"Product Type","Event ID","Status","Recalling Firm","City","State","Country","Voluntary/Mandated","Initial Firm Notification of Consignee or Public","Distribution Pattern","Recall Number","Classification","Product Description","Code Info","Product Quantity","Reason for Recall","Recall Initiation Date","Report Date"
"Biologics","44326","Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Utah.","B-1281-13","Class II","Red Blood Cells Leukocytes Reduced ","020H06535 ","1 component","Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.","12/14/2006","06/12/2013"
"Biologics","47061","Terminated","American National  Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon and California.","B-1279-13","Class II","Red Blood Cells Leukocytes Reduced ","021FJ57141 ","1 component","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.","12/17/2007","06/12/2013"
"Biologics","47061","Terminated","American National  Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","Oregon and California.","B-1280-13","Class II","Plasma Frozen ","021FJ57141 ","1 component","Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.","12/17/2007","06/12/2013"
"Biologics","47297","Terminated","American Red Cross Blood Services","Omaha","NE","US","Voluntary: Firm Initiated","Telephone","IA","B-1139-13","Class II","Red Blood Cells Leukocytes Reduced Irradiated ","09KG49760; 09KG46759 ","2 units","Blood products, which were incompletely irradiated, were distributed.","01/16/2008","06/12/2013"
"Biologics","48041","Terminated","American National  Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California and Washington.","B-1276-13","Class II","Blood and Blood Products for Reprocessing ","21LL23077. ","1 component","Blood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed..","03/13/2008","06/12/2013"
"Biologics","48041","Terminated","American National  Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California and Washington.","B-1277-13","Class II","Red Blood Cells Leukocytes Reduced ","21LL23077. ","1 component","Blood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed..","03/13/2008","06/12/2013"
"Biologics","48041","Terminated","American National  Red Cross","Portland","OR","US","Voluntary: Firm Initiated","Letter","California and Washington.","B-1278-13","Class II","Cryoprecipitated AHF ","21LL23077. ","1 component","Blood products, collected from a donor who was in close contact with an individual diagnosed as a  hepatitis B carrier,  were distributed..","03/13/2008","06/12/2013"
"Biologics","50723","Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Iowa","B-1265-13","Class III","Red Blood Cells ","W037908102316 ","1 Unit","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.","12/02/2008","06/12/2013"
"Food/Cosmetics","55288","Ongoing","LL Bakery, Inc.","Torrance","CA","US","Voluntary: Firm Initiated","Letter","HI, WA, and CA","F-1474-2013","Class I","White Farm Enriched White Bread. 16 oz (454g), 9pc/box.  UPC 0 10314 10002 0.     The label is white with blue and green lettering and red design accents.  The LL Bakery Logo is on the bottom left corner. ","no lot codes ","1020 units","LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements.  ","05/18/2013","06/12/2013"
"Food/Cosmetics","55288","Ongoing","LL Bakery, Inc.","Torrance","CA","US","Voluntary: Firm Initiated","Letter","HI, WA, and CA","F-1475-2013","Class I","Butter Farm Enriched White Bread 16 oz (454g), 9pc/box.  UPC 0 10314 10004 4.      The label is white with blue and green lettering and red design accents.  The LL Bakery Logo is on the bottom left corner. ","no lot codes ","1020 units","LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements.  ","05/18/2013","06/12/2013"
"Food/Cosmetics","55288","Ongoing","LL Bakery, Inc.","Torrance","CA","US","Voluntary: Firm Initiated","Letter","HI, WA, and CA","F-1476-2013","Class I","Italian Cream Danish 8.5 oz (240g), 14pc/box.  UPC 0 10314 40056 4.     The pastry is braided and has yellow creamy swirls and sliced almonds.  The label is white with black lettering and a tan colored border.  The LL Bakery Logo is on the bottom left corner. ","Not available ","1020 units","LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen milk, in the whey powder listed in their ingredient statements.  ","05/18/2013","06/12/2013"
"Devices","64164","Completed","Bion Enterprises Ltd","Des Plaines","IL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)","Z-1477-2013","Class III","Plastic bottle containing 10.5 mL of IgG Conjugate     Product Usage:   Product is a used as a counterstain for various indirect fluorescent assay kits    ","Product Code: CCG-9912;      Lot: CCG-0280 ","207 units","Affected products have a labeled expiration date of one year too long.","01/23/2013","06/12/2013"
"Devices","64164","Completed","Bion Enterprises Ltd","Des Plaines","IL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)","Z-1478-2013","Class III","Plastic bottle containing 10.5 mL of IgM Conjugate     Product Usage:   Product is a used as a counterstain for various indirect fluorescent assay kits    ","Product Code: CCM-9914;      Lot: CCM-0281 ","201 units","Affected products have a labeled expiration date of one year too long.","01/23/2013","06/12/2013"
"Devices","64164","Completed","Bion Enterprises Ltd","Des Plaines","IL","US","Voluntary: Firm Initiated","E-Mail","Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)","Z-1479-2013","Class III","Plastic bottle containing 3.5 mL of IgG FITC Conjugate     Product Usage:   Product is a used as a counterstain for various indirect fluorescent assay kits    ","Product Code: CCG-9972;      Lot: CCG-0281 ","504 units","Affected products have a labeled expiration date of one year too long.","01/23/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-503-2013","Class II","AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant,  Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04 ","Lot # 12HQ002  Exp. 07/14. ","1398 - 4 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime.   ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-504-2013","Class II","AMBI 20DM100GFN10PEH, Antitussive,  Expectorant,  Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16 ","Lot # 12DQ002, Exp. 03/14. ","348 - 16 ounce bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-505-2013","Class II","AMBI 25DPH/7.5PEH, Antihistamine,  Nasal Decongestant,  Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16 ","Lot # 12DQ005, Exp. 03/14. ","352 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime.   ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-506-2013","Class II","AMBI 12.5 CPD/100GFN/30PSE, Antitussive,  Expectorant,  Nasal Decongestant,  Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16 ","Lot # 12HQ005, Exp. 07/14. ","348 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-507-2013","Class II","AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant,  Expectorant,  Nasal Decongestant,  Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16  ","Lot # 12HQ006, Exp. 07/14. ","348 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-508-2013","Class II","AMBI 25CPD/200GFN, Antitussive,  Expectorant,  Berry Vanilla  Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16. ","Lot # 12HQ007 Exp. 07/14. ","348 - 16 ounce bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-509-2013","Class II","AMBI 2CPM/15DM/5PEH, Antihistamine,  Nasal Decongestant,  Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16. ","Lot # 12DQ004, Exp. 03/14. ","355 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-510-2013","Class II","AMBI 3BRM/15DM/30PSE,  Antihistamine,  Cough Suppressant,  Nasal Decongestant,    Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16. ","Lot # 12HQ003, Exp. 07/14. ","348 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-511-2013","Class II","AMBI 3BRM/30DM/50PSE, Antihistamine,  Cough Suppressant,  Nasal Decongestant,    Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16 ","Lot # 12HQ004,  Exp. 07/14. ","348 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-512-2013","Class II","AMBI 40PSE/400GFN/20DM,  Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01 ","Lot # 11D001 Exp. 03/13; Lot # 11D002 Exp. 03/13; Lot#11K003 Exp. 09/13; Lot# 12C010 Exp. 02/14. ","1772 bottles per 100 count each","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-513-2013","Class II","AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01 ","Lot # 12C007 Exp. 02/14; Lot # 12C008 Exp. 02/14. ","886 bottles  - 100-count tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-514-2013","Class II","Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10 ","Lot # 11E002  Exp. 04/2013. ","2957 bottles 100-count tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-515-2013","Class II","ED A-HIST TABLETS,  Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01 ","Lot# 11L008 Exp. 10/13; Lot# 12A001 Exp. 12/13; Lot# 12A002  Exp. 12/13; Lot# 12A006  Exp. 12/13; Lot#12A006 Exp. 12/13; Lot# 12A007  Exp. 12/13; Lot#12D013 Exp. 03/14; Lot# 12F002 Exp. 05/14; Lot# 12H006 Exp.07/14;  Lot# 12J001 Exp. 08/14; Lot# 12J001 Exp. 08/14; Lot# 12K005 Exp. 09/14; Lot #12M002 Exp. 11/14; Lot# 12M003 Exp. 11/14.   ","242,470","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-516-2013","Class II","NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01  ","Lot# 11K010 Exp. 09/13.   ","4824 bottles - 100-count ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-517-2013","Class II","Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01 ","Lot# 11L006 Exp. 10/13; Lot# 11L006  Exp. 10/13; Lot# 12B003 Exp 01/14; Lot# 12B003 Exp. 01/14; Lot#12D005  Exp. 03/14; Lot# 12D005 Exp. 03/14;  Lot# 12H001  Exp. 07/14.   ","31,739 bottles 100-count; 842,617 Bulk tablet bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-518-2013","Class II","Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01 ","Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002 Exp 01/14; Lot# 12F013  Exp. 05/2014; Lot# 12F013 Exp. 05/2014. ","8296 bottles  - 100-count and 153,028 Bulk tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-519-2013","Class II","BROMPHENIRAMINE/PSEUDOEPHEDRINE  DM, LIQUID,    Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16 ","Lot# 12B001 Exp. 01/14; Lot# 12B001 Exp. 01/14; Lot# 12B002  Exp 01/14; Lot# 12F013 Exp. 05/14; Lot# 12F013 Exp. 05/14. ","22,721 - 16 ounce bottles ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-520-2013","Class II","Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30 ","Lot# 11DQ009 Exp. 03/13; Lot# 11JQ002 Exp. 08/13. ","26,536 bottles - 30 mL","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-521-2013","Class II","Cardec DM Drops,  Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30 ","Lot# 11CQ001 Exp. 02/13; Lot# 11CQ009 Exp. 02/13; Lot # 11JQ003 Exp. 08/13; Lot# 11JQ004 Exp. 08/23; Lot# 11MQ002 Exp. 11/13. ","216,838 bottles - 30 mL","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-522-2013","Class II","Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01   ","Lot# 11B002  Exp. 01/13; Lot# 11B003 Exp. 01/13; Lot # 11G007  Exp. 06/13; Lot# 11J002 Exp. 08/13; Lot# 11K002 Exp. 09/13; Lot# 12C011 Exp. 02/14. ","2706 bottles of 100 count tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-523-2013","Class II","Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604,  NDC 58605-0408-01 ","Lot# 11G006 Exp. 06/13; Lot# 11K001  Exp. 09/13; Lot # 11K001  Exp. 09/13; Lot# 12C009 Exp. 02/14. ","1623 bottles of 100-count tablets.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-524-2013","Class II","BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01 ","Lot# 11A001  Exp. 12/12; Lot# 11L002  Exp. 10/13; Lot # 12K007 Exp. 09/14.  ","10,036 bottles - 100-count tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime.  ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-525-2013","Class II","BroveX PSE DM, Antihistamine, Cough Suppressant,   Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737    NDC 58605-441-01 ","Lot# 11A002  Exp. 12/12; Lot# 11A003  Exp. 12/12; Lot # 11A004  Exp. 12/12; Lot# 11A005 Exp. 12/12; Lot# 11L003 Exp. 10/13. ","16,836 bottles - 100-count.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-526-2013","Class II","BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01  b) 20 ml NDC 58605-150-02,  Manufactured for: Pernix Therapeutics, Gonzales, LA 70737  ","Lot# 11CQ005  Exp. 02/13; Lot# 11LQ002  Exp. 10/13; Lot # 12CQ005-Exp. 02/14; Lot# 12EQ003  Exp. 04/14; Lot# 12EQ004  Exp. 04/14; Lot# 12JQ004  Exp. 08/14.  ","57,936 bottles - 20 mL and 7,476  bottles -16 ounce","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-527-2013","Class II","BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01  b) 20 ml NDC 58605-151-02,  Manufactured for: Pernix Therapeutics, Gonzales, LA 70737  ","Lot# 11AQ004  Exp. 12/12; Lot# 11AQ005  Exp. 12/12; Lot # 11AQ006  Exp. 12/12; Lot# 11AQ007  Exp. 12/12; Lot # 11BQ012  Exp. 01/13; Lot# 11LQ003  Exp. 10/13; Lot# 11LQ004  Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/2013.  ","19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-528-2013","Class II","Lusair Liquid, 1 PINT bottle, OTC, Marketed by:  Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16 ","Lot# 11AQ004 Exp. 12/12; Lot# 11AQ005  Exp. 12/12; Lot # 11AQ006  Exp. 12/12; Lot# 11AQ007 Exp. 12/12; Lot # 11BQ012 - 19728 20 mL, Exp. 01/13; Lot# 11LQ003  Exp. 10/13; Lot# 11LQ004 Exp. 10/13; Lot# 11LQ005 Exp 10/13; Lot# 11LQ006 Exp. 10/13.  ","","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-529-2013","Class II","Poly Hist Forte, Nasal Decongestant, Antihistamine,  100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01 ","Lot# 12L005  Exp 10/14. ","330158 Bulk tablets. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-530-2013","Class II","Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60 ","Lot# 11F005  Exp 05/13; Lot# 11M008 Exp 11/13; Lot# 12J003  Exp 08/12.    ","977,719 Bulk Tablets ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-531-2013","Class II","Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60 ","Lot# 11F003 Exp 05/13; Lot# 11M007 Exp 11/13; Lot# 12J002  Exp 08/14.    ","978,092 Bulk Tablets","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-532-2013","Class II","TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604  NDC 29273-0706-10 ","Lot# 11A006 Exp 12/12; Lot# 11A007  Exp 12/12; Lot# 11G004  Exp 06/14; Lot# 11G005  Exp 06/14; Lot# 12C004  Exp 02/14; Lot# 12F007  Exp 05/14; Lot# 12F008 Exp.05/14; Lot #12F009  Exp. 05/14; Lot# 12G005  Exp 06/14.    ","386  - 1000-count bottles ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime.  ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-533-2013","Class II","CPM / PSE Drops, Antihistamine, Nasal  Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30 ","Lot# 11GQ003 Exp 06/13. ","6551 30 mL bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-534-2013","Class II","CPM / PSE DM Drops, Antihistamine, Cough Suppressant  Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30 ","Lot# 11EQ007 Exp 04/13; Lot# 12BQ001  Exp. 01/14.. ","26,315 - 30 mL bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime.  ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-535-2013","Class II","Mesehist DM,  Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872     NDC 13811-0085-16 ","Lot# 11CQ010 Exp 02/13; Lot# 11EQ003 Exp. 04/13; Lot# 11FQ002  Exp. 05/13; Lot# 11FQ003  Exp. 05/13; Lot# 12HQ009  Exp. 07/14. ","12,120 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-536-2013","Class II","Mesehist WC,  Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16 ","Lot# 11DQ001 Exp 03/13; Lot# 11MQ010 Exp. 11/13. ","4,884 - 16 ounce bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-537-2013","Class II","TL-DEX DM,  Cough Suppressant  Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16 ","Lot# 11AQ003  Exp 12/12. ","2532 - 16 ounce bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-538-2013","Class II","TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872,      NDC 13811-068-16 ","Lot# 11CQ011  Exp 02/13; Lot# 11DQ007 Exp. 03/13; Lot# 11DQ008  Exp. 03/13; Lot# 11EQ002  Exp. 04/13; Lot # 11KQ004  Exp 09/13; Lot# 11KQ005  Exp. 09/13  ","98,202 16 ounce bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-539-2013","Class II","TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30 ","Lot# 12GQ003 Exp 06/14. ","13,031 30 mL bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-540-2013","Class II","Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16 ","Lot# 11FQ004  Exp 05/13; Lot# 11KQ001 Exp. 09/13; Lot# 11KQ002  Exp. 09/13; Lot#11KQ003  Exp. 09/13; Lot# 12HQ010  Exp. 07/14.   ","12,198 - 16 ounce bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-541-2013","Class II","Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30 ","Lot# 11EQ010  Exp 04/13; Lot# 12AQ001  Exp. 12/13; Lot# 12JQ006  Exp. 08/14.   ","39,403 - 30 mL bottles","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-542-2013","Class II","Trigofen DM Drops,  Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872,  NDC 13811-0082-30 ","Lot# 11EQ008  Exp 04/13; Lot# 11HQ003  Exp. 07/13; Lot# 12JQ007  Exp. 08/14.   ","40,149 - 30 mL bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-543-2013","Class II","Z-Dex Pediatric Drops, Cough Suppressant  Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872,     NDC 13811-0001-30 ","Lot# 11DQ004  Exp 03/13. ","12,988 - 30 mL bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-544-2013","Class II","Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16 ","Lot# 11EQ004  Exp 04/13. ","2388 - 16 ounce bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-545-2013","Class II","ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30 ","Lot# 11EQ009  Exp 04/13; Lot# 12AQ004  Exp. 12/13; Lot# 12KQ001  Exp. 09/14. ","39,801 - 30 mL bottles. ","CGMP Deviations: Products are underdosed or have an incorrect dosage regime.  ","01/30/2013","06/12/2013"
