111691  DE35111692  DE35111693  DE35111694  DE35111695  DE35111696  DE35113722  DE35113727  DE35113731  DE35113732  DE35113739  DE3511","E35120337  DE35120338  DE35120339  DE35120340  DE35120341  DE35120342  DE35120343  DE35120344  DE35120345  DE35120346  DE35120355  DE35120356  DE35120357  DE35120359  DE35120360  DE35120361  DE35120389  DE35120648  DE35120649  DE35120650  DE35120651  DE35120652  DE35120654  DE35120655  DE35120656  DE35120657  DE35120676  DE35120742  DE35120743  DE35120744  DE35120746  DE35120747  DE35120748  DE35120749  DE35120750  DE35120751  DE35120752  DE35120753  DE35120754  DE35120755  DE35120757  DE35120759  DE35120760  DE35120761  DE35120762  DE35120763  DE35120764  DE35120765  DE35120766  DE35120767  DE35120769  DE35120770  DE35120771  DE35120772  DE35120773  DE35120775  DE35120776  DE35120778  DE35120779  DE35120781  DE35120782  DE35120785  DE35120786  DE35120787  DE35120788  DE35120789  DE35120790  DE35120792  DE35120794  DE35120795  DE35120796  DE35131131  DE35122979  DE35122980  DE35122982  DE35122983  DE35130534  DE35130535  DE35130536  DE35130537  DE35130570  DE35130571  DE35130573  DE35130575  DE35130576  DE35130577  DE35130580  DE35130587  DE35130639  DE35127995  DE35127996  DE35128008  DE35128009  DE35130582  DE35130583  DE35130584  DE35130588  DE35102835  DE35102836  DE35102837  DE35102838  DE35103657  DE35103668  DE35102822  DE35102823  DE35102824  DE35102826  DE35102827  DE35102828  DE35102829  DE35102830  DE35102831  DE35102832  DE35102833  DE35102834  DE35126908  DE35126909  DE35126910  DE35146758  DE35146759  DE35146760  DE35146761  DE35146762  DE35146763  DE35145700  DE35146365  DE35146366  DE35146367  DE35135242  DE35135243  DE35145686  DE35145687  DE35145688  DE35145689  DE35145690  DE35145691  DE 35145692  DE35145693  DE35145695  DE35145697  DE35145698  DE35145699  DE35145712  DE35146327  DE35146328  DE35146329  DE35146332  DE35146333  DE35146334  DE35146335  DE35146336  DE35146337  DE35146338  DE35146339  DE35146340  DE35146341  DE35146342  DE35146343  DE35146344  DE35146345  DE35146346  DE35146347  DE35146349  DE35146350  DE35146351  DE35146352  DE35146354  DE35146355  DE35146356  DE35146357  DE351","E35144101  DE35144120  DE35113173  DE35113181  DE35113182  DE35113183  DE35113184  DE35113185  DE35113187  DE35113188  DE35113189  DE35113190  DE35114763  DE35114764  DE35114765  DE35114766  DE35114767  DE35114768  DE35114769  DE35114770  DE35139067  DE35139069  DE35139071  DE35139072  DE35139076  DE35139108  DE35110531  DE35110547  DE35149371  DE35149372  DE35149373  DE35149374  DE35153377  DE35144494  DE35144495  DE35144496  DE35144497  DE35144499  DE35144500  DE35144511  DE35144515  DE35144527  DE35109409  DE35109410  DE35109411  DE35109413  DE35109414  DE35119960  DE35132672  DE35132673  DE35132674  DE35132675  DE35132676  DE35132677  DE35132678  DE35132679  DE35132680  DE35132681  DE35132682  DE35132683  DE35132686  DE35132687  DE35132688  DE35132695  DE35132707  DE35139319  DE35139320  DE35139321  DE35139322  DE35139323  DE35139324  DE35139325  DE35139326  DE35139327  DE35128468  DE35128469  DE35128470  DE35128471  DE35128472  DE35128474  DE35106971  DE35106972  DE35106973  DE35106974  DE35106975  DE35106976  DE35122399   DE35122400  DE35125427  DE35125428  DE35125429  DE35153160  DE35153161  DE35104932  DE35106799  DE35106800  DE35111784  DE35111786  DE35111787  DE35111788  DE35111790  DE35111791  DE35111792  DE35111793  DE35111794  DE35111795  DE35111796  DE35111797  DE35111798  DE35111799  DE35111800  DE35111801  DE35111802  DE35111803  DE35111804  DE35111805  DE35111806  DE35111807  DE35111808  DE35111809  DE35111810  DE35111812  DE35111813  DE35111814  DE35111815  DE35111816  DE35111817  DE35111818  DE35111819  DE35111820  DE35111821  DE35111823  DE35111824  DE35111825  DE35111840  DE35111841  DE35113071  DE35113072  DE35113074  DE35113075  DE35113077  DE35113078  DE35113079  DE35113089  DE35113090  DE35114526  DE35114527  DE35114528  DE35114529  DE35114530  DE35114531  DE35114532  DE35114533  DE35114534  DE35114535  DE35114536  DE35114537  DE35114538  DE35114539  DE35114540  DE35114541  DE35114542  DE35114543  DE35114545  DE35114546  DE35114547  DE35114548  DE35114549  DE35114551  DE35114568  DE351","E35149763  DE35149764  DE35149765  DE35149780  DE35149802  DE35149741  DE35149742  DE35149743  DE35149744  DE35149745  DE35149746  DE35149747  DE35149945  DE35149946  DE35149948  DE35149949  DE35149950  DE35149951  DE35149952  DE35150170  DE35150187  DE35154165  DE35154166  DE35154167  DE35154168  DE35154172  DE35154173  DE35154169  DE35154170  DE35154171  DE35154249  DE35154250  DE35154251  DE35154252  DE35154253  DE35154254  DE35154174  DE3515 4175  DE35154473  DE35154475  DE35154476  DE35154477  DE35150218  DE35150219  DE35150221  DE35150222  DE35150223  DE35150224  DE35150226  DE35150227  DE35150228  DE35150229  DE35150232  DE35150233  DE35150234  DE35150235  DE35150236  DE35150237  DE35150238  DE35150239  DE35150240  DE35150241  DE35150242  DE35127710  DE35155200  DE35155201  DE35155202  DE35155203  DE35155204  DE34100771  DE34100772  DE34100773  DE34100774  DE34100775  DE34100776  DE34100777  DE34100779  DE34100780  DE34100787  DE35116798  DE35140798  DE35140799  DE35140800  DE35140812  DE35140813  DE35140814  DE35140815  DE35140816  DE35140817  DE35140818  DE35140819  DE35140820  DE35140881  DE35140882  DE35140883  DE35140884  DE35140885  DE35140887  DE35140888  DE35140889  DE35140891  DE35140894  DE35140895  DE35140896  DE35140898  DE35140899  DE35140900  DE35140912  DE35123588  DE35123590  DE35123591  DE35123592  DE35123593  DE35123594  DE35123595  DE35123597  DE35123598  DE35123599  DE35123600  DE35123601  DE35123603  DE35123604  DE35123605  DE35123606  DE35123607  DE35123608  DE35123609  DE35123610  DE35123611  DE35123612  DE35123625  DE35123325  DE35123326  DE35123327  DE35123328  DE35123329  DE35123330  DE35123331  DE35123332  DE35123333  DE35123334  DE35123335  DE35124192  DE35144011  DE35144012  DE35144013  DE35144014  DE35144015  DE35144016  DE35144017  DE35144018  DE35144020  DE35144022  DE35144023  DE35144024  DE35144026  DE35144027  DE35144028  DE35144029  DE35144030  DE35144031  DE35144033  DE35144043  DE35144044  DE35144045  DE35144046  DE35144047  DE35144063  DE35123489  DE35149328  DE351",,,,,,,,,,,,,,,,,,,,,,
"Devices",74752,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Belgium, Italy, Spain, and Poland","Z-2588-2016","Class II","PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. ","14 units","Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Item Number PHA01212 (Short AR VV1 Ti Neck).  ","08/18/2016",," Lot number 1645222",6/30/2016,"06/30/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74753,"Ongoing","Zydus Pharmaceuticals USA Inc","73 Route 31 N",,"Pennington","NJ","08534-3601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1460-2016","Class II","Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by :  Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.     ","223,776 bottles","Failed Dissolution Specifications: out of specification dissolution results in retained samples ","08/18/2016",," Lot #: a) MR10518, Exp. 9/2017; MR11051, MR11052, MR11053, MR11054, Exp. 10/2017; MR11403, Exp. 11/2017.  Lot #: b)  MR10197, MR10195, Exp. 09/2017; MR11482, Exp.10/2017; MR11479, MR11480, MR11481,  MR11483, MR11665  Exp. 11/2017.  Lot #: c) MR10404, MR10406, MR10521, Exp. 09/2017;  MR10744, MR11055, MR11228, MR11287, MR11285, MR11288, MR11289, MR11286, Exp.10/2017;   MR11567, Exp.11/2017.",7/19/2016,"07/19/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74753,"Ongoing","Zydus Pharmaceuticals USA Inc","73 Route 31 N",,"Pennington","NJ","08534-3601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1461-2016","Class II","Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by :  Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.     ",,"Failed Dissolution Specifications: out of specification dissolution results in retained samples ","08/18/2016",," Lot #: a) MS1217,  MS1218 , Exp.12/2017.  Lot #: b) MS1215, Exp.12/2017  Lot #: c) MR11150, MR11151, MR11854, Exp. 10/2017; MR11798, MR11799, MS1214, Exp.11/2017",7/19/2016,"07/19/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74756,"Completed","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","FAX","Florida","B-0701-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from an ineligible donor, were distributed. ","08/31/2016",," W036812499283; ",6/16/2016,"06/16/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74756,"Completed","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","FAX","Florida","B-0702-16","Class II","Fresh Frozen Plasma","2 units","Blood products, collected from an ineligible donor, were distributed. ","08/31/2016",," W036812499283; W036812478591",6/16/2016,"06/16/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74756,"Completed","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","FAX","Florida","B-0705-16","Class II","Red Blood Cells","3 units","Blood products, collected from an ineligible donor, were distributed. ","08/31/2016",," W036812478591; W036812373665; W036811020337; ",6/16/2016,"06/16/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74756,"Completed","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","FAX","Florida","B-0704-16","Class II","Pooled Platelets, Leukocytes Reduced","3 units","Blood products, collected from an ineligible donor, were distributed. ","08/31/2016",," W036812839860; W036811827216; W036811804872; ",6/16/2016,"06/16/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74756,"Completed","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","FAX","Florida","B-0703-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from an ineligible donor, were distributed. ","08/31/2016",," W036812373665; ",6/16/2016,"06/16/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74757,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : FL, VA, OK, CO, DC and IN.","Z-2387-2016","Class II","Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229","111 units","Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.","08/11/2016",," Lot # QJ0139, QJ0148, QJ0140, QJ0149, QJ0287   ",7/20/2016,"07/20/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74757,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : FL, VA, OK, CO, DC and IN.","Z-2386-2016","Class II","Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219 ","495 units","Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.","08/11/2016",," Lot # GT0420 and GT0419",7/20/2016,"07/20/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74758,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","800 Macarthur Blvd",,"Mahwah","NJ","07430-2001","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada","Z-2689-2016","Class II","A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.  Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)","167 units (165 units - US) and (2 units - International)","Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.","08/30/2016",," P/N 0632F-PA0000X - (Domestic) and 0632B-PA00014 - (International)      Serial numbers  FR-5B000341, FR-5B000342, FR-5B000343, FR-5B000348, FR-5B000349, FR-51000148, FR-51000149, FR-51000150, FR-51000151, FR-51000152, FR-51000153, FR-51000154, FR-51000159 , FR-51000161, FR-51000162, FR-51000163, FR-51000164, FR-51000165, FR-51000166, FR-51000167, FR-51000168, FR-51000170, FR-51000171, FR-52000172, FR-52000173, FR-52000175, FR-52000176, FR-52000177, FR-52000178, FR-52000180, FR-52000181, FR-52000182, FR-52000183, FR-52000184, FR-52000185, FR-52000186, FR-53000187, FR-53000188, FR-53000189, FR-53000190, FR-53000191, FR-53000192, FR-53000193, FR-53000194, FR-53000197, FR-53000198, FR-53000199, FR-53000200, FR-53000203, FR-53000205, FR-53000206, FR-53000207, FR-53000209, FR-53000211, FR-53000212, FR-53000213, FR-53000214, FR-53000215, FR-53000216, FR-53000217, FR-54000218, FR-54000220, FR-54000221, FR-54000223, FR-54000224, FR-54000228, FR-54000229, FR-54000231, FR-54000233, FR-54000234, FR-54000235, FR-54000236, FR-54000237, FR-54000238, FR-54000239, FR-54000240, FR-54000241, FR-54000242, FR-54000243, FR-54000244, FR-56000245, FR-56000246, FR-56000247, FR-56000248, FR-56000249, FR-56000250, FR-56000251, FR-56000252, FR-56000253, FR-56000254, FR-56000255, FR-56000256, FR-56000257, FR-56000258, FR-56000259, FR-56000260, FR-56000261, FR-56000262, FR-56000265, FR-56000266, FR-56000267, FR-56000268, FR-57000269, FR-57000270, FR-57000271, FR-57000272, FR-57000274, FR-57000275, FR-57000276, FR-57000277, FR-57000278, FR-57000279, FR-57000280, FR-57000281, FR-57000282, FR-57000283, FR-57000284, FR-57000285, FR-57000286, FR-57000287, FR-57000288, FR-58000289, FR-58000290, FR-58000291, FR-58000292, FR-58000293, FR-58000294, FR-58000295, FR-58000296, FR-58000297, FR-58000298, FR-58000299, FR-58000300, FR-58000301, FR-58000302, FR-58000303, FR-58000304, FR-58000305, FR-58000306, FR-58000307, FR-58000308, FR-58000312, FR-58000313, FR-58000314, FR-58000315, FR-58000316, FR-58000317, FR-58000318, FR-58000319, FR-58000320, FR-58",6/15/2016,"06/15/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74759,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Domestic:MI, CA, ID, IA    VA/DOD: None  Foreign: None","Z-2630-2016","Class II","120 V Neptune 3 Rover, Model Number: 0703-001-000","78","Stryker  initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room.  ","08/23/2016",," 120 V Neptune 3 Rover, Model Number: 0703-001-000; Serial Numbers: 1606300523, 1610606263, 1610903973, 1610904293, 	1612303683, 1612303823, 1612303963, 1606300553, 1610606273, 1610904063, 1610904313, 1612303703, 1612303833, 1612303973, 1606300583, 1610606303, 1610904083 , 1610904343, 1612303713, 1612303843 , 1612303993, 1606300593, 1610606323, 1610904103, 1610904353, 1612303723, 1612303853 , 1613106443, 1606300613, 1610606353, 1610904123, 1610904363 , 1612303733, 1612303863, 1613106463, 1606300623, 1610619473, 1610904163, 1610904373 , 1612303743, 1612303873, 1613106583, 1606300643, 1610619483, 1610904173, 1610904403, 1612303763 , 1612303883 , 1613201233, 1606300653, 1610619543, 1610904183, 1612303633, 1612303783, 1612303903, 1613201243 , 1607503463 , 1610619573 , 1610904193, 1612303643, 1612303793, 1612303913, 1613201303,     1607503493, 1610619603 , 1610904203, 1612303663, 1612303813, 612303933, 1613201323, 1610409473, 1610903893, 1610904213, 1612303673  			  ",7/1/2016,"07/01/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74760,"Ongoing","Hill-Rom, Inc.","1069 State Road 46 E",,"Batesville","IN","47006-7520","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA, FL, IN, KS, LA, MI, MO, NC, NY, OK, OR, PA, TN, TX, WA, WY    Foreign:BULGARIA, INDIA, UNITED ARAB EMIRATES","Z-2750-2016","Class II","Affinity Four Birthing Bed  Model  P3700    The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.    ","94 beds",,"09/08/2016",," Affected Bed Lot Numbers: R062AA7482	R064AA7505	R042AA7318	R041AA7300  R062AA7483	R064AA7506	R042AA7320	R041AA7302  R062AA7484	R027AA7180	R042AA7321	R041AA7303  R046AA7345	R036AA7274	R042AA7323	R041AA7305  R039AA7278	R041AA7308	R042AA7324  R039AA7279	R039AA7276	R036AA7263  R039AA7281	R046AA7337	R039AA7275  R039AA7284	R046AA7346	R039AA7277  R063AA7503	R053AA7396	R061AA7475  R061AA7471	R053AA7400	R039AA7283  R061AA7472	R053AA7402	R039AA7285  R061AA7473	R053AA7404	R040AA7286  R061AA7474	R042AA7319	R039AA7282  R043AA7325	R046AA7342	R040AA7287  R043AA7327	R050AA7395	R040AA7289  R043AA7328	R056AA7443	R040AA7290  R043AA7329	R061AA7477	R040AA7292  R046AA7336	R040AA7291	R040AA7293  R046AA7339	R040AA7295	R040AA7294  R046AA7338	R041AA7301	R040AA7288  R063AA7492	R041AA7304	R040AA7296  R063AA7493	R041AA7307	R040AA7297  R063AA7494	R041AA7309	R042AA7322  R063AA7495	R041AA7310	R043AA7326  R063AA7496	R041AA7311	R043AA7330  R063AA7497	R041AA7312	R043AA7331  R063AA7498	R042AA7313	R043AA7332  R063AA7501	R042AA7314	R043AA7333  R063AA7502	R042AA7315	R041AA7298  R064AA7504	R042AA7316	R041AA7299    ",7/15/2016,"07/15/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74761,"Ongoing","BioMerieux SA","Chemin De L'Orme",,"Marcy L'Etoile",,,"France","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, and the countries of Angola, Argentina, Austria, Australia, Austria, Botswana, Brazil, Burkina Faso, Cambodia, China, Columbia, Djibouti Antilles, Estonia, Georgia, Germany, Greece, India, Israel, Italy, Kuwait, Latvia, Malaysia, Mexico, Netherlands, Poland, Qatar, Russia, Senegal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Zambia, and Zimbabwe","Z-2342-2016","Class I","NucliSENS easyMAG Magnetic Silica    The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals.  They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous.  These products are intended for in vitro diagnostic use by healthcare professionals only.","7,845 units","Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.","08/09/2016",," Lots - Z017BB1MS, Z017BF1MS, Z017CA1MS, Z017BE1MS, Z017CC1MS, Z017CD1MS, Z017CH1MS, Z017BD1MS, Z017DB1MS, Z017BA1MS, Z017CF1MS, Z017CE1MS, Z017CG1MS, Z017DA1MS, Z017DC1MS, Z017DD1MS, Z017EA1MS, Z017EB1MS, Z017FB1MS, Z017KF1MS, Z017KG1MS, Z017KH1MS  ",7/8/2016,"07/08/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74762,"Ongoing","J&D's Down Home Enterprises, Inc.","8230 5th Ave S Ste A-1",,"Seattle","WA","98108-4557","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, MI, TX.  The firm also sold product online nationwide from the company's website http://www.jdfoods.net/","F-2013-2016","Class I","Original Bacon Flavored Seasoning Salt, Big Pig brand, 16oz plastic jars, 3 jars per case.  UPC 98300 00110","231 cases (3/16 oz. jars per case)","Original Bacon Flavored Seasoning Salt, Big Pig brand, is recalled due to a potential to be contaminated with E. coli O121.","08/29/2016",," Lot 16145. Best by date: 24-05-18",7/18/2016,"07/18/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74764,"Ongoing","ORTHO-CLINICAL DIAGNOSTICS","FELINDRE MEADOWS",,"Bridgend",,,"United Kingdom","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, Puerto Rico, and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, Venezuela.","Z-2352-2016","Class II","VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.","Domestic: 1620; Foreign: 7597","Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug Fulvestrant and theVITROS Immunodiagnostic Estradiol Reagent assay. The firm conducted an internal investigation and was able to confirm biased positive (ranging from 1303-4046%) on Estradiol results, obtained from postmenopausal females taking Fulvestrant. ","08/05/2016",," Lot numbers: 1470 (expiry date 02-Aug-16); 1480 (expiry date 05-Aug-16), 1490 (expiry date 10-Oct-16), 1500 (expiry date 10-Oct-16), 1510 (expiry date 01-Nov-16), 1528 (expiry date 01-Nov-16) 1538 (expiry date 14-Mar-17), 1548 (expiry date 09-Mar-17), 1558 (expiry date 09-Mar-17) and 1568 (expiry date 29-Mar-17)",7/14/2016,"07/14/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74766,"Completed","Aurora Area Blood Bank Dba Heartland Blood Centers","1200 N Highland Ave",,"Aurora","IL","60506-1401","United States","Voluntary: Firm Initiated","Letter","Illinois; Switzerland","B-0710-16","Class II","Red Blood Cells","1 unit","Blood products, collected from an ineligible donor, were distributed. ","08/31/2016",," W0397150191608; ",6/10/2016,"06/10/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74766,"Completed","Aurora Area Blood Bank Dba Heartland Blood Centers","1200 N Highland Ave",,"Aurora","IL","60506-1401","United States","Voluntary: Firm Initiated","Letter","Illinois; Switzerland","B-0711-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from an ineligible donor, were distributed. ","08/31/2016",," W0397150191608; ",6/10/2016,"06/10/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74768,"Terminated","BloodSource, Inc.","10536 Peter a McCuen Blvd",,"Mather","CA","95655-4128","United States","Voluntary: Firm Initiated","Telephone","California","B-0687-16","Class II","Apheresis Fresh Frozen Plasma","1 unit","Apheresis product, collected from a donor who had not had an annual physical exam performed, was distributed.","08/05/2016","08/05/2016"," W035814144663",6/14/2016,"06/14/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74769,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","Telephone","Georgia","B-0688-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product mislabeled with incorrect Rh antigen type was distributed.","08/05/2016","08/05/2016"," W043216048659",6/29/2016,"06/29/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74770,"Terminated","Innovative Blood Resources","737 Pelham Blvd",,"Saint Paul","MN","55114-1739","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0671-16","Class III","Blood and Blood Products for Reprocessing","1 unit"," classification, was distributed.","08/05/2016","08/05/2016"," W051516048049 ",6/9/2016,"06/09/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74771,"Ongoing","Smith & Nephew, Inc.","130 & 120 Forbes Blvd",,"Mansfield","MA","02048","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, and the countries of:  AU, AT, BE, CA, CH, CR, DB, DE, ES, FI, FR, GB, GR, IC, IL, IN, IT, MY, NL, NO, PL, PR, PT,SE, SG, TH, and ZA.","Z-2745-2016","Class II","Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture.   PN: 7211015 Used during ligament reconstruction.","34,065 units","Sterility compromised due to breach in sterile packaging","09/07/2016",," Lot codes:  50387867  50388745  50389780  50390947  50392219  50392401  50393765  50394079  50395093  50396528  50396841  50397925  50399974  50400293  50401451  50402461  50402959  50403376  50403941  50405570  50406358  50407001  50407434  50407950  50407951  50408878  50409545  50410397  50411389  50412044  50413155  50414113  50415145  50415520  50415873  50416326  50416832  50417399  50417668  50418103  50418994  50420164  50421033  50421623  50422190  50422891  50422892  50423320  50424442  50424933  50426325  50427350  50428379  50429275  50429625  50433984  50434656  50436573  50437136  50437526  50437759  50438338  50439087  50439765  50439766  50440062  50440837  50441687  50442651  50442880  50444065  50446669  50446768  50446770  50448070  50448602  50449028  50450098  50450473  50451227  50452947  50453834  50454699  50456357  50457059  50457933  50458614  50460363  50461194  50462494  50463802  50464798  50466235  50466505  50467033  50467808  50468830  50469933  50471415  50472190  50473438  50474159  50475156  50475855  50477527  50478007  50478622  50479617  50481285  50481730  50483050  50483361  50485995  50487659  50488891  50492846  50492847  50492848  50492849  50492851  50492852  50493064  50493806  50494458  50495857  50496836  50498479  50499120  50499121  50500273  50502177  50503259  50503943  50505008  50506627  50507250  50507728  50508689  50510084  50513573  50514115  50515369  50516858  50517711  50518586  50519608  50519938  50521068  50521840  50522157  50522313  50522481  50522791  50523907  50524119  50524707  50525171  50526231  50526605  50527117  50527848  50528880  50529519  50529834  50530093  50530468  50530782  50530799  50531351  50531553  50532380  50532717  50533143  50533646  50534235  50534638  50537501  50549463  50549468  50553176  50553177  50553178  50553585  50554431  50555221  50555642  50556017  50556125  50558051  50559082  50560192  50560193  50562713  50563407  50565147  50565408  50567384  50569692  50570896  50572075  50574212  50575366  50577597  50",7/19/2016,"07/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74772,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution-USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.","Z-0313-2017","Class III","VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598    For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.","1,621 units","The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days.  Increased results may occur on both the negative and positive Controls.  The positive Control, although showing elevated results, was still within acceptable performance.","10/25/2016",," Product Code 6800598-Lot #'s: 1) 0860, 2) 0870, 3) 0880, 4) 0890, 5) 0908  Expiration: 1) 29-MAR-17, 2) 12-JUN-17, 3) 02-JUL-17, 4) 23-NOV-17, 5) 29-JAN-18",6/22/2016,"06/22/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74773,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The software was distributed to medical facilities nationwide.  Government distribution was made to MN.  Foreign distribution was made to Australia and to the United Kingdom.  There was no military distribution.","Z-2379-2016","Class II","Merge PACS software.  Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.","93 sites have the affected version","The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. ","08/10/2016",," Versions: V6.0.2.0 MR2 and earlier",1/30/2016,"01/30/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74774,"Ongoing","ConMed Corporation","525 French Rd",,"Utica","NY","13502-5945","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.","Z-0132-2017","Class II","CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300  The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.",,"The packaging seal may contain a crease.  The crease may result in an open channel. These channels may compromise sterility of the product. ","10/18/2016",," Beginning Lot Code 110609X to Ending Lot Code 20160308X",6/27/2016,"06/27/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74774,"Ongoing","ConMed Corporation","525 French Rd",,"Utica","NY","13502-5945","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.","Z-0135-2017","Class II","CORE¿ Trumpet Handpiece only, Catalog Number CD8450  The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures",,"The packaging seal may contain a crease.  The crease may result in an open channel. These channels may compromise sterility of the product. ","10/18/2016",," Beginning Lot Code 110609X to Ending Lot Code 20160308X",6/27/2016,"06/27/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74774,"Ongoing","ConMed Corporation","525 French Rd",,"Utica","NY","13502-5945","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.","Z-0130-2017","Class II","CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution  or Dual Bags, Catalog Number CD8190  The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.",,"The packaging seal may contain a crease.  The crease may result in an open channel. These channels may compromise sterility of the product. ","10/18/2016",," Beginning Lot Code 110609X to Ending Lot Code 20160308X",6/27/2016,"06/27/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74774,"Ongoing","ConMed Corporation","525 French Rd",,"Utica","NY","13502-5945","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.","Z-0134-2017","Class II","CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400  The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures",,"The packaging seal may contain a crease.  The crease may result in an open channel. These channels may compromise sterility of the product. ","10/18/2016",," Beginning Lot Code 110609X to Ending Lot Code 20160308X",6/27/2016,"06/27/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74774,"Ongoing","ConMed Corporation","525 French Rd",,"Utica","NY","13502-5945","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.","Z-0131-2017","Class II","CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200  The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for ",,"The packaging seal may contain a crease.  The crease may result in an open channel. These channels may compromise sterility of the product. ","10/18/2016",," Beginning Lot Code 110609X to Ending Lot Code 20160308X",6/27/2016,"06/27/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74774,"Ongoing","ConMed Corporation","525 French Rd",,"Utica","NY","13502-5945","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.","Z-0133-2017","Class II","CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302  The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.",,"The packaging seal may contain a crease.  The crease may result in an open channel. These channels may compromise sterility of the product. ","10/18/2016",," Beginning Lot Code 110609X to Ending Lot Code 20160308X",6/27/2016,"06/27/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74774,"Ongoing","ConMed Corporation","525 French Rd",,"Utica","NY","13502-5945","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.","Z-0129-2017","Class II","CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185  The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.",,"The packaging seal may contain a crease.  The crease may result in an open channel. These channels may compromise sterility of the product. ","10/18/2016",," Beginning Lot Code 110609X to Ending Lot Code 20160308X",6/27/2016,"06/27/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74775,"Completed","Kwik Trip, Inc.","2200 Palace Street",,"La Crosse","WI","54603","United States","Voluntary: Firm Initiated","E-Mail","Product distribution is limited to Kwik Trip, Inc. owned and operated retail stores located in Iowa, Minnesota and Wisconsin only.","F-2210-2016","Class I","Kitchen Cravings Strawberry Parfait, Net Wt. 8.25 oz (234 g).  UPC 39779-18435  Creamy Parfait Base, Strawberries with Sweetened Granola. Keep Refrigerated.","10294 units from initial recall 7/21/16 & 1098 from expanded recall 7/20/16.","Kwik Trip is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits because they may contain undeclared traces of peanuts.     EXPANDED 7-29-2016 Kwik Trip has expanded their recall of Kitchen Craving Strawberry and Mixed Berry Parfaits because they may contain undeclared traces of peanuts or almonds.","09/14/2016",," All sell by dates on or before 7/21/16 for initial recall and  All sell by dates in commerce for the expanded recall.    ",7/21/2016,"07/21/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74775,"Completed","Kwik Trip, Inc.","2200 Palace Street",,"La Crosse","WI","54603","United States","Voluntary: Firm Initiated","E-Mail","Product distribution is limited to Kwik Trip, Inc. owned and operated retail stores located in Iowa, Minnesota and Wisconsin only.","F-2211-2016","Class I","Kitchen Cravings Mixed Berry Parfait, Net Wt. 8.25 oz (234 g).  UPC 39779-18436  Creamy Parfait Base, Strawberries & Blueberries with Sweetened Granola. Keep Refrigerated.","18602 units from 7/21/16 recall & 11370 from expanded recall 7/29/16.","Kwik Trip is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits because they may contain undeclared traces of peanuts.     EXPANDED 7-29-2016 Kwik Trip has expanded their recall of Kitchen Craving Strawberry and Mixed Berry Parfaits because they may contain undeclared traces of peanuts or almonds.","09/14/2016",," All sell by dates on or before 7/21/16 for initial recall and  All sell by dates in commerce for the expanded recall.    ",7/21/2016,"07/21/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74776,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Telephone","Worldwide Distribution --  USA and Australia.","Z-2363-2016","Class II","Merge PACS software.  The firm name on the label is Merge Healthcare, Inc., Hartland, WI.    Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.","49 sites potentially have the affected versions","When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.","08/08/2016",," Software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1",2/5/2016,"02/05/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74779,"Ongoing","Domino Foods, Inc.","99 Wood Ave S Ste 901",,"Iselin","NJ","08830-2733","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ, MA, NY, MN, PA, OH","F-1936-2016","Class II","Domino PURE CANE LARGE GRAIN GRANULATED SUGAR, NET WT 50 LB (22.67 kg), Distributed by Domino Foods, Inc., Yonkers, NY 10705","467,850 lbs","Product was found to contain metal fragments.","08/16/2016",," Codes 56131 through 56177 and Codes 56181 through 56207 ",7/15/2016,"07/15/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74780,"Ongoing","Pollio Italian Cheese Company","8596 Main St",,"Campbell","NY","14821-9636","United States","Voluntary: Firm Initiated","Letter","Product was distributed to 14 U.S. firms. The firm did not distribute to any foreign countries.","F-2325-2016","Class II","12 oz flexible plastic bag containing 12 individually wrapped mozzarella cheese sticks, 24 oz flexible plastic bag containing 24 individually wrapped mozzarella cheese sticks. The product is packaged in a Blue and clear bag with white and black lettering. UPC number: 00 710400 65560 0","6,576 cases, 12 bags per case. ","A thin layer of the packaging film may remain on the cheese after the consumer opens it potentially causing choking. ","09/16/2016",," 06 OCT 2016 PD 1  06 OCT 2016 PD 3  06 OCT 2016 PD 4  06 OCT 2016 PD 5  08 OCT 2016 PD 3",7/23/2016,"07/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74780,"Ongoing","Pollio Italian Cheese Company","8596 Main St",,"Campbell","NY","14821-9636","United States","Voluntary: Firm Initiated","Letter","Product was distributed to 14 U.S. firms. The firm did not distribute to any foreign countries.","F-2324-2016","Class II","10 oz flexible plastic bag containing 12 individually wrapped mozzarella cheese sticks. The product is packaged in a Blue and clear bag with white and black lettering. UPC number: 0 71040 00060 2","5,259 cases, 12 bags per case ","A thin layer of the packaging film may remain on the cheese after the consumer opens it potentially causing choking. ","09/16/2016",," 05 OCT 2016 PD 4  05 OCT 2016 PD 5  ",7/23/2016,"07/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74781,"Terminated","Reshape Medical Inc","100 Calle Iglesia",,"San Clemente","CA","92672-7502","United States","Voluntary: Firm Initiated","Letter","US: Distribution to the states of :  NY, OH and CA.","Z-2552-2016","Class II","ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001    The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.","56 units","Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter.  The possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.","08/17/2016","08/17/2016"," 160317-001, 160371-002, 160317-003, 160324-010.",5/4/2016,"05/04/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74782,"Ongoing","Nobel Biocare Usa Llc","22715/22725 Savi Ranch Pkwy",,"Yorba Linda","CA","92887","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.","Z-2375-2016","Class II",", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit.    The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.","231 kits","Incorrect drill protocol in the Instructions for Use (IFU)","08/09/2016",," Article 38072-all lots",7/20/2016,"07/20/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74783,"Ongoing","BAKE N JOY FOODS, INC.","351 Willow St S",,"North Andover","MA","01845","United States","Voluntary: Firm Initiated","Telephone","CT, GA, MA. ME, NJ. NY, PA, VA","F-2140-2016","Class II","Bake'n Joy Sanding Sugar Net Wt. 16 lbs. pail  Product Number:  0209416","1497 16-lb. pails","Sanding sugar may contain metal fragments (supplier Domino Sugar)","09/13/2016",," Lot Codes:  20160428  20160505  20160525  20160614  20160705  20160715  ",7/18/2016,"07/18/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2698-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY,MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","86 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2693-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","34 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2702-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","47 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2695-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","110 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2701-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","60 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2697-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","169 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2696-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","98 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2703-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","38 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2694-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","36 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2699-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","134 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74785,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom","Z-2700-2016","Class I","ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base,  REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.","77 units","ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.","09/08/2016",," all codes",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74786,"Ongoing","BBI SOLUTIONS OEM LTD","8 Tom McDonald Avenue",,"Dundee",,,"United Kingdom","Voluntary: Firm Initiated","E-Mail","US distribution to CT and IN","Z-0314-2017","Class II","SimpliRED D-Dimer, Product Code DSRK4  The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood","420 units (183 units quarantined)","A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life.  Qualitative results may be affected.  False negative results are possible which may incorrectly influence the clinical diagnostic decision. ","10/27/2016",," Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B  Expiration Date: 31 JUL 2016",6/1/2016,"06/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74788,"Ongoing","Becton, Dickinson and Company, BD Biosciences","2350 Qume Dr",,"San Jose","CA","95131-1812","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA","Z-2378-2016","Class III","BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD);  Catalog number 340383.  Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide.      Hematology:  BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte  subsets in erythrocyte-lysed whole blood.   ","14,089","Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.","08/09/2016",," Catalog number: 340383;  lot No.      Expiration Date  49983,      31 July 2016;  01810,      30 September 2016;  82527,      30 September 2016;  54689 ,     30  November 2016;  36715 ,     31 December 2016;  15614,      31 January 2017;  57797,      28 February 2017.",7/18/2016,"07/18/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74789,"Ongoing","Warren Produce Co., LLC","824 W Monte Cristo Rd",,"Edinburg","TX","78539-9219","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, OK, KS, GA, CA, LA, IN, CO, MO, NY","F-2036-2016","Class I","Primo Fresh Serrano Peppers Distributed by Warren Produce, 824 W. Monte Cristo Rd, Edinburg, TX packaged in 1/4 bushel waxed cardboard boxes, 1 1/9 bushel waxed cardboard boxes, 10 lb waxed cardboard boxes, 5 lb waxed cardboard boxes and 35 lb RPC crates.","14,000 pounds","Product tested positive for Salmonella","08/31/2016",," 115158, 115181, 115186",7/22/2016,"07/22/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74790,"Ongoing","Bovie Medical Corporation","5115 Ulmerton Rd",,"Clearwater","FL","33760-4004","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.","Z-2647-2016","Class II","BVX-330NR Bovie Precise 360 Handpiece 33cm, needle     Product  is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.","95","The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.","08/24/2016",," Lot 0316D and 0516B. ",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74790,"Ongoing","Bovie Medical Corporation","5115 Ulmerton Rd",,"Clearwater","FL","33760-4004","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.","Z-2646-2016","Class II","BVX-330BR Bovie Precise 360 Handpiece 33cm, blade     Product  is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.","95","The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.","08/24/2016",," Lot 0316D, 0416L, and 0516B. ",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74790,"Ongoing","Bovie Medical Corporation","5115 Ulmerton Rd",,"Clearwater","FL","33760-4004","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.","Z-2648-2016","Class II","BVX-450BR Bovie Precise 360 Handpiece 45cm, blade   Product  is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.","95","The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.","08/24/2016",," Lot 0316D. ",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74790,"Ongoing","Bovie Medical Corporation","5115 Ulmerton Rd",,"Clearwater","FL","33760-4004","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.","Z-2649-2016","Class II","BVX-450NR Bovie Precise 360 Handpiece 45cm, needle     Product  is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.","95","The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.","08/24/2016",," Lot 0316D. ",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74791,"Ongoing","Intermex Products USA, Ltd","1375 Avenue S Ste 300",,"Grand Prairie","TX","75050-1293","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US.","F-1973-2016","Class II","la Torre Copito Marshmallow Chocolate Cookie NET WT 4.94 oz packaged in a cardboard box.","16,262 cartons","Calcium caseinate is declared on the label, but milk is not listed.","08/23/2016",," Lot Numbers: 07 16, 09 16, 10 16, 12 16, 01 17, 03 17, 05 17",7/26/2016,"07/26/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74792,"Ongoing","US Compounding Inc","1270 Don's Lane",,"Conway","AR","72032","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX","D-0219-2017","Class I","Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR","10,665 syringes","Microbial Contamination of Non-Sterile Products;  microbial contamination with B. cepacia","12/22/2016",," All Lots",7/25/2016,"07/25/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74793,"Completed","Teleflex Medical","3015 Carrington Mill Blvd",,"Morrisville","NC","27560-5437","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : FL, KS, and WV.","Z-2683-2016","Class II","MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.","2,700 units","Cracking may occur at the 15mm and 22mm ISO female  connector.  ","08/29/2016",," Model number: 01-06-8125-8, Product code: XKC01-06-8125-8, Lot numbers: 201450, 201451, 201452 and 201504.",12/3/2015,"12/03/2015",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74794,"Ongoing","Akorn, Inc.","1925 W Field Ct Ste 300",,"Lake Forest","IL","60045-4862","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1469-2016","Class III","Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only,  Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.","4,045 units","Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point","08/24/2016",," Lot#: 1967800, Exp10/2016",7/27/2016,"07/27/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74796,"Ongoing","Medtronic Cardiovascular Surgery-the Heart Valve Division","1851 E Deere Ave",,"Santa Ana","CA","92705-5720","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece,  Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.","Z-2546-2016","Class II","Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US.    Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.","7,319 units","Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).  ","08/16/2016",," all lots",8/3/2016,"08/03/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2126-2016","Class II","Mini Roll Tondo    No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","302 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2131-2016","Class II","Specialty Sandwich Bread    No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","2006 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2133-2016","Class II","Tramezzino - PAN 3 lbs. SLC Bread; Tramezzino - PAN 3 lbs. Whole Bread    No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","66 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2127-2016","Class II","Palline Integrale; and Pane Integrale PAN 3 lbs. SLC Bread    No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","939 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2041-2016","Class II","Caraway Multigrain PAN  Bread 3 lbs. SLC;    The 3lb designation is for dough weight, not net wt.    No ingredient statement on label.  No labeling agreement with consignees.    Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name.    Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag.  More than one individually packaged unit can be placed in the larger plastic bag.    Rolls are sold individually.    Firm stated that product can be distinguished by size and shape from other products.","307 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2132-2016","Class II","Three Seed - PAN 3 lbs. SLC Bread    No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","413 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2042-2016","Class II","***Panzanella Bread Company Italian Peasant Bread 24 oz. ***INGREDIENTS:  Unbleached enriched wheat flour (Niacin, reduced iron, thiamine mononitrate, riboflavin, frolic acid, enzyme, ascorbic acid [dough conditioner]), Sea Salt (Salt, magnesium carbonate) Canola Oil, Olive Oil Yeast (Sorbitan monosterate, ascorbic acid)***    Please note there are spelling error contained in the ingredient statement (frolic), commas are missing between ingredients, and capital letters are sometimes used.      A cooking spray containing soy was used to produce the recalled product and soy was not declared on the label.","retail and wholesale includes 1458 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2125-2016","Class II","Frusta aka Italian Peasant Bread    No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","1458 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2128-2016","Class II","Panino Tondo; and Small Tondo Bread;  No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","1354 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2130-2016","Class II","Sourdough PAN 3 lbs. SLC Bread;    No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","763 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2124-2016","Class II","Ciros PAN Bread 3 lbs. SLC;    No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","63 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74797,"Terminated","Golden Crown Bakery, Inc. dba Panzanella Bread Company","12310 Highway 99",,"Everett","WA","98204-8518","United States","Voluntary: Firm Initiated","Letter","WA State only","F-2129-2016","Class II","Rustic Roll;     No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag.    The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole products are packed in a brown paper bag and are generally not labeled. The brown paper bags containing product may also be wrapped with a larger unlabeled plastic bag. More than one individually packaged unit can be placed in the larger plastic bag. Rolls are sold individually. Firm stated that product can be distinguished by size and shape from other products","8997 units","Golden Crown Bakery, Inc. dba Panzanella is recalling all of their bread products due to undeclared soy, undeclared wheat and lack of product labeling.","09/12/2016","09/12/2016"," No lot codes on package",6/14/2016,"06/14/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74798,"Ongoing","Biomet Microfixation, LLC","1520 Tradeport Dr",,"Jacksonville","FL","32218-2480","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.","Z-2751-2016","Class II","Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made.  HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.","54 units","Potential sterility deficiency. ","09/08/2016",," Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016 ",6/13/2016,"06/13/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74799,"Ongoing","Straumann Manufacturing, Inc.","60 Minuteman Rd",,"Andover","MA","01810-1008","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution.","Z-2535-2016","Class II","Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP  Article Number: 021.4512","33 pieces","Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration","08/12/2016",," Lot Number:  LT123",7/14/2016,"07/14/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74799,"Ongoing","Straumann Manufacturing, Inc.","60 Minuteman Rd",,"Andover","MA","01810-1008","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution.","Z-2534-2016","Class II","Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP  Article Number: 021.4510","70 pieces","Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration","08/12/2016",," Lot Numbers:  LR810; LT122",7/14/2016,"07/14/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74800,"Ongoing","Encore Medical, Lp","9800 Metric Blvd",,"Austin","TX","78758-5445","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2606-2016","Class II","Cobalt HV Bone Cement    Product Usage:  Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.","866 units",".  The bone cement does not contain antibiotics.","08/19/2016",," Lot 507970",7/26/2016,"07/26/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74801,"Ongoing","Novus Scientific Ab","Virdings Alle 2",,"Uppsala",,,"Sweden","Voluntary: Firm Initiated","Letter","US : IL, CA, FL, KY, MO, NH, VA, TX, NC, OH, NY, TN,   Worldwide:  Sweden, Italy, Denmark, UK, Singapore, Germany, Belgium, Spain, Austria, Israel, Malta, Switzerland, Ireland, Norway, Netherlands, Turkey, New Zealand, Bulgaria, France, Iran, Finland, Poland, South Africa","Z-2603-2016","Class II","TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030","3458 units total (657 units in US)","Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.","08/19/2016",," n/a",7/19/2016,"07/19/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74802,"Ongoing","Prime Foods, Inc. LLC","885 American Way",,"Booneville","IN","47601","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IN","F-2112-2016","Class I","Prime Foods / Kramer Farms - Salad Grade Hard Cooked Eggs.    Hard cooked eggs in 20 lb. modified atmospheric packaging.   2, 20 lb. units per case  ","192 cases","Product tested positive for Salmonella.","09/09/2016",," Lot Code: 187-6  Use By: 09/03/2016  GTIN-14: 00754102000146  Item Number: 3650",7/25/2016,"07/25/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74803,"Ongoing","Cepheid","904 E Caribbean Dr",,"Sunnyvale","CA","94089-1189","United States","Voluntary: Firm Initiated","Letter","US only: PA, DE, FL, SC, ME, CA, IL, NC, TX, WA, NY, TN, FL, OR, OK, MO, MS, GA, NM, IN, OH, MD, VA, CO, AZ, and NC.","Z-2548-2016","Class II","Xpert MRSA  Catalog GXMRSA-120, Rev. AJ    Microbiology:    The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System  (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization","68 kit for lot 1000037539 and 127 kit s for lot 1000029307.","Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.","08/16/2016",," Catalog number: GXMRSA-120, Rev. AJ;  Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).",7/18/2016,"07/18/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74804,"Completed","Meijer Distribution, Inc","2929 Walker Ave Nw",,"Grand Rapids","MI","49544-6402","United States","Voluntary: Firm Initiated","E-Mail","IL, IN, KY, MI, OH, WI","F-2157-2016","Class I","MEIJER POTATO SALAD AMISH 3 LB  plastic retail container","15564 units","salads and sandwiches contain a sourced cooked egg ingredient which tested positive for Salmonella by the supplier.","09/14/2016",," UPC:  0-41250-16076-2    Sold in Meijer stores from 7/20/16 to 7/25/16  code date: 8/19/16",7/25/2016,"07/25/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74804,"Completed","Meijer Distribution, Inc","2929 Walker Ave Nw",,"Grand Rapids","MI","49544-6402","United States","Voluntary: Firm Initiated","E-Mail","IL, IN, KY, MI, OH, WI","F-2160-2016","Class I","MARKETS OF MEIJER EGG SALAD SANDWICH  8 OZ EA   individual packaged sandwich   ","4131 units","salads and sandwiches contain a sourced cooked egg ingredient which tested positive for Salmonella by the supplier.","09/14/2016",," UPC:  7-08820-54345-4     Sold in Meijer stores from 7/20/16 to 7/25/16  code dates: 7/25/16, 7/26/16, 7/27/16, 7/29/16",7/25/2016,"07/25/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74804,"Completed","Meijer Distribution, Inc","2929 Walker Ave Nw",,"Grand Rapids","MI","49544-6402","United States","Voluntary: Firm Initiated","E-Mail","IL, IN, KY, MI, OH, WI","F-2156-2016","Class I","MEIJER MACARONI SALAD 3 LB. plastic retail container","27173 units","salads and sandwiches contain a sourced cooked egg ingredient which tested positive for Salmonella by the supplier.","09/14/2016",," UPC:  0-41250-16060-1   Sold in Meijer stores from 7/20/16 to 7/25/16  code dates: 8/21/16, 8/26/16",7/25/2016,"07/25/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74804,"Completed","Meijer Distribution, Inc","2929 Walker Ave Nw",,"Grand Rapids","MI","49544-6402","United States","Voluntary: Firm Initiated","E-Mail","IL, IN, KY, MI, OH, WI","F-2155-2016","Class I","MEIJER MACARONI SALAD 1 LB. plastic retail container","20169 units","salads and sandwiches contain a sourced cooked egg ingredient which tested positive for Salmonella by the supplier.","09/14/2016",," UPC:  0-41250-16058-8   Sold in Meijer stores from 7/20/16 to 7/25/16  code date 8/21/16",7/25/2016,"07/25/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74804,"Completed","Meijer Distribution, Inc","2929 Walker Ave Nw",,"Grand Rapids","MI","49544-6402","United States","Voluntary: Firm Initiated","E-Mail","IL, IN, KY, MI, OH, WI","F-2158-2016","Class I","MARKETS OF MEIJER SALAD SEASHELL MACARONI   Food service ","2363 units","salads and sandwiches contain a sourced cooked egg ingredient which tested positive for Salmonella by the supplier.","09/14/2016",," UPC:  2-17306-00000-3   Sold in Meijer stores from 7/20/16 to 7/25/16  code date: 8/16/16",7/25/2016,"07/25/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74804,"Completed","Meijer Distribution, Inc","2929 Walker Ave Nw",,"Grand Rapids","MI","49544-6402","United States","Voluntary: Firm Initiated","E-Mail","IL, IN, KY, MI, OH, WI","F-2159-2016","Class I","MARKETS OF MEIJER TUNA SALAD SANDWICH WEDGE   7 OZ EA  individual packaged sandwich   ","3071 units","salads and sandwiches contain a sourced cooked egg ingredient which tested positive for Salmonella by the supplier.","09/14/2016",," UPC:  7-08820-52935-9    Sold in Meijer stores from 7/20/16 to 7/25/16  code dates: 7/25/16, 7/26/16, 7/27/16",7/25/2016,"07/25/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74804,"Completed","Meijer Distribution, Inc","2929 Walker Ave Nw",,"Grand Rapids","MI","49544-6402","United States","Voluntary: Firm Initiated","E-Mail","IL, IN, KY, MI, OH, WI","F-2162-2016","Class I","MEIJER CHICKEN SALAD SPREAD 12 OZ.    retail plastic container   ","3516 units","salads and sandwiches contain a sourced cooked egg ingredient which tested positive for Salmonella by the supplier.","09/14/2016",," UPC:  7-08820-62033-9     Sold in Meijer stores from 7/20/16 to 7/25/16  8/20/16, 8/24/16",7/25/2016,"07/25/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74804,"Completed","Meijer Distribution, Inc","2929 Walker Ave Nw",,"Grand Rapids","MI","49544-6402","United States","Voluntary: Firm Initiated","E-Mail","IL, IN, KY, MI, OH, WI","F-2161-2016","Class I","MEIJER EGG SALAD SPREAD 12 OZ   retail plastic container   ","3533 units","salads and sandwiches contain a sourced cooked egg ingredient which tested positive for Salmonella by the supplier.","09/14/2016",," UPC:  7-08820-62022-3     Sold in Meijer stores from 7/20/16 to 7/25/16  code date: 8/6/16",7/25/2016,"07/25/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74805,"Ongoing","Trividia Health","2400 NW 55th Ct",,"Fort Lauderdale","FL","33309-2672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and Puerto Rico and countries of: Austria, Bangladesh, Cambodia, Canada, Pakistan, Sri Lanka, Thailand, Turkey, United Kingdom, and Vietnam.","Z-2882-2016","Class II","TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters.    Quantitatively measure whole blood glucose in a professional setting or by self-testing.","5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally","Product gives incorrect low blood glucose levels.","09/23/2016",," Strip Lot #: PS2265 PS2283 PS2285 PS2281 PS2278 PS2276 PS2275 PS2215 PS2271 PS2279 PS2209 PS2299 PS2273 PS2274 PS2280 PS2219 PS2277 PS2268 PS2282 PS2296 PS2288 PS2284 PS2291 PS2287 PS2286 PS2297 PS2252 PS2293 PS2302 PS2292 PS2313 PS2270 PS2190 PS2189 PS2290 PS2298 PS2303 PS2289 PS2294 PS2295 PS2300 PS2304 PS2325 PS2312 PS2311 PS2305 PS2306 PS2315 PS2301 PS2314 PS2310 PS2347 PS2309 PS2318 PS2395 PS2320 PS2321 PS2316 PS2317 PS2330 PS2327 PS2324 PS2323 PS2333 PS2326 PS2328 PS2334 PS2329 PS2331 PS2332 PS2336 PS2335 PS2340 PS2345 PS2308 PS2341 PS2339 PS2307 PS2343 PS2353 PS2352 PS2338 PS2348 PS2342 PS2355 PS2344 PS2359 PS2362 PS2357 PS2349 PS2376 PS2356 PS2350 PS2367 PS2351 PS2346 PS2354 PS2371 PS2360 PS2366 PS2364 PS2370 PS2355SER PS2363 PS2319 PS2365 PS2361 PS2368 PS2372 PS2381 PS2369 PS2377 PS2392 PS2380 PS2374 PS2375 PS2373 PS2378 PS2379 PS2382 PS2380SER PS2383 PS2389 PR2068 PS2393 PS2384 PS2400 PS2391 PS2401 PS2402 PS2408 PS2388 PS2386 PS2387 PS2390 PS2385 PS2399 PS2396 PS2406 PS2398 PS2409 PS2337 PS2397 PS2404 PS2403 PS2322 PS2412 PS2416 PS2417 PS2419 PS2418 PS2420 PS2405 PS2413 PS2414 PS2394 PS2411 PS2415 PS2421 PS2267INT PS2336ILA PS2190IGB PS2267IGB PR2122INT PS2189INT PS2319INT PS2252ILA PS2345INT PS2279ILA PS2319IGB PS2407IGB PS2322IGB PS2349ITT PS2394ILA PS2307ILA PS2309ILA PS2308ILA PS2415INT PS2351ILA PS2337ILA PS2415ILA PS2411ILA PS2384ILA PS2394INT PS2413ILA PR2156INT PS2284ICA PS2316ICA PS2335ICA RS4646 RS4631 RS4649 RS4645 RS4652 RS4641 RS4653 RS4638 RS4612 RS4644 RS4655 RS4669 RS4567 RS4639 RS4605 RS4659 RS4654 RS4657 RS4608 RS4660 RS4662 RS4634 RS4676 RS4670 RS4665 RS4544 RS4674 RS4607 RS4688 RS4673 RS4667 RS4678 RS4680 RS4686 RS4677 RS4679 RS4695 RS4699 RS4703 RS4689 RS4704 RS4692 RS4694 RS4698 RS4663 RS4705 RS4708 RS4719 RS4710 RS4715 RS4717 RS4714 RS4723 RR4521 RS4716 RS4724 RS4645IGB RS4567ICA RS4704ICA DR4559 DS4648 DS4624 DS4658 DS4579 DS4672 DR4559IBR DR4559INT DS4624INT DS4648IBR DS4658INT DS4658IBR DS4624IBR DS4579IBR DS4711INT DS4672INT BS4643 BS4640 BS4650 BS4668 BS4661 BS4588 BS4651",6/28/2016,"06/28/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74805,"Ongoing","Trividia Health","2400 NW 55th Ct",,"Fort Lauderdale","FL","33309-2672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and Puerto Rico and countries of: Austria, Bangladesh, Cambodia, Canada, Pakistan, Sri Lanka, Thailand, Turkey, United Kingdom, and Vietnam.","Z-2881-2016","Class II","TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters.    Quantitatively measure whole blood glucose in a professional setting or by self-testing.","5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally","Product gives incorrect low blood glucose levels.","09/23/2016",," Strip Lot #: PS2265 PS2283 PS2285 PS2281 PS2278 PS2276 PS2275 PS2215 PS2271 PS2279 PS2209 PS2299 PS2273 PS2274 PS2280 PS2219 PS2277 PS2268 PS2282 PS2296 PS2288 PS2284 PS2291 PS2287 PS2286 PS2297 PS2252 PS2293 PS2302 PS2292 PS2313 PS2270 PS2190 PS2189 PS2290 PS2298 PS2303 PS2289 PS2294 PS2295 PS2300 PS2304 PS2325 PS2312 PS2311 PS2305 PS2306 PS2315 PS2301 PS2314 PS2310 PS2347 PS2309 PS2318 PS2395 PS2320 PS2321 PS2316 PS2317 PS2330 PS2327 PS2324 PS2323 PS2333 PS2326 PS2328 PS2334 PS2329 PS2331 PS2332 PS2336 PS2335 PS2340 PS2345 PS2308 PS2341 PS2339 PS2307 PS2343 PS2353 PS2352 PS2338 PS2348 PS2342 PS2355 PS2344 PS2359 PS2362 PS2357 PS2349 PS2376 PS2356 PS2350 PS2367 PS2351 PS2346 PS2354 PS2371 PS2360 PS2366 PS2364 PS2370 PS2355SER PS2363 PS2319 PS2365 PS2361 PS2368 PS2372 PS2381 PS2369 PS2377 PS2392 PS2380 PS2374 PS2375 PS2373 PS2378 PS2379 PS2382 PS2380SER PS2383 PS2389 PR2068 PS2393 PS2384 PS2400 PS2391 PS2401 PS2402 PS2408 PS2388 PS2386 PS2387 PS2390 PS2385 PS2399 PS2396 PS2406 PS2398 PS2409 PS2337 PS2397 PS2404 PS2403 PS2322 PS2412 PS2416 PS2417 PS2419 PS2418 PS2420 PS2405 PS2413 PS2414 PS2394 PS2411 PS2415 PS2421 PS2267INT PS2336ILA PS2190IGB PS2267IGB PR2122INT PS2189INT PS2319INT PS2252ILA PS2345INT PS2279ILA PS2319IGB PS2407IGB PS2322IGB PS2349ITT PS2394ILA PS2307ILA PS2309ILA PS2308ILA PS2415INT PS2351ILA PS2337ILA PS2415ILA PS2411ILA PS2384ILA PS2394INT PS2413ILA PR2156INT PS2284ICA PS2316ICA PS2335ICA RS4646 RS4631 RS4649 RS4645 RS4652 RS4641 RS4653 RS4638 RS4612 RS4644 RS4655 RS4669 RS4567 RS4639 RS4605 RS4659 RS4654 RS4657 RS4608 RS4660 RS4662 RS4634 RS4676 RS4670 RS4665 RS4544 RS4674 RS4607 RS4688 RS4673 RS4667 RS4678 RS4680 RS4686 RS4677 RS4679 RS4695 RS4699 RS4703 RS4689 RS4704 RS4692 RS4694 RS4698 RS4663 RS4705 RS4708 RS4719 RS4710 RS4715 RS4717 RS4714 RS4723 RR4521 RS4716 RS4724 RS4645IGB RS4567ICA RS4704ICA DR4559 DS4648 DS4624 DS4658 DS4579 DS4672 DR4559IBR DR4559INT DS4624INT DS4648IBR DS4658INT DS4658IBR DS4624IBR DS4579IBR DS4711INT DS4672INT BS4643 BS4640 BS4650 BS4668 BS4661 BS4588 BS4651",6/28/2016,"06/28/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74805,"Ongoing","Trividia Health","2400 NW 55th Ct",,"Fort Lauderdale","FL","33309-2672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and Puerto Rico and countries of: Austria, Bangladesh, Cambodia, Canada, Pakistan, Sri Lanka, Thailand, Turkey, United Kingdom, and Vietnam.","Z-2880-2016","Class II","TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters.    Quantitatively measure whole blood glucose in a professional setting or by self-testing.","5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally","Product gives incorrect low blood glucose levels.","09/23/2016",," Strip Lot #: PS2265 PS2283 PS2285 PS2281 PS2278 PS2276 PS2275 PS2215 PS2271 PS2279 PS2209 PS2299 PS2273 PS2274 PS2280 PS2219 PS2277 PS2268 PS2282 PS2296 PS2288 PS2284 PS2291 PS2287 PS2286 PS2297 PS2252 PS2293 PS2302 PS2292 PS2313 PS2270 PS2190 PS2189 PS2290 PS2298 PS2303 PS2289 PS2294 PS2295 PS2300 PS2304 PS2325 PS2312 PS2311 PS2305 PS2306 PS2315 PS2301 PS2314 PS2310 PS2347 PS2309 PS2318 PS2395 PS2320 PS2321 PS2316 PS2317 PS2330 PS2327 PS2324 PS2323 PS2333 PS2326 PS2328 PS2334 PS2329 PS2331 PS2332 PS2336 PS2335 PS2340 PS2345 PS2308 PS2341 PS2339 PS2307 PS2343 PS2353 PS2352 PS2338 PS2348 PS2342 PS2355 PS2344 PS2359 PS2362 PS2357 PS2349 PS2376 PS2356 PS2350 PS2367 PS2351 PS2346 PS2354 PS2371 PS2360 PS2366 PS2364 PS2370 PS2355SER PS2363 PS2319 PS2365 PS2361 PS2368 PS2372 PS2381 PS2369 PS2377 PS2392 PS2380 PS2374 PS2375 PS2373 PS2378 PS2379 PS2382 PS2380SER PS2383 PS2389 PR2068 PS2393 PS2384 PS2400 PS2391 PS2401 PS2402 PS2408 PS2388 PS2386 PS2387 PS2390 PS2385 PS2399 PS2396 PS2406 PS2398 PS2409 PS2337 PS2397 PS2404 PS2403 PS2322 PS2412 PS2416 PS2417 PS2419 PS2418 PS2420 PS2405 PS2413 PS2414 PS2394 PS2411 PS2415 PS2421 PS2267INT PS2336ILA PS2190IGB PS2267IGB PR2122INT PS2189INT PS2319INT PS2252ILA PS2345INT PS2279ILA PS2319IGB PS2407IGB PS2322IGB PS2349ITT PS2394ILA PS2307ILA PS2309ILA PS2308ILA PS2415INT PS2351ILA PS2337ILA PS2415ILA PS2411ILA PS2384ILA PS2394INT PS2413ILA PR2156INT PS2284ICA PS2316ICA PS2335ICA RS4646 RS4631 RS4649 RS4645 RS4652 RS4641 RS4653 RS4638 RS4612 RS4644 RS4655 RS4669 RS4567 RS4639 RS4605 RS4659 RS4654 RS4657 RS4608 RS4660 RS4662 RS4634 RS4676 RS4670 RS4665 RS4544 RS4674 RS4607 RS4688 RS4673 RS4667 RS4678 RS4680 RS4686 RS4677 RS4679 RS4695 RS4699 RS4703 RS4689 RS4704 RS4692 RS4694 RS4698 RS4663 RS4705 RS4708 RS4719 RS4710 RS4715 RS4717 RS4714 RS4723 RR4521 RS4716 RS4724 RS4645IGB RS4567ICA RS4704ICA DR4559 DS4648 DS4624 DS4658 DS4579 DS4672 DR4559IBR DR4559INT DS4624INT DS4648IBR DS4658INT DS4658IBR DS4624IBR DS4579IBR DS4711INT DS4672INT BS4643 BS4640 BS4650 BS4668 BS4661 BS4588 BS4651",6/28/2016,"06/28/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74805,"Ongoing","Trividia Health","2400 NW 55th Ct",,"Fort Lauderdale","FL","33309-2672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and Puerto Rico and countries of: Austria, Bangladesh, Cambodia, Canada, Pakistan, Sri Lanka, Thailand, Turkey, United Kingdom, and Vietnam.","Z-2883-2016","Class II","TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters.    Quantitatively measure whole blood glucose in a professional setting or by self-testing.","5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally","Product gives incorrect low blood glucose levels.","09/23/2016",," Strip Lot #: PS2265 PS2283 PS2285 PS2281 PS2278 PS2276 PS2275 PS2215 PS2271 PS2279 PS2209 PS2299 PS2273 PS2274 PS2280 PS2219 PS2277 PS2268 PS2282 PS2296 PS2288 PS2284 PS2291 PS2287 PS2286 PS2297 PS2252 PS2293 PS2302 PS2292 PS2313 PS2270 PS2190 PS2189 PS2290 PS2298 PS2303 PS2289 PS2294 PS2295 PS2300 PS2304 PS2325 PS2312 PS2311 PS2305 PS2306 PS2315 PS2301 PS2314 PS2310 PS2347 PS2309 PS2318 PS2395 PS2320 PS2321 PS2316 PS2317 PS2330 PS2327 PS2324 PS2323 PS2333 PS2326 PS2328 PS2334 PS2329 PS2331 PS2332 PS2336 PS2335 PS2340 PS2345 PS2308 PS2341 PS2339 PS2307 PS2343 PS2353 PS2352 PS2338 PS2348 PS2342 PS2355 PS2344 PS2359 PS2362 PS2357 PS2349 PS2376 PS2356 PS2350 PS2367 PS2351 PS2346 PS2354 PS2371 PS2360 PS2366 PS2364 PS2370 PS2355SER PS2363 PS2319 PS2365 PS2361 PS2368 PS2372 PS2381 PS2369 PS2377 PS2392 PS2380 PS2374 PS2375 PS2373 PS2378 PS2379 PS2382 PS2380SER PS2383 PS2389 PR2068 PS2393 PS2384 PS2400 PS2391 PS2401 PS2402 PS2408 PS2388 PS2386 PS2387 PS2390 PS2385 PS2399 PS2396 PS2406 PS2398 PS2409 PS2337 PS2397 PS2404 PS2403 PS2322 PS2412 PS2416 PS2417 PS2419 PS2418 PS2420 PS2405 PS2413 PS2414 PS2394 PS2411 PS2415 PS2421 PS2267INT PS2336ILA PS2190IGB PS2267IGB PR2122INT PS2189INT PS2319INT PS2252ILA PS2345INT PS2279ILA PS2319IGB PS2407IGB PS2322IGB PS2349ITT PS2394ILA PS2307ILA PS2309ILA PS2308ILA PS2415INT PS2351ILA PS2337ILA PS2415ILA PS2411ILA PS2384ILA PS2394INT PS2413ILA PR2156INT PS2284ICA PS2316ICA PS2335ICA RS4646 RS4631 RS4649 RS4645 RS4652 RS4641 RS4653 RS4638 RS4612 RS4644 RS4655 RS4669 RS4567 RS4639 RS4605 RS4659 RS4654 RS4657 RS4608 RS4660 RS4662 RS4634 RS4676 RS4670 RS4665 RS4544 RS4674 RS4607 RS4688 RS4673 RS4667 RS4678 RS4680 RS4686 RS4677 RS4679 RS4695 RS4699 RS4703 RS4689 RS4704 RS4692 RS4694 RS4698 RS4663 RS4705 RS4708 RS4719 RS4710 RS4715 RS4717 RS4714 RS4723 RR4521 RS4716 RS4724 RS4645IGB RS4567ICA RS4704ICA DR4559 DS4648 DS4624 DS4658 DS4579 DS4672 DR4559IBR DR4559INT DS4624INT DS4648IBR DS4658INT DS4658IBR DS4624IBR DS4579IBR DS4711INT DS4672INT BS4643 BS4640 BS4650 BS4668 BS4661 BS4588 BS4651",6/28/2016,"06/28/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74806,"Ongoing","Tecan US, Inc.","9401 Globe Center Drive","Suite 140","Morrisville","NC","27560","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.","Z-2665-2016","Class II","Tecan Infinite M1000 PRO  The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards.","11 units","The batteries have the potential to overheating, melt or char.","08/25/2016",," Instrument Material #30063849, PC Serial # 2CE3362609, Instrument Serial #1110008219; PC Serial # CND5219H33, Instrument Serial #1204007588;  PC Serial # 2CE3462FTJ, Instrument Serial #1301009861; PC Serial # 2CE3462FTD, Instrument Serial #1311007574; PC Serial #2CE33625KP, Instrument Serial #1404000703; PC Serial #2CE33625ND, Instrument Serial #1404000704; PC Serial #2CE41503PY, Instrument Serial #1406000407; PC Serial #2CE41503NW, Instrument Serial #1408001415; PC Serial #2CE41503K0, Instrument Serial #1407003406; PC Serial #CND5219GY7, Instrument Serial #1509001006 and PC Serial #CND44273YB, Instrument Serial #1604003735.  ",7/25/2016,"07/25/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74806,"Ongoing","Tecan US, Inc.","9401 Globe Center Drive","Suite 140","Morrisville","NC","27560","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.","Z-2666-2016","Class II","Hydroflex ELISA  The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have been validated for processing of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) and therefore are intended for professional use in in-vitro diagnostics. The instrument has not been validated for other areas of application not mentioned in the Intended Use (e.g. veterinary, biopharma). ","1 unit","The batteries have the potential to overheating, melt or char.","08/25/2016",," Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.  ",7/25/2016,"07/25/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74806,"Ongoing","Tecan US, Inc.","9401 Globe Center Drive","Suite 140","Morrisville","NC","27560","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.","Z-2663-2016","Class II","Infinite 200 PRO  The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.","27 units","The batteries have the potential to overheating, melt or char.","08/25/2016",," Instrument Material #30050303, PC Serial numbers: CND5219H0B, Instrument Serial #1208002673; PC Serial numbers: CND44273RW, Instrument Serial #1211001074; PC Serial numbers: CND44273SC, Instrument Serial #1309006773; PC Serial numbers: 2CE3461RNR, Instrument Serial #1311008588; PC Serial numbers: 2CE33625KT, Instrument Serial #1401006356; PC Serial numbers: 2CE33626Q9, Instrument Serial #1403000833; PC Serial numbers: 2CE3461RR3, Instrument Serial #1403003928; PC Serial numbers: 2CE33625M4, Instrument Serial #1403005482; PC Serial numbers: 2CE41503JF, Instrument Serial #1405000420; PC Serial numbers: CND5219H4R, Instrument Serial #1405002510; PC Serial numbers: 2CE42406YJ, Instrument Serial #1406009472; PC Serial numbers: 2CE4220LGP, Instrument Serial #1410002321; PC Serial numbers: 2CE424072G, Instrument Serial #1410004940: PC Serial numbers: 2CE4240DJ7, Instrument Serial #1411008631; PC Serial numbers: 2CE424071M, Instrument Serial #1412005274; PC Serial numbers: CND44273XR, Instrument Serial #1503001536; PC Serial numbers: CND5219H1S, Instrument Serial #1503002986; PC Serial numbers: CND44262KJ, Instrument Serial #1503004890; PC Serial numbers: CND442625D, Instrument Serial #1501008506; PC Serial numbers: CND442627J, Instrument Serial #1501008513; PC Serial numbers: CND44273SB, Instrument Serial #1505009092; PC Serial numbers: CND442626B, Instrument Serial #1509001022; PC Serial numbers: CND5219H11, Instrument Serial #1509008146; PC Serial numbers: CND5219H6D, Instrument Serial #1511009716; PC Serial numbers: 2CE3461RSX, Instrument Serial #1512005211; PC Serial numbers: 2CE3381HT1, Instrument Serial #1601005141 and PC Serial numbers: CND5219H2K, Instrument Serial #1510004918.  ",7/25/2016,"07/25/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74806,"Ongoing","Tecan US, Inc.","9401 Globe Center Drive","Suite 140","Morrisville","NC","27560","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.","Z-2660-2016","Class II","Infinite F50 instrument.  The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics","1 unit","The batteries have the potential to overheating, melt or char.","08/25/2016",," Instrument Material #330087508, PC Serial # CND5219H07, Instrument Serial #1508007738.",7/25/2016,"07/25/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74806,"Ongoing","Tecan US, Inc.","9401 Globe Center Drive","Suite 140","Morrisville","NC","27560","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.","Z-2664-2016","Class II","Tecan Infinite M1000  The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards","1 unit","The batteries have the potential to overheating, melt or char.","08/25/2016",," Instrument Material #30034301, PC Serial number: 2CE33625NS, Instrument Serial #1508007738.",7/25/2016,"07/25/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74806,"Ongoing","Tecan US, Inc.","9401 Globe Center Drive","Suite 140","Morrisville","NC","27560","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.","Z-2661-2016","Class II","SUNRISE instrument.  The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics","19 units","The batteries have the potential to overheating, melt or char.","08/25/2016",," Instrument Material #16039400, PC Serial # 2CE4220L6Z, Instrument Serial # 1201008596 and Instrument Material #30087502, PC Serial #2CE3362777, Instrument Serial #1403008116; PC Serial #2CE3461RV1, Instrument Serial #1404001455; PC Serial #2CE3461RVY, Instrument Serial #1404001456; PC Serial #2CE41503MD, Instrument Serial #1405003467; PC Serial #2CE3462FX0, Instrument Serial #1405002373; PC Serial #2CE4220BW9, Instrument Serial #1407000866; PC Serial #2CE42406XP, Instrument Serial #1409007597; PC Serial #CND4426259, Instrument Serial #1412005606; PC Serial #CND442618S, Instrument Serial #1503003902; PC Serial #CND44261R2, Instrument Serial #1504007122; PC Serial #CND44273XJ, Instrument Serial #1504004857; PC Serial #CND5219GYY, Instrument Serial #1506006286; PC Serial #CND5219GYX, Instrument Serial #1509005071; PC Serial #CND5219H21, Instrument Serial #1511009478; PC Serial #CND5219GYN, Instrument Serial #1512005969; PC Serial #CND5219H68, Instrument Serial #1603000018; PC Serial #CND5219GYJ, Instrument Serial #1606001277 and PC Serial #CND5219GZW, Instrument Serial #1606001263.",7/25/2016,"07/25/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74806,"Ongoing","Tecan US, Inc.","9401 Globe Center Drive","Suite 140","Morrisville","NC","27560","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.","Z-2662-2016","Class II","Tecan Infinite 200.  The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics. ","5 units","The batteries have the potential to overheating, melt or char.","08/25/2016",," Instrument Material #30050303, PC Serial numbers: CND5219H0B, Instrument Serial #1208002673; PC Serial numbers: CND44273RW, Instrument Serial #1211001074; PC Serial numbers: CND44273SC, Instrument Serial #1309006773; PC Serial numbers: 2CE3461RNR, Instrument Serial #1311008588; PC Serial numbers: 2CE33625KT, Instrument Serial #1401006356; PC Serial numbers: 2CE33626Q9, Instrument Serial #1403000833; PC Serial numbers: 2CE3461RR3, Instrument Serial #1403003928; PC Serial numbers: 2CE33625M4, Instrument Serial #1403005482; PC Serial numbers: 2CE41503JF, Instrument Serial #1405000420; PC Serial numbers: CND5219H4R, Instrument Serial #1405002510; PC Serial numbers: 2CE42406YJ, Instrument Serial #1406009472; PC Serial numbers: 2CE4220LGP, Instrument Serial #1410002321; PC Serial numbers: 2CE424072G, Instrument Serial #1410004940; PC Serial numbers: 2CE4240DJ7, Instrument Serial #1411008631; PC Serial numbers: 2CE424071M, Instrument Serial #1412005274; PC Serial numbers: CND44273XR, Instrument Serial #1503001536; PC Serial numbers: CND5219H1S, Instrument Serial #1503002986; PC Serial numbers: CND44262KJ, Instrument Serial #1503004890; PC Serial numbers: CND442625D, Instrument Serial #1501008506; PC Serial numbers: CND442627J, Instrument Serial #1501008513; PC Serial numbers: CND44273SB, Instrument Serial #1505009092; PC Serial numbers: CND442626B, Instrument Serial #1509001022; PC Serial numbers: CND5219H11, Instrument Serial #1509008146; PC Serial numbers: CND5219H6D, Instrument Serial #1511009716; PC Serial numbers: 2CE3461RSX, Instrument Serial #1512005211; PC Serial numbers: 2CE3381HT1, Instrument Serial #1601005141 and PC Serial numbers: CND5219H2K, Instrument Serial #1510004918.  ",7/25/2016,"07/25/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74807,"Ongoing","Arcobasso Foods ","8850 Pershall Rd",,"Hazelwood","MO","63042-2916","United States","Voluntary: Firm Initiated","Other","Distributed nationwide to Sam's Club only.","F-2342-2016","Class III","Panera Bread Balsamic Vinaigrette Dressing, NET 20 FL OZ (1.25 PT) 591 mL, most responsible firm on the label is Panera Bread St. Louis, MO 63127 PaneraAtHome.com.  Product packaged in plastic bottles and shrink wrapped as a twin pack (2 bottles together).  UPC code is 018959753168 for the single bottle.  The UPC code for the twin pack is 018959753175.","240,000 single bottles","Consumer complaints of bulging bottles.","09/16/2016",," Lot numbers: 10/4/16, 10/6/16, 10/7/16, 10/8/16, 10/15/16, and 10/22/16.  These are expiration dates which are also the lot numbers.",7/23/2016,"07/23/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74808,"Ongoing","GE OEC Medical Systems, Inc","384 N Wright Brothers Dr",,"Salt Lake City","UT","84116-2862","United States","Voluntary: Firm Initiated","Letter","Distribution US nationwide and Korea.","Z-2629-2016","Class II","OEC 9800, fluoroscopic x-ray system","47 total","A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.","08/23/2016",," monitor part numbers: 5448359-01, 5459219-01, or 5475662-03:89-3853, 82-1593, 8S-1935, 89-3356, 89-1323, 8S-2885, 82-0700, 8S-1708, 82-0420, 82-1998, 8S-2027, 82-7101-MH, 8S-2670, P6-0375-L, 8S-1614, 89-0846, 82-0576, 82-3256, 8S-2202, 89-0711,89-1927, 89-1453, 82-1504, 82-0794, 82-3494, 8S-3125, 8S-1845-RC, 89-3725, 8S-1592, 89-3129,82-1182, 82-0986, 8S-0199, 8S-3613, 82-3748, 82-2335, 8S-2889, 82-0596, 89-3020, 82-1515, 8S-0645, 8S-3614, 82-3925, 89-0416, 89-1363, 82-3258, 8S-0347",7/22/2016,"07/22/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74808,"Ongoing","GE OEC Medical Systems, Inc","384 N Wright Brothers Dr",,"Salt Lake City","UT","84116-2862","United States","Voluntary: Firm Initiated","Letter","Distribution US nationwide and Korea.","Z-2628-2016","Class II","OEC UroView 2800, fluoroscopic x-ray system","47 total","A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.","08/23/2016",," monitor part numbers: 5448359-01, 5459219-01, or 5475662-03:89-3853, 82-1593, 8S-1935, 89-3356, 89-1323, 8S-2885, 82-0700, 8S-1708, 82-0420, 82-1998, 8S-2027, 82-7101-MH, 8S-2670, P6-0375-L, 8S-1614, 89-0846, 82-0576, 82-3256, 8S-2202, 89-0711,89-1927, 89-1453, 82-1504, 82-0794, 82-3494, 8S-3125, 8S-1845-RC, 89-3725, 8S-1592, 89-3129,82-1182, 82-0986, 8S-0199, 8S-3613, 82-3748, 82-2335, 8S-2889, 82-0596, 89-3020, 82-1515, 8S-0645, 8S-3614, 82-3925, 89-0416, 89-1363, 82-3258, 8S-0347",7/22/2016,"07/22/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74809,"Ongoing","TZ Medical, Inc.","17750 SW Upper Boones Ferry Rd Ste 150",,"Portland","OR","97224-7086","United States","Voluntary: Firm Initiated","Telephone","Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX,  and WV.","Z-0298-2017","Class II","Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03  Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy","1410 (141 boxes of 10)","Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER.  This statement should not appear on label.","10/21/2016",," Lot R970249",7/7/2016,"07/07/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74810,"Ongoing","MFA Inc","201 Ray Young Dr",,"Columbia","MO","65201","United States","Voluntary: Firm Initiated","Visit","Product was distributed to one customer in Holden, MO.","V-488-2016","Class II","This is a custom horse feed, packaged in 50 pound bags, Net Weight 50 Lb (22.6 kg).  Most responsible firm listed on the label is West Central AgriServices Chilhowee, Missouri 64733.","21 - 50 pound bags","Product is misbranded and contains monensin and sulfamethazine which caused two horse deaths.","08/29/2016",," Lot number 10899",7/23/2016,"07/23/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74811,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US (nationwide) Internationally  to  Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,","Z-2675-2016","Class II","STAPLER,IS4000; Model number 470298;    General and Plastic Surgery:  The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).   ","875 instruments (827 a la carte + 48 in kits) total, all models","Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30  instruments having an interruption in shaft rotation and / or instrument jaws not opening.","08/26/2016",," All model 470298",7/14/2016,"07/14/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74811,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US (nationwide) Internationally  to  Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,","Z-2677-2016","Class II","CURVED-TIP STAPLER 30,IS4000; Model number 470530;    General and Plastic Surgery:  The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult  and pediatric use. The device can be used with staple line or tissue buttressing material.","875 instruments (827 a la carte + 48 in kits); total, all models","Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30  instruments having an interruption in shaft rotation and / or instrument jaws not opening.","08/26/2016",," All model 470530",7/14/2016,"07/14/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74811,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US (nationwide) Internationally  to  Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,","Z-2676-2016","Class II","STAPLER 30,IS4000; Model number 470430;    General and Plastic Surgery:  The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult  and pediatric use. The device can be used with staple line or tissue buttressing material."," 875 instruments (827 a la carte + 48 in kits) total, all models","Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30  instruments having an interruption in shaft rotation and / or instrument jaws not opening.","08/26/2016",," All model 470430",7/14/2016,"07/14/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74812,"Ongoing","Boston Scientific Corporation","4100 Hamline Ave N",,"Saint Paul","MN","55112-5700","United States","Voluntary: Firm Initiated","Visit","Distributed to the states of TX, NH, MA, PA, and MN.","Z-2749-2016","Class II","Pacemakers:  Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111.      These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.      ","5","Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted.  This alternate configuration did not receive FDA approval yet.","09/07/2016",," serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.",6/15/2016,"06/15/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74815,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","E-Mail","Distribution was nationwide to medical facilities.  Government distribution was made to LA and OK.","Z-2796-2016","Class II","RadSuite software.  The firm name on the label is Merge Healthcare, Hartland, WI.","45 sites potentially have the affected versions","Multiple studies were missing at a customer location that never made it to the archive before watermarking","09/14/2016",," This potential patient safety issue is only present in the following versions when a reverse workflow is used: 2004-R6.x, 5.10.x, 5.20, 5.25, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 8.30.0.    NOTE:  The standard workflow is not impacted.   .  ",5/6/2013,"05/06/2013",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74816,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0023-2017","Class II","Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).  "," 27,547 vials","CGMP Deviations","10/12/2016",," Lot # 7080315, 7400315, 7410315, 7980415",7/29/2016,"07/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74816,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0024-2017","Class II","Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).  ","11,844 vials","CGMP Deviations","10/12/2016",," Lot # 2381114, 2771114, 4760915",7/29/2016,"07/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0009-2017","Class II","Gourmet Blueberry Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100737004000  ",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0037-2017","Class II","Gourmet Pistachio Flavored Monster Muffins (4 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100807004008",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0023-2017","Class II","Tripple Berry Loaf Bread (1 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2107736005007",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0010-2017","Class II","Gourmet Corn Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100747004007",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0024-2017","Class II","Banana Chocolate Chip Loaf Bread (1 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2122396005006",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0034-2017","Class II","Sour Cream Cookies (6 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100775004499",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0018-2017","Class II","Gingerbread Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100887004004",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0025-2017","Class II","Banana Walnut Loaf Bread (1 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2122196005008",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0020-2017","Class II","Gourmet Pumpkin Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100917004004",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0035-2017","Class II","Gourmet Double Dutch Monster Muffins (4 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100827004002",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0032-2017","Class II","Chocolate Sugar Cookies (6 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 221045335004491",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0028-2017","Class II","Blueberry Lemon Loaf Bread (1 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2122096005009",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0019-2017","Class II","Gourmet Cranberry Orange Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100907004007",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0021-2017","Class II","Monster Size Pina Colada Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100837004009",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0026-2017","Class II","Apple Cinnamon Loaf Bread (1 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2122106005005",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0013-2017","Class II","Gourmet Orange Pineapple Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100757004004",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0031-2017","Class II","Old Fashioned Shortcake (4 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2101477004008",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0029-2017","Class II","Irish Soda Bread (1 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2107620003997",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0014-2017","Class II","Gourmet Banana Nut Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100727004003",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0016-2017","Class II","Gourmet Cinnamon Chip Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 22100957004002",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0012-2017","Class II","Gourmet Butter Rum Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100787004005",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0015-2017","Class II","Gourmet Lemon Poppy Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100927004001",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0022-2017","Class II","Gourmet Chocolate Chip Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100857004003",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0033-2017","Class II","Sour Creme Cookies with Chocolate Chips (6 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100945004496",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0030-2017","Class II","8 Irish Soda Scones","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 22107980003996",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0027-2017","Class II","Peach Melba Loaf Bread (1 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2122566005003",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0017-2017","Class II","Gourmet Red Velvet Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 22103007004007",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0036-2017","Class II","Gourmet Raisin Bran Monster Muffins (4 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100817004005",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0011-2017","Class II","Gourmet Cherry Almond Monster Muffins (4 count)  ","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100797004002",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74818,"Ongoing","Weis Markets, Inc., Ice Cream Division","1000 S 2nd St",,"Sunbury","PA","17801-3318","United States","Voluntary: Firm Initiated","E-Mail","Products were distributed to: PA,NJ,NY,MD,VA","F-0038-2017","Class II","Gourmet Apple Spice Monster Muffins (4 count)","170,186 total units","WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.","10/11/2016",," UPC # 2100867004000",7/21/2016,"07/21/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74819,"Ongoing","Sage Products LLC","3909 3 Oaks Rd",,"Cary","IL","60013-1804","United States","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.","D-0230-2017","Class II","COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;   c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.  ","616,561 cases total","CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.","12/22/2016",," Lot #: a) 45489, Exp. 8/23/2016; 45537, Exp. 8/25/2016; 45631, Exp. 9/1/2016; 45781, Exp. 9/10/2016; 46345, Exp. 10/18/2016; 46708, Exp. 11/9/2016; 46763, Exp. 11/11/2016; 47378, Exp. 1/5/2017; 47723, Exp. 1/27/2017; 48347, Exp. 3/4/2017; 49057, Exp. 4/18/2017; 49498, Exp. 5/16/2017; 49576, Exp. 5/19/2017; 49869, Exp. 6/8/2017; 51306, Exp. 9/10/2017; 51309, Exp. 9/10/2017; 51720, Exp. 10/6/2017; 52187, Exp. 11/7/2017; 52216, Exp. 11/8/2017; 52226, Exp. 11/8/2017; 52235, Exp. 11/9/2017; 52239, Exp. 11/9/2017; 52415, Exp. 11/19/2017; 52694, Exp. 12/8/2017; 52702, Exp. 12/8/2017; 52711, Exp. 12/9/2017; 52722, Exp. 12/9/2017; 52968, Exp. 1/4/2018; 53000, Exp. 1/5/2018; 54543, Exp. 4/10/2018; 54597, Exp. 4/12/2018; 55814, Exp. 6/20/18; b) 45408, Exp. 8/17/2016; 45427, Exp. 8/18/2016; 45451, Exp. 8/19/2016; 45468, Exp. 8/20/2016; 45483, Exp. 8/21/2016; 45557, Exp. 8/26/2016; 45650, Exp. 9/2/2016; 45768, Exp. 9/9/2016; 45893, Exp. 9/17/2016; 45998, Exp. 9/23/2016; 46169, Exp. 10/5/2016; 46432, Exp. 10/22/2016; 46512, Exp. 10/27/16; 46551, Exp. 10/29/16; 46608, Exp. 11/2/16; 46647, Exp. 11/4/2016; 46669, Exp. 11/6/2016; 46841, Exp. 11/17/2016; 46851, Exp. 11/17/2016; 46970, Exp. 11/29/2016; 47058, Exp. 12/2/2016; 47115, Exp. 12/7/2016; 47202, Exp. 12/14/2016; 47309, Exp. 12/20/2016; 47420, Exp. 1/8/2017; 47436, Exp. 1/10/2017; 47512, Exp. 1/13/2017; 47560, Exp. 1/17/2017; 47800, Exp. 2/2/2017; 47837, Exp. 2/3/2017; 48134, Exp. 2/19/2017; 48154, Exp. 2/21/2017; 48928, Exp. 4/9/2017; 48943, Exp. 4/11/2017; 49149, Exp. 4/25/2017; 49222, Exp. 4/29/2017; 49386, Exp. 5/9/2017; 49466, Exp. 5/12/2017; 49600, Exp. 5/20/2017; 49926, Exp. 6/13/2017; 50578, Exp. 7/27/2017; 50585, Exp. 7/27/2017; 50596, Exp. 7/28/2017; 50600, Exp. 7/28/2017; 50910, Exp. 8/15/2017; 51204, Exp. 9/6/2017; 51260, Exp. 9/8/2017; 51268, Exp. 9/8/2017; 51293, Exp. 9/9/2017; 51344, Exp. 9/13/2017; 51438, Exp. 9/19/2017; 51522, Exp. 9/23/2017; 51527, Exp. 9/23/2017; 51531, Exp. 9/23/2017; 51755, Exp. 10/7/2017; 51824, Exp. 10/13/2017; 52016, Exp. 10/26/20",7/29/2016,"07/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74819,"Ongoing","Sage Products LLC","3909 3 Oaks Rd",,"Cary","IL","60013-1804","United States","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.","D-0231-2017","Class II","2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.","2756 cases","CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.","12/22/2016",," Lot #: a) 50749, Exp. 9/29/16; 50765, Exp. 9/30/16; 50771, Exp. 9/30/16; 50773, Exp. 10/01/16; 52839, Exp. 2/9/17; 52843, Exp. 2/9/17; 52855, Exp. 2/10/17; 52861, Exp. 2/10/17; 53840, Exp. 4/21/17; 56081, Exp. 9/1/17; 56513, Exp. 9/26/17; b) 54760, Exp. 6/15/17; c) 54763, Exp. 6/16/17  a)  Lot # 50749 , Exp. 9/29/2016 ;  Lot # 50765 , Exp. 9/30/2016 ;  Lot # 50771 , Exp. 9/30/2016 ;  Lot # 50773 , Exp. 10/1/2016 ;  Lot # 52839 , Exp. 2/9/2017 ;  Lot # 52843 , Exp. 2/9/2017 ;  Lot # 52855 , Exp. 2/10/2017 ;  Lot # 52861 , Exp. 2/10/2017 ;  Lot # 53840 , Exp. 4/21/2017 .    b)  Lot # 54763, Exp. 6/16/2017.    c)  Lot # 54760, Exp. 6/15/2017.  ",7/29/2016,"07/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74819,"Ongoing","Sage Products LLC","3909 3 Oaks Rd",,"Cary","IL","60013-1804","United States","Voluntary: Firm Initiated","Letter","Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.","D-0229-2017","Class I","COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;   c)  24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.  ","576,802 cases total for product codes 7503, 7905, and 7526","Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.","12/22/2016",," Lot #: a) 53957, Exp 03/06/18; b) 54769, Exp 04/22/18; 54922, Exp 05/03/18; 55781, Exp 06/19/18; c) 53095, Exp 07/13/17",7/29/2016,"07/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74820,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,  MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM,  NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY","Z-2655-2016","Class II","Brilliance 16, Model number 728246    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","192","After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.","08/25/2016",," 728246 -- Brilliance 16         3010	3017	3031	3040	3043	3070	3072	3085	3090	3117	3149	3216	3247	3293	3314	5006	5012	5018	5020	5024	5026	5028	5030	5031	5035	5044	5045	5052	5053	5054	5055	5058	5059	5060	5064	5069	5070	5081	5086	5088	5091	5093	5097	5099	5103	5107	5108	5110	5111	5115	5116	5118	5120	5123	5126	5127	5128	5131	5138	5140	5155	5160	5161	5163	5166	5184	5186	5188	5190	5191	5192	5193	5195	5197	5208	5209	5216	5219	5235	5236	5238A	5270	5272	5279	5282	5285	5287	5294	5295	5315	5316	5350	5354	5357	5360	5368	5394	5433	5434	5443	5453	5457	5480	5487	5501	5502	5505	5519	5523	5526	5554	5572	5573	5576	5609	5615	5633	5647	5653	5683	5723	5758	5762	5764	5771	5811	5897	5929	5937	5956	5974	5995	6021	6022	6031	6033	6048	6053	6072	6220	6229	6243	6280	6283	6298	6309	6321	6360	6375	6405	6426	6441	6465	6474	6484	6503	6511	6517	6519	6523	6549	6559	30049	32287	50011	50053	50087	50180	3123	5674	6555	32366	3465	50181	5135	5237	3179	3411	5009	5048	5077	5412	6154	30011	30110	5101	5181	3324	5405	3050	3441	6387  ",7/20/2016,"07/20/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74820,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,  MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM,  NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY","Z-2656-2016","Class II","Brilliance CT 16 Power, Model number 728240    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","50","After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.","08/25/2016",," 728240 -- Brilliance CT 16 Power        3100	5043	5047	5280	5345	5390	5413	5430	5495	5499	5512	6007	6009	6013	6032	6041	6045	6049	6051	6058	6064	6066	6070	6071	6077	6080	6081	6084	6089	6095	6100	6106	6109	6113	6115	6116	6123	6124	6131	6132	6134	6141	6144	6155	6161	6162	5476	6098	6120	6067  ",7/20/2016,"07/20/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74820,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,  MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM,  NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY","Z-2654-2016","Class II","Brilliance BigBore Radiology CT Model number 728244    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","24","After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.","08/25/2016",," 728244  Brilliance BigBore Radiology CT          7375	7781	7614	7633	7708	7789	7721	7760	7252	7380	7390	7514	7052	7244	7384	7533	7172	7200	7546	7427	7452	7407	7453	7586   ",7/20/2016,"07/20/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74820,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,  MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM,  NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY","Z-2657-2016","Class II","Ingenuity Core, Model number 728321    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","30","After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.","08/25/2016",," 728321 -- Ingenuity Core        310004 310005	310012	310016	310020	310021	310027	310028	310033	310034	310041	310044	310045	310057	310061	310065	310072	310074	310076	310077	310078	310094	310099	310100	310103	310105	310117	310120	310122	310135  ",7/20/2016,"07/20/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74820,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,  MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM,  NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY","Z-2658-2016","Class II","Ingenuity Core128, Model number 728323    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","3","After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.","08/25/2016",," 728323 -- Ingenuity Core128              320004	320053	 320056  ",7/20/2016,"07/20/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74820,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,  MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM,  NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY","Z-2652-2016","Class II","Brilliance 64 CT Model number 728231    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","283","After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.","08/25/2016",," 9033	9037	9043	9045	9064	9065	9070	9075	9086	9089	9104	9108	9120	9151	9156	9172	9190	9243	9259	9507	9508	9511	9526	9530	9531	9534	9547	9564	9580	9584	9598	9603	9606	9608	9613	9614	9630	9642	9655	9672	9695	9697	9690	9706	9713	9732	9735	9736	9757	9759	9812	9830	9835	9866	9875	9881	9889	9918	9936	9937	9951	9965	9968	9969	9975	9978	9992	9999	10036	10041	10046	10054	10067	10070	10080	10095	10103	10125	10141	10256	10292	10359	10363	10372	10380	10381	10386	10426	10473	10486	10505	10513	10527	10535	10561	10570	10645	10651	10655	10673	10686	10733	10743	10773	10776	29007	29016	29018	29025	29027	29037	29053	29097	90031	90047	90063	90128	95003	95058	95068	95210	95357	95811	29054	9107	9666	9700	29038	9858	9009	9029	9038	9051	9058	9067	9068	9072	9073	9092	9105	9106	9502	9503	9512	9516	9522	9525	9533	9545	9550	9551	9556	9572	9577	9591	9594	9596	9612	9618	9620	9624	9625	9626	9628	9633	9634	9635	9639	9641	9648	9650	9663	9676	9678	9685	9691	9692	9694	9705	9716	9726	9729	9740	9750	9751	9752	9753	9754	9775	9777	9780	9788	9790	9793	9809	9811	9821	9823	9826	9843	9846	9855	9857	9861	9869	9873	9878	9879	9882	9885	9894	9895	9902	9906	9917	9924	9938	9942	9948	9954	9960	9961	9966	9974	9982	9985	9994	10001	10014	10035	10037	10045	10065	10079	10085	10086	10096	10098	10111	10112	10113	10120	10148	10190	10200	10202	10224	10263	10291	10310	10332	10353	10365	10370	10371	10388	10413	10417	10424	29005	29035	29068	64015	90062	95008	95057	95348	9851T	10122	10373	10211	9139	10005	10026	10030	10031	10194	95149	95377	95392	9980	9698	9787    ",7/20/2016,"07/20/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74820,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,  MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM,  NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY","Z-2653-2016","Class II","Brilliance CT Big Bore Oncology, Model number 728243    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","33","After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.","08/25/2016",," 728243  Brilliance BigBore Oncology CT         7116	7611	7354	7063	7309	7169	7205	7016	7019	7043	7069	7073	7091	7112	7132	7163	7141	7194	7226	7325	7294	7350	7316	7480	7114	7210	7310	7438	7530	7186	7119	7042  ",7/20/2016,"07/20/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74821,"Ongoing","Natrium Products Inc","58 Pendleton St",,"Cortland","NY","13045-2702","United States","Voluntary: Firm Initiated","Telephone","RI, MI, NJ","F-2005-2016","Class III","SODIUM BICARBONATE, CAS # 144-55-8, USP/FCC GRADE 1, NET WEIGHT 50 lbs./22.68 kg --- Natrium Products, Inc. 58 Pendleton Street, Cortland, NY 13045 ","1677 - 50 lbs. bags","Sodium Bicarbonate bulk lot 08315A may contain varying amounts of lubricating oil (food grade oil designated NSF 11).  ","08/26/2016",," Lot 08315A (exp. 8/31/2018)",7/27/2016,"07/27/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1989-2016","Class I","OSSIE'S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1983-2016","Class I","OSSIE'S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1988-2016","Class I","OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1980-2016","Class I","OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1976-2016","Class I","OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1987-2016","Class I","OSSIE'S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1985-2016","Class I","OSSIE'S SHMALTZ HERRING, NET WT. 8 OZ., UPC 739885104182; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1981-2016","Class I","OSSIE'S SWEDISH MATJES HERRING, NET WT. 7 OZ., UPC 739885109101; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1978-2016","Class I","OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1979-2016","Class I","OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1982-2016","Class I","OSSIE'S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1986-2016","Class I","OSSIE'S ROMAN SHMALTZ HERRING, NET WT. 7 OZ., UPC 739885109026; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1984-2016","Class I","OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74823,"Terminated","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey","F-1977-2016","Class I","OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114174; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","Total of 336 containers for all products","The product has the potential to be contaminated with Listeria monocytogenes based on the presence of the bacteria in the plant.","08/25/2016","08/25/2016"," Best By date codes of 7/21/16 through 08/20/16 (located on the bottom of the plastic tub)",7/29/2016,"07/29/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74824,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailand, United Kingdom (Great Britain and Ireland), and United Arab Emirates. *** While this product is available in the US, these lots were not distributed to US consignees ***","Z-2708-2016","Class II","Alcon AcrySof IQ IOL with ULTRASERT Delivery System    Product Usage:  The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.  ","371 units","The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System","09/01/2016",," Lot numbers: 12407022, 12407085, 12407087, 12409013, 12409024, 12409026, 12409028",7/28/2016,"07/28/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74825,"Ongoing","Alcon Research, Ltd.","6201 South Fwy",,"Fort Worth","TX","76134-2099","United States","Voluntary: Firm Initiated","Letter","Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories.  However, donated units are in use by a reduced number of USA clients for Medical Missions outside the country.","Z-2834-2016","Class II","LAUREATE World Phaco System","8,646 UNITS","Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)","09/15/2016",," Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H",7/28/2016,"07/28/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74827,"Ongoing","Limacorporate S.p.A","Via Nazionale 52",,"San Daniele Del Friuli",,,"Italy","Voluntary: Firm Initiated","Letter","US, Italy, Australia","Z-2707-2016","Class II","SMR allen wrench 5 mm, product code 9013.50.210","76","Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.","08/31/2016",," 14AA311",7/21/2016,"07/21/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74828,"Ongoing","ORTHO-CLINICAL DIAGNOSTICS","FELINDRE MEADOWS",,"Bridgend",,,"United Kingdom","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada","Z-2580-2016","Class III","VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK  For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.","Domestic: 2883, Foreign: 1261","A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples.  Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.  ","08/17/2016",," Lot 5040 (Expiry date 19 Dec 2016)",7/28/2016,"07/28/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74829,"Ongoing","Drews LLC","926 Vermont Rt 103 S",,"Chester","VT","05143","United States","Voluntary: Firm Initiated","Other","OH, FL, IL, MD, CT","F-2237-2016","Class II","SimplyNature Organic Chipotle Ranch Dressing, Net Wt. 12 FL OZ (354mL), UPC: 0 41498 21862 1","2,011  cases","Product contains undeclared wheat. ","09/14/2016",," W170G ",7/29/2016,"07/29/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74830,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US to MA, NY, MI, IL, TX, CO, AZ, CA, WA and Foreign distribution to the following countries: Australia, Austria, Bahrain, Brazil, China, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Malaysia, Netherlands, New Zealand, Norway, Portugal, Portugal, Republic Korea, Singapore, Slovakia, Spain, Sweden, Turkey, United Kingdom, and Vietnam.","Z-2704-2016","Class II","ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR).   The ADVIA Chemistry XPT System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour","Domestic: 32 units; Foreign: 197 units","Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123).  This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR).  The ratio equation used to calculate ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results in IFCC units contains an error.  The error results in falsely depressed HbA1cR results.  ","08/30/2016",," CA1275002940294 and lower ",7/20/2016,"07/20/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74831,"Ongoing","Mount Franklin Foods LLC","1800 Northwestern Dr",,"El Paso","TX","79912-1122","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","TX, IL, and WI","F-2089-2016","Class I","AZ House Granola MANUFACTURED BY: Azar Nut Company El Paso, TX 79912 packaged in 5 pound plastic bags; 1 case containing one 5 pound bag","2071 cases","Undeclared peanuts, almonds and milk","09/13/2016",," 16181, 16182, 16189, 16202",7/28/2016,"07/28/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74833,"Ongoing","Hampton Creek Foods","2000 Folsom St",,"San Francisco","CA","94110-1318","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide to Wal-Mart stores","F-2019-2016","Class I","JUST Devil's Food Cake Mix;   NET WT 20 oz. (1 lb 4 oz) 567 g);   UPC 8 54829 00643 5.     Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour, malted barley flour, niacin, reduced Iron, thiamine Monocitrate, riboflavin, folic acid), Sugar, Palm Oil., Alkalized Cocoa. . Contains less than 2% of Baking Powder )Sodium acid pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate) Baking Soda, Citric Acid, Coconut Milk Powder (coconut milk, tapioca syrup), Natural Flavors, Oat Bran, Oat Hull Fiber, Salt, Sodium Aliginate, Sorghum Flour, Soy milk powder, Xanthan Gum.     Blueberry Mix: Blueberries, Water: Crumble Mix: Sugar, Brown Sugar, Maltodextrin, Palm Oil, Enriched flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine monocitrate, riboflavin, folic acid), cinnamon, Salt, Natural Flavors:     Contains: Wheat, Soy, Coconut. Bake at 350 degrees for 24-34 minutes depending on pan size. Distributed by Hampton Creek, Inc., San Francisco, CA 94103. ","3,786 cases (6 units per cse)","Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.","08/31/2016",," Sell by Date: 06/07/2017. Lot codes: 13016A . .    .    ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74833,"Ongoing","Hampton Creek Foods","2000 Folsom St",,"San Francisco","CA","94110-1318","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide to Wal-Mart stores","F-2016-2016","Class I","JUST Chocolate Chunk Muffin Mix;  NET WT 20.8 oz. (1 lb 4.8 oz) 590 g);  UPC 8 54829 00656 5.    Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine monomonitrate, riboflavin, folic acid), Sugar, Palm Oil, Baking Powder (sodium acid pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate.   Contains less than 2% of Baking Soda,  Coconut Milk Powder )coconut milk, tapioca syrup), Dextrose, Lactic Acid, Natural Flavors, Oat Bran, Oat Hull Fiber, Seasoning (Potassium Chloride, Wheat Flour) , Salt, Sodium Aliginate, Sorghum Flour, Soy Lecithin (emulsifier), X.anthan Gum.  Chocolate Pack: Bittersweet chocolate chunks (unsweetened alkalized chocolate, sugar, cocoa butter, soy lecithin (emulsifier)..    Contains: Wheat, Soy, Coconut.  Bake at 400 degrees for 16-19 minutes.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.","1,569 cases (6 units per case)","Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.","08/31/2016",," Sell by Date: 06/06/2017;  Lot code: 11916  ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74833,"Ongoing","Hampton Creek Foods","2000 Folsom St",,"San Francisco","CA","94110-1318","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide to Wal-Mart stores","F-2034-2016","Class I","JUST White Cake Mix;  NET WT 20 oz. (1 lb 4 oz) 567 g);  UPC 8 54829 00688 6.    Ingredients: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), Sugar Palm Oil, Contains less than 2% of Baking Powder (sodium acid Pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate), Baking Soda, Citric acid, Coconut Milk Powder (coconut milk, tapioca  syrup), }, Natural Flavors, Oat Bran, Oat Hull Fiber, Salt, Sodium Aliginate, Sorghum Flour, Soy Milk Powder, X.an than Gum.    Contains: Wheat, Soy, Coconut.  Bake 350 degrees 24-26 minutes depending on pan size.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.","2,421cases (2 x 20 oz box per case)","Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.","08/31/2016",," Sell by Date: 05/25/2017;  Lot codes: 11616; 13016-B.  ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74833,"Ongoing","Hampton Creek Foods","2000 Folsom St",,"San Francisco","CA","94110-1318","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide to Wal-Mart stores","F-2035-2016","Class I","JUST Cinnamon Roll Coffee Cake Mix;  NET WT 26.9 oz. (1 lb 10.9 oz) 762 g);  UPC 8 54829 00644 2.    Ingredients: Cake Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine monomonitrate, riboflavin, folic acid), Sugar. Contains less than 2% of Baking Powder (sodium acid Pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate), Baking Soda, Citric acid, Natural Flavors, Oat Bran, Oat Hull Fiber, Palm Oil, Salt, Sodium Aliginate, Sorghum Flour, Soy Milk Powder, X.an than Gum.  Icing Mix: Powdered Sugar (dried cane syrup, corn starch), Canola Oil, Soy Milk Powder, Corn Starch, Modified Food Starch, Salt, Natural Flavors, Citric Acid.  Swirl Mix: Brown Sugar, Sugar, Canola Oil, Invert Sugar, Cinnamon, Salt, Natural Flavors, Spice, Citric Acid.  Yeast Pack: Yeast (yeast, Sorbitan monostearate, ascorbic acid.    Contains: Wheat, Soy, Coconut.  Bake at 350 degrees for 30-44 minutes depending on pan size.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.","3,731 (6 units per case)","Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.","08/31/2016",," Sell by Date: 05/28/2017;  Lot code: 11616C    ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74833,"Ongoing","Hampton Creek Foods","2000 Folsom St",,"San Francisco","CA","94110-1318","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide to Wal-Mart stores","F-2018-2016","Class I","JUST Blueberry Muffin Mix;  NET WT 23.3 oz. (1 lb 7.3 oz) 660 g);  UPC 8 54829 00685 5.    Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine Monocitrate, riboflavin, folic acid), Sugar, Palm Oil., Baking Powder Sodium acid pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate.  Contains less than 2% of Baking Soda,  Coconut Milk Powder (coconut milk, tapioca syrup), Dextrose, Lactic Acid, Natural Flavors, Oat Bran, Oat Hull Fiber, Salt, Sodium Aliginate, Sorghum Flour, Soy lecithin (emulsifier), Xanthan Gum.    Blueberry Mix: Blueberries, Water:  Crumble Mix: Sugar, Brown Sugar, Maltodextrin, Palm Oil, Enriched flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine monocitrate, riboflavin, folic acid), cinnamon, Salt, Natural Flavors:    Contains: Wheat, Soy, Coconut.  Bake at 350 degrees for 16-19 minutes.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.","3,414 cases (6 units per cse)","Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.","08/31/2016",," Sell by Date: 06/04/2017.   Lot codes: 13316A; 13316B; 13416.    .    ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74833,"Ongoing","Hampton Creek Foods","2000 Folsom St",,"San Francisco","CA","94110-1318","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide to Wal-Mart stores","F-2017-2016","Class I","JUST Yellow Cake Mix;  NET WT 20 z. (1 lb 4oz) 567 g);  UPC 8 54829 00642 8.    Ingredients: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour,  malted barley flour, niacin, reduced Iron, thiamine monomonitrate, riboflavin, folic acid), Sugar, Palm Oil. Contains less than 2% of Baking Powder (sodium acid Pyrophosphate, sodium bicarbonate, corn starch, monocalcium phosphate), Baking Soda, Citric acid, Coconut Milk Powder (coconut milk, tapioca syrup), Fruit and Vegetable Juice (color) Natural Flavors, Oat Bran, Oat Hull Fiber, Salt, Sodium Aliginate, Sorghum Flour, Soy Milk Powder, X.anthan Gum.    Contains: Wheat, Soy, Coconut.  Bake at 350 degrees for 24-16 minutes depending on pan size.  Distributed by Hampton Creek, Inc., San Francisco, CA 94103.","3,938 cases (6 units per case)","Firm received a positive test result for Salmonella in Coconut Milk powder which was used in the manufacturing on six cake and muffin mixes.","08/31/2016",," Sell by Date: 06/02/2017, 07/13/2017;  Lot codes: 12316; 12316; 13116-A  .    ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74835,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil,  Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.","Z-2784-2016","Class I","Adaptor for Small Battery Drive and Small Battery Drive II.    Product Usage:  The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II.  ","1,833 devices (05.001.024 and 05.001.108)","There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. ","09/26/2016",," Model/Catalog:   Adapter for Small Battery Drive and Small Battery Drive II for Electric Pen Drive 05.001.024;  Lot/Set/Serial:  All Manufactured Lots/Serial Numbers. ",6/24/2016,"06/24/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74835,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil,  Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.","Z-2783-2016","Class I","Light Adaptor for Small Battery Drive and Small Battery Drive II.     Product Usage:  Adaptors (05.001.024 ) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II. The adapter can be inserted into the SBD or SBD II handpiece and removed like a battery pack.  The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone.","1,833 devices (05.001.024 and 05.001.108)","There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst. ","09/26/2016",," Model/Catalog: Light Adapter for Small Battery Drive and Small Battery Drive II (05.001.108)  Lot/Set/Serial:  All Manufactured Lots/Serial Numbers. ",6/24/2016,"06/24/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74836,"Ongoing","Productos La Finca, Inc.","Zona Industrial Machuchal","Ave. Quilinchini #61","Sabana Grande","PR","00637","United States","Voluntary: Firm Initiated","E-Mail","USA only: Florida","F-0347-2017","Class II","Iberia Codfish Fritter Mix","282 boxes of 12 (4.5 oz) pouches each","Undeclared food allergen: Soy","11/08/2016",," Lot #16076, Exp. 3/16/17 and Lot # 16089, Exp. 3/29/17",7/13/2016,"07/13/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74837,"Ongoing","Thermo Finnigan LLC","355 River Oaks Pkwy",,"San Jose","CA","95134-1908","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution - US including FL, NY and Internationally to Japan.","Z-2775-2016","Class II","Endura MR Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1.  In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.    Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.","6 (5 in Us distribuion and 1 in Japan)","Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy.","09/09/2016",," TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.",7/19/2016,"07/19/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74838,"Ongoing","Northridge Tri-Modality Imaging,","9457 de Soto Ave",,"Chatsworth","CA","91311-4920","United States","FDA Mandated","Letter","USA  Distribution","Z-2833-2016","Class II","TriFoillmaging Triumph/Triumph II Research CT scanners.    ","3","The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northridge Trimodality Imaging, inc dba TriFoillmaging (or by Gamma Medica-Ideas, Inc and field upgraded with a replacement  x-ray tube) may be out of compliance with 21 CFR 1020.40 (Cabinet X-ray standards)","09/30/2016",," n/a",5/24/2016,"05/24/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74839,"Ongoing","Hologic, Inc","250 Campus Dr",,"Marlborough","MA","01752-3020","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2766-2016","Class II","SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.  ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece    Product Usage:  The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator  ","535 units","Tip Breakage at the glue joint between the obturator body and tip","09/08/2016",," Lot Codes:  512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.  ",8/2/2016,"08/02/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74839,"Ongoing","Hologic, Inc","250 Campus Dr",,"Marlborough","MA","01752-3020","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2765-2016","Class II","SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.  ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)","1440 units","Tip Breakage at the glue joint between the obturator body and tip","09/08/2016",," Lot Codes:  512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.  ",8/2/2016,"08/02/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74840,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Distributed to: MI, NY, CA, KY, ND, NE","Z-2626-2016","Class II","SOMATOM Definition Edge  with software version VA48A-SP2; Model # 8098027  computed tomography x-ray system","4 systems","Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved.  This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.","08/23/2016",," Model # 8098027    Serial # 96020, 96047, 96011, and 96029",7/13/2016,"07/13/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74840,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Distributed to: MI, NY, CA, KY, ND, NE","Z-2624-2016","Class II","SOMATOM Definition AS with software version VA48A-SP2;   Model # 10430603, computed tomography x-ray system","1 unit","Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved.  This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.","08/23/2016",," Model # 10430603  Serial #  74192",7/13/2016,"07/13/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74840,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Distributed to: MI, NY, CA, KY, ND, NE","Z-2625-2016","Class II","SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system","2 systems","Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved.  This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.","08/23/2016",," Model # 10590000  Serial #  83398, and 83387",7/13/2016,"07/13/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2043-2016","Class I","Vanilla Ice Cream Devils Food Rollcake-8941-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box.  Roll cake is packed 8 per case. Product is frozen.  ","1,762 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 89417/01/2017  89417/06/2017   89417/22/2017   89417/24/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2052-2016","Class I","Oreo Cookies 'n Cream Chocolate Sheet Cake Ice Cream Cake-8981-Baskin Robbins.Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.","3,856 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 89817/05/2017  89817/12/2017    ",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2051-2016","Class I","Cookies 'n Cream White Sheet Cake-8978-Baskin Robbins.  Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.","4,644 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 89787/05/2017  89787/12/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2049-2016","Class I","Chocolate Chip Devils Food Sheet Cake- 8976-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.","3,681 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 8976 7/04/2017  8976 7/12/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2044-2016","Class I","Mint Chocolate Chip Devils Food Rollcake -8939-Baskin Robbins.Cakes are sealed in plastic and packed in a labeled cardboard box. Roll cake is packed 8 per case. Product is frozen.  Label has Baskin Robbins ","2,081 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 89397/01/2017  8939-7/06/2017  89397/16/2017   89397/23/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2048-2016","Class I","Pralines n Cream White Sheet Cake Ice Cream Cake-8979-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.","1,680 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 89797/12/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2050-2016","Class I","Mint Chocolate Chip Devils Food Sheet Cake-8975-Baskin Robbins.  Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.","2,583 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 8975  7/05/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2047-2016","Class I","Vanilla Devils Food Sheet Cake-8977-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.  ","3,649 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 8977 7/04/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2046-2016","Class I","Chocolate Chip Devils Food Rollcake-8940-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Roll cake is packed 8 per case. Product is frozen.  ","546 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 89407/01/2017  89407/23/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74841,"Ongoing","Superior Dairy Inc","4719 Navarre Rd SW",,"Canton","OH","44706-2338","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states CA, GA, IL, MI, PA, UT","F-2045-2016","Class I","Oreo Cookies n Cream Ice Cream Rollcake-8943-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Roll cake is packed 8 per case. Product is frozen.  ","949 cases","Undeclared walnuts in bakery cakes utilized in ice cream cakes ","09/16/2016",," 8943-7/01/2017  8943-7/22/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74842,"Ongoing","Teva North America","425 Privet Rd",,"Horsham","PA","19044-1220","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0005-2017","Class III","Claravis (isotretinoin capsules USP), 10mg,  packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86","3,569 capsules","Failed Impurities/Degradation Specifications.","10/05/2016",," Lot #: 34025714A, Exp. Date 12/2016",8/5/2016,"08/05/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74843,"Ongoing","OraSure Technologies, Inc.","1745 Eaton Ave",,"Bethlehem","PA","18018-1769","United States","Voluntary: Firm Initiated","E-Mail","Distributed to one customer only in US state of Georgia.","Z-2403-2016","Class I","OraQuick Ebola Rapid Antigen Test, Product Code  3001-2807;   Intended for the qualitative detection of antigens for Ebola viruses.","3,075 units","Failed stability testing at 8 months.  This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.","08/17/2016",," Product Code  3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.",7/20/2016,"07/20/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74844,"Ongoing","Consumers Supply Distributing Co","5101 Harbor Dr",,"Sioux City","IA","51102","United States","Voluntary: Firm Initiated","Telephone","Product was distributed to customers is NE, WI, MO, MN, IL, MT, IN, IA, and KY.","V-516-2016","Class II","Fish meal, A Protein Source for Livestock Feeds, Stabilized with Ethoxyquin, Net Weight 50 LBS. Consumers Supply, North Sioux City, SD packaged in poly-woven bags","996 50lb bags = 49,800lbs","Fish meal is potentially contaminated with Salmonella","09/16/2016",," Lot 15318, exp N/A",8/1/2016,"08/01/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74845,"Ongoing","Minnie Marie Bakers, Inc. dba Awrey's Bakery","12301 Farmington Rd",,"Livonia","MI","48150-1747","United States","Voluntary: Firm Initiated","E-Mail","Ohio","F-2020-2016","Class I","White Sponge Cake 8x12  30 lb case  20, 24oz cakes per case  ","1106 cases","Products may contain undeclared tree nuts (walnuts).  People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.","08/30/2016",," product 6075  ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74845,"Ongoing","Minnie Marie Bakers, Inc. dba Awrey's Bakery","12301 Farmington Rd",,"Livonia","MI","48150-1747","United States","Voluntary: Firm Initiated","E-Mail","Ohio","F-2022-2016","Class I","Deep Chocolate Sheet Cake 8x12   28.125 lb case 20,   22.5 oz cakes per case ","560 cases","Products may contain undeclared tree nuts (walnuts).  People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.","08/30/2016",," product 658040 ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74845,"Ongoing","Minnie Marie Bakers, Inc. dba Awrey's Bakery","12301 Farmington Rd",,"Livonia","MI","48150-1747","United States","Voluntary: Firm Initiated","E-Mail","Ohio","F-2021-2016","Class I","Devils Food Sheet Cake 8x12 Mega   28.125 lb case 20, 2  2.5oz cakes per case ","2418 cases","Products may contain undeclared tree nuts (walnuts).  People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.","08/30/2016",," product 6585 ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74845,"Ongoing","Minnie Marie Bakers, Inc. dba Awrey's Bakery","12301 Farmington Rd",,"Livonia","MI","48150-1747","United States","Voluntary: Firm Initiated","E-Mail","Ohio","F-2023-2016","Class I","Chocolate Roll Cake 15x24   22 lb case 8,   2 lb 12 oz cakes per case ","2971 cases","Products may contain undeclared tree nuts (walnuts).  People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.","08/30/2016",," product 6595 ",7/29/2016,"07/29/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74846,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","E-Mail","US Distribution to states of: CA, PA, TX, and  MT.","Z-2551-2016","Class II","Merge Unity Z3D software.    Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.","9 sites potentially have the affected version","The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.","08/16/2016",," Version 11.0",7/23/2015,"07/23/2015",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74847,"Ongoing","Golden State Medical Supply Inc.","5187 Camino Ruiz",,"Camarillo","CA","93012-8601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1458-2016","Class II","Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS. ","65,401 bottles","Failed Dissolution Specifications: Out-of-specification results in retained sample.","08/16/2016",," Lot #: a) GS011931,  Exp 10/2017; GS011932, Exp 11/2017  b) GS010773, GS011242, 09/2017; GS011061, GS011315, GS011357,   GS011585, GS011586, GS011588, GS011591, Exp 10/2017; GS011933, Exp 11/2017    ",8/3/2016,"08/03/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74847,"Ongoing","Golden State Medical Supply Inc.","5187 Camino Ruiz",,"Camarillo","CA","93012-8601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1459-2016","Class II","Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg,  90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90","40,631 bottles","Failed Dissolution Specifications: Out-of-specification results in retained sample.","08/16/2016",," Lot #: GS011692, GS011938, Exp 10/2017; GS012638, GS012639, Exp 11/2017	          ",8/3/2016,"08/03/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74848,"Terminated","Odyssey Enterprises Inc","2729 6th Ave S Ste 200",,"Seattle","WA","98134-2101","United States","Voluntary: Firm Initiated","Letter","distributed in WI","F-2037-2016","Class II",".","400 cases (20 lbs. per case)","Cooked King crab legs & claws were recalled due to a contamination with Listeria monocytogenes.","09/08/2016","09/08/2016"," Lot 63043",8/1/2016,"08/01/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74849,"Ongoing","Ortho Solutions Inc","330 Franklin Tpke",,"Mahwah","NJ","07430-3524","United States","Voluntary: Firm Initiated","Letter","US Distribution","Z-2835-2016","Class II","FPS 35mm x 3.5 mm non-locking screw","15","Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.","09/16/2016",," Part number - OS326835  Lot number: 10100/269A12-68051",7/21/2016,"07/21/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74850,"Ongoing","Medtronic Sofamor Danek USA Inc","1800 Pyramid Pl",,"Memphis","TN","38132-1703","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, MN,MA","Z-2631-2016","Class II","RESPONSIVE, KNEE:  FEMORAL COMPONENT CR/CS, SIZE 3R,  REF 90-SRK-311300, QTY:  1, STERILE R, ","3 units","The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.","08/23/2016",," P239050",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74850,"Ongoing","Medtronic Sofamor Danek USA Inc","1800 Pyramid Pl",,"Memphis","TN","38132-1703","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, MN,MA","Z-2638-2016","Class II","TIBIAL TRAY , SIZE 5,  REF 90-SRK-200500, QTY:  1, STERILE R, Responsive Orthopedics, total knee replacement ","1 unit","The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.","08/23/2016",," P239175",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74850,"Ongoing","Medtronic Sofamor Danek USA Inc","1800 Pyramid Pl",,"Memphis","TN","38132-1703","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, MN,MA","Z-2636-2016","Class II","TIBIAL TRAY , SIZE 3,  REF 90-SRK-200300, QTY:  1, STERILE R, total knee replacement ","3 units","The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.","08/23/2016",," P236112, P239165",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74850,"Ongoing","Medtronic Sofamor Danek USA Inc","1800 Pyramid Pl",,"Memphis","TN","38132-1703","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, MN,MA","Z-2632-2016","Class II","RESPONSIVE, KNEE:  FEMORAL  total knee replacement COMPONENT CR/CS, SIZE 4R,  REF 90-SRK-311400, QTY:  1, STERILE R, ","3","The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.","08/23/2016",," P239150",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74850,"Ongoing","Medtronic Sofamor Danek USA Inc","1800 Pyramid Pl",,"Memphis","TN","38132-1703","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, MN,MA","Z-2633-2016","Class II","RESPONSIVE, KNEE:  FEMORAL total knee replacement   COMPONENT CR/CS, SIZE 5R,  REF 90-SRK-311500, QTY:  1, STERILE R, ",,"The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.","08/23/2016",," P239157",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74850,"Ongoing","Medtronic Sofamor Danek USA Inc","1800 Pyramid Pl",,"Memphis","TN","38132-1703","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, MN,MA","Z-2634-2016","Class II","RESPONSIVE, KNEE:  FEMORAL total knee replacement COMPONENT CR/CS, SIZE  3L,  REF 90-SRK-312300, QTY:  1, STERILE R,","4 units","The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.","08/23/2016",," P239049, P239142",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74850,"Ongoing","Medtronic Sofamor Danek USA Inc","1800 Pyramid Pl",,"Memphis","TN","38132-1703","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, MN,MA","Z-2637-2016","Class II","TIBIAL TRAY , SIZE 4,  REF 90-SRK-200400, QTY:  1, STERILE R, Responsive Orthopedics, total knee replacement ","2 units","The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.","08/23/2016",," P239168, P239169",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74850,"Ongoing","Medtronic Sofamor Danek USA Inc","1800 Pyramid Pl",,"Memphis","TN","38132-1703","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, MN,MA","Z-2635-2016","Class II","TIBIAL TRAY , SIZE 2,  REF 90-SRK-200200, QTY:  1, STERILE R, total knee replacement . ","3 units","The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.","08/23/2016",," P239166, P239167, ",7/18/2016,"07/18/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74851,"Ongoing","Allergy Laboratories, Inc.","1005 SW 2nd St",,"Oklahoma City","OK","73109-1006","United States","Voluntary: Firm Initiated","Telephone","US Distribution to the state of : NC","Z-2785-2016","Class II","GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap","81,625 vials (3,265 packs)","Potential for glass particles within the vials","09/12/2016",," SEV2120414, SEV2120514",2/3/2015,"02/03/2015",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74852,"Terminated","BloodSource, Inc.","10536 Peter a McCuen Blvd",,"Mather","CA","95655-4128","United States","Voluntary: Firm Initiated","FAX","France","B-0695-16","Class II","Source Plasma","1 unit","Blood product, collected from a donor who was allowed to donate without a current physical, was distributed. ","08/10/2016","08/10/2016"," W035816053952",6/27/2016,"06/27/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74853,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","E-Mail","Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.","Z-2715-2016","Class II","Merge RadSuite software. Radiological image processing system.","10 sites have the affected software that is configured with the specific conditions listed in Code Information"," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient. ","09/02/2016",," RadSuite Versions:  5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT ONLY  if they are configured with all of the following conditions:  (1) Must have IPID enabled;    (2) Must use IPID morphers    (3) Must Define a Defaultvalue in the IPID Morpher;    (4) Must use the Aggregating Morpher;    (5) Must not set OverwritelfPresent=false; and    (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA).  ",4/9/2015,"04/09/2015",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74854,"Ongoing","Reese Pharmaceutical Company","10617 Frank Ave",,"Cleveland","OH","44106-4218","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, CA, FL, GA, HI, IL, KY, MA, MI, MN, MO, NC, OH, PA, TX, UT, VA, WA","F-2194-2016","Class III","Good Neighbor Pharmacy Cranberry Tablets, Cranberry Supplement 450mg. Urinary Health.  Tablets are packed in a labeled carton, 50 tablets per carton. Distributed by Amerisource Bergen 1300 Morris Drive Chesterbrook, PA 19087. ","2,880 finished goods","The finished product label on the Cranberry supplement does not include Calcium. Users of the product may be unaware of the Calcium in the supplement. Additionally the amount per serving as written on the product label is incorrect and should be 500mg, not 900mg.","09/14/2016",," Lot P15J478, Expiration 10/17",8/2/2016,"08/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74855,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA","Z-2600-2016","Class II","Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only,     Product Usage:  The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.","120 units from multiple lots",".","08/19/2016",," Model Numbers: 121530S, 121535S, 121540S, 121545S, 121550S, 121555S, 121560S, 121565S, 121570S, 121575S, 121580S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S and 121820S",7/21/2016,"07/21/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74856,"Ongoing","Terumo Cardiovascular Systems Corp","28 Howe St",,"Ashland","MA","01721-1305","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign: Canada, Latin America","Z-2706-2016","Class II","Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing  as follows:      This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit.        US Product Codes:  72021                      72358                      71180-01                   76021                      76022                      76023                      76024                      76025                      71801-01                   71801-01                   71801-01                   71801-01                   71801-01                   74163-03                   71296-01                   74460-01                   74460-01                   74460-01                   73208-03                   74382-01                   74382-01                   74382-01                   74916                      74916                      74916                      70089-07                   74063-01                   74063-01                   74460-01                   74460-01                   74460-01                   74460-01                   75252-01                   74951                      75881                      74271-01                   71085-02                   72742                      75314                      75368                      75368                      76095                      76095                      73339-01                   73789                      74417                      72204                      72965-03                   73644                      73645-01                   73700                 ","2207 kits","Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated","08/31/2016",," US Lot Codes:  UG06                            UE18R                           UF31                            UF31A                           UF31T                                        UG13                            UG13A                           UG20                            UG20T                           UG27                            UG27T      OUS Lot Codes:                     UG13                            UG13T                           UG20                            UG20T                                             ",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74858,"Ongoing","ASK Foods Inc","77 N Hetrick Ave",".","Palmyra","PA","17078-1501","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","ME, NH, VT","F-0607-2017","Class I","Taste of Inspirations Classic Red Skin Potato Salad; Creamy redskin potatoes & white onion in a tangy dressing. Net Wt. 16 OZ. Sell By: 08-01-16 4238",,"A.S.K. Foods, Inc. of Palmyra, Pennsylvania is voluntarily recalling one lot of Taste of Inspirations Classic Red Skin Potato Salad because it may contain undeclared egg.  ","12/07/2016",," Sell By: 08-01-16 4238",7/29/2016,"07/29/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74860,"Terminated","Penrose-St Francis Health Services Blood Bank","2222 N Nevada Ave",,"Colorado Springs","CO","80907-6819","United States","Voluntary: Firm Initiated","FAX","Colorado","B-0696-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, for which Chagas Disease testing was not performed, was distributed.","08/10/2016","08/10/2016"," W290616079909",6/16/2016,"06/16/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74861,"Ongoing","Microgenics Corporation","46500 Kato Rd",,"Fremont","CA","94538-7310","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR  and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.","Z-2884-2016","Class II","DRI Salicylate Serum Tox Assay, Catalog number 0977.    Toxicology:  The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.","1708 kits","Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.","09/23/2016",," Lot Number      Expiration Date  60704602         DEC 2016;  72035410         JUL 2017;  72208738          FEB 2018;  72409454          OCT 2018.",7/25/2016,"07/25/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74862,"Ongoing","Best Sanitizers Inc","154 Mullen Dr",,"Walton","KY","41094-9606","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to one (1) account in the state of PA.  Distributed to one (1) account in Canada","Z-2714-2016","Class II","Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer)  banded together.  ","3,023 cases USA; 666 cases shipped to Canada (OTC drug there) ","Certain lots of the acid solution in Acecide-C are degrading faster than normal. ","09/02/2016",," Lot Numbers: 16012ACE EXP 01/17,16036ACE EXP 02/17,   16015ACE EXP 01/17, 16040ACE EXP 02/17, 16019ACE EXP 01/17, 16043ACE EXP 02/17, 16022ACE EXP 01/17, 16048ACE EXP 02/17, 16026ACE EXP 01/17, 16050ACE EXP 02/17, 16033ACE EXP 02/17.    Lot Numbers 16015ACE EXP 01/17, 16036ACE EXP 02/17 were shipped to Olympus in Canada",8/2/2016,"08/02/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74864,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2146-2016","Class I","Grassfields Leyden Cheese, cut and wrapped in clear plastic","296.71 pounds","Possible contamination with Shiga toxin-producing E. coli (STEC).","09/16/2016",," dates through 9/2/2016",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74864,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2143-2016","Class I","Grassfields Gouda Cheese, cut and wrapped in clear plastic","385.39 pounds","Possible contamination with Shiga toxin-producing E. coli (STEC).","09/16/2016",," dates through 9/2/2016",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74864,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2145-2016","Class I","Grassfields Country Dill Cheese, cut and wrapped in clear plastic","242.14 pounds","Possible contamination with Shiga toxin-producing E. coli (STEC).","09/16/2016",," dates through 9/2/2016",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74864,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2148-2016","Class I","Grassfields Lamont Cheddar Cheese, cut and wrapped in clear plastic","283.03 pounds","Possible contamination with Shiga toxin-producing E. coli (STEC).","09/16/2016",," dates through 9/2/2016",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74864,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2149-2016","Class I","Grassfields Fait Gras Cheese, cut and wrapped in clear plastic","105.16 pounds","Possible contamination with Shiga toxin-producing E. coli (STEC).","09/16/2016",," dates through 9/2/2016",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74864,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2150-2016","Class I","Grassfields Polkton Corners Cheese, cut and wrapped in clear plastic","199.37 pounds","Possible contamination with Shiga toxin-producing E. coli (STEC).","09/16/2016",," dates through 9/2/2016",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74864,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2144-2016","Class I","Grassfields Onion N Garlic Cheese, cut and wrapped in clear plastic","180.12 pounds","Possible contamination with Shiga toxin-producing E. coli (STEC).","09/16/2016",," dates through 9/2/2016",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74864,"Ongoing","Whole Foods Market","550 Bowie St",,"Austin","TX","78703-4648","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-2147-2016","Class I","Grassfields Edam Cheese, cut and wrapped in clear plastic","250.08 pounds","Possible contamination with Shiga toxin-producing E. coli (STEC).","09/16/2016",," dates through 9/2/2016",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74865,"Ongoing","Whole Foods Market Northeast Regional Office","930 Sylvan Ave",,"Englewood Cliffs","NJ","07632-3310","United States","Voluntary: Firm Initiated","E-Mail","NE region","F-2239-2016","Class II","Whole Food Market Thai Shrimp Salad Serving Size 8 oz.  Distributed by Whole Foods Market Englewood Cliffs NJ 07632 UPC 8-2510-00081","88 units","Whole Food Market Spicy Harissa Salmon Salad sold in the NE region  was mislabeled as Thai Shrimp Salad. This resulted in undeclared salmon (Fish) and Pistachio (treenut).  ","09/15/2016",," Lot 21516",8/3/2016,"08/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74867,"Ongoing","Integra LifeSciences Corp. d.b.a. Integra Pain Management","3498 W 2400 S Ste 1050",,"Salt Lake City","UT","84119-1135","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : OH and CA.  No foreign, Govt/VA/military consignee.","Z-2684-2016","Class II","INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. ","200 packages (20 cases) ","Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the  Spinal Trays.","08/29/2016",," The affected lots of Integra¿ Spinal Trays were manufactured on 2/11/205 and on 7/11/2015.  Lots: W1503004; S1501531; S1505556; ",8/4/2016,"08/04/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74868,"Ongoing","Mann Packing Company, Inc.","1250 Hansen St",,"Salinas","CA","93901-4552","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","To DC's in AZ. OR, TX,  CA. HI, AZ, WA, AK, NY.","F-2338-2016","Class I","O Organics Vegetable Tray, 18 oz. (1 lb. 2 oz.) 510g plastic tray.  Best If Used By: AUG 11  UPC (incorrect, which is on the tray): 021130984282  Product of USA & Mexico.","844 cases; 4 x 18 oz. trays per case.","Incorrect ingredient label was attached to 18 oz. O Organics vegetable Trays with Creamy Ranch Dressing Dip and therefore do not correctly identify the allergens egg, milk and soy.","09/16/2016",," Finished product lot serial number 3517681.   Best If Used By: AUG 11.   ",8/4/2016,"08/04/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74869,"Ongoing","El Alteno","1200 E 8th St",,"Los Angeles","CA","90021-1514","United States","Voluntary: Firm Initiated","E-Mail","U.S. distribution to the following; CA, AZ, NV.    No foreign distribution.","F-2344-2016","Class II","El Alteno  Coconut  Shredded Coconut  8 oz.  UPC: 8 20202 00362 9","53 dozen packages","Undeclared sulfites","09/16/2016",," Exp Date 06/30/2017",8/5/2016,"08/05/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74870,"Ongoing","El Alteno","1200 E 8th St",,"Los Angeles","CA","90021-1514","United States","Voluntary: Firm Initiated","E-Mail","U.S. distribution to the following; CA, AZ, NV.    No foreign distribution.","F-2343-2016","Class II","El Alteno   Raisinettes  Dovales  12 oz.  UPC: 8 20202 00411 4","20 dozen packages","Undeclared milk and soy lecithin.","09/16/2016",," Exp Date 06/30/2017",8/5/2016,"08/05/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74871,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","FDA Mandated","Letter","US Distribution to the states of: PA,  IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.","Z-0047-2017","Class II","Toshiba America Medical Systems, Inc .  Aquilion RXL  TSX-1 01 AIR, U CT Scanner    Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.      ","165","It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.","10/06/2016",," LL 500",4/25/2016,"04/25/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74871,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","FDA Mandated","Letter","US Distribution to the states of: PA,  IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.","Z-0048-2017","Class II","Toshiba America Medical Systems, Inc .  Aquilion LB  TSX-201A/2, 3 CT Scanner","165","It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.","10/06/2016",," XL 700",4/25/2016,"04/25/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74871,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","FDA Mandated","Letter","US Distribution to the states of: PA,  IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.","Z-0046-2017","Class II","Toshiba America Medical Systems, Inc  Aquilion Lightning TSX-035A  CT Scanner.","165","It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.","10/06/2016",," LL 500",4/25/2016,"04/25/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74871,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","FDA Mandated","Letter","US Distribution to the states of: PA,  IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.","Z-0049-2017","Class II","Toshiba America Medical Systems, Inc .  Celesteion PCA-9000rV2 CT Scanner","165","It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.","10/06/2016",," XL 700",4/25/2016,"04/25/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74872,"Ongoing","Ricker Hill Orchards","11 Ricker Hill Rd",,"Turner","ME","04282-3615","United States","Voluntary: Firm Initiated","Telephone","ME","F-2096-2016","Class II","Ricker Hill Orchards Cran-Breeze, 1/2 GAL (64 FL OZ) 1.89 LITERS Produced by Ricker Hill Orchards, Turner, ME 04282","1,391 gallons  (total for all recalled products)","Product contains patulin at levels higher than the FDA established limit of 50 ppb. ","09/08/2016",," 09/06/16",8/4/2016,"08/04/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74872,"Ongoing","Ricker Hill Orchards","11 Ricker Hill Rd",,"Turner","ME","04282-3615","United States","Voluntary: Firm Initiated","Telephone","ME","F-2095-2016","Class II","Apple Cider: Ricker Hill Orchards Apple Cider 1/2 GAL (64 FL OZ) 1.89 LITERS; NORTHLAND APPLES Pure SWEET MAINE CIDER 1 QUART 947.2ML, UPC: 074613 70009 1 and   NORTHLAND APPLES Pure SWEET MAINE CIDER 12 FL. OZ. 355.2 ML, UPC: 0 74613 60009","1,391 gallons (total for all products)","Product contains patulin at levels higher than the FDA established limit of 50 ppb. ","09/08/2016",," 09/06/16 and 9/07/16",8/4/2016,"08/04/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74873,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.","F-2033-2016","Class I","All American Burger  Product ID 470007, C47007","590 cases","Potential Listeria monocytogenes contamination.","08/31/2016",," Lot #052016D, 052516C, 060916C, 061016C",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74873,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.","F-2026-2016","Class I","Cheeseburger Sliders  Product ID C47220, 470220","2,085 cases","Potential Listeria monocytogenes contamination.","08/31/2016",," Lot #051816C, 051916C, 052016C, 052016D, 052316C, 052516D, 052616C ",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74873,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.","F-2029-2016","Class I","BBQ Rib Sandwich  Product ID C46007, 460007","687 cases","Potential Listeria monocytogenes contamination.","08/31/2016",," Lot #052416C, 052516B",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74873,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.","F-2025-2016","Class I","Chili Dog, Low Fat/Low Sodium  Product ID 952000","878 cases","Potential Listeria monocytogenes contamination.","08/31/2016",," Lot #051816D, 052716B, 052716D",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74873,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.","F-2032-2016","Class I","Chicken Double Dogs on Whole Grain Bun  Product ID 809021","253 cases","Potential Listeria monocytogenes contamination.","08/31/2016",," Lot #060316D",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74873,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.","F-2031-2016","Class I","Beef Sausage Breakfast Sandwich  Product ID C99018","167 cases","Potential Listeria monocytogenes contamination.","08/31/2016",," Lot #052416B",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74873,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.","F-2028-2016","Class I","Beef Sausage & Cheese Mini Bagel Sandwich  Product ID C80916","32 cases","Potential Listeria monocytogenes contamination.","08/31/2016",," Lot #052016C",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74873,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.","F-2030-2016","Class I","Chicken Patty Sandwich on a Whole Grain Bun  Product ID 400003","7 cases","Potential Listeria monocytogenes contamination.","08/31/2016",," Lot #052516D",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74873,"Ongoing","Let's Do Lunch, Inc.","310 W Alondra Blvd",,"Gardena","CA","90248-2423","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; CA, NM, OH, VA, AZ, MI, TX, NC, PA.    No foreign distribution.","F-2027-2016","Class I","All American Cheeseburger  Product ID 470007","207 cases","Potential Listeria monocytogenes contamination.","08/31/2016",," Lot #051916B, 060916D",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74874,"Ongoing","Pharmatech LLC","4131 Sw 47th Ave","Suite 1403","Davie","FL","33314-4026","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1523-2016","Class II","Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0536-1025-47. ","12,308 bottles","CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.","09/27/2016",," Lot #: 23261501, Exp 10/17",8/8/2016,"08/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74874,"Ongoing","Pharmatech LLC","4131 Sw 47th Ave","Suite 1403","Davie","FL","33314-4026","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1524-2016","Class II","Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0536-1001-85.","19,656 bottles","CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.","09/27/2016",," Lot #: 22941505, Exp 10/17; 229416601, Exp 01/18; 22941602, Exp 03/18",8/8/2016,"08/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74874,"Ongoing","Pharmatech LLC","4131 Sw 47th Ave","Suite 1403","Davie","FL","33314-4026","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1526-2016","Class II","Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0904-6289-09.","68,908 bottles","CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.","09/27/2016",," Lot #: 20391517, Exp 09/17; 20391518, Exp10/17; 20391519, Exp 11/17; 20391601, Exp 01/18; 20391602, Exp 02/18; 20391604, 20391605, Exp 03/18; 20391608, Exp 06/18",8/8/2016,"08/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74874,"Ongoing","Pharmatech LLC","4131 Sw 47th Ave","Suite 1403","Davie","FL","33314-4026","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1522-2016","Class II","Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL  35243, NDC 23359-033-16.","1,332 bottles","CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.","09/27/2016",," Lot #: 25291601, Exp 04/18 ",8/8/2016,"08/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74874,"Ongoing","Pharmatech LLC","4131 Sw 47th Ave","Suite 1403","Davie","FL","33314-4026","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1520-2016","Class II","Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL  33619, NDC 76518-100-08.","1,008 bottles","CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.","09/27/2016",," Lot #: 20391519, Exp 11/17",8/8/2016,"08/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74874,"Ongoing","Pharmatech LLC","4131 Sw 47th Ave","Suite 1403","Davie","FL","33314-4026","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1525-2016","Class II","Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0536-1000-59.","96,704 bottles","CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.","09/27/2016",," Lot #: 20391515, 20391516, Exp 08/17; 20391517, Exp 09/17; 20391518, Exp 10/17; 20391520, Exp 11/17; 20391521, Exp 12/17; 20391601, Exp 01/18; 20391603, 20391604, Exp 03/18; 20391606, 20391607, Exp 04/18; 20391609, Exp 06/18.",8/8/2016,"08/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74874,"Ongoing","Pharmatech LLC","4131 Sw 47th Ave","Suite 1403","Davie","FL","33314-4026","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1521-2016","Class II","Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL  35243, NDC 23359-032-16.","5,928 bottles","CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.","09/27/2016",," Lot #: 25291601, Exp 03/18",8/8/2016,"08/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74875,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait, Malaysia, Mayotte, Mexico, New Zealand, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, and Vietnam.","Z-2692-2016","Class II","UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222  UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU)   Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear","759 units total (358 units in US)","Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.","08/30/2016",," AZ28094  AW01001  AY01010  AY04011  AW20069  AV14059  AZ12033  AZ12034  AZ06021  AY52153  AV01003  AT40021  AV22105  AV12048  AZ12039  AU01015  AU40218  AU40217  AV22099  AU36203  AU36202  AV01012  AW35121  AW35120  AY08031  AU40222  AU11071  AV01008  AY52154  AY52152  AY23080  AV16090  AT49047  AV42151  AV44158  AY10040  AW20067  AW16061  AU40221  AU11070  AW28093  AW10045  AV16079  AV14065  AU01032  AV10042  AU49257  AZ08032  AW23075  AY17061  AY17063  AW35124  AU21134  AW42129  AW20065  AY04013  AU14087  AV48179  AV49181  AW49163  AY01009  AZ22072  AW01010  AU19114  AT35018  AT35017  AT40020  AV06026  AV06030  AY19075  AU08046  AU29170  AU01027  AT49051  AV49183  AZ02004  AZ06022  AU43236  AU20131  AU01005  AU01004  AV01016  AU14086  AW01015  AW06026  AW06024  AV16085  AU01029  AZ02010  AU19116  AZ22073  AZ22074  AZ12041  AZ12042  AZ25090  AZ28091  AY30082  AY30083  AY10054  AY10037  AY04015  AY32106  AY10055  AV01005  AU23152  AU28154  AY35118  AU20123  AU36204  AU13078  AW45141  AY41137  AU28159  AY35110  AU08045  AU08042  AV27119  AV39133  AU16106  AV36129  AV36130  AY01006  AW49162  AV48178  AU30179  AU35188  AW16053  AU36193  AV48177  AU11051  AW20064  AW35113  AU35187  AU28162  AV40142  AV12052  AU11063  AV21094  AY32094  AU43226  AV10035  AV01004  AV01007  AY01002  AY01004  AZ20070  AU20124  AU01017  AU01021  AU14083  AU16104  AU01031  AZ24084  AV06024  AU30175  AU11066  AU19121  AU08044  AZ08030  AU23151  AY19074  AU19120  AV12054  AU19119  AV16081  AU16107  AV39134  AT45034  AU01002  AU01026  AV40140  AW35115  AV44161  AV44163  AZ24083  AZ24085  AW06028  AW09032  AW09033  AV21096  AV21093  AV21095  AT49063  AU43240  AW35116  AV14060  AZ06018  AZ17048  AW16056  AV23112  AU43237  AV49190  AU43225  AW09031  AU08041  AZ18054  AV12047  AU13073  AV10038  AY30090  AU43233  AW10039  AW09035  AU08050  AV49184  AU11064  AU14091  AW20066  AU13082  AZ25087  AZ25086  AU28155  AU28157  AU19113  AV01009  AW10042  AW23079  AW49158  AV14070  AW45145  AW16058  AW16059  AY19068  AW28097  AY08030  AU29163  AV36127  A",8/4/2016,"08/04/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74876,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","Voluntary: Firm Initiated","Letter","US Distribution","Z-2542-2016","Class II","Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.","93 units","Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.  ","08/16/2016",," 99B1422854  99B1422858  99B1422859  99B1422860  99B1422861  99B1422862  99B1422863  99B1433093  99B1433097  99B1433098  99B1433100  99B1443176  99B1443177  99B1443178  99B1443179  99B1443180  99B1453269  99B1453270  99B1453271  99B1453272  99B1453273  99B1453274  99B1453277  99B1453278  99B1453293  99B1453294  99B1453295  99B1453296  99B1453297  99B1453300  99B1453301  99B1453302  99B1453303  99B1453304  99B1463369  99B1463370  99B1463371  99B1463372  99B1463373  99B1463376  99B1463377  99B1463378  99B1463379  99B1463380  99B1493642  99B1493643  99B1493644  99B1493645  99B1493646  99B1493647  99B1493648  99B1493649  99B1493650  99B1493651  99B1493716  99B1493717  99B1493719  99B1493720  99C1554630  99C1554631  99C1554632  99C1554633  99C1554634  99C1554635  99C1564695  99C1564696  99C1564697  99C1564698  99C1564699  99C1564700  99C1564701  99C1564704  99C1574785  99C1574786  99C1574787  99C1574788  99C1574789  99C1574790  99C1574791  99C1574792  99C1574793  99C1574794  99C1574795  99C1574796  99C1574797  99C1574798  99C1574799  99B1422855  99B1422856  99B1422857  99B1433091  99B1433092  99B1433094  99B1433095  99B1433096  99B1433099  99B1453275  99B1453276  99B1493718  99C1524295  99C1564702  99C1564703  ",8/4/2016,"08/04/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74877,"Ongoing","Cedar Crest Specialties, Inc.","2000 S 10th St",,"Manitowoc","WI","54220-6259","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IA, NH, NJ, WI.","F-0046-2017","Class III","Enlightened Peanut Butter Chocolate Chip Ice Cream, one pint","125 pints","Select cases from a single production run of Enlightened brand Peanut Butter Chocolate Chip ice cream is being recalled because they may have been packaged in Mint Chocolate Chip ice cream containers and thus contain undeclared peanuts.","11/18/2016","."," Best By November 18, 2017",8/5/2016,"08/05/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74878,"Ongoing","Sperian Eye & Face Protection, Inc","825 E Business Highway 151",,"Platteville","WI","53818-3763","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.  Outside the US to include:  Australia, Mexico and United Arab Emirates.","D-0216-2017","Class I","Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI  53818  ","9,744 bottles","Non Sterility; contaminated with Klebsiella pneumoniae","12/22/2016",," Lot number:  F16091-61, exp 03/2019    Product Codes:  32-000455-0000-H5, 32-000455-0036, 32-000461-0036, 32-000462-0000-H5, 32-000462-0036",8/16/2016,"08/16/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74879,"Ongoing","B. Braun Medical, Inc.","901 Marcon Blvd",,"Allentown","PA","18109-9512","United States","Voluntary: Firm Initiated","Letter","US Distribution to: AL, IL, OK, MN, MA and WI.","Z-0327-2017","Class II","Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP)    Injection of anesthetics to provide regional anesthesia","1704 units","B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection, USP that Hospira Inc. has recalled because the drug product does not meet the specification for color throughout shelf life.  ","11/01/2016",," Catalog Number: 560399 (Lot # 0061418559, 0061422389, 0061434523, 0061438084, 0061440188, 0061446168, 0061450971, 0061459227, 0061464239, Catalog Number: 560511 (Lot # 0061413435, 0061425996, 0061438393, 0061452272, 0061465310), Catalog # 560605 (0061420240, 0061429962, 0061442280, 0061449510, 0061460497, 0061471580), Catalog # 560631 (Lot# 0061438803), Catalog # 560632 (0061438818).  ",7/11/2016,"07/11/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74880,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -  US Nationwide and in the countries of  Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.","Z-2544-2016","Class II","1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile  REF# 1009-00J    Product Usage:  The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves  ","380 units","Wire which deploys the loop may be come detached at the handle causing the device to be inoperable","08/16/2016",," Lot Number                     Exp Date  ELVH1078V¿                   2020-10  ELVH1079VA                 2020-10",8/3/2016,"08/03/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74880,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -  US Nationwide and in the countries of  Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.","Z-2545-2016","Class II","1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile  REF # 1010-00    Product Usage:  The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves  ","50 units","Wire which deploys the loop may be come detached at the handle causing the device to be inoperable","08/16/2016",," Lot Number                     Exp Date  ELVH1089V¿                    2021-03  ELVH1091V                     2021-03¿  ",8/3/2016,"08/03/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74880,"Ongoing","LeMaitre Vascular, Inc.","63 2nd Ave",,"Burlington","MA","01803-4413","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -  US Nationwide and in the countries of  Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.","Z-2543-2016","Class II","1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile   REF # 1009-00    Product Usage:  The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves  ","1992 units","Wire which deploys the loop may be come detached at the handle causing the device to be inoperable","08/16/2016",," Lot Number                     Exp Date  ELVH1072V                     2020-07  ELVH1082V                     2021-01  ELVH1083V                     2021-01  ELVH1084V                     2021-02  ELVH1085V                     2021-02  ELVH1086V                     2021-02  ELVH1087V                     2021-02  ELVH1088V                     2021-03  ",8/3/2016,"08/03/2016",8/24/2016,"08/24/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74881,"Ongoing","Level Ground Trading Limited","1970 Keating Cross Rd Unit B",,"Saanichton",,,"Canada","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to NE, OR, KS, PA, IA, MO, OH, IL, TX, IN, UT, TN, NY, FL, VA, and Puerta Rico.","F-0480-2017","Class III","Organic Cacao Nibs, packaged in 200g (7.05 oz) brown bags,  UPC code 661594002032","480kg packaged into 2400 packages of 200g each","Product may contain glass fragments","11/18/2016","."," Lot numbers: 241201 and 641102.  Both are best by April 2017",8/4/2016,"08/04/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74882,"Ongoing","Sprouts Extraordinaire, LLC","4350 Grape St",,"Denver","CO","80216-4516","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The company currently distributes this product to its customers in Colorado. They in turn potentially distribute to Kansas, Arkansas, Louisiana, New Mexico, Texas, Wyoming and Wisconsin. No foreign, VA/govt/Military consignees.","F-2010-2016","Class I","5 lb Living Alfalfa Sprouts. One package per case. Distributed by and/or Manufactured by Astec Ltd. dba Sprouts Extraordinaire","425 cases","Sprouts Extraordinaire, LLC is recalling 5 lb Living Alfalfa Sprout cases due to the potential for Salmonella contamination.","09/09/2016",," Expiration dates: 07/05/16, 07/12/16, 07/18/16, 07/19/16, 07/26/16.",8/5/2016,"08/05/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74883,"Ongoing","Allergy Laboratories, Inc.","1005 SW 2nd St",,"Oklahoma City","OK","73109-1006","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-1498-2016","Class II","Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY  10605.","1,928,075 vials","Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.","09/07/2016",," Lot #s: 102814, 102914, 103014, 103114, Exp 10/16; 110314, 110414, 110514, 110614, 110714, 111014, Exp 11/16; 121014, 121114, 121214, 121514, Exp 12/16; 011415, 011515, 011615, 012015, 012115, Exp 01/17; 021315, 021715, 021815, 021915, 022015, Exp 02/17; 030415, 030515, 030615, 031015, 031715, Exp 03/17; 042415, 042815, 042915, 043015, Exp 04/17; 050115, 050515, 052815, 052915, Exp 05/17; 060315, 060415, 061615, 061715, Exp 06/17",8/10/2016,"08/10/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74884,"Ongoing","INNOKAS MEDICAL OY","TARJUSOJANTIE 12",,"KEMPELE",,,"Finland","Voluntary: Firm Initiated","Letter","AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI","Z-2604-2016","Class II","CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.","1458 units","A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.","08/19/2016",," SK514130002YA   SK514130016YA   SK514150001YA   SK514150017YA   SK514150020YA   SK514150021YA   SK514150022YA   SK514150032YA   SK514450012YA   SK514470018YA   SK514490005YA   SK514490006YA   SK514490009YA   SK514490010YA   SK514490011YA   SK514490012YA   SK515040001YA   SK515050016YA   SK515050017YA   SK515050018YA   SK515050019YA   SK515050020YA   SK515050021YA   SK515050022YA   SK515050023YA   SK515050024YA   SK515050025YA   SK515060001YA   SK515060002YA   SK515060003YA   SK515060005YA   SK515100057YA   SK515100065YA   SK515100066YA   SK515100068YA   SK515110063YA   SK515110066YA   SK515110073YA   SK515110118YA   SK515110174YA   SK515110183YA   SK515110184YA   SK515110185YA   SK515110186YA   SK515110187YA   SK515110188YA   SK515110189YA   SK515110190YA   SK515110192YA  SK515110193YA   SK515110195YA   SK515120002YA   SK515120003YA   SK515120004YA   SK515120007YA   SK515120008YA   SK515120012YA   SK515120015YA   SK515120017YA   SK515120018YA   SK515120040YA   SK515120042YA   SK515120043YA   SK515120044YA   SK515120045YA   SK515120046YA   SK515120048YA   SK515120049YA   SK515120050YA   SK515120051YA   SK515120052YA   SK515130007YA   SK515130024YA   SK515150036YA   SK515160006YA   SK515160010YA   SK515160016YA   SK515160017YA   SK515160018YA   SK515160022YA   SK515160024YA   SK515160025YA   SK515160028YA   SK515160030YA   SK515160034YA   SK515160035YA   SK515160036YA   SK515160037YA   SK515160039YA   SK515160040YA   SK515160043YA   SK515160044YA   SK515160045YA   SK515160047YA   SK515160048YA   SK515160049YA   SK515160050YA   SK515160051YA   SK515160052YA   SK515160053YA   SK515160054YA   SK515160055YA   SK515160056YA   SK515160057YA   SK515180004YA   SK515180006YA   SK515230005YA   SK515230006YA   SK515230007YA   SK515230008YA   SK515230009YA   SK515230012YA   SK515230014YA   SK515230015YA   SK515230016YA   SK515230017YA   SK515230018YA   SK515230020YA   SK515240010YA   SK515260002YA   SK515260003YA   SK515260004YA   SK515260005YA   SK515260006YA   SK515260007YA   SK515260008YA   SK515260009YA   SK515260010YA",7/27/2016,"07/27/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74885,"Ongoing","Smith & Nephew, Inc.","970 Lake Carillon Dr Ste 110",,"Saint Petersburg","FL","33716-1130","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution to AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI, Hawaii, and Puerto Rico  Argentina, Australia, Bermuda, Brazil, Brunai, Canada, Curacao, Germany, Great Britain, Hong Kong, Ireland, Jordan, Malaysia, New Zeland, Peru, Saudi Arabia, Serbia, Singapore, South Africa, SriLanka, Tunisia, Turkey, United Arab Emirates, and United Kingdom.","Z-2848-2016","Class II","RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film  Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.","45,455 devices (in the USA)","Sterility seal integrity failures on the Renasys Sterile Transparent Film","09/20/2016",," Product Code 66020933 RENASYS G Small with Soft Port - Lots #'s 2015100134, 2015100313, 2015100314, 2016040686, and 2016040687 - US ONLY   Product Code 66020934 RENASYS G Medium with Soft Port - Lots #'s 2015100135, 2015100315, 2015100316, 2015110540, 2016040715, and 2016040963  US ONLY  Product Code 66020935 RENASYS G Large with Soft Port- Lots #'s 2015100282, 2015100317, 2015110542, and 2016041021  US ONLY   Product Code 66020936 RENASYS G X Large with Soft Port Lot # 2016041035  US ONLY  Product Code 66800394 RENASYS Transparent Film Lots #'s 2014010176, 2014011449, 2014030463, 2014040241, 2014050736, 2014051132, 2014061169, 2014113986, 2015020655, 2015040522, 2015050927, 015060209, 2015071095, 2015101044, 2015110749, 2015120664, and 2015121019 - GLOBAL  Product Code 66800494  RENASYS G Medium Kit Flat Drain Lots #'s 02014P, 05014D, 06914E, 13414K, 15414T, 16014CV, 18114AV, 23214D, 25214J, and 26515H  GLOBAL (NOT US)  Product Code 66800495  RENASYS G Large Kit 19Fr Round Drain Lots #'s 00815K, 14014L, 23314E, 25214H, and 32214D  GLOBAL (NOT US)  Product Code 66800496  RENASYS G Large Kit Flat Drain Lots #'s 00815N, 01215G, 02214J, 05014F, 09014K, 09914K, 16014F, 17514T, 24114D, 25214K, 28015M, and 31714H  GLOBAL (NOT US)  Product Code 66800497  REANSYS G X-Large Kit 19Fr Round Drain Lot # 05014M  GLOBAL (NOT US)  Product Code 66800932  RENASYS High Output Fistula Kit Lots #'s 07715M, 09214H, 15514G, 18814K, and 27915G  GLOBAL (NOT US)  Product Code 66800933 RENASYS G Small with Soft Port Lots #'s 2014010183, 2014011414, 2014020037, 2014021119, 2014021324, 2014021837, 2014030094, 2014030840, 2014030933, 2014031770, 2014040674, 2014041232, 2014041489, 2014050297, 2014050582, 2014051447, 2014051561, 2014060367, 2014060603, 2014060606, 2014071097, 2014080670, 2014080729, 2014091593, 2014091612, 2014091896, 2014091951, 2014102569, 2014103236, 2014103501, 2014103566, 2014125085, 2014125464, 2015016495, 2015016793, 2015016824, 2015020606, 2015020633, 2015021230, 015030904, 2015030938, 2015031168, 20150503",7/21/2016,"07/21/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74886,"Ongoing","Omega Medical Imaging, Inc.","675 Hickman Cir",,"Sanford","FL","32771-6931","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, MN, GA, NC, IN, OH, KY, IL, NY, AL, MO, LA, PA, and SD Denmark","Z-2734-2016","Class II","2 over 2 Elevating Monitor Suspension  - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.","26 units","Elevating Monitor Suspension separated from the lifting column bracket","09/03/2016",," Model:  Elevating Monitor Suuspension P/Ns:  1000-0085, 1000-0095 and (1000-0129 one unit produced does not use bracket 1040-0071 or 1040-0031).",6/21/2016,"06/21/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2470-2016","Class I","Crofters  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2469-2016","Class I","Polkton Corners  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2462-2016","Class I","Onion n Garlic  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2461-2016","Class I","Gouda  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2467-2016","Class I","Chili Cheese  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2465-2016","Class I","Edam  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2463-2016","Class I","Country Dill  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2466-2016","Class I","Lamont Cheddar  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2464-2016","Class I","Leyden  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74887,"Ongoing","Grassfields Cheese, LLC","14238 60th Ave",,"Coopersville","MI","49404-9707","United States","Voluntary: Firm Initiated","Press Release","MI, GA, IL, IN, CT, NY, CO, WA, TN, OH","F-2468-2016","Class I","Fait Fras  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.","2250 lbs","contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.","09/23/2016",," All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date ",8/3/2016,"08/03/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74888,"Ongoing","Spectrum Laboratory Products, Inc.","755 and 769 Jersey Ave",,"New Brunswick","NJ","08901-3605","United States","Voluntary: Firm Initiated","Letter","US: MA, TN, GA, MO and Canada","D-1456-2016","Class II","Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901","14,000 grams","Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.","08/10/2016",," Lot # 2EH0257",8/1/2016,"08/01/2016",8/17/2016,"08/17/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74891,"Ongoing","Riverpoint Medical, LLC","825 NE 25th Ave",,"Portland","OR","97232-2304","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.","Z-2761-2016","Class II","Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon.  Product is sterile. Part numbers:  663BK  663BL  664BL  928BK    Product Usage:  For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.  ","2110 boxes distributed in the US and 72 boxes distributed outside US","Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.  ","09/08/2016",," Lot For human use:   160210-02.    Lots For Vet use:   160223-03V  160302-06V  160202-01V  160217-02V  160224-03V  160218-03V  160204-01  ",8/5/2016,"08/05/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74891,"Ongoing","Riverpoint Medical, LLC","825 NE 25th Ave",,"Portland","OR","97232-2304","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.","Z-2762-2016","Class II","Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665    Product Usage:  For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.  ","61 boxes distributed in the US only","Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.  ","09/08/2016",," Lot For Vet use: 160218-05V    ",8/5/2016,"08/05/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74892,"Ongoing","Zyno Medical LLC","10 Tech Cir",,"Natick","MA","01760-1029","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2895-2016","Class II","Zyno Medical Administration Set, Sterile. RX  For Use with Zyno Medical Infusion Pumps or Gravity Feed  Product Code: B2-70071-DF    Product Usage:  Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.      ","78063 sets","Administration Set potential filter leaking","09/27/2016",," Lot Code:  14015279  14026620  14046841  14055191  14055786  14056225  14085743  14085742  15035297  15045941  15045940  15046600  15075275  15075835  15076761  15085107  15086621  15095200  15095647  15097179  15105595  ",7/29/2016,"07/29/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74892,"Ongoing","Zyno Medical LLC","10 Tech Cir",,"Natick","MA","01760-1029","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2893-2016","Class II","Zyno Medical Administration Set, Sterile. Rx  For Use with Zyno Medical Infusion  Pumps or Gravity Feed  Product Code: A2-80071-DF  Product Usage:  Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.  ","114081 sets","Administration Set potential filter leaking","09/27/2016",," Lot Code:  13125968  13126110  13126111  14026150  14055090  14056598  14065315  14065624  14067149  14075494  14085636  14105960  14106106  14106544  14116251  15045374  15045866  15046986  15055122  15055728  15067196  15085624  15085570  15086315  15086421  15086583  15105241  ",7/29/2016,"07/29/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74892,"Ongoing","Zyno Medical LLC","10 Tech Cir",,"Natick","MA","01760-1029","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2896-2016","Class II","Zyno Medical Administration Set Sterile. Rx  For Use with Zyno Medical Infusion Pumps or Gravity Feed  Product Code: B2-70072-F  Product Usage:  Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.  ","47989 sets","Administration Set potential filter leaking","09/27/2016",," Lot Code:  14015368  14056014  14056664  14105490  14106247  14115294  15035318  15046218  15065675  15066275  15095552  15097055  15105046  ",7/29/2016,"07/29/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74892,"Ongoing","Zyno Medical LLC","10 Tech Cir",,"Natick","MA","01760-1029","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2894-2016","Class II","Zyno Medical Administration Set, Sterile. Rx  For Use with Zyno Medical Infusion Pumps or Gravity Feed  Product Code: A2-80072-F  Product Usage:  Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle or a catheter inserted into a vein.  ","78069 sets","Administration Set potential filter leaking","09/27/2016",," Lot Code:  14015257  14016574  14026116  14055563  14056558  14056578  14056564  14097009  14105233  14105981  14106122  14115694  14116060  14116061  15035164  15036531  15036532  15066217  15086619  15096764  15096765  15096843  15105499  ",7/29/2016,"07/29/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74893,"Ongoing","Blackrock Microsystems, LLC","630 S Komas Dr","Ste 200","Salt Lake City","UT","84108-1247","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide and Canada,","Z-2764-2016","Class II","Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons.     Product Usage:  The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)  ","120 total cables","Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts. ","09/08/2016",," Part Number 4460: All Serial Numbers  Part Number 6735: All Serial Numbers",8/10/2016,"08/10/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74893,"Ongoing","Blackrock Microsystems, LLC","630 S Komas Dr","Ste 200","Salt Lake City","UT","84108-1247","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide and Canada,","Z-2763-2016","Class II","Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747.    Product Usage:  The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electrooculography (EOG) and Evoked Potential (EP)  ","81 total amplifiers","Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal Amplifier and the Patient Cable are incorrectly labeled as Type CF Applied Parts. ","09/08/2016",," Part Number 4208: Serial Numbers 0014 and 0016 Only  Part Number 5703: All Serial Numbers   Part Number 5748: All Serial Numbers   Part Number 5747: All Serial Numbers ",8/10/2016,"08/10/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74894,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.","Z-2736-2016","Class II","BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)","424 units","The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient.  The issue was caused by a software defect in the workflow setup script.  ","09/03/2016",," 6000016, 6000111, 6000114, 6000122, 6000002, 6000003, 6000004, 6000005, 6000006, 6000010, 6000011, 6000012, 6000013, 6000015, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000032, 6000033, 6000035, 6000036, 6000037, 6000038, 6000040, 6000041, 6000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000057, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000068, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000075, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 6000106, 6000107, 6000108, 6000109, 6000110, 6000112, 6000113, 6000115, 6000116, 6000117, 6000118, 6000119, 6000120, 6000121, 6000123, 6000125, 6000126, 6000127, 6000128, 6000129, 6000130, 6000131, 6000132, 6000133, 6000134, 6000135, 6000136, 6000138, 6000139, 6000140, 6000141, 6000142, 6000143, 6000144, 6000145, 6000146, 6000147, 6000148, 6000149, 6000150, 6000151, 6000152, 6000153, 6000154, 6000155, 6000156, 6000157, 6000158, 6000159, 6000160, 6000161, 6000162, 6000164, 6000165, 6000166, 6000167, 6000168, 6000169, 6000170, 6000171, 6000172, 6000173, 6000174, 6000175, 6000176, 6000177, 6000178, 6000179, 6000180, 6000181, 6000182, 6000183, 6000184, 6000185, 6000186, 6000187, 6000188, 6000189, 6000190, 6000191, 6000192, 6000193, 6000194, 6000195, 6000196, 6000197, 6000198, 6000199, 6000200, 6000201, 6000202, 6000203, 6000204, 6000205, 6000206, 6000207, 6000208, 6000209, 6000210, 6000211, 6000212, 6000213, 6000214, 6000215, 6000216, 6000217, 6000218, 6000219, 6000220, 6000221, 6000222, 6000223, 6000224, 6000225, 6000226, 6000227, 6000228, 6000229, 6000230, 6000231, 6000232, 6000233, 6000234, 6000235, 6000236, 6000237, 6000238, 6000239, 6000240, 6",5/25/2016,"05/25/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74894,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.","Z-2735-2016","Class II","BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging","117 units","The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient.  The issue was caused by a software defect in the workflow setup script.  ","09/03/2016",," 11000003, 11000008, 11000030, 11000004, 11000005, 11000006, 11000007, 11000009, 11000010, 11000011, 11000012, 11000013, 11000014, 11000016, 11000017, 11000018, 11000019, 11000020, 11000022, 11000023, 11000024, 11000025, 11000026, 11000027, 11000028, 11000029, 11000031, 11000032, 11000033, 11000034, 11000035, 11000036, 11000037, 11000038, 11000039, 11000040, 11000041, 11000042, 11000043, 11000044, 11000045, 11000046, 11000047, 11000048, 11000049, 11000050, 11000051, 11000052, 11000054, 11000055, 11000056, 11000057, 11000058, 11000059, 11000060, 11000061, 11000062, 11000063, 11000064, 11000065, 11000066, 11000067, 11000068, 11000069, 11000070, 11000071, 11000072, 11000073, 11000074, 11000075, 11000076, 11000077, 11000078, 11000079, 11000080, 11000081, 11000083, 11000084, 11000085, 11000086, 11000087, 11000088, 11000089, 11000090, 11000091, 11000092, 11000093, 11000094, 11000095, 11000096, 11000097, 11000098, 11000099, 11000100, 11000101, 11000102, 11000103, 11000104, 11000105, 11000106, 11000107, 11000108, 11000109, 11000110, 11000112, 11000113, 11000114, 11000115, 11000116, 11000117, 11000118, 11340001, 11340002, 11340003, 11340004, 11340005, 11000015",5/25/2016,"05/25/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74894,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.","Z-2737-2016","Class II","BrightView XCT Upgrade Model 882454","3 units","The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient.  The issue was caused by a software defect in the workflow setup script.  ","09/03/2016",," 11000021, 11000082, 11000111",5/25/2016,"05/25/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74895,"Ongoing","Mentor Texas, LP.","3025 Skyway Cir N",,"Irving","TX","75038-3524","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.","Z-2747-2016","Class II"," Tall Height TE With Sutures 350cc PN: 354-9312    The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.","65 units","Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc","09/07/2016",," Lot 6981537",8/9/2016,"08/09/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74895,"Ongoing","Mentor Texas, LP.","3025 Skyway Cir N",,"Irving","TX","75038-3524","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.","Z-2748-2016","Class II"," Tall Height TE With Sutures 450cc PN: 354-9313    The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.","70 units","Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc","09/07/2016",," Lot 6981543",8/9/2016,"08/09/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74896,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","Letter","US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.","Z-2845-2016","Class II","3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.","92 units","Product was incorrectly packaged.","09/19/2016",," Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.",8/8/2016,"08/08/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74897,"Ongoing","Country Home Bakers","720 Metropolitan Pkwy Sw",,"Atlanta","GA","30310-2000","United States","Voluntary: Firm Initiated","Press Release","CT and PA.","F-2090-2016","Class II","Country Home Bakers, All Natural Chocolate Chunk with Salty Caramel Cookie Dough, Net Wt: 22.5 lbs (10.2 kg), Count: 240-1.5oz (43g) portions, Country Home Bakers, Atlanta, GA 30310, ready to bake.","1,238 cases (22.5 lbs per case)","Metal shavings found in cookie dough.","09/13/2016",," 061017",8/5/2016,"08/05/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74898,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: NC, OH, FL, and MD.","Z-2772-2016","Class II","Cather, Ultrasound, Intravascular    The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.","6,121 units in total","Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.","09/09/2016",," Lot/Batch Numbers:   23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259  23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514  23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533  23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836  23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285",2/17/2016,"02/17/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74898,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: NC, OH, FL, and MD.","Z-2771-2016","Class II","Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days.    An access kit only, contains no base components","6,121 units in total","Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.","09/09/2016",," Lot/Batch Numbers:   23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259  23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514  23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533  23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836  23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285",2/17/2016,"02/17/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74898,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: NC, OH, FL, and MD.","Z-2774-2016","Class II","Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days    The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.","6,121 units in total","Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.","09/09/2016",," Lot/Batch Numbers:   23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259  23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514  23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533  23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836  23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285",2/17/2016,"02/17/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74898,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: NC, OH, FL, and MD.","Z-2773-2016","Class II","Catheter, Percutaneous    The Arrow Single-Lumen Catheter permits venous access to the central circulation.","6,121 units in total","Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.","09/09/2016",," Lot/Batch Numbers:   23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259  23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514  23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533  23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836  23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285",2/17/2016,"02/17/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74899,"Ongoing","Mentor Texas, LP.","3025 Skyway Cir N",,"Irving","TX","75038-3524","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium","Z-2781-2016","Class II","CPX4 Breast Tissue Expander 650 cc  :  Product Usage:  Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.  ","30 units","The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.","09/09/2016",," Lot 6947019",8/9/2016,"08/09/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74899,"Ongoing","Mentor Texas, LP.","3025 Skyway Cir N",,"Irving","TX","75038-3524","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium","Z-2780-2016","Class II","Artoura Breast Tissue Expander 700 cc    Product Usage:  Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.  ","48 units","The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.","09/09/2016",," Lot 6944785",8/9/2016,"08/09/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74900,"Ongoing","Nidek Inc","47651 Westinghouse Dr",,"Fremont","CA","94539-7474","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of:  TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN.","Z-2711-2016","Class II","SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09.    Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured  images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.  ","29 affected devices","Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed  and approved by the FDA.","09/01/2016",," Microscopes with serial numbers:  120004,120005, 120006, 120007, 120009, 120010, 120011,120012, 120013, 120014, 0120016, 120019, 120021, 120023, 120024, 120026, 120030, 120036, 0120038, 120039, 120040, 120042, 120044,120045, 120046, 120047, 120048, 120049, 120050.                                                      ",8/8/2016,"08/08/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74901,"Ongoing","Ethicon, Inc.","US Highway 22 West",,"Somerville","NJ","08876","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.","Z-2889-2016","Class II"," Tape  (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)","396,024 eaches"," Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert.","09/27/2016",,"  D9212",8/1/2016,"08/01/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74902,"Ongoing","Actavis Inc","400 Interpace Pkwy",,"Parsippany","NJ","07054-1120","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1472-2016","Class III","Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61    ","2543 bottles","Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).  ","08/24/2016",," L503092, Exp 04/2016",8/2/2016,"08/02/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74902,"Ongoing","Actavis Inc","400 Interpace Pkwy",,"Parsippany","NJ","07054-1120","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1471-2016","Class III","Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82","672 bottles","Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).  ","08/24/2016",," L503092, Exp 04/2016",8/2/2016,"08/02/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74903,"Ongoing","Hospira Inc., A Pfizer Company","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including ND, TX, MI, MN, WI, IA, ME, HI, PA, MA, NJ, NY, CT, and Internationally to Canada.","Z-2790-2016","Class II","Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump  Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.","20","Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.","09/13/2016",," List Numbers 16037-64-02 and 16037-64-03",7/28/2016,"07/28/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74904,"Terminated","Blood Systems, Inc","3231 11th St S",,"Fargo","ND","58104-6238","United States","Voluntary: Firm Initiated","Telephone","South Dakota; North Dakota","B-0733-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.","09/12/2016","09/12/2016"," W042516034189K; ",7/11/2016,"07/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74904,"Terminated","Blood Systems, Inc","3231 11th St S",,"Fargo","ND","58104-6238","United States","Voluntary: Firm Initiated","Telephone","South Dakota; North Dakota","B-0732-16","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood products, in which quality control and distribution of products did not meet specifications, were distributed.","09/12/2016","09/12/2016"," W042516038055L; ",7/11/2016,"07/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74905,"Terminated","Puget Sound Blood Center and Program","921 Terry Ave",,"Seattle","WA","98104-1239","United States","Voluntary: Firm Initiated","Telephone","Washington","B-0734-16","Class III","Pooled Platelets, Leukocytes Reduced, Irradiated","1 unit","Blood product, for which unit was outside monitored storage for greater than two hours, was distributed.","09/12/2016","09/12/2016"," W141616919607; ",7/3/2016,"07/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74906,"Terminated","Houchin Community Blood bank","11515 Bolthouse Drive",,"Bakersfield","CA","93311","United States","Voluntary: Firm Initiated","Telephone","Austria; California","B-0737-16","Class II","Fresh Frozen Plasma","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","09/12/2016","09/12/2016"," W224316504203; ",7/2/2016,"07/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74906,"Terminated","Houchin Community Blood bank","11515 Bolthouse Drive",,"Bakersfield","CA","93311","United States","Voluntary: Firm Initiated","Telephone","Austria; California","B-0736-16","Class III","Blood and Blood Products for Reprocessing","13 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","09/12/2016","09/12/2016"," W224316307717; W224316307709; W224316307664; W224316307702; W224316307719; W224316307721; W224316307708; W224316307510; W224316307742; W224316307506; W224316307522; W224316103022; W224316801532; ",7/2/2016,"07/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74906,"Terminated","Houchin Community Blood bank","11515 Bolthouse Drive",,"Bakersfield","CA","93311","United States","Voluntary: Firm Initiated","Telephone","Austria; California","B-0738-16","Class II","Red Blood Cells, Leukocytes Reduced","24 units","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","09/12/2016","09/12/2016"," W224316307717; W224316307709; W224316307664; W224316307719; W224316307721; W224316307708; W224316307510; W224316307742; W224316307506; W224316700734; W224316307522; W224316103022; W224316308031; W224316504536; W224316308075; W224316801532; W224316103189; W224316504513; W224316504203; W224316307702; W224316801675; W224316801659; W224316801653; W224316801679; ",7/2/2016,"07/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74906,"Terminated","Houchin Community Blood bank","11515 Bolthouse Drive",,"Bakersfield","CA","93311","United States","Voluntary: Firm Initiated","Telephone","Austria; California","B-0735-16","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","09/12/2016","09/12/2016"," W224316307761; ",7/2/2016,"07/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74908,"Ongoing","Innovative Food Processors, Inc.","2125 Airport Dr",,"Faribault","MN","55021-7798","United States","Voluntary: Firm Initiated","Telephone","one processor in AR","F-2088-2016","Class II","Prime CAP Sugar, S 95-135, Encapsulated Sugar.  Ingredients:  Sugar and Hydrogenated Palm Oil, #10040870, Net WT. 125 lbs. Poly lined cardboard drum.   DIFP, Inc., 2125 Airport Dr., Ferial, MN  55021","196,000 lbs.","Specific lots of Prime Cap Sugar 95-135 is being recalled because of possible contamination caused by metal shavings.","09/08/2016",," Lot Codes:  J099-6, J102-6, J123-6, J131-6, J133-6.",7/13/2016,"07/13/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74909,"Ongoing","Becton Dickinson & Company","1 Becton Dr",,"Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US and International","Z-2710-2016","Class II",", REF 367342.","1,788,150 units","Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of the safety feature, which retracts the needle.","09/01/2016",," Lot number: 5355531, 5355533, 5356681, 5356682, 6006629, 6006630, 6006631, 6006633, 6006634 and 6006650.",8/8/2016,"08/08/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74910,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Albania  Algeria  Angola  Argentina  Armenia  Australia  Austria  Bahrain  Bangladesh  Belarus  Belgium  Bosnia Herzeg.  Botswana  Brazil  Brunei  Bulgaria  Canada  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  Finland  France  Fren.Polynesia  Georgia  Germany  Greece  Hong Kong  Hungary  Iceland  India  Indonesia  Iraq  Ireland  Israel  Italy  Ivory Coast  Japan  Kazakhstan  Kenya  Kuwait  Latvia  Lebanon  Lesotho  Lithuania  Luxembourg  Macedonia  Malaysia  Mexico  Netherlands  New Caledonia  New Zealand  Norway  P.R. China  Peru  Philippines  Poland  Portugal  Qatar  Rep. of Yemen  Republic Korea  Romania  Russian Fed.  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Tunisia  Turkey  Turkmenistan  U.A.E.  United Kingdom  Uruguay  Vatikancity  Vietnam","Z-2799-2016","Class II","Siemens RAPIDPoint  500 Blood Gas Analyzer   Siemens Material Number (SMN):  10492730, 10696855, 10696857, 10697306  ","6786 units","There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system","09/14/2016",," All Serial Numbers",8/11/2016,"08/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74910,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Albania  Algeria  Angola  Argentina  Armenia  Australia  Austria  Bahrain  Bangladesh  Belarus  Belgium  Bosnia Herzeg.  Botswana  Brazil  Brunei  Bulgaria  Canada  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  Finland  France  Fren.Polynesia  Georgia  Germany  Greece  Hong Kong  Hungary  Iceland  India  Indonesia  Iraq  Ireland  Israel  Italy  Ivory Coast  Japan  Kazakhstan  Kenya  Kuwait  Latvia  Lebanon  Lesotho  Lithuania  Luxembourg  Macedonia  Malaysia  Mexico  Netherlands  New Caledonia  New Zealand  Norway  P.R. China  Peru  Philippines  Poland  Portugal  Qatar  Rep. of Yemen  Republic Korea  Romania  Russian Fed.  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Tunisia  Turkey  Turkmenistan  U.A.E.  United Kingdom  Uruguay  Vatikancity  Vietnam","Z-2800-2016","Class II","Siemens RAPIDLab 1240 Blood Gas Analyzer  Siemens Material Number (SMN):  10321840, 10491392","144 units","There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system","09/14/2016",," All Serial Numbers",8/11/2016,"08/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74910,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Albania  Algeria  Angola  Argentina  Armenia  Australia  Austria  Bahrain  Bangladesh  Belarus  Belgium  Bosnia Herzeg.  Botswana  Brazil  Brunei  Bulgaria  Canada  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  Finland  France  Fren.Polynesia  Georgia  Germany  Greece  Hong Kong  Hungary  Iceland  India  Indonesia  Iraq  Ireland  Israel  Italy  Ivory Coast  Japan  Kazakhstan  Kenya  Kuwait  Latvia  Lebanon  Lesotho  Lithuania  Luxembourg  Macedonia  Malaysia  Mexico  Netherlands  New Caledonia  New Zealand  Norway  P.R. China  Peru  Philippines  Poland  Portugal  Qatar  Rep. of Yemen  Republic Korea  Romania  Russian Fed.  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Tunisia  Turkey  Turkmenistan  U.A.E.  United Kingdom  Uruguay  Vatikancity  Vietnam","Z-2803-2016","Class II","RAPIDLab 1265 Blood Gas Analyzer  Siemens Material Number (SMN):  10321852, 10470366, 10491395","2602 units","There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system","09/14/2016",," All Serial Numbers",8/11/2016,"08/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74910,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Albania  Algeria  Angola  Argentina  Armenia  Australia  Austria  Bahrain  Bangladesh  Belarus  Belgium  Bosnia Herzeg.  Botswana  Brazil  Brunei  Bulgaria  Canada  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  Finland  France  Fren.Polynesia  Georgia  Germany  Greece  Hong Kong  Hungary  Iceland  India  Indonesia  Iraq  Ireland  Israel  Italy  Ivory Coast  Japan  Kazakhstan  Kenya  Kuwait  Latvia  Lebanon  Lesotho  Lithuania  Luxembourg  Macedonia  Malaysia  Mexico  Netherlands  New Caledonia  New Zealand  Norway  P.R. China  Peru  Philippines  Poland  Portugal  Qatar  Rep. of Yemen  Republic Korea  Romania  Russian Fed.  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Tunisia  Turkey  Turkmenistan  U.A.E.  United Kingdom  Uruguay  Vatikancity  Vietnam","Z-2798-2016","Class II","Siemens RAPIDPoint 405 Blood Gas Analyzer nBili  Siemens Material Number (SMN):  10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784","2910 units","There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system","09/14/2016",," All Serial Numbers",8/11/2016,"08/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74910,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Albania  Algeria  Angola  Argentina  Armenia  Australia  Austria  Bahrain  Bangladesh  Belarus  Belgium  Bosnia Herzeg.  Botswana  Brazil  Brunei  Bulgaria  Canada  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  Finland  France  Fren.Polynesia  Georgia  Germany  Greece  Hong Kong  Hungary  Iceland  India  Indonesia  Iraq  Ireland  Israel  Italy  Ivory Coast  Japan  Kazakhstan  Kenya  Kuwait  Latvia  Lebanon  Lesotho  Lithuania  Luxembourg  Macedonia  Malaysia  Mexico  Netherlands  New Caledonia  New Zealand  Norway  P.R. China  Peru  Philippines  Poland  Portugal  Qatar  Rep. of Yemen  Republic Korea  Romania  Russian Fed.  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Tunisia  Turkey  Turkmenistan  U.A.E.  United Kingdom  Uruguay  Vatikancity  Vietnam","Z-2801-2016","Class II","RAPIDLab 1245 Blood Gas Analyzer  Siemens Material Number (SMN):  10321844, 10337179, 10491393","197 units","There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system","09/14/2016",," All Serial Numbers",8/11/2016,"08/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74910,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Albania  Algeria  Angola  Argentina  Armenia  Australia  Austria  Bahrain  Bangladesh  Belarus  Belgium  Bosnia Herzeg.  Botswana  Brazil  Brunei  Bulgaria  Canada  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  Finland  France  Fren.Polynesia  Georgia  Germany  Greece  Hong Kong  Hungary  Iceland  India  Indonesia  Iraq  Ireland  Israel  Italy  Ivory Coast  Japan  Kazakhstan  Kenya  Kuwait  Latvia  Lebanon  Lesotho  Lithuania  Luxembourg  Macedonia  Malaysia  Mexico  Netherlands  New Caledonia  New Zealand  Norway  P.R. China  Peru  Philippines  Poland  Portugal  Qatar  Rep. of Yemen  Republic Korea  Romania  Russian Fed.  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Tunisia  Turkey  Turkmenistan  U.A.E.  United Kingdom  Uruguay  Vatikancity  Vietnam","Z-2797-2016","Class II","Siemens RAPIDPoint¿ 400 Blood Gas Analyzer  Siemens Material Number (SMN):  10291507,10314585, 10318899,10321239,10322654,10324081,  10328803, 10331381 , 10339634","492 units","There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system","09/14/2016",," All Serial Numbers",8/11/2016,"08/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74910,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Albania  Algeria  Angola  Argentina  Armenia  Australia  Austria  Bahrain  Bangladesh  Belarus  Belgium  Bosnia Herzeg.  Botswana  Brazil  Brunei  Bulgaria  Canada  Chile  Colombia  Croatia  Czech Republic  Denmark  Ecuador  Egypt  Estonia  Finland  France  Fren.Polynesia  Georgia  Germany  Greece  Hong Kong  Hungary  Iceland  India  Indonesia  Iraq  Ireland  Israel  Italy  Ivory Coast  Japan  Kazakhstan  Kenya  Kuwait  Latvia  Lebanon  Lesotho  Lithuania  Luxembourg  Macedonia  Malaysia  Mexico  Netherlands  New Caledonia  New Zealand  Norway  P.R. China  Peru  Philippines  Poland  Portugal  Qatar  Rep. of Yemen  Republic Korea  Romania  Russian Fed.  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Taiwan  Thailand  Tunisia  Turkey  Turkmenistan  U.A.E.  United Kingdom  Uruguay  Vatikancity  Vietnam","Z-2802-2016","Class II","RAPIDLab 1260 Blood Gas Analyzer  Siemens Material Number (SMN):  10321846, 10491394","114 units","There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system","09/14/2016",," All Serial Numbers",8/11/2016,"08/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74912,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Affected geographies: Andorra, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, Egypt, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.","Z-2732-2016","Class II","UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System.    Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System).  Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).","5,282 units total (2,877 units in US)","There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.","09/02/2016",," Serial No.  AZ28848  AZ20791  AZ20789  AZ25359  AZ25362  AM51052  AZ23820  AZ28405  AZ28406  AZ02009  AW23066  AW16273  AW02003  AV52153  AU44687  AU44682  AV09188  AY50973  AZ25374  AV09197  AZ03660  AZ06661  AW23164  AY10661  AT48671  AY17706  AV11202  AS24187  AU42604  AU42605  AU47775  AU47783  AU45705  AW02013  AT09135  AT18249  AT18247  AW05068  AW02059  AW12090  AU19248  AU19249  AU19248  AW02020  AV35049  AV38713  AU36511  AU36519  AY17711  AY04037  AY01034  AY17198  AV28561  AZ28855  AY42926  AY42921  AU44671  AY24762  AY24768  AU36524  AW16124  AW14113  AW45310  AV09167  AW26208  AV44863  AW35273  AW35269  AW23085  AZ12149  AU47757  AV44103  AW23167  AW20160  AW31265  AW31263  AV32042  AW23060  AW23061  AV49123  AV14278  AV14283  AZ12183  AZ12182  AU38543  AU40576  AV06152  AU42632  AZ10095  AZ10107  AZ12140  AZ12141  AZ12165  AZ12166  AV27520  AV27522  AW51368  AZ12146  AZ12145  AZ12148  AZ12147  AV28609  AV28610  AZ12151  AZ12153  AZ10109  AZ10101  AZ06687  AZ19767  AW16135  AW20152  AS07010  AS07024  AS07025  AW31250  AY06635  AY08646  AU49788  AU47779  AY01606  AW51367  AW51366  AY21742  AY19734  AV14297  AV24463  AV24462  AZ16736  AY33822  AW04034  AY40896  AZ02605  AZ02601  AY52691  AY52692  AY28792  AY30802  AY30800  AY30799  AV02047  AV02048  AV16314  AV16318  AS12049  AS12048  AU36491  AU36509  AV28573  AV28587  AV28586  AV28607  AY42915  AV27512  AV26506  AY40903  AY40904  AT40549  AT40548  AW23168  AV09191  AV09196  AW14260  AZ23348  AZ23344  AV18346  AT23304  AT31426  AT31411  AY28349  AV01006  AV16342  AU49795  AU49816  AU49809  AU49796  AU49794  AU49806  AU49797  AZ06681  AU49807  AU49805  AZ12706  AV50129  AT48660  AT48657  AV09172  AV44853  AV44862  AU47769  AY01022  AT12164  AT12174  AN42122  AY19722  AU04021  AU02008  AU45700  AU44684  AU32440  AU32445  AU44679  AU44677  AU36494  AU36498  AZ20796  AT27348  AV16321  AV37063  AU05046  AU05045  AW02011  AZ23819  AW23162  AY36860  AY38867  AU44686  AU44691  AV12245  AV12247  AU40571  AU40564  AU40574  AU40568  AV16339  AV16337  AV14295",8/8/2016,"08/08/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74913,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","1200 N Highland Ave",,"Aurora","IL","60506-1401","United States","Voluntary: Firm Initiated","Telephone","Illinois","B-0739-16","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Blood products, for which the quality control testing was incomplete, were distributed.","09/12/2016","09/12/2016"," W039716214298I; W039716214298I; ",6/27/2016,"06/27/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74914,"Terminated","Medic Inc","1601 Ailor Ave",,"Knoxville","TN","37921-6702","United States","Voluntary: Firm Initiated","Telephone","Tennessee","B-0740-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, manufactured with insufficient Adsol added to product, was distributed.","09/12/2016","09/12/2016"," W071216022295; ",7/13/2016,"07/13/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74915,"Ongoing","Maquet Cardiovascular Us Sales, Llc","45 Barbour Pond Dr",,"Wayne","NJ","07470-2094","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI","Z-2746-2016","Class II","The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment.   The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount","19 units (US) and 1975 units (OUS)","Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken.","09/07/2016",," Part Number/Catalog Number 1002.64A0",8/12/2016,"08/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",74916,"Completed","Cleanlife Products LLC","868 Pleasant Valley Dr",,"Springboro","OH","45066-1159","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide.  The product was shipped to the following states: GA, IL, NC, NY, and TX.","F-0789-2017","Class II","Cardinal Health Shampoo Cap Fragrance Free.  1 unit per package, 30 packages per case.","853 cases (25590 units)","The firm has recalled the product due to cladosporium (mold).","12/19/2016",," 004316, 005316, 018316, 019316, 020316, 021316, 022316, 062316, 063316, 064316, 067316, 068316, 090316, 091316, 092316, 095316, 096316, 097316, 128415, 131415, 132415, 133415, 134415, 153316, 154316, 155316, 158316, 159316, 160316, 166316, 167316, 168316, 169316, 172316, 281315, 282315, 285315, 286315, 317315, 320315, 321315, 322315, 323315, 362315, 363315, 364315",8/8/2016,"08/08/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74917,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Nationwide   Albania  Algeria  Angola  Armenia  Austria  Bahrain  Belgium  Bulgaria  Burkina Faso  Croatia  Cyprus  Czech Republic  Denmark  Egypt  Estonia  Finland  France  Georgia  Germany  Great Britain  Greece  Hungary  Iceland  Iraq  Italy  Jordan  Kazakhstan  Latvia  Lithuania  Luxembourg  Macedonia  Malta  Netherlands  Norway  Pakistan  Poland  Portugal  Qatar  Romania  Russian Fed.  Senegal  Serbia  Slovakia  Slovenia  Spain  Sweden  Switzerland  Tunisia  Turkey  Unit.Arab Emir.  Uzbekistan  Vatican","Z-2742-2016","Class II","ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)",,"Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. ","09/07/2016",," SMN 10310292 - 100 test kits  Lot# UDI#  40776268 0063041420300340776268160922  53535268 0063041420300353535268160922  67015269 0063041420300367015269161124  72335269 00630414203003723352691611 24  82156270 0063041420300382156270161229  87504270 0063041420300387504270161229  93298271 0063041420300393298271170205  5702271 0063041420300305702271170205  17339271 006304142030031733927 11 70205  19110272 0063041420300319110272170418  27655272 0063041420300327655272170418    SMN 10310293- 500 test kits  Lot#  39805268  50851268  60225269  71544269  81085270  86551270  93505271  7329271  16252272  24689272  33327272  UDI#  0063041420299039805268160922  0063041420299050851268160922  0063041420299060225269161124  0063041420299071544269161124  0063041420299081085270161229  0063041 420299086551270161229  0063041 420299093505271 170205  0063041420299007329271 170205  0063041420299016252272170418  0063041420299024689272170418  0063041420299033327272170418",8/9/2016,"08/09/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74918,"Ongoing","Synergetics Inc","3845 Corporate Centre Dr",,"O Fallon","MO","63368-8678","United States","Voluntary: Firm Initiated","Letter","Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT.  Foreign distribution to the UK, France, Mexico, and India.","Z-0121-2017","Class II","25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.","255 units","Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.","10/18/2016",," Lot number M543990 (1 each or box of 6 each), exp 10/2018  Lot number M545780 (1 each or box of 6 each), exp 10/2018  Lot number M569020 (1 each or box of 6 each), exp 01/2019  Lot number M578140 (1 each or box of 6 each), exp 02/2019",8/11/2016,"08/11/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74918,"Ongoing","Synergetics Inc","3845 Corporate Centre Dr",,"O Fallon","MO","63368-8678","United States","Voluntary: Firm Initiated","Letter","Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT.  Foreign distribution to the UK, France, Mexico, and India.","Z-0119-2017","Class II","25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.","72 units","Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.","10/18/2016",," Lot number M545040 (1 each or box of 6 each), exp 10/2018  Lot number M586070 (1 each or box of 6 each), exp 03/2019",8/11/2016,"08/11/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74918,"Ongoing","Synergetics Inc","3845 Corporate Centre Dr",,"O Fallon","MO","63368-8678","United States","Voluntary: Firm Initiated","Letter","Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT.  Foreign distribution to the UK, France, Mexico, and India.","Z-0122-2017","Class II","25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration.","9 units","Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.","10/18/2016",," Lot number M546500 (1 each or box of 6 each), exp 10/2018  ",8/11/2016,"08/11/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74918,"Ongoing","Synergetics Inc","3845 Corporate Centre Dr",,"O Fallon","MO","63368-8678","United States","Voluntary: Firm Initiated","Letter","Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT.  Foreign distribution to the UK, France, Mexico, and India.","Z-0120-2017","Class II","25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.","72 units","Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.","10/18/2016",," Lot number M548370 (1 each or box of 6 each), exp 11/2018  Lot number M578150 (1 each or box of 6 each), exp 02/2019",8/11/2016,"08/11/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74919,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","E-Mail","Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA.  Government distribution was made to OK.  There was no foreign/military distribution.","Z-2627-2016","Class II","RadSuite software.  The firm name on the label is Merge Healthcare, Hartland, WI.","25 sites potentially have the affected versions","Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport. ","08/23/2016",," Versions: 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E, SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, and 5.35.4 HF0513",1/31/2016,"01/31/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74920,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,  ND, NH, NJ, NM, NV,  NY, OH, OR, PA, TX, VT, WA, WI, WV,  and WY; and, the countries of Canada, Brazil, Germany, Iraq, Japan, Korea, Kuwait, Libya, Mexico, Portugal, and Qatar.","Z-2681-2016","Class II","PCR Compano Basic Reader using 100-127V as mains voltage.  Model numbers: 732027, 732028, and 732040.      Radiological image processing system (Computed Radiography).  ","388","A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.","08/29/2016",," Serial Numbers: 2704471  2704473  16620843  16620844  16620845  16720992  16721001  17121932  26523285  26523287  26523292  26824120  26924172  26924179  27024418  27124646  27124650  27224878  27225020  36125096  36225366  36225367  36225370  36225371  36225372  36225373  36225429  36225431  36225432  36225437  36225438  36325634  36325635  36325639  36325641  36325805  36325810  36325811  36325812  36325813  36325814  36325819  36325820  36425835  36425837  36425838  36425839  36425842  36526123  36526129  36526134  36526135  36526138  36526139  36526140  36526141  36526142  36526144  36526201  36526202  36526206  36526211  36526212  36526213  36626333  36726559  36726560  36726562  36826721  36826722  36826726  36826728  36926990  36926991  37127470  37127472  37127473  46127902  46127903  46127905  46127906  46127909  46127910  46127911  46127912  46127913  46127914  46127992  46127994  46127997  46128000  46128001  46128003  46128004  46128008  46128009  46128010  46128011  46228209  46228211  46228215  46228216  46228228  46228229  46328495  46328496  46328498  46328502  46328529  46328546  46328547  46328548  46358530  46428796  46428799  46428802  46428803  46428804  46428805  46428807  46428815  46428816  46529074  46529085  46629338  46629344  46629346  46629352  46629355  46629356  46629357  46629359  46629360  46629363  46729628  46729629  46729631  46729632  46729633  46729634  46729635  46729636  46729637  46729639  46729640  46729644  46729723  46729725  46729726  46829974  46829975  46829976  46829978  46829980  46829981  46829982  46829983  46829984  46829985  46829992  46829993  46829994  46829995  46829996  46930348  46930350  46930351  46930352  46930354  46930521  46930523  46930524  46930525  46930528  46930529  47030712  47030713  47030714  47030715  47030716  47030719  47030721  47030723  47030724  47030725  47030726  47131062  47131069  47131070  47131071  47131072  47131073  47131074  47131075  47231476  47231481  56232069  56232070  56232089  56232090  56232091  56332428  56332430  ",8/12/2016,"08/12/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74922,"Ongoing","Winco Mfg., LLC","5516 SW 1st Ln",,"Ocala","FL","34474-9307","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico;  and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.","Z-0066-2017","Class II","TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair.    Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.","264 Stretcher Chairs","Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.","10/09/2016",," All identified serial numbers.",6/29/2016,"06/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74922,"Ongoing","Winco Mfg., LLC","5516 SW 1st Ln",,"Ocala","FL","34474-9307","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico;  and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.","Z-0065-2017","Class II","TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair.    Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.","264 Stretcher Chairs","Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.","10/09/2016",," All identified serial numbers.",6/29/2016,"06/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74922,"Ongoing","Winco Mfg., LLC","5516 SW 1st Ln",,"Ocala","FL","34474-9307","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico;  and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.","Z-0064-2017","Class II","TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair.    Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.","264 Stretcher Chairs","Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.","10/09/2016",," All identified serial numbers.",6/29/2016,"06/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74923,"Ongoing","Medtronic Inc., Cardiac Rhythm and Heart Failure","8200 Coral Sea St NE",,"Mounds View","MN","55112-4391","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.","Z-2651-2016","Class II","Medtronic, Evera Implantable Cardioverter Defibrillators:    Product       Model  EVERA XT   DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1.  EVERA S     DDBC3D1, DDBC3D4    Product Usage:  The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardioverter defibrillator (lCD) are a family of multiprogrammable cardiac devices that monitor and regulate the patients heart rate by providing dual or single chamber rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies (dual-chamber devices only).  ","78 (39 US, 39 OUS)","78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.","08/24/2016",," Product Name: Evera XT DR lCD.  Models: DDBB1D4, DDBB1D1, DDBB2D4, DDBB2D1.  Serial Numbers:   BWC202738H, BWC202754H, BWB202998H, BWB203157H, BWB203167H, BWB203173H, BWB203186H, BWE601558S, BWE601571S, BWE601578S, BWE601579S, BWE601581S, BWE601589S, BWE601591S, BWE601594S, BWE601600S, BWE601605S, BWD602122S.    Product Name: Evera S DR lCD.  Models: DDBC3D1, DDBC3D4.  Serial Numbers:   BWG600597S, BWF600969S, BWF600970S, BWF600972S, BWF600973S, BWF600975S, BWF600977S, BWF600978S, BWF600979S, BWF600983S, BWF600984S, BWF600985S, BWF600987S, BWF600989S, BWF600991S, BWF600992S, BWF600996S, BWF601001S.    Product Name: Evera XT VR lCD.  Models: DVBB1D1, DVBB2D4.  Serial Numbers:   BWI201423H, BWI201436H, BW1201440H, BWI201451H, BWI201454H, BWI201462H, BWI201473H, BWJ601102S, BWJ601108S, BWJ601112S, BWJ601479S, BWJ601101S, BWJ601103S, BWJ601106S.  ",8/12/2016,"08/12/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74923,"Ongoing","Medtronic Inc., Cardiac Rhythm and Heart Failure","8200 Coral Sea St NE",,"Mounds View","MN","55112-4391","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.","Z-2650-2016","Class II","Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators:  Product                 Model  VIVAXTCRT-D     DTBA1D1, DTBA1D4  VIVASCRT-D       DTBB1D1, DTBB1D4    Product Usage:  The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies.  ","78 (39 US, 39 OUS)","78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.","08/24/2016",," Product Name:  Viva XT CRT -D .  Models:  DTBA1D4, DTBA1D1.  Serial Numbers:   BLF203128H, BLF204746H, BLE202888H, BLE202889H, BLE202890H, BLE202901H, BLE202941H, BLE202947H, BLE202954H, BLE202958H, BLE202961H, BLE202962H, BLE202964H, BLE202981H, BLE202987H, BLE202989H, BLE202990H, BLE202991H, BLE203019H, BLE203026H, BLE203027H, BLE203029H, BLE203032H, BLE203046H, BLE203052H, BLE203073H    Product Name: Viva S CRT-D.  Models:  DTBB1D4, DTBB1D1.  Serial Numbers: BLO202272H, BLN202206H.  ",8/12/2016,"08/12/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74924,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution to: CO and OK.","Z-2685-2016","Class II","RadSuite software.  The firm name on the label is Merge Healthcare, Hartland, WI.    RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. ","96 sites potentially have the affected versions for both products","Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.","08/29/2016",," Versions V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3",1/30/2016,"01/30/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74924,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Distribution to: CO and OK.","Z-2686-2016","Class II","iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI.     iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.","96 sites potentially have the affected versions for both products","Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.","08/29/2016",," Version: 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, and 8.80.2.1",1/30/2016,"01/30/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74925,"Ongoing","Hospira Inc., A Pfizer Company","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0218-2017","Class I","Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02  ","143,250 vials","Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.","12/22/2016",," Lot # 59064DK, Exp. 11/17",8/4/2016,"08/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74926,"Ongoing","Phibro Animal Health Corporation","300 Frank W Burr Blvd Ste 21",,"Teaneck","NJ","07666-6704","United States","Voluntary: Firm Initiated","Letter","nationwide","V-0037-2017","Class II","Stafac 20 Type A Medicated Article   20 g/Ib equivalent to 44 g/KG  NDC 66104-1220      Phibro Animal Health Corporation  Teaneck, NJ     Packed in a 50 Ib/bag (22.6 kg/bag) Multi-wall bag, with the following  construction/configuration: 4 ply Natural Kraft and 1 ply of HDPE 2.0 or 0.5miL.","400 bags/units","Stafac 20 lot numbers N32704049VW and N32764167VW tested below the potency specification of 17.0-23.0 g/lb at the 18 month stability interval under VICH long-term condition.","12/14/2016",," N32704049VW; N32764167VW     April 30, 2015",4/22/2015,"04/22/2015",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74927,"Ongoing","DeRoyal Industries Inc","200 Debusk Ln",,"Powell","TN","37849-4703","United States","Voluntary: Firm Initiated","Letter","Distributed in LA and TN.","Z-2679-2016","Class II","DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,   ","24 units","The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap.  The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.","08/26/2016",," Lot Number 40004006",8/11/2016,"08/11/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74927,"Ongoing","DeRoyal Industries Inc","200 Debusk Ln",,"Powell","TN","37849-4703","United States","Voluntary: Firm Initiated","Letter","Distributed in LA and TN.","Z-2678-2016","Class II","Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO,  Custom surgical kit. ","26 units","The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap.  The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.","08/26/2016",," Lot Number 40259236",8/11/2016,"08/11/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74928,"Ongoing","OrthoPediatrics Corp","2850 Frontier Dr",,"Warsaw","IN","46582-7001","United States","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA    Foreign: None    VA/DOD: None","Z-2844-2016","Class II","3.5mm Bowed Locking Compression Femur Plates, 18 hole  Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.","41","OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.  ","09/19/2016",," Product Number: 00-1050-3218  Lot Number: NM02346",7/27/2016,"07/27/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74928,"Ongoing","OrthoPediatrics Corp","2850 Frontier Dr",,"Warsaw","IN","46582-7001","United States","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA    Foreign: None    VA/DOD: None","Z-2843-2016","Class II","3.5mm Bowed Locking Compression Femur Plates, 14 hole  Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.","41 ","OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.  ","09/19/2016",," Product Number: 00-1050-3214  Lot Number: NM02341  Product Number: 00-1050-3214  Lot Number: NM02342  ",7/27/2016,"07/27/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74930,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AL, AZ, CA, CT, GA, MN, NC, OH, OR  and Internationally to Australia, Germany, Japan, Korea, and Taiwan.","Z-2752-2016","Class II","Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the outer cavity. The patient record label is placed on the Tyvek outerlid. The sealed cavities and package insert is placed into a folding carton, sealed and shrink wrapped.  Total elbow prosthesis designed for use with bone cement","25 units","Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing.  The missing bushing could result in a surgical delay or additional surgery if a replacement is not available. ","09/08/2016",," Item Number: 32-8105-027-01  Lot Number: 62811341",8/16/2016,"08/16/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74931,"Ongoing","Howmedica Osteonics Corp.","2 Pearl Ct",,"Allendale","NJ","07401-1611","United States","Voluntary: Firm Initiated","Letter","NationwideDistribution","Z-2787-2016","Class II","AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion",,"Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.","09/12/2016",," Catalog #400008  Lot #'s 01141602, 01141607, 01141610, 01141612, 01141617, 02021601, 02021603, 02021605, 02161503. 02161504, 02161506, 02161507, 02161508, 02161509, 02161510, 02161511, 02161512, 02161513, 02161514, 02161515,  03061309, 04161501, 04161502, 04161503, 04161504, 04161505, 04161506, 04161507, 04161508, 05171305, 05181505, 05181506, 05181507, 05181508, 05181509, 05181510, 05181511, 05181512, 05181513, 05181514, 05181515, 06031401, 06031402, 06031403, 06031404, 06201309, 07291404, 07291405,  08191310, 08191311, 08261506, 08261507, 08261508, 10111302, 10111303, 10111304, 10111305, 10291405, 10291406, 11101406, 11101407, 11101408, 11101409, 11101410, 11101411, 11121525,  12151510, 12151515, 12151516, 12151523, 12151526 and 12301315",7/26/2016,"07/26/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74931,"Ongoing","Howmedica Osteonics Corp.","2 Pearl Ct",,"Allendale","NJ","07401-1611","United States","Voluntary: Firm Initiated","Letter","NationwideDistribution","Z-2788-2016","Class II","AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion",,"Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.","09/12/2016",," Catalog #400010  Lot #'s 01021403, 01121508, 01121509, 01271515, 01271516, 02021512, 02021513, 02021514, 02021515, 02021602, 03221310, 04141508, 04141509, 04141510, 04141511, 04141512, 04251312, 06101405, 06101406, 06101407, 06251311, 07011406, 07201510, 07201511, 07201512, 08141303, 08141313, 09251504, 09281512, 10081301, 10081302, 10201502, 10201503, 10301504, 11121514, 11121518, 11121521, 12151511 and 12151517",7/26/2016,"07/26/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74931,"Ongoing","Howmedica Osteonics Corp.","2 Pearl Ct",,"Allendale","NJ","07401-1611","United States","Voluntary: Firm Initiated","Letter","NationwideDistribution","Z-2786-2016","Class II","AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.",,"Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.","09/12/2016",," Catalog #400006  Lot #'s 01141604, 01141609, 01141614, 01231506, 01231507, 01271513, 01271514, 02021508, 02021509, 02021510, 02021511, 03271306, 04291403, 04291404, 04301513, 04301514, 04301515, 04301516, 06251504, 06291506, 06291507, 06291508, 06291509, 06291510, 06291511, 07081301, 07201503, 07201504, 07201505, 07201506, 08191309, 08251402, 08251403, 09231504, 09251502, 09281510, 10071307, 10071308, 10141504, 10141505, 10261507, 10261508, 11061405, 11061406, 11061407, 11061408, 11121513, 11121517, 11121520,  11121524, 12151512, 12151518, 12151522 and 12301314",7/26/2016,"07/26/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74932,"Ongoing","Clark Laboratories, Inc. (dba,Trinity Biotech USA)","2823 Girts Rd",,"Jamestown","NY","14701-9666","United States","Voluntary: Firm Initiated","Letter","Distribution to US nationwide including California, and China (Hong Kong).","Z-2782-2016","Class III","Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD ","US: 6 kits, Foreign: 50 kits","The product lot failed to meet QC acceptance criteria during stability testing.   The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).","09/12/2016",," Lot Number 2326060-043, Expiration Date 31 May 2017  ",7/11/2016,"07/11/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74934,"Ongoing","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.","Z-2756-2016","Class II","Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery.  The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.  The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip","200 units worldwide","Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement. ","09/08/2016",," Lot Numbers: 1526500032, 1529300026, 1602600042.",8/12/2016,"08/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74934,"Ongoing","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.","Z-2757-2016","Class II","Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.","1205 units worldwide","The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement. ","09/08/2016",," Lot Numbers: 1425900137, 1433900079, 1433900080, 1435300088.",8/12/2016,"08/12/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74936,"Ongoing","The Dannon Company, Inc.","120 White Plains Rd Ste 120",,"Tarrytown","NY","10591-5588","United States","Voluntary: Firm Initiated","Letter","Alabama, Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky,  Louisiana, Massachusetts, Maine, Minnesota, Missouri, Mississippi, North Carolina, Nebraska,  New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico,  South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming","F-2099-2016","Class II","Activia FIBER Lowfat Yogurt Strawberry/Pineapple Flavors 12 Packs of 4 OZ Cups UPC 3663202884 packaged in form fill seal plastic cups","53,545 cases"," mark while the product contains and the overwrap label correctly lists WHEAT as an ingredient.","09/08/2016",," AUG 12 2016,  AUG 16 2016,  AUG 19 2016,  AUG 22 2016,  AUG 27 2016,  SEP 03 2016,  SEP 08 2016,  SEP 14 2106,  SEP 21 2016,  SEP 25 2016",8/11/2016,"08/11/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74937,"Ongoing","Novarad Corporation","752 E 1180 S Ste 200",,"American Fork","UT","84003-3561","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Canada and other foreign consignees.","Z-2659-2016","Class II","NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)   Product Usage	NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection fraction, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual colonoscopy, and vessel analysis. Images and data are stored on a digital archive with multiple redundancies; images and data are available on-site and offsite. Novarad provides all software, including third party software (i.e. Windows¿ OS). NovaPACS software resides on third party hardware, which may vary depending on the client s PACS needs. All hardware is connected to the radiology department local area network. NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities. NovaPACS is intended for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinician","90"," that was prematurely released. ","08/25/2016",," Versions 8.4.7, 8.5.3, and 8.5.6",8/12/2016,"08/12/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74938,"Ongoing","Town and Country Compounding and Consultation Services","106 Prospect St",,"Ridgewood","NJ","07450-4433","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, NY, NJ & FL; Canada","D-0228-2017","Class I","Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502","12 vials","Non-Sterility; microbial contamination identified as Bacillus circulans ","12/22/2016",," lot #07172016@1, exp 1/13/2017",8/1/2016,"08/01/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74940,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - U.S Nationwide in the states of:  TN, MA, GA, OK, VA, FL, TN, MO, AL, TX, IL, NY, VT, RI, KY, WI, AL, NC, LA, SD, TX, VA, MI, MN, IN, IA, CA, AR, PA, HI, WV, KS, CO, CT, UT and the countries of Japan, England, Canada","Z-2778-2016","Class III","LDX Optical Check Cassettes (OCC)  Model Number: 10-228 and 14-535    Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer.    Product Usage:  The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.  ","12,951","Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.","09/09/2016",," Model Number: 10-228 and 14-535  Lot Number: 332994",8/2/2016,"08/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74941,"Ongoing","Newly Weds Foods Inc","2501 N Keeler Ave",".","Chicago","IL","60639-2131","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Oregon","F-0616-2017","Class III","G72642 Ham Pump 35%, 41.92 LB bag composed of one 39.67 LB bag of seasoning and one 2.25 LB bag of cure. ","4233.92 lbs","Foreign material (wood chips) potentially within product. ","12/07/2016",," MD667625, MD667626",8/19/2016,"08/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74943,"Ongoing","WTI, Inc  -World Technology Ingredients","281 Mlk Ave",,"Jefferson","GA","30549-1447","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL and Canada.","F-2100-2016","Class III","WTI (World Technology Ingredients) DV, All Natural, 35 lbs./15.9 kg, WTI, Inc., 281 MLK Ave., Jefferson, GA 30549.","308,140 lbs","Foreign matter, wood pieces, were found in the product.","09/09/2016",," Lot numbers: JF-005747, JF-005748, JF-005751, JF-005752, JF-005758, JF-005776, JF-005778, JF-005787, JF-005795 and JF-005799.",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74944,"Ongoing","Lupin Limited","15-B, Phase 1A, Verna Industrial Area",,"Verna, Salcette, Goa",,,"India","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1516-201","Class III","Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01"," 3,192 bottles (319,200 tablets)","Labeling: Incorrect or Missing Lot and/or Expiration Date","09/21/2016",," Lot # G510086; Exp. 11/17    ",3/24/2016,"03/24/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74945,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin.  No recalled product was distributed to any foreign consignees by Lupin.","D-1502-2016","Class III","Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD  21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.  ","20,556 bottles","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.","09/16/2016",," Batch number: H303487, H303488, H303489, Exp 09/16  ",4/6/2016,"04/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74945,"Ongoing","Lupin Pharmaceuticals Inc.","111 S Calvert St Fl 21ST",,"Baltimore","MD","21202-6174","United States","Voluntary: Firm Initiated","E-Mail","All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin.  No recalled product was distributed to any foreign consignees by Lupin.","D-1503-2016","Class III","Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD  21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.  ","5,880 bottles","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.","09/16/2016",," Batch number: H303449, Exp 09/16",4/6/2016,"04/06/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74946,"Terminated","Bakers Of Paris, Inc.","99 Park Ln",,"Brisbane","CA","94005-1309","United States","Voluntary: Firm Initiated","E-Mail","CA  Bay area only","F-2240-2016","Class I","  PLU 481976 or clam shell package of 4 - PLU 241593.    Ingredient: Water, Wheat Flour, Sugar Butter (Pasteurized Cream, Salt), Milk (Powder Fat Whole), Salt, Yeast, Ascorbic Acid.  Contains Wheat, Milk    Whole Foods Market, Emeryville, CA","799 croissants","Labeling for Croissants and Chocolate Croissants fails to declare  egg in the ingredients list or allergen information. The croissants are manufactured with an egg wash.","09/15/2016","09/15/2016"," Packed on dates of 8/16/16 or earlier and best by dates of 8/18/16 or earlier",8/16/2016,"08/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74946,"Terminated","Bakers Of Paris, Inc.","99 Park Ln",,"Brisbane","CA","94005-1309","United States","Voluntary: Firm Initiated","E-Mail","CA  Bay area only","F-2241-2016","Class I","  PLU 481976 or clam shell package of 4 - PLU 241595.    Ingredient: Water, Wheat Flour, Sugar Butter (Pasteurized Cream, Salt), Milk (Powder Fat Whole), Semisweet Chocolate Chips, Eggs, Salt, Yeast, Ascorbic Acid.  Contains Wheat, Milk    Whole Foods Market, Emeryville, CA","565 croissants","Labeling for Croissants and Chocolate Croissants fails to declare  egg in the ingredients list or allergen information. The croissants are manufactured with an egg wash.","09/15/2016","09/15/2016"," Packed on dates of 8/16/16 or earlier and best by dates of 8/18/16 or earlier",8/16/2016,"08/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",74947,"Completed","Dechra Veterinary Products Inc","7015 College Blvd Ste 525",,"Overland Park","KS","66211-1551","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Recalled product was distributed to 3 customers in MO and 1 customer in PA.","V-524-2016","Class III","Felimazole (methimazole) Coated Tablets, 5mg, packaged in 100 tablets per bottle, 144 bottles packed per case, most responsible firm on the label is: Distributed by: Dechra Veterinary Products, 7015 College Blvd, Ste 525, Overland Park, KS 66211.","3648 bottles","Batch of Felimazole 5mg tablets analyzed for Assay test at 3 months was found to be subpotent.","09/27/2016",," Lot GC60497, Exp Jan 2019",8/14/2016,"08/14/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74948,"Ongoing","Angiodynamics Inc. (Navilyst Medical Inc.)","10 Glens Falls Tech Park",".","Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX","Z-0715-2017","Class II","Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019     The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.","50 cartons (boxes of 5)","There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.","12/07/2016",," Lot #: 4945781",6/8/2016,"06/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74948,"Ongoing","Angiodynamics Inc. (Navilyst Medical Inc.)","10 Glens Falls Tech Park",".","Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX","Z-0714-2017","Class II","Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014  The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring","48 cartons (boxes of 5)","There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.","12/07/2016",," Lot #: 4941411",6/8/2016,"06/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74949,"Ongoing","Aurobindo Pharma USA Inc","666 Plainsboro Rd Ste 210",,"Plainsboro","NJ","08536-3004","United States","Voluntary: Firm Initiated","Letter","CA","D-1499-2016","Class II","Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90  ","23016 bottles","Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole. ","09/14/2016",," PSSB16011-A, Exp 01/18",8/3/2016,"08/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74950,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy,  Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.","Z-0089-2017","Class II","VITROS Chemistry Products GLU Slides, REF/Product Code  170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD ---    For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System","US: 192,459 sales units; Foreign: 231,710 sales units ","Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.  Ortho also tested several compounds following industry standard CLSI EP7-A2 for potential interference on VITROS GLU Slides during validation testing for a proposed change and confirmed Dextran 40 and Glutathione may interfere with current VITROS GLU Slides. ","10/17/2016",," Current/In-date GENs 10, 11, 20 through 31",8/11/2016,"08/11/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74950,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy,  Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.","Z-0090-2017","Class II","VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD ---    For in vitro diagnostic use only. VITROS Chemistry Products LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.","US: 32,081 sales units; Foreign: 29,932 sales units","Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.  ","10/17/2016",," Current/In-date GENs 30, 31",8/11/2016,"08/11/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74950,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy,  Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.","Z-0091-2017","Class II","VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales unit) and 832 9930 (90 slides per sales unit), Unique Device Identifier Nos. 10758750008889 and 10758750004768, Rx ONLY, IVD ---   For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders","US: 60,372 sales units; Foreign: 145,611 sales units","Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.  ","10/17/2016",," Current/In-date GENs 16, 17, 19, 20, 22, 23, 24, 25, 27 through 32",8/11/2016,"08/11/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74950,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy,  Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.","Z-0092-2017","Class II","VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit),  Unique Device Identifier No. 10758750000340, Rx ONLY, IVD ---   For in vitro diagnostic use only.","US: 18,749 sales units; Foreign: 94,928 sales units","Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.  ","10/17/2016",," Current/In-date GENs 26, 27, 28, 29, 31",8/11/2016,"08/11/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74951,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - Nationwide Distribution including the countries of:    Argentina                   Australia                Brazil                   Canada                   Chile                    China                   Ecuador                    India                   Japan                   Korea                    Mexico                    Malaysia                    Peru                    Philippines                    Saudi Arabia                  Singapore                   Taiwan                    Vietnam                   South Africa","Z-2899-2016","Class II","' systems: Myoglobin cTnl  Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)","2,248 kits","Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization","09/28/2016",," Kit Lots ending in 63 and 64 as follows:  65710A63, 77825A63, 99481A64, 08835A64, 22955A64  ",8/8/2016,"08/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74952,"Ongoing","Global Healthcare Inc","11350 Old Roswell Rd","Suite 700","Alpharetta","GA","30009-2291","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","FL","Z-2870-2016","Class II",", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243  Made in China.","282 cartons (1000 units per carton)","The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.","09/22/2016",," Model Number: MED 5223, Lot Number: 201505 l0",8/9/2016,"08/09/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74953,"Ongoing","Impax Laboratories, Inc.","31153 San Antonio Street",,"Hayward","CA","94544","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","D-0215-2017","Class I","Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA ","3,054 boxes (30 count boxes)","Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs","12/22/2016",," Lot Number 502240, expiry date 11/2017",8/19/2016,"08/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74954,"Ongoing","Pentax of America Inc","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2875-2016","Class II","Pentax Video Bronchoscope   Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.","1719 units","Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.","09/22/2016",," EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K",5/31/2016,"05/31/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74955,"Ongoing","Medtronic Inc.","18000 Devonshire Street",,"Northridge","CA","91325-1219","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to TN, MN, and WA","Z-2898-2016","Class II","CareLink iPro Version 1.10, Catalog No. MMT-7340  With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.","33 units ","Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.  ","09/27/2016",," n/a",8/5/2016,"08/05/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74956,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","4139 Carmichael Rd",,"Montgomery","AL","36106-2803","United States","Voluntary: Firm Initiated","FAX","AL","B-0763-16","Class II","Apheresis Platelets, Leukocytes Reduced","3 units","Blood products, with unacceptable pH levels, were distributed.","09/12/2016","09/12/2016"," W115116191012Z-part 1; W115116191012Z- part 2; W115116191012Z-part 3 ",8/3/2016,"08/03/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74957,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","424 S Mesa Hills Dr",,"El Paso","TX","79912-5441","United States","Voluntary: Firm Initiated","Telephone","TX","B-0766-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.","09/12/2016","09/12/2016"," W0412160230334",7/8/2016,"07/08/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74958,"Terminated","Department of Army William Beaumont Army Medical Center","5005 N Piedras St",,"El Paso","TX","79920-5001","United States","Voluntary: Firm Initiated","FAX","NJ","B-0765-16","Class II","Red Blood Cells","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.","09/12/2016","09/12/2016"," W012716002909",8/5/2016,"08/05/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74960,"Terminated","Gulf Coast Regional Blood Center","1400 La Concha Ln",,"Houston","TX","77054-1802","United States","Voluntary: Firm Initiated","FAX","Korea, Republic Of(South)","B-0764-16","Class III","Source Leukocytes","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","09/12/2016","09/12/2016"," W044616316336 ",7/13/2016,"07/13/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74961,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, to the states of AK, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Nambia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.","Z-2712-2016","Class II","Monaco RTP System    Used to make treatment plans for patients with prescriptions for external beam radiation therapy.","3,012 units","In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.","09/01/2016",," Software 3.1 and higher.",8/18/2016,"08/18/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74963,"Ongoing","AirStrip Technologies, Inc.","565 Pearl St Ste 209",,"La Jolla","CA","92037-5050","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AR, LA.    Foreign distribution to the following; South Africa, Netherlands.","Z-2829-2016","Class II","AirStrip Sense4Baby Model C Fetal Monitor    The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.","42","Belt clip may become detached causing electronic components to be exposed.","09/15/2016",," Serial Number:  C2386DA70E  C2386EC9CD  C2386ECAF3  C2386EC9CE  C2386EC9B6   C2386EC9C5   C2386EC9C0   C2386EC9CB   C2386DA70D   C2386EC9AF   C2386EC9B7   C2386EC9CF   C2386EC9B4   C2386DA718   C2386ECAF5   C2386EC9B5   C2387684D9   C2386DA771   C2386EC9B8   C2386EC9D4   C2386EC9C3   C2386EC9B3   C2386ECAFA   C2386EC4C4   C2386EC9C9   C2386EC9D3   C2386ECAE6   C2386DA77E   C2386EC9B1   C2386DA715   C2386EC9CE   C2386EC9BC   C2386ECB36   C2386EC9C1   C2386EC9DC   C2386ECAF8   C2386DA786   C2386ECAFB   C2386EC9AE   C2386EC9C8   C2386EC9D0   C2386ECAEE ",8/4/2016,"08/04/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74964,"Ongoing","Lupin Limited","15-B, Phase 1A, Verna Industrial Area",,"Verna, Salcette, Goa",,,"India","Voluntary: Firm Initiated","E-Mail","US      No recalled product was distributed to any foreign consignees by Lupin.","D-1492-2016","Class III","Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09"," 43,536 bottles","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. ","09/06/2016",," Lot #: G304799, Exp. 4/2016  ",2/19/2016,"02/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74964,"Ongoing","Lupin Limited","15-B, Phase 1A, Verna Industrial Area",,"Verna, Salcette, Goa",,,"India","Voluntary: Firm Initiated","E-Mail","US      No recalled product was distributed to any foreign consignees by Lupin.","D-1493-2016","Class III","Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03","11,812 bottles  ","CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. ","09/06/2016",," Lot #: G304677, G304540, G304536,  G304537, G304535, G304541,  G304545, G304533, G304532, G304539, G304538, G304534,  Exp. 4/2016  ",2/19/2016,"02/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74965,"Ongoing","Reckitt Benckiser LLC","399 Interpace Pkwy",,"Parsippany","NJ","07054-1133","United States","Voluntary: Firm Initiated","Letter","FL, MA and NJ","D-1517-2016","Class III","Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60","738 boxes","Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.","09/22/2016",," WO00809739, 9/2017",8/3/2016,"08/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2820-2016","Class II","Bifurcated SafeSet Kit with 03mL Flush Device for Bryan Memorial Hospital, Item No. 46091-75    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3281259",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2809-2016","Class II"," Tubing, Disposable Transducer, 3 mL Squeeze Flush, Macrodrip (Pole Mount), Item No. 42646-06    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","4180 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3261710  3265457",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2814-2016","Class II","Single Monitoring Kit with 30mL Flush Device for Egleston Hospital, Item No. 46073-38    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3264706",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2815-2016","Class II","Monitoring Kit with 30mL Flush Device for UTMB, Item No. 46076-15    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3281057",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2822-2016","Class II"," Manifold with Transpac IV, Item No. 46100-29    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3281417",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2817-2016","Class II","Double Kit with SafeSet and 03mL Flush Device for O.H.S.U., Item No. 46080-37    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","110 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3274859",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2807-2016","Class II","Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush  and Needleless Valve, Item No. 42500-66    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3265419",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2818-2016","Class II","Monitoring Kit with 03mL Flush Device for Iowa Methodist Hospital, Item No. 46080-57  Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","70 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3265519",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2805-2016","Class II"," Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","420 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3273075  3265340  ",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2826-2016","Class II","Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item No. 46107-35, 46110-07    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","70 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3275010, 3264743",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2828-2016","Class II","Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3265807",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2827-2016","Class II","Transpac IV Trifurcated  Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","150 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3264164",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2819-2016","Class II","SafeSet Kit with 30 mL Flush Device for Children's Hospital, Item No. 46083-42    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","125 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3281099",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2811-2016","Class II"," Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","980 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3280989",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2816-2016","Class II","Triple Line SafeSet Kit with 03mL Flush Device for E.U.S.H.C, Item No. 46076-27    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","150 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3274852",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2808-2016","Class II"," TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item No. 42619-08    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","60 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3280976",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2824-2016","Class II"," Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53  Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3281531",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2806-2016","Class II"," Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","250 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3264103",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2810-2016","Class II"," Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","1420 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3279178  3261715  ",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2812-2016","Class II",", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","760 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3279183",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2825-2016","Class II","TP4  Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","140 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3275005",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2823-2016","Class II","Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22    Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3264739",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2813-2016","Class II"," SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","90 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3279181",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74966,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2821-2016","Class II","Pediatric Kit with 30mL Flush Device for University of Colorado, Item No. 46099-10    Product Usage:  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","09/15/2016",," 3274952",8/10/2016,"08/10/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74967,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.","Z-2691-2016","Class II","HexaPOD evo RT System    Product Usage:  The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.  ","13","Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.","08/30/2016",," iGuide 2.2.0",8/18/2016,"08/18/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74968,"Ongoing","Genzyme Corporation / Genzyme Biosurgery","1125 Pleasantview Ter",,"Ridgefield","NJ","07657-2310","United States","Voluntary: Firm Initiated","Letter","nationwide","D-1518-2016","Class III","Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by:  Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01      ","9,530 vials","Labeling: Incorrect or Missing Lot and/or Exp. Date","09/22/2016",," Lot # 5RZ002; Exp. 04/18",8/4/2016,"08/04/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74969,"Ongoing","Superior Foods","275 Westgate Dr",,"Watsonville","CA","95076-2470","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH, CA, IA, FL, TX, MD, MA","F-2085-2016","Class II","Archer Farms Corn & Black Bean Quinoa Blend with pineapple & red pepper packaged in a flexible plastic bag","2021 cases","Product contains undeclared wheat","09/06/2016",," 6103SFK7 through 6103SFK9",8/11/2016,"08/11/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74969,"Ongoing","Superior Foods","275 Westgate Dr",,"Watsonville","CA","95076-2470","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","OH, CA, IA, FL, TX, MD, MA","F-2086-2016","Class II","Archer Farms Quinoa 10 oz packaged in flexible plastic bag","298 cases","Product contains undeclared wheat","09/06/2016",," 6103SFK5 through 6103SFK7",8/11/2016,"08/11/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",74970,"Ongoing","Sage Products LLC","3909 3 Oaks Rd",,"Cary","IL","60013-1804","United States","Voluntary: Firm Initiated","Letter","Domestic: Nationwide, Washington D.C., and Puerto Rico. Foreign: UAE, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.",,"Class I","Comfort Bath Cleansing Washcloths    c) DEODORANT BATH 5-PACK, 84 packages per case, Product Code 7815    d) DEODORANT BATH 8-PACK, 60 packages per case, Product Code 7818    i) DEODORANT BATH 8-PACK, 44 packages per case, Product Code 7942    j) DEODORANT CLEAN-UP BATH 3-PACK, 100 packages per case, Product Code 7943  ","34,984 cases","Potential contamination with the bacteria, Burkholderia cepacia.","10/14/2016",," c) DEODORANT BATH 5-PACK, Product Code 7815    d) DEODORANT BATH 8-PACK, Product Code 7818    i) DEODORANT BATH 8-PACK, Product Code 7942    j) DEODORANT CLEAN-UP BATH 3-PACK, Product Code 7943    No expiration dates.",8/19/2016,"08/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",74970,"Ongoing","Sage Products LLC","3909 3 Oaks Rd",,"Cary","IL","60013-1804","United States","Voluntary: Firm Initiated","Letter","Domestic: Nationwide, Washington D.C., and Puerto Rico. Foreign: UAE, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.",,"Class I","Incontinence Clean-Up Cloths with dimethicone and aloe, Fragrance-Free, Product Code 7505, 8 cloths per package, 30 packages per case","7898 cases","Potential contamination with the bacteria, Burkholderia cepacia.","10/14/2016",," Lot # 52588 ,  Lot # 52596 ,  Lot # 52603 ,  Lot # 52607 ,  Lot # 53401 ,  Lot # 53425 ,  Lot # 54432 ,  Lot # 55892 .    No expiration dates.",8/19/2016,"08/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",74970,"Ongoing","Sage Products LLC","3909 3 Oaks Rd",,"Cary","IL","60013-1804","United States","Voluntary: Firm Initiated","Letter","Domestic: Nationwide, Washington D.C., and Puerto Rico. Foreign: UAE, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.",,"Class I","M-Care Meatal Cleansing Cloths for the Foley Catheterized Patient    a) M-CARE CLEANSING CLOTH 2-PACK, 168 packages per case, Product Code 7952    b) M-CARE CLEANSING CLOTH 4 2-PACKS, 36 packages per case, Product Code 7954","6058 cases","Potential contamination with the bacteria, Burkholderia cepacia.","10/14/2016",," a) Lot Numbers 46651, 47524, 49247, 49782, 50894, 50899, 50904, 51181, 52169, 53283, 54171, 54956, 55721, and 56302.    b) Lot Numbers 47528, 48233, 51197, 52174, 53297, 54189, 55754, 56327, 47851, 47880, 47940, 48497, 51512, 52339, 52381, 52386, 52424, 53200, 54026, 54852, 55337, 55739, 56205.     No expiration dates.",8/19/2016,"08/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",74970,"Ongoing","Sage Products LLC","3909 3 Oaks Rd",,"Cary","IL","60013-1804","United States","Voluntary: Firm Initiated","Letter","Domestic: Nationwide, Washington D.C., and Puerto Rico. Foreign: UAE, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.",,"Class I","Comfort Bath Cleansing Washcloths    a) ESSENTIAL BATH 8-PACK, Fragrance Free, 60 packages per case, Product Code 7803    b) Dignity Health ESSENTIAL BATH 8-PACK, Fragrance Free, 60 packages per case, Product Code 7805    c) COMFORT ESSENTIAL BATH 5-PACK, 84 packages per case, Product Code 7855    d) ESSENTIAL BATH 5-PACK, Fragrance Free, 84 packages per case, Product Code 7856    e) COMFORT BATH 8-PACK, Fragrance Free, 44 packages per case, Product Code 7903    f) COMFORT BABY BATH 4-PACK, Fragrance Free, 110 packages per case, Product Code 7907    g) COMFORT BATH 5-PACK, Fragrance Free, 48 packages per case, Product Code 7956    h) BATH CLOTHS 5-PACK, Fragrance Free, 78 packages per case, Product Code 7959    i) BATH CLOTHS 8-PACK, 88 packages per case, Product Code 7982    j) IMPREVA BATH 5-PACK, Fragrance Free, 78 packages per case, Product Code 7987    k) IMPREVA BATH 8-PACK, Fragrance Free, 60 packages per case, Product Code 7988    l) COMFORT BATH 2-PACK, Fragrance Free, 96 packages per case, Product Code 9775    m) ESSENTIAL BATH 8-PACK, 60 packages per case, Product Code 7800-MC    n) COMFORT BATH 2-PACK, 96 packages per case, Product Code 9702-P  ","66,118 cases","Potential contamination with the bacteria, Burkholderia cepacia.","10/14/2016",," a) ESSENTIAL BATH 8-PACK, Product Code 7803    b) ESSENTIAL BATH 8-PACK, Product Code 7805    c) COMFORT BATH 5-PACK, Product Code 7855    d) ESSENTIAL BATH 5-PACK, Product Code 7856    e) COMFORT BATH 8-PACK, Product Code 7903    f) COMFORT BATH 4-PACK, Product Code 7907    g) COMFORT BATH 5-PACK, Product Code 7956    h) BATH CLOTHS 5-PACK, Product Code 7959    i) BATH CLOTHS 8-PACK, Product Code 7982    j) IMPREVA BATH 5-PACK, Product Code 7987    k) IMPREVA BATH 8-PACK, Product Code 7988    l) COMFORT BATH 2-PACK, Product Code 9775    m) ESSENTIAL BATH 8-PACK, Product Code 7800-MC    n) COMFORT BATH 2-PACK, Product Code 9702-P    a) Lot Numbers 46651, 47524, 49247, 49782, 50894, 50899, 50904, 51181, 52169, 53283, 54171, 54956, 55721, and 56302.    b) Lot Numbers 47851, 47880, 47940, 48497, 51512, 52339, 52381, 52386, 52424,   53200, 54026, 54852, 55337, and 55739.    No expiration dates.",8/19/2016,"08/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74971,"Ongoing","McCormick &  Company - Corporate Headquarters","18 Loveton Cir",,"Sparks","MD","21152-9202","United States","Voluntary: Firm Initiated","E-Mail","Product shipped to the following states: AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KY, LA, MD, MS, NC, OR, PA, SC, TN, TX, VA, WA, and WI  .     Other Countries: Curacao","F-2329-2016","Class II","ZATARAINS WHITE CHEDDAR CHIPOTLE PASTA DINNER   6 OZ PACKAGE  ","1972 Cases","The Zatarains plant in Gretna, LA was contacted by General Mills to inform the plant that they were impacted by General Mills flour recall.  Fifty (50) bags of 	WONDRA ENR 50 UNMALTED were shipped to Gretna in March 2016. This material has been used in the production of four different Zatarains brand pasta 	dinner mixes over several processing dates.","09/16/2016",," McCormick   Material Code  900851309    BEST BY OCT 31 17Z  BEST BY NOV 1 17Z  BEST BY DEC 23 17Z  ",8/12/2016,"08/12/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74971,"Ongoing","McCormick &  Company - Corporate Headquarters","18 Loveton Cir",,"Sparks","MD","21152-9202","United States","Voluntary: Firm Initiated","E-Mail","Product shipped to the following states: AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KY, LA, MD, MS, NC, OR, PA, SC, TN, TX, VA, WA, and WI  .     Other Countries: Curacao","F-2327-2016","Class II","ZATARAINS GUMBO PASTA DINNER 5.7 OZ PACKAGE","1191 Cases","The Zatarains plant in Gretna, LA was contacted by General Mills to inform the plant that they were impacted by General Mills flour recall.  Fifty (50) bags of 	WONDRA ENR 50 UNMALTED were shipped to Gretna in March 2016. This material has been used in the production of four different Zatarains brand pasta 	dinner mixes over several processing dates.","09/16/2016",," McCormick   Material Code  900723033    BEST BY MAR18 18Z  BEST BY APR 26 18  BEST BY JUN 20 18Z  ",8/12/2016,"08/12/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74971,"Ongoing","McCormick &  Company - Corporate Headquarters","18 Loveton Cir",,"Sparks","MD","21152-9202","United States","Voluntary: Firm Initiated","E-Mail","Product shipped to the following states: AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KY, LA, MD, MS, NC, OR, PA, SC, TN, TX, VA, WA, and WI  .     Other Countries: Curacao","F-2328-2016","Class II","ZATARAINS SCAMPI PASTA DINNER 5.2 OZ PACKAGE","2329 Cases","The Zatarains plant in Gretna, LA was contacted by General Mills to inform the plant that they were impacted by General Mills flour recall.  Fifty (50) bags of 	WONDRA ENR 50 UNMALTED were shipped to Gretna in March 2016. This material has been used in the production of four different Zatarains brand pasta 	dinner mixes over several processing dates.","09/16/2016",," McCormick   Material Code  900723034    BEST BY SEP 19 17Z        ",8/12/2016,"08/12/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74971,"Ongoing","McCormick &  Company - Corporate Headquarters","18 Loveton Cir",,"Sparks","MD","21152-9202","United States","Voluntary: Firm Initiated","E-Mail","Product shipped to the following states: AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KY, LA, MD, MS, NC, OR, PA, SC, TN, TX, VA, WA, and WI  .     Other Countries: Curacao","F-2326-2016","Class II","ZATARAINS SOUTHERN STROGANOFF PASTA DINNER 6.5 OZ. PACKAGE","3250 Cases","The Zatarains plant in Gretna, LA was contacted by General Mills to inform the plant that they were impacted by General Mills flour recall.  Fifty (50) bags of 	WONDRA ENR 50 UNMALTED were shipped to Gretna in March 2016. This material has been used in the production of four different Zatarains brand pasta 	dinner mixes over several processing dates.","09/16/2016",," McCormick   Material Code  900723030    BEST BY SEPT 20 17Z  BEST BY SEPT 21 17Z   BEST BY OCT 31 17Z  BEST BY DEC 23 17Z  BEST BY DEC 27 17Z       ",8/12/2016,"08/12/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2629-2016","Class I","Ultra-Soy Imitation Bacon Flavored Bits-B163, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","1,200 boxes = 30,000lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16194, exp Nov 9, 2016",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2631-2016","Class I","Ultra-Soy Imitation Bacon Flavored Chiplets-B100, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","19 boxes of 25lb bags = 475lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16201, exp Jul 19, 2017",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2637-2016","Class I","Ultra-Soy Textured Vegetable Protein (Red Chips)-BS140, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","285 bags=14250lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16181, exp Jun 29, 2018  ",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2638-2016","Class I","Ultra-Soy Imitation Bacon Flavored Chiplets-B106, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","7 boxes =175lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16612, exp Aug 3, 2017  ",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2633-2016","Class I","Ultra-Soy Textured Vegetable Protein-BS104, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","158 bags = 7900lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16181, exp Jun 29, 2018",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2635-2016","Class I","Ultra-Soy Textured Vegetable Protein (Red Chips)-BS135, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","651 bags = 32550lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16180, exp Jun 28, 2018  ",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2630-2016","Class I","Ultra-Soy Imitation Bacon Flavored Chips-B162, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","1,600 boxes = 40,000lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16196, exp Nov 11, 2016",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2634-2016","Class I","Ultra-Soy Textured Vegetable Protein (Red Chiplets)-BS100, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","83 50lb bags = 4150lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16181, exp Jun 29, 2018  Lot number 16182, exp Jun 30, 2018",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2636-2016","Class I","Ultra-Soy Textured Vegetable Protein (Red Bits)-BS138, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","487 bags=24350lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16180, exp Jun 28, 2018  ",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74973,"Ongoing","C H S Inc","2701 E. 11th Ave","P O Box 1099","Hutchinson","KS","67504","United States","Voluntary: Firm Initiated","Telephone","Shipped to IL, MO, MD, OR, and Guyana.","F-2632-2016","Class I","McCormick Code 601091 Imitation Bacon Flavored Granules-B130, packaged in an 850lb tote, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006","57 totes = 48,450lbs","Copacker notified firm of positive results for Salmonella in finished product testing.","09/30/2016",," Lot number 16202, exp Jul 20, 2017",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74974,"Ongoing","Bayer Healthcare","1 Bayer Dr",,"Indianola","PA","15051-9702","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.","Z-2768-2016","Class II","Certegra Workstation used in conjunction with Medrad Stellant CT Injection System   Catalog Number # CWKS DISPLAY  Serial Numbers   The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications","165 systems","CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.","09/08/2016",," Serial Numbers:   KSA0517595  KSA0518535  KSA0519948  KSA0518539  KSA0518498  KSA0517618  KSA0518500D  KSA0518536  KSA0518456  KSA0518504  KSA0518520  KSA0519940  KSA0518507  KSA0519991  KSA0517568  KSA0517592  KSA0517649  KSA0518496  KSA0518508  KSA0519971  KSA0518534  KSA0517600  KSA0517566  KSA0517587  KSA0518469  KSA0518452  KSA0518460  KSA0518532  KSA0518516  KSA0519946  KSA0517641  KSA0519968  KSA0519941  KSA0518399  KSA0518479  KSA0517609  KSA0517617  KSA0518446  KSA0518453  KSA0518410  KSA0518466  KSA0517581  KSA0517574  KSA0518524  KSA0519956  KSA0518459  KSA0518495  KSA0518481  KSA0518513  KSA0518528  KSA0519989  KSA0518429  KSA0518523  KSA0517620  KSA0518509  KSA0517634  KSA0519964  KSA0518418  KSA0518474  KSA0518526  KSA0518468  KSA0518499  KSA0518463  KSA0517571  KSA0517648  KSA0517564  KSA0517644  KSA0518423  KSA0517582  KSA0518427  KSA0518518  KSA0518419  KSA0518397  KSA0518505  KSA0518522  KSA0517660  KSA0518492  KSA0519955  KSA0517629  KSA0518461  KSA0519951  KSA0518471  KSA0517597  KSA0517565  KSA0517656  KSA0518506  KSA0517607  KSA0517659  KSA0518491  KSA0517632  KSA0519978  KSA0517590  KSA0517612  KSA0517613  KSA0518447  KSA0518424  KSA0518400  KSA0519939  KSA0518431  KSA0518435  KSA0518515  KSA0518490  KSA0517624  KSA0518455  KSA0517661  KSA0518493  KSA0519945  KSA0517575  KSA0517588  KSA0517616  KSA0517653  KSA0517657  KSA0517658  KSA0518449  KSA0519982  KSA0519959  KSA0518426  KSA0519984  KSA0519976  KSA0519952  KSA0518511  KSA0518540  KSA0517584  KSA0517651  KSA0519947  KSA0518413  KSA0518405  KSA0518502  KSA0519954  KSA0519980  KSA0518531  KSA0518443  KSA0518529  KSA0519972  KSA0518510  KSA0517637  KSA0519990  KSA0518484  KSA0517602  KSA0518437  KSA0518477  KSA0517583  KSA0518530  KSA0518412  KSA0517577  KSA0519958  KSA0518442  KSA0518525  KSA0517635  KSA0517662  KSA0519957  KSA0519961  KSA0519981  KSA0518521  KSA0517646  KSA0518464  KSA0517576  KSA0518420  KSA0518433  KSA0519960  KSA0518414  KSA0517596  KSA0519970  KSA0518473  ",8/2/2016,"08/02/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74975,"Ongoing","Aribex Inc","11727 Fruehauf Dr",,"Charlotte","NC","28273-6507","United States","Voluntary: Firm Initiated","Letter","AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA. HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY , Puerto Rico, Afghanistan, Argentina, Australia, Bahamas, Bahrain, Belgium, Bermuda, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kuwait, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Saudi Arabia, Papua New Guinea, Philippines, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, UAE, United Kingdom, Venezuela, Vietnam","Z-2716-2016","Class II","NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part Number 08500019","16,871","  Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB. ","09/02/2016",," Part Number 08500009 - Serial Number Range BX-011008-01 - XB-141219049; Part Number 08500011- Serial Number Range XC -090305-03 - XC-140312-02; Part Number 08500013 - Serial Number Range XB-110411-01 - XB-140616-13; Part Number 08500017 - Serial Number Range XB-120911-04 - XB-141210-50; Part Number 08500019 - Serial Number Range XB-120517-09 - XB-121212-24 ",7/18/2016,"07/18/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74975,"Ongoing","Aribex Inc","11727 Fruehauf Dr",,"Charlotte","NC","28273-6507","United States","Voluntary: Firm Initiated","Letter","AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA. HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY , Puerto Rico, Afghanistan, Argentina, Australia, Bahamas, Bahrain, Belgium, Bermuda, Chile, China, Columbia, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kuwait, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Saudi Arabia, Papua New Guinea, Philippines, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, UAE, United Kingdom, Venezuela, Vietnam","Z-2717-2016","Class II"," NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029","16,871","  Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB. ","09/02/2016",," Part Number 08500021 - Serial Number Range XD-100921-05 - XD-150109-11, 10000 - 20811, XD-140929-39 - XD-150123-20; Part Number 08500022 - Serial Number Range XE-130528-03 - XE-150123-38, 10000 - 20541, XE-140908-32 - XE-150123-40; Part Number 08500023 - Serial Number Range XF-121008-05 - XF-150205-03, 10003 - 20032, XE-150205-01; Part Number 08500024 - Serial Number Range XG-130520-01 - XG-141210-05, 1000 - 20019; Part Number 08500025 - Serial Number Range XI-140303-02 - XI-150210-9, XI-150202-04 - XI-150210-19; Part Number 08500026 - Serial Number Range 10039 - 20041; Part Number 08500027 - Serial Number Range 1000 - 20006, Part Number 08500028 - Serial Number Range 10000 - 20030; Part Number 08500029 - Serial Number Range 10000.",7/18/2016,"07/18/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74976,"Ongoing","CAMBRIDGE FARMS OF HANOVER LLC D","201 Granite Run Dr Ste 250",,"Lancaster","PA","17601-6807","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, FL, MA, MD, NC, PA","F-2389-2016","Class II","Better Value Mix Vegetables, Federated Group, Inc./Arlington Heights, IL 60005-1096; 14 oz. pkgs; BB 05/06/18;   Morning Fresh Farms Mix Vegetables; Merchants Distributors Inc. of Hickory, NC 28601; 32 oz. pkgs; BB  06/01/18;   Morning Fresh Farms Mix Vegetables, Merchants Distributors Inc. of Hickory, NC 28601; 16 oz. pkgs; BB 5/06/18;   Key Foods Mixed Vegetables, Key Foods Stores/ Staten Island, NY 10314; 16 oz. pkgs; BB 04/22/2018;   Laura Lynn Mixed 5 Way Vegetables, Ingle's Markets Inc./Asheville, NC 28816; 16 oz. pkgs; BB 06/17/18;   Key Foods Steamed Mix Vegetable, Key Foods Stores/ Staten Island, NY 10314; 12 oz. pkgs; BB 04/13/18;  ","3051 cs, 12 units/case","Firm was notified by North Carolina Dept. of Agriculture that a sample of Better Valu Cut Corn was found positive for Listeria monocytogenes. Firm initiated a recall based on the sample results.","09/20/2016",," 007980124564  12/14 Better Value Mix Vegetables;   007145220333  12/32 Morning Fresh Farms Mix Vegetables;   007145220332  12/16 Morning Fresh Farms Mix Vegetables;   007329607086  12/16 Key Foods Mixed Vegetables;   007329630483  12/12 Key Foods Steamed Mixed Vegetable;   007329607203  12/16 Key Foods Mix Vegetables;   008685401746  12/16 Laura Lynn Mixed Vegetables 5 Way ;     With Best By date ranges: 04/12/18 thru 06/17/18.",8/18/2016,"08/18/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74976,"Ongoing","CAMBRIDGE FARMS OF HANOVER LLC D","201 Granite Run Dr Ste 250",,"Lancaster","PA","17601-6807","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, FL, MA, MD, NC, PA","F-2393-2016","Class II","Key Foods Soup Mix Vegetables, Key Foods Stores/ Staten Island, NY 10314; 16 oz. pkgs; BB 05/02/18;   Laura Lynn Vegetable Soup Mix, Ingle's Markets Inc./Asheville, NC 28816; 16 oz. pkgs.; BB 04/12/18  ","1050 cases, 12 units/case","Firm was notified by North Carolina Dept. of Agriculture that a sample of Better Valu Cut Corn was found positive for Listeria monocytogenes. Firm initiated a recall based on the sample results.","09/20/2016",," Key Foods: Best By: 05/02/18  Laura Lynn: Best By: 4/12/18",8/18/2016,"08/18/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74976,"Ongoing","CAMBRIDGE FARMS OF HANOVER LLC D","201 Granite Run Dr Ste 250",,"Lancaster","PA","17601-6807","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, FL, MA, MD, NC, PA","F-2390-2016","Class II","Giant Eagle Sweet & Savory Island Quinoa, Giant Eagle, Pittsburgh, PA; 12 oz. pkgs; BB 06/10/18","450 cases, 12 units/cs.","Firm was notified by North Carolina Dept. of Agriculture that a sample of Better Valu Cut Corn was found positive for Listeria monocytogenes. Firm initiated a recall based on the sample results.","09/20/2016",," BB 06/10/2018",8/18/2016,"08/18/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74976,"Ongoing","CAMBRIDGE FARMS OF HANOVER LLC D","201 Granite Run Dr Ste 250",,"Lancaster","PA","17601-6807","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, FL, MA, MD, NC, PA","F-2391-2016","Class II","Laura Lynn Vegetable Gumbo Mix; Ingle's Markets Inc./Asheville, NC 28816, 16 oz. pkgs, BB 05/06/18","300 cs 12/case","Firm was notified by North Carolina Dept. of Agriculture that a sample of Better Valu Cut Corn was found positive for Listeria monocytogenes. Firm initiated a recall based on the sample results.","09/20/2016",," Best By: 05/06/2018",8/18/2016,"08/18/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74976,"Ongoing","CAMBRIDGE FARMS OF HANOVER LLC D","201 Granite Run Dr Ste 250",,"Lancaster","PA","17601-6807","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, FL, MA, MD, NC, PA","F-2392-2016","Class II","The Perfect Bite Co Hawaiian Style Rice & Vegetable Blend, 4 - 12 OZ Bags, Net Weight 3 LBS., Distributed by: TPBC, Glendale, CA 91203; Best By: 05/20/18.","253 cs, 12 units/case","Firm was notified by North Carolina Dept. of Agriculture that a sample of Better Valu Cut Corn was found positive for Listeria monocytogenes. Firm initiated a recall based on the sample results.","09/20/2016",," Best By: 05/20/18",8/18/2016,"08/18/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74976,"Ongoing","CAMBRIDGE FARMS OF HANOVER LLC D","201 Granite Run Dr Ste 250",,"Lancaster","PA","17601-6807","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CT, FL, MA, MD, NC, PA","F-2388-2016","Class II","Best Valu Cut/Cortado; Yellow Corn; Maiz Amarillo;  Net Wt 14 OZ;  Code: SSFF/R 10308; Best By: 04/11/18;  Product of Canada; Distributed by Federated Group Inc., Arlington Heights, IL  ;   Laura Lynn Cut Corn;  Net Wt 16 oz.; Cut Corn Fresh Frozen For Freshness  Best By: 04/11/18, 05/09/18, 06/06/18; Product of Canada; Distributed by Ingle's Markets Inc., Asheville, NC 28816;     Laura Lynn Family Economy Cut Corn; New Wt 32 OZ.;  Best By: 05/10/18; Product of Canada; Distributed by Ingle's Markets Inc., Asheville, NC 28816;     Key Food Premium Fresh Frozen Vegetables Cut Corn; Keep Frozen; Net Wt 16 OZ.; Best By: 04/11/18, 05/02/18, Product of Canada; Distributed by Key Food Stores, Staten Island, NY 10314;        ","2648 cs, 12 units/case","Firm was notified by North Carolina Dept. of Agriculture that a sample of Better Valu Cut Corn was found positive for Listeria monocytogenes. Firm initiated a recall based on the sample results.","09/20/2016",," 7980124561	  Better Value Cut Corn;   8685401734	 Laura Lynn Cut Corn;   7329607091	  Key Foods Cut Corn;   732960169895	  Key Foods Cut Corn;   8685401717	 Laura Lynn Cut Corn    Best By date range: 04/11/18 thru 06/06/18.      ",8/18/2016,"08/18/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",74977,"Ongoing","Balanced Guru","5030 Champion Blvd Ste G11 # 254",,"Boca Raton","FL","33496-2477","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed to the following states: AL, CA, CT, FL, IL, LA, MA, MD, MI, NM, NY, OH, OR, TX, WA,  WY. Distributed worldwide to Canada, Colombia, France, Hong Kong.","F-0376-2017","Class II","Balanced Guru Calming Masque, Organic Calendula & Echinacea Facial Masque, 4 oz and 1 oz.","33 units (1 oz), 193 units (4 oz)","Tested positive for microbial contamination.","10/28/2016",," Lot code 7855115. No expiration date.",9/2/2016,"09/02/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74978,"Terminated","Michigan Blood","1771 Tittabawassee Rd",,"Saginaw","MI","48604-9431","United States","Voluntary: Firm Initiated","E-Mail","Switzerland","B-0716-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. ","08/26/2016","08/26/2016"," W12061633098",7/7/2016,"07/07/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74979,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana","B-0726-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected form a donor who previously tested positive for the antibody to Hepatitis B core Antigen on more than one occasion, was distributed.","08/26/2016","08/26/2016"," W040716329007",6/6/2016,"06/06/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74981,"Ongoing","Chaos and Pain","5149 Selkirk Dr",,"Birmingham","AL","35242-4129","United States","Voluntary: Firm Initiated","E-Mail","UK","F-0081-2017","Class II","CANNIBAL RIOT, SUPER STIMULANT PRE-WORKOUT ENERGY COMPLEX, FIVE FINGER DEATH PUNCH, Chaos and Pain, DIETARY SUPPLEMENTS, NET.WT. 10.5 oz (300g), UPC 610563314652 ","1000 units","The products are being recalled because they contain 750 mg of Agmatine and 50 mg 1,3 Dimethylamyamine per serving which is not declared on the label. 1,3   Dimethylamyamine is not permitted for use in dietary supplements in the EU.  ","10/11/2016",,"  Lot 1607017 EXP 07/18",8/10/2016,"08/10/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74981,"Ongoing","Chaos and Pain","5149 Selkirk Dr",,"Birmingham","AL","35242-4129","United States","Voluntary: Firm Initiated","E-Mail","UK","F-0082-2017","Class II","CANNIBAL RIOT, SUPER STIMULANT PRE-WORKOUT ENERGY COMPLEX, UNICORN BLOOD, Chaos and Pain, DIETARY SUPPLEMENTS, NET.WT. 10.5 oz (300g), UPC 610563314669",,"The products are being recalled because they contain 750 mg of Agmatine and 50 mg 1,3 Dimethylamyamine per serving which is not declared on the label. 1,3   Dimethylamyamine is not permitted for use in dietary supplements in the EU.  ","10/11/2016",," Lot 1607018 EXP 07/18",8/10/2016,"08/10/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74982,"Ongoing","Microgenics Corporation","46500 Kato Rd",,"Fremont","CA","94538-7310","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of KY, CA, NY, DC, NC, TX, IL, OH, IL, FL, IK, IA, MS and countries of Mexico, Taiwan, Guatemala, Malaysia, Argentina, Dominican Republic, Philippines, Germany, Australia.","Z-0008-2017","Class II","Thermo Scientific QMS Everolimus Assay;  Model number:  0380000 (US Distribution);  0373852 (Foreign Distribution)    Product Usage:  The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.  ","163 kits in US, 669 kits worldwide - toatal 831.","A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range.  For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed.  Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the QMS everolimus assay to an everolimus LC-MS reference method.  Patient samples across the measuring range  sub-therapeutic, therapeutic, and supra-therapeutic  could be affected.   ","10/03/2016",," Lot number: 72258049, Expiry date: 07/31/2017;  Lot number: 72258007, Expiry date 07/31/2017.",8/15/2016,"08/15/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74984,"Ongoing","Commerce International Inc.","4300 L B McLeod Rd Ste C",,"Orlando","FL","32811-5686","United States","Voluntary: Firm Initiated","Letter","FLORIDA","F-2401-2016","Class I","Eastern Feast, Green Raisin, 7 oz plastic container.","31 lbs","Initiated by the Florida Department of Agriculture and Consumer Services due to undeclared sulfites on the finished product label.","09/27/2016",," No lot code. UPC 665603780379",8/5/2016,"08/05/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74986,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OH, IN, TN, NC, and KY.","Z-2741-2016","Class II","Radial Artery Catheterization Kit with Sharps Safety Features  Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.","690 kits","Shipping carton labeling error.","09/07/2016",," Device Listing # D025180",8/8/2016,"08/08/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74986,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OH, IN, TN, NC, and KY.","Z-2740-2016","Class II","Arterial Line Catheterization Kit with Sharps Safety Features  Permits access to the peripheral arterial circulation or to other small vessels.","690 kits","Shipping carton labeling error.","09/07/2016",," Device Listing # D025180",8/8/2016,"08/08/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74987,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain.","Z-0039-2017","Class II","Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge  Device Listing No.:  D011443  Batch Number: 16060BB               ","5,991 cartridges","Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.","10/04/2016",," Device Listing No: D011443  Batch Number 16060BB",8/3/2016,"08/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",74988,"Ongoing","Supernus Pharmaceuticals, Inc.","1550 E Gude Dr",,"Rockville","MD","20850-1339","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0112-2017","Class II","Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15    ","17,128 (30-count blister packs)","Superpotent Drug: Failure of assay specifications in the capsule. ","10/20/2016",," Lot # 426636, Exp 4/22/18",7/12/2016,"07/12/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74989,"Ongoing","Hologic, Inc","250 Campus Dr",,"Marlborough","MA","01752-3020","United States","Voluntary: Firm Initiated","Letter","Nationwide.","Z-2869-2016","Class II","Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.   ","570 units","Incorrect label on the Sertera Biopsy Kit","09/21/2016",," Lot number: 15C10RA.",8/22/2016,"08/22/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74990,"Terminated","Blood Bank Of San Bernardino And Riverside Counties","384 E Orange Show Rd",,"San Bernardino","CA","92408-2414","United States","Voluntary: Firm Initiated","Telephone","California","B-0713-16","Class III","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, lacking assurance of proper leukoreduction, were distributed. ","08/25/2016","08/25/2016"," W036216767483E; W036216786415R; ",7/11/2016,"07/11/2016",8/31/2016,"08/31/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74991,"Ongoing","Circulatory Technology Inc","21 Singworth St",,"Oyster Bay","NY","11771-3703","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: LA, MI, NY, OH, OR & TX.","Z-2832-2016","Class II"," long tubing, ITEM BBB38-72    A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.","20 units","The seal between the balloon and the housing may leak.","09/15/2016",," Lot # 014648  USE BY: 09/01/2018",7/1/2016,"07/01/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74992,"Terminated","Blood Bank Of San Bernardino And Riverside Counties","384 E Orange Show Rd",,"San Bernardino","CA","92408-2414","United States","Voluntary: Firm Initiated","FAX","California","B-0748-16","Class II","Red Blood Cells","1 unit","Blood product, which did not meet the acceptable product specifications, was distributed.","09/12/2016","09/12/2016"," W125616424130O; ",6/29/2016,"06/29/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74993,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","Telephone","Indiana","B-0750-16","Class II","Cryoprecipitated AHF","1 unit","Blood products, collected from a donor who were previously deferred, were distributed.","09/12/2016","09/12/2016"," W040714446814; ",8/19/2016,"08/19/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74993,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","Telephone","Indiana","B-0749-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor who were previously deferred, were distributed.","09/12/2016","09/12/2016"," W040714446814; ",8/19/2016,"08/19/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74994,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Pennsylvania; California","B-0751-16","Class II"," Pooled Cryoprecipitated AHF","2 units","Blood products, collected from a donor who was previously deferred, were distributed.","09/12/2016","09/12/2016"," W040714320654; W040713110764; ",6/29/2016,"06/29/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74994,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Pennsylvania; California","B-0752-16","Class II","Red Blood Cells, Leukocytes Reduced","5 units","Blood products, collected from a donor who was previously deferred, were distributed.","09/12/2016","09/12/2016"," W040711533080; W040714134608; W040714432382; W040714217919; W040714210060; ",6/29/2016,"06/29/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74994,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Pennsylvania; California","B-0753-16","Class II","Cryoprecipitated AHF","1 unit","Blood products, collected from a donor who was previously deferred, were distributed.","09/12/2016","09/12/2016"," W040711533080; ",6/29/2016,"06/29/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74995,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Michigan; Florida; Switzerland; Illinois; California","B-0754-16","Class II","Cryoprecipitated AHF","2 units","Blood products, collected from a donor who were previously deferred, were distributed.","09/12/2016","09/12/2016"," W040715171105; W040714631147; ",6/16/2016,"06/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74995,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Michigan; Florida; Switzerland; Illinois; California","B-0757-16","Class III","Blood and Blood Products for Reprocessing","25 units","Blood products, collected from a donor who were previously deferred, were distributed.","09/12/2016","09/12/2016"," W040713610449; W040709340152; W040715171105; W040716261295; W040714631147; W040713673676; W040712673371; W040715116976; W040715142784; W040714142759; W040712145612; W040711236012; W040716267807; W040715181671; W040715112321; W040714531639; W040714233270; W040712635351; W040712130216; W040712234150; W040711116052; W040711619168; W040711610432; W040710237186; W040710437733; ",6/16/2016,"06/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74995,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Michigan; Florida; Switzerland; Illinois; California","B-0756-16","Class II","Red Blood Cells, Leukocytes Reduced","26 units","Blood products, collected from a donor who were previously deferred, were distributed.","09/12/2016","09/12/2016"," W040709340152; W040715171105; W040713610449; W040716261295; W040714631147; W040713673676; W040712673371; W040715116976; W040715142784; W040714142759; W040712145612; W040711236012; W040716267807; W040715181671; W040715112321; W040714531639; W040714233270; W040713234938; W040712635351; W040712130216; W040712234150; W040711116052; W040711619168; W040711610432; W040710237186; W040710437733; ",6/16/2016,"06/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74995,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Michigan; Florida; Switzerland; Illinois; California","B-0755-16","Class II"," Pooled Cryoprecipitated AHF","3 units","Blood products, collected from a donor who were previously deferred, were distributed.","09/12/2016","09/12/2016"," W040716261295; W040715142784; W040714142759; ",6/16/2016,"06/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74996,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Michigan; Switzerland; California","B-0760-16","Class II","Red Blood Cells, Leukocytes Reduced","3 units","Blood products, collected from a donor who were previously deferred, were distributed.","09/12/2016","09/12/2016"," W040715217099; W040716265669; W040715118049; ",6/16/2016,"06/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74996,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Michigan; Switzerland; California","B-0759-16","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from a donor who were previously deferred, were distributed.","09/12/2016","09/12/2016"," W040715138386; ",6/16/2016,"06/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",74996,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Michigan; Switzerland; California","B-0758-16","Class III","Blood and Blood Products for Reprocessing","3 units","Blood products, collected from a donor who were previously deferred, were distributed.","09/12/2016","09/12/2016"," W040715217099; W040716265669; W040715118049; ",6/16/2016,"06/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74998,"Ongoing","Baptista's Bakery, Inc","4625 W Oakwood Park Dr",,"Franklin","WI","53132-8872","United States","Voluntary: Firm Initiated","E-Mail","WI","F-2163-2016","Class II","Snack Factory , Pretzel Crisps Original, UPC 049508006008,  7.2 oz (204g)."," 281,880 bags (261 pallets with 90 cases each)","Baptista's Bakery was notified by a consumer that their package of original pretzel crisp contained some seasoned product. The seasoned product has the milk allergen which is not declared in the original product. ","09/13/2016",," Item Code  110600",8/16/2016,"08/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",74998,"Ongoing","Baptista's Bakery, Inc","4625 W Oakwood Park Dr",,"Franklin","WI","53132-8872","United States","Voluntary: Firm Initiated","E-Mail","WI","F-2164-2016","Class II","Snack Factory, Pretzel Crisps Srircha Lime, UPC 049508006060,  7.2 oz(204g).","58,320 bags (54 pallets with 90 cases each)","Baptista's Bakery was notified by a consumer that their package of original pretzel crisp contained some seasoned product. The seasoned product has the milk allergen which is not declared in the original product. ","09/13/2016",," Item Code  105782",8/16/2016,"08/16/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",74999,"Ongoing","HeartWare, Inc","14400 NW 60th Ave",,"Miami Lakes","FL","33014-2807","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.","Z-0006-2017","Class I","HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103;  and International Product:  Model No.: 1104XX.      Product Usage:  For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.  ","344 pumps","Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults. ","10/13/2016",," All sterile un-implanted stock manufactured prior to HW25838 is subject to removal. ",8/17/2016,"08/17/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75002,"Terminated","Blood Centers of the Pacific - Irwin Center","270 Masonic Ave",,"San Francisco","CA","94118-4496","United States","Voluntary: Firm Initiated","Telephone","California","B-0777-16","Class II","Red Blood Cells, Leukocytes Reduced","1","Blood product, for which the residual white blood cell count testing was not performed, was distributed.","09/19/2016","09/19/2016"," W041916012280R",8/2/2016,"08/02/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2101-2016","Class II","Inland Market, Premium Blue Crab Spread, Net Wt. 7 oz. (198 g.) and 16 oz. (454g), Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083.","2880 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 9-11-16, 9-12-16, 9-13-16, 9-14-16, 9-16-16, 9-18-16, 9-20-16, 9-21-16 and 9-23-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2111-2016","Class II","Inland Market, Maryland Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083, for Whole Foods Market","86 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 8-11-16, 8-15-16, 8-18-16 and 8-23-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2107-2016","Class II","Spicy Crab Dip, 12 x 8 oz., for Whole Foods Market.","27 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 8-28-16, 9-04-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2110-2016","Class II","Inland Market, Traditional Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083, for Whole Foods Market","46 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 8-11-16, 8-15-16, 8-18-16 and 8-23-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2106-2016","Class II","Spinach Krab & Artichoke Dip, 12 x 8 oz., for Whole Foods Market.","35 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 8-28-16, 9-04-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2105-2016","Class II","Alaskan Salmon Salad, 12 x 8 oz. and 5 lb., for Whole Foods Market","218 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 8-29-16, 9-04-16 and 9-06-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2103-2016","Class II","Original Seafood Cheese Spread, Net Wt. 7 oz. (198 g.), for Publix","1324 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 9-16-16, 9-18-16, 9-22-16, 9-23-16, 9-25-16 and 9-27-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2104-2016","Class II","Reduced Fat Seafood Cheese Spread, Net Wt. 7 oz. (198 g.), for Publix","1157 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 9-16-16, 9-17-16, 9-23-16 and 9-25-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2109-2016","Class II","Inland Market, Dungeness Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083, for Whole Foods Market","54 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 8-11-16, 8-15-16, 8-18-16 and 8-23-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2102-2016","Class II","Inland Market, Premium, Maine Lobster Spread, Net Wt. 7 oz. (198 g.) and 16 oz. (454g), Inland Market, 1667 Lewis Way,  Stone Mountain, GA 30083.","2145 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 9-11-16, 9-13-16, 9-14-16, 9-16-16, 9-18-16 and 9-21-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75003,"Ongoing","Inland Seafood, Inc.","1651 Montreal Cir",,"Tucker","GA","30084-6933","United States","Voluntary: Firm Initiated","E-Mail","CT, FL, GA, MA, MD, NC, NJ, NY, PA, SC, and VA.","F-2108-2016","Class II","Smoked Whitefish Salad, 12 x 8 oz., for Whole Foods Market.","18 cases","Possible contamination with foreign matter; wood pieces.","09/08/2016",," Lot numbers: 8-27-16, 9-04-16.",8/19/2016,"08/19/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75006,"Ongoing","NOVADAQ TECHNOLOGIES INC.","8329 Eastlake Dr Unit 101",,"Burnaby",,,"Canada","Voluntary: Firm Initiated","Letter","US Distribution in states of: FL, MI, and VA.","Z-2767-2016","Class II","Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001))    The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures.  For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery. ","20 units","Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation testing. ","09/08/2016",," Lot # 16047 and 16046",8/18/2016,"08/18/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75007,"Completed","The Scoular Grain Company","250 Marquette Ave Ste 1050",,"Minneapolis","MN","55401-1877","United States","Voluntary: Firm Initiated","Telephone","WI","V-0029-2017","Class II","IPC 600 - Fish Meal, Net Wgt. 50 lb(22.68kg).  Manufacturer Origin:  Gateway Co-Packing, 901 Kingshighway, Washington Park, IL  62204","800 lbs","Customer tested Fish Meal upon receipt and found it positive for Salmonella","11/28/2016",," Lot #:  19489",7/19/2016,"07/19/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75008,"Ongoing","Waismed Ltd","10, Amal St",,"Rosh Haayin",,,"Israel","Voluntary: Firm Initiated","E-Mail","WI, TX, CA, LA and the following countries: UK, Spain, Poland, Israel, Czech Republic, France, Belgium, Denmark, Italy, Cyprus, Austria, Greece, Slovenia, Australia, Germany, Estonia, New Zealand, Switzerland, Costa Rica, Guatemala, Canada, Malaysia, Poland, Singapore, Lithuania, Romania","Z-2680-2016","Class II","NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set.  The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.","50","WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle was released spontaneously. NIO-A and the NIO-P models  have the same activation mechanism. However, none of the affected lots of the NIO-A are distributed in the US, and thus the company is only recalling a single lot of NIO-P in the US.","08/27/2016",," 1620005",8/18/2016,"08/18/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75009,"Terminated","New York Blood Center, Inc.","4501 Vernon Blvd",,"Long Island City","NY","11101-5201","United States","Voluntary: Firm Initiated","FAX","New York; New Jersey","B-0778-16","Class II","Red Blood Cells, Leukocytes Reduced","6 units","Blood products, in which quality control for residual WBC count did not meet specifications, were distributed.","09/19/2016","09/19/2016"," W047016162190; W047016150977; W047016136514; W047016130775; W047016129943; W047016124376",6/10/2016,"06/10/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75011,"Ongoing","Merit Medical Systems, Inc.","1600 W Merit Pkwy",,"South Jordan","UT","84095-2416","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0649-2017","Class II","Custom Fluid Management Set, Sterile, EO, Rx Only    Used to transfer contrast media and saline from a container to a patients  vascular system.","107,341 total devices","Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to mold in the drip chamber. ","11/21/2016","."," Part Number: 701610001, K08-02053A, K08-02111A, K-08-2192A, K08-02385, K08-02385P, K08-02649, K08-02690, K08-02930a, K08-03044, K08T-02829, K09-00807AD, K09-01467AC, K09-01467AD, K09-01732N, K09-02334N, K09-02608A, K09-03491HP, K09-03586AC, K09-03743L, K09-04300Q, K09-04775HP, K09-04916JP, K09-05525A, K09-05648GP, K09-05993F, K09-07692D, K09-08374C, K09-08485F, K09-08556G, K09-08592N, K09-08603B, K09-08720G, K09-08720H, K09-08743L, K09-08743M, K09-08790C, K09-08813J, K09-09067C, K09-09144B, K09-09221CP, K09-09280A, K09-09326, K09-09418CP, K09-09439, K09-09474H, K09-09527D, K09-09657AP, K09-09672AP, K09-09677A, K09-09683l, K09-09683LP, K09-09859FP, K09-09966AP, K09-09966BP, K09-09983A, K09-10008C, K09-10009D, K09-10312, K09-10457C, K09-10590, K09-10593A, K09-10745BP, K09-10784A, K09-10800CP, K09-10870C, K09-10915F, K09-10947J, K09-10947LP, K09-10992CP, K09-11004F, K09-11004FP, K09-11132CP, K09-11132DP, K09-11137A, K09-11165B, K09-11259B, K09-11270A, K09-11303, K09-11303A, K09-11306, K09-11309D, K09-11336B, K09-11389, K09-11433F, K09-11452AP, K09-11530P, K09-11549D, K09-11655A, K09-11704, K09-11796C, K09-11796CP, K09-11867AP, K09-11901B, K09-11912, K09-11923C, K09-11940AP, K09-11971B, K09-12000, K09-12000A, K09-12006, K09-12065CP, K09-12065D, K09-12065DP, K09-12123A, K09-12138, K09-12138A, K09-12138B, K09-12216, K09-12276, K09-12304, K09-12305, K09-12356, K09-12376, K09-12393, K09-12408, K09-12408A, K09-12421, K09-12431, K09-12529, K09-12530, K09-12530P, K09-12562P, K09-12610, K09-12610P, K09-12647, K09-12689, K09-12698, K09T-03491C, K09T-09672G, K09T-10728C, K09T-11022C, K09T-11410C, K09T-11796C, K09T-11796D, K09T-11940A, K09T-12624, K10-05097A, K11-01028, K11-01376, K12T-06138A, K12T-07389A, and K12T-08215.",8/12/2016,"08/12/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75012,"Ongoing","Biosense Webster, Inc.","15715 Arrow Hwy",,"Irwindale","CA","91706-2006","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution to China","Z-2776-2016","Class II","CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 and v 4.3  The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.","54 units","Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).","09/09/2016",," V 3.2: 2258, 10284, 10332, 10345, 11640, 11642, 60011, 60012, 60606, 60611, 60613, 60618, 60621, 60625, 60634, 60644, 60651, 60654, 60657, 60658, 60660, 60661, 60664, 60671, 60673, 60674, 60680, 60682, 60683, 61000, 61002, 61005, 61010, 61014, 61038, 61039, 61041, 61045, 61046, 61050, 61055, 61060, 61062, 61064, 61071, 61501, 66114, 66115, 66117, 66118, 66119.    V 4.3: 61053, 61054, 61059.    ",8/15/2016,"08/15/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75014,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-2911-2016","Class II","Walrus Arterial Embolectomy Catheter    The arterial embolectomy catheter is intended for use in removing arterial emboli.","2,425 catheters","Arrow  is  recalling  due  to  incorrect  labeling  of  products.  ","09/30/2016",," Lot/Batch 14F15H0292, 14F15J0139, 14F15A0174, CF3016366, 14F14E0300, 14F15G0349, 14F15H0261, CF2079921, 14F15J0363, 14F14J0155, 14F15F0406, 14F15E0263, 14F15H0258, 14F15H0251, 14F15G0347. CF2125865, 14F15D0197, 14F15H0025, 14F15H0332, 14F15B0244, 14F15G0348",7/7/2016,"07/07/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75015,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide and Internationally","Z-2789-2016","Class II","Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10)    The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and secure it in position while the surgeon removes any excess cement and when cement polymerization occurs.","2,039 units","Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.","09/13/2016",," Catalog No. 3182-1000  Lot #'s: RD8E100, RD8A054TT, RD8A054T, RD8E099M, RD8E099A, RD8E099, RD8A054A, RD8E099D, RD8A053A, RD8A054, RD8A053T, RD7K062L, RD8A052A, RD8A052E, RD8A052, RD8A053, RD7E128D, RD5T290H, RD7E128T, RD5S262D, RD5T290W, RD7K062E, RD5S262X, RD7E128Y, RD7A076MA, RD6W102MA, RD7K062A, RD7K062, RD7E128H, RD7A076A, RD7E128A, RS7E128, RD6W103D, RD6V108J, RD6V108K, RD6V108H, RD7A076H, RD6V112M, RD7A074D, RD7A076J, RD6V112H, RD6W102m, RD5H286A, RD2V022, RD2K049, RD6W103, RD5H286J, RD2T037A, RD7A076M, RD6S136A, RD5H286, RD2V031C, RD5N361T, RD6V112A, RD4M068J, RD2V021C, RD7A076, RD6V112, RD4E226W, RD2V021, RD7A074H, RD6W102, RD4S220W, RD2V023X2, RD6W103A, RD6S136M, RD4M069D, RD2V023X3, RD6V108, RD5W148M, RD4S220, RD2V023, RD7A074, RD5M237K, RD4S220A, RD2V031A, RD7A074A, RD5T290X, RD4S220A1, RD2V023X1, RD6W103M, RD5T290A, RD4M069, RD2V031, RD5K116A, RD6S137A, RD4L128X1, RD2V031X2, RD5M236T, RD5W148A, RD4L128V, RD2V031X1, RD5K116T, RD6S137, RD4E226J, RD2N030K, RD3V002A, RD6S136, RD4M068< RD2T037, RD5M237, RD5W148X, RD4L128, RD2T037X, RD5K116N, RD5W148, RD4E226M, RD2N030E, RD5K116, RD5T290M, RD4E226L1, RD2N030S, RD5M236, RD5T290E, RD4C230L, RD2N030X, RD5H286L, RD5T290, RD4E226L, RD2N030XX, RD3T155L, RD5T290D, RD4E226, RD2N030, RD2V021E, RD5N361A, RD4C162L, RD2K068W, RD2V022W, RD5S305J, RD4C162, RD2N030X1, RD2V021S, RD5S305M, RD4C230, RD2M019E, RD2V022K, RD5N361M, RD4C230X, RD2M039, RD2V022E, RD5S305, RD3V002P, RD2M019H, RD2V021H, RD5S262A, RD3V002X1, RD2K049H, RD2V023E, RD5S262M1, RD3V002X2, RD2M003H, RD2T037W, RD5S262M, RD3V002D1, RD2M038H, RD2K068X1, RD5S262J, RD3V002, RD2K068B, RD2K068, RD5S262, RD3V002D, RD2M003, RD2K049R, RD5N361H, RD3V206D, RD2M038, RD2K049E, RD5M259M, RD3T160L1, RD2M019, RD2K017E, RD5N316, RD3V206X1, RD2K068S, RD2H056, RD5H286D, RD3T155L1, RD2K056S, RD2K056, RD5M259T, RD3T160L3, RD2K065S, RD2K065, RD5M236H, RD3T160, RD2K049S, RD2K017, RD5M259, RD3T160L2, RD2K068E, RD5M237L, RD3T160L, RD2H056E, RD5K116J, RD3V206, RD2K065E, RD4S220D, RD3T155 and RD2K056E",8/1/2016,"08/01/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75016,"Ongoing","R & D Systems, Inc.","614 McKinley Pl NE",,"Minneapolis","MN","55413-2610","United States","Voluntary: Firm Initiated","Letter","US: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA.    OUS: AUSTRALIA, China, INDIA, INDONESIA, ISRAEL, JAPAN, MEXICO, SOUTH KOREA, UNITED KINGDOM.","Z-2887-2016","Class II","R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.","725 kits (502 US, 223 OUS)","R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human sTfR Immunoassay kit were out of the range high.  Internal testing within R&D Systems confirmed a problem with Control results being out of range high.","09/26/2016",," 331636, 331637, 332060, 332090, 332924, 334184, 335062, 335740, 336694, 339307, 340362.  ",8/24/2016,"08/24/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75017,"Ongoing","Panoramic Rental Corp.","4321 Goshen Rd",,"Fort Wayne","IN","46818-1201","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution including Puerto Rico","Z-0016-2017","Class II","Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate    Product Usage:  The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.  ","13,340","Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.","10/03/2016",," Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340",8/19/2016,"08/19/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75018,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","US Nationwide in the states of  RI, WA, CA, CO, WI,FL, ID, ND, MD,TX      Foreign: Australia, New Zealand, Netherlands, France, Italy","Z-0112-2017","Class II","Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090    Product Usage:  Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the following handpieces; 4208-000-000 (SYSTEM 5 SAGITTAL SAW) 6208-000-000 (SYSTEM 6 SAG SAW) 6298-000-000 (ES6 SAGITTAL SAW) 7208-000-000 (SYSTEM 7 SAG SAW)  ","225","Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging.","10/17/2016",," Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090, Lot # 16029017",8/17/2016,"08/17/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75019,"Ongoing","Cardinal Health","1430 S Waukegan Rd",,"Waukegan","IL","60085-6726","United States","Voluntary: Firm Initiated","Letter","Nationwide to U.S. consignees located in the following states:AL ,AR ,AZ ,CA ,CT ,FL ,GA ,IL ,IN ,KY ,LA ,MA ,MD ,MI ,MO ,NC ,NJ ,NM ,NV ,NY ,OH ,PA ,SC ,TX ,UT ,VA ,WA and WV.","Z-2917-2016","Class II","BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific.   An isolation gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material   ","4,062,511 eaches","Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard defines a specific test method that quantifies the rate of flame propagation against a minimum value using an engineered test fixture. The method requires that the test be performed on different orientations of the film (machine direction and cross direction). The machine direction is defined by the manufacturing process generating the film. The formed film exits the machine moving in the machine direction. The cross direction is at 90 degrees to the machine direction. The more rapid burning direction defines the results of the test (either a pass or fail). The products being recalled failed when tested in the machine direction with a result of 1.9-2.0 inches/second versus a limit of 1.2 inches/second. They passed by self-extinguishing when tested in the cross direction.","09/30/2016",," All Lots with material number 5213PG and V5213PG",7/20/2016,"07/20/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75020,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution US Nationwide in the states of FL, IL, KY, MI, NY and OK and countries of Mexico and Canada.","Z-2759-2016","Class II"," Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111,     Product Usage:   Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as indicated. Applier color coding matches the color of the ligating clip cartridge for which it is to be used. Hemoclip Plus appliers are easily identified by one black-ring handle.","49 units","Misbranded: Incorrect etching on the device.","09/08/2016",," Product Code: 337111, Lot Number: 06F1515745.",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75021,"Terminated","BloodSource, Inc.","1880 Park Marina Dr",,"Redding","CA","96001-0913","United States","Voluntary: Firm Initiated","Telephone","California","B-0741-16","Class III","Apheresis Platelets, Leukocytes Reduced, Irradiated","2 units","Misbranded apheresis products were distributed.  ","09/01/2016","09/01/2016"," W035816090149; W035816104346",7/25/2016,"07/25/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75022,"Terminated","Blood Centers of the Pacific - Irwin Center","270 Masonic Ave",,"San Francisco","CA","94118-4496","United States","Voluntary: Firm Initiated","Telephone","California","B-0742-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, not meeting product specifications, was distributed.","09/01/2016","09/01/2016"," W117016037329N",7/18/2016,"07/18/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75023,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","4139 Carmichael Rd",,"Montgomery","AL","36106-2803","United States","Voluntary: Firm Initiated","FAX","Alabama","B-0743-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Plateletpheresis product, for which the quality control testing for pH did not meet specifications, was distributed.","09/01/2016","09/01/2016"," W115116141913A",8/8/2016,"08/08/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75024,"Terminated","American Natl Red Cross Mid Atlantic Region","611 W Brambleton Ave",,"Norfolk","VA","23510-1004","United States","Voluntary: Firm Initiated","Telephone","Ohio; Pennsylvania; Indiana; West Virginia; Virginia","B-0040-2017","Class II","Red Blood Cells, Leukocytes Reduced","23 units","Blood products, collected in a manner with a potential for air contamination, were distributed.  ","10/05/2016","10/05/2016"," W202916385210; W202916385219; W202916385233; W202916391947; W202916391953; W202916391956; W202916392874; W202916392908; W202916423168; W202916423184; W202916423186; W202916423207; W202916423261; W202916423273; W202916423283; W202916423353; W202916423354; W202916423360; W202916423365; W202916423367; W202916423380; W202916423390; W202916423395",6/23/2016,"06/23/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75024,"Terminated","American Natl Red Cross Mid Atlantic Region","611 W Brambleton Ave",,"Norfolk","VA","23510-1004","United States","Voluntary: Firm Initiated","Telephone","Ohio; Pennsylvania; Indiana; West Virginia; Virginia","B-0039-2017","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","Blood products, collected in a manner with a potential for air contamination, were distributed.  ","10/05/2016","10/05/2016"," W202916423191",6/23/2016,"06/23/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75024,"Terminated","American Natl Red Cross Mid Atlantic Region","611 W Brambleton Ave",,"Norfolk","VA","23510-1004","United States","Voluntary: Firm Initiated","Telephone","Ohio; Pennsylvania; Indiana; West Virginia; Virginia","B-0038-2017","Class II","Plasma Frozen within 24 hours (FP24)","2 units","Blood products, collected in a manner with a potential for air contamination, were distributed.  ","10/05/2016","10/05/2016"," W202916391947; W202916392874 ",6/23/2016,"06/23/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75025,"Ongoing","Stason Pharmaceuticals, Inc.","11 Morgan",,"Irvine","CA","92618-2005","United States","Voluntary: Firm Initiated","Letter","North Carolina","D-1479-2016","Class III","Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06","17,013 units","Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.","09/02/2016",," Lot #: 14F030, 14F031, 14F032, Exp. June 2017; 15G022, Exp. July 2018",8/23/2016,"08/23/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75026,"Ongoing","Creative Occasions, Inc.","1605 County Hospital Rd",,"Nashville","TN","37218-2503","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AR, LA, MS, TN, OH, TX, WI, FL, MO","F-2606-2016","Class III","Patti's good life PREMIUM APPLE PECAN CAKE, NET WT 20 OZ (1 LB 4 OZ) 567g, UPC 89028800290",,"Apple Pecan Cake, which was labeled correctly on the principle display panel, was labeled with the incorrect UPC and ingredient statement, which did not declare pecans.   ","09/30/2016",," Lot Numbers: 6219E11272180, 6219F11272180, 6218F1127280, 6218E1127280, 6218F2127280, 6218E2127280 ",8/24/2016,"08/24/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75027,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution","Z-2709-2016","Class II","Merge Cardio software.  The firm name on the label is Merge Healthcare, Hartland, WI.","116 customers potentially have the affected versions","A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR). ","09/01/2016",," Versions 10.1 and 10.1.1",2/9/2016,"02/09/2016",9/7/2016,"09/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75028,"Ongoing","Integra LifeSciences Corp. d.b.a. Integra Pain Management","3498 W 2400 S Ste 1050",,"Salt Lake City","UT","84119-1135","United States","Voluntary: Firm Initiated","Letter","Nationwide and VA/govt/military.  No foreign consignees.","Z-2733-2016","Class II","Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND","710"," Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.","09/02/2016",," Lot W1605101: Exp 2016-12  Lot W1605103: Exp 2016-11  Lot W1605106: Exp 2016-11  Lot W1606063: Exp 2016-12  Lot W1605101: Exp 2016-12  W1605103: 2016-11  W1605106: 2016-11  W1606063: 2016-12  ",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75029,"Ongoing","Integra LifeSciences Corp. d.b.a. Integra Pain Management","3498 W 2400 S Ste 1050",,"Salt Lake City","UT","84119-1135","United States","Voluntary: Firm Initiated","E-Mail","Distributed to CA.","Z-2868-2016","Class II","PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379.    Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics. ","320 packages ","Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.","09/21/2016",," Lot Number affected: W1503532",8/24/2016,"08/24/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75030,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1501-2016","Class III","buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03  ","2626 bottles","Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing. ","09/15/2016",," Lot #: MS1509, Exp 12/17",8/4/2016,"08/04/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75031,"Ongoing","Baxter Corporation Englewood","14445 Grasslands Dr",,"Englewood","CO","80112-7062","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and countries of: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.","Z-0007-2017","Class I","0.2 Micron Filter, 50 mm    Product Usage:  The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.  ","202,647","Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.","10/06/2016",," All unexpired lots-Product Code: H93835",8/24/2016,"08/24/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75032,"Ongoing","Sandoz Inc","100 College Rd W",,"Princeton","NJ","08540-6604","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1514-2016","Class II","Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ  08540.","a) 1,584 cartons; b) 62,170 vials","Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.","09/19/2016",," Lot #: a) 091914, Exp 09/16; b) 080114, Exp 08/16; 090414, 092614, Exp 09/16",8/24/2016,"08/24/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75032,"Ongoing","Sandoz Inc","100 College Rd W",,"Princeton","NJ","08540-6604","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-1513-2016","Class II","Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ  08540.","32,099 cartons","Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.","09/19/2016",," Lot #: 080514, 080614, 081114, 081214, 081314, 081414, 082714, 082814, 082914, Exp 08/16; 090214, 090314, 090814, 090914, 091014, 091114, 091214, 091514, Exp 09/16",8/24/2016,"08/24/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75033,"Ongoing","Advanced Medical Solutions Ltd.","Premier Park 33, Road One","Windford Industrial Estate","Winsford",,,"United Kingdom","Voluntary: Firm Initiated","E-Mail","OH","Z-2720-2016","Class II","ReliaMed¿ Alginate/CMC.  Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU)  leaflet.","29,204 cartons","On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse ","09/02/2016",," 51593  51772  52013  52001  52074  52668  52752  52756  52810  52851  53233  53234  53467  53655  53727  53685  53769  01129  01332  01569  02390  02584  02429  03696  03813  04095  04137  ",1/15/2015,"01/15/2015",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75033,"Ongoing","Advanced Medical Solutions Ltd.","Premier Park 33, Road One","Windford Industrial Estate","Winsford",,,"United Kingdom","Voluntary: Firm Initiated","E-Mail","OH","Z-2719-2016","Class II","ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU)  leaflet.","47,569 cartons ","On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse ","09/02/2016",," AMS Lot number  51594  51800  51883  51928  52023  52024  52002  52065  52230  52750  52754  52782  52775  52811  53213  53488  53532  53628  53665  53633  53981  53989  54066  01334  01263  01341  02112  02438  02583  02592  02582  02523  03138  03667  03675  03819  03908  03779  04254  04142  05996  06086  06256  ",1/15/2015,"01/15/2015",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75034,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution","Z-2865-2016","Class II","Merge Cardio software.      Product Usage:  Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.  ","42 sites potentially have the affected version","Patient information in the header is only found on the first page of the report and not on the subsequent pages.","09/21/2016",," Version 10.1",1/30/2016,"01/30/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75035,"Ongoing","Bayer Health Care LLC","12707 Shawnee Mission Pkwy",,"Shawnee","KS","66216-1846","United States","Voluntary: Firm Initiated","Letter","Distributed nationwide","V-0008-2017","Class II","Florfenicol Mometasone Furoate Terbinafine HCl Otic Solution Claro (15mg/mL Florfenicol, 2.0mg/mL Mometasone Furoate, and 13.3mg/mL Terbinafine HCl), packaged in a tube with foil seal which is in a blister package, most responsible firm name on the label is: Bayer Healthcare LLC, Animal Health Division, Shawnee Mission, Kansas 66201 USA.","8931-10pack units of lot 2218300, 3980-10pack units of lot 2287300","Multiple complaints for leaking tubes within the blister packing.","10/14/2016",," Lot 2218300, exp 3/2018  Lot 2287300, exp 3.2018",8/29/2016,"08/29/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75036,"Ongoing","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, HI, KS, MA, NC, TX, UT and the countries of: Great Brittan, Peru, Russia, India, Hungary, Thailand, Germany, Azerbaijan, Austria, Italy, Slovakia, Bahrain, and Malaysia.","Z-2866-2016","Class II","St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console    Product Usage:  The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.  ","5264 Units Worldwide","Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.","09/21/2016",," Item No.: 48-30-00 Serial No: 28E24640, 28E24651, 28E24642, 28E24674, 28E24657, 28E24652, 28E24671, 28E24675, 28E24676, 28E24678, 28E24670    Item No 48-40-00 Serial No: 28E24644, 28E24641, 28E24648, 28E24661, 28E24643, 28E24650, 28E24677, 28E24659, 28E24658, 28E24672, 28E24666, 28E24660, 28E24665, 28E24645, 28E24646, 28E24667, 28E24668, 28E24669, 28E24679    Item No 48-50-00 Serial No: 28E24647, 28E24663, 28E24673, 28E24664    Item No 58-00-00 Serial No.: 28E24653, 28E24654, 28E24655, 28E24656",8/25/2016,"08/25/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75037,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries:  Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab Emirates, and Uruguay.","Z-0081-2017","Class II","SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD ---    For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.","Foreign: 359 Kits","Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms. ","10/13/2016",," Kit lots 0333 and 0334 (OUS)",8/24/2016,"08/24/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75037,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries:  Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab Emirates, and Uruguay.","Z-0082-2017","Class II","SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD ---    For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age","Domestic: 177 Kits; Foreign: 3435 Kits","Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms. ","10/13/2016",," Kit lots 236M, 237, 238, 239, 239L (OUS) and D236M and D238 (US)",8/24/2016,"08/24/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75038,"Terminated","Department of Army William Beaumont Army Medical Center","5005 N Piedras St",,"El Paso","TX","79920-5001","United States","Voluntary: Firm Initiated","FAX","New Jersey","B-0747-16","Class II","Apheresis Fresh Frozen Plasma","1 unit","Apheresis product, collected from a donor who previously tested repeat reactive for anti-HTLV on two separate occasions, was distributed.    ","09/07/2016","09/07/2016"," W012716200118",8/11/2016,"08/11/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75039,"Terminated","American Natl Red Cross Mid Atlantic Region","611 W Brambleton Ave",,"Norfolk","VA","23510-1004","United States","Voluntary: Firm Initiated","Telephone","North Carolina; Indiana; Virginia; South Carolina; Georgia","B-0042-2017","Class II","Red Blood Cells, Leukocytes Reduced","9 units","Blood products, possibly contaminated with air, were distributed.","10/05/2016","10/05/2016"," W202916376811; W202916421092; W202916421104; W202916377367; W202916377372; W202916377382; W202916377388; W202916376877; W202916376879",7/6/2016,"07/06/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75039,"Terminated","American Natl Red Cross Mid Atlantic Region","611 W Brambleton Ave",,"Norfolk","VA","23510-1004","United States","Voluntary: Firm Initiated","Telephone","North Carolina; Indiana; Virginia; South Carolina; Georgia","B-0041-2017","Class II"," Pooled Cryoprecipitated AHF","3 units","Blood products, possibly contaminated with air, were distributed.","10/05/2016","10/05/2016"," W201216931572; W201216931612; W201216931580",7/6/2016,"07/06/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75039,"Terminated","American Natl Red Cross Mid Atlantic Region","611 W Brambleton Ave",,"Norfolk","VA","23510-1004","United States","Voluntary: Firm Initiated","Telephone","North Carolina; Indiana; Virginia; South Carolina; Georgia","B-0043-2017","Class II","Plasma Frozen within 24 hours (FP24)","3 units","Blood products, possibly contaminated with air, were distributed.","10/05/2016","10/05/2016"," W202916376811; W202916376877; W202916376879",7/6/2016,"07/06/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75041,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US Nationwide, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and UNITED KINGDOM.","Z-2842-2016","Class II","HeartStart MRx Monitor/Defibrillator  Models: M3535A and M3536A","394 units","The handle can separate from the MRx housing due to breakage of mounts on the rear case.","09/19/2016",," US Serial Numbers:  US00100227  US00100297  US00100326  US00100337  US00100429  US00100715  US00101184  US00101468  US00101676  US00101690  US00102018  US00203809  US00205745  US00205756  US00206142  US00206498  US00206615  US00206821  US00207095  US00207101  US00207144  US00207209  US00207268  US00207295  US00207321  US00207324  US00207345  US00208019  US00208263  US00208431  US00208519  US00210744  US00210966  US00211478  US00211485  US00212939  US00213455  US00213819  US00214103  US00214173  US00214222  US00316387  US00316389  US00316444  US00317530  US00318184  US00318460  US00321017  US00321936  US00323885  US00325280  US00326630  US00327632  US00328050  US00328154  US00328968  US00330028  US00330043  US00330093  US00331414  US00332111  US00534036  US00534522  US00535148  US00535803  US00539517  US00540460  US00541251  US00541256  US00541257  US00541366  US00541627  US00543683  US00543856  US00544956  US00545221  US00545649  US00554157  US00555242  US00571887  US00574441  US00574758    Canada:  US00100770  US00101622  US00101811  US00204864  US00204987  US00205107  US00325446  US00325734  US00539650  US00565585  US00569569    ROW:  US00101691  US00208635  US00327490  US00101209  US00206875  US00208214  US00209571  US00212610  US00212964  US00100372  US00536445  US00100883  US00207958  US00100861  US00211015  US00100171  US00100628  US00534545  US00321215  US00205732  US00208194    MRx units that have the Old Cap Plate, shipped before 2010.",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75042,"Ongoing","Actavis Laboratories, FL, Inc.","4955 Orange Dr",,"Davie","FL","33314-3902","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0118-2017","Class III","Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ  07054, NDC 16252-570-30.","15,984 bottles","Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.","11/01/2016",," Lot #: 1136091A, Incorrectly Labeled Exp: 03/18",8/30/2016,"08/30/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75043,"Ongoing","Greatbatch Medical","2300 Berkshire Ln N",,"Plymouth","MN","55441-4575","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, IN, KS,NJ, NC, TN, TX, and UT and Internationally to ITALY, JAPAN, FRANCE, SPAIN, GERMANY, NETHERLANDS, GREECE, LUXEMBOURG, SOUTH KOREA, IRELAND, UNITED KINGDOM, AUSTRALIA, AUSTRIA, BELGIUM, SWITZERLAND, NORWAY, SWEDEN, and TAIWAN.","Z-0367-2017","Class I","Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #:   Tl0600 ~ MMP3100CHA04  T10491 MIMP3100CHA04  T12230 M2M1P3100CHA04  T15752 ~MMP3100CHA04  T15949 ~MMP3100CHA04  T17238   MMP3100CHA04  T9954     MMP3100CHA04  T9955     MMP3100CHA04  T8468     MMP3100CHA04  T11506   MMP3100CHA13  T10281   MMP3100CHA04  T8044   ~MMP3100CHA04  T17203   87-4 20-00980  T8177 ~ MMP3100CHA04  T16934  MMP3100CHA62  Tll340 SHP9109.00010  T8043 ~ MMP3100CHA04  T17321 MMPP3100CHA04  T15311 GG920010029  T1 7650 255000110  T8143 803-t 1-103  Tl4384 EK-00200690  T1666t XEB227242  T9316 MIMP3100CHA04  Tl3642 500325  T10753 ~MMP3100CH04  T9348 ~ MMP3100CHA04  T13480  MMP3100CHA042  T10243 ~MIMP3001CHA08  Tll209 ~  MMP300CHA12  Tl0861    MMP3100CHA04  T16427   MMP3100CHA04  T9894 :-. MMP3100CHA04  T12861  MMP3100CHA\041  T8088 2002CUPI  T1661 1 T16611  Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. They are equipped with a suitable connection system to the acetabular cup (e.g. a thread) and can be supplied with a fixed or removable shock absorber. A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument.","4478 (2906 US, 1572 OUS)","On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU).","11/29/2016",," Lot Number  30491  34897  2495656  2500095  2530283  2543053  2561976  2564518  2565790  2661673  2742720  2742725  2742726  2750445  2750447  2789308  2794360  2799474  2799475  2816992  2828788  2832952  2842658  2853782  2927152  2970762  2970798  3016939  3018991  3018992  3018993  3029352  3058553  3087813  3138763  3148504  3166474  3172918  3187998  3188004  3252224  3270048  3275306  5780001  2233370001  2233670001  2242190001  2259200001  2259210001  2271650001  2299480001  2299490001  2315880001  2315890001  2315900001  2315910001  2315920001  2322180001  2362520001  2363250001  2371900001  2371910001  2371920001  2371950001  2378420001  2459710001  2471740001  2487360001  2490460001  2491700001  2491710001  2504910001  2504930001  2504950001  2516110001  2518340001  2518350001  2518370001  2528690001  2553410001  2553440001  2553450001  2559210001  2566230001  2595380001  2627950001  2665630001  2724230001  2725870001  2725880001  2745160001  2766420001  2781250001  2782010001  3006450001  3007860001  3029980001  3037400001  3037470001  3038530001  3038560001  3038700001  3038720001  3038730001  3038740001  3038750001  3038760001  3038790001  3038800001  3038810001  3038820001  3038830001  3038840001  3038850001  3038860001  3039320001  3039330001  3046100001  3046200001  3060700001  3061130001  3061390001  3061930001  3062700001  3065930001  3066030001  3066060001  3068430001  3083790001  3086350001  3091750001  3092720001  3092730001  3093900001  4006680001  4007350001  4007560001  6342540001  6411410001  6411450001  7004290001  7008770001  7010540001  7011200001  7011240001  7014640001  7019390001  7022800001  7022810001  7023900001  7023900002  7032220001  7032230001  7033140001  7033830001  7036020001  7043510001  7046530001  7047580001  7054290001  7055180001  7064180001  7064340001  7067270001  7067280001  7068200001  7068300001  7068310001  7070520001  7072060001  7072070001  7072370001  7072370001  7072380001  7072610001  7075380001  7084500001  7085220001  7085620001  7085660001  70945800",8/2/2016,"08/02/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75044,"Ongoing","Misono Food Ltd","75 9th Ave",,"New York","NY","10011-7006","United States","Voluntary: Firm Initiated","E-Mail","NYC, NY - 1 retailer","F-2255-2016","Class II","Smoked Herring Slow Food (Quality: Polar Golden Presidia), Net weight 0.378 (others may vary slightly), Produced by: Njardar AS 6094 Leinoy, Product of Norway","5.39 kg ","Foreign processor failed to meet HACCP requirements","09/15/2016",," Lot #0512015  Best before: 20.12.2016",7/19/2016,"07/19/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75044,"Ongoing","Misono Food Ltd","75 9th Ave",,"New York","NY","10011-7006","United States","Voluntary: Firm Initiated","E-Mail","NYC, NY - 1 retailer","F-2256-2016","Class II","Smoked Herring Roe, Salted and smoked herring roe,  Net weight 0.152 (others may vary slightly), Produced by: Njardar AS 6094 Leinoy, Product of Norway","8.76 kg ","Foreign processor failed to meet HACCP requirements","09/15/2016",," Lot #0522015  Best before 21.12.2016",7/19/2016,"07/19/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75045,"Ongoing","LiDestri Foods, Inc.","815 Whitney Rd W",,"Fairport","NY","14450-1030","United States","Voluntary: Firm Initiated","Letter","PA thru Wegmans markets","F-0045-2017","Class III","Wegmans ITALIAN CLASSICS Organic BLUSH SAUCE, NET WT 23.5 OZ (1 LB 7.5 OZ) 667g","66 cases ","Incorrect rear panel label was applied to jars of cream sauce which declared milk allergen","10/11/2016",," USE BY 02/11/18  F0881 TIME  ",7/24/2016,"07/24/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75046,"Completed","EKOS Corporation","11911 N Creek Pkwy S",,"Bothell","WA","98011-8809","United States","Voluntary: Firm Initiated","E-Mail","Three international consignees - Germany, New Zealand and Taiwan","Z-2854-2016","Class II","EkoSonic Endovascular Devices    EKOS Intelligent Drug Delivery Catheter","10 units","The recalling firm identified ten devices which were distributed and could potentially be non-compliant.  These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone.  It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.","09/21/2016",," Table 1: Device Identification Information  Catalog Number; Lot Number; Serial Number; Expiration Date  500-5518;              160711017; 160711017-005; 06-30-2019  500-5518;              160711017; 160711017-006; 06-30-2019.  500-5518;              160711017; 160711017-003; 06-30-2019.  500-5518;              160711017; 160711017-004; 06-30-2019.  500-5512;              160711042; 160711042-010; 06-30-2019.  500-5518;              160711017; 160711017-001; 06-30-2019.  500-5518;              160711017; 160711017-002; 06-30-2019.  500-5518;              160711017; 160711017-007; 06-30-2019.  500-5518;              160711017; 160711017-008; 06-30-2019.  500-5518;              160711017; 160711017-009; 06-30-2019.    3001627457  08/09/2016-002R  CONFIDENTIAL 3  ¿ Name, address, and type of responsible firm on label; number and description of private labels.  Manufacturer:  EKOS Corporation  11911 North Creek Parkway South  Bothell, WA 98011  ¿ Collect a complete copy of all labeling (include product inserts, information sheets.)  Applicable labeling is included in Attachment 1.  B. CODE:  ALL lot and/or serial numbers, batch numbers, catalog numbers, product numbers, packer or  manufacturer numbers, etc., exactly as they appear on the product, container, or labeling.  There are 10 total devices in distribution. Identification information for the implicated devices is  found in Table 1:  Table 1: Device Identification Information  Catalog Number Lot Number Serial Number Expiration Date  500-5518 160711017 160711017-005 06-30-2019  500-5518 160711017 160711017-006 06-30-2019  500-5518 160711017 160711017-003 06-30-2019  500-5518 160711017 160711017-004 06-30-2019  500-5512 160711042 160711042-010 06-30-2019  500-5518 160711017 160711017-001 06-30-2019  500-5518 160711017 160711017-002 06-30-2019  500-5518 160711017 160711017-007 06-30-2019  500-5518 160711017 160711017-008 06-30-2019  500-5518 160711017 160711017-009 06-30-2019  ¿ Give a breakdown of the code  Catalog Number consists of 7 digits (XXX-YYYY), wher",8/9/2016,"08/09/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75047,"Ongoing","Willis Ocean Inc.","968 Meeker Ave # 970",".","Brooklyn","NY","11222-3816","United States","Voluntary: Firm Initiated","Press Release","Florida","F-0611-2017","Class I","Willis Eagle brand MUT GUNG SWEETENED GINGER, NET WEIGHT 200 g (7 oz), UPC 8935129760691","30 cases (48 x 7 oz. units per case)","The imported product was found to contain undeclared sulfites ","12/07/2016",," UPC 8935129760691 and no other coding",8/26/2016,"08/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75048,"Ongoing","New Star Lasers, Inc.","9085 Foothills Blvd",,"Roseville","CA","95747-7130","United States","Voluntary: Firm Initiated","Letter","US distribution only.","Z-2916-2016","Class II","ReNew (a.k.a. Trio)    Dermatology:  for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue;  for use in the treatment of fine lines and wrinkles;  for treatment of back acne and atrophic acne scars;  for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis","5 systems","FDA inspection found that customers who had received devices with promotional material  with outside use indications were not notified when labeling was revised to remove these indications.","09/30/2016",," Serial numbers:  ABKK03  ABKK04  ABKM02  ABSG01  ABUP01.  ",9/19/2016,"09/19/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75048,"Ongoing","New Star Lasers, Inc.","9085 Foothills Blvd",,"Roseville","CA","95747-7130","United States","Voluntary: Firm Initiated","Letter","US distribution only.","Z-2915-2016","Class II","VariaBreeze; Catalog number: 7300-0035-2.      Podiatry:  ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas.  The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)","17 systems","FDA inspection found that customers who had received devices with promotional material  with outside use indications were not notified when labeling was revised to remove these indications.","09/30/2016",," Serial numbers:  XSB02-VB  AESB01  AHSF02  AHSF04  AHSF05  AHSF06  AHSF07  AHSF08  AHTE01  AHSF03  AHTF01  AHTF02  AHTH01  AHTM02  AHTM01  AHTS01  AHTS03.  ",9/19/2016,"09/19/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75048,"Ongoing","New Star Lasers, Inc.","9085 Foothills Blvd",,"Roseville","CA","95747-7130","United States","Voluntary: Firm Initiated","Letter","US distribution only.","Z-2914-2016","Class II","CT3Plus (a.k.a. CT3PZ);  Catalog number: 7300-0038/ 7300-0038-1.      Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue;  For treatment of fine lines and wrinkles;  For mild to moderate inflammatory acne vulgaris;  For back acne and atrophic scarring, and;  For podiatry, (incision, excision, and coagulation of soft tissue), including.  matrixectomy, periungal and subungal warts, plantar warts,  radical nail excision, and neuromas","44 systems CT3Plus;  47 systems CT3PZ","FDA inspection found that customers who had received devices with promotional material  with outside use indications were not notified when labeling was revised to remove these indications.","09/30/2016",," Serial numbers CT3Plus:   4009  4023  ABB0271  4030  4016  ABB0900  ABC0363  BBC1457  ABB0862  ABD0757  ABD1363  ABE0101  ABE1258  BBE1875  ABC1193  BBG1209  ABH1818  ABC1067  ABK2803  ABM0371  ABM1206  ABP1160  ABS1067  ACA1652  ACA1790  ACA2139  ACC1485  ACD0843  ACC1158  ACA1333  ABB0388  SEM02  SEM07  ABB0423  ABE1663  4014  UHG01  UHM02  ABS1761  ABC0921  ABF0613  3045  ABM1410  ABC1252.    Serial numbers CT3PZ:  ACA1011  ABD0501  UKH01-Z  ADMS01  ADMS02  ADMS03  ADPA01  ADPA02  ABS1353-Z  ADPD02  ADPD03  ADPD04  ADPD05  ADPD06  ADPE01  ADPE02  ABM1999  ADPE06  ADPE05  ADPG01  ABP1509  ADPH01  ADPH02  ADPH04  ADPH05  ADPH06  ADPH07  ADPE04  ADPK01  ADPK04  ADPK05  ADPK07  ADPM03  ADPP02  ADSB01  3023  4004  ACD1006  4002-Z  ACD1621-Z  ADSP01  UHK01-Z  ADSS04  ADTE01  ADTG01  ABS1171-Z  ADUE01.",9/19/2016,"09/19/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75050,"Ongoing","Arthrex, Inc.","1370 Creekside Blvd",,"Naples","FL","34108-1945","United States","Voluntary: Firm Initiated","Letter","OR, NY, MN, KY, CA, ID, CO, MA, and FL.  Thailand.","Z-2918-2016","Class III","Arthrex Suture Washer","45 devices","The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. ","09/30/2016",," Unique Device Identifier (UDI):  00888867118607;   Catalog # AR-7000-18T; Batch #10028617.",8/12/2016,"08/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2863-2016","Class II","TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00  The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag","41 units","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," Serial No.  8213991504  8214001504  8214011504  8214021504  8214031504  8214041504  8214051504  8214061504  8214071504  8214101504  8538801603  8538821603  8538831603  8538841603  8538871603  8538891603  8538901603  8538971603  8538981603  8416821507  8416831507  8416841507  8416851507          8416911507  8416921507  8416951507  8416961507  8416971507  8416991507  8417001507  8417011507  8417021507  8417041507  8417071507  8417081507  8417091507  8417101507  8445191507  8505901605  8505911605  8505961605  ",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2857-2016","Class II","TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00  The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag.","10 units ","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," Serial No.  8618391605  8618441605  8231911605  8231921605  8231931605  8231961605  8496921508  8496931508  8496941508  8496951508  ",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2861-2016","Class II","TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.","217 units","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," Serial No.  7138841403  2648831412  2648971412  2649011412  2649071412  2649101412  2649181412  2649221412  2649241412  2649261412  2649281412  2649301412  7138301403  7138311403  7138321403  7138331403  7138341403  7138351403  7138361403  7138371403  7138381403  7138391403  7138401403  7138411403  7138431403  7138441403  7138451403  7138461403  7138471403  7138481403  7138491403  7138501403  7138511403  7138521403  7138531403  7138541403  7138551403  7138561403  7138571403  7138581403  7138591403  7138601403  7138611403  7138621403  7138631403  7138641403  7138651403  7138661403  7138671403  7138681403  7138691403  7138701403  7138711403  7138721403  7138731403  7138741403  7138751403  7138761403  7138771403  7138781403  7138791403  7138801403  7138811403  7138821403  7138831403  7138851403  7138881403  7138891403  7138901403  7138911403  7138921403  7138941403  7138951403  7138961403  7138971403  7138981403  7138991403  7139001403  7139011403  7139021403  7139031403  7139041403  7139051403  7139061403  7139071403  7139081403  7139091403  7139101403  7139111403  7139121403  7139131403  7139141403  2648751412  2648761412  2648771412  2648781412  2648791412  2648801412  2648811412  2648821412  2648841412  2648851412  2648861412  2648871412  2648881412  2648891412  2648901412  2648911412  2648921412  2648931412  2648941412  2648951412  2648961412  2648981412  2648991412  2649001412  2649021412  2649031412  2649041412  2649061412  2649081412  2649091412  2649111412  2649121412  2649131412  2649141412  2649151412  2649161412  2649171412  2649191412  2649201412  2649211412  2649231412  2649251412  2649271412  2649291412  2649311412  2397761605  2397981605  3125171501  3125181501  7731731310  7731741310  7731751310  7731761310  7731771310  7731781310  7731791310  7731801310  7731811310  7731821310  7731831310  7731841310  7731851310  7731861310  7731871310  7731881310  7731891310  7731901310  7731911310  7731921310  7731931310  7731941310  7731951310  7731961310  7731971310  7731981310  7731991310  7732001310  7732",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2860-2016","Class II","SENSAR 1-Piece IOL, Model No. AAB00  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.","1 unit","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," Serial No.  5050941602",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2855-2016","Class II","SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.","84 units ","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," Serial No.  5626941507  5626961507  5626981507  5627001507  2003061505  2004131506  2015871503  3848581509  5626621507  5626641507  5626651507  5626661507  5626671507  5626681507  5626691507  5626701507  5626711507  5626721507  5626731507  5626741507  5626751507  5626761507  5626771507  5626791507  5626801507  5626811507  5626821507  5626831507  5626841507  5626851507  5626861507  5626871507  5626881507  5626891507  5626901507  5626911507  5626921507  5626931507  5626951507  5626971507  5627011507  5627021507  5627031507  5627041507  5627051507  5627061507  5627071507  5627081507  5627091507  5627101507  5627111507  5627121507  5627131507  5627141507  5627151507  5627161507  5627171507  5627181507  5627191507  5627201507  5627211507  5627221507  ",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2862-2016","Class II","TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery  System, Model No. PCB00V  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag","70 units ","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," Serial No.  5860621403  5860631403  5860641403  5860651403  5860661403  5860671403  5860681403  5860691403  5860701403  5860711403  5860721403  5860731403  5860741403  5860751403  5860771403  5860781403  5860791403  5860801403  5860811403  5860821403  5860831403  5860851403  5860871403  5860881403  5860891403  5860901403  5860911403  5860921403  5860931403  5860941403  5860951403  5860961403  5860971403  5860981403  5860991403  5861001403  5861011403  5861021403  5861031403  5861041403  5861051403  5861061403  5861081403  5861091403  5861101403  5861111403  5861391403  5861401403  5861411403  5861421403  5861431403  5861441403  5861451403  5861461403  5861471403  5861481403  5861491403  5861501403  5861511403  5861521403  5861531403  5861541403  5861551403  5861561403  5861581403  5861591403  5861601403  5861611403  5861621403  5861631403  ",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2858-2016","Class II","TECNIS 1-Piece IOL, Model No. ZCB00  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag","65 units ","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," Serial No.  2005271506  5914601206  4651021512  5807371506  4427981206  4427991206  4428001206  4428011206  4428021206  4428031206  4428041206  4428051206  4428061206  4428071206  4428081206  4428091206  4428101206  4428111206  4428121206  4428131206  4428141206  4428151206  4428161206  4428171206  4428181206  4428191206  4428201206  4428211206  4428221206  4428231206  4428241206  4428251206  4428261206  4428271206  4428281206  4428291206  4428311206  4428321206  4428331206  4428341206  4428351206  4428361206  4428371206  4428381206  5152461501  5152471501  5152481501  5152491501  5152501501  5152531501  5152541501  5152551501  5152561501  5152571501  5152581501  5152591501  5152601501  5152611501  5152621501  5152631501  5152641501  5152651501  5152661501  5152671501  4428301206",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2859-2016","Class II","TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.","131 units ","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," Serial No.  2624401411  2624411411  2624421411  2624431411  2624441411  2624451411  2624461411  2624471411  2624481411  2624491411  2624501411  2624511411  2624521411  2624531411  2624541411  2624551411  2624561411  2624571411  2624581411  2624591411  2624601411  2624611411  2624621411  2624631411  2624641411  2624651411  2624661411  2624671411  2624681411  2624691411  2624701411  2624711411  5259101407  5259111407  5259121407  5259131407  5259141407  5259151407  5259161407  5259171407  5259181407  5259191407  5259201407  5259211407  5259221407  5259231407  5259241407  5259251407  5259261407  5259271407  5259281407  5259291407  5259301407  5259311407  5259321407  5259331407  5259341407  5259351407  5259361407  5259371407  5259381407  5259391407  5259401407  5259411407  5259421407  5259431407  5259441407  5259451407  5259461407  5259471407  5259481407  5259491407  5259501407  5259511407  5259521407  5259531407  5259541407  5259551407  5259561407  5259571407  5259581407  5259591407  5259601407  5259611407  5259621407  5259631407  5259641407  5259651407  5259661407  5259671407  5259681407  5259691407  5259701407  5259711407  5259721407  5259731407  5259741407  5259751407  5259761407  5259771407  5259781407  5259791407  5259801407  5259811407  5259821407  5259831407  5259841407  5259851407  5259861407  5259871407  5259881407  5259891407  5259901407  5259911407  5259921407  5259931407  5259941407  5259951407  5259961407  5259971407  5259981407  5259991407  5260001407  5260011407  5260021407  5260031407  5260041407  5260051407  5260061407  5260071407  5260081407  ",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2856-2016","Class II","TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00;   The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag","77 units","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," ZKB00 Serial No.  8667461602	  8667751602  8667471602	  8667761602  8667481602	  8667771602  8667491602	  8667781602  8667501602	  8667801602  8667511602	  8667811602  8667521602	  8667821602  8667531602	  8667831602  8667541602	  8667841602  8667551602	  8667851602  8667561602	  8667861602  8667571602	  8667871602  8667581602	  8667881602  8667591602	  8667891602  8667601602	  8667901602  8667611602	  8667911602  8667621602	  8667921602  8667631602	  8667931602  8667641602	  8667961602  8667661602	  8667971602  8667671602	  8667981602  8667681602	  8667991602  8667691602	  8668001602  8667701602	  8668011602  	    ZLB00 Serial No.  8960421506  8960431506  8960441506  8960451506  8960461506  8960471506  8960481506  8960501506  8960511506  8960531506  8960541506  8960581506  8960591506  8960621506  8960631506  8960641506  8960651506  8960661506  8960671506  8960681506  8960691506  8960701506  8960711506  8960721506  8960731506  8960741506   ",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75051,"Ongoing","Abbott Medical Optics Inc. (AMO)","1700 E Saint Andrew Pl",,"Santa Ana","CA","92705-4933","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.","Z-2864-2016","Class II","AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.","41 units","Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.","09/21/2016",," Serial No.  1104621505  1164491602  1164501602  1164511602  1164521602  1164541602  1164551602  1164561602  1164571602  1164581602  1164601602  1164611602  1164621602  1164641602  1164651602  1164711602  1074911602  1074921602  1074931602  1074941602  1074951602  1074961602  1074971602  1074981602  1074991602  1075001602  1075011602  1075021602  1075031602  1075041602  1075051602  1075061602  1075071602  1075081602  1075091602  1075101602  1075111602  1075131602  1075141602  1075151602  1075121602",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75052,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil,  China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Japan, Jordan, Lebanon, Libya, Morocco, Mexico, Nigeria, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Portugal, Serbia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, Yemen","Z-2721-2016","Class II","Medical Linear Accelerator","553","There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.","09/02/2016",," 105639, 105652, 105608, 151187, 151401, 105792, 105570, 151577, 151563, 151562, 151444, 151347, 151746, 105557, 151434, 105801, 151702, 151052, 151384, 151661, 105873, 151138, 105875, 151606, 151246, 151649, 105729, 151642, 105820, 151097, 151063, 105857, 105952, 151227, 151208, 105935, 151345, 151120, 151057, 151018, 105684, 151122, 105573, 105973, 105688, 105768, 151078, 105908, 151039, 151323, 105953, 151607, 151023, 151164, 151304, 105569, 105900, 151070, 151293, 151548, 151631, 151618, 151609, 151547, 151105, 105994, 151437, 151124, 105597, 105839, 105947, 105753, 151205, 151240, 151239, 151382, 105779, 151490, 105732, 151270, 151648, 151232, 151440, 151307, 151408, 105552, 151485, 105746, 105745, 151276, 105889, 151147, 151056, 151294, 105830, 151592, 151286, 151282, 151118, 151381, 151375, 151376, 151400, 151593, 151508, 151589, 151590, 151637, 151726, 151721, 151707, 151750, 151742, 105897, 151342, 151069, 151019, 151163, 105747, 151407, 151182, 151081, 151646, 151113, 105605, 151106, 151242, 151337, 151641, 105917, 105899, 151564, 151591, 151021, 151535, 105933, 151290, 105985, 151068, 151343, 151027, 151732, 151218, 151219, 151220, 105735, 151554, 151192, 105834, 105752, 105642, 105599, 151191, 105674, 151645, 151131, 151111, 151277, 105993, 105634, 105919, 105848, 105620, 105579, 151402, 151193, 105740, 105613, 151257, 105901, 151283, 151355, 151635, 151202, 105877, 105756, 151221, 151518, 151575, 105592, 105733, 105965, 105940, 151139, 151409, 151204, 151230, 151559, 151146, 151152, 105824, 105662, 105651, 105730, 105623, 105686, 151758, 105670, 151261, 151048, 151279, 105931, 105631, 151665, 151126, 151426, 151037, 151036, 151513, 151738, 151543, 151339, 105689, 151753, 151174, 151745, 105755, 151473, 151241, 105737, 105999, 105920, 151668, 151013, 151336, 105817, 105804, 151603, 151395, 105748, 105996, 151536, 151172, 151392, 151100, 151210, 151161, 105680, 151263, 151058, 151028, 105842, 151417, 151331, 151109, 105743, 105742, 105635, 151004, 105802, 105797, 105786, 105695, 151478, 105906, 1059",7/8/2016,"07/08/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75053,"Ongoing","Teleflex Medical","3015 Carrington Mill Blvd",,"Morrisville","NC","27560-5437","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) to CA and countries of:  Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.","Z-0044-2017","Class I","Willy Rusch GmbH Tracheostomy Tube Set    Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.","1095 units","The connector may disconnect from the tracheostomy tube during use.","10/18/2016",," Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491 ",8/26/2016,"08/26/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75054,"Terminated","Blood Centers of the Pacific - Irwin Center","270 Masonic Ave",,"San Francisco","CA","94118-4496","United States","Voluntary: Firm Initiated","Telephone","NV","B-0019-2017","Class III","Red Blood Cells, Leukocytes Reduced","1 unit"," Blood products, labeled with an incorrect expiration date, were distributed","10/05/2016","10/05/2016"," W0425160326417",8/10/2016,"08/10/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75055,"Ongoing","Ultroid Technologies, Inc.","3140 W Kennedy Blvd Suite 103",,"Tampa","FL","33609-3175","United States","Voluntary: Firm Initiated","Letter","AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico  Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam","Z-0785-2017","Class II","Ultroid Sterile Disposable Probes sold individually","7,784","Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)","12/17/2016",," ALL serial numbers and lot numbers sold since January 14, 2003.",10/19/2016,"10/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75055,"Ongoing","Ultroid Technologies, Inc.","3140 W Kennedy Blvd Suite 103",,"Tampa","FL","33609-3175","United States","Voluntary: Firm Initiated","Letter","AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico  Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam","Z-0782-2017","Class II","Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes","1,129 ","Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)","12/17/2016",," ALL serial numbers and lot numbers sold since 2003.",10/19/2016,"10/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75055,"Ongoing","Ultroid Technologies, Inc.","3140 W Kennedy Blvd Suite 103",,"Tampa","FL","33609-3175","United States","Voluntary: Firm Initiated","Letter","AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico  Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam","Z-0784-2017","Class II","Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.","52,084","Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)","12/17/2016",," ALL serial numbers and lot numbers sold since January 14, 2003.",10/19/2016,"10/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75055,"Ongoing","Ultroid Technologies, Inc.","3140 W Kennedy Blvd Suite 103",,"Tampa","FL","33609-3175","United States","Voluntary: Firm Initiated","Letter","AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico  Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam","Z-0783-2017","Class II","Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes ","62 units","Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)","12/17/2016",," ALL serial numbers and lot numbers sold since January 14, 2003.",10/19/2016,"10/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75056,"Ongoing","ConMed Corporation","525 French Rd",,"Utica","NY","13502-5945","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:  CA, HI, IL, IN, KS, LA, MA, NC, NM, NY, OH, OK, PA, TN, TX, UT, WA and WI; plus Foreign distribution to Australia, Canada, France, Germany, Italy, Spain, Czech Republic, Lithuania, Netherlands, Poland, Korea,Morocco, Malaysia, Mexico, Taiwan, and South Africa.","Z-0085-2017","Class II","CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only   Product Usage:  The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.  ","Domestic: 1740; Foreign: 4770","CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft.  If the shaft insulation is damaged in any way, it could increase the risk of patient burn.  ","10/13/2016",," All lots codes manufactured from 09/01/2011 through 11/17/2015:  267221, 301001, 309889, 318652, 319649, 325019, 354759, 334627, 336041, 341704, 343927, 349952, 384294, 354768, 365239, 369773, 374480, 378521, 406137, 385695, 388538, 392382, 394178, 396542, 436808, 413702, 456341, 423877, 427704, 433503, 478513, 451923, 488101, 464062, 468012, 471297, 511327, 482366, 522335, 494840, 499981, 505321, 544240, 515060, 551152, 527734, 531802, 536700, 581072, 550988, 590037, 557461, 570449, 574167, 611804, 588892, 621304, 597982, 598682, 605515, 643396, 619686, 656909, 629202, 634911, 643395, 676005, 654991, 692617, 667118, 671471, 674410, 683144, 695062, 695063, 297982.",8/29/2016,"08/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75057,"Terminated","Blood Bank Of San Bernardino And Riverside Counties","384 E Orange Show Rd",,"San Bernardino","CA","92408-2414","United States","Voluntary: Firm Initiated","FAX","CA","B-0022-2017","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units"," Blood products, collected using equipment that required requalification/validation before returning to service, were distributed. ","10/05/2016","10/05/2016"," W125616425998F- part 1; W125616425998F-part 2 ",7/19/2016,"07/19/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75058,"Terminated","LifeShare Blood Centers","2909 Kilpatrick Blvd",,"Monroe","LA","71201-5120","United States","Voluntary: Firm Initiated","E-Mail","TX","B-0020-2017","Class II","Blood and Blood Products for Reprocessing","1 unit"," Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","10/05/2016","10/05/2016"," W036515326016",5/6/2016,"05/06/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75059,"Terminated","LifeServe Blood Center","431 E Locust St",,"Des Moines","IA","50309-1909","United States","Voluntary: Firm Initiated","E-Mail","NC","B-0021-2017","Class III","Blood and Blood Products for Reprocessing","1 unit"," Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed","10/05/2016","10/05/2016"," W037915130106",6/17/2016,"06/17/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75062,"Ongoing","Mindray DS USA, Inc. dba Mindray North America","800 Macarthur Blvd",,"Mahwah","NJ","07430-2001","United States","Voluntary: Firm Initiated","Letter","US and Canada","Z-0321-2017","Class II","TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China","1,278 units","Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Central Station may crack on the bezel surrounding the display and also the transmitter may not power on or will power on but display an error message.","10/28/2016",," p/n 115-029485-00, Serial #'s HHA59001430, HHA59001439, HHA59001450 thru HHA59001460, HHA59001537, HHA59001540, HHA59001549 thru HHA59001550, HHA59001591,HHA59001609, HHA59001615, HHA59001626, HHA59001632, HHA5A003110, HHA5A003113 thru HHA5A003115, HHA5A003118 thru HHA5A003119, HHA5C004233, HHA5C004485, HHA59001420 thru HHA59001429, HHA5B003441 thru HHA5B003450, HHA5C004059, HHA5C004065, HHA5C004075, HHA5C004077, HHA5C004091, HHA5C004095 thru HHA5C004097, HHA5C004102, HHA5C004106, HHA57000155 thru HHA57000161, HHA57000163 thru HHA57000168, HHA57000171, HHA57000173 thru HHA57000180, HHA57000182 thru HHA57000184, HHA57000195 thru HHA57000199, HHA57000201 thru HHA57000205, HHA57000207, HHA57000209 thru HHA57000223, HHA58001037, HHA59001386, HHA59001432, HHA5A003075, HHA5A003079, HHA5A003264, HHA5B003365, HHA5B003386, HHA5B003451 thru HHA5B003452, HHA5B003877, HHA5B003880, HHA5C004098, HHA5C004104, HHA5C004110, HHA5C004113, HHA5C004126, HHA5C004134, HHA5C004200, HHA5C004464, HHA5C004470, HHA57000357, HHA57000363 thru HHA57000364, HHA58000631, HHA58000636 thru HHA58000639, HHA58000641, HHA58000858 thru HHA58000868, HHA58000890 thru HHA58000891, HHA58000893, HHA58000897 thru HHA58000906, HHA58000908 thru HHA58000910, HHA58000912 thru HHA58000913, HHA58000916 thru HHA58000918, HHA5800920 thru HHA58000921, HHA58000937, HHA58000957, HHA58000961, HHA58000984, HHA58000986 thru HHA58000997, HHA58000999 thru HHA58001003, HHA58001005 thru HHA58001007, HHA58001009, HHA58001012 thru HHA58001013, HHA58001042 thru HHA58001048, HHA58001052, HHA58001055, HHA5A003071, HHA5A003078, HHA5A003080, HHA5A003085, HHA5A003263, HHA5A003272, HHA5B003376 thru HHA5B003379, HHA5C004130, HHA5C004135, HHA5C004151, HHA5C004472, HHA5C004483, HHA5C004496, HHA5C004509, HHA5C004517, HHAZA003070, HHAZA003072 thru HHAZA003074, HHAZC004203, HHAZC004220, HHAZC004473, SHHA5B003478, SHHA5C004069, HHA5A003100 thru HHA5A003103, HHA5A003105 thru HHA5A003109, HHA5C004469, HHA59001440 thru HHA59001449, HHA59001578, HHA59001582, HHA59001584, HHA5A002980 thru HH",9/8/2016,"09/08/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75063,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.","Z-0687-2017","Class III","Conserve Shells:  REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF 38024450, REF 38024454, REF 38024652, REF 38024656, REF 38024854, REF 38024858, REF 38025056, REF 38025060, REF 38025258, REF 38025262, REF 38025460, REF 38025464, REF 38025662, REF 38025664, REF 38025666, REF 38025668, REF 38123844, REF 38124046, REF 38124248, REF 38124450, REF 38125056, REF 38125662, REF 38HA3642, REF 38HA3844, REF 38HA4046, REF 38HA4248, REF 38HA4450, REF 38HA4652, REF 38HA4854, REF 38HA5056, REF 38HA5258, REF 38HA5460, REF 38HA5662, REF 38HA5664, REF 38HA5864, REF 38HA6066, REF 38SP3642, REF 38SP3844, REF 38SP4046, REF 38SP4248, REF 38SP4450, REF 38SP4652, REF 38SP4854, REF 38SP5056, REF 38SP5258, REF 38SP5460, REF 38SP5662, REF 38SP5664  For use with the conserve metal head","68,199 units","Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R)  metal acetabular liner systems.","12/01/2016",," REF 38021146  Serial Numbers:  02210174, 09217496, 01333507, 02334561, 03336229, 04338462, 05340904, 05341951, 10349882, 11351847, 04460698, 04460243, 06480454, 07488190     REF 38021148  Serial Numbers:  02210175, 05216035, 11228750, 01334562, 02336230, 03338463, 05340563, 05340911, 05341952, 09349879, 10352999, 10352998, 10351848, 01457244, 04460700, 04460699, 06481575, 07488019     REF 38021150  Serial Numbers:  01210176, 02210612, 04216036, 05216626, 07218586, 10230051, 03338616, 03338464, 03336231, 03337220, 05340564, 05340914, 05341953, 09349877, 10353000, 10351849, 12353001, 03460701, 04461613, 04461614, 07487904, 059819773     REF 38021152  Serial Numbers:  01210171, 03210614, 09216037, 11232599, 01334560, 01334563, 03336232, 03337221, 03338465, 05340915, 05341909, 06341954, 07348270, 08348659, 09349871, 09349872, 10351850, 11353002, 11353003, 11355254, 02458854, 03469912, 03469913, 06480452, 07485576, 07487905, 104109633, 09496818, 11496825, 059819775, 059821148     REF 38021154  Serial Numbers:  01210177, 02210611, 02211334, 06218587, 07216038, 07221034, 07222228, 10228749, 12232600, 01334564, 02335957, 02336233, 02337222, 03338466, 04339246, 05340565, 05340916, 07343890, 07341955, 08348653, 09348652, 09349881, 09350565, 10351851, 10353004, 11353005, 11355255, 12356822, 12356821, 02458856, 03460702, 04461615, 04461616, 06482947, 06485577, 07487906, 09496819, 09496826, 104109634     REF 38021156  Serial Numbers:  01210434, 01210187, 03210186, 05216627, 06215011, 07221035, 07219757, 11230053, 01335137, 01334292, 03336234, 03337223, 03338617, 03338467, 05341917, 05341626, 05341627, 05343892, 07345060, 07346548, 07347125, 08348592, 08348650, 08348651, 10349875, 10349876, 10351852, 11353006, 11353007, 12356823, 12356824, 03460703, 03460704, 03461618, 04478089, 04478090, 06482948, 07481393, 08487907, 09496820, 09496821, 09496827, 104109635, 035140879, 085227410, 105263402     REF 38021158  Serial Numbers:  01210090, 01210188, 01210178, 01210179, 01211740, 04214482, 05214483, 05216628, 09219758, 11231915, ",6/21/2016,"06/21/2016",12/7/2016,"12/07/2016","6459,   067426460, 067430920, 067430921, 077437753, 077444755, 087442058, 087456537, 097460693,   107463825, 058525925, 068573302, 078573303, 078605231, 088591134, 088632958, 108668995,   118706239, 118690191, 049819957, 059834726, 069847482, 069847484, 089886766, 099888799,   0501062358, 0501062359, 0601139753, 0601139754, 0801164227, 0801163078, 0801163564,   0801163087, 0111231469, 0111231470     REF 38HA4450  Serial Numbers:  09350261, 01457572, 02458819, 03469038, 03461888, 03469319, 04461671,   04470684, 04474922, 06481750, 06480519, 104115163, 114115101, 065208753, 095249049,   105262958, 105268088, 115281169, 125283320, 026301523, 036301385, 076333743, 076349355,   076349880, 096362316, 096366899, 096370242, 106370241, 106372710, 106376226, 106378168,   116380025, 116381300, 116381299, 126385208, 126385920, 017388276, 027392677, 027388277,   027392676, 027395039, 027395040, 057419214, 057419215, 057421518, 057421519, 067426462,    067426461, 077435309, 077437754, 077444756, 097455274, 097455273, 107460694, 107463826,   107464073, 018499154, 018483303, 018489027, 018483304, 028498236, 058552439, 058530726,   068552440, 068580396, 068580397, 078587972, 078580398, 078587973, 088610360, 098632960,   098632961, 098632959, 108690188, 108690189, 118690187, 118706240, 049789147, 049819955,   049819956, 059834728, 059834729, 069852485, 069852484, 079861034, 079861033, 089886771,   089872401, 099894761, 109933794, 119937611, 119932182, 010964134, 020989173, 020993334,   0301036769, 0301036770, 0301036771, 0401062360, 0501062361, 0501062362, 0701146209,   0701148132, 0701146416, 0701147759, 0701148209, 0701147183, 0701151659, 0701147141,   0801152798, 0901165715, 0901188153, 1001188447,100118815, 1001188446, 1101219268,   1101219489, 1101220029, 1101218551, 1101219307, 1101218550, 1101218647, 1201217382,   1201220127, 0111218648, 1388731, 1388683     REF 38HA4652  Serial Numbers:  10351677, 01457573, 02461300, 02469037, 03461672, 03461887, 03469320, 03470685, 06480520, 07476420, 07491126, 07484526, 055199122, 065",,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75063,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.","Z-0689-2017","Class III","Cobalt Chromium Heads  Transcend:  26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028      Conserve:    38013800, 38013804, 38013835, 38014000, 38014004, 38014035, 38014200, 38014204, 38014235, 38014400, 38014404, 38014435, 38014600, 38014604, 38014635, 38014800, 38014804, 38014835, 38015000, 38015004, 38015035, 38015200, 38015204, 38015235, 38015400, 38015404, 38015435,   38015600, 38015604, 38015635, 38AC3600, 38AC3800, 38AC4000, 38AC4200, 38AC4400, 38AC4600, 38AC4800, 38AC5000, 38AC5200, 38AC5400, 38AC5600, 38AM3600, 38AM3604, 38AM3635, 38AM3800, 38AM3804, 38AM3835, 38AM4000, 38AM4004, 38AM4035, 38AM4200,   38AM4204, 38AM4235, 38AM4400, 38AM4404, 38AM4435, 38AM4600, 38AM4604, 38AM4635, 38AM4800, 38AM4804, 38AM4835, 38AM5000, 38AM5004, 38AM5035, 38AM5200, 38AM5204, 38AM5235, 38AM5400, 38AM5404, 38AM5435, 38AM5600, 38AM5604, 38AM5635, PL38HM4400,   PL38HM4404, PL38HM4435, PL38HM4600, PL38HM4604, PL38HM4635, PL38HM4800, PL38HM4804, PL38HM4835, PL38HM5000, PL38HM5004, PL38HM5035, PL38HM5200,  PL38HM5204, PL38HM5235     ","108,362 units","Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R)  metal acetabular liner systems.","12/01/2016",," Transcend     REF 26000017  Serial Numbers:  1392035, 1394262, 1403269, 1404128, 1405348, 1406868, 1416193, 1416410, 416916,   1417966, 1421701, 1424398, 1427395, 1429561, 1432313, 1432727, 1435174, 1436773, 1437714, 1444931, 1463853, 1469307, 1469928, 1472480, 1473802, 1475742, 1483472, 1485543, 1485544,   1491257, 1495872, 1495873, 1497225, 1497226, 1497227, 1497228, 1502990, 1502991, 1504262,   1509260, 1509261, 1513940, 1513941, 1516239, 1519175, 1523291, 1527824, 1527825, 1532934,   1532935, 1532936, 1534591, 1544282, 1544283, 1544284, 1548096, 1548097, 1553540, 1553541,   1555918, 1555919, 1555920, 1564763, 1564764, 1567221, 1567222, 1567223, 1567765, 1574244,   1574245, 1574246, 1586932, 1586937, 1587450, 1587451, 1587452, 1594879, 1602102, 1602103,   1607364, 1607365, 1612602, 1616179, 1618966, 1618967, 1636635, 1638711, 1638712, 1643938,   1643939, 1647724, 1647725, 1648020, 1648021, 1654503, 1654504, 1657402, 1659130, 02465512,   02465513, 02469868, 03211703, 03211704, 03217505, 04479690, 06345789, 06483517, 06485500,   10352345, 11230587, 12358929, 12360234, 015158577, 016305137, 017385213, 018513341,   018523879, 018523880, 026316750, 027411850, 035191682, 035191683, 037414681, 037417015,   037420473, 038542236, 038548053, 046336505, 047426887, 047431539, 049843313, 056332870,   057433631, 058595417, 058595419, 065229799, 066343506, 067442240, 067446422, 068595420,   068595422, 069876963, 069876964, 075255286, 076360909, 077450626, 077455529, 085258369,   086369486, 086370994, 087460631, 087462039, 087469136, 088672406, 088672407, 088672408,   094104768, 096372363, 097480313, 097481152, 098694953, 098703737, 0101010115, 104104769,   105275570, 107483300, 107489009, 108716008, 109938837, 0111278886, 114131980, 114135078,   115290207, 118738338, 118741128, 119978431, 119994169, 125301489, 127496633, 127513339,   127513340, 128739171, 0201069672, 0201069673, 0201069674, 0211297628, 0211299902, 0301089722, 0301091275, 0301096837, 0311323467, 0311325664, 0311330683, 0311332184,   0401100071, 0401100107",6/21/2016,"06/21/2016",12/7/2016,"12/07/2016","84, 016308000, 017404757, 018507031, 028523889, 039825936, 047426442, 057438326, 058602426, 069870373, 077455264, 078657274,   078660970, 085262946, 087468371, 087469509, 088679477, 089905088, 089915885, 107489490,   108700628, 109938838, 109947891, 109960510, 117495714, 119986824, 119986957, 124135082,   126396173, 128755754, 0201048290, 0301074288, 0301081719, 0301081720, 0301089732, 0311316620, 0411343205, 0411343206, 0548352301, 0611365946, 0611374907, 0701178782,   0901196481, 0901208792, 0901208996, 16453591651601           Conserve     REF 38013800  Serial Numbers:  01336252, 01336648, 01465788, 01467492, 1561766, 02338825, 02339631, 02470528,   02470533, 02473240, 03477697, 04481833, 05342022, 07484291, 08348056, 09353669, 10232864, 10355850, 11234642, 12360787, 017397516, 018523897, 037420861, 037423780, 038568859, 039825303, 039838301, 048575671, 049850492, 057432005, 058594224, 065233869, 067449131, 076362909, 085257534, 086370585, 087460705, 088685275, 105270444, 116388901, 127515855,   128746770, 0201030497, 0201044688, 0211296900, 0211299343, 0301083872, 0401117838, 0601145349, 0801192556, 0901197216    REF 38013804  Serial Numbers:  01336643, 01461784, 01467493, 02338605, 02339237, 02339632, 02470529, 03476222, 04481835, 05342021, 06483920, 06485107, 06485503, 08348055, 09353670, 10231641,   11234641, 12360249, 017398845, 028544861, 037420822, 037423183, 047431575, 048577483, 049840536, 058594223, 067444759, 067449132, 078608779, 085257535, 086370586, 088685276,   105285957, 107481164, 116389030, 117496647, 128752498, 0411322524, 0601145350, 0701165734      REF 38013835  Serial Numbers:  01336255, 1394264, 01465477, 01467494, 02338611, 02339630, 02470530, 03341483, 03477702, 04481837, 05342023, 07485504, 08347658, 09352749, 10231504, 10233020, 10355852, 11355957, 12361305, 037420869, 038568860, 047427004, 049840535, 058594222, 067444760, 085260582, 087459469, 088669038, 095270445, 098690182, 116389877, 117495024, 127515856, 128744507, 0548392101, 0601145351, 0601161457, 0901192558, 0901197218   ","1141, 089922082, 098690253, 098700790, 108715112, 108728960, 117506075, 118722757, 119976434,   0301058384, 0411335255, 0411339017, 0511359164, 0511359746, 0601148210, 0601155557, 0611362495, 0611363290, 0801181827, 0801182732, 0901213858, 1001214137, 1101241342, 1201242473      REF 38AM3604  Serial Numbers:  1398726, 1401119, 1405718, 1406645, 1409292, 1409403, 1409960, 1413650, 1413651, 1414570, 1416481, 1432652, 1432679, 1435900, 1438199, 1448380, 1450191, 1452346, 1456424, 1459882, 1460664, 1462718, 1477349, 1477536, 1484370, 1484739, 1492232, 1493476, 1496144, 1501675, 1501808, 1507557, 1507762, 1513861, 1513863, 1542178, 1543429, 1555138, 1555139, 1555140, 1572007, 1612609, 1634160, 1638022, 1647086, 1656680, 017395494, 028548127, 029792975, 029798201, 037422290, 038552357, 039821652, 039832450, 046337625, 048585771, 056339972, 057437831, 057438631, 058617072, 066342397, 067445890, 068628867, 068635564, 069871613, 069880125, 075204839, 078648087, 079890283, 085261218, 085269473, 088662880, 098695710, 107480810, 108722758, 117508399, 118744190,125270447, 128755726, 0211299336, 0301041083, 0301085942, 0511355230, 0601156630, 0611355263, 0701171827, 0711370670, 0801188062, 0883681291, 1001214996, 1101251437, 1291010896     REF 38AM3635  Serial Numbers:  1402518, 1406871, 1409961, 1450676, 1451089, 1459883, 1462719, 1468924,   1477350, 1477671, 1497349, 1507780, 1525243, 1534148, 1541688, 1541689, 1560848, 1580081,   1580082, 1606606, 1617420, 1634733, 1638461, 1656681, 017395495, 028552897, 029798202, 036276112, 036287554, 039825296, 039830309, 047422771, 048580387, 056339980, 057438208,   058622133, 067443016, 068625420, 068634572, 069869336, 075204840, 077450129, 078647840,   078660992, 085261219, 085261220, 098695712, 099934272, 118739167, 125271455, 127510021,   128755727, 0201017298, 0301081062, 0511363319, 0601145040, 1001214997, 1101251436     REF 38AM3800  Serial Numbers: 1402556, 1405255, 1406089, 1414899, 1415271, 1415272, 1425078, 1425711, 1433461,   1438198, 1483573, 1523000, 1524616, 1528094, 1",,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75063,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.","Z-0688-2017","Class III","Conserve Cups:  REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP,   REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF 38BF5460SP, REF 38BF5662, REF 38BF5662SP, REF 38BF5864,   REF 38BF5864SP, REF 38BF6066, REF 38BF6066SP, REF 38QH3644, REF 38QH3846, REF 38QH4048, REF 38QH4250, REF 38QH4452, REF 38QH4654, REF 38QH4856, REF 38QH5058,   REF 38QH5260, REF 38QH5462, REF 38QH5664, REF 38QH5666, REF 38SC3650, REF 38SC3852,   REF 38SC4054, REF 38SC4256, REF 38SC4458, REF 38SC4660, REF 38SC4862, REF 38SC5064, REF 38SC5266, REF 38SC5468, REF 38SC5670, REF 38SC5672  For use with the conserve metal head","68,221 units","Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R)  metal acetabular liner systems.","12/01/2016",," REF 38BF3642  Serial Numbers:  1380112, 1399025, 1402166, 1340677, 1427276, 1429743      REF 38BF3642SP  Serial Number 1416590    REF 38BF3844  Serial Numbers:  1368260, 1402167, 1399026, 1380113, 1418795     REF 38BF3844SP  Serial Number 1416814    REF 38BF4046  Serial Numbers:  1368261, 1380114, 1402168, 1399027, 1418796, 1429744, 1449113     REF 38BF4046SP  Serial Number 1416950    REF 38BF4248  Serial Numbers: 1397139, 1368262, 1381417, 1399029, 1422026, 1418797, 1433514, 1449114, 1452995     REF 38BF4248SP  Serial Number 1416816    REF 38BF4450  Serial Numbers:  1380115, 1399031, 1399231, 1373711, 1366654, 1418948, 1433515, 1431187, 1449115, 1482461, 1484998    REF 38BF4450SP  Serial number 1416563    REF 38BF4652  Serial Numbers:  1380116, 1395709, 1368263, 1373712, 1399233, 1427277, 1429745, 1433516, 1445264, 1449116, 1460186, 1460187, 1482463, 1481980     REF 38BF4652SP  Serial Numbers:  1417403, 1417616    REF 38BF4854  Serial Numbers:  1381418, 1399234, 1373904, 1368264, 1399235, 1427278, 1431188, 1433517, 1445265, 1460189, 1460188, 1468891, 1481979, 1484999     REF 38BF5056  Serial Numbers:  1381419, 1399236, 1373905, 1368265, 1397140, 1402169, 1413708, 1427279, 1445266, 1449117, 1452997, 1468892, 1468893, 1476014, 1476013, 1482462, 1571773, 1571772, 1650637, 1650638, 1651368     REF 38BF5258  Serial Numbers:  1397141, 1399237, 1368266, 1380117, 1422025, 1431189, 1445267, 1449118, 1452996, 1468894, 1476016, 1482460, 1481456, 1571771, 1571770, 1589362, 1650639     REF 38BF5258SP  Serial numbers:  1416945    REF 38BF5460  Serial Numbers:  1368267, 1380118, 1397142, 1399238, 1402170, 1429746, 1433518, 14335181454410, 14335181454409, 1452478, 1476017, 1481978, 1484997, 1651370      REF 38BF5460SP  Serial Number 1416944    REF 38BF5662  Serial Numbers:  1368268, 1381420, 1399239, 1422021, 1431190, 1452994, 1484996     REF 38BF5662SP  Serial Number 1416957    REF 38BF5864  Serial Numbers:  1368269, 1402171, 1380124, 1399240     REF 38BF5864SP  Serial Number 1416589    REF 38BF6066  Serial Numbers:  13992",6/21/2016,"06/21/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75063,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.","Z-0684-2017","Class III","Dynasty Liners:  REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56,   For use with the conserve metal head","6,250 units","Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R)  metal acetabular liner systems.","12/01/2016",," Serial Numbers:    REF DLCOGA28  Seral Numbers:  1509498, 1509897, 107461555, 117476083, 127477625, 0411341968, 0611341969, 0901199714    REF DLCOGB32  Serial Numbers:  1428321, 027403682, 027403684, 027412214, 027412216, 027412218, 027412220, 027412222, 029789268, 048571448, 058605178, 068625411, 069837383, 078628910, 079859721, 087467577, 097474918, 097476396, 097477626, 098657540, 099905615, 099927666, 0101018635,   107480309, 107486655, 109968495, 0111248666, 0111254637, 117486656, 117501983, 119982392, 127504540, 127508429, 0211298850, 0211298851, 0401072608, 0501123237, 0601150684, 0711370347, 0711370832, 0711371855, 0711388872, 0801184970, 0801185465, 0901196484, 0901199209, 0901200444, 0901200704     REF DLCOGC36  Serial Numbers:  1389336, 1411596, 1412300, 1419309, 1421706, 1421872, 1421873, 1425040, 1425041, 1426635, 1441425, 1447128, 1448009, 017395680, 017396168, 017398843, 019752394, 027406078, 027406080, 027406549, 027408437, 027408506, 027412667, 029797073,038565179,   038571449, 039808007, 039823319, 039830311, 058576611, 059835277, 059843767, 059859139, 059869515, 067444752, 068608657, 069876613, 069885333, 077449136, 078628911, 078648401, 078648402, 086356142, 086364960, 087462096, 089905617, 089920491, 089924903, 097475888,   097475891, 097475892, 099932177, 099937595, 0101009548, 108705038, 109966090, 0111273375, 0111274786, 118728271, 119975127, 127506074, 127508430, 127514978, 129979634, 129990530, 0201044377, 0201044378, 0201048252, 0201071222, 0211301143, 0301068674, 0301084452, 0401085769, 0501125124, 0611343376, 0611343377, 0611365354, 0611366004, 0611366646, 0701164679, 0701165562, 0701178783, 0801190509, 0901189893, 0901191386, 0901200880, 0901201441, 0901201663     REF DLCOGD38  Serial Numbers:  1390011, 1422255, 1422256, 017395681, 017396169, 019751147, 019752153, 027404999, 027405000, 027408507, 027408521, 027411898, 027412100, 029793006, 038565180, 038571452, 039808008, 039823320, 039831045, 048576612, 049839752, 059846062, 059846677,   059868799, 059869517, 067445955, 06744729",6/21/2016,"06/21/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75063,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.","Z-0686-2017","Class III","Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464  For use with the conserve metal head","22 units","Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R)  metal acetabular liner systems.","12/01/2016",," REF 36693646  Serial Numbers:  09230967, 09229086, 10230508    REF 36693848  Serial Numbers:  08228745, 10230509, 11235075    REF 36694050  Serial Numbers:  09229091, 09230501    REF 36694252  Serial Numbers:  09229131, 10230510    REF 36694454  Serial Numbers:  LLALMB161A, 09230503    REF 36694656  Serial Numbers:  09230505, 11230847    REF 36694858  Serial Numbers:  09229167, 10230511    REF 36695060  Serial Numbers:  09229169, 09230506    REF 36695262  Serial Numbers:  09230507, 09229170    REF 36695464  Serial Numbers:  08228747, 10230512  ",6/21/2016,"06/21/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75063,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.","Z-0683-2017","Class III","Lineage Liners:  REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664  For use with the conserve metal head","5,009 units","Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R)  metal acetabular liner systems.","12/01/2016",," REF 70102846  Serial numbers:  06217334, 06217335, 06217336, 07218879, 10229555, 12339970, 12342378, 09345262, 11356669, 03459689, 03460757, 05478476, 06487845, 09491060, 11497839, 114131987, 025179937, 035198678, 035199154, 075211008, 085258159, 095267627, 085267672, 125294335,   016302354, 026317823, 026322014, 056332874, 056340972, 066346343, 066347890, 066349011, 076361472, 086364785, 086365941, 086365942, 086366614, 027403696, 027405367, 037417244, 037417245, 037423200, 047423201, 057426382, 057436510, 067442040, 067445874, 067447459,   077449134, 077456252, 077456253, 077458343, 087458991, 097465277, 097465278, 107473197, 097476410, 107481165, 107485823, 107486701, 117486702, 117495033, 127500338, 127500339, 038523902, 028523903, 028533974, 028533976, 038533977, 048571510, 048571511, 078595472,   078595473, 108669048, 108694963, 108694964, 118706230, 029763680, 029780243, 069816370, 069829627, 069835276, 069840533, 069841537, 069842578, 069871618, 099893231, 0301059446, 0301059448, 0301059449, 0301076824, 0301080515, 0301084486, 0301084488, 0301085776, 0301089607, 0301089608, 0401112808, 0601145034, 0601146232, 0801172562, 0801172985, 1101217377, 1381687, 1382260     REF 70202852  Serial Numbers:  06217338, 03442273, 03457113, 094103603, 114115155, 114131988, 067444763, 097458085, 117501995, 018507062, 078595474, 022A147720    REF 70202852  Serial Numbers:  022A147721, 022A147722, 022A147723, 022A147723, 022A147724, 06217340, 04217341, 04217342, 04217343, 04218880, 05218881, 04218882, 08225650, 08227481, 08227482, 10228744, 11228846, 03334611, 05335140, 03339967, 03339968, 08342274, 09345234, 08345235,   10349867, 10349868, 10349869, 03455651, 03457114, 03460758, 05478475, 06487846, 08491061, 08497840, 08499658, 094103604, 114115156, 114131989, 015140898, 015145854, 015167730, 025182498, 025182499, 025185569, 035198684, 055208762, 055228595, 055229916, 065242431,   075242432, 065245652, 085258160, 095267361, 095267673, 085267674, 105281165, 115291529, 125292876, 115292878, 016311871, 016311871, 01631187",6/21/2016,"06/21/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75063,"Ongoing","MicroPort Orthopedics Inc.","5677 Airline Rd",,"Arlington","TN","38002-9501","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.","Z-0685-2017","Class III","Procotyl (Rim- Lock) Liners:  REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714  For use with the conserve metal head","500 units","Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R)  metal acetabular liner systems.","12/01/2016",," REF PHA04702  Serial Numbers: PHA04702, 087461467, 089909592, 106368684, 106379196, 106381827, 109949208, 129989153, 0201018636, 0301049040      REF PHA04704  Serial Numbers:  010989155, 027373842, 038461468, 057433172, 077453350, 089924904, 106379197, 106380366, 106381751, 0201018637     REF PHA04706  Serial Numbers:  1414640, 010990534, 017400915, 037415861, 039755749, 047420835, 047424536, 077459275, 087461469, 089906466, 0101034747, 106379879, 106381773, 0301084459, 0401100079, 0501122040, 0801189074     REF PHA04708  Serial Numbers:  010990535, 017400568, 037420836, 047424415, 077455537, 087461470, 089901226, 106380367, 106381752, 0311304891, 0401118999, 0601163086, 0711360334     REF PHA04710  Serial Numbers:  1372615, 1413361, 017400673, 037415862, 037420837, 047423789, 047424535, 077457450, 077460608, 089901146, 098695744, 098695746, 106380368, 106381542, 106381753, 108695745, 109944906, 116380977, 119983782, 129990536, 0201016259, 0301076759, 0311303536, 0311305118, 0401089452, 0401121936, 0501131023, 0801187747, 1291000322     REF PHA04712  Serial Numbers:  029695877, 037414678, 047418090, 057426407, 077457328, 098464129, 099906467, 106373846, 106380571, 116389410, 0201058381, 0301084465, 0311303537, 0401117709, 0601163076,   0801188639     REF PHA04714  Serial Numbers:  1414641, 017400569, 029807399, 037415854, 047423790, 077432883, 077445957, 106368690, 0201025145, 0901196483   ",6/21/2016,"06/21/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75064,"Ongoing","Snyder's-Lance Inc.","13515 Ballantyne Corporate Pl",,"Charlotte","NC","28277-2706","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US - CA, WA, UT, AZ, OR, FL, TX, HI, ID, OK, GA, IN, PA, MI, IL, SD, MN, KS, MO, NJ, LA, WI, KY, VA, MD, NY, and CT.","F-2644-2016","Class I","Diamond of California¿ Macadamia Halves and Pieces   2.25oz packages  ","30,768 - 12ct/2.25oz packages","Product may be potentially contaminated with Salmonella.","09/30/2016",," UPC: 070450743918    Lot #:   16137D331S  16159D331S  ",8/30/2016,"08/30/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75064,"Ongoing","Snyder's-Lance Inc.","13515 Ballantyne Corporate Pl",,"Charlotte","NC","28277-2706","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US - CA, WA, UT, AZ, OR, FL, TX, HI, ID, OK, GA, IN, PA, MI, IL, SD, MN, KS, MO, NJ, LA, WI, KY, VA, MD, NY, and CT.","F-2640-2016","Class I","Diamond of California¿ Chopped Macadamia Nuts 4oz","23,270 -10ct/4oz packages","Product may be potentially contaminated with Salmonella.","09/30/2016",," UPC: 010300345848    Lot #:   16137D331S  16138D331S  16158D331S  ",8/30/2016,"08/30/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75065,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to KS only","Z-2907-2016","Class II","Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage","18","During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.","09/30/2016",," Catalog Number 910420, Lot #0195878 with expiry 10/2018",8/23/2016,"08/23/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75065,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to KS only","Z-2910-2016","Class II","Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1) sealed package of lumbar catheter and External drainage system is finally packaged in a cardboard box. Intended for CSF external drainage","1","During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.","09/30/2016",," Catalog Number 910120A, Lot #0195870 with expiry 05/2019",8/23/2016,"08/23/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75065,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to KS only","Z-2908-2016","Class II","Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box.   Used for Intraoperative drainage of CSF","1","During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.","09/30/2016",," Catalog Number 910122, Lot #0195615 with expiry 04/2019",8/23/2016,"08/23/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75065,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to KS only","Z-2909-2016","Class II","Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box.   F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems","14","During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.","09/30/2016",," Catalog Number 951303, Lot #0195786 with expiry 05/2019",8/23/2016,"08/23/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75065,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to KS only","Z-2906-2016","Class II","CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box.   For use with CUSA DISSECTRON Hand pieces and Sontrodes","9","During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.","09/30/2016",," Catalog Number F75221, Lot #0195486 with expiry 04/2021",8/23/2016,"08/23/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75065,"Ongoing","Integra LifeSciences Corp.","311 Enterprise Dr",,"Plainsboro","NJ","08536-3344","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to KS only","Z-2905-2016","Class II","Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box.   Silicone elastomer Ventricular Catheter for use with hydrocephalus valves","10 ","During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.","09/30/2016",," Catalog Number VC-1, Lot #0195451 with expiry 05/2019",8/23/2016,"08/23/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75066,"Ongoing","Azer Scientific, Inc.","701 Hemlock Rd",,"Morgantown","PA","19543-9768","United States","Voluntary: Firm Initiated",,"Nationwide Distribution","Z-0330-2017","Class II","Fruit Punch Glucose, 100 Gram Concentration, Liquid,  4/Pack of 6 Bottles, 24/cs  Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.","1,141 Cases","Out of Specification Microbiological test results","11/02/2016",," Item Number: 10-FP-100  Lot Number: 49936  Expiration Date: 11/2017  ",8/24/2016,"08/24/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75066,"Ongoing","Azer Scientific, Inc.","701 Hemlock Rd",,"Morgantown","PA","19543-9768","United States","Voluntary: Firm Initiated",,"Nationwide Distribution","Z-0329-2017","Class II","Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case  Accessory  to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.","426 cases","Out of Specification Microbiological test results","11/02/2016",," Item Number: 10-O-050  Lot Number: 51426  Expiration Date: 05/2018  ",8/24/2016,"08/24/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",75067,"Ongoing","Sensible Organics, Inc.","3740 W 4th Ave",,"Beaver Falls","PA","15010-1904","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","F-2460-2016","Class II","Nourish Organic Renewing & Cooling Eye Treatment  0.5 FL. oz/15 mL","8,621 units","Sensible Organics decided to voluntarily recall Nourish Organic Renewing & Cooling Eye Treatment Lot G06216 due to samples that were tested positive for microbes.","09/21/2016",," Lot # G06216",8/24/2016,"08/24/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75068,"Ongoing","LDR Spine USA, Inc.","13785 Research Blvd Ste 200",,"Austin","TX","78750-1895","United States","Voluntary: Firm Initiated","E-Mail","US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.","Z-0045-2017","Class II","ROI-A Anterior Delivery Device.  Orthopedic manual surgical instrument. Model number: SI-ROIA-0023    Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device. ","24 units","The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle.  There have been no reports of patient injury","10/05/2016",," Lot # 2295101A, 2295101A-R, 2296101A-R",8/29/2016,"08/29/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75070,"Ongoing","PM Resources, Inc. dba Virbac Animal Health, Inc.","13001 Saint Charles Rock Rd",,"Bridgeton","MO","63044-2421","United States","Voluntary: Firm Initiated","Letter","CA, FL, GA, IA, IN, MN, MO, OR, PA, TN, TX, WI and Puerto Rico","V-0038-2017","Class III","RILEXINE (cephalexin) Chewable Tablets 150 mg, 100 Tablets, NDC 051311-026-10, NADA # 141-326, Virbac ANIMAL HEALTH label, Rx only --- Mfd. for Virbac AH, Inc. Fort Worth, TX 76137.","US: 28,968 bottles","Labeling Defects: missing label, double label, missing lot/expiration, partial or illegible lot/expiration date. The same lots may contain bottles with possible foil seal defects (loose or incompletely sealed to the bottle).","12/19/2016",," Lot C5484P11, exp. 02/18; Lot C5486P11, exp. 04/18;   Lot C5496P11, exp. 05/18  ",8/31/2016,"08/31/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75070,"Ongoing","PM Resources, Inc. dba Virbac Animal Health, Inc.","13001 Saint Charles Rock Rd",,"Bridgeton","MO","63044-2421","United States","Voluntary: Firm Initiated","Letter","CA, FL, GA, IA, IN, MN, MO, OR, PA, TN, TX, WI and Puerto Rico","V-0039-2017","Class III","RILEXINE (cephalexin) Chewable Tablets 300 mg, 100 Tablets, NDC 051311-036-10, NADA # 141326, Virbac ANIMAL HEALTH label, Rx only --- Mfd. for: Virbac AH, Inc. Fort Worth, TX 76137","US: 19,776 bottles","Labeling Defects: missing label, double label, missing lot/expiration, partial or illegible lot/expiration date.  The same lots may contain bottles with possible foil seal defects (loose or incompletely sealed to the bottle).","12/19/2016",," Lot C5473P31, exp. 02/18; Lot C5485P31, exp. 02/18;   Lot C5487P31, exp. 03/18; Lot C5497P31, exp. 05/18",8/31/2016,"08/31/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75070,"Ongoing","PM Resources, Inc. dba Virbac Animal Health, Inc.","13001 Saint Charles Rock Rd",,"Bridgeton","MO","63044-2421","United States","Voluntary: Firm Initiated","Letter","CA, FL, GA, IA, IN, MN, MO, OR, PA, TN, TX, WI and Puerto Rico","V-0040-2017","Class III","RILEXINE (cephalexin) Chewable Tablets 600 mg, 100 tablets, NDC 051311-046-10, NADA # 141-326, Virbac ANIMAL HEALTH label, Rx only --- Mfd. for: Virbac AH, Inc. Fort Worth, TX 76137","US: 44,737 bottles","Labeling Defects: missing label, double label, missing lot/expiration, partial or illegible lot/expiration date.  The same lots may contain bottles with possible foil seal defects (loose or incompletely sealed to the bottle).","12/19/2016",," Lot C5477P61, exp. 11/17; Lot C5478P61, exp. 11/17;   Lot C5479P61, exp. 12/17; Lot C5480P61, exp. 01/18;   Lot C5481P61, exp. 01/18; Lot C5482P61, exp. 01/18;  Lot C5483P61, exp. 01/18; Lot C5488P61, exp. 02/18;   Lot C5489P61, exp. 03/18; Lot C5490P61, exp. 03/18;   Lot C5491P61, exp. 03/18; Lot C5492P61, exp. 03/18;  Lot C5493P61, exp. 04/18; Lot C5495P61, exp. 04/18;    Lot C5501P61, exp. 05/18; Lot C5502P61, exp. 06/18;  Lot C5506P61, exp. 07/18  ",8/31/2016,"08/31/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75071,"Terminated","Department of the Army, Tripler Army Medical Center","1 Jarrett White Rd",,"Tripler Army Medical Center","HI","96859-5000","United States","Voluntary: Firm Initiated","FAX","CA","B-0023-2017","Class III","Red Blood Cells","23 units"," Blood products, collected using expired blood collection bags, were distributed.","10/05/2016","10/05/2016"," W012116001755; W012116001764; W012116001766; W012116001767; W012116001769; W012116001756; W012116001757; W012116001760; W012116001761; W012116001770; W012116001771; W012116001772; W012116001773; W012116001774; W012116001775; W012116001776; W012116001777; W012116001778; W012116001779; W012116001783; W012116001784; W012116001786; W012116001762",8/11/2016,"08/11/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75072,"Terminated","American Red Cross Blood Services Tennessee Valley Region","2201 Charlotte Ave",,"Nashville","TN","37203-1817","United States","Voluntary: Firm Initiated","FAX","Tennessee","B-0003-2017","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","2 units","Blood products, which did not meet the acceptable product specification, were distributed.","10/05/2016","10/05/2016"," W201916832520; W201916832520; ",6/28/2016,"06/28/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75072,"Terminated","American Red Cross Blood Services Tennessee Valley Region","2201 Charlotte Ave",,"Nashville","TN","37203-1817","United States","Voluntary: Firm Initiated","FAX","Tennessee","B-0004-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood products, which did not meet the acceptable product specification, were distributed.","10/05/2016","10/05/2016"," W201916832520; ",6/28/2016,"06/28/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75073,"Terminated","Stanford Medical School Blood Center","3373 Hillview Ave",,"Palo Alto","CA","94304-1204","United States","Voluntary: Firm Initiated","FAX","California","B-0006-2017","Class III","Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.","10/05/2016","10/05/2016"," W117016031232; ",7/14/2016,"07/14/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75073,"Terminated","Stanford Medical School Blood Center","3373 Hillview Ave",,"Palo Alto","CA","94304-1204","United States","Voluntary: Firm Initiated","FAX","California","B-0005-2017","Class III","Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated","4 units","Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.","10/05/2016","10/05/2016"," W117016037220; W117016037220; W117016021274; W117016021274; ",7/14/2016,"07/14/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75074,"Terminated","The American National Red Cross - Southern Region","9851 Commerce Way",,"Douglasville","GA","30135-3101","United States","Voluntary: Firm Initiated","Telephone","Georgia","B-0008-2017","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","10/05/2016","10/06/2016"," W200316623919; ",7/7/2016,"07/07/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75074,"Terminated","The American National Red Cross - Southern Region","9851 Commerce Way",,"Douglasville","GA","30135-3101","United States","Voluntary: Firm Initiated","Telephone","Georgia","B-0007-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","10/05/2016","10/06/2016"," W200316623919; ",7/7/2016,"07/07/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75075,"Ongoing","Vetix Inc.","961 Beasley St Ste 270",,"Lexington","KY","40509-4120","United States","Voluntary: Firm Initiated","Letter","US nationwide.  The product was distributed to the followin states: CA, CO, FL, ID, IN, KY, LA, MA, MI, MN, MO, NE, NJ, NM, OH, PA, SC, TN, and TX.  The product was also distributed in Puerto Rico.","V-0047-2017","Class I","Optimend 0.2% Sodium Hyaluronate Gel Drops for Corneal Repair, packaged in 10 mL bottle gel drops for animal use only, NDC # 51031-013-10","3990 bottles","The products were found to contain microbial contamination.","12/21/2016",," 01122015",8/31/2016,"08/31/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75075,"Ongoing","Vetix Inc.","961 Beasley St Ste 270",,"Lexington","KY","40509-4120","United States","Voluntary: Firm Initiated","Letter","US nationwide.  The product was distributed to the followin states: CA, CO, FL, ID, IN, KY, LA, MA, MI, MN, MO, NE, NJ, NM, OH, PA, SC, TN, and TX.  The product was also distributed in Puerto Rico.","V-0046-2017","Class I","OptiVet Eye Irrigating Solution with Sodium Hyaluronate, 0.1% per 14.78 mL bottle for animal use only, NDC # 51031-011-15","2041 bottles","The products were found to contain microbial contamination.","12/21/2016",," 12032015",8/31/2016,"08/31/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75075,"Ongoing","Vetix Inc.","961 Beasley St Ste 270",,"Lexington","KY","40509-4120","United States","Voluntary: Firm Initiated","Letter","US nationwide.  The product was distributed to the followin states: CA, CO, FL, ID, IN, KY, LA, MA, MI, MN, MO, NE, NJ, NM, OH, PA, SC, TN, and TX.  The product was also distributed in Puerto Rico.","V-0045-2017","Class I","Hy-Optic Eye Irrigating Solution, Sodium Hyaluronate packaged in 14.78 mL bottles, NDC # 51031-011-15","6246 bottles","The products were found to contain microbial contamination.","12/21/2016",," 10092015",8/31/2016,"08/31/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1481-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---   Carton NDC 68084-874-25; Blister NDC 68084-874-95	  ","221 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 163220, exp. 10/31/17 and lot 164194, exp. 11/20/17  ",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1486-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx,  Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95  	    	    	  	  	  	  ","834 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 152254, exp. 12/31/16, lot 152324, exp. 3/31/17, lot 154833, exp. 5/31/17, lot 162406, exp. 12/31/17  ",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1487-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33  	      	    	  	  	  	  ","126 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 162489, exp. 9/30/17 and lot 162910, exp. 10/31/17  ",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1483-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ----   Carton NDC 60687-133-25; Blister NDC 60687-133-95	    	  	  ","1,416 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 150950, exp. 3/31/17 and lot 154813, exp. 5/31/2017  ",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1490-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-887-32; Blister NDC 68084-887-33  	  	        	  	  	  	  ","761 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 152418, exp. 12/31/16, lot 153544, exp. 3/31/17, lot 154835, exp. 5/31/17        ",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1489-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx,  Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33      	  	  	  	  ","115 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 162490, exp. 9/30/17      ",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1488-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95    	    	  	  	  	  ","666 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 152325, exp. 12/31/16, lot 154834, exp. 5/31/17        ",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1482-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ----   Carton NDC 68084-936-25; Blister NDC 68084-936-95	  	  ","2,276 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 150130, exp. 10/31/16 and lot 161296, exp. 8/31/17  ",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1485-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---   Carton NDC 60687-154-25; Blister NDC 60687-154-95     	  	  ","156 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 162278, exp. 10/31/17",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75076,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: Nationwide","D-1484-2016","Class II","Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---   Carton NDC 68084-943-25; Blister NDC 68084-943-95    	  	  ","867 cartons","Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule","09/02/2016",," Lot 162276, exp. 9/30/17",8/24/2016,"08/24/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75077,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US and Internationally","Z-0060-2017","Class II","Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430, USA, A Subsidiary of Stryker Corp.","3,768 units","Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.","10/07/2016",," Catalog No: 2101-0200, Lot Nos. SMM7A00, SMM7A00L, SMM7A02, SMM7A02A, SMM7A02E, SMM7A02EE, SMM7A01T, SMM7A01TT, SMM7A01TD, SMM7A01TDD, SMM7C02H, SMM7C02, SMM7C01, SMM7C01T, SMM7C01TT, SMM7C01W, SMM7E03, SMM7E03A, SMM7E00, SMM7A00E, SMM7E02, SMM7E02A, SMM7E01, SMM7E01A, SMM7K00. SMM7K01, SMM7K01A, SMM7K03, SMM7K03L, SMM7K02, SMM7K02T, SMM7K03X, SMM7K03Y, SMM7C02J, SMM7L00H, SMM7L00J, SMM7L00K, SMM7L00, SMM7C01TW, SMM7M01, SMM7A02T, SMM7M00, SMM7M00A, SMM7M02H, SMM7M02, SMM7E02M, SMM7E01JK, SMM7K03J, SMM7K00A, SMM6N04, SMM7N01J, SMM7N01, SMM7M06, SMM7M09, SMM7N03, SMM7N03A, SMM7M06A, SMM7M09, SMM7N00, SMM7M05, SMM7M08A, SMM7M10, SMM7N00A, SMM7N02L, SMM7M05J, SMM7M08, SMM7N02, SMM7N04, SMM7N04J, SMM8C00, SMM7M01R, SMM7M01RW, SMM7M01W, SMM7M07, SMM7M07J, SMM6C00, SMM7M03, SMM7M03A, SMM7M03D, SMM7M03E, SMM7M03L, SMM7M04, SMM7M04L, SMM7M03K, SMM8C00J, SMM8L05, SMM8L05A, SMM8L02X, SMM8L04, SMM6N00, SMM6N01, SMM6N01A, SMM6N02, SMM6N03, SMM6N04A, SMM8L07T, SMM8L08, SMM8M00K, SMM8M00L, SMM8M01, SMM8M01E, SMM8M01EE, SMM8N02, SMM8N02A, SMM8M01A, SMM8N00, SMM8N00A, SMM8N00D, SMM8N01, SMM8N01A, SMM8N01T, SMM8S00, SMM8S00T, SMM8S00TT, SMM8S01, SMM8S01A, SMM8S01D, SMM8T00, SMM8N02T, SMM8S02, SMM8V00, SMM8V00A, SMM8V00E, SMM8T00A, SMM8V01, SMM8V01A, SMM8W02, SMM8W03A, SMM8V02, SMM8W01, SMM8W01A, SMM8W02X, SMM8W03M, SMM8W03P, SMM8W04, SMM8W04A, SMM8W05, SMM8W05A, SMM8W03D, SMM8W03, SMM8W05D, SMM8W00A, SMM8W00E, SMM8W00J, SMM8W00K, SMM8W00, SMM8V02J, SMM8W00D, SMM8V07, SMM8W06H, SMM8W05H, SMM8W00H, SMM8W07, SMM8W07K, SMM8W07L, SMM8W08, SMM8W08E, SMM8W07A, SAMPLE25, SMM8W08EE, SMM9A00, SMM9A00R, SMM9A00T, SMM9A01, SMM9A01E, SMM9A01EL, SMM9A02, SMM9A02E, SMM9A03, SMM9A03K, SMM9A03L, SMM9A03P, SMM8L01, SMM8L03, SMM8L07, SMM8L00T, SMM8L07, SMM9A05, SMM9A06, SMM9A06E, SMM9A07, SMM9A08, SMM9A12, SMM9A12J, SMM9A12T, SMM9A09, SMM9A09K, SMM9A09L, SMM9A10, SMM9A11, SMM9A11D, SMM9A07L, SMM9E01, SMM9E02, SMM9E02A, SMM9E03, SMM9E00, SMM9C00A, SMM9C00D, SMM9C00, SMM9C00J, SMM9C00K, SMM9E05A, SMM9E04, SMM9E04A, SMM9E04D, SMM9E04E, SMM9E05, SM",8/18/2016,"08/18/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75078,"Ongoing","Spacelabs Healthcare Inc","35301 SE Center St",,"Snoqualmie","WA","98065-9216","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.","Z-2886-2016","Class II","Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280.  Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. ","316 XTR units total (248 units in the US and 68 units outside US)","The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.","09/26/2016",," Serial numbers of units distributed in the US       6280-000053, 6280-000056, 6280-000057, 6280-000058, 6280-000059,   6280-000066, 6280-000067, 6280-000068, 6280-000077, 6280-000078,   6280-000079, 6280-000083, 6280-000084, 6280-000085, 6280-000086,   6280-000088, 6280-000090, 6280-000092, 6280-000093, 6280-000095,   6280-000096, 6280-000097, 6280-000098, 6280-000099, 6280-000100,   6280-000101, 6280-000102, 6280-000103, 6280-000104, 6280-000105,   6280-000106, 6280-000107, 6280-000108, 6280-000109, 6280-000110,   6280-000111, 6280-000112, 6280-000113, 6280-000114, 6280-000115,   6280-000116, 6280-000117, 6280-000118, 6280-000120, 6280-000121,   6280-000122, 6280-000123, 6280-000124, 6280-000125, 6280-000126,   6280-000127, 6280-000128, 6280-000129, 6280-000131, 6280-000132,   6280-000137, 6280-000138, 6280-000140, 6280-000141, 6280-000142,   6280-000143, 6280-000146, 6280-000147, 6280-000148, 6280-000149,   6280-000151, 6280-000152, 6280-000153, 6280-000154, 6280-000155,   6280-000156, 6280-000158, 6280-000159, 6280-000160, 6280-000161,   6280-000167, 6280-000168, 6280-000170, 6280-000171, 6280-000172,   6280-000173, 6280-000174, 6280-000176, 6280-000177, 6280-000200,   6280-000228, 6280-000229, 6280-000233, 6280-000234, 6280-000235,   6280-000236, 6280-000238, 6280-000239, 6280-000240, 6280-000241,   6280-000242, 6280-000243, 6280-000245, 6280-000250, 6280-000251,   6280-000252, 6280-000253, 6280-000254, 6280-000255, 6280-000256,   6280-000257, 6280-000260, 6280-000261, 6280-000263, 6280-000264,   6280-000265, 6280-000266, 6280-000267, 6280-000268, 6280-000269,   6280-000271, 6280-000272, 6280-000273, 6280-000274, 6280-000275,   6280-000278, 6280-000279, 6280-000280, 6280-000281, 6280-000283,   6280-000284, 6280-000285, 6280-000286, 6280-000287, 6280-000288,   6280-000289, 6280-000298, 6280-000301, 6280-000302, 6280-000303,   6280-000306, 6280-000307, 6280-000308, 6280-000310, 6280-000311,   6280-000312, 6280-000315, 6280-000316, 6280-000318, 6280-000319,   6280-000321, 6280-000322, 6280-000324, 6280-00032",8/25/2016,"08/25/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75078,"Ongoing","Spacelabs Healthcare Inc","35301 SE Center St",,"Snoqualmie","WA","98065-9216","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.","Z-2885-2016","Class II","Spacelabs Healthcare Xhibit Central Station, Model 96102.  Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. ","798 units total (488 units in the US and 310 units outside US)","The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.","09/26/2016",," Serial numbers of units distributed in the US     SLA0216F01822, SLA0216F01827, SLA0416F01924, SLA0516F01935, SLA0216F01771, SLA0216F01773, SLA0216F01784, SLA0216F01787, SLA0416F01897, SLA0416F01898, SLA0416F01899, SLA0416F01905, SLA0416F01909, SLA0416F01910, SLA0416F01911, SLA0416F01912, SLA0416F01914, SLA0416F01915, SLA0416F01916, SLA0416F01917, SLA0416F01918, SLA0416F01919, SLA0416F01920, SLA0516F01971, SLA0516F01995, SLA0314F00534, SLA0314F00535, SLA0314F00548, SLA0314F00561, SLA0314F00567, SLA0715F01310, SLA0814F00713, SLA1115F01593, SLA1115F01595, SLA1115F01596, SLA1115F01597, SLA1115F01602, SLA1115F01609, SLA0216F01806, SLA0216F01810, SLA0216F01817, SLA0216F01818, SLA0216F01832, SLA0216F01833, SLA0216F01835, SLA0216F01839, SLA0515F01104, SLA0515F01105, SLA0515F01107, SLA0515F01111, SLA0515F01115, SLA0515F01116, SLA0515F01119, SLA0515F01120, SLA0515F01121, SLA0515F01123, SLA0515F01129, SLA0515F01142, SLA0515F01144, SLA0515F01145, SLA0515F01146, SLA0515F01147, SLA0515F01148, SLA0515F01149, SLA0515F01150, SLA0515F01151, SLA0515F01152, SLA0515F01153, SLA0515F01154, SLA0515F01155, SLA0515F01156, SLA0515F01157, SLA0515F01158, SLA0716F02010, SLA0115F00919, SLA0115F00921, SLA0115F00927, SLA0115F00928, SLA0115F00934, SLA0515F01106, SLA0515F01108, SLA0515F01143, SLA0715F01327, SLA0715F01328, SLA0715F01329, SLA0915F01439, SLA0915F01442, SLA0915F01447, SLA0915F01451, SLA0915F01452, SLA0915F01457, SLA0915F01459, SLA0915F01468, SLA0915F01474, SLA0915F01496, SLA0915F01497, SLA0915F01498, SLA0915F01499, SLA0915F01501, SLA0915F01503, SLA0915F01506, SLA0915F01507, SLA0915F01508, SLA0915F01510, SLA0915F01511, SLA0915F01512, SLA0915F01513, SLA0915F01514, SLA0115F00926, SLA0115F00963, SLA0115F00964, SLA0115F00986, SLA0116F01711, SLA0214F00497, SLA0216F01796, SLA0216F01808, SLA0216F01811, SLA0216F01812, SLA0216F01834, SLA0216F01843, SLA0216F01845, SLA0516F01948, SLA0516F01950, SLA0516F01951, SLA1015F01536, SLA1015F01539, SLA1215F01636, SLA1215F01637, SLA1215F01638, SLA1215F01645, SLA1215F01646, SLA1215F01651, SLA1215F01652,",8/25/2016,"08/25/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75079,"Ongoing","BIMBO Bakeries USA Inc.","255 Business Center Dr",,"Horsham","PA","19044-3424","United States","Voluntary: Firm Initiated","Visit","Nationwide","F-0166-2017","Class II","Entenmann's Little Bites Fudge Brownies - 20 muffins, 5 Pouches; Net Wt. 9.75 OZ.; Bimbo Bakeries USA, Inc., Horsham, PA 19044; Best By: October 8, 2016/3098; UPC: 7203001342","244,704 boxes","Presence of plastic in muffins and brownies.","10/18/2016",," Best By: October 8, 2016/3098; UPC: 7203001342",8/30/2016,"08/30/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75079,"Ongoing","BIMBO Bakeries USA Inc.","255 Business Center Dr",,"Horsham","PA","19044-3424","United States","Voluntary: Firm Initiated","Visit","Nationwide","F-0164-2017","Class II","Entenmann's Little Bites Chocolate Chip Muffins; 10 Pouches; Net Wt. 1 lb. 0.5 OZ. ; Bimbo Bakeries USA, Inc.; PO #976, Horsham, PA 19044. Best By: October 8, 2016/3098; UPC: 7203002111;    Entenmann's Little Bites Chocolate Chip Muffins; 20 Muffins, 5 Pouches; Net Wt. 8.25 OZ. ; Bimbo Bakeries USA, Inc.; Horsham, PA 19044. Best By: October 8 2016/3098; UPC: 7203001353","10 pouch - 14814 boxes; 5 pouch - 305,772 boxes","Presence of plastic in muffins and brownies.","10/18/2016",," 10 pouches: UPC Code 7203002111, Best By Date 10/08/2016/3098;  5 pouches: Best By: October 8 2016/3098; UPC: 7203001353",8/30/2016,"08/30/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75079,"Ongoing","BIMBO Bakeries USA Inc.","255 Business Center Dr",,"Horsham","PA","19044-3424","United States","Voluntary: Firm Initiated","Visit","Nationwide","F-0165-2017","Class II","Entenmann's Little Bites Variety - 20 pouches labeled for resale  10 Chocolate Chip; 5 Blueberry; 5 Fudge Brownie;  Net Wt 2 lbs.;  Distributed by: Entenmann's Inc., General Offices, PO #976, Horsham, PA 19044.  Best by: September 24, 2016/ 3098;  UPC:7203001799","45,600 boxes","Presence of plastic in muffins and brownies.","10/18/2016",," Best by: September 24, 2016/ 3098;  UPC:7203001799",8/30/2016,"08/30/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75080,"Ongoing","Trimed Inc","27533 Avenue Hopkins",,"Santa Clarita","CA","91355-3910","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.","Z-2849-2016","Class II","TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10    Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.","30 units","TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.","09/20/2016",," Lot no. 06206",8/29/2016,"08/29/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75081,"Ongoing","GE Healthcare, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI.    OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, Martinique, Mexico, MOROCCO, Netherlands, New Zealand, OMAN, Pakistan, Philippines, Poland, Portugal, Romania, SAUDI ARABIA, Singapore, South Africa, Spain,Sweden, Tanzania, Thailand,   Turkey, United Arab Emirates, United Kingdom, Vietnam.","Z-2731-2016","Class II","GE Healthcare SIGNA Creator, SIGNA Explorer.  Diagnostic Imaging Device.","383 (US = 24;OUS = 359)","GE Healthcare is conducting a recall dealing with  an incorrect RF Power Monitor Function  involving  SIGNA CREATOR and SIGNA EXPLORER which  could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.","09/02/2016",,"  002757TA3	PL3697MR01  002267TA3	PL1724MR01  003795TA2	PL3810MR01  002268TA1	PL3595MR01  002684TA9	PL1778MR01  002595TA7	PL3596MR01  003075TA9	PPR58104  001496TA9	MRR1448  002875TA3	MRR3155  003084TA1	MRR2728  003479TA3	GON: 4420297  002447TA1	RO1321MR01  002381TA2	RO1311MR01  003400TA9	RO1090MR02  003022TA1	RO1200MR01  003020TA5	RO1252MR01  003402TA5	GON: 4381507  003021TA3	RO1038MR01  002221TA0	SA2330MR01  002089TA1 	SA2468MR01  002383TA8	SA2167MR01  003753TA1	GON: 4398438  003305TA0	SA2118MR01  001980TA2 	6073MR0008  002681TA5	1573MR0004  002220TA2	6073MR0009  002682TA3	0847270018  003505TA5	6073MR0012  002271TA5	ZA2222MR02  002440TA6	YP170A26  001770TA7	CP749713  002266TA5	FPG40900  002377TA0	FPG97802  003777TA0	DPN29025  003726TA7	GON: 4424831  002451TA3	YP602101  002378T A8	DEL71943  003132TA8	NPV71300  003308TA4	GON: 4399370  003353TA0	GON: 4399371  002575TA9	N006MR01  002881TA1	A013MR02  003357TA1	TZ1052MR01  003509TA7	1573MR0008  003603TA8	1573MR0007  003482TA7	1573MR0009  002655TA9	1573MR0003  002686TA4	1573MR0005  003433TA0	02008MRS01  001141TA1	06167MRS01  002449TA7	06169MRS01  003434TA8	16003MRS01  003442TA1	25008MRS01  002439TA8	34416MRS01  002021TA4	46008MRS01  003015TA5	06172MRS01  003622TA8	33044MRS02  003781TA2	GON: 4410001  002947TA0	34419MRS01  003477TA7	34433MRS01  003474TA4	52013MRS01  002946TA2	53012MRS01  003794TA5	09018MRS01  003130TA2	GON: 4294813  001769TA9	IE1590MR01  001404TA3	10718MRS01  001140TA3	10719MRS01  002941TA3	70001MRM01  002269TA9	10724MRS01  003300TA1	10079MRM83  003216TA9	5973MR0009  003476TA9	5973MR0010  ",8/31/2016,"08/31/2016",9/14/2016,"09/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75082,"Ongoing","Prismatik Dentalcraft, Inc","2181 Dupont Dr",,"Irvine","CA","92612-1301","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY","Z-2897-2016","Class II","BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006	    The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.","150 units","Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed.  Prismatik failed to properly identify the lots as quarantined product.","09/27/2016",," BZ0004415   BZ0004745   BZ0004416   BZ0004747   BZ0004522   BZ0004360   BZ0004496   BZ0004593   BZ0004094   BZ0004614   ",8/15/2016,"08/15/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75083,"Ongoing","West-Ward Pharmaceuticals Corp.","401 Industrial Way West",,"Eatontown","NJ","07724-2209","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1515-2016","Class III","Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only,  Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,","32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)","Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.","09/19/2016",," Lot #: AS1413A, AS1414A; Exp. 11/18",8/18/2016,"08/18/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75084,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",,"Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","FAX","Colorado","B-0010-2017","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood product, in which labels applied to blood unit or product incorrect or missing information were distributed.","10/05/2016","10/05/2016"," W036216714594; W036216887855; ",7/20/2016,"07/20/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75085,"Terminated","Delta Blood Bank","65 N Commerce St",,"Stockton","CA","95202-2318","United States","Voluntary: Firm Initiated","FAX","California","B-0009-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who had been incarcerated, was distributed. ","10/05/2016","10/05/2016"," W128716160469; ",7/29/2016,"07/29/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75086,"Terminated","Community Blood Center Of Gtr KC","4040 Main St",,"Kansas City","MO","64111-2308","United States","Voluntary: Firm Initiated","FAX","Missouri; Kansas","B-0744-16","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","4 units","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.","09/19/2016","09/19/2016"," W045015020552 (double collection); W045015058685 (double collection)",8/15/2016,"08/15/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75086,"Terminated","Community Blood Center Of Gtr KC","4040 Main St",,"Kansas City","MO","64111-2308","United States","Voluntary: Firm Initiated","FAX","Missouri; Kansas","B-0745-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.","09/19/2016","09/19/2016"," W045016005817",8/15/2016,"08/15/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75087,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0761-16","Class II","Pooled Platelets, Leukocytes Reduced","1 unit","Pooled platelets, which did not meet acceptable product specifications was distributed.","09/19/2016","09/19/2016"," W035216188043L",7/15/2016,"07/15/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75088,"Terminated","American National Red Cross, The","3470 E Universal Way",,"Tucson","AZ","85756-5042","United States","Voluntary: Firm Initiated","Telephone","California","B-0762-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, identified as unsuitable due to a collection deviation was distributed.","09/12/2016","09/12/2016"," W200716185682",3/15/2016,"03/15/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Cosmetics",75089,"Ongoing","Frontier Natural Products CO-OP","3021 78th St",,"Norway","IA","52318-9520","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to IA, CA, NH, WA, FL, NJ, IL, MA, TX, IN, NY, ND, PA, WI, TN, CO, and MN as well as through internet sales.","F-0378-2017","Class II","Aura Cacia Relaxing Lavender Milk and Oat Bath, packaged in 9.75 oz plastic jars UPC 0-51381-90317-6,1.75 oz foil pouches UPC 0-51381-90307-7, and 49.6 g foil pouches (with Canadian labeling) UPC 0-51381-30307-5, Distributed by Frontier Natural Products Co-op Norway, IA","1221 units (9.75 oz  jars), 8,565 units (1.75 oz. packets)  [American labeling], 815 units (49.6g packets) [Canadian labeling]","Products tested high for microbial contamination.","11/02/2016",," 5296, 5289, and 5281",9/1/2016,"09/01/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75090,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution- US (Nationwide) and countries of: United Arab Emirates, Afghanistan, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Dominican Republic, Algeria, Ecuador, Egypt, Spain, France, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iraq, Italy, Jordan, Canary Islands, Kyrgyzstan, Rep. Korea (S), Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macedonia, Mexico, Malaysia, Nicaragua, Netherlands, Norway, Nepal, Peru, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, El Salvador, Syria, Turkmenistan, Tunisia, Turkey, Uruguay, Uzbekistan, Vietnam, Serbia,and South Africa.","Z-0320-2017","Class II","IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI  00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD ---   Siemens Healthcare Diagnostics Products Ltd., Llanberis, Gwynedd, LL55 4EL UK    For in vitro diagnostic use with IMMULITE 2000 analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities.","US: 326 kits; Foreign: 9633 kits","Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the  IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above. ","10/27/2016",," UDI 00630414985725/Catalog # L2KCM2(D): Kit lots D255, D256, D257, D258, D259, D260, D261, D262, D263, D264, D266;  UDI 00630414961163/Catalog # L2KCM2: Kit lots 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, 267  ",8/30/2016,"08/30/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75090,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution- US (Nationwide) and countries of: United Arab Emirates, Afghanistan, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Dominican Republic, Algeria, Ecuador, Egypt, Spain, France, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iraq, Italy, Jordan, Canary Islands, Kyrgyzstan, Rep. Korea (S), Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macedonia, Mexico, Malaysia, Nicaragua, Netherlands, Norway, Nepal, Peru, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, El Salvador, Syria, Turkmenistan, Tunisia, Turkey, Uruguay, Uzbekistan, Vietnam, Serbia,and South Africa.","Z-0319-2017","Class II","IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and  REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK Siemens Healthcare Diagnostics Products Ltd., Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK    For in vitro diagnostic use with the IMMULITE Systems Analyzers for the qualitative detection of IgM antibodies to Cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the determination of an acute CMV infection.","US: 5 kits; Foreign: 372 kits","Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above. ","10/27/2016",," UDI 00630414985718/Catalog # LKCM1(D): Kit lot D0330;   UDI 00630414963747/Catalog # LKCM1: Kit lots 0330, 0331",8/30/2016,"08/30/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75091,"Ongoing","Regalo's Favorite of Hawaii Inc.","421 N King St",,"Honolulu","HI","96817-4704","United States","Voluntary: Firm Initiated","Telephone","A. Love's Bakery (Distributor)  911 Middle St. 	  Honolulu, HI, 96819	  Phone: (808) 841-2088  Contact: Byron Chong / Director of Sales and Marketing    B. Seafood City Supermarket, Hawaii  (Retail)  94-050 Farrington Hwy.   Waipahu, HI 96797  Phone: (808) 675-2350  Contact: Michael Solis / Store Manager","F-0234-2017","Class I"," [UPC#78253230920]: Packaged on a foam tray, containing six pieces, and wrapped in a clear plastic film. This product contains wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).","50 UNITS","Regalo Bakery is recalling Kababayan due to undeclared wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6). ","10/21/2016",," No code",9/1/2016,"09/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75091,"Ongoing","Regalo's Favorite of Hawaii Inc.","421 N King St",,"Honolulu","HI","96817-4704","United States","Voluntary: Firm Initiated","Telephone","A. Love's Bakery (Distributor)  911 Middle St. 	  Honolulu, HI, 96819	  Phone: (808) 841-2088  Contact: Byron Chong / Director of Sales and Marketing    B. Seafood City Supermarket, Hawaii  (Retail)  94-050 Farrington Hwy.   Waipahu, HI 96797  Phone: (808) 675-2350  Contact: Michael Solis / Store Manager","F-0229-2017","Class I","[UPC#78253230919]: Packaged in a clear plastic bag, containing eight pieces, with a net weight of 14 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)   ","125 UNITS","Regalo Bakery is recalling Spanish Rolls due to undeclared eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).  ","10/21/2016",," No code",9/1/2016,"09/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75091,"Ongoing","Regalo's Favorite of Hawaii Inc.","421 N King St",,"Honolulu","HI","96817-4704","United States","Voluntary: Firm Initiated","Telephone","A. Love's Bakery (Distributor)  911 Middle St. 	  Honolulu, HI, 96819	  Phone: (808) 841-2088  Contact: Byron Chong / Director of Sales and Marketing    B. Seafood City Supermarket, Hawaii  (Retail)  94-050 Farrington Hwy.   Waipahu, HI 96797  Phone: (808) 675-2350  Contact: Michael Solis / Store Manager","F-0230-2017","Class I"," [UPC#78253230917]  packaged on a foam tray with six pieces each, wrapped in clear plastic film. This product contains: eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)","30 UNITS","Regalo Bakery is recalling Manju Blackbeans (Hopia Monggo due to undeclared  eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).","10/21/2016",," No code",9/1/2016,"09/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75091,"Ongoing","Regalo's Favorite of Hawaii Inc.","421 N King St",,"Honolulu","HI","96817-4704","United States","Voluntary: Firm Initiated","Telephone","A. Love's Bakery (Distributor)  911 Middle St. 	  Honolulu, HI, 96819	  Phone: (808) 841-2088  Contact: Byron Chong / Director of Sales and Marketing    B. Seafood City Supermarket, Hawaii  (Retail)  94-050 Farrington Hwy.   Waipahu, HI 96797  Phone: (808) 675-2350  Contact: Michael Solis / Store Manager","F-0233-2017","Class I"," [UPC#78253231001] : Packaged in a clear plastic bag, containing twelve pieces, and have a net weight of 20 ounces This product contains This product contains: eggs, wheat, milk, soy, coconut, and artificial food coloring (Red 40 & 3, Yellow 5 & 6, Blue 1).","125 UNITS","Regalo Bakery is recalling Taro Bread due to undeclared  eggs, wheat, milk, soy, coconut, and artificial food coloring (Red 40 & 3, Yellow 5 & 6, Blue 1).","10/21/2016",," No code",9/1/2016,"09/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75091,"Ongoing","Regalo's Favorite of Hawaii Inc.","421 N King St",,"Honolulu","HI","96817-4704","United States","Voluntary: Firm Initiated","Telephone","A. Love's Bakery (Distributor)  911 Middle St. 	  Honolulu, HI, 96819	  Phone: (808) 841-2088  Contact: Byron Chong / Director of Sales and Marketing    B. Seafood City Supermarket, Hawaii  (Retail)  94-050 Farrington Hwy.   Waipahu, HI 96797  Phone: (808) 675-2350  Contact: Michael Solis / Store Manager","F-0232-2017","Class I"," [UPC#78253203095] : Packaged on a foam tray, containing four pieces, wrapped in clear plastic film, and have a net weight of  16 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).","65 UNITS","Regalo Bakery is recalling Balintawak due to undeclared eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).","10/21/2016",," No code",9/1/2016,"09/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75091,"Ongoing","Regalo's Favorite of Hawaii Inc.","421 N King St",,"Honolulu","HI","96817-4704","United States","Voluntary: Firm Initiated","Telephone","A. Love's Bakery (Distributor)  911 Middle St. 	  Honolulu, HI, 96819	  Phone: (808) 841-2088  Contact: Byron Chong / Director of Sales and Marketing    B. Seafood City Supermarket, Hawaii  (Retail)  94-050 Farrington Hwy.   Waipahu, HI 96797  Phone: (808) 675-2350  Contact: Michael Solis / Store Manager","F-0231-2017","Class I"," [UPC#78253230918]: packaged on a foam tray with six pieces each, wrapped in clear plastic film. This product contains: eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)","20 UNITS","Regalo Bakery is recalling Manju Onions (Hopia Baboy) due to undeclared eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6). ","10/21/2016",," No code",9/1/2016,"09/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75094,"Ongoing","CooperSurgical, Inc.","95 Corporate Dr",,"Trumbull","CT","06611-1350","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, GA, and NY","Z-2851-2016","Class III","Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium   Product Number: ART-8018  Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).","4 units","Products contain international package insert and not  the correct USA package insert","09/20/2016",," Lot no 16140184 expires April 2017  Lot no 15430149 expires Oct. 2016",8/25/2016,"08/25/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75094,"Ongoing","CooperSurgical, Inc.","95 Corporate Dr",,"Trumbull","CT","06611-1350","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, GA, and NY","Z-2850-2016","Class III","Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number:  ART -8017  SAGE In Vitro Fertilization, Inc.  A CooperSurgical Company  95 Corporate Drive  Trumbull, CT 06611 USA","1 unit","Products contain international package insert and not  the correct USA package insert","09/20/2016",," Lot No. 15420123  Expires Oct. 2016",8/25/2016,"08/25/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75095,"Ongoing","Westby Coop Creamery","401 S Main St",,"Westby","WI","54667-1311","United States","Voluntary: Firm Initiated","Press Release","WI, IL","F-0504-2017","Class II","4% cottage cheese packaged in 16-ounce, 22-ounce, and 24-ounce plastic containers; under the Westby, Food Club, Oberweis, and Shurfine brand names.","695 cases","The firm is conducting a recall of the 4% cottage cheese because the product tested positive for residue phosphatase.","11/23/2016","."," Lot Code 10-6-16 cc, and Plant #55-372.",8/27/2016,"08/27/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0362-2017","Class II","Wilton Yellow Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","13,104 bottles ","Airbrush color has the potential to be contaminated with mold, yeast or bacteria.","10/26/2016",," Lots: 701-2414; 2201-2579",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0356-2017","Class II","Wilton Black Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","16,446 bottles","Airbrush color found to contain mold, yeast or bacteria","10/26/2016",," Lots: 701-2421; 2201-2586",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0357-2017","Class II","Wilton Blue Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","16,188 bottles","Airbrush color found to contain mold, yeast, or bacteria","10/26/2016",," Lots: 701-2416; 2201-2581  ",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0367-2017","Class II","Wilton Brown Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","11,103 bottles ","Airbrush color has the potential to be contaminated with mold, yeast or bacteria.","10/26/2016",," Lots: 701-2420; 2201-2585",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0365-2017","Class II","Wilton Purple Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","14,595 bottles ","Airbrush color has the potential to be contaminated with mold, yeast or bacteria.","10/26/2016",," Lots: 701-2418; 2201-2583",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0364-2017","Class II","Wilton Green Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","14,943 bottles ","Airbrush color has the potential to be contaminated with mold, yeast or bacteria.","10/26/2016",," Lots: 701-2417; 2201-2582",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0359-2017","Class II","Wilton Gold Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","22,182 bottles","Airbrush color has the potential to be contaminated with mold, yeast or bacteria.","10/26/2016",," Lots: 701-2410; 2201-2575",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0358-2017","Class II","Wilton Silver Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","17,670 bottles","Airbrush color found to contain mold, yeast or bacteria","10/26/2016",," Lots: 701-2411; 2201-2576",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0361-2017","Class II","Wilton Red Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","16,197 bottles","Airbrush color has the potential to be contaminated with mold, yeast or bacteria.","10/26/2016",," Lots: 701-2413; 2201-2578",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0366-2017","Class II","Wilton Teal Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","10,914 bottles","Airbrush color has the potential to be contaminated with mold, yeast or bacteria.","10/26/2016",," Lots: 701-2419; 2201-2584",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0363-2017","Class II","Wilton Pink Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","13,533 bottles ","Airbrush color has the potential to be contaminated with mold, yeast or bacteria.","10/26/2016",," Lots: 701-2415; 2201-2580",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75097,"Ongoing","Wilton Brands.","2240 75th St",,"Woodridge","IL","60517-2333","United States","Voluntary: Firm Initiated","Telephone","Nationwide in U.S. and Canada","F-0360-2017","Class II","Wilton Pearl Airbrush Color, Net Wt 0.64 FL OZ (19 mL)","16,680","Airbrush color has the potential to be contaminated with mold, yeast or bacteria.","10/26/2016",," Lots: 701-2412; 2201-2577",9/6/2016,"09/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75099,"Ongoing","Wegmans Food Markets, Inc.","1500 Brooks Ave",,"Rochester","NY","14624","United States","Voluntary: Firm Initiated","Press Release","New York, New Jersey, Pennsylvania, Virginia, Maryland, and Massachusetts","F-0042-2017","Class II","Wegmans ITALIAN CLASSICS RICOTTA & SPINACH STRIPED JUMBO RAVIOLI, NET WT 9 OZ. (255g), UPC 0-77890-38934, KEEP REFRIGERATED -- Distributed By: Wegmans Foods Markets, Inc. Rochester, NY 14603, Product of Canada --- Packaged in a plastic tray and sold in a refrigerated case in the dairy department.","1,638 units","Product may contain pieces of white plastic.","10/06/2016",," Use or freeze by date of Sept. 30, 2016 (sold in Wegmans stores between Tuesday, Aug. 2 and Tuesday, Aug. 30, 2016) ",9/2/2016,"09/02/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75100,"Ongoing","EKOS Corporation","11911 N Creek Pkwy S",,"Bothell","WA","98011-8809","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY.","Z-2890-2016","Class II","The EKOS cart has the catalog number 700-60101.    The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking. ","455 units","Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.","09/27/2016",," Lot numbers:  030915  032615  040915  061515  071515  081715  103015  120715  010416  011816  022216  032116  052416  ",8/22/2016,"08/22/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75101,"Terminated","Community Blood Center Of Gtr KC","4040 Main St",,"Kansas City","MO","64111-2308","United States","Voluntary: Firm Initiated","Telephone","New York","B-0767-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, not meeting product specifications, was distributed.","09/19/2016","09/19/2016"," W045016065426",7/26/2016,"07/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75102,"Terminated","Inland Northwest Blood Center","210 W Cataldo Ave",,"Spokane","WA","99201-2217","United States","Voluntary: Firm Initiated","Telephone","Washington","B-0768-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","2 units","Apheresis products, in which quality control for residual WBC count was not performed, were distributed.","09/19/2016","09/19/2016"," W0685161751139 (double collection)",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75103,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","Switzerland; Georgia","B-0770-16","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","09/19/2016","09/19/2016"," W333615065903",7/14/2016,"07/14/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75103,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","Switzerland; Georgia","B-0769-16","Class II","Cryoprecipitated AHF","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","09/19/2016","09/19/2016"," W333615065903",7/14/2016,"07/14/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75106,"Terminated","Penrose-St Francis Health Services Blood Bank","2222 N Nevada Ave",,"Colorado Springs","CO","80907-6819","United States","Voluntary: Firm Initiated","Telephone","Colorado","B-0771-16","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit","Apheresis product, in which platelet yield did not meet specifications, was distributed.","09/19/2016","09/19/2016"," W290616081573",8/18/2016,"08/18/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75107,"Ongoing","Summit Import Corporation","100 Summit Pl",,"Jersey City","NJ","07305-4524","United States","Voluntary: Firm Initiated","Press Release","AL FL IA  NY OH MI MN MD NJ NY  PA SC & VA","F-0008-2017","Class I","Yu Yee Brand Black Pepper Powder, Net Wt. 19.4 oz (550g), UPC 0 23452 06084 2, Packed for Summit Import Corp., Jersey City, NJ 07305, Product of China","40 cases (12 bottles each)","Yu Yee Brand Black Pepper Powder may be contaminated with Salmonella.","10/04/2016",," None",8/31/2016,"08/31/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75108,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide:  Foreign:  Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia","Z-2912-2016","Class III","Siemens RAPIDPoint 400 Measurement Cartridge   Siemens SMN numbers:10329756, 10341161","689 cartridges","Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge","09/30/2016",," Serial Numbers:2610900214 through 2621001325  Expiry Dates: Sept 13, 2016 through Dec. 6, 2016",9/2/2016,"09/02/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75108,"Ongoing","Siemens Healthcare Diagnostics Inc","2 Edgewater Dr",,"Norwood","MA","02062-4637","United States","Voluntary: Firm Initiated","Letter","Nationwide:  Foreign:  Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia","Z-2913-2016","Class III","Siemens RAPIDPoint 405 Measurement Cartridge   Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469","6638 cartridges","Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge","09/30/2016",," Serial Numbers:2610900214 through 2621001325.  Expiry Dates: Sept 13, 2016 through Dec. 6, 2016",9/2/2016,"09/02/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75109,"Ongoing","Kanan Enterprises, Inc.","31900 Solon Rd",,"Solon","OH","44139-3536","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US nationwide.  The product was distributed to the following states: OH, KS, MN.","F-2330-2016","Class II","Southern Grove Cashews with Sea Salt, a 10 ounce stand up pouch bag with a UPC 0 38445 12286 5 and the date codes of Best By May 24 2017 KN and August 05 2017 KN","485 cases (7760 individual bags)","This recall has been initiated due to the possible presence of peanuts.","09/16/2016",," UPC 0 38445 12286 5 and the date codes of Best By May 24 2017 KN and August 05 2017 KN.",9/3/2016,"09/03/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75111,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","US: IL, PA, NY, GA, WA, FL, SC.    Affected geographies: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Panama, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Uganda, United Kingdom and Zambia","Z-2900-2016","Class II","AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.","148 units total (12 units in US)","Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.","09/28/2016",," AY20032  AZ19046  AZ12030  AY51072  AZ19047  AZ15044  AY47071  AZ15038  AY47063  AZ12033  AZ19052  AY51075  AY03004  AZ12027  AY25038  ",9/6/2016,"09/06/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75112,"Ongoing","Perfetti Van Melle USA Inc","3645 Turfway Rd",".","Erlanger","KY","41018-3109","United States","Voluntary: Firm Initiated","Letter","US Nationwide.  The product was distributed to the following states: AL, CA, IL, IN, KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK PA, SC, TX, VA, VT, WA, and WI.","F-0676-2017","Class III","Airheads Mini Bars 12oz bags of assorted flavors.  12 - 12oz bags are included in cardboard cartons.  Assorted flavors include Cherry, Watermelon, Blue Raspberry, and White Mystery.","4,147 cases of 12/12oz bags","Blood was observed on equipment during packaging.","12/08/2016",," On the cardboard cases: Lot codes 100061918 and 100063678 -   On the retail bags: 61918 Best By 05-02-2018 and 63678 Best By 06-06-2018 -   On individually wrapped candy pieces: 61469",9/2/2016,"09/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75113,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution","Z-2878-2016","Class II","Syngo RT Therapist, Accelerator, Linear, Medical  Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording","103 accelerators","Software patch installation to address several safety issues.  ","09/23/2016",," Model # 08162815, 8168754  Serial # 10019, 10626, 10651,10672.10678,10702,10703,10706,10712,10758,10767,10804,10625,10063,10770,10831,10008,10786,10789,10756,10045,10589,10698,10642,10792,10822,10821,10849,10850,10592,10676,10785,10047,10722,10665,10754,10004,10007,10823,10002,10803,10074,10778,10046,10762,10835,10694,10844,10603,10788,10600,10634,10570,10815,10744,10624,10513,10015,10805,10635,10755,10776,10022,10524,10586,10035,10843,10828,10578,10790,10817,10105,10699,10793,10794,10784,10783,10096,10501,10796,10024,10021,10023,10641,90245,10795,10571,10013,10039,10658,10005,10725,10025,10707,10708,10798,10010,10814,10050,10763,10580,10846,10791",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75113,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution","Z-2877-2016","Class II","PRIMUS, Accelerator, Linear, Medical  The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer","103 accelerators","Software patch installation to address several safety issues.  ","09/23/2016",," Model # 08162815, 8168754  Serial # 10019, 10626, 10651,10672.10678,10702,10703,10706,10712,10758,10767,10804,10625,10063,10770,10831,10008,10786,10789,10756,10045,10589,10698,10642,10792,10822,10821,10849,10850,10592,10676,10785,10047,10722,10665,10754,10004,10007,10823,10002,10803,10074,10778,10046,10762,10835,10694,10844,10603,10788,10600,10634,10570,10815,10744,10624,10513,10015,10805,10635,10755,10776,10022,10524,10586,10035,10843,10828,10578,10790,10817,10105,10699,10793,10794,10784,10783,10096,10501,10796,10024,10021,10023,10641,90245,10795,10571,10013,10039,10658,10005,10725,10025,10707,10708,10798,10010,10814,10050,10763,10580,10846,10791",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75113,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution","Z-2876-2016","Class II","ARTISTE, Accelerator, Linear, Medical  The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.","103 accelerators","Software patch installation to address several safety issues.  ","09/23/2016",," Model # 08162815, 8168754  Serial # 10019, 10626, 10651,10672.10678,10702,10703,10706,10712,10758,10767,10804,10625,10063,10770,10831,10008,10786,10789,10756,10045,10589,10698,10642,10792,10822,10821,10849,10850,10592,10676,10785,10047,10722,10665,10754,10004,10007,10823,10002,10803,10074,10778,10046,10762,10835,10694,10844,10603,10788,10600,10634,10570,10815,10744,10624,10513,10015,10805,10635,10755,10776,10022,10524,10586,10035,10843,10828,10578,10790,10817,10105,10699,10793,10794,10784,10783,10096,10501,10796,10024,10021,10023,10641,90245,10795,10571,10013,10039,10658,10005,10725,10025,10707,10708,10798,10010,10814,10050,10763,10580,10846,10791",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75114,"Ongoing","Ormco/Sybronendo","1332 S Lone Hill Ave",,"Glendora","CA","91740-5339","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.","Z-2836-2016","Class II","Sealapex Xpress, Part No. 33639    The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.","179 units","SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.","09/16/2016",," lot # 5-1310",8/31/2016,"08/31/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75115,"Ongoing","Trumpf Medical Systems, Inc.","1046 Legrand Blvd",,"Charleston","SC","29492-7672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally  to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia,  and Switzerland","Z-0041-2017","Class II","Stationary Column TruSystem 7599, Material Number 1717020    Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.","84 units","Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.","10/05/2016",," Serial Numbers - 101863421, 101863427, 101863433, 101875827, 101879148, 101879149, 101882031, 101884650, 101884651, 101884653, 101884654, 101890658, 101890659, 101895636, 101904999, 101907202, 101907203",7/10/2016,"07/10/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75115,"Ongoing","Trumpf Medical Systems, Inc.","1046 Legrand Blvd",,"Charleston","SC","29492-7672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally  to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia,  and Switzerland","Z-0042-2017","Class II","Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878   Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.","84 units","Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.","10/05/2016",," Serial Numbers - 101900011, 101900018, 101904491, 101904998",7/10/2016,"07/10/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75115,"Ongoing","Trumpf Medical Systems, Inc.","1046 Legrand Blvd",,"Charleston","SC","29492-7672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally  to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia,  and Switzerland","Z-0040-2017","Class II","Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822  Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system","84 units","Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.","10/05/2016",," Serial Numbers - 101281354, 101856082, 101858789, 101858794, 101861232, 101871990, 101871991, 101871994, 101871995, 101871998, 101872002, 101872003, 101875823, 101884649, 101884662, 101890660, 101890661, 101890683, 101895634, 101912771, 101912832, 101912833, 101912837, 101912838, 101916174, 101924149, 101863428, 101875818, 101882033, 101882034, 101882037, 101882038, 101901949, 101901951, 101904490, 101904492, 101907204, 101907205, 101909370, 101909371, 101909372, 101909464, 192052657",7/10/2016,"07/10/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75115,"Ongoing","Trumpf Medical Systems, Inc.","1046 Legrand Blvd",,"Charleston","SC","29492-7672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally  to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia,  and Switzerland","Z-0043-2017","Class II","Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786  Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system","84 units","Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.","10/05/2016",," Serial Numbers - 101863316, 101872464, 101879109, 101880571, 101880672, 101880673, 101928935, 101932527, 101937343, 101941055, 101941064, 101941995, 101942798, 101948309, 101954296, 102051758, 102061764, 101926753, 101928934, 101941978, 101941994",7/10/2016,"07/10/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75116,"Ongoing","Addiction Foods Llc","8228 S 192nd St",,"Kent","WA","98032-1195","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, FL, NC, PA, WA and in Canada","V-525-2016","Class II","New Zealand Venison & Apples Entr¿e, canned dog food, Addiction brand, net wt. 13.8 oz/390 g, UPC Code 8 885004 070462","347 cases of Venison & Apples Entree and 8 cases of Brushtail & Vegetables Entree","New Zealand Venison & Apple Canned Dog Food are recalled due to  elevated levels of Vitamin A and slight variance in calcium and phosphorous ratios.","09/28/2016",," Lot Number: 8936:01Dec2018  Expiration date: December 2018  ",8/30/2016,"08/30/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75116,"Ongoing","Addiction Foods Llc","8228 S 192nd St",,"Kent","WA","98032-1195","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, FL, NC, PA, WA and in Canada","V-526-2016","Class II","New Zealand Brushtail & Vegetables Entr¿e, Canned Dog Food, net wt. 13.8 oz/390 g, UPC 8 885004 070028  ","will be provided","New Zealand Brushtail & Vegetables Entr¿e, Canned Dog Food, are recalled due to  elevated levels of Vitamin A and slight variance in calcium and phosphorous ratios.","09/28/2016",," Lot Number:  8940:02 Dec2018  Expiration date: December 2018  ",8/30/2016,"08/30/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75117,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0773-16","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","09/19/2016","09/19/2016"," W069115153258",8/4/2016,"08/04/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75117,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Switzerland; Mississippi","B-0772-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","09/19/2016","09/19/2016"," W069115153258",8/4/2016,"08/04/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75118,"Completed","Terumo Cardiovascular Systems Corporation","125 Blue Ball Rd",,"Elkton","MD","21921-5315","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - USA (nationwide) Distribution.","Z-0001-2017","Class III","CDI¿ H/S Cuvette    The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.      ","140,000  units  ","Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.    ","10/03/2016",," 6912 , 6913  6914, 6932, 6933  6934, 6922, 6923  6924, CV-6912, CV-6913, CV-6914  Cardiovascular Procedure Kits- Various  ",12/11/2015,"12/11/2015",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75119,"Ongoing","Osteogenics Biomedical, Inc.","4620 71st St"," Bldg 75-77","Lubbock","TX","79424-2230","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution and to the countries of :  Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.","Z-0113-2017","Class II","Cytoplast Titanium-Reinforced Posterior Singles Membrane     A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.","32 boxes","The device has the potential to be packaged in the wrong product box.","10/18/2016",," Lot 47295",9/7/2016,"09/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75120,"Ongoing","Island Soups Company Inc.","19422 115th Ave",,"Saint Albans","NY","11412-2729","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide (possible) via internet website orders","F-0551-2017","Class II","ISLAND SOUPS, GUNGO PEAS SOUP, NET WT. 16 OZ (28.4G)","unknown","Possible contamination with Clostridium botulinum","11/29/2016",," All products are coded BEST BEFORE dates July 2015 through June 2018",9/7/2016,"09/07/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75120,"Ongoing","Island Soups Company Inc.","19422 115th Ave",,"Saint Albans","NY","11412-2729","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide (possible) via internet website orders","F-0550-2017","Class II","ISLAND SOUPS, GUNGO PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)","unknown","Possible contamination with Clostridium botulinum","11/29/2016",," All products are coded BEST BEFORE dates July 2015 through June 2018",9/7/2016,"09/07/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75120,"Ongoing","Island Soups Company Inc.","19422 115th Ave",,"Saint Albans","NY","11412-2729","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide (possible) via internet website orders","F-0549-2017","Class II","ISLAND SOUPS, MANNISH WATER, NET WT. 16 OZ (28.4G)","unknown","Possible contamination with Clostridium botulinum","11/29/2016",," All products are coded BEST BEFORE dates July 2015 through June 2018",9/7/2016,"09/07/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75120,"Ongoing","Island Soups Company Inc.","19422 115th Ave",,"Saint Albans","NY","11412-2729","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide (possible) via internet website orders","F-0554-2017","Class II","ISLAND SOUPS, FISH SOUP, NET WT. 16 OZ (28.4G)","unknown","Possible contamination with Clostridium botulinum","11/29/2016",," All products are coded BEST BEFORE dates July 2015 through June 2018",9/7/2016,"09/07/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75120,"Ongoing","Island Soups Company Inc.","19422 115th Ave",,"Saint Albans","NY","11412-2729","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide (possible) via internet website orders","F-0553-2017","Class II","ISLAND SOUPS, RED PEAS SOUP, NET WT. 16 OZ (28.4G)","unknown","Possible contamination with Clostridium botulinum","11/29/2016",," All products are coded BEST BEFORE dates July 2015 through June 2018",9/7/2016,"09/07/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75120,"Ongoing","Island Soups Company Inc.","19422 115th Ave",,"Saint Albans","NY","11412-2729","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide (possible) via internet website orders","F-0552-2017","Class II","ISLAND SOUPS, RED PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)","unknown","Possible contamination with Clostridium botulinum","11/29/2016",," All products are coded BEST BEFORE dates July 2015 through June 2018",9/7/2016,"09/07/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75121,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","AZ, DC, CA, MD, MI, and OR  Switzerland","Z-2838-2016","Class II","G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.","88","The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.","09/16/2016",," Material M-3DC-2-G1 Batch J313108568 & J316017637",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75121,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","AZ, DC, CA, MD, MI, and OR  Switzerland","Z-2837-2016","Class II","G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.","177","Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed.","09/16/2016",," Material L-7B-G1 Batch K043113667",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75121,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","AZ, DC, CA, MD, MI, and OR  Switzerland","Z-2839-2016","Class II","G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.","63","The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.","09/16/2016",," Material M-3SB-2-G1 Batch J316017640",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75121,"Ongoing","The Anspach Effort, Inc.","4500 Riverside Dr",,"Palm Beach Gardens","FL","33410-4235","United States","Voluntary: Firm Initiated","Letter","AZ, DC, CA, MD, MI, and OR  Switzerland","Z-2840-2016","Class II","G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.","69","The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.","09/16/2016",," Material M-6DC-2-G1 Batch J313108573 and J 316017642",8/26/2016,"08/26/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75123,"Ongoing","Novo Nordisk Inc","800 Scudders Mill Road",,"Plainsboro","NJ","08536","United States","Voluntary: Firm Initiated","Press Release","Nationwide and Worldwide","D-0217-2017","Class I","GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15  ","71,215 kits","Defective delivery system: detached needles on the syringe in the kit.","12/22/2016",," Lots: FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875; Exp 9/30/2017  ",9/8/2016,"09/08/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75124,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.","Z-0323-2017","Class II","Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches.  The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile.  The visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures.","100 total units","Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field. ","10/28/2016",," Lot number 151591",9/1/2016,"09/01/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75124,"Ongoing","Medtronic Navigation, Inc.","826 Coal Creek Cir",,"Louisville","CO","80027-9710","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.","Z-0322-2017","Class II","Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches.  The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile.  The visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures","100 total units","Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field. ","10/28/2016",," Lot number 151481",9/1/2016,"09/01/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75125,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2794-2016","Class II","Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. ","101 Systems","Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values.  This suffix stands for on projection and indicates that a shown measurement value may be different from the real value. ","09/14/2016",," Model Numbers: 10863171, 10863172, 10863173, 10592457   Serial Numbers:   100262,100389,100198,100258,100259,100538,100135,100133,100213,100214,100031,100032,100484,100362,100233,100140,100141,100142,100143,100144,100416,100105,100106,100109,100110,100111,100112,100113,100114,100115,100116,100117,100119,100120,100461,100457,100245,100447,100364,100314,100298,100299,100386,200277,100139,100027,100028,100300,100559,100440,100441,100197,100170,100025,100026,100084,100186,100189,100190,100191,100192,100195,100196,100550,100033,100034,100306,100307,100232,100449,100450,100185,100596,100256,100199,100188,100193,100194,100257,100226,100228,100425,100029,100030,100253,100203,100204,100132,100247,100248,100434,100215,100491,100495,100230,100221,100212,100539,100206",8/2/2016,"08/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75125,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-2793-2016","Class II","Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. ","101 Systems","Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values.  This suffix stands for on projection and indicates that a shown measurement value may be different from the real value. ","09/14/2016",," Model Numbers: 10863171, 10863172, 10863173, 10592457   Serial Numbers:   100262,100389,100198,100258,100259,100538,100135,100133,100213,100214,100031,100032,100484,100362,100233,100140,100141,100142,100143,100144,100416,100105,100106,100109,100110,100111,100112,100113,100114,100115,100116,100117,100119,100120,100461,100457,100245,100447,100364,100314,100298,100299,100386,200277,100139,100027,100028,100300,100559,100440,100441,100197,100170,100025,100026,100084,100186,100189,100190,100191,100192,100195,100196,100550,100033,100034,100306,100307,100232,100449,100450,100185,100596,100256,100199,100188,100193,100194,100257,100226,100228,100425,100029,100030,100253,100203,100204,100132,100247,100248,100434,100215,100491,100495,100230,100221,100212,100539,100206",8/2/2016,"08/02/2016",9/21/2016,"09/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75126,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0015-2017","Class II","YSIO Max     Product Usage:  The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography.  ","37 Systems","Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems.  There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.","10/03/2016",," Model Number: 10762470, 10893300, 10746665  Serial Numbers: 24644,24613,24615,40328,24611,24612,24614,40326,40322,40316,24599,24600,40404,24634,2464124590,40402,1314,40312,24591,24592,40327,40323,24656,24659,40335,1315,40332,40403,24605,40325,40313,24645,24610,24580,24648,24581  ",8/1/2016,"08/01/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75126,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0014-2017","Class II","Multix Fusion VA10    Product Usage:  The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.  ","37 Systems","Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems.  There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.","10/03/2016",," Model Number: 10762470, 10893300, 10746665  Serial Numbers: 24644,24613,24615,40328,24611,24612,24614,40326,40322,40316,24599,24600,40404,24634,2464124590,40402,1314,40312,24591,24592,40327,40323,24656,24659,40335,1315,40332,40403,24605,40325,40313,24645,24610,24580,24648,24581  ",8/1/2016,"08/01/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75126,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0013-2017","Class II","Multix Fusion Stationary X-Ray System    Product Usage:  The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.  ","37 Systems","Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems.  There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.","10/03/2016",," Model Number: 10762470, 10893300, 10746665  Serial Numbers: 24644,24613,24615,40328,24611,24612,24614,40326,40322,40316,24599,24600,40404,24634,2464124590,40402,1314,40312,24591,24592,40327,40323,24656,24659,40335,1315,40332,40403,24605,40325,40313,24645,24610,24580,24648,24581",8/1/2016,"08/01/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75127,"Ongoing","Merit Medical Systems, Inc.","1600 W Merit Pkwy",,"South Jordan","UT","84095-2416","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.","Z-0002-2017","Class II","Merit Inflation Syringe Kit. Catalog Number KOS-02857","1,297 total units","Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information. ","10/03/2016",," Lot Numbers: H959038, H970334, H984351. ",8/25/2016,"08/25/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75128,"Ongoing","Medline Industries Inc","1 Medline Pl",,"Mundelein","IL","60060-4485","United States","Voluntary: Firm Initiated","Letter","US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX  and WA.","Z-0352-2017","Class II","Rigid Suction Canister 3000 CC and 2000 CC.","7,680 units","Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.","11/03/2016",," RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx ",8/10/2016,"08/10/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0057-2017","Class II","Cherry Decadent Danish | NET WT 14 OZ  (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050033","461 cases","Presence of small metal shavings. ","10/07/2016",," Lot: 6197; Best By: July 15, 2017",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0068-2017","Class II","Publix Guava Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802. UPC: 002-19562-00000","Unknown","Presence of small metal shavings. ","10/07/2016",," UPC: 002-19562-00000  All date codes through expiration date 1/19/2017",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0059-2017","Class II","Kroger Raspberry Danish Strip, Naturally and Artificially Flavored  | NET WT 14 OZ  (396g) | Distributed by The Kroger Co., Cincinnati, Ohio 45202 | UPC: 011110836489","1,260 cases","Presence of small metal shavings. ","10/07/2016",," Lot: 071516",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0066-2017","Class II","The Bakery Raspberry Crumb Coffee Cake| Net Wt 15 OZ (425g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 078742052953","2,850 cases ","Presence of small metal shavings. ","10/07/2016",," Lot: 071716; 072516",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0064-2017","Class II","The Bakery Strawberry Cheese Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 078742100401","1,364  cases ","Presence of small metal shavings. ","10/07/2016",," Lots: 071516, 072616",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0052-2017","Class II","Publix Apple Strip Danish | Count, 1 |  NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802","6,132 cases ","Presence of small metal shavings. ","10/07/2016",," Lot: 6201; Best By: Jan. 19 17 |  Lot: 6206; Best By: Jan. 24 17 |  Lot: 6209; Best By: Jan. 27 17 |",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0065-2017","Class II","The Bakery Apple Crumb Coffee Cake| Net Wt 15 OZ (425g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 078742052953","566 cases","Presence of small metal shavings. ","10/07/2016",," Lot: 072116",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0062-2017","Class II","The Bakery Cheese Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 605388124487","4,041 cases","Presence of small metal shavings. ","10/07/2016",," Lots: 071416, 071816, 072516",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0054-2017","Class II","Publix Almond Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802","1,752 cases","Presence of small metal shavings. ","10/07/2016",," Lot: 6196; Best By: Jan. 14 17  ",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0061-2017","Class II","Archer Farms Strawberry Danish | NET WT 14 OZ  (397g) | Distributed by Target Corporation Minneapolis, MN 55403 | UPC 085239101094","1,619 cases","Presence of small metal shavings. ","10/07/2016",," Lot: 6196; Best By: July 13, 2017  ",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0067-2017","Class II","Publix Cherry Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802. UPC: 002-19562-00000","Unknown","Presence of small metal shavings. ","10/07/2016",," UPC: 002-19562-00000  All date codes through expiration date 1/19/2017",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0060-2017","Class II","Archer Farms Cheese Danish | NET WT 14 OZ  (397g) | Distributed by Target Corporation Minneapolis, MN 55403 | UPC 085239101094","3,092 cases ","Presence of small metal shavings. ","10/07/2016",," Lot: 6194; Best By: July 12, 2017  Lot: 6200; Best By: July 18, 2017",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0056-2017","Class II","Cheese Decadent Danish | NET WT 14 OZ  (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050019","525 cases","Presence of small metal shavings. ","10/07/2016",," Lot: 6197; Best By: July 15, 2017",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0055-2017","Class II","Publix Maple Walnut Strip Danish | Count, 1 | NET WT 14.