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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 020H06535 Class II Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 021FJ57141 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Plasma Frozen 021FJ57141 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced Irradiated 09KG49760; 09KG46759 Class II Blood products, which were incompletely irradiated, were distributed. American Red Cross Blood Services
Biologics Blood and Blood Products for Reprocessing 21LL23077. Class II Blood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed.. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 21LL23077. Class II Blood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed.. American National Red Cross
Biologics Cryoprecipitated AHF 21LL23077. Class II Blood products, collected from a donor who was in close contact with an individual diagnosed as a hepatitis B carrier, were distributed.. American National Red Cross
Biologics Red Blood Cells W037908102316 Class III Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. LifeServe Blood Center
Food 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 Class I 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. LL Bakery, Inc.
Food 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 Class I 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. LL Bakery, Inc.
Food 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 Class I 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. LL Bakery, Inc.
Devices 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 Class III Affected products have a labeled expiration date of one year too long. Bion Enterprises Ltd
Devices 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 Class III Affected products have a labeled expiration date of one year too long. Bion Enterprises Ltd
Devices 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 Class III Affected products have a labeled expiration date of one year too long. Bion Enterprises Ltd
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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.. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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 Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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. Class II CGMP Deviations: Products are underdosed or have an incorrect dosage regime. TG United, Inc.
Drugs 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 Class III 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. Novartis Consumer Health
Drugs 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 Class III 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.. Novartis Consumer Health
Drugs 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). Class III The products have illegible lot and/or expiration dates on the product container. Novartis Consumer Health
Drugs 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. Class III 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. Novartis Consumer Health
Drugs 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 Class III 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. Novartis Consumer Health
Biologics Platelets Pheresis Leukocytes Reduced W115112335533G; Class II Blood product, which did not meet acceptable product specifications, was distributed. Lifesouth Community Blood Centers, Inc. - Mobile Region
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W1151130013868; Class II Blood product, which did not meet acceptable product specifications, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Fresh Frozen Plasma (Apheresis) W036512123500; W036512123495; Class III Blood products, labeled with an incorrect expiration dates, were distributed. LifeShare Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced W036512123499; W036512123500; W036512123495; W036512123497; W036512123795; W036512123796; W036512123792; W036512123792; W036512123793; W036512123793; W036512123794; W036512123499; Class II Blood products, labeled with an incorrect expiration dates, were distributed. LifeShare Blood Centers
Biologics Platelets Pooled Leukocytes Reduced 2935922; 2917309; 2906733; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma 2615454; 2536100; 1791712; 1692582; 1699599; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036810024856; W036810024856; W036808146279; W036808146279; 2084027; 2084027; 9638986; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets 1791712; 9671521; 9638986; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells 2615454; 2536100; 2351667; 1791712; 1692582; 1699599; 9671521; 9458747; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing 2351667; 9671521; 9638986; 9458747; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells W045613818099; W045613818100; W045613818110; Class III Blood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed. Community Blood Bank of Erie County
Biologics Red Blood Cells W036810231777; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Community Blood Centers of South FL, Inc.
Biologics Red Blood Cells Leukocytes Reduced W280312001390; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Upstate New York Transplant Services
Biologics Cryoprecipitated AHF W280312001390; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Upstate New York Transplant Services
Biologics Platelets Pheresis Leukocytes Reduced W1151130020407; Class II Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced 038GZ69902; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Svs. Indiana-Ohio Region
Biologics Blood and Blood Products for Reprocessing 038GZ69902; 038Y79139; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American Red Cross Blood Svs. Indiana-Ohio Region
Biologics Platelets Pheresis Leukocytes Reduced W28031280552; Class II Blood product, with platelet yield below the specified minimum requirement, was distributed. Upstate New York Transplant Services
Biologics Red Blood Cells Leukocytes Reduced W0470123710240; W0470123710240; (double unit) Class II Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed. New York Blood Center, Inc.