"Drugs","64188","Ongoing","TG United, Inc.","Brooksville","FL","US","Voluntary: Firm Initiated","Letter","FL, MS, SC, LA  and TX","D-546-2013","Class II","ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872     NDC 13811-0073-16 ","Lot# 11CQ012  Exp 02/13; Lot# 12GQ002 Exp. 06/14.   ","4811 - 16 ounce bottles.","CGMP Deviations: Products are underdosed or have an incorrect dosage regime. ","01/30/2013","06/12/2013"
"Drugs","64372","Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama.  Military distribution made.","D-573-2013","Class III","Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal,  Novartis Consumer Health, Inc., Parsippany, NJ.      (a)12 gm (.42 oz), packaged with UPC code 300673998421 and NDC code: 0067-3998-42;    (b) 12 gm  (.42 oz), packaged with UPC code:  300673998124 and NDC code: 0067-3998-12;   (c) 30 gm  (1 oz), packaged with UPC code:  300673998308 and NDC code: 0067-3998-30;   (d) 30 gm  (1 oz), packaged with UPC code:  300673998339 and NDC code: 0067-3998-33. ","(12 gm) Lot numbers and Exp dates:  10109586  30-Apr-2013, 10116816  31 May 2013, 10117695  31-Jul-2013, 10120283  31-Aug-2013, 10104980  28-Feb-2013, 10108711  31-Mar-2013, 10111313 30-Apr-2013, 10111509  30-Apr-2013,  10115506 30-Jun-2013, 10117696  30-Jun-2013, 10120763  31-Aug-2013, 10122695  30-Sep-2013, 10104983  28-Feb-2013, 10108714  31-Mar-2013, 10119643  31-Jul-2013        (30 gm) Lot numbers and Exp dates:     10104979  28-Feb-2013   10108712 31-Mar-2013   10109588 30-Apr-2013   10111507 30-Apr-2013   10115133 31-May-2013   10115619 30-Jun-2013   10117694 31-Aug-2013   10120762 30-Sep-2013   10109981 31-Mar-2013   10111316 31-Mar-2013   10114223 31-May-2013   10117697 30-Jun-2013   10104982  28-Feb-2013   10108355 31-Mar-2013, 10112072  30-Apr-2013, 10112073  30-Apr-2013   10113501 31-May-2013, 10122772  31-Aug-2013    ","818,064 (12-gm) tubes and 836,376 (30-gm) tubes ","Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.","02/19/2013","06/12/2013"
"Drugs","64372","Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama.  Military distribution made.","D-574-2013","Class III","Target Up & Up, athlete's foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30 g (1 oz), compare to active ingredient in Lamisil, NDC 0067-6382-30 & UPC code: 300676382302 (Novartis) Target NDC 1167-3401-04, Distributed by Target Corp., Minneapolis, MN.  ","Lot numbers and exp dates:  10108716  31-Mar-2013,   10111510  30-Apr-2013, 10113801  31-May-2013, 10113839  30-Apr-2013, 10115616  31-Aug-2013 ","99,660  tubes","Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..","02/19/2013","06/12/2013"
"Drugs","64372","Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama.  Military distribution made.","D-575-2013","Class III","Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal),  a) 12 g (.42 oz) Tube, NDC 0067-3999-12,  Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300673999121,  (Vertical Pack) and b)  packaged in a horizontal package12 gm (.42 oz) Tube, NDC 0067-3999-42, Novartis Consumer Health, Inc., Parsippany, NJ. UPC code:  300673999428. ","Lot number and exp date:  10104145  30-Apr-2013. (Vertical package) and Lot number and exp date:  10109587  30-Apr-2013, 10111508  31-May-2013; 10119095 31-Jul-2013 and 10119096  30-Sep-2013 (Horizontal package). ","219,600 tubes","The products have illegible lot and/or expiration dates on the product container.","02/19/2013","06/12/2013"
"Drugs","64372","Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama.  Military distribution made.","D-576-2013","Class III","Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm (1 oz) Tubes packaged in one box,  Novartis Consumer Health, Inc., Parsitan, NJ. UPC code: 300676249438.  (Club Pack), NDC 0067-6295-43 ","Lot #:  10109590, 10111050, Exp 2/28/13. ","41,400 Boxes","Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.","02/19/2013","06/12/2013"
"Drugs","64372","Ongoing","Novartis Consumer Health","Lincoln","NE","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico, and Panama.  Military distribution made.","D-577-2013","Class III","Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405),  Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.  ","Lot #'s and Expiration dates: a) 20 gm tubes: 10116298 05/31/14 10116299 05/31/14 10116300 05/31/14 10117402 07/31/14 10117403 07/31/14 10117404 08/31/14 10117405 08/31/14 10117406 08/31/14 10117407 10/31/14 10117408 10/31/14 b) 100 gm tubes: 10119436 10119436 10119437 10119437 10119438 10119438 10119439 10119439 10119440 10119440 10119441 10119441 10119442 10119442 10119443 10119443 10119444 10119444 10119445 10119445 10119446 10119446 100 gm/3 pack: 10085217 2/28/2013 10085218 2/28/2013 10085219 2/28/2013 10085220 2/28/2013 10085221 2/28/2013 10085222 2/28/2013 10085223 2/28/2013 10085224 2/28/2013 10085225 2/28/2013 10085226 2/28/2013 10085227 2/28/2013 10085228 2/28/2013 10085229 2/28/2013 10085230 2/28/2013 10085231 2/28/2013 10085232 2/28/2013 10085233 2/28/2013 10085234 2/28/2013 10085235 2/28/2013 10085236 2/28/2013 10085238 2/28/2013 10085239 2/28/2013 10085240 2/28/2013 10085241 2/28/2013 10085242 2/28/2013 10085243 2/28/2013 10085244 2/28/2013 10085245 2/28/2013 10085246 3/31/2013 10085247 3/31/2013 10085248 3/31/2013 10085249 3/31/2013 10085260 3/31/2013 10085261 3/31/2013 10085262 3/31/2013 10085263 3/31/2013 10085264 3/31/2013 10085265 3/31/2013 10085266 3/31/2013 10085267 3/31/2013 10085268 3/31/2013 10085269 3/31/2013 10085270 3/31/2013 10085271 3/31/2013 10085272 3/31/2013 10087039 3/31/2013 10087040 3/31/2013 10087041 3/31/2013 10087042 3/31/2013 10087043 3/31/2013 10087052 3/31/2013 10087053 3/31/2013 10087054 3/31/2013 10087055 3/31/2013 10087063 3/31/2013 10087064 3/31/2013 10087065 3/31/2013 10088276 4/30/2013 10088277 4/30/2013 10088278 4/30/2013 10088279 4/30/2013 10088280 4/30/2013 10088281 4/30/2013 10088282 4/30/2013 10088289 4/30/2013 10088290 4/30/2013 10088291 4/30/2013 10088292 4/30/2013 10088293 4/30/2013 10088294 4/30/2013 10088295 4/30/2013 10088296 4/30/2013 10088297 4/30/2013 10088298 4/30/2013 10088299 4/30/2013 10088300 4/30/2013 10088301 4/30/2013 10088302 4/30/2013 10088303 4/30/2013 10088304 4/30/2013 10088305 4/30/2013 10088306 4/30/2013 10088307 4/30/2013 10088308 4/30/2013 10088309 4/30/2013 10088310 4/30/2013 10088311 4/30/2013 10088312 4/30/2013 10088313 4/30/2013 10088314 4/30/2013 10088315 4/30/2013 10088897 5/31/2013 10088898 5/31/2013 10088899 5/31/2013 10088900 5/31/2013 10088901 5/31/2013 10088902 5/31/2013 10088903 5/31/2013 10088904 5/31/2013 10088905 5/31/2013 10088906 5/31/2013 10088907 5/31/2013 10088908 5/31/2013 10088909 5/31/2013 10088910 5/31/2013 10088911 6/30/2013 10088921 7/31/2013 10088922 7/31/2013 10088923 7/31/2013 10088924 7/31/2013 10088925 7/31/2013 10088926 7/31/2013 10088927 7/31/2013 10088928 7/31/2013 10088929 7/31/2013 10088930 7/31/2013 10088931 7/31/2013 10090306 4/30/2013 10090307 4/30/2013 10090308 4/30/2013 10092277 7/31/2013 10092278 7/31/2013 10092279 7/31/2013 10092280 7/31/2013 10092281 7/31/2013 10092282 7/31/2013 10092283 7/31/2013 10092284 8/31/2013 10092285 8/31/2013 10092288 8/31/2013 10092289 8/31/2013 10092290 8/31/2013 10092291 8/31/2013 10092292 8/31/2013 10092293 8/31/2013 10092294 8/31/2013 10094387 8/31/2013 10094388 8/31/2013 10094389 8/31/2013 10094390 8/31/2013 10094394 9/30/2013 10094395 9/30/2013 10094396 9/30/2013 10094397 9/30/2013 10094398 9/30/2013 10097030 9/30/2013 10097031 9/30/2013 10097032 9/30/2013 10097033 9/30/2013 10097035 10/31/2013 10097036 10/31/2013 10098681 10/31/2013 10098692 10/31/2013 10098693 10/31/2013 10098694 10/31/2013 10098695 10/31/2013 10098697 10/31/2013 10098698 10/31/2013 10098699 10/31/2013 10098700 10/31/2013 10098701 10/31/2013 10098702 10/31/2013 10098703 10/31/2013 10098704 10/31/2013 10098708 11/30/2013 10098709 11/30/2013 10100515 11/30/2013 10100516 11/30/2013 10100517 11/30/2013 10100524 12/31/2013 10100525 12/31/2013 10100526 12/31/2013 10100527 12/31/2013 10100528 12/31/2013 10102312 12/31/2013 10102313 12/31/2013 10102314 12/31/2013 10102315 12/31/2013 10102316 12/31/2013 10102317 12/31/2013 10102318 12/31/2013 10102319 1/31/2014 10102320 1/31/2014 10102321 1/31/2014 10102322 1/31/2014 10102323 1/31/2014 10102324 1/31/2014 10102325 1/31/2014 10102326 1/31/2014 10102328 1/31/2014 10102329 1/31/2014 10102330 1/31/2014 10102331 1/31/2014 10102332 1/31/2014 10102337 1/31/2014 10102338 1/31/2014 10104246 2/28/2014 10104247 2/28/2014 10104248 2/28/2014 10104249 2/28/2014 10104250 2/28/2014 10104251 2/28/2014 10104252 2/28/2014 10104257 2/28/2014 10104258 2/28/2014 10104259 2/28/2014 10104260 2/28/2014 10104261 2/28/2014 10104262 2/28/2014 10107735 2/28/2014 10107736 3/31/2014 10107737 3/31/2014 10107738 3/31/2014 10107739 3/31/2014 10107740 3/31/2014 10107741 3/31/2014 10107749 3/31/2014 10107750 3/31/2014 10107751 3/31/2014 10107752 3/31/2014 10107753 3/31/2014 10107754 3/31/2014 10110430 4/30/2014 10110431 4/30/2014 10110432 4/30/2014 10110433 4/30/2014 10110434 4/30/2014 10110435 4/30/2014 10110436 4/30/2014 10110437 4/30/2014 10110438 4/30/2014 10110439 4/30/2014 10110440 4/30/2014 10110441 4/30/2014 10110442 4/30/2014 10110443 4/30/2014 10110444 4/30/2014 10111080 4/30/2014 10111081 4/30/2014 10111082 5/31/2014 10111083 5/31/2014 10113475 5/31/2014 10113476 5/31/2014 10113477 5/31/2014 10113478 5/31/2014 10113479 5/31/2014 10113480 5/31/2014 10113481 5/31/2014 10113482 5/31/2014 10113483 5/31/2014 10113484 5/31/2014 10113485 6/30/2014 10113486 6/30/2014 10113487 6/30/2014 10113488 6/30/2014 10113489 6/30/2014 10113490 6/30/2014 10115859 6/30/2014 10115860 6/30/2014 10115861 6/30/2014 10115862 6/30/2014 10115863 6/30/2014 10115864 6/30/2014 10115865 6/30/2014 10115866 6/30/2014 10115867 6/30/2014 10115868 6/30/2014 10115869 6/30/2014 10115870 6/30/2014 10115871 7/31/2014 10115872 7/31/2014 10115873 7/31/2014 10115876 7/31/2014 10115877 7/31/2014 10115878 7/31/2014 10117411 7/31/2014 10117413 7/31/2014 10117414 7/31/2014 10117416 7/31/2014 10117417 7/31/2014 10119416 9/30/2014 10119417 9/30/2014 10119418 9/30/2014 10119419 9/30/2014 10119420 9/30/2014 10119429 9/30/2014 10119430 9/30/2014 10119431 9/30/2014 10119432 9/30/2014 10119433 10/31/2014 10119434 10/31/2014 10120546 8/31/2014 10120547 8/31/2014 10120548 8/31/2014 10120549 8/31/2014 10120550 8/31/2014 10120551 8/31/2014 10120552 8/31/2014 10120553 8/31/2014 10120554 8/31/2014 10120555 9/30/2014 10120556 9/30/2014 10120557 9/30/2014 10120558 9/30/2014 100 gm/5 pack: 10085250 3/31/2013 10085251 3/31/2013 10085252 3/31/2013 10085253 3/31/2013 10085254 3/31/2013 10085255 3/31/2013 10085256 3/31/2013 10085257 3/31/2013 10085258 3/31/2013 10085259 3/31/2013 10087044 3/31/2013 10087048 3/31/2013 10087049 3/31/2013 10087050 3/31/2013 10087051 3/31/2013 10087056 3/31/2013 10087057 3/31/2013 10087058 3/31/2013 10087059 3/31/2013 10087060 3/31/2013 10087061 3/31/2013 10087062 3/31/2013 10088283 4/30/2013 10088284 4/30/2013 10088285 4/30/2013 10088286 4/30/2013 10088287 4/30/2013 10088288 4/30/2013 10088912 6/30/2013 10088913 6/30/2013 10088914 6/30/2013 10088915 6/30/2013 10088916 6/30/2013 10088917 6/30/2013 10088918 6/30/2013 10088919 6/30/2013 10088920 7/31/2013 10092286 8/31/2013 10092287 8/31/2013 10094391 8/31/2013 10094392 8/31/2013 10094393 9/30/2013 10097029 9/30/2013 10097034 9/30/2013 10098696 10/31/2013 10098705 10/31/2013 10098706 10/31/2013 10098707 11/30/2013 10100518 11/30/2013 10100519 11/30/2013 10100520 11/30/2013 10100521 11/30/2013 10100522 12/31/2013 10100523 12/31/2013 10102327 1/31/2014 10102333 1/31/2014 10102334 1/31/2014 10102335 1/31/2014 10102336 1/31/2014 10104253 2/28/2014 10104254 2/28/2014 10104255 2/28/2014 10104256 2/28/2014 10107742 3/31/2014 10107743 3/31/2014 10107744 3/31/2014 10107745 3/31/2014 10107746 3/31/2014 10107747 3/31/2014 10107748 3/31/2014 10111084 5/31/2014 10111085 5/31/2014 10111086 5/31/2014 10111087 5/31/2014 10111088 5/31/2014 10111089 5/31/2014 10111090 5/31/2014 10115874 7/31/2014 10115875 7/31/2014 10117412 7/31/2014 10117415 7/31/2014 10119409 7/31/2014 10119410 7/31/2014 10119411 7/31/2014 10119412 8/31/2014 10119413 8/31/2014 10119414 8/31/2014 10119415 8/31/2014 10119435 10/31/2014 10119436 10/31/2014 ","a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes","Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.","02/19/2013","06/12/2013"
"Biologics","64377","Terminated","Lifesouth Community Blood Centers, Inc. - Mobile Region","Mobile","AL","US","Voluntary: Firm Initiated","FAX","Alabama","B-1272-13","Class II","Platelets Pheresis Leukocytes Reduced ","W115112335533G;  ","1","Blood product, which did not meet acceptable product specifications, was distributed.","12/11/2012","06/12/2013"
"Biologics","64378","Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1273-13","Class II","Platelets Pheresis Leukocytes Reduced Irradiated ","W1151130013868;  ","1","Blood product, which did not meet acceptable product specifications, was distributed.","12/19/2012","06/12/2013"
"Biologics","64379","Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Louisiana","B-1274-13","Class III","Fresh Frozen Plasma (Apheresis) ","W036512123500; W036512123495;  ","2","Blood products, labeled with an incorrect expiration dates, were distributed.","01/04/2013","06/12/2013"
"Biologics","64379","Terminated","LifeShare Blood Centers","Shreveport","LA","US","Voluntary: Firm Initiated","FAX","Louisiana","B-1275-13","Class II","Platelets Pheresis Leukocytes Reduced ","W036512123499; W036512123500; W036512123495; W036512123497; W036512123795; W036512123796; W036512123792; W036512123792; W036512123793; W036512123793; W036512123794; W036512123499;  ","12","Blood products, labeled with an incorrect expiration dates, were distributed.","01/04/2013","06/12/2013"
"Biologics","64429","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1409-13","Class II","Platelets Pooled Leukocytes Reduced ","2935922; 2917309; 2906733;  ","3","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/30/2013","06/12/2013"
"Biologics","64429","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1410-13","Class II","Fresh Frozen Plasma ","2615454; 2536100; 1791712; 1692582; 1699599;  ","5","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/30/2013","06/12/2013"
"Biologics","64429","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1411-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced ","W036810024856; W036810024856; W036808146279; W036808146279; 2084027; 2084027; 9638986;  ","7","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/30/2013","06/12/2013"
"Biologics","64429","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1412-13","Class II","Platelets ","1791712; 9671521; 9638986;  ","3","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/30/2013","06/12/2013"
"Biologics","64429","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1413-13","Class II","Red Blood Cells ","2615454; 2536100; 2351667; 1791712; 1692582; 1699599; 9671521; 9458747;  ","8","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/30/2013","06/12/2013"
"Biologics","64429","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Letter","Switzerland; Florida; New York","B-1414-13","Class III","Blood and Blood Products for Reprocessing ","2351667; 9671521; 9638986; 9458747;  ","4","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/30/2013","06/12/2013"
"Biologics","64430","Terminated","Community Blood Bank of Erie County","Erie","PA","US","Voluntary: Firm Initiated","Telephone","Pennsylvania; New York","B-1384-13","Class III","Red Blood Cells ","W045613818099; W045613818100; W045613818110;  ","3","Blood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed.     ","02/07/2013","06/12/2013"
"Biologics","64432","Terminated","Community Blood Centers of South FL, Inc.","Orlando","FL","US","Voluntary: Firm Initiated","Letter","Florida","B-1104-13","Class II","Red Blood Cells ","W036810231777;  ","1","Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.","01/29/2013","06/12/2013"