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802","1,743 cases","Presence of small metal shavings. ","10/07/2016",," Lot: 6196; Best By: Jan. 14 17  ",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0058-2017","Class II","Strawberry Cheese Decadent Danish | NET WT 14 OZ  (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050064","318 cases ","Presence of small metal shavings. ","10/07/2016",," Lot: 6197; Best By: July 15, 2017",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0063-2017","Class II","The Bakery Raspberry Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 605388124487","1,629 cases ","Presence of small metal shavings. ","10/07/2016",," Lots: 71316, 72116",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75129,"Ongoing","Gold Standard Baking, Inc.","3700 S Kedzie Ave",,"Chicago","IL","60632-2768","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0053-2017","Class II","Publix Raspberry Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802","5,198 cases ","Presence of small metal shavings. ","10/07/2016",," Lot: 6198; Best By: Jan. 16 17 |  Lot: 6199; Best By: Jan. 17 17 |  ",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75130,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: AZ, CA, FL, NY, NC, and TX.","Z-0058-2017","Class II","Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709    The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.","160 ea. in total","The product is being recalled due to a labeling error.  The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.","10/07/2016",," Lot Number 73M1500175 ",9/9/2016,"09/09/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75130,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: AZ, CA, FL, NY, NC, and TX.","Z-0059-2017","Class II","Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709    The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.","160 ea. in total","The product is being recalled due to a labeling error.  The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.","10/07/2016",," Lot Number 73M1500176 ",9/9/2016,"09/09/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75131,"Ongoing","C. H. Guenther & Son, Inc.dba Morrison Milling","319 E Prairie St",,"Denton","TX","76201-6109","United States","Voluntary: Firm Initiated","Telephone","Texas via direct account.  Within the Southwestern region of the US via sub-accounts.","F-0084-2017","Class III","The Baker's Scoop 100% WHOLE WHEAT FLOUR NET WT. 5 LB (2.27 kg) packaged in white paper bag","385 cases","Potential for the presence of soft nylon fragments in the whole wheat flour.","10/12/2016",," Best By 021418DIT 6236, Best By 021518DIT 6237",9/7/2016,"09/07/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75133,"Terminated","Community Blood Bank of Erie County","2646 Peach St",,"Erie","PA","16508-1823","United States","Voluntary: Firm Initiated","Letter","Pennsylvania","B-0025-2017","Class II","Red Blood Cells","1 unit","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. ","10/05/2016","10/05/2016"," W045616811220",8/19/2016,"08/19/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75134,"Terminated","Blood Systems, Inc. dba United Blood Services Texas","424 S Mesa Hills Dr",,"El Paso","TX","79912-5441","United States","Voluntary: Firm Initiated","Telephone","Texas","B-0026-2017","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Apheresis products for which white blood cell count testing was not performed, were distributed.","10/05/2016","10/05/2016"," W041516018416I (double collection)",8/8/2016,"08/08/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75135,"Terminated","Biotest Pharmaceuticals","1112 N Main St",,"Gainesville","FL","32601-4372","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0027-2017","Class II","Source Plasma","4 units","Blood product,s collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","10/05/2016","10/05/2016"," 0041701524; 0041701143; 0041700418; 0041700034",8/2/2016,"08/02/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75136,"Terminated","Delta Blood Bank","65 N Commerce St",,"Stockton","CA","95202-2318","United States","Voluntary: Firm Initiated","FAX","California","B-0028-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, in which quality control for WBC count was not performed, was distributed.","10/05/2016","10/05/2016"," W128716060843",4/6/2016,"04/06/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75137,"Terminated","Blood Centers of the Pacific - Irwin Center","270 Masonic Ave",,"San Francisco","CA","94118-4496","United States","Voluntary: Firm Initiated","Telephone","California","B-0030-2017","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood product,s collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/05/2016","10/05/2016"," W1170160170274 ",8/3/2016,"08/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75137,"Terminated","Blood Centers of the Pacific - Irwin Center","270 Masonic Ave",,"San Francisco","CA","94118-4496","United States","Voluntary: Firm Initiated","Telephone","California","B-0029-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product,s collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/05/2016","10/05/2016"," W1170160170274",8/3/2016,"08/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75138,"Terminated","American Red Cross Blood Services Appalachian Region","352 Church Ave SW",,"Roanoke","VA","24016-5008","United States","Voluntary: Firm Initiated","Other","CA","B-0059-2017","Class III","Blood and Blood Products for Reprocessing","1 unit"," Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","10/18/2016","10/18/2016"," W203516136908",7/30/2016,"07/30/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75139,"Terminated","LifeSource","5505 Pearl St Floor 1",,"Rosemont","IL","60018-5317","United States","Voluntary: Firm Initiated","Telephone","IL","B-0060-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit"," Blood products, for which the sterility may have been compromised, were distributed.","10/18/2016","10/18/2016"," W288016002684",7/25/2016,"07/25/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75140,"Ongoing","Shearers Foods, Llc","100 Lincoln Way E",".","Massillon","OH","44646-6673","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The product was distributed to the following states: MI.","F-0617-2017","Class I","Meijer brand No Salt Added Original Kettle Cooked Potato Chips, 8.5oz bag.  15 bags per case.","280 cases (4200 bags)","Undeclared allergens: milk (whey) and soy.","12/07/2016",," Lot #: OCT 31 2016, Expiration Date: 10/31/16",9/8/2016,"09/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75141,"Ongoing","Mckesson Packaging Services","7101 Weddington Rd NW",,"Concord","NC","28027-3412","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-1550-2016","Class III","Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10  ","181 unit cartons of 10 x 10 blister cards","Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules. ","09/28/2016",," Lot # 0111295, Exp 9/17",9/8/2016,"09/08/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75142,"Ongoing","Aesculap Implant Systems LLC","3773 Corporate Pkwy",,"Center Valley","PA","18034-8217","United States","Voluntary: Firm Initiated","Letter","Distributed in Arizona","Z-0316-2017","Class II","Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture","180 units","There is a potential for the needle to detach from the suture thread during surgery.  If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.  ","10/26/2016",," Lot # 115441  Product Code C1046619",8/1/2016,"08/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75143,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-2853-2016","Class II","Syngo.via picture archiving and communication system    Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.","338 systems","Software error.  Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.","09/21/2016",," Serial Numbers: 220755  101060  220807  221363  220497  221053  100662  130301  101494  130643  101312  310364  102213  221225  130653  220687  220811  310395  102048  100741  102523  101739  221244  102125  102401  310397  102036  220939  100915  221110  100598  130765  130321  130118  310310  102477  130692  102008  130159  101757  101773  100751  100713  101802  102535  310536  221199  102089  220451  101559  101479  130252  100417  100421  100641  100642  100644  100646  100418  100419  100420  100643  100645  100811  100812  100813  100814  102369  101521  221129  310363  220909  400047  100669  130326  101839  311011  130712  131011  101027  100744  130784  310524  311001  101313  101233  101114  221192  130201  130180  220604  100518  100735  102296  130629  102532  102158  101843  102447  102533  220930  102515  220684  220725  130908  102271  130309  102265  101638  102449  102377  102553  130396  101864  101826  102563  102374  100704  102340  310365  310388  102197  101938  100929  310348  100963  100729  221280  102229  102537  130852  100008  101355  101163  101192  102409  130539  101201  102490  101051  101205  101220  101202  101206  101854  220448  220466  400058  400061  130438  101046  101565  101612  102381  101855  101784  310486  101561  102113  221299  102064  101225  101515  221154  130628  130174  130175  130777  130635  102526  101834  102418  101183  102120  130377  101137  101740  220577  100485  221344  130569  221264  102455  130125  101701  100950  130267  101885  130716  101578  221345  310472  102108  100692  100826  102175  101371  100675  100700  101257  130229  220617  102142  130734  310396  102021  100760  101338  101354  130491  101566  130410  310460  101878  310410  130241  130242  130243  130244  102281  101251  101309  101631  130630  102031  100796  130563  102270  102405  220512  130916  130611  100620  101444  100957  310379  100039  130335  101998  130695  102417  221233  101043  101066  311012  101503  400062  100677  400065  221204  102127  101416  130837  1000",8/5/2016,"08/05/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75143,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-2852-2016","Class II","Syngo.x picture archiving and communication system    Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.","338 systems","Software error.  Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.","09/21/2016",," Serial Numbers: 220755  101060  220807  221363  220497  221053  100662  130301  101494  130643  101312  310364  102213  221225  130653  220687  220811  310395  102048  100741  102523  101739  221244  102125  102401  310397  102036  220939  100915  221110  100598  130765  130321  130118  310310  102477  130692  102008  130159  101757  101773  100751  100713  101802  102535  310536  221199  102089  220451  101559  101479  130252  100417  100421  100641  100642  100644  100646  100418  100419  100420  100643  100645  100811  100812  100813  100814  102369  101521  221129  310363  220909  400047  100669  130326  101839  311011  130712  131011  101027  100744  130784  310524  311001  101313  101233  101114  221192  130201  130180  220604  100518  100735  102296  130629  102532  102158  101843  102447  102533  220930  102515  220684  220725  130908  102271  130309  102265  101638  102449  102377  102553  130396  101864  101826  102563  102374  100704  102340  310365  310388  102197  101938  100929  310348  100963  100729  221280  102229  102537  130852  100008  101355  101163  101192  102409  130539  101201  102490  101051  101205  101220  101202  101206  101854  220448  220466  400058  400061  130438  101046  101565  101612  102381  101855  101784  310486  101561  102113  221299  102064  101225  101515  221154  130628  130174  130175  130777  130635  102526  101834  102418  101183  102120  130377  101137  101740  220577  100485  221344  130569  221264  102455  130125  101701  100950  130267  101885  130716  101578  221345  310472  102108  100692  100826  102175  101371  100675  100700  101257  130229  220617  102142  130734  310396  102021  100760  101338  101354  130491  101566  130410  310460  101878  310410  130241  130242  130243  130244  102281  101251  101309  101631  130630  102031  100796  130563  102270  102405  220512  130916  130611  100620  101444  100957  310379  100039  130335  101998  130695  102417  221233  101043  101066  311012  101503  400062  100677  400065  221204  102127  101416  130837  1000",8/5/2016,"08/05/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0240-2017","Class I","OSSIE'S SWEDISH MATJES HERRING, NET WT. 7 OZ., UPC 739885109101; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","100 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0249-2017","Class I","OSSIE'S LITE TUNA, NET WT. 7 OZ., UPC 73988570551; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","431 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0235-2017","Class I","OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","70 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0242-2017","Class I","OSSIE'S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","105 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0245-2017","Class I","OSSIE'S ROMAN SHMALTZ HERRING, NET WT. 7 OZ., UPC 739885109026; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","92 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0238-2017","Class I","OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","108 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0241-2017","Class I","OSSIE'S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","110 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0251-2017","Class I","OSSIE'S EGG SALAD, NET WT. 7 OZ., UPC 73988570552; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","225 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0243-2017","Class I","OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","170 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0248-2017","Class I","OSSIE'S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","82 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0250-2017","Class I","OSSIE'S HOME MADE TUNA SALAD, NET WT. 7 OZ., UPC 73988570550; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","534 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0253-2017","Class I","OSSIE'S EGG WITH SCALLION, NET WT. 7 OZ., UPC 73988570555; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.",,"The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0246-2017","Class I","OSSIE'S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","167 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0244-2017","Class I","OSSIE'S SHMALTZ HERRING, NET WT. 8 OZ., UPC 739885104182; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","100 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0247-2017","Class I","OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","163 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0236-2017","Class I","OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114714; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","168 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0237-2017","Class I","OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","106 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0252-2017","Class I","OSSIE'S EGG WITH MUSHROOM, NET WT. 7 OZ., UPC 73988570556; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","110 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75144,"Completed","SM Fish Corp.","5001 Rockaway Beach Blvd",,"Far Rockaway","NY","11691-1138","United States","Voluntary: Firm Initiated","Press Release","New York and New Jersey via retail stores","F-0239-2017","Class I","OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.","65 units","The products have the potential to be contaminated with Listeria monocytogenes based on the findings of the bacteria in the plant via FDA environmental sampling plus the district's inspectional findings","10/25/2016",," Best By date codes of 08/21/16 through 10/18/16 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75145,"Ongoing","Greatbatch Medical","2300 Berkshire Ln N",,"Plymouth","MN","55441-4575","United States","Voluntary: Firm Initiated","Letter","US: NY, TX.","Z-0623-2017","Class II","Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR.    The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initial puncture of a 21G introducer. The device is sold to customers  in a bulk non-sterile configuration.","23,075","Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.","11/18/2016","."," GBP3176925, GBP3176927, VN3470927, VN3470929, VN3486000, VN3485998, VN3495047, GBP3421664, VN3433259, VN3451654, VN3487654, VN3491069, VN3470925, VN3451646.",9/8/2016,"09/08/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75146,"Ongoing","VIRTUS PHARMACEUTICALS OPCO II L","1321 Murfreesboro Pike #",,"Nashville","TN","37217-2726","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-0213-2017","Class I","Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN  37217, NDC 76439-307-10.","10,572 bottles","Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.","12/22/2016",," Lot #: 30011601, Exp 01/18",9/2/2016,"09/02/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75146,"Ongoing","VIRTUS PHARMACEUTICALS OPCO II L","1321 Murfreesboro Pike #",,"Nashville","TN","37217-2726","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-0214-2017","Class I","Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN  37217, NDC 76439-308-10.","24,444 bottles","Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.","12/22/2016",," Lot #: 30031601, 30031602, Exp 01/18",9/2/2016,"09/02/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75146,"Ongoing","VIRTUS PHARMACEUTICALS OPCO II L","1321 Murfreesboro Pike #",,"Nashville","TN","37217-2726","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico","D-0212-2017","Class I","Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.","94,643 bottles","Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.","12/22/2016",," Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.",9/2/2016,"09/02/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75147,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",,"Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to the following states: AL, FL, GA, NC, SC, TN.","F-0736-2017","Class II","Publix Danish Almond Coffee Cake Strip, 15 oz.  UPC 002-19562-00000","not provided","Presence of small metal shavings","12/14/2016",," All date codes through expiration date 01/19/2017    ",9/8/2016,"09/08/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75147,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",,"Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to the following states: AL, FL, GA, NC, SC, TN.","F-0732-2017","Class II","Publix Danish Apple Coffee Cake Strip, 15 oz.  UPC 002-19562-00000","Appproximately 14,788 cases total (12 units per case)","Presence of small metal shavings","12/14/2016",," All date codes through expiration date 01/19/2017.      ",9/8/2016,"09/08/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75147,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",,"Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to the following states: AL, FL, GA, NC, SC, TN.","F-0737-2017","Class II","Publix Danish Guava Coffee Cake Strip, 15 oz.  UPC 002-19562-00000","Appproximately 14,788 cases total (12 units per case)","Presence of small metal shavings","12/14/2016",," All date codes through expiration date 01/19/2017.      ",9/8/2016,"09/08/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75147,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",,"Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to the following states: AL, FL, GA, NC, SC, TN.","F-0734-2017","Class II","Publix Danish Raspberry Coffee Cake Strip, 15 oz.  UPC 002-19562-00000","Appproximately 14,788 cases total (12 units per case)","Presence of small metal shavings","12/14/2016",," All date codes through expiration date 01/19/2017.    ",9/8/2016,"09/08/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75147,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",,"Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to the following states: AL, FL, GA, NC, SC, TN.","F-0733-2017","Class II","Publix Danish Maple Walnut Coffee Cake Strip, 14 oz.  UPC 002-19562-00000","Appproximately 14,788 cases total (12 units per case)","Presence of small metal shavings","12/14/2016",," All date codes through expiration date 01/19/2017.      ",9/8/2016,"09/08/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75147,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",,"Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to the following states: AL, FL, GA, NC, SC, TN.","F-0735-2017","Class II","Publix Danish Cherry Coffee Cake Strip, 15 oz.  UPC 002-19562-00000","Appproximately 14,788 cases total (12 units per case)","Presence of small metal shavings","12/14/2016",," All date codes through expiration date 01/19/2017.      ",9/8/2016,"09/08/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75148,"Ongoing","Brathwaites Oliver Medical","96 Terracon Place",,"Winnipeg","Manitoba",,"Canada","Voluntary: Firm Initiated","Letter","U.S. Consignee located in the following states: IL, WI, WE, OR, NY, UT, IN, NE, PA, MO, OH, AZ, MA, CT  and NC.*** Foreign Consignee: Canada.","Z-0067-2017","Class II","The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.","760 units","The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.","10/11/2016",," Model OL-E12102, lot# 101615.",8/19/2016,"08/19/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75150,"Ongoing","Becton Dickinson & Company","1 Becton Dr",,"Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Nationwide.","Z-0394-2017","Class II"," Whitacre Spinal Needle, TW    ","39,130 trays "," Spinal Trays contain the 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, 2mL Ampul (NDC Number 0409-4712-01) being recalled by Hospira. As a result, BD is initiating a recall for the affected BD Spinal Trays.","11/10/2016",," Whitacre Spinal Needle, TW  B02H077D 1-Jun-2015  B03H106D 1-Jun-2015",8/2/2016,"08/02/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75151,"Ongoing","Complete Packaging & Manufacturing, LLC","926 N 1430 W",,"Orem","UT","84057-6403","United States","Voluntary: Firm Initiated","Telephone","nationwide.  No foreign or govt/military/VA consignees.","F-0049-2017","Class I","Dietary Supplement Acidophilus Blend, 90 capsules, Product No. E-420, packaged in 225cc HDPE white bottle, room temp, sold individually","1327 bottles","Nature's Power Solutions Acidophilus Blend due to undeclared milk allergen.","10/07/2016",," 12/28/15 Lot# 24553-295 bottles  3/18/16 Lot# 24631 -328 bottles  5/10/16 Lot# 24674 -344 bottles  7/28/16 Lot# 24774 -360 bottles  ",8/26/2016,"08/26/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75153,"Ongoing","Apple Tree Goat Dairy","129 Nenix Hill Rd",,"Richfield","PA","17086-8555","United States","Voluntary: Firm Initiated","Telephone","DC, MD, NJ, NY, PA and VA","F-0109-2017","Class I","Apple Tree Goat Dairy Chevre,  Net Wt. 8 oz. shrink wrap and wt. 5 lb blocks, Richfield, PA 17086.      ","not provided","Product may be contaminated with  Listeria monocytogenes.","12/14/2016",," All lots",9/9/2016,"09/09/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75153,"Ongoing","Apple Tree Goat Dairy","129 Nenix Hill Rd",,"Richfield","PA","17086-8555","United States","Voluntary: Firm Initiated","Telephone","DC, MD, NJ, NY, PA and VA","F-0110-2017","Class I","Apple Tree Goat Dairy Gouda; Net Wt. 8 oz. shrink wrap block and 5 lb. blocsk, Richfield, PA 17086.    Raw cultured goat milk; Aged 60 days.","not provided","Product may be contaminated with  Listeria monocytogenes.","12/14/2016",," All lots",9/9/2016,"09/09/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75153,"Ongoing","Apple Tree Goat Dairy","129 Nenix Hill Rd",,"Richfield","PA","17086-8555","United States","Voluntary: Firm Initiated","Telephone","DC, MD, NJ, NY, PA and VA","F-0112-2017","Class I","Apple Tree Goat Dairy,  Cheddar; Raw cultured goat milk; Aged 60 days. Net Wt. 8 oz. and 5 lb. blocks, Richfield, PA 17086.",,"Product may be contaminated with  Listeria monocytogenes.","12/14/2016",," all lots",9/9/2016,"09/09/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75153,"Ongoing","Apple Tree Goat Dairy","129 Nenix Hill Rd",,"Richfield","PA","17086-8555","United States","Voluntary: Firm Initiated","Telephone","DC, MD, NJ, NY, PA and VA","F-0111-2017","Class I","Apple Tree Goat Dairy FETA; Raw cultured goat milk; Aged 60 days. Net Wt. 8 oz. and 5 lb. blocks, Richfield, PA 17086. ","not provided","Product may be contaminated with  Listeria monocytogenes.","12/14/2016",," all lots",9/9/2016,"09/09/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75153,"Ongoing","Apple Tree Goat Dairy","129 Nenix Hill Rd",,"Richfield","PA","17086-8555","United States","Voluntary: Firm Initiated","Telephone","DC, MD, NJ, NY, PA and VA","F-0711-2017","Class I","Apple Tree Goat Dairy French Herb Chevre, Net WT. 8 oz shrink wrap and 5 lb. block; Richfield, PA 17086.","Not available","Product may be contaminated with  Listeria monocytogenes.","12/14/2016",," all lots",9/9/2016,"09/09/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75154,"Terminated","DCI Biologicals Greenville, Inc","2727 E 10th St",,"Greenville","NC","27858-3127","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0044-2017","Class III","Source Plasma","1 unit","Blood product, in which donor suitability was not adequately determined, was distributed.","10/05/2016","10/06/2016"," GL0677274",7/30/2016,"07/30/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75155,"Terminated","NIH Clinical Center","10 Center Drive","Msc 1184, Rm 1c711","Bethesda","MD","20892-0001","United States","Voluntary: Firm Initiated","Telephone","District of Columbia; Maryland","B-0016-2017","Class II","Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced","2 units","Blood Products collected from a donor who traveled to a malaria endemic area were distributed.","10/05/2016","10/05/2016"," W092116030910; W092116030239",8/5/2016,"08/05/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75155,"Terminated","NIH Clinical Center","10 Center Drive","Msc 1184, Rm 1c711","Bethesda","MD","20892-0001","United States","Voluntary: Firm Initiated","Telephone","District of Columbia; Maryland","B-0014-2017","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated","10 units","Blood Products collected from a donor who traveled to a malaria endemic area were distributed.","10/05/2016","10/05/2016"," W092116025145; W092115010006; W092115010029; W092115010241; W092115010257; W092115010444; W092115011174; W092115011189; W092115011440; W092115011815",8/5/2016,"08/05/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75155,"Terminated","NIH Clinical Center","10 Center Drive","Msc 1184, Rm 1c711","Bethesda","MD","20892-0001","United States","Voluntary: Firm Initiated","Telephone","District of Columbia; Maryland","B-0015-2017","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","8 units","Blood Products collected from a donor who traveled to a malaria endemic area were distributed.","10/05/2016","10/05/2016"," W092115030019; W092115030318; W092115030493; W092115030575; W092115030581; W092115030770; W092115031184; W092115032400 ",8/5/2016,"08/05/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75155,"Terminated","NIH Clinical Center","10 Center Drive","Msc 1184, Rm 1c711","Bethesda","MD","20892-0001","United States","Voluntary: Firm Initiated","Telephone","District of Columbia; Maryland","B-0017-2017","Class II","Red Blood Cells, Leukocytes Reduced","51 units","Blood Products collected from a donor who traveled to a malaria endemic area were distributed.","10/05/2016","10/05/2016"," W092116011168; W092116011175; W092116011319; W092116011402; W092116011646; W092116011650; W092116011654; W092116012000; W092116025214; W092116012089; W092116012429; W092116012983; W092114015554; W092114015634; W092115010539; W092115010586; W092115010939; W092115011007; W092115011008; W092115011019; W092115011091; W092115012743; W092115012755; W092115012789; W092115013042; W092115013043; W092115013053; W092115013178; W092115013541; W092115025353; W092115014074; W092115025355; W092115014712; W092115014736; W092115014756; W092115025457; W092115015071; W092115025467; W092115015338; W092115015348; W092115015479; W092115015504; W092115015513; W092115015516; W092116010063; W092116010119; W092116010428; W092116010462; W092116010640; W092116010652; W092116010827",8/5/2016,"08/05/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75156,"Ongoing","Hospira Inc., A Pfizer Company","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0096-2017","Class II","Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.","15 vials","Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.","10/13/2016",," Lot #: 60295DD,  Ep 1DEC2017",9/16/2016,"09/16/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75156,"Ongoing","Hospira Inc., A Pfizer Company","275 N Field Dr",,"Lake Forest","IL","60045-2579","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0097-2017","Class II","Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.  ","4768 vials","Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.","10/13/2016",," Lot #: 59310DD, Exp 1NOV2017",9/16/2016,"09/16/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75157,"Ongoing","Philips Medical Systems ","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France,  Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain,  Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.","Z-0011-2017","Class II","Ingenuity Core 128 Model Number 728323    Product Usage:  Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","524","The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution.  As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation.  The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default.  Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.  ","10/03/2016",," 30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026, 32028, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047,  32048, 32049, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32057, 32058, 32059, 32060, 32061, 32062, 32063, 32064, 32065, 32066, 32067, 32068, 32069, 32070, 32071, 32072, 32073, 32074, 32075, 32076, 32077, 32078, 32079, 32080, 32081, 32082, 32084, 32085, 32086, 32087, 32088, 32089, 32090, 32091, 32092, 32093, 32094, 32095, 32096, 32097, 32098, 32099, 32100, 32101, 32102, 32103, 32104, 32105, 32106, 32108, 32109, 32110, 32111, 32112, 32113, 32114, 32115, 32116, 32117, 32118, 32119, 32120, 32121, 32122, 32123, 32124, 32125, 32126, 32127, 32128, 32129, 32130, 32131, 32133,                                                                                                                                                  32134, 32135, 32136, 32137, 32138, 32139, 32140, 32141, 32142, 32143, 32144, 32145, 32146, 32147, 32148, 32149, 32150, 32151, 32152, 32153, 32154, 32155, 32156, 32157, 32158, 32159, 32160, 32161, 32162, 32163, 32164, 32165, 32166, 32167, 32168, 32169, 32171, 32173, 52023, 52028, 52049, 52073,   320001, 320002, 320003, 320005, 320006, 320008, 320010, 320018, 320019, 320024, 320026, 320029, 320030, 320031, 320033, 320037, 320054, 320058, 320059, 320069, 320073, 320074, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320088, 320090, 320092, 320096, 320099, 320100, 320101, 320103, 320107, 320111, 320114, 320115, 320119, 320122, 320123, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320136, 320138, 320144, 320146, 320147, 320200, 320201, 320202, 320203, 320204, 320206, 320207, 320208, 320209, 320210, 320211, 320212, 320213, 320214, 320215, 320216, 320217, 320218, 320219, 320220, 320221, 320222, 320223, 320224, 320225, 320226, 320227, 320228, 320229, 320230, 320231, 320232, 320233, 320234, 320235, 320236, 320237, 320238, 320239, 320240, 320241, 320242, 320243, 320245, 320246, 32",8/24/2016,"08/24/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75157,"Ongoing","Philips Medical Systems ","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France,  Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain,  Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.","Z-0009-2017","Class II","Brilliance 64 CT Model Number 728231    Product Usage:  Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","185","The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution.  As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation.  The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default.  Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.  ","10/03/2016",," 4001, 4016, 5169, 9056, 9071, 9074, 9099, 9112, 9134, 9251, 9280, 9367, 9515, 9529, 9538, 9541, 9548, 9549, 9554, 9559, 9561, 9573, 9574, 9600, 9614, 9618, 9625, 9631, 9638, 9640, 9646, 9653, 9565, 9659, 9667, 9670, 9678, 9686, 9688, 9689, 9703, 9707, 9711, 9720, 9738, 9740, 9755, 9763, 9781, 9782, 9802, 9805, 9811, 9822, 9833, 9837, 9838, 9859, 9859, 9862, 9864, 9876, 9890, 9898, 9901, 9909, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9996, 9997, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9993, 9997, 10012, 10014, 10021, 10024, 10032, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10179, 10180, 10193, 10206, 10207, 10208, 10213, 10216, 10221, 10250, 10255, 10299, 10302, 10379, 10394, 10422, 10446, 10470, 10473, 10503, 10514, 10605, 10610, 10671, 10698, 10743, 29002, 29005, 29014, 29015, 29049, 29056, 29057, 29107, 29115, 90098, 90106, 90124, 90131, 90154, 90205, 91003, 95022, 95024, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95239, 95244, 95258, 95261, 95341, 95343, 95345, 95351, 95364, 95374, 95387, 95399, 95409, 95410, 94539, 95441, 95475, 95496, 95504, 95507, 95512, 95524, 95538, 95551, 95563, 95614, 95616, 95656, 95668, 95688, 123029, 95691, 95707, 95811, 122921, 122921, 123092, 123096, 123116, 123117, 6003368, 95341A",8/24/2016,"08/24/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75157,"Ongoing","Philips Medical Systems ","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France,  Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain,  Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.","Z-0010-2017","Class II","Ingenuity Core Model Number 728321  Product Usage:  Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","358","The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution.  As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation.  The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default.  Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.  ","10/03/2016",," 30041, 31001, 33084, 52000, 52004, 52007, 52008, 52010, 52012, 52013, 52014, 52015, 52018, 52019, 52020, 52021, 52022, 52024, 52025, 52026, 52027, 52029, 52030, 52031, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52039, 52040, 52041, 52042, 52043, 52044, 52045, 52046, 52047, 52048, 52050, 25052, 52053, 52054, 52055, 52056, 52057, 52058, 52059, 52061, 52063, 52064, 52065, 52067, 52068, 52069, 52070, 52071, 52072, 52073, 52074, 52075, 52076, 52077, 52078, 52079, 52080, 52081, 52082, 52083, 52084, 132164, 132465, 310001, 310002, 310003, 310009, 310017, 310019, 310022, 310023, 310026, 310032, 310039, 310042, 310052, 310054, 310055, 310059, 310064, 310069, 310070, 310071, 310081, 310087, 310088, 310090, 310096, 310098, 310105, 310107, 310111, 310113, 310116, 310119, 310121, 310125, 310129, 310133, 310134, 310135, 310141, 310143, 310149, 310150, 310151, 310157, 310159, 310160, 310170, 310203, 310204, 310205, 310206, 310207, 310208, 310209, 310210, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310235, 310236, 310237, 310238, 310239, 310240, 310241, 310242, 310243, 310244, 310245, 310246, 310247, 310248, 310249, 310250, 310251, 310252, 310253, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310268, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310279, 310280, 310281, 310282, 310283, 310284, 310285, 310286, 310287, 310288, 310289, 310290, 310291, 310292, 310293, 310294, 310295, 310296, 310297, 310298, 310299, 310300, 310301, 310302, 310303, 310304, 310305, 310306, 310307, 310308, 310309, 310310, 310311, 310313, 310315, 310316, 310317, 310318, 310319, 310320, 310321, 310322, 310323, 310324, 310325, 310326, 310327, 310328, 310329, 310330, 310331, 333002, 333005, 333009, 333010, 333014, 333015, 333018, 333019, 333021, 333030, 333031, 333037, 333041, 333042, 333043, 333044, 3330",8/24/2016,"08/24/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75157,"Ongoing","Philips Medical Systems ","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France,  Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain,  Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.","Z-0012-2017","Class II","Ingenuity CT Model Number 728326    Product Usage:  Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.  ","235","The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution.  As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation.  The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default.  Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.  ","10/03/2016",," 30003, 30004, 30005, 30006, 30007, 30008, 30009, 30010, 30011, 30012, 30013, 30014, 30015, 30017, 30018, 30019, 30020, 30021, 30022, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 30044, 30045, 30046, 30047, 30049, 32045, 32083, 32107, 52051, 52060, 52062, 300003, 300004, 300005, 300009, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020, 300021, 300022, 300024, 300025, 300027, 300028, 300029, 300030, 300031, 300032, 300033, 300034, 300035, 300036, 300037, 300038, 300039, 300040, 300041, 300042, 300043, 300044, 300045, 300047, 300049, 300050, 300051, 300052, 300053, 300054, 300055, 300056, 300057, 300058, 300059, 300060, 300061, 300062, 300063, 300064, 300065, 300066, 300068, 300069, 300070, 300071, 300072, 300073, 300074, 300075, 300077, 300078, 300079, 300080, 300081, 300082, 300083, 300084, 300086, 300087, 300088, 300089, 300090, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300109, 300110, 300111, 300112, 300113, 300114, 300115, 300116, 300117, 300118, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131, 300132, 300133, 300135, 300136, 300137, 300138, 300139, 300140, 300141, 300142, 300143, 300144, 300145, 300147, 300148, 300149, 300150, 300151, 300156, 300157, 300158, 300159, 300160, 300161, 300162, 300163, 300164, 300165, 300166, 300200, 300201, 300202, 300203, 300204, 300205, 300206, 300207, 300208, 300209, 300210, 300211, 300212, 300213, 300214, 300146, 600023, 600047, 300215, 300216, 300217, 300218, 300219, 300220, 300221, 300223, 310058, 310144, 320205, 333057, 333084, 333128, 336061, 336084, 336121, 336233,  30004-1",8/24/2016,"08/24/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75158,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution","Z-2871-2016","Class II","CADstream software.     Product Usage:  CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.  ","1,349 sites potentially have the affected versions","An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.","09/22/2016",," All versions - Versions 4.1.3 and prior versions",11/1/2012,"11/01/2012",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75159,"Ongoing","BEDEMCO IMPORT EXPORT INC.","3 Barker Ave Ste 325",".","White Plains","NY","10601-1524","United States","Voluntary: Firm Initiated","E-Mail","MA, NY & OH","F-0594-2017","Class I","BEDEMCO INC. WORLDWIDE BRAZIL NUTS, SMALL BROKEN, Net Weight: 44 lb., Product of Bolivia, Packed Exclusively for BEDEMCO INC. White Plains, NY (USA)","20 cartons","Product contaminated with Salmonella. ","12/07/2016",," Shipment No: 114682 /30",9/10/2016,"09/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75159,"Ongoing","BEDEMCO IMPORT EXPORT INC.","3 Barker Ave Ste 325",".","White Plains","NY","10601-1524","United States","Voluntary: Firm Initiated","E-Mail","MA, NY & OH","F-0596-2017","Class I","BEDEMCO INC. WORLDWIDE Nut Mix, Net Wt: 25 LBS, Packed Exclusively for BEDEMCO INC. White Plains, NY, USA, 10601","560 cartons","Product contaminated with Salmonella. ","12/07/2016",," H504676 ",9/10/2016,"09/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75159,"Ongoing","BEDEMCO IMPORT EXPORT INC.","3 Barker Ave Ste 325",".","White Plains","NY","10601-1524","United States","Voluntary: Firm Initiated","E-Mail","MA, NY & OH","F-0595-2017","Class I","BEDEMCO INC. WORLDWIDE Brazil Nuts XL Diced, Net Wt: 30 LBS, Packed Exclusively for Bedemco, Inc. White Plains, NY, USA, 10601","62 cartons","Product contaminated with Salmonella. ","12/07/2016",," H114682-11",9/10/2016,"09/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75160,"Completed","Spiegelberg Gmbh & Co. KG","Tempowerkring 4",,"Hamburg",,,"Germany","Voluntary: Firm Initiated","Letter","Nationwide Distribution to PA only","Z-2888-2016","Class II","Spiegelberg Brain Pressure Monitoring System  Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P    Product Usage:  lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.    ","22 units","In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg.    The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.   ","09/26/2016",," Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393;   Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122",12/29/2009,"12/29/2009",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75161,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution","Z-0118-2017","Class II","CADstream software      Product Usage:  CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.  ","844 sites potentially have the affected versions","Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.","10/18/2016",," Versions prior to 5.2.6",10/19/2011,"10/19/2011",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75162,"Ongoing","Dr. Reddy's Laboratories, Inc.","107 College Rd E",,"Princeton","NJ","08540-6623","United States","Voluntary: Firm Initiated","Letter","nationwide","D-0098-2017","Class III","ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81   ","3,858 prescription packs (115,680 capsules)","Failed Dissolution Specifications","10/13/2016",," Lot # 79KB60205; Exp. 02/18",8/29/2016,"08/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75163,"Ongoing","Tearscience, Inc","5151 McCrimmon Pkwy Ste 250",,"Morrisville","NC","27560-5427","United States","Voluntary: Firm Initiated","Letter","US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico.","Z-0093-2017","Class II","LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100    The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.","1,200 Activators (120 boxes of 10 units)","Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.","10/17/2016",," Lot 201615220020",9/13/2016,"09/13/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1539-2016","Class II","Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS","1 vial","Lack of Assurance of Sterility","09/27/2016",," Lot# 396689, Use by 12-13-16  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1529-2016","Class II","Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402","108 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 373003, 381408, Use by 02-11-17",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1541-2016","Class II","Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402","8 bottles","Lack of Assurance of Sterility","09/27/2016",," Lot#:  390325, Use by 08/01/16; 382789, Use by 08/07/16; 396766, Use by 08/11/16; 393470, Use by 08/14/16; 393036, Use by 08/14/16; 398131, Use by 08/15/16; 389288, Use by 08/20/16; 392969, Use by 08/21/16",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1546-2016","Class II","Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS",,"Lack of Assurance of Sterility","09/27/2016",," Lot# 389278, Use by 8-9-16  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1535-2016","Class II","Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402","386606 - 3 vials, 393302 - 3 vials","Lack of Assurance of Sterility","09/27/2016",," Lot#: 386606, Use by 8-9-16, 393302, Use by 10-28-16  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1533-2016","Class II","MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402 ","6 vials","Lack of Assurance of Sterility","09/27/2016",," Lot#:  399080, Use by 8-14-16; 399740, Use by 8-25-16; 398952, Use by 8-13-16; 398865, Use by 8-11-16; 399057, Use by 8-13-16; 398864, Use by 8-11-16",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1536-2016","Class II","Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402","62 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 396770, Use by 09-13-16  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1532-2016","Class II","Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml,  Rx only, For ophthalmic use only, Vital Care Compounder, Hattiesburg, MS","1 vial","Lack of Assurance of Sterility","09/27/2016",," Lot# 396627, Use by 8-10-16  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1534-2016","Class II","Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402","3 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 386184, Use by 08-03-16",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1548-2016","Class II","Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402","23 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 398178, Use by 12/30/16  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1547-2016","Class II","C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS  ","1vial","Lack of Assurance of Sterility","09/27/2016",," Lot# 397877, USE BY 1-6-17  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1542-2016","Class II","Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS","6 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 397267, Use by 9/20/16  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1540-2016","Class II","Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402","36 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 396814, Use by 12-14-16  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1531-2016","Class II","Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS","1 vial","Lack of Assurance of Sterility","09/27/2016",," Lot# 397876, Use by 10-27-16",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1544-2016","Class II","Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS","139 vials","Lack of Assurance of Sterility","09/27/2016",," Lot #: 365204, Use by 8/1/16 and 384395, Use by 3/12/17  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1530-2016","Class II","Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS","5 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 396691, Use by 09-13-16",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1549-2016","Class II","DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS","6 vials","Lack of Assurance of Sterility","09/27/2016",," Lot # 389321, Use by 3/10/17  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1543-2016","Class II","Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS    ","6 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 397269, Use be 9/20/16",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1545-2016","Class II","C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402","1 vial","Lack of Assurance of Sterility","09/27/2016",," Lot# 397877, USE BY 1-6-17  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1538-2016","Class II","Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402","16 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 396607, Use by 08/13/16  ",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75164,"Ongoing","Pharmacy Plus, Inc. dba Vital Care Compounder","115 S 40th Ave",,"Hattiesburg","MS","39402-6600","United States","Voluntary: Firm Initiated","Telephone","MS","D-1537-2016","Class II","Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402    ","14 vials","Lack of Assurance of Sterility","09/27/2016",," Lot# 396817, Use by 09/13/16",7/26/2016,"07/26/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75166,"Ongoing","NEW SEASONS MARKET","1300 SE Stark St",,"Portland","OR","97214-2471","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon and California New Seasons Markets","F-0209-2017","Class I","  UPC 4060010401;  ","3741 units","New Seasons Markets is recalling their brand name Almond Butter due to a labeling error.  Some of the jars labeled Almond Butter actually contain Peanut Butter.","10/20/2016",," BEST BY 06/16/2017, BEST BY 08/15/2017, and BEST BY 08/30/2017.    The 08/15/2017 lot was added to the recall on 9/13/16, after initiation.  Press release contained all three lot codes.  ",9/12/2016,"09/12/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75167,"Ongoing","Ortho-Clinical Diagnostics","100 Indigo Creek Dr",,"Rochester","NY","14626-5101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution-(Nationwide) and foreign distribution to the following countries: Belgium, Bermuda, Canada, Chile, Denmark, France, Italy, Mexico, Norway, Portugal, Sweden, Taiwan and United Kingdom.","Z-0300-2017","Class II","enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code   952040-EG 6844097.    The VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).","60 (US: 24; Foreign: 36)","Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module.  It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System.  Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient. ","10/22/2016",," Software Versions 3.6.1 and below;  Affected US Serial Numbers: 5GV6W2J,GBX395J, J2QKG25J, 2Z3YV1J, 3RHC23J, 4HX7S4J, 54FC01J, 5J4B45J, 736BM4J, 7KSC15J, J86PWC5J, 953209, 953221, 953266, 953270, B3ZHP2J, CXL941J, JFBX395J, FCM073J, FXCBG3J, JG7BFB5J, GWXQ52J, HJ5K84J, HPKG25J -- Affected Foreign Serial Numbers: DWXO52J, GWJZY4J, J16XQH4J, BGV6W2J, 17QP94J, 4SHPF4J, 1K5K84J, 37QP34J, H5PWC5J, J2V6LW4J, F6MXR3J, JT6LW4J, N0551107, F1150698, 46XQH4J, 2S5OP0J, CRKM82, J41BCY4J, J56T205J, BGV6W2J, 7YCF43J, 96XQHAJ, C1JNZ5J, C3JTP4J, D3JTP4J, 86T205J, 18BFB5J, 96PWC5J, 1LSSF5J, 4drj44j, 8W7WG3J, J953222, J953244, JCT20Q3J, HWJZY4J, 38769917923.",9/7/2016,"09/07/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75168,"Ongoing","Sandoz Inc","100 College Rd W",,"Princeton","NJ","08540-6604","United States","Voluntary: Firm Initiated","Letter","TN","D-0133-2017","Class II","Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054 ","42,740 cartons (24 count carton from 7 total lots)","Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.","11/09/2016",," NDC 10019-553-02 (24 ct. carton) and NDC 10019-553-88 (patch); Lot #'s FV5908 and FX1520 both with expiry 06/2018; GB4910 and GC4210 both with expiry 09/2018; GE1927 with expiry 12/2018; GF7017 with expiry 01/2019 and GH8065 with expiry 02/2019.",8/24/2016,"08/24/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75169,"Ongoing","Federico's Bakery","1860 Evergreen St",,"Duarte","CA","91010-2906","United States","Voluntary: Firm Initiated","Letter","CA","F-2617-2016","Class II","Federico's Mexican Cookies Excelente Variedad, Net Wt. 21oz, 10packs/case, UPC 9154450521.","9,520 units","Federico's Bakery is recalling Mexican Cookies because it contains undeclared milk as the sub ingredient for butter.","09/27/2016",," none",9/12/2016,"09/12/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75170,"Ongoing","Shire","1200 Morris Dr",,"Chesterbrook","PA","19087-5507","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0006-2017","Class III","Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10","7,680 bottles (768,000 capsules)","Presence of Foreign Tablets/Capsules","10/05/2016",," Lot # AF3360B; Exp. 04/19",9/2/2016,"09/02/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75171,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-2892-2016","Class II","Syngo.plaza VB10A, Picture Archiving and Communication System","47 systems","Software upgrade to eliminate several issues","09/27/2016",," Serial Numbers:  100262  100198  100258  100259  100538  100133  100213  100214  100031  100484  100362  100416  100461  100457  100447  100139  100027  100559  100440  100441  100025  100084  100186  100189  100190  100191  100192  100195  100196  100033  100232  100449  100450  100199  100256  100228  100425  100029  100253  100203  100204  100132  100434  100491  100495  100206  ",9/6/2016,"09/06/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75171,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-2891-2016","Class II","Syngo.plaza, Picture Archiving and Communication System","47 systems","Software upgrade to eliminate several issues","09/27/2016",," Serial Numbers:  100262  100198  100258  100259  100538  100133  100213  100214  100031  100484  100362  100416  100461  100457  100447  100139  100027  100559  100440  100441  100025  100084  100186  100189  100190  100191  100192  100195  100196  100033  100232  100449  100450  100199  100256  100228  100425  100029  100253  100203  100204  100132  100434  100491  100495  100206  ",9/6/2016,"09/06/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75172,"Ongoing","Four Brothers Packaging Inc.","13220 Cloverdale St",,"Oak Park","MI","48237-3260","United States","Voluntary: Firm Initiated","Letter","Domestic: MI only    Foreign:None  VA/DOD: None","F-2621-2016","Class II","Jakes Candy Assorted Starlight Kisses, Product label(s):***Jakes Candy *** ASST. STARLIGHT KISSES *** Net Wt.  1.5 oz. *** Exp. 7/2019 *** INGREDIENTS: Corn syrup, citric acid, natural and artificial flavor, artificial flavors may contain citric acid or including FD&C yellow 5 & yellow #6. ***   o	Product label(s):***Jakes Candy *** ASST. STARLIGHT KISSES *** Net Wt.  3.0 oz. *** Exp. 1/2021 *** INGREDIENTS: Corn syrup, citric acid, natural and artificial flavor, artificial flavors may contain citric acid or including FD and C yellow #5 & yellow #6. *** 12 bags per case","480 bags of the 1.5 oz; and 240 bags of the 3.0 oz. ","Four Brothers Packaging, Inc.dba Jake's Candy is voluntarily recalling Assorted Starlight Kisses Mints due to undeclared FD&C colors Red 40, Blue 1, and Red 3.","09/29/2016",," Expiration Date: 7/2019 (1.5 oz), UPC: 835976007438 (1.5 oz);   and UPC: 815136010287 (3.0 oz), Expiration Date: 1/2021 (3.0 oz)  ",7/6/2016,"07/06/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75172,"Ongoing","Four Brothers Packaging Inc.","13220 Cloverdale St",,"Oak Park","MI","48237-3260","United States","Voluntary: Firm Initiated","Letter","Domestic: MI only    Foreign:None  VA/DOD: None","F-2623-2016","Class II","Jakes Candy Gummies Worms. o	Product label(s): ***Jakes Candy *** GUMMIES WORMS *** Net Wt.  1.1 oz. *** Exp. 12/2020 *** INGREDIENTS: Corn syrup, sugar, citric acid, natural and artificial flavors, artificial colors, including FD&C #5. ***   12 bags per case","480 bags","Four Brothers Packaging, Inc.dba Jake's Candy is voluntarily recalling Gummy Worms due to undeclared FD&C colors Red 40, Yellow 6 and Blue 1.","09/29/2016",," Expiration Date:12/2020 None Listed, UPC: 815136012052",7/6/2016,"07/06/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75172,"Ongoing","Four Brothers Packaging Inc.","13220 Cloverdale St",,"Oak Park","MI","48237-3260","United States","Voluntary: Firm Initiated","Letter","Domestic: MI only    Foreign:None  VA/DOD: None","F-2622-2016","Class II","Jakes Candy Assorted Jelly Fruit Slices, Product label(s):***Jakes Candy *** ASST. JELLY FRUIT SLICES *** Net Wt.  3.5 oz. *** INGREDIENTS: Corn syrup, sucrose, corn starch, natural flavor, red #3, red #40, yellow #6.  12 bags per case","240 bags","Four Brothers Packaging, Inc.dba Jake's Candy is voluntarily recalling Assorted Jellies due to undeclared FD&C colors Yellow 5 and Blue 1.","09/29/2016",," Expiration Date: None Listed, UPC: 815136010098",7/6/2016,"07/06/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75173,"Ongoing","RAYSEARCH LABORATORIES AB","Sveavaegen 9",,"Stockholm",,,"Sweden","Voluntary: Firm Initiated","E-Mail","Nationwide distribution","Z-0038-2017","Class II","RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System  RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.","USA: 522 units, OUS 846 units","RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline (External ROI) in RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0).  ","10/04/2016",," Build Numbers: 2.5.0.144, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.3.0.14, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 or 5.0.2.35.",9/1/2016,"09/01/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75174,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","Letter","Texas","B-0728-16","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from an ineligible donor, was distributed. ","09/19/2016","09/19/2016"," W040716346020; ",7/28/2016,"07/28/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75176,"Ongoing","Drews LLC","926 Vermont Rt 103 S",".","Chester","VT","05143","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","IL","F-0677-2017","Class I","Field Day Organic Ranch Dressing packaged in an 8 fl. oz. glass bottle, UPC #042563600242. The lot code is located on the back of the bottle above the label. Specifically, the front label of the affected product is correctly labeled Field Day Organic Ranch Dressing, 8 fl oz. The issue is some bottles have an incorrect back label such that the contains statement does not list milk and egg as allergens. These bottles can be identified by UPC# 042563600259.",,"Undeclared milk and egg allergen.","12/08/2016",," Lot Code W210I, Best By date of Jan. 28, 2018",9/14/2016,"09/14/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75177,"Ongoing","A & D Enginering Inc","1756 Automation Pkwy",,"San Jose","CA","95131-1873","United States","Voluntary: Firm Initiated","Letter","to distributors in NY, MA, VA. TX,","Z-0063-2017","Class II","Blood Pressure Monitor UA-767PBT-Ci for small cuff.  Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate.","378 units","A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.","10/09/2016",," Serial numbers:  5150100209     5150100207     5150100204     5150100203     5150100210     5150301449     5150301448     5150301444     5150301445     5150301446     5150301443     5150301450     5150301441     5150301442     5150301447     5150402687     5150402720     5150402711     5150402729     5150402714     5150402830     5150402810     5150402826     5150402839     5150402730     5150402835     5150402716     5150402762     5150402769     5150402768     5150402834     5150402726     5150402832     5150402809     5150402829     5150402764     5150402823     5150402760     5150402806     5150402787     5150402756     5150402784     5150402761     5150402783     5150402801     5150402821     5150402802     5150402805     5150402833     5150402824     5150402838     5150402649     5150402827     5150402650     5150402804     5150402757     5150402685     5150402763     5150402770     5150402790     5150402645     5150402755     5150402715     5150402782     5150402789     5150402753     5150402807     5150402644     5150402803     5150402688     5150402767     5150402786     5150402686     5150402721     5150402713     5150402682     5150402728     5150402717     5150402723     5150402689     5150402712     5150402752     5150402727     5150402725     5150402648     5150402684     5150402690     5150402642     5150402647     5150402683     5150402719     5150402759     5150402766     5150402751     5150402681     5150402754     5150402765     5150402722     5150402724     5150402758     5150402643     5150402718     5150402641     5150402788     5150402837     5150402828     5150402646     5150402840     5150402836     5150402808     5150402781     5150402822     5150402785     5150402825     5150402831     5150200109     5150200108     5150200469     5150200468     5150200102     5150200242     5150200103     5150200529     5150200522     5150200526     5150200525     5150200467     5150200523     5150200521     5150200528     5150200527     5150200465     5150200341     5150200463     5150200106     51",9/12/2016,"09/12/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75178,"Ongoing","AtriCure, Inc.","7555 Innovation Way",,"Mason","OH","45040-9695","United States","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution to the follwoing states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT & WI.    Product was also shipped to the following countries: Poland and Switzerland","Z-0377-2017","Class II","AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip  Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.","298","There is a potential for a component failure of the device which could necessitate medical intervention.","11/09/2016",," Model Numbers: PRO235, PRO240, PRO245 and PRO250    Lot Numbers: 65622 to 66773",9/22/2016,"09/22/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75180,"Ongoing","Censea Inc","650 Dundee Rd Ste 180",,"Northbrook","IL","60062-2753","United States","Voluntary: Firm Initiated","E-Mail","NY, NJ, RI, MA, TX, IL, CT, VA, KY","F-0738-2017","Class I","A-PAC Farm Raised Shrimp, A Product of Vietnam, Keep Frozen At 0 Degrees F (-18 Degrees Celsius), Net Weight 4 lbs (64 oz). Above UPC Code:  APAC 8/12 ct Headless Tiger Shrimp","1,100 cases","Salmonella detected in product","12/15/2016",," Lot 38453NK",9/9/2016,"09/09/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75180,"Ongoing","Censea Inc","650 Dundee Rd Ste 180",,"Northbrook","IL","60062-2753","United States","Voluntary: Firm Initiated","E-Mail","NY, NJ, RI, MA, TX, IL, CT, VA, KY","F-0739-2017","Class I","A-PAC Farm Raised Shrimp, A Product of Vietnam, Keep Frozen At 0 Degrees F (-18 Degrees Celsius), Net Weight 4 lbs (64 oz). Above UPC Code:  APAC 4/6 ct Headless Tiger Shrimp","6 cases","Salmonella detected in product","12/15/2016",," Lot 38452NK",9/9/2016,"09/09/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75181,"Ongoing","Leonhard Lang Medizintechnik GmbH","Archenweg 56",,"Innsbruck",,,"Austria","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland.","Z-0004-2017","Class I","Skintact Electrodes for Defibrillation, DF29N.    Product Usage:  Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring.  The device is non-sterile and for single use only.  ","11,110 ( US 8,040; OUS 3,070)","There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all.  This may cause a situation in which a patient, who is in a life threatening condition and requires a  defibrillation shock, cannot be treated in good time.","10/14/2016",," US: 60602-0774; 60502-0779; 60308-077; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 50130-0777; 41023-077; 41008-0778; 40730-0778; 40618-0778; and, 40130-0776.  Outside US: 60725-0774; 60620-0776; 60602-0774; 60502-0779; 60308-0771;  60114-0773; 51023-0775; 50904-0777; 50403-0778; 40827-0777; 40730-0778; 40618-0778; and, 40130-0776.",9/1/2016,"09/01/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75182,"Ongoing","Louis Hong Inc Dba Mei Shun Noodle Inc","610 W 26th St",,"Chicago","IL","60616-1806","United States","Voluntary: Firm Initiated","Telephone","Illinois","F-0113-2017","Class I","6 Five, Rice Noodles, Keep Refrigerated, Ingredients: Rice flour, water, salt and corn oil.  Weight: 12 oz, Manufactured by: Mei Shun Noodle Inc, 610 W. 26th Street Chicago IL 60613, (312) 842-6500. Noodles on styrofoam tray visible through clear plastic wrap. ","60 packages","Undeclared shrimp, soybean oil and green onions in fresh rice noodles. ","10/14/2016",," No batch, serial or lot numbers available on the packaging.",8/17/2016,"08/17/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75183,"Terminated","Blood Assurance Inc","705 E 4th St",,"Chattanooga","TN","37403-1916","United States","Voluntary: Firm Initiated","Telephone","Tennessee","B-0779-16","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor whose arm inspection was not adequately documented, was distributed.","09/19/2016","09/19/2016"," W043216055791",8/31/2016,"08/31/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75185,"Ongoing","PAO DE MILHO III, LLC","12-24 Jabez St",,"Newark","NJ","07105-3082","United States","Voluntary: Firm Initiated","E-Mail","NJ","F-2620-2016","Class II","Triana Family Brioche Donuts Bavarian Cream Net Wt. 0.75 LBS (340 g)  12 -24 Jabez St., Newark, NJ 07106 UPC 000260003995    packaged in a clear plastic clam shell container","60 units","Brioche Donuts- Bavarian Cream contain undeclared FD&C yellow #5 and FD&C yellow #6.","09/28/2016",," 9/13/2016",8/30/2016,"08/30/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0096-2017","Class II","cobas 6000 Series system  c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer    Product Usage:  The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0104-2017","Class II","RSD 800A Aliquoting System  calculator/data processing module, for clinical use    Product Usage:  The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests.      ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0107-2017","Class II","cobas p 512 Pre-Analytical Instrument  calculator/data processing module, for clinical use    Product Usage:  The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnostic laboratories.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0099-2017","Class II","URISYS 2400 Urine Analyzer  Automated Urinalysis System    Product Usage:  The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0100-2017","Class II","Roche COBAS INTEGRA 800 /800 CTS Analyzer  Analyzer, Chemistry (Photometric, Discrete for Clinical use    Product Usage:  The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0097-2017","Class II","cobas 8000 Modular Analyzer Series  c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer    Product Usage:  The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcoded secondary tube for processing on an off-line analyzer.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0108-2017","Class II","cobas p 471 centrifuge unit  calculator/data processing module, for clinical use    Product Usage:  The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0106-2017","Class II","cobas p 612 Pre-Analytical Instrument  calculator/data processing module, for clinical use    Product Usage:  The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0095-2017","Class II","cobas e411 Immunoassay Analyzer  e411: Immunoassay Analyzer    Product Usage:  The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0103-2017","Class II","VS II Aliquoter System  calculator/data processing module, for clinical use    Product Usage:  Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0101-2017","Class II","cobas p 701 Post-Analytical Unit  calculator/data processing module, for clinical use    Product Usage:  The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, In addition, the analyzer determines specific gravity, color, and clarity. The URISYS 2400 is intended for professional use only.    ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0110-2017","Class II","cobas 6800/8800 system  Hepatitis Viral B DNA Detection    Product Usage:  The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping of sample tubes, liquid level detection (optional) and sample quality detection (optional), as well as recapping of sample tubes (optional).    ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0109-2017","Class II","cobas p 312 Pre-Analytical System  calculator/data processing module, for clinical use    Product  Usage:  The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0102-2017","Class II","cobas p 501 Post-Analytical Unit  calculator/data processing module, for clinical use    Product Usage:  The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR SYSTEMS analyzers.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0094-2017","Class II","Roche/Hitachi MODULAR Analytics Combination Systems  Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer    Product Usage:  The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0098-2017","Class II","Modular Pre Analytics ( EVO/Plus)    Product Usage:  The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the host.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75186,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0105-2017","Class II","RSD 800 Sorting System  calculator/data processing module, for clinical use    Product Usage:  The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.  ","9014 in total","Roche has received four reports of injury caused by the sharp edge of the center guide rail of an  analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.","10/25/2016",," Not applicable",7/15/2016,"07/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75187,"Ongoing","Trilliant Surgical Ltd.","6721 Portwest Dr Ste 160",,"Houston","TX","77024-8019","United States","Voluntary: Firm Initiated","Letter","CA, AZ, WI, FL, NJ, OH","Z-0609-2017","Class II"," ","11","Screws were identified as having the incorrect part number and lot number marked upon them.  The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721.   ","11/17/2016",," Lot TSL003721",9/2/2016,"09/02/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75188,"Ongoing","Ozturk Gardens","28872 S Big Hollow Rd",,"Park Hill","OK","74451-2948","United States","Voluntary: Firm Initiated","Telephone","OK","F-0168-2017","Class II",,"10 cases","Product was found to have an elevated pH level.  ","10/18/2016",," Lot # 6/1217 and 07/0117 and UPC Code # 7361187719",9/13/2016,"09/13/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75192,"Ongoing","Fujifilm Medical Systems U.S.A., Inc.","419 West Ave",,"Stamford","CT","06902-6343","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0073-2017","Class II","Fujifilm Synapse PACS, Software versions: 4.0.xxx,  4.1.xxx, version 4.2.xxx, version 4.3.xxx    Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities ","251 units","Image data for a patients image may not be correct ","10/12/2016",," Software versions: 4.0.xxx,  4.1.xxx, version 4.2.xxx, version 4.3.xxx",9/15/2016,"09/15/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75194,"Ongoing","Mckesson Medical Imaging Group","10711 Cambie Rdsuite 130",,"Richmond","British Columbia",,"Canada","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS,  KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA WV, WI, WY, and Internationally to Canada, France, Great Britain and Ireland","Z-2872-2016","Class II","McKesson Radiology, versions 12.1.1 and 12.2       McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.","164 devices","The STAT priority icon was not displayed in the Study List when the study was opened.","09/22/2016",," McKesson Radiology versions 12.1.1 and 12.2",7/12/2016,"07/12/2016",9/28/2016,"09/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75195,"Ongoing","Get Drizzled Custom Wine Drizzle, LLC","2204 Highway 13",,"Higginsville","MO","64037-1457","United States","Voluntary: Firm Initiated","Telephone","Distributed to direct accounts in the state Missouri.","F-0414-2017","Class II","White Wine & Garlic Wine Drizzle, packaged in 5 oz and 8 oz glass bottles, www.winedrizzle.com, Higginsville, MO 64037","90 8-oz bottles, 50 5-oz bottles.","Drizzle product contains undeclared milk, a subingredient of a listed ingredient: Parmesan cheese","11/08/2016",," All batch numbers",9/1/2016,"09/01/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75196,"Ongoing","Safecor Health, LLC","317 New Boston St",".","Woburn","MA","01801-6231","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-0606-2017","Class III","Safecor Vitamin B-1 (THIAMINE) 100 mg tablets  NDC: 48433-0108-01  Distributed by: SAFECOR HEALTH, 317 NEW BOSTON STREET, WOBURN, MA","1431 boxes","Box labeled Thiamine Hydrochloride instead of Thiamine Mononitrate","12/06/2016",," Safecor Health Lot # A15012, A15021, 16A004, 16A015 and 16A035",9/12/2016,"09/12/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75197,"Ongoing","Hill-Rom, Inc.","1069 State Road 46 E",,"Batesville","IN","47006-7520","United States","Voluntary: Firm Initiated","Letter","WA  NC  OH  PA  MI  Australia  Sweden","Z-0326-2017","Class II","Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling  installed rail systems: Multirall 200, Likorall 200, 242, 243, 250,  and LikoGuard L and XL.","188","Ceiling Bracket 71 was  shipped with a larger center hole. A potentially  hazardous situation exists that if the Ceiling Bracket 71  with a larger center hole is used for a concrete ceiling  Ultra System installation with the M8 screw and the safe  working load is exceeded, the system could fall.","10/31/2016",," manufacturing date between Dec 01, 2015- Apr 14, 2016",8/9/2016,"08/09/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75199,"Ongoing","National Foods Packaging Inc","8200 Madison Ave",,"Cleveland","OH","44102-2727","United States","Voluntary: Firm Initiated","Letter","US Nationwide.  The product was distributed to the following states: IN, TX, VA","F-0226-2017","Class III","Hillcrest Farms Poultry Gravy Mix in 25lb brown poly-lined bags","1250 lb","Product contains a spice which was tested and found to contain elevated levels of lead.","10/20/2016",," Item#10225; Mfr. date/Lot# 06/02/16; Shipped 06/03/16; UPC 0 85019 10225 9; Exp. 06/02/17",9/16/2016,"09/16/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75199,"Ongoing","National Foods Packaging Inc","8200 Madison Ave",,"Cleveland","OH","44102-2727","United States","Voluntary: Firm Initiated","Letter","US Nationwide.  The product was distributed to the following states: IN, TX, VA","F-0228-2017","Class III","National Foods Packaging Low Sodium Chicken Base in 50 lb white poly-lined paper bags","2000 lb","Product contains a spice which was tested and found to contain elevated levels of lead.","10/20/2016",," Item# 41251; Mfr. date/Lot# 06/17/16 & 06/27/16; Shipped 06/30/16; UPC 8 50194 41220 8; Exp. 06/17/17 & 06/27/17",9/16/2016,"09/16/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75199,"Ongoing","National Foods Packaging Inc","8200 Madison Ave",,"Cleveland","OH","44102-2727","United States","Voluntary: Firm Initiated","Letter","US Nationwide.  The product was distributed to the following states: IN, TX, VA","F-0227-2017","Class III","National Foods Packaging Chicken Base in 25 lb white poly-lined paper bags","8825 lb","Product contains a spice which was tested and found to contain elevated levels of lead.","10/20/2016",," Item# 41220; Mfr. date/Lot# 08/22/16; Shipped 08/24/16; UPC 8 50194 41220 8; Exp. 08/24/17",9/16/2016,"09/16/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75200,"Completed","Northern Tier Bakery","625 2nd St",,"St Paul Park","MN","55071-1807","United States","Voluntary: Firm Initiated","E-Mail","Wisconsin and Minnesota.","F-0069-2017","Class II","Supermoms Kitchen Roast Beef & Cheddar Melt, Net Wt. 3.7 oz (105g).  Keep Refrigerated.  UPC 63913-94236","1,016 units","One lot of Super moms Roast Beef & Cheddar Melt was mislabeled and did not declare monosodium glutamate, yellow 5, and yellow 6.","10/07/2016",," Enjoy Through 8/19",8/14/2016,"08/14/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75201,"Ongoing","Ferrara Candy Comp","1 Tower Ln",,"Oakbrook Terrace","IL","60181-4671","United States","Voluntary: Firm Initiated","Telephone","NE, WI, IL, IN, WA, MO, IA, FL, MN, OH, TX, MI, MT, SC, CA (individual in CA is a sales rep for the firm and received one case of product for marketing purposes).","F-0368-2017","Class I","BRACH'S Chocolate Creations, Milk Chocolate Almond Supremes, Fresh roasted almonds drenched in rich creamy milk chocolate.  NET WT 5 oz (142 g).  Best By 04/22/2017","9,036 bags","Undeclared peanuts and wheat in product. ","10/26/2016",," Lot: 6G23CC33102  UPC: 011300397332",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75203,"Ongoing","Tomales BayFoods","2080 Lakeville Hwy",,"Petaluma","CA","94954-6713","United States","Voluntary: Firm Initiated","E-Mail","CA only","F-0083-2017","Class I","Corra Lin Sheep Milk Cheese; Raw Sheep's Milk, Starter and Ripening Cultures, Salt and Rennet  Sold in wheels, wt.  range of 13.24 to 15.90 lb.  Neal's Yard Dairy, London    Neal's Yard Dairy - exporter  Manufactured by Errington Cheese Ltd., South Lanarkshire, United Kingdom.","4 wheels - wt. range of 13.24  to 15.90 lbs.","Food Standards Scotland (FSS) has ordered all cheese from Errington Cheese to be pulled from distribution after detection of O157 and O157 E. Coli.","10/11/2016",," Production dates of 06/05/2015, 06/29/2016 and 07/07/2015.",9/15/2016,"09/15/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75205,"Ongoing","Unichem Pharmaceuticals Usa Inc","777 Terrace Ave","Suite 102","Hasbrouck Heights","NJ","07604-3102","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1519-2016","Class III","Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only,  Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.","368 bottles","Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.","09/23/2016",," Lot #: GLEH 16003, Exp 03/31/18",8/19/2016,"08/19/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75206,"Ongoing","Sun Pharmaceutical Industries, Inc.","270 Prospect Plains Rd",,"Cranbury","NJ","08512-3605","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-0007-2017","Class III","buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868  NDC 47335-737-86  ","31,762 bottles","Failed Dissolution Specifications","10/06/2016",," JKN5124A and JKN5229A, exp 10/2016",9/13/2016,"09/13/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75207,"Ongoing","Randox Laboratories Ltd.","55 Diamond Road",,"Crumlin (North)",,,"Ireland","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution","Z-0123-2017","Class II","Randox Lipase (Colorimetric)    Product Usage:  A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.  ","18","According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to amend the running order for all instruments using these reagents to ensure Lipase is not place directly before or after LDL or Triglycerides.   A correction was made to the IFU for the Lipase assay and all customers who purchased the Lipase kit in the USA were contacted with the updated instruction.  ","10/18/2016",," Catalogue number:      LI3837, LI7979, LI8050, LI8361",8/2/2016,"08/02/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75208,"Ongoing","Randox Laboratories Ltd.","55 Diamond Road",,"Crumlin (North)",,,"Ireland","Voluntary: Firm Initiated","E-Mail","All consignees are in the US.","Z-0050-2017","Class II","IgE Calibrator Series","4","According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234.    Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.","10/06/2016",," Catalogue number    IE2492    Batch number    354213, 386994",9/7/2016,"09/07/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75209,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy,  Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain  Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.","Z-0293-2017","Class II","Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g  Product Number: 865352    Exchange part:  453564262491  453564262511  453564615311  453564615331  453564262571  453564262591    Exchange part:  453564262531  453564262551  453564262571  453564262591  453564615351  453564615371  453564467761 (Korea)  453564467781 (Korea)  453564451791 (Japan, Taiwan, Indonesia)  453564451811 (Japan, Taiwan, Indonesia)  453564467821 (Mexico)  453564467841 (China)  453564467861 (China)    Worldwide   SW Revisions: B.05.28, B.05.29, and B.05.32   Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals ","2,212 units","Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX","10/20/2016",," SW Revisions: B.05.28, B.05.29, and B.05.32",9/19/2016,"09/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75209,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy,  Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain  Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.","Z-0292-2017","Class II","Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz)  Product Number: 865351   Worldwide Except USA    Exchange part:  453564262491  453564262511  453564615311  453564615331  453564262571  453564262591    Exchange part:  453564262531  453564262551  453564262571  453564262591  453564615351  453564615371  453564467761 (Korea)  453564467781 (Korea)  453564451791 (Japan, Taiwan, Indonesia)  453564451811 (Japan, Taiwan, Indonesia)  453564467821 (Mexico)  453564467841 (China)  453564467861 (China)  Worldwide except for the USA  SW Revisions: B.05.28, B.05.29, and B.05.32  	  Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals ","1824 units","Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX","10/20/2016",," SW Revisions: B.05.28, B.05.29, and B.05.32 ",9/19/2016,"09/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75209,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy,  Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain  Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.","Z-0291-2017","Class II","Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz)    Product Number: 865350   Exchange part:  453564262491  453564262511  453564615311  453564615331  453564262571  453564262591  USA only  SW Revisions: B.05.28, B.05.29, and B.05.32   Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals ","9804 units","Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX","10/20/2016",," SW Revisions: B.05.28, B.05.29, and B.05.32 ",9/19/2016,"09/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75211,"Ongoing","Sequent Medical Inc","11 Columbia",,"Aliso Viejo","CA","92656-1460","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, TN, WV and Internationally to Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark,","Z-0114-2017","Class II","VIA 27 Microcatheter,  Part No. FG27-154-01, Model No. VIA-27-154-01    The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).","618 units","Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.","10/27/2016",," 16031101, 16042901, 16051201, 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16012901, 16040801, 16041501, 16052603, 16061701",9/23/2016,"09/23/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75212,"Ongoing","The Apothecary Shoppe LLC","6136 E 51st St",,"Tulsa","OK","74135-7704","United States","Voluntary: Firm Initiated","Telephone","Oklahoma","D-0004-2017","Class II","Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK","247.5 mL total volume","Lack of Assurance of Sterility; medication was sterilized with a recalled filter","10/04/2016",," 07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016",9/12/2016,"09/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75212,"Ongoing","The Apothecary Shoppe LLC","6136 E 51st St",,"Tulsa","OK","74135-7704","United States","Voluntary: Firm Initiated","Telephone","Oklahoma","D-0002-2017","Class II","Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK","419 mL total","Lack of Assurance of Sterility; medication was sterilized with a recalled filter","10/04/2016",," 071222016@24 BUD 01/08/2017, 05112016@8 BUD 11/07/2016",9/12/2016,"09/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75212,"Ongoing","The Apothecary Shoppe LLC","6136 E 51st St",,"Tulsa","OK","74135-7704","United States","Voluntary: Firm Initiated","Telephone","Oklahoma","D-0003-2017","Class II","Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK","455 mL total volume","Lack of Assurance of Sterility; medication was sterilized with a recalled filter","10/04/2016",," 05162016@18 BUD 09/13/2016; 07052016@9 BUD 11/02/2016; 08032016@13 BUD 12/01/2016",9/12/2016,"09/12/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75213,"Ongoing","Argon Medical Devices, Inc","1445 Flat Creek Rd",,"Athens","TX","75751-5002","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.","Z-0051-2017","Class II","MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F.    A sheath used to facilitate placing a catheter through the skin into a vein or artery.","200 units","The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath","10/06/2016",," 11149662, 11151447, 11151617, and 11149822.",9/8/2016,"09/08/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75214,"Ongoing","Encore Medical, Lp","9800 Metric Blvd",,"Austin","TX","78758-5445","United States","Voluntary: Firm Initiated","Letter","US","Z-0325-2017","Class II","Empowr PS Knee System Box Cut Guide;  Used to make the housing resection for the post of the posterior stabilized implant.","436 units","It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.","10/28/2016",," 202351L01,  202434L01,  203779L01,  202351L02,  202434L02,  202351L03,  202434L03,  203779L03,  202351L04,  202434L04,  202351L05,  202434L05,  202351L06,  202434L06,  203779L06,  202351L07,  202434L07,  203779L07,  202351L08,  202434L08,  203779L08,  202351L09,  202434L09,  202351L10,  202434L10,  203203L01",9/19/2016,"09/19/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75215,"Ongoing","Mckesson Packaging Services","7101 Weddington Rd NW",,"Concord","NC","28027-3412","United States","Voluntary: Firm Initiated","Letter","CO, IL, LA, OH","D-1527-2016","Class III","Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz  Inc., Princeton, NJ 08805, NDC  63739-669-10","3,492 unit cartons of 10 x 10 blister cards ","Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry). ","09/27/2016",," Lot #: 0111512; Exp. 08/17",9/15/2016,"09/15/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75217,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0032-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/18/2016","10/18/2016"," W036315037619; ",8/10/2016,"08/10/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75217,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0031-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/18/2016","10/18/2016"," W036315037619; ",8/10/2016,"08/10/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75218,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0034-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/18/2016","10/18/2016"," W036316185312; ",8/10/2016,"08/10/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75218,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0033-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/18/2016","10/18/2016"," W036316185312; ",8/10/2016,"08/10/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75221,"Ongoing","Stryker Sustainability Solutions","1810 W Drake Dr",,"Tempe","AZ","85283-4327","United States","Voluntary: Firm Initiated","Letter","U.S. distribution nationwide.  No foreign distribution","Z-0324-2017","Class II","Reprocessed Pressure Tourniquet Cuff (PTC)    Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field.  Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.    ","1,695,760","Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.","10/28/2016",," Model                              Lot            Lot Created    Expiration  5921-018-135 2990595 5/5/2014 May-16  5921-018-235 2989898 5/5/2014 May-16  5921-018-235 2992868 5/5/2014 May-16  5921-024-235 2992501 5/5/2014 May-16  5921-030-135 2990147 5/5/2014 May-16  5921-030-135 2991575 5/5/2014 May-16  5921-030-235 2993033 5/5/2014 May-16  5921-034-135 2990152 5/5/2014 May-16  5921-034-135 2992555 5/5/2014 May-16  5921-034-235 2989674 5/5/2014 May-16  5921-034-235 2990240 5/5/2014 May-16  5921-034-235 2991095 5/5/2014 May-16  5921-034-235 2991413 5/5/2014 May-16  5921-034-235 2993046 5/5/2014 May-16  5921-034-235 2993509 5/5/2014 May-16  5921-218-235 2990217 5/5/2014 May-16  5921-218-235 2990553 5/5/2014 May-16  5921-218-235 2991743 5/5/2014 May-16  5921-218-135 2990106 5/5/2014 May-16  5921-218-135 2992540 5/5/2014 May-16  60-7070-102 2990697 5/5/2014 May-16  60-7070-103 2984111 5/5/2014 May-16  60-7070-103 2989473 5/5/2014 May-16  60-7070-103 2990110 5/5/2014 May-16  60-7070-103 2991030 5/5/2014 May-16  60-7070-103 2992398 5/5/2014 May-16  60-7070-103 2992636 5/5/2014 May-16  60-7070-105 2989822 5/5/2014 May-16  60-7070-105 2990012 5/5/2014 May-16  60-7070-105 2991271 5/5/2014 May-16  60-7070-105 2993392 5/5/2014 May-16  60-7070-104 2992643 5/5/2014 May-16  60-7070-106 2990433 5/5/2014 May-16  60-7070-106 2991817 5/5/2014 May-16  60-7070-106 2993407 5/5/2014 May-16  60-7075-004 2989867 5/5/2014 May-16  60-7075-103 2990650 5/5/2014 May-16  60-7075-103 2991432 5/5/2014 May-16  60-7075-103 2992627 5/5/2014 May-16  60-7075-105 2992282 5/5/2014 May-16  60-7075-106 2990451 5/5/2014 May-16  60-7075-106 2990958 5/5/2014 May-16       5921-018-135 2996601 5/8/2014 May-16  5921-024-135 2996808 5/8/2014 May-16  5921-030-235 2995775 5/8/2014 May-16  5921-030-235 2998064 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Aug-16  60-7070-103 3168127 8/7/2014 Aug-16       60-7070-103 3168865 8/7/2014 Aug-16  60-7070-103 3170034 8/7/2014 Aug-16  60-7070-103 3170676 8/7/2014 Aug-16  60-7070-103 3172026 8/7/2014 Aug-16  60-7070-103 3172799 8/7/2014 Aug-16  60-7070-105 3168463 8/7/2014 Aug-16  60-7070-105 3170109 8/7/2014 Aug-16  60-7070-105 3170828 8/7/2014 Aug-16  60-7070-105 3172331 8/7/2014 Aug-16  60-7070-104 3169578 8/7/2014 Aug-16  60-7070-006 3172969 8/7/2014 Aug-16  60-7070-106 3168896 8/7/2014 Aug-16  60-7070-106 3170047 8/7/2014 Aug-16  60-7070-106 3170338 8/7/2014 Aug-16  60-7070-106 3170902 8/7/2014 Aug-16  60-7070-106 3171756 8/7/2014 Aug-16  60-7070-106 3172128 8/7/2014 Aug-16  60-7075-006 3172365 8/7/2014 Aug-16  60-7075-006 3172930 8/7/2014 Aug-16  60-7075-103 3168808 8/7/2014 Aug-16  60-7075-103 3170533 8/7/2014 Aug-16  60-7075-103 3171495 8/7/2014 Aug-16  60-7075-103 3171827 8/7/2014 Aug-16  60-7075-103 3173077 8/7/2014 Aug-16  60-7075-105 3170496 8/7/2014 Aug-16  60-7075-106 3168353 8/7/2014 Aug-16  60-7075-106 3168849 8/7/2014 Aug-16  60-7075-106 3170611 8/7/2014 Aug-16  60-7075-106 3173020 8/7/2014 Aug-16  5921-018-235 3174002 8/11/2014 Aug-16  5921-018-235 3177554 8/11/2014 Aug-16  5921-024-235 3176909 8/11/2014 Aug-16  5921-030-135 3178281 8/11/2014 Aug-16  5921-030-235 3173737 8/11/2014 Aug-16  5921-030-235 3175283 8/11/2014 Aug-16  5921-030-235 3177667 8/11/2014 Aug-16  5921-034-1","7070-104 3253237 9/23/2014 Sep-16  60-7070-104 3255689 9/23/2014 Sep-16  60-7070-003 3256528 9/23/2014 Sep-16  60-7070-004 3254064 9/23/2014 Sep-16  60-7070-106 3251900 9/23/2014 Sep-16  60-7070-106 3253394 9/23/2014 Sep-16  60-7070-106 3254157 9/23/2014 Sep-16  60-7070-106 3254436 9/23/2014 Sep-16  60-7070-106 3255658 9/23/2014 Sep-16  60-7070-106 3255997 9/23/2014 Sep-16  60-7070-107 3252170 9/23/2014 Sep-16  60-7070-107 3256769 9/23/2014 Sep-16  60-7075-006 3251729 9/23/2014 Sep-16  60-7075-006 3252492 9/23/2014 Sep-16  60-7075-104 3255141 9/23/2014 Sep-16  60-7075-105 3255248 9/23/2014 Sep-16  60-7075-106 3251755 9/23/2014 Sep-16  60-7075-106 3254979 9/23/2014 Sep-16  5921-018-135 3257498 9/24/2014 Sep-16  5921-018-135 3262370 9/24/2014 Sep-16  5921-018-136 3256867 9/24/2014 Sep-16  5921-018-235 3261002 9/24/2014 Sep-16  5921-024-135 3260616 9/24/2014 Sep-16  5921-024-235 3258163 9/24/2014 Sep-16  5921-030-135 3258144 9/24/2014 Sep-16  5921-030-135 3260951 9/24/2014 Sep-16  5921-030-135 3262130 9/24/2014 Sep-16  5921-030-235 3257927 9/24/2014 Sep-16  5921-030-235 3259166 9/24/2014 Sep-16  5921-030-235 3261883 9/24/2014 Sep-16  5921-034-135 3257390 9/24/2014 Sep-16  5921-034-135 3260157 9/24/2014 Sep-16  5921-034-235 3257319 9/24/2014 Sep-16  5921-034-235 3257666 9/24/2014 Sep-16  5921-034-235 3258137 9/24/2014 Sep-16  5921-034-235 3259994 9/24/2014 Sep-16  5921-034-235 3261693 9/24/2014 Sep-16  5921-218-235 3256833 9/24/2014 Sep-16  5921-218-235 3258057 9/24/2014 Sep-16  5921-218-235 3260347 9/24/2014 Sep-16  5921-212-135 3258159 9/24/2014 Sep-16  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 5921-030-135 3336267 11/5/2014 Nov-16  5921-030-135 3336866 11/5/2014 Nov-16  5921-030-235 3334517 11/5/2014 Nov-16  5921-030-235 3338002 11/5/2014 Nov-16  5921-034-135 3334875 11/5/2014 Nov-16  5921-034-135 3335210 11/5/2014 Nov-16  5921-034-235 3335313 11/5/2014 Nov-16  5921-034-235 3336982 11/5/2014 Nov-16  5921-034-236 3334615 11/5/2014 Nov-16  5921-218-235 3333420 11/5/2014 Nov-16  5921-218-235 3335456 11/5/2014 Nov-16  5921-218-235 3337292 11/5/2014 Nov-16  5921-218-135 3333742 11/5/2014 Nov-16  5921-218-135 3336298 11/5/2014 Nov-16  60-7070-103 3333918 11/5/2014 Nov-16  60-7070-103 3334474 11/5/2014 Nov-16  60-7070-103 3336088 11/5/2014 Nov-16  60-7070-103 3336222 11/5/2014 Nov-16  60-7070-103 3337011 11/5/2014 Nov-16  60-7070-103 3337394 11/5/2014 Nov-16  60-7070-105 3336279 11/5/2014 Nov-16  60-7070-104 3333301 11/5/2014 Nov-16  60-7070-104 3334173 11/5/2014 Nov-16  60-7070-003 3333579 11/5/2014 Nov-16  60-7070-106 3333892 11/5/2014 Nov-16  60-7070-106 3334187 11/5/2014 Nov-16  60-7070-106 3335252 11/5/2014 Nov-16  60-7070-106 3335500 11/5/2014 Nov-16  60-7070-106 3337007 11/ 5/2014 Nov-16  60-7070-106 3337683 11/5/2014 Nov-16  60-7070-106 3337942 11/5/2014 Nov-16  60-7070-107 3338056 11/5/2014 Nov-16  60-7075-103 3335661 11/5/2014 Nov-16  60-7075-103 3335795 11/5/2014 Nov-16  60-7075-103 3336969 11/5/2014 Nov-16  60-7075-105 3336308 11/5/2014 Nov-16  60-7075-106 3335898 11/5/2014 Nov-16  5921-018-135 3341184 11/7/2014 Nov-16  5921-018-235 3339566 11/7/2014 Nov-16  5921-024-135 3"," Dec-16  60-7075-103 3414194 12/15/2014 Dec-16  60-7075-104 3416438 12/15/2014 Dec-16  60-7075-105 3414351 12/15/2014 Dec-16  60-7075-105 3416128 12/15/2014 Dec-16  60-7075-106 3413757 12/15/2014 Dec-16  60-7075-106 3415186 12/15/2014 Dec-16  60-7075-106 3417259 12/15/2014 Dec-16  5921-018-135 3420138 12/18/2014 Dec-16  5921-024-235 3419862 12/18/2014 Dec-16  5921-024-235 3420880 12/18/2014 Dec-16  5921-024-235 3422683 12/18/2014 Dec-16  5921-030-135 3420776 12/18/2014 Dec-16  5921-030-135 3421403 12/18/2014 Dec-16  5921-030-135 3423266 12/18/2014 Dec-16  5921-030-235 3418213 12/18/2014 Dec-16  5921-030-235 3419993 12/18/2014 Dec-16  5921-030-235 3421139 12/18/2014 Dec-16  5921-030-235 3423348 12/18/2014 Dec-16  5921-034-135 3418934 12/18/2014 Dec-16  5921-034-135 3420164 12/18/2014 Dec-16  5921-034-135 3420592 12/18/2014 Dec-16  5921-034-135 3422339 12/18/2014 Dec-16  5921-034-135 3423503 12/18/2014 Dec-16  5921-034-235 3419235 12/18/2014 Dec-16  5921-034-235 3420223 12/18/2014 Dec-16  5921-034-235 3420949 12/18/2014 Dec-16   5921-034-235 3422048 12/18/2014 Dec-16  5921-034-235 3422791 12/18/2014 Dec-16  5921-034-235 3423245 12/18/2014 Dec-16  5921-034-236 3418459 12/18/2014 Dec-16  5921-218-235 3417302 12/18/2014 Dec-16  5921-218-235 3420748 12/18/2014 Dec-16  5921-218-235 3421806 12/18/2014 Dec-16  5921-218-235 3422704 12/18/2014 Dec-16  5921-030-236 3420977 12/18/2014 Dec-16  5921-044-235 3421000 12/18/2014 Dec-16  5921-218-135 3421899 12/18/2014 Dec-16  5921-218-135 3423369 12/18/2014 Dec-16  5921-218-136 3418266 12/18/2014 Dec-16  5921-218-236 3419344 12/18/2014 Dec-16  60-7070-102 3418158 12/18/2014 Dec-16  60-7070-103 3418444 12/18/2014 Dec-16       60-7070-103 3419870 12/18/2014 Dec-16  60-7070-103 3420186 12/18/2014 Dec-16  60-7070-103 3420661 12/18/2014 Dec-16  60-7070-103 3421248 12/18/2014 Dec-16  60-7070-103 3422762 12/18/2014 Dec-16  60-7070-103 3423232 12/18/2014 Dec-16  60-7070-105 3418353 12/18/2014 Dec-16  60-7070-105 3419804 12/18/2014 Dec-16  60-7070-105 3420140 12/18/2014 Dec-16  60-7070-","85432 2/2/2015 Feb-17  5921-218-235 3485581 2/2/2015 Feb-17  5921-218-235 3486123 2/2/2015 Feb-17  5921-030-236 3484010 2/2/2015 Feb-17  5921-212-135 3484291 2/2/2015 Feb-17  5921-218-135 3483966 2/2/2015 Feb-17  5921-218-135 3486759 2/2/2015 Feb-17  60-7070-103 3482108 2/2/2015 Feb-17  60-7070-103 3483921 2/2/2015 Feb-17  60-7070-103 3484579 2/2/2015 Feb-17  60-7070-103 3485360 2/2/2015 Feb-17  60-7070-103 3485762 2/2/2015 Feb-17  60-7070-103 3 486405 2/2/2015 Feb-17  60-7070-103 3487058 2/2/2015 Feb-17  60-7070-103 3487563 2/2/2015 Feb-17  60-7070-103 3487619 2/2/2015 Feb-17  60-7070-105 3484514 2/2/2015 Feb-17  60-7070-105 3485356 2/2/2015 Feb-17  60-7070-105 3485631 2/2/2015 Feb-17  60-7070-105 3486077 2/2/2015 Feb-17  60-7070-105 3487043 2/2/2015 Feb-17  60-7070-104 3484317 2/2/2015 Feb-17       60-7070-104 3485770 2/2/2015 Feb-17  60-7070-104 3486175 2/2/2015 Feb-17  60-7070-003 3484695 2/2/2015 Feb-17  60-7070-106 3484522 2/2/2015 Feb-17  60-7070-106 3484885 2/2/2015 Feb-17  60-7070-106 3485620 2/2/2015 Feb-17  60-7070-106 3485736 2/2/2015 Feb-17  60-7070-106 3486414 2/2/2015 Feb-17  60-7070-106 3486860 2/2/2015 Feb-17  60-7070-106 3487275 2/2/2015 Feb-17  60-7070-107 3461299 2/2/2015 Feb-17  60-7070-107 3485387 2/2/2015 Feb-17  60-7075-003 3484204 2/2/2015 Feb-17  60-7075-006 3486771 2/2/2015 Feb-17  60-7080-102 3483847 2/2/2015 Feb-17  60-7075-103 3484580 2/2/2015 Feb-17  60-7075-103 3485864 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1/4/2016 Jan-18  5921-034-135 4236566 1/4/2016 Jan-18  5921-034-135 4237038 1/4/2016 Jan-18  5921-034-135 4240951 1/4/2016 Jan-18  5921-034-235 4237103 1/4/2016 Jan-18  5921-034-235 4237368 1/4/2016 Jan-18  5921-034-235 4240038 1/4/2016 Jan-18  5921-034-235 4241574 1/4/2016 Jan-18  5921-218-235 4237086 1/4/2016 Jan-18  5921-218-235 4238420 1/4/2016 Jan-18  5921-218-235 4238925 1/4/2016 Jan-18  5921-218-235 4242153 1/4/2016 Jan-18  5921-030-236 4240352 1/4/2016 Jan-18       5921-218-135 4239246 1/4/2016 Jan-18  5921-218-135 4241428 1/4/2016 Jan-18  5921-218-236 4238355 1/4/2016 Jan-18  60-7070-103 4236760 1/4/2016 Jan-18  60-7070-103 4238047 1/4/2016 Jan-18  60-7070-103 4238109 1/4/2016 Jan-18  60-7070-103 4239061 1/4/2016 Jan-18  60-7070-103 4239845 1/4/2016 Jan-18  60-7070-103 4240709 1/4/2016 Jan-18  60-7070-103 4240980 1/4/2016 Jan-18  60-7070-103 4241798 1/4/2016 Jan-18  60-7070-103 4242916 1/4/2016 Jan-18  60-7070-105 4237848 1/4/2016 Jan-18  60-7070-105 4238648 1/4/2016 Jan-18  60-7070-105 4239349 1/4/2016 Jan-18  60-7070-105 4240093 1/4/2016 Jan-18  60-7070-105 4240811 1/4/2016 Jan-18  60-7070-105 4241353 1/4/2016 Jan-18  60-7070-105 4242273 1/4/2016 Jan-18  60-7070-105 4243164 1/4/2016 Jan-18  60-7070-105 4243234 1/4/2016 Jan-18  60-7070-104 4241056 1/4/2016 Jan-18  60-7070-003 4240628 1/4/2016 Jan-18  60-7070-106 4236532 1/4/2016 Jan-18  60-7070-106 4237998 1/4/2016 Jan-18  60-7070-106 4238580 1/4/2016 Jan-18  60-7070-106 4239185 1/4/2016 Jan-18  60-7070-106 4239625 1/4/2016 Jan-18  60-7070-106 4239982 1/4/2016 Jan-18  60-7070-106 4240518 1/4/2016 Jan-18  60-7070-106 4240882 1/4/2016 Jan-18  60-7070-106 4242614 1/4/2016 Jan-18  60-7070-106 4243397 1/4/2016 Jan-18  60-7070-107 4240381 1/4/2016 Jan-18  60-7070-107 4240415 1/4/2016 Jan-18  60-7075-103 4237093 1/4/2016 Jan-18  60-7075-103 4240853 1/4/2016 Jan-18  60-7075-103 4243425 1/4/2016 Jan-18  60-7075-103 4243711 1/4/2016 Jan-18  60-7075-104 4239057 1/4/2016 Jan-18  60-7075-104 4240713 1/4/2016 Jan-18  60-7075-105 4238844 1/4/2016 Jan-18  ","/8/2016 Feb-18  60-7070-006 4326544 2/8/2016 Feb-18  60-7070-106 4326275 2/8/2016 Feb-18  60-7070-106 4326439 2/8/2016 Feb-18  60-7070-106 4326559 2/8/2016 Feb-18  60-7070-106 4329262 2/8/2016 Feb-18  60-7070-106 4332327 2/8/2016 Feb-18  60-7070-106 4332389 2/8/2016 Feb-18  60-7070-107 4326155 2/8/2016 Feb-18  60-7070-107 4326537 2/8/2016 Feb-18  60-7075-104 4330126 2/8/2016 Feb-18  60-7075-106 4330103 2/8/2016 Feb-18  5921-024-235 4336612 2/10/2016 Feb-18  5921-030-135 4334112 2/10/2016 Feb-18  5921-030-135 4336484 2/10/2016 Feb-18  5921-030-235 4334901 2/10/2016 Feb-18  5921-030-235 4335941 2/10/2016 Feb-18  5921-034-135 4333880 2/10/2016 Feb-18       5921-034-135 4335505 2/10/2016 Feb-18  5921-034-235 4332826 2/10/2016 Feb-18  5921-034-235 4334718 2/10/2016 Feb-18  5921-034-235 4335774 2/10/2016 Feb-18  5921-034-235 4335863 2/10/2016 Feb-18  5921-034-235 4337618 2/10/2016 Feb-18  5921-218-235 4335121 2/10/2016 Feb-18  5921-218-135 4334476 2/10/2016 Feb-18  60-7070-103 4332793 2/10/2016 Feb-18  60-7070-103 4334067 2/10/2016 Feb-18  60-7070-103 4335068 2/10/2016 Feb-18  60-7070-103 4336259 2/10/2016 Feb-18  60-7070-103 4337781 2/10/2016 Feb-18  60-7070-103 4338530 2/10/2016 Feb-18  60-7070-105 4264490 2/10/2016 Feb-18  60-7070-105 4333062 2/10/2016 Feb-18  60-7070-105 4335630 2/10/2016 Feb-18  60-7070-105 4336665 2/10/2016 Feb-18  60-7070-104 4333027 2/10/2016 Feb-18  60-7070-104 4336497 2/10/2016 Feb-18  60-7070-003 4335477 2/10/2016 Feb-18  60-7070-106 4334261 2/10/2016 Feb-18  60-7070-106 4334566 2/10/2016 Feb-18  60-7070-106 4335682 2/10/2016 Feb-18  60-7070-106 4338147 2/10/2016 Feb-18  60-7070-107 4333931 2/10/2016 Feb-18  60-7075-103 4332937 2/10/2016 Feb-18  60-7075-103 4333234 2/10/2016 Feb-18  60-7075-103 4334787 2/10/2016 Feb-18  60-7075-103 4336696 2/10/2016 Feb-18  60-7075-105 4335184 2/10/2016 Feb-18  60-7075-106 4332803 2/10/2016 Feb-18  60-7075-106 4335052 2/10/2016 Feb-18  60-7075-106 4336620 2/10/2016 Feb-18  5921-018-135 4341851 2/12/2016 Feb-18  5921-018-235 4338744 2/12/2016 Feb-18  5921-","2016 Mar-18  60-7070-106 4430416 3/21/2016 Mar-18  60-7070-106 4430767 3/21/2016 Mar-18  60-7070-106 4431897 3/21/2016 Mar-18  60-7070-106 4432046 3/21/2016 Mar-18  60-7075-103 4429677 3/21/2016 Mar-18  60-7075-104 4429534 3/21/2016 Mar-18  60-7070-104 4376947 3/22/2016 Mar-18  5921-018-135 4434204 3/23/2016 Mar-18  5921-024-135 4435704 3/23/2016 Mar-18  5921-024-235 4436684 3/23/2016 Mar-18  5921-030-135 4433913 3/23/2016 Mar-18  5921-030-135 4435432 3/23/2016 Mar-18  5921-030-135 4436771 3/23/2016 Mar-18  5921-030-235 4434215 3/23/2016 Mar-18  5921-030-235 4435654 3/23/2016 Mar-18  5921-030-235 4437101 3/23/2016 Mar-18  5921-030-235 4437537 3/23/2016 Mar-18  5921-034-135 4432891 3/23/2016 Mar-18  5921-034-135 4435180 3/23/2016 Mar-18  5921-034-135 4436286 3/23/2016 Mar-18  5921-034-135 4438273 3/23/2016 Mar-18  5921-034-235 4433765 3/23/2016 Mar-18  5921-034-235 4434317 3/23/2016 Mar-18  5921-034-235 4436818 3/23/2016 Mar-18  5921-034-235 4437456 3/23/2016 Mar-18  5921-218-235 4433037 3/23/2016 Mar-18       5921-218-235 4434052 3/23/2016 Mar-18  5921-218-235 4436152 3/23/2016 Mar-18  5921-218-235 4436962 3/23/2016 Mar-18  5921-218-235 4437439 3/23/2016 Mar-18  60-7070-103 4432532 3/23/2016 Mar-18  60-7070-103 4433754 3/23/2016 Mar-18  60-7070-103 4434010 3/23/2016 Mar-18  60-7070-103 4434892 3/23/2016 Mar-18  60-7070-103 4435198 3/23/2016 Mar-18  60-7070-103 4435450 3/23/2016 Mar-18  60-7070-103 4437350 3/23/2016 Mar-18  60-7070-105 4432938 3/23/2016 Mar-18  60-7070-105 4433834 3/23/2016 Mar-18  60-7070-105 4434270 3/23/2016 Mar-18  60-7070-105 4435053 3/23/2016 Mar-18  60-7070-105 4437193 3/23/2016 Mar-18  60-7070-105 4437769 3/23/2016 Mar-18  60-7070-104 4433538 3/23/2016 Mar-18  60-7070-104 4437268 3/23/2016 Mar-18  60-7070-106 4433457 3/23/2016 Mar-18  60-7070-106 4434184 3/23/2016 Mar-18  60-7070-106 4435259 3/23/2016 Mar-18  60-7070-106 4436293 3/23/2016 Mar-18  60-7070-106 4437027 3/23/2016 Mar-18  60-7070-106 4438084 3/23/2016 Mar-18  60-7070-107 4433689 3/23/2016 Mar-18  60-7070-107 4438468 3/23/201","7 4520327 4/29/2016 Apr-18  60-7075-003 4517142 4/29/2016 Apr-18  60-7075-103 4515406 4/29/2016 Apr-18  60-7075-103 4517784 4/29/2016 Apr-18  60-7075-103 4519673 4/29/2016 Apr-18  60-7075-104 4515786 4/29/2016 Apr-18  60-7075-104 4515971 4/29/2016 Apr-18  60-7075-105 4515698 4/29/2016 Apr-18  60-7075-105 4515916 4/29/2016 Apr-18  60-7075-106 4516610 4/29/2016 Apr-18  5921-018-135 4521012 5/2/2016 May-18  5921-018-135 4521595 5/2/2016 May-18  5921-018-135 4522404 5/2/2016 May-18  5921-018-135 4524276 5/2/2016 May-18  5921-018-235 4520667 5/2/2016 May-18  5921-024-135 4522265 5/2/2016 May-18  5921-024-235 4522458 5/2/2016 May-18  5921-030-135 4524426 5/2/2016 May-18  5921-030-235 4522489 5/2/2016 May-18  5921-030-235 4523695 5/2/2016 May-18  5921-034-135 4521927 5/2/2016 May-18  5921-034-135 4526035 5/2/2016 May-18  5921-034-235 4520793 5/2/2016 May-18  5921-034-235 4521763 5/2/2016 May-18  5921-034-235 4522086 5/2/2016 May-18  5921-034-235 4523973 5/2/2016 May-18  5921-034-235 4525635 5/2/2016 May-18  5921-218-235 4520937 5/2/2016 May-18  5921-218-235 4521621 5/2/2016 May-18  5921-218-235 4524615 5/2/2016 May-18  5921-218-235 4526504 5/2/2016 May-18  5921-218-135 4525210 5/2/2016 May-18  60-7070-102 4522368 5/2/2016 May-18  60-7070-103 4521020 5/2/2016 May-18  60-7070-103 4523546 5/2/2016 May-18  60-7070-103 4524852 5/2/2016 May-18  60-7070-103 4526365 5/2/2016 May-18       60-7070-105 4521678 5/2/2016 May-18  60-7070-105 4522157 5/2/2016 May-18  60-7070-105 4522283 5/2/2016 May-18  60-7070-105 4525206 5/2/2016 May-18  60-7070-105 4525908 5/2/2016 May-18  60-7070-104 4436012 5/2/2016 May-18  60-7070-104 4522436 5/2/2016 May-18  60-7070-104 4526486 5/2/2016 May-18  60-7070-003 4522038 5/2/2016 May-18  60-7070-006 4522220 5/2/2016 May-18  60-7070-106 4521904 5/2/2016 May-18  60-7070-106 4522415 5/2/2016 May-18  60-7070-106 4524282 5/2/2016 May-18  60-7070-106 4526057 5/2/2016 May-18  60-7070-106 4526312 5/2/2 016 May-18  60-7075-006 4521744 5/2/2016 May-18  60-7075-103 4522443 5/2/2016 May-18  60-7075-103 4523742",,,,,,,,,,,
"Food",75223,"Ongoing","Kellogg Company","425 Porter St",,"Battle Creek","MI","49014-6800","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, CT, DE, GA, IA, IL, IN, KS, MA, MD, ME, MI, MN, MO, ND, NE, NH, NJ, NY, OH, PA, VA, VT, WI, WY","F-0050-2017","Class II","Kelloggs ¿ Eggo ¿  Nutri-Grain¿ Whole Wheat Waffles  12.3 oz (10 ct) retail carton  8, 12.3 oz retail cartons per case","10,950 Cases","Potential to be contaminated with Listeria monocytogenes. ","10/07/2016",," UPC: 38000 40370    Better If Used Before Date:   NOV21 17 ER   and  NOV22 17 ER    The date code can be found on the side of the package. ",9/19/2016,"09/19/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75224,"Ongoing","Keystone Dental Inc","154 Middlesex Tpke",,"Burlington","MA","01803-4403","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy","Z-0299-2017","Class II","Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm.  Product code:15613K  Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework","55 units","Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)","10/21/2016",," Lot # 27714",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75225,"Ongoing","Pfizer Inc.","235 East 42nd Street",,"New York","NY","10017-5703","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1528-2016","Class III","PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91","1,316 bottles (1,316,000 tablets)","Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.  ","09/27/2016",," Lot  # M35953S; Exp. 11/17 (labeled).",9/15/2016,"09/15/2016",10/5/2016,"10/05/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75227,"Ongoing","Interbake Foods","3951 Westerre Pkwy Ste 200",,"Richmond","VA","23233-1312","United States","Voluntary: Firm Initiated","E-Mail","US: IA, PA, TN, WI.    OUS: CANADA","F-0942-2017","Class II","Girl Scout Peanut Butter Sandwich, NET WT 8 0Z (227 g). UPC 0 20200 07007 8, ABC Bakers/Interbake Foods LLC, Richmond, VA 23233.   ","9,537 cases","A single lot code of peanut butter used by the firm contained elevated aflatoxin levels","12/21/2016",," 07GF23X8  07GF24Z8  07GF24Y8              ",9/1/2016,"09/01/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75227,"Ongoing","Interbake Foods","3951 Westerre Pkwy Ste 200",,"Richmond","VA","23233-1312","United States","Voluntary: Firm Initiated","E-Mail","US: IA, PA, TN, WI.    OUS: CANADA","F-0943-2017","Class II","Benton's Peanut Butter filled Cookies covered in Rich Fudge, NET WT 9.5 OZ (269 g), UPC 041 498 1896 55, Distributed by ALDI INC.    Great Value, Fudge Covered Peanut Butter, 269 g, Imported for Wal-Mart Canada Corp, Product of USA, UPC 6 28915 24342 0.","22,321 cases","A single lot code of peanut butter used by the firm contained elevated aflatoxin levels","12/21/2016",," 434205217A  896505217A  896505217B  896505217C  896505227A    ",9/1/2016,"09/01/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75228,"Ongoing","Natus Medical Incorporated","5900 1st Ave S",,"Seattle","WA","98108-3248","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, ND, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, WV and Puerto Rico.  , and to the countries of :  Argentina, Austria, Canada, Chile, China, Denmark, Dominican Republic, Finland, France, Germany, Hong Kong, Hungary, Indonesia, Italy, Latvia, Malaysia, Namibia, Paraguay, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Taiwan, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Virgin Islands (British).","Z-0769-2017","Class II","Updated Natus neoBLUE blanket LED Phototherapy Systems.  It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant.    Affected systems including:    1)  Updated light boxes (serial number xxxx004283 or greater) have protection built in to turn off the device if an overheat condition is detected.    2) Updated fiberoptic blankets (Lot Nxxxx16-xx or greater) have an improved fiberoptic cable end to reduce the degradation and increase its useful life.    Affected Part Numbers and Description:    006244 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad  006254 neoBLUE blanket LED Light Box  006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad  007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR  007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR  007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK  007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK  007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS  007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS  ","713 units total (403 units in US and 310 units outside US)","The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.","12/15/2016",," *************Serial Numbers of Units distributed in the US **************    004329, 004330, 004349, 004360, 004361, 004362, 004363, 004364, 004365, 004366, 004367, 004369, 004370, 004371, 004417, 004421, 004426, 004436, 004437, 004443, 004448, 004449, 004454, 004456, 004473, 004481, 004488, 004490, 004494, 004495, 004502, 004507, 004517, 004523, 004525, 004526, 004527, 004528, 004530, 004533, 004539, 004541, 004544, 004545, 004546, 004548, 004552, 004553, 004554, 004555, 004556, 004557, 004558, 004567, 004568, 004573, 004578, 004581, 004582, 004584, 004588, 004591, 004602, 004608, 004630, 004632, 004637, 004640, 004647, 004659, 004667, 004668, 004670, 004672, 004673, 004677, 004678, 004679, 004681, 004683, 004684, 004685, 004686, 004693, 004694, 004696, 004700, 004706, 004707, 004708, 004709, 004710, 004711, 004712, 004713, 004714, 004715, 004716, 004717, 004718, 004719, 004720, 004721, 004722, 004723, 004724, 004725, 004726, 004727, 004728, 004729, 004730, 004731, 004732, 004733, 004734, 004735, 004736, 004737, 004738, 004739, 004740, 004741, 004742, 004743, 004745, 004746, 004747, 004749, 004750, 004753, 004754, 004756, 004757, 004760, 004761, 004762, 004763, 004764, 004766, 004767, 004768, 004771, 004772, 004773, 004774, 004775, 004776, 004777, 004778, 004779, 004780, 004781, 004782, 004783, 004784, 004785, 004787, 004788, 004789, 004790, 004791, 004793, 004794, 004795, 004796, 004797, 004798, 004800, 004801, 004802, 004803, 004804, 004805, 004806, 004807, 004808, 004810, 004811, 004812, 004814, 004815, 004816, 004818, 004819, 004820, 004822, 004823, 004824, 004825, 004826, 004827, 004828, 004829, 004830, 004831, 004832, 004833, 004834, 004835, 004836, 004837, 004838, 004839, 004840, 004841, 004842, 004843, 004844, 004845, 004846, 004847, 004848, 004849, 004850, 004851, 004852, 004853, 004854, 004855, 004856, 004857, 004858, 004859, 004860, 004861, 004862, 004863, 004864, 004865, 004866, 004867, 004868, 004869, 004870, 004871, 004872, 004873, 004874, 004876, 004877, 004878, 004879, 004880, 004881, 004882,",9/16/2016,"09/16/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75229,"Ongoing","Zimmer Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: MD,TX, FL, GA, VA and PA.","Z-0087-2017","Class II","Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK  Pin, Fixation, Smooth    A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture has been reduced.","22 units","The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball Tip Guide Pins and zero (0) 467255-02 Plain Tip Guide Pins or with zero (0) 467265-01 Ball Tip Guide Pins and two (2) 467255-02 Plain Tip Guide Pins.  If the G-PIN 2.8BL 3.2PL 60 CM 2PK contains the incorrect combination of Plain Tip Guide Pins and Ball Tip Guide Pins, the surgeon would either have to implant the nail without the Plain Tip Guide Pin as a guide, ream with a Plain Tip Guide Pin, or choose to not ream the humeral canal. The risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.","10/14/2016",," Item Number  467265  Lot Number  662420",8/2/2016,"08/02/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75230,"Ongoing","Leiter's Compounding","17 Great Oaks Blvd",,"San Jose","CA","95119-1359","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0017-2017","Class II","Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA ","76,315 total units, all products","Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","10/12/2016",," All unexpired lots;  Expirations dates of 10/11/2016 to 01/16/2017",9/20/2016,"09/20/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75230,"Ongoing","Leiter's Compounding","17 Great Oaks Blvd",,"San Jose","CA","95119-1359","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0013-2017","Class II","Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38","76,315 total units, all products","Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","10/12/2016",," All unexpired lots;  a) Expirations dates of 10/03/2016 to 11/06/2016 and b) 09/25/2016 to 10/01/2016",9/20/2016,"09/20/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75230,"Ongoing","Leiter's Compounding","17 Great Oaks Blvd",,"San Jose","CA","95119-1359","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0014-2017","Class II","Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water  for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35","76,315 total units, all products","Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","10/12/2016",," All unexpired lots;  Expirations dates of 10/03/2016 to 12/19/2016",9/20/2016,"09/20/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75230,"Ongoing","Leiter's Compounding","17 Great Oaks Blvd",,"San Jose","CA","95119-1359","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0015-2017","Class II","Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection  (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35","76,315 total units, all products","Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","10/12/2016",," All unexpired lots;  Expirations dates of .11/05/2016 to 12/10/2016.",9/20/2016,"09/20/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75230,"Ongoing","Leiter's Compounding","17 Great Oaks Blvd",,"San Jose","CA","95119-1359","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0018-2017","Class II","Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1  mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35","76,315 total units, all products","Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","10/12/2016",," All unexpired lots;  Expirations dates of 10/05/2016 to 01/10/2017",9/20/2016,"09/20/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75230,"Ongoing","Leiter's Compounding","17 Great Oaks Blvd",,"San Jose","CA","95119-1359","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0016-2017","Class II","Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS)  Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35","76,315 total units, all products","Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","10/12/2016",," All unexpired lots;  Expirations dates of 09/21/2016 to 2/2/2017",9/20/2016,"09/20/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75230,"Ongoing","Leiter's Compounding","17 Great Oaks Blvd",,"San Jose","CA","95119-1359","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0010-2017","Class II","Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic  Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39","76,315 total units, all products","Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","10/12/2016",," All unexpired lots;  Expirations dates of 11/13/2016 to 01/02/2017",9/20/2016,"09/20/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75230,"Ongoing","Leiter's Compounding","17 Great Oaks Blvd",,"San Jose","CA","95119-1359","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0012-2017","Class II","Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride  (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35","76,315 total units, all products","Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","10/12/2016",," All unexpired lots;  Expirations dates of 09/24/2016 to 02/06/2017",9/20/2016,"09/20/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75230,"Ongoing","Leiter's Compounding","17 Great Oaks Blvd",,"San Jose","CA","95119-1359","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0011-2017","Class II","Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35","76,315 total units, all products","Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters","10/12/2016",," All unexpired lots;  Expirations dates of .09/20/2016 to 10/10/2016",9/20/2016,"09/20/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75231,"Terminated","Inland Northwest Blood Center","210 W Cataldo Ave",,"Spokane","WA","99201-2217","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0035-2017","Class III","Blood and Blood Products for Reprocessing","1 unit"," Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.","10/18/2016","10/18/2016"," W068516400082T; ",8/25/2016,"08/25/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75232,"Terminated","BPL Plasma, Inc.","2320 E Bell Rd Ste 101",,"Phoenix","AZ","85022-2991","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0036-2017","Class III","Source Plasma","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","10/18/2016","10/18/2016"," PH0017814; ",7/8/2016,"07/08/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75233,"Terminated","DCI Biologicals Greenville, Inc","2727 E 10th St",,"Greenville","NC","27858-3127","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0037-2017","Class III","Source Plasma","1 unit","Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","10/18/2016","10/18/2016"," GL0669782; ",6/23/2016,"06/23/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75234,"Ongoing","Zimmer Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX.","Z-0084-2017","Class II","Phoenix Recon Targeting Arm  Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm    Product Usage:  The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. These instruments are used in support of the surgery.  ","31","Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm.  Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.","10/13/2016",," Item number: 14-442018  Lot number:   290610  290620  386780",8/9/2016,"08/09/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75234,"Ongoing","Zimmer Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX.","Z-0083-2017","Class II","Phoenix Recon Soft Tissue Sleeve  Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm    Product Usage:  The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. These instruments are used in support of the surgery.  ","31","Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm.  Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.","10/13/2016",," Item number: 14-442008  Lot number: 2095181",8/9/2016,"08/09/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75235,"Ongoing","Zimmer Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution to the states of :  VA, UT, TX. OR, MN, AL, PA, CA and KY.,  and to the countries of : AUSTRALIA, China, Italy, Netherlands and Japan.","Z-0003-2017","Class II","Vanguard 360 Revision Knee System  Knee prostheses","454","The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification.  As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened.    The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.","10/03/2016",," ITEM LOT DESCRIPTION  185220 262690 BMT 360 TIB AUG 59X5MM  185221 475560 BMT 360 TIB AUG 63X5MM  185222 262720 BMT 360 TIB AUG 67X5MM  185222 475570 BMT 360 TIB AUG 67X5MM  185222 524160 BMT 360 TIB AUG 67X5MM  185222 690770 BMT 360 TIB AUG 67X5MM  185223 421690 BMT 360 TIB AUG 71X5MM  185223 475580 BMT 360 TIB AUG 71X5MM  185223 475590 BMT 360 TIB AUG 71X5MM  185223 524170 BMT 360 TIB AUG 71X5MM  185224 475600 BMT 360 TIB AUG 75X5MM  185224 475610 BMT 360 TIB AUG 75X5MM  185224 524180 BMT 360 TIB AUG 75X5MM  185224 647840 BMT 360 TIB AUG 75X5MM  185224 690790 BMT 360 TIB AUG 75X5MM  185225 342740 BMT 360 TIB AUG 79X5MM  185225 421700 BMT 360 TIB AUG 79X5MM  185225 524190 BMT 360 TIB AUG 79X5MM  185225 524200 BMT 360 TIB AUG 79X5MM  185225 690800 BMT 360 TIB AUG 79X5MM  185226 647850 BMT 360 TIB AUG 83X5MM  185226 751570 BMT 360 TIB AUG 83X5MM  185228 647910 BMT 360 TIB AUG 91X5MM  185228 751420 BMT 360 TIB AUG 91X5MM  185230 524210 BMT 360 TIB AUG 59X10MM  185231 421730 BMT 360 TIB AUG 63X10MM  185231 475620 BMT 360 TIB AUG 63X10MM  185231 524220 BMT 360 TIB AUG 63X10MM  185232 377450 BMT 360 TIB AUG 67X10MM  185232 377460 BMT 360 TIB AUG 67X10MM  185232 421750 BMT 360 TIB AUG 67X10MM  185232 475630 BMT 360 TIB AUG 67X10MM  185232 524230 BMT 360 TIB AUG 67X10MM  185233 342750 BMT 360 TIB AUG 71X10MM  185233 377470 BMT 360 TIB AUG 71X10MM  185233 475640 BMT 360 TIB AUG 71X10MM  185233 524240 BMT 360 TIB AUG 71X10MM  185234 262780 BMT 360 TIB AUG 75X10MM  185234 262790 BMT 360 TIB AUG 75X10MM  185234 524250 BMT 360 TIB AUG 75X10MM  185235 421770 BMT 360 TIB AUG 79X10MM  185235 421780 BMT 360 TIB AUG 79X10MM  185237 229750 BMT 360 TIB AUG 87X10MM  185238 229760 BMT 360 TIB AUG 91X10MM  185238 262820 BMT 360 TIB AUG 91X10MM  185239 511390 BMT 360 TIB AUG BOLT 10MM  185241 148190 BMT 360 TIB AUG 63X15MM RL/LM  185242 969710 BMT 360 TIB AUG 67X15MM RL/LM  185243 377480 BMT 360 TIB AUG 71X15MM RL/LM  185247 262750 BMT 360 TIB AUG 87X15 RL/LM  185250 421790 BMT 360 TIB AUG 59X15MM LL/RM  185251 262770 BMT 360 TIB A",8/8/2016,"08/08/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75236,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0095-2017","Class III","mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA  92618, NDC 0703-4685-01.","11,214 vials","Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.  ","10/12/2016",," Lot Numbers: 31318574B, Exp 09/16; 31319610B, Exp 07/17; 31320058B, Exp 11/17; 31320497B, Exp 12/17; 31320744B, Exp 02/18  ",9/13/2016,"09/13/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75237,"Ongoing","Zimmer Biomet, Inc.","56 E Bell Dr",,"Warsaw","IN","46582-6989","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.","Z-0111-2017","Class II","Vanguard Distal Femoral Augment 75 X 5 RL/LM    Product Usage:   Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  Correction of varus, valgus, or posttraumatic deformity.  Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.  The device is a single use implant intended for implantation with bone cement.  ","5","Contents of the package do not match the product labeling.  Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM  Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM  Risks:  Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure.  As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.","10/17/2016",," Item Number  184108  Lot Number  183410  Exp. 8/27/2025",8/9/2016,"08/09/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75238,"Ongoing","KRISHNA FOOD CORP","59 Ariel Ct",,"Branchburg","NJ","08853-4233","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ, NY, PA via Retail stores and restaurants","F-0051-2017","Class I","BIKAJI Chowpati BHELPURI,  NET WT : 300 g [ 10.58 OZ ], Item No: B022, PRODUCT OF INDIA","16 cartons","FDA sample analysis revealed the presence of Salmonella contamination","10/07/2016",," BATCH NO: 2016 F 97  BEST BEFORE: JUNE 2017",9/22/2016,"09/22/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75239,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution -  USA (nationwide) Distribution.  Foreign/military/government distribution was also made.","Z-0137-2017","Class II","CADstream software.  The firm name on the label is Merge Healthcare, Hartland, WI.","844 sites potentially have the affected versions","The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display.  This may result in incorrect patient follow-up.  ","10/19/2016",," Versions prior to 5.2.9",1/30/2016,"01/30/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75240,"Ongoing","Contour Fabricators Inc","14241 N Fenton Rd",,"Fenton","MI","48430-1541","United States","Voluntary: Firm Initiated","Letter","Nationwide. Canada.  AUSTRALIA  AUSTRIA  BELGIUM  BRUNEI  CHINA  FRANCE  GERMANY  INDA  INDONESIA  ISRAEL  ITALY  KSA  MALAYSIA  NETHERLANDS  POLAND  QATAR  QUEBEC  SAUDI ARABIA   SINGAPORE  SOUTH AFRICA  TAIWAN (R.O.C.)","Z-0080-2017","Class II","Zero-Gravity Radiation Protection System  Radiology  Personnel protective shield.","447","Two customer complaints  suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise)  without allowing the cable to unwind to its normal condition may cause the cable to break  suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the  Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body  shield will fall immediately. A fall of this nature places the user, associated staff and the patient  at risk for a potential injury.","10/13/2016",," All serial numbers for all models listed below manufactured/distributed between June 28, 2010  August 25, 2016.    Part No. : Description    ZGM-6-.5H : Zero-Gravity floor unit  ZGM-6-5ROUNDH : Zero-Gravity floor unit  ZGM-6Demo  : Zero-Gravity demo floor unit  ZGCM-48 : Zero-Gravity ceiling mounted monorail with 48 boom arm  ZGCM-48-SPECIAL : Zero-Gravity ceiling mounted monorail with 48 boom arm with monorail extension  ZG48 : Zero-Gravity 48 boom arm assembly and body shield for monorail  ZGCM-66 : Zero-Gravity ceiling mounted monorail with 66 boom arm  ZGCM-HSA : Zero-Gravity ceiling mounted monorail with hinged swing arm  ZGCH : Zero-Gravity ceiling mounted monorail Contour track with 48 boom arm  ZGCH48 : Zero-Gravity 48 boom arm assembly and body shield for Contour track  ZGHSA : Zero-Gravity single point, ceiling mount with hinged swing arm  ZGCSP : Zero-Gravity single point, ceiling mount with hinged swing arm  29858 : Zero-Gravity floor unit  ",9/9/2016,"09/09/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75241,"Ongoing","Roche Diabetes Care, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","E-Mail","US Distribution to the states of :  Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin      Foreign: None provided","Z-0586-2017","Class II","Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016","7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads Internationally","Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which  could lead to an incorrect insulin bolus recommendation. ","11/16/2016",," Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000",9/14/2016,"09/14/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75242,"Ongoing","RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)","375 River Park Cir",,"Marquette","MI","49855-1781","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.","Z-0290-2017","Class II","RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L)    Product Usage:  When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.  ","66","RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline¿ OCT Straight  Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods.  The small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.  ","10/19/2016",," Part Number: 23-CC-ROD-240; Lot Number: 234829, UDI Number: (01)0084646802 7179( 10}234829; Lot Number: 246678, UDI Number: {01}00846468027179{10}246678",9/16/2016,"09/16/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75243,"Ongoing","Vascular Solutions, Inc.","6464 Sycamore Ct N",,"Maple Grove","MN","55369-6032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico and country of Italy.","Z-0053-2017","Class I","Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230.  Sterilized with Ethylene Oxide.    The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature.  The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment.  The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters.    Model 5200 also has hydrophilic coating on the distal 18cm of the catheter.    The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively.  The Twin-Pass catheter has a marker band located 1mm from the distal tip.  Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.  ","11,670 units total","Vascular Solutions is recalling Twin-Pass dual access catheters  because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. ","10/20/2016",," Model 5200, Lot numbers:    575653, 577278, 577761, 578419, 578996, 579472, 579787, 580186, 580612, 581252, 582138, 582579, 582580, 583785, 584155, 584156, 584812, 585176, 585784, 585785, 586399, 587030, 587407, 587772, 588499, 588962, 589457, 589884, 590169, 590350, 590561, 590717, 591037, 591261, 591521, 591739, 592078, 592525, 592920, 593076, 593678, 593695, 593717, 594199, 594419, 594678, 595191, 595412, 595413, 596317, 596930, 596936, 597006, 597034, 597035, 597036, 597037.  ",9/16/2016,"09/16/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75243,"Ongoing","Vascular Solutions, Inc.","6464 Sycamore Ct N",,"Maple Grove","MN","55369-6032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico and country of Italy.","Z-0054-2017","Class I","Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210.  Sterilized with Ethylene Oxide.    The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature.  The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment.  The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters.    Model 5200 also has hydrophilic coating on the distal 18cm of the catheter.    The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively.  The Twin-Pass catheter has a marker band located 1mm from the distal tip.  Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.  ","11,670 units total","Vascular Solutions is recalling Twin-Pass dual access catheters  because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. ","10/20/2016",," Model 5210, Lot number:  577762  ",9/16/2016,"09/16/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75243,"Ongoing","Vascular Solutions, Inc.","6464 Sycamore Ct N",,"Maple Grove","MN","55369-6032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution: US (nationwide) including Puerto Rico and country of Italy.","Z-0055-2017","Class I"," Dual Access Catheter, model 5230.  Sterilized with Ethylene Oxide.    The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature.  The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal segment.  The Twin-Pass catheter has a working length of 135cm and is compatible with various guidewire diameters.    Model 5200 also has hydrophilic coating on the distal 18cm of the catheter.    The Twin-Pass catheter has white positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, respectively.  The Twin-Pass catheter has a marker band located 1mm from the distal tip.  Model 5200 contains a second marker band located 11mm from the distal tip to identify the distal end of the OTW lumen.  ","11,670 units total","Vascular Solutions is recalling Twin-Pass dual access catheters  because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. ","10/20/2016",," Model 5230, Lot numbers:    577279, 578997, 580613, 583021, 584463, 586310, 588542, 590739, 591262, 593696, 593985.    ",9/16/2016,"09/16/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75244,"Terminated","West TN Regional Blood Ctr, Inc dba Lifeline Blood Services","183 Sterling Farm Dr",,"Jackson","TN","38305-5727","United States","Voluntary: Firm Initiated","FAX","TN","B-0061-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit"," Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ","10/18/2016","10/18/2016"," W040816108531",9/1/2016,"09/01/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75245,"Terminated","Michigan Blood","1036 Fuller Ave Ne","PO Box 1704","Grand Rapids","MI","49503-1304","United States","Voluntary: Firm Initiated","FAX","MI","B-0064-2017","Class II","Pooled Platelets, Leukocytes Reduced","1 unit","Blood products, collected from a donor possibly at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","10/18/2016","10/18/2016"," W120616381666",8/5/2016,"08/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75245,"Terminated","Michigan Blood","1036 Fuller Ave Ne","PO Box 1704","Grand Rapids","MI","49503-1304","United States","Voluntary: Firm Initiated","FAX","MI","B-0063-2017","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","Blood products, collected from a donor possibly at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","10/18/2016","10/18/2016"," W120616125292",8/5/2016,"08/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75245,"Terminated","Michigan Blood","1036 Fuller Ave Ne","PO Box 1704","Grand Rapids","MI","49503-1304","United States","Voluntary: Firm Initiated","FAX","MI","B-0062-2017","Class II","Fresh Frozen Plasma","1 unit"," Blood products, collected from a donor possibly at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","10/18/2016","10/18/2016"," W120616125292",8/5/2016,"08/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75246,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide and Internationally","Z-0378-2017","Class II","LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.","42,519 units (total Catalog numbers)","Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.","11/09/2016",," Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #6260-9-240 - Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-244 - Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-340 - Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-440 - Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and Catalog #6260-9-444 - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11.",8/29/2016,"08/29/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75247,"Ongoing","Wells Pharmacy Network, LLC","450 US Hwy 51 Byp N",,"Dyersburg","TN","38024-3655","United States","Voluntary: Firm Initiated","Telephone","U.S.","D-0130-2017","Class III","Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network","301 pellets","Superpotent and Subpotent drugs ","11/08/2016",," Lot Number 08082016@1, BUD:  02/04/2017",9/19/2016,"09/19/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75247,"Ongoing","Wells Pharmacy Network, LLC","450 US Hwy 51 Byp N",,"Dyersburg","TN","38024-3655","United States","Voluntary: Firm Initiated","Telephone","U.S.","D-0127-2017","Class III","Testosterone Cholesterol ,100 mg Pellet,  Compounded by: Wells Pharmacy Network","1 pellet","Superpotent and Subpotent drugs ","11/08/2016",," Lot Number 06072016@5, BUD 12/04/2016",9/19/2016,"09/19/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75247,"Ongoing","Wells Pharmacy Network, LLC","450 US Hwy 51 Byp N",,"Dyersburg","TN","38024-3655","United States","Voluntary: Firm Initiated","Telephone","U.S.","D-0128-2017","Class II","Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network","358 pellets","Superpotent and Subpotent drugs ","11/08/2016",," Lot Number 08012016@2, BUD 01/28/2017",9/19/2016,"09/19/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75247,"Ongoing","Wells Pharmacy Network, LLC","450 US Hwy 51 Byp N",,"Dyersburg","TN","38024-3655","United States","Voluntary: Firm Initiated","Telephone","U.S.","D-0129-2017","Class III","Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network","322 pellets","Superpotent and Subpotent drugs ","11/08/2016",," Lot Number 08052016@3, BUD 02/01/2017",9/19/2016,"09/19/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75247,"Ongoing","Wells Pharmacy Network, LLC","450 US Hwy 51 Byp N",,"Dyersburg","TN","38024-3655","United States","Voluntary: Firm Initiated","Telephone","U.S.","D-0132-2017","Class III","Estradiol 12.5 mg Pellet,  Compounded by: Wells Pharmacy Network","353 pellets","Superpotent and Subpotent drugs ","11/08/2016",," Lot Number 08172016@9, BUD:  02/13/2017",9/19/2016,"09/19/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75247,"Ongoing","Wells Pharmacy Network, LLC","450 US Hwy 51 Byp N",,"Dyersburg","TN","38024-3655","United States","Voluntary: Firm Initiated","Telephone","U.S.","D-0126-2017","Class II","Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network","690 pellets","Superpotent and Subpotent drugs ","11/08/2016",," BUD:  10/04/2016, Lot number 04072016@40  BUD:  12/03/2016, Lot number 06162016@2  BUD:  01/07/2017, Lot number CA07112016@4",9/19/2016,"09/19/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75247,"Ongoing","Wells Pharmacy Network, LLC","450 US Hwy 51 Byp N",,"Dyersburg","TN","38024-3655","United States","Voluntary: Firm Initiated","Telephone","U.S.","D-0131-2017","Class II","Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network","318 pellets","Superpotent and Subpotent drugs ","11/08/2016",," Lot Number 08162016@5, BUD:  02/12/2017",9/19/2016,"09/19/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0787-2017","Class II","24CT Double Chocolate Cookies Net Wt. 24oz  UPC 208722004195            ","unknown","Cookies may contain metal pieces.","12/19/2016",," 08/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0778-2017","Class II","24CT Take&Bake Oatmeal Rasin Cookies Net Wt. 24oz  UPC 20873004194          ","unknown","Cookies may contain metal pieces.","12/19/2016",," 09/24/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0780-2017","Class II","24CT Take&Bake Sugar Cookies Net Wt. 24oz  UPC 208906004195          ","unknown","Cookies may contain metal pieces.","12/19/2016",," 09/24/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0772-2017","Class II","12 pack Gourmet Oatmeal Raisin Cookies Net Wt 15 oz. UPC 289784203993     24 pack Gourmet Oatmeal Raisin Cookies  Net Wt. 30 oz.  UPC 289774706992    Gourmet Oatmeal/Raisin Cookies Net Wt. 30 oz UPC 289771006996      ","unknown","Cookies may contain metal pieces.","12/19/2016",," 12 pack Gourmet Oatmeal Raisin Cookies Net Wt 15 oz. UPC 289784203993   08/29/16    24 pack Gourmet Oatmeal Raisin Cookies  Net Wt. 30 oz.  UPC 289774706992    Gourmet Oatmeal/Raisin Cookies Net Wt. 30 oz UPC 289771006996    08/29/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0771-2017","Class II","12 pack Gourmet White Choc Chunk Macadamia Cookies Net Wt. 15 oz  UPC 289783203994    Gourmet White Chocolate  Macadamia Nut Cookies Net Wt. 30 oz.  UPC  289770006997    ","unknown","Cookies may contain metal pieces.","12/19/2016",," 8/29/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0777-2017","Class II","Gourmet Chocolate Dipped Cookies  Net Wt. 46 oz UPC 269969414994              ","unknown","Cookies may contain metal pieces.","12/19/2016",," Gourmet Chocolate Dipped Cookies  Net Wt. 46 oz UPC 269969414994  08/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0774-2017","Class II","12PK Gourmet Variety Pack Cookies  15 Oz.. UPC 289786203991    24 pack Variety Cookies Net Wt. 24 oz.  UPC 208726004191          ","unknown","Cookies may contain metal pieces.","12/19/2016",," 12PK Gourmet Variety Pack Cookies  15 Oz.. UPC 289786203991 8/29/16    24 pack Variety Cookies Net Wt. 24 oz.  UPC 208726004191  8/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0770-2017","Class II","12 pack Gourmet Salted Caramel Chocolate Chunk Cookies - Net Wt.15 oz.  UPC 2897850203992 ;UPC 289785003998    ","unknown","Cookies may contain metal pieces.","12/19/2016",," 12 pack Gourmet Salted Caramel Chocolate Chunk Cookies  Net Wt.15 oz.UPC 289785003998;     24 pack Gourmet Chocolate Chunk Salted Caramel Cookies- Net Wt. 30 oz  UPC 28977606991    8/14/2016;     12 pack Gourmet Salted Caramel Chocolate Chunk Cookies  Net Wt.15 oz.  UPC 289785020399;     24 pack Gourmet Chocolate Chunk Salted Caramel Cookies- Net Wt. 30 oz.  UPC 289776706990    28/29/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0782-2017","Class II","24CT Oatmeal Raisin Cookies  Net Wt. 24oz  UPC 208710004190          ","unknown","Cookies may contain metal pieces.","12/19/2016",," 08/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0775-2017","Class II","Kid's Rainbow Sprinkled Cookie Platter 4 lb 14 oz UPC 269935316994                ","unknown","Cookies may contain metal pieces.","12/19/2016",," Kid's Rainbow Sprinkled Cookie Platter 4 lb 14 oz UPC 269935316994  08/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0785-2017","Class II","24CT Candy Cookies Net Wt. 24oz  UPC 208713004197          ","unknown","Cookies may contain metal pieces.","12/19/2016",," 08/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0769-2017","Class II","12 Gourmet Variety Pack Cookies - Net Wt. 15 oz  UPC 289786003997    Gourmet Variety Pack Cookies Net Wt. 30 oz   UPC 289772006995    ","unknown","Cookies may contain metal pieces.","12/19/2016",," 8/14/2016",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0781-2017","Class II","24CT Take&Bake Party Candy Cookies Net Wt. 24oz  UPC 208902004199            ","unknown","Cookies may contain metal pieces.","12/19/2016",," 09/24/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0779-2017","Class II","24CT Take&Bake Chocolate Chip Cookies Net Wt. 24oz  UPC 208727004190        ","unknown","Cookies may contain metal pieces.","12/19/2016",," 09/24/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0783-2017","Class II","24CT Peanut Butter Cookies Net Wt. 24oz  UPC 208716004194          ","unknown","Cookies may contain metal pieces.","12/19/2016",," 08/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0784-2017","Class II","24CT Sugar Cookies Net Wt. 24oz  UPC  208719004191          ","unknown","Cookies may contain metal pieces.","12/19/2016",," 08/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0786-2017","Class II","24CT Chocolate Chip Cookies Net Wt. 24oz  UPC 208707004198          ","unknown","Cookies may contain metal pieces.","12/19/2016",," 08/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0773-2017","Class II","24 pack Gourmet Red Velvet Cookies  Net WT. 30 oz.    UPC 28977400000            ","unknown","Cookies may contain metal pieces.","12/19/2016",," 08/29/2016",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75248,"Ongoing","Wakefern Food Corp.","505 Division St",,"Elizabeth","NJ","07201-2038","United States","Voluntary: Firm Initiated","Letter","CT, DE, MD, PA, NY, & NJ","F-0776-2017","Class II","Dipped Chocolate Chip Cookies  Net Wt. 24 oz UPC 269954004995                ","unknown","Cookies may contain metal pieces.","12/19/2016",," Dipped Chocolate Chip Cookies  Net Wt. 24 oz UPC 269954004995  08/30/16",8/5/2016,"08/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75249,"Ongoing","Pentax of America Inc","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0757-2017","Class II","Ultrasound Video Bronchoscope   The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.","113 units","The EB-1970UK Ultrasound Video Bronchoscope shipped between the  clearance date of April 2014 and September 2015 contained the Operation and  Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not  include the cleared Operation and Reprocessing IFUs.","12/14/2016",," EB-1970UK",5/31/2016,"05/31/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75250,"Ongoing","Becton, Dickinson and Company, BD Biosciences","2350 Qume Dr",,"San Jose","CA","95131-1812","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, MN, OH and TX.","Z-0128-2017","Class II","CD79b PE (ASR) , Catalog number 335816 ;    Hematology:  The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively.    antigen","14 units","CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity","10/18/2016",," Lot number: 5348570; Expiration Date: 31 July 2017",9/21/2016,"09/21/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75252,"Ongoing","Becton Dickinson & Company","1 Becton Dr",,"Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution- US (nationwide) and countries of: Canada, Belgium, Brazil.","Z-0745-2017","Class II","BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood  Collection Set with 12 in. Tubing    Catalog # 367342    Intended for venipuncture to obtain blood specimens from patients.","1,788,150 units","BD has  received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer¿ Push Button Blood  Collection Set with 12 in. Tubing whose lots are exhibiting separation of  front and rear barrels upon activation of the safety feature, which retracts the  needle.","12/12/2016",," 5355531  5355533  5356681  5356682  6006629  6006630  6006631  6006633  6006634  6006650    ",8/8/2016,"08/08/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75255,"Ongoing","Hand Biomechanics Lab Inc","77 Scripps Dr Ste 104",,"Sacramento","CA","95825-6209","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution","Z-0136-2017","Class II","Agee-WristJack¿ Fracture Reduction System;  Item number: CFD-147.  The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery    The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box.    Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.","65 units","A number of Agee WristJack¿ Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device. ","10/18/2016",," Lot number: HBL-115-165, serial numbers 47460959 and 47460980;  Lot number: HBL-116-014 - all serial numbers;  Lot number : HBL-116-040 - 15 systems shipped prior to recall",9/14/2016,"09/14/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75256,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0402-2017","Class III","Dimension IRON Flex reagent cartridges","38,230 cartridges","Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU). ","11/11/2016",," Device Listing # D011391  Lot # DB6267, FD6309, FB6310,BA7006,BB7006,GB7060,BA7116,EC7200  Exp Date: 09/23/2016-0-7/19/2017",8/25/2016,"08/25/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75256,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0401-2017","Class III","Dimension Vista IRON Flex reagent cartridges"," 30,247 units","Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU). ","11/11/2016",," Device Listing # D011391  Lot # 15244AB, 15301BA,15345BB,16026BA,16075BB,16117BD,16166BA,16201BD  Exp Date 08-31-2016 - 07/19-2016.",8/25/2016,"08/25/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75257,"Ongoing","SenTec AG","Ringstrasse 39",,"Therwil",,,"Switzerland","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.","Z-0088-2017","Class II","SDMS (SenTec Digital Monitoring System)","75 (54 US; 21 =OUS)","Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain  circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).","10/17/2016",," SN 306497 to SN 306571.",9/15/2016,"09/15/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75258,"Terminated","DCI Biologicals Greenville, Inc","2727 E 10th St",,"Greenville","NC","27858-3127","United States","Voluntary: Firm Initiated","E-Mail","NC","B-0065-2017","Class III","Source Plasma","1 unit"," Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","10/18/2016","10/18/2016"," GL0671345",9/22/2016,"09/22/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75259,"Terminated","BPL Plasma, Inc. ","3744 Blanding Blvd",,"Jacksonville","FL","32210-5243","United States","Voluntary: Firm Initiated","E-Mail","NC; United Kingdom","B-0066-2017","Class II","Source Plasma","49 units"," Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","10/26/2016","10/26/2016"," JK0587577; JK0589068; JK0589994; JK0591789; JK0594272; JK0598131; JK0601207; JK0601904; JK0603166; JK0603908; JK0605993; JK0607245; JK0609304; JK0611430; JK0612795; JK0613994; JK0616546; JK0617018; JK0620296; JK0630908; JK0632866; JK0633646; JK0635040; JK0635952; JK0637302; JK0639548; JK0641461; JK0642274; JK0644177; JK0644858; JK0647656; JK0648445; JK0649824; JK0650489; JK0651854; JK0657461; JK0658986; JK0659552; JK0663557; JK0664722; JK0665451; JK0666796; JK0670053; JK0670478; JK0671935; JK0680144; JK0682026; JK0685077; JK0685606",7/18/2016,"07/18/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75260,"Ongoing","West-Ward Pharmaceutical","1809 Wilson Rd",,"Columbus","OH","43228-9579","United States","Voluntary: Firm Initiated","Letter","US Nationwide.","D-0008-2017","Class II","PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ  07724, NDC 0054-4741-25.","15,109 bottles","Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.","10/06/2016",," Lot # 660621A, Exp 01/31/18",10/3/2016,"10/03/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75261,"Ongoing","West-Ward Pharmaceuticals Corp.","401 Industrial Way West",,"Eatontown","NJ","07724-2209","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-1045-2017","Class II","Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01",,"Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point","11/18/2016","."," Lot #: 71294A, Exp. 5/2017",10/3/2016,"10/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75262,"Ongoing","Randox Laboratories","55 The Diamond Road",,"Antrim",,,"United Kingdom","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Distribution.","Z-0762-2017","Class II","The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.","2817","An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.","12/14/2016",," CQ5053 CQ5052",9/16/2016,"09/16/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75263,"Ongoing","Randox Laboratories, Limited","Ardmore 55 The Diamond Road",".","Crumlin",,,"United Kingdom","Voluntary: Firm Initiated","E-Mail","Nationwide Distribution The product was only distributed to US Consignees.","Z-0725-2017","Class II","Magnesium on RX Imola analyser  IVD","15","According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid wash recommended when setting up the magnesium assay. A correction was made to the IFU for the Magnesium assay and all RX Imola customers in the USA were contacted with the updated instruction. ","12/08/2016",," reagent: MG3880  analyser: RX4900  ",4/14/2016,"04/14/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75264,"Ongoing","K & P Marketplace Ltd. d.b.a Mt. Kisco Smokehouse Ltd.","520 Lexington Ave",,"Mount Kisco","NY","10549-2715","United States","Voluntary: Firm Initiated","Press Release","CT & NY via retail stores","F-0211-2017","Class I","ATLANTIC Smoked SALMON Whole, Net Wt. 8 OZ (225.89), Keep Refrigerated 38¿F or Below","158 units","Environmental samples collected by the Food and Drug Administration revealed the presence of Listeria monocytogenes which has the potential to contaminate food products.   ","10/20/2016",," lot # 13723516 USE BY 09 12 16  lot # 12125316 USE BY 09 30 16  ",9/26/2016,"09/26/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75264,"Ongoing","K & P Marketplace Ltd. d.b.a Mt. Kisco Smokehouse Ltd.","520 Lexington Ave",,"Mount Kisco","NY","10549-2715","United States","Voluntary: Firm Initiated","Press Release","CT & NY via retail stores","F-0210-2017","Class I","Sliced - Smoked ATLANTIC SALMON, Net Wt. 8 OZ (225.89), Keep Refrigerated 38¿F or Below","952  units","Environmental samples collected by the Food and Drug Administration revealed the presence of Listeria monocytogenes which has the potential to contaminate food products.   ","10/20/2016",," lot # 12125116 USE BY 09 28 16  lot # 12125216 USE BY 09 29 16  lot # 11325716 USE BY 10 03 16  lot # 11325816 USE BY 10 05 16  ",9/26/2016,"09/26/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75265,"Ongoing","TEM Systems Inc","3210 E Nc Hwy 54",,"Durham","NC","27709","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.","Z-0302-2017","Class II","ex-TEM Assay for ROTEM delta Thromboelastometry System.  Art. no.: 503-05 US, ex-tem.    Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.  ","637 boxes x 10 vials","Customers complained of low/empty reagent vials.","10/23/2016",," Lot No. 21929007",9/13/2016,"09/13/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75267,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI.","Z-0614-2017","Class II","Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31.  Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k) are used and that digitized secondary captures of these images are not viewed for assisting in diagnosis, utilization of thirdparty electronic orthopedic templates, the display of Standard Uptake Value, recording voice reports using third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data    The application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2D and reconstructed 3D radiological images using Webenabled viewers over both local and wide area networks. The application provides workflow integration capabilities for health care enterprises, wherein:  ¿ Radiologists can view, annotate, and tag studies as diagnostically Read.  ¿ Referring physicians can view patient images and radiologists annotations.  ¿ Tertiary care physicians, medical technologists, and information technology professionals can receive patient records.  ","29","It was reported by a customer  that RadSuite images are not appearing as readable images.     This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray).  ","11/18/2016","."," RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31",7/14/2016,"07/14/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75268,"Ongoing","Guardian Pharmacy Services","7920 Elmbrook Dr Ste 108",,"Dallas","TX","75247-4933","United States","Voluntary: Firm Initiated","Telephone","Two medical facilities in TX","D-0211-2017","Class I","Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only ","180 syringes","Non-Sterility: failed sterility test result.","12/22/2016",," Lot #: 50699:00, Exp 10/04/16",9/23/2016,"09/23/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75269,"Ongoing","Pure Ghee, Inc.","6018 Big Wheeling Creek Rd",,"Wheeling","WV","26003-7277","United States","Voluntary: Firm Initiated","E-Mail","The product was distributed in NJ and NY","F-0086-2017","Class II"," COW GHEE, Ingredients: 100% clarified butter","347 Cases","PURE GHEE, INC. VOLUNTARY RECALLS VRINDAVAN COW GHEE DUE TO AN UNDECLARED MILK ALLERGEN","10/12/2016",," CODE:      2 fl. oz.          (UPC #753642000999)  8 fl. oz.          (UPC #753642001002)  16 fl. oz.        (UPC #753642001002)  32 fl. oz.        (UPC #753642001019)  64 fl. oz.        (UPC #753642001033)  128 fl. oz.      (UPC #753642001040)    ",9/8/2016,"09/08/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75270,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",".","Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US: Nationwide including DC, GU, PR and Internationally to Canada, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark,  Ecuador, Estonia, Finland, France, Germany, Greece, Guatemala, hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.","Z-0707-2017","Class II","Merge, eFilm Workstation and eFilm Lite   eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians","2163","A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct. The .cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on Pixel Spacing.","12/05/2016",," EFilm Workstation and eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1.",10/20/2016,"10/20/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75271,"Ongoing","Maquet Cardiovascular Us Sales, Llc","45 Barbour Pond Dr",,"Wayne","NJ","07470-2094","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide","Z-0348-2017","Class II","Heater Cooler Unit    Usage:  The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.  ","305 units ","There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species. ","11/02/2016",," HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371  HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653  HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718  All serial numbers are affected.  ",9/27/2016,"09/27/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0258-2017","Class II","Cerovite Liquid, 8 oz./236 mL, OTC Non-Sterile.  Dietary supplement.","129,268 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 005362790590; Lot No. 20471516, 20471517, 20471518, 20471519, & 20471520, Exp. Date 11/2017; Lot No. 20471521, Exp. Date 12/2017; Lot No. 20471601, Exp. Date 01/2018; Lot No. 20471608, Exp. Date 04/2018; Lot No. 20471610 & 20471613, Exp. Date 05/2018; Lot No. 20471614, Exp. Date 06/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0266-2017","Class II","Poly-Vita Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.","42,984 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 0904-5099-50; Lot No. 20701509 & 20701511, Exp. Date 09/2017; Lot No. 20701513, Exp. Date 12/2017; Lot No. 20701601, Exp. Date 02/2018; Lot No. 20701602 & 20701603, Exp. Date 04/2018; Lot No. 20701606, Exp. Date 06/2016.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0256-2017","Class II","Calcionate Syrup, Calcium Glubionate Syrup, 16 oz./473 mL, OTC Non-Sterile.  Dietary supplement.","6,048 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 005362770851, Exp. Date 06/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0275-2017","Class II","Renew HC, Hydrolyzed Clinoptilolite, 1 oz./30 mL, OTC Non-Sterile.  Dietary supplement.","62,228 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," Lot No. 30161601, Exp. Date 01/2018; Lot No. 30161602 & 30161603.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0271-2017","Class II","Pedia Tri-Vite Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.","8,712 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 76518-020-50, Lot No. 20731506, Exp. Date 08/2017; Lot No. 20731508, Exp. Date 11/2017.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0259-2017","Class II","Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile.  Dietary supplement.","75,972 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 005360650858; Lot No. 22461511 & 22461512, Exp. Date 10/2017; Lot No. 22461513 & 22461514, Exp. Date 11/2017; Lot No. 22461515 & 22461516, Exp. Date 12/2017; Lot No. 22461601 & 22461602, Exp. Date 02/2018; Lot No. 22461603 & 22461604, Exp. Date 04/2018; Lot No. 22461605 & 22461606, Exp. Date 05/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0262-2017","Class II","Polyvitamin Liquid, 50 mL, OTC Non-Sterile.  Dietary supplement.","188,640 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 005368450801; Lot No. 20701511, Exp. Date 09/2018; Lot No. 20701514, Exp. Date 12/2017; Lot No. 20701605, Exp. Date 05/2018; Lot No. 20701606, Exp. Date 06/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0257-2017","Class II","D3 Vitamin Liquid, 50 mL, OTC Non-Sterile.  Dietary supplement.","229,464 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 005368400806; Lot No. 20691509, Exp. Date11/2017; Lot No. 20691601, Exp. Date 01/2018; Lot No. 20691602, Exp. Date 02/2018; Lot No. 20691604, Exp. Date 05/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0254-2017","Class II","Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.","34,612 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 69543-367-16; Lot No. 28601502, Exp. Date 11/2017; Lot No. 28601601, Exp. Date 01/2018; Lot No. 28601602, Exp. Date 03/2018; Lot No. 28601603, Exp. Date 06/2018; Lot No. 28601604, Exp. Date 06/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0270-2017","Class II","Tri-Vita Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.","23,736 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 0904-6274-50; Lot No. 20731506, Exp. Date 08/20107; Lot No. 20731507, Exp. Date 11/2017; Lot No. 20731604 & 20731605, Exp. Date 06/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0265-2017","Class II","CertaVite with Antioxidants, 8 oz./236 mL, OTC Non-Sterile.   Dietary supplement.","110,136 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 0904-5023-09; Lot No. 20471602, Exp. Date 01/2018; Lot No. 20471603 & 20471604, Exp. Date 02/2018; Lot No. 20471605 & 20171606, Exp. Date 03/2018; Lot No. 20471607, Exp. Date 04/2018; Lot No. 20471609, 20471611& 20471612, Exp. Date 05/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0260-2017","Class II","Fer-Iron Liquid, 50 mL, OTC Non-Sterile.  Dietary supplement.","99,024 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 005360710804; Lot No. 20901507, Exp. Date 07/2017; Lot No. 20901507, Exp. Date 11/2017; Lot No. 20901603, Exp. Date 05/2018",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0261-2017","Class II","Polyvitamin Liquid with Iron, 50 mL, OTC Non-Sterile.  Dietary supplement.","201,784 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 005360710801; Lot No. 21021510, Exp. Date 07/2017; Lot No. 21021601, Exp. Date 01/2018; Lot No. 21021602, Exp. Date 02/2018; Lot No. 21021604, Exp. Date 05/2016.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0272-2017","Class II","Pedia Tri-Vite Drops with Iron, 50 mL, OTC Non-Sterile.  Dietary supplement.","6,024 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 76518-040-50, Lot No. 21021511, Exp. Date 11/2017.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0269-2017","Class II","Ferrous Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.","31,224 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 0904-6060-50; Lot No. 20901509 & 20901510, Exp. Date 11/2017; Lot No. 20901601, Exp. Date 02/2018; Lot No. 20901602, Exp. Date 03/2018; Lot No. 20901603, Exp. Date 05/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0274-2017","Class II","Pedia D-Vite Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.","5,040 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 76518-050-50; Lot No. 20691509, Exp. Date 11/2017",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0264-2017","Class II","Liquid Vitamin C, 4 oz./118 mL, OTC Non-Sterile.   Dietary supplement.","48,024 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 005360160975; Lot No. 20331510 & 20331511, Exp. Date 12/2017; Lot No. 20331601 & 20331602, Exp. Date 03/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0273-2017","Class II","Pedia Poly-Vite Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.","6,600 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 76518-030-50; Lot No. 20701512, Exp. Date 11/2017.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0268-2017","Class II","D-Vita Drops, 50 mL, OTC Non-Sterile.  Dietary supplement.","90,504 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 0904-6273-50; Lot No. 20691509, Exp. Date 11/2017; Lot No. 20691510, Exp. Date 12/2017; Lot No. 206916603, Exp. Date 03/2018; Lot No. 20691605, Exp. Date 04/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0276-2017","Class II","CytoDetox, Hydrolyzed Clinoptilolite Fragments, 1 oz./30 mL, OTC Non-Sterile.  Dietary supplement.","1,990 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 632687615989; Lot No. 30661601, Exp. Date 05/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0263-2017","Class II","Tri-Vitamin, 50 mL, OTC Non-Sterile.  Dietary supplement.","105,456 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," UPC No. 005368501800; Lot No. 20731506, Exp. Date 08/2017; Lot No. 20731603, Exp. Date 02/2018; Lot No. 20731604, Exp. Date 06/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0267-2017","Class II","Poly-Vita Drops with Iron, 50 mL, OTC Non-Sterile.  Dietary supplement.","47,525 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 0904-5100-50; Lot No. 21021510, Exp. Date 07/2017; Lot No. 21021601, Exp. Date 01/2018; Lot No. 21021602, Exp. Date 02/2016; Lot No. 21021603, Exp. Date 04/2018; Lot No. 21021604, Exp. Date 05/2018.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75272,"Ongoing","Pharmatech LLC","4131 SW 47th Ave Ste 1403",,"Davie","FL","33314-4036","United States","Voluntary: Firm Initiated","Letter","FL, MI, MS, and OH.","F-0255-2017","Class II","Virtrate-K, Potassium Citrate and Citric Acid, 16oz./473 mL, OTC Non-Sterile.  Dietary supplement.","8,232 bottles","Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.","10/25/2016",," NDC No. 69543-262-16; Lot No. 28891502, Exp. Date 12/2017; Lot No. 28891503, Exp. Date 12/2017.",8/8/2016,"08/08/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75273,"Ongoing","Surgical Specialties Mexico S DE RL DE CV","Corredor Tijuana - Rosarito 2000-24702 B","Ejido Francisco Villa","Tijuana",,,"Mexico","Voluntary: Firm Initiated","Letter","US: OH, PA, CO, MA, DE, CA, NY, VA, WA, NJ, CT, FL, TX, NH, ID, OK, AZ, GA, PA, NV, VT.    Worldwide: Spain, Italy, United Kingdom, Portugal, Turkey, Germany, Denmark,","Z-0068-2017","Class II","BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.","512 boxes (2560 units)","Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.","10/11/2016",," MAWX380, MAZD460, MAZR350, MBCF540",9/24/2016,"09/24/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75274,"Ongoing","Banyan Medical, LLC","89 Bellows St",,"Warwick","RI","02888-1503","United States","Voluntary: Firm Initiated","Letter","IN, TN","Z-0075-2017","Class II","Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/  Sideport. Laproscopic Use- Sterile Single Use Only  Product Code 400-009","64 boxes of 5","Potential lack of assurance of sterility","10/13/2016",," Lot Numbers:140718, 160209",9/7/2016,"09/07/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75274,"Ongoing","Banyan Medical, LLC","89 Bellows St",,"Warwick","RI","02888-1503","United States","Voluntary: Firm Initiated","Letter","IN, TN","Z-0074-2017","Class II","Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula.  For Laproscopic Use- Sterile Single Use Only.  Product Code 400-008 ","19 boxes of 5","Potential lack of assurance of sterility","10/13/2016",," Lot Numbers: 140310, 140806",9/7/2016,"09/07/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75275,"Terminated","Community Blood Bank of Erie County","2646 Peach St",,"Erie","PA","16508-1823","United States","Voluntary: Firm Initiated","Letter","PA","B-0106-2017","Class II","Apheresis Platelets, Leukocytes Reduced","2 units"," Blood products, which did not meet the acceptable product specifications, were distributed.","10/27/2016","10/27/2016"," W045616005396-Part 1; W045616005396- Part 2 ",9/15/2016,"09/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75276,"Terminated","BPL Plasma, Inc. (Hot Springs)","630 Malvern Ave",,"Hot Springs","AR","71901-5432","United States","Voluntary: Firm Initiated","E-Mail","NC","B-0107-2017","Class III","Source Plasma","1 unit"," Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","10/27/2016","10/27/2016"," HS0437277",9/23/2016,"09/23/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75277,"Ongoing","Del Monte Research Center - Walnut Creek","205 N Wiget Ln",,"Walnut Creek","CA","94598-2403","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US distribution only to AL, AR, CO, IL, MD, MO, MS, FL, GA, KS, KY, LA, OK, PA, NC, SC, TN, TX, UT, VA, WI, WV.","F-0212-2017","Class I","Cut Green Beans packed under brand names of:    Allens Cut Green Beans (Ejotes Cortados Lago Azul)  Blue Lake .  Allens Cracker Barrel Label (Both labels have same UPC # - different sodium content - 140 mg  for Allens Cut Green Beans and 250 for Cracker Barrel label  Peso Neto: 6 lbs 10 oz. (3.00 kg)  UPC 0 34700 01224 7;  Distributed by Sager Creek Vegetable Company, Siloam Springs, AR 72761-0250  USA;    Monarch Blue Lake Green Beans (De Primera, Lago Azul Ejotes Cortados, Tamano 4);  Peso Neto 6 lb. 10 oz. (3 kg)  UPC 7 58108 01041 3    Monarch Cut Green Beans mixed Sieve;  NET WT. 6 lb. 10 oz. (3.00kg);  UPC: 7 58108 01048 2  Distributed by US Foods, Inc. Rosemont, IL 60018;    SYSCO  Reliance Green Beans (Ejotes),  Cut Mix Sieve;  NET WT.  6 lb. 10 oz. (300 kg)  UPC 0 74865 12172 9  SYSCO Green Beans, Mixed & Short Cuts;  NET. WT. 6 lb. 10 oz. (3.00 kg)  UPC: 0 74865 12175 0;  Distributed by Sysco Corporation, Houston, TX    Silver Source Short Cut Green Beans;  NET WT. 6 lb. 10 oz. (3.00 kg)  UPC 8 06795 02895 9  Distributed by Performance Food Group, Richmond, VA 23238            ","15, 859 cases (6 cans per case) total, all varieties","Customer complaint of finding crawfish parts in green beans initiated this recall for approximately 15,000 cases of 106 oz. metal cans of green beans or  field peas with snaps sold under various brand names.","10/20/2016",," Lot Number  615383  Best By Date  06 01 19  ",9/23/2016,"09/23/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75277,"Ongoing","Del Monte Research Center - Walnut Creek","205 N Wiget Ln",,"Walnut Creek","CA","94598-2403","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US distribution only to AL, AR, CO, IL, MD, MO, MS, FL, GA, KS, KY, LA, OK, PA, NC, SC, TN, TX, UT, VA, WI, WV.","F-0213-2017","Class I","Allens East Texas Fair Brand, Tiny Tender Field Peas with snaps;  NET.WT. 6 lbs. 15 oz.. (3.15kg)    UPC 0 34700 623214 8  Distributed by Sager Creek Vegetable Company, Siloam Springs, AR 72761-0250  USA;  UPC 0 34700 63213 1    ","15, 859 cases (6 cans per case) total, all varieties","Customer complaint of finding crawfish parts in green beans initiated this recall for approximately 15,000 cases of 106 oz. metal cans of green beans or  field peas with snaps sold under various brand names.","10/20/2016",," Lot Number  615383  Best By Date  06 01 19  ",9/23/2016,"09/23/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75278,"Ongoing","Cadila Pharmaceuticals Limited","294, G.I.D.C. Industrial Estate",,"Ankleshwar",,,"India","Voluntary: Firm Initiated","E-Mail","According to the firm, the API distributed to two consignees in the US.  See Consignee list below.      Consignee List:    1). LLC LENS Phanna.         Russia    2). Claris  irljectable,        Ahmedabad    3). CPL. Inc, USA","D-0164-2017","Class II","Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002","6.0kg","Microbial Contamination of Non-Sterile Product","12/01/2016",," Supplied Batch, 150N004; Exp. 08/20   Supplied Batch, 150N006; Exp. 09/20",9/9/2016,"09/09/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75279,"Ongoing","Medtronic Navigation, Inc.-Littleton","300 Foster Street",,"Littleton","MA","01460-2017","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland","Z-0070-2017","Class II","Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000    Product Usage:  The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions  ","14 units","O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images","10/11/2016",," Software revisions 4.0.0, 4.0.1 and 4.0.2.  System Serial Numbers:  C0930   C0981   C0986   C1113  C1069  C1050  C1208  C1043  C1144  C1163  C1145  C1162  C1002  C1074  ",9/22/2016,"09/22/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75280,"Ongoing","McCain Foods USA","2275 Cabot Dr",,"Lisle","IL","60532-3653","United States","Voluntary: Firm Initiated","Press Release","Recalled product was distributed to direct accounts in AL, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NY, OH, TN, TX, VA, and WI","F-0433-2017","Class I","Frozen Onion Rings sold and distributed under the following private label retail brands:  1) Premium Pick 5 Mix and Match Onion Rings, NET WT 40 OZ, packaged in plastic bags;   2) Krasdale Onion Rings, NET WT 16 OZ, packaged in plastic bags;   3) Spartan Onion Rings, NET WT 20 OZ,  packaged in plastic bags;  4) Shur Fine Onion Rings, NET WT. 16 OZ,  packaged in plastic bags;  5) Kroger Onion Rings, NET WT. 20 OZ, packaged in plastic bags; and  6) Fareway Breaded Onion Rings, NET WT. 20 OZ, packaged in plastic bags.","1) 29,956 cases; 2) 1,318 cases; 3) 5,087 cases; 4) 4,313 cases; 5) 16,440 cases; 6) 2,200 cases","Product label does not declare milk.","11/15/2016",," Product manufactured after October 20, 2015 and prior to September 23, 2016 with production date codes:  V151020 through V160923.",9/23/2016,"09/23/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0284-2017","Class II","Koffee Kup Hoogie Rolls- Wheat, Sourdough, Potatoe packaged 15 oz and 15.6 and 17 oz","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0285-2017","Class II",", packaged 16 oz. 18, oz, 20 oz, 25 oz, 29 oz   ","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0288-2017","Class II","Koffee Kup Hot Dog Buns- 8 pk and 16 pk ","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0292-2017","Class II","Big Y Plain Bulkie Rolls-white packaged 15 oz and 17 oz","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0289-2017","Class II","Koffee Kup Bar-B-Que Sweet Buns- Plain, Corn, Sesame Seed and Wheat w/Oat Topping, packaged 8 oz.","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0287-2017","Class II",", packaged 20.4 oz.","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0290-2017","Class II","Market Basket Bulkie Rolls- Plain, Wheat packaged 15.6 oz","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0286-2017","Class II","Koffee Kup Sandwich Rolls- Plain, packaged 17 oz and 27 oz","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0293-2017","Class II","Big Y Plain Grinders- Enriched wheat  and Enriched White packaged 15 oz","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0282-2017","Class II","Koffee Kup  Potatoe Hamburger Buns, Plain and Seeded, 8 pk","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0283-2017","Class II","Koffee Kup Kaiser Rolls: Egg,  Plain, Corn, White, Wheat, Sesame, Seeded Poppy packaged 12, and 15 oz","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75281,"Completed","Koffee Kup Bakery Inc.","436 Riverside Ave",,"Burlington","VT","05401-1452","United States","Voluntary: Firm Initiated","Press Release","VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD, VA  and District of Columbia","F-0291-2017","Class II","Market Basket Plain Sub (Grinder) rolls- ","98,893 packages total","Baked bread products may contain foreign material-plastic pieces","11/10/2016",," Use by Dates: 9/30/16, 10/1/16, 10/2/16 or 10/3/16",9/17/2016,"09/17/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75283,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates","Z-0350-2017","Class II","TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR,   REF NUMBERS:    71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057   ","2352 units","Some Bipolar shells were manufactured with an out of specification retainer groove.","11/03/2016",," REF NUMBER 71322040  Serial Numbers:  14AM13511, 14AM13511A    REF NUMBER 71322041  Serial Numbers:  14AM21654    REF NUMBER 71322042  Serial Numbers:  13LM06353, 13MM17938, 13MM17940, 14AM01852, 14AM04660, 14AM04662, 13LM06354, 13MM17939        REF NUMBER 71322043  Serial Numbers:  13KM21801, 13LM09191, 13MM09504, 14AM01946, 14AM04663, 14BM15318, 13LM06356, 13LM09204, 13MM09507, 14AM02029, 14AM21664, 14BM15318A, 13LM06356A, 13MM02843, 14AM01855, 14AM02046, 14BM01137, 14BM19345    REF NUMBER 71322044  Serial Numbers:    13KM21825, 13LM09225, 13MM09510, 14AM02112, 14AM04670, 14BM08940A, 13KM24083, 13LM09236, 13MM09517, 14AM02118, 14AM13546, 13KM24083A, 13LM09236A, 13MM09517A, 14AM02120, 14BM01133, 13KM24084, 13MM02853, 13MM09517B, 14AM02120A, 14BM01133A, 13LM06357, 13MM02857, 13MM14125, 14AM04667, 14BM08938, 13LM06361, 13MM02857A, 13MM14135, 14AM04668, 14BM08940      REF NUMBER 71322045  Serial Numbers:    13KM17382, 13KM24087, 13MM02862A, 13MM17942, 14AM04672, 14BM08950, 13KM21826, 13LM00819, 13MM09520, 13MM17943, 14AM13549, 14BM08958,   13KM22753, 13LM09243, 13MM09520A, 13MM17943A, 14AM21666, 14BM15339, 13KM22755, 13LM09247, 13MM09523, 14AM02117, 14AM21669, 13KM24086,   13MM02862, 13MM17941, 14AM02117A,  14BM06955       REF NUMBER 71322046  Serial Numbers:    13KM17387, 13LM09274, 13LM11684, 13MM09524A, 14AM04682, 14BM15355, 13KM22756, 13LM09275, 13MM02888A, 13MM09526, 14AM13552, 14BM15358, 13KM22756A, 13LM09275A, 13MM02892, 13MM09527, 14AM21677, 14BM16787,   13KM24089, 13LM09278, 13MM02893, 13MM09991, 14AM21681, 14BM19253, 13LM00818, 13LM09281, 13MM02893A, 14AM02121, 14BM06952, 13LM00818A, 13LM11683, 13MM02897, 14AM02121A, 14BM12173, 13LM09258, 13LM11683A, 13MM09524, 14AM02124, 14BM12174       REF NUMBER 71322047  Serial Numbers:    13LM00809, 13LM00817B, 13LM11695, 13MM02901, 14AM21693, 14BM16794A, 13LM00809A, 13LM09285A, 13LM11700, 13MM02901B, 14BM12175, 14BM16795, 13LM00810, 13LM09289, 13LM14993, 13MM09528, 14BM12176, 14BM16795A, 13LM00816, 13LM09289A, 13LM15004, 13MM09529, 14BM16791, 13LM00817A,   13LM1",8/29/2016,"08/29/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75283,"Ongoing","Smith & Nephew, Inc.","1450 E Brooks Rd",,"Memphis","TN","38116-1804","United States","Voluntary: Firm Initiated","Letter","Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates","Z-0351-2017","Class II","TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR,   REF NUMBERS:    71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325052, 71325053, 71325054, 71325055, 71325057, 71372047   ","5806 units","Some Bipolar shells were manufactured with an out of specification retainer groove.","11/03/2016",," REF NUMBER 71324038  Serial Numbers:    13LM19426, 13LM19431, 14BM10263, 14BM10264    REF NUMBER 71324039  Serial Numbers:    13LM16207, 14AM08786, 14AM08786A    REF NUMBER 71324040  Serial Numbers:    13LM12963, 13LM17120, 13MM18005, 14BM00728, 14BM10265A, 14BM16804, 13LM12964, 13MM18000, 14AM02711, 14BM00729, 14BM10266, 14BM16815, 13LM16210,   13MM18001, 14AM12034, 14BM01149, 14BM10266A, 13LM17118, 13MM18003, 14BM00727, 14BM10265, 14BM10268      REF NUMBER 71324041  Serial Numbers:    13LM12870, 13LM12880, 13MM18006, 14AM02713, 14AM12043, 14BM20733, 13LM12874, 13LM17121, 14AM02712, 14AM02714, 14BM00730        REF NUMBER 71324042  Serial Numbers:    13LM14881, 13MM02907, 13MM09996, 14BM00737, 14BM06960, 14BM16819A, 13LM14881A, 13MM02907A, 13MM09998, 14BM01141, 14BM06961, 14BM16820,   13LM14883, 13MM02908, 13MM09998A, 14BM01144, 14BM14307, 14BM16822, 13LM14883A, 13MM02909, 14AM12035, 14BM03060, 14BM14318, 14BM16825,   13LM14885, 13MM02910, 14AM12042, 14BM03110, 14BM16819     REF NUMBER 71324043  Serial Numbers:    13LM17122, 13LM19387, 13MM04114, 13MM04124, 13MM08123, 14AM12038, 13LM17123, 13LM19387A, 13MM04116, 13MM04126, 13MM08124, 14AM12038A, 13LM17123A, 13LM19389, 13MM04117, 13MM04126A, 13MM08124A, 14BM00775, 13LM17124, 13MM04108, 13MM04118, 13MM08116, 13MM08126, 14BM00775A, 13LM17125, 13MM04108A, 13MM04120, 13MM08116A, 13MM09999, 14BM01146,   13LM17126, 13MM04111, 13MM04123, 13MM08118, 13MM10001, 13LM19386, 13MM04112, 13MM04123A, 13MM08121, 14AM07555       REF NUMBER 71324044  Serial Numbers:    13KM22764, 13LM00822, 13LM00828, 13LM00831, 13LM00899, 13LM00900, 13LM06362, 13LM06363, 13LM06364, 13LM17127, 13LM17128, 13LM17128A, 13LM17129, 13LM17132, 13LM17133, 13LM17134, 13LM17136, 13LM17157, 13LM17160, 13MM04130, 13MM04130A, 13MM04132, 13MM04132A, 13MM04134, 13MM04135, 13MM04136, 13MM04139, 13MM04139A, 13MM04141, 13MM10009, 14AM15528, 14AM15529, 14AM21699, 14AM21701, 14AM21704, 14AM21707, 14AM24082, 14AM24083, 14AM24084, 14AM24084A, 14AM24085, 14AM24086, 14AM24087, 14AM24088, 14AM24091, 14AM24098, 14BM040",8/29/2016,"08/29/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75284,"Ongoing","Wedgewood Village Pharmacy, Inc.","405 Heron Dr Ste 200",,"Swedesboro","NJ","08085-1749","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","V-0014-2017","Class II","Wedgewood  Pharmacy Cyclosporine 0.2%  in Corn Oil Ophthalmic Solution 15 ml Drop-Tainers, white LPDE sterile     ","62 Units","Routine sterility testing of Cyclosporine 0.2%  in Corn Oil Ophthalmic Solution 15 ml  indicated that the finished ophthalmic solution returned a positive result.","10/31/2016",," Lot # 000-00731315 Beyond Use Date 02/12/2017 CYCLOS-OPH057VC  ",9/2/2016,"09/02/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75285,"Ongoing","Waymouth Farms, Inc","5300 Boone Ave N",,"New Hope","MN","55428-4054","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AR, IA, IL, KS, LA, MN, MO, ND, NE, NY, OH, OR, SD, TX, UT, and WI.","F-0682-2017","Class II","Good Sense Trail Mix, Cranberries 'N More, Net Wt. 6 oz. (170g). Cranberries, Sunflower Nuts, Cashews, Pumpkin Seeds, Almonds, Apples.   UPC 30243-86343.","2640 packages","Good Sense Cranberries 'N More, 6 oz., may contain undeclared pecans, walnuts, wheat, milk and soy.","12/09/2016",," Freshest if Used by:  8/16/17 A 15:00 thru 8/16/17 A 23:00",9/21/2016,"09/21/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75286,"Terminated","Eversight Michigan","4889 Venture Dr",,"Ann Arbor","MI","48108-9560","United States","Voluntary: Firm Initiated","E-Mail","Pakistan; Korea, Republic Of(South)","B-0047-2017","Class II","Cornea","2 human corneas"," Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. ","10/05/2016","10/05/2016"," W403416005339; (Left and Right Corneas)",8/11/2016,"08/11/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75287,"Terminated","CSL Plasma Inc","10970 New Halls Ferry Rd",,"Saint Louis","MO","63136-4433","United States","Voluntary: Firm Initiated","Other","Illinois","B-0048-2017","Class II","Source Plasma","5 units","Blood products, collected from a donor with a history of intravenous drug use, were distributed.","10/13/2016","10/13/2016"," 10700678007; 10700650266; 10700659009; 10700662996; 10700651883 ",4/15/2016,"04/15/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75288,"Ongoing","Schaerer Medical USA Inc","675 Wilmer Ave",,"Cincinnati","OH","45226-1802","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA,  and VA    Replcement cylinders wre distributed","Z-0371-2017","Class II","The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable.        Product Usage:  The cylinders are used to lock the surgical table in place.  ","4 surgical tables with defective floor locking cylinders were distributed. Each table contains  3 cylinders for a total of 12 cylinders. "," ring which may cause the cylinder to leak. ","11/08/2016",," Lot Codes for the four (4) model 7300 Surgical Tables   TFX-1653, TFX1654, TFX1655, TFX1656",9/27/2016,"09/27/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75288,"Ongoing","Schaerer Medical USA Inc","675 Wilmer Ave",,"Cincinnati","OH","45226-1802","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA,  and VA    Replcement cylinders wre distributed","Z-0372-2017","Class II","Replacement floor locking cylinders for the Schaerer model 7300 surgical tables. Replacement cylinders are part number 85118.     Product Usage:  The cylinders are used to lock the surgical table in place.  ","10 replacement cylinders. "," ring which may cause the cylinder to leak. ","11/08/2016",," Lot code of the replacement cylinders, 2016-02-01  ",9/27/2016,"09/27/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75292,"Ongoing","Truco Enterprises, Inc","10515 King William Dr",,"Dallas","TX","75220-2410","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US","F-0326-2017","Class II","On the Border Blue Corn Tortilla Chips 7.25 oz. and 10 oz. packaged in laminated polypropylene film with windows.","11,753 cases","Possible metal fragments in corn flour.","11/04/2016",," UPC 781138730075 and 781138730105; Batch Codes - 102216CYC, 100416CYC, 100516CYC, 100916CYC, 11216CYC",9/23/2016,"09/23/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75292,"Ongoing","Truco Enterprises, Inc","10515 King William Dr",,"Dallas","TX","75220-2410","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide throughout the US","F-0325-2017","Class II","On the Border Cafe Style Tortilla Chips 18 oz. and 28 oz. packaged in laminated polypropylene film with windows.","48,808 cases","Possible metal fragments in corn flour.","11/04/2016",," UPC 781138710183 and 781138710282; Batch Codes - 092816SHA, 092916SHA, 100316SHA, 100416SHA, 100516SHA, 100316SHM, 101116SHM, 101216SHM, 101716SHM, 101816SHM, 101916SHM, 102416SHM, 102516SHM, 101116SHV, 101216SHV, 102316SHV, 092816FES, 092916FES, 100416FES",9/23/2016,"09/23/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75293,"Completed","Western Milling, LLC","31120 West Street",,"Goshen","CA","93227","United States","Voluntary: Firm Initiated","Visit","CA only.","V-0048-2017","Class I","Rumensin 1200GM Loose 50#;  50 pound poly woven bags.  Product code: 11005    Type B Medicated Feed. Important - must be mixed thoroughly into feed before use. This medicated feed is designed to be fed to dairy cattle.    Active ingredient: Monensin (as monensin Sodium) 1200 g/ton","926 bags","Preliminary findings indicate that mixing procedures were not correctly followed leading to the possibility that lot 6222 might not be completely uniform","12/21/2016",," Lot code 6222",9/16/2016,"09/16/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75294,"Ongoing","CV EAST LLC, CORNERSTONE MARION LLC","3701 S Adams St",,"Marion","IN","46953-4371","United States","Voluntary: Firm Initiated","E-Mail","Domestic: Alabama, Illinois, Kansas, Massachusetts, Mississippi, Missouri, Ohio, Vermont.","F-0481-2017","Class I","12ct Banana Nut mini muffins labeled as 12ct Lemon poppy seed mini muffins; Date code 160803 ink jet printed on top near the label.","1170 cases of Banana nut mini muffins labeled as Lemon poppy seed mini muffins","Caf¿ Valley Inc. of Marion, Indiana is voluntarily recalling cases of Banana nut mini muffins labeled as Lemon poppy seed mini muffins, because they may contain undeclared allergen walnuts.  ","11/22/2016","."," Date code 160803 ink jet printed on top near the label; #71205 12ct Banana Nut Muffin; MFM 08/03/16  time BEST BY 05/03/17; GTIN code: 10040697712050, UPC: 0 40697 71213 8  ",9/16/2016,"09/16/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75295,"Ongoing","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","1718 Northrock Ct",,"Rockford","IL","61103-1201","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0135-2017","Class III","Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only,  Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505","1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each)  ","Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.","11/10/2016",," Lot#: a) 3061779, Exp 11/16; 3071447, Exp 04/17;  b)3071789, Exp 04/17  ",9/28/2016,"09/28/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75295,"Ongoing","Mylan Institutional, Inc. (d.b.a. UDL Laboratories)","1718 Northrock Ct",,"Rockford","IL","61103-1201","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0136-2017","Class III","Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20","46,472 unit dose blister cards (10 cards of 10 tablets each)","Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.","11/10/2016",," Lot#: 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17    ",9/28/2016,"09/28/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75296,"Ongoing","Varian Medical Systems, Inc.","911 Hansen Way",,"Palo Alto","CA","94304-1028","United States","Voluntary: Firm Initiated","Letter","US Distribution and Internationally to 1 site in Canada, India and Morocco","Z-0077-2017","Class II","Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016).      The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.    ","75 devices","Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue","10/13/2016",," All Head Frame Posts and Post kits",9/13/2016,"09/13/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75297,"Ongoing","Cardinal Health 200, LLC","1500 S Waukegan Rd",,"Waukegan","IL","60085-6728","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand.","Z-0069-2017","Class II","V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.","72,076 units","Potential risk associated with corrosion demonstrated on the distraction screw surface.","10/11/2016",," 12 MM Screw Distraction with Product Code: S-0088 and etched  with Manufacturing lot number and date:     G11 07/25/2011, J11 10/27/2011, D12 04/24/2012, D12 04/24/2012, F12 06/06/2012, K12 11/06/2012, K12 11/06/2012, L12 12/12/2012, F13 06/20/2013, H13 08/26/2013, I13 09/04/2013, J13 10/29/2013, J13 10/29/2013, A14 01/03/2014, A14 01/22/2014, C14 03/06/2014, D14 04/24/2014, G14 07/31/2014, I14 09/03/2014, L14 12/16/2014, D15 04/01/2015, D15 04/01/2015, F15 06/04/2015, H15 08/11 /2015, I15 09/23/2015, K15 11/18/2015, A16 01/06/2016, B16 02/15/2016, C16 03/08/2016, D16 04/21/2016, E16 05/18/2016 and F16 06/14/2016.      Contained in sterile packages with the following packaging lot numbers and date:    979662 01/07/2011, 985463 03/08/2011, 009375 06/23/2011, 043419 10/21/2011, 064776 02/03/2012, 102167 09/11/2012, 110798 09/25/2012, 127811 12/11/2012, 859648 01/09/2014, 859649 01/09/2014, 859650 01/09/2014, 859651 01/09/2014, 862414 04/23/2014, 862415 04/23/2014, 862416 04/23/2014, 862417 04/23/2014, 862418 04/23/2014, 862419 04/23/2014, 862420 04/23/2014, 868984 02/16/2015, 868985 02/16/2015, 868986 02/16/2015, 873620 08/11/2015, 873621 08/11/2015, 873622 08/11/2015, 873623 08/11/2015, 876504 12/14/2015, 876505 12/14/2015, 876506 12/14/2015, 879271 04/04/2016, 879272 04/04/2016, 881178 06/10/2016, 881179 06/10/2016 and 881180 06/10/2016.     14MM Screw Distraction with Product Code: S-0089 and etched  with Manufacturing lot number and date:     E11 05/25/2011, G11 07/28/2011, J11 10/27/2011, C12 03/27/2012, F12 06/12/2012, G12 07/26/2012, I12 09/19/2012, I12 09/19/2012, J12 10/09/2012, J12 10/31/2012, L12 12/03/2012, L12 12/07/2012, A13 01/08/2013, G13 07/19/2013, I13 09/04/2013, J13 10/29/2013, J13 10/29/2013, A14 01/03/2014, A14 01 /22/2014, 014 04/24/2014 I, F14 06/16/2014, F14 06/16/2014, C14 03/06/2014, G14 07/24/2014, I14 09/03/2014, J14 10/17/2014, L14 12/1 6/2014, D15 04/01/2015, D15 04/01/2015, F15 06/04/2015, F15 06/02/2015, G15 07/16/2015, I15 09/15/2015, K15 11/18/2015, A16 01/06/2016, 816 02/15/2",9/23/2016,"09/23/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75298,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",,"Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","FAX","Colorado","B-0049-2017","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from donors who lived in  malarial endemic areas, were distributed.","10/11/2016","10/11/2016"," W036216750188; W036216865907",8/10/2016,"08/10/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75299,"Terminated","Biotest Pharmaceuticals","1112 N Main St",,"Gainesville","FL","32601-4372","United States","Voluntary: Firm Initiated","E-Mail","North Carolina; Kentucky; Florida","B-0050-2017","Class II","Source Plasma","4 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. ","10/11/2016","10/11/2016"," 0041680872; 0041679515; 0041679165; 0041680630",8/22/2016,"08/22/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75300,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0109-2017","Class III","PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD  21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0093-7656-56.","32,015 bottles","Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. ","10/19/2016",," Lot #: 13013.013A, Exp  04/17 ",9/22/2016,"09/22/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75300,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0111-2017","Class III","PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD  21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0093-7658-56.","5,398 bottles","Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. ","10/19/2016",," Lot #: 13010.006A, Exp  09/16; 13010.007A, Exp 05/17 ",9/22/2016,"09/22/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75300,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",,"North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0110-2017","Class III","PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD  21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0093-7657-56.","5,556 bottles","Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. ","10/19/2016",," Lot #: 13016.011A, Exp  03/17 ",9/22/2016,"09/22/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75301,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide)  Foreign:  Austria  Belgium  Bulgaria  Brazil  Chile  Cyprus  Denmark  Egypt  Finland  France  France  Germany  Greece  Hungary  Iran  Ireland  Israel  Italy  Japan  Kenya  Kuwait  Latvia  Luxembourg  Mexico  Namibia  Netherlands  Nigeria  Norway  Poland  Portugal  Romania  Saudi Arabia  Serbia  Slovakia  South Africa  Spain  Sweden  Switzerland  Turkey  United Arab Emirates  United Kingdom","Z-0889-2017","Class II","Covidien Clearify Visualization System  Item  Code: 21-345  Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens","1,293,169  systems","Product sterility is compromised due to breach of the sterile barrier","12/22/2016",," Lots beginning with:  P4J, P4K, P4L, P4M, P5A, P5B, P5C, P5D, P5E, P5F, P5G, P5H, P5J, P5K, P5L, P5M,  P6A, P6B, P6C, P6D and lots P6E0016GX,P6E0049GX, , P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, P6E0212GX",10/4/2016,"10/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75301,"Ongoing","Medtronic","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide)  Foreign:  Austria  Belgium  Bulgaria  Brazil  Chile  Cyprus  Denmark  Egypt  Finland  France  France  Germany  Greece  Hungary  Iran  Ireland  Israel  Italy  Japan  Kenya  Kuwait  Latvia  Luxembourg  Mexico  Namibia  Netherlands  Nigeria  Norway  Poland  Portugal  Romania  Saudi Arabia  Serbia  Slovakia  South Africa  Spain  Sweden  Switzerland  Turkey  United Arab Emirates  United Kingdom","Z-0890-2017","Class II","Best Practices kits containing certain production lots of Clearify Visualization System  Item  Code: 21-345  Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens","230 systems","Product sterility is compromised due to breach of the sterile barrier","12/22/2016",," Kit Parent Codes:  00Z2224  00Z2232  00Z2298  00Z2363   00Z2364   00Z2365  00Z2366   00Z2421   00Z2425  00Z2430   00Z2431   00Z2460  00Z2493    00Z2534    00Z2535    000Z2544   00Z5000B   00Z5001B   GYNKIT2                          ",10/4/2016,"10/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75302,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide  Foreign:  Canada:  Andorra  Austria  Belgium  Czech Republic  Denmark  Finland  France  Germany  Greece  Ireland  Israel  Italy  Latvia  Luxembourg  Monaco  Netherlands  Norway  Poland  Portugal  Russian Federation   Saudi Arabia  Slovenia  South Africa  Spain  Sweden  Switzerland  United Arab Emirates  United Kingdom","Z-0366-2017","Class II","Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove   Item Number                                            Description  380789003                           SURE SET SINGLE BASIN PACK  400383006                           MAJOR BASIN PACK  400383007                           MAJOR BASIN PACK  618275004                           BASIN PACK    Product  Usage:  A disposable, sterile, single-use cover for compatible surgical light handles  ","4950 units","Added Instructions for Use: After application, inspect the Light Glove for barrier integrity","11/08/2016",," All lot codes in the following:    Item Number                                            Description  380789003                           SURE SET SINGLE BASIN PACK  400383006                           MAJOR BASIN PACK  400383007                           MAJOR BASIN PACK  618275004                           BASIN PACK  ",9/29/2016,"09/29/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75302,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide  Foreign:  Canada:  Andorra  Austria  Belgium  Czech Republic  Denmark  Finland  France  Germany  Greece  Ireland  Israel  Italy  Latvia  Luxembourg  Monaco  Netherlands  Norway  Poland  Portugal  Russian Federation   Saudi Arabia  Slovenia  South Africa  Spain  Sweden  Switzerland  United Arab Emirates  United Kingdom","Z-0365-2017","Class II","Covidien Devon Light Glove sub-assembly non-sterile  For Kit Packers    Product  Usage:  A disposable, sterile, single-use cover for compatible surgical light handles  ","118,800 ","Added Instructions for Use: After application, inspect the Light Glove for barrier integrity","11/08/2016",," All lot codes in the following:  Item Number   Decription  56479 7335-SMC DELIVERY KIT  573208 7519-DHCG SURGI-START KIT  573210 7581-CSD SURGI-START KIT  573310 7417-SSC SURGI-START KIT  573326 7497-HLS MINI-PLUS KIT  573328 7437-NRF SURGI FOOTPACK ASCKIT  573343 7499-88 SURGICAL KIT  573346 7499-TLG SURGICAL KIT  573359 7499-HLW MINI-PLUS KIT  573368 7494-CAB2 SURGICAL KIT  573370 7411-SSI MINI PLUS KIT  573509 7696-GSL-VL SINGLE BASIN KIT  573529 7697-T4E SINGLE BASIN SURGI KI  573558 7665-CPB SINGLE BASIN KIT  573561 7696-KSC SINGLE BASIN KIT  573713 7553-SBT MINI-PLUS KIT  573732 7620-CWA SURGICAL ASC KIT  573741 7667-HMI SURGICAL ASC KIT  573776 7520-BHP SURGICAL ASC KITS  573777 7527-BHB SURGICAL ASC KITS  573798 7496-8KB MINI-PLUS KIT  573799 7516-UNIKB SET-UP KIT  573813 7590-GHF HAND AND FOOT PACK  773501 7692-WIW2 SURGI-START KIT  773701 7600-ESC SURGI-START KIT  31140208 3611 FLEXBL LITE GLOVE 1EA/PKG  31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG  31140257 3612 LITE GLV-FLEXIBLE 2EA/PKG  31141479 K-1842-S STD. MINI-KIT STERILE  31141487 K-1560-S3 STD. MINI KIT STER.  31141495 K-1530-S3 STANDARD MINI-KIT  31141537 K-1940-S STD. MINI KIT STER.  31141552 K-1920-S STANDARD MINI-KIT  31141560 K-1200-S3 STD MINI-KIT  31141578 K-1840-S STD. MINI KIT STER.  31141586 K-1660-S STD. MINI-KIT STER.  31141602 K-1630-S STD. MINI KIT STER.  31141610 K-1615-S STD. MINI KIT STER.  31141628 K-1614-S STD MINI-KIT  31141651 K-1560-S STD. MINI KIT STERILE  31141669 K-1530-S STD. MINI KIT  31141677 K-1200-S STD. MINI KIT  31141784 K-1960-S STANDARD MINI-KIT  31141859 K-1615-S3 STD MINI-KIT  31141875 K-1940-S3 STD. MINI-KIT STER.  31144507 7519 BUNNY KIT - GENERAL BUNNY  31144879 7815 SURGI-START KIT STERILE  31144895 7614-T4 SURGI-START KIT  31144960 7693-T4 SURGI-START KIT  31144978 7766 SURGI-START KIT  31145025 7496-8 MINI-PLUS KIT - STERILE  31145215 7896 STANDARD SURGI-START KIT  31145231 7897 STD, SURGI-START KIT  31145249 7897-T8 SURGI-START KIT STER  31145298 7896-T8 STANDARD,SURGI START  31145363 7496-88 STANDARD,M",9/29/2016,"09/29/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75302,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide  Foreign:  Canada:  Andorra  Austria  Belgium  Czech Republic  Denmark  Finland  France  Germany  Greece  Ireland  Israel  Italy  Latvia  Luxembourg  Monaco  Netherlands  Norway  Poland  Portugal  Russian Federation   Saudi Arabia  Slovenia  South Africa  Spain  Sweden  Switzerland  United Arab Emirates  United Kingdom","Z-0364-2017","Class II","Covidien Devon Light Glove packaged in sterile surgical kits  Reference: 31140208    Product  Usage:  A disposable, sterile, single-use cover for compatible surgical light handles  ","13,786,893 in total Distributed in USA","Added Instructions for Use: After application, inspect the Light Glove for barrier integrity","11/08/2016",," All lot codes in the following kits:  Item Number   Decription  56479 7335-SMC DELIVERY KIT  573208 7519-DHCG SURGI-START KIT  573210 7581-CSD SURGI-START KIT  573310 7417-SSC SURGI-START KIT  573326 7497-HLS MINI-PLUS KIT  573328 7437-NRF SURGI FOOTPACK ASCKIT  573343 7499-88 SURGICAL KIT  573346 7499-TLG SURGICAL KIT  573359 7499-HLW MINI-PLUS KIT  573368 7494-CAB2 SURGICAL KIT  573370 7411-SSI MINI PLUS KIT  573509 7696-GSL-VL SINGLE BASIN KIT  573529 7697-T4E SINGLE BASIN SURGI KI  573558 7665-CPB SINGLE BASIN KIT  573561 7696-KSC SINGLE BASIN KIT  573713 7553-SBT MINI-PLUS KIT  573732 7620-CWA SURGICAL ASC KIT  573741 7667-HMI SURGICAL ASC KIT  573776 7520-BHP SURGICAL ASC KITS  573777 7527-BHB SURGICAL ASC KITS  573798 7496-8KB MINI-PLUS KIT  573799 7516-UNIKB SET-UP KIT  573813 7590-GHF HAND AND FOOT PACK  773501 7692-WIW2 SURGI-START KIT  773701 7600-ESC SURGI-START KIT  31140208 3611 FLEXBL LITE GLOVE 1EA/PKG  31140216 3613 LITE GLV-FLEXIBLE 3EA/PKG  31140257 3612 LITE GLV-FLEXIBLE 2EA/PKG  31141479 K-1842-S STD. MINI-KIT STERILE  31141487 K-1560-S3 STD. MINI KIT STER.  31141495 K-1530-S3 STANDARD MINI-KIT  31141537 K-1940-S STD. MINI KIT STER.  31141552 K-1920-S STANDARD MINI-KIT  31141560 K-1200-S3 STD MINI-KIT  31141578 K-1840-S STD. MINI KIT STER.  31131141602 K-1630-S STD. MINI KIT STER.  31141610 K-1615-S STD. MINI KIT STER.  31141628 K-1614-S STD MINI-KIT  31141651 K-1560-S STD. MINI KIT STERILE  31141669 K-1530-S STD. MINI KIT  31141677 K-1200-S STD. MINI KIT  31141784 K-1960-S STANDARD MINI-KIT  31141859 K-1615-S3 STD MINI-KIT  31141875 K-1940-S3 STD. MINI-KIT STER.  31144507 7519 BUNNY KIT - GENERAL BUNNY  31144879 7815 SURGI-START KIT STERILE  31144895 7614-T4 SURGI-START KIT  31144960 7693-T4 SURGI-START KIT  31144978 7766 SURGI-START KIT  31145025 7496-8 MINI-PLUS KIT - STERILE  31145215 7896 STANDARD SURGI-START KIT  31145231 7897 STD, SURGI-START KIT  31145249 7897-T8 SURGI-START KIT STER  31145298 7896-T8 STANDARD,SURGI START  31145363 7496-88 STANDARD,MINI-PLUS KIT  31145397 7497-8 S",9/29/2016,"09/29/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75303,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI.  Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Portugal, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Zimbabwe.","Z-0076-2017","Class II","Monaco RTP System  The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups","365","When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.","10/13/2016",," Software Builds 5.10 and 5.20",9/29/2016,"09/29/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75304,"Completed","Dollar General Corporation ","100 Mission Rdg",,"Goodlettsville","TN","37072-2171","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","F-0177-2017","Class II","Cookies Bergen, Soft Baked Chocolate Brownie Cookies, NET WEIGHT: 4.44 OZ (126g), Produced by P.W. Sponmet Sp.l., Poland","146,455 units","Mold found in cookie product","10/18/2016",," Lot number: L1615123  Expiration Date: April 11,2017  ",9/22/2016,"09/22/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75306,"Ongoing","Pentax of America Inc","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Japan","Z-0636-2017","Class II","Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.","5,090 (US) and 14,209 (OUS)","Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).","11/19/2016","."," Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK",8/15/2016,"08/15/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75307,"Ongoing","Bob's Red Mill Natural Foods, Inc.","13521 Se Pheasant Ct",,"Milwaukie","OR","97222-1248","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Canada","F-0281-2017","Class III","    Product is packaged in multilayered flexible film with multiple colors.  Firm brand name is printed in red.    Case contains 8/8 oz. packages.    UPC 0 39978 00554 0 or  0 39978 00554 1","443 cs","The firm is voluntarily recalling one lot of Guar Gum due to due to the inclusion of a misidentified ingredient, hydroxyethylcellulose.","10/25/2016",," Cases for US - Item # 1598C088; lot 212463; Best By: 7/18/2018, GTIN # 30039978005541, UPC 039978005540.    Cases for Canada - Item # 1598C226G8CA; lot 213189, Best By: 7/18/2018, GTIN # 30039978305542, UPC 039978005541.",9/24/2016,"09/24/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75308,"Ongoing","Good Earth Egg Company","4411 Highway K",".","Bonne Terre","MO","63628-3533","United States","Voluntary: Firm Initiated","Telephone","Missouri, Kansas, and Illinois","F-0578-2017","Class I","Chicken eggs packaged in the following configurations    1) Premium Farm Fresh White Eggs, packaged in 6 count, 10 count, 12 count, and 18 count styrofoam cartons    2) Farm Fresh Eggs, packaged in 15 dozen and 30 dozen cardboard boxes."," 59,129-15 dz cases & 26,795-30dz cases","Eggs may be contaminated with Salmonella Oranienburg","12/06/2016",," Everything with a sell-by date prior to October 8, 2016",10/1/2016,"10/01/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75309,"Terminated","Soft Computer Consultants, Inc.","5400 Tech Data Dr",,"Clearwater","FL","33760-3116","United States","Voluntary: Firm Initiated","Letter","TX, WI and MN","B-0045-2017","Class II","SoftBank versions 25.3.0.3 - 25.3.0.4","7 ","Softbank Blood Bank Software, with a defect or glitch, was distributed. ","10/05/2016","10/05/2016"," Versions 25.3.0.3 - 25.3.0.4",4/28/2015,"04/28/2015",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75310,"Completed","Clear Spring Foods Specialty Products Plant Inc.","240 Clear Lakes Rd",,"Buhl","ID","83316-1814","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, CA, IA, MO, and PA  No foreign distribution  No DoD distribution","F-0718-2017","Class II","***SUN-DRIED TOMATO & ROASTED GARLIC TROUT FILLETS *** Product of USA *** CONTAINS:  FISH (TROUT), WHEAT, MILK. *** UPC 10 070765 08761 2    Individual retail packages are mostly green with information panel in white with black lettering.    Cases are 10 lbs and contain 26-29 portions (pieces)    Individual packages are 6 oz    ","4720 lbs. bulk pack - 10 lbs. case","Product recalled due to potential contamination with E. coli bacteria. ","12/14/2016",," SP-08761:317  Packed on 04/20/16;    The code is defined: the first two letters are the facility the product was processed at, the next five digits stand for the item number, the sixth digit is the day of the week, and the last two digits are the week of the year.  ",9/28/2016,"09/28/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75311,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution, Puerto Rico and Canada","Z-0672-2017","Class II","V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE:  The speakers are a part of the rear case assembly located in the back of the infusion pump.  The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.  Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump.  It is not a registered finished good.","439 units","A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely. ","11/29/2016",," Product Code 35701; distributed between 02/04/2015 - 06/02/2015.",9/28/2016,"09/28/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75311,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution, Puerto Rico and Canada","Z-0670-2017","Class II","sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE:  The speakers are a part of the rear case assembly located in the back of the infusion pump.  The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.","5,976 units (US: 5972, Canada: 4) ","A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely. ","11/29/2016",," Contact CDRH for list of affected serial numbers (5976 units)",9/28/2016,"09/28/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75311,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution, Puerto Rico and Canada","Z-0671-2017","Class II","Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library,  V8 Spectrum Infusion Pump, Product Code 35700BAX2,  Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE:  The speakers are a part of the rear case assembly located in the back of the infusion pump.  The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended. ","15,517 units (US: 9560; Canada: 5957) ","A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely. ","11/29/2016",," Contact CDRH for list of affected serial numbers (15,517).",9/28/2016,"09/28/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75312,"Ongoing","Inovo, Inc","401 Leonard Blvd N",,"Lehigh Acres","FL","33971-6302","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution to states of: AL, AR, CT, FL, IA, KS, KY, MD, MI, MN, MO, NE, NJ, NV, NY, OH, RI, SC, TN, TX, UT, and WA.","Z-0760-2017","Class II","INOVO Purefill Oxygen Compressor Model PF1100    Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders. ","117 units","Device can fail during operation.","12/14/2016",," Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843. ",7/21/2016,"07/21/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0070-2017","Class II","Trader Joes, Veggie Flaxseed Tortilla Chips, Net Wt. 12oz. (340g), Distributed and Sold by Trader Joes, Monrovia, CA 91014.","3228 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #4020, PO numbers: 78405399, 78208540, 78223406, 78223448, 78223452 and 79296976, Date codes: 11/30/2016 and 12/01/2016.",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0076-2017","Class II","RW Garcia, 3 Seed, Kale Crackers, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092, Distributed by Clean Foods, Ltd, Legion House, 75 Lower Road, Kenley, Surrey, CR8 5NH.","49 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #3082, PO numbers: B43200 and 120231, Date Code: 2/28/2017.",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0077-2017","Class II","RW Garcia, 3 Seed.Graines, Kale Crackers, Craquelins de Kale, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092, Distributed by Clean Foods, Ltd, Legion House, 75 Lower Road, Kenley, Surrey, CR8 5NH.","200 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #3086, PO numbers: RWGC140, Date Code: 4/15/2017.",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0078-2017","Class II","RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Sesame & Chia), Gluten Free, Net Wt., 30 oz., Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., San Jose, CA 95112 and Lincolnton, NC 28092.","9760 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #2165, PO numbers: 12030711428 and 2670711592, Date Code: 1/14/2017.",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0072-2017","Class II","Harris Teeter, Multigrain, Tortilla Chips, Net Wt. 12 oz. (340g), Produced by Harris Teeter, Mathews, NC 28105.","72 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #4179, PO numbers: 900947 and 900946, Date Code: 12/11/2016.",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0071-2017","Class II","Central Market, Tortilla Chips, Veggie & Seed Blend, Net Wt.; 12oz (340g), Distributed by H.E.B Central Markets, Austin, TX 78735.","848 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #4081, PO numbers: 84x738690, 84x738703, 84x738691, 84x746485 and 84x772493, Date Code: 12/01/2016.",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0074-2017","Class II","365, White Corn, Tortilla Chips, Lightly Salted, Net Wt. 16 oz. (1 lb.) 454g., Distributed by Whole Foods Market, Austin, TX 78703.","776 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #4070, PO numbers: 3624584, 3620661, 3624856 and 3633589, Date Code: 11/10/2016",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0075-2017","Class II","365, White Corn, Tortilla Chips, Unsalted, Net Wt. 16 oz. (1 lb.) 454g., Distributed by Whole Foods Market, Austin, TX 78703.","425 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #4068, PO numbers: 3624852, 3624853, 3624856, 3624851, 3624855, 3624857, 3629149, Date Code: 11/12/2016.",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0079-2017","Class II","RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Black & White sesame Seeds), Gluten Free, Net Wt., 180g and 850g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., San Jose, CA 95112 and Lincolnton, NC 28092.","4700 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #3085, PO numbers: RWGC138 and RWGC138, Date Code: 03/18/2017 and 4/15/2017 and Item #3089, PO number: 119-6930-443, Date Code: 4/12/2017.",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75313,"Ongoing","R.W.Garcia Co., Inc.","3181 Progress Dr",,"Lincolnton","NC","28092-5203","United States","Voluntary: Firm Initiated","E-Mail","Consignees were notified via email on 09/25/2016.","F-0073-2017","Class II","365, Lightly Salted Tortilla Chips, Multigrain, Net Wt. 16oz. (1 lb.) 454g, Distributed by Whole Foods Market, Austin, TX 78703.","143 cases","Foreign material (metal fragments) detected in raw material.","10/11/2016",," Item #4059, PO numbers: 3611086, 3611089, 36234584, 3620661 and 3624765, Date Code: 11/12/2016.",9/25/2016,"09/25/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75314,"Terminated","LifeSouth Community Blood Centers, Inc.","4891 Ashford Dunwoody Rd",,"Dunwoody","GA","30338-4894","United States","Voluntary: Firm Initiated","FAX","Georgia","B-0051-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Apheresis product, in which platelet yield did not meet specifications, was distributed.","10/11/2016","10/11/2016"," W1151162367803",9/5/2016,"09/05/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75315,"Terminated","LifeSouth Community Blood Centers, Inc.","1221 NW 13th St",,"Gainesville","FL","32601-4111","United States","Voluntary: Firm Initiated","FAX","Alabama","B-0052-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Apheresis product, in which platelet yield did not meet specifications, was distributed.","10/11/2016","10/11/2016"," W115116227035B",8/27/2016,"08/27/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75322,"Ongoing","Angiodynamics Inc. (Navilyst Medical Inc.)","10 Glens Falls Tech Park",".","Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.","Z-0710-2017","Class II","BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019  The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media","200 packages (boxes of 5)","Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.","12/05/2016",," Batch/Lot: 5018263, 5020646, 5046472, 5051539  ",8/29/2016,"08/29/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75322,"Ongoing","Angiodynamics Inc. (Navilyst Medical Inc.)","10 Glens Falls Tech Park",".","Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.","Z-0708-2017","Class II","Xcela Power Injectable PICC Maximal Barrier Nursing Kit  The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media","75 packages (boxes of 5)","Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.","12/05/2016",," Batch/Lot: 505722, 5056512",8/29/2016,"08/29/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75322,"Ongoing","Angiodynamics Inc. (Navilyst Medical Inc.)","10 Glens Falls Tech Park",".","Glens Falls","NY","12801-3864","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.","Z-0709-2017","Class II","BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit -   1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468  The BioFlo PICCs with ENDEXO Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media","153 packages (boxes of 5)","Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.","12/05/2016",," Batch/Lot: 1) 5018265, 2) 5024787, 3) 5021872, 4) 5020644, 5) 5026458,  6) 5026468",8/29/2016,"08/29/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75324,"Ongoing","Bausch & Lomb Inc Irb","1400 Goodman St N",,"Rochester","NY","14609-3547","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-U.S. Nationwide and country of: Canada.","Z-0651-2017","Class II","PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609.    PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.","4,652,822 units","Product was found to contain excess residual levels of hydrogen peroxide.","11/21/2016","."," Item #623815, UPC: 310119038154, Lot number: GE15012ST, Lot Exp. Date: 2016/11/30, Lot number: GF15055ST, Lot Exp. Date: 2016/12/31, Lot numbers: GH15053R, GH15056-1, GH15067ST, GH15070ST, GH15076ST, GH15081ST and   GH15086-1, Lot Exp. Date: 2017/02/28, Lot numbers: GK15116ST, GK15118A1, Lot Exp. Date: 2017/04/30, Lot numbers: GL15148-1 and GL15148-2, Lot Exp. Date: 2017/05/31, Lot number: GC16080-1, Lot Exp. Date: 2017/09/30 and 623815C (3 oz.), Lot numbers: GE16060A1 and GE16066-1, Lot Exp. Date: 2017/11/30; Item #623816 (12oz.), UPC 310119038161, Lot numbers: GC15002ST, GC15008ST, GC15008ST1 and GC15012AST, Lot Exp Date: 2016/09/30, Lot numbers: GD15100ST1, GD15115AST, GD15124ST and GD15124ST2, Lot Exp Date: 2016/10/31, Lot numbers: GE15132ST and GE15156ST, Lot Exp Date: 2016/11/30, Lot numbers: GF15110ST and GF15110ST1, Lot Exp Date: 2016/12/31, Lot numbers: GG15023STR, GG15038ST and GG15044ST, Lot Exp Date: 2017/01/31, Lot numbers: GH15036ST, GH15039ST, GH15045ST and GH15128ST, Lot Exp Date: 2017/02/28, Lot numbers: GJ15070ST and GJ15081ST, Lot Exp Date: 2017/03/31, Lot numbers: GK15129ST and GK15131ST, Lot Exp Date: GL15004STR, GL15012ST and GL15048ST, Lot Exp Date: 2017/05/31, Lot numbers: GM15027AST, GM15034ST, GM15041ST and GM15044ST, Lot Exp Date: 2017/06/30, Lot numbers: GA16023ST1, GA16052ST and GA16056ST, Lot Exp Date: 2017/07/31, Lot numbers: GC16035ST, GC16044ST and GC16060ST, Lot Exp Date: 2017/09/30, Lot numbers: GE16001ST, GE16004ST, GE16009ST and GE16009ST1, Lot Exp Date: 2017/11/30, Lot numbers: GF16087ST and GF16087ST1, Lot Exp Date: 2017/12/31, Lot number: GG16003ST, Lot Exp Date: 2018/01/31 and 623816B, UPC 310119038161, Lot number:  GG16116ST, Lot Exp Date: 2017/10/31; Item #623817 (12 oz. Twin Pack), UPC 310119038178, Lot number: GC15026ST, Lot Exp Date: 2016/09/30, Lot numbers: GD15095ST, Lot Exp Date: 2016/10/31, Lot numbers: GE15131ST, GE15133ST, GE15149ST and GE15161AST, Lot Exp Date: 2016/11/30, Lot number: GF15107ST1, Lot Exp Date: 2016/12/31, Lot numbers: GG15002STR and GG15037",9/19/2016,"09/19/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75325,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",,"Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","FAX","CO","B-0104-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit"," Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.","10/27/2016","10/27/2016"," W036216714484",9/23/2016,"09/23/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75326,"Terminated","American National Red Cross The","100 Red Cross Cir",,"Pomona","CA","91768-2580","United States","Voluntary: Firm Initiated","Telephone","CA","B-0105-2017","Class II","Plasma Frozen within 24 hours (FP24)","1 unit"," Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","10/27/2016","10/27/2016"," W200616115539",8/24/2016,"08/24/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75327,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","New York","B-0046-2017","Class II","Plasma Frozen within 24 hours (FP24)","1 unit"," Blood products, collected from an ineligible donor, were distributed. ","10/05/2016","10/05/2016"," W039516008180; ",8/15/2016,"08/15/2016",10/12/2016,"10/12/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75328,"Terminated","American National Red Cross (The)","6230 Claremont Ave",,"Oakland","CA","94618-1324","United States","Voluntary: Firm Initiated","FAX","CA","B-0103-2017","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit"," Blood product, which did not meet acceptable product specifications, was distributed.","10/27/2016","10/27/2016"," W2084168627132",8/7/2016,"08/07/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75330,"Ongoing","GE OEC Medical Systems, Inc","384 N Wright Brothers Dr",,"Salt Lake City","UT","84116-2862","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide  in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.","Z-0071-2017","Class II","OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance    Product Usage:  The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.  ","148 total","GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command. ","10/11/2016",," GE Brivo OEC715: Serial Numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051    GE Brivo OEC785: Serial Numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152    GE Brivo OEC865: Serial Numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029",9/23/2016,"09/23/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75331,"Ongoing","Fresh Express Incorpated","4757 The Grove Dr",,"Windermere","FL","34786-8426","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, FL, GA, NC, SC & TN","F-0146-2017","Class I","Fresh Express American Salad, 11 oz., Product Code G264A12B, Use-By Date OCT 05  ","480 cases/6 bags (2880 bags)","Fresh Express American had inadvertently inserted incorrect condiment kits in some bags.","10/14/2016",," G264A12B",9/29/2016,"09/29/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75332,"Ongoing","Pentax of America Inc","3 Paragon Dr",,"Montvale","NJ","07645-1782","United States","Voluntary: Firm Initiated","Letter","US Nationwide and Japan","Z-0318-2017","Class II","Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.","3,436 (US) and 14,488 (OUS)","Pentax is initiating the product removal of several model numbers of Pentax's Gastroscopes that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).","10/26/2016",," EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK",8/15/2016,"08/15/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75334,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide Distribution","Z-0664-2017","Class II","Merge FlexConnect software, a component of Merge LIS.  Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications","324 sites potentially have the affected version","Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.","11/28/2016",," Version 1.0",1/30/2016,"01/30/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75335,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0009-2017","Class III","Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.","648 cartons","Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.","10/11/2016",," Lot 154341, Exp 03/17",9/30/2016,"09/30/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75336,"Ongoing","Hamilton Medical, Inc.","4990 Energy Way",,"Reno","NV","89502-4123","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0666-2017","Class II","Hamilton-MR1 Ventilator: Catalog# 161010   The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.","44 units","Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation. ","11/28/2016",," Serial Numbers between 2001 and 2103",9/26/2016,"09/26/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75337,"Ongoing","Alphatec Spine, Inc.","5830 El Camino Real",,"Carlsbad","CA","92008-8816","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.","Z-0592-2017","Class II","Arsenal Spinal Fixation System, Set Screw, Part No. 47127  Product Usage:  Usage:  The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).   ","16,972 units","Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.","11/16/2016",," Lot Numbers  695621   696252   697128   698437   700943   7689801  695622   696253   697129   698438   700944   7689802  695623   696254   697130   698439   700945   7689803  695624   696255   697131   698440   701393   7689804  695625   696256   697520   698441   701394   695626   696257   697521   698442   701395   695627   696258   697522   700611   701396   696124   696558   697523   700612   701397   696125   696574   697524   700613   701398  696126   696575   698433   700614   701399  696127   696576   698434   700615   701400  696128   696577   698435   700941   701401  696251   697127   698436   700942   701851  7878901  7829602  7766302  7766301",10/5/2016,"10/05/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75339,"Terminated","LifeSouth Community Blood Centers Inc","8190 Madison Blvd",,"Madison","AL","35758","United States","Voluntary: Firm Initiated","FAX","AL","B-0109-2017","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","1 unit"," Blood product, with a low platelet count, was distributed.","10/27/2016","10/27/2016"," W1151161994455",9/3/2016,"09/03/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75340,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","4139 Carmichael Rd",,"Montgomery","AL","36106-2803","United States","Voluntary: Firm Initiated","E-Mail","Alabama","B-0053-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood product, which did not meet acceptable product specifications, was distributed.","10/18/2016","10/18/2016"," W1151161485891; ",9/12/2016,"09/12/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75341,"Terminated","Hoxworth Blood Center","3130 Highland Ave",,"Cincinnati","OH","45267-0001","United States","Voluntary: Firm Initiated","Letter","Ohio","B-0054-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Blood product, which did not meet the acceptable product specifications for release, was distributed.","10/18/2016","10/18/2016"," W037716033123; ",6/30/2016,"06/30/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0482-2017","Class III","Simeons Program. 2oz HCG Drops. Amber Plastic.","40 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: IC0104B; IC0116N  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0484-2017","Class III","Natural Protocols. 2oz HCG Drops. Amber Glass","40 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: HC0815B; IC1215L-MW",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0497-2017","Class III","Original HCG. 2oz HCG Drops. Amber Glass  ","4,900 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: D051612; D061619; IC0116K; IC0116M  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0488-2017","Class III","Supervision Weightloss. 2oz HCG Drops. Amber Glass  ","200 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: IC0216B; IC0216Q-TH; IC0615J; IC1015X-MW  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0491-2017","Class III","Believe HCG. 2oz HCG Drops. Blue Glass.","100 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lot: IC0216X  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0500-2017","Class III","Slim Life. 2oz HCG Drops. Blue Plastic","440 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lot: IC0104B        ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0498-2017","Class III","Slimming Herbs. 2oz HCG Drops. Amber Glass  ","1,247 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: D051609; D061620; IC0316W; IC0316X; IC04161F; SHH0316-1  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0499-2017","Class III","Amino Complex Formula. 2oz HCG Drops. Blue Glass.","30 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: MW0616; 0815    ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0490-2017","Class III","HCG ASAP. 2oz HCG Drops. Blue Glass.","1,300 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: D051614; HC0815B; IC0104B; IC0216X      ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0496-2017","Class III","Pounds and Inches. 1oz HCG Drops. Amber Glass.  ","310 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lot: 142913-E  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0487-2017","Class III","SkinEHCG. 2oz HCG Drops. Blue Plastic.","134 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: 151262; D051617; IC0216W; IC0316B3; IC0316L; 151261; 151261; IC0216B  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0493-2017","Class III","HCG Complex. 2oz HCG Drops. Blue Plastic. ","37,500 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: D051617; D061611; IC0216R; IC0316B2; IC0316J; IC04161A; IC0516S; IC0516T  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0485-2017","Class III","Health & Beyond. 2oz HCG Drops. Amber Glass.  ","146 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: D051615; HC0815B; IC0116H-8  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0492-2017","Class III","B-Slim. 2oz & 4oz HCG Drops. Blue Plastic. ","35 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lot: 1115; 0715  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0483-2017","Class III","HCG Plus. 2oz HCG Drops. Blue Glass","64 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: IC0104B; IC0216X",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0495-2017","Class III","Omni Drops. 4oz HCG Drops. Amber Plastic  ","78,049 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: 416; 616; 1015; 1115; 0216; IC0416D; IC0416W; MW0216  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0486-2017","Class III","A New You HCG. 1oz HCG Drops. Blue Glass.  ","60 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: 1115; 0715  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0494-2017","Class III","Official HCG Diet Plan. 1oz, 2oz & 4oz HCG Drops. Amber Plastic and Glass. ","9,500 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: 416; 1015 ;1115; 0616; IC0416D; MW0216; WM0216  ",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75342,"Ongoing","Infiniti Creations, LLC","1453 W 40 S",,"Lindon","UT","84042-1626","United States","Voluntary: Firm Initiated","Letter","Nationwide and Canada. No other foreign and military/govt/VA consignees.","F-0489-2017","Class III","Athens Clinic of Clinic of Chiropractic. 2oz HCG Drops. Blue Glass.   ","100 units","The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.","11/22/2016","."," Lots: 416; 0815",9/30/2016,"09/30/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75343,"Ongoing","Fred Meyers Inc","3800 Se 22nd Ave",,"Portland","OR","97202-2918","United States","Voluntary: Firm Initiated","Press Release","distributed at Fred Meyer stores in in Alaska, Idaho, Oregon and Washington.","F-0163-2017","Class I","Product is refrigerated Boars Head To Go (BTG) Superfood Wrap, sold at deli department.  The wraps are made in store and the weight varies and they are sold as one each (wrap).   The UPC is  41573 11053.","unknown- firm did not provide","Deli Boars Head To Go (BTG) Superfood Wrap was recalled due to undeclared milk, soybeans (edamame), wheat and cashews.","10/18/2016",," All Sell by Dates of 9/29/2016 or before.  BGT wraps are disposed of after one day if they do not sell in the service case at deli department.",9/30/2016,"09/30/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75344,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Letter","Hawaii","B-0055-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. ","10/18/2016","10/18/2016"," W333415021258; ",9/19/2016,"09/19/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75345,"Terminated","American National Red Cross","3131 N Vancouver Ave",,"Portland","OR","97227-1560","United States","Voluntary: Firm Initiated","FAX","Oregon; Arizona; Washington; Nevada","B-0057-2017","Class II","Apheresis Platelets, Leukocytes Reduced","10 units","Blood products, which did not meet the acceptable product specifications, were distributed.","10/18/2016","10/18/2016"," W202116886633; W202116886641; W202116886646; W202116886646; W202116886648; W202116886648; W202116886648; W202116886650; W202116886629; W202116886629; ",8/7/2016,"08/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75345,"Terminated","American National Red Cross","3131 N Vancouver Ave",,"Portland","OR","97227-1560","United States","Voluntary: Firm Initiated","FAX","Oregon; Arizona; Washington; Nevada","B-0056-2017","Class II","Apheresis Platelets, Leukocytes Reduced, Irradiated","2 units","Blood products, which did not meet the acceptable product specifications, were distributed.","10/18/2016","10/18/2016"," W202116886633; W202116886633; ",8/7/2016,"08/07/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75346,"Terminated","BioLife Plasma Services, L.P","1565 S Liberty Dr",,"Bloomington","IN","47403-5168","United States","Voluntary: Firm Initiated","Other","Austria; California","B-0058-2017","Class III","Source Plasma","69 units","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/18/2016","10/18/2016"," 14BING4624; 14BING3866; 14BING2257; 14BINF8079; 14BINF7631; 14BINF6461; 14BINF6019; 15BINC7454; 15BINC6708; 15BINC5074; 15BINC8200; 15BINC4520; 15BINC3447; 15BINC2878; 15BINC1721; 15BINC1129; 15BINB9916; 16BINC7699; 16BINC5964; 16BINC4194; 16BINC2373; 16BINB5190; 16BINB4677; 16BINB2984; 16BINB1332; 16BINB0133; 16BINA4528; 15BINH6991; 15BINH1234; 15BING8732; 15BING4210; 15BING3653; 15BING0984; 15BINF9756; 15BINF9186; 15BIND0413; 15BINC9626; 15BINC9009; 15BING7914; 15BING7014; 15BING5930; 15BING5334; 15BINB7791; 15BINB6895; 15BINB4548; 15BINB3213; 15BINB2660; 15BINB1349; 15BINB0871; 15BINA9370; 15BINA8355; 15BINA7318; 15BINA6442; 15BINA5464; 15BINA4530; 15BINA3703; 15BINA2882; 15BINA2110; 14BINI0079; 14BINH9050; 14BINH7308; 14BINH2277; 14BINH0554; 14BING9654; 14BING8014; 14BING7176; 14BING6290; 14BING5457; 14BINF4788; ",8/23/2016,"08/23/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75347,"Ongoing","Atrium Medical Corporation","5 Wentworth Dr",,"Hudson","NH","03051-4929","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia,   South Africa, Spain, Sweden, Switzerland, and Venezuela.","Z-0582-2017","Class II","Atrium Medical  28 Fr Trocar catheter, Sterile  Model Number:   8428    Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.","7043 cases (10/cs)","Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.","11/16/2016",," All lot codes",10/26/2016,"10/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75347,"Ongoing","Atrium Medical Corporation","5 Wentworth Dr",,"Hudson","NH","03051-4929","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia,   South Africa, Spain, Sweden, Switzerland, and Venezuela.","Z-0581-2017","Class II","Atrium Medical 24 Fr Trocar catheter, Sterile  Model Number:  8424    Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.","5005 cases (10/cs)","Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.","11/16/2016",," All lot codes",10/26/2016,"10/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75347,"Ongoing","Atrium Medical Corporation","5 Wentworth Dr",,"Hudson","NH","03051-4929","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia,   South Africa, Spain, Sweden, Switzerland, and Venezuela.","Z-0579-2017","Class II","Atrium Medical 16 Fr Trocar catheter  Model Number: 8416    Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.","2172 cases (10/cs)","Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.","11/16/2016",," All lot codes",10/26/2016,"10/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75347,"Ongoing","Atrium Medical Corporation","5 Wentworth Dr",,"Hudson","NH","03051-4929","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia,   South Africa, Spain, Sweden, Switzerland, and Venezuela.","Z-0576-2017","Class II","Atrium Medical 8 Fr Trocar catheter, Sterile   Model Number: 8408    Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.","1617 cases (10/cs)","Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.","11/16/2016",," All lot codes",10/26/2016,"10/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75347,"Ongoing","Atrium Medical Corporation","5 Wentworth Dr",,"Hudson","NH","03051-4929","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia,   South Africa, Spain, Sweden, Switzerland, and Venezuela.","Z-0578-2017","Class II","Atrium Medical 12 Fr Trocar catheter, Sterile  Model Number: 8412    Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.","2697 cases (10/cs)","Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.","11/16/2016",," All lot codes",10/26/2016,"10/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75347,"Ongoing","Atrium Medical Corporation","5 Wentworth Dr",,"Hudson","NH","03051-4929","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia,   South Africa, Spain, Sweden, Switzerland, and Venezuela.","Z-0577-2017","Class II","Atrium Medical 10 Fr Trocar catheter, Sterile  Model Number: 8410    Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.","2822 cases (10/cs)","Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.","11/16/2016",," All lot codes",10/26/2016,"10/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75347,"Ongoing","Atrium Medical Corporation","5 Wentworth Dr",,"Hudson","NH","03051-4929","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia,   South Africa, Spain, Sweden, Switzerland, and Venezuela.","Z-0580-2017","Class II","Atrium Medical 20 Fr Trocar catheter, sterile  Model Number:  8420    Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.","4836 cases (10/cs)","Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.","11/16/2016",," All lot codes",10/26/2016,"10/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75347,"Ongoing","Atrium Medical Corporation","5 Wentworth Dr",,"Hudson","NH","03051-4929","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia,   South Africa, Spain, Sweden, Switzerland, and Venezuela.","Z-0583-2017","Class II","Atrium Medical 32 Fr Trocar catheter, Sterile  Model Number:   8432    Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.","5055 cases (10/cs)","Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.","11/16/2016",," All lot codes",10/26/2016,"10/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75349,"Ongoing","Taro Pharmaceuticals, Inc.","130 East Dr",,"Brampton",,,"Canada","Voluntary: Firm Initiated","Letter","US & Puerto Rico","D-0116-2017","Class II","Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7","15,576 units","Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).","11/01/2016",," Lot #: B5093-18608, B5094-18608,  Exp. Jan 2017; Lot #: C5141-18954, C5142-18954, E5109-19625,  Exp . Feb 2017",9/13/2016,"09/13/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75349,"Ongoing","Taro Pharmaceuticals, Inc.","130 East Dr",,"Brampton",,,"Canada","Voluntary: Firm Initiated","Letter","US & Puerto Rico","D-0117-2017","Class II","Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7","6,756 units","Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).","11/01/2016",," Lot #: E0598-19624, E5099-19624, Exp. Jan 2017  ",9/13/2016,"09/13/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75350,"Completed","Biocompatibles U.K., Ltd.","Bortoli House","Weydon Lane; Old Farnham Lane","Farnham",,,"United Kingdom","Voluntary: Firm Initiated","Telephone","Worldwide Distribution - US to CA, FL, IL, WI, IN, OR, PA, MA, NY, KY, TX, MI, MD, NV, WA, OH, MN, and Internationally to Germany, Turkey, Hong Kong, Italy, Portugal","Z-0078-2017","Class II","TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION  TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.","64 doses ","One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect).  The product ws labeled as 10 GBq and the actual does was 5 GBq.","10/13/2016",," Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)",9/21/2015,"09/21/2015",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75351,"Ongoing","Ellman International, Inc.","400 Karin Ln",,"Hicksville","NY","11801-5352","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, FL, MA, MD, MI, MN, MS, OH, PA, VA, TX & WV; **International**Australia, Bangladesh, Greece, Italy, Japan, Lebanon, Russian Federation, Singapore, Spain & Vietman.","Z-0748-2017","Class II","ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE  The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.","370 boxes (US - 159 boxes, OUS - 211 boxes)",".  The expiration date on the outer box and the individual pouches do not match.  The expiration date on the box is correct with a date of 2018-02.    ","12/13/2016",," Lot Numbers 45572 (Box), (Individual packages) 48543, 50382, 48543, 50704, 50858  Exp Date - 2018-02",9/7/2016,"09/07/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75352,"Ongoing","Beverage International","2539 Preston Ave Ste 150",,"Pasadena","TX","77503-3764","United States","Voluntary: Firm Initiated","E-Mail","TX","F-0382-2017","Class II","Nu-Quench Lime Bar Mix 32 Oz. packaged in plastic bottle, 12 bottles per case","635 gallons","Undeclared Yellow #5 in product.","11/02/2016",," Bar Code# UPC638845774734",9/30/2016,"09/30/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75354,"Ongoing","Del Monte Research Center - Walnut Creek","205 N Wiget Ln",,"Walnut Creek","CA","94598-2403","United States","Voluntary: Firm Initiated","Letter","AZ, CA, NV, UT","F-0279-2017","Class II","DM Light Slices Yellow Cling Peaches -15 oz (425g) 300 x 407","5728 cases x 12 cans/case = 68,736 cans","Between September 7 thru September 29, 2016, consumer complaints led firm to believe that cans of Lite Sliced Peaches were mislabeled as they appeared to contain Fruit Cocktail in Heavy Syrup. The label on the can states Lite Sliced Peaches (Yellow cling peach in Extra Light Syrup) and the product inside contains Fruit Cocktail in Heavy Syrup. Fruit Cocktail contains cherries colored with carmine. FDA regulations requires carmine to be labeled due to its potential allergen status (21 CFR 73.100 (d)(2)). ","10/25/2016",," Lot Number: 522701  Manufacture Date: 8/15/2015  UPC  Sliced Peaches:  2400016719   Best By Date: 08/14/2018",10/4/2016,"10/04/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75355,"Ongoing","Oasis Foods Co","635 Ramsey Ave",,"Hillside","NJ","07205-1032","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, CT, DC, FL, GA, MA, MD, NJ, NY, OH and PA","F-0380-2017","Class III","Select Recipe Buttermilk Ranch Dressing, Net contents: 1 GAL (3.79 L), 4 X 1 GAL","2,212 cases","Oasis is recalling several lots of the Select Recipe Buttermilk Ranch Dressing and the Garden Harvest Buttermilk Ranch because they were shipped with an incorrect label not listing Soy Lecithin as an ingredient in the ingredient statement or elsewhere on the display panel.","11/03/2016",," Single Unit - UPC 732146132931 and Case Unit UPC 732146 101326; Product Item Number FDRA0FGO, Lot #'s 02252016, 03222016, 04192016, 04202016, 05192016, 06142016 and 07142016",8/15/2016,"08/15/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75355,"Ongoing","Oasis Foods Co","635 Ramsey Ave",,"Hillside","NJ","07205-1032","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO, CT, DC, FL, GA, MA, MD, NJ, NY, OH and PA","F-0381-2017","Class III","Garden Harvest Buttermilk Ranch, Net contents: 1 GAL (3.8 L), 4 X 1 GAL.","2,858 cases","Oasis is recalling several lots of the Select Recipe Buttermilk Ranch Dressing and the Garden Harvest Buttermilk Ranch because they were shipped with an incorrect label not listing Soy Lecithin as an ingredient in the ingredient statement or elsewhere on the display panel.","11/03/2016",," Product Item Number FD164GGH, Lot #'s 02232016, 03222016, 04192016, 05192016, 06142016 07122016 and 07142016",8/15/2016,"08/15/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75357,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0387-2017","Class II","Roche COBAS INTEGRA c111  Analyzer, Chemistry (Photometric, Discrete), for clinical use    Product Usage:  The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.  ","139","cobas c 111 analyzers (catalog numbers 04777433001 and  04528778001) with software versions up to and including 4.20 may encounter the following alarm:  7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing  error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run  restarts.  If a used cuvette is used again result of the test(s) will be erroneous.  These erroneous results may not be flagged.  Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic  decisions. The medical risk depends on the parameter.","11/09/2016",," 04777433001  Cobas c111 with ISE  04528778001  Cobas c111 without ISE    cobas c 111 analyzers (catalog numbers 04777433001 and  04528778001) with software versions up to and including 4.20",9/27/2016,"09/27/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75358,"Ongoing","Micro Therapeutics Inc, Dba Ev3 Neurovascular","9775 Toledo Way",,"Irvine","CA","92618-1811","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-0310-2017","Class I","X-Celerator Hydrophilic Exchange Guidewire","84,278 units total (17,811 in US)","Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.","11/09/2016",," 103-0601-300  103-0601-350V10  103-0602-350V06  103-0601-300V01  103-0602-300  103-0602-350V09  103-0601-300V02  103-0602-300V01  103-0602-350V10  103-0601-300V03  103-0602-300V02  103-0601-300V06  103-0602-300v06  103-0601-300V10  103-0602-300V09  103-0601-300V11  103-0602-300V10  103-0601-350  103-0602-350  103-0601-350V01  103-0602-350V01  103-0601-350V06  103-0602-350V02  9530849  9709603  9797735  A002136  A043280  A123449  A183571  9530851  9743324  9802698  A002460  A043281  A123450  A185838  9531882  9743328  9802700  A002610  A043969  A123452  A185841  9567732  9746399  9848318  A004560  A044251  A134837  A194324  9585211  9746403  9882269  A004561  A044252  A136164  A194327  9585247  9750614  9931088  A005008  A097470  A136165  A195347  9585249  9750615  9931089  A005011  A097472  A142394  A200386  9585282  9750618  9931093  A005477  A097473  A142395  A200387  9585283  9750619  9979485  A005478  A097474  A145004  A202560  9594629  9750621  9979495  A006080  A097475  A136161  A202563  9601922  9750624  9979497  A006171  A097476  A145006  A211246  9601924  9751548  9979498  A006176  A097477  A145149  A211248  9612762  9767048  9979500  A006182  A114384  A145150  A217138  9612763  9794407  201401398X  A006887  A114385  A145152  A217141  9628372  9794409  201601079E  A008199  A114389  A145153  A217142  9641711  9794795  201602502E  A008201  A114391  A150759  A221040  9643550  9794924  201603429E  A014137  A114393  A150762  A221041  9660868  9794925  201603430E  A014297  A114543  A150764  A221042  9666144  9795119  201605381E  A014819  A114545  A151577  A221043  9666146  9795120  201605382E  A014821  A114546  A152854  A237364  9666148  9795516  201605383E  A014825  A115726  A152856  A237366  9666835  9795517  201605384E  A019031  A116267  A159822  A237368  9667132  9796816  201606174E  A019337  A116270  A159826  A243986  9690683  9796817  201606178E  A035856  A116271  A165319  A243987  9690686  9796817  201606179E  A035858  A116272  A165320  A243988  9690687  9796818  201606180E  A037439  A116274  A16532",10/5/2016,"10/05/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75358,"Ongoing","Micro Therapeutics Inc, Dba Ev3 Neurovascular","9775 Toledo Way",,"Irvine","CA","92618-1811","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-0307-2017","Class I","Pipeline Embolization Device (Pipeline Classic)  The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements.","84,278 units total (17,811 in US)","Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.","11/09/2016",," FA-71300-25V09  FA-71350-25V16  FA-71400-25V10  FA-71425-35V13  FA-71475-30V16  FA-71300-25V12  FA-71350-25V17  FA-71400-25V11  FA-71425-35V15  FA-71475-30V18  FA-71300-25V13  FA-71350-25V18  FA-71400-25V12  FA-71425-35V18  FA-71475-35V09  FA-71300-25V15  FA-71350-25V19  FA-71400-25V13  FA-71450-25V09  FA-71475-35V10  FA-71300-25V16  FA-71350-30V09  FA-71400-25V15  FA-71450-25V10  FA-71475-35V11  FA-71300-25V17  FA-71350-30V10  FA-71400-25V16  FA-71450-25V11  FA-71475-35V12  FA-71300-25V18  FA-71350-30V12  FA-71400-25V18  FA-71450-25V12  FA-71475-35V13  FA-71300-25V19  FA-71350-30V13  FA-71400-25V19  FA-71450-25V13  FA-71475-35V15  FA-71300-30V09  FA-71350-30V15  FA-71400-30V09  FA-71450-25V15  FA-71475-35V18  FA-71300-30V12  FA-71350-30V16  FA-71400-30V10  FA-71450-25V16  FA-71475-35V19  FA-71300-30V13  FA-71350-30V18  FA-71400-30V11  FA-71450-25V18  FA-71500-25V09  FA-71300-30V15  FA-71350-35V09  FA-71400-30V12  FA-71450-25V19  FA-71500-25V10  FA-71300-30V16  FA-71350-35V10  FA-71400-30V13  FA-71450-30V09  FA-71500-25V11  FA-71300-30V19  FA-71350-35V12  FA-71400-30V15  FA-71450-30V10  FA-71500-25V12  FA-71300-35V09  FA-71350-35V13  FA-71400-30V16  FA-71450-30V11  FA-71500-25V13  FA-71300-35V12  FA-71350-35V15  FA-71400-30V18  FA-71450-30V12  FA-71500-25V15  FA-71300-35V13  FA-71350-35V18  FA-71400-35V09  FA-71450-30V13  FA-71500-25V16  FA-71300-35V15  FA-71375-25V09  FA-71400-35V13  FA-71450-30V15  FA-71500-25V18  FA-71325-25V09  FA-71375-25V10  FA-71400-35V15  FA-71450-30V16  FA-71500-25V19  FA-71325-25V10  FA-71375-25V11  FA-71400-35V18  FA-71450-30V18  FA-71500-30V09  FA-71325-25V12  FA-71375-25V12  FA-71425-25V09  FA-71450-30V19  FA-71500-30V10  FA-71325-25V13  FA-71375-25V13  FA-71425-25V10  FA-71450-35V09  FA-71500-30V11  FA-71325-25V15  FA-71375-25V15  FA-71425-25V11  FA-71450-35V10  FA-71500-30V12  FA-71325-25V18  FA-71375-25V16  FA-71425-25V12  FA-71450-35V12  FA-71500-30V13  FA-71325-25V19  FA-71375-25V17  FA-71425-25V13  FA-71450-35V13  FA-71500-30V15  FA-71325-30V09  FA-71375-25V18  FA-71425-25V",10/5/2016,"10/05/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75358,"Ongoing","Micro Therapeutics Inc, Dba Ev3 Neurovascular","9775 Toledo Way",,"Irvine","CA","92618-1811","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-0309-2017","Class I","Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter  Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature.","84,278 units total (17,811 in US)","Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.","11/09/2016",," 105-5055V02  105-5055V02  105-5055V05  105-5065V02  105-5065V05  105-5066V02  105-5066V05  9946730  9960999  9965968  9974493  A004327  A011297  A016502  A024591  9952156  9961016  9965970  9975117  A004329  A011515  A016504  A024594  9952519  9961297  9965980  9975118  A004435  A011522  A016507  A024893  9952892  9961308  9965983  9976018  A004436  A011731  A016510  A024894  9953171  9961313  9965984  9976024  A004437  A011735  A016632  A024896  9953177  9963245  9966022  9976049  A004535  A011818  A017149  A025130  9953699  9963247  9966200  9976052  A004537  A011845  A017150  A025857  9953892  9963249  9966203  9976055  A004542  A011972  A017154  A025862  9955091  9963378  9966205  9978598  A004543  A012088  A018239  A026331  9955406  9963380  9966550  A000215  A004544  A012341  A018301  A026336  9955408  9963382  9966562  A000219  A004614  A012591  A018307  A026337  9955530  9963386  9966563  A000220  A004616  A012691  A018310  A026375  9955561  9963622  9966674  A000369  A005866  A012738  A018721  A027449  9955726  9963627  9966674  A000453  A005870  A012743  A018722  A027805  9955727  9963633  9966676  A002304  A005980  A012755  A018741  A027862  9955845  9963851  9966934  A002305  A006045  A013058  A018885  A027922  9956028  9964145  9966945  A002307  A006222  A013211  A019293  A028081  9956396  9964148  9966946  A002404  A006225  A013685  A019401  A028468  9956460  9964157  9971999  A002406  A006229  A013686  A019539  A028566  9957242  9964161  9972000  A002408  A006237  A013688  A019550  A028760  9957512  9964259  9972002  A002595  A006829  A013689  A019567  A028777  9957684  9964494  9972610  A002606  A006831  A013796  A019573  A028780  9957685  9964496  9972613  A002616  A006834  A013969  A019834  A028787  9957927  9964498  9972719  A002898  A007148  A014018  A019912  A029143  9957947  9964756  9972720  A003029  A007150  A014061  A020026  A029145  9957949  9964810  9973291  A003038  A007304  A014063  A020056  A029146  9958187  9964826  9973322  A003039  A007344  A014351  A020244  A029318  9958345  ",10/5/2016,"10/05/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75358,"Ongoing","Micro Therapeutics Inc, Dba Ev3 Neurovascular","9775 Toledo Way",,"Irvine","CA","92618-1811","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.","Z-0308-2017","Class I","Alligator Retrieval Device  The device is intended for use in the peripheral and neurovasculature for foreign body removal.","84,278 units total (17,811 in US)","Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.","11/09/2016",," FA-88810-20V04  FA-88810-20V06  FA-88810-30V04  FA-88810-30V06  FA-88810-40V04  FA-88810-40V06  FA-88810-50V04  FA-88810-50V06  9948077  9972887  A010848  A053541  A116064  A131036  9948396  9972889  A011322  A053542  A117476  A132044  9952512  9972890  A011359  A053543  A118368  A154323  9957329  9974418  A013554  A053763  A120498  A154324  9957336  9976051  A013556  A053764  A122265  A156580  9957342  9976060  A014832  A053766  A123213  A156581  9944965  9977018  A014868  A066445  A124445  A161317  9945280  9977019  A014953  A066446  A125283  A161318  9951876  9977396  A016804  A068660  A132937  A163895  9954273  9977397  A018473  A068664  A134257  A163896  9957330  9978556  A019068  A071295  A134900  A166199  9957339  9978557  A021485  A072578  A135945  A168759  9957343  9979590  A022023  A091991  A137794  A168760  9957347  9980261  A022527  A093697  A138489  A173721  9945281  9980272  A024541  A094487  A142716  A173722  9946234  A002055  A026133  A095510  A147975  A177071  9952511  A002875  A027036  A096506  A147976  A177073  9957331  A002976  A028730  A098665  A147978  A197692  9957340  A004046  A028731  A098667  A150526  A242153  9957344  A004049  A030919  A102229  A150527  A242931  9948387  A005156  A030920  A102232  A150529  A242936  9950866  A006168  A033160  A104111  A152100  A242937  9953649  A006169  A033161  A104113  A153748  A242939  9954974  A007336  A036879  A107473  A153749  A247199  9955940  A007955  A037969  A110323  A127224  A247612  9957333  A008188  A039135  A111254  A127844  A254814  9957341  A009329  A039136  A112093  A129002  A282350  9957346  A010342  A039142  A114200  A130573  A290956  A311410  A312892  A321463",10/5/2016,"10/05/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75359,"Ongoing","King Henry's, Inc.","29124 Hancock Pkwy",,"Valencia","CA","91355","United States","Voluntary: Firm Initiated","Letter","US: CA, OH, TX, CO","F-0187-2017","Class II","Gummy Frogs, 2.5oz, UPC 61054635210","470 units total","King Henry is recalling King Henry's Gummy Frogs because they may contain undeclared colors (FD&C Yellow #6, Red #40).","10/19/2016",," 3072018, 4182018, 4262018, 5162018, 5262018, 6132018, 6232018, 7142018, 8172018 ",10/5/2016,"10/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75359,"Ongoing","King Henry's, Inc.","29124 Hancock Pkwy",,"Valencia","CA","91355","United States","Voluntary: Firm Initiated","Letter","US: CA, OH, TX, CO","F-0188-2017","Class II","Gummy Frogs, 6oz, UPC 6105465200, 61054645500 ","470 units total","King Henry is recalling King Henry's Gummy Frogs because they may contain undeclared colors (FD&C Yellow #6, Yellow #5, Red #40).","10/19/2016",," 3072018, 4182018, 4262018, 5162018, 5262018, 6132018, 6232018, 7142018, 8172018 ",10/5/2016,"10/05/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75360,"Ongoing","Mericon Industries Inc.","8819 N Pioneer Rd",,"Peoria","IL","61615-1519","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NC, MA, NJ, WI, IA, one customer in England","F-0419-2017","Class II","Monocal, Calcium & Fluoride Supplement, 100 Tablets; Mericon Industries, Inc., Peoria, Illinois 61615; UPC: 0394-0105-02","158 bottles ","Dietary supplement contains excess amount of fluoride. ","11/08/2016",," Lot: 73007",9/23/2016,"09/23/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75363,"Terminated","Arc Blood Services, New England Region","180 Rustcraft Rd Ste 115",,"Dedham","MA","02026-4551","United States","Voluntary: Firm Initiated","Telephone","Vermont; New Hampshire; New York; Maine; Massachusetts","B-0163-2017","Class III","Red Blood Cells, Leukocytes Reduced","9 units"," Blood products, lacking assurance of sterility, were distributed. ","11/17/2016","11/17/2016"," W203416460551; W203416460560; W203416460564; W203416460571; W203416460575; W203416460584; W203416460596; W203416460602; W203416460592; ",8/26/2016,"08/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75363,"Terminated","Arc Blood Services, New England Region","180 Rustcraft Rd Ste 115",,"Dedham","MA","02026-4551","United States","Voluntary: Firm Initiated","Telephone","Vermont; New Hampshire; New York; Maine; Massachusetts","B-0162-2017","Class III","Red Blood Cells, Leukocytes Reduced, Irradiated","2 units"," Blood products, lacking assurance of sterility, were distributed. ","11/17/2016","11/17/2016"," W203416460591; W203416460544; ",8/26/2016,"08/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75363,"Terminated","Arc Blood Services, New England Region","180 Rustcraft Rd Ste 115",,"Dedham","MA","02026-4551","United States","Voluntary: Firm Initiated","Telephone","Vermont; New Hampshire; New York; Maine; Massachusetts","B-0161-2017","Class III","Plasma Frozen within 24 hours (FP24)","3 units"," Blood products, lacking assurance of sterility, were distributed. ","11/17/2016","11/17/2016"," W203416460571; W203416460575; W203416460584; ",8/26/2016,"08/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75364,"Terminated","Blood Bank of Alaska","3010 Airport Way",,"Fairbanks","AK","99709-4752","United States","Voluntary: Firm Initiated","FAX","CA","B-0136-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit"," Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ","11/14/2016","11/14/2016"," W066516251382",9/29/2016,"09/29/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75365,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.","Z-0600-2017","Class II","Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile    Product Usage:  The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. It is packaged with a water sachet that is manually burst to hydrate the catheter coating at time of use. The catheters are packaged in a film-to-film pouch and are sterilized by electron beam irradiation and are distributed as a single use device. The catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction and surgical procedures. Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established. The device is not intended to be used as a treatment for active urinary tract infection. For urological use only; urinary catheters are intended for use for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.  ","10,290 units","Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).","11/16/2016",," Product Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.",10/5/2016,"10/05/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75366,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","Nationwide.","Z-0396-2017","Class II","COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test  Catalog number 04528123160","4976",".Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual  Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles.  This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected.  The issue can lead to erroneously high HbA1c results.   ","11/11/2016",," Not applicable",10/4/2016,"10/04/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75366,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","Nationwide.","Z-0395-2017","Class II","Tina-Quant Hemoglobin A1c Gen. 2  Hemoglobin A1c test  Catalog number 04528123190 / 05401640190","4976","Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual  Tina-quant¿ Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles.  This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected.  The issue can lead to erroneously high HbA1c results. If a patient with known diabetes is affected,  an erroneously high HbA1c result might lead to therapeutic consequences, such as therapy escalation  (introduction of another oral antidiabetic medication or insulin) or increase of the dosage. This can  further lead to an increased risk of hypoglycemia. Considering the unreliable detectability of the issue,  relevant medical risk for the patient cannot entirely be excluded.","11/11/2016",," Not applicable",10/4/2016,"10/04/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75367,"Ongoing","Merit Medical Systems, Inc.","1600 W Merit Pkwy",,"South Jordan","UT","84095-2416","United States","Voluntary: Firm Initiated","Letter","Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.","Z-0633-2017","Class II","Waste Management Kit. Catalog Number K10-04381AP","30 units","Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.","11/19/2016","."," Lot Number: H996569",9/23/2016,"09/23/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75367,"Ongoing","Merit Medical Systems, Inc.","1600 W Merit Pkwy",,"South Jordan","UT","84095-2416","United States","Voluntary: Firm Initiated","Letter","Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.","Z-0632-2017","Class II","Manifold Kit. Catalog Number K09-11867AP","40 units","Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.","11/19/2016","."," Lot Number: H996495",9/23/2016,"09/23/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75367,"Ongoing","Merit Medical Systems, Inc.","1600 W Merit Pkwy",,"South Jordan","UT","84095-2416","United States","Voluntary: Firm Initiated","Letter","Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.","Z-0634-2017","Class II","). Catalog Number K11-00232G","130 units","Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.","11/19/2016","."," Lot Number: H996490",9/23/2016,"09/23/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75367,"Ongoing","Merit Medical Systems, Inc.","1600 W Merit Pkwy",,"South Jordan","UT","84095-2416","United States","Voluntary: Firm Initiated","Letter","Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.","Z-0635-2017","Class II","Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A","53 units","Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.","11/19/2016","."," Lot Numbers: H992344 and H996476",9/23/2016,"09/23/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75367,"Ongoing","Merit Medical Systems, Inc.","1600 W Merit Pkwy",,"South Jordan","UT","84095-2416","United States","Voluntary: Firm Initiated","Letter","Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.","Z-0631-2017","Class II","Fluid Management Set. Catalog Number K08-MP5159A","178 units","Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.","11/19/2016","."," Lot Number: H996433",9/23/2016,"09/23/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75368,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.  Canada.","F-0816-2017","Class II","Brownwood Farms Jalapeno Cherry Butter.  12oz glass bottles and 1 gallon.  ","17000 units","Products contain yellow#5 ingredients not declared on the label.","12/19/2016",," All product on market, any best by date prior to 9/30/2018",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75368,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.  Canada.","F-0811-2017","Class II","Brownwood Farms Cherry BBQ Sauce.  21oz glass bottles, 1 gallon, 5 gallon.  Private labels:  Arbor Day Farm (Cherry BBQ Sauce).  Bowers Harbor Vineyard (Cherry BBQ Sauce 12oz).  Benjamin Twiggs (Northwoods Cherry BBQ Sauce 16oz).   Crossroads.  Friske Orchards.  Kimmel Orchard & Vineyard (Cherry BBQ Sauce 21oz).   Six Lugs.  Spirit Valley.  Westborn's cherished (Cherry barbecue sauce 21oz).    ","100000 units","Products contain soy ingredients not declared on the label.","12/19/2016",," All product on market, any best by date prior to 9/21/2018.  ",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75368,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.  Canada.","F-0813-2017","Class II","Brownwood Farms Apple Riesling Salsa.  21oz glass bottles and 1 gallon.  Private labels:  Arbor Day Farm (Apple Riesling Salsa 21oz).  Kimmel Orchard & Vineyard (Apple Riesling Salsa 21oz).  St. Julian Winery (Apple Riesling Salsa 19oz).  ","12000 units","Products contain yellow#5 ingredients not declared on the label.","12/19/2016",," All product on market, any best by date prior to 9/30/2017",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75368,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.  Canada.","F-0815-2017","Class II","Brownwood Farms Jalapeno Cherry Salsa.  21oz glass bottles and 1 gallon.  Private labels:  Arbor Day Farm (Cherry Jalapeno Salsa 21oz).  Kimmel Orchard & Vineyard.  ","28000 units","Products contain yellow#5 ingredients not declared on the label.","12/19/2016",," All product on market, any best by date prior to 9/30/2017",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75368,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.  Canada.","F-0810-2017","Class II","Brownwood Farms Yankee Bourbon BBQ Sauce.  19oz glass bottles and 1 gallon ","26000 units","Products contain soy  ingredients not declared on the label.","12/19/2016",," All product on market, any best by date prior to 9/21/2018.  ",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75368,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.  Canada.","F-0814-2017","Class II","Brownwood Farms Peach Salsa.  17oz glass bottles.  Private labels:  Bowers Harbor Vineyard (Peach Salsa 12oz).  Crossroads.","4600 units","Products contain yellow#5 ingredients not declared on the label.","12/19/2016",," All product on market, any best by date prior to 9/30/2017",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75368,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide.  Canada.","F-0812-2017","Class II","Brownwood Farms BBQ Mustard Glaze.  11oz glass bottles and 1 gallon.  Private labels:  Kimmel Orchard & Vineyard (Barbeque Mustard 11oz)","4500 units","Products contain soy  ingredients not declared on the label.","12/19/2016",," All product on market, any best by date prior to 9/21/2018",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75369,"Terminated","Eola Bottling Company Inc.","3213 Waconda Rd NE",".","Gervais","OR","97026-9709","United States","Voluntary: Firm Initiated","Telephone","Oregon and Washington","F-0577-2017","Class II","    The product is packaged in a blue colored plastic bottle.  16.9 FL OZ.   Case contains 12/16.9 FL OZ. or 24/16.9 FL OZ.","90 cases of the 24 pack and 228 cases of the 12 pack","Eola Bottling Company is recalling one lot code of Oregon Rain bottled water due to mold.","12/08/2016","12/08/2016"," Lot code 061616## : ## The two digits : two digits at the end of the code represent the time the bottle was capped in the bottling line.    061616 represents June 16, 1016;     16.9 fl oz. Bottle - UPC 8 11033 90911 2    Cases contain either 12 or 24 bottles ",6/29/2016,"06/29/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75370,"Ongoing","Terumo Medical Corp","2101 Cottontail Ln",,"Somerset","NJ","08873-1277","United States","Voluntary: Firm Initiated","Letter","Nationwide","Z-0669-2017","Class II","MISAGO RX Self Expanding Peripheral Stem","7,965 units","During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.","11/29/2016",," 150401 150429 150713 150821 150923 151009 160314    150413 150501 150708 150824 150915 151013 151111    150415 150515 150701 150716 150902 151005 151106    150407 150514 150707 150827 151008 151109 160509    150406 150501 150713 150716 150825 151001 151102 160315 160509  150410 150710 150831 150909 151007 151012 151014 151103 151208  150417 150429 150717 150910 151002 151102 160510    150408 150429 150701 150717 150831 151013 151103 160512   150409 150430 150518 150703 150706 150903 150914 151005   150331 150430 150708 150714 150904 150910 151001 151102   150414 150429 150715 150903 151005 151029 160323    150416 150518 150715 150908 150915 151002 151106 160328   150401 150430 150716 150828 151006      150403 150514 150717 150901 150909 151012     150408 150430 150713 150907 151001      150402 150512 150713 150907 151001      ",8/4/2016,"08/04/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75371,"Ongoing","Zimmer Biomet, Inc.","1800 W Center St",,"Warsaw","IN","46580-2304","United States","Voluntary: Firm Initiated","Letter","Nationwide.  CANADA  HONG KONG  KOREA  SINGAPORE  CHINA  VENEZUELA  AUSTRALIA  JAPAN  NETHERLANDS  GERMANY  INDIA  TAIWAN","Z-0317-2017","Class II"," Patellofemoral Joint Prosthesis  Milling Handpiece","703","Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery ","10/26/2016",," Item Number  00-5927-040-00  Serial Number  All",9/28/2016,"09/28/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75372,"Ongoing","Arrow International Inc","2400 Bernville Rd",,"Reading","PA","19605-9607","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution","Z-0331-2017","Class II","HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination.","330 units in US and 1,031 units OUS","Labeling inconsistency","11/02/2016",," Lot # 16F15C0114, 16F15D0003, 16F15A0072, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, 16F16E0030",9/2/2016,"09/02/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75373,"Ongoing","AtriCure, Inc.","7555 Innovation Way",,"Mason","OH","45040-9695","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution -- USA, in the following states AL, AR, AZ, CA, CO, CT, GA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI, & VA; and, to the countries of Albania, Australia, Belgium, France,  Germany, Ireland, Italy, Norway, Netherlands, Poland, Sweden, Turkey, United Arab Emirates, & United Kingdom.","Z-0653-2017","Class II","COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System.  Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003.    Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).    ","5,263","Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.","11/22/2016","."," on the product label as: MM-YYYY, e.g. 02-2016 or earlier.  ",9/22/2016,"09/22/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75374,"Ongoing","Boehringer Ingelheim Pharmaceuticals, Inc.","900 Ridgebury Rd",,"Ridgefield","CT","06877-1058","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0113-2017","Class II","Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT  06877, NDC 0597-0019-01  ","2562 bottles","Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and  50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.","10/24/2016",," Lot #:456520, Exp.  5/17",10/6/2016,"10/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75374,"Ongoing","Boehringer Ingelheim Pharmaceuticals, Inc.","900 Ridgebury Rd",,"Ridgefield","CT","06877-1058","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0114-2017","Class II","DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25","6400 bottles","Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and  50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.","10/24/2016",," Lot #: 554820, Exp 5/17",10/6/2016,"10/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75375,"Completed","Becton Dickinson & Co.","7 Loveton Cir","BD Diagnostic Systems","Sparks","MD","21152-9212","United States","Voluntary: Firm Initiated","E-Mail","BD has contacted all 31 US customers and 22 Ex-US sites which received product from the associated catalog numbers.    US:  AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA and WI.    Ex-US:  Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand and Vietnam    4 US government sites were contacted","Z-0312-2017","Class III","PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec &#38; Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.","94","BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date (year).  The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.","10/25/2016",," Part/Catalog Number.: 440911    Lot / Serial Number. 5327782",6/1/2016,"06/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75375,"Completed","Becton Dickinson & Co.","7 Loveton Cir","BD Diagnostic Systems","Sparks","MD","21152-9212","United States","Voluntary: Firm Initiated","E-Mail","BD has contacted all 31 US customers and 22 Ex-US sites which received product from the associated catalog numbers.    US:  AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA and WI.    Ex-US:  Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand and Vietnam    4 US government sites were contacted","Z-0311-2017","Class III","PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.      ","20","BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year).  The expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.","10/25/2016",," Part/Catalog Number.: 440911, 441951    Lot / Serial Number. :5364776, 5345796  ",6/1/2016,"06/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75376,"Ongoing","AccessClosure, Inc., A Cardinal Health Company","5452 Betsy Ross Dr",,"Santa Clara","CA","95054-1101","United States","Voluntary: Firm Initiated",,"US distribution to FL and NJ","Z-0297-2017","Class II","The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.","6 in USA","AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device   because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy.  This is a deviation from the firm's standard catheterization technique.   ","10/21/2016",," Product Model ACX101,  Manufacturer UDI *+ M465ACX10106*    Lot No: F1614503    ",10/6/2016,"10/06/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75380,"Terminated","Central California Blood Center","4343 W Herndon Ave",,"Fresno","CA","93722-3794","United States","Voluntary: Firm Initiated","E-Mail","California","B-0069-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Red Blood Cells, collected from a donor who was allowed to donate without documentation regarding history of travel to a Zika endemic risk area, were distributed.","11/03/2016","11/03/2016"," W115916053412",8/29/2016,"08/29/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75381,"Terminated","ARUP Laboratories, Inc.","9786 S. Sandy Parkway",,"Sandy","UT","84070-2565","United States","Voluntary: Firm Initiated","Telephone","Utah","B-0068-2017","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Apheresis products, collected from a donor who traveled to a Zika endemic area were distributed.","11/03/2016","11/03/2016"," W158016801352; W158016801218",8/25/2016,"08/25/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75382,"Terminated","Central California Blood Center","4343 W Herndon Ave",,"Fresno","CA","93722-3794","United States","Voluntary: Firm Initiated","Telephone","California","B-0124-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Red Blood Cells, collected from a donor who was allowed to donate without documentation regarding history of travel to a Zika endemic risk area, were distributed.","11/03/2016","11/03/2016"," W115916252302",8/22/2016,"08/22/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75384,"Ongoing","Lumenis Limited","13 Hayetzira St.,Yokneam Ind. Park",,"Yokneam",,,"Israel","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.","Z-0301-2017","Class II"," Tip (SPSA-20002590)    Provide fractional treatments in gynecology.","69 units","The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.","10/23/2016",," All serial numbers",9/25/2016,"09/25/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75385,"Ongoing","Steris Corporation","5960 Heisley Rd",,"Mentor","OH","44060-1834","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including AK, AZ, CA, CO, FL, IL, KY, MI, MO, NB, NJ, NY, OH, PA, RI, SD, TN, TX, UT, WA & WV.","Z-0746-2017","Class II","Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS)  The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required","64","The Drager Pendula spring arm device has a  set of screws located on the spring arm that were not properly secured with Loctite and may become loose.  ","12/12/2016",," 0419016160  0421416123  0420816119  0415216095  0409016039  0409016038  0404716127  0434815015  0429915001  0429915002  0418015066  0418015065  0416815002  0416015002  0416015001  0413515012  0409615011  0407615001  0407615002  0405015102  0429614003  0401515015  0431714001  0430914002  0430914001  0427614022  0428014006  0423914014  0421714007  0416814001  0415014002  0414314082  0413914001  0412714043  0411414001  0411414003  0411414002  0411114001  0401614001  0404814128  0405014014  0403814116  0402214076  0401314131  0401514013  0400614027  0434413019  0433813017  0429113164  0430113149  0427313064  0417013083  0414813001  0412113002  0412113001  0410013001  0405213038  0404413018  0404413017  0404413016  0404413016  0436112019  0436112018  0434912001",10/5/2016,"10/05/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75386,"Ongoing","Maquet Medical Systems USA","45 Barbour Pond Dr",,"Wayne","NJ","07470-2094","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA","Z-0390-2017","Class II","Accessory Adapter Part number 600525A0    Product Usage:  designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.  ","9 Units (US) 141 Units (OUS)","Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.","11/09/2016",," 600525A0 ",10/5/2016,"10/05/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75387,"Ongoing","Bayer Healthcare","1 Bayer Dr",,"Indianola","PA","15051-9702","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Netherlands, Mexico, Malta, Morraco, Libyan, Lithuania, Lebanon, Kuwait, Italy, Israel, Hungray, United Kingdom, France, Finland, Spain, Denmark, Germany, Czech Republic, Chile, Switzerland, Belguim, Bosnia, Austria, Australia,","Z-0400-2017","Class II","PET Infusion Pump","165,127 (79,714 units in U.S.)","The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.","11/11/2016",," Impacted Batch Numbers: 20044  8401230  20110777  20110778  20129053  20130260  20143029  20168043  20168044  20218499  20223554  20226461  20229069  50378230  50508655  50514420  50515055  50515057  50562833  50562834  50562835  50562836  50572481  50574207  50574208  50574209  50585611  50586105  50596605  50597703  50597850  50600435  50601580  50602572  50604785  50606331  50620077  50629437  50632873  50634213  50657181  50663447  50665086  50669881  50677540  50686154  50688724  50693453  50695189  50696540  50696563  50698651  50699741  50699882  50699883  50705397  50705398  50718205  50718756  50720431  50721421  50725617  50725618  50731457  50735273  50738861  50740290  50743615  50747279  50748947  50750243  50752501  50755005  50781643  50782219  50783201  50784811  50786091  50786092  50786096  50789117  50789131  50789132  50792077  50793811  50795111  50798463  50801293  50801294  50804590  50804591  50808994  50812469  50826288  50826491  50826492  50827614  50827615  50828779  50831229  50831230  50833827  50834754  50836287  50837233  50838024  50840343  50840344  50841688  50843787  50845969  50847291  50848267  50848268  50848269  50853167  50855436  50856405  50857510  50860994  50866789  50867921  50869464  50869465  50871131  50872965  50878229  50878230  50878231  50878232  50881328  50881393  50881394  50881395  50881506  50881511  50881512  50882753  50886316  50886467  50886468  50886469  50888285  50888286  50888287  50888373  50890483  50890484  50890485  50892357  50892358  50892359  50892360  60000321  60000790  60000833  60000835  60000914  60000973  60001065  60001078  60001558  60001766  60001767  60001864  60002113  60002164  60002324  60002467  60002845  60002846  60003127  60003128  60003256  60003265  60003368  60003703  60004022  60004099  60004159  60004454  60004625  60004711  60005487  60006206  60006545  60006624  60007219  60007220  60007221  60007925  60008270  60008271  60008539  60008540  60008541  ",9/30/2016,"09/30/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75388,"Terminated","Akita Sumitomo Bakelite Co., Ltd.","27-4, Aza Nakajimita",,"Akita",,,"Japan","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US in the states of MA","Z-0389-2017","Class II","SB (Sumitomo Bakelite Co.,) Electrosurgical Knife  Size: Working Length 1.8M Maximum OD 2.6mm.      Product Usage:  The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.  ","8 units","Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type","11/09/2016","11/10/2016"," Lot No.: 60564713",9/9/2016,"09/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75388,"Terminated","Akita Sumitomo Bakelite Co., Ltd.","27-4, Aza Nakajimita",,"Akita",,,"Japan","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US in the states of MA","Z-0388-2017","Class II","SB  Knife -Electrosurgical Knife, Sterile  Size:  Working Length 2.3M Maximum OD 2.6mm.    Product Usage:  The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.  ","15 units","Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long","11/09/2016","11/10/2016"," Lot No.: 60564711",9/9/2016,"09/09/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75389,"Ongoing","Mel-O Cream Donuts International, Inc.","5456 International Pkwy",,"Springfield","IL","62711-7086","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI, IL, OH","F-0548-2017","Class II","Hy Vee Shells (Bavarian Filled);  Best If Used By 02/25/2017; Batch 162724703; NET WT 26.48 Pounds; Approximate Unit Count: 84 units","24 cases","Human fingertip found in product filling line. ","11/25/2016",," Product Code: 63222; Batch 162724703; UPC: 4792463222; Best If Used By 02/25/2017",10/3/2016,"10/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75389,"Ongoing","Mel-O Cream Donuts International, Inc.","5456 International Pkwy",,"Springfield","IL","62711-7086","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI, IL, OH","F-0543-2017","Class II","Jumbo Ring Donut; Best If Used By 02/26/2017; Approximate Unit Count: 84 Units;  Brands: Mel-O-Cream and Hy-Vee","544 cases","Human fingertip found in product filling line. ","11/25/2016",," Product Code: 33010, 63000; Batch 162734721, 162734722; UPC: 44792433010, 4792433000; Best If Used By 02/26/2017",10/3/2016,"10/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75389,"Ongoing","Mel-O Cream Donuts International, Inc.","5456 International Pkwy",,"Springfield","IL","62711-7086","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI, IL, OH","F-0547-2017","Class II","Hy Vee Long Shells (Red Raspberry Filled); Best If Used By 02/26/2017; Batch 162734720; NET WT 26.48 Pounds; Approximate Unit Count: 84 units","93 cases","Human fingertip found in product filling line. ","11/25/2016",," Product Code: 63221; Batch 162734720; UPC: 4792463221; Best If Used By 02/26/2017",10/3/2016,"10/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75389,"Ongoing","Mel-O Cream Donuts International, Inc.","5456 International Pkwy",,"Springfield","IL","62711-7086","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI, IL, OH","F-0541-2017","Class II","Arrowhead/Christmas Tree Shells; Best If Used By 02/26/2017; Batch 162734737; NET WT 12 Pounds; Approximate Unit Count [Per Case]: 8 Dozen [96 units]","20 cases ","Human fingertip found in product filling line. ","11/25/2016",," Product Code: 23520; Batch: 162734737; UPC: 4792423520; Best If Used By 02/26/2017",10/3/2016,"10/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75389,"Ongoing","Mel-O Cream Donuts International, Inc.","5456 International Pkwy",,"Springfield","IL","62711-7086","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI, IL, OH","F-0542-2017","Class II","Star Shaped Shells;  Best If Used By 02/26/2017; Batch 162734736; NET WT 11.46 Pounds; Approximate Unit Count [Per Case]: 9 Dozen [108 units]","9 cases","Human fingertip found in product filling line. ","11/25/2016",," Product Code: 23510; Batch 162734736; UPC: 4792423510; Best If Used By 02/26/2017",10/3/2016,"10/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75389,"Ongoing","Mel-O Cream Donuts International, Inc.","5456 International Pkwy",,"Springfield","IL","62711-7086","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI, IL, OH","F-0545-2017","Class II","Fried Danish; Best If Used By 02/25/2017; Batch 162724711; NET WT 11.25 Pounds; Approximate Unit Count: 89 pcs.","23 cases","Human fingertip found in product filling line. ","11/25/2016",," Product Code: 33600; Batch 162724711; UPC: 4792433800; Best If Used By 02/25/2017",10/3/2016,"10/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75389,"Ongoing","Mel-O Cream Donuts International, Inc.","5456 International Pkwy",,"Springfield","IL","62711-7086","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI, IL, OH","F-0546-2017","Class II","Hy Vee Long Johns (Red Raspberry Filled); Best If Used By 02/25/2017; Batch 162724690; NET WT 14.63 Pounds; Approximate Unit Count: 72 units","3 cases","Human fingertip found in product filling line. ","11/25/2016",," Product Code: 63171; Batch 162724690; UPC: 4792403171; Best If Used By 02/25/2017",10/3/2016,"10/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75389,"Ongoing","Mel-O Cream Donuts International, Inc.","5456 International Pkwy",,"Springfield","IL","62711-7086","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI, IL, OH","F-0544-2017","Class II","Jumbo Apple Fritter; Approximate Unit Count: 6 Dozen; Mel-O-Cream Donuts Intl. Inc. Springfield, IL 62711","196 cases","Human fingertip found in product filling line. ","11/25/2016",," Product Code: 33401, 33452; Batch 162734729, 162724700; UPC: 4792433401, 4792433452;  Best If Used By 02/25-26/2017",10/3/2016,"10/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75389,"Ongoing","Mel-O Cream Donuts International, Inc.","5456 International Pkwy",,"Springfield","IL","62711-7086","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","WI, IL, OH","F-0540-2017","Class II","Jumbo Pershing (Cinnamon) Rolls; NET WT 11.25 and 16.1 Pounds; Approximate Unit Count [Per Case]: 6-8 Dozen; Brands: Mel-O-Cream and Hy-Vee","226 cases","Human fingertip found in product filling line. ","11/25/2016",," Product Codes: 23251, 23250, 63251; Batch 162764724, 162734725,162734723;  UPC: 4792423251, 4792423250, 4792463251; Best If Used By 02/26/2017",10/3/2016,"10/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75390,"Ongoing","Rikki USA, Inc.","14590 NE 95th St",,"Redmond","WA","98052-2550","United States","Voluntary: Firm Initiated","E-Mail","distributed in MD and OR.","F-0377-2017","Class III","***HOLLANDAISE SAUSE***Use on chicken, seafood and vegetables***.","125 cases (or 750/7 oz. tubs total)","Hollandaise Sauce was recalled due to presence of mold.","11/02/2016",," Lot  # 1640288. Best by: 11-22-2016",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75391,"Ongoing","Mccormick","226 Schilling Cir",,"Hunt Valley","MD","21031-8647","United States","Voluntary: Firm Initiated","Press Release","Nationwide Distribution.  Not distributed to any Foreign Countries or Governmental Agencies.","F-0280-2017","Class I","Club Size McCormick Original Taco Seasoning Mix 24 oz. ,   CASE PACK: 12/case","14,570 individual 24 ounce containers are in commerce.","Product was recalled due to undeclared milk. ","10/27/2016",," UPC NUMBER:  52100302461  MCCORMICK ITEM NUMBER:  930246 or 900272507  SCC NUMBER ON SHIPPER: 52100302461 or 52100012476    AFFECTED DATE CODE FOR FOLLOWING ITEM NUMBERS:  932046 - BEST BY JUL 08 18 H through BEST BY SEPT 16 18 H; 900272507 - BEST BY JUN 27 18 H through BEST BY SEPT 16 18 H  ",9/17/2016,"09/17/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75393,"Ongoing","St Jude Medical Inc.","15900 Valley View Ct",,"Sylmar","CA","91342-3577","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and OUS","Z-0115-2017","Class I","Fortify VR, Model No. CD1231-40, CD1231-40Q.  Fortify ST VR, Model No. CD1241-40, CD1241-40Q.  Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C.  Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q.  Fortify DR, Model No. CD2231-40, CD2231-40Q.  Fortify ST DR, Model No. CD2241-40, CD-2241-40Q, CD2263-40, CD2363-40C, CD2363-40Q.  Fortify Assura DR, Model No. CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q.  Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing   ","204,785 units","St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization  therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit. ","10/21/2016",,"  Serial  607591  607592  607593  607594  607595  607596  607597  607598  607599  607600  607801  607802  607803  607804  607805  607806  607807  607808  607809  607810  607811  607812  607813  607814  607815  607816  607817  607818  607819  607820  607911  607912  607913  607914  607915  607916  607917  607918  607919  607920  607921  607922  607923  607924  607925  607927  607928  607929  607930  608221  608222  608223  608224  608225  608226  608227  608228  608229  608230  608231  608232  608233  608234  608235  608236  608237  608238  608239  608240  608241  608242  608243  608244  608245  608246  608247  608248  608249  608250  608391  608392  608393  608394  608395  608396  608397  608398  608399  608400  608401  608402  608403  608404  608405  608406  608407  608408  608409  608410  608531  608532  608533  608534  608535  608536  608537  608538  608539  608540  608541  608542  608543  608544  608545  608546  608547  608548  608549  608550  608671  608672  608673  608674  608675  608676  608677  608678  608679  608680  608681  608682  608683  608684  608685  608686  608687  608688  608689  608690  608801  608802  608803  608804  608805  608806  608807  608808  608809  608810  608931  608932  608933  608935  608936  608937  608938  608939  608940  609071  609072  609073  609074  609075  609076  609078  609079  609080  609211  609212  609213  609214  609215  609217  609218  609219  609220  609351  609352  609353  609354  609355  609356  609357  609359  609360  609491  609492  609493  609494  609495  609496  609497  609498  609499  609500  609631  609632  609633  609635  609636  609637  609638  609639  609640  609771  609772  609773  609774  609775  609776  609777  609778  609779  609780  609911  609912  609913  609914  609915  609916  609917  609918  609919  609920  610051  610052  610053  610054  610055  610056  610057  610058  610059  610060  610261  610262  610263  610264  610265  610266  610267  610268  610269  610270  610411  610412  610413  610414  610415  610416  610417  610418  610419  610420  610",10/10/2016,"10/10/2016",11/2/2016,"11/02/2016","  737876  737877  737878  737879  737880  737881  737882  737884  737885  737886  737887  737888  737889  737890  737891  737892  737893  737894  737895  737896  737897  737898  737899  737900  737901  737902  737904  737905  737906  737907  737908  737909  737910  737911  737912  737913  737915  737916  737917  737918  737919  737920  737921  737922  737924  737925  737927  737928  737929  737930  737931  737932  737934  737935  737936  737937  737938  737939  737940  737941  737943  737944  737945  737946  737948  737949  737950  737951  737953  737954  737955  737956  737957  738918  738919  738920  738921  738922  738923  738924  738925  738926  738927  738929  738931  738934  738935  738936  738937  738938  738940  738941  738942  738943  738944  738945  738947  738948  738949  738950  738951  738952  738953  738954  738955  738956  738957  738958  738959  738961  738962  738963  738964  738965  738966  738967  738969  738970  738971  738972  738973  738974  738975  738976  738977  738978  738979  738980  738981  738982  738983  738984  738985  738986  738987  738988  738989  738990  738991  738992  738993  738994  738995  738996  738997  738998  738999  739000  739001  739003  739004  739005  739006  739007  739008  739009  739010  739011  739013  739014  739015  739016  739017  739218  739219  739220  739221  739222  739223  739224  739225  739226  739227  739229  739230  739231  739233  739234  739236  739237  739238  739239  739240  739241  739242  739243  739244  739246  739247  739248  739249  739251  739252  739253  739254  739255  739256  739257  739258  739259  739261  739262  739263  739264  739265  739266  739267  739268  739269  739270  739271  739272  739273  739274  739275  739276  739277  739278  739279  739280  739281  739282  739283  739284  739286  739287  739288  739289  739290  739291  739292  739293  739294  739295  739296  739297  739299  739300  739301  739302  739303  739305  739306  739307  739308  739309  739310  739311  739312  739313  739314  739315  739316  739317  739424  739","54  613385  613386  613387  613388  613389  613390  613391  613392  613393  613394  613525  613526  613527  613528  613529  613530  613531  613532  613533  613534  613665  613666  613667  613668  613669  613670  613671  613672  613673  613674  613805  613806  613807  613808  613809  613810  613811  613812  613813  613814  613815  613816  613817  613818  613819  613820  613821  613822  613823  613824  613825  613826  613827  613828  613829  613830  613831  613832  613833  613834  613945  613946  613947  613948  613949  613950  613951  613952  613953  613954  614085  614086  614087  614088  614089  614090  614091  614092  614093  614094  614225  614226  614227  614228  614229  614230  614231  614232  614233  614234  614365  614366  614367  614368  614369  614370  614371  614372  614373  614374  614505  614506  614507  614508 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"Devices",75393,"Ongoing","St Jude Medical Inc.","15900 Valley View Ct",,"Sylmar","CA","91342-3577","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and OUS","Z-0116-2017","Class I","Unify, Model No. CD3231-40, CD3231-40Q.  Unify Quadra, Model No. CD3249-40, CD3249-40Q.  Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q.  Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing.","204,785 units","St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization  therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit. 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"Devices",75393,"Ongoing","St Jude Medical Inc.","15900 Valley View Ct",,"Sylmar","CA","91342-3577","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and OUS","Z-0117-2017","Class I","Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q.  Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C.  Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing","193,954 units","St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization  therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit. 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7015830  7015831  7015832  7015833  7015834  7015835  7015836  7015837  7015838  7015839  7015840  7015841  7015842  7016463  7016464  7016465  7016466  7016467  7016468  7016469  7016470  7016471  7016472  7016788  7016789  7016790  7016791  7016792  7016793  7016794  7016795  7016796  7016797  7016798  7016799  7016800  7016801  7016802  7016803  7016804  7016805  7016806  7016807  7017198  7017199  7017200  7017201  7017202  7017203  7017204  7017205  7017206  7017207  7017208  7017209  7017210  7017211  7017212  7017213  7017214  7017215  7017216  7017217  7017498  7017499  7017500  7017501  7017502  7017503  7017504  7017505  7017506  7017507  7017508  7017509  7017510  7017511  7017512  7017513  7017514  7017515  7017516  7017517  7017698  7017699  7017700  7017701  7017702  7017703  7017704  7017705  7017706  7017707  7017708  7017709  7017710  7017711  7017712  7017713  7017714  7017715  7017716  7017717  7018468  7018469  7018470  7018471  7018472  7018473  7018474  7018475  7018476  7018477  7018478  7018479  7018480  7018481  7018482  7018483  7018484  7018485  7018486  7018487  7018488  7018489  7018490  7018491  7018492  7018493  7018494  7018495  7018496  7018497  7018818  7018819  7018820  7018821  7018822  7018823  7018824  7018825  7018826  7018827  7018828  7018829  7018830  7018831  7018832  7018833  7018834  7018835  7018836  7018837  701902"," 7054254  7054255  7 054256  7054257  7054258  7054259  7054260  7054261  7054262  7054263  7054264  7054265  7054266  7054267  7054268  7054269  7054270  7054271  7054272  7054273  7054274  7054275  7054276  7054277  7054278  7054279  7054280  7054281  7054282  7054283  7054284  7054285  7054286  7054287  7054288  7054289  7054290  7054291  7054292  7054293  7054294  7054295  7054296  7054297  7054298  7054299  7054300  7054521  7054522  7054523  7054524  7054525  7054526  7054527  7054528  7054529  7054530  7054531  7054532  7054533  7054534  7054535  7054536  7054537  7054538  7054539  7054540  7054541  7054542  7054543  7054544  7054545  7054546  7054547  7054548  7054549  7054550  7054551  7054552  7054553  7054554  7054555  7054556  7054557  7054558  7054559  7054560  7054761  7054762  7054763  7054764  7054765  7054766  7054767  7054768  7054769  7054770  7054771  7054773  7054774  7054775  7054776  7054777  7054778  7054779  7054780  7054781  7054782  7054783  7054784  7054785  7054786  7054787  7054789  7054790  7057747  7057748  7057749  7057750  7057751  7057752  7057753  7057754  7057755  7057756  7057757  7057759  7057760  7057761  7057762  7057763  7057764  7057765  7057766  7057767  7057768  7057769  7057770  7057771  7057772  7057773  7057774  7057775  7057776  7057777  7057778  7057779  7057780  7057782  7057783  7057784  7057785  7057786  7057977  7057978  7057979  7057980  7057981  7057982  7057983  7057984  7057985  7057986  7057987  7057988  7057989  7057990  7057991  7057992  7057994  7057995  7057996  7057997  7057998  7057999  7058000  7058001  7058002  7058003  7058004  7058005  7058006  7058007  7058008  7058009  7058010  7058011  7058012  7058013  7058014  7058015  7058016  7058017  7058018  7058019  7058020  7058021  7058022  7058023  7058024  7058025  7058026  7058027  7058028  7058029  7058030  7058031  7058032  7058033  7058034  7058035  7058036  7058037  7058038  7058039  7058040  7058041  7058042  7058043  7058044  7058045  7058046  7058507  7058508  7058509  7058510  7058511  ",