Biologics Red Blood Cells 2625668; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing 2625668; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Source Plasma ST1068311; ST1068692; ST1068971; ST1070131; ST1070344; ST1070813; ST1071082; ST1072200; ST1072433; ST1072809; ST1073309; ST1073493; ST1074119; ST1074203; ST1074732; ST1067724; ST1067959; Class II Blood products, collected from a donor who had not had an annual physical performed, were distributed. DCI Biologicals LLC
Biologics Red Blood Cells Leukocytes Reduced W043209019747; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Assurance Inc
Biologics Plasma Frozen within 24 hours (FP24) W043209019747; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W021512002231; Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Dept Of The Navy, Naval Medical Center
Biologics Red Blood Cells Leukocytes Reduced W021512001845; W021512004439; Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Dept Of The Navy, Naval Medical Center
Biologics Red Blood Cells Leukocytes Reduced W040812117735; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. West Tennessee Regional Blood Center Inc
Biologics Red Blood Cells Leukocytes Reduced W021512004565; Class II Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. Dept Of The Navy, Naval Medical Center
Biologics Blood and Blood Products for Reprocessing W036812599383; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced W036812599383; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells W036812566971; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Platelets Pooled Leukocytes Reduced W036812843768; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma W036812566971; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W044113003135; Class II Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. LifeServe Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W044112128378 Part 1; W044112128378 Part 2; Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced W089811607217; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Blood and Blood Products for Reprocessing W089811607217; Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W041013005157E; W041013005157E Class II Blood Products, collected from an ineligible donor, were distributed. Blood Systems Inc
Devices SlingBar 350. Designed to meet the needs for lifting humans. 3156015, 3156002, 3156008' 3156004 Class II 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. Hill-Rom, Inc.
Devices SlingBar 360. Designed to meet the needs for lifting humans. Product # 3156013 Class II 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. Hill-Rom, Inc.
Devices SlingBar Wide 670. Designed to meet the needs for lifting humans. Product # 3156012, 3156017 Class II 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. Hill-Rom, Inc.
Devices SlingBar Standard. Designed to meet the needs for lifting humans. Product #3156011 Class II 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. Hill-Rom, Inc.
Biologics Fresh Frozen Plasma W051712639896; Class II Blood product, collected from a donor with risk factors for vCJD, was distributed. Rhode Island Blood Center
Biologics Red Blood Cells 2320628 Class II Blood products, collected from an inelgible donor, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 2476618; 2476618 Class II Blood products, collected from an inelgible donor, were distributed. Community Blood Centers of South Florida, Inc.
Devices 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. Class I 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. Medtronic Xomed, Inc.
Drugs 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] Class II cGMP Deviation Petnet Solution Inc
Drugs 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. Class III CGMP Deviation; cotton coil is missing in some packaged bottles Teva Pharmaceuticals USA, Inc.
Drugs Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60 L-04009 Exp.11/15 Class III Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 Legacy Pharmaceutical Packaging LLC
Devices 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 Class II 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. Shimadzu Medical Systems
Devices 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 Class II 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. I-Flow LLC
Devices 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 Class II 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. I-Flow LLC
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. ; Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Food 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. Class II 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. Chemi- Source Inc, Nutra Pak
Biologics Plasma Frozen within 24 hours (FP24) 20GY55052; 20GY55090; 20GY55096; 20GY55097 Class II Blood products, collected from an ineligible donor, were distributed. American National Red Cross
Biologics Blood and Blood Products for Reprocessing 20GS49322; 20GS49377; 20GS49493; 20GS49495; 20GY55895; 20GY56039; 20GY55598; 20GY55610; 20FP12306; 20GS48814; 20GS49166; 20GH75559; 20GS48838; 20GS49245; 20GY55041; 20GY55126 Class III Blood products, collected from an ineligible donor, were distributed. American National Red Cross
Biologics 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 Class II Blood products, collected from an ineligible donor, were distributed. American National Red Cross
Biologics Capture-P Indicator Red Cells package 1 x 11.5 mL Lot Nos. 226192, 22613, 226194 Class III Capture-P and Capture-P Ready Screen assays, with confirmed reduced reactivity with the weak positive control, were distributed. Immucor Inc
Biologics Cornea 1302059; 1302060; Class III 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. Arkansas Lions Eye Bank & Laboratory
Biologics Cornea 06431301; 06431302 Class III Human Corneas, recovered using an expired Prep Kit, were distributed. North Carolina Eye Bank, Inc. (The)
Devices 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 Class II An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position. Kreg Medical Inc.
Devices 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 Class II An LPC Fine Mesh Cassette failed to stay closed during processing operations. Leica Microsystems, Inc.
Devices 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 Class II During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. SpineFrontier, Inc.
Devices 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 Class II 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. Alcon Grieshaber AG
Food 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 Class III The Golden Flower Dried Ginger (Net Weight 6 oz. 170 gms) Product of China is in violations to the Agriculture and Markets Law. Prosperity Resources International, Inc.
Devices 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. Class II The firm received complaints for unintended movements. Berchtold Corp.