"Biologics","64450","Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1441-13","Class II","Red Blood Cells Leukocytes Reduced ","W280312001390;  ","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","02/11/2013","06/12/2013"
"Biologics","64450","Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1442-13","Class II","Cryoprecipitated AHF ","W280312001390;  ","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","02/11/2013","06/12/2013"
"Biologics","64451","Terminated","LifeSouth Community Blood Centers, Inc.","Gainesville","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1017-13","Class II","Platelets Pheresis Leukocytes Reduced ","W1151130020407;  ","1","Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.","01/21/2013","06/12/2013"
"Biologics","64462","Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","FAX","California; Indiana","B-1467-13","Class II","Red Blood Cells Leukocytes Reduced ","038GZ69902;  ","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/10/2013","06/12/2013"
"Biologics","64462","Terminated","American Red Cross Blood Svs. Indiana-Ohio Region","Fort Wayne","IN","US","Voluntary: Firm Initiated","FAX","California; Indiana","B-1468-13","Class III","Blood and Blood Products for Reprocessing ","038GZ69902; 038Y79139;  ","2 units","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","01/10/2013","06/12/2013"
"Biologics","64472","Terminated","Upstate New York Transplant Services","Buffalo","NY","US","Voluntary: Firm Initiated","Telephone","New York","B-1474-13","Class II","Platelets Pheresis Leukocytes Reduced ","W28031280552;  ","1","Blood product, with platelet yield below the specified minimum requirement, was distributed.","01/18/2013","06/12/2013"
"Biologics","64473","Terminated","New York Blood Center, Inc.","New Brunswick","NJ","US","Voluntary: Firm Initiated","FAX","New York","B-1473-13","Class II","Red Blood Cells Leukocytes Reduced ","W0470123710240; W0470123710240; (double unit) ","2","Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.","02/19/2013","06/12/2013"
"Biologics","64474","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-1380-13","Class II","Red Blood Cells ","2625668;  ","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","02/12/2013","06/12/2013"
"Biologics","64474","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","Telephone","Switzerland; Florida","B-1381-13","Class III","Blood and Blood Products for Reprocessing ","2625668;  ","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","02/12/2013","06/12/2013"
"Biologics","64475","Terminated","DCI Biologicals LLC","Stillwater","OK","US","Voluntary: Firm Initiated","FAX","California","B-1472-13","Class II","Source Plasma ","ST1068311; ST1068692; ST1068971; ST1070131; ST1070344; ST1070813; ST1071082; ST1072200; ST1072433; ST1072809; ST1073309; ST1073493; ST1074119; ST1074203; ST1074732; ST1067724; ST1067959;  ","17","Blood products, collected from a donor who had not had an annual physical performed, were distributed.","01/10/2013","06/12/2013"
"Biologics","64484","Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1382-13","Class II","Red Blood Cells Leukocytes Reduced ","W043209019747;  ","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","02/12/2012","06/12/2013"
"Biologics","64484","Terminated","Blood Assurance Inc","Chattanooga","TN","US","Voluntary: Firm Initiated","FAX","Tennessee","B-1383-13","Class II","Plasma Frozen within 24 hours (FP24) ","W043209019747;  ","1","Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.","02/12/2012","06/12/2013"
"Biologics","64488","Terminated","Dept Of The Navy, Naval Medical Center","Portsmouth","VA","US","Voluntary: Firm Initiated","FAX","Virginia","B-1360-13","Class II","Red Blood Cells Leukocytes Reduced ","W021512002231;  ","1","Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.","09/24/2012","06/12/2013"
"Biologics","64489","Terminated","Dept Of The Navy, Naval Medical Center","Portsmouth","VA","US","Voluntary: Firm Initiated","FAX","Virginia","B-1361-13","Class II","Red Blood Cells Leukocytes Reduced ","W021512001845; W021512004439;  ","2","Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.","09/24/2012","06/12/2013"
"Biologics","64491","Terminated","West Tennessee Regional Blood Center Inc","Jackson","TN","US","Voluntary: Firm Initiated","Letter","Tennessee","B-1362-13","Class II","Red Blood Cells Leukocytes Reduced ","W040812117735;  ","1","Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.","02/11/2013","06/12/2013"
"Biologics","64492","Terminated","Dept Of The Navy, Naval Medical Center","Portsmouth","VA","US","Voluntary: Firm Initiated","FAX","New Jersey","B-1363-13","Class II","Red Blood Cells Leukocytes Reduced ","W021512004565;  ","1","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.","09/25/2012","06/12/2013"
"Biologics","64516","Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1351-13","Class III","Blood and Blood Products for Reprocessing ","W036812599383;  ","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","02/18/2013","06/12/2013"
"Biologics","64516","Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1352-13","Class II","Red Blood Cells Leukocytes Reduced ","W036812599383;  ","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","02/18/2013","06/12/2013"
"Biologics","64516","Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1353-13","Class II","Red Blood Cells ","W036812566971;  ","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","02/18/2013","06/12/2013"
"Biologics","64516","Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1354-13","Class II","Platelets Pooled Leukocytes Reduced ","W036812843768;  ","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","02/18/2013","06/12/2013"
"Biologics","64516","Terminated","OneBlood / dba CBCF","Lauderhill","FL","US","Voluntary: Firm Initiated","Telephone","Florida","B-1355-13","Class II","Fresh Frozen Plasma ","W036812566971;  ","1","Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.","02/18/2013","06/12/2013"
"Biologics","64517","Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","Telephone","Nebraska","B-1356-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced ","W044113003135;  ","1","Blood product, collected from a donor, whose suitability to donate was not adequately determined, was  distributed.","02/14/2013","06/12/2013"
"Biologics","64518","Terminated","LifeServe Blood Center","Des Moines","IA","US","Voluntary: Firm Initiated","E-Mail","Iowa; South Carolina","B-1357-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced ","W044112128378 Part 1; W044112128378 Part 2;  ","2","Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.","02/08/2013","06/12/2013"
"Biologics","64520","Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Letter","New York; Indiana","B-1358-13","Class II","Red Blood Cells Leukocytes Reduced ","W089811607217;  ","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","01/28/2013","06/12/2013"
"Biologics","64520","Terminated","Inova Health Care Services, Inova Blood Donor Services","Sterling","VA","US","Voluntary: Firm Initiated","Letter","New York; Indiana","B-1359-13","Class II","Blood and Blood Products for Reprocessing ","W089811607217;  ","1","Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.","01/28/2013","06/12/2013"
"Biologics","64523","Completed","Blood Systems Inc ","Scottsdale","AZ","US","Voluntary: Firm Initiated","FAX","Arizona","B-1483-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced ","W041013005157E; W041013005157E ","2 units","Blood Products, collected from an ineligible donor, were distributed. ","01/22/2013","06/12/2013"
"Devices","64550","Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.","Z-1473-2013","Class II","SlingBar 350.     Designed to meet the needs for lifting humans.  ","3156015, 3156002, 3156008' 3156004   ","3556","Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom  is requesting products be removed from field use and   replaced with an updated design.","04/30/2013","06/12/2013"
"Devices","64550","Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.","Z-1474-2013","Class II","SlingBar 360.     Designed to meet the needs for lifting humans.  ","Product # 3156013 ","16","Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom  is requesting products be removed from field use and   replaced with an updated design.","04/30/2013","06/12/2013"
"Devices","64550","Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.","Z-1475-2013","Class II","SlingBar Wide 670.      Designed to meet the needs for lifting humans.  ","Product # 3156012,  3156017   ","412","Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom  is requesting products be removed from field use and   replaced with an updated design.","04/30/2013","06/12/2013"
"Devices","64550","Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.","Z-1476-2013","Class II","SlingBar Standard.     Designed to meet the needs for lifting humans.  ","Product #3156011 ","726","Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom  is requesting products be removed from field use and   replaced with an updated design.","04/30/2013","06/12/2013"
"Biologics","64573","Terminated","Rhode Island Blood Center","Providence","RI","US","Voluntary: Firm Initiated","Telephone","New York","B-1475-13","Class II","Fresh Frozen Plasma ","W051712639896;  ","1 product","Blood product, collected from a donor with risk factors for vCJD, was distributed. ","02/15/2013","06/12/2013"
"Biologics","64627","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1484-13","Class II","Red Blood Cells ","2320628  ","1 unit","Blood products, collected from an inelgible donor, were distributed. ","03/11/2013","06/12/2013"
"Biologics","64627","Terminated","Community Blood Centers of South Florida, Inc.","Hialeah","FL","US","Voluntary: Firm Initiated","FAX","Florida","B-1485-13","Class II","Red Blood Cells (Apheresis) Leukocytes Reduced ","2476618; 2476618 ","2 units","Blood products, collected from an inelgible donor, were distributed. ","03/11/2013","06/12/2013"
"Devices","64631","Ongoing","Medtronic Xomed, Inc.","Jacksonville","FL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: AL, AR, AZ, CA, CO, FL, GA, HI,  IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA,  and WA; and countries of : Australia, Canada, Germany, Italy, Norway, Poland and United Kingdom.","Z-1420-2013","Class I","REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D.  Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE  Rx Only     The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device. ","Product Catalog Numbers: REF 8229705, 8229706, 8229707, 8229708, 8229709, 8229735, 8229736, 8229737, 8229738, 8229739.     Lot Numbers: 205830052 to 206486732. 0206516104, 0206516105, 0206516106, 0206516108, 0206520224, 0206520225, 0206520226, 0206520227, 0206520228, 0206520358, 0206542163, 0206545356, 0206545502. ","2,591 units","In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.","03/04/2013","06/12/2013"
"Drugs","64635","Terminated","Petnet Solution Inc","Irvine","CA","US","Voluntary: Firm Initiated","Telephone","Within the state of CA.","D-579-2013","Class II","Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN ","Batch # BN-3350  Rx #s:   [38126044]   [38126058] [38126059]   [38126021] [38126022] [38126023]   [38125981]   [38125991] [38125992]   [38126016] [38126017]   [38126004] [38126005] [38126006] [38126007]   [38126057] [38125999]   [38126036] [38126037] [38126038]   [38125998]   [38126033] ","28 doses","cGMP Deviation","02/22/2013","06/12/2013"
"Drugs","64680","Ongoing","Teva Pharmaceuticals USA, Inc.","Sellersville","PA","US","Voluntary: Firm Initiated","Letter","Nationwide","D-578-2013","Class III","Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01 ","NDC 0093-5035-01, Lot numbers 14064211A, exp 3/2014; 14064311A, exp 3/2014; 14064411A, exp 3/2014; 14064511A, exp 3/2014; 14090312A, exp 4/2015; 14092512A, exp 4/2015; 14092712A, exp 4/2015; 14094612A, exp 4/2015; 14099412A, exp 4/2015; 14099612B, exp 4/2015; 14099712A, exp 5/2015; 14110111A, exp 5/2014; 14110211A, exp 5/2014; 14110311A, exp 5/2014; 14110411A, exp 5/2014 and 34090212A, exp 4/2015. ","68,322 bottles","CGMP Deviation; cotton coil is missing in some packaged bottles","03/19/2013","06/12/2013"
"Drugs","64794","Ongoing","Legacy Pharmaceutical Packaging LLC","Earth City","MO","US","Voluntary: Firm Initiated","Letter","Distribution was made to IN.","D-580-2013","Class III","Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60 ","L-04009  Exp.11/15 ","1,644 bottles","Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009  ","03/27/2013","06/12/2013"
"Devices","64803","Ongoing","Shimadzu Medical Systems","Torrance","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution","Z-1369-2013","Class II","Shimadzu Corporation - Mobile DaRt Evolution     This device is a mobile X-ray system in order to take general radiography of  patients in the hospital who cannot move and/or of out patients in emergency . ","In combination with CXDI-70C:     Serial Numbers:      410001F0A004   410001B13012   410001B13016   410001F0A005   410001B1300E   410001B13010   0162S67303   410001B13018   410001B1300A   410001B13017   410001B1301B   410001B1301A   410001B13019   410001B1301D   410001B13011   410001B1301C   410001B13001   410001B13015   410001F0B004   410001B13008   410001B13013   410001F0B005   410001F0B006   410001F0A007   410001B13009   410001B1300B   410001B15035   410001B13014   410001B14009   410001B1301F   410001B14002   410001B14001   410001B14006   410001B14004   410001B15005   410001B13002   410001B1301E   410001B15016   410001B15009   410001B15007   410001B15006   410001B1300F   410001B15001   410001B15017   410001B15002   410001B15020      In combination with CXDI-55C:      Serial Numbers:      0162S65805   0162S65810   0162S65808   0162S66001   0162S66008   0162S65809   0162S66004   0162S66005   0162S66009   0162S66010   0162S66201   0162S66202   0162S66207   0162S66208   0162S66206   0162S66302   0162S66402   0162S66409   0162S66410   0162S66403   0162S66501   0162S66405   0162S66407   0162S66406   0162S66505   0162S66502   0162S66503   0162S66408   0162S66504   0162S66603   0162S66508   0162S66507   0162S66510   0162S66709   0162S66601   0162S66610   0162S66609   0162S66605      In combination with CXDI-55G      Serial Numbers:   0162S66205   0162S66307   0162S66309   0162S65901   0162S66003   0162S66306   0162S66308   0162S66509   0162S65709   0162S66606   0162S66802   0162S66803 ","103 units","The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C, CXDI-55C, and CXDI-55G.  As a result of Shimadzu's investigation, there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.","03/18/2013","06/12/2013"
"Devices","64826","Completed","I-Flow LLC","Lake Forest","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide distribution: USA including states of:  CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.","Z-1444-2013","Class II","I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T     The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission. ","Lot # AW207202O ","450 units","I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.","06/01/2012","06/12/2013"