"Devices",75394,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Afghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil,  Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt,  Finland, France, French Polynesia, Georgia, Germany, Great Britain, Greece, Guadeloupe,  Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Jordan, Latvia, Lebanon,  Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Nepal, Netherlands,  New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar,  Romania, Russian Federation, Saudi Arabia, Singapore, Serbia, Slovakia, South Africa, South  Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates,  Uruguay, Vietnam","Z-0397-2017","Class II","Siemens ADVIA Centaur¿ Vitamin D Total Assay  SMN 10699201 (100 test)","69781 kits","Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples","11/11/2016",," All  lot codes",10/5/2016,"10/05/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75394,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Afghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil,  Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt,  Finland, France, French Polynesia, Georgia, Germany, Great Britain, Greece, Guadeloupe,  Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Jordan, Latvia, Lebanon,  Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Nepal, Netherlands,  New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar,  Romania, Russian Federation, Saudi Arabia, Singapore, Serbia, Slovakia, South Africa, South  Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates,  Uruguay, Vietnam","Z-0398-2017","Class II","Siemens ADVIA Centaur¿ Vitamin D Total Assay  SMN SMN 10699533 (500 test)","37437 kits","Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples","11/11/2016",," All lot codes",10/5/2016,"10/05/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75395,"Ongoing","SentreHeart Inc","300 Saginaw Dr",,"Redwood City","CA","94063-4743","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany","Z-0328-2017","Class I","FindrWIRZ Guidewire System Catalog# 40-05    Cardiology:  The system is intended for use in the cardiovascular system for  introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures. ","132 worldwide distribution (98) of those units in US","A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three  FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.","11/09/2016",," Lot# 01160568 . Lot#02160586, (no products shipped from this lot)  Lot# 07160639 -150  ",9/29/2016,"09/29/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75396,"Ongoing","Nestle Dreyer's Ice Cream Company","7301 District Blvd",,"Bakersfield","CA","93313","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","United States Only. See consignee lists.","F-0277-2017","Class II","Nestle Drumstick Club variety -  16x4.6floz US  UPC# 72554-11096  Best Before Date: Between June 2 - June 15, 2017","103366 cases"," Nestl¿ USA, Inc. is initiating a voluntary recall of its Nestl¿ Drumstick Club 16 count Variety Pack and 24 count Vanilla Pack (with cones marked for easy individual sale) due to possible  Listeria monocytogenes (LM) from equipment contact surfaces from a location on the production line where these products are made.","10/25/2016",," UPC:  72554-11096    Production Code:  6244580212  6245580212  6246580212  6247580212  6248580212  6249580212  6250580212  6251580212  6252580212  6253580212  6254580212  6255580212  6256580212  6257580212  ",10/7/2016,"10/07/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75396,"Ongoing","Nestle Dreyer's Ice Cream Company","7301 District Blvd",,"Bakersfield","CA","93313","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","United States Only. See consignee lists.","F-0278-2017","Class II","Nestle Drumstick Vanilla pack- 24x4.6fl oz US  UPC# 72554-00160  Best Before Date: Between June 16 - June 19, 2017","12699 cases"," Nestl¿ USA, Inc. is initiating a voluntary recall of its Nestl¿ Drumstick Club 16 count Variety Pack and 24 count Vanilla Pack (with cones marked for easy individual sale) due to possible  Listeria monocytogenes (LM) from equipment contact surfaces from a location on the production line where these products are made.","10/25/2016",," UPC:  72554-00160    Production Code:  6258580212  6259580212  6260580212  6261580212  ",10/7/2016,"10/07/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75397,"Ongoing","Le Petit Belge","1311 E 34th St",,"Brooklyn","NY","11210-4819","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas, Maryland, California, Illinois, and Canada","F-0310-2017","Class I","BELGIAN BOYS MINI PANCAKES, NET WT. 10.6 oz (300g), 36 Count, UPC 857290005204, Product of The Netherlands --- Produced exclusively for Belgian Boys, 140 Carolyn Blvd., Farmingdale, NY 11735","US: 240 cases (12 units per case); Canada: 240 cases (12 units per case)","The product/lot contains undeclared milk.","10/28/2016",," Lot 20432, Best Before Jul 07 2017",10/7/2016,"10/07/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75398,"Ongoing","Professional Botanicals","1069 Stewart St",,"Ogden","UT","84404-1351","United States","Voluntary: Firm Initiated","Letter","Nationwide. No VA/govt/military, Canadian, or other foreign consignees.","F-0351-2017","Class I","Professional Botanicals MealPlex (756 grams) and Veo Natural Pearl 3.0 (378 grams) Ultimate Meal Drinks in Plastic Tub Containers.  Dietary Supplement. ","192","Professional Botanicals announces a voluntary field action for MealPlex and Pearl due to undeclared milk allergen. ","11/08/2016",," Lot# 032119",10/5/2016,"10/05/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75402,"Ongoing","Mars Petcare USA","315 Cool Springs Blvd",,"Franklin","TN","37067-1632","United States","Voluntary: Firm Initiated","Letter","US nationwide.  The products were shipped to three government facilities. The products were distributed to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA SC, TN, TX, UT, VA, VT, and WI.","V-0049-2017","Class I","CESAR Classics Filet Mignon Flavor, 100 g (3.5 oz) in plastic trays, 24 or 30 trays/case","54,255 cases","There is a potential presence of white plastic in the finished product.","12/21/2016",," 631FKKC, 631GKKC, 632D14JC, 633B24JC, 634A14JC, 634A24JC, 634B14JC, 634B24JC, 634E14JC, 635A24JC, 635B14JC, 636D24JC, and 636E14JC;    Best Before Dates 08/04/18 and 08/05/18.   Best Before: 08/04/2016 and 08/05/2016",10/7/2016,"10/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75403,"Ongoing","One Lambda Inc","21001 Kittridge St",,"Canoga Park","CA","91303-2801","United States","Voluntary: Firm Initiated","E-Mail","Nationwide U.S. distribution    Foreign distribution to the following; United Arab Emirates, Argentina, Australia, Brazil, Chile, China, Costa Rica, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, United Kingdom, Greece, Guatemala, Indonesia, India, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Kazakhstan, Lebanon, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Quatar, Russia, Saudi Arabia, Sweden, Thailand, Turkey, Taiwan, Vietnam, South Africa, and Canada.","B-0085-2017","Class III","LABType SSO Typing Tests    Model No.:  RSSO2B1, RSO2B1T, RSSOH2B1,  RSOH2B1T, RSSOH2B1X, RSSO2Q,  RSSO2QX, RSO2QT, RSSOMICA,  RSSO1S4, RSO1S4T, RSSOX2B1","15,750 test kits","HLA test kits containing lot specific user documents, misbranded with incorrect allele specificity  information, were distributed. ","10/18/2016",," Cat ID  RSSO2B1  (Lot 018)    Batch  031, 32, 33, 34, 36, 37, 38, 39, 40, 41, 42, 0000057023, 0000057026, 0000059795, 0000060110, 0000062200, 0000062969, 0000063379, 0000066581, 0000070108, 0000071031, 0000076607, 0000077580, 0000078201, 0000079037, 0000079811, 0000080301, 0000087412, 0000087909, 0000089414, 0000097258, 0000103005, 0000107016, 0000114081, 0000114736, 0000120357    Cat ID  RSSO2B1  (Lot 019)    Batch  0000120363, 0000124377, 0000119913    Cat ID  RSO2B1T  (Lot 018)    Batch  011, 012, 0000053117, 0000055412, 0000055832, 0000063644, 0000064406, 0000071285, 0000084881, 0000085909, 0000112558, 0000117677    Cat ID  RSO2B1T  (Lot 019)    Batch  0000120892    Cat ID  RSSOH2B1  (Lot 009)    Batch  033, 034, 035, 036, 0000053275, 0000057250, 0000058667, 0000061327,  0000062968, 0000063092, 0000063728, 0000053070, , 0000071281, 0000074348, 0000079511, 0000081969, 0000084459, 0000092756, 0000094518    Cat ID  RSSOH2B1  (Lot 010)    Batch  0000110068, 0000110548, 0000114596, 0000115883, 0000118315, 0000120362, 0000120642    Cat ID  RSOH2B1T  (Lot 009)    Batch  010, 011, 0000054823, 0000064410, 0000064952, 0000066808, 0000089318    Cat ID  RSOH2B1T  (Lot 010)    Batch  0000110547    Cat ID  RSSOH2B1X  (Lot 009)    Batch  0000064446, 0000070911    Cat ID  RSSOH2B1X  (Lot 010)    Batch  0000111323, 0000124895    Cat ID  RSSO2Q  (Lot 010)    Batch  002, 003, 004, 005, 006, 007, 008, 009, 0000054593, 0000055231, 0000056058, 0000060053, 0000060784, 0000061599, 0000062603, 0000063652, 0000066921, 0000070566, 0000076222, 0000077803, 0000078350, 0000079319, 0000079929, 0000081865, 0000083143, 0000084412, 0000085077, 0000087193, 0000087755,  0000091499, 0000097260, 00000101211, 0000102893, 0000105847, 0000107310, 0000108579, 0000116017, 0000118442, 0000124698, I000094035         Cat ID  RSSO2QX  (Lot 010)    Batch  0000062810, 0000064445, 0000070913, 0000112688, 0000112690, 0000118313    Cat ID  RSO2QT  (Lot 010)    Batch  002, 003, 004, 005, 0000056055, 0000060877, 0000063729, 0000064407, 0000066546, 0000054510",9/29/2016,"09/29/2016",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75404,"Completed","Handicare USA, Inc.","2201 Hangar Pl","Ste 200","Allentown","PA","18109-9342","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : NY, NJ,  NV, NE,  IL, CT, PA and ME","Z-0303-2017","Class II","ReTurn 7500/7500  Aid, transfer","29 units , plus 47 wing handles were shipped as spare parts","During the period of April 2009  May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder. ","10/24/2016",," Model # 7400, 7500 and 7322 (spare part)  Serial # 373317697270501334, 373317697270501430, 073317697400500012, 073317697400500057",4/15/2014,"04/15/2014",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75405,"Completed","Wells Enterprises, Inc.","1 Blue Bunny Dr SW","PO Box 1310","Le Mars","IA","51031-2207","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed to NE, OK, KS, MO, AZ, and TX.","F-0479-2017","Class I","Blue Bunny Ice Cream Hoppin' Holidoodle ice cream 46 fl. oz. UPC 070640014644 and UPC 070640014651 (high altitude).  ","7192 cases","Product may be contaminated with Listeria Monocytogenes.","11/18/2016","."," UPC 070640014644  LOT 60001 MM 19115 6228  BEST IF USED BY 02/13/18; and    UPC 070640014651  (High altitude)  LOT 60001 MM 19115 6229  BEST IF USED BY 02/14/18",10/10/2016,"10/10/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75406,"Ongoing","Chocolate Shoppe Ice Cream Co., Inc.","2221 Daniels St",".","Madison","WI","53718-6745","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, ND, NE, OH, OK, PA, SC, TX, WA, WI, WV  EXPANDED  STATES AFFECTED  AL, AZ, CA, FL, IA, IL, IN, MI, MN, NE, OH, PA, SC, VT, WA & WI.","F-0573-2017","Class I","Peanut Butter Cookie Dough Ice Cream, 3 gallons; UPC 40994-42487","3,209 3 Gallon Cartons & 816 Pints total EXPANDED 3,301 3 Gallon Cartons & 984 Pints total","The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes.       EXPANDED 11/10/2016  Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.","12/06/2016",," Code Dates:  12/1/17 and 11/18/17. EXPANDED 10/9/17, 10/18/17 & 11/1/17",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75406,"Ongoing","Chocolate Shoppe Ice Cream Co., Inc.","2221 Daniels St",".","Madison","WI","53718-6745","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, ND, NE, OH, OK, PA, SC, TX, WA, WI, WV  EXPANDED  STATES AFFECTED  AL, AZ, CA, FL, IA, IL, IN, MI, MN, NE, OH, PA, SC, VT, WA & WI.","F-0571-2017","Class I","Cookie Dough Ice Cream packed under the following brand names and sizes:    1.  Chocolate Shoppe Ice Cream Company,  3 gallons, UPC 40994-42109  2.  Chocolate Shoppe Ice Cream Company, pint;  UPC 40994-12109  3.  The Baked Bear, 3 gallons; UPC 40994-72093","3,209 3 Gallon Cartons & 816 Pints total  EXPANDED 11/10/2016 3,301 3 Gallon Cartons & 984 Pints total","The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes.       EXPANDED 11/10/2016  Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.","12/06/2016",," Code Dates:    Product 1:  12/29/17, 12/19/17, 12/13/17, 12/6/17, 11/26/17, and 11/15/17. EXPANDED 10/15/17, 10/21/17, 11/1/17 & 11/8/17.  Product 2:  12/13/17, 12/9/17, and 11/26/17. EXPANDED 10/21/17.  Product 3:  12/6/17, 11/26/17, and 11/15/17 EXPANDED 10/13/17, 10/15/17, 10/21/17, 11/1/17.",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75406,"Ongoing","Chocolate Shoppe Ice Cream Co., Inc.","2221 Daniels St",".","Madison","WI","53718-6745","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, ND, NE, OH, OK, PA, SC, TX, WA, WI, WV  EXPANDED  STATES AFFECTED  AL, AZ, CA, FL, IA, IL, IN, MI, MN, NE, OH, PA, SC, VT, WA & WI.","F-0574-2017","Class I","Sticks & Stones Ice Cream, 3 gallons; UPC 40994-42593","3,209 3 Gallon Cartons & 816 Pints total EXPANDED 3,301 3 Gallon Cartons & 984 Pints total","The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes.       EXPANDED 11/10/2016  Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.","12/06/2016",," Code Dates:  12/27/17, 12/2/17,and 11/10/17. EXPANDED 10/26/17",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75406,"Ongoing","Chocolate Shoppe Ice Cream Co., Inc.","2221 Daniels St",".","Madison","WI","53718-6745","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, ND, NE, OH, OK, PA, SC, TX, WA, WI, WV  EXPANDED  STATES AFFECTED  AL, AZ, CA, FL, IA, IL, IN, MI, MN, NE, OH, PA, SC, VT, WA & WI.","F-0575-2017","Class I","Yippee Skippee Ice Cream, 3 gallons; UPC 40994-42879","3,209 3 Gallon Cartons & 816 Pints total EXPANDED 3,301 3 Gallon Cartons & 984 Pints total","The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes.       EXPANDED 11/10/2016  Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.","12/06/2016",," Code Dates:  12/1/17",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75406,"Ongoing","Chocolate Shoppe Ice Cream Co., Inc.","2221 Daniels St",".","Madison","WI","53718-6745","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AL, AZ, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, ND, NE, OH, OK, PA, SC, TX, WA, WI, WV  EXPANDED  STATES AFFECTED  AL, AZ, CA, FL, IA, IL, IN, MI, MN, NE, OH, PA, SC, VT, WA & WI.","F-0572-2017","Class I","Heaps of Love Ice Cream, 3 gallons; UPC 40994-43251","3,209 3 Gallon Cartons & 816 Pints total EXPANDED 3,301 3 Gallon Cartons & 984 Pints total","The Chocolate Chip Cookie Dough pieces in the ice cream have the potential to be contaminated with Listeria monocytogenes.       EXPANDED 11/10/2016  Recall has been expanded after being notified by supplier of cookie dough pieces, that their recall was expanded.","12/06/2016",," Code Dates:  12/29/17, 11/24/17, and 11/8/17. EXPANDED 10/20/17, 10/28/17 & 11/8/17",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75407,"Ongoing","Roland Foods, LLC.","71 W 23rd St",,"New York","NY","10010-4102","United States","Voluntary: Firm Initiated","Press Release","Nationwide, Canada, and Nether Antilles","F-0369-2017","Class II","Roland¿ Preserved Lemons, NET WT. 12.35 OZ., and Roland¿ PRESERVED LEMONS - BELDI, NET WT. 13 OZ., Item UPC 4122461002 and Case UPC 10041224610023 -- PACKED EXCLUSIVELY FOR ROLAND FOODS LLC, NEW YORK, NY 10010 --- The product is packed in a glass jar.","905 cases (12 jars per case)","The product contains undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets and private laboratory testing. ","10/28/2016",," Lot # 20, Production Codes DA:169Z  P:0618 (ink jet printed on the jar lid); Lot # 21, Production Code P:Q0303 (ink jet printed on the jar lid);  Item # 61002 (on case label) ",10/11/2016,"10/11/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75408,"Ongoing","Nova Ortho-Med Inc","1470 Beachey Pl",,"Carson","CA","90746-4002","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: CA, IN, HI, CT, UT, WA, FL, VA, WI, OH, MN, KS, MD, IL, MO, WY, MT, ME, PA, TN, MI, OR, NY, NJ, ID, NC, IA, OK, AR, VT, SC, TX","Z-0304-2017","Class II","4205 Journey Rolling Walker     Product Usage:  used to assist people in walking     ","1,380 units","Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out. ","10/24/2016",," Serial No.  YA 4205RDFG004 TO YA4205RDFG0098  YZ4205BKFC0002 TO YZ4205RDFE0100  ",10/1/2016,"10/01/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75409,"Ongoing","Stryker Sustainability Solutions","1810 W Drake Dr",,"Tempe","AZ","85283-4327","United States","Voluntary: Firm Initiated","Letter","U.S. distribution to the following; AZ, MN and MO.","Z-0380-2017","Class II","Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters    Model Numbers:   401940, 402004    UPC Code:  00885825007409  00885825007744    Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes.    Reprocessed Diagnostic EP Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.","4 devices","The EP Catheters may be mislabeled for French size during reprocessing.","11/09/2016",," Item Number Serial Number Manufacturing Date  401940 1902898 3/31/2015  401940 1908621 3/31/2015  402004 1902392 1/9/2015  402004 1902389 1/9/2015",10/6/2016,"10/06/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75410,"Ongoing","Norbrook Inc","9733 Loiret Blvd",".","Lenexa","KS","66219-2409","United States","Voluntary: Firm Initiated",,"Product was distributed to FL, IA, KS, KY, LA, MO, MN, ND, NE, OK, and Puerto Rico.","V-0030-2016","Class II","Hexasol Injection (oxytetracycline and flunixin meglumine) 300 mg oxytetracycline and 20 mg flunixin per mL; NADA 141-312; packaged in a 250 mL (NDC 55529-016-04) and 500 mL (NDC 55529-016-05)  vials; packed in boxes of 6 vials.  The responsible name on the label is Norbrook Laboratories Limited, Northern Ireland.","8907 vials","Crystallization; crystals observed suspended in the injectable solution.","12/02/2016",," Lot numbers: 5281-94A (250 ml) and 5281-95A (500 ml)  Expiration date:  July 2017",10/10/2016,"10/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75411,"Ongoing","Cinnabar Specialty Foods, Inc.","1134 Haining St",,"Prescott","AZ","86305-1654","United States","Voluntary: Firm Initiated","Letter","US: AZ, CA, ID, MT, WI, WA","F-0704-2017","Class II","Neeras Spicy Thai Sauce and Marinade, Net Volume 150ml/5 fl. oz.., 12 units/case, or 6 units/partial case, 2.0 gallon pail.  ","41 units","Product contains undeclared wheat.","12/15/2016",," 042817, 101917, 120317, 033018, 051018, 062118, 083118",10/13/2016,"10/13/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75412,"Ongoing","Trumpf Medical Systems, Inc.","1046 Legrand Blvd",,"Charleston","SC","29492-7672","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide in the states of AZ and SC and the countries of  Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, Switzerland","Z-0391-2017","Class II","OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799    Product Usage:  Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.  ","4 (US) & 229 (Foreign)","Trumpf has identified six incidents of pinched cables.","11/09/2016",," Model # 190973 - Serial Number Range 102394262 - 102974610; Model # 1909794 - 102884276; Model # 1909796 - 102440024 - 102981676; Model # 1909797 - 102757564 - 102958935; Model # 1909798 - 102831498 - 102831519; Model # 1909799 - 102393683 - 102969656",10/25/2016,"10/25/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75413,"Ongoing","Unilever United States, Inc.","800 Sylvan Ave",,"Englewood Cliffs","NJ","07632-3113","United States","Voluntary: Firm Initiated","Letter","Nationwide","F-0833-2017","Class II","Ben & Jerrys Brownie Batter Core Ice Cream One Pint (473 mL).  Case UPC- 10076840529879  Consumer UPC - 7684052987    Paper carton  8 units per shrink-wrapped case  Frozen","194,952 units","Certain pints of Ben & Jerrys Brownie Batter Core Ice Cream may contain soft plastic pieces.","12/21/2016",," Best by dates of MAR0418BJ, MAR0518BJ",10/12/2016,"10/12/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75414,"Ongoing","Baxter Healthcare Corp.","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.","Z-0370-2017","Class II","GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634      Product Usage:  The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.    ","22,656 units","Potential presence of particulate matter on the blood side of the dialyzer","11/08/2016",," C416201601",10/12/2016,"10/12/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75415,"Ongoing","North American Rescue LLC.","35 Tedwall Ct",".","Greer","SC","29650-4791","United States","Voluntary: Firm Initiated","Letter","Nationwide, Australia & Switzerland","D-0178-2017","Class II","Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue","unknown","Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.","12/08/2016",," Kit Part # 85-0742  Kit Lot # 85-0742071816; Kit Part # 85-0748  Kit Lot # 85-0746061016; Kit Part # 85-0745 - Kit Lot # 85-0745042516; Kit Part # 85-0639 - Kit Lot # 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639090716, 85-0639080116, 85-0639091316; Kit Part # 85-0744 - Kit Lot # 85-0744072516, 85-0744060916, 85-0744052516; Kit Part # 85-0741- Kit Lot # 85-0741071416",9/27/2016,"09/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75415,"Ongoing","North American Rescue LLC.","35 Tedwall Ct",".","Greer","SC","29650-4791","United States","Voluntary: Firm Initiated","Letter","Nationwide, Australia & Switzerland","D-0180-2017","Class II","Amphibious Trauma Kit - Product Code 85-0639,  North American Rescue","unknown","Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.","12/08/2016",," Kit Part # 85-0639 - Kit Lot # 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639091316",9/27/2016,"09/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75415,"Ongoing","North American Rescue LLC.","35 Tedwall Ct",".","Greer","SC","29650-4791","United States","Voluntary: Firm Initiated","Letter","Nationwide, Australia & Switzerland","D-0181-2017","Class II","Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue ","unknown","Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.","12/08/2016",," Kit Part # 85-0835 - Kit Lot # 85-0835061016, 85-0835052416, 85-0835051116, 85-0835050216, 85-0835042916, 85-0835072616, 85-0835072016",9/27/2016,"09/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75415,"Ongoing","North American Rescue LLC.","35 Tedwall Ct",".","Greer","SC","29650-4791","United States","Voluntary: Firm Initiated","Letter","Nationwide, Australia & Switzerland","D-0176-2017","Class II","Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298,  North American Rescue","unknown","Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.","12/08/2016",," Kit Part # 80-0213 - Kit Lot # 80-0213080816W, 80-0213071316W, 80-0213041816W, 80-0213051716W, 80-0213050516W, 80-0213050916W, 80-0213081116W, 80-0213081716W, 80-0213082516W, 80-0213090216W, 80-0213090916W, 80-0213070716W, 80-0213080316W, 80-0213080116W, 80-0213072716W, 80-0213090916W; Kit Part # 80-0299 - Kit Lot # 80-0299080916W, 80-0299071116W, 80-0299060116W, 80-0299051916W, 80-0299081716W, 80-0299050316W, 80-0299051016W, 80-0299082216W; 80-0299082416W, 80-0299090616W, 80-0299090716W, 80-0299090716W, 80-0299080416W; Kit Part # 80-0298 - Kit Lot # 80-0298081116W, 80-0298060116W, 80-0298062316W, 80-0298090716W",9/27/2016,"09/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75415,"Ongoing","North American Rescue LLC.","35 Tedwall Ct",".","Greer","SC","29650-4791","United States","Voluntary: Firm Initiated","Letter","Nationwide, Australia & Switzerland","D-0175-2017","Class II","Range Trauma Kit Hardcase - Product Code 85-0889,  North American Rescue","unknown","Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.","12/08/2016",," Kit Part # 85-0889 - Kit Lot # 85-0889082416, 85-0889071816, 85-0889071916, 85-0889071416, 85-0889052316, 85-0889050416, 85-0889042016, 85-0889041416, 85-0889090616, 85-0889090716, 85-0889060216, 85-0889062216, 85-0889080116, 85-0889080816",9/27/2016,"09/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75415,"Ongoing","North American Rescue LLC.","35 Tedwall Ct",".","Greer","SC","29650-4791","United States","Voluntary: Firm Initiated","Letter","Nationwide, Australia & Switzerland","D-0182-2017","Class II","Aid Backpack Kit - Product Code 85-0917, North American Rescue","unknown","Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.","12/08/2016",," Kit Part # 85-0917 - Kit Lot # 85-0917041916",9/27/2016,"09/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75415,"Ongoing","North American Rescue LLC.","35 Tedwall Ct",".","Greer","SC","29650-4791","United States","Voluntary: Firm Initiated","Letter","Nationwide, Australia & Switzerland","D-0179-2017","Class II","K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue","unknown","Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.","12/08/2016",," Kit Part # 80-0211 - Kit Lot # 80-0211070616, 80-0211051316, 80-0211041816, 80-0211030216, 80-0211072216, 80-0210070716, 80-0210050416W, 80-0210072216; Kit Part # 80-0304 - Kit Lot # 80-0304041916; Kit Part # 80-0209 - Kit Lot # 80-0209082216, 80-0209051816, 80-0209051616, 80-029050316, 80-0209041916, 80-0209060316; Kit Part # 80-210  Kit Lot # 80-021007076, 80-0210050416W, 80-0210072216; Kit Part # 80-0300 - Kit Lot # 80-0300081216, 80-0300050916, 80-0300050316, 80-0300041916, 80-0300082416; Kit Part #80-0301 - Kit Lot # 80-0301042916, 80-0301050316",9/27/2016,"09/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75415,"Ongoing","North American Rescue LLC.","35 Tedwall Ct",".","Greer","SC","29650-4791","United States","Voluntary: Firm Initiated","Letter","Nationwide, Australia & Switzerland","D-0177-2017","Class II","Range Trauma Kit - Product Code 85-1274, North American Rescue","unknown","Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.","12/08/2016",," Kit Part # 85-1274 - Kit Lot # 85-1274072516W",9/27/2016,"09/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75415,"Ongoing","North American Rescue LLC.","35 Tedwall Ct",".","Greer","SC","29650-4791","United States","Voluntary: Firm Initiated","Letter","Nationwide, Australia & Switzerland","D-0183-2017","Class II","USCG Boat Response Kit - Product Code 80-0353, North American Rescue","unknown","Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.","12/08/2016",," Kit Part # 80-0353 - Kit Lot # 80-0353051916   ",9/27/2016,"09/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75416,"Ongoing","Nutrisystem Inc","600 Office Center Dr",,"Fort Washington","PA","19034-3232","United States","Voluntary: Firm Initiated","Letter","Product distributed to: CT. DE. MA. NH. NJ. NY. PA. RI. VA. and VT.  and online through Amazon.com and Walmart.com","F-0322-2017","Class I","Chocolate Chip Cookie Dough Bar 1.6 oz, 5 count carton  ","455 Cases","Product may be contaminated with Listeria monocytogenes.  ","11/03/2016",," UPC 6 32674 85579 4, Enjoy by Aug 22 2017 and Lot Code NF082216A. ",10/11/2016,"10/11/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75417,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide and to the following countries:  Australia, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Germany, Greece, Indonesia, Italy, Kingdom Saudi Arabia, Lebanon, Malaysia, P.R. China, Philippines, Portugal, Qatar, Republic Korea, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam","Z-0591-2017","Class II","FlexLab Automation Modules ","448 units",,"11/16/2016",," Refrigerated Storage Module (RSM): 11171750.  Centrifuge (CM): 11171747.  i2000SR (i2000SR): 11171801.  ",9/29/2016,"09/29/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75417,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide and to the following countries:  Australia, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Germany, Greece, Indonesia, Italy, Kingdom Saudi Arabia, Lebanon, Malaysia, P.R. China, Philippines, Portugal, Qatar, Republic Korea, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam","Z-0590-2017","Class II","Aptio Automation Modules ","448 units","Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.  ","11/16/2016",,"i2000SR Interface Module (i2000SR): 10989303, 10989304.  ",9/29/2016,"09/29/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75418,"Ongoing","Akorn Inc","1925 W Field Ct",,"Lake Forest","IL","60045-4862","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0124-2017","Class II","Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.","29,972 bottles","Subpotent Drug: concentration of product is less than labeled amount. ","11/02/2016",," Lot: 041306A, Exp 04/19",10/21/2016,"10/21/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75419,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Other","Distribution was made nationwide and to the Virgin Islands.  Foreign distribution was made to the Bahamas.","Z-0399-2017","Class II","Merge LIS software.  ","413 sites potentially have the affected software","There is a potential for duplicate container numbers to be created for patients.","11/11/2016",," Versions: 4.0.1 and earlier.",3/5/2015,"03/05/2015",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75420,"Ongoing","Angiodynamics, Inc.","603 Queensbury Ave",,"Queensbury","NY","12804-7619","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX","Z-0772-2017","Class III","ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick","162 boxes","Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use.  AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits. ","12/16/2016",," Batch/Lot: 1) 5046426, 2) 5022317, 5032458, 5040672, 5046428, 5063983 & 5081983",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75420,"Ongoing","Angiodynamics, Inc.","603 Queensbury Ave",,"Queensbury","NY","12804-7619","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX","Z-0776-2017","Class III","ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick","145 boxes","Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use.  AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits. ","12/16/2016",," Batch/Lot: 1) 5066410, 2) 5029429, 5043441, 5074176        ",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75420,"Ongoing","Angiodynamics, Inc.","603 Queensbury Ave",,"Queensbury","NY","12804-7619","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX","Z-0777-2017","Class II","ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705, Catalog No.REF 06597070  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick","7 boxes","Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use.  AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits. ","12/16/2016",," Batch/Lot: 1) 5034280, 5067423, 2) 5061461, 5070972",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75420,"Ongoing","Angiodynamics, Inc.","603 Queensbury Ave",,"Queensbury","NY","12804-7619","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX","Z-0778-2017","Class III","ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick","4 boxes","Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use.  AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits. ","12/16/2016",," Batch/Lot: 1) 5034283",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75420,"Ongoing","Angiodynamics, Inc.","603 Queensbury Ave",,"Queensbury","NY","12804-7619","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX","Z-0774-2017","Class III","ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog No.REF 06597052, 3) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970545, Catalog No.REF 06597054  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick","751 units","Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use.  AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits. ","12/16/2016",," Batch/Lot: 1) 5030257, 5046424, 5063169, 5073449, 5074171, 2) 5031722, 5043440, 5061392, 5066414, 3) 5037972, 5046429",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75420,"Ongoing","Angiodynamics, Inc.","603 Queensbury Ave",,"Queensbury","NY","12804-7619","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX","Z-0773-2017","Class III","ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog No. REF 06597048  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick","80 boxes","Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use.  AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits. ","12/16/2016",," Batch/Lot: 1) 5074174, 2) 5043439, 5061389 & 5067424",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75420,"Ongoing","Angiodynamics, Inc.","603 Queensbury Ave",,"Queensbury","NY","12804-7619","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX","Z-0775-2017","Class III","ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2)  5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG,  Item Number H787065970535, Catalog No.REF 06597053, 3) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG,  Item Number H787065970555, Catalog No.REF 06597055  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick","996 boxes","Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use.  AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits. ","12/16/2016",," Batch/Lot: 1) 5030537, 5037976, 5043444, 5059984, 5066413, 2) 5024545, 5031723, 5038659, 5042534, 5065538, 5071294, 5076428, 5082169, 3) 5022318, 5032456, 5034279, 5081986, 5082446",9/28/2016,"09/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75422,"Ongoing","JJBL LLC","211 N Front St",,"Central Point","OR","97502-2004","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, AR, CA, CT, MD, NJ, NY, OR, PA, TX, and WA","F-0321-2017","Class II","The Most Awesome Chocolate Bar Ever, Net wt. 1.5 oz. UPC 8 55966 00178 9.","2,214 bars","The Most Awesome Chocolate Bar Ever is recalled due to undeclared wheat.","11/03/2016",," Best by dates:   100116;   110116;   010117;   020117;   030117;   040117.",10/11/2016,"10/11/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75422,"Ongoing","JJBL LLC","211 N Front St",,"Central Point","OR","97502-2004","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in AK, AR, CA, CT, MD, NJ, NY, OR, PA, TX, and WA","F-0320-2017","Class II","The Stone Ground Peanut Butter Chocolate Bar, Net wt. 2.5 oz. UPC 8 55966 00107 9.","1,416 bars ","The Stone Ground Peanut Butter Chocolate Bar is recalled due to undeclared soy lecithin.  ","11/03/2016",," Best by dates:   110116;   120116;   010117;   020117;   030117;   040117;   050117;   060117;   070117;   080117;   090117;   100117",10/11/2016,"10/11/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75423,"Ongoing","Publix Super Markets, Inc.","3300 Publix Corporate Pkwy",,"Lakeland","FL","33811-3311","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed to the following states: AL, FL, GA, NC, SC, & TN.","F-0502-2017","Class I","Publix Premium Chocolate Cookie Dough Ice Cream, 1/2 gallon carton.","11,014 cases","Possible contamination with Listeria monocytogenes.","11/22/2016","."," UPC 00-41415-03843; sell by date of MAY 27, 2017.",10/10/2016,"10/10/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75425,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Other","Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.","Z-0294-2017","Class II","Fusion Workstation.; Indicated for the transmission and review of radiological images.   ","13 sites potentially hae the affected version","After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.","10/20/2016",," Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.",10/28/2011,"10/28/2011",10/26/2016,"10/26/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0435-2017","Class I","Fata's Best Four Blend Feather Shred Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated","3200 lbs. ","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," lot 27916",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0441-2017","Class I"," Cubed Cheese, 5 lb. packages packed in plastic bags, keep refrigerated","360  lbs. ","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," Lot 27816",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0438-2017","Class I","Fata's Best PepperJack Feather Shred Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated","120 lbs","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," lot  27816",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0442-2017","Class I","Kuster's Dairy Foods Sliced Colby JackCheese, 5 lb. packages packed in plastic bags, keep refrigerated","360 lbs. ","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," packed on 10/04/2016",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0434-2017","Class I","Kuster's Dairy Foods Three Blend Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated","345 lbs.","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," pack date 10/05/16 & 10/7/2016",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0437-2017","Class I","Fata's Best Monterey Jack Feather Shred Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated","100 lbs. ","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," lot  27816",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0436-2017","Class I","Fata's Best Mozzarella Muenster Provolone Feather Shred Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated","3200 lbs.","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," lot  27916",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0443-2017","Class I","A New Dairy Pepper Jack cut Cheese, 5 lb. packages packed in plastic bags, keep refrigerated","363 lbs. ","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," packed on 10/04/2016",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0440-2017","Class I","Nor-Tech Dairy Sharp White Cheddar Feather Shred  Cheese, 5 lb. packages packed in plastic bags, keep refrigerated","3200 lbs.","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," packed on 10.04.2016",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75426,"Ongoing","Kuster's Inc.","9351 S Edon Rd",,"Camden","MI","49232-9010","United States","Voluntary: Firm Initiated","Telephone","Domestic: Michigan, Indiana, Illinois, Ohio,Pennsylvania, South Dakota.","F-0439-2017","Class I","Nor-Tech Dairy  Mozz/Muenster/Prov Feather Shred  Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated","2740 lbs. ","Kuster's, Inc. is voluntarily recalling its shredded, sliced and cubed cheese following a supplier's recall of cheese due to the potential for the cheese to be contaminated with Listeria monocytogenes or inadequately pasteurized. ","11/29/2016",," best used by: 12-05-2016",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75427,"Ongoing","Farm Country Cheese House, Inc.","7263 Kendaville Rd",,"Lakeview","MI","48850-9563","United States","Voluntary: Firm Initiated","Telephone","Domestic: MI","F-0430-2017","Class II","White Cheddar, thirty-nine, 40 lb. blocks from Vat A and 25 40 lb. blocks from Vat C","1869.34 lbs. Vat A + 1016.55 lbs. Vat C","Farm Country Cheese House is conducting a voluntary recall of multiple vats of cheese due to inadequate pasteurization.  ","11/14/2016",," Made on 09/26/2016, Vat A, and Vat C",10/10/2016,"10/10/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75427,"Ongoing","Farm Country Cheese House, Inc.","7263 Kendaville Rd",,"Lakeview","MI","48850-9563","United States","Voluntary: Firm Initiated","Telephone","Domestic: MI","F-0432-2017","Class II","Marble Cheese, thirty-three 40 lb. blocks","1294.96 lbs. ","Farm Country Cheese House is conducting a voluntary recall of multiple vats of cheese due to inadequate pasteurization.  ","11/14/2016",," Made on 09/28/2016, Vat B",10/10/2016,"10/10/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75427,"Ongoing","Farm Country Cheese House, Inc.","7263 Kendaville Rd",,"Lakeview","MI","48850-9563","United States","Voluntary: Firm Initiated","Telephone","Domestic: MI","F-0431-2017","Class II","Hot Pepper Cheese, forty-five 40 lb. blocks","1878.76","Farm Country Cheese House is conducting a voluntary recall of multiple vats of cheese due to inadequate pasteurization.  ","11/14/2016",," Made on 09/28/2016, Vat A",10/10/2016,"10/10/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75427,"Ongoing","Farm Country Cheese House, Inc.","7263 Kendaville Rd",,"Lakeview","MI","48850-9563","United States","Voluntary: Firm Initiated","Telephone","Domestic: MI","F-0429-2017","Class II","Monterey Jack  Cheese, 40 lb. blocks","1869.34 lbs","Farm Country Cheese House is conducting a voluntary recall of multiple vats of cheese due to inadequate pasteurization.  ","11/14/2016",," Made on 09/26/2016, Vat A",10/10/2016,"10/10/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75427,"Ongoing","Farm Country Cheese House, Inc.","7263 Kendaville Rd",,"Lakeview","MI","48850-9563","United States","Voluntary: Firm Initiated","Telephone","Domestic: MI","F-0428-2017","Class I","White Cheddar Cheese, 40 lb. blocks","1247.53 lbs.","Farm Country Cheese House is conducting a voluntary recall of multiple vats of cheese due to potential contamination with Listeria monocytogenes.","11/14/2016",," Made on 09/23/2016, Vat A",10/10/2016,"10/10/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75428,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","FL, GA, LA, OH, VA and WA.","Z-0585-2017","Class II"," Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.","70 units","Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.","11/16/2016",," Product Code: 355325, Lot Numbers: NGAQ5248 and NGAN2854",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75429,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Missouri; Florida","B-0072-2017","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","10/13/2016","10/13/2016"," W040712324178",9/28/2016,"09/28/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75429,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Missouri; Florida","B-0071-2017","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","10/13/2016","10/13/2016"," W040712539883",9/28/2016,"09/28/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75429,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Missouri; Florida","B-0070-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","10/13/2016","10/13/2016"," W040712539883",9/28/2016,"09/28/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75430,"Terminated","Greer Laboratories Inc","639 Nuway Cir NE","PO Box 800","Lenoir","NC","28645-0800","United States","Voluntary: Firm Initiated","Telephone","Multiple U.S. States","B-0079-2017","Class II","Ash, White","28 vials"," Allergenic Extract, associated with an error in the assignment of bulk lots for filling, was distributed. ","10/13/2016","10/13/2016"," 307190; ",9/16/2016,"09/16/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75431,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","FAX","Texas; Austria","B-0074-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/13/2016","10/13/2016"," W0352160647279",9/22/2016,"09/22/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75431,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","FAX","Texas; Austria","B-0075-2017","Class II","Platelets","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/13/2016","10/13/2016"," W0352160647279",9/22/2016,"09/22/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75431,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","FAX","Texas; Austria","B-0076-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","10/13/2016","10/13/2016"," W0352160647279",9/22/2016,"09/22/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75432,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","4139 Carmichael Rd",,"Montgomery","AL","36106-2803","United States","Voluntary: Firm Initiated","FAX","Alabama","B-0073-2017","Class II","Apheresis Platelets, Leukocytes Reduced","2 units","Plateletpheresis products, for which the quality control testing for pH did not meet specifications, were distributed.","10/13/2016","10/13/2016"," W115116228647D (double collection)",9/19/2016,"09/19/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75433,"Terminated","Greer Laboratories Inc","639 Nuway Cir NE","PO Box 800","Lenoir","NC","28645-0800","United States","Voluntary: Firm Initiated","Telephone","North Carolina; Multiple U.S. States","B-0077-2017","Class III","Juniper, Western","A total of 13 product vails were distributed"," Allergenic Extracts, labeled with an incorrect PNU measurement, were distributed. ","10/13/2016","10/13/2016"," 304876; 309023; ",9/16/2016,"09/16/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75433,"Terminated","Greer Laboratories Inc","639 Nuway Cir NE","PO Box 800","Lenoir","NC","28645-0800","United States","Voluntary: Firm Initiated","Telephone","North Carolina; Multiple U.S. States","B-0078-2017","Class III","Allergenic Extracts","A total of 13 product vails were distributed"," Allergenic Extracts, labeled with an incorrect PNU measurement, were distributed. ","10/13/2016","10/13/2016"," 302627; ",9/16/2016,"09/16/2016",10/19/2016,"10/19/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75436,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",,"Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","FAX","Colorado; California","B-0126-2017","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood products, collected from a donor considered to be at increased risk for Zika virus, were distributed.  ","11/14/2016","11/14/2016"," W036216886887; ",8/11/2016,"08/11/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75436,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",,"Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","FAX","Colorado; California","B-0127-2017","Class II","Red Blood Cells, Leukocytes Reduced","2 units","Blood products, collected from a donor considered to be at increased risk for Zika virus, were distributed.  ","11/14/2016","11/14/2016"," W036216748905; W036216749865; ",8/11/2016,"08/11/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75437,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Pennsylvania; Austria; Florida","B-0088-2017","Class II","Cryoprecipitated AHF","1 unit","Blood products, in which donor screening/deferral screening not done or incorrectly performed, including incorrect ID used during search,prior deferral due to testing were distributed. ","11/01/2016","11/01/2016"," W040711134961; ",10/4/2016,"10/04/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75437,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Pennsylvania; Austria; Florida","B-0089-2017","Class II"," Pooled Cryoprecipitated AHF","1 unit","Blood products, in which donor screening/deferral screening not done or incorrectly performed, including incorrect ID used during search,prior deferral due to testing were distributed. ","11/01/2016","11/01/2016"," W040710322589; ",10/4/2016,"10/04/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75437,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Pennsylvania; Austria; Florida","B-0091-2017","Class III","Blood and Blood Products for Reprocessing","4 units","Blood products, in which donor screening/deferral screening not done or incorrectly performed, including incorrect ID used during search,prior deferral due to testing were distributed. ","11/01/2016","11/01/2016"," W040711134961; W040710466569; W040710139033; W040709530775; ",10/4/2016,"10/04/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75437,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana; Pennsylvania; Austria; Florida","B-0090-2017","Class II","Red Blood Cells, Leukocytes Reduced","4 units","Blood products, in which donor screening/deferral screening not done or incorrectly performed, including incorrect ID used during search,prior deferral due to testing were distributed. ","11/01/2016","11/01/2016"," W040711134961; W040710466569; W040710139033; W040709530775; ",10/4/2016,"10/04/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75438,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",,"Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","FAX","California; Switzerland","B-0092-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit"," Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","11/01/2016","11/01/2016"," W036215514944; ",8/29/2016,"08/29/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75438,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",,"Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","FAX","California; Switzerland","B-0093-2017","Class II","Blood and Blood Products for Reprocessing","1 unit"," Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed","11/01/2016","11/01/2016"," W036215514944; ",8/29/2016,"08/29/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75439,"Ongoing","Osage Gardens, Incorporated","36730 River Frontage Rd",,"New Castle","CO","81647-9805","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Colorado and Kansas. No Canadian, VA/govt/military or other foreign consignees.","F-0375-2017","Class I","Organic 2oz Micro Greens. Clear Plastic Clamshell. Keep Refrigerated","222 clamshell units","Osage Gardens announces a voluntary recall of Organic 2oz Micro Greens due to a positive test for Salmonella. ","10/28/2016",," Julian codes: 266, 269, 272, 274, & 279.",10/7/2016,"10/07/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0460-2017","Class II","Orange Cake, Net Wt. 10 oz. (283g), UPC 7 80890 28604 2.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0459-2017","Class II","Vanilla Cake, Net Wt. 10 oz. (283g), UPC 7 80890 28614 1.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat and soy lecithin.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0464-2017","Class II","Croissant with Jam, Net Wt. 10 oz. (283g), UPC 7 80890 28608 0.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, soy lecithin, Yellow#5, and sulfur dioxide.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0470-2017","Class II","Assorted Cookies, Net Wt. 10 oz. (284g), UPC 7 80890 28651 6.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat and soy lecithin.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0461-2017","Class II","Low Sugar Nazook, Net Wt. 10 oz. (283g), UPC 7 80890 28605 9.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat and soy lecithin.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0463-2017","Class II","Raisin Cookies, Net Wt. 10 oz. (283g), UPC 7 80890 28611 0.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, soy lecithin, Yellow#5, and sulfur dioxide.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0467-2017","Class II","Zaban, Net Wt. 10 oz. (283g), UPC 7 80890 28616 5.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, milk and soy lecithin.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0466-2017","Class II","Pappion, Net Wt. 10 oz. (283g), UPC 7 80890 28612 7.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat and milk.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0456-2017","Class II","Nazook, Net Wt. 10 oz. (283g), UPC 7 80890 28606 6.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, milk, and soy lecithin.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0457-2017","Class II","Walnut Nazook and Walnut, Net Wt. 10 oz. (283g), UPC 7 80890 28609 7.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, milk, soy lecithin.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0468-2017","Class II","Puff Pastry Net Wt. 10 oz. (283g), UPC 7 80890 28615 8.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, milk and soy lecithin.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0469-2017","Class II","Coconut Macaroon, Net Wt. 10 oz. (283g), UPC 7 80890 28613 4.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared metabisulfate.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0458-2017","Class II","Walnut and Raisin Cake, Net Wt. 10 oz. (283g), UPC 7 80890 28603 5.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, soy lecithin.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0462-2017","Class II","Apricot Perouk, Net Wt. 10 oz. (283g), UPC 7 80890 28601 1.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, milk, Yellow#5, and sulfur dioxide.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75441,"Ongoing","Nobel Bakery","5638 Cahuenga Blvd",,"N Hollywood","CA","91601-2103","United States","Voluntary: Firm Initiated","Letter","US","F-0465-2017","Class II","French Cookies, Net Wt. 10 oz. (283g), UPC 7 80890 28610 3.","unknown","Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared wheat, soy lecithin, Yellow#5, and sulfur dioxide.","11/16/2016",," no lot codes",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75443,"Ongoing","Alere San Diego, Inc.","9975 Summers Ridge Rd",,"San Diego","CA","92121-2997","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0588-2017","Class II","Alere Triage Total 5 Control Level 1, Model No. 88753    Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for     Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.","513 kits","Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.","11/16/2016",," C3233A",10/12/2016,"10/12/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75444,"Ongoing","Tornier, Inc","10801 Nesbitt Ave S",".","Bloomington","MN","55437-3109","United States","Voluntary: Firm Initiated","Letter","US Distribution TX, CA, and MI","Z-0699-2017","Class II","Aequalis Fx2 implant parts and instrument trays.     Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B.    Stem Component:  Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B.    Product Usage:  Total or partial replacement of the Gleno-humeral articulation.  ","30","Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due  to reports of dislocations of the poly insert and the stem.","12/02/2016",," 0924AR, 0809AR, 1110AR, 1290AR, 0811AR, 0151AR, 2447AR, 6082AQ, 5935AQ, 6373AQ, 7153AQ, 7532AQ, 9966AQ, 0018AQ, 0385AR, 0386AR, 0384AR, 3014AR, 6892AQ, 8250AQ, 6893AQ, 6924AQ, 8249AQ, 6853AQ, 6925AQ, 6962AQ, 8795AQ, 8210AQ, YKAD241, YKAD244.",9/19/2016,"09/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75445,"Ongoing","Actavis Elizabeth LLC","200 Elmora Ave",,"Elizabeth","NJ","07202-1106","United States","Voluntary: Firm Initiated","Letter","US","D-0143-2017","Class III","NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10","27,517 bottles","Presence of Foreign Tablets/Capsules","11/18/2016","."," Lot # 0598B151; Exp 03/18",10/6/2016,"10/06/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0344-2017","Class II","Guider Softip XF;  GUIDER MPXF 5F 90CM, Model number: M003100630.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lots 18845284,  18845814. Expiration 1/31/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0343-2017","Class II","Guider Softip XF;  GUIDER/ST XF/6FR/100 cm, Model number:M003101500 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lots 18829078, 18831032, 18831033. Expiration 1/31/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0347-2017","Class II","Guider Softip XF;  GUIDER 40XF 5F 90CM, Model number:M003100620 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lots 18932470, 18932472.  Expiration .2/28/2019",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0337-2017","Class II","Guider Softip XF;  GUIDER/ST XF/8FR/90CM, Model number: H965100520.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lot 18725364,  Expiration 12/31/18.  Lot 18904600, Expiration 02/28/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0339-2017","Class II","Guider Softip XF;  GUIDER MPXF 5F 100CM, Model number: M003101630.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lot  18753510; Expiration 12/31/18.  Lot 18847876, Expiration 01/31/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0346-2017","Class II","Guider Softip XF;  GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640.  Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lot 18903166,  Expiration .2/28/2019",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0333-2017","Class II","Guider Softip XF;  GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.   ","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lots 18709130,  18709234, 18709643, 18774858, 18775292;  Expiration 12/31/2019.  Lots 18785727, 18785933, 18849986; Expiration 01/31/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0341-2017","Class II","Guider Softip XF;  GUIDER/40XF/8FR/90CM, Model number: H965100440 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lots  18775812, 18775993 ;  Expiration 01/31/19.  Lot 18904219, Expiration 02/28/2019;  Lots 19025649,  19025651.  Expiration 03/31/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0335-2017","Class II","Guider Softip XF;  GUIDER/MP XF/7FR/90CM, Model number: H965100470.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lots 18713978, 18714267,18716054. Expiration 12/31/2018.  Lots 18786405, 18786441, Expiration date -1/31/2019",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0338-2017","Class II","Guider Softip XF;  GUIDER/40DEG XF/6FR/90CM, Model number: H965100420.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lot s: 18725976,  18726252, 18726453. Expiration 12/31/18.  Lot: 18771999, Expiration 01/31/2019.  Lot 19022528, Expiration 03/31/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0342-2017","Class II","Guider Softip XF;  GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lot 18786335, 18790229, 18790450. Expiration 12/31/2018.  Lot 18851082. Expiration 1/31/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0340-2017","Class II","Guider Softip XF;  GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lot s 18771332, 18771915;  Expiration 12/31/18.  Lot s18903165, 18928715;  Expiration 01/31/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0334-2017","Class II","Guider Softip XF;  GUIDER/MP XF/8FR/100 cm, Model number: M003101480.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices total, all model numbers and lots.","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lot 18713574. Expiration 11/30/18.  Lot s18849984, 18848795.  Expiration 01/31/19.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0345-2017","Class II","Guider Softip XF;  GUIDER STRAIGHT XF 5F 90CM, Model number: .  M003100640.  Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lot 18846232. Expiration 1/31/2019.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75447,"Ongoing","Stryker Neurovascular","47900 Bayside Pkwy",,"Fremont","CA","94538-6515","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.","Z-0336-2017","Class II","Guider Softip XF;  GUIDER/MP XF/6FR/90CM, Model number: H965100460.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.","1478 devices, all models and lot numbers","Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.","11/02/2016",," Lots: 18716056 , 18752458, 18752804. Expiration 12/31/18.",10/5/2016,"10/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75448,"Ongoing","Abbott Laboratories","100 Abbott Park Rd",,"Abbott Park","IL","60064-3502","United States","Voluntary: Firm Initiated","Letter","Nationwide and Worldwide Distribution.","Z-0379-2017","Class II","ARCHITECT Lactic Acid Part # 09D891T21    The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.","26, 837 kits","Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).","11/09/2016",," Lot: 31497UN14 Exp.: 17 Oct. 2016; Lot: 09353UNI15 Exp.: 12 Feb. 2017; Lot: 45216UN15 12 May 2017; Lot: 14596UN15 Exp.: 30 Jul. 2017; Lot: 37055UN15 Exp.: 12 Oct. 2017; Lot: 14782UN16 Exp.: 21 Apr. 2018",10/11/2016,"10/11/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75449,"Ongoing","Janssen Ortho L.L.C.","Carr # 933 Km 0.1",,"Gurabo","PR","00778","United States","Voluntary: Firm Initiated",,"Nationwide and Puerto Rico","D-0115-2017","Class III","Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only,  Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60","5346 bottles","Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.","10/25/2016",," Lot #: 16GG581X,  Exp 09/17",10/19/2016,"10/19/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75451,"Terminated","American National Red Cross (the)","825 John St",,"West Henrietta","NY","14586-9790","United States","Voluntary: Firm Initiated","Telephone","New York","B-0129-2017","Class III","Pooled Platelets, Leukocytes Reduced","1 unit","Blood products, collected from an unsuitable donor due to a donor screening deviation, were distributed.","11/03/2016","11/03/2016"," W200116129644",9/8/2016,"09/08/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75451,"Terminated","American National Red Cross (the)","825 John St",,"West Henrietta","NY","14586-9790","United States","Voluntary: Firm Initiated","Telephone","New York","B-0128-2017","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from an unsuitable donor due to a donor screening deviation, were distributed.","11/03/2016","11/03/2016"," W200116129644",9/8/2016,"09/08/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75452,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.","Z-0363-2017","Class II","X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081    The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath. ","192 units","Contract manufacturer packaged an incorrect sheath with the product.  Packaged 30Fr instead of 24Fr. ","11/04/2016",," Lot BMZCE039, Expiration Date 2018-12-31",10/12/2016,"10/12/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75453,"Ongoing","Turkey Hill Dairy, LP","2601 River Rd",,"Conestoga","PA","17516-9327","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CO  CT  DE  GA  IL  IN  KY  MA  MN  NY  OH  PA  SC  VA  VT","F-0454-2017","Class I","    On body of Tub:  Turkey Hill Rocky Road, 48 FL. OZ.  On bottom of Tub:  Sell By May 23, 2017   UPC: 020735420911","6840 units","The product was recalled because it may contain almond (tree-nut) and egg and, if eaten, could result in severe allergic reactions in persons sensitive to these ingredients. ","11/15/2016",," Sell By May 23, 2017 ",10/7/2016,"10/07/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75454,"Ongoing","DePuy Spine, Inc.","325 Paramount Dr",,"Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.","Z-0627-2017","Class II","DePuy Spine SKYLINE  ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm  Item Code: 186852026    The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. ","6 units","SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.","11/19/2016","."," Lot Codes:  DFLBGO",10/12/2016,"10/12/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75454,"Ongoing","DePuy Spine, Inc.","325 Paramount Dr",,"Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.","Z-0626-2017","Class II","DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm  Item Code: 186852020    The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. ","1  unit","SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.","11/19/2016","."," Lot Codes:  ANNCJW",10/12/2016,"10/12/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75454,"Ongoing","DePuy Spine, Inc.","325 Paramount Dr",,"Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.","Z-0625-2017","Class II","DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm   Item Code: 186852018     The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. ","14 units","SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.","11/19/2016","."," Lot Codes:  AMMBPW  AMPCML  ANCDJ0  APPBYD",10/12/2016,"10/12/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75454,"Ongoing","DePuy Spine, Inc.","325 Paramount Dr",,"Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.","Z-0624-2017","Class II","DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm   Item Code: 186850018     The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. ","9  units","SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.","11/19/2016","."," AFNBMH  AHJBC4  ANHFCW  AHLBC4",10/12/2016,"10/12/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75454,"Ongoing","DePuy Spine, Inc.","325 Paramount Dr",,"Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.","Z-0628-2017","Class II","DePuy Spine  SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm  Item Code: 186854018    The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. ","9 units","SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.","11/19/2016","."," Lot Codes:  AFFBMZ  AFN6D5  AMMDVJ",10/12/2016,"10/12/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75454,"Ongoing","DePuy Spine, Inc.","325 Paramount Dr",,"Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.","Z-0629-2017","Class II","DePuy Spine  SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm  Item Code:  186862018    The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. ","21 units","SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.","11/19/2016","."," Lot Codes:  AGFB1H  AGFB1V  AGFBYK",10/12/2016,"10/12/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75454,"Ongoing","DePuy Spine, Inc.","325 Paramount Dr",,"Raynham","MA","02767-5199","United States","Voluntary: Firm Initiated","Letter","US Distribution to states of: CA, ID, IL, IN, KS, KY, LA, MO, NC, OR, PA, TX, VA, WA, and WV.","Z-0630-2017","Class II","DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm  Item Code:  186864018     The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy. ","12 units","SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.","11/19/2016","."," Lot Codes:  1GFBQW  AGFB01  AGFB0W",10/12/2016,"10/12/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75455,"Ongoing","Par Pharmaceutical, Inc.","1 Ram Ridge Rd",,"Chestnut Ridge","NY","10977-6714","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0121-2017","Class III","Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811    ","822,009 tablets","Subpotent Drug; Ethinyl Estradiol","11/01/2016",," Lot Numbers:  4101072, 4101073, 4101074, 4149704, 4152054, 4152056, 4152057, 4159857, 4169950, 4169951, 4187122, 4187123, 4187124, 4187125, 4190275, 4190276, 4190278, 4190279, 4265208, 4265209, 4265210, 4265211, 4265212, 4265213, 4265214, 4265215, 4265216, 4266535, 4266536, 4266537, 4266538, 4266539, 4267686, 4267687, 4267688, 4267689, 4329888, 4334997, 4334998, 4334999, 4359303, 4359304, 4359305, 4359306, 4359307, 4359308, 4362141, 4362142, 4362143, 4362144, 4362145, 4365282, 4367923, 4367924, 4367925, 4367926, 4367927, 4367928, 4367929, 4467392, 4467393, 4467394,   4467395, 4482870, 4487638, 4501269, 4501270, 4506358, 4563356, 4563357, 4563358, 4563359, 4563360, 4563361, 4572329, 4572331, 4572332, 4572333, 4583326, 4614355, 4614356, 4614357, 4615487, 4696445, 4696446, 4698118, 4731576, 4731577, 4731578, 4731579, 4731580, 4798710, 4798711, 4798712, 4798713",9/27/2016,"09/27/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75455,"Ongoing","Par Pharmaceutical, Inc.","1 Ram Ridge Rd",,"Chestnut Ridge","NY","10977-6714","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0122-2017","Class III","Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811    ","278,406 tablets","Subpotent Drug; Ethinyl Estradiol","11/01/2016",," Lot Numbers:  4169952, 4169953, 4169954, 4185520, 4187127, 4190281, 4228446, 4258626,   4258627, 4279364, 4279365, 4279366, 4279369, 4359310, 4365283, 4365285, 4365286, 4365287, 4365288, 4379816, 4379817, 4479997, 4501273, 4501274, 4501275, 4563362, 4563363, 4563364, 4614359, 4614360, 4614361",9/27/2016,"09/27/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75455,"Ongoing","Par Pharmaceutical, Inc.","1 Ram Ridge Rd",,"Chestnut Ridge","NY","10977-6714","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0119-2017","Class III","Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811 ","221,017 tablets","Subpotent Drug; Ethinyl Estradiol","11/01/2016",," Lot Numbers  (a) 4169949, 4297235, 4359298, 4501268, 4614353  (b) 4101064, 4196576, 4228443, 4265206, 4265207, 4267685, 4365281, 4365284, 4365289, 4501276, 4563354, 4563355, 4614354, 4731574, 4731575, 4793332, 4798708, 4798709  ",9/27/2016,"09/27/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75455,"Ongoing","Par Pharmaceutical, Inc.","1 Ram Ridge Rd",,"Chestnut Ridge","NY","10977-6714","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0123-2017","Class III","Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811","44,127 tablets","Subpotent Drug; Ethinyl Estradiol","11/01/2016",," Lot Numbers  (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286  (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736",9/27/2016,"09/27/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75455,"Ongoing","Par Pharmaceutical, Inc.","1 Ram Ridge Rd",,"Chestnut Ridge","NY","10977-6714","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0120-2017","Class III","Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811","393,981 tablets","Subpotent Drug; Ethinyl Estradiol","11/01/2016",," Lot Numbers  (a) 4101059, 4101062, 4190536, 4265205, 4359294, 4501265, 4572326, 4651818, 4731571, 4798704  (b) 4187113, 4187114, 4187115, 4190273, 4190274, 4190280, 4265203, 4265204, 4359296, 4367922, 4379814, 4403535, 4403536, 4501267, 4506357, 4563352, 4563353, 4572327, 4572328, 4627845, 4731572, 4731573, 4798705, 4936585  ",9/27/2016,"09/27/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75456,"Ongoing","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Letter","Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.","Z-0412-2017","Class II","The ORCHESTRA Programmer     A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant  patients.","847 programmers","Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS  Programmer because the residual longevity estimate may be less accurate.","11/15/2016",,"BB0011103G BC0206105G BC0408064G BB0011111G BD0505094I BC0405016G BB0102071G BC0206096G BD0507033I BD0505110I BD0507019I BC0206076G BE0611036I BB0203034G BB0011099G BB0103048G BC0408067G BD0509044I BB0012010G BD0501100G BC0206131G BD0501096G BA0006167G BB0011169G BD0510018I BD0505029I BD0505039I BB0102074G BD0507014I BB0101021G BD0506112I BA0007003G BB0010078G BB0010213G BC0206089G BC0205079G BD0501099G BA0004162G BB0011101G BD0501094G BB0103027G BB0012068G BD0507005I BB0011003G BB0011086G BC0408057G BB0012075G BA0005050G BC0303071G BD0507060I BB0010268G BB0012154G BC0303073G BA0006171G BB0011080G BC0312045G BC0206144G BD0505016I BC0206029G BB0012184G BD0505018I BC0405050G BD0501085G BD0506136I BB0011083G BB0012056G BE0611013I BD0507053I BD0505028I BC0408078G BE0603002I BE0603012I BB0011166G BB0012150G BB0012067G BB0012171G BB0011020G BC0212074G BB0010250G BD0507025I BB0203012G BD0501061G BC0206110G BE0611023I BB0011141G BD0502041G BE0611087I BB0012017G BB0010193G BC0205082G BD0509048I BA0006178G BB0010252G BB0101092G BB0012182G BC0405037G BD0505001I BD0507065I BC0405022G BB0203059G BD0505097I BD0502013G BB0012125G BD0506123I BD0501074G BB0102069G BC0405024G BB0012151G BB0012183G BB0203052G BD0505061I BE0611062I BC0212076G BD0510028I  BB0010063G BB0012019G BB0203028G BB0012062G BB0010057G BC0212080G BE0603018I BC0312059G BE0611082I BC0405025G BC0206067G BB0010273G BB0102068G BB0011032G BB0010080G BB0010271G BA0005233G BD0506111I BD0502035G BD0509046I BC0206138G BD0505002I BB0012166G BC0408072G BD0506106I BE0611041I BE0611043I BA0004161G BB0011037G BB0203037G BD0505045I BD0505052I BD0505008I BB0010294G BB0011042G BB0012070G BD0501118G BD0501116G BE0611008I BC0212068G BC0212083G BD0501109G BB0012027G BB0010207G BC0212085G BC0212086G BD0501087G BB0203050G BB0010291G BC0212079G BE0611022I BE0611009I BB0012060G BD0510024I BD0505068I BD0510022I BD0506125I BC0212048G BD0505090I BB0102059G BC0312055G BC0206146G BC0206073G BD0506124I BC0303082G BB0102075G BC0408075G BC0405047G BD0505106I BB0012131G BC0212046G BC0312066",9/29/2016,"09/29/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75456,"Ongoing","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Letter","Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.","Z-0413-2017","Class II","The ORCHESTRA PLUS Programmer     A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.","586 programmers","Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS  Programmer because the residual longevity estimate may be less accurate.","11/15/2016",," Serial Numbers: NB1006418K NB1107409K NB1203456K NB1107407K NB1105419K NB0908405K NB1202447K NA0804365K NB1201447K NA0807425K NB0909407K NB1112470K NB0909402K NB1112474K NB1112444K NB1201403K NB1201402K NB1102423K NB1112471K NA0804393K NB1203431K NA0804389K NB1004403K NB1202418K NB1108403K NB1007410K NB1105438K NA0804367K NB1102406K NA0804384K NB1202458K NA0804321K NB1006415K NB1201455K NB1102402K NB1107417K NB1109421K NB1202454K NC1503413K NA0804353K NB1112482K NB1108404K NB1105436K NB0907430K NB1112485K NA0804343K NB1109418K NB1104409K NB1112414K NB0908415K NB1112407K NB1108425K NB1006402K NB1203428K NA0804426K NA0804390K NB0911402K NB0907419K NB0909417K NB1203415K NB1201442K NA0804363K NB0911414K NB0908411K NB0910412K NA0807414K NA0804387K NB1102405K NB1201409K NB1201423K NB1004416K NB1108401K NB1002406K NB1203429K NB0907433K NB1202474K NB1103415K NB1112427K NB1202462K NB1202469K NA0804319K NB1102425K NA0804339K NB1003402K NB1102404K NB0909410K NB0911404K NB1108429K NB1203444K NB1203423K NB1201434K NA0804410K NB0909430K NB1202413K NB1201454K NB1001405K NA0904419K NA0902423K NB0907425K NB1202435K NB1203417K NA0904415K NB0907413K NB1105401K NB1112455K NA0904413K NB1112423K NB1201410K NB1112404K NA0904414K NB1108428K NB1112454K NB0911401K NB1007406K NB1102428K NB1201450K NB1001409K NB1112463K NA0804433K NB1105404K NB1202423K NB1201430K NB1203453K NB1006410K NC1503412K NA0804373K NA0804378K NB1201449K NA0804358K NB1108412K NB1201406K NB0907410K NB1006403K NA0804362K NB1004406K NB0908414K NA0902406K NA0804432K NB1002401K NB0909405K NA0807429K NB0911415K NA0804313K NB1109402K NB1203454K NB1202409K NB1202453K NB1201440K NB0905015K NB1202464K NB1202442K NA0804340K NB1201439K NB1109412K NB1102407K NB1112410K NB1108418K NB1104416K NB0907414K NB1202424K NB1201445K NB1201452K NB0907417K NB1202432K NA0804411K NB1202408K NB1007402K NB1103409K NB1112459K NB1202430K NA0804383K NB1108426K NB1010412K NB0911412K NB1202440K NB1102429K NB1104405K NB1203409K NB1010408K NB1109417K NB1108410K NB1203437K NA0804324K NA0804422K NB09",9/29/2016,"09/29/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75457,"Ongoing","Arrow Reliance Inc","350 Treck Dr",,"Tukwila","WA","98188-7604","United States","Voluntary: Firm Initiated","E-Mail","internet sale","V-0052-2017","Class I","ZooLogics brand, frozen, raw Turkey with Vegetable Meals for Dogs, 2 lbs. packages.","1337 units","Several meals for dogs are recalled due to contamination with Listeria monocytogenes","12/21/2016",," Lot # 3155070; manufacturing date 7/25/16.",10/17/2016,"10/17/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75457,"Ongoing","Arrow Reliance Inc","350 Treck Dr",,"Tukwila","WA","98188-7604","United States","Voluntary: Firm Initiated","E-Mail","internet sale","V-0051-2017","Class I","Darwin's Natural Selections brand, frozen, raw Beef with Organic Vegetables Meals for Dogs, 2 lbs. packages","2391 packages","Several meals for dogs are recalled due to contamination with Listeria monocytogenes","12/21/2016",," Lot # 3146070, manufacturing date: 7/21/16.",10/17/2016,"10/17/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75457,"Ongoing","Arrow Reliance Inc","350 Treck Dr",,"Tukwila","WA","98188-7604","United States","Voluntary: Firm Initiated","E-Mail","internet sale","V-0050-2017","Class I","Darwin's Natural Selections brand, frozen, raw Turkey  with Organic Vegetable Meals for Dogs, 2 lbs. packages","1192 packages","Several meals for dogs are recalled due to contamination with Listeria monocytogenes","12/21/2016",," Lot # 3142070, manufacturing date: 7/20/16.",10/17/2016,"10/17/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75458,"Ongoing","Medtronic Neuromodulation","7000 Central Ave",".","Minneapolis","MN","55421-1241","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including DC    OUS: Canada and others.","Z-0700-2017","Class II","Model 37751 Recharger    Product Usage:  The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an AC power supply and power cord (Model 37761) and an antenna.  ","42,887","Medtronic has identified an increased number of complaints from customers involving reports of Rechargers  (Medtronic Model 37751 Recharger, which is included in Models 37754 and 97754 Charging Systems,Spinal Cord Stimulation)that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. Medtronic has determined all Rechargers manufactured starting in November 2014 (indicated by serial numbers beginning with NKA4 or NKU4) are more susceptible to this error state.","12/03/2016",,"  serial numbers beginning with NKA4 or NKU4",10/3/2016,"10/03/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75459,"Ongoing","Nuvectra","10675 Naples St NE",,"Blaine","MN","55449-5802","United States","Voluntary: Firm Initiated","Letter","US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS,AR, CO, NE, NY, VA, AZ, OK).    OUS: Germany","Z-0781-2017","Class II","Algovita Spinal Cord Stimulation System,  Percutaneous Leads, 8-Electrode Percutaneous Lead Kit;    Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit;   Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit;  Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit.   Model Number (s)  112x-xx (CT), 108x-xx(T).   These are part of the Algovita Spinal Cord Stimulation System.    The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patients spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patients brain. The stimulators are rechargeable, and the frequency of recharging is dependent on  individual patients use of the system.","406 US, 985 OUS","Nuvectra is conducting a recall due to two clinical risks that are  associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System.  It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.","12/17/2016",," all serial numbers",10/11/2016,"10/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75460,"Ongoing","GF Health Products, Inc","336 Trowbridge Dr",,"Fond Du Lac","WI","54937-9103","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA ( nationwide) Distribution including Puerto Rico  and to the countries of : Bahamas, Canada, Chile, El Salvador and Santo Domingo.","Z-0732-2017","Class II","Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors.      Description                                                                           Part Number  Motor and Pendant Patriot Full Electric 120V               690-3001-943 / 690-7001-943  Boxed Full Electric 220V Motor                                     690-3220-943  Motor and Pendant Patriot LX Full Electric 120V          690-8004-912","3,547 (3063 beds, 484 motors)"," Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000.  The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design.  If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported.  ","12/12/2016",," BED                                                      SERIAL NUMBER RANGE  US0458 / US0468 Patriot Full Electric 120V  697142145108 through 697142147927  US0458 / US0468 Patriot Full Electric 220V  697144140132 through 697144140172  US6000 Patriot LX Full Electric 120V             69204141262 through 69204141737      SERVICE MOTOR KITS WITH SHIP DATES OF MAY 4, 2015 THROUGH JUNE 30, 2016  Description                                                                           Part Number  Motor and Pendant Patriot Full Electric 120V               690-3001-943 / 690-7001-943  Boxed Full Electric 220V Motor                                     690-3220-943  Motor and Pendant Patriot LX Full Electric 120V          690-8004-912",9/30/2016,"09/30/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75461,"Terminated","American Red Cross Blood Services","209 Farmington Ave",,"Farmington","CT","06032-1955","United States","Voluntary: Firm Initiated","E-Mail","California","B-0086-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product collected from a donor for whom donor suitability was not adequately determined, was distributed.","11/01/2016","11/01/2016"," W203315227618",9/20/2016,"09/20/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75462,"Terminated","West TN Regional Blood Ctr, Inc dba Lifeline Blood Services","183 Sterling Farm Dr",,"Jackson","TN","38305-5727","United States","Voluntary: Firm Initiated","FAX","Tennessee","B-0094-2017","Class II","Red Blood Cells, Leukocytes Reduced","3 units","Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. ","11/01/2016","11/01/2016"," W040816113461; W040815115312; W040815101434; ",9/2/2016,"09/02/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75463,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0095-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ","11/01/2016","11/01/2016"," W036316406616; ",9/9/2016,"09/09/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75463,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",,"Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Wisconsin; Switzerland","B-0096-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. ","11/01/2016","11/01/2016"," W036316406616; ",9/9/2016,"09/09/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75465,"Terminated","Delta Blood Bank","65 N Commerce St",,"Stockton","CA","95202-2318","United States","Voluntary: Firm Initiated","FAX","CA","B-0138-2017","Class II","Red Blood Cells, Leukocytes Reduced","2 units"," Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ","11/14/2016","11/14/2016"," W128716063102; W128716061198 ",9/8/2016,"09/08/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75467,"Completed","Yoma Myanmar","5 N Beacon St",,"Boston","MA","02134-1901","United States","Voluntary: Firm Initiated","Telephone","CA, KY MA, NY, IL, IN, TX","F-0478-2017","Class I","Yoma Myanmar Tea Salad Snack - Regular, 7 oz cello bag. Product of Myanmar"," 24 cases (24/cs= units)","Product contains undeclared peanuts","11/22/2016","."," Expiration date of 6/15/2018 ",10/8/2016,"10/08/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75467,"Completed","Yoma Myanmar","5 N Beacon St",,"Boston","MA","02134-1901","United States","Voluntary: Firm Initiated","Telephone","CA, KY MA, NY, IL, IN, TX","F-0477-2017","Class I","Yoma Myanmar Tea Salad Snack - Spicy, 7 oz cello bag. Product of Myanmar","21  cases (24/cs= units )","Product contains undeclared peanuts","11/22/2016","."," Expiration date of 6/15/2018 ",10/8/2016,"10/08/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75468,"Ongoing","Bindi North America","507 Main St",,"Belleville","NJ","07109-3322","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NJ and NY","F-0383-2017","Class I","Bindi Fantasia nel dessert, 7982 Coconut Gran Sorbetto, 1.24 Gal (4.8L), UPC 8 15073 01326 6, Distributed by: Bindi North America, Kearny, NJ 07032","27 cases (Lot #6211) and 6 cases (Lot #6265)","Product recalled due to undeclared milk allergen (sodium caseinate). ","11/08/2016",," Lot #6211 with best before date 07/29/18 and Lot #6265 with best before date 09/21/18",10/13/2016,"10/13/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75469,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.","Z-0738-2017","Class II","BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.",,"Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.","12/12/2016",," Product Code: 802065, Lot Numbers: NGZC4950, NGZD2121, NGZD4043, NGZD4876, NGZE2323, NGZE3389, NGZF0189, NGZF2494 and NGZF4014.",8/3/2016,"08/03/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75469,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.","Z-0737-2017","Class II","BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.",,"Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.","12/12/2016",," Product Code: 750375, Lot Numbers: NGZC4960, NGZD3108, NGZE1244, NGZE3556 and NGZF2584.",8/3/2016,"08/03/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75469,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.","Z-0735-2017","Class II","BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile,    The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.","452,728 units","Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.","12/12/2016",," Product Code: 0038460, Lot Numbers: NGZC3768, NGZC5029, NGZD0924, NGZD1664, NGZD1983, NGZD3103, NGZD3241, NGZD3989, NGZD4053, GZD4923, NGZE1190, NGZE2134, NGZE3406, NGZF0305, NGZF1546, NGZF2589, NGZF3934, NGZF4488 and NGZF4885.",8/3/2016,"08/03/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75469,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.","Z-0736-2017","Class II","BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.",,"Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.","12/12/2016",," Product Code: 0038470, Lot Numbers: NGZC3890, NGZC4955, NGZD0763, NGZD2107, NGZD3104, NGZD3990, NGZD4739, NGZE1149, NGZE2054, NGZE3535, NGZF0244, NGZF1565, NGZF2670, NGZF4104 and NGZF5006.",8/3/2016,"08/03/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75470,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","Letter","US","D-0144-2017","Class III","AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217","5283 cartons (100 capsules per carton = 528,300 capsules)","Presence of Foreign Tablets/Capsules","11/18/2016","."," Lot #155404 ; Exp 01/18  Lot #161139,163060,164054, 164809; Exp 03/18  ",10/13/2016,"10/13/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75471,"Ongoing","Par Pharmaceutical, Inc.","1 Ram Ridge Rd",,"Chestnut Ridge","NY","10977-6714","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0154-2017","Class II","Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977","a) 182,856 bottles; b) 59,448 bottles","Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container","11/25/2016",," a) G40814 - Exp. Date 09/2016, GA50089 - Exp. Date 12/2016, GA50259 - Exp. Date 01/2017, GA50657 - Exp. Date 03/2017, GA51073 - Exp. Date 06/2017, GA51651 - Exp. Date 09/2017, GA51652 - Exp. Date 09/2017, GA51722 - Exp. Date 09/2017, GA51723 - Exp. Date 09/2017, GA51760 - Exp. Date 10/2017, and GA51761 - Exp. Date 10/2017    b) GA45033 - Exp. Date 10/2016, GA50258 - Exp. Date 01/2017, GA50944 - Exp. Date 05/2017, GA50174 - Exp. Date 06/2017, GA51340 - Exp. Date 07/2017, GA51479 - Exp. Date 08/2017, and GA51762 - Exp. Date 10/2017",10/5/2016,"10/05/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75472,"Completed","Batista Bakery & Pastries, Inc.","75 Franklin St",,"Bristol","RI","02809-2337","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, RI","F-0474-2017","Class II","Baptista Bakery & Pastry Inc. Portugese Sliced Bread, 16 oz. plastic","30 units","Product labels fails to declare flour as wheat flour as required by FALCPA","11/17/2016",," Product manufctured prior to 9/23/16",9/23/2016,"09/23/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75472,"Completed","Batista Bakery & Pastries, Inc.","75 Franklin St",,"Bristol","RI","02809-2337","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, RI","F-0472-2017","Class II","Baptista Bakery & Pastry Inc. Italian Bread, 16 oz. plastic","30 units","Product labels fails to declare flour as wheat flour as required by FALCPA","11/17/2016",," Product manufctured prior to 9/23/16",9/23/2016,"09/23/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75472,"Completed","Batista Bakery & Pastries, Inc.","75 Franklin St",,"Bristol","RI","02809-2337","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, RI","F-0473-2017","Class II","Baptista Bakery & Pastry Inc. Bulkie Rolls, 16 oz. plastic","30 units","Product labels fails to declare flour as wheat flour as required by FALCPA","11/17/2016",," Product manufctured prior to 9/23/16",9/23/2016,"09/23/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75472,"Completed","Batista Bakery & Pastries, Inc.","75 Franklin St",,"Bristol","RI","02809-2337","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, RI","F-0471-2017","Class II","Baptista Bakery & Pastry Inc. Torpedo Rolls, 16 oz. plastic","30 units","Product labels fails to declare flour as wheat flour as required by FALCPA","11/17/2016",," Product manufctured prior to 9/23/16",9/23/2016,"09/23/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75473,"Ongoing","Intuitive Surgical, Inc.","1266 Kifer Rd Bldg 100",,"Sunnyvale","CA","94086-5304","United States","Voluntary: Firm Initiated","Telephone","Australia, Austria, Belgium, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Qatar, Romania, South  Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States","Z-0315-2017","Class II"," Surgical System, model number IS4000, A70_P5x with P5 Software;    General and Plastic Surgery:  The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders,  endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic  surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.","677 devices","Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in  unexpected master movement and potential instrument tip movement under certain circumstances","10/26/2016",," All systems manufactured with or upgraded to P5 software.",10/5/2016,"10/05/2016",11/2/2016,"11/02/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75474,"Ongoing","Baylis Medical Corp *","5959 TransCanada Highway",,"Montreal",,,"Canada","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.","Z-0393-2017","Class II","NRG Transseptal Needle and NRG RF Transseptal Kit.    Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0.     The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch.    Used to create an atrial septal defect  in the heart.","28,093 units","The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG  Transseptal Needle.","11/10/2016",," Lot numbers: NGFA240216  NGFC041115  NGFH211215  NGFA071015  NGFA151215  NGFB021115  NGFB090216  NGFB090616  NGFB101115  NGFB220216  NGFB231115  NGFB281015  NGFC110416  NGFC120116  NGFC180416  NGFC211015  NGFC250116  NGFC301115  NGFD030616  NGFD080716  NGFD091215  NGFD171115  NGFD250416  NGFE020216  NGFE090516  NGFE200116  NGFE240516  NGFF180716  NGFF211215  NGFH210316  NGFH290416  NGFI120216  NGFI270616  NGFA211015  NGFB111115  NGFB120116  NGFB140316  NGFB200616  NGFB271015  NGFC090516  NGFC161115  NGFC211215  NGFD021115  NGFD081215  NGFD160516  NGFE050116  NGFE090216  NGFE120216  NGFE290416  NGFF220216  NGFF231115  NGFF250416  NGFF270616  NGFF301115  NGFG240316  NGFG260116  NGFG300516  NGFH240516  NGFH290216  NGFI020216  NGFI210316  NGFD220216  NGFF050116  NGFA250116  NGFA240516  NGFD111115  NGFF180416  NGFH140316  NGFH151215  NGFI090616  NGFA241215  NGFB041115  NGFB070316  NGFC020216  NGFC060116  NGFC080816  NGFC120216  NGFC290416  NGFD110116  NGFD210316  NGFE200616  NGFG151215  NGFI250416  NGFB300415  NGFD040915  NGFG140715  NGFB301115  NGFA020316  NGFA030616  NGFA081215  NGFA120216  NGFA211215  NGFA270616  NGFB110116  NGFC071015  NGFC090616  NGFC240316  NGFC240516  NGFD090516  NGFD260116  NGFE040416  NGFE250416  NGFE300616  NGFF070316  NGFF110416  NGFF140316  NGFG180416  NGFJ290416  NGFA081015  NGFA210316  NGFA210616  NGFA240316  NGFA271015  NGFA301115  NGFA310316  NGFB020216  NGFB020316  NGFB030616  NGFB050516  NGFB080716  NGFB090516  NGFB120816  NGFB161115  NGFB270616  NGFB300616  NGFC151215  NGFC160516  NGFC300516  NGFD120216  NGFE020816  NGFE070316  NGFE190116  NGFF290216  NGFG040416  NGFG050116  NGFG140316  NGFG290416  NGFH110416  NGFH180716  NGFI180416  NGFI290416  NGFB180716  NGFB081215  NGFB171115  NGFB210316  NGFB240516  NGFC151015  NGFF190116  NGFF240316  NGFG090616  NGFI110416  NGFA021115  NGFA050516  NGFA090216  NGFA090516  NGFA160516  NGFA161115  NGFA300616  NGFC030616  NGFC110116  NGFD020816  NGFE180416  NGFF151215  NGFG151015  NGFH040416  NGFH090616  NGFJ240316  NGFJ290216  NGFA071215  NGF",10/11/2016,"10/11/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75475,"Ongoing","Reshape Medical Inc","100 Calle Iglesia",,"San Clemente","CA","92672-7502","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL","Z-0392-2017","Class II","ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110    product Usage:  The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.  ","114 units","ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.","11/09/2016",," Lot Number            Expiration Date  160815-001            2018-08-07  160816-001            2018-08-07  160824-003            2018-08-18  160825-001            2018-08-18  160825-002            2018-08-18",10/14/2016,"10/14/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75477,"Ongoing","Spacelabs Healthcare Inc","35301 SE Center St",,"Snoqualmie","WA","98065-9216","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA, to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico; and, to the countries of AUSTRALIA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, MEXICO, NETHERLANDS, PANAMA, SAUDI ARABIA, SWITZERLAND, TAIWAN, and UNITED KINGDOM.","Z-0332-2017","Class II","Xhibit Central Station, Model 96102.      Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.","343 units (287 units in the US and 56 units outside the US)","The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display.  Desaturation, high, and low limit alarms work normally.","11/02/2016",," Software version 1.1.5, Affected Serial Numbers in the US *************************************    SLA0114F00445, SLA0114F00446, SLA0114F00447, SLA0115F00917, SLA0115F00918, SLA0115F00919, SLA0115F00921, SLA0115F00923, SLA0115F00924, SLA0115F00927, SLA0115F00928, SLA0115F00934, SLA0115F00955, SLA0115F00961, SLA0115F00968, SLA0115F00969, SLA0115F00972, SLA0115F00976, SLA0116F01718, SLA0116F01720, SLA0116F01722, SLA0214F00489, SLA0216F01807, SLA0216F01809, SLA0216F01813, SLA0216F01821, SLA0216F01824, SLA0216F01837, SLA0216F01840, SLA0216F01844, SLA0314F00534, SLA0314F00535, SLA0314F00540, SLA0314F00543, SLA0314F00547, SLA0314F00548, SLA0314F00549, SLA0314F00552, SLA0314F00561, SLA0314F00567, SLA0414F00568, SLA0414F00585, SLA0416F01850, SLA0416F01853, SLA0416F01857, SLA0416F01860, SLA0416F01875, SLA0416F01876, SLA0416F01883, SLA0416F01885, SLA0416F01889, SLA0416F01895, SLA0416F01923, SLA0516F01969, SLA0516F01970, SLA0516F01972, SLA0516F01974, SLA0516F01975, SLA0516F01976, SLA0516F01977, SLA0516F01978, SLA0516F01981, SLA0516F01982, SLA0516F01985, SLA0516F01986, SLA0516F01987, SLA0516F01992, SLA0516F02002, SLA0516F02005, SLA0614F00631, SLA0614F00654, SLA0615F01188, SLA0615F01194, SLA0615F01197, SLA0615F01198, SLA0615F01199, SLA0615F01213, SLA0615F01237, SLA0615F01238, SLA0615F01239, SLA0615F01240, SLA0615F01244, SLA0615F01248, SLA0615F01261, SLA0714F00678, SLA0714F00688, SLA0714F00694, SLA0714F00702, SLA0714F00703, SLA0715F01274, SLA0715F01310, SLA0715F01314, SLA0715F01325, SLA0715F01331, SLA0715F01334, SLA0715F01346, SLA0715F01347, SLA0716F02009, SLA0716F02011, SLA0716F02013, SLA0716F02015, SLA0716F02016, SLA0716F02017, SLA0716F02020, SLA0716F02021, SLA0716F02022, SLA0716F02028, SLA0716F02034, SLA0716F02042, SLA0716F02043, SLA0716F02044, SLA0716F02045, SLA0814F00713, SLA0815F01371, SLA0815F01372, SLA0815F01373, SLA0815F01374, SLA0815F01375, SLA0815F01376, SLA0815F01379, SLA0815F01380, SLA0815F01381, SLA0815F01382, SLA0815F01383, SLA0815F01384, SLA0815F01386, SLA0815F01387, SLA0815F01388, SLA0815F01390, SLA0815F01",10/18/2016,"10/18/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75478,"Ongoing","Diasorin Inc.","1951 Northwestern Ave S",,"Stillwater","MN","55082-7536","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA (nationwide)  Distribution and Worldwide Distribution including the states of :  AR, AZ, CA, FL, ID, NJ, NV, NY and PA.., and to the countries of :   Saudi Arabia, Colombia, Mauritius, Iraq, Mongolia, Greece, Albania, Austria, Bosnia, Bosnia Herzegovina, Belarus, Bulgaria, Macedonia, Poland, Serbia, Dominican Rep., Tunisia, Paraguay, Hungary, Jordan, Egypt, Belgium, Caribbean, Germany, Brazil, Mexico, Italy, India, South Korea, Cyprus, Bangladesh, Morocco, Chile, Bahrain, Palestine, Utd.Arab.Emir., Kosovo, Uruguay, Venezuela, Hungary, Australia, Vietnam, Sri Lanka, Turkey, Vietnam, Romania, Mauritius, Ecuador, Lebanon, Nepal, Argentina, Hong Kong, China and Canada.","Z-0645-2017","Class II","LIAISON Estradiol II Gen, 310680, 310680-CN    The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family.","10,739","DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. Due to the risk of a recently identified cross reactivity, the LIAISON¿ Estradiol II Gena assay should not be used to test patients being treated with fulvestrant (Faslodex).","11/21/2016","."," Catalog Number 31 0680, 31 0680-CN",7/13/2016,"07/13/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75480,"Terminated","Mississippi Valley Reg Bld Ctr","5500 Lakeview Pkwy",,"Davenport","IA","52807-3481","United States","Voluntary: Firm Initiated","Telephone","Illinois","B-0118-2017","Class III","Apheresis Platelets, Leukocytes Reduced","6 units","Blood products, in which no documentation that products were shipped or stored at appropriate temperature, were distributed. ","11/14/2016","11/14/2016"," W039516019965; W333616076127; W333516018167; W039516020104; W039516020120; W039516020146; ",8/29/2016,"08/29/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75481,"Ongoing","Covidien LLC","60 Middletown Ave",,"North Haven","CT","06473-3908","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Japan","Z-0756-2017","Class II","Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile  Item Code: 17099","5,187,100 Units ","Sterility of the outer surface of the container compromised due to packaging defect.","12/14/2016",," All lots starting with 3, 4, 5 and all lots from 600586264X to  613480164X",10/14/2016,"10/14/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75482,"Ongoing","GSK Consumer Healthcare","184 Liberty Corner Rd Ste 200",,"Warren","NJ","07059-6868","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide in the USA","D-0142-2017","Class III","Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01","462,732 bottles",".","11/17/2016",," Lot #: 5M02ST*, 5M03ST*, 5M04ST*, Exp 10/17; 5P01ST, 5P01STA, 5P02ST, 5P03ST, 5P04ST, 5P05ST, Exp 11/17; 6C03ST, 6C04ST, 6C05ST, 6C06ST, 6C07ST, Exp 02/18    *Lots 5M02ST, 5M03ST, and 5M04ST contain the NDC code error only on front label, back label is correct.    ",10/18/2016,"10/18/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75483,"Ongoing","Zimmer Surgical Inc","200 W Ohio Ave",,"Dover","OH","44622-9642","United States","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.","Z-0368-2017","Class II","Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box.  A product label is applied to the lid of the box.  The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.    ","1030 units","Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. Given that the frequency of this surface coating condition can worsen with age, Zimmer Biomet Surgical is currently making preparations for replacement activities to follow in order to prevent future complaints. This document is provided to alert all users of the potential for the surface coating to exhibit blistering, peeling, and discoloring after usage over time. A separate recall removal notice will be issued to facilities, in phases, with detailed instructions beginning in August 2016. Your sales representatives will be notified when a replacement is ready. Do not return product at this time as part of this action.  Image 1.","11/04/2016",," There are no lot code(s) for the 01-8851-001-00 loaner part number due to when the device is physically manufactured, it is done so as part number 00-8851-001-00 and lot codes   are assigned to this part number.  The 01-8851-001-00 exists in order to differentiate that the device is being distributed as a loaner rather than a sale of the device",7/4/2016,"07/04/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75484,"Ongoing","Siemens Healthcare Diagnostics, Inc.","500 Gbc Dr Ms 514","PO BOX 6101","Newark","DE","19702-2466","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally to  Australia, Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Qatar, Saudi Arabia, South Korea, Slovakia, Slovenia, Spain, and Switzerland.","Z-0652-2017","Class II","Dimension Vista Chemistry 1 Calibrator  The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System","9,935 units","Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista¿ CHEM 1 CAL lots 5GM081 and 5GM082.","11/21/2016","."," Device Listing Number: D011448 (Kc110) and D244577 (KC110B)  Lot numbers: MGM081 and MGM082",9/15/2016,"09/15/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75485,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY      Foreign:France, Germany, Canada, UK, Lebanon, South Africa, Chile, Hong Kong, Poland, Argentina, Spain, Greece, Italy, India, Brazil, Switzerland, Netherlands, Sweden      VA/DOD:","Z-0584-2017","Class III","RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U","2,675","Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.","11/16/2016",," RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U",10/11/2016,"10/11/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75486,"Ongoing","Medtronic Neuromodulation","7000 Central Ave",,"Minneapolis","MN","55421-1241","United States","Voluntary: Firm Initiated","Visit","US Nationwide Distribution.","Z-0788-2017","Class II","Medtronic SynchroMed II Implantable Drug Infusion System.  This system includes:  Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer,  and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.)     Product  Usage:  The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer  ","22,298 software cards","Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System.  Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.","12/18/2016",," software application cards with versions other than AAU01",10/3/2016,"10/03/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75487,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) Internationally to Canada, Mexico, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, Cyprus, Denmark, Egypt, Ecuador, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Russian Fed. Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, Vatican City and Vietnam","Z-0589-2017","Class II","Advia Chemistry Calibrator   For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)         ","10,614 units","Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for Direct Bilirubin measurement. ","11/16/2016",," Device Listing # D033650  Model# SMN# 10312279  Lot Numbers: 680726, 680726A, 680726B, 680726C, 680726D",10/7/2016,"10/07/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75488,"Ongoing","Rosa Foods HQ","207 S Broadway Fl 7",,"Los Angeles","CA","90012-3609","United States","Voluntary: Firm Initiated","E-Mail","US: Nationwide  Worldwide: Canada","F-0532-2017","Class II","Soylent Food Bars, Net Wt. 2.12 oz (60g), 12 pack.","545,508 bars","Rosa Foods is recalling Soylent Bar because a number of their customers have experienced gastrointestinal issues after consuming Soylent Bars.","11/25/2016",," 14JUL17 F1-F2 1966;  15JUL17 F1 1976;  14JUL17 F3-F4 1966;  14JUL17 F3 1976;  18JUL17 F1 2006;  02AUG17 F3 2166;  02AUG17 F3-F4 2156;  08AUG17 F3 2216;  04AUG17 F3 2186;  08AUG17 F3 2226;  10AUG17 F3 2236",10/10/2016,"10/10/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75489,"Terminated","OneBlood, Inc.","8669 Commodity Cir",,"Orlando","FL","32819-9003","United States","Voluntary: Firm Initiated","E-Mail","Kentucky","B-0110-2017","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.","11/01/2016","11/01/2016"," W036815409257",9/20/2016,"09/20/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75490,"Ongoing","CutisPharma, Inc.","841 Woburn St",,"Wilmington","MA","01887-3414","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0139-2017","Class III","FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only,  Manufactured for CutisPharma Wilmington, MA,  NDC# 65628-070-03","8,748 kits","Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL","11/16/2016",," Lot #: E1414, Exp. 08/2018",10/20/2016,"10/20/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75490,"Ongoing","CutisPharma, Inc.","841 Woburn St",,"Wilmington","MA","01887-3414","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0138-2017","Class III","FIRST Omeprazole 2mg/mL in FIRST  PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05    ","5,904 kits","Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL","11/16/2016",," Lot #: E1396, Exp. 08/2018 ",10/20/2016,"10/20/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0499-2017","Class II","CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","360 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265552  3288453       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0500-2017","Class II","CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","272 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3245747  3261659         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0492-2017","Class II","MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No. 46085-47  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3259389  3265536     ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0462-2017","Class II","KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","60 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3256122",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0520-2017","Class II","CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","1320 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226745  3245752               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0458-2017","Class II","ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","1240 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3253214  3281003  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0519-2017","Class II","CATH LAB KIT, Item No. 46096-25  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","120 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3281286  3288479  3310930             ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0549-2017","Class II",", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE  FLUSH, MACRODRIP AND RED PLUGS, Item No. 46104-10  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","1740 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226843  3264741             ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0539-2017","Class II"," Manifold w/TRANSPAC¿ IV, Item No. 46100-29  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3281417                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0430-2017","Class II",", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP), Item No. 42586-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","800 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3265438",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0517-2017","Class II","PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","50 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3241909           ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0509-2017","Class II","OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3256932         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0565-2017","Class II"," Reservoir, 03 ml Squeeze Flush Device, Needleless Valves, Red, Blue and Yellow Stripe TBG, Item No. 46113-88  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","60 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3230678  3239499                         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0540-2017","Class II"," HP Tubing, Item No. 46100-83  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","90 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3235629                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0534-2017","Class II","Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringes and 3 Way Stopcock, Item No. 46098-87NS  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","140 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3281315               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0424-2017","Class II","TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK, Item No. 42582-08  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","2310 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3260791  3265428  3278802  3284256  3288262  3310777  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0568-2017","Class II"," Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No. 46114-24  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","260 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3261682                       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0498-2017","Class II","TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/BAYVIEW, Item No. 46088-74  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","1440 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3240639  3245746  3265550  3281175     ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0420-2017","Class II"," TUBING, 2 SQUEEZE FLUSHES, 2 DISPOSABLE TRANSDUCER, MACRODRIP (POLE MOUNT), Item No. 42500-06  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","340 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3226086",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0559-2017","Class II"," Reservoir and Needleless Valves, Item No. 46112-03  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","275 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3240856                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0481-2017","Class II","CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","560 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226637  3264129  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0522-2017","Class II","PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3264147  3265574                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0508-2017","Class II","PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","40","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3235554         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0572-2017","Class II"," Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3288582                       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0456-2017","Class II","SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","130 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3249812   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0423-2017","Class II","TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","4580 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3253195  3264105  3265427  3274783  3280951  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0538-2017","Class II"," Macrodrip¿ Admin Set, Item No. 46099-77  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","50 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3264156  3274963                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0445-2017","Class II"," TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42640-06  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","280 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3240663",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0450-2017","Class II","TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO¿ FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42651-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","60 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3235504",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0453-2017","Class II","TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND STOPCOCK WITHOUT COVERS, Item No. 42663-01NS  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","710 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265464  3274815  3280993  3288354  3303694  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0515-2017","Class II","Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Item No. 46094-71  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","25 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3253973           ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0542-2017","Class II"," Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","120 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3249839                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0506-2017","Class II","TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","144 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3256145  3264711         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0471-2017","Class II","LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","336 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3272733  3274843  3284331  3293001  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0525-2017","Class II","TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","60 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3231400             ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0475-2017","Class II","ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","200 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3279153",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0532-2017","Class II"," MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS, Item No. 46098-78  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.  ","380 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3274951               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0556-2017","Class II","Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT Tubing, Item No. 46107-68  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","210 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226908  3281606                   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0472-2017","Class II","RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","125 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3274845  3281034  3293002  3296790  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0466-2017","Class II","CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","140 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265491  3274839  3281031  3288402  3303710  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0550-2017","Class II",", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Red Stripe Pressure Tubing and Color Plug, Item No. 46104-31  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","260 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226845  3265753               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0477-2017","Class II","KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3264128",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0474-2017","Class II","OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-48  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","290 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3247291  3249820  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0503-2017","Class II","MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3245748       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0529-2017","Class II","Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold  Right OFF Rotator and TP4, Item No. 46098-19  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","30 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3245753  3268530                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0436-2017","Class II"," Arterial Pressure Tubing, Item No. 42594-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","40 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265442",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0491-2017","Class II","Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","70 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3247302   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0502-2017","Class II","CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226691         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0486-2017","Class II","HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","30 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265513",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0482-2017","Class II","MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","70 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265508  3268507  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0431-2017","Class II",", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42587-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","4360 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3242377  3247898  3268465  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0426-2017","Class II","TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (INTENDED FOR PATIENT MOUNT), Item No. 42583-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","3640 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3226090  3280957  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0494-2017","Class II","TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","880 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3279215     ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0470-2017","Class II","PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","650 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226610",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0510-2017","Class II","BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","210 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3264142       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0442-2017","Class II"," TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42620-08  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","3020 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3242384  3264114  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0555-2017","Class II","Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush and Macrodrip, Item No. 46106-91  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","440 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3281591                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0561-2017","Class II",", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and Macrodrip, Item No. 46112-10  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","2640 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3203493  3226937  3264167                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0429-2017","Class II",", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","17420 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3235444  3238904  3243135  3247867  3247901  3247902  3261560  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0533-2017","Class II"," PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item No. 46098-79  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3235619               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0536-2017","Class II","Quad Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3261672             ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0505-2017","Class II","PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","25 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3268515       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0501-2017","Class II","Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","295 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226690         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0490-2017","Class II","MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","90 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3188653   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0511-2017","Class II","TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","130 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3261662       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0478-2017","Class II","PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","80 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3242450",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0493-2017","Class II","MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV. OF NEW MEXICO, Item No. 46085-50  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265538     ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0448-2017","Class II"," TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42643-06  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","200 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3227581",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0570-2017","Class II"," Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and 8 cc Control Syringe, Item No. 46300-01  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","270 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3235660  3264173                         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0460-2017","Class II","CATH LAB KIT #2 FOR MARY HITCHCOCK MEM. HOSP., Item No. 46057-18  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265486  3274836  3281027  3288397  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0455-2017","Class II","Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","500 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226573   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0546-2017","Class II"," Tubing,03 ml Intraflo¿ Flush and Needleless Valve, Item No. 46103-68  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","240 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3259421           ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0531-2017","Class II"," MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","750 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3273544  3274949  3284432  3288502  3293484  3296873               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0469-2017","Class II","ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-64  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","175 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3235525",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0434-2017","Class II","TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42590-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","4470 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3239173  3261651  3292882  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0521-2017","Class II"," KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3256959               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0446-2017","Class II"," TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42641-06  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","820 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3249806",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0551-2017","Class II","TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","260 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3268549  3269902  3284456  3310919                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0573-2017","Class II","Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","1000 unit","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3258299                     ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0514-2017","Class II","MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","235 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226738           ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0483-2017","Class II","TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","150 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3245745  3256133  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0415-2017","Class II","TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","60,560 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3192360  3210327  3225634  3242228  3242233  3242235  3242236  3242237  3242245  3242247  3242248  3242249  3242255  3242260  3242262  3242263  3253912  3264057  3264059  3264062  3264063  3273065  3273070  3273071  3284136",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0449-2017","Class II"," TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42644-06   The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","2200 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3260808   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0544-2017","Class II","Transpac¿ w/Safeset Reservoir, Squeeze 03 ml Flush and Needleless Valve, Item No. 46101-82  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","140 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226821             ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0421-2017","Class II"," 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-19  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","260 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3261534  3274777  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0560-2017","Class II"," Reservoir and Needleless Valves, Item No. 46112-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3259439                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0487-2017","Class II","Cath Lab Kit For Elkhart Hosp., Item No. 46078-17  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","205 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3274856  65-033-SJ  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0557-2017","Class II"," Reservoir and Needleless Valve, Item No. 46108-36  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3257011                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0497-2017","Class II","TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","30 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265549     ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0440-2017","Class II",", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42607-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","2240 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3195741  3280973  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0473-2017","Class II","M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","75 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226619",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0552-2017","Class II",", Disposable Transducer, 30 ML Intraflo¿ Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3249845                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0443-2017","Class II",", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42632-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","11100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3242385  3242386  3261653  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0558-2017","Class II"," Blood Sampling Port and 03 ml Squeeze Flush Device 10 cc Sheathed Syringe, Item No. 46109-74  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","50 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3249855                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0441-2017","Class II",", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42608-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","900 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226306  3251016  3264112  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0575-2017","Class II","LEFT HEART KIT, Item No. AG8052-NS  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","80 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3264177                   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0571-2017","Class II"," (600 psi), Transpac¿ IV, Waste Bag System and 10 cc Control Syringe, Item No. 46300-11NS  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","40 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3275023                       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0488-2017","Class II","CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","110 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3279205  3281083  3288437  3315377  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0439-2017","Class II","TRANSPAC¿ IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH AND MACRODRIP (POLE MOUNT), Item No. 42606-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","3460 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226298  3240645  3264111  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0468-2017","Class II","TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","130 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3259345",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0541-2017","Class II"," HP Tubing, Item No. 46100-87  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","40 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3251051                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0554-2017","Class II","Monitoring Kit w/TP4, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, Blue Plugs and Needleless Valve, Item No. 46106-49  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","60 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3257003                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0518-2017","Class II","CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3256154  3265569           ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0451-2017","Class II"," TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42645-06  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","1100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3243142",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0516-2017","Class II"," Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and 30 ml Contrast Reservoir, Item No. 46095-16  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","40 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3247308  3269930           ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0416-2017","Class II",", 2 Disposable Transducers, 2 03 ml Intraflo¿ Flush Devices, Macrodrip (Pole Mount), Item No. 011-42592-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","130 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3235241",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0553-2017","Class II"," Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves 1 Bonded, Item No. 46104-75  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","660 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226851  3249846                   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0484-2017","Class II"," KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-25  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","640 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3176094  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0547-2017","Class II"," Pressure Tubing, Reservoir, 03 ml Squeeze Flush and 2 Needleless Valves, Item No. 46103-77  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.",,"ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226830           ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0512-2017","Class II","MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","40 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3242482  3265564         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0574-2017","Class II"," MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","30 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3280366                     ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0485-2017","Class II"," KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","950 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3190676  3227610  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0567-2017","Class II"," Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","25 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226952                       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0457-2017","Class II","CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","60 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3284322   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0419-2017","Class II","TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","380 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3232120",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0543-2017","Class II"," Reservoir, TP4, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-55  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3245759               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0504-2017","Class II","ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","380 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3231380       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0537-2017","Class II","CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","370 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3197959  3256970               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0480-2017","Class II","TRIPLE PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, Item No. 46072-51  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3267623",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0444-2017","Class II",", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (FOR USE WITH INFUSION PUMP), Item No. 42634-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","2900 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226342  3264691  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0530-2017","Class II"," MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.-75  ","105 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3274948  3281379  3293483                   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0465-2017","Class II","BIFURCATED TRANSPAC¿ 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No. 46063-34  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","120 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3235523",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0454-2017","Class II","TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. 42664-01NS  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","1480 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3280995   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0414-2017","Class II"," Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3288582                       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0425-2017","Class II","TRANSPAC¿ IV DISPOSABLE TRANSDUCER  MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUSH, Item No. 42582-09  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","520 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3265429",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0428-2017","Class II",", DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42584-09  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","3480 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3188534  3226099  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0435-2017","Class II"," 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42590-08  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","730 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3226281  3264110  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0566-2017","Class II"," w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3235658                         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0569-2017","Class II","Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set, Item No. 46114-80  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3253990                       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0463-2017","Class II","DOUBLE LINE KIT WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item No. 46063-03  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265488",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0422-2017","Class II","TRANSPAC¿ IV DISPOSABLE TRANSDUCER, Item No. 42582-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","3060 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3264104  3265426  3274779  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0526-2017","Class II","TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","10 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3256962             ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0545-2017","Class II",", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO¿ FLUSHES, MACRODRIP (POLE MOUNT), Item No. 46101-39  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","30 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265745           ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0562-2017","Class II"," Reservoir, 03 ml Squeeze Flush Device and Needleless Valves, Item No. 46112-13  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","520 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3203497  3235654                   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0563-2017","Class II","Transpac¿ IV Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. 46112-30NS  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","180 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265805  3281660                     ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0527-2017","Class II","SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","430 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226756  3261667               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0467-2017","Class II","OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","120 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226606",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0513-2017","Class II","QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","200 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3227657  3235558           ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0528-2017","Class II","Cath Lab Kit w/Waste Bag, dyePod¿, Sosa Spike & Syringe, Item No. 46098-11  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","135 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3256966               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0476-2017","Class II","NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN HOSP., Item No. 46068-65  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","40 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265497",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0535-2017","Class II","DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","90 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226777             ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0524-2017","Class II","TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","200 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3227664               ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0417-2017","Class II","TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-46106-45  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","140 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3265352",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0432-2017","Class II",", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","1740 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3226274  3264108  3265439  3269745  3280964  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0459-2017","Class II","MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","370 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3231359  3264121  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0418-2017","Class II",", DISPOSABLE TRANSDUCER WITH 2 BONDED STOPCOCKS, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-02  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","260 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3226084",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0548-2017","Class II","Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","220 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226840  3247322             ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0489-2017","Class II"," AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","160 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226654   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0461-2017","Class II","ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE CHILDRENS HOSP., Item No. 46059-28  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","190 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3264124",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0427-2017","Class II",", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","38160 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3178532  3184461  3202001  3240576  3240578  3240583  3247915  3253198  3253199  3261706  3261707  3261708  3265284    ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0464-2017","Class II","TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 46063-11  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","100 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265488",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0496-2017","Class II","CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","180 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3251030  3265547     ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0433-2017","Class II",", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (PATIENT MOUNT), Item No. 42589-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","500 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits  containing the Transpac IV transducers.","11/15/2016",," 3245732  3251014  3265440  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0438-2017","Class II","Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 42598-01  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","200 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226295  3242382  ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0479-2017","Class II","RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","20 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265500",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0507-2017","Class II","CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","140 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3235552  3256929         ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0495-2017","Class II","ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","660 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226664   ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0564-2017","Class II"," Pressure TBG, Item No. 46112-77  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","325 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3264169  3242573                       ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0437-2017","Class II"," Arterial Pressure Tubing, Item No. 42594-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","40 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265442",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0452-2017","Class II","TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42652-05  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","740 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3265462",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0523-2017","Class II","QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","70 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3226751                 ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75491,"Ongoing","ICU Medical, Inc.","951 Calle Amanecer",,"San Clemente","CA","92673-6212","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0447-2017","Class II"," TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42642-06  The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.","1960 units","ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.","11/15/2016",," 3238756",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75492,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","U.S. Nationwide.","Z-0404-2017","Class II","BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.","75,089 units","Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.","11/14/2016",," Product Codes: 776400, 776600, 776700, and 776800.",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75492,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","U.S. Nationwide.","Z-0405-2017","Class II","Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi- Length Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.","75,089 units","Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.","11/14/2016",," Product Codes: 777400, 777600, 777700, 777800, 778400, 778600, 778700, 778800, 786400, 786600, 786700,786800, 787400, 787600, 787700, 787800, 788400, 788600, 788700 and 788800.",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75492,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","U.S. Nationwide.","Z-0403-2017","Class II",", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.","75,089 units","Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.","11/14/2016",," Product Codes: 277405, 277406, 277407, 277408, 288405, 288406, 288407 and 288408.",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75492,"Ongoing","C.R. Bard, Inc.","8195 Industrial Blvd NE",,"Covington","GA","30014-1497","United States","Voluntary: Firm Initiated","Letter","U.S. Nationwide.","Z-0406-2017","Class II","I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.","75,089 units","Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.","11/14/2016",," Product Codes: REK32N and FEK32HW.",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75493,"Terminated","DCI Biologicals Greenville, Inc","2727 E 10th St",,"Greenville","NC","27858-3127","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0111-2017","Class II","Source Plasma","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","11/03/2016","11/03/2016"," GL0674042",9/5/2016,"09/05/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75494,"Ongoing","Mevion Medical Systems, Inc.","300 Foster Street",,"Littleton","MA","01460-2017","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  FL, MO, NJ,  OH, OK","Z-0411-2017","Class II","MEVION S250     Product Usage:  Proton Radiation Therapy System","6 units","Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter","11/14/2016",," Serial Numbers: S250-0001 through S250-0006",10/20/2016,"10/20/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75495,"Completed","St Clair Foods, Inc.","3100 Bellbrook Dr",,"Memphis","TN","38116-1702","United States","Voluntary: Firm Initiated","Telephone","AL","F-0528-2017","Class I","HEARTLAND ENTREES DUMPLINGS AND BROTH, Product Code 856140, NET WEIGHT:  (320 ozs)(9.09 kg)(4-5 Lbs), KEEP FROZEN ","155 cases","Dumplings in the Broth and Dumplings product contains undeclared milk.","11/23/2016","."," PRODUCTION DATE 9/13/16, CODE DATE 15627",10/20/2016,"10/20/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75496,"Ongoing","Mevion Medical Systems, Inc.","300 Foster Street",,"Littleton","MA","01460-2017","United States","Voluntary: Firm Initiated","Letter","US Nationwide in the states of FL, MO, NJ and OK","Z-0409-2017","Class II","MEVION S250    Product Usage:  Proton Radiation Therapy","6 units","Completing Setup Without Program Move Complete Can Cause An Isocenter Error","11/14/2016",," Serial NUmbers: S250-0001 through S250-0006",10/31/2016,"10/31/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75497,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distribution was made to medical facilities nationwide.  Foreign distribution was also made.","Z-0611-2017","Class II","iConnect Access software.  The firm name on the label is Merge Healthcare, Hartland, WI.","60 sites potentially have the affected versions","Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.","11/17/2016",," Versions 3.0.1, 3.1, and 3.2",5/25/2016,"05/25/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75498,"Ongoing","Mevion Medical Systems, Inc.","300 Foster Street",,"Littleton","MA","01460-2017","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of FL, MO, NJ,  OH and OK,","Z-0410-2017","Class II","MEVION S250     Product Usage:  Proton Radiation Therapy System","6 units","Recovery of Incorrect Isocenter -operational change ","11/14/2016",," Serial Number: S250-0001 through S250-0006",10/21/2016,"10/21/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75499,"Ongoing","OMNI LIFE SCIENCE","480 Paramount Dr",,"Raynham","MA","02767-1085","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution: US distribution to OK, MD, TX and country of:  Australia.","Z-0610-2017","Class III","OMNIBotics Tracker Kit -Model: RM-10000     The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty","15 units","Incorrect lot number on outer kit","11/17/2016",," Lot  number: 19-09-021",10/14/2016,"10/14/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75500,"Ongoing","Chesterman Co","4700 S Lewis Blvd",".","Sioux City","IA","51106-9516","United States","Voluntary: Firm Initiated","Visit","Product was distributed to AR, CO, IA, KS, MN, NE, OK, SD, and TN","F-0675-2017","Class II","A&W Cream Soda, 20 FL OZ, Caffeine Free","1,010/24/20 fl oz/bottles/cases"," but testing revealed the presence of caffeine.","12/08/2016",," Nov0716PLE, Nov2116PLB, Dec1216PLC, Jan0217PLA",10/25/2016,"10/25/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75501,"Ongoing","1 Epic, LLC","PO Box 3202",,"Gilbert","AZ","85299-3202","United States","Voluntary: Firm Initiated","E-Mail","AL, CA, FL, GA, IL, KY, MD, MI, NY, OH, PA, TN, TX, VA.","F-0418-2017","Class II","Fruit 66 Passion Fruit Mango, 8 FL OZ (240 mL) 100% Juice Non-Carbonated.  Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients.  UPC 98341-00109.","5,832 cases (24 cans per cases)","1 Epic is recalling specific lots of various Fruit 66 100% Fruit Juice products because the cans are experiencing swelling that can cause the lids of the can to pop off and potentially cause an injury.","11/08/2016",," Lot Code:  6200CS, 6201CS and 6266CS",10/18/2016,"10/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75501,"Ongoing","1 Epic, LLC","PO Box 3202",,"Gilbert","AZ","85299-3202","United States","Voluntary: Firm Initiated","E-Mail","AL, CA, FL, GA, IL, KY, MD, MI, NY, OH, PA, TN, TX, VA.","F-0415-2017","Class II","Fruit 66 Mixed Berry, 8 FL OZ (240 mL) 100% Juice Non-Carbonated.  Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients.  UPC 98341-00117.  ","1,944 cases (24 cans per cases)","1 Epic is recalling specific lots of various Fruit 66 100% Fruit Juice products because the cans are experiencing swelling that can cause the lids of the can to pop off and potentially cause an injury.","11/08/2016",," Lot Codes:  6200CS and 6273CS",10/18/2016,"10/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75501,"Ongoing","1 Epic, LLC","PO Box 3202",,"Gilbert","AZ","85299-3202","United States","Voluntary: Firm Initiated","E-Mail","AL, CA, FL, GA, IL, KY, MD, MI, NY, OH, PA, TN, TX, VA.","F-0417-2017","Class II","Fruit 66 Tropical Punch, 8 FL OZ (240 mL) 100% Juice Non-Carbonated.  Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients.  UPC 98341-00108.","6,552 cases (24 cans per case)","1 Epic is recalling specific lots of various Fruit 66 100% Fruit Juice products because the cans are experiencing swelling that can cause the lids of the can to pop off and potentially cause an injury.","11/08/2016",," Lot Codes:  6200CS and 6266CS",10/18/2016,"10/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75501,"Ongoing","1 Epic, LLC","PO Box 3202",,"Gilbert","AZ","85299-3202","United States","Voluntary: Firm Initiated","E-Mail","AL, CA, FL, GA, IL, KY, MD, MI, NY, OH, PA, TN, TX, VA.","F-0416-2017","Class II","Fruit 66 Strawberry Melon, 8 FL OZ (240 mL) 100% Juice Non-Carbonated.  Flavored 100% Juice Blend from concentrate with other natural Flavors and added Ingredients.  UPC 98341-00116.  ","5,688 cases (24 cans per case)","1 Epic is recalling specific lots of various Fruit 66 100% Fruit Juice products because the cans are experiencing swelling that can cause the lids of the can to pop off and potentially cause an injury.","11/08/2016",," Lot Codes:  6201CS and 6266CS",10/18/2016,"10/18/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75502,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0639-2017","Class II","3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile","4578 units","The peel pouches for the affected reaming rods and extraction hooks are delaminating. ","11/19/2016","."," Catalog ID 351.76S, Lot Numbers: 9938361; 9970591; H000103; H001021; H032765; H032769; H033313; H043056; H043057; H043058; H043551; H043564; H054931; H054932; H054933; H056192; H056193; H056194; H058374; H058375; H058376; H058377; H058378; H059426; H059427; H059428; H067852; H067853; H069071; H069073; H077277; H077452; H077704; H086318; H086319; H087018; H089848; H089849; H089850; H090012; H090013; H090014; H090745; H099607; H099608; H099610; H099611; H115889; H115890; H115891; H115892; H122535; H122998; H123001; H123002; H123970; H123975; H135276; H135277; H135278; H141083; H141085.",10/3/2016,"10/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75502,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0637-2017","Class II","2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile","1,433 units","The peel pouches for the affected reaming rods and extraction hooks are delaminating. ","11/19/2016","."," Catalog ID 351.707S, Lot Numbers: 9963694; 9963695; 9963696; 9963697; 9963698; 9963699; 9972862; H040500; H040502; H040503; H060093; H060094; H060095; H060096; H060097; H080022; H080023; H080024; H080025; H089873; H089874; H089875.",10/3/2016,"10/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75502,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0638-2017","Class II","3.0 mm Reaming Rod/950 mm, Sterile","810 units","The peel pouches for the affected reaming rods and extraction hooks are delaminating. ","11/19/2016","."," Catalog ID 351.71S, Lot Numbers: H000111; H033314; H067857; H067858; H069074; H069079; H087019; H090015; H090747; H100713; H123976.",10/3/2016,"10/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75502,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0641-2017","Class II","2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile","139 units","The peel pouches for the affected reaming rods and extraction hooks are delaminating. ","11/19/2016","."," Catalog ID 355.042S, Lot Numbers: H085634; H094463.",10/3/2016,"10/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75502,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0644-2017","Class II","2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile","2,157 units","The peel pouches for the affected reaming rods and extraction hooks are delaminating. ","11/19/2016","."," Catalog ID 351.709S, Lot Numbers: 9913251; 9913252; 9913254; 9913256; 9913259; 9913260; 9950460; 9950461; 9950462; 9950463; 9950464; 9963747; 9963748; 9963749; 9963751; 9963752; 9963753; 9963755; 9963756; 9963757; 9985371; 9985372; 9985373; 9985374; H040508; H040509; H040510; H040511; H040512; H040517; H040518; H040519; H060103; H060104; H060105; H060106; H060107; H060108; H060114; H060115; H060116; H080034; H080035; H080036; H080037; H080038; H080039; H080040; H080041; H080081; H080082; H080083; H080084; H080085; H080086; H080087; H080088; H080089; H105527; H105528; H105529; H105530.",10/3/2016,"10/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75502,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0640-2017","Class II","3.0 mm Guide Rod/950 mm with Smooth Tip, sterile","319 units","The peel pouches for the affected reaming rods and extraction hooks are delaminating. ","11/19/2016","."," Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756",10/3/2016,"10/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75502,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0643-2017","Class II","2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile","195 units","The peel pouches for the affected reaming rods and extraction hooks are delaminating. ","11/19/2016","."," Catalog ID 359.083S, Lot Numbers: H115566; H116597; H116601; H117049",10/3/2016,"10/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75502,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0642-2017","Class II","Extraction Hook - Sterile for TI Cannulated Nails","88 units","The peel pouches for the affected reaming rods and extraction hooks are delaminating. ","11/19/2016","."," Catalog ID 355.399S, Lot Numbers: H102610",10/3/2016,"10/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75503,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Italy, Malaysia, Netherlands, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom and Zambia","Z-0648-2017","Class II","AQUIOS Lyse Reagent Kit, Catalog No. B23538    Product Usage:  AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.  ","2367 units total (207 units in US)","Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application.  The issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. Depending on the specimen age, a new blood specimen may be required.","11/21/2016","."," 6040014K  6040015K",10/19/2016,"10/19/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75504,"Terminated","Inland Northwest Blood Center","210 W Cataldo Ave",,"Spokane","WA","99201-2217","United States","Voluntary: Firm Initiated","Letter","Ohio","B-0112-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Apheresis product, in which quality control for residual WBC count was not performed, was distributed.","11/01/2016","11/01/2016"," W0425160400900",10/17/2016,"10/17/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75505,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","1200 N Highland Ave",,"Aurora","IL","60506-1401","United States","Voluntary: Firm Initiated","Telephone","Illinois","B-0123-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Platelet product, for which quality control and distribution did not meet specifications, was distributed.","11/03/2016","11/03/2016"," W0397162476818",9/13/2016,"09/13/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75506,"Terminated","Aurora Area Blood Bank Dba Heartland Blood Centers","1200 N Highland Ave",,"Aurora","IL","60506-1401","United States","Voluntary: Firm Initiated","Telephone","Illinois","B-0125-2017","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","1 unit","RBC product, for which quality control and distribution of product did not meet specifications, was distributed.","11/03/2016","11/03/2016"," W039716198651J",9/13/2016,"09/13/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75508,"Ongoing","PerkinElmer, Inc","68 Elm St",,"Hopkinton","MA","01748-1602","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA, MA, NY, IA, OR , PA, WA and Internationally  to Belgium, Canada, Finland, France, Germany, Japan, Netherlands, Singapore, and UK","Z-0747-2017","Class II","Perkin Elmer  RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized   Item Number: 6000689.  Supplied for use with JANUS Automated Workstations:  Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS  The JANUS Automated Workstation is an automated, programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows","595 trays (571,200 tips)","Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing","12/12/2016",," Lot Numbers:15470394, 15471775, 1601067, 16071147",6/24/2016,"06/24/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75509,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0374-2017","Class II","SOMATOM Definition Flash  system, x-ray, tomography, computed  ","57 systems distributed in USA","Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts. ","11/08/2016",," Model Numbers: 8098027  10430603  ",10/19/2016,"10/19/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75509,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0373-2017","Class II","SOMATOM Definition AS  system, x-ray, tomography, computed","57 systems distributed in USA","Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts. ","11/08/2016",," Model Numbers: 8098027  10430603  ",10/19/2016,"10/19/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75510,"Ongoing","Medimaps Group","Fongit","Chemin des Aulx 18","Plan-les-Ouates",,,"Switzerland","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.","Z-0369-2017","Class II","TBS iNsight Version v.3.0.1    Product Usage:  TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.  ","15 units in US","The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded.","11/05/2016",," Version v.3.0.1; Serial # 14295, 300409, 70580, 200042, 500581, 70103, 70174, 80936, 100202, 201120, 84584, 83769, 100112, 210020, 210440",10/3/2016,"10/03/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75511,"Ongoing","Lsi Medience Corporation","13-4 Uchikanda 1 Chome",,"Tokyo",,,"Japan","Voluntary: Firm Initiated","E-Mail","US Distribution to the states of : AL, FL, ID and MA.","Z-0646-2017","Class II","Pathfast D-Dimer, Reference number: PF1051-KUS","42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).","Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.","11/21/2016","."," Lot T528",8/16/2016,"08/16/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75513,"Ongoing","Inpeco S.A.","Via San Gottardo 10",,"Lugano",,,"Switzerland","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including Texas and New York. Foreign Consignees: Germany, Italy, France, Austria and Spain.","Z-0587-2017","Class II","FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.  The systems consolidate multiple Analytical instruments into a unified workstation.  ","188 units","Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets.","11/16/2016",," Shucko Socket with P/N: 693822160, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 3 meters; Shucko Socket with P/N: 693822170, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 5 meters; Shucko Socket with P/N: 693822190, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 7 meters; Shucko Socket with P/N: 0C00005640, Model: CMSA/HETTICH - STORAGE - i2000SR, Length: 2 meters.    The Serial number of the impacted products globally distributed are the following:  ACP.009, ACP.024, ACP.039, ACP.054, ACP.069, ACP.084, ACP.100, ACP.115 , ACP.010, ACP.025, ACP.040, ACP.055, ACP.070, ACP.085, ACP.101, ACP.116, ACP.011, ACP.026, ACP.041, ACP.056, ACP.071, ACP.086, ACP.102, ACP.117, ACP.012, ACP.027, ACP.042, ACP.057, ACP.072,ACP.087, ACP.103, ACP.118 , ACP.013, ACP.028, ACP.043, ACP.058, ACP.073, ACP.088, ACP.104, ACP.119, ACP.014, ACP.029,  ACP.044, ACP.059, ACP.074, ACP.089, ACP.105, ACP.120, ACP.015, ACP.030, ACP.045, ACP.060, ACP.075, ACP.090, ACP.110, ACP.121, ACP.016, ACP.031, ACP.046, ACP.061, ACP.076, ACP.091, ACP.107, ACP.122 ,ACP.017, ACP.032, ACP.047, ACP.062, ACP.077, ACP.092, ACP.108, ACP.123 ,ACP.018, ACP.033, ACP.048, ACP.063, ACP.078, ACP.093, ACP.109, ACP.124, ACP.019, ACP.034, ACP.049, ACP.064, ACP.079, ACP.094, ACP.110, ACP.125, ACP.020, ACP.035, ACP.050, ACP.065, ACP.080, ACP.096, ACP.111, ACP.126 ,ACP.021, ACP.036, ACP.051, ACP.066, ACP.081, ACP.097, ACP.112, ACP.127 , ACP.022, ACP.037, ACP.052, ACP.067, ACP.082, ACP.098, ACP.113, ACP.128, ACP.023, ACP.038, ACP.053, ACP.068, ACP.083, ACP.099, ACP.114, ACP.129, FLX.103, FLX.0120, FLX.0131, FLX.0137, FLX.0143, FLX.0161, FLX.0166, FLX.0179, FLX.0104, FLX.0124, FLX.0134, FLX.0140, FLX.0152, FLX.0163, FLX.0175, FLX.0108, FLX.0125, FLX.0135, FLX.0141 FLX.0155, FLX.0164, FLX.0176, FLX.0115, FLX.0126, FLX.0136, FLX.0142, FLX.0158, FLX.0165, FLX.0178, AP2.0001, AP2.0004, AP2.0006, AP2.0008, AP2.0010, AP2.0012, AP2.0014, AP2.0003, AP2.0002, AP2.0005, AP2.0007, AP2.0009, AP2.0011, AP2.0013, AP2.0015, FLX.0008, FLX.0133, FLX.0149, FLX.0153, FLX.0159, FLX.0167,",10/4/2016,"10/04/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75514,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Press Release","Nationwide.  Canada.","F-0425-2017","Class II","Brownwood Farms Michigan Cherry Preserves  12oz glass bottles and 1 gallon.  Private labels:  Art's Tavern (Cherry Preserves 12oz).  ","115195 units","Products contain milk not declared on the label.","11/08/2016",," All product on market, any best by date prior to 9/28/2018.  ",10/20/2016,"10/20/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75514,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Press Release","Nationwide.  Canada.","F-0422-2017","Class II","Brownwood Farms Jalapeno Cherry Butter  12oz and 20oz glass bottles and 1 gallon.  Private labels:  Kimmel Orchard & Vineyard (Jalapeno Cherry Butter 12oz).  Benjamin Twiggs (Cherry Pepper Jam 10oz).  Central Market (16oz).    ","17024 units","Products contain milk not declared on the label.","11/08/2016",," All product on market, any best by date prior to 9/28/2018.  ",10/20/2016,"10/20/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75514,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Press Release","Nationwide.  Canada.","F-0423-2017","Class II","Brownwood Farms America's Original Cherry Butter   12oz and 22oz glass bottles and 1 gallon.  Private labels:  Arbor Day Farm (Cherry Butter 12oz).  Bowers Harbor Vineyards (Cherry Butter 12oz).  Crossroads (10oz).  Central Market (16oz).    ","52510 units","Products contain milk not declared on the label.","11/08/2016",," All product on market, any best by date prior to 9/28/2018.  ",10/20/2016,"10/20/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75514,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Press Release","Nationwide.  