Devices 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 Class II Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Covidien LP
Devices 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 Class II Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Covidien LP
Devices 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 Class II Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Covidien LP
Devices 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 Class II Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Covidien LP
Devices 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 Class II Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Covidien LP
Devices 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 Class II Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity Covidien LP
Devices FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. Lot Numbers 07912-06 12912-04 Class II 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. American Optisurgical Inc
Food DiGiorno pizzeria, bianca/white pizza , Net Wt.18.0 OZ (510 g), UPC 71921-91484 Production code: 3068525951 Class II Plastic contamination. Four pizzas with specific production codes, are being recalled because they may contain fragments of clear plastic Nestle USA, Inc - Northbrook Pizza Head Office
Food 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 Class II Plastic contamination. Four pizzas with specific production codes, are being recalled because they may contain fragments of clear plastic Nestle USA, Inc - Northbrook Pizza Head Office
Devices 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 Class II 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. Carl Zeiss Meditec, Inc.
Devices 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 Class II 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. American Optisurgical Inc
Drugs Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. THE COMPOUNDING SHOP, INC.
Drugs Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. THE COMPOUNDING SHOP, INC.
Drugs Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. THE COMPOUNDING SHOP, INC.
Drugs Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. THE COMPOUNDING SHOP, INC.
Drugs Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs 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 Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs 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 Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Drugs Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL All Lots Class II Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes THE COMPOUNDING SHOP, INC.
Food Whole Foods Salad Chicken Curry , 1 lb plastic bag (bulk) Sell By Date: 5/10/13 Class I Undeclared allergen: egg Whole Foods Market Group Inc.
Food Whole Foods Salad Curried Vegan Chick N , 1 lb plastic bags (bulk) Sell By Date: 5/10/13 Class I Undeclared allergen: soy Whole Foods Market Group Inc.
Devices 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. Class II 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. Philips Medical Systems (Cleveland) Inc
Devices 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 Class II 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. Maytex Corp
Devices 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) Class II 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. GE Healthcare, LLC
Devices 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 Class II 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). Intuitive Surgical, Inc.
Devices 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 Class II 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). Intuitive Surgical, Inc.
Food 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 Class II Elevated standard plate counts and detectable coliform bacteria. Smiling Hill Farm, Inc. dba Silvery Moon Creamery
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Drugs 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 Class II Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions. Pentec Health
Devices 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 Class II Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch. Cordis Corporation
Devices 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 Class II Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch. Cordis Corporation
Devices 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 Class II Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch. Cordis Corporation
Devices 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 Class II Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch. Cordis Corporation
Devices 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 Class II Holes and/or tears can be introduced in the FLEXSTENT® inner pouch under some conditions, and to a lesser degree, in the outer pouch. Cordis Corporation
Food 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 Class III Undeclared Splenda ingredient. Arizona Beverages USA LLC
Devices 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. Class III 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. Optovue, Inc.
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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 Class I 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. Symbios Medical Products, LLC
Devices 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. Class II 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. Biomet, Inc.
Devices 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. Class II 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. Intuitive Surgical, Inc.
Devices 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 Class II Customers could potentially experience intermittent, unintended and illogical movement when using the product. AGFA Corp.
Devices 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 Class II iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Siemens Healthcare Diagnostics, Inc
Devices 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 Class II iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Siemens Healthcare Diagnostics, Inc
Devices 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 Class II iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Siemens Healthcare Diagnostics, Inc
Devices 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 Class II iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Siemens Healthcare Diagnostics, Inc
Drugs 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 Class II Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. Hospira Inc.
Devices 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 Class II lack of sterility assurance Gyrus Acmi, Incorporated
Food 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 Class II Possible presence of metal fragments. HP Hood LLC
Food 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 Class II Possible presence of metal fragments. HP Hood LLC
Food 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 Class II Possible presence of metal fragments. HP Hood LLC
Devices 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. Class II Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame. Hill-Rom, Inc.
Devices 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 Class II 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. Zimmer Surgical Inc
Devices 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 Class II 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. Zimmer Surgical Inc
Devices 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 Class II 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. Zimmer Surgical Inc
Drugs 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. Class II Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications. Physicians Total Care, Inc.
Drugs 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. Class III 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. Physicians Total Care, Inc.
Devices 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. Class II 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. Coloplast Manufacturing US, LLC
Drugs 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 Class II Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Hospira Inc.
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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. Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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. Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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. Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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. Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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. Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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 Class II 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. Stryker Instruments Div. of Stryker Corporation
Devices 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. Class II 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. Stryker Instruments Div. of Stryker Corporation
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