"Devices","64826","Completed","I-Flow LLC","Lake Forest","CA","US","Voluntary: Firm Initiated","E-Mail","Nationwide distribution: USA including states of:  CA, CT, FL, IL, IN, KY, NY, OH, OR, TN, TX, VA and WI.","Z-1445-2013","Class II","I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T     The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission. ","Lot # AW207202U ","75 units","I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.","06/01/2012","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1478-2013","Class II","All Natural Whey - Natural Flavor 1.89 LBS: Whey Protein Concentrate and Isolate, Casein/Caseinate, Nitrozyme    UPC 6-09492 72000-9 : ","expiration date between Jan 2013 and March 2016.  "," 24924","Source of whey ingredient not listed as milk, an allergen.  Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1479-2013","Class II","Isolate Whey Protein Chocolate Malt 2.03 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Cocoa, Xylitol ; UPC 6-09492 73010-7 "," expiration date between Jan 2013 and March 2016.  ","10,860","Source of whey ingredient not listed as milk, an allergen.  Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1480-2013","Class II","Isolate Whey Protein French Vanilla 1.99 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate, Contains: Soy, Dairy, Xylitol  UPC 6-09492 73011-4 ","expiration date between Jan 2013 and March 2016.  ","12,431","Source of whey ingredient not listed as milk, an allergen.  Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1481-2013","Class II","Low Carb Protein - Strawberry/Banana 1.78 LBS: Whey Protein Concentrate/ Isolate, Casein/Caseinate,Soy Lecithin, Red Beet Powder UPC 6-09492 72018-4 "," expiration date between Jan 2013 and March 2016.  ","7,441","Source of whey ingredient not listed as milk, an allergen.  Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1482-2013","Class II","Metabolic Whey - Straw/Banana 5 LBS & 10 LBS: Whey Protein Concentrate/ Isolate, UPC 6-09492 72052-8, 72055-9 ","expiration date between Jan 2013 and March 2016.  ","5# x 12,925; 10 # x  2,054","Source of whey ingredient not listed as milk and source of lecithin not listed as soy.  Milk and soy are allergens.  Consumers who have an allergy or severe sensitivity to milk, soy run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1483-2013","Class II","UPC6-09492 72050-4,  72053-5 , Metabolic Whey - Rich Chocolate 5 LBS, 10 LBS : Whey Protein Concentrate/ Isolate, Cocoa "," expiration date between Jan 2013 and March 2016.  ","5 # x 34,409; 10# x 7,983","Source of whey ingredient not listed as milk and source of lecithin ingredient not listed as soy, Milk and soy are allergens.  Consumers who have an allergy or severe sensitivity to milk, soy run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1484-2013","Class II","It Works Ultimate Profit Chocolate 1.6 LBS: Whey Protein Concentrate/ Isolate, Soy Protein Extract, Soy Hull Fiber; Soy Protein Isolate; Contains: Dairy, Cocoa ",":  Product distributed with expiration date between Jan 2013 and March 2016.  ","74409","Source of whey ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1485-2013","Class II","It Works Ultimate Profit Vanilla 1.55 LBS: Whey Protein Concentrate/ Isolate, Soy Protein, Soy Hull Flower Contains: Dairy ","Product distributed with expiration date between Jan 2013 and March 2016.  ","69519","Source of whey ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1486-2013","Class II","Casein - 100% Micellar Casein - Rich Chocolate 2.02 LBS: Soy Lecithin,Casein/Caseinate, Cocoa  UPC 6-09492 72240-9  ","expiration date between Jan 2013 and March 2016.  ","2932","Source of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1487-2013","Class II","Casein - 100% Micellar Casein - Cookies & Cream 2.02 LBS: Soy Lecithin,Casein/Caseinate,Wheat  UPC 6-09492 72242-3 ","expiration date between Jan 2013 and March 2016.  ","1,320","Source of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1488-2013","Class II","Casein - 100% Micellar Casein - Vanilla Ice Cream 2.04 LBS: Soy Lecithin,Casein/Caseinate  UPC 6-09492 72241-6  "," expiration date between Jan 2013 and March 2016.  ","1,182","Source of casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1489-2013","Class II","Massive Muscle Gainer- Weight Gainer  French Vanilla 10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate  UPC 6-09492 73003-9  "," expiration date between Jan 2013 and March 2016.  ","3,227","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1490-2013","Class II","Low Carb Protein- French Vanilla 1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate  UPC 6-09492 72016-0 ","expiration date between Jan 2013 and March 2016.  ","UPC 6-09492 72016-0","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1491-2013","Class II","All Natural Gainer- Rich Vanilla 3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate  UPC 6-09492 73003-9 ","expiration date between Jan 2013 and March 2016.  ","19,338","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1492-2013","Class II","Low Carb Protein  -  Creamy Chocolate 1.78 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa  UPC 6-09492 72017-7  "," expiration date between Jan 2013 and March 2016.  ","22,712","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1493-2013","Class II","All Natural Gainer - Chocolate 3.3 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa  UPC 6-09492 73004-6 ","expiration date between Jan 2013 and March 2016.  ","16,318","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1494-2013","Class II","Massive Muscle Gainer- Weight Gainer  Dutch Chocolate 10 LBS: Whey Protein/Isolate, Soy Lecithin, Casein/Caseinate, Cocoa UPC 6-09492 73002-2 "," expiration date between Jan 2013 and March 2016.  ","14,813","Source of whey and casein ingredient not listed as milk, an allergen.Consumers who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1495-2013","Class II","Metabolic Whey - Vanilla 5 LBS French Vanilla 10lbs: Whey Protein/Isolate, Soy Lecithin  UPC 6-09492 72051-1 (VANILLA)   UPC 6-09492 72054-2 (FRENCH VANILLA)    ","expiration date between Jan 2013 and March 2016.  ","5 # x  34,409    ; 10 # x 12,925","Source of whey ingredient not listed as milk, an allergen; soy lecithin stated as ''lecithin''.Consumers who have an allergy or severe sensitivity to milk or soy run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1496-2013","Class II","Fruit-N-Whey 2.03lbs and Fruit-N-Whey Mixed Berries 2.03 lbs: Whey Protein/Isolate, Soy Lecithin. Contains: Dairy, Benefruit Blend, Natural Berry Flavors  UPC 6-09492 72065-8  "," expiration date between Jan 2013 and March 2016.  ","5047","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk  run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1497-2013","Class II","Flax-N-Whey and Flax-N-Whey Vanilla Nut 1.99 lbs: Whey Protein/Isolate Contains: Soy, Dairy, Flaxseed  UPC 6-09492 72064-1  "," expiration date between Jan 2013 and March 2016.  ","4072","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk  run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1498-2013","Class II","MRM All Natural Whey - Dutch Chocolate 2.02 lbs, 1.01 lbs;  All Natural Whey 10pk/bx Dutch Chocolate: Whey Protein/Isolate Contains: Soy, Dairy, Cocoa, Nitrozyme UPC 6-09492 72004-7 (2.02 lbs)  UPC 6-09492 72095-5 (10 pk)   UPC 6-09492 72005-4(1.01 lbs)    "," expiration date between Jan 2013 and March 2016. ;    ","2.02 # x 136726; 1.01 # x 49,235; 10 pak x 42,699","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk  run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1499-2013","Class II","All Natural Whey - Rich Vanilla:  2.02 lbs, 1.01 lbs and   10pk/bx : Whey Protein/Isolate Contains: Soy, Dairy, Nitrozyme  UPC 6-09492 72002-3 (2.02 lbs)   UPC 6-09492 72006-1 (1.01 lbs)   UPC 6-09492 72094-8 (10 pk)    ","expiration date between Jan 2013 and March 2016.     ","2.02# x 187,888; 1.01#x 80,085; 10 pk x 13, 578","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk  run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1500-2013","Class II","Sprouts Farmers Market Whey Protein Vanilla:  1 lbs, 2 lbs  : Whey Protein/Isolate, Soy Lecithin  UPC 6-46670 68118-9 (1 lbs)   UPC  6-46670 68124-0 (2 lbs)    "," expiration date between Jan 2013 and March 2016.  ","1 # x 16,010; 2 # x 12,727","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk  run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1501-2013","Class II","Sprouts Farmers Market Whey Protein Chocolate:  1 lbs, 2 lbs  : Whey Protein/Isolate, Soy Lecithin UPC 6-46670 68120-2 (1 lbs)  UPC 6-46670 68126-4 (2 lbs)    ","expiration date between Jan 2013 and March 2016.  ","1 # x 5,872; 2#  x 7,798","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk  run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1502-2013","Class II","Sprouts Farmers Market Whey Protein Strawberry:  1 lbs, 2 lbs  : Whey Protein/Isolate, Soy Lecithin  UPC 6-46670 68122-6 (1 lbs)   UPC 6-46670 68128-8 (2 lbs):   ","expiration date between Jan 2013 and March 2016.  ","1 lb x 4,946; 2 lb x 4715","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk  run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Food/Cosmetics","64831","Ongoing","Chemi- Source Inc, Nutra Pak","Grand Rapids","MI","US","Voluntary: Firm Initiated","Telephone","nationwide","F-1503-2013","Class II","Delicious Whole-istic Whey Protein Duch Chocolate 1.6 lbs: Whey Protein/Isolate, Contains: Dairy, Soy Lecithin  UPC8-54809 0030-9 "," expiration date between Jan 2013 and March 2016.  ","0 , corrected in warehouse","Source of whey ingredient not listed as milk, an allergen. Consumers who have an allergy or severe sensitivity to milk  run the risk of a serious or life-threatening allergic reaction if they consume these products. ","04/02/2013","06/12/2013"
"Biologics","64842","Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","Nevada; Pennsylvania; Maryland; Virginia; District of Columbia; California; Idaho; Montana","B-1543-13","Class II","Plasma Frozen within 24 hours (FP24) ","20GY55052; 20GY55090; 20GY55096; 20GY55097 ","4 units","Blood products, collected from an ineligible donor, were distributed. ","02/19/2013","06/12/2013"
"Biologics","64842","Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","Nevada; Pennsylvania; Maryland; Virginia; District of Columbia; California; Idaho; Montana","B-1544-13","Class III","Blood and Blood Products for Reprocessing ","20GS49322; 20GS49377; 20GS49493; 20GS49495; 20GY55895; 20GY56039; 20GY55598; 20GY55610;  20FP12306; 20GS48814; 20GS49166; 20GH75559; 20GS48838; 20GS49245; 20GY55041; 20GY55126          ","16 units","Blood products, collected from an ineligible donor, were distributed. ","02/19/2013","06/12/2013"
"Biologics","64842","Terminated","American National Red Cross","Boise","ID","US","Voluntary: Firm Initiated","Telephone","Nevada; Pennsylvania; Maryland; Virginia; District of Columbia; California; Idaho; Montana","B-1545-13","Class II","Red Blood Cells Leukocytes Reduced ","20GS49322; 20GS49377; 20GS49493; 20GS49495; 20GY55895; 20GY56039; 20GY56426; 20FP12306; 20GH75559; 20GS48814; 20GS48838; 20GS49166; 20GS49245; 20GY55041; 20GY55052; 20GY55090; 20GY55096; 20GY55097; 20GY55126; 20GY55598; 20GY55610 ","21 units","Blood products, collected from an ineligible donor, were distributed. ","02/19/2013","06/12/2013"
"Biologics","64849","Ongoing","Immucor Inc","Norcross","GA","US","Voluntary: Firm Initiated","Letter","Nationwide;  Brazil, China, Costa Rica, Germany, Hong Kong, India, Ireland, Mexico, Singapore, Taiwan","B-1482-13","Class III","Capture-P Indicator Red Cells package 1 x 11.5 mL ","Lot Nos. 226192,  22613,  226194 ","3 units","Capture-P and Capture-P Ready Screen assays, with confirmed reduced reactivity with the weak positive control, were distributed. ","03/26/2013","06/12/2013"
"Biologics","64864","Terminated","Arkansas Lions Eye Bank & Laboratory","Little Rock","AR","US","Voluntary: Firm Initiated","Letter","Arkansas","B-1495-13","Class III","Cornea ","1302059; 1302060;  ","2 corneas","Human Cornea, recovered from a donor whose donor eligibility was not determined in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed. ","03/26/2013","06/12/2013"
"Biologics","64865","Terminated","North Carolina Eye Bank, Inc. (The)","Winston Salem","NC","US","Voluntary: Firm Initiated","E-Mail","Egypt","B-1494-13","Class III","Cornea ","06431301; 06431302 ","2 corneas","Human Corneas, recovered using an expired Prep Kit, were distributed. ","03/15/2013","06/12/2013"
"Devices","64927","Completed","Kreg Medical Inc.","Chicago","IL","US","Voluntary: Firm Initiated","Visit","Nationwide Distribution including IL and IN.","Z-1480-2013","Class II","E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology ","Models ASM100100 and ASM100104;      Lot 1 (Blue Beds) Serian Numbers: KM100101, KM100102, KM100103, KM100104, KM100105, KM100106,  KM100107, KM100108, KM100209, KM100100;       Lot 2 (White Beds) Serial Numbers: KM100109, KM100111, KM100112, KM100113, KM100114, KM100115, KM100116, KM100117, KM100118, KM100119, KM100120;       Lot 3 (White Beds) Serial Numbers: KM100144, KM100145, KM100146, KM100147, KM100148, KM100149, KM100150, KM100151, KM100152, KM100153, KM100154, KM100155, KM100156, KM100156, KM100157, KM1000158;       Lot 4: (White Beds) Serial Numbers: KM100194, KM100195, KM100196, KM100197, KM100198, KM100199, KM100200, KM100201, KM100202, KM100203, KM100204, KM100205, KM100206, KM100207, KM100208;       Lot 5: (White Beds) Serial Numbers: KM100211, KM100212, KM100213, KM100214, KM100215, KM100216, KM100217, KM100218 ","59 beds","An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position.","08/02/2012","06/12/2013"
"Devices","64968","Ongoing","Leica Microsystems, Inc.","Buffalo Grove","IL","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.","Z-1446-2013","Class II","LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing. ","1) Part No.: 14060546848; Batch No.s: 8280-10309, 82801-0310;      2) Part No.: 14060546846; Batch No.s: 1034710114;       3) Part No.: 14060546845; Batch No.s: 1021420914;       4) Part No.: 14060546933; Batch No.s: 82801-0217;       5) Part No.: 14060546932; Batch No.s: 1030730112, 1101110204;       6) Part No.: 14060546852; Batch No.s: 1101910322;       7) Part No.: 14060546850; Batch No.s: 1034710204, 1034710328, 1113910803;       8) Part No.: 14060546847; Batch No.s: 913920827    ","20,160 units","An LPC Fine Mesh Cassette failed to stay closed during processing operations. ","04/04/2013","06/12/2013"
"Devices","64991","Completed","SpineFrontier, Inc.","Beverly","MA","US","Voluntary: Firm Initiated","Other","Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.","Z-1482-2013","Class II","Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices. ","Lot number:  20856 ","10","During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.  ","05/10/2008","06/12/2013"
"Devices","65006","Ongoing","Alcon Grieshaber AG","Schaffhausen","","CH","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Egypt, France, Germany, Great Britain, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Kyrgyzstan, Lebanon, Korea, Malaysia, Mexico, Pakistan, Peru, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Turknenistan, Venezula, and Viet Nam.","Z-1506-2013","Class II","The Constellation Vision System Pneumatic Handpiece.     Indicated for both anterior and posterior segment opthalmic surgery.  ","All Lots of the Constellation Vision System Pneumatic Handpiece, DSP, product number 725.01 ","8,455 units","Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01.  This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.","04/17/2013","06/12/2013"
"Food/Cosmetics","65030","Ongoing","Prosperity Resources International, Inc.","Linden","NJ","US","Voluntary: Firm Initiated","Telephone","Retail customers in New York State.","F-1504-2013","Class III","Golden Flower Dried Ginger Net Wt. 6 oz (170g).  Packed By:  S&Y Co., LTD. No 12 Yuenjiang Road, Gaoming City Guangdong, China.  Distributed by:  Prosperity Resources Int'l., Inc. USA.  Product of China. ","UPC 64740601186 ","50 cases (each case contains 50 individual 6 oz. plastic packages)","The Golden Flower Dried Ginger (Net Weight 6 oz. 170 gms) Product of China is in violations to the Agriculture and Markets Law.","03/11/2013","06/12/2013"
"Devices","65062","Ongoing","Berchtold Corp.","N Charleston","SC","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution","Z-1488-2013","Class II","Hand Controls for Operon D750, D752, D760, D820 and D850     The hand controls are used to operate OPERON surgical tables ","The hand controls are neither serialized nor lot coded. ","3763","The firm received complaints for unintended movements.","03/12/2013","06/12/2013"
"Devices","65093","Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries:  Canada   Austria   Bahrain   Benoni   Centurion   Chatsworth   Czech Republic   Denmark   Egypt   Finland   France   Germany   Ireland   Israel   Italy   Japan   Kuwait   Netherlands   Norway   Portugal   QATAR   Saudi Arabia   Serbia   Singapore   South Africa   Spain   OMAN   Sweden   Switzerland   UAE   United Kingdom   Venezuela","Z-1467-2013","Class II","Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long   Product Code: ONB5LGF      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. ","Lot Numbers: N2H0414X through N3A0294X     Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX ","2716 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity","05/06/2013","06/12/2013"
"Devices","65093","Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries:  Canada   Austria   Bahrain   Benoni   Centurion   Chatsworth   Czech Republic   Denmark   Egypt   Finland   France   Germany   Ireland   Israel   Italy   Japan   Kuwait   Netherlands   Norway   Portugal   QATAR   Saudi Arabia   Serbia   Singapore   South Africa   Spain   OMAN   Sweden   Switzerland   UAE   United Kingdom   Venezuela","Z-1468-2013","Class II","Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short     Product Code: ONB5SHF      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. ","Lot Numbers: N2h0413X through N3A0391X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX ","23050 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity","05/06/2013","06/12/2013"