Canada.","F-0420-2017","Class II","Brownwood Farms Cherry Raspberry Preserves  12oz glass bottles and 1 gallon.","31205 units","Products contain milk not declared on the label.","11/08/2016",," All product on market, any best by date prior to 9/28/2018.  ",10/20/2016,"10/20/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75514,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Press Release","Nationwide.  Canada.","F-0424-2017","Class II","Brownwood Farms Strawberry Preserves  12oz glass bottles and 1 gallon.  Private labels:  Art's Tavern (Strawberry Preserves 12oz).  ","32362 units","Products contain milk not declared on the label.","11/08/2016",," All product on market, any best by date prior to 9/28/2018.  ",10/20/2016,"10/20/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75514,"Ongoing","Brownwood Farms","6211 S Railway Cmn",,"Williamsburg","MI","49690-8544","United States","Voluntary: Firm Initiated","Press Release","Nationwide.  Canada.","F-0421-2017","Class II","Brownwood Farms Pear & Cinnamon Preserves  10oz glass bottles and 1 gallon.","17059 units","Products contain milk not declared on the label.","11/08/2016",," All product on market, any best by date prior to 9/28/2018.  ",10/20/2016,"10/20/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75516,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT.    There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104.    There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5.    There were zero (0) Mexican accounts for this recall.    The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0595-2017","Class III","Ingenuity CT Computed Tomography X-ray system, Model 728326","27","The product label does not include the correct current rating.","11/16/2016",," 30003, 30004, 30008, 30014, 30033, 30039, 30040, 30041, 30042, 30043, 30044, 300037, 300066, 300097, 300151, 300156, 300157, 300203, 300204, 300205, 300206, 300207, 300208, 300209, 300210, 300211, 300212",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75516,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT.    There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104.    There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5.    There were zero (0) Mexican accounts for this recall.    The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0594-2017","Class III","Brilliance ICT SP Computed Tomography X-ray system, Model 728311","3","The product label does not include the correct current rating.","11/16/2016",," 200208, 200211, 200213",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75516,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT.    There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104.    There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5.    There were zero (0) Mexican accounts for this recall.    The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0598-2017","Class III","IQon Spectral CT Computed Tomography X-ray system, Model 728332","3","The product label does not include the correct current rating.","11/16/2016",," 860005, 860006, 860010",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75516,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT.    There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104.    There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5.    There were zero (0) Mexican accounts for this recall.    The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0597-2017","Class III","Ingenuity Core Computed Tomography X-ray system, Model 728321","2","The product label does not include the correct current rating.","11/16/2016",," 310160, 310234",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75516,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT.    There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104.    There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5.    There were zero (0) Mexican accounts for this recall.    The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0593-2017","Class III","Brilliance iCT Computed Tomography X-ray system, Model 728306","67","The product label does not include the correct current rating.","11/16/2016",," 85003, 85004, 85010, 85033, 85035, 85038, 85043, 85054, 85060, 100054, 100064, 100093, 100113, 100119, 100134, 100180, 100181, 100185, 100280, 100304, 100318, 100328, 100356, 100368, 100466, 100600, 100606, 100611, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100638, 100643, 100645, 100648, 100649, 100652, 100653, 100654, 100655, 100658, 100663, 100665, 100673, 100674, 100680, 100684, 100685, 100688, 100690, 100693, 100695, 100698, 100699, 100700, 100701, 100702, 100703, 100704, 100708, 100720, 100743, 200005",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75516,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",,"Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT.    There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104.    There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5.    There were zero (0) Mexican accounts for this recall.    The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.","Z-0596-2017","Class III","Ingenuity Core 128 Computed Tomography X-ray system, Model 728323","15","The product label does not include the correct current rating.","11/16/2016",," 32012, 32057, 320202, 320207, 320227, 320232, 336011, 336034, 336076, 336100, 336129, 336133, 336142, 36145, 336163",10/13/2016,"10/13/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75517,"Ongoing","JML Holdings Inc","6210 Merger Drive",,"Holland","OH","43528-9593","United States","Voluntary: Firm Initiated","E-Mail","Product was distributed in the following states: IL, MI, and OH.","F-0503-2017","Class I","Three Way Popcorn Sampler that contains three types of popcorn (cheese, carmel and buttered popcorn) packed inside one unlabeled clear plastic bag, physically divided by a three-way paperboard divider.  The bag is packed inside a metal tin.","8 cans","Undeclared eggs on the finished product label. ","11/22/2016","."," None",10/21/2016,"10/21/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75518,"Ongoing","Krispy Kreme Doughnut Corporation","380 Knollwood St Ste M",,"Winston Salem","NC","27103-1865","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","VA","F-0327-2017","Class III","Krispy Kreme Doughnuts Original Glazed Doughnuts, 6 count and 12 count boxes.  ","12 ct boxes - 1,672; 6 ct boxes - 985","Possible piece of plastic in the product.","11/10/2016",," N/A - Product produced on October 20, 2016",10/21/2016,"10/21/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75519,"Terminated","South Texas Blood & Tissue Center","6211 W Interstate 10",,"San Antonio","TX","78201-2023","United States","Voluntary: Firm Initiated","FAX","TX","B-0137-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit"," Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. ","11/14/2016","11/14/2016"," W140916024617",10/11/2016,"10/11/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75521,"Terminated","Hoxworth Blood Center","3130 Highland Ave",,"Cincinnati","OH","45267-0001","United States","Voluntary: Firm Initiated","Telephone","Ohio","B-0119-2017","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, in which quality control and distribution of product did not meet specifications, was distributed. ","11/14/2016","11/14/2016"," W037716022702; ",7/6/2016,"07/06/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75522,"Terminated","Sanofi Pasteur S.A.","Campus Merieux - 1541 Av Marcel Merieux",,"Marcy l'Etoile",,,"France","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0120-2017","Class III","Rabies Immune Globulin (Human)","1 lot; 15,189 doses"," Sanofi Pasteur's IMOGAM RABIES-HT (Rabies Immune Globulin [Human] USP, Heat Treated), with an antibody content that has declined below the stability specification limit, was distributed.","11/14/2016","11/14/2016"," K15642; ",4/26/2016,"04/26/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75523,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy,  Japan, Jordan, Kazakhstan, Latvia, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, Vietnam","Z-0613-2017","Class II","ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with  the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.  Siemens Material Number(SMN): 10491244    In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that  the assay is being marketed on the XPT following FDAs Reagent Replacement Policy.  Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016. ","30,222 kits","CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT  systems as stated in the Instructions for Use.","11/17/2016",," Kit lots ending in:    380                 Exp Date        2016-10-21;   382/                                       2017-01-09;  384                                        2017-02-06;  386                                        2017-03-24 ;  388                                        2017-05-14 ;  390                                        2017-06-12 .    And all future lots until the issue is resolved. Siemens will also include a notecard in future lots of reagents referring customers to the communications.",10/19/2016,"10/19/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75523,"Ongoing","Siemens Healthcare Diagnostics, Inc","333 Coney St",,"East Walpole","MA","02032-1516","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy,  Japan, Jordan, Kazakhstan, Latvia, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, Vietnam","Z-0612-2017","Class II","ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with  the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.  Siemens Material Number(SMN): 10491379    In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that  the assay is being marketed on the XPT following FDAs Reagent Replacement Policy.  Siemens plans to request  CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016. ","18,733 kits","CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT  systems as stated in the Instructions for Use.","11/17/2016",," Kit lots ending in:  380                 Exp Date        2016-10-21;   382/                                       2017-01-09;  384                                        2017-02-06;  386                                        2017-03-24 ;  388                                        2017-05-14 ;  390                                        2017-06-12 .    And all future lots until the issue is resolved.  Siemens will also include a notecard in future lots of reagents referring customers to the communications .  ",10/19/2016,"10/19/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75524,"Terminated","BPL Plasma, Inc.","630 Malvern Ave",,"Hot Springs","AR","71901-5432","United States","Voluntary: Firm Initiated","E-Mail","USA - (Connecticut)  and United Kingdom","B-0209-2017","Class III","Source Plasma","250 units"," Blood products, collected from ineligible donors, were distributed. ","12/14/2016","12/14/2016"," 0477867, 0478374, 0478382, 0478612, 0479022, 0479011, 0479600, 0479612, 0479573, 0479800, 0479746, 0479776, 0480052, 0479967, 0480681, 0480655, 0480646, 0480782, 0480999, 0481227, 0481753, 0481773, 0481961, 0482088, 0482112, 0482147, 0482132, 0483260, 0483484, 0483434, 0483444, 0483467, 0483450, 0483564, 0483606, 0483517, 0483855, 0483887, 0483832, 0483895, 0484227, 0484167, 0484222, 0484422, 0484411, 0484714, 0484774, 0485276, 0485279, 0485302, 0485280, 0485508, 0485473, 0485500, 0486062, 0486189, 0486279, 0486686, 0486585, 0486693, 0486560, 0486754, 0486963, 0486975, 0487040, 0486979, 0486952, 0486935, 0487172, 0487226, 0487213, 0487553, 0487939, 0488188, 0488184, 0488714, 0489347, 0489497, 0489739, 0489754, 0489691, 0489623, 0489938, 0490064, 0490119, 0490477, 0490524, 0490693, 0490775, 0491029, 0491030, 0491483, 0491548, 0491568, 0491546, 0492491, 0492544, 0492806, 0492814, 0492766, 0492760, 0492822, 0493132, 0493238, 0493240, 0493206, 0493480, 0493904, 0493901, 0494170, 0494210, 0494549, 0494542, 0494631, 0494554, 0494792, 0494967, 0495058, 0495227, 0495188, 0495550, 0495803, 0495783, 0496082, 0496767, 0496789, 0497509, 0497617, 0497585, 0497425, 0497610, 0497598, 0497761, 0497743, 0497899, 0497970, 0499054, 0499248, 0499516, 0499438, 0499405, 0499501, 0499555, 0499743, 0500081, 0500069, 0500170, 0500179, 0500236, 0500182, 0500468, 0500531, 0500761, 0500730, 0500910, 0501151, 0501136, 0501121, 0501833, 0501875, 0502009, 0501952, 0502445, 0502479, 0502525, 0502500, 0502693, 0502880, 0502777, 0502891, 0502938, 0503010, 0503630, 0503729, 0503929, 0503892, 0503980, 0504085, 0504124, 0504622, 0504706, 0504788, 0505011, 0505016, 0504928, 0505048, 0505131, 0505194, 0505172, 0505504, 0505601, 0505699, 0506089, 0506067, 0506224, 0506449, 0507350, 0507325, 0507209, 0507316, 0507446, 0507521, 0507530, 0507492, 0507431, 0507817, 0507972, 0508372, 0508537, 0509197, 0509270, 0509773, 0509849, 0509806, 0509781, 0510519, 0510675, 0511072, 0511092, 0511109, 0511300, 0511881, 0512030, 0511963, 0511966, 0512033, 0511951, 0",10/10/2016,"10/10/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75526,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL.    Affected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.","Z-0407-2017","Class II","Access Ostase Calibrators, Catalog No. 37305, B83876    Product Usage:  The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.","357 kits total (94 kits in US)","Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.","11/14/2016",," 623207  626000  628294  628296",10/24/2016,"10/24/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75526,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of:  UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL.    Affected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.","Z-0408-2017","Class II","Access Ostase QC, Catalog No. 37309, B83877    Product Usage:    The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.","625 kits total (113 kits in US)","Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.","11/14/2016",," 628297  623207  626001",10/24/2016,"10/24/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75530,"Terminated","GCAM Inc","222 E Rio Grande St",,"Eagle Pass","TX","78852-4837","United States","Voluntary: Firm Initiated","E-Mail","Korea, Republic Of(South)","B-0132-2017","Class II","Source Plasma","34 units","Blood products, collected from a donor who did not have a complete physical examination, were distributed.","11/03/2016","11/03/2016"," 5450023479; 5450029701; 5450030351; 5450054424; 5450053906; 5450053232; 5450052626; 5450051879; 5450051545; 5450050253; 5450049510; 5450048909; 5450048159; 5450047726; 5450047220; 5450046595; 5450046086; 5450045430; 5450044917; 5450044207; 5450043910; 5450042936; 5450042783; 5450041796; 5450040911; 5450040683; 5450039655; 5450039317; 5450037751; 5450037217; 5450034662; 5450034381; 5450031157; 5450030069",6/8/2016,"06/08/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75531,"Terminated","GCAM Inc","815 Grant St",,"Laredo","TX","78040-5856","United States","Voluntary: Firm Initiated","E-Mail","Korea, Republic Of(South)","B-0122-2017","Class III","Source Plasma","3 units","Source Plasma, collected from an ineligible donor, was distributed.  ","11/01/2016","11/01/2016"," 5420131690; 5420130762; 5420130135; ",5/17/2016,"05/17/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75532,"Terminated","AlloSource, Inc.","6278 S Troy Cir",,"Centennial","CO","80111-6422","United States","Voluntary: Firm Initiated","Letter","Illinois","B-0121-2017","Class II","Tendon","1 tendon allograft"," Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed. ","11/01/2016","11/01/2016"," 1561331015; ",6/15/2016,"06/15/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75533,"Ongoing","Kar Nut Products Company","1200 E. 14 Mile Rd.",,"Madison Heights","MI","48071","United States","Voluntary: Firm Initiated","E-Mail","PA  KS  MI  IL  NC  OH  CT","F-0384-2017","Class II","Fit & Active 100 Calorie Whole Almonds  7  0.63oz bags per retail carton  Flexible film bags in paperboard carton","59760 cartons","Walnuts undeclared on outer retail unit carton.      ","11/08/2016",," Product 7056  Aldi 47969 100 Cal Nut/24ct  Lot WO0023406  Best By 6/8/2017  UPC 41498166083",10/7/2016,"10/07/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75534,"Ongoing","Pastian's Bakery","3320 2nd Street, NW",".","Albuquerque","NM","87107-1420","United States","Voluntary: Firm Initiated","Visit","Only distributed in New Mexico. No Canadian, other foreign, VA/govt/military consignees.","F-0585-2017","Class II","French Baguette Bread. 9.5 oz. Clear Plastic Bag. 1 loaf","2 loaves","Pastian's Bakery announces a voluntary field action for various breads due to undeclared wheat allergen.","12/06/2016",," Manufactured On: October 25",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75534,"Ongoing","Pastian's Bakery","3320 2nd Street, NW",".","Albuquerque","NM","87107-1420","United States","Voluntary: Firm Initiated","Visit","Only distributed in New Mexico. No Canadian, other foreign, VA/govt/military consignees.","F-0584-2017","Class II","Pumpernickle Bread. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf","1 loaf","Pastian's Bakery announces a voluntary field action for various breads due to undeclared wheat allergen.","12/06/2016",," Manufactured On: October 21",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75534,"Ongoing","Pastian's Bakery","3320 2nd Street, NW",".","Albuquerque","NM","87107-1420","United States","Voluntary: Firm Initiated","Visit","Only distributed in New Mexico. No Canadian, other foreign, VA/govt/military consignees.","F-0582-2017","Class II","Texas Toast. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf","49 loaves","Pastian's Bakery announces a voluntary field action for various breads due to undeclared wheat allergen.","12/06/2016",," Manufactured On: October 17, 18, 19, 20, 21, & 24.",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75534,"Ongoing","Pastian's Bakery","3320 2nd Street, NW",".","Albuquerque","NM","87107-1420","United States","Voluntary: Firm Initiated","Visit","Only distributed in New Mexico. No Canadian, other foreign, VA/govt/military consignees.","F-0583-2017","Class II","Home Wheat Texas Toast 1 lb. 8 oz. Clear Plastic Bag. 1 loaf","62 loaves","Pastian's Bakery announces a voluntary field action for various breads due to undeclared wheat allergen.","12/06/2016",," Manufactured On: October 10 and 11.",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75534,"Ongoing","Pastian's Bakery","3320 2nd Street, NW",".","Albuquerque","NM","87107-1420","United States","Voluntary: Firm Initiated","Visit","Only distributed in New Mexico. No Canadian, other foreign, VA/govt/military consignees.","F-0586-2017","Class II","Extra Sourdough Bread. 32 oz. Clear Plastic Bag. 1 loaf","6 loaves","Pastian's Bakery announces a voluntary field action for various breads due to undeclared wheat allergen.","12/06/2016",," Manufactured On: October 25.",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75534,"Ongoing","Pastian's Bakery","3320 2nd Street, NW",".","Albuquerque","NM","87107-1420","United States","Voluntary: Firm Initiated","Visit","Only distributed in New Mexico. No Canadian, other foreign, VA/govt/military consignees.","F-0581-2017","Class II","Homestyle Texas Toast. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf","121 loaves","Pastian's Bakery announces a voluntary field action for various breads due to undeclared wheat allergen.","12/06/2016",," Manufactured On: October 18, 19, 20, 21, & 24",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75534,"Ongoing","Pastian's Bakery","3320 2nd Street, NW",".","Albuquerque","NM","87107-1420","United States","Voluntary: Firm Initiated","Visit","Only distributed in New Mexico. No Canadian, other foreign, VA/govt/military consignees.","F-0587-2017","Class II","Extra Sourdough Bread-2 Squares. 32 oz. Clear Plastic Bag. 1 loaf",,"Pastian's Bakery announces a voluntary field action for various breads due to undeclared wheat allergen.","12/06/2016",," All products within expiration.",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75534,"Ongoing","Pastian's Bakery","3320 2nd Street, NW",".","Albuquerque","NM","87107-1420","United States","Voluntary: Firm Initiated","Visit","Only distributed in New Mexico. No Canadian, other foreign, VA/govt/military consignees.","F-0588-2017","Class II","1 1/2 French Bread. 1lb. 8 oz.. Clear Plastic Bag. 1 loaf","50 loaves","Pastian's Bakery announces a voluntary field action for various breads due to undeclared wheat allergen.","12/06/2016",," Manufactured On: October 21 & 25.",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75536,"Ongoing","Centurion Medical Products Corporation","100 Centurion Way",".","Williamston","MI","48895-9086","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0647-2017","Class I","Multi-Med Single Lumen Catheters sold in Centurion convenience kits.  The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.","1000 kits","The kits contain Multi-Med Single Lumen Catheters that  have a potential for excess material to remain at the tip of the catheter from the manufacturing process. It  is possible that the excess material may separate from the catheter during use and pose a potential risk  of embolism, which could result in serious injury or death.","12/02/2016",," Centurion Kit Code    ECVC1680    Kit Description  SINGLE LUMEN INSERTION BUNDLE  Lot Number(s)  2016062150  2016062950  2016070650  Centurion Kit Code  ECVC4785   Kit Description  SINGLE LUMEN BUNDLE  Lot Number(s)  2016081550  Centurion Kit Code  M11620HKIC   Kit Description  MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)    Lot numbers  2016051050    2016053150  2016060750  2016061550  2016063050  2016072050  2016080250  2016091950  Centurion Kit Code  M11620HKICNL  Kit Description   MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)   Lot numbers  2016060750  2016072650  2016093050  2016101050  Centurion Kit Code  M11620HS   Kit Description  MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)    Lot numbers  2016052050  2016062850  2016082350  2016082650  2016090250  Centurion Kit Code  M11620KC   Kit Description  MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)   Lot numbers  2016050950  2016053150  2016060750  2016071250  2016080350  2016082950  Centurion Kit Code  M11620KCNL   Kit Description  MULTI-MED - Central Venous Catheter (1 Lumen, 16G, 20cm)   Lot numbers    2016060850  2016061650  2016062050  2016070550  2016071950  2016080250  2016090750  Centurion Kit Code  M12013K   Kit Description  MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm)   Lot numbers   2016071350  2016072050  2016092650  2016100650  Centurion Kit Code  M12013KNL   Kit Description  MULTI-MED - Central Venous Catheter (1 Lumen, 20G, 13cm)   Lot numbers    2016072950  2016082450  ",10/21/2016,"10/21/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75537,"Ongoing","Love My Tru Body","289 Jonesboro Rd Ste 106",,"McDonough","GA","30253-3725","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0223-2017","Class I","Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle","74 bottles","Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.","12/22/2016",," Bottles stamped MFD: 03.07.2016 EXP: 03.06.2018",10/28/2016,"10/28/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75538,"Ongoing","DFI Organics","575 Lexington Ave FL 4",".","New York","NY","10022-6146","United States","Voluntary: Firm Initiated","Letter","New Jersey","F-0570-2017","Class I","100% Org. Sesame Seeds natural, 50 LBS, Product of Uganda  The sesame seeds are packed in multi ply paper bags. ","4200 lbs.","Product may contain Salmonella","12/06/2016",," Lot LTI000292-1 and LTI000292-2",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75539,"Completed","Montana Compounding Pharmacy P.C.","111 N Higgins Ave",".","Missoula","MT","59802-4437","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in MT only","V-0032-2017","Class II","Cisapride Aqueous, 10mg/mL, suspension, RX # 163741, RX #163662, and RX #164342","160 mL"," Solution lot #08192016:21@4 were recalled due to FDA's concern over the quality of the water used.","12/02/2016",," expiration dates: 10/26/16; 11/13/16; 11/4/16; and 11/9/16",10/24/2016,"10/24/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75539,"Completed","Montana Compounding Pharmacy P.C.","111 N Higgins Ave",".","Missoula","MT","59802-4437","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in MT only","V-0033-2017","Class II","Methimazole Aqueous, 10mg/mL, suspension, RX # 163887 and RX #163700","60 mL"," Solution lot #08192016:21@4 were recalled due to FDA's concern over the quality of the water used.","12/02/2016",," expiration dates: 10/24/16 and 11/7/16",10/24/2016,"10/24/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75539,"Completed","Montana Compounding Pharmacy P.C.","111 N Higgins Ave",".","Missoula","MT","59802-4437","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in MT only","V-0035-2017","Class II","Prednisolone, 20mg/mL, suspension, RX # 164219","15 mL"," Solution lot #08192016:21@4 were recalled due to FDA's concern over the quality of the water used.","12/02/2016",," expiration dates: 12/5/16",10/24/2016,"10/24/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75539,"Completed","Montana Compounding Pharmacy P.C.","111 N Higgins Ave",".","Missoula","MT","59802-4437","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in MT only","V-0034-2017","Class II","Methimazole Aqueous, 5mg/mL, suspension, RX # 162647","90 mL"," Solution lot #08192016:21@4 were recalled due to FDA's concern over the quality of the water used.","12/02/2016",," expiration dates: 10/26/16",10/24/2016,"10/24/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75539,"Completed","Montana Compounding Pharmacy P.C.","111 N Higgins Ave",".","Missoula","MT","59802-4437","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in MT only","V-0031-2017","Class II","Cisapride Aqueous, 5mg/mL, suspension, RX #163848, RX #164496; RX 164045, RX 164302; ","150 mL"," Solution lot #08192016:21@4 were recalled due to FDA's concern over the quality of the water used.","12/02/2016",," expiration dates: 10/22/16; 11/3/16; 11/4/16; 11/10/16; and 11/16/16.",10/24/2016,"10/24/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75540,"Ongoing","Depuy Orthopaedics Inc. ","700 Orthopaedic Dr",,"Warsaw","IN","46582-3994","United States","Voluntary: Firm Initiated","E-Mail","US Distribution to the states of: CA, KY, LA, MD, ME, NC, NH, NY, TX, VA, WA    Foreign: Austria, Ireland, and Japan    VA/DOD:","Z-0650-2017","Class II","ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU","137","DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.","11/21/2016","."," Product Codes: 201001210, ACTIS FLEX REAMER SZ 0/1, GTIN: 10603295434818; 201001220, ACTIS FLEX REAMER SZ 2/3, GTIN: 10603295434870; 201001230, ACTIS FLEX REAMER SZ 4/5, GTIN: 10603295434849; 201001240, ACTIS FLEX REAMER SZ 6/7, GTIN: 10603295434856; 201001250, ACTIS FLEX REAMER SZ 8/9, GTIN: 10603295434863; 201001260, ACTIS FLEX REAMER SZ 10/11, GTIN: 10603295434825; 201001270, ACTIS FLEX REAMER SZ 12, GTIN: 10603295434832",10/25/2016,"10/25/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75541,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","Mississippi","B-0133-2017","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","1 unit","Apheresis product collected from a donor who traveled to a malaria endemic area, was distributed.","11/03/2016","11/03/2016"," W069116149636",10/4/2016,"10/04/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75542,"Terminated","Michigan Blood","1036 Fuller Ave Ne","PO Box 1704","Grand Rapids","MI","49503-1304","United States","Voluntary: Firm Initiated","Telephone","Michigan","B-0134-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Apheresis product, associated with a unit that was found to contain a leak, was distributed.","11/03/2016","11/03/2016"," W120616013188",9/11/2016,"09/11/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75543,"Terminated","Michigan Blood","1036 Fuller Ave Ne","PO Box 1704","Grand Rapids","MI","49503-1304","United States","Voluntary: Firm Initiated","Telephone","Michigan","B-0153-2017","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. ","11/28/2016","11/28/2016"," W120616501901; ",9/12/2016,"09/12/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75544,"Terminated","BPL Plasma, Inc. ","3744 Blanding Blvd",,"Jacksonville","FL","32210-5243","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0154-2017","Class III","Source Plasma","5 units","Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. ","11/28/2016","11/28/2016"," JK0691800; JK0692303; JK0694274; JK0694660; JK0696017; ",9/2/2016,"09/02/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75545,"Terminated","American Red Cross Blood Services","209 Farmington Ave",,"Farmington","CT","06032-1955","United States","Voluntary: Firm Initiated","Telephone","Connecticut; Maine","B-0155-2017","Class II","Fresh Frozen Plasma","1 unit","Blood products, in which donor screening/donor record incomplete or incorrect, were distributed. ","11/28/2016","11/28/2016"," W203316329459; ",7/21/2016,"07/21/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75545,"Terminated","American Red Cross Blood Services","209 Farmington Ave",,"Farmington","CT","06032-1955","United States","Voluntary: Firm Initiated","Telephone","Connecticut; Maine","B-0156-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, in which donor screening/donor record incomplete or incorrect, were distributed. ","11/28/2016","11/28/2016"," W203316329459; ",7/21/2016,"07/21/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75547,"Ongoing","STEWARTS SHOPS CORP","461 Route 9N",,"Saratoga Springs","NY","12866-0435","United States","Voluntary: Firm Initiated","Press Release","Upstate New York and Southern Vermont","F-0501-2017","Class I","Stewart's SPORTADE FRUIT PUNCH Isotonic Beverage 20 Fl Oz (591 mL), UPC 0 82086 31006 8. The product is packaged in a plastic bottle, and has a black label with a red plastic cap.","1622 bottles","The specific code of SPORTADE FRUIT PUNCH may contain undeclared milk. ","11/22/2016","."," Expiration date code DEC 02 (found on the neck of the bottle)",10/26/2016,"10/26/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75549,"Ongoing","Fanega Mexican Food Products, Inc.","320 S. Nina Drive, Suites 15 & 16",,"Mesa","AZ","85210-8430","United States","Voluntary: Firm Initiated","Visit","AZ","F-0311-2017","Class II"," Flour Tortillas 12 count, Net Wt. 25oz (732g)","280 units","Fanega Mexican Foods is recalling flour tortillas because they contain undeclared wheat.","11/03/2016",," 10-28-16  10-29-16  10-30-16  11-1-16  11-2-16  11-4-16  11-5-16   ",10/26/2016,"10/26/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75550,"Ongoing","Sokol and Co","5315 Dansher Rd",,"Countryside","IL","60525-3101","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MA, MI, TX","F-0427-2017","Class II","Solo Almond Paste, 6/7 LB. Cans, Net Weight: 42 LBS. (19.09 KG.)","486 cans","Pieces of plastic and metal discovered within product. ","11/10/2016",," Lot: 16278",10/21/2016,"10/21/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75551,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","FDA Mandated","Letter","USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.","Z-0376-2017","Class II","Philips Healthcare System X-ray Tomography Computed :  ","1363","It was discovered the patient support  tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.","11/22/2016","."," Ingenuity CT,  Ingenuity Core, Ingenuity Core 128.",3/15/2016,"03/15/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75551,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","FDA Mandated","Letter","USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.","Z-0375-2017","Class II","Philips Healthcare System X-ray Tomography Computed :     ","1363","It was discovered the patient support  tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.","11/22/2016","."," Brilliance iCT SP,  Brilliance iCT,  Brilliance 64,  Brilliance 40, Brilliance 16,  Brilliance 16P, Brilliance 10, Brilliance 6,  Brilliance Big Bore.          ",3/15/2016,"03/15/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75553,"Completed","ConforMIS, Inc.","28 Crosby Dr",,"Bedford","MA","01730-1402","United States","Voluntary: Firm Initiated","Telephone","Distributed to the states of CO and NV.","Z-0658-2017","Class II","ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile  Catalog Number: TCR-111-1111.    Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use  of a prosthetic device.","2 units","Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. ","11/25/2016",," Serial Numbers: 0381024; 0381042  Exp Date: 2017-02-28",10/18/2016,"10/18/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. Nationwide and the countries of: Canada, Belgium, Singapore and Thailand.","Z-0385-2017","Class II","LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","1,339,745 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","11/09/2016",," Product Code: MAD710, Lot# 160120.",10/27/2016,"10/27/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. Nationwide and the countries of: Canada, Belgium, Singapore and Thailand.","Z-0382-2017","Class II","FLEXI NOZZLE LONG, 10 Boxes of 25 units each    Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","1,339,745 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","11/09/2016",," Product Code: MAD510L, Lot# 160118, 160324, 160509, 160709, 160810 and 160833.",10/27/2016,"10/27/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. Nationwide and the countries of: Canada, Belgium, Singapore and Thailand.","Z-0384-2017","Class II","LMA MADgic, Atomization Device with 3mL Syringe, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","1,339,745 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","11/09/2016",," Product Code: MAD600, Lot# 160110, 160119m, 160128, 160140, 160207, 160228, 160304, 160411, 160442, 160525, 160703 and 160807; Product Code: MAD700, Lot# 160111, 160129, 160141, 160209, 160233, 160316, 160329, 160403, 160431, 160502, 160520, 160604, 160624, 160634, 160712, 160809 and 160818; Product Code: MAD720, Lot# 160142, 160404, 160511, 160725 and 160909; Product Code: MAD730, Lot# 160427; Product Code: MAD730OS, Lot# 160305.  ",10/27/2016,"10/27/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. Nationwide and the countries of: Canada, Belgium, Singapore and Thailand.","Z-0381-2017","Class II","LMA MADomizer, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","1,339,745 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","11/09/2016",," Product Code: MAD500, Lot # 160127, 160314, 160441, 160508, 160632 and 160805; Product Code: MAD510, Lot# 160109, 160115, 160206, 160220, 160227, 160303, 160315, 160323, 160328, 160401, 160426, 160501, 160519, 160603, 160612, 160622, 160633, 160702, 160719 and 160808.",10/27/2016,"10/27/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. Nationwide and the countries of: Canada, Belgium, Singapore and Thailand.","Z-0383-2017","Class II","FLEXI NOZZLE SHORT    Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","500/10 boxes of 50 units ","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","11/09/2016",," Product Code: MAD510L, Lot# 160118, 160324, 160509, 160709, 160810 and 160833.",10/27/2016,"10/27/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. Nationwide and the countries of: Canada, Belgium, Singapore and Thailand.","Z-0386-2017","Class II","LMA MADdy, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","1,339,745 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","11/09/2016",," Product Code: MAD800, Lot# 160208 and 160625 and Product Code: MAD900, Lot# 160605.  ",10/27/2016,"10/27/2016",11/16/2016,"11/16/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.","Z-0384-2017","Class II","LMA MADgic, Atomization Device with 3mL Syringe, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","2,674,650 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","12/22/2016",," Product Code: MAD600, Lot# 160110, 160119m, 160128, 160140, 160207, 160228, 160304, 160411, 160442, 160525, 160703 and 160807; Product Code: MAD700, Lot# 160111, 160129, 160141, 160209, 160233, 160316, 160329, 160403, 160431, 160502, 160520, 160604, 160624, 160634, 160712, 160809 and 160818; Product Code: MAD720, Lot# 160142, 160404, 160511, 160725 and 160909; Product Code: MAD730, Lot# 160427; Product Code: MAD730OS, Lot# 160305.  ",10/27/2016,"10/27/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.","Z-0386-2017","Class II","LMA MADdy, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","2,674,650 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","12/22/2016",," Product Code: MAD800, Lot# 160208 and 160625 and Product Code: MAD900, Lot# 160605.  ",10/27/2016,"10/27/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.","Z-0381-2017","Class II","LMA MADomizer, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","2,674,650 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","12/22/2016",," Product Code: MAD500, Lot # 160127, 160314, 160441, 160508, 160632 and 160805; Product Code: MAD510, Lot# 160109, 160115, 160206, 160220, 160227, 160303, 160315, 160323, 160328, 160401, 160426, 160501, 160519, 160603, 160612, 160622, 160633, 160702, 160719 and 160808.",10/27/2016,"10/27/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.","Z-0898-2017","Class II","Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical.  For atomization of topical solutions across the naso and oropharyngeal mucosal membranes","2,674,650 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","12/22/2016",," Product code MAD100, Batch/Lot numbers 160105, 160137, 160302, 160321, 160402, 160435, 160506, 160523, 160609, 160620, 160707, 160802, 160813;   Product code MAD100OS, Batch/Lot numbers 160322, 160524, 160630;   Product code MAD110, Batch/Lot numbers 160217, 160507; Product code MAD110OS, Batch/Lot numbers 160240, 160312; Product code MAD130, Batch/Lot numbers 160107, 160138, 160517; Product code MAD130OS, Batch/Lot numbers 160436, 160803; Product code MAD140, Batch/Lot numbers 160125, 160218, 160437, 160610, 160801; Product code MAD140OS, Batch/Lot numbers 160226, 160438, 160727; Product code MAD300, Batch/Lot numbers 160108, 160117, 160126, 160145, 160146, 160200, 160219, 160225, 160231, 160300, 160313, 160327, 160400, 160409, 160422, 160432, 160440, 160500, 160518, 160602, 160611, 160621, 160631, 160701, 160708, 160718, 160728, 160800, 160804, 160814, 160816, 160823; Product code MAD300B, Batch/Lot number 160410.  ",10/27/2016,"10/27/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.","Z-0383-2017","Class II","FLEXI NOZZLE SHORT    Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","2,674,650 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","12/22/2016",," Product Code: MAD510L, Lot# 160118, 160324, 160509, 160709, 160810 and 160833.",10/27/2016,"10/27/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.","Z-0382-2017","Class II","FLEXI NOZZLE LONG, 10 Boxes of 25 units each    Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","2,674,650 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","12/22/2016",," Product Code: MAD510L, Lot# 160118, 160324, 160509, 160709, 160810 and 160833.",10/27/2016,"10/27/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75554,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide distribution.  U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.","Z-0385-2017","Class II","LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.  ","2,674,650 units in total","Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.","12/22/2016",," Product Code: MAD710, Lot# 160120.",10/27/2016,"10/27/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75555,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0604-2017","Class II","SOMATOM Definition AS, Computed tomography system    Product Usage:  SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.  ","760 systems distrtibuted in U.S.","A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.","11/16/2016",," Serial Numbers:   73064  64789  64492  65127  64464  64471  65380  66632  65852  64668  64239  65364  64580  73476  73339  64278  64756  73059  64800  64412  65288  64645  64725  73421  64508  65339  65346  64714  65831  64123  64246  65690  65752  64658  73312  66858  65491  66611  64465  65076  64454  65762  64485  64446  64673  66319  64419  66518  65968  66506  66171  66243  73544  64368  64736  65620  64081  64117  64549  65175  65569  64112  66287  66292  64164  64180  66087  65322  65768  65425  65810  73343  73374  65326  64461  65764  66929  65615  66251  66327  66826  64497  66146  64067  64428  65355  66635  66225  65039  64111  65314  64371  66188  66355  66476  64138  73518  65209  66467  64860  66649  66182  73258  64342  73579  64372  66998  66759  64420  65264  66150  64235  65712  66461  66604  73120  66411  64179  65515  66498  73108  64178  66688  66164  64172  66433  66141  64074  66572  66944  64253  65015  66768  64482  64170  66405  64825  64328  65075  65671  64418  65437  66222  65263  66406  66574  65713  64270  66700  65926  73427  66475  65614  73187  65013  66791  64909  65014  65110  65856  64429  65087  65197  64764  64570  64467  64410  73533  64248  64604  66119  66193  64841  64707  64821  73423  73424  73493  73520  66233  65804  66085  73459  64290  64274  65306  66790  64337  65554  73303  65960  64734  65036  73240  73279  73278  64575  64289  64724  65311  65366  65407  64623  66451  64685  73224  66928  65403  64079  64823  64905  66690  64807  64770  66964  65568  66924  64709  64082  65233  66075  66626  66965  66151  66911  64863  65959  66557  65576  66148  66705  65418  66822  73352  64968  64481  65393  65755  66450  65799  65501  66234  65413  66556  73526  65186  65927  65466  65267  64296  64421  64423  66745  64259  65802  73487  73492  73494  73497  64430  73016  73310  65286  65302  66918  64801  64284  66527  64624  66458  64959  66850  73409  64627  64692  64397  64947  64228  66472  64463  65283  66667  64913  65736  64835  64834  65423  65313  66011  650",10/19/2016,"10/19/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75555,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0605-2017","Class II","SOMATOM Definition Flash, Computed tomography system    Product Usage:  SOMATOM Definition AS systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.  ","3077 systems worldwide, 760 systems distributed in the U.S.","A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.","11/16/2016",," Serial Numbers:   73064  64789  64492  65127  64464  64471  65380  66632  65852  64668  64239  65364  64580  73476  73339  64278  64756  73059  64800  64412  65288  64645  64725  73421  64508  65339  65346  64714  65831  64123  64246  65690  65752  64658  73312  66858  65491  66611  64465  65076  64454  65762  64485  64446  64673  66319  64419  66518  65968  66506  66171  66243  73544  64368  64736  65620  64081  64117  64549  65175  65569  64112  66287  66292  64164  64180  66087  65322  65768  65425  65810  73343  73374  65326  64461  65764  66929  65615  66251  66327  66826  64497  66146  64067  64428  65355  66635  66225  65039  64111  65314  64371  66188  66355  66476  64138  73518  65209  66467  64860  66649  66182  73258  64342  73579  64372  66998  66759  64420  65264  66150  64235  65712  66461  66604  73120  66411  64179  65515  66498  73108  64178  66688  66164  64172  66433  66141  64074  66572  66944  64253  65015  66768  64482  64170  66405  64825  64328  65075  65671  64418  65437  66222  65263  66406  66574  65713  64270  66700  65926  73427  66475  65614  73187  65013  66791  64909  65014  65110  65856  64429  65087  65197  64764  64570  64467  64410  73533  64248  64604  66119  66193  64841  64707  64821  73423  73424  73493  73520  66233  65804  66085  73459  64290  64274  65306  66790  64337  65554  73303  65960  64734  65036  73240  73279  73278  64575  64289  64724  65311  65366  65407  64623  66451  64685  73224  66928  65403  64079  64823  64905  66690  64807  64770  66964  65568  66924  64709  64082  65233  66075  66626  66965  66151  66911  64863  65959  66557  65576  66148  66705  65418  66822  73352  64968  64481  65393  65755  66450  65799  65501  66234  65413  66556  73526  65186  65927  65466  65267  64296  64421  64423  66745  64259  65802  73487  73492  73494  73497  64430  73016  73310  65286  65302  66918  64801  64284  66527  64624  66458  64959  66850  73409  64627  64692  64397  64947  64228  66472  64463  65283  66667  64913  65736  64835  64834  65423  65313  66011  650",10/19/2016,"10/19/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75558,"Ongoing","Hologic, Inc","250 Campus Dr",,"Marlborough","MA","01752-3020","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.","Z-0655-2017","Class II","SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices.  SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices.    For uterine sound","600  units (US) ; 24 units (OUS)","Breach in sterile barrier compromising product sterility","11/22/2016","."," Lot Code US:  16E25RC  16E25RD  16F16R    Lot Code OUS:  16E25RB",10/28/2016,"10/28/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75563,"Ongoing","Sandoz Inc","100 College Rd W",,"Princeton","NJ","08540-6604","United States","Voluntary: Firm Initiated","Letter","WI","D-0145-2017","Class III","Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria,  NDC 0409-7332-01","139,430 vials","Labeling: Missing Label","11/19/2016","."," Sandoz - Lot GJ7151(Pfizer- Lot 670028M); Exp. 07/19",10/19/2016,"10/19/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75564,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0665-2017","Class II","Merge Hemo software.     Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories","192 sites potentially have the affected software","The application may crash during the cath lab procedure.","11/28/2016",," Versions 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, and 9.40.2 with Windows 7 Operating System",4/30/2014,"04/30/2014",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75565,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",".","North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0170-2017","Class III","Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples). ","201, 234 Canisters","Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing. ","12/08/2016",," Lot #: 150096, Exp. 3/2017; Lot #: 150327, Exp. 10/2017",11/1/2016,"11/01/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75565,"Ongoing","Teva Pharmaceuticals USA","1090 Horsham Rd",".","North Wales","PA","19454-1505","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0171-2017","Class III","Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.",,"Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing. ","12/08/2016",," Lot #: 150335, 150336, Exp. 4/2017  ",11/1/2016,"11/01/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75566,"Ongoing","Burel Pharmaceuticals Inc","199 Interstate Dr Ste N",,"Richland","MS","39218-9433","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0155-2017","Class II","Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90","2861 bottles","CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures","11/29/2016",," LOT # 29001501, EXP 07/17",10/24/2016,"10/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75566,"Ongoing","Burel Pharmaceuticals Inc","199 Interstate Dr Ste N",,"Richland","MS","39218-9433","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0160-2017","Class II","Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains:  Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10      ","795 bottles","CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures","11/29/2016",," LOT # 29401501, EXP 10/17",10/24/2016,"10/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75566,"Ongoing","Burel Pharmaceuticals Inc","199 Interstate Dr Ste N",,"Richland","MS","39218-9433","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0156-2017","Class II","UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains:  Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS ","11,539 bottles","CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures","11/29/2016",," (a) LOT # 28981501, EXP 8/17, NDC 35573-302-30;    (b) LOT # 28981501, EXP 8/17, LOT # 28981601, EXP 4/18, NDC 35573-302-10    ",10/24/2016,"10/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75566,"Ongoing","Burel Pharmaceuticals Inc","199 Interstate Dr Ste N",,"Richland","MS","39218-9433","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0158-2017","Class II","UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains:  Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10    	  ","823 bottles","CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures","11/29/2016",," LOT # 29131501, EXP 9/17",10/24/2016,"10/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75566,"Ongoing","Burel Pharmaceuticals Inc","199 Interstate Dr Ste N",,"Richland","MS","39218-9433","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0161-2017","Class II","Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10  ","17,788 bottles","CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures","11/29/2016",," Lot #: 28161601, EXP 1/18; 28161603, EXP 5/18; and 28161604, EXP 6/18  ",10/24/2016,"10/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75566,"Ongoing","Burel Pharmaceuticals Inc","199 Interstate Dr Ste N",,"Richland","MS","39218-9433","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0157-2017","Class II","URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains:  Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10    ","2,771 bottles","CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures","11/29/2016",," LOT # 28751601, exp 8/18",10/24/2016,"10/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75566,"Ongoing","Burel Pharmaceuticals Inc","199 Interstate Dr Ste N",,"Richland","MS","39218-9433","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0162-2017","Class II","Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10  ","35,149 bottles","CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures","11/29/2016",," Lot #: 28181601, EXP 1/18; 28181603, EXP 5/18; 28181604, EXP 5/18; 28181605, EXP 5/18; 28181606, EXP 6/18; 28181607, EXP 5/18",10/24/2016,"10/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75566,"Ongoing","Burel Pharmaceuticals Inc","199 Interstate Dr Ste N",,"Richland","MS","39218-9433","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0159-2017","Class II","AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains:  Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10      ","604 bottles","CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures","11/29/2016",," LOT # 29421501, EXP 10/17",10/24/2016,"10/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75567,"Ongoing","Pharmedium Services, LLC","150 N Field Dr Ste 350",,"Lake Forest","IL","60045-2506","United States","Voluntary: Firm Initiated","Telephone","Nationwide","D-0125-2017","Class II","Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.","1550 units","Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.","11/03/2016",," Lot #: 162790012M, Exp. 1/3/2017",10/12/2016,"10/12/2016",11/9/2016,"11/09/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75568,"Ongoing","SSI-GoPicnic LLC","10517 United Pkwy # 21",".","Schiller Park","IL","60176-1715","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0562-2017","Class II","GoPicnic Turkey Slices & Cheddar Cheese; 4 Individually Packed Snacks; GLUTEN FREE; Best by: 31 JAN 2017","1,584 individual cartons ",,"12/05/2016",," Lot: M 1 6244 / Best By: 31 JAN 2017",9/26/2016,"09/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75569,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI","Z-0673-2017","Class II","MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the  Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system  The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate","97","Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure.  In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder.  Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated.  Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded.","11/29/2016",," Lot Number(s):  All lots within shelf life.  Expiration Date(s):  All  ",10/31/2016,"10/31/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75570,"Ongoing","Sorin Group USA, Inc.","14401 W 65th Way",".","Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (Nationwide) including states of: MD, ME, MA, NH, NY, NJ, AL, MS, VA, FL, CA, HI, TN, GA, WI, TX, MI, OH, KS, MN, NC, IL, IN, WA MO, PA, NM, and UT and countries of: Austria, Australia, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Jordan, India, Italy, Iran, Islamic Republic of, Ireland, Israel, Korea, Republic of, Kuwait,  Luxembourg, Malaysia, Malta, Mexico, Netherland, New Zealand, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South African, Spain, Switzerland, Romania, Russian Federation,Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.","Z-0716-2017","Class II","Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27.    The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.","845 units","Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.","12/07/2016",," All Lots",10/31/2016,"10/31/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75571,"Ongoing","Firefly Medical, Inc.","320 E Vine Dr Ste 312",,"Fort Collins","CO","80524-2332","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- USA and Canada.","Z-0767-2017","Class II","IVEA 500A    Intended for Med-Surg patient care.","239","The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.","12/15/2016",," Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.",11/1/2016,"11/01/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75572,"Ongoing","Golden Star International Inc.","9017 63rd Dr",".","Rego Park","NY","11374-3847","United States","Voluntary: Firm Initiated","Telephone","NY & NJ","F-0610-2017","Class I","BON APPETITO WALNUT LADIES FINGER, Net Wt.: 10oz. (340g), UPC 6 44744 69876 7 ","approximately 48 units","Undeclared Eggs and Soy Oil/Lecithin","12/07/2016",," Exp Date 11/14/16",11/1/2016,"11/01/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75573,"Completed","Sorin Group USA, Inc.","14401 W 65th Way",,"Arvada","CO","80004-3503","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (Nationwide and Puerto Rico) and Internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, Trinidad, and Tobago.","Z-0682-2017","Class II","ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz  The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours","1,618 units in the US; 129 units outside of US","On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).","12/01/2016",," All Serial Numbers",8/1/2014,"08/01/2014",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75574,"Ongoing","Mondelez International","200 Deforest Ave",".","East Hanover","NJ","07936-2833","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, PR, St. Croix and St. Thomas    Phillipines","F-0671-2017","Class I","Nabisco Oreo Fudge Creme Original Variety, Net Wt. 11.3 oz  Distributed by: Mondelez Global LLC East Hanover, NJ UPC 044000026943","unknown","Mondelez Global LLC is recalling certain Oreo Fudge Cremes (Original and mint varieties) due to milk allergen not being declared on the ingredient list. ","12/08/2016",," 19 AUG 16  20 Aug 16  14 SEP 16  13 OCT 16  14 OCT 16  17 OCT 16  ",10/28/2016,"10/28/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75574,"Ongoing","Mondelez International","200 Deforest Ave",".","East Hanover","NJ","07936-2833","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide, PR, St. Croix and St. Thomas    Phillipines","F-0672-2017","Class I","Nabisco Oreo Fudge Creme Mint Variety, Net Wt. 11.3 oz  Distributed by: Mondelez Global LLC East Hanover, NJ UPC 044000026967","unknown","Mondelez Global LLC is recalling certain Oreo Fudge Cremes (Original and mint varieties) due to milk allergen not being declared on the ingredient list. ","12/08/2016",," 20 AUG 16  21 AUG16  14 SEP 16  15 SEP 16  16 SEP 16  17 OCT 16  18 OCT 16  ",10/28/2016,"10/28/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75575,"Ongoing","Olympus Scientific Solutions Americas","48 Woerd Ave",".","Waltham","MA","02453-3824","United States","FDA Mandated","Letter","US Distribution to the states of : TX, WA, GA, MA, SC, AZ, PA, VA, CA, OH, NJ, MD, CO, IL, LA, and MN.","Z-0680-2017","Class II","Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System","41 units","Possible unintentional x-ray emission after users attempt early termination of the sequence.","12/07/2016",," Model - Vanta VCR ",10/27/2016,"10/27/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75576,"Ongoing","Beckman Coulter Inc.","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -- United States and Mexico.","Z-0768-2017","Class II","MicroScan LabPro Data Management System.    Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.","131 units total (130 units in US)","Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using  LabPro Data Management System version 4.42.  The issue could cause workflow interruption with a potential of delaying reporting results due to the inability to begin processing new panels.","12/15/2016",," Software Version 4.42,  Part No. 6000-0050, 6000-0051, 6000-0052, 6000-0053, 6000-0054, and 6000-0060.",10/25/2016,"10/25/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75577,"Ongoing","Conifer Specialties, Inc.","15500 Woodinville-Redmond Road","C400","Woodinville","WA","98072","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in CA, IN, MI, NC, NY, OH, OR, PA, and WI.","F-0455-2017","Class III","Simply Balanced brand White Chicken Chili dry soup mix.  This is not a ready to eat product and it does not contain any chicken.  It is packaged in a clear poly bag with print on front and back, Net WT. 10 oz.., UPC is 0 85239 18973 3.","1494 packages (10 oz. per package)","Simply Balanced brand White Chili dry soup mix is recalled because it was contaminated with metal shavings.  ","11/16/2016",," Lot # 6288, Best By 30APR2018 ",10/28/2016,"10/28/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75578,"Terminated","Inland Northwest Blood Center","210 W Cataldo Ave",,"Spokane","WA","99201-2217","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0067-2017","Class II","Blood and Blood Products for Reprocessing","1 unit"," Blood product, collected from an ineligible donor, was distributed. ","11/11/2016","11/11/2016"," W042415033653V",10/5/2016,"10/05/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75579,"Terminated","American National Red Cross","3131 N Vancouver Ave",,"Portland","OR","97227-1560","United States","Voluntary: Firm Initiated","Telephone","Oregon","B-0130-2017","Class III","Apheresis Platelets, Leukocytes Reduced","1 unit","Misbranded platelet product was distributed. ","11/11/2016","11/11/2016"," W202116887499",9/4/2016,"09/04/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75580,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0656-2017","Class II","Synthes Flexible Shaft, Orthopedic manual surgical instrument    The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.","198 units ","Non-conforming material used.  ","11/23/2016","."," Part Number 352.040 - Lot # 9947895, L084498    Part Number 352.044 - Lot # 9916503  9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632  L082974  ",10/31/2016,"10/31/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75581,"Ongoing","Amerisource Health Services","2550 John Glenn Ave Ste A",,"Columbus","OH","43217-1188","United States","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-0137-2017","Class III","Bupropion Hydrochloride Extended-Release Tablets, USP  (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05),  b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India  For BluePoint Laboratories ","a) 15,409 bottles b) 5,128 bottles","Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.","11/16/2016",," Lot #: a)  M601509, Exp 3/31/2018; M606506, Exp 4/30/2018; b) M601510, Exp 3/31/2018;  M604444, Exp 4/30/2018; M606515, Exp 4/30/2018.",10/27/2016,"10/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75583,"Ongoing","Greencore USA, Inc.","13949 Alvarez Rd",".","Jacksonville","FL","32218-9433","United States","Voluntary: Firm Initiated","E-Mail","FL, GA, LA, MD, NC, OH, and TX.","F-0579-2017","Class II","Slow Roasted Ham and Swiss Croissant, 5.6 oz. ","60,232 sandwiches","Product may contain metal foreign material in the Croissant Bun.","12/05/2016",," Best Before 20 DEC 2016, UPC 7 62111 10496 8",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75583,"Ongoing","Greencore USA, Inc.","13949 Alvarez Rd",".","Jacksonville","FL","32218-9433","United States","Voluntary: Firm Initiated","E-Mail","FL, GA, LA, MD, NC, OH, and TX.","F-0580-2017","Class II","Double Smoked Bacon, Cheddar and Egg on Croissant Bun, 5.2 oz. ","313,148 sandwiches","Product may contain metal foreign material in the Croissant Bun.","12/05/2016",," Best Before 19 JAN 2017, 20 JAN 2017, 25 JAN 2017, 26 JAN 2017. UPC 7 62111 09172 7",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75584,"Ongoing","GE Healthcare, LLC","3000 N Grandview Blvd",,"Waukesha","WI","53188-1615","United States","Voluntary: Firm Initiated","Letter","USA ( nationwide) Distribution including Puerto Rico and DC. and to the countries of    Australia  AUSTRIA  Azerbaijan  Bahrain  Bangladesh  Barbados  Belarus  Belgium  BOLIVIA  BOSNIA-HERZEGOVINA  Brazil  BRUNEI  BULGARIA  Canada  CHILE  China  COLOMBIA  COSTA RICA  Croatia  Cyprus  Czech Republic  Denmark  ECUADOR  Egypt  Estonia  Ethiopia  Finland  FRANCE  Georgia  GERMANY  Ghana  Gibraltar  GREECE  HONG KONG  HUNGARIA  Iceland  India  Indonesia  IRAQ  Ireland  Israel  ITALY  JAPAN  JORDAN  KAZAKHSTAN  Kenya  KOREA, REPUBLIC OF   Kuwait  Latvia  Lebanon  Libyan Arab Jamahiriya  LITHUANIA  MACEDONIA  MALAYSIA  Malta  Mexico  MOLDOVA  MOROCCO  NAMIBIA  Netherlands  New Zealand  Nicaragua  Nigeria  NORWAY  Oman  Pakistan  Panama  PARAGUAY  PERU  PHILIPPINES  Poland  PORTUGAL  Qatar  ROMANIA  Russian Federation  Saudi Arabia  Serbia  SERBIA-MONTENE  Singapore  Slovakia  SLOVENIA  SOUTH AFRICA  SPAIN  SWEDEN  SWITZERLAND  SYRIA  TAIWAN  Thailand  Tunisia  TURKEY  Ukraine  United Arab Emirates  UNITED KINGDOM  Uruguay  UZBEKISTAN  Venezuela  VietNam  Yemen","Z-0755-2017","Class II","GE Healthcare, Avance, Avance CS2, Amingo.","23,098 (US = 8,711; OUS = 14,387)","GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if  the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.    ","12/14/2016",," FMI 34079 Initial Consignee List  Mfg. Lot or Serial #  ANBM00775  ANBM00776  ANBM00779  ANBN00775  ANBR01060  APKS01034  APKT00107  APKT02107  APKU00169  APKU00170  APKU00171  APKU01696  APKU01697  APKU01698  APKU01699  APKV00455  APKV00456  APKV00457  APKV00458  ANBH00259  ANBP00673  ANBP01851  ANBP02120  ANBP02121  APKS01352  APKS01353  APKS01354  APKS01355  APKS01356  APKT02322  APKT02323  APKT02324  APKT02325  APKT02326  APKV01600  APKV01601  APKV01602  APKV01554  APKV01555  APKV01556  APKV01557  APKV01558  APKV01559  APKV01560  APKV01561  APKV01562  APKV01198  APKV01199  APKV01200  APKV01201  ANBQ01418  ANBQ01419  ANBQ01420  ANBQ01421  ANBR01342  APKV00450  APKV00451  ANBM00230  ANBM00273  ANBM00497  ANBR00289  ANBR00290  ANBR00291  ANBR00292  ANBR00293  ANBR00294  ANBR00295  APKV01885  APKV01210  APKV01211  APKV00205  APKV00206  APKV00207  APKV00208  APKV00209  APKV00210  APKV00211  APKV00212  APKV00213  APKV00214  APKU00134  APKU00135  ANBQ01520  ANBQ01521  ANBQ01522  ANBQ01523  ANBQ01524  ANBQ02209  ANBQ02210  ANBQ02211  ANBQ02212  ANBQ02213  ANBS00535  ANBR01078  ANBR01079  ANBR01080  ANBK00957  APKU02425  APKU02426  APKU02427  APKU02428  APKU02429  APKU02430  APKU02431  APKU02432  ANBL01069  ANBP01486  ANBP01487  ANBP01488  ANBP01489  ANBP01490  ANBP01491  ANBP01492  ANBP01493  ANBN00773  ANBN00774  ANBN00791  ANBN00797  ANBN00798  ANBN00799  ANBN00800  ANBN00634  ANBN00921  ANBN00922  ANBN00923  ANBN00925  ANBN00926  ANBN00927  ANBN00928  ANBN00929  ANBN00930  ANBN00931  ANBN00932  ANBN00945  ANBN00946  ANBP01359  APKU01872  ANBR01053  ANBR01054  APKV01598  ANBN00633  ANBQ01015  ANBP00529  ANBP00530  ANBP00531  ANBQ01480  ANBQ01484  ANBQ01965  ANBQ01966  ANBS00304  ANBS00305  APKT00144  APKT02991  ANBN01391  ANBP01331  ANBN01672  ANBN01673  APKT02494  APKT02495  APKT02496  APKU00698  APKU00699  APKU00700  APKS01106  APKS01107  APKS01108  APKS01109  APKS01110  ANBJ01449  ANBJ01450  ANBK00679  ANBK00680  ANBM00539  ANBP01113  ANBP01114  ANBP01115  ANBP01116  ANBP01117  ANBP01118  ANBP01119  ANBQ0175",11/3/2016,"11/03/2016",12/21/2016,"12/21/2016","12  APKT03310  APKT03311  ANBR00163  ANBR00164  APKT03362  APKT03363  APKT03364  APKU00154  APKU00155  ANBK00576  ANBK00577  ANBK00578  ANBK00579  ANBK00580  ANBK00581  ANBK00582  ANBK00583  ANBK00584  ANBK00630  ANBK00631  ANBK00632  ANBK00633  ANBK00634  ANBK00644  ANBK00645  APKV00907  APKT00422  APKT00423  APKT00424  APKT00425  APKT00426  APKT00427  APKT00428  APKT00429  APKT00430  ANBS00245  APKT03355  APKT03356  APKT03357  ANBN00552  ANBN00553  ANBN00554  ANBN01098  ANBN01099  ANBN01100  ANBN01416  ANBN01417  ANBN01418  ANBN01419  ANBN01420  ANBN01421  ANBP02163  ANBQ01293  ANBQ01294  APKU02128  APKU02129  APKV01179  APKR00141  APKV01221  ANBL02000  ANBL02001  ANBL02002  ANBN01368  ANBN01369  ANBN01383  ANBN01384  ANBN01386  ANBP01685  ANBM01014  ANBN01367  ANBN01385  ANBN01387  ANBP01686  ANBS00319  ANBS00603  ANBS00604  ANBS01448  APKT00579  APKT00580  APKT00977  APKU01438  APKU02100  APKU02101  APKU02102  APKU02116  APKU02117  APKT03387  APKV00991  ANBR02387  ANBR02388  ANBR02389  APKU02112  APKT02088  APKT02089  APKT02090  APKT02091  APKT02092  APKT02093  APKT02094  APKT02095  APKV00883  APKV00884  APKV00885  APKV00886  APKV00887  APKT00572  APKT00573  ANBL01657  ANBL01663  ANBL01674  ANBM00498  ANBM00525  ANBN01684  ANBQ01763  ANBQ01764  ANBQ01765  ANBL00734  ANBL00735  ANBQ00314  ANBQ00315  ANBQ00316  ANBQ00317  ANBQ00318  ANBQ00319  ANBQ00320  ANBQ00321  ANBQ00322  ANBQ00323  ANBQ00324  ANBQ00325  ANBQ00326  ANBQ00327  ANBQ00328  ANBP00636  ANBN01683  ANBQ01760  ANBR00595  ANBS00244  APKU03027  ANBM00106  ANBM00107  ANBM00108  ANBM00109  ANBQ01962  ANBH00564  ANBP01844  ANBP01845  ANBP01846  ANBP01847  ANBP01848  APKV01886  APKV01887  ANBN00458  ANBL01659  ANBL01665  ANBL01668  ANBM00522  ANBM00524  ANBM00526  ANBM00529  ANBM00587  ANBM00620  ANBP01498  ANBQ00937  ANBQ00938  APKT00312  APKT00313  ANBK00879  ANBK00880  ANBK00881  ANBK00882  APKS00283  ANBM00843  ANBM00844  ANBM00845  ANBM00846  ANBM00848  ANBM00849  ANBM00850  ANBM00851  ANBN00760  ANBN00762  ANBN00763  ANBN00764  ANBN00765  ANBM01","473  ANBN00474  ANBN00475  ANBN00476  ANBN00477  ANBN00478  ANBN00479  ANBN00480  ANBN00481  ANBN00482  ANBN00483  ANBN00484  ANBN00485  ANBM00960  ANBP01677  ANBP01678  ANBP01679  ANBP01680  ANBQ00243  APKS00994  APKS00995  APKS00996  APKT02752  ANBL00610  ANBP02161  APKS00900  APKT02039  APKT02040  APKT03319  APKT03320  APKU03028  APKU03029  ANBN01661  ANBN01662  ANBS01724  ANBP01411  ANBP01412  ANBP01413  ANBP01414  ANBP01415  ANBP01416  ANBP01417  ANBP01418  ANBP01419  ANBP01420  ANBP01421  ANBL00569  ANBP02137  ANBP01777  ANBP01778  ANBP01779  ANBP01780  ANBP01781  ANBP02134  ANBP02135  ANBN01649  ANBN01650  ANBN01651  ANBN01652  ANBQ01414  ANBQ01415  ANBQ01416  ANBQ01417  ANBL00728  ANBL00729  ANBL00730  ANBL00731  ANBL00732  ANBL00733  ANBL01114  ANBL01115  ANBL01116  ANBL01117  ANBL01699  ANBM00111  ANBM00112  ANBM00139  ANBM00140  ANBM00142  ANBM00143  ANBM00144  ANBM00145  ANBM00146  ANBM00147  ANBM00148  ANBM00149  APKV00137  APKT02884  APKT02885  APKT02886  APKU00912  APKU00913  APKU00914  APKT00438  APKT00439  APKT00440  APKT00441  APKT00442  APKT00443  ANBN00451  ANBN00452  ANBP02128  ANBP02129  ANBP02131  ANBP02133  ANBR00552  ANBQ01533  ANBQ01534  ANBQ01535  ANBQ01536  ANBQ01537  ANBQ01538  ANBQ01539  ANBQ01540  ANBM01425  ANBM01429  ANBM01430  ANBM01433  ANBL01980  ANBL01981  ANBL01982  ANBL01983  ANBL01984  ANBL01985  ANBR00393  APKT00340  APKT00341  APKT00342  APKT00501  ANBL01148  ANBR00795  ANBP00883  ANBP00884  ANBP00885  ANBP00886  ANBP00887  ANBP00889  ANBP00891  ANBP00892  ANBP00893  ANBP00894  ANBP00895  ANBP00897  APKT02792  ANBP00890  ANBP00896  ANBP00898  ANBQ02190  ANBQ02191  ANBQ02192  ANBQ02193  ANBQ02194  ANBQ02195  ANBL01802  ANBL01803  ANBL01804  ANBL01805  ANBQ01016  ANBM00977  ANBM01063  ANBM01079  ANBM01081  ANBM01082  ANBQ01972  ANBQ01973  APKU01926  ANBQ00696  ANBQ00697  ANBQ00694  ANBQ00695  ANBP00888  ANBP00572  ANBQ00133  ANBQ01049  APKT00750  ANBR00151  APKU01391  APKU00121  APKU00132  APKU00133  ANBP02139  ANBP02140  ANBP02141  APKT03043  ANBN00503  ANBM01327  ANBM0","0754  APKU01817  APKS00656  APKS00657  APKS00658  APKS00659  APKS00660  APKR00136  APKR00135  ANBL00270  ANBJ01107  ANBJ01108  ANBJ01109  ANBJ01110  ANBJ01297  ANBJ01299  ANBJ01300  ANBJ01407  ANBJ01408  ANBJ01409  ANBJ01410  ANBJ01411  ANBJ01427  ANBK00220  ANBK00465  ANBK00524  ANBK00866  ANBK00867  ANBK01071  ANBL00271  ANBL00921  ANBL00982  ANBL01250  ANBL01251  ANBM00358  ANBM00563  ANBM01948  ANBN00743  ANBN00744  ANBN00828  ANBP01422  ANBP01423  ANBP01707  ANBP01888  ANBP01889  ANBQ00900  ANBR00847  APKR00145  APKS00151  APKS00584  APKS00636  APKS01057  APKS01320  APKS01321  APKS01322  APKS01323  APKS01324  APKT00479  APKT00480  APKT00481  APKT00482  APKT02112  APKT02113  APKT02115  APKT02116  ANBT00130  ANBT00131  ANBT00132  ANBT00133  ANBT00134  ANBT00135  ANBT00334  ANBS00889  ANBS01023  ANBM00301  ANBM01587  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"Food",75585,"Ongoing","Back To Nature Foods, Llc","10641 Airport Pulling Rd N Ste 26",,"Naples","FL","34109-7338","United States","Voluntary: Firm Initiated","Press Release","Products distributed to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.","F-0690-2017","Class I","Back to Nature Chocolate Chunk Cookies, 9.5 oz (269g) . pouches, 6 pouches per case. UPC 8-19898-01100-1.  ","26,021 cases (156,126 cartons)","Produces contains undeclared milk. ","12/09/2016",," Lot Codes/ Exp Date (Production Date): 8 MAY 17 (8 AUG 16), 9 MAY 17 (9 AUG 16), 11 MAY 17 (11 AUG 16), 12 MAY 17 (12 AUG 16) ",10/27/2016,"10/27/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75585,"Ongoing","Back To Nature Foods, Llc","10641 Airport Pulling Rd N Ste 26",,"Naples","FL","34109-7338","United States","Voluntary: Firm Initiated","Press Release","Products distributed to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.","F-0691-2017","Class I","Back to Nature Mini Chocolate Chunk Cookies, 6 - 1.25oz (35g) UPC 8-19898-01114-8 (tray) and UPC 8-19898-01115-5 (pouch);  100 - 1.25oz (35g) UPC 8-19898-01148-3 (case) and UPC 8-19898-01115-5 (pouch), 50 - 2.5oz (70g) UPC 8-19898-01139-1 (case) and UPC 8-19898-01143-8 (pouch), and 9 x 2.5oz (70g) UPC 8-19898-01144-5 (caddy) and UPC 8-19898-01143-8 (pouch).  ","7,982 cases (47,892 units)","Produces contains undeclared milk. ","12/09/2016",," Lot Codes/ Exp Date 1 MAY 17, Production Date 1 AUG 17.        ",10/27/2016,"10/27/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75585,"Ongoing","Back To Nature Foods, Llc","10641 Airport Pulling Rd N Ste 26",,"Naples","FL","34109-7338","United States","Voluntary: Firm Initiated","Press Release","Products distributed to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.","F-0688-2017","Class I","Back to Nature, Gluten-Free, Chocolate Delight Granola, 11 oz.(311g) pouches, 6 per case. UPC 8-19898-01201-5.","79,098 cases (474,588 pouches)","Produces contains undeclared milk. ","12/09/2016",," Lot Codes/ Exp Date (Production Date): 25 DEC 2016 (25 FEB 2016 ), 26 DEC 2016 (26 FEB 2016), 9 JAN 2017 (9 MAR 2016), 9 JAN 2017 (10 MAR 2016), 10 JAN 2017 (11 MAR 2016), 12 FEB 2017 (12 APR 2016), 13 FEB 2017 (13 APR 2016), 14 FEB 2017 (14 APR 2016), 15 FEB 2017 (15 APR 2016), 23 MAR 2017 (23 MAY 2016), 24 MAR 2017 (24 MAY 2016), 25 MAY 2016 (25 MAR 2017), 17 APR 2017 (17 JUN 2016), 18 APR 2017 (18 JUN 2016), 19 APR 2017 (19 JUN 2016), 20 APR 2017 (20 JUN 2016), 13 MAY 2017 (13 JUL 2016), 14 MAY 2017 (14 JUL 2016), 15 MAY 2017 (15 JUL 2016), 12 JUN 2017 (12 AUG 2016), 13 JUN 2017 (13 AUG 2016), 26 JUL 2017 (26 SEP 2016), 27 JUL 2017 (27 SEP 2016)",10/27/2016,"10/27/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75585,"Ongoing","Back To Nature Foods, Llc","10641 Airport Pulling Rd N Ste 26",,"Naples","FL","34109-7338","United States","Voluntary: Firm Initiated","Press Release","Products distributed to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.","F-0689-2017","Class I","Back to Nature, Gluten Free, Dark Chocolate Coconut Granola, 11 oz (311g) pouches, 6 pouches per case.  UPC 8-19898-01225-8. ","5,448 cases (32,688 pouches)","Produces contains undeclared milk. ","12/09/2016",," Lot Codes/ Exp Date (Production Date): 9 MAY 17 (9 JUL 16), 10 MAY 17 (10 JUL 16), 11 MAY 17 (11 JUL 16), 13 JUN 17 (13 AUG 16), 14 JUN 17 (14 AUG 16).",10/27/2016,"10/27/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75586,"Terminated","Omrix Biopharmaceuticals Ltd. (FPPF)","14 Einstein Street","Weizmann Science Park PO Box 619","Rehovot",,,"Israel","Voluntary: Firm Initiated","Letter","Multiple U.S. States","B-0131-2017","Class III","Fibrin sealant patch","1 Lot; 218 units subject to recall"," Misbranded Fibrin Sealant Patch was distributed. ","11/14/2016","11/14/2016"," U01F012A; ",4/14/2016,"04/14/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75587,"Ongoing","Blount Fine Foods Corporation","630 Currant Rd",,"Fall River","MA","02720-4713","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, IL, IN, WY, FL, PA, CT, OK","F-0475-2017","Class III","Panera Bread Broccoli Cheddar Soup, 48 oz. sleeve (2/24 oz. cups/sleeve). Refrigerated  UPC Code: 077958790918","11,608 units","Presence of Foreign object","11/17/2016",," Lot codes:  092616-5F  Use or Freeze By: 12/5/2016 and  092616-6F Use of Freeze By: 12/5/2016",11/2/2016,"11/02/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75588,"Ongoing","PerkinElmer, Inc","68 Elm St",,"Hopkinton","MA","01748-1602","United States","Voluntary: Firm Initiated","Letter","IA, MD, NY, WA  Foreign: France, Germany, The Netherlands, Hungary, Singapore","Z-0780-2017","Class II","PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960)  Item Number: 6000677.  Used with the: JANUS AUTOMATED WORKSTATION   Product Codes:  AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01  NGS EXPRESS Product Codes: AJS4NGS","33312 ","Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.","12/16/2016",," Lot Codes: 16091338, 16150558, 16091337, 16150559, 16160100, 16160099",10/13/2016,"10/13/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75589,"Ongoing","Terumo BCT, Inc.","10811 W Collins Ave",,"Lakewood","CO","80215-4440","United States","Voluntary: Firm Initiated","Letter","Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.","Z-0674-2017","Class II","Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.","660 ","Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.","11/30/2016",," Product Code: 51431, Lot Codes: 07Z9913; 07Z9933; 08Z9932; 09Z9908; 10Z9908  Product Code: 51432, Lot Codes: 08Z9907; 09Z9931. Product Code: 51433, Lot Codes: 08Z9901; 08Z9933. Product Code: 514001-347, Lot Codes: 05Z9956; 05Z9956; 07Z9917; 07Z9917; 07Z9917; 07Z9917; 05Z9956; 05Z9956; 07Z9917       ",11/3/2016,"11/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75590,"Ongoing","AC Creamery","1835 N Orangethorpe Park Ste B",".","Anaheim","CA","92801-1143","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following; CA and FL.    No foreign distribution.","F-0624-2017","Class I","Manila Sky Purple Yumm Ice Cream  16 oz.","83 cases","Potential Listeria monocytogenes contamination.","12/07/2016",," Expiration date Mar 06, 2018.",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75592,"Ongoing","OLMA-XXI INC.","204 28th St",".","Brooklyn","NY","11232-1604","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, MD, PA, MA, CA VA, FL, CT, TX, IL, GA & WA distributed by refrigerated trucks through retail stores and warehouses","F-0597-2017","Class I","Premium Norwegian Salmon, Smoked, slice 8oz (227g), UPC # 856687004288, Keep refrigerated","5530 units","Products have the potential to be contaminated with  Listeria monocytogenes","12/06/2016",," lot # 606002, Best By 02/23/2017",11/4/2016,"11/04/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75592,"Ongoing","OLMA-XXI INC.","204 28th St",".","Brooklyn","NY","11232-1604","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NJ, MD, PA, MA, CA VA, FL, CT, TX, IL, GA & WA distributed by refrigerated trucks through retail stores and warehouses","F-0598-2017","Class I","SALMON, TURBOT, BUTTERFISH, smoked sliced, Net Weight: 8oz (227g), UPC # 856687004448, Keep refrigerated","2100 units","Products have the potential to be contaminated with  Listeria monocytogenes","12/06/2016",," lot # 606002, Best By 02/23/2017",11/4/2016,"11/04/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75594,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",".","Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-0692-2017","Class II","SOMATOM Force, System x-ray, tomography, computed","48 units distributed in U.S.","Siemens is providing software update version  VA50A_SP3 to address the software bugs that  were identified through normal field monitoring  and the Global Complaint Handling Process.  Correction for the problems are as follows:  1. Correction to volumetric  misrepresentations of high contrast  objects when using ADMIRE.  2. Correction to highly sporadic scan  aborts due to temporarily tube  currents at 0mA.  3. Correction to missing Microsoft  Hotfixes (MS16-001, MS15-135,  MS15-088, MS15-048).  4. Correction to highly sporadic image  artifacts caused by error signals from  high voltage chain at extremely high  tube currents.  5. Correction to highly sporadic  incomplete image reconstruction due  to temporary slow hard disk write  speed.  6. Correction to highly sporadic scan  aborts due to temporarily high disk  load of system disk.  7. Correction to highly sporadic image  artifacts generated by scatter  correction in case of tube arcings.","12/02/2016",," Model Number 10742326, Serial Numbers: 75708,75709,75607,75617,75550,75526  75512,75567,75536,75711,75514,75600,75563,75510,75454,75540,75571,75500  75527,75475,75535,75481,75482,75710,75460,75476,75588,75493,75458,75528  75467,75602,75487,75464,75478,75604,75513,75532,75555,75524,75515,75559  75610,75501,75570,75616,75576,75605  ",10/20/2016,"10/20/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75595,"Ongoing","Roche Diagnostics Operations, Inc.","9115 Hague Rd",,"Indianapolis","IN","46256-1025","United States","Voluntary: Firm Initiated","Letter","Nationwide.","Z-0657-2017","Class II","Handheld Base Unit for CoaguChek XS Plus and CoaguChek XS Pro Systems","720","CoaguChek XS Pro and CoaguChek XS Plus Handheld Base Units might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). In case of a patient mismatch, taking into account the difficulty in detecting the issue, the potential for a serious medical adverse event cannot be excluded.  The issue will only occur at sites using POTCT1-A communication via USB.","11/23/2016","."," Handheld Base Unit Product catalog number:  04805658160  All Units in Serial Number Range:  UU00007003 through UU00018502",2/11/2016,"02/11/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75596,"Ongoing","Whole Foods Market Brand 365, Llc","601 N Lamar Blvd Ste 300",,"Austin","TX","78703-5424","United States","Voluntary: Firm Initiated","E-Mail","Select Whole Foods Market stores in Pennsylvania, Maryland, Ohio, Kentucky, New Jersey, Virginia and Washington D.C.","F-0620-2017","Class I","CROISSANT CHOCOLATE 6 PK   ","Total volume made and distributed from 8/1/2016-11/2/2016: Chocolate Croissant 6pk: 7892 units. ","Product contains undeclared eggs.","12/20/2016",," UPC Code   Product Desc   Lot Code      0248422008994  CROISSANT CHOCOLATE 6 PK  sell by 11/5 and before     ",11/2/2016,"11/02/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75596,"Ongoing","Whole Foods Market Brand 365, Llc","601 N Lamar Blvd Ste 300",,"Austin","TX","78703-5424","United States","Voluntary: Firm Initiated","E-Mail","Select Whole Foods Market stores in Pennsylvania, Maryland, Ohio, Kentucky, New Jersey, Virginia and Washington D.C.","F-0619-2017","Class II"," MULTI GRAIN CROISSANT 6 PK   ","Total volume made and distributed from 8/1/2016-11/2/2016: Multigrain Croissant 6pk: 1547 units. ","Product contains undeclared eggs.","12/20/2016",," UPC Code   Product Desc   Lot Code      0241654006998  MULTIGRAIN CROISSANT 6PK  sell by 11/4/16 and before         ",11/2/2016,"11/02/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75596,"Ongoing","Whole Foods Market Brand 365, Llc","601 N Lamar Blvd Ste 300",,"Austin","TX","78703-5424","United States","Voluntary: Firm Initiated","E-Mail","Select Whole Foods Market stores in Pennsylvania, Maryland, Ohio, Kentucky, New Jersey, Virginia and Washington D.C.","F-0618-2017","Class II","CROISSANT 6 PK  ","Total volume made and distributed from 8/1/2016-11/2/2016: Plain Croissant 6pk: 42118 units.","Product contains undeclared eggs.","12/20/2016",," UPC Code   Product Desc   Lot Code      0248421006991  CROISSANT 6 PK.  sell by 11/4/16 and before         ",11/2/2016,"11/02/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75597,"Terminated","American National Red Cross","995 E Broad St","Central Ohio Region","Columbus","OH","43205-1322","United States","Voluntary: Firm Initiated","Telephone","Ohio","B-0167-2017","Class III","Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit","Blood product, that was irradiated twice, was distributed.","11/28/2016","11/28/2016"," W201616430122",9/22/2016,"09/22/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75598,"Terminated","Community Blood Center of the Ozarks","220 W Plainview Rd",,"Springfield","MO","65810-2619","United States","Voluntary: Firm Initiated","Letter","Missouri","B-0168-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product collected from a donor who traveled to a malaria endemic area, was distributed.","11/28/2016","11/28/2016"," W045116128469 ",9/28/2016,"09/28/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75600,"Ongoing","SynCardia Systems Inc.","1992 E Silverlake Rd",".","Tucson","AZ","85713-3865","United States","Voluntary: Firm Initiated","Telephone","US distribution to Virginia and Arizona.","Z-0659-2017","Class I","5000 Series Freedom Drivers.  Freedom Driver System for Temporary Total Artificial Heart (TAH-t).  Part number 595000-001","5","The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.","12/08/2016",," S/N 5002  UDI (01)00858000003121(21)5002  S/N 5005  UDI (01)00858000003121(21)5005  S/N 5008  UDI (01)00858000003121(21)5008  S/N 5009  UDI (01)00858000003121(21)5009  S/N 5010  UDI (01)00858000003121(21)5010",10/21/2016,"10/21/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75601,"Ongoing","Olympus Corporation of the Americas","3500 Corporate Pkwy","PO Box 610","Center Valley","PA","18034-0610","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0754-2017","Class II","HF Cable WA00014A, Endoscopic electrosurgical unit and accessories","494 units","Software malfunction that results in incorrect generation or display of error codes. ","12/14/2016",," Model Number: WA00014A  Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W",11/3/2016,"11/03/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75603,"Ongoing","McConnell's Ice Cream, Inc.","835 E Canon Perdido St",".","Santa Barbara","CA","93103-3040","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, FL, PA, WA, CO, IA, NJ, OH, NY, NV, TX, SC, and IL.    No foreign distribution.","F-0567-2017","Class I","McConnell's Fine Ice Cream  Sweet Cream","22,662 gallons total for all products","Potential Listeria monocytogenes contamination.","12/05/2016",," Best By:  JUL 27, 2017, SEP 08, 2017, OCT 01, 2017, OCT 21, 2017, DEC 08, 2017, DEC 21, 2017, DEC 24, 2017",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75603,"Ongoing","McConnell's Ice Cream, Inc.","835 E Canon Perdido St",".","Santa Barbara","CA","93103-3040","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, FL, PA, WA, CO, IA, NJ, OH, NY, NV, TX, SC, and IL.    No foreign distribution.","F-0569-2017","Class I","McConnell's Fine Ice Cream  Vanilla Bean","22,662 gallons total for all products","Potential Listeria monocytogenes contamination.","12/05/2016",," Best By:  JUL 13, 2017, JUL 25, 2017, JUL 27, 2017, OCT 01, 2017, OCT 15, 2017, DEC 07, 2017, DEC 25, 2017, JAN 03, 2018, JAN 06, 2018",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75603,"Ongoing","McConnell's Ice Cream, Inc.","835 E Canon Perdido St",".","Santa Barbara","CA","93103-3040","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, FL, PA, WA, CO, IA, NJ, OH, NY, NV, TX, SC, and IL.    No foreign distribution.","F-0565-2017","Class I","McConnell's Fine Ice Cream  Peppermint Stick","22,662 gallons total for all products","Potential Listeria monocytogenes contamination.","12/05/2016",," Best By:  JUL 25, 2017, JUL 26, 2017, SEP 30, 2017",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75603,"Ongoing","McConnell's Ice Cream, Inc.","835 E Canon Perdido St",".","Santa Barbara","CA","93103-3040","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, FL, PA, WA, CO, IA, NJ, OH, NY, NV, TX, SC, and IL.    No foreign distribution.","F-0563-2017","Class I","McConnell's Fine Ice Cream  Dutchman's Chocolate","22,662 gallons total for all products","Potential Listeria monocytogenes contamination.","12/05/2016",," Best By:  JUL 27 2017, OCT 01 2017 and OCT 05 2017",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75603,"Ongoing","McConnell's Ice Cream, Inc.","835 E Canon Perdido St",".","Santa Barbara","CA","93103-3040","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, FL, PA, WA, CO, IA, NJ, OH, NY, NV, TX, SC, and IL.    No foreign distribution.","F-0568-2017","Class I","McConnell's Fine Ice Cream  Turkish Coffee","22,662 gallons total for all products","Potential Listeria monocytogenes contamination.","12/05/2016",," Best By:  JUL 28, 2017, SEP 22, 2017, OCT 07, 2017, Dec 06, 2017",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75603,"Ongoing","McConnell's Ice Cream, Inc.","835 E Canon Perdido St",".","Santa Barbara","CA","93103-3040","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, FL, PA, WA, CO, IA, NJ, OH, NY, NV, TX, SC, and IL.    No foreign distribution.","F-0566-2017","Class I","McConnell's Fine Ice Cream  Salted Caramel Chip","22,662 gallons total for all products","Potential Listeria monocytogenes contamination.","12/05/2016",," Best By:  OCT 07, 2017, OCT 20, 2017, DEC 22, 2017, JAN 06,  2018, JAN 07, 2018",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75603,"Ongoing","McConnell's Ice Cream, Inc.","835 E Canon Perdido St",".","Santa Barbara","CA","93103-3040","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; CA, FL, PA, WA, CO, IA, NJ, OH, NY, NV, TX, SC, and IL.    No foreign distribution.","F-0564-2017","Class I","McConnell's Fine Ice Cream  Mint Chip","22,662 gallons total for all products","Potential Listeria monocytogenes contamination.","12/05/2016",," Best By:  SEP 08 2017, SEP 30 2017, OCT 07 2017, DEC 01, 2017, DEC 30, 2017, JAN 04, 2018, JAN 05, 2018",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75604,"Ongoing","West-Ward Pharmaceuticals Corp.","401 Industrial Way West",,"Eatontown","NJ","07724-2209","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0147-2017","Class III","Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01","32,102 bottles","Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. ","11/22/2016","."," Lot #: AS1466A, Exp. Jan 2019",11/4/2016,"11/04/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75605,"Ongoing","Commerce International Inc.","4300 L B McLeod Rd Ste C",".","Orlando","FL","32811-5686","United States","Voluntary: Firm Initiated","Letter","FL, GA, NC, and SC.","F-0621-2017","Class I","Eastern Feast, Green Raisin, 7 oz, 11 oz, and 14 oz plastic containers.","At least approximately 688.5 pounds","Initiated by the Florida Department of Agriculture and Consumer Services due to undeclared sulfites on the finished product label.","12/08/2016",," No lot codes ",8/5/2016,"08/05/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75606,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0601-2017","Class II","Artis Q, Angiographic x-ray system    Product Usage:  The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.  ","4,657 systems (worldwide)","The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.  ","11/16/2016",," Model Numbers:  10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355",11/1/2016,"11/01/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75606,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0602-2017","Class II","Artis zee/zeego, Angiographic x-ray system    Product Usage:  The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.  ","4,657 systems Worldwide","The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.  ","11/16/2016",," Model Numbers:  10094135, 10094137, 10094139, 10094141, 10280959",11/1/2016,"11/01/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75606,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-0603-2017","Class II","AXIOM Artis,  Angiographic x-ray system    Product Usage:  The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.  ","4,657 systems Worldwide","The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.  ","11/16/2016",," Model Numbers:  5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392",11/1/2016,"11/01/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0807-2017","Class II","Sausage, Egg and Cheese on Kaiser wrapped in clear film, 5 oz.  Undeclared allergens - Wheat, Soy(oil, lecithin) Milk  ","3 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0800-2017","Class II","Turkey Club on White wrapped in clear film, 4 oz.   Undeclared allergens - Wheat, Soy (oil)  ","14 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0795-2017","Class II","Turkey, Bacon and Swiss on Macaroni Salad wrapped in clear film, 8 oz.   Undeclared allergens - Wheat, Soy (oil, flour), Milk, Egg  ","7 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0809-2017","Class II","Salisbury Steak with Gravy on Kaiser with whipped potatoes wrapped in clear film, 8 oz.   Undeclared allergens - Wheat, Soy (oil, flour), Milk  ","6 units","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0794-2017","Class II","Hot Sausage on Club wrapped in clear film, 6 oz.  Undeclared allergens - Wheat, Soy (oil)  ","32 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0798-2017","Class II","Ham and Cheese on Club wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy (oil, lecithin), Milk  ","19 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0801-2017","Class II","Regular Hoagie on Italian Roll, wrapped in clear film, 7 oz.   Undeclared allergens - Wheat, Soy (oil), Milk  ","25 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0792-2017","Class II","Egg Salad on Wheat wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy (oil) and eggs","13 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0790-2017","Class II","Bagel and Cream Cheese wrapped in clear film, 5. oz.  ","51 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0804-2017","Class II","Vegetable and dip, 6 oz.   Undeclared allergens - Soy( oil), Milk  ","9 units","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0791-2017","Class II","Raisin Bagel with Cream Cheese wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy (oil), and Milk","26 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0797-2017","Class II","Roast Beef and Cheddar Cheese on Kaiser Roll wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy (oil, flour), Milk  ","11 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0805-2017","Class II","Mild Italian Sausage on Italian Roll wrapped in clear film, 6 oz.   Undeclared allergens - Wheat, Soy (oil, flour)  ","27 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0796-2017","Class II","Imported Ham with Potato salad wrapped in clear film, 8 oz.   Undeclared allergens - Wheat, Soy (oil), Milk, Egg  ","13 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0793-2017","Class II"," Cheeseburger wrapped in clear film, 5 oz.   Undeclared Allergens - Wheat, Soy (Lecithin, oil, flour), Milk,   ","38 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0808-2017","Class II","1/4 1b. Hot Dog with Cheese wrapped in clear film, 6 oz.   Undeclared allergens - Wheat, Soy(oil, lecithin) Milk  ","18 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0799-2017","Class II","Chicken Salad on Kaiser Roll, 5 oz.  Undeclared allergens - Wheat, Soy (oil, flour)  ","20 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0803-2017","Class II","Bacon Egg and Cheese on Kaiser Roll wrapped in clear film, 5 oz.   Undeclared allergen - Wheat, Soy (oil, lecithin), Milk, Egg  ","13 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0806-2017","Class II","Hot Sicilian- Ham, Pepperoni and Provolone Cheese wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy( oil flour), Milk  ","24 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75607,"Ongoing","Crescent Vending Co. Inc.","1446 Ulmer Ave",,"Oreland","PA","19075-1712","United States","Voluntary: Firm Initiated","Press Release","Distributed in the state of Pennslyvania.","F-0802-2017","Class II","Meatball on an Italian Roll with Cole Slaw wrapped in clear film, 8 oz.    Undeclared allergens - Wheat, Soy (oil, flour), Milk, Egg  ","13 sandwiches","Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.","12/19/2016",," No codes associated with this product.",11/4/2016,"11/04/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75608,"Ongoing","DePuy Orthopaedics, Inc.","700 Orthopaedic Dr",".","Warsaw","IN","46582-3994","United States","Voluntary: Firm Initiated","Letter","US Distribution in the state of TN","Z-0703-2017","Class II","LCS Complete Knee Revision System VVC Insert    Product Usage:  LCS VVC Insert is used in Knee Revision Surgery  ","1","DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of  specifications, which prevents the insert from properly seating in the mating tibial tray.","12/03/2016",," LCS COMP VVC INS SM 22.5MM, Product Code: 129424122, Lot# C08294,  GTIN: (01)10603295024484, Expiry: 31-Mar-2021",11/8/2016,"11/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75617,"Ongoing","Spectranetics Corporation","9965 Federal Drive",,"Colorado Springs","CO","80921-3617","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide and PR)  Internationally  to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.","Z-0663-2017","Class II","Bridge Occlusion Balloon. Model: 590-001  Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.","875 units","Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging. ","12/01/2016",," FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A  FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A  ",10/31/2016,"10/31/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75617,"Ongoing","Spectranetics Corporation","9965 Federal Drive",,"Colorado Springs","CO","80921-3617","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide and PR)  Internationally  to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.","Z-0662-2017","Class II","ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009  The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.","2,885 units","Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging. ","12/01/2016",," FDD16D20A; FDD16E02A; FBM16D15B; FBM16F17A; FHH16D05B; FHH16G13A  FHH16D12A; FHH16G22A; FHH16D19A; FHH16H05A; FHH16D26A; FHH16H08C  FHH16D27A; FHH16H12A; FHH16E03A; FHH16H15A; FHH16E13A; FHH16H17A  FHH16E16A; FHH16H24A; FHH16F03A; FHH16H29A; FHH16F07A; FHH16J19A  FHH16F22A ; FHH16J29A; FHH16F28A; FTT16D07A; FTT16F24A; FTT16E23A; FTT16H04A; FTT16F01A; FTT16J09A; FUU16E18A; FUU16F30A; FUU16F08A; FBB16D18A; FBB16H03A; FBB16F01A; FBB16H03B; FBB16G11A; FBB16H26A  FBB16G20A; FLL16G21A   ",10/31/2016,"10/31/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75617,"Ongoing","Spectranetics Corporation","9965 Federal Drive",,"Colorado Springs","CO","80921-3617","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide and PR)  Internationally  to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.","Z-0661-2017","Class II","Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01  The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.","13,288 units","Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging. ","12/01/2016",," FBD16D01A; FBD16F20A; FBD16D11A; FBD16F29A; FBD16D14A; FBD16G18A; FBD16D23A; FBD16G29A; FBD16E05A; FBD16H03A; FBD16E11A; FBD16H26A  FBD16E19A; FBD16J06A; FBD16E26A; FBD16J21A; FBD16F03A; FBD16J26A; FBE16C30A; FBE16H24A; FBE16E25A; FBE16J14A; FBE16F15A; FAY16C29A; FAY16G14A; FAY16D08A; FAY16G29A; FAY16D26A; FAY16H23A; FAY16E17A; FAY16H31A; FAY16F08A; FAY16J23B; FAY16G01A; FBF16D27A; FBF16G07A  FBF16E12A ; FBF16H10B; FBF16F17A; FBF16J16A; FAZ16C31A; FAZ16G25A; FAZ16D14A ; FAZ16H01A; FAZ16D25A; FAZ16H22A; FAZ16E06A; FAZ16H30A  FAZ16F24B; FAZ16J20A; FAZ16F27A; FBG16E02A; FBG16H31A; FBG16F23A; CBA16H19A; FBA16F27A; CBA16H19B; FBA16G11A; CBA16H19C; FBA16G15A; FBA16D04A; FBA16G19A; FBA16D06A; FBA16G27B; FBA16D18A; FBA16H02A  FBA16D21A; FBA16H08A; FBA16E09A; FBA16H17A; FBA16E10A; FBA16J02A  FBA16E13A; FBA16J07A; FBA16E19A; FBA16J19A; FBA16F07A; FBA16J22A; FBA16F21A ",10/31/2016,"10/31/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75619,"Ongoing","Hospira Inc.","600 N Field Dr",,"Lake Forest","IL","60045-4835","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0153-2017","Class II","Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32","797,800 ampules","Lack of Assurance of Sterility: Complaints of broken tips on the ampules.","11/23/2016","."," Lot  #5 9277EV, 60028EV, 6008EV, Exp 11/1/17",11/1/2016,"11/01/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75620,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",".","Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  Canada and Australia","Z-0719-2017","Class II","Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY --     Product Usage:  Dental impression material  ","US: 2090 units, Canada: 331 units, Australia: 465 units","The firm received complaints claiming the dental material failed to set up.  As the dental material ages, the set time may increase.   ","12/07/2016",," Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75620,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",".","Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  Canada and Australia","Z-0718-2017","Class II","Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY --     Product Usage:  Dental impression material  ","US: 1867 units, Canada: 465 units","The firm received complaints claiming the dental material failed to set up.  As the dental material ages, the set time may increase.   ","12/07/2016",," Lot No./Expiration Date: UL2221/July 28, 2017; TL4056/Nov 28, 2016",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75620,"Ongoing","Ivoclar Vivadent, Inc.","175 Pineview Dr",".","Amherst","NY","14228-2231","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide and the countries of  Canada and Australia","Z-0717-2017","Class II","Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY --   product Usage:  Dental impression material  ","US: 4659 units, Canada: 729 units","The firm received complaints claiming the dental material failed to set up.  As the dental material ages, the set time may increase.   ","12/07/2016",," Lot No./Expiration Date: UL2395/June 28, 2018; UL2293/Dec 31, 2017; UL2222/Aug 28, 2017; UL2220/July 28, 2017; TL4121/ Mar 28, 2017  ",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75621,"Ongoing","Shri Shiva Foods Inc","10339 98th St",,"Ozone Park","NY","11417-1644","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY and OH thru one wholesale store each","F-0941-2017","Class I","MTR MASALA Sambar Powder, Net Quantity: 200g","20 cartons/66 units/200g","The firm distributed a product prior to FDA release for an article which appears to contain Salmonella and was Subject to Import Alert #99-19 ","12/21/2016",," LOT NO: 15J27C  MFD. 27.10.15",11/7/2016,"11/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75623,"Terminated","Blood Bank Of Hawaii","2043 Dillingham Blvd",,"Honolulu","HI","96819-4024","United States","Voluntary: Firm Initiated","FAX","Hawaii; California","B-0165-2017","Class II","Red Blood Cells, Leukocytes Reduced","3 units"," Blood products, untested for communicable disease agents, were distributed. ","11/17/2016","11/17/2016"," W088416505380; W088416513955; W088416506371; ",9/23/2016,"09/23/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75623,"Terminated","Blood Bank Of Hawaii","2043 Dillingham Blvd",,"Honolulu","HI","96819-4024","United States","Voluntary: Firm Initiated","FAX","Hawaii; California","B-0164-2017","Class II","Plasma Frozen within 24 hours (FP24)","1 unit","Blood products, untested for communicable disease agents, were distributed. ","11/17/2016","11/17/2016"," W088416513955; ",9/23/2016,"09/23/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75623,"Terminated","Blood Bank Of Hawaii","2043 Dillingham Blvd",,"Honolulu","HI","96819-4024","United States","Voluntary: Firm Initiated","FAX","Hawaii; California","B-0166-2017","Class II","Blood and Blood Products for Reprocessing","1 unit"," Blood products, untested for communicable disease agents, were distributed. ","11/17/2016","11/17/2016"," W088416506371; ",9/23/2016,"09/23/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75624,"Terminated","BPL Plasma, Inc.","7180 Eastex Fwy",,"Beaumont","TX","77708-3831","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0169-2017","Class II","Source Plasma","9 units","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.","11/28/2016","11/28/2016"," NG0429701; NG0429956; NG0430772; NG0431125; NG0431970; NG0432373; NG0433245; NG0433588; NG0434320",7/29/2016,"07/29/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75627,"Ongoing","Domain Surgical, Inc.","1370 S 2100 E",,"Salt Lake City","UT","84108-2244","United States","Voluntary: Firm Initiated","Letter","Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.","Z-0690-2017","Class II","FMsealer Open Shears. Model FM3001","70 units US; 175 units OUS","Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.","12/01/2016",," Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091",10/24/2016,"10/24/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75629,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide including Canada.","Z-0599-2017","Class II","Merge PACS software.      Product Usage:  Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.  ","534 sites potentially have the affected versions","The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.","11/16/2016",," Versions: V6.0 MR2, 6.0 MR3, 6.0 MR3 CU, 6.0 MR4, 6.0 MR4 CU1, 6.0 MR4 CU2, 6.0 MR4 CU3, 6.0 MR4 CU4, 6.0 MR4 CU5, 6.0 MR4 CU6, 6.0 MR4, CU7, 6.0 MR4 CU8, 6.0 MR4 CU9, 6.0 MR4 CU10, 6.0 MR4 CU11, 6.1, 6.1.1, 6.1.2, 6.1.3, 6.2, 6.2.1, 6.2.2, 6.2.3, 6.2.4, 6.2.5, 6.3, 6.4, 6.4.1, 6.4.2, 6.4.3, 6.4.4, 6.4.5, 6.4.6, 6.4.7, 6.5, 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1, and 7.0.2.",3/28/2016,"03/28/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75630,"Ongoing","Thayer Intellectual Property, Inc.","1331 N California Blvd Ste 320",".","Walnut Creek","CA","94596-4563","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of CA, TX. MD, MI,VA, DC, UT, CT, ID,  SD, IN, and GA.","Z-0702-2017","Class II","MANOS EX (CAT#TY-12-101)    Product Usage:  Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.  ","339 devices","The firm failed to notify current customers of IFU update/warning. During a recent FDA inspection, it was discovered that Thayer Intellectual Property, Inc. had revised their IFU to include a warning not to bend, deform or otherwise modify any part of the device. The warning was added as a result of a MAUDE report filed in December 2014 where a piece of the MANOS EX broke during use and was left in the patient's hand. The patient suffered a tendon injury and an additional surgery was required to remove the broken piece of the device and repair the tendon. FDA inspection found that while the firm had updated their IFU, they had not notified customers who had been shipped the device with the older version that did not include the warning. Risk: It is important for MANOS EX users to be aware that bending, deforming, or modifying the device could result in device breakage which could impact patient safety and device performance. ","12/03/2016",," LOT 1055337, Expiry 4/01/2015;  LOT 1071800. Expiry 5/1/2017;  LOT 1102580; Expiry 8/1/2017;  LOT 1154179; Expiry 12/01/2017.",11/4/2016,"11/04/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75631,"Ongoing","Prime Time International","86705 Avenue 54 Ste A",".","Coachella","CA","92236-3814","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","CA, PA, AZ, OR","F-0576-2017","Class I","***CUCUMBERS***PRIME TIME***CUCUMBERS***6/10 BUSHEL","1,119 cartons","Prime Time is recalling cucumber bushels because they have the potential to be contaminated with Salmonella.","12/06/2016",," Lot 1-2885  Julian date code sticker: 280  Stamp: Agricola Maui   ",11/8/2016,"11/08/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75632,"Ongoing","Elana, Inc.","10480 Little Patuxent Pkwy Ste 400",".","Columbia","MD","21044-3576","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.","Z-0698-2017","Class II","Elana Surgical KitHUD  The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity","4","Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to potentially compromised integrity of the outer sterile packaging of the Elana Catheter 2.0.  ","12/02/2016",," Manufacturers Product Number, 801-H    Lot/Serial Number, 160301  ",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75633,"Ongoing","RAYSEARCH LABORATORIES AB","Sveavaegen 9",".","Stockholm",,,"Sweden","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, MA, MD, MN, MI, MS, MO, NJ, NY, NC, OH, PA, RI, TX & WA","Z-0720-2017","Class II","Radiation Therapy Treatment Planning System     Product Usage:  RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.  ","540 units","An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. If a CT image set with the same Frame of Reference as the displayed auxiliary CT set exists in another case, the dose display may be incorrect.  When the error occurs, the display of dose in patient views, including the maximum dose position, the dynamic isodose lines and the dose grid may be incorrect.  The dose value normally displayed in the upper left corner when pointing in the 2D view may be incorrect or missing.","12/07/2016",,"5.0.0.37, 5.0.1.11 or 5.0.2.35.  Only 5.0.2.35 was distributed in the U.S.",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75634,"Ongoing","Mylan Pharmaceuticals Inc.","781 Chestnut Ridge Rd",,"Morgantown","WV","26505-2730","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0151-2017","Class III","Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA","51,983 extended release capsules","Failed Impurities/Degradation Specifications: OOS results for known compound.","11/23/2016","."," 0378-5220-01 Lot# 3065133; Exp. 03/17  0378-5220-01 Lot# 3066564; Exp. 05/17  0378-5220-05 Lot# 3066564; Exp. 05/17  0378-5220-01 Lot# 3069645; Exp. 08/17  0378-5220-05 Lot# 3069645; Exp. 08/17  ",11/3/2016,"11/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75635,"Ongoing","Meijer, Inc.","2929 Walker Ave Nw",".","Grand Rapids","MI","49544-9428","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Domestic:IN,  IL, KY, MI, OH, WI    Foreign: None  VA/DOD: None","F-0669-2017","Class I","Meijer Almonds Salted Caramel, 14 oz. packaged in plastic pouches","480 cases","Meijer initiated a voluntary recall of Meijer Almonds Salted Caramel on 11/7/2016 due to undeclared allergen peanuts. ","12/08/2016",," UPC: 7-19283-23759-0",11/7/2016,"11/07/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75636,"Ongoing","R & J Almonds, Inc. dba Jonny Almond Nut Co.","G4254 Fenton Rd",".","Flint","MI","48507-3614","United States","Voluntary: Firm Initiated","Telephone","Domestic only- Customer in Michigan    Foreign: None  VA/DOD: None","F-0600-2017","Class I","Salted Caramel Almonds ","80 cases 36 lbs/case","R&J Almonds, Inc. dba Jonny Almond Nut Co. initiated a voluntary recall of Salted Caramel Almonds due to undeclared allergen peanuts.  ","12/06/2016",," LOT# 101716  Production Date 10/18/16  Use by date 6/18/17  UPC# 818224010442  ",11/7/2016,"11/07/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75637,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Internationally  to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.","Z-0678-2017","Class II","OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients",,"Sterility: Due to a potential incomplete seal on the outer sterile package.","11/30/2016",," Material # 9470-VC-006, Lot numbers: 010859 & 011511.",11/8/2016,"11/08/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75637,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Internationally  to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.","Z-0676-2017","Class II","ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients",,"Sterility: Due to a potential incomplete seal on the outer sterile package.","11/30/2016",," Material # 9451-VC-006, Lot numbers: 010183, 010560, 010780, 010951, 010972, 011042, 011050, 011348, 011382, 011583, 011709, 011952, 012343, 012568, 012690, 013071, 013247, 013470, 013692, 013735, 013898, 014125, 014138, 014232, 014312 & 014565 and 9458-VC-006, Lot numbers: 010182, 010436, 010437, 010561, 010562, 010723, 010781, 010782, 010817, 010872, 010893, 010952, 010953, 010964, 010969, 010977, 011039, 011040, 011041, 011060, 011061, 011223, 011378, 011379, 011555, 011556, 011557, 011710, 011711, 011712, 011949, 011950, 011951, 012143, 012144, 012145, 012146, 012344, 012345, 012346, 012460, 012461, 012462, 012575, 012576, 012577, 012691, 012692, 012693, 012897, 012898, 013072, 013086, 013248, 013249, 013250, 013471, 013472, 013473, 013694, 013695, 013696, 013734, 013904, 013905, 013906, 013907, 014116, 014117, 014118, 014119, 014129, 014130, 014131, 014132, 014193, 014194, 014195, 014196, 014313, 014314, 014315, 014402, 014404, 014405, 014406, 014607, 014608 & 014609.",11/8/2016,"11/08/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75637,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Internationally  to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.","Z-0675-2017","Class II","ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical,    The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients","113,647 units","Sterility: Due to a potential incomplete seal on the outer sterile package.","11/30/2016",," Material # 9408-VC-006, Lot numbers: 010256, 010257, 010438, 010439, 010556, 010557, 010737, 010738, 010739, 010946, 010947, 011037, 011046, 011047, 011048, 011215, 011216, 011217, 011380, 011381, 011383, 011384, 011385,  011675, 011676, 011945, 011946, 011947, 012139, 012140, 012141, 012142, 012353, 012354, 012355, 012356, 012463, 012464, 012465, 012570, 012572, 012573, 012686, 012687, 012688, 012895, 012896, 013074, 013084, 013085, 013122, 013185, 013255, 013256, 013257, 013258, 013477, 013478, 013688, 013894, 013895, 013896, 013897, 014111, 014112, 014113, 014114, 014115, 014134, 014135, 014136, 014199, 014200, 014201, 014202, 014306, 014307, 014308, 014420, 014422, 014423, 014569, 014570, 014571, 014703 & 014805 and Material #9411-VC-006, Lot numbers: 010184, 010440, 010559, 010949, 011052, 011218, 011374, 011386 011720, 011948, 012352, 012459, 012578, 012689, 012894, 013060, 013246, 013468, 013509, 013689, 013891, 014121, 014139, 014168, 014197, 014203, 014310, 014425 & 014617.",11/8/2016,"11/08/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75637,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Internationally  to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.","Z-0677-2017","Class II","ARROW  OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.",,"Sterility: Due to a potential incomplete seal on the outer sterile package.","11/30/2016",," Material # 9461-VC-001, Lot numbers: 012579S, 013469S, 011227 & 011492;   Material # 9461-VC-006, 011938, 012694, 013065, 013686 & 014615;   Material # 9462-VC-001, Lot numbers: 010743S, 10778S, 010954S, 012580S & 012891S; Material # 9462-VC-006, Lot numbers: 010444, 010743, 010778, 010954, 011495, 011545, 011582, 011714, 012130, 012581, 013251, 013860, 013893, 014128 & 014316; Material # 9463-VC-001, Lot numbers: 010331S, 010955S, 011716S, 012133S & 013066S; Material # 9463-VC-006, Lot numbers: 010331, 010955, 011513, 011584, 011717, 011834, 012131, 012349, 013070, 013474, 013890, 013899, 014230, 014317 & 014616; Material # 9464-VC-001, Lot numbers: 010445S, 010744S, 010956S, 011718S, 012135S, 012695S & 013262S; Material # 9464-VC-006, Lot numbers: 010445, 010744, 010956, 011051, 011491, 011590, 011719, 011939, 012136, 012350, 012696, 012778, 013252, 013902, 014025, 014120, 014231, 014319, 014453 & 014618; Material # 9465-VC-001, Lot numbers: 010957S, 011940S & 014321S; Material # 9465-VC-006, Lot numbers: 010957, 011496, 011941, 012137, 012351, 013286, 013901 & 014322; Material # 9466-VC-001, Lot numbers: 010333S, 10844S, 010958S, 011722S & 012685S; Material # 9466-VC-006, Lot numbers: 010333, 010844, 010958, 011512, 011544, 011589, 011723, 012129, 012466, 013887, 014123, 014209 & 014323.   ",11/8/2016,"11/08/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75637,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Internationally  to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.","Z-0679-2017","Class II","ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients",,"Sterility: Due to a potential incomplete seal on the outer sterile package.","11/30/2016",," Material # 9471-VC-006, Lot numbers: 013107, 013260, 013889, 014126 & 014324; Material # 9472-VC-006, Lot numbers: 013108 & 013261; Material # 9403-VC-006, Lot numbers: 010848, 011230, 011587, 012101, 012348, 012697, 013245, 013888, 014127, 014208 & 014407.",11/8/2016,"11/08/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75638,"Ongoing","CYPRESS MEDICAL PRODUCTS","9954 Mayland Dr Ste 4000",,"Richmond","VA","23233-1464","United States","Voluntary: Firm Initiated","Telephone","US Distribution.  This recall is limited to one distribution center in Auburn, Washington, and the customers serviced from that distribution center.","Z-0741-2017","Class II","McKesson Powder Free Vinyl Exam Gloves  Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140  ","2005.2 cases have been distributed","A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed. ","12/12/2016",," Lot Number: CDZF06-03",10/12/2016,"10/12/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75639,"Ongoing","Siemens Medical Solutions USA, Inc.","685 E Middlefield Rd",,"Mountain View","CA","94043-4045","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY,  JAPAN, SWEDEN","Z-0667-2017","Class II","Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113.    Radiology:  The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological,  Neurological-skeletal Conventional, and Musculo-skeletal Superficial applications. The system  also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctive with other medical data obtained by a physician for clinical diagnosis purposes.   ","33"," and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.","11/28/2016",," Model number 10436113 -Z6Ms Transesophageal tranducer.  US Serial numbers:  63229007  63229008  63432010  63530518  63322007  63230009  63260584  63530516  63432007  63319012  63332004  63325007  63328003  63328007  63332002  63029015  63329017  63230003.  Foreign serial numbers:  63260585  63230002  63029009  63329018  63229011  63432015  63229012  63430524  63029016  63360611  63360612  63432017.  ",11/7/2016,"11/07/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75641,"Ongoing","Cincinnati Sub-Zero Products Inc","12011 Mosteller Rd",,"Cincinnati","OH","45241-1528","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of :  CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.","Z-0654-2017","Class II","The Hemotherm 400CE 115v, containing power board p/n 39945","50","The device may not maintain water flow or temperature control.  ","11/22/2016","."," 154-10360CE 163-10502CE 163-10512CE   163-10527CE 164-10537CE                 163-10491CE   163-10503CE 163-10513CE 163-10528CE   164-10538CE                 163-10493CE  163-10504CE   163-10514CE 163-10529CE 164-10539CE  163-10495CE 163-10505CE 163-10515CE   163-10530CE 164-10540CE                 163-10496CE   163-10506CE 163-10521CE 164-10531CE   164-10543CE                 163-10497CE 163-10507CE   163-10522CE 164-10532CE 164-10544CE  163-10498CE 163-10508CE 163-10523CE   164-10533CE 164-10545CE                 163-10499CE   163-10509CE 163-10524CE 164-10534CE   164-10547CE                 163-10500CE 163-10510CE   163-10525CE 164-10535CE 164-10548CE  163-10501CE 163-10511CE 163-10526CE   164-10536CE 164-10549CE  ",11/7/2016,"11/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75642,"Ongoing","Inventia Healthcare Private Limited","F1- F 1/1, Additional Ambernath MIDC","Ambernath (east)","Thane",,,"India","Voluntary: Firm Initiated","Telephone","United States","D-0224-2017","Class II","Duloxetine Delayed-release Capsules USP 30 mg  30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02","46,848 delayed-release capsules","Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle    The Initial reports stated one or two capsules in a bottle count of 30s opening.  First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.  ","12/22/2016",," Batch # 130/16/001, 130/16/002, 130/16/003;   Exp. Date 10/17       ",10/19/2016,"10/19/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75644,"Ongoing","3M Company - Health Care Business","3m Center 2510 Conway Ave , B# 275-5-W-6",".","Saint Paul","MN","55144-0001","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, FL, GA, ID, IL, KY, NC, NY, TN, TX, VA and the countries of Canada, Chile, Costa Rica, Germany, Japan, Mexico and South Africa.","Z-0701-2017","Class II","3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and    3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case)    Product Usage:  3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY, etc.). 3M Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended application could lead to an unsafe condition.  ","32,000 pads","3M is recalling Universal Electrosurgical Pads because a report of an unintended material (process liner) in the product.  This may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation.  This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body.","12/03/2016",," Product REF 9130 Lot Numbers:  2019-02DT (Expiration 02-2019) and 2019-03DU (Expiration   03-2019)  Product REF 9735-LP Lot Numbers:  2019-02DB and 2019-02CY.  (Both with  Expiration 02-2019)",10/26/2016,"10/26/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75645,"Ongoing","Encore Medical, Lp","9800 Metric Blvd",,"Austin","TX","78758-5445","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0766-2017","Class II","Empowr PS Knee System Box Cut Guide  The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant","162 units","It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.  ","12/14/2016",," 202351L01, 202351L02, 202351L03, 202351L04, 202351L05, 202351L06, 202351L07, 202351L08, 202351L09, 203779L09, 202351L10, 203779L10, 203203L01",9/19/2016,"09/19/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75646,"Ongoing","ISB Food Group, LLC","21534 Devonshire St Ste A",".","Chatsworth","CA","91311-2989","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, FL, SC.    No foreign distribution.","F-0593-2017","Class I","L.A. Creamery Salted Caramel Ice Cream  14 oz.  UPC Code 51005 00304","90 cases","Potential Listeria monocytogenes contamination.","12/06/2016",," Expiration Date: March 18, 2017",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75646,"Ongoing","ISB Food Group, LLC","21534 Devonshire St Ste A",".","Chatsworth","CA","91311-2989","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, FL, SC.    No foreign distribution.","F-0590-2017","Class I","Nancy's Fancy Butterscotch Budino Gelato  16 oz.  UPC Code 51005 00329","296 cases & 5 pints ","Potential Listeria monocytogenes contamination.","12/06/2016",," Expiration Date: March 18, 2017",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75646,"Ongoing","ISB Food Group, LLC","21534 Devonshire St Ste A",".","Chatsworth","CA","91311-2989","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, FL, SC.    No foreign distribution.","F-0592-2017","Class I","L.A. Creamery Honeycomb Ice Cream  14 oz.  UPC Code 51005 00302","105 cases & 7 pints ","Potential Listeria monocytogenes contamination.","12/06/2016",," Expiration Date: March 18, 2017",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75646,"Ongoing","ISB Food Group, LLC","21534 Devonshire St Ste A",".","Chatsworth","CA","91311-2989","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, FL, SC.    No foreign distribution.","F-0591-2017","Class I","Nancy's Fancy Peanut Butter with Crunchy Peanuts Gelato  16 oz.  UPC Code 51005 00326","43 cases","Potential Listeria monocytogenes contamination.","12/06/2016",," Expiration Date: March 18, 2017",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75649,"Ongoing","Owens & Minor Distribution, Inc.","9120 Lockwood Blvd",,"Mechanicsville","VA","23116-2015","United States","Voluntary: Firm Initiated","Telephone","US Nationwide Distribution.","Z-0888-2017","Class II","Medi Choice Arm Slings    ASL 2103	Small 7.5 x 12.5 Inch	1/EA, 24 ENCA  ASL 2104	Medium 8 x 15 Inch	1/EA, 24 ENCA  ASL 2105	Large 8.5 x 17.5 Inch	1/EA, 24 ENCA  ASL 2106	Extra-Large 9 x 20 Inch	1/EA, 24 ENCA  ASL 2150	Universal 7 x 18 Inch	1/EA, 24 ENCA    Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.","568 cases","1, 2016 reported surface contamination on the arm slings.  Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue.    Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions.  A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016.  The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots.    Owens & Minor has quarantined the affected product lots.  The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time.    Based  on the frequency  of the product  defect as well as evaluation of potential  adverse health event risk, Owens & Minor initiated  a voluntary  recall for the above stated affected  product  lots.  ","12/22/2016",," Item#             Lot Number(s)    SL2103          1605BC02A, 1606BC02A    V'-SL2104           1605BC03A, 1606BC03A, 1607BC03A   V'-SL2105           1605BC04A, 1606BC04A, 1607BC04A   V'-SL2106           1605BC05A, 1606BC05A, 1607BC05A  ASL2150             1605BC06A, 1607BC06A  ",10/31/2016,"10/31/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75652,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",".","Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution to the states of  including Puerto Rico and : CA, CO, FL, IL, MI, NJ, NY, OH, TX, WA, WI, WI and WY., and to the countries of :  Angola, Australia, Belgium,  Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, France, Germany, Greece, India, Italy, Japan, Kenya, Malaysia, Mexico, Myanmar, Netherlands, Norway, Pakistan, Portugal, Saudi Arabia, Slovenia, Spain,  Switzerland, Turkey, Uganda, United Kingdom, Vietnam.","Z-0723-2017","Class II","ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. ","US: 23 systems; Foreign: 141 systems","Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date.  If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.","12/08/2016",," All serial numbers of ADVIA 560 Hematology Systems",10/21/2016,"10/21/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75654,"Ongoing","Sandoz Inc","100 College Rd W",,"Princeton","NJ","08540-6604","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the USA","D-0141-2017","Class II","L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.","33,624 vials","Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.","11/17/2016",," Lot #: 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215, Exp 07/17; 2092315, 2093015, Exp 09/17; 2100115, Exp 10/17; 2120115, 2120215, Exp 12/17",11/9/2016,"11/09/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75654,"Ongoing","Sandoz Inc","100 College Rd W",,"Princeton","NJ","08540-6604","United States","Voluntary: Firm Initiated","Letter","Nationwide throughout the USA","D-0140-2017","Class II","L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ  08540.","18,751 vials","Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.","11/17/2016",," Lot #: 2081915, 2082015, 2082115, 2082815, 2083115, Exp 08/17; 2090115, Exp 09/17",11/9/2016,"11/09/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75655,"Ongoing","Nationwide Laboratories, LLC","33 Wood Ave S Ste 600",,"Iselin","NJ","08830-2717","United States","Voluntary: Firm Initiated","Letter","Nationwide in USA and Puerto Rico","D-0165-2017","Class II","Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey  08830.  ","2,882,661 tablets","CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.","12/01/2016",," Lot #: a) 28121501, 28121502, 28121503, 28121504, Exp 03/17;  28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; b) 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; c) 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17",10/28/2016,"10/28/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75655,"Ongoing","Nationwide Laboratories, LLC","33 Wood Ave S Ste 600",,"Iselin","NJ","08830-2717","United States","Voluntary: Firm Initiated","Letter","Nationwide in USA and Puerto Rico","D-0168-2017","Class II","Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey  08830, NDC 42937-702-10.","5,786,653 tablets","CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.","12/01/2016",," Lot #: 28181501, 28181502, Exp 03/17; 28181503, 28181504, Exp 08/17; 28181505, 28181506, Exp 09/17; 28181601, Exp 01/18  ",10/28/2016,"10/28/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75655,"Ongoing","Nationwide Laboratories, LLC","33 Wood Ave S Ste 600",,"Iselin","NJ","08830-2717","United States","Voluntary: Firm Initiated","Letter","Nationwide in USA and Puerto Rico","D-0167-2017","Class II","Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey  08830, NDC 42937-701-10.","6,333,669 tablets","CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.","12/01/2016",," Lot #: 28161501, Exp 03/17; 28161502, 28161503, Exp 08/17; 28161601, 28161602, Exp 01/18    ",10/28/2016,"10/28/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75655,"Ongoing","Nationwide Laboratories, LLC","33 Wood Ave S Ste 600",,"Iselin","NJ","08830-2717","United States","Voluntary: Firm Initiated","Letter","Nationwide in USA and Puerto Rico","D-0166-2017","Class II","Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey  08830.","2,514,500 tablets","CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.","12/01/2016",,"  Lot #: a) 28141502, 28141503, 28141504, 28141505, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; b) 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; c) 28141501, 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17",10/28/2016,"10/28/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75656,"Ongoing","Agave Dream","4823 Oakwood Ave",".","La Canada","CA","91011-2541","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, OR, IL, TX, IN, SC, NJ, WA.    No foreign distribution.","F-0603-2017","Class I","Agave Dream Cappuccino  1 Pint  UPC Code 8 9934900204 8","8,094 cases total","Potential Listeria monocytogenes contamination.","12/06/2016",," Dates: 7/4/17, 9/9/17, 12/2/17",11/10/2016,"11/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75656,"Ongoing","Agave Dream","4823 Oakwood Ave",".","La Canada","CA","91011-2541","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, OR, IL, TX, IN, SC, NJ, WA.    No foreign distribution.","F-0601-2017","Class I","Agave Dream Lavender  1 Pint  UPC Code 8 9934900206 2  ","8,094 cases total","Potential Listeria monocytogenes contamination.","12/06/2016",," Dates: 12/2/17",11/10/2016,"11/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75656,"Ongoing","Agave Dream","4823 Oakwood Ave",".","La Canada","CA","91011-2541","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, OR, IL, TX, IN, SC, NJ, WA.    No foreign distribution.","F-0605-2017","Class I","Agave Dream Vanilla  1 Pint  UPC Code 8 9934900201 7","8,094 cases total","Potential Listeria monocytogenes contamination.","12/06/2016",," Dates: 7/4/17, 9/9/17,10/9/17, 12/12/17, 7/14/18",11/10/2016,"11/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75656,"Ongoing","Agave Dream","4823 Oakwood Ave",".","La Canada","CA","91011-2541","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, OR, IL, TX, IN, SC, NJ, WA.    No foreign distribution.","F-0602-2017","Class I","Agave Dream Chocolate Chip  1 Pint  UPC Code 8 9934900302 1","8,094 cases total","Potential Listeria monocytogenes contamination.","12/06/2016",," Dates: 8/5/17, 12/12/17",11/10/2016,"11/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75656,"Ongoing","Agave Dream","4823 Oakwood Ave",".","La Canada","CA","91011-2541","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA, OR, IL, TX, IN, SC, NJ, WA.    No foreign distribution.","F-0604-2017","Class I","Agave Dream Chocolate  1 Pint  UPC Code 8 9934900202 4","8,094 cases total","Potential Listeria monocytogenes contamination.","12/06/2016",," Dates: 7/4/17, 8/5/17, 9/9/17, 10/9/17, 12/12/17, 12/24/17",11/10/2016,"11/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75657,"Terminated","DCI Biologicals Greenville, Inc","2727 E 10th St",,"Greenville","NC","27858-3127","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0152-2017","Class III","Source Plasma","1 unit"," Source Plasma, collected from an ineligible donor, was distributed. ","11/11/2016","11/11/2016"," GL0665601; ",11/8/2016,"11/08/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75659,"Terminated","LifeServe Blood Center","431 E Locust St",,"Des Moines","IA","50309-1909","United States","Voluntary: Firm Initiated","Telephone","NC","B-0224-2017","Class II","Red Blood Cells, Leukocytes Reduced, Irradiated","1 unit"," Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.","12/16/2016","12/16/2016"," W037916156302",9/6/2016,"09/06/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75661,"Ongoing","Toshiba American Medical Systems Inc","PO Box 2068","2441 Michelle Dr","Tustin","CA","92780-7047","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0622-2017","Class II","Aquilion Prime TSX-303A  Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.","291 units","Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it  has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.","11/18/2016","."," 5LA1392001  5LA1392002  5LA1392004  5LA13X2005  5LA13X2006  5LA13X2007  5LA13X2008  5LA13X2010  5LA13Y2011  5LA13Y2012  5LA13Y2013  5LA13Y2014  5OA13Y2015  5OA13Y2016  5LA13Y2017  5DA13Z2018  5LA13Z2019  5LA13Z2020  5LA13Z2021  5LA13Z2022  5LA13Z2023  5LA13Z2024  5LA13Z2025  5DA13Z2026  5LA13Z2027  5LA1412028  5LA1412029  5LA1412030  5LA1412031  5DA1422032  5LA1422033  5DA1422034  5LA1422035  5LA1422036  5LA1422037  5DA1422038  5LA1422039  5GA1422040  5OA1422041  5DA1422042  5DA1422043  5OA1422044  5DA1432045  5LA1432046  5DA1432047  5GA1432048  5LA1442050  5DA1442051  5LA1442052  5OA1442053  5DA1442054  5LA1452055  5DA1452056  5DA1452057  5DA1452058  5DA1452059  5LA1452060  5OA1452061  5LA1452062  5DB1462063  5LB1462064  5LB1462065  5DB1462066  5LB1462067  5GB1462068  5DB1462069  5DB1462070  5DB1462071  5DB1462072  5DB1472073  5DB1472074  5LB1472075  5LB1472076  5LB1472077  5OB1472078  5LB1472080  5LB1482081  5DB1482082  5DB1482083  5LB1482084  5LB1482085  5DB1482086  5DB1482087  5DB1482088  5DB1492089  5DB1492090  5LB14X2091  5DB14X2092  5GB14X2093  5LB14X2094  5LB14X2096  5GB14X2097  5LB14X2098  5LB14X2099  5LB14X2100  5DB14Y2101  5DB14Y2102  5LB14Y2103  5GB14Y2104  5DB14Y2105  5DB14Y2106  5DB14Y2107  5LB14Y2108  5LB14Y2109  5DB14Z2110  5DB14Z2111  5DB14Z2112  5LB14Z2113  5GB14Z2114  5LB14Z2115  5LB14Z2116  5DB14Z2117  5DB14Z2118  5DB14Z2119  5LB14Z2120  5DB14Z2121  5DB14Z2122  5DB14Z2123  5GB14Z2124  5DB14Z2125  5DB1512126  5DB1512127  5LB1512128  5LB1512129  5DB1512130  5DB1512131  5DB1512132  5DB1512133  5GB1512134  5LB1512135  5OB1512136  5DB1512137  5DB1522138  5DB1522139  5DB1522140  5DB1522141  5GB1522142  5LB1522143  5DB1522144  5DB1522145  5DB1522146  5DB1522147  5GB1522148  5DB1522149  5DB1522150  5DB1522151  5DB1522152  5LB1542153  5GB1542154  5LB1542155  5LB1542156  5GB1542157  5LB1542158  5OB1542159  5GB1542160  5LB1542161  5LB1542162  5LB1552163  5LB1552164  5DB1552165  5LB1552166  5LB1552167  5DB1552168  5LB1552169  5DB1562170  5DB1562171  5LB1562172  5OB1562173  5DB1562174  5LB1562175  5LB1",10/25/2016,"10/25/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75663,"Ongoing","Halyard Health","1400 Holcomb Bridge Rd",,"Roswell","GA","30076-2190","United States","Voluntary: Firm Initiated","Letter","CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.","Z-0758-2017","Class II","Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.","59 cases","Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.","12/14/2016",," Product Code: 53130 01 (105313001), Lot numbers: SM52741 and SM52721.",11/10/2016,"11/10/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75664,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI,  MN, MO, NV, NH, NY, NC, OH,  OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India,  Israel, Italy, Japan, Laos, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, Serbia, Singapore,  South Africa, Spain, Sweden,  Switzerland, Thailand, Turkey, United Kingdom, Venezuela,","Z-0660-2017","Class II","Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.","671","Incorrect Dose when using the reset function. ","11/25/2016",," Software Builds 5.11 and 5.20",11/3/2016,"11/03/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75665,"Ongoing","DeRoyal Industries Inc","200 Debusk Ln",".","Powell","TN","37849-4703","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0713-2017","Class II","PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only,     Product Usage:  Lateral and medial epicondylitis  ","791 units","DeRoyal received complaints of mold on Tennis Elbow Straps.","12/06/2016",," Lots: 47001, 49894, and 51311",11/7/2016,"11/07/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75665,"Ongoing","DeRoyal Industries Inc","200 Debusk Ln",".","Powell","TN","37849-4703","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-0712-2017","Class II","TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only,     Product Usage:  Lateral and medial epicondylitis  ","56 units","DeRoyal received complaints of mold on Tennis Elbow Straps.","12/06/2016",," Lots: 42249787, 42490802, 42737908, 42944296, 43000801, 43031421, 43036118, 43068890, 43134851, 4363109, and 43454441",11/7/2016,"11/07/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75666,"Ongoing","KRAFT HEINZ FOODS COMPANY","200 E Randolph St",".","Chicago","IL","60601-6436","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0625-2017","Class I","Weight Watchers Smart Ones, Chocolate Chip Cookie Dough Sundae, Keep Frozen,  4 Individual Sundaes, 4-2.11 OZ (60g), NET WT. 8.44 OZ (239g)","99,492 cases","Possible contamination of product with Listeria monocytogenes. ","12/07/2016",," Lot code MS5M01A, Best by 12/28/2016  ;  Lot code MS5M02A,  Best By 12/28/2016  ;  Lot code MS5M07A, Best by 12/28/2016  ;  Lot code MS5M08A, Best by 12/28/2016  ;  Lot code MS6A18A, Best by 01/28/2017  ;  Lot code MS6A19A, Best by 01/28/2017  ;  Lot code MS6A20A, Best by 01/28/2017  ;  MS6B15A, Best by 02/28/17  ;  Lot code MS6B16A, Best by 02/28/17  ;  Lot code MS6B17A, Best by 02/28/17  ;  Lot code MS6C28A, Best by 03/28/2017  ;   Lot code MS6C29A, Best by 03/28/2017  ;  Lot code MS6C30A, Best by 03/28/2017  ;  Lot code MS6E10A, Best by 05/28/2017  ;  Lot code MS6F27A, Best by 06/28/2017  ;  Lot code MS6F28A, Best by 06/28/2017  ;  Lot code MS6F29A, Best by 06/28/2017  ;  Lot code MS6G28A, Best by 07/28/2017  ;  Lot code MS6G25, Best by 07/28/2017 ;  Lot code MS6G26, Best by 07/28/2017  ;  Lot code MS6G27, Best by  07/28/2017     ",11/12/2016,"11/12/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75667,"Ongoing","Seth Ellis Chocolatier, LLC","6880 Winchester Cir Unit E",,"Boulder","CO","80301-3528","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide. No Canadian, other foreign, or VA/govt/military consignees.","F-0527-2017","Class I","Free2b Sun Cups Chocolate. Made With SunButter Sunflower Spread. Packaged in 2 Cups. Net weight 1.5 oz (45g) and 1 Cup. Net weight 0.75 oz (21g)","189 master cases","Free2b Foods recalled the Sun Cups Chocolate due to potential contamination with milk ingredients. ","11/23/2016","."," 2 cups: UPC  895444001405. SELL BY Dates:  8/2/17, 8/4/17, 8/7/17 and 1 cup: UPC 895444001443. SELL BY Dates:  8/2/17, 8/4/17, 8/7/17",11/9/2016,"11/09/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75668,"Terminated","Mississippi Blood Services Inc.","115 Tree St",,"Flowood","MS","39232-7661","United States","Voluntary: Firm Initiated","FAX","MS","B-0223-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit"," Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","12/16/2016","12/16/2016"," W069112102682",11/8/2016,"11/08/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75669,"Terminated","American Red Cross Blood Services Tennessee Valley Region","2201 Charlotte Ave",,"Nashville","TN","37203-1817","United States","Voluntary: Firm Initiated","Letter","TN","B-0214-2017","Class II","Apheresis Platelets, Leukocytes Reduced","2 units"," Blood products, which did not meet the acceptable product specifications, were distributed.","12/16/2016","12/16/2016"," W201916837346- part 1; W201916837346- part 2 ",10/27/2016,"10/27/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75670,"Terminated","Old Dominion Eye Foundation, Inc.","9200 Arboretum Pkwy Ste 104",,"North Chesterfield","VA","23236-3489","United States","Voluntary: Firm Initiated","Telephone","Virginia","B-0101-2017","Class II","Cornea",," Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. ","11/17/2016","11/17/2016"," 20160501ODCN; 20160501OSCN; ",11/3/2016,"11/03/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75672,"Terminated","Michigan Blood","2575 Aero Park Dr",,"Traverse City","MI","49686-8495","United States","Voluntary: Firm Initiated","FAX","Michigan; Switzerland","B-0187-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.  ","12/09/2016","12/09/2016"," W120616420499; ",9/30/2016,"09/30/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75672,"Terminated","Michigan Blood","2575 Aero Park Dr",,"Traverse City","MI","49686-8495","United States","Voluntary: Firm Initiated","FAX","Michigan; Switzerland","B-0186-2017","Class II","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.  ","12/09/2016","12/09/2016"," W120616420499; ",9/30/2016,"09/30/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75673,"Terminated","Jubilant HollisterStier, LLC","3525 N Regal St",,"Spokane","WA","99207-5788","United States","Voluntary: Firm Initiated","Letter","Nationwide","B-0160-2017","Class III","Pullularia pullulans","1 Lot; 44 vials"," Misbranded allergenic extract was distributed. ","11/17/2016","11/17/2016"," U1600830; ",10/19/2016,"10/19/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75674,"Terminated","American National Red Cross (the)","825 John St",,"West Henrietta","NY","14586-9790","United States","Voluntary: Firm Initiated","FAX","New York; California","B-0189-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.","12/16/2016","12/16/2016"," W200116759297; ",9/26/2016,"09/26/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75674,"Terminated","American National Red Cross (the)","825 John St",,"West Henrietta","NY","14586-9790","United States","Voluntary: Firm Initiated","FAX","New York; California","B-0188-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.  ","12/16/2016","12/16/2016"," W200116759297; ",9/26/2016,"09/26/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75675,"Ongoing","Stryker Sustainability Solutions","1810 W Drake Dr",,"Tempe","AZ","85283-4327","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) and Internationally to Israel and Canada    Foreign distribution to the following; IL and CA","Z-0765-2017","Class II","Reprocessed Xcel Bladeless Trocar (H12LP)  Model # H12LP  Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry  for endoscopic instruments in patients requiring minimally invasive surgical procedures.     ","40,476 devices","An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.","12/14/2016",," Model Lot Manufacture Date Expiration  H12LP 3 5 3 6 585 3/3/2015 Mar-18  H12LP 3 5 3 6 880 3/3/2015 Mar-18  H12LP 3 5 3 9 579 3/3/2015 Mar-18  H12LP 3 5 4 0 175 3/5/2015 Mar-18  H12LP 3 5 4 2 016 3/5/2015 Mar-18  H12LP 3 5 4 3 606 3/5/2015 Mar-18  H12LP 3 5 4 3 610 3/9/2015 Mar-18  H12LP 3 5 4 6 115 3/9/2015 Mar-18  H12LP 3 5 4 6 751 3/9/2015 Mar-18  H12LP 3 5 4 6 767 3/9/2015 Mar-18  H12LP 3 5 4 8 518 3/11/2015 Mar-18  H12LP 3 5 4 8 368 3/13/2015 Mar-18  H12LP 3 5 4 9 294 3/13/2015 Mar-18  H12LP 3 5 4 9 583 3/13/2015 Mar-18  H12LP 3 5 5 7 373 3/16/2015 Mar-18  H12LP 3 5 5 9 424 3/16/2015 Mar-18  H12LP 3 5 5 9 453 3/16/2015 Mar-18  H12LP 3 5 6 0 044 3/16/2015 Mar-18  H12LP 3 5 6 0 160 3/16/2015 Mar-18  H12LP 3 5 6 1 254 3/16/2015 Mar-18  H12LP 3 5 6 1 368 3/16/2015 Mar-18  H12LP 3 5 6 1 797 3/16/2015 Mar-18  H12LP 3 5 6 2 147 3/16/2015 Mar-18  H12LP 3 5 6 2 759 3/16/2015 Mar-18  H12LP 3 5 6 2 771 3/16/2015 Mar-18  H12LP 3 5 6 4 013 3/16/2015 Mar-18  H12LP 3 5 6 7 588 3/20/2015 Mar-18  H12LP 3 5 6 9 977 3/20/2015 Mar-18  H12LP 3 5 7 2 483 3/20/2015 Mar-18  H12LP 3 5 7 3 055 3/20/2015 Mar-18  H12LP 3 5 7 4 237 3/23/2015 Mar-18  H12LP 3 5 7 4 758 3/23/2015 Mar-18  H12LP 3 5 7 6 241 3/26/2015 Mar-18  H12LP 3 5 7 6 256 3/26/2015 Mar-18  H12LP 3 5 7 8 827 3/26/2015 Mar-18  H12LP 3 5 7 9 519 3/27/2015 Mar-18  H12LP 3 5 8 1 796 3/27/2015 Mar-18  H12LP 3 5 8 4 936 3/27/2015 Mar-18  H12LP 3 5 8 5 050 3/27/2015 Mar-18  H12LP 3 5 8 5 045 3/31/2015 Mar-18  H12LP 3 5 9 0 552 3/31/2015 Mar-18  H12LP 3 5 9 1 204 3/31/2015 Mar-18  H12LP 3 5 9 5 638 4/6/2015 Apr-18  H12LP 3 6 0 0 132 4/6/2015 Apr-18  H12LP 3 5 9 5 640 4/9/2015 Apr-18  H12LP 3 5 9 8 881 4/9/2015 Apr-18  H12LP 3 6 0 0 653 4/9/2015 Apr-18  H12LP 3 6 1 8 260 4/23/2015 Apr-18  H12LP 3 6 0 0 885 4/28/2015 Apr-18  H12LP 3 6 0 1 108 4/28/2015 Apr-18  H12LP 3 6 2 7 407 4/28/2015 Apr-18  H12LP 3 6 0 0 956 4/29/2015 Apr-18  H12LP 3 6 1 8 738 5/4/2015 May-18  H12LP 3 6 1 8 740 5/4/2015 May-18  H12LP 3 6 2 1 258 5/4/2015 May-18  H12LP 3 6 2 1 270 5/4/2015 May-18  H12LP 3 ",11/11/2016,"11/11/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75677,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MI, NY, CA, KY, ND, and NE.","Z-0608-2017","Class II","SOMATOM Definition Flash, Computed tomography x-ray system  The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles","7 systems","Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.","11/17/2016",," Model Number: 10430603   Serial Numbers:96020, 96047,74192,83398,96011,83387  96029  ",11/2/2016,"11/02/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75677,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MI, NY, CA, KY, ND, and NE.","Z-0606-2017","Class II","SOMATOM Definition AS, Computed tomography x-ray system  The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles","7 systems","Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.","11/17/2016",," Model Number: 8098027  Serial Numbers:96020, 96047,74192,83398,96011,83387  96029  ",11/2/2016,"11/02/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75677,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide distribution to MI, NY, CA, KY, ND, and NE.","Z-0607-2017","Class II","SOMATOM Definition Edge, Computed tomography x-ray system  The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles","7 systems","Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.","11/17/2016",," Model Number: 1059000  Serial Numbers:96020, 96047,74192,83398,96011,83387  96029  ",11/2/2016,"11/02/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75680,"Ongoing","4 C Foods, Corp.","580 Fountain Ave",".","Brooklyn","NY","11208-6002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0628-2017","Class I","4C All Natural Parmesan/Romano Grated Cheese, UPC 41387-37126, 6 oz","1,122,617 cases (12,594,792 jars) total","FDA sample revealed the presence of Salmonella contamination","12/07/2016",," BEST BY dates between November 12, 2016 and November 12, 2018 ",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75680,"Ongoing","4 C Foods, Corp.","580 Fountain Ave",".","Brooklyn","NY","11208-6002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0634-2017","Class I","Cento Romano Grated Cheese, UPC 70796-90501, 6 oz","1,122,617 cases (12,594,792 jars) total","FDA sample revealed the presence of Salmonella contamination","12/07/2016",," BEST BY dates between November 12, 2016 and November 12, 2018 ",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75680,"Ongoing","4 C Foods, Corp.","580 Fountain Ave",".","Brooklyn","NY","11208-6002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0629-2017","Class I","4C All Natural 100% Imported Italian Pecorino Romano Cheese, UPC 41387-77126, 6 oz","1,122,617 cases (12,594,792 jars) total","FDA sample revealed the presence of Salmonella contamination","12/07/2016",," BEST BY dates between November 12, 2016 and November 12, 2018 ",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75680,"Ongoing","4 C Foods, Corp.","580 Fountain Ave",".","Brooklyn","NY","11208-6002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0631-2017","Class I","4C Homestyle All Natural Parmesan/Romano Grated Cheese, UPC 41387-11627, 6 oz","1,122,617 cases (12,594,792 jars) total","FDA sample revealed the presence of Salmonella contamination","12/07/2016",," BEST BY dates between November 12, 2016 and November 12, 2018 ",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75680,"Ongoing","4 C Foods, Corp.","580 Fountain Ave",".","Brooklyn","NY","11208-6002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0627-2017","Class I","4C All Natural Parmesan Grated Cheese, UPC 41387-33126, 6 oz","1,122,617 cases (12,594,792 jars) total","FDA sample revealed the presence of Salmonella contamination","12/07/2016",," BEST BY dates between November 12, 2016 and November 12, 2018 ",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75680,"Ongoing","4 C Foods, Corp.","580 Fountain Ave",".","Brooklyn","NY","11208-6002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0632-2017","Class I","4C Homestyle All Natural 100% Imported Italian Pecorino Romano Cheese, UPC 41387-12302, 6 oz","1,122,617 cases (12,594,792 jars) total","FDA sample revealed the presence of Salmonella contamination","12/07/2016",," BEST BY dates between November 12, 2016 and November 12, 2018 ",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75680,"Ongoing","4 C Foods, Corp.","580 Fountain Ave",".","Brooklyn","NY","11208-6002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0630-2017","Class I","4C Homestyle All Natural Parmesan Grated Cheese, UPC 41387-32790, 6 oz","1,122,617 cases (12,594,792 jars) total","FDA sample revealed the presence of Salmonella contamination","12/07/2016",," BEST BY dates between November 12, 2016 and November 12, 2018 ",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75680,"Ongoing","4 C Foods, Corp.","580 Fountain Ave",".","Brooklyn","NY","11208-6002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0633-2017","Class I","Cento Parmesan Grated Cheese, UPC 70796-90502, 6 oz","1,122,617 cases (12,594,792 jars) total","FDA sample revealed the presence of Salmonella contamination","12/07/2016",," BEST BY dates between November 12, 2016 and November 12, 2018 ",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75681,"Ongoing","OraSure Technologies, Inc.","1745 Eaton Ave",".","Bethlehem","PA","18018-1769","United States","Voluntary: Firm Initiated","Telephone","Distributed to KS, and VA","Z-0722-2017","Class III","Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate)    Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.","4 kits","Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing. ","12/08/2016",," Lot # 6654085",11/10/2016,"11/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75682,"Ongoing","Ulthera Inc","1840 S Stapley Dr Ste 200",,"Mesa","AZ","85204-6681","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)","Z-0749-2017","Class II","Cellfina Prep Pack, Part No. CP1","6562 units","It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. ","12/13/2016",," all",11/14/2016,"11/14/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75683,"Ongoing","Halyard Health, Inc","5405 Windward Pkwy",".","Alpharetta","GA","30004-3894","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US Nationwide Distribution in the states of AL, FL, GA, IL, KS, MN, MO, NE, NJ, OH, PH, TN, VA, WI, WY","Z-0724-2017","Class II","Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear Screen (Sterile), Product Code 44968 00; C-Section Drape with Pouch and Fenestration (Non-Sterile), Product Code 44977 NS; C-Section Drape with Pouch and Fenestration (Sterile), Product Code 44978 00    Product Usage:  A surgical drape is a device made of natural or synthetic materials intended to be use as a protective patient covering, such as to isolate a site or surgical incision from microbial and other contamination.  ","132 cases","Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site.","12/08/2016",," Product Code 44965 NS - Lot Numbers AC6174###, AC62266###, AC6229###, AC6243###, AC6252###; Product Code 44966 00 - Lot Numbers AC6146##L, AC6157##L, AC6177##L, AC6215##L, AC6221##L, AC6228##L, AC6245##L, AC6252##L, AC6258##L, AC6272##L, AC6277##L; Product Code 44967 NS - Lot Numbers AC6170###, AC6219###, AC6223###, AC6229###, AC625###; Product Code 44068 00 - Lot Numbers AC6146##L, AC6177##L, AC6230##L, AC6231##L, AC6234##L, AC6242##L, AC6245##L, AC6264##L, AC6271##L, AC6277##L; Product Code 44077 NS - Lot Numbers AC6170###, AC6213###, AC6214###, AC6222###, AC6223###, AC6251###; Product Code 44978 00 - Lot Numbers AC6147##L, AC6177##L, AC6243##L, AC 6252##L - (# = includes numbers 0, 1, 2, 3, 4, 5, 6, 7, 8 or 9 - L = includes letters a, b, or c)",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75685,"Terminated","Mary's Harvest Fresh Foods, Inc.","2705 NE Argyle St",,"Portland","OR","97211-1952","United States","Voluntary: Firm Initiated","Telephone","distributed in Oregon","F-0680-2017","Class I",".    ","43 bags (5 lbs. per bag)","Sliced cucumber Coin, 5 lbs bags, are recalled due to a potential contamination with Salmonella.  ","12/09/2016","12/12/2016"," packed on 10/30/16",11/8/2016,"11/08/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75686,"Terminated","BPL Plasma, Inc.","7180 Eastex Fwy",,"Beaumont","TX","77708-3831","United States","Voluntary: Firm Initiated","E-Mail","United Kingdom","B-0170-2017","Class III","Source Plasma","1 unit","Blood product, in which donor suitability was not adequately determined, was distributed.","11/28/2016","11/28/2016"," NG0454828",10/1/2016,"10/01/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75687,"Terminated","BloodSource, Inc.","10536 Peter a McCuen Blvd",,"Mather","CA","95655-4128","United States","Voluntary: Firm Initiated","Telephone","California","B-0171-2017","Class II","Apheresis Fresh Frozen Plasma","2 units","Apheresis products, collected from a donor who was allowed to donate without a current physical, were distributed.","11/28/2016","11/28/2016"," W035816149536 (double collection)",10/17/2016,"10/17/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75689,"Terminated","American National Red Cross, Penn Jersey Region","700 Spring Garden St",,"Philadelphia","PA","19123-3508","United States","Voluntary: Firm Initiated","FAX","Pennsylvania","B-0159-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit"," Misbranded red blood cells were distributed. ","11/17/2016","11/17/2016"," W202215353409; ",9/27/2016,"09/27/2016",11/23/2016,"11/23/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75690,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","FAX","Texas","B-0172-2017","Class II","Platelets","3 units","Blood products, collected from a donors who had taken Feldene,  Clopidogrel, and Plavix medication were distributed.","11/28/2016","11/28/2016"," W035216187143T; W035216155817V; W035216165713F",10/25/2016,"10/25/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75691,"Ongoing","Pfizer Inc.","235 East 42nd Street",,"New York","NY","10017-5703","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0150-2017","Class II","LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by:  King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01","2,666 bottles","Superpotent","11/23/2016","."," 16H21, Exp. 08/2017",11/7/2016,"11/07/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75692,"Ongoing","Ortho-Clinical Diagnostics","513 Technology Blvd",,"Rochester","NY","14626-3601","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of :  Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.","Z-0864-2017","Class III","VITROS CRP Slides: 1)  VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740","124,063 units","CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result.  The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result.  Orthos diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP.  Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.  ","12/21/2016",," Affected Generations (GENs): 3, 11, 12, 30 through 36",10/26/2016,"10/26/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75693,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Domestic; US Nationwide; International: Belgium, Canada.","Z-0759-2017","Class II","Weck Facial  Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.","2265 units"," The devices wings may become partially detached from the EFx Shield during use.","12/14/2016",," Product Code: EFX002, Lot numbers: 3264480000, 3269990000, 3270100000.",11/16/2016,"11/16/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75694,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Distributed Nationwide","Z-0681-2017","Class II","Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm   Non-Sterile","84 units","Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.","12/01/2016",," Model/Catalog # 316.15  Lot/Serial Number U172728",11/1/2016,"11/01/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75695,"Ongoing","Fallon Wellness Pharmacy, L.L.C.","1057 Troy Schenectady Rd",".","Latham","NY","12110-1002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY","D-0173-2017","Class II","PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY  12110.","10 vials ","Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.","12/08/2016",," Lot #: 09192016@41,09192016@69, Exp 11/04/2016  ",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75695,"Ongoing","Fallon Wellness Pharmacy, L.L.C.","1057 Troy Schenectady Rd",".","Latham","NY","12110-1002","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY","D-0174-2017","Class II","PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL  Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY  12110.        ","5 vials","Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.","12/08/2016",," Lot #: 09202016@8, Exp 11/04/2016  ",11/2/2016,"11/02/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75696,"Ongoing","Zydus Pharmaceuticals USA Inc","73 Route 31 N",,"Pennington","NJ","08534-3601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0149-2017","Class III","BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg,  Rx Only, 500-count bottles,  Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05","2,472 units","Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.","11/22/2016","."," Lot #: MR3365, Exp. Feb 17",8/3/2016,"08/03/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75698,"Ongoing","Ascend Laboratories LLC","180 Summit Ave Ste 200",,"Montvale","NJ","07645-1722","United States","Voluntary: Firm Initiated","Letter","AL, FL, GA, SC & TN","D-0163-2017","Class II","Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only  Manufactured by: Alkem Laboratories Ltd., Mumbai  - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ  NDC 67877-217-10  ","1739 bottles ","Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP ","11/29/2016",," Lot 6121056, exp 5/2019",11/2/2016,"11/02/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0831-2017","Class II","  Packaged in bulk 10lb case.","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0821-2017","Class II","***NORTHERN CLASSICS NATURAL SMOKED SALMON. Net WT. is filled in on a separate white label. Product is frozen and vacuum packed.  Product also referred to as SALMON HOT SMKD SIDE ATL SK-ON.    ","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0822-2017","Class II","***PREMIUM SMOKED SALMON***CRACKED PEPPER*** NET WT: 4OZ***Packaged 5 lbs case 20/4oz vacuum packages/case. Cardboard type label is folded over and affixed to the top of the package.  Sell by date is marked on the label by the consignee.  UPC 7 02772 00560 2.  ","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0829-2017","Class II","    Packaged in bulk 5lb case.","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0826-2017","Class II","PREMIUM SMOKED SALMON  UPC 7 02772 00564 0    Packaged in a 5 lb case 20/4oz vacuum packaged per case. Cardboard type label is folded over and affixed to the top of the package.  Sell by date is marked on the label by the consignee.","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0824-2017","Class II","***NORTHERN CLASSICS FINEST QUALITY KIPPERED SALMON CHUNKLETS. This package can be combined with other products and placed into a combination package. Each package is individually labeled.  Bulk cases contain 5 lbs.  ","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0830-2017","Class II","NORTHERN CLASSICS NATURAL SMOKED STEELHEAD***  Product  is packaged in bulk 5lb case.  Product  is vacuum packaged catch weight.  ","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0827-2017","Class II","    Packaged in bulk 5lb case.","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0823-2017","Class II","WILD CATCH PREMIUM SMOKED SALMON***NATURAL***NET WT: 4OZ***  UPC 7 02772 00559 6.  Cardboard type label is folded over and affixed to the top of the package.  Sell by date is marked on the label by the consignee.  ","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0828-2017","Class II","    Packaged in bulk 5lb case.","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75699,"Ongoing","Northern Fish Products, Inc.","3911 S 56th St",,"Tacoma","WA","98409-2607","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries","F-0825-2017","Class II","PREMIUM SMOKED SALMON***CAJUN***NET WT:  4OZ***Cardboard type label is folded over and affixed to the top of the package.  Sell by date is marked on the label by the consignee.  UPC 7 02772 00562 6.","28,487 lbs.(total)","Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.","12/20/2016",," E1016, E1116, E1216, E1316, E1616, E1716, E1816, E1916, E2016, E2316, E2416, E2516, E2616, E2716, E3016, E3116, F0116, F0216, F0316, F0616, F0716, F0816, F0916, F1016, F1316, F1416, F1516, F1616, F1716, F2016, F2916, F3016, G0116, G0416, G0516, G0616, G0716, G0816, G1116, G1216, G1316, G1416, G1516, G1816, G1916, G2016, G2116, G2216,  G2516, G2616, G2716, G2816, G2916, H0116, H0216, H0316, H0416, H0516, H0816, H0916,  F2116, F2216, F2316, F2416, F2716, and F2816.    A through L represent the Month (January through December); The first 2 digits represent the day of the month; the second two digits represent the year.",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75701,"Ongoing","The Popcorn Shoppe","42 Ashwood Dr Ste C",".","Tiffin","OH","44883-1908","United States","Voluntary: Firm Initiated","Telephone","Product was shipped to IL & OH.","F-0608-2017","Class I","The Popcorn Shoppe Popcorn Balls (4) 5 oz balls, sold under the brand names of Olde Tyme Recipe, Edwards Orchards & Edwards Orchards West.","156cs/30/5 oz bags","The firm was notified by the state that the labeling for their product failed to declare milk, soy and yellow #5 on their label.","12/07/2016",," No codees available",11/14/2016,"11/14/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75706,"Terminated","Arc Blood Services, New England Region","180 Rustcraft Rd Ste 115",".","Dedham","MA","02026-4551","United States","Voluntary: Firm Initiated","Telephone","Vermont; New Hampshire; New York; Massachusetts","B-0207-2017","Class III","Apheresis Platelets, Leukocytes Reduced, Irradiated","8 units"," Blood products, not tested according to specifications  for relevant transfusion transmitted disease, were distributed. ","12/07/2016","12/07/2016"," W2004168047231; W2004168047231; W2004168063401; W2004168063402; W2004168063403; W2004168080721; W2004168080722; W2004168087251; ",6/20/2016,"06/20/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75706,"Terminated","Arc Blood Services, New England Region","180 Rustcraft Rd Ste 115",".","Dedham","MA","02026-4551","United States","Voluntary: Firm Initiated","Telephone","Vermont; New Hampshire; New York; Massachusetts","B-0208-2017","Class III","Apheresis Platelets, Leukocytes Reduced","18 units","Blood products, not tested according to specifications  for relevant transfusion transmitted disease, were distributed. ","12/07/2016","12/07/2016"," W2004168047211; W2004168047212; W200416808080; W2004168087161; W2004168087162; W2004168087201; W2004168087202; W2004168087211; W2004168087212; W2004168087221; W2004168087222; W2004168087223; W2004168087241; W2004168087242; W2004168087252; W2004168087253; W2004168087261; W2004168087262; ",6/20/2016,"06/20/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75708,"Ongoing","PerkinElmer Health Sciences, Inc.","940 Winter St",,"Waltham","MA","02451-1457","United States","Voluntary: Firm Initiated","Letter","CA, CO, NY, WA  Foreign:  Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands,  Japan, Great Britain,","Z-0779-2017","Class III","DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum  ","79 kits","A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera.  The -11.3% bias was observed at an hFSH target concentration of 101 IU/L.  The change observed in the serum samples within the range 1.76  67.0 IU/L hFSH averaged -2.9%.  The reference range of the assay spans 0.60 to 98.0 IU/L. ","12/16/2016",," Lot Number: 646091",11/16/2016,"11/16/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75710,"Ongoing","Integra York PA, Inc","589 Davies Dr",,"York","PA","17402-8630","United States","Voluntary: Firm Initiated","Letter","US Distribution in NC and TX.","Z-0751-2017","Class II","Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile.    The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.","150 units","The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.    ","12/13/2016",," Catalog # ST7-138; lot# 352",10/28/2016,"10/28/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75710,"Ongoing","Integra York PA, Inc","589 Davies Dr",,"York","PA","17402-8630","United States","Voluntary: Firm Initiated","Letter","US Distribution in NC and TX.","Z-0752-2017","Class II","Metzenbaum Scissors 7, Curved, Sterile    The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.","50 units","The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.    ","12/13/2016",," Catalog # ST5-182; lot# 355",10/28/2016,"10/28/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75713,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",".","Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US (nationwide) Canada and foreign distribution","Z-0726-2017","Class II","Merge PACS software.     Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.","537 sites potentially have the affected versions","Cut lines on the image may present horizontally rather than vertically.","12/08/2016",," Versions V6 GA, 6.0 MR1, V6 MR1 CU1,V6 MR1 CU1 SF1, V6 MR1 CU4, V6 MR1 CU5, V6 MR1 CU6, V6 MR1 CU7,V6 MR1 CU8, 6.0 MR2, 6.0 MR3, 6.0 MR3 CU, 6.0 MR4, 6.0 MR4 CU1, 6.0 MR4 CU2, 6.0 MR4 CU3, 6.0 MR4 CU4, 6.0 MR4 CU5, 6.0 MR4 CU6, 6.0 MR4, CU7, 6.0 MR4 CU8, 6.0 MR4 CU9, 6.0 MR4 CU10, 6.0 MR4 CU11, 6.1, 6.1.1, 6.1.2, 6.1.3, 6.2, 6.2.1, 6.2.2, 6.2.3, 6.2.4, 6.2.5, 6.3, 6.4, 6.4.1, 6.4.2, 6.4.3, 6.4.4, 6.4.5, 6.4.6, 6.4.7, 6.5, 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1, and 7.0.2",3/28/2016,"03/28/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75714,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Other","Nationwide Distribution","Z-0730-2017","Class II","Merge Cardio software.     Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data","116 sites potentially have the effected versions","Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost. ","12/09/2016",," Versions V10.1 and 10.1.1",10/1/2015,"10/01/2015",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75715,"Ongoing","Encore Medical, Lp","9800 Metric Blvd",".","Austin","TX","78758-5445","United States","Voluntary: Firm Initiated","Letter","US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ","Z-0711-2017","Class II","Empowr Knee System    Product Usage:  Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.  ","7 units","A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.","12/06/2016",," 033T1022",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75716,"Ongoing","Northgate Technologies, Inc.","1591 Scottsdale Ct",,"Elgin","IL","60123-9361","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including FL and MA.  Internationally to Canada","Z-0866-2017","Class II","Insufflator, laparoscopic    The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures","49 devices","Device could cause a patient overpressure situation without any visual or auditory indication or warning","12/21/2016",," Serial Numbers: #89170HXB, #89556DYD, #89652FYA, #89661FYA, #89663FYA, #89664FYA, #89670FYA, #89672FYA, #89675FYA, #89677FYA, #89685FYB, #89697FYB, #89708GYA, #89713GYA, #89719GYB, #89720GYB, #89729GYB, #89732GYB, #89734GYB, #89737GYB, #89889IYD, #90165AZB, #90285BZD, #90387DZB, #90391DZB, #90415DZD, #90438DZD, #90469EZB, #90528EZD, #90555FZB, #90556FZB, #90557FZB, #90558FZB, #90561FZB, #90583GZC, #90621GZB, #90654HZB, #90739IZD, #90869KZD, #90931LZD, #90936LZD, #90954LZD, #90962LZD, #90972LZD, #91105CAD, #91108CAD, #91114CAD, #91120CAD, #91380FAC, #91406FAD, #91471GAC, #91544IAC",11/21/2016,"11/21/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75717,"Ongoing","Seely Family Farm","18865 Hermo Rd",".","Clatskanie","OR","97016-2012","United States","Voluntary: Firm Initiated","Telephone","in WA only","F-0599-2017","Class II","Spearmint candy canes, Net wt. 1.4 oz. The UPC is 8 54502 00321 8 ","900 pieces","Spearmint candy canes are recalled due to undeclared soy lecithin.","12/06/2016",," Lot code: 11052016    Best by: 01/05/2017",11/15/2016,"11/15/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75718,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico and Internationally  to Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq,  Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Unite Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.","Z-0668-2017","Class II","Monaco TRP System  The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.","2148","Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.","11/28/2016",," Software Builds 5.00 and higher",11/17/2016,"11/17/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75720,"Terminated","United Blood Services","6220 E Oak St",,"Scottsdale","AZ","85257-1101","United States","Voluntary: Firm Initiated","FAX","Tennessee; Switzerland","B-0203-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","12/09/2016","12/09/2016"," W041015145978A; ",9/28/2016,"09/28/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75720,"Terminated","United Blood Services","6220 E Oak St",,"Scottsdale","AZ","85257-1101","United States","Voluntary: Firm Initiated","FAX","Tennessee; Switzerland","B-0202-2017","Class II","Plasma Frozen within 24 hours (FP24)","1 unit"," Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","12/09/2016","12/09/2016"," W041016057031L; ",9/28/2016,"09/28/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75721,"Terminated","ARUP Laboratories, Inc.","9786 S. Sandy Parkway",,"Sandy","UT","84070-2565","United States","Voluntary: Firm Initiated","Telephone","Utah","B-0204-2017","Class II","Platelets, Pathogen Reduced","1 unit","Blood product, in which component preparation was not prepared in accordance with specifications, was distributed.","12/09/2016","12/09/2016"," W158016801653; ",10/3/2016,"10/03/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75722,"Terminated","Indiana Blood Center","3450 N Meridian St",,"Indianapolis","IN","46208-4437","United States","Voluntary: Firm Initiated","FAX","Indiana","B-0205-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, in which donor gave history which warranted deferral or follow up questions were not asked, was distributed. ","12/09/2016","12/09/2016"," W040716365605; ",10/7/2016,"10/07/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75723,"Terminated","American National Red Cross SW Region","10151 E 11th St",,"Tulsa","OK","74128-3005","United States","Voluntary: Firm Initiated","Telephone","TX","B-0217-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products, mislabeled as to antigen phenotype, were distributed.","12/20/2016","12/20/2016"," W20491619130200",9/26/2016,"09/26/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75724,"Terminated","LifeShare Blood Centers","8910 Linwood Ave",,"Shreveport","LA","71106-6508","United States","Voluntary: Firm Initiated","FAX","LA","B-0216-2017","Class III","Red Blood Cells, Leukocytes Reduced","1 unit"," Blood Product, collected from a donor who disclosed receiving a vaccine within eight weeks of donating, was distributed.","12/16/2016","12/16/2016"," W036516448043 ",9/29/2016,"09/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75725,"Terminated","LifeShare Blood Centers","8910 Linwood Ave",,"Shreveport","LA","71106-6508","United States","Voluntary: Firm Initiated","FAX","TX","B-0215-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit"," Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.","12/16/2016","12/16/2016"," W036516423422",8/23/2016,"08/23/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75726,"Ongoing","Request Foods Inc.","3460 John F Donnelly Dr",,"Holland","MI","49424-9294","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","MI, OH, FL, KY","F-0723-2017","Class I","GFS Cheese Manicotti in tomato sauce.  retail 68 oz. pan.  4 retail units per case   ","1592 cases","Undeclared Eggs","12/15/2016",," lot code 15268  UPC 9390121983  order number 219835",11/15/2016,"11/15/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75729,"Ongoing","American Blue Ribbon Holdings DBA Legendary Baking","16425 Kilbourne Ave",,"Oak Forest","IL","60452-4602","United States","Voluntary: Firm Initiated","Telephone","IA, IL, IN,  MN, WI, OH","F-0687-2017","Class I","Ultimate Chocolate Chip Cookie Dough Pie, refrigerated/frozen. A 9-inch pastry shell with a layer of chocolate chip cookie dough baked in the bottom followed by a layer of French silk.  Finished with whipped cream, chocolate drizzle and chocolate chip cookie dough bites distributed across the top of pie. 39 oz. ","7,273 pies ","Product incorporated cookie dough that was potentially contaminated with Listeria Monocytogenes. ","12/09/2016",," Material #29578 and #29978  Batch Numbers:  2016188, 2016190, 2016193, 2016195, 2016197, 2016200, 2016202, 2016204, 2016207, 2016209, 2016211  ",11/10/2016,"11/10/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75730,"Ongoing","purely elizabeth.","3200 Carbon Pl Ste 100",,"Boulder","CO","80301-6135","United States","Voluntary: Firm Initiated","E-Mail","5 distributer nationwide.  No foreign/VA/govt/or military","F-0559-2017","Class II","Chocolate Sea Salt Probiotic Granola, Purely Elizabeth, 8oz, PET/LLDPE Pouch, 6 units/case, ","16,728 retail units","Chocolate Sea Salt Probiotic Granola due to undeclared soy lecithin.","11/29/2016",," Purely Elizabeth Item: 111222 Best By: OCT102017 and OCT112017",11/17/2016,"11/17/2016",12/7/2016,"12/07/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75731,"Ongoing","RAYSEARCH LABORATORIES AB","Sveavaegen 9",".","Stockholm",,,"Sweden","Voluntary: Firm Initiated","E-Mail","US Nationwide Distribution in the states of California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas, Washington","Z-0721-2017","Class II","RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System    Product Usage:  RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.      ","US: 66 units","Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0.  For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.  ","12/07/2016",," Build numbers: 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 or 5.0.2.35",11/9/2016,"11/09/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Veterinary",75732,"Ongoing","ZOETIS SERVICES LLC","10 Sylvan Way",,"Parsippany","NJ","07054-3825","United States","Voluntary: Firm Initiated","Letter","Nationwide and Guam.","V-0036-2017","Class II","Veterinary IV sets.  PRIMARY PIGGYBACK IV SET, 106 INCH A.  PRIMARY PIGGYBACK IV SET, 80 INCH A.  PRIMARY IV SET, 78 INCH - VENTED A.  PRIMARY IV SET, 78 INCH A.  PRIMARY IV SET, 70 INCH, 60 DROPS/ML A.  PRIMARY IV SET, 103 INCH B.  PRIMARY IV SET, 105 INCH B.  PRIMARY PIGGYBACK IV SET, 106 INCH B.  PRIMARY PIGGYBACK IV SET, 100 INCH B.  PRIMARY IV SET, 78 INCH - VENTED B.  PRIMARY IV SET, 78 INCH B.  PRIMARY IV SET, 70 INCH, 60 DROPS/ML B.    Individually plastic wrapped and sterilized 50 units per case.  ","992,227 units ","Cracks and leaking at the Y-site","12/09/2016",," lot numbers:  95264KY  96213KY  96215KY  96287KY  97196KY  97199KY  97200KY  97388KY  97389KY  97390KY  97391KY  98215KY  98216KY  99196KY  99197KY  99395KY      Exp dates 2020-10 to 2021-02  ",11/17/2016,"11/17/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75733,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",".","Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Michigan; Wisconsin; Switzerland","B-0179-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.","12/07/2016","12/07/2016"," W036316008799",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75733,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",".","Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Michigan; Wisconsin; Switzerland","B-0181-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.","12/07/2016","12/07/2016"," W036316008799",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75733,"Terminated","BloodCenter of Wisconsin, Inc","638 N 18th St",".","Milwaukee","WI","53233-2121","United States","Voluntary: Firm Initiated","FAX","Michigan; Wisconsin; Switzerland","B-0180-2017","Class II","Cryoprecipitated AHF","1 unit","Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.","12/07/2016","12/07/2016"," W036316008799",10/11/2016,"10/11/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75734,"Terminated","CSL Plasma, Inc.","2055 SE Tualatin Valley Hwy Ste 15",".","Hillsboro","OR","97123-5011","United States","Voluntary: Firm Initiated","Other","Switzerland","B-0182-2017","Class III","Source Plasma","3 units","Blood products, collected from a donor who did not have a complete health assessment, were distributed.","12/07/2016","12/07/2016"," 12600551358; 12600565784; 12600560916 ",9/22/2016,"09/22/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75735,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.","Z-0764-2017","Class II","WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical,  NC 27709.    The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.","96,402 units (9,120 ea US, 87,282 ea OUS)","Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.","12/14/2016",," Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75737,"Ongoing","Ansell Healthcare Products LLC","111 Wood Ave S Ste 210",,"Iselin","NJ","08830-2700","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : PA, FL, NJ, IL and MA.","Z-0893-2017","Class II","Gammex  Non-Latex Sensitive  Neoprene Surgical Gloves  Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka    Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium    Manufactured for/ Fabrique' pour:  Ansell Healthcare products LLC.  1635 Industrial Road Dothan, AL 36303, USA  TEL USA- 1-800-952-9916 CAN- 1-844-494-7854    catalog  #20277285","15 Cartons","Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.","12/22/2016",," Lot 1607018105",10/24/2016,"10/24/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75738,"Ongoing","Nutra Manufacturing","1050 Woodruff Rd",".","Greenville","SC","29607-4120","United States","Voluntary: Firm Initiated","E-Mail","PA","F-0626-2017","Class I","GNC, Womens Ultra Mega, Dietary Supplement, 180 Caplets, ","12,534 bottles/180 caplets per bottle.","Undeclared Allergen: Milk.","12/07/2016",," GNC number: 202422, Nutra Manufacturing Lot Number: 3044FQ2024.",11/10/2016,"11/10/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75739,"Ongoing","Hummingbird Wholesale","150 Shelton Mcmurphey Blvd  ","Suite 104","Eugene","OR","97401-4960","United States","Voluntary: Firm Initiated","Telephone","distributed in CA, OR, and WA","F-0944-2017","Class II","Ariels OM Grown Granola.    Product number GR200, net wt. 5 lb., packaged in bulk bag inside plastic bucket.  Product number GR201, net wt.15 lb., packaged in bulk bag inside plastic bucket.  Product number BAG-GR200, net wt. 8 oz., packaged in cellophane bag with cardstock label.  Product number SBAG-GR200, net wt. 4 oz., packaged in cellophane bag with cardstock label.  ","total 2,259.2 lbs.","Ariels Om Grown Granola is recalled because it was contaminated with wheat seed.","12/21/2016",," 5lb and 15lb bulk containers have a manufacturing date (mm/dd/yy) stamped on label or bucket: 070315 through 100616, or a Julian date of 16294 through 16331.    4 oz and 8 oz packages have a Julian code of 15184 through 16331.  ",11/17/2016,"11/17/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75740,"Ongoing","Exactech, Inc.","2320 NW 66th Ct",,"Gainesville","FL","32653-1630","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MD, ME, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TN, VA, WA and WI., and to the countries of :  Austria, Australia, Canada, Germany, France, Spain, India, Switzerland, Italy, South Korea, United Kingdom, Brazil, Luxembourg, Greece, Guatemala, Netherlands, South Africa, and Sweden","Z-0900-2017","Class II","Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit","2,278 units","Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. ","12/22/2016",," Catalog No. 320-20-00; Unique Device Identifier 10885862086518; Serial Range 4410696-4410819, 4415393-4415492, 4418789-4418888, 4422658-4423007, 4423542-4423591, 4424509-4424558, 4458153-4458252, 4458303-4458352, 4461732-4461806, 4464592-4464691, 4467733-4467824, 4471099-4471298, 4485494-4485543, 4488224-4488260, 4504738-4504987, 4513150-4513199, 4513250-4513299, 4517116-4517215, 4519806-4520005, 4533291-4533390, 4542043-4542092.",10/25/2016,"10/25/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75742,"Ongoing","Smiths Medical ASD Inc.","6000 Nathan Ln N",,"Minneapolis","MN","55442-1690","United States","Voluntary: Firm Initiated","Letter","Foreign Distribution in the  Italy, France, Switzerland, Germany, Sweden","Z-0789-2017","Class II","Acuvance¿2 Safety Catheter, Product No. 1720-AI    Product Usage:  The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The catheter has a Safety Needle Assembly (SAN) designed to reduce risk of accidental needle sticks to the operators. The lateral port is equipped with a non-return silicone valve and a polypropylene snap cap with a winged polypropylene hub for fastening.  ","26,750","Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.  ","12/18/2016",," 3120882, 3120883, 3220733",11/21/2016,"11/21/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75743,"Completed","Physio-Control, Inc.","11811 Willows Rd NE",,"Redmond","WA","98052-2003","United States","Voluntary: Firm Initiated","Letter","worldwide","Z-0761-2017","Class II","The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical  personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX","1399 units (866 in the US and 533 outside US)","Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use.  When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.","12/14/2016",," This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.",3/11/2010,"03/11/2010",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0185-2017","Class II","Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-171-12","30,796 syringes","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 8502 BUD: 11/21/2016, Lot: 8962 BUD: 02/21/2017",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0194-2017","Class II","HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-002-03","2509 syringes","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 8742",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0200-2017","Class II","Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15 ","24,547 syringes","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 8997 BUD: 12/1/2016, Lot: 9246 BUD: 1/23/2017",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0193-2017","Class II","Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5 USP units/mL), Single-Dose Bag.,Hospital/Office Use Only, Injection Solution For IV Use, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-097-24","150 bags","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 167081",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0197-2017","Class II","Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207","162 syringe","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 165538",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0184-2017","Class II","Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37","80 bags","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 169170",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0204-2017","Class II","Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12","9859 syringes","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 169262 BUD: 1/8/2017, Lot: 169812 BUD: 1/19/2017",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0196-2017","Class II","Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10","93 vials","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 163941 ",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0190-2017","Class II","Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 100 mL* Bag, Epidural Use Only, Single-Dose Bag, Hospital/Office Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-080-75","2889 bags","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 8942 BUD: 2/19/2017, Lot: 9207 BUD: 4/17/2017",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0203-2017","Class II","Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75","87 bags","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 169064",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0189-2017","Class II","Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-61 ","2545 bags","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 8990",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0199-2017","Class II","Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-160-75 ","1748 bags","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 8625",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0188-2017","Class II","Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Road, AR 72207, NDC 52533-024-35 ","471 bags","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 9002",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0201-2017","Class II","Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag,  Injection Solution for IV Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-056-30","2681 bags","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 9210",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0191-2017","Class II","Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-028-15","48,592 syringes","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 9006 BUD: 1/20/2017, Lot: 8757 BUD: 11/30/2016, Lot: 8954 BUD: 1/6/2017, Lot: 9174 BUD: 2/20/2017",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0192-2017","Class II","Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-148-16","1494 syringes","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 9220",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0198-2017","Class II","Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04","37 syringes","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 169619",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0195-2017","Class II","HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04","935 syringes","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",,"  Lot: 9016 BUD: 3/7/2017",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0202-2017","Class II","Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-064-15 ","5067 syringes","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 8995",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0187-2017","Class II","Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207","645 vials","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 169924",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75745,"Ongoing","Cantrell Drug Company","7321 Cantrell Rd",,"Little Rock","AR","72207-4144","United States","Voluntary: Firm Initiated","Press Release","Nationwide","D-0186-2017","Class II","Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Single-Dose Bag Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207,  NDC 52533-102-09","73 bags","Lack of Assurance of Sterility - the firm is recalling select sterile drug products.","12/13/2016",," Lot: 168032",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75746,"Ongoing","Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables","75 Arkay Dr",,"Hauppauge","NY","11788-3707","United States","Voluntary: Firm Initiated","Letter","PA, FL, VA","Z-0894-2017","Class II","CARPAL TUNNEL PACK, Surgical Instrument Tray,  REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.","US: 14 cases","Covidien issued a labeling update for the Covidien Devon Light Gloves.  Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.","12/22/2016",," Lot Number 1230783, Exp. Date February 2017;   Lot Number 1330825, Exp. Date April 2018",11/15/2016,"11/15/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75746,"Ongoing","Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables","75 Arkay Dr",,"Hauppauge","NY","11788-3707","United States","Voluntary: Firm Initiated","Letter","PA, FL, VA","Z-0896-2017","Class II","SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147","US: 82 cases","Covidien issued a labeling update for the Covidien Devon Light Gloves.  Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.","12/22/2016",," Lot Number 1530330, Exp. Date November 2017;   Lot Number 1530241, Exp. Date September 2017;   Lot Number 1530095, Exp. Date September 2017;   Lot Number 1431734, Exp. Date August 2017;   Lot Number 1431066, Exp. Date May 2017",11/15/2016,"11/15/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75746,"Ongoing","Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables","75 Arkay Dr",,"Hauppauge","NY","11788-3707","United States","Voluntary: Firm Initiated","Letter","PA, FL, VA","Z-0895-2017","Class II","BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.","US: 35 cases","Covidien issued a labeling update for the Covidien Devon Light Gloves.  Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.","12/22/2016",," Lot Number 1230323, Exp. Date December 2016;   Lot Number 1230387, Exp. Date December 2016;   Lot Number 1231616, Exp. Date December 2016",11/15/2016,"11/15/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75750,"Terminated","Ochsner Health System  Blood Bank","1516 Jefferson Hwy",,"New Orleans","LA","70121-2429","United States","Voluntary: Firm Initiated","E-Mail","Louisiana; Florida","B-0190-2017","Class III","Red Blood Cells","1 unit","Blood products, collected from an ineligible donor, were distributed. ","12/14/2016","12/14/2016"," W303813017512",6/16/2016,"06/16/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75752,"Ongoing","VistaPharm, Inc.","7265 Ulmerton Rd",,"Largo","FL","33771-4809","United States","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0146-2017","Class II","Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.","1497 cases","Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia. ","11/22/2016","."," Lot No. 378300, Exp 11/16",11/9/2016,"11/09/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75754,"Ongoing","H-E-B GROCERY COMPANY LP DBA HEB","646 S Flores St",,"San Antonio","TX","78204","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0715-2017","Class II","HEB Baby Banana Carrot Mango 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve","6947 units","Customer reported a small piece of rubber inside one variety of the recalled product.","12/12/2016",," UPC 4122025540: Lots L16G071, L16G291, L16G301",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75754,"Ongoing","H-E-B GROCERY COMPANY LP DBA HEB","646 S Flores St",,"San Antonio","TX","78204","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0714-2017","Class II","HEB Baby Green Beans 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve","855 units","Customer reported a small piece of rubber inside one variety of the recalled product.","12/12/2016",," UPC 4122005670; Lots L16E101, L16G051, L16G271",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75754,"Ongoing","H-E-B GROCERY COMPANY LP DBA HEB","646 S Flores St",,"San Antonio","TX","78204","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0713-2017","Class II","HEB Baby Sweet Potato 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve","4400 units","Customer reported a small piece of rubber inside one variety of the recalled product.","12/12/2016",," UPC 4122005686; Lots L16E161, L16G011, L16H041, L16I141",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75754,"Ongoing","H-E-B GROCERY COMPANY LP DBA HEB","646 S Flores St",,"San Antonio","TX","78204","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0712-2017","Class II","HEB Baby Pear Carrot Blueberry 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve","3542 units","Customer reported a small piece of rubber inside one variety of the recalled product.","12/12/2016",," UPC 4122005673; Lots L16G021 and L16I151",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75754,"Ongoing","H-E-B GROCERY COMPANY LP DBA HEB","646 S Flores St",,"San Antonio","TX","78204","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0717-2017","Class II","HEB Baby Pear Peas Zucchini 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve","5866 units","Customer reported a small piece of rubber inside one variety of the recalled product.","12/12/2016",," UPC 4122079172: Lots L16G081 and L16G261",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75754,"Ongoing","H-E-B GROCERY COMPANY LP DBA HEB","646 S Flores St",,"San Antonio","TX","78204","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Texas","F-0716-2017","Class II","HEB Baby Squash Sweet Corn Tomato 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve","502 units","Customer reported a small piece of rubber inside one variety of the recalled product.","12/12/2016",," UPC 4122066357: Lots L16F301",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75756,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",".","Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.","Z-0693-2017","Class II","Brilliance 64 728231  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories","184","Software error due to the filament on timer ","12/02/2016",," 4001, 4016, 9056, 9071, 9074, 9099, 9112, 9134, 9194, 9251, 9280, 9367, 9515, 9529, 9538, 9541, 9548, 9549, 9554, 9559, 9561, 9573, 9574, 9600, 9607, 9614, 9618, 9625, 9631, 9638, 9640, 9646, 9653, 9656, 9659, 9667, 9670, 9678, 9686, 9688, 9689, 9703, 9707, 9711, 9720, 9738, 9740, 9755, 9763, 9781, 9782, 9802, 9805, 9811, 9822, 9833, 9837, 9838, 9859, 9862, 9864, 9876, 9890, 9898, 9901, 9909, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9996, 9997, 10012, 10014, 10021, 10024, 10032, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10179, 10180, 10193, 10206, 10206, 10207, 10208, 10213, 10216, 10221, 10250, 10255, 10299, 10302, 10307, 10379, 10394, 10422, 10446, 10470, 10473, 10503, 10514, 10540, 10605, 10610, 10671, 10698, 10743, 29002, 29005, 29014, 29049, 29056, 29057, 29107, 29115, 90098, 90106, 90124, 90131, 90154, 90205, 90224, 91003, 95022, 95024, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95239, 95244, 95258, 95261, 95341, 95343, 95345, 95351, 95364, 95374, 95387, 95399, 95409, 95410, 95439, 95441, 95475, 95496, 95504, 95507, 95512, 95524, 95526, 95538, 95542, 95551, 95563, 95614, 95616, 95656, 95668, 95688, 95691, 95707, 95811, 6003368,  95341A  ",11/12/2016,"11/12/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75756,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",".","Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.","Z-0695-2017","Class II","Ingenuity Core 728321  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories","337","Software error due to the filament on timer ","12/02/2016",," 30041, 31001, 33084, 52000, 52004, 52007, 52008, 52010, 52012, 52013, 52014, 52015, 52018, 52019, 52020, 52021, 52022, 52024, 52025, 52026, 52027, 52029, 52030, 52031, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52039, 52040, 52041, 52042, 52043, 52044, 52045, 52046, 52047, 52048, 52050, 52052, 52053, 52054, 52055, 52056, 52057, 52058, 52059, 52061, 52063, 52064, 52065, 52067, 52068, 52069, 52070, 52071, 52072, 52074, 52075, 52076, 52077, 52078, 52079, 52081, 132164, 132465, 310001, 310002, 310003, 310009, 310017, 310019, 310022, 310023, 310026, 310032, 310039, 310042, 310052, 310054, 310055, 310059, 310064, 310069, 310070, 310071, 310081, 310087, 310088, 310090, 310096, 310098, 310105, 310107, 310111, 310113, 310116, 310119, 310121, 310125, 310129, 310133, 310134, 310135, 310141, 310143, 310149, 310150, 310151, 310157, 310159, 310160, 310170, 310203, 310204, 310205, 310206, 310207, 310208, 310209, 310210, 310211, 310212, 310213, 310214, 310215, 310216, 310217, 310218, 310219, 310220, 310221, 310222, 310223, 310224, 310225, 310226, 310227, 310228, 310229, 310230, 310231, 310232, 310233, 310234, 310235, 310236, 310237, 310238, 310239, 310240, 310241, 310242, 310243, 310245, 310246, 310247, 310248, 310249, 310250, 310252, 310253, 310254, 310255, 310256, 310257, 310258, 310259, 310260, 310261, 310262, 310263, 310264, 310265, 310266, 310267, 310269, 310270, 310271, 310272, 310273, 310274, 310275, 310276, 310277, 310278, 310279, 310280, 310281, 310282, 310283, 310284, 310285, 310286, 310287, 310288, 310289, 310290, 310291, 310292, 310293, 310294, 310295, 310296, 310297, 310299, 310300, 310301, 310303, 310304, 310308, 310311, 310312, 310313, 310315, 310316, 310318, 310320, 310328, 310329, 310333, 310336, 310337, 310341, 310342, 310343, 333002, 333005, 333009, 333010, 333014, 333015, 333018, 333019, 333021, 333030, 333031, 333037, 333041, 333042, 333043, 333044, 333045, 333046, 333048, 333049, 333050, 333051, 333052, 333053, 333054, 333055, 333056, 333059, 333060, 333061, 333062, 333063, 333064, 333065, 333066,",11/12/2016,"11/12/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75756,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",".","Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.","Z-0694-2017","Class II","Brilliance 64 728232  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories","18","Software error due to the filament on timer ","12/02/2016",," 122921, 123029, 123092, 123096, 123116, 123117, 123148, 123150, 123164, 123170, 123172, 123176, 123179, 123180, 123182, 123183, 123185 and  123191  ",11/12/2016,"11/12/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75756,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",".","Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.","Z-0696-2017","Class II","Ingenuity Core 128 728323","509","Software error due to the filament on timer ","12/02/2016",," 30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026, 32028, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32057, 32058, 32059, 32060, 32061, 32062, 32063, 32064, 32065, 32066, 32067, 32068, 32069, 32070, 32071, 32072, 32073, 32074, 32075, 32076, 32077, 32078, 32079, 32080, 32081, 32082, 32084, 32085, 32086, 32087, 32088, 32089, 32090, 32091, 32092, 32093, 32094, 32095, 32096, 32097, 32098, 32099, 32100, 32101, 32102, 32103, 32104, 32105, 32106, 32108, 32109, 32110, 32111, 32112, 32113, 32114, 32115, 32116, 32117, 32118, 32119, 32120, 32121, 32122, 32123, 32124, 32125, 32126, 32127, 32128, 32129, 32130, 32131, 32132, 32133, 32134, 32135, 32136, 32137, 32138, 32139, 32140, 32141, 32142, 32143, 32144, 32145, 32146, 32147, 32148, 32149, 32150, 32151, 32152, 32153, 32154, 32155, 32156, 32157, 32158, 32159, 32160, 32161, 32162, 32163, 32164, 32165, 32166, 32167, 32168, 32169, 32172,   52023, 52028, 52049, 52073, 320001, 320002, 320003, 320005, 320006, 320008, 320010, 320018, 320019, 320024, 320026, 320029, 320030, 320031, 320033, 320037, 320054, 320058, 320059, 320069, 320073, 320074, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320088, 320090, 320092,  320096, 320099, 320100, 320101, 320103, 320107, 320111, 320114, 320115, 320119, 320122, 320123, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320136, 320138, 320144, 320146, 320147, 320200, 320201, 320202, 320203, 320204, 320206, 320207, 320208, 320209, 320210, 320211,  320212, 320213, 320214, 320215, 320216, 320217, 320218, 320219, 320220, 320221, 320222, 320223, 320224, 320225, 320226, 320227, 320228, 320229, 320230, 320231, 320232, 320233, 320234, 320235, 320236, 320237, 320238, 320239, 320240, 320241, 320242, 320243, 320245, 320246, 320247, 320248,  320250, 320251, 320252, 320253, 320254, 320255, 320256, 320257, 320258, 320260, 320261, 320262, 320263, 320264, 320265, 320266, 3",11/12/2016,"11/12/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75756,"Ongoing","Philips Medical Systems (Cleveland) Inc","595 Miner Rd",".","Cleveland","OH","44143-2131","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.","Z-0697-2017","Class II","Ingenuity CT 728326  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories","371","Software error due to the filament on timer ","12/02/2016",," 30003, 30004, 30005, 30006, 30007, 30008, 30009, 30010, 30011, 30012, 30013, 30014, 30015, 30017, 30018, 30019, 30020, 30021, 30022, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 30044, 30045, 30046, 30047, 30048, 30049, 32045, 32083, 32107, 52051, 52060, 52062, 300003, 300004, 300005, 300009, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020, 300021, 300022, 300024, 300025, 300027, 300028, 300029, 300030, 300031, 300032, 300033, 300034, 300035, 300036, 300037, 300038, 300039, 300040, 300041, 300042, 300043, 300044, 300045, 300047, 300049, 300050, 300051, 300052, 300053, 300054, 300055, 300056, 300057, 300058, 300059, 300060, 300061, 300062, 300063, 300064, 300065, 300066, 300068, 300069, 300070, 300071, 300072, 300073, 300074, 300075, 300077, 300078, 300079, 300080, 300081, 300082, 300083, 300084, 300086, 300087, 300088, 300089, 300090, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103, 300104, 300105, 300106, 300107, 300108, 300109, 300110, 300111, 300112, 300113, 300114, 300115, 300116, 300117, 300118, 300119, 300120, 300121, 300122, 300123, 300124, 300125, 300126, 300127, 300128, 300129, 300130, 300131, 300132, 300133, 300135, 300136, 300137, 300138, 300139, 300140, 300141, 300142, 300143, 300144, 300145, 300146, 300147, 300148, 300149, 300150, 300151, 300156, 300157, 300158, 300159, 300160, 300161, 300162, 300163, 300164, 300165, 300166, 300200, 300201, 300202, 300203, 300204, 300205, 300206, 300207, 300208, 300209, 300210, 300211, 300212, 300213, 300214, 300215, 300216, 300217, 300218, 300220, 300221, 300222, 300223, 300224, 300225, 300226, 300227, 300228, 300229, 300230, 300231, 300232, 300233, 310058, 310144, 320205, 333057, 333084, 333128, 336061, 336084, 336121, 30004-1, 52082, 52083, 310251, 310317, 310319, 310321, 310322, 310323, 310324, 310325, 310326, 310327, 310330, 310331, 333137, 333140, 333144, 333146, 333150, 333151, 320259",11/12/2016,"11/12/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75758,"Ongoing","OrthoPediatrics Corp","2850 Frontier Dr",,"Warsaw","IN","46582-7001","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.","Z-0879-2017","Class III","OrthoPediatrics PediNail Intramedullary Nailing System  4.5mm X 48mm Cortical Screw","22 units","Labeled as a 48mm Cortical Screw but measuring at 50mm","12/22/2016",," Product Number: 10-1500-3048  Lot Number: 161421-G",11/18/2016,"11/18/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75759,"Ongoing","Cre 8 It, Inc.","3130 Talmage Ave SE",".","Minneapolis","MN","55414-2715","United States","Voluntary: Firm Initiated","Telephone","MN","F-0615-2017","Class II","Cre 8 It, Inc. Stuffing, 011951311916 in covered aluminum foil pans.  Net Weight  2/4 lb. (3.63kg) containers per shipping case ","683 cases","Stuffing Mix was recalled after receiving a complaint of sour taste.  Firm determined storage trailer thermometer was 4 degrees off.","12/07/2016",," Expiration dates of 12/4, 12/7, 12/9, 12/11,12/14",11/18/2016,"11/18/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0838-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","123","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPC441 Lot # 2016021500",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0834-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","228","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPAC4530 Lot # 2015111373, 2015111778, 201520886, 2015120887, and 2016021477",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0832-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","431","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPAC4330 Lot # 2015111372, 201611713, 2016020101, and 2016050131",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0862-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","191","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPCTIC2 Lots # 2015110366,  2015110389, 2015110450, 2015110451, 2015110452, 2016021488, 2016021489, 2016021490, and 2016040888  ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0844-2017","Class II","BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","20","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPAC3330 Lot # 2015120640",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0856-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","28","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPCPIC1 Lot # 2015110454",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0852-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","50","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPC443 Lot # 201611726",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0850-2017","Class II","BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","204","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPC441U Lot # 2015120620",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0857-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","458","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPCPIC2  Lot #'s  2015112084, 2016011162, 2016011163, 2016031299, 2016041629 and 2016042021  ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0837-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","64","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPC344U Lot # 2016011182 and 2016041553",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0830-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","27","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPAC3530 Lot # 2016030311",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0847-2017","Class II","BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H)   An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","175","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPAC4330 Lot #'s 2016010803 and 2016030830  ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0860-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","108","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPCTC1  Lot #  2016030247    ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0828-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","127","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPAC3217 Lot # 2015111777  ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0835-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","50","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPC342 Lot # 2015121064 and 2016030816",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0853-2017","Class II","BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","191","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPC443U Lot # 2015120622",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0858-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","270","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part #LPCPTC2 Lot #'s  2016011174, 2016011175 and 2016011178    ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0863-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","1,633","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPCTSH Lots # 2016021930, 2016022074, 2016031247, 2016031248, 2016040024, 2016040025, 2016040064, 2016040898, 2016041632, 2016041635,   2016042030, and 2016042036  ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0840-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","108","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPC442 Lot # 2016030811",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0843-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","108","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPC444U Lot # 201602051 and 2016040048",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0846-2017","Class II","BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","246","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPAC4217 Lot # 2015110506, 2016030834, 2016042066, 2016042068",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0836-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","101","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPC342U Lot # 2016020057,",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0831-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","735","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPAC4217 Lot # 2015112156, 2015112157, 2015112158, 2015112159, 2015120466, 2016010159, 2016031210, 2016040438, and 2016061525",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0839-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","450","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPC441U Lot # 2015112073, 2016040049, 2016040914, and 2016042048",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0859-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation    ","60","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPCQB  Lot #  2016040022    ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0851-2017","Class II","BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","137","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPC442U Lot # 2015101819",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0842-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","46","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPC443U Lot # 2015120624",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0848-2017","Class II","BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation   ","216","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPAC4417 Lot #'s 2015110513, 2016010805 and 2016050344  ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0849-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","160","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPC441 Lot # 2015110365  ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0833-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","150","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPAC4417 Lot # 2016011141, 2016020088, and 2016031214",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0829-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","53","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPAC3417 Lot # 2015111355",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0861-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","1,371","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPCTC2 Lot's # 2015111121, 2015120492, 2015120495, 2015120497, 2015121108, 2015121114, 2015121115, 2016011524, 2016031197, 2016031875, 2016031878, 2016050008, 2016060232, 2016060233, 2016060234, and 2016062347  ",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0845-2017","Class II","BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","4","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPAC3530 Lot # 2015110514",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0841-2017","Class II","BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","525","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # ILPC442U Lot # 2015110458, 2015111460, 2015121066, 2016020509, and 2016042047",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0854-2017","Class II","BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","124","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPC444U Lot # 2016030294",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75761,"Ongoing","Biomet 3i, LLC","4555 Riverside Dr",,"Palm Beach Gardens","FL","33410-4200","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden","Z-0855-2017","Class II","BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation","391","A limited number of product pouches may not have been sealed during packaging. ","12/20/2016",," Part # LPCHC Lot # 2016030791, 2016030792, 2016030793, and 2016060693",9/14/2016,"09/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75762,"Ongoing","NATURECOM INC","8 Rancho Cir",,"Lake Forest","CA","92630-8325","United States","Voluntary: Firm Initiated","Press Release","Nationwide in US &     Worldwide:    CA, AU, GB, ES, FR, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, DO, FI, GI, GR, HR, HU, IE, IL, IT, JP, LT, LV, MT, MX, MY, NG, NL, NO, NZ, PH, PL, RE, RO, RU, SE, SG, SI, SK, TH, TR","F-0762-2017","Class II"," x 11 silver and clear mylar ziplock bags that contain 500g of DMAA.","320kg","Naturecom dba NutriVitaShop is recalling DMAA net weight 500 g because there may be presence of 1,3-dimethylamylamine.   ","12/16/2016",," 20141102, 20150715, 20151022, 20160226, 20160701, 20161017, 20150323",11/23/2016,"11/23/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75764,"Ongoing","Zydus Pharmaceuticals USA Inc","73 Route 31 N",,"Pennington","NJ","08534-3601","United States","Voluntary: Firm Initiated","Letter","Nationwide","D-0207-2017","Class III","BuPROPion Hydrochloride Extended-Release Tablets (XL),  300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and  b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534  ","16,356 bottles","Failed Dissolution Specifications; 6 month time point","12/20/2016",," a) MS1667 exp 01/2018; M601708, exp 03/2018;       b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018",11/2/2016,"11/02/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75766,"Ongoing","Topnotch Foods Inc","1988 E 57th St",,"Vernon","CA","90058-3464","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","U.S. distribution to the following; CA.    No foreign distribution.","F-0685-2017","Class I","Topnotch Foods Regular Bread Crumbs  2,000 lb. bulk bag, 50 lb. bulk bag, and 10 lb. bulk bag","3 tons","Undeclared allergens; egg, tree nuts (unspecified), and the milk.","12/09/2016",," 11/1/16",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75767,"Terminated","Oklahoma Blood Institute - Sylvan N Goldman Center","1001 N Lincoln Blvd",".","Oklahoma City","OK","73104-3299","United States","Voluntary: Firm Initiated","Telephone","New York; New Jersey","B-0198-2017","Class II","Washed Apheresis Platelets, Leukocytes Reduced, Irradiated","2 units","Platelet Pheresis products, for which white blood cell count testing was not performed, were distributed.","12/07/2016","12/07/2016"," W091016556043 (double collection)",10/4/2016,"10/04/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75768,"Terminated","Northern California Community Blood Bank","2524 Harrison Ave",,"Eureka","CA","95501-3229","United States","Voluntary: Firm Initiated","FAX","Texas","B-0225-2017","Class II","Apheresis Platelets, Leukocytes Reduced","3 units","Platelet products, which failed leukoreduction quality control, were distributed. ","12/20/2016","12/20/2016"," W149516956918 (Triple collection)",10/14/2016,"10/14/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75769,"Ongoing","Sun Pharmaceutical Industries, Inc.","270 Prospect Plains Rd",,"Cranbury","NJ","08512-3605","United States","Voluntary: Firm Initiated","Letter","NJ and further distributed Nationwide in the USA.","D-0148-2017","Class III","KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL  32257, UPC 3 10631 09335 8.","326,103 bottles","Failed Stability Specifications: Low Out of Specification results for alcohol content.","11/22/2016","."," Lot: GHEN, GLGL, GLGL-1, Exp 10/31/2016; HACS, HACS-1, HAFK, HAFK-1, Exp 1/31/2017; HDBB, HDBB-1, HDFS, HDFS-1, Exp 4/30/2017; HFDP, HFDP-1, Exp 6/30/2017",10/28/2016,"10/28/2016",11/30/2016,"11/30/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75770,"Ongoing","Oculus Innovative Sciences, Inc.","1129 N McDowell Blvd",,"Petaluma","CA","94954-1110","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0763-2017","Class II","Ceramax Skin Barrier Cream:   NET WT 0.1 OZ (3 g professional sample - not for retail sale)  Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment.    General and Plastic Surgery: Ceramax is intended to be used as a topical  skin care preparation to relieve and to manage the burning and itching associated with various  dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and  other dry skin conditions, by maintaining a moist wound and skin environment.  ","68,970 units","Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.","12/14/2016",," Lot 3045639, expiration date: 01/2018",11/21/2016,"11/21/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75771,"Ongoing","Snow Monkey","2000 Main St Apt 303",,"Santa Monica","CA","90405-1089","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm refused to provide a distribution list.  According to the firm products were gifted through a kickstarter website in which people received the product as a result of donating money.","F-0720-2017","Class I","Snow Monkey Subzero Superfood   Cacao  8oz. ","400 pods (total)","Potential Listeria monocytogenes contamination.","12/13/2016",," Delivered between May and June 2016",11/21/2016,"11/21/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75771,"Ongoing","Snow Monkey","2000 Main St Apt 303",,"Santa Monica","CA","90405-1089","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","The firm refused to provide a distribution list.  According to the firm products were gifted through a kickstarter website in which people received the product as a result of donating money.","F-0721-2017","Class I","Snow Monkey Subzero Superfood   Goji Berry  8oz. ","400 pods (total)","Potential Listeria monocytogenes contamination.","12/13/2016",," Delivered between May and June 2016",11/21/2016,"11/21/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75772,"Ongoing","Miravalle Foods, Inc.","9921 Garvey Ave",".","El Monte","CA","91733-1229","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution to the following; NV.    No foreign distribution.","F-0670-2017","Class I","Miravalle   Pan Rallado  Bread Crumbs  Net Wt. 7 oz., 8 oz.","235 lbs.","Undeclared allergens; eggs, milk, and tree nuts.","12/08/2016",," Lot #044",11/21/2016,"11/21/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75773,"Ongoing","Midwest International Corp","47 Bridgewater St # 57",".","Brooklyn","NY","11222-3820","United States","Voluntary: Firm Initiated","FAX","FL, GA, IN, IL, MD, MA, VA, TX & MN","F-0613-2017","Class II","Dai Yu, 80g, Hairtail, NET WT: 2.8 oz (80g), Item #D526","56 cartons x 40 retail packages x 80 g","The product is an acidified food without a registered manufacturer and scheduled process","12/07/2016",," MFD:07.01.2016  EXP:03.30.2017",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75774,"Ongoing","Taylor Farms Pacific Inc. (MacArthur Facility)","1820 N Macarthur Dr Ste 500",".","Tracy","CA","95376-2831","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US only - MO, TX, LA, NV, TN, NC, GA, AL, IN, MO, IL, OH. MS","F-0612-2017","Class I","Taylor Farms Veggie & Hummus Bistro Box:    Baby Carrots, Hummus Dip, Grape Tomatoes, Flatbread squares, Celery Sticks.  NET WT 6.8 oz. (193 g)  Perishable, Keep Refrigerated.    UPC: 0 30223 01037 1    Distributed by Taylor Farms.    Also packed as Schnucks Vegetable & Hummus Snack Tray:  Hummus dip, baby carrots, grape tomatoes, flatbread crackers and celery sticks.  NET WT 6.8 oz. (193g)  Perishable, Keep refrigerated;    UPC:  0 41318 09193 9;    Sabra 2 oz. x 48 ct - UPC 040822011112.","211 cases - Dallas; 260 cases  - Tracy, CA; 1080 cases TN. 6 units per case","Firm was notified by supplier that the hummus included in their vegetable and hummus trays has been recalled due to Listeria monocytogenes contamination.","12/07/2016",," Taylor Farms Use By Dates: 11/11/16  12/1/16:  Package Codes: TFPM304A34 - CA;  TFT310, TFT313, TFT314, TFT315, TFT317, TFT319, TFT320, TFT321, TFT322 - TN;  TFD313AU7,TFD316AU7,TFD320AU7  - TX;    Schnucks Use By Dates: 11/18/16 & 11/23/16.    Package Codes:   TFT310, TFT315",11/19/2016,"11/19/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75776,"Completed","First Source, LLC","100 Pirson Pkwy",,"Tonawanda","NY","14150-6727","United States","Voluntary: Firm Initiated","Telephone","MA, MD, NJ, NY, PA and VA thru Wegmans Retail stores","F-0722-2017","Class III","Wegmans Milk Chocolate Covered Pretzels, NET WT 9.5 OZ (269g)","400 units ","Milk Chocolate covered pretzels have incorrect rear label.  The rear label is for the Dark Chocolate pretzels which lack allergen declaration.","12/15/2016",," Best Before 06-06-17",11/11/2016,"11/11/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75778,"Ongoing","To Your Heart's Content","3811 W Magnolia Blvd",".","Burbank","CA","91505-2820","United States","Voluntary: Firm Initiated","Telephone","U.S. distribution via internet nationwide.    No foreign distribution.","F-0674-2017","Class II","Plush Puffs Marshmallows  Toasty Coconut  4oz. and 2lb bulk bag","566 lbs.","Undeclared allergen of milk from the declared ingredient coconut cream powder.","12/08/2016",," 1386F; 1526N; 1746P;1896H; 2216K; 2426O; 2506N; 2586Q; 2706R; 2986S; 3206P",11/22/2016,"11/22/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75779,"Ongoing","LSG Sky Chefs, Inc.","4600 37th Ave SW",,"Seattle","WA","98126-2720","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distributed in Oregon and Washington","F-0750-2017","Class I","FRESH TO GO Mediterranean Chicken with Hummus sandwich, close-face ready-to-eat sandwich, refrigerated, packed in plastic clam shell, net wt. 8 oz.  The UPC is 0 52548 58888 5.","103 pieces","Mediterranean Chicken with Hummus ready to eat sandwich, refrigerated product, is recalled due to a potential contamination with Listeria monocytogenes.  The sandwich contains the affected Roasted Red Pepper Hummus which was recalled by Sabra Dipping Co., LLC.","12/15/2016",," Best By 11/19/2016 (production date 11/17/2016)  Best By 11/20/2016 (production date 11/18/2016)  Best By 11/21/2016 (production date 11/19/2016)   ",11/20/2016,"11/20/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75780,"Ongoing","Medtronic Inc","710 Medtronic Pkwy","NE Mailstop LS245","Minneapolis","MN","55432-5603","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, NC, WA","Z-0892-2017","Class II"," OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.","315"," .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.","12/22/2016",," UDI/Product         Lot/Serial Product Number     UPN/GTIN Number  00821684046647      A358626                             AB18W030100150  00821684046883      A357386                             AB18W060100150  00821684046722      A357070                             AB18W040100150  00821684046777      A358043                             AB18W050040150  00821684046722      A356360                             AB18W040100150  00821684046777      A357348                             AB18W050040150  00821684046562      A359219                             AB18W025040150",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75781,"Ongoing","Teleflex Medical","2917 Weck Dr",,"Research Triangle Park","NC","27709-0186","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA,  MO, MS, NC, NJ, NY, OH, OK, OR, PA and TX.","Z-0771-2017","Class II","RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile,    Intermittent self-catheterization","102,843 units","Labeling Inconsistency: The products have been  labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.  ","12/16/2016",," Product Code: 10096080, Lot number: 74F1501853 (8 FR); Product Code: 10096120, Lot numbers: 74E1602795, 74F1503201, 74G1600723 & 74J1500576 (12 FR); Product Code: 10096140, Lot numbers: 74A1600023, 74A1601105, 74A1602234, 74D1602007, 74E1602235, 74E1602796, 74F1501855, 74G1600486, 74H1500530 & 74L1500363 (14 FR); Product Code: 10096100, Lot numbers: 74A1600799, 74A1600800, 74A1602236, 74A1603122, 74D1600231, 74D1600923, 74D1601540, 74D1602136, 74E1600845, 74E1601768, 74E1602237, 74F1501857, 74F1501962, 74F1601966, 74F1601988, 74H1500534, 74H1500978, 74J1501157, 74K1502306, 74L1500364, 74L1501303, 74L1501938, 74M1500227 and 74M1501087 (10 FR) and Product Code: 10096160, Lot numbers: 74A1600024, 4A1600801, 74A1601106, 74A1603123, 74D1601541, 74E1600846, 74E1602797, 74G1600724, 74H1500979, 74J1501158, 74K1501837, 74L1501202 &74L1501939 (16 FR).  ",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75783,"Ongoing","GREENCORE USA","222 Rosewood Dr Ste 240",,"Danvers","MA","01923-4520","United States","Voluntary: Firm Initiated","E-Mail","Illinois, Indiana, Iowa, Wisconsin and Massachusetts, Rhode Island, Connecticut, maine, Vermont, New Hampshire and New York","F-0686-2017","Class I","Fresh to Go Mediterranean Chicken Hummus Sandwich, Fresh  Refrigerated  Net Wt 8 oz (227g). Packaged in sandwich wedge plastic container.  ","8795 sandwiches","Product may be contaminated with Listeria monocytogenes.  ","12/09/2016",," Use By Dates:  10/17/2016 10/18/2016 10/19/2016 10/20/2016 10/21/2016 10/22/2016  10/23/2016 10/24/2016 10/25/2016 10/26/2016 10/27/2016 10/28/2016 10/29/2016 10/30/2016 10/31/2016 11/1/2016 11/2/2016 11/3/2016 11/4/2016 11/5/2016 11/6/2016 11/7/2016 11/8/2016 11/9/2016 11/10/2016 11/11/2016 11/12/2016 11/13/2016 11/14/2016 11/15/2016 11/16/2016 11/17/2016 11/18/2016 11/19/2016 11/20/2016 11/21/2016 10/17/2016 10/18/2016  10/19/2016 10/20/2016 10/21/2016 10/22/2016 10/23/2016 10/24/2016 10/25/2016 10/26/2016 10/27/2016 10/28/2016 10/29/2016 10/30/2016 10/31/2016 11/1/2016 11/2/2016 11/3/2016 11/4/2016 11/5/2016 11/6/2016 11/7/2016 11/8/2016 11/9/2016 11/10/2016 11/11/2016 11/12/2016 11/13/2016 11/14/2016 11/15/2016 11/16/2016 11/17/2016 11/18/2016 11/19/2016  11/20/2016 11/21/2016",11/20/2016,"11/20/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75784,"Ongoing","West-Ward Pharmaceuticals Corp.","401 Industrial Way West",".","Eatontown","NJ","07724-2209","United States","Voluntary: Firm Initiated","Letter","US nationwide","D-0172-2017","Class III","SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only,  Mfd: Hikma Farmaceutica (Portugal,) SA   Distributed by: Westward Eatowntown NJ  07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01","5,142 Shelf-packs","Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.","12/08/2016",," Lot #: 152032.1, Exp. Date. 2/2017",11/17/2016,"11/17/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0819-2017","Class II","MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F  C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","45","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-12665 Exp. July 26, 2019",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0796-2017","Class II","OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","61","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: OR-04632 Exp. March 10, 2018, OR-04632 Exp. March 10, 2018,  OR-04632 Exp. March 10, 2018, OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, C1-11635 Exp. September 29, 2018,  OR-04632 Exp. March 10, 2018,  OR-04632 Exp. March 10, 2018,  OR-04692 Exp. July 16, 2018,  OR-04692 Exp. July 16, 2018, OR-04692 Exp. July 16, 2018, and C1-09412 Exp. December 1, 2017",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0800-2017","Class II","OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM  D66CM Catalog # AB101072  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","22","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-09396 Exp. November 17, 2017, C1-09396 Exp. November 17, 2017, C1-08804 Exp. April 1, 2017, and C1-09396 Exp. November 17, 2017 ",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0815-2017","Class II","MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F  C55¿ S79CM D84CM GLOBAL  Catalog # 990079-055-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","59","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08936 Exp. May 18, 2017 and OR-04635 Exp. March 10, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0797-2017","Class II","OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM  D84CM  Catalog # AB081047  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","11","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-09372 Exp. November 5, 2017,  C1-10142 Exp.  April 22, 2018 and OR-04728 Exp. October 21, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0812-2017","Class II","MEDTRONIC  ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F  C70¿ S61CM D66CM GLOBAL  Catalog # 990061-070-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","1,729","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08273 Exp. October 8, 2016, C1-08340 Exp. November 11, 2016, C1-08605 Exp. February 20, 2017,  C1-08608 Exp. February 20, 2017, C1-08816 Exp. April 8, 2017, C1-08940 Exp. May 19, 2017, C1-09102 Exp. July 21, 2017, C1-09169 Exp. August 21, 2017, C1-09170 Exp. August 21, 2017, C1-09361 Exp. November 3, 2017, C1-09693 Exp. February 10, 2018, C1-09742 Exp. February 16, 2018, C1-09743 Exp. February 16, 2018,  C1-09862 Exp. March 5, 2018,  C1-09903 Exp. March 15, 2018,  C1-10041 Exp. April 5, 2018, C1-10148 Exp. April 23, 2018,  C1-10185 Exp. April 27, 2018,  C1-10214 Exp. April 29, 2018,  C1-10324 Exp. May 11, 2018,C1-11439 Exp. September 16, 2018, C1-11440 Exp. September 16, 2018,  C1-11485 Exp. September 22, 2018,  C1-11623 Exp. September 29, 2018,  C1-11622 Exp. September 29, 2018, C1-11852 Exp. October 16, 2018, OR-04759 Exp.  December 22, 2018, and OR-04758 Exp. December 22, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0807-2017","Class II","OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM  D66CM  Catalog # AB101218  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","34","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-10984 Exp. July 28, 2018, C1-10983 Exp. July 28, 2018, C1-11198 Exp. August 23, 2018, C1-11200 Exp. August 23, 2018, C1-11200 Exp. August 23, 2018, C1-11198 Exp. August 23, 2018, C1-11200 Exp. August 23, 2018, and C1-10984 Exp. July 28, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0810-2017","Class II","OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","255","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08260 Exp. October 6, 2016 and C1-08283 October 14, 2016",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0795-2017","Class II","OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM  Catalog # AB081045  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","76","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-09374 Exp. November 5, 2017,  C1-10319 Exp. May 11, 2018, C1-11202 Exp. August 24, 2018,  C1-11202 Exp. August 24, 2018,  C1-11671 Exp. September 30, 2018,  C1-11671 Exp. September 30, 2018,  C1-11202 Exp. August 24, 2018, C1-11671 Exp. September 30, 2018,  C1-11672 Exp. September 30, 2018,  and C1-09374 Exp. November 5, 2017",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0809-2017","Class II","OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM  D66CM  Catalog # AB10218  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","20","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-11201 Exp. August 23, 2018, C1-11200 Exp. August 23, 2018, and C1-11873 Exp. October 21, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0802-2017","Class II","OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM  D66CM  Catalog # AB101075  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","8","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-12145 Exp. November 29, 2018, C1-08466 Exp. December 19, 2016 and OR-04823 Exp. June 16, 2019",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0817-2017","Class II","MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F  C90¿ S79CM D84CM GLOBAL  Catalog # 990079-090-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","991","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08341 Exp. November 11, 2016, C1-08607 Exp. February 20, 2017, C1-08803 Exp. April 3, 2017, C1-08941 Exp. May 19, 2017, C1-09173 Exp. August 25, 2017, C1-09394 Exp. November 16, 2017, C1-09531 Exp. December 29, 2017, C1-09718 Exp. February 11, 2018, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, and  OR-04757 Exp. December 22, 2018 53",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0790-2017","Class II","OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM  Catalog # AB081040  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","156","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-09714 Exp. February 11, 2018, OR-04657 Exp. April 20, 2018, C1-10900 Exp. July 19, 2018, C1-10899 Exp. July 19, 2018, C1-11048 Exp. August 3, 2018,  C1-11729 Exp. October 4, 2018, C1-11729 Exp. October 4, 2018,   OR-04729 Exp. October 29, 2018, C1-12233 Exp. December 21, 2018, C1-12234 Exp. December 22, 2018, C1-12234 Exp. December 22, 2018, C1-09062 Exp. June 24, 2017, C1-09062 Exp. June 24, 2017, C1-11047 Exp. August 3, 2018 and C1-12234 Exp. December 22, 2018 2",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0811-2017","Class II","MEDTRONIC  ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","566","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08604 Exp. February 20, 2017, C1-08938Exp.  May 19, 2017, C1-08986 Exp. June 1, 2017, OR-04488 Exp. June 30, 2017, C1-09756 Exp. February 18, 2018, C1-09757 Exp. February 18, 2018, OR-04633 Exp. March 10, 2018, C1-10118 Exp. April 17, 2018, C1-10119 Exp. April 17, 2018, C1-10147 Exp. April 23, 2018, and C1-12525 Exp. May 17, 2019",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0798-2017","Class II","OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM  D66CM  Catalog # AB081210  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","26","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: OR-04691 Exp. July 16, 2018, C1-11728 Exp. October 4, 2018, C1-09375 Exp. November 5, 2017 and C1-09375 Exp. November 5, 2017",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0806-2017","Class II","OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM  D84CM  Catalog # AB101078  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","16","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: OR-04725 Exp. October 20, 2018, C1-10042 Exp. April 5, 2018, C1-10042 Exp. April 5, 2018, and C1-11868 Exp. October 20, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0791-2017","Class II","OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM  Catalog # AB081041  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","87","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-12312 Exp. January 18, 2019, OR-04686 Exp. July 16, 2018, Exp. April 21, 2015, OR-04655 Exp. April 20, 2018, C1-10985 Exp. July 28, 2018, OR-04686 Exp. July 16, 2018, C1-12312 Exp. January 18, 2019, C1-12312 Exp. January 18, 2019, and OR-04655 Exp. April 20, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0794-2017","Class II","OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM  Catalog # AB081044  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","991","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-12152 Exp. November 30, 2018, C1-09518 Exp.  December 21, 2017, C1-09748 Exp. February 16, 2018, C1-09899 Exp. March 12, 2018, C1-10040 Exp. April 5, 2018, C1-10040 Exp. April 5, 2018, C1-10149 Exp. April 23, 2018, C1-10330 Exp. May 11, 2018, C1-10329 Exp. May 11, 2018, C1-10382 Exp. May 17, 2018, C1-11571 Exp. September 25, 2018, C1-11571 Exp. September 25, 2018, and OR-04757 Exp. December 22, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0808-2017","Class II","OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM  D84CM  Catalog # AB101219  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","33","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-11932 Exp. October 28, 2018, C1-08935 Exp. May 14, 2017,  C1-11932 Exp. October 28, 2018, C1-12448 Exp. April 14, 2019, and C1-12448 Exp. April 14, 2019",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0813-2017","Class II","MEDTRONIC  ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","215","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08939 Exp. May 19, 2017, C1-08985 Exp. June 1, 2017, C1-09584 Exp. January 18, 2018, and C1-10120 Exp. April 17, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0792-2017","Class II","OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM  Catalog # AB081042  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","30","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: OR-04634 Exp. March 10, 2018 and C1-12597 Exp. June 18, 2019",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0818-2017","Class II","MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F  C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","55","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-12493 Exp. May 5, 2019",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0805-2017","Class II","OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM  Catalog # AB101078  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","110","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-09848 Exp. March 4, 2018, C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018, C1-09099 Exp. July 15, 2017, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017, C1-09848 Exp. March 4, 2018, C1-10382 Exp. May 17, 2018,  C1-11207 Exp. August 24, 2018, C1-11249 Exp. August 30, 2018,  OR-04730 Exp. October 29, 2018, C1-09099 Exp. July 15, 2017, C1-09407 Exp. November 24, 2017 and C1-09848 Exp. March 4, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0801-2017","Class II","OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM  D66CM  Catalog # AB101073  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","70","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-09395 Exp. November 17, 2017 and C1-11621 Exp. November 2, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0804-2017","Class II","OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM  D84CM  Catalog # AB101077  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","124","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08611 Exp. February 20, 2017,  C1-09397 Exp. November 17, 2017,  C1-09408 Exp. November 25, 2017, C1-09408 Exp. November 25, 2017, C1-09861 Exp. March 5, 2018, C1-09858 Exp. March 5, 2018, C1-09861 Exp. March 5, 2018, C1-10901 Exp. July 19, 2018,  C1-11205 Exp. August 24, 2018, C1-11205 Exp. August 24, 2018, C1-12250 Exp. January 4, 2019, C1-08611 Exp. February 20, 2017, and C1-11205 Exp. August 24, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0803-2017","Class II","OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM  D84CM  Catalog # AB101076  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","74","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-12572 Exp. June 17, 2019,  C1-10896 Exp. July 16, 2018,  C1-10896 Exp. July 16, 2018,  C1-12139 Exp. November 24, 2018, C1-12572 Exp.  June 17, 2019, C1-09133 Exp. August 3, 2017, C1-09133 Exp. August 3, 2017,  C1-09943 Exp. March 19, 2018, OR-04641 Exp. March 26, 2018, and C1-10896 Exp. July 16, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0816-2017","Class II","MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F  C70¿ S79CM D84CM GLOBAL  Catalog # 990079-070-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","1,269","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08310 Exp. October 29, 2016,  C1-08364 Exp. November 21, 2016,  C1-08606 Exp. February 20, 2017,  C1-08611 Exp. February 20, 2017,  C1-08802 Exp. April 3, 2017,  C1-08857 Exp. April 22, 2017,  C1-09091 Exp. July 10, 2017,  C1-09090 Exp. July 10, 2017,  C1-09859 Exp. March 5, 2018,  C1-09860 Exp. March 5, 2018,  C1-09880 Exp. March 11, 2018,  C1-09921 Exp. March 16, 2018,  C1-10039 Exp. April 5, 2018,  C1-10141 Exp. April 22, 2018,  C1-10141 Exp. April 22, 2018,  C1-10146 Exp. April 23, 2018, C1-10242 Exp. May 4, 2018,  C1-10240 Exp. May 4, 2018,  C1-10241 Exp. May 4, 2018, C1-11206 Exp. August 24, 2018, C1-11206 Exp. August 24, 2018, C1-11572 Exp. September 25, 2018,  C1-11572 Exp. September 25, 2018, C1-11850 Exp. October 16, 2018, and C1-11849 Exp. October 16, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0793-2017","Class II","OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM  D66CM  Catalog # AB081043  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","21","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08337 Exp. November 7, 2016, OR-4658 Exp. April 20, 2018, C1-08337 Exp. November 7, 2016, and C1-08337 Exp. November 7, 2016",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0799-2017","Class II","OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM  D84CM  Catalog # AB081211  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","21","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08988 Exp. June 1, 2017, C1-08988 Exp. June 1, 2017, OR-04708 Exp. August 19, 2018, C1-08988 Exp. June 1, 2017, C1-08988 Exp. June 1, 2017, C1-09373 Exp. November 5, 2017, C1-09373 Exp. November 5, 2017, OR-04708 Exp. August 19, 2018, and C1-11734 Exp. October 5, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75785,"Ongoing","Oscor, Inc.","3816 Desoto Blvd",,"Palm Harbor","FL","34683-1618","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM","Z-0814-2017","Class II","MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL  Catalog # 990061-120-000  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.","186","Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.","12/19/2016",," Lot #'s: C1-08466 Exp. December 19, 2016, C1-09857 Exp. March 5, 2018, C1-10215 Exp. April 29, 2018, and C1-11438 Exp. September 16, 2018",10/5/2016,"10/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75786,"Ongoing","Roche Molecular Systems, Inc.","1080 US Highway 202 S",,"Branchburg","NJ","08876-3733","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0750-2017","Class II","LightMix¿ Zika rRT-PCR Test  The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. ¿263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities. Within the United States and its territories positive results must be reported to appropriate state/local public health authorities. Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The LightMix¿ Zika rRT-PCR Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of realtime PCR and in vitro diagnostic procedures. The Test is only for use under the Food and Drug Administration s Emergency Use Authorization.","24 pieces","The LightCycler¿ 480 algorithm used for the LightMix¿ Zika rRT-PCR Test, EUA (catalog number  07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there is  an inflection point in the fluorescence signal.","12/13/2016",," 38161611",11/16/2016,"11/16/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75787,"Ongoing","LSG Sky Chefs","452 Tower Rd., Bldg. 453 (PIT)",,"Coraopolis","PA","15108","United States","Voluntary: Firm Initiated","E-Mail","OH, PA, NY, WV","F-0751-2017","Class I","7-Eleven Chicken with Hummus Sandwich. Keep Refrigerated; NET WT. 8.0 OZ.; LSG Sky Chefs, Coraopolis, PA 15108 packed in plastic clam shell. Best By: 1119, 1120, 1121.","389 sandwiches","On 11/20/16 the firm received notification that Sabra Red Pepper Hummus was recalled for Listeria monocytogenes. Sabra Hummus Red Pepper  was  in the 7-11 Mediterranean Style Chicken with Hummus Sandwich.","12/15/2016",," Best By: 1119, 1120, 1121.",11/20/2016,"11/20/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75788,"Ongoing","J F C International Inc","7101 E. Slauson Ave.",,"Los Angeles","CA","90040-3622","United States","Voluntary: Firm Initiated","Letter","CA, CT, MA, NJ, and NY","F-0725-2017","Class II","You-ka Punch Ramune Net Wt. 3.87oz (110g), Item No. 23926, 20 packs/case","500 packs","JFC International is recalling Fizzy Candy Punch Ramune because it may contain undeclared wheat allergen.","12/15/2016",," JAN CODE: 4 902486 308594  Best By 2017.11.15 or before",11/23/2016,"11/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75788,"Ongoing","J F C International Inc","7101 E. Slauson Ave.",,"Los Angeles","CA","90040-3622","United States","Voluntary: Firm Initiated","Letter","CA, CT, MA, NJ, and NY","F-0724-2017","Class II","You-ka Fresh Ramune Net Wt. 3.87oz (110g), Item No. 23925, 20 packs/case","391 packs","JFC International is recalling Fizzy Candy Punch Ramune because it may contain undeclared wheat allergen.","12/15/2016",," JAN CODE: 4 902486 111064   Best By 2017.11.15 or before",11/23/2016,"11/23/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75790,"Ongoing","LSG Sky Chefs #1393","1355 Airport Blvd",,"San Jose","CA","95110-1204","United States","Voluntary: Firm Initiated","E-Mail","CA Bay area and Las Vegas","F-0752-2017","Class I","7-Eleven Fresh to Go Chicken and Hummus Sandwich;  Net Wt. 8.0 oz. (227 g). Sold in Clamshell package  UPC 052548588885","72 units in Las Vegas, 241 in San Jose","LSG Sky Chefs was notified by supplier of hummus that was used in ready to eat sandwiches is being recalled due to contamination with Listeria Monocytogenes","12/15/2016",," Best by Dates of 11/19/16, 11/20/16 and 11/21/16",11/20/2016,"11/20/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75791,"Ongoing","Les Emballages Knowlton Inc.","315  Knowlton Road","Lac Brome","Knowlton",,,"Canada","Voluntary: Firm Initiated","E-Mail","Nationwide","D-0225-2017","Class III","Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada,  Unit UPC: 077326831953   Case UPC: 10077326831950","1,964 cases (35,352 cannisters)","Labeling: Label Mix Up- Incorrect back label applied to the product.","12/22/2016",,"  Lot: 6282CA3818  Exp: 10/18",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75792,"Ongoing","Stryker Howmedica Osteonics Corp.","325 Corporate Dr",,"Mahwah","NJ","07430-2006","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.","Z-0880-2017","Class II","GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R    Intended for the temporary stabilization of bone segments or fragments","2,084 units","A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.","12/22/2016",," GAM Kirschner Wire - Manufacturing Part Number 12106450S, Lot #'s K0800BB, K0800BC, K0800BD, K0800BE, K0800BF, K0800C0, K081720, K081721, K0810872, K081723, K081727, K082C8B, K084F89, K084F98, K08683D, K08683E, K086841, K08820B, K089AF5, K08E1E1, K0911F4, K09379B, K096A26, K096A2A, K09A2C, K098213, K098215, K099AA0, K09AD33, K09BA4F, K09D564, K09F026, K0A1EF8, K0A1EFA, KoA1EFB, K0A38FB, K0A63AB, K0A63AC and K0A7BC1    T2 K-Wire - Manufacturing Part Number 18060050S, Lot #'s K084FBF, K0920A4, K0A1EFD, K093747, K0937C4, K09BA53, K09BA54, K09BA55 and K09BA56    T2 K-Wire Recon - Manufacturing Part Number 18063030S, Lot #'s K086847, K08E1E9 and K099AA8",11/9/2016,"11/09/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75793,"Ongoing","Cook Inc.","750 N Daniels Way",,"Bloomington","IN","47404-9120","United States","Voluntary: Firm Initiated","Letter","AZ  CA  DC  GA  IL  LA  MN  MS  NC  NV  NY  OK  PA  TN  TX  WI","Z-0733-2017","Class II","Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray  Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray","99 units ","Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle.  Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.","12/12/2016",," catalog number: C-UDLMY-401J-ABRM-HC-FST  Lot 6498570  catalog number: C-UTLMY-501J-ABRM-HC-FST  Lot 6501835    Exp date 9/30/2018 ",11/28/2016,"11/28/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75794,"Ongoing","AbbVie Inc.","1 N Waukegan Rd",,"North Chicago","IL","60064-1802","United States","Voluntary: Firm Initiated","Letter","U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.","Z-0786-2017","Class II","AbbVie PEG Kit 20 FR ","541 units","AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.","12/17/2016",," AbbVie PEG Kit 20 Fr    Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336  ",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75795,"Ongoing","Medtronic Inc","710 Medtronic Pkwy","NE Mailstop LS245","Minneapolis","MN","55432-5603","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) in states of: AK, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, LA, MN, ND, NV, NY, SD, TN, TX, WI, WY and countries of: Canada, Chile, Croatia, Germany, Greece, Hungary, Iran, Italy, Latvia,   Lebanon, Poland, Portugal, Romania, Spain, Tanzania, and United Kingdom.","Z-0826-2017","Class II"," Oxygenator with Integrated Arterial Filter,  Affinity Fusion cardiotomy/Venous Reservoir,  Perfusion Tubing Packs    The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. ","5609 (663 US; 4946 OUS)","Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.","12/19/2016",," Product UPN/GTIN Lot Number Product Number  00643169650749 212028376 HY8N22R8  00643169802421 211984809 BB9D23R3  00643169707801 211991294 BB1D41R27  00643169871908 212073806 HY8B75R12  00643169621473 211950617 BB8U95R1  00643169860322 211865249 BB8E47R15  00643169865365 211975385 BB9D32R2  00643169860322 211991184 BB8E47R15  00643169717336 211991250 BB8Q09R2  00643169792852 211991385 BB9G59R5  00643169740020 211991295 HY8C67R10  00643169649101 211991248 BB7H73R14  00643169868120 212028234 BB8G43R3  00643169860322 212028305 BB8E47R15  00643169873032 212034498 HY9L88R2  00643169534629 212109150 BB7Z44R6  00643169591738 211846477 BB1A19R44  00643169786790 211991196 BB8X02R7  00643169639058 211846421 BB8N94R4  00643169649767 211991286 HY8J73R6  00643169869783 211991482 BB9E16R4  00643169861534 211914227 SSHY9M26R  00643169869516 211974259 BB9L66R  00643169872127 212020797 BB9L72R1  00643169736283 212028295 BB8S37R11  00643169776807 212028317 BB7X32R12  00643169546431 212028362 BB8C09R4  00643169786042 212028304 BB8Y15R1  00643169471597 212028389 BB4W65R13  00643169793699 212073805 BB8C33R6  00643169792036 211846376 BB8N34R5  00643169631649 212021402 BB8T05R1  00643169587106 212073934 HY0W84R28  00643169862920 211991252 HY8H59R17  00643169845121 212073924 BB4B15R13  00643169648111 211885327 BB8A57R11  00643169741720 211804528 BB3M00R29  00643169700284 211807907 HY1F66R18  00643169766839 211957793 BB8D44R4  00643169518131 211957865 HY8B26R4  00643169463929 211885289 BB5Z97R14  00643169714229 211991298 BB7U21R17  00643169617971 211918715 BB4Z62R17  00643169648111 211991256 BB8A57R11  00643169463929 211991381 BB5Z97R14  00643169724457 211892942 BB9B43R2  00643169862036 211951238 BB9H96R  00643169552852 211991198 BB8L58R3  00643169430143 212028385 BB1S56R19  00643169467873 211957783 BB7J04R9  00643169860322 212028306 BB8E47R15  00643169711945 212028358 BB8T77R2  00643169661295 212028419 HY8M65R2  00643169869820 212046220 HY7G33R8  00643169842441 212073804 HY8R55R3  00643169839274 212073871 HY5V41R19  00643169652941 2",11/16/2016,"11/16/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75796,"Ongoing","Ultradent Products, Inc.","505 W 10200 S",".","South Jordan","UT","84095-3800","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Worldwide Distribution - US Nationwide","Z-0704-2017","Class II","UltraSeal XT Plus Clear Refill.  The package contains 4x 1.2 ml UltraSeal XT Plus.    Product Usage:  The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.  ","31","There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T.  The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.","12/03/2016",," Lot BD79T",11/17/2016,"11/17/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75797,"Terminated","Taiwan Seafood & Fish Corporation","733 Gladys Ave",".","Los Angeles","CA","90021-1413","United States","Voluntary: Firm Initiated","Telephone","US: NY, CA, MA,","F-0678-2017","Class II","Yellowfin Tuna Ground Meat, 22 lbs./case, 5500 lbs    Two boxes per case, 11 one pound packages per box, 22 one pound packages per case  ","250 cases (5500 lbs.)","Taiwan Seafood & Fish Corp initiated a recall of the ground Yellowfin tuna due to high levels of histamine.","12/08/2016","12/08/2016"," 6037",10/3/2016,"10/03/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75798,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide)and the following countries: Afghanistan, Albania, Algeria, Argentina, Aruba, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg, Brazil, British Guyana, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Rep., Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Great Britain, Grenada, Guatemala, Honduras, Hungary, Iceland,  India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico,  Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines,  Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, South Africa, South Korea, Suriname, Switzerland, Syria, Taiwan, Tadjikistan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0884-2017","Class II","IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK    For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.","4705 kits (US: 390 kits; OUS: 4315 kits)","Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use. ","12/22/2016",," All lots  LKPS1/LKPS5 - Lots 443, 445, 446  LKPTS1 - Lot D116",11/18/2016,"11/18/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75798,"Ongoing","Siemens Healthcare Diagnostics, Inc.","511 Benedict Ave",,"Tarrytown","NY","10591-5005","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide)and the following countries: Afghanistan, Albania, Algeria, Argentina, Aruba, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg, Brazil, British Guyana, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Rep., Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Great Britain, Grenada, Guatemala, Honduras, Hungary, Iceland,  India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico,  Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines,  Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, South Africa, South Korea, Suriname, Switzerland, Syria, Taiwan, Tadjikistan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.","Z-0885-2017","Class II","IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK    For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.","6697 kits (US: 1646 kits; OUS: 5081 kits)","Siemens Healthcare Diagnostics confirmed that the  IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use. ","12/22/2016",," All lots  L2KPS2/L2KPS6 - Lots 408, 409, 410  L2KPTS2/L2KPTS6 - Lots D112, D123, D124",11/18/2016,"11/18/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75799,"Ongoing","HANDY SEAFOOD INCORPORATED","700 E Main St",".","Salisbury","MD","21804-5037","United States","Voluntary: Firm Initiated","E-Mail","Gloucester, MA. (product further distributed by consignee to stores in CT, ME, MA, NH, RI)","F-0614-2017","Class II","Handy Seafood, Blue Crab Cake Mini, Mini Crab Cakes, 0.5oz per Cake/12 Cakes per Tray, Skin Packed Tray, 12 Trays per Case, 2 Year Shelf Life, Best By Nov 9, 2018.","71 Cases Distributed to Whole Foods North Atlantic","Handy Seafood states that they are initiating this recall of  Blue Crab Cake Mini, Mini Crab Cakes due to Milk (due to Butter in the ingredient statement) and Anchovies (in the Worcestershire Sauce) were not declared in the allergens statement on the package.  ","12/07/2016",," 116314  Best By Nov 9, 2018    ",11/22/2016,"11/22/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75801,"Ongoing","Green Dirt Farm, LLC","20363 Mount Bethel Rd",".","Weston","MO","64098-9074","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide through internet sales and other retail locations via distributor.","F-0623-2017","Class II"," sheep's milk cheese packaged in cases of 8, 4-6 oz.. units, sold by case weight. Made by Green Dirt Farm, LLC, Weston, MO 64098.","8 cases - 21.9 lbs.","Product is contaminated with Staphylococcus aureus exceeding action limit of 10,000 cfu/g.","12/08/2016",," lot 3316312, exp. date 2/6/2017",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75801,"Ongoing","Green Dirt Farm, LLC","20363 Mount Bethel Rd",".","Weston","MO","64098-9074","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product was distributed nationwide through internet sales and other retail locations via distributor.","F-0622-2017","Class II"," blended milk cheese packaged in cases of 6, 10 - 12 oz.. units, sold by case weight. Made by Green Dirt Farm, LLC, Weston, MO 64098.","31 cases:  147 lbs","Product is contaminated with Staphylococcus aureus exceeding action limit of 10,000 cfu/g.","12/08/2016",," lot 3316260, exp date 12/15/2016;  lot 3316274, exp. date 12/30/2016;  lot 3316288, exp. date 1/13/2017;  and lot 3316302, exp. date 1/27/2017;  ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75802,"Ongoing","Becton Dickinson & Company","1 Becton Dr",,"Franklin Lakes","NJ","07417-1815","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0740-2017","Class II","BD Spinal Anesthesia Tray  The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure   ","4500","BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot  B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot Epidural Tray,  Cat (Ref) 406069.","12/12/2016",," B01K089D",11/7/2016,"11/07/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75805,"Ongoing","Calbee North America, LLC","72600 Lewis & Clark Dr",".","Boardman","OR","97818","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","F-0609-2017","Class I","HARVEST SNAPS, SNAPEA CRISPS, BLACK PEPPER FLAVORED GREEN PEA CRISPS, NET WT 3.3 OZ (93g)","3588 units","One lot of black pepper flavored green pea crisps may contain wasabi ranch flavored green pea crisps which contain milk which is not declared on the black pepper flavored product.","12/07/2016",," MAR3117 0141S, Exp 2017-03-31 ",11/16/2016,"11/16/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75806,"Terminated","Coliman Pacific Corp","4151 W Lindbergh Way",,"Chandler","AZ","85226-4719","United States","Voluntary: Firm Initiated","Letter","US: CA, AZ,","F-0768-2017","Class I","Jalapeno Peppers, 40lbs (19 kg) per case, 1 1/9 Bushel Box, 49 cases per pallet ","637 cartons","Coliman Pacific Corp is recalling Jalapeno Peppers because they may be contaminated with Salmonella.","12/19/2016","12/27/2016"," Lot No. 252414, No PLU",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75807,"Ongoing","Midwest International Corp","47 Bridgewater St # 57",,"Brooklyn","NY","11222-3820","United States","Voluntary: Firm Initiated","Letter","MA, IL, & TX thru 4 retail stores","F-0788-2017","Class II","DRIED VEGETABLE, NET WT: 17.6oz (500g)","100 cartons/25 units","The product is an acidified food without a registered manufacturer and scheduled process","12/19/2016",," Best Before: Feb.10.2017",11/23/2016,"11/23/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75809,"Completed","Linnane & Co","44 Rabbit Rd",,"Salisbury","MA","01952-1824","United States","Voluntary: Firm Initiated","Telephone","MA","F-0560-2017","Class II","Rissois De Camarao Cong. Frozen Shrimp Cakes, Frozen 50 count. Net Weight: 4,50Kg (2 x 2,25Kg)  Country of Origin: PORTUGAL ","48 cases","Failure to declare ingredients in English: allergens (soy, sulfite, yellow #5, and MSG ) and unpermitted food color E124 - Ponceau 4R","12/19/2016",," Batch: 031.016  Best before: 22 Mar 2018",11/9/2016,"11/09/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0665-2017","Class II","WHOLE MILK CHEESE 8/6# MAGIC MOZZI;           Pasteurized Milk, Cheese Cultures, Salt, Enzymes.    UPC:    #075805890378    Saputo code:  #989037            ","7939.89 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017008      ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0667-2017","Class II","MOZZARELLA SUPREME 8/6# CONTADINO ;           Pasteurized Milk, Cheese Cultures, Salt, Enzymes.  UPC:    #075805888825    Saputo code:  #988882            ","9934.45 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017011          ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0662-2017","Class II","MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# CHEESECAKE FACTORY TCCFI;           Pasteurized Milk, Cheese Cultures, Salt, Enzymes.    UPC: #    #075805884759    Saputo code:  #988475            ","26563.14 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017025  ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0661-2017","Class II","WHOLE MILK CHEESE 8/6# ARREZZIO CLASSIC;         Pasteurized Milk, Cheese Cultures, Salt, Enzymes.  UPC: #    #074865692694       Saputo code:  #987371     ","1312.12 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017005  ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0657-2017","Class II","MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# DRAGONE    ;  Low moisture Mozzarella Cheese Pasteurized Milk, Cheese Cultures, Salt, Enzymes.    UPC: #070348121002             Saputo code:   #112100       ","3541.98 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017028  ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0660-2017","Class II","MOZZARELLA LOW MOISTURE WHOLE MILK 8/6#    ROSELI;         Pasteurized Milk, Cheese Cultures, Salt, Enzymes.  US Foods    UPC: #    #758108015111        Saputo code:  #984639                 ","34985.97 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017033  ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0658-2017","Class II","MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# ANTONIO     Pasteurized Milk, Cheese Cultures, Salt, Enzymes.  UPC: #  #90075805843919           Saputo code:   #984391              ","3971.43 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017029    ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0664-2017","Class II","MOZZARELLA STYLE LOW MOISTURE WHOLE MILK 8/6# HARVEST VALUE;           Pasteurized Milk, Cheese Cultures, Salt, Enzymes.  UPC:     #758108633766    Saputo code:  #988995            ","1972.76 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017013    ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0666-2017","Class II","WHOLE MILK CHEESE 8/6# VESUVIO BELLA;           Pasteurized Milk, Cheese Cultures, Salt, Enzymes.  Distributed by US Foods  UPC:    #075805891658    Saputo code:  #989165            ","6722.93","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017002        ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0655-2017","Class II","MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# ARREZZIO IMPERIAL;  UPC: 0 74865 30185 5  Saputo code: #101379 ;  ","1981.56 lbs,","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016;  Lot #8861017030  ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0656-2017","Class II","WHOLE MILK CHEESE 8/6# LA GONDOLA;  Mozzarella Cheese Pasteurized Milk, Cheese Cultures, Salt, Enzymes.    UPC: #075805010141    Saputo code: #1014 ;          ","1582.24 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017006  ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0659-2017","Class II","MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# CHUCK E CHEESE            Pasteurized Milk, Cheese Cultures, Salt, Enzymes.    UPC: #  #075805845347            Saputo code:   #984534          ","50804.490 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017017  ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0668-2017","Class II","ITALIAN WHITE TRIM;           Pasteurized Milk, Cheese Cultures, Salt, Enzymes.  UPC:    #063549076820      Saputo code:  #107682    ","558 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot #8861017022            ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75811,"Ongoing","Saputo Cheese USA, Inc.","901 E Levin Ave",".","Tulare","CA","93274-6525","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributors AL, AZ. CA, FL, GA, IA, IL, IN, KS, MI, MN, MO, MS. NJ, NJ. NM. NY, OH,  OK, OR, PA,, SC,  TN, TX, UT, WA","F-0663-2017","Class II","WHOLE MILK CHEESE 8/6# MOZZERIA - Saputo;           Pasteurized Milk, Cheese Cultures, Salt, Enzymes.    UPC:     #075805888948      Saputo code:  #988947            ","4766.14 lbs.","Firm received one consumer complaint of white plastic found in a loaf of cheese ","12/08/2016",," Expiration date: 20161201 - December 1, 2016  Lot  #8861017015  ",11/23/2016,"11/23/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75812,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0742-2017","Class II","SOMATOM Definition AS System, x-ray, tomography, computed  Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.","104 systems","Software update that provides software and firmware bug-fixes to improve system performance ","12/12/2016",," Serial Numbers: 65127  95798  73739  83277  66219  65491  65453  95738  96357  65615  73726  66467  64860  73860  65712  65304  65437  65614  65856  96305  73296  73831  83403  73840  64709  96335  73673  65639  95003  65501  96351  73778  96028  96316  83520  96288  66396  96238  96352  96324  96336  65480  96312  95768  73777  95955  73883  83399  73783  96226  96303  96047  65609  73791  73887  73071  96266  95701  74368  83537  73895  96214  95925  96347  96061  83533  74226  74297  65760  74376  65017  65516  73162  64065  65455  83524  66041  65618  73818  66066  73028  83306  65680  65734  73905  95797  65672  73886  96302  83398  73538  95717  96053  65972  95278  96326  96327  96286  95447  74200  74289  96364  95510  64140  ",11/15/2016,"11/15/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75812,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0743-2017","Class II","SOMATOM Definition Flash System, x-ray, tomography, computed  Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles","104 systems","Software update that provides software and firmware bug-fixes to improve system performance ","12/12/2016",," Serial Numbers: 65127  95798  73739  83277  66219  65491  65453  95738  96357  65615  73726  66467  64860  73860  65712  65304  65437  65614  65856  96305  73296  73831  83403  73840  64709  96335  73673  65639  95003  65501  96351  73778  96028  96316  83520  96288  66396  96238  96352  96324  96336  65480  96312  95768  73777  95955  73883  83399  73783  96226  96303  96047  65609  73791  73887  73071  96266  95701  74368  83537  73895  96214  95925  96347  96061  83533  74226  74297  65760  74376  65017  65516  73162  64065  65455  83524  66041  65618  73818  66066  73028  83306  65680  65734  73905  95797  65672  73886  96302  83398  73538  95717  96053  65972  95278  96326  96327  96286  95447  74200  74289  96364  95510  64140  ",11/15/2016,"11/15/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75812,"Ongoing","Siemens Medical Solutions USA, Inc","40 Liberty Blvd",,"Malvern","PA","19355-1418","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0744-2017","Class II","SOMATOM Definition Edge System, x-ray, tomography, computed  Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles","104 systems","Software update that provides software and firmware bug-fixes to improve system performance ","12/12/2016",," Model # 10590000  Serial Numbers: 65127  95798  73739  83277  66219  65491  65453  95738  96357  65615  73726  66467  64860  73860  65712  65304  65437  65614  65856  96305  73296  73831  83403  73840  64709  96335  73673  65639  95003  65501  96351  73778  96028  96316  83520  96288  66396  96238  96352  96324  96336  65480  96312  95768  73777  95955  73883  83399  73783  96226  96303  96047  65609  73791  73887  73071  96266  95701  74368  83537  73895  96214  95925  96347  96061  83533  74226  74297  65760  74376  65017  65516  73162  64065  65455  83524  66041  65618  73818  66066  73028  83306  65680  65734  73905  95797  65672  73886  96302  83398  73538  95717  96053  65972  95278  96326  96327  96286  95447  74200  74289  96364  95510  64140  ",11/15/2016,"11/15/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75814,"Terminated","UMTB Biomedical, Inc.","1951 NW 7th Ave Ste 200",".","Miami","FL","33136-1131","United States","Voluntary: Firm Initiated","E-Mail","Korea, Republic Of(South)","B-0206-2017","Class II","Cartilage","5 allografts","Human tissue allografts, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. ","12/07/2016","12/07/2016"," UFR0167760024; UFR0167760025; UFR0167760021; UFR0167760022; UFR0167760023; ",10/13/2016,"10/13/2016",12/14/2016,"12/14/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75815,"Terminated","Belle Bonfils Memorial Blood Center","717 Yosemite St",,"Denver","CO","80230-6918","United States","Voluntary: Firm Initiated","FAX","Colorado","B-0210-2017","Class III","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, manufactured without additive solution, was distributed.","12/14/2016","12/14/2016"," W036216752363",10/15/2016,"10/15/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75816,"Ongoing","Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.","87 Venture Dr",,"Dover","NH","03820-5914","United States","Voluntary: Firm Initiated","Letter","US distribution in the state of CA","Z-0787-2017","Class II"," Microbore extension set with slide clamp; Product Code: AMS-651    Product Usage:  Accessory devices used to administer medical fluids.  ","31,500","Incorrect priming volume is printed on the device package. ","12/18/2016",," 1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D",11/18/2016,"11/18/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75819,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).","Z-0872-2017","Class II"," A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.","1,257 in total","Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. ","12/21/2016",," Lot Number:16060017, Product Number: 8450-010-040  ",11/30/2016,"11/30/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75819,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).","Z-0869-2017","Class II"," A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.","1,257 in total","Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. ","12/21/2016",," Lot Number:16056017, Product Number: 8450-107-525    ",11/30/2016,"11/30/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75819,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).","Z-0873-2017","Class II"," A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.","1,257 in total","Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. ","12/21/2016",," Lot Number:16032017, Product Number: 8450-009-030  ",11/30/2016,"11/30/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75819,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).","Z-0874-2017","Class II"," A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.","1,257 in total","Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. ","12/21/2016",," Lot Number:16029017, Product Number: 8450-009-040  ",11/30/2016,"11/30/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75819,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).","Z-0868-2017","Class II"," A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.","1,257 in total","Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. ","12/21/2016",," Lot Number:16032017, Product Number: 8450-009-030    ",11/30/2016,"11/30/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75819,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).","Z-0870-2017","Class II"," A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.","1257 in total ","Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. ","12/21/2016",," Lot Number(s):16049017 & 16053017, Product Number: 8470-009-030    ",11/30/2016,"11/30/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75819,"Ongoing","Stryker Instruments Div. of Stryker Corporation","4100 E Milham Ave",,"Portage","MI","49002-9704","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).","Z-0871-2017","Class II"," A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.","1,257 in total","Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion. ","12/21/2016",," Lot Number:16038017, Product Number: 8470-009-040  ",11/30/2016,"11/30/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75820,"Ongoing","Stryker Medical Division of Stryker Corporation","3800 E Centre Ave",,"Portage","MI","49002-5826","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution to AK, AL , AR , AZ , CA , CT , DC , DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA , RI, SC, TN, TX, UT,VA, VT ,WA ,WV ,WY and Internationally to Canada and the Netherlands","Z-0739-2017","Class II","Performance-LOAD Ambulance Cot Fastener  Stretcher, Wheeled","749 units","Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back during loading which could cause injury to consumers.","12/12/2016",," Model(s): 6392-000-001, 6392-000-002, 6393-000-003, 6393-000-004; GTIN: 07613327282542, 07613327282603, 07613327282597, 07613327282610      ",11/8/2016,"11/08/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75821,"Terminated","LifeSouth Community Blood Centers, Inc.","1221 NW 13th St",,"Gainesville","FL","32601-4111","United States","Voluntary: Firm Initiated","FAX","Alabama","B-0211-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Apheresis product, in which platelet yield did not meet specifications, was distributed.","12/14/2016","12/14/2016"," W115116219887Y",9/28/2016,"09/28/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75822,"Terminated","Carter BloodCare","2205 Highway 121",,"Bedford","TX","76021-5950","United States","Voluntary: Firm Initiated","Letter","Texas","B-0212-2017","Class II","Apheresis Red Blood Cells, Leukocytes Reduced","2 units","Apheresis products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","12/14/2016","12/14/2016"," W035216100799I (double collection)",11/22/2016,"11/22/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75823,"Terminated","DCI Biologicals Greenville, Inc","2727 E 10th St",,"Greenville","NC","27858-3127","United States","Voluntary: Firm Initiated","E-Mail","North Carolina","B-0213-2017","Class III","Source Plasma","1 unit","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","12/14/2016","12/14/2016"," GL0686133",11/10/2016,"11/10/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75825,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated",,"Nationwide Distribution","Z-0729-2017","Class II","Merge Cardio software.     Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.","198 sites potentially have the effected versions","If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).","12/09/2016",," Versions:   8.30.0, 8.30.1, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, and 10.1.1",3/28/2016,"03/28/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75826,"Ongoing","Ecolab Inc","370 Wabasha St N",,"Saint Paul","MN","55102-1323","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA..","Z-0753-2017","Class III","Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.","40 cases (144 eaches per box)","The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The  manufacturing date was inadvertently used as the expiration date on the inner carton box labels.","12/14/2016",," 15302",11/30/2016,"11/30/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75828,"Ongoing","Synthes (USA) Products LLC","1301 Goshen Pkwy",,"West Chester","PA","19380-5986","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-0867-2017","Class II","Synthes VA Implant Rack for the Compact Distal Radius System  Tray/Surgical/Instrument","31 units","The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.","12/21/2016",," Catalog ID (part # 60.119.012), Lot Number FL00528",11/29/2016,"11/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75831,"Ongoing","Baxter Healthcare Corporation","1 Baxter Pkwy",,"Deerfield","IL","60015-4625","United States","Voluntary: Firm Initiated","Letter","United States, United Arab Emirates, and Colombia","D-0206-2017","Class II","Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.","30,910 bags","Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.   ","12/19/2016",," Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017",12/6/2016,"12/06/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75832,"Ongoing","Ultimate Body Tox","PO Box 637",,"Rowland","NC","28383-0637","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Product distributed in NC and nationwide through the internet.","D-0210-2017","Class I","Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY  10007.","25 bottles","Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.","12/22/2016",," All lots and manufacturing dates.",11/13/2016,"11/13/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75836,"Ongoing","Radiometer America Inc","250 S Kraemer Blvd",,"Brea","CA","92821-6232","United States","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.","Z-0899-2017","Class II","AQURE System   Software Version 2.2.0  Model #: 933-599  UDI: (01)05700699335999(10)2.2.0   Catalog number: 933-599  The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.","7 total (2 in US)","Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.","12/22/2016",," UDI: (01)05700699335999(10)2.2.0",11/23/2016,"11/23/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75839,"Terminated","Innovative Blood Resources","100 N 84th St",,"Lincoln","NE","68505-3101","United States","Voluntary: Firm Initiated","FAX","Illinois","B-0218-2017","Class II","Red Blood Cells, Leukocytes Reduced","1 unit","Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.","12/14/2016","12/14/2016"," W087914309176",10/31/2016,"10/31/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75844,"Ongoing","Philips Electronics North  America Corporation","3000 Minuteman Rd",,"Andover","MA","01810-1032","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand","Z-0825-2017","Class II","Ingenia MR-OR; 781437, 781438  The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite","9","Possibility that a patient or user may be exposed to a very small level of touch current.","12/19/2016",," 781437: 15001, 15002, 15003  781438: 30001, 30002, 30003, 30004, 30005, 30006  ",12/1/2016,"12/01/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75847,"Ongoing","Preferred Meal Systems, Inc.","5240 Saint Charles Rd",,"Berkeley","IL","60163-1341","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, IL","F-0765-2017","Class II","Preferred Meals, Cook and Serve, Cavatappi Pasta with Mascarpone Tomato Cream Sauce; 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY","95,364 individual units","Possible contamination of product with Listeria monocytogenes. ","12/16/2016",," Lot 50329-16251, 50329-16252, 50329-16253, 50326-16254, 50329-16261",11/29/2016,"11/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75847,"Ongoing","Preferred Meal Systems, Inc.","5240 Saint Charles Rd",,"Berkeley","IL","60163-1341","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","AZ, IL","F-0764-2017","Class II","Preferred Meals, Cook and Serve, Creamy Red Pepper Sauce and Cheese Tortellini with Parmesan Cheese, 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY","35,964 individual units ","Possible contamination of product with Listeria monocytogenes. ","12/16/2016",," Lot 50325-16095; 50325-16261",11/29/2016,"11/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75848,"Ongoing","Two Chefs On A Roll, Inc","18201 Central Ave",,"Carson","CA","90746-4007","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following Trader Joe's store locations; IA, IL, IN, KS, KY, MI, MN, MO, NE, OH, WI, AL, AZ, CA, CO, FL, GA, ID, LA, NC, NM, NV, OK, OR, SC, TN, TX, UT, VA and WA.    No foreign distribution.","F-0749-2017","Class I","Trader Joe's White Bean & Basil Hummus  SKU #91107","1249 cases","Potential Listeria monocytogenes contamination.","12/15/2016",," Use By Date up through December 15, 2016",12/1/2016,"12/01/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75848,"Ongoing","Two Chefs On A Roll, Inc","18201 Central Ave",,"Carson","CA","90746-4007","United States","Voluntary: Firm Initiated","Press Release","U.S. distribution to the following Trader Joe's store locations; IA, IL, IN, KS, KY, MI, MN, MO, NE, OH, WI, AL, AZ, CA, CO, FL, GA, ID, LA, NC, NM, NV, OK, OR, SC, TN, TX, UT, VA and WA.    No foreign distribution.","F-0748-2017","Class I","Trader Joe's Mediterranean Hummus  SKU #90642","9895 cases","Potential Listeria monocytogenes contamination.","12/15/2016",," Use By Date up through December 15, 2016",12/1/2016,"12/01/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75853,"Ongoing","Elekta, Inc.","400 Perimeter Center Ter NE Ste 50",,"Atlanta","GA","30346-1227","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution-US (nationwide) to states of: FL, IL, MO, NJ, OH, OK, TN, TX, VA, and countries of:  Italy, Japan, South Korea, Sweden and United Kingdom.","Z-0731-2017","Class II","MOSAIQ  Oncology Information System    The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.","47","Edits to Particle field definition parameters may not be saved when the field definition window is saved. ","12/09/2016",," Versions 2.60 an higher",12/2/2016,"12/02/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75855,"Ongoing","Amendia, Inc","1755 W Oak Pkwy",,"Marietta","GA","30062-2260","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : GA. MI, OK, SC, TX, VA","Z-0827-2017","Class II","Zeus-P Lumbar Interbody Device","25 units","Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match.  The primary label matched the label on the inner pouch, but the patient label was incorrect.","12/20/2016",," Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946  ",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75856,"Ongoing","Amendia, Inc","1755 W Oak Pkwy",,"Marietta","GA","30062-2260","United States","Voluntary: Firm Initiated","Letter","US Distribution to the states of : FL, GA. IL, MO, TX","Z-0891-2017","Class II","Optimus Fixed Awl","9 devices","Complaints that the tip of the awl broke after impaction during surgery.","12/22/2016",," Part Number 139005 - Lot Number 182-16146 ",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75858,"Ongoing","Amendia, Inc","1755 W Oak Pkwy",,"Marietta","GA","30062-2260","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico","Z-0881-2017","Class II"," Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U  The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone","5833 units","The rods are packaged in packages with unacceptable seals.  In some cases, the integrity of the seal is compromised by channels or voids.","12/22/2016",," Part Number 9080-12U  Lot Number 121306, 121307, 122628, 122721, 124400, 132732, 135403; Part Number 9080-18T  Lot Number 122486, 122626, 123957, 124408, 127435, 129132, 129803, 129935, 131072, 135560, 135566, 135567; Part Number 9080-18U  Lot Number 122470, 123948, 129802, 129936, 130390, 130391, 131073; Part Number 9080-24T  Lot Number 133359; Part Number 9080-24U  Lot Number 134108, 134112, 134908; Part Number 9080B-18T  Lot Number 124547, 126820, 127437, 131454, 132592, 134181, 135401; Part Number 9080B-18U  Lot Number 122468, 123938, 126504, 127436, 129800, 130947, 131453, 132750, 133645, 134169, 134907, 135563, 135578, 135579, 135580; Part Number 9080B-24U  Lot Number 122239, 130392, 130393, 131839, 133988, 135359, 135360, 135400; Part Number 9080B-N-18T  Lot Number 124137, 125331, 128472, 130612, 132229, 135584, 135585, 137464; Part Number 9080B-N-18U  Lot Number 123556, 125199, 126821, 128348, 128469, 129443, 129915, 130836, 131626, 133118, 134180, 135208; Part Number 9080L-18U  Lot Number 127877, 128351, 130389, 130946, 133261, 135210, 135593; Part Number 9080-N-18T  Lot Number  122488, 123863, 130914; Part Number 9080-N-18U  Lot Number  122487, 123564, 124402, 126125, 129005, 129077, 133499, 135562, 137462.",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75858,"Ongoing","Amendia, Inc","1755 W Oak Pkwy",,"Marietta","GA","30062-2260","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico","Z-0883-2017","Class II","Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200     The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone","240 units","The rods are packaged in packages with unacceptable seals.  In some cases, the integrity of the seal is compromised by channels or voids.","12/22/2016",," Part Number 10704-200  Lot Number 124422, 129766, 130739, 132430; Part Number 10704-250  Lot Number 129790, 130738, 131211, 131309, 131310, 131509, 132811; Part Number 10704-300  Lot Number 129862, 134229; Part Number 10704-400  Lot Number 129861, 130145, 130147, 130502, 131499, 131646; Part Number 10704-500  Lot Number 127934, 127937, 129770, 129863, 130130, 130143, 130781, 134228; Part Number 10705-200  Lot Number 122654, 123583, 129773, 130131, 132153, 132154, 132762; Part Number 10705-220  Lot Number 128818, 131311, 132881; Part Number 10705-240  Lot Number 130500; Part Number 10705-260  Lot Number 121521, 131500, 132199; Part Number 10705-280  Lot Number 121519, 130740; Part Number  10705-300  Lot Number 130140, 130332, 134299; Part Number 10706-200  Lot Number  128522, 129567, 129781, 129891, 130741; Part Number 10707-200  Lot Number 128815, 129782, 129783, 129784, 130182, 131410, 132880. ",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75858,"Ongoing","Amendia, Inc","1755 W Oak Pkwy",,"Marietta","GA","30062-2260","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico","Z-0882-2017","Class II","Dual Stylet Needle, Part Number 812-11R-15  The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone","1078 units","The rods are packaged in packages with unacceptable seals.  In some cases, the integrity of the seal is compromised by channels or voids.","12/22/2016",," Part Number 812-11R-15  Lot Number 121945, 123231, 124146, 125418, 126822, 127868, 128459, 128464, 130818, 131492, 13496, 132594, 132813, 134514, 134515, 134517, 134909, 135290, 137302  ",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75862,"Ongoing","PerkinElmer Health Sciences, Inc.",,,,,,,"Voluntary: Firm Initiated","Letter","MA, AK","Z-0897-2017","Class III"," EnLite instrument.  The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U  ","73 kits","Unique Device Identifier (UDI) is missing from outer kit box label. ","12/22/2016",," Lot Number: 1065060401",12/5/2016,"12/05/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75863,"Ongoing","Accuray Incorporated","1310 Chesapeake Ter",,"Sunnyvale","CA","94089-1100","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Distribution to the states of : PA, WA, MT, NY, SC, CA, MN, AK, NJ, FL, KY, WI., and to the countries of : Bulgaria, Canada, France, Germany, India, Japan, Luxembourg, Netherlands, Portugal, Switzerland and Turkey","Z-0734-2017","Class II","CyberKnife Robotic Radiosurgery System using software version 10.6;  Catalog/Part Number: 54000  UDI: M658053301 0    Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when  radiation treatment is indicated.","40 affected devices","Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife¿ Systems with software version 1 0.6.  ","12/12/2016",," Catalog/Part Number: 54000  manufacturing or serial number of UDI: M658053301 0;  Serial numbers:   C0330  C0334  C0336  C0338  C0342  C0344  C0348  C0349  C0351  C0358  C0359  C0360  C0361  C0363  C0364  C0366  C0367  C0370  C0372  C0376  C0387  C0389  C0390  C0391  C0393  C0394  C0395  C0396  C0397  C0398  C0400  C0402  C0404  C0406  C0407  C0408  C0409  C0410  C0413  C0414  ",11/22/2016,"11/22/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75864,"Ongoing","ARON STREIT INC","171 Route 303",,"Orangeburg","NY","10962-2209","United States","Voluntary: Firm Initiated","E-Mail","IL, MD, CA, & IL","F-0945-2017","Class II","Streit's Quinoa with Mushrooms & Herbs, Net Wt. 7.7 oz (220g). Product of Israel","162 cases","The Commonwealth of Virginia sampled the product and revealed the presence of undeclared sulfites at 57 ppm and 10 ppm","12/21/2016",," Lot numbers: 0045 & 2743",11/18/2016,"11/18/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75867,"Terminated","LifeSouth Community Blood Centers, Inc.","1221 NW 13th St",,"Gainesville","FL","32601-4111","United States","Voluntary: Firm Initiated","FAX","Florida","B-0226-2017","Class II","Platelets, Pathogen Reduced","1 unit","Platelet product, for which quality control testing did not meet specifications, was distributed.","12/20/2016","12/20/2016"," W115116239390K ",10/29/2016,"10/29/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75868,"Terminated","Lifesouth Community Blood Centers - Montgomery Region","4139 Carmichael Rd",,"Montgomery","AL","36106-2803","United States","Voluntary: Firm Initiated","FAX","Alabama","B-0227-2017","Class II","Apheresis Platelets, Leukocytes Reduced","1 unit","Platelet component, for which product QC was unacceptable, was distributed.","12/20/2016","12/20/2016"," W1151162652632",10/25/2016,"10/25/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75869,"Ongoing","Amendia, Inc","1755 W Oak Pkwy",,"Marietta","GA","30062-2260","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to IN, LA, and TX","Z-0886-2017","Class II","Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123   The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region","48 units","There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.  ","12/22/2016",," Part Number TBP119  Lot Number WT103014B, WT112210B, 01838, WT111213A, WT040813A, WT042213C; Part Number TB123  Lot Number NM01839, WT080112A, WT081712E, WT112210C, WT112113A, WT112713B, WT110714A, WT1127, 09286, WT041213A, WT112713",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75869,"Ongoing","Amendia, Inc","1755 W Oak Pkwy",,"Marietta","GA","30062-2260","United States","Voluntary: Firm Initiated","Letter","Nationwide Distribution to IN, LA, and TX","Z-0887-2017","Class II","Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030  The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region","96 units","There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.  ","12/22/2016",," Part Number TBS020  Lot Number 0825R, NM01836, WT090314A, 09281, 09282, 09285, WT040412A, 08344, 09154, 09281R, NM01836R;  Part Number TBS025  Lot Number 09161, 09286R, WT090314B, WT112613B, 08218, 08337, 09287R, NM01837, 08216; Part Number TBS030  Lot Number 08218, WT011711B, WT071014A",11/22/2016,"11/22/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75870,"Ongoing","Phil-Am Trading, Inc.","324 Hoboken Ave",,"Jersey City","NJ","07306-1614","United States","Voluntary: Firm Initiated","Press Release","GA, NY, NJ &PA","F-0767-2017","Class I","Phil-Am Smoked Mackerel (Hasa Hasa) Net. Wt. 200g (7.05 oz.)   packaged: Clear flexible plastic pouch and is topped by a predominantly red tag affixed to the top seal which has the products information.","25 cases (40 pieces in each case)","Phil-am Trading, Inc.  is recalling Phil-am Smoked Mackerel (Hasa-Hasa), because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death.","12/19/2016",," distribution dates -February and November 2016;    no codes on product",12/2/2016,"12/02/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75877,"Terminated","American National Red Cross (The), Lewis and Clark Region","6616 S 900 E",,"Salt Lake City","UT","84121-2492","United States","Voluntary: Firm Initiated","E-Mail","California","B-0185-2017","Class III","Blood and Blood Products for Reprocessing","2 units","Blood products, for which donor screening was performed incorrectly, were distributed.","12/20/2016","12/20/2016"," W202015280811; W202014150206",9/1/2016,"09/01/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75879,"Ongoing","Clif Bar & Company","1451 66th St",,"Emeryville","CA","94608-1004","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US distribution only.","F-0719-2017","Class II","Chocolate Hazelnut Butter CLIF¿ Nut Butter Filled Energy Bars; NET WT: 1.76 oz (50 g).  Packages in boxes of 12 individual bars.  UPC - bar: 7 22252 26800 6;  UPC - 12 count box: 7-22252-36800-3;  UPC-case: 00722252-56800-7    Distributed by Clif Bar & Company, Emeryville, CA  Made in Canada","35,575 cartons (12 ct.)","Clif Bar & Company initiated a recall of one production run of Chocolate Hazelnut Butter Clif Nut Butter Filled Energy Bars after receiving complaints of foreign material in the product.","12/13/2016",," 10JUN17N4 and 11JUN17N4",11/18/2016,"11/18/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75885,"Ongoing","Midwest International Corp","47 Bridgewater St # 57",,"Brooklyn","NY","11222-3820","United States","Voluntary: Firm Initiated","FAX","CA, IL, NY, MD, MA, KY, TX and VA","F-0747-2017","Class II","Malayuguo, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)","80 cartons/20 units","The product is a low acid canned food (LACF) without a registered manufacturer and scheduled process.","12/19/2016",," Item # D566",12/7/2016,"12/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75885,"Ongoing","Midwest International Corp","47 Bridgewater St # 57",,"Brooklyn","NY","11222-3820","United States","Voluntary: Firm Initiated","FAX","CA, IL, NY, MD, MA, KY, TX and VA","F-0746-2017","Class II","Qiejidingxiangyu, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)","80 cartons/20 units","The product is a low acid canned food (LACF) without a registered manufacturer and scheduled process.","12/19/2016",," Item # D565",12/7/2016,"12/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75885,"Ongoing","Midwest International Corp","47 Bridgewater St # 57",,"Brooklyn","NY","11222-3820","United States","Voluntary: Firm Initiated","FAX","CA, IL, NY, MD, MA, KY, TX and VA","F-0745-2017","Class II","Heihujiaoyupai, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)","50 cartons/20 units","The product is a low acid canned food (LACF) without a registered manufacturer and scheduled process.","12/19/2016",," 2016/06/23  Item # D567",12/7/2016,"12/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75886,"Completed","Becton Dickinson & Co.","7 Loveton Cir","BD Diagnostic Systems","Sparks","MD","21152-9212","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of:  China, Europe, Hong Kong, India, Korea, Mexico, New Zealand, Panama, Singapore, and Taiwan.    480 US customers and 3 US distributors. Product was also shipped to 10 ex-US regions.     15 US government sites received affected product","Z-0877-2017","Class II","BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097.     SurePath¿ Preservative Fluid is designed for use with the PrepStain¿ System. SurePath¿ Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens.","16,682.396"," collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.  ","12/21/2016",," SurePath Collection Vial Replacement Cap, cat no. 490505  SurePath GYN Preservative Vial Kit, cat no. 490527  SurePath GYN Preservative Vial Kit with Cervex-Brush, cat no. 491095  SurePath GYN Preservative Vial Kit with Cervex-Brush Combi, cat no. 491096  SurePath GYN Preservative Vial Kit with Brush/Spatula, cat no. 491097  ",2/12/2016,"02/12/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75891,"Ongoing","Accuray Incorporated","1310 Chesapeake Ter",,"Sunnyvale","CA","94089-1100","United States","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US including CA. MN, OK. FL. MO, TN, KS, TX, AZ, MS, IA, MA. NC, NY. IN, NJ, VA. LA, WA, WI, PA. CT, G,. MT, MD, LA., WV, OH, and DC.  Foreign distribution to Taiwan, Japan, Korea, Turkey. Malaysia, Vietnam, Greece, China, Spain, France, Italy, Pakistan, and Georgia,","Z-0865-2017","Class II","CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI.    Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when  radiation treatment is indicated.   ","115 affected devices.","Accuray has become aware of a potential safety issue involving the possibility of electric shock during  maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.","12/21/2016",," models: G3, G4, VSI.  Serial numbers:  C0023  C0030  C0045  C0046  C0047  C0006  C0012  C0040  C0048  C0049  C0013  C0011  C0052  C0055  C0022  C0053  C0042  C0057  C0017  C0059  C0056  C0060  C0062  C0061  C0067  C0068  C0070  C0041  C0063  C0065  C0074  C0071  C0079  C0078  C0080  C0064  C0090  C0024  C0087  C0091  C0095  C0094  C0092  C0093  C0097  C0098  C0099  C0100  C0101  C0102  C0103  C0106  C0089  C0108  C0107  C0105  C0112  C0114  C0118  C0119  C0113  C0123  C0126  C0124  C0121  C0132  C0130  C0131  C0125  C0133  C0135  C0117  C0134  C0038  C0136  C0137  C0127  C0143  C0144  C0014  C0138  C0146  C0140  C0145  C0150  C0033  C0151  C0152  C0147  C0149  C0148  C0158  C0155  C0159  C0007  C0163  C0157  C0165  C0008  C0162  C0085  C0161  C0086  C0073  C0115  C0076  C0153  C0077  C0111  C0066  C0027  C0075  C0084  C0096  C0154.  ",12/6/2016,"12/06/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75892,"Ongoing","Stanmore Implants Worldwide Ltd.","210 Centennial Avenue Centennial Park","Centennial Park","Borehamwood",,,"United Kingdom","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA","Z-0821-2017","Class II","Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short  The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone","51 units","The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.","12/19/2016",," A10337,  A11525,  A7823,  A9990,  A11289,  A11979,  A12134,  A7186,  A8679,  A9743,  A10344,  A10629,  A10791,  A10348a,  A11198,  A11557,  A11895,  A12090,  A12129,  A12220,  A12223,  A12229",12/7/2016,"12/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75892,"Ongoing","Stanmore Implants Worldwide Ltd.","210 Centennial Avenue Centennial Park","Centennial Park","Borehamwood",,,"United Kingdom","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA","Z-0822-2017","Class II","Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm  The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone","11 units","The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.","12/19/2016",," B10191,  B10443,  B9920,  B10561,  B9921,  B9922  ",12/7/2016,"12/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75892,"Ongoing","Stanmore Implants Worldwide Ltd.","210 Centennial Avenue Centennial Park","Centennial Park","Borehamwood",,,"United Kingdom","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA","Z-0824-2017","Class II","DF Coated Integral Shaft & Stem    15x30x38; DF Coated Integral Shaft & Stem    15x36x44; DF Coated Integral Shaft & Stem    30x30x38; DF Coated Integral Shaft & Stem    30x36x44    The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone","15 units","The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.","12/19/2016",," B10586,  B11126,  B9875,  B9946,  B10751,  B11513,  B9874,  B10602,  B9876  ",12/7/2016,"12/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75892,"Ongoing","Stanmore Implants Worldwide Ltd.","210 Centennial Avenue Centennial Park","Centennial Park","Borehamwood",,,"United Kingdom","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA","Z-0823-2017","Class II","Femoral Integral Shaft & Stem  15x27  HA Coated; Femoral Integral Shaft & Stem  15x30  HA Coated; Femoral Integral Shaft & Stem  30x27  HA Coated; Femoral Integral Shaft & Stem  30x30  HA Coated  The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone    ","15 units","The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.","12/19/2016",," B10635,  B11820,  B12776,  B10636,  B10638,  B9866  ",12/7/2016,"12/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75892,"Ongoing","Stanmore Implants Worldwide Ltd.","210 Centennial Avenue Centennial Park","Centennial Park","Borehamwood",,,"United Kingdom","Voluntary: Firm Initiated","Letter","Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA","Z-0820-2017","Class II","Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short  The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone","13 units","The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.","12/19/2016",," A11290, A10107, A11828, A10610, A10765, A11439, A11922",12/7/2016,"12/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75896,"Ongoing","Fairway  Group Holding Corp dba  Fairway Bakery LLC","400 Walnut Ave",,"Bronx","NY","10454-2018","United States","Voluntary: Firm Initiated","E-Mail","New York, New Jersey and Connecticut and via the internet","F-0818-2017","Class II","FAIRWAY LIKE NO OTHER MARKET brand CANDY CORN, of varying weight, Item Code 228402 XXXXXX -- The product is packaged in clear, plastic cello bags of varying weights, each weighing less than one pound. --- PACKAGED BY FAIRWAY MARKET 2284 12TH AVE., NEW YORK, NY 10027","Unknown","The product may contain undeclared egg. ","12/21/2016",," All SELL BY Date codes ",12/6/2016,"12/06/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75907,"Ongoing","Chaos and Pain","2304 Craft Ln",,"Birmingham","AL","35242-5040","United States","Voluntary: Firm Initiated","E-Mail","Nationwide, China, Germany, Norway, UK, Canada, Ireland, Italy, Australia, New Zealand, Hong Kong,  Croatia","F-0766-2017","Class II","CANNIBAL FEROX AMPED, FACE-MELTING NOOTROPIC, PRE-WORKOUT ENERGY COMPLEX, STRAWBLOODY KIWI CRUSH, DIETARY SUPPLEMENT, NET. WT. 9.9 OZ (280g), Chaos and Pain, UPC 1056331460","277 units","Product was analyzed and found to contain 1,3- dimethylbutylamine which was not declared on the label and is a prohibited substance.","12/21/2016",," 1607016, EXP 07/2018",11/8/2016,"11/08/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Devices",75909,"Ongoing","Merge Healthcare, Inc.","900 Walnut Ridge Dr",,"Hartland","WI","53029-8347","United States","Voluntary: Firm Initiated","Other","Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI.  Foreign distribution was made to Canada, as well as other countries.","Z-0878-2017","Class II","Merge OrthoCase software.  The firm name on the label is Merge  Healthcare, Hartland, WI.","30 sites potentially have the effected versions","Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.","12/21/2016",," Versions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3",10/8/2015,"10/08/2015",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75913,"Ongoing","Haemonetics Corporation","400 Wood Rd",,"Braintree","MA","02184-2412","United States","Voluntary: Firm Initiated","Letter","Nationwide  Foreign:  Dubai, Egypt, Guam","B-0237-2017","Class II","Haemonetics El Dorado Donor  Blood Establishment Computer Software (BECS)","43 units","Blood bank software, with a defect or glitch, was distributed. ","12/22/2016",," Software versions: 1.0.0 and higher",12/7/2016,"12/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75920,"Terminated","UMTB Biomedical, Inc.","1951 NW 7th Ave Ste 200",,"Miami","FL","33136-1131","United States","Voluntary: Firm Initiated","Telephone","Massachusetts","B-0231-2017","Class II","Bone","1 allograft"," Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed. ","12/22/2016","12/22/2016"," UMP017016004216; ",10/20/2016,"10/20/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75930,"Ongoing","Real Fudge","601 Klamath Rd",,"Mesa","WA","99343-9779","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Idaho, Maryland, Nevada, Oregon, and Washington","F-0760-2017","Class II","White Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.","16/8 oz units","White Fudge is recalled due to undeclared blue #1.","12/16/2016",," no codes",12/11/2016,"12/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75930,"Ongoing","Real Fudge","601 Klamath Rd",,"Mesa","WA","99343-9779","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Idaho, Maryland, Nevada, Oregon, and Washington","F-0754-2017","Class II","Plain Fudge, brand Real Fudge.  Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.","290/8 oz. units; 60/12 oz. units; 18/16 oz. units; and 5/24 oz. units","Plain Fudge is recalled due to undeclared blue #1.","12/16/2016",," no codes",12/11/2016,"12/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75930,"Ongoing","Real Fudge","601 Klamath Rd",,"Mesa","WA","99343-9779","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Idaho, Maryland, Nevada, Oregon, and Washington","F-0759-2017","Class II","Salted Caramel Fudge, brand Real Fudge.  Product is sold in clear plastic deli container in 8, 16, and 24 oz.","73/8 oz. units; 4/16 oz. units;  3/24 oz. units","Salted Caramel Fudge is recalled due to undeclared blue #1.","12/16/2016",," no codes",12/11/2016,"12/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75930,"Ongoing","Real Fudge","601 Klamath Rd",,"Mesa","WA","99343-9779","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Idaho, Maryland, Nevada, Oregon, and Washington","F-0758-2017","Class II","Dark Chocolate Fudge, brand Real Fudge.    Product is sold in clear plastic deli container in 8, 16, and 24 oz.","82/8 oz. units;  5/16 oz. units; and 2/24 oz.","Dark Chocolate Fudge is recalled due to undeclared blue #1.","12/16/2016",," no codes",12/11/2016,"12/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75930,"Ongoing","Real Fudge","601 Klamath Rd",,"Mesa","WA","99343-9779","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Idaho, Maryland, Nevada, Oregon, and Washington","F-0756-2017","Class II","Peanut Butter Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12, and 16 oz.","78/8 oz. units; 60/12 oz. units; and 7/16 oz. units","Peanut Butter Fudge is recalled due to undeclared blue #1.","12/16/2016",," no codes",12/11/2016,"12/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75930,"Ongoing","Real Fudge","601 Klamath Rd",,"Mesa","WA","99343-9779","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Idaho, Maryland, Nevada, Oregon, and Washington","F-0757-2017","Class II","Rocky Road Fudge, brand Real Fudge.   Product is sold in clear plastic deli container in 8, 12, and 16 oz.","59/8 oz. units; 60/12 oz. units; and 7/16 oz. units","Rocky Road Fudge is recalled due to undeclared blue #1.","12/16/2016",," no codes",12/11/2016,"12/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75930,"Ongoing","Real Fudge","601 Klamath Rd",,"Mesa","WA","99343-9779","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Idaho, Maryland, Nevada, Oregon, and Washington","F-0755-2017","Class II","Nutty fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.","261/8 oz. units; 60/12 oz. units; 16/16 oz. units; and 11/24 oz. units","Nutty fudge is recalled due to undeclared blue #1.","12/16/2016",," no codes",12/11/2016,"12/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75930,"Ongoing","Real Fudge","601 Klamath Rd",,"Mesa","WA","99343-9779","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Idaho, Maryland, Nevada, Oregon, and Washington","F-0761-2017","Class II","Coconut Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.","22/8 oz. units","Coconut Fudge is recalled due to undeclared blue #1.","12/16/2016",," no codes",12/11/2016,"12/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Food",75930,"Ongoing","Real Fudge","601 Klamath Rd",,"Mesa","WA","99343-9779","United States","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Distributed in Idaho, Maryland, Nevada, Oregon, and Washington","F-0753-2017","Class II","White Fudge Oreo, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz. and 16 oz. ","65/8 oz. units and 2/16 oz. units","White Fudge Oreo is recalled due to undeclared wheat and blue # 1. ","12/16/2016",," no codes",12/11/2016,"12/11/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75934,"Terminated","American National Red Cross (the)","825 John St",,"West Henrietta","NY","14586-9790","United States","Voluntary: Firm Initiated","Telephone","New York","B-0232-2017","Class III","Red Blood Cells, Leukocytes Reduced","2 units"," Blood products, not tested according to specifications, were distributed. ","12/22/2016","12/22/2016"," W200116783784; W200116005559; ",4/18/2016,"04/18/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",75954,"Ongoing","Jubilant Cadista Pharmaceuticals, Inc.","207 Kiley Dr",,"Salisbury","MD","21801-2249","United States","Voluntary: Firm Initiated","E-Mail","Nationwide and Puerto Rico.","D-0205-2017","Class III","Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD  21801, NDC 59746-003-14.","1512 bottles","Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.","12/15/2016",," Lot #: 16P0176, Exp 02/2018 but labeled incorrectly as 02/0218.  ",6/13/2016,"06/13/2016",12/21/2016,"12/21/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75963,"Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","1212 E California Rd",,"Fort Wayne","IN","46825-5812","United States","Voluntary: Firm Initiated","E-Mail","California","B-0238-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product collected from a donor for whom donor suitability was not adequately determined, was distributed.","12/22/2016","12/22/2016"," W203815174126",11/7/2016,"11/07/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Biologics",75980,"Terminated","American National Red Cross, Penn Jersey Region","700 Spring Garden St",,"Philadelphia","PA","19123-3508","United States","Voluntary: Firm Initiated","E-Mail","California","B-0239-2017","Class III","Blood and Blood Products for Reprocessing","1 unit","Blood product, in which donor suitability was not adequately determined, was distributed.","12/22/2016","12/22/2016"," W202213047269",11/10/2016,"11/10/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",76012,"Ongoing","Amgen, Inc.","1 Amgen Center Dr",,"Thousand Oaks","CA","91320-1730","United States","Voluntary: Firm Initiated","Letter","United States and Puerto Rico  No foreign distribution.","D-0226-2017","Class II","AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial,  Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01","11,434 vials","Lack of Assurance of Sterility: Potential cracks in glass vials","12/22/2016",," Lot #1071559, 1071629; Exp. 05/18",12/15/2016,"12/15/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,
"Drugs",76027,"Ongoing","Meta Pharmacy Services","8352 W Warm Springs Rd Ste 120",,"Las Vegas","NV","89113-3629","United States","Voluntary: Firm Initiated","E-Mail","One consignee in Las Vegas","D-0227-2017","Class II","Phenylephrine  2.5% + Tropicamide 1%  Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99    Sterile compounded drug, Hospital/office use only, Not for resale  Storage: ROOM TEMP","150 mL","Lack of Sterility Assurance","12/22/2016",," Lot: 112716SB, Exp. 12/27/2016",12/15/2016,"12/15/2016",12/28/2016,"12/28/2016",,,,,,,,,,,,,,,,,,,,,,,,,,,,