"Devices","65093","Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries:  Canada   Austria   Bahrain   Benoni   Centurion   Chatsworth   Czech Republic   Denmark   Egypt   Finland   France   Germany   Ireland   Israel   Italy   Japan   Kuwait   Netherlands   Norway   Portugal   QATAR   Saudi Arabia   Serbia   Singapore   South Africa   Spain   OMAN   Sweden   Switzerland   UAE   United Kingdom   Venezuela","Z-1469-2013","Class II","Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm  Product Code: ONB5STF      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. ","Lot Numbers: N2H0353X through N3D0033X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX ","126925 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity","05/06/2013","06/12/2013"
"Devices","65093","Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries:  Canada   Austria   Bahrain   Benoni   Centurion   Chatsworth   Czech Republic   Denmark   Egypt   Finland   France   Germany   Ireland   Israel   Italy   Japan   Kuwait   Netherlands   Norway   Portugal   QATAR   Saudi Arabia   Serbia   Singapore   South Africa   Spain   OMAN   Sweden   Switzerland   UAE   United Kingdom   Venezuela","Z-1470-2013","Class II","Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm     Product Code: ONB5STF2C      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. ","Lot Numbers: N2J0211X through N3D0118X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX ","5364 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity","05/06/2013","06/12/2013"
"Devices","65093","Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries:  Canada   Austria   Bahrain   Benoni   Centurion   Chatsworth   Czech Republic   Denmark   Egypt   Finland   France   Germany   Ireland   Israel   Italy   Japan   Kuwait   Netherlands   Norway   Portugal   QATAR   Saudi Arabia   Serbia   Singapore   South Africa   Spain   OMAN   Sweden   Switzerland   UAE   United Kingdom   Venezuela","Z-1471-2013","Class II","Versaport Bladeless Optical Fixation Cannula - 5mm Short     Product Code: ONBFCA5SH      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. ","Lot Numbers: N2J0315X through N3A0389X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX ","2705 units","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity","05/06/2013","06/12/2013"
"Devices","65093","Ongoing","Covidien LP","North Haven","CT","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and internationally to the following countries:  Canada   Austria   Bahrain   Benoni   Centurion   Chatsworth   Czech Republic   Denmark   Egypt   Finland   France   Germany   Ireland   Israel   Italy   Japan   Kuwait   Netherlands   Norway   Portugal   QATAR   Saudi Arabia   Serbia   Singapore   South Africa   Spain   OMAN   Sweden   Switzerland   UAE   United Kingdom   Venezuela","Z-1472-2013","Class II","Versaport Bladeless Optical Fixation Cannula - 5mm  Product Code: ONBFCA5ST      The Versaport'' Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. ","Lot Numbers: N2J0150X through N3C0683X  Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use:   N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX ","57461 untis","Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity","05/06/2013","06/12/2013"
"Devices","65098","Ongoing","American Optisurgical Inc","Lake Forest","CA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI.","Z-1505-2013","Class II","FAST Procedure Kit.     Intended for use as a Minor Surgical Procedures Tray. ","Lot Numbers  07912-06   12912-04 ","63 individual applicators","American Optisurgical, Inc initiated a recall of  ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual  unit packaging.","04/30/2013","06/12/2013"
"Food/Cosmetics","65106","Ongoing","Nestle USA, Inc - Northbrook Pizza Head Office","Northbrook","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US nationwide distribution only.  NO OUS.","F-1468-2013","Class II","DiGiorno pizzeria, bianca/white pizza ,  Net Wt.18.0 OZ (510 g), UPC 71921-91484  ","Production code:  3068525951 ","5,958 cases (10 pizzas/case)","Plastic contamination.   Four pizzas with specific production codes, are being recalled because they may contain fragments of clear plastic","05/02/2013","06/12/2013"
"Food/Cosmetics","65106","Ongoing","Nestle USA, Inc - Northbrook Pizza Head Office","Northbrook","IL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","US nationwide distribution only.  NO OUS.","F1467-2013","Class II","california Pizza Kitchen crispy thin crust, White, Crispy thin crust pizza topped with garlic creme fraiche sauce, spinach, garlic, mozzarella,cheeses, parmesan, asiago and romano cheeses.  Net Wt.12.8 OZ (363 g), UPC 71921-98745  ","Production codes:  3062525951, 3062525952. and 3063525951 ","16,163 cases (14 pizzas/case)","Plastic contamination.   Four pizzas with specific production codes, are being recalled because they may contain fragments of clear plastic","05/02/2013","06/12/2013"
"Devices","65109","Ongoing","Carl Zeiss Meditec, Inc.","Dublin","CA","US","Voluntary: Firm Initiated","Letter","US Nationwide Distribution.","Z-1440-2013","Class II","Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C),        Product Usage:   A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.       ","Serial Numbers:  6725000708, 6725000709, 6725000710, 6725000713, 6725100725, 6725120813 ","6 units","Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one microscope installation was found to have 3 (three) broken screws out of 6 (six) in the lower section of the ceiling mount.     ","04/18/2013","06/12/2013"
"Devices","65113","Ongoing","American Optisurgical Inc","Lake Forest","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines.","Z-1516-2013","Class II","American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.             ","Serial#:  5510124   55400000   55400001   55400002   55400003   55400004   55400005   55400006   55400007   55400008   55400009   55400010   55400011   55400012   55400013   55400014   55400015   55400016   55400017   55400018   55400019   55400020   55400021   55400022   55400023   55400024   55400025   55400026   55400027   55400028   55400029   55400030   55400031   55400032   55400033   55400034   55400035   55400036   55400037   55400038   55400039   55400040   55400041   55400042   55400043   55400044   55400045   55400046   55400047   55400048   55400049   55400050   55400051   55400052   55400053   55400054   55400055   55400056   55400057   55400058   55400059   55400060   55400061   55400062   55400063   55400064   55400065   55400066   55400067   55400068   55400069   55400070   55400071   55400072   55400073   55400074   55400075   55400076   55400077   55400078   55400079   55400080   55400081   55400082   55400083   55400084   55400085   55400086   55400087   55400088   55400089   55400090   55400091   55400092   55400093   55400094   55400095   55400096   55400097   55400098   55400099   55400100   55400101   55400102   55400103   55400104   55400105   55400106   55400107   55400108   55400109   55400110   55400111   55400112   55400113   55400114   55400115   55400116   55400117   55400118   55400119   55400120   55400121   55400122   55400123   55400124   55400125   55400126   55400127   55400128   55400129   55400130   55400131   55400132   55400133   55400134   55400135   55400136   55400137   55400138   55400139   55400140   55400141   55400142   55400143   55400144   55400145   55400146   55400147   55400148   55400149   55400150   55400151   55400152   55400153   55400154   55400155   55400156   55400157   55400158   55400159   55400160   55400161   55400162   55400163   55400164   55400165   55400166   55400167   55400168   55400169   55400170   55400171   55400172   55400173   55400174   55400175   55400176   55400177   55400178   55400179   55400180   55400181   55400182   55400183   55400184   55400185   55400186   55400187   55400188   55400189   55400190   55400191   55400192   55400193   55400194   55400195   55400196   55400197   55400198   55400199   55400200   55400201   55400202   55400203   55400204    ","194 units","The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop working.","03/30/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-548-2013","Class II","Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","19 vials of 10ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-549-2013","Class II","Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","80 vials of 4mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-550-2013","Class II","Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","1 vial of 22mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-551-2013","Class II","Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","1  vial of 20mL and 1 vial of 40mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-552-2013","Class II","Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","3 vials of 45mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-553-2013","Class II","Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","20 vials of 5mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-554-2013","Class II","Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","2 vials of 100mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-555-2013","Class II","Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","41 vials of  2mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-556-2013","Class II","Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-557-2013","Class II","Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","43 vials of 250mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-558-2013","Class II","Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","7 vials of 50mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-559-2013","Class II","Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","55 vials of 100mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-560-2013","Class II","Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","4 vials of 10mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-561-2013","Class II","Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","44 vials of 50mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-562-2013","Class II","Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","2 vials of 250mL and 26 vials of 100mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-563-2013","Class II","Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","78 vials of 500ml and 92 vials of 100mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-564-2013","Class II","B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","56 vials of 50mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-565-2013","Class II","Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","32 vials of 50mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-566-2013","Class II","MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL   ","All Lots ","14 vials of 30mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-567-2013","Class II","Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-568-2013","Class II","Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","1 vial of 40mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-569-2013","Class II","Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","1 vial of 40ml","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-570-2013","Class II","Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","5 vials of 50mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-571-2013","Class II","MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","10 vials of 30 mL each","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Drugs","65125","Ongoing","THE COMPOUNDING SHOP, INC.","St Petersburg","FL","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Florida, California, Minnesota, and Maine","D-572-2013","Class II","Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL ","All Lots ","4 vials of 5mL and 22 vials of 10mL","Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes","05/02/2013","06/12/2013"
"Food/Cosmetics","65132","Terminated","Whole Foods Market Group Inc.","Everett","MA","US","Voluntary: Firm Initiated","E-Mail","Maine, Massachusetts, Rhode Island, Connecticut, New York, New Jersey","F-1469-2013","Class I","Whole Foods Salad Chicken Curry , 1 lb plastic bag (bulk) ","Sell By Date: 5/10/13 ","493 lbs","Undeclared allergen: egg","05/08/2013","06/12/2013"
"Food/Cosmetics","65132","Terminated","Whole Foods Market Group Inc.","Everett","MA","US","Voluntary: Firm Initiated","E-Mail","Maine, Massachusetts, Rhode Island, Connecticut, New York, New Jersey","F-1470-2013","Class I","Whole Foods Salad Curried Vegan Chick N , 1 lb plastic bags (bulk) ","Sell By Date: 5/10/13 ","171 lbs","Undeclared allergen: soy","05/08/2013","06/12/2013"
"Devices","65140","Ongoing","Philips Medical Systems (Cleveland) Inc","Cleveland","OH","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV & WY.  Internationally to Australia, Austria, Bahrain, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, India, Indonesia, Iran, Italy, Japan, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Syria, Thailand, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Venezuela & Viet Nam.","Z-1481-2013","Class II","BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143     BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies. ","Model # 882480, Serial #'s: 400054,400381, 4000089, 4000090, 4000091, 4000093, 4000094, 4000095, 4000098, 4000099, 4000100, 4000102, 4000103, 4000104, 4000105, 4000106, 4000107, 4000108, 4000109, 4000110, 4000111, 4000112, 4000113, 4000114, 4000115, 4000116, 4000117, 4000118, 4000119, 4000120,4000121, 4000122, 4000123, 4000124, 4000125, 4000126, 4000127, 4000128, 4000129, 4000130, 4000132, 4000133, 4000135, 4000136, 4000137, 4000138, 4000139, 4000140, 4000141, 4000142, 4000143, 4000144, 4000145, 4000146, 4000148, 4000149, 4000151, 4000152, 4000153, 4000154, 4000155, 4000156, 4000157, 4000158, 4000159, 4000160, 4000161, 4000162, 4000164, 4000165, 4000166, 4000167, 4000168, 4000169, 4000170, 4000171, 4000173, 4000174, 4000175, 4000176, 4000177, 4000178, 4000179, 4000180, 4000181, 4000182, 4000183, 4000184, 4000185, 4000186, 4000187, 4000188, 4000189, 4000190, 4000191, 4000192, 4000193, 4000194, 4000195, 4000196, 4000197, 4000198, 4000200, 4000202, 4000203, 4000204, 4000205, 4000206, 4000207, 4000208, 4000209, 4000212, 4000214, 4000215, 4000216, 4000218, 4000219, 4000220, 4000221, 4000222, 4000223, 4000224, 4000225, 4000226, 4000227, 4000228, 4000229, 4000230, 4000231, 4000232, 4000233, 4000234, 4000235, 4000236, 4000237, 4000238, 4000239, 4000240, 4000241, 4000242, 4000243, 4000244, 4000245, 4000246, 4000247, 4000248, 4000249, 4000250, 4000251, 4000252, 4000253, 4000254, 4000255, 4000256, 4000257, 4000258, 4000259, 4000260, 4000261, 4000262, 4000263, 4000264, 4000265, 4000266, 4000267, 4000268, 4000269, 4000270, 4000271, 4000272, 4000273, 4000274, 4000275, 4000276, 4000277, 4000278,4000279, 4000280, 4000282, 4000283, 4000284, 4000285, 4000287, 4000289, 4000290, 4000291, 4000292, 4000293, 4000295, 4000296, 4000297, 4000298, 4000300, 4000301, 4000302, 4000303, 4000304, 4000305, 4000306, 4000307, 4000308, 4000309, 4000310, 4000311, 4000312, 4000313, 4000314, 4000315, 4000316, 4000317, 4000318, 4000319, 4000320, 4000321, 4000322, 4000323, 4000324, 4000325, 4000326, 4000327, 4000328, 4000329, 4000330, 4000331, 4000332, 4000333, 4000334, 4000335, 4000336, 4000337, 4000338, 4000339, 4000340, 4000341, 4000342, 4000343, 4000344, 4000345, 4000346, 4000347, 4000348, 4000349, 4000351, 4000352, 4000353, 4000354, 4000355, 4000356, 4000357, 4000358, 4000359, 4000360, 4000361, 4000362, 4000363, 4000364, 4000365, 4000366, 4000367, 4000368, 4000369, 4000370, 4000371, 4000372, 4000374, 4000375, 4000376, 4000377, 4000378, 4000379, 4000380, 4000381, 4000382, 4000383, 4000384, 4000385, 4000386, 4000387, 4000388, 4000389, 4000390, 4000391, 4000392, 4000394, 4000396, 4000397, 4000398, 4000399, 4000400, 4000401, 4000402, 4000403, 4000404, 4000405, 4000406, 4000407, 4000408, 4000410, 4000411, 4000412, 4000414, 4000415, 4000416, 4000417, 4000418, 4000419, 4000420, 4000421, 4000422, 4000423, 4000424, 4000425, 4000426, 4000428, 4000429, 4000430, 4000431, 4000432, 4000433, 4000434, 4000435, 4000436, 4000437, 4000438, 4000439, 4000440, 4000441, 4000442, 4000443, 4000444, 4000445, 4000446, 4000447, 4000448, 4000449, 4000450, 4000451, 4000452, 4000453, 4000454, 4000455, 4000456, 4000459, 4000460, 4000461, 4000462, 4000463, 4000464, 4000466, 4000467, 4000468, 4000469, 4000470, 4000473, 4000474, 4000475, 4000476, 4000478, 4000479, 4000480, 4000481, 4000482, 4000483, 4000485, 4000485, 4000486, 4000487, 4000488, 4000489, 4000490, 4000491, 4000492, 4000493, 4000494, 4000495, 4000496, 4000497, 4000498, 4000499, 4000500, 4000501, 4000502, 4000503, 4000504, 4000505, 4000506, 4000507, 4000508, 4000509, 4000510, 4000511, 4000513, 4000516, 4000517, 4000518, 4000519, 4000520, 4000521, 4000522, 4000523, 4000524, 4000525, 4000526, 4000527, 4000527, 4000528, 4000529, 4000530, 4000531, 4000532, 4000533, 4000534, 4000535, 4000536, 4000537, 4000538, 4000539, 4000540, 4000541,4000542, 4000543, 4000544, 4000546, 4000547, 4000549, 4000550, 4000551, 4000552, 4000553, 4000554, 4000555, 4000556, 4000557, 4000558, 4000559, 4000560, 4000561, 4000562, 4000563, 4000564, 4000565, 4000566, 4000567, 4000568, 4000569, 4000571, 4000572, 4000573, 4000574, 4000575, 4000576, 4000577, 4000578, 4000580, 4000581, 4000582, 4000583, 4000584, 4000585, 4000586, 4000587, 4000588, 4000590, 4000591, 4000592, 4000593, 4000594, 4000595, 4000596, 4000597, 4000598, 4000600, 4000601, 4000602, 4000603, 4000604, 4000605, 4000606, 4000607, 4000609, 4000610, 4000611, 4000614, 4000614, 4000616, 4000620, 4000621, 4000623, 4000636, 4340004, 40000092, 0000101, 41443714, 49544434, 4000703001, 40007050005, 40007060007, 40007060008, 4000098A, 4000103-4000151-1,4000223-1, 4000246A, 4000301-1, 4000472A & 4000484A. ","505 units","Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly. ","04/25/2013","06/12/2013"
"Devices","65160","Ongoing","Maytex Corp","Hayward","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: USA (nationwide) including states of: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OK, OR, PA, PR, TN, TX, UT, WA, and WI; and country of: Mexico.","Z-1451-2013","Class II","Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA     Ear-loop face mask for basic medical/dental procedures.    ","All cases of item #: 3100 face mask with PO #.   PO #, Date of receipt:      809-01, 2/5/08;   837-02, 7/29/08;   852-03, 10/10/08;   901-01, 2/3/09;   921-02, 6/8/09;   923-03, 7/8/09;   926-04, 8/26/09;   931-05, 11/10/09;   942-06, 12/16/09;   001-01, 2/17/10;   003-03, 4/12/10;   002-02 , 3/24/10;   003-03A, 7/23/10;   042-04, 11/29/10;   105-01, 1/31/11;   117-02, 4/29/11;   127/03, 7/8/11;   147-04, 12/16/11;   202-01, 3/8/2012;   224-02, 5/24/2012;   235-03, 9/12/2012;   253-04 , 12//192012       ","43,915 Cases","Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of ''Differential Pressure of only 1.6 Delta P (mm H2O/cm2)'' as indicated on the box/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as Fluid Resistant. ","05/15/2013","06/12/2013"
"Devices","65164","Ongoing","GE Healthcare, LLC","Waukesha","WI","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of  INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HERZEGOWINA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARY, INDONESIA, IRAQ,ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA,LEBANON, MALAYSIA, MEXICO, NETHERLAND,NEW ZEALAND, OMAN, PARAGUAY, PERU., PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, THAILAND, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, and VIET NAM.","Z-1443-2013","Class II","Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850.      Intended to provide general inhalation anesthesia and ventilatory support. ","Canisters with date code of 02-2013 (Feb 2013)  ","800","GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.  ","05/14/2013","06/12/2013"
"Devices","65168","Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.","Z-1463-2013","Class II","da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.     Used to establish a port of entry for Intuitive Surgical EndoWrist instruments, ","Model number 420011 ","2101 consignees","Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).","05/06/2013","06/12/2013"
"Devices","65168","Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.","Z-1464-2013","Class II","da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.     Used to establish a port of entry for Intuitive Surgical EndoWrist instruments ","Model number 420262 ","2101 consignees","Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).","05/06/2013","06/12/2013"
"Food/Cosmetics","65174","Ongoing","Smiling Hill Farm, Inc. dba Silvery Moon Creamery","Westbrook","ME","US","Voluntary: Firm Initiated","Telephone","ME, NH, CT","F-1477-2013","Class II","Smiling Hill Farm brand Butter, 1/2 lb, 5 lb;  Unlabeled: 1/2 lb, 5 lb, 30-40 lb (variable in 5 gallon buckets)   Product in plastic snap-lid containers.  ","E4-11, E5-11, E6-11, A1-12, A2-12, A3-12, A4-12, A5-12, A6-12, A7-12, A8-12, A9-12, A10-12, A11-12, A12-12, B1-12, B2-12, B3-12, B4-12, B5-12, B6-12, B7-12, B8-12, B9-12, B10-12, B11-12, B12-12, C1-12, C2-12, C3-12, C4-12,  C5-12, C6-12, C7-12, C8-12, C9-12, C10-12, C11-12, C12-12, D1-12, D2-12, D3-12, D4-12, D5-12, D6-12, D7-12, D8-12, D9-12, D10-12, D11-12, D12-12,   E1-12, E2-12, E3-12, E4-12, E5-12, E6-12, E7-12, E8-12, E9-12, E10-12, E11-12, E12-12, F1-12, F2-12, F3-12, F4-12, F5-12, F6-12, F7-12, F8-12, F9-12, A1-13, A2-13, A3-13, A4-13, A5-13, A6-13, A7-13, A8-13, A9-13, A10-13, A11-13, A12-13, B1-13, B2-13, B3-13, B4-13, B5-13, B6-13, B7-13, B8-13, B9-13, B10-13, B11-13, B12-13, C1-13 ","9046 pounds","Elevated standard plate counts and detectable coliform bacteria.  ","05/10/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-581-2013","Class II","Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-13132 ","Compounding Date: 4/25/13  Discard after: 5/16/13 ","1 Bag","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-582-2013","Class II","Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132 ","Date: 04/30/13 Discard After: 05/21/13   ","3 units","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-583-2013","Class II","Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132 ","a) Compounding Date: 04/30/13 Discard After: 05/21/13  b) Compounding Date: 04/30/13 Discard After: 05/21/13   c) Compounding Date: 04/25/13, 04/30/13   Discard After: 05/16/13, 05/21/13    ","5 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-584-2013","Class II","Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132 ","Compounding Date: 04/30/13 Discard after: 05/21/13 ","1 Bag","Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-585-2013","Class II","IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132 ","Compounding Date: a) 04/25/13, b) 04/24/13    Discard After: a) 05/20/13, b) and c) 05/15/13   ","3 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-586-2013","Class II","Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc  4 Creek Parkway Suite A Boothwyn, PA  19061-3132    ","Compounding Date: 04/24/13 Discard after: 05/15/13   ","9 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-587-2013","Class II","Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc  4 Creek Parkway Suite A Boothwyn, PA  19061-3132 ","Compounding Date: 04/24/13, 04/25/13, 04/29/13 Discard after: 05/15/13, 05/16/13, 05/20/13   ","25 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-588-2013","Class II","Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A  Boothwyn, PA  19061-3132 ","Compounding Date: 04/23/13, 04/24/13, 04/29/13, 05/01/13    Discard after: 05/20/13, 05/22/13   ","59 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-589-2013","Class II","Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc  4 Creek Parkway Suite A Boothwyn, PA  19061-3132    ","Compounding Date: 04/24/13 Discard after: 05/15/13   ","38 Bags","Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-590-2013","Class II","Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA  19061-3132   ","Compounding Date: 04/24/13                Discard after: 5/15/13   ","1 Bag","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-591-2013","Class II","Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA  19061-3132   ","Compounding Date: 04/23/13                Discard after: 5/15/13   ","1 Bag","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-592-2013","Class II","Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA  19061-3132   ","Compounding Date: 04/24/13                Discard after: 5/15/13   ","4 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-593-2013","Class II","Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132 ","Compounding Date: 04/29/13                Discard after: 5/21/13   ","1 Bag","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-594-2013","Class II","Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132 ","Compounding Date: 04/24/13, 04/29/13      Discard after: 5/21/13, 05/22/13   ","8 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Drugs","65180","Ongoing","Pentec Health","Boothwyn","PA","US","Voluntary: Firm Initiated","Telephone","Dialysis Centers  Direct to patient","D-595-2013","Class II","Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA  19061-3132 ","Compounding Date: a) 04/26/13, b) 04/30/13      Discard after: a) and b) 5/21/13 ","3 Bags","Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.","05/15/2013","06/12/2013"
"Devices","65182","Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1507-2013","Class II","FLEXSTENT Biliary Self-Expanding Stent System.      Product Usage:   The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.    ","27 Catalog Numbers      FLX-50030-B1, FLX-60030-B1, FLX-70030-B1, FLX-80030-B1, FLX-50040-B1, FLX-60040-B1, FLX-70040-B1, FLX-80040-B1, FLX-50060-B1, FLX-60060-B1, FLX-70060-B1, FLX-80060-B1, FLX-50080-B1, FLX-60080-B1, FLX-70080-B1, FLX-80080-B1, FLX-50100-B1, FLX-60100-B1, FLX-70100-B1, FLX-80100-B1, FLX-50120-B1, FLX-60120-B1, FLX-70120-B1, FLX-80120-B1, FLX-60150-B1, FLX-70150-B1, FLX-80150-B1          ","23 units","Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.","04/23/2013","06/12/2013"
"Devices","65182","Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1508-2013","Class II","FLEXSTENT Femoropopliteal Self-Expanding Stent System.      Product Usage:   The FSS FLEXSTENT® Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.    ","28 Catalog Numbers      CAC-50030-V2, CAC-60030-V2, CAC-70030-V2, CAC-80030-V2, CAC-50040-V2, CAC-60040-V2, CAC-70040-V2, CAC-80040-V2, CAC-50060-V2, CAC-60060-V2, CAC-70060-V2, CAC-80060-V2, CAC-50080-V2, CAC-60080-V2, CAC-70080-V2, CAC-80080-V2, CAC-50100-V2, CAC-60100-V2, CAC-70100-V2, CAC-80100-V2, CAC-50120-V2, CAC-60120-V2, CAC-70120-V2, CAC-80120-V2, CAC-50150-V2, CAC-60150-V2, CAC-70150-V2, CAC-80150-V2                ","784","Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.","04/23/2013","06/12/2013"
"Devices","65182","Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1509-2013","Class II","FLEXSTENT Biliary Self-Expanding Stent System.      Product Usage:   The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.    ","27 Catalog Numbers      FLX-50030-B2, FLX-60030-B2, FLX-70030-B2, FLX-80030-B2, FLX-50040-B2, FLX-60040-B2, FLX-70040-B2, FLX-80040-B2, FLX-50060-B2, FLX-60060-B2, FLX-70060-B2, FLX-80060-B2, FLX-50080-B2, FLX-60080-B2, FLX-70080-B2, FLX-80080-B2, FLX-50100-B2, FLX-60100-B2, FLX-70100-B2, FLX-80100-B2, FLX-50120-B2, FLX-60120-B2, FLX-70120-B2, FLX-80120-B2, FLX-60150-B2, FLX-70150-B2, FLX-80150-B2    ","1357","Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.","04/23/2013","06/12/2013"
"Devices","65182","Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1510-2013","Class II","FLEXSTENT Femoropopliteal Self-Expanding Stent System.      Product Usage:   The FSS FLEXSTENT® Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.    ","32 Catalog Numbers      FLX-50030-V1, FLX-60030-V1, FLX-70030-V1, FLX-80030-V1, FLX-50040-V1, FLX-60040-V1, FLX-70040-V1, FLX-80040-V1, FLX-50060-V1, FLX-60060-V1, FLX-70060-V1, FLX-80060-V1, FLX-50080-V1, FLX-60080-V1, FLX-70080-V1, FLX-80080-V1, FLX-50100-V1, FLX-60100-V1, FLX-70100-V1, FLX-80100-V1, FLX-50120-V1, FLX-60120-V1, FLX-70120-V1, FLX-80120-V1, FLX-50150-V1, FLX-60150-V1, FLX-70150-V1, FLX-80150-V1, FLX-50200-V1, FLX-60200-V1, FLX-70200-V1, FLX-80200-V1    ","250","Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.","04/23/2013","06/12/2013"
"Devices","65182","Ongoing","Cordis Corporation","Miami Lakes","FL","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand","Z-1511-2013","Class II","FLEXSTENT Femoropopliteal Self-Expanding Stent System.      Product Usage:   The FSS FLEXSTENT® Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.    ","32 Catalog Numbers      FLX-50030-V2, FLX-60030-V2, FLX-70030-V2, FLX-80030-V2, FLX-50040-V2, FLX-60040-V2, FLX-70040-V2, FLX-80040-V2, FLX-50060-V2, FLX-60060-V2, FLX-70060-V2, FLX-80060-V2, FLX-50080-V2, FLX-60080-V2, FLX-70080-V2, FLX-80080-V2, FLX-50100-V2, FLX-60100-V2, FLX-70100-V2, FLX-80100-V2, FLX-50120-V2, FLX-60120-V2, FLX-70120-V2, FLX-80120-V2, FLX-50150-V2, FLX-60150-V2, FLX-70150-V2, FLX-80150-V2, FLX-50200-V2, FLX-60200-V2, FLX-70200-V2, FLX-80200-V2    ","310","Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch.","04/23/2013","06/12/2013"
"Food/Cosmetics","65186","Ongoing","Arizona Beverages USA LLC","Woodbury","NY","US","Voluntary: Firm Initiated","E-Mail","CT, PA, NY, NJ, MI, IL and WI.","F-1466-2013","Class III","ORIGINAL BRAND Arizona SOUTHERN STYLE UNSWEETENED Brewed Tea, Net Wt. 128 FL.OZ (1 GAL.).  Product is packaged in a cardboard case, each case contains four 1 Gallon plastic containers.  UPC Code: 6 1300871981 4.   ","Codes: KP 072 13 {1004} CT120.    Starting with the time stamp code at 10.04 am and onward ","8,989 cases (4 containers per case)","Undeclared Splenda ingredient. ","05/15/2013","06/12/2013"
"Devices","65191","Ongoing","Optovue, Inc.","Fremont","CA","US","Voluntary: Firm Initiated","Letter","Distributed Nationwide and in Canada.","Z-1441-2013","Class III","Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.     Intended for in vivo imaging. ","iVue software version 3.0 and 3.1  3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities. ","~329 users","Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.","05/14/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","US Nationwide distribution.","Z-1452-2013","Class I","Part 510031 Disposable Single Infusion Pump,  quantity Includes...  TOTAL VOLUME:   150mL, 2 mL/hr continuous   Delivery Time : App. 72 hrs when filled to capacity   Sterile EO...     found in the following GoPump Kits:     GoPump Kit 510042, w/ Epidural Catheter   GoPump Kit  510042 - BP, w/ Epidural Catheter, BIOPATCH   GoPump Kit 510110,  w/2.5'' Fenestrated Catheter     GoPumpKit 510110-BP,  w/2.5'' Fenestrated Catheter,BioPatch     GoPumpKit 510350  w/ Epidural Catheter    GoPump Kit 510350-BP  w/ Epidural Catheter, BIOPATCH   GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH      Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication.  ","Pump 510031, Lot 11-l 00106 to Lot 12-101133   Kit 510042,  lots 11-100251  to 13-100128   Kit 510042-BP , lot 12-101300   Kit 510110, lot 11-100664   Kit 510110-BP, Lots 11-100838 to 12-101560   Kit 510350, Lots 11-100353 to 12-100233    Kit 510350-BP, Lots12-100429 to 13-100047      Kit 510556-BP Lots 11-100779 to 12-101552  "," 33, 543 in all sizes/ kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1453-2013","Class I","Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile,  found in the following kits: GoPump kit 510080-BP,  5 fenestrated catheter & BIOPATCH;   GoPump kit 510112-BP,  2.5'' fenestrated catheter & BIOPATCH   Go Pump Kit 510141-BP,10'' fenestrated catheter& BIOPATCH      Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.  ","Pump 510076 Lot 11-100222 to 12-101087 found in:   Kit 510080 BP. Lot 11-100215 to 12-100508   Kit 510141-BP Lot 12-100460 to 12-100673    Kit 510112-BP, Lot 11-100839-to 13-100225 ","all kits  33,543","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1454-2013","Class I","Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL,  2mL/hr,...  found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH;   Go Pump Kit 510349-BP, Epidural Catheter, BioPatch;    Go Pump Kit 510642    Disposable Single Infusion Pump, Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate ","Pump Part 510180, Lot 11-100453 to 12-101003 found in:   Go Pump Kit 510201-BP. Lot 12-100108 to 12-101538    Go Pump Kit 510349-BP. Lot 12-100935   Go Pump Kit 510642, Lot 12-100616 to 13-100590 ","all kits 33, 543","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1455-2013","Class I","Part 510121 Disposable Infusion Pump, ...Elastomeric  Pump 300 mL,  4mL/hr,...sterile..  found in the following kits  GoPump Kit 510203-BP, Epidural catheter & BIOPATCH   GoPump Kit 510204, 2.5'' Fenestrated catheter   GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch   GoPump Kit 510205BP, 5'' Fenestrated catheter & Biopatch   GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch   GoBlock kit 510608   Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.  ","Pump Part 510121, Lot 11-100081 to 12-101406 found in:   Go Pump Kit 510203-BP. Lot 12-101301 to 13-101538   GoPump Kit 510204, Lot 11-100505 to 11-1-665   GoPump Kit 510204 BP, Lot 11-100721 to 13-100680    GoPump Kit 510205BP, Lot 11-100722 to 13-100087   GoBlock kit 510608 ","33,543 in all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1456-2013","Class I","Part510447 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL,  2mL/hr/side,...  found in the following kits  GoPump Kit 510462-BP, 5 '' catheter & BIOPATCH   GoPump Kit 510558-BP 10 '' catheter& BIOPATCH   GoPump Kit 64310       Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication.        ","GoPump Kit 510462-BP, Lot 11-100694- Lot 13-100092  GoPump Kit 510558-BP , Lot 12-100230 - Lot12-101343   GoPump Kit 510643, Lot 12-100332 - Lot 13-100183 ","34517 for all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1457-2013","Class I","Part 510449 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL( 8mL/hr ),...  found in the following kits  GoBlock Kit 510472,   Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. ","Pump Part 510449, Lot 11-100271 - Lot 130100137  found in:    GoBlock Kit 510472, Lot 11-100385 to 13-100354     ","","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1458-2013","Class I","Part 510450 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL( 10mL/hr ),...  found in the following kits  GoBlock Kit 510458,   Disposable Single Infusion Pump  ","Pump Part 510450, Lot 11-100351- Lot 12-101243 found in:   GoBlock Kit 510458, Lot 11-100618 to 13-100703     ","33, 543 for all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1459-2013","Class I","Part 510490 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL( 300 ml per side)( 6mL/hr ),...  found in the following kits  GoBlock Kit 510491,   Disposable Single Infusion Pump for drug delivery ","Pump Part 510490, Lot 11-100379- Lot 12-101132 found in:   GoBlock Kit 510491, Lot 11-100601 to 13-100705 ","33, 543 for all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1460-2013","Class I","Part 510613 Disposable  Infusion Pump, ...Elastomeric  Pump 300mL (150 mL side)( 6mL/hr ),...  found in the following kits  GoBlock Kit 510612,      Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.  ","Pump Part 510613 , Lot 11-100136- Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475 ","33,543 all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","nationwide USA,","Z-1461-2013","Class I","Part 510613 Disposable  Infusion Pump, ...Elastomeric  Pump 300mL (150 mL side)( 6mL/hr ),...  found in the following kits  GoBlock Kit 510612,      Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.  ","Pump Part 510613 , Lot 11-100815 - Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475 ","33,543 all kits","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65192","Ongoing","Symbios Medical Products, LLC","Indianapolis","IN","US","Voluntary: Firm Initiated","Letter","US Nationwide distribution.","Z-1462-2013","Class I","Part 510636 Disposable  Infusion Pump, ...Elastomeric  Pump 600 mL( 300 ml perside), 2 to 10 ml/hr.  Delivery time 60 to 144 hours;  found in the following kits:  GoBlock Kit 510646,      Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.  ","Pump Part 510636 , Lot 11-100632- Lot 12-101233 found in:   GoBlock Kit 510646,  Lot 11-100632- Lot 12-101233  ","33543","Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.","05/10/2013","06/12/2013"
"Devices","65209","Ongoing","Biomet, Inc.","Warsaw","IN","US","Voluntary: Firm Initiated","Letter","Distributed in New York.","Z-1465-2013","Class II","Active Articulation E1.     Intended for use with either primary or revision hip arthroplasty.  ","Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880. ","8 units","Biomet is recalling Active Articulation E1  Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size.  The implant itself is etched with the correct O.D. size.","04/26/2013","06/12/2013"
"Devices","65216","Ongoing","Intuitive Surgical, Inc.","Sunnyvale","CA","US","Voluntary: Firm Initiated","E-Mail","Worldwide distribution - USA (nationwide)  Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela.","Z-1442-2013","Class II","8 mm Monopolar Curved Scissors (a.k.a. Hot Shears)     Manufactured and Distributed by:   Intuitive Surgical   Sunny vale, CA        The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.  ","Model Numbers 420179-09 and -10 and 400179-09 and -10. ","~132,441 instruments","Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.","05/08/2013","06/12/2013"
"Devices","65223","Ongoing"," AGFA Corp.","Greenville","SC","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada","Z-1487-2013","Class II","AGFA Digital Radiography X-Ray System DX-D 100     Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.        ","Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U ","104","Customers could potentially experience intermittent, unintended and illogical movement when using the product.","05/15/2013","06/12/2013"
"Devices","65224","Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1512-2013","Class II","ADVIA Centaur® iPTH ReadyPack Assay 100 Tests; REF 10492368.     For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). ","Reagent Lot Number: 056301 and 56302  Kit Lot Number/Exp. Date:   61655301 09 Nov 2011   61950302 09 Nov 2011 ","309 (100 test) kits","iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability","05/14/2013","06/12/2013"
"Devices","65224","Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1513-2013","Class II","ADVIA Centaur® iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361.     For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). ","Reagent Lot Numbers: 056301 and 56302  Kit Lot Number/Exp. Date:   REF 10492369- 500 Tests   61639301 09 Nov 2011   REF 1 0493615 - 500 Tests   63607301 09 Nov 2011   68004301 09 Nov 2011   70229301 09 Nov 2011   74126301 09Nov2011   REF 10493616-500 Tests   62645302 09 Nov 2011   66612302 09 Nov 2011   74129302 09 Nov 2011 ","3302  Kits (500 test)","iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability","05/14/2013","06/12/2013"
"Devices","65224","Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1514-2013","Class II","ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394.     For in vitro diagnostic use in calibrating Intact PTH assays. ","Calibrator Lot Number: C5601 and C5602  Kit Lot Number/Exp. Date:   61405A01 27 Oct 2011   66517A02 27 Oct 2011   66611A02 27 Oct 2011   71997C02 27 Oct 2011 ","99 (2 pk)","iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability","05/14/2013","06/12/2013"
"Devices","65224","Ongoing","Siemens Healthcare Diagnostics, Inc","East Walpole","MA","US","Voluntary: Firm Initiated","Letter","Nationwide Distribution.","Z-1515-2013","Class II","ADVIA Centaur® iPTH Calibrator 6 pk; REF:  10492387, 10630628.     For in vitro diagnostic use in calibrating Intact PTH assays. ","Calibrator Lot Numbers: C5601, C5602 and C5603  Kit Lot Number/Exp. Date:   REF 10492387 - 6 pk    61404A01     27 Oct 2011   66516A02     27 Oct 2011   66610A02     27 Oct 2011   67824B02     27 Oct 2011   70657B02     27 Oct 2011   74448A03     13 Jul2012      REF 10630628 - 6 pk   668748B02    27 Oct 2011   68015B02      27 Oct 2011   72400B02     27 Oct 2011   74449B02     27 Oct 2011 ","198 (6 pk)","iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability","05/14/2013","06/12/2013"
"Drugs","65225","Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide  and Puerto Rico","D-502-2013","Class II","DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32 ","Lot 11-309-KL ","44,748 bags","Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.","04/30/2013","06/12/2013"
"Devices","65255","Ongoing","Gyrus Acmi, Incorporated","Southborough","MA","US","Voluntary: Firm Initiated","Letter","Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.","Z-1439-2013","Class II","GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA  01722-2104     Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.  ","JC477666 ","100 boxes of 6 units ","lack of sterility assurance","05/24/2013","06/12/2013"
"Food/Cosmetics","65256","Ongoing","HP Hood LLC","Vernon","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CT, MD, PA, MO, MN, WI, IA, UT, OR, AZ,  IL, FL, WI, AL,  ME, OH, NE, NV, IN, and CA","F-1471-2013","Class II","Cottage Cheese with Chive distributed under the following labels and sizes: (a) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 16 OZ. (453g), UPC 044100102264, HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 24 OZ (680 g), UPC 044100104916, HP HOOD LLC, LYNNFIELD, MA 01940; (c) Big Y brand Small Curd Cottage Cheese With Chives, 4% MILKFAT, NET WT 16 OZ (1 LB) 453g, UPC 018894300960, DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, MA 01104. ","Date Code JUN 14 13 ","","Possible presence of metal fragments.","05/22/2013","06/12/2013"
"Food/Cosmetics","65256","Ongoing","HP Hood LLC","Vernon","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CT, MD, PA, MO, MN, WI, IA, UT, OR, AZ,  IL, FL, WI, AL,  ME, OH, NE, NV, IN, and CA","F-1472-2013","Class II","4% Cottage Cheese distributed under the following labels and sizes: (a) Hannaford brand Cottage Cheese, 4% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268114504, DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074; (b) Weis brand SMALL CURD original cottage cheese, 4% MILKFAT MIN., NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041497096855, PACKED FOR WEIS MARKETS, INC., SUNBURY, PA 17801; (c) Big Y brand Small Curd Cottage Cheese, 4% MILK FAT MIN, NET WT 24 OZ (680g), UPC 018894300984, DISTRIBUTED BY BIG Y FOODS, INC., SPRINGFIELD, MA 01104; (d) Shurfine brand SMALL CURD Cottage Cheese, 4% MILKFAT, NET WT 24 OZ (1LB 8 OZ) 680g, UPC 015400832984, Distributed By: Western Family Foods, Inc. Portland, OR 97208; (e) Friendly Farms brand Small Curd Cottage Cheese, 4% MILKFAT MINIMUM, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041498192174, Distributed by ALDI, Inc., Batavia, IL 60510. ","Date Code JUN 14 13 ","","Possible presence of metal fragments.","05/22/2013","06/12/2013"
"Food/Cosmetics","65256","Ongoing","HP Hood LLC","Vernon","NY","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","NY, CT, MD, PA, MO, MN, WI, IA, UT, OR, AZ,  IL, FL, WI, AL,  ME, OH, NE, NV, IN, and CA","F-1473-2013","Class II","1% Low Fat Cottage Cheese distributed under the following labels and sizes: (a) Fiber One brand Lowfat Cottage Cheese, 1% Milkfat Minimum, NET WT, 16 OZ (453g), UPC 041483035585, DISTRIBUTED BY HP HOOD LLC, LYNNFIELD, MA 01940; (b) Hood brand Low Fat Cottage Cheese, SMALL CURD, 1% MILKFAT, NET WT 24 OZ (680g), UPC 044100106330; HP HOOD LLC, LYNNFIELD, MA 01940; (c) Hannaford brand Lowfat Cottage Cheese, 1% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268148615, DISTRIBUTED BY; HANNAFORD BROS. CO., SCARBOROUGH, ME 04074; (d) Weis brand lowfat cottage cheese, SMALL CURD, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 041497096886, PACKED FOR WEIS MARKETS, INC., SUNBURY, PA 17801; (e) Big Y brand Small Curd Low Fat Cottage Cheese, 1% MILKFAT, NET WT 24 OZ (1 LB 8Z) 680g, UPC 018894300977, DISTRIBUTED BY: BIG Y FOODS, INC., SPRINGFIELD, MA 01104; (f) Market Basket brand Lowfat Cottage Cheese, Small Curd, 1% Milkfat, NET Wt. 24 OZ. (680g), UPC 049705682968, PACKED EXCLUSIVELY FOR DEMOULAS SUPERMARKETS INC., TEWKSBURY, MA 01876; (g) Shurfine brand LOWFAT Cottage Cheese, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680g, UPC 015400834605, Proudly Distributed By: Western Family Foods, Inc., Portland, OR 97208; (h) Friendly Farms brand Small Curd Cottage Cheese, Low Fat, 1% MILKFAT, NET WT 24 OZ (1 LB 8 OZ) 680 g, UPC 041498154905.  ","Date Code JUN 14 13 ","","Possible presence of metal fragments.","05/22/2013","06/12/2013"
"Devices","65257","Ongoing","Hill-Rom, Inc.","Batesville","IN","US","Voluntary: Firm Initiated","Letter","Worldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands, Pakistan, panama, Paraguay, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, United States, US Virgin Islands, Venezuela and Vietnam.","Z-1466-2013","Class II","Hill-Rom 1000 Bed,   Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital. ","Product number (P1160) with Serial Numbers J143AP0937 thru O080AP5661. ","8,737 devices","Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.  ","04/15/2013","06/12/2013"
"Devices","65258","Ongoing","Zimmer Surgical Inc","Dover","OH","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.","Z-1483-2013","Class II","The Zimmer Air Dermatome, REF  00- 8801- 001- 00 ,  Rx, non-sterile      grafting instruments intended to provide variable graft thickness and width capabilities ","Serial Number 100211, 100338, 100515, 100560, 100647, 100755, 101104, 101345, 101562, 101769, 101890, 101983, 102560, 103407, 103509, 103816, 104529, 104863, 105049, 105072, 105604, 106394, 106474, 106624, 107861, 108103, 108203, 108210, 108339, 108911, 109445, 109543, 110034, 110837, 111046, 111047, 111048, 111049, 111050, 111051, 111052, 111053, 111054, 111055, 111056, 111057, 111058, 111059, 111060, 111061, 111062, 111063, 111064, 111065, 111066, 111067, 111068, 111069, 111071, 111072, 111073, 111074, 111075, 111076, 111079, 111081, 111083, 111084, 111085, 111086, 111087, 111089, 111090, 111091, 111092, 111096, 111100, 111101, 111102, 111104, 111105, 111116, 111121, 111122   ","84 units","This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken.  This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.","05/07/2013","06/12/2013"
"Devices","65258","Ongoing","Zimmer Surgical Inc","Dover","OH","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.","Z-1484-2013","Class II","Zimmer Air Dermatome II, REF 00-8851-001-00  handpiece   Rx, non-sterile      grafting instruments intended to provide variable graft thickness and width capabilities ","Serial Number 500191 , 500192,500193, 500194,500196,500197,500198,500199, 500200, 500201,500202,500203, 500204, 500205,500206, 500207,500208,500209,500210, 500211,500212, 500213,500215,500216,500217, 500219,500220, 500221,500222, 500223,  500224, 500225,500226,500227,500228,500229,500230, 500231,500232, 500233,500234,500235,500236, 500237, 500238,500239,500240,500241 ,   500242, 500243,500244,500245,500246,500247,500248,500249, 500250, 500251,500252,500253,500254, 500255,500256,500257,500258,500259,   500260,500261,500262,500263,500264, 500265,500266,500267,500268,500269, 500270,500291,   500292,500293,500295,500296,500297,500298,   500299,500300,500301 , 500302,500303, 500304,   500306, 500307,500308,500309,500310, 500331 ,   500332, 500334, 500335, 500336, 500337, 500338,   500339, 500340, 500341,500342, 500343, 500344,   500345, 500346, 500347, 500348,500349, 500350,   500351 , 500352, 500353, 500354,500355, 500357,   500358, 500359, 500368, 500369,500370,500371 ","126 units","This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken.  This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.","05/07/2013","06/12/2013"
"Devices","65258","Ongoing","Zimmer Surgical Inc","Dover","OH","US","Voluntary: Firm Initiated","Telephone","Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.","Z-1485-2013","Class II","Zimmer Air Dermatome II, REF 00-8851-001-01  handpiece, w/o hose, Rx, non-sterile      grafting instruments intended to provide variable graft thickness and width capabilities.  ","Serial Number 500311, 500312, 500317, 500320, 500321, 500322, 500323, 500324, 500325, 500326, 500327, 500328, 500329 ","13 units","This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or  operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken.  This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.","05/07/2013","06/12/2013"
"Drugs","65269","Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","Nationwide","D-547-2013","Class II","Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK  74146. ","Entry Format for Lots is: PTC Lot #; Exp Date; Distributor Bulk Lot #.PTC Lot #614S; Exp 05/31/2013; Teva Lot #14108110A. PTC Lot #6HFC; Exp 06/30/2013; Teva Lot #14127710A. PTC Lot #615S; Exp 08/31/2013; Teva Lot #14180910A. PTC Lot #4614; Exp 04/30/2011; Barr Lot #306670. PTC Lot #46TQ; Exp 04/30/2011; Barr Lot #306670. PTC Lot #48GN; Exp 05/31/2011; Barr Lot #307039. PTC Lot #4A36; Exp 05/31/2011; Barr Lot #307127. PTC Lot#4AA9; Exp 05/31/2011; Barr Lot #307127. PTC Lot #4ASM; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4AWE; Exp 05/31/2011; Barr Lot# 307128. PTC Lot #4AWG; Exp 05/31/2011; Barr Lot#307128. PTC Lot#4AZR; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4B72; Exp 05/31/2011; Barr Lot #307128. PTC Lot #4C50; Exp 06/30/2011; Barr Lot #307360. PTC Lot# 4BOZ; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4BPO; Exp 06/30/2011; Barr Lot #307537. PTC Lot #4E2R; Exp 07/31/2011; Barr Lot #307901. PTC Lot #4D68; Exp 08/31/2011; Barr Lot #307953. PTC Lot #4ETP; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4F8Y; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4F8Z; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4FCP; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GCM; Exp 08/31/2011; Barr Lot #307954. PTC Lot #4GY4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HR8; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4HZ4; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4IE9; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4J14; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JBR; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JN3; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4JQ0; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KFL; Exp 09/30/2011; Barr Lot #308266. PTC Lot #4KT7; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4L2L; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4LWK; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MAL; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MEY; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4MX9; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBB; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4NBZ; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4O56; Exp 08/31/2011; Barr Lot #308403. PTC Lot #4ORJ; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4PEJ; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4PL1; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4QQF; Exp 10/31/2011; Barr Lot #308743. PTC Lot #4R6O; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4RSK; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4S1U; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4SFI; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4SRT; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4TB2; Exp 11/30/2011; Barr Lot #309609. PTC Lot #4U8D; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4V2G; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4VJG; Exp 11/30/2011; Barr Lot #310817. PTC Lot #4X6N; Exp 12/31/2011; Barr Lot #311069. PTC Lot #4Y9Q; Exp 12/31/2011; Barr Lot #311069. PTC Lot #4XVB; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4XZH; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4Y9P; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5031; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5172; Exp 12/31/2011; Barr Lot #311074. PTC Lot #5698; Exp 12/31/2011; Barr Lot #311074. PTC Lot #56NJ; Exp 12/31/2011; Barr Lot #311074. PTC Lot #56NL; Exp 12/31/2011; Barr Lot #311074. PTC Lot #58XM; Exp 12/31/2011; Barr Lot #311074. PTC Lot #59D2; Exp 12/31/2011; Barr Lot #311074. PTC Lot #4WEJ; Exp 01/31/2012; Barr Lot #311075. PTC Lot #527Z; Exp 12/31/2011; Barr Lot #311145. PTC Lot #52FT; Exp 12/31/2011; Barr Lot #311145. PTC Lot #5328; Exp 12/31/2011; Barr Lot #311145. PTC Lot #53CU; Exp 12/31/2011; Barr Lot #311145. PTC Lot #54AE; Exp 12/31/2011; Barr Lot #311145. PTC Lot #557T; Exp 12/31/2011; Barr Lot #311145. PTC Lot #55QA; Exp 02/28/2012; Barr Lot #311365. PTC Lot #563R; Exp 02/28/2012; Barr Lot #311365. PTC Lot #57WL; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5ASQ; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5BTD; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5BZ9; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5CCB; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5CO2; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5DXG; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5F86; Exp 02/28/2012; Barr Lot #311443. PTC Lot #5KE5; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5KJS; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5KSX; Exp 07/31/2012; Barr Lot #313415. PTC Lot #5DIO; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5DUW; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5H9T; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5HZ3; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5I1B; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5IJ2; Exp 08/31/2012; Barr Lot #313418. PTC Lot #5J2T; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5LPO; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5ME4; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5MNG; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5N7Q; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5OC6; Exp 11/30/2012; Barr Lot #314312. PTC Lot #5PRW; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5QOH; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5QOI; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5RGR; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5RGT; Exp 12/31/2012; Barr Lot #314702. PTC Lot #5OLD; Exp 01/31/2013; Barr Lot #315019. PTC Lot #5TWL; Exp 01/31/2013; Barr Lot #315021. PTC Lot #5SXH; Exp 12/31/2012; Barr Lot #315023. PTC Lot #5T2J; Exp 12/31/2012; Barr Lot #315023. PTC Lot #5TWK; Exp 01/31/2013; Barr Lot #315181. PTC Lot #5U96; Exp 01/31/2013; Barr Lot #315181. PTC Lot #5VDI; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5VNI; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5W14; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5W9R; Exp 01/31/2013; Barr Lot #315677. PTC Lot #5WNV; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOC; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOD; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5WOE; Exp 01/31/2013; Barr Lot #315678. PTC Lot #5UHJ; Exp 02/28/2013; Barr Lot #315679. PTC Lot #5UUI; Exp 02/28/2013; Barr Lot #315679. PTC Lot #5ZKM; Exp 02/28/2013; Barr Lot #315836. PTC Lot #5ZKN; Exp 02/28/2013; Barr Lot #315836. PTC Lot #60CN; Exp 02/28/2013; Barr Lot #315836. PTC Lot #68C8; Exp 02/28/2013; Barr Lot #316205. PTC Lot #68U6; Exp 02/28/2013; Barr Lot #316205. PTC Lot #68UH; Exp 02/28/2013; Barr Lot #316205. PTC Lot #69QO; Exp 02/28/2013; Barr Lot #316205. PTC Lot #60NB; Exp 11/30/2012; Barr Lot #316241. PTC Lot #60UT; Exp 11/30/2012; Barr Lot #316241. PTC Lot #60UU; Exp 11/30/2012; Barr Lot #316241. PTC Lot #615Y; Exp 11/30/2012; Barr Lot #316241. PTC Lot #6168; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61KO; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61KP; Exp 11/30/2012; Barr Lot #316241. PTC Lot #61RM; Exp 11/30/2012; Barr Lot #316241. PTC Lot #62CO; Exp 03/31/2013; Barr Lot #316298. PTC Lot #63CZ; Exp 03/31/2013; Barr Lot #316298. PTC Lot #63M7; Exp 03/31/2013; Barr Lot #316298. PTC Lot #64AW; Exp 03/31/2013; Barr Lot #316298. PTC Lot #64VH; Exp 03/31/2013; Barr Lot #316450. PTC Lot #6513; Exp 03/31/2013; Barr Lot #316450. PTC Lot #62HE; Exp 03/31/2013; Barr Lot #316622. PTC Lot #66KC; Exp 03/31/2013; Barr Lot #316626. PTC Lot #66KD; Exp 03/31/2013; Barr Lot #316626. PTC Lot #66MC; Exp 03/31/2013; Barr Lot #316626. PTC Lot #683O; Exp 03/31/2013; Barr Lot #316772. PTC Lot #6G1B; Exp 04/30/2013; Barr Lot #317017. PTC Lot #6G1C; Exp 04/30/2013; Barr Lot #317017. PTC Lot #69GY; Exp 03/31/2013; Barr Lot #317018. PTC Lot #69GZ; Exp 03/31/2013; Barr Lot #317018. PTC Lot #69H0; Exp 03/31/2013; Barr Lot #317018. PTC Lot #6G2G; Exp 05/31/2013; Barr Lot #317477. PTC Lot #6GOH; Exp 05/31/2013; Barr Lot #317479. PTC Lot # 494L; Exp 04/30/2011; Barr Lot #701252. PTC Lot #49K7; Exp 04/30/2011; Barr Lot #701252. ","25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles","Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.","04/06/2011","06/12/2013"
"Drugs","65295","Completed","Physicians Total Care, Inc.","Tulsa","OK","US","Voluntary: Firm Initiated","FAX","Nationwide","D-596-2013","Class III","Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa OK 74146, Mfg By: Novartis Consumer Health, Parsippany, NJ 07054, NDC 54868-5965-00 ","PTC Lot #; Exp Date; Distributor Novartis Lot #.  PTC #651L; Exp 03/31/2013; Novartis #10085272. PTC #G8OO; Exp 04/30/2013; Novartis #10088292. PTC #67GO; Exp 04/30/2013; Novartis #10088311. PTC #67J7; Exp 04/30/2013; Novartis #10088311. PTC #68JC; Exp 05/31/2013; Novartis #10088899. PTC #68KA; Exp 05/31/2013; Novartis #10088899. PTC #6B0I; Exp 05/31/2013; Novartis #10088905. PTC #6AA4; Exp 05/31/2013; Novartis #10088907. PTC #6D9R; Exp 07/31/2013; Novartis #10088924. PTC #6DBP; Exp 07/31/2013; Novartis #10088925. PTC #6M81; Exp 07/31/2013; Novartis #10088929. PTC #6ME2; Exp 07/31/2013; Novartis #10088929. PTC #6F98; Exp 08/31/2013; Novartis #10094389. PTC #6QFU; Exp 09/30/2013; Novartis #10094396. PTC #6I2S; Exp 10/31/2013; Novartis #10098702. PTC #6KJG; Exp 12/31/2013; Novartis #10102313. PTC #6KC1; Exp 12/31/2013; Novartis #10102314. PTC #6SQ7; Exp 02/28/2014; Novartis #10104248. PTC #6Q3B; Exp 03/31/2014; Novartis #10107749. PTC #6NRO; Exp 03/31/2014; Novartis #10107750. PTC #6OVH; Exp 03/31/2014; Novartis #10107750. PTC #6QTV; Exp 04/30/2014; Novartis #10110442. PTC #6REN; Exp 04/30/2014; Novartis #10110442. PTC #6ROG; Exp 04/30/2014; Novartis #10110442. PTC #6VGM; Exp 05/31/2014; Novartis #10113476. PTC #6VOR; Exp 05/31/2014; Novartis #10113476. PTC #6VQ2; Exp 05/31/2014; Novartis #10113476. PTC #6VWW; Exp 05/31/2014; Novartis #10113476. PTC #6SQ6; Exp 05/31/2014; Novartis #10113478. PTC #6XO2; Exp 05/31/2014; Novartis #10113481. PTC #6Y4L; Exp 05/31/2014; Novartis #10113481. PTC #6YTH; Exp 05/31/2014; Novartis #10113481. PTC #6V3L; Exp 06/30/2014; Novartis #10115860. PTC #6X79; Exp 09/30/2014; Novartis #10119418. PTC #6WQ4; Exp 09/30/2014; Novartis #10120557.    ","76 Tubes","Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because the lot number and expiration date on the tube may not be legible.","03/02/2013","06/12/2013"
"Devices","65314","Ongoing","Coloplast Manufacturing US, LLC","Minneapolis","MN","US","Voluntary: Firm Initiated","Letter","US Distribution to: KY, MI, OH, PR, TX, and VA.","Z-1486-2013","Class II","Digitex Absorbable Polydiaxanone Suture, Size 2-0.   Catalog Number / Code of product: 52031, 5203101400.      The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.  ","Lots 3390331, 3390339, 3390490. ","772 units","Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date. ","05/13/2013","06/12/2013"
"Drugs","65315","Ongoing","Hospira Inc.","Lake Forest","IL","US","Voluntary: Firm Initiated","Letter","Nationwide and Puerto Rico","D-501-2013","Class II","Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 ","17-099-EV  Exp 05/14 ","95,700 vials","Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.","05/16/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1489-2013","Class II","Stryker Instruments 0400-710-000  T4 Pullover Toga (S/M)    Sterile, EO; single use;    Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1006134, 1101020, 1106424 ","2,980 units (298 boxes) ","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1490-2013","Class II","Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use;         Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1005105, 1010244, 1101004, 1104289, 1107568, 1005119, 1010261, 1101030, 1104324, 1108625, 1006129, 1011276, 1101047, 1105390, 1108672, 1006140, 1011296, 1102073, 1105355, 1109730, 1007151, 1012314, 1102127, 1106431, 1109782, 1007163, 1012337, 1102131, 1106467, 1109858, 1009213, 1012346, 1104253, 1107515.  ","48,040 units, ( 4804 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1491-2013","Class II","Stryker Instruments 0400-720-000S5 T5 Pullover Toga  w/Peel Away,  Sterile, EO; single use.      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1007157, 1103202 ","1,980 units (198 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1492-2013","Class II","Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular  Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1005111, 1011282,1107491, 1107492 ","3,000 units (300 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1493-2013","Class II","Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large  Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1006134, 1012304, 1104308, 1007152, 1101020, 1105365, 1007170, 1102080, 1106421, 1008188, 1102147, 1106469, 1009205, 1103193, 1108628, 1010229, 1103198, 1108697, 1010253, 1102149, 1109789, 1011277, 1104248 ","34,640 units (3,464 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1494-2013","Class II","Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large  Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1005105, 1009214, 1104308, 1006130, 1010260, 1104312, 1007152, 1012346, 1105378, 1007163, 1012303, 1106460, 1007164, 1101062, 1107542, 1008189, 1101063, 1108660, 1008188, 1102149, 1109760, 1009213, and 1103219. ","21,660 units (2166 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1495-2013","Class II","Stryker Instruments 0400-810-000 T4 Zipper Toga  (S/M) Sterile, EO; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1006129, 1103201, 1009197, 1105391, 1009198, 1107548, 1012302, 1109788,  and 1102127 ","7960 units (796 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1496-2013","Class II","Stryker Instruments 0400-820-000 T4 Zipper Toga  (L/XL) Sterile, O; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1005097, 1009205, 1011294, 1102105, 1104268, 1106463, 1108633, 1109857, 1005098, 1009219, 1012313, 1102109, 1104305, 1106465, 1108648, 1109812, 1005104, 1008192, 1011281, 1102119, 1104307, 1106470, 1108654, 1109860, 1005105, 1009213, 1012325, 1102123, 1104308, 1107493, 1108659, 1109817, 1005110, 1009197, 1012327, 1102141, 1104320, 1107488, 1108666, 1005111, 1009204, 1012335, 1102147, 1104327, 1107497, 1108667, 1005118, 1010227, 1012345, 1102150, 1105370, 1106474, 1108671, 1006123, 1010234, 1101014, 1103170, 1105342, 1107511, 1108675, 1007155, 1010235, 1012344, 1103171, 1105356, 1107512, 1108701, 1006127, 1010251, 1101003, 1103223, 1105110, 1107516, 1108704, 1006133, 1010258, 1101017, 1103189, 1105379, 1107537, 1109778, 1006140, 1010243, 1101002, 1103194, 1105390, 1107546, 1107520, 1008181, 1012314, 1101029, 1103184, 1105401, 1107595, 1108710, 1007163, 1010259, 1101046, 1103227, 1106418, 1107604, 1108713, 1007145, 1010252, 1101053, 1104280, 1106432, 1107561, 1109740, 1007156, 1011266, 1102073, 1104248, 1106453, 1108624, 1109750, 1007169, 1011267, 1102092, 1104259, 1106444, 1107599, 1109729, 1007151, 1011275, 1101055, 1104264, 1106451, 1107567, 1109735, 1008176, 1011280, 1102085, 1104290, 1106437, 1107578, 1109755, 1008178, 1011295, 1102099, 1104278, 1106455, 1107570, 1109781, 1008188, 1011276, 1102080, 1104283, 1106460, 1108619, and 1109809. ","334,520 units (33,452 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1497-2013","Class II","Stryker Instruments 0400-820-000S3 T4 Toga w/Inside  Shoulder Ties, Sterile, O; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1007145, 1101004, 1107487 ","3000 units (300 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1498-2013","Class II","Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3  Cut, Sterile, O; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1005098, 1010228, 1012337, 1105367 ","3,980 units ( 398 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1499-2013","Class II","Stryker Instruments 0400-820-100 T5 Zipper Toga  with Peel Away, Sterile, O; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1006130, 1101034, 1006134, 1102133, 1007151, 1103208, 1007170, 1104297, 1009205, 1105360, 1010228, 1106476, 1010260, 1107569, 1011296, 1108676, 1012336, 11097861006141, 1012303, 1102110, 1104324, and 1108664. ","25,770 units (2,577 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1500-2013","Class II","Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1006141, 1012303, 1102110, 1104324, and  1108664  ","5,000 units ( 500 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1501-2013","Class II","Stryker Instruments  0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1105390, 1107543 ","9,930 units (993 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1502-2013","Class II","Stryker Instruments 0400-850-000 T4 Toga, Zipper,  (XL-Tall) Sterile, EO; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1005097, 1008188, 1011281, 1103194, 1106465, 1107519, 1005105, 1008192, 1011296, 1103201, 1107501, 1109763, 1005111, 1009198, 1012303, 1103223, 1107550, 1109777, 1005118, 1009213, 1012314, 1104282, 1107560, 1109822, 1006129, 1009219, 1012325, 1104290, 1107605, 1109850, 1008181, 1009220, 1012335, 1104320, 1107606, 1006135, 1010228, 1012344, 1104312, 1108618, 1007145, 1010236, 1101003, 1105346, 1108663, 1007151, 1010235, 1101030, 1105355, 1108677, 1007156, 1010243, 1101055, 1105378, 1108709, 1007163, 1010252, 1102109, 1106411, 1108714, 1007169, 1010260, 1102123, 1105405, 1109728, 1008183, 1011276, 1102141, 1106430, and 1104275. ","88,040 units (8,804 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1503-2013","Class II","Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use;      Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1010236, 1108682 ","2,000 units ( 200  boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"
"Devices","65321","Ongoing","Stryker Instruments Div. of Stryker Corporation","Portage","MI","US","Voluntary: Firm Initiated","Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","USA Nationwide Distribution","Z-1504-2013","Class II","Stryker Instruments 0400-850-100 T5 zipper Toga  with Peel Away, Sterile, EO; single use;       Product Usage:   Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.    ","1006124, 1007164, 1010236, 1011296, 1103168, 1105341, and 1108634.  ","6,990 units ( 699 boxes)","Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the   aging of the packaging. Stryker is conducting additional testing and assessing this product    packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.","05/23/2013","06/12/2013"