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U.S. Department of Health and Human Services

Enforcement Report - Week of September 3, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Oxyphen XR, 12 HR / CLINICAL STRENGTH FAT BURNER, 45 FAST ACTING EXTENDED RELEASE CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599747 Lot #s 200910 and 200911, Exp 10/16 Class II The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements. Beta Labs
Food PHENTALENE (TM), PHARMACEUTICAL GRADE, With 50 mg of Ephedra Extract, 90 CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599822 Lot # 58800512, Exp 05/16 Class I The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements. Beta Labs
Food PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559802 Lot # 1205129, Exp 12/16 Class II The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements. Beta Labs
Food RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559819 Lot # 1205128 (90ct Bottle) Expires 12/16 Class II The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements. Beta Labs
Drugs MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX Lot number 11142013@74 Class I Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis Abrams Royal Pharamacy
Drugs All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX All unexpired lots of sterile drug products Class II Lack of Assurance of Sterility Abrams Royal Pharamacy
Food Cheese Pre-mix, CF 21-1, in 50 lbs bags, intended to be used in the manufacture of cheese dip Lot # 090313-103, Exp date 3/3/2014; Exp date Lot #091 91 3-1 04, Exp date 3/19/2014; Lot # 093013-105, Exp date 3/30/2014; Lot # 102813-101, Exp date 4/28/2014; Lot # 112113-107, Exp date 5/21/2014; Lot# 121013-102, Exp date 6/10/2014; Lot # 012814-102, Exp date 7/28/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix, LG 18-1,in 50 lbs bags, used in the manufacture of cheese dip Lot # 09041 3-1 03, Exp Date 12/4/2013; Lot # 091913-101, Exp Date 12/19/2013; Lot # 09301 3-1 07, Exp Date 12/30/2013; Lot # 1 0281 3-1 02, Exp Date 1/28/2014; Lot # 112013-106, Exp Date 2/20/2014; Lot # 121213-102, Exp Date 3/12/2014; Lot # 012814-101, Exp Date 4/28/2014 Class II Undeclared wheat Custom Ingredients LLC
Food French Onion Dip Pre--mix CJ 7-3, in 50 lbs bags intended to be used in the manufacture of French onion dip Lot # 111413-107, Exp Date 2/14/2014;.Lot # 112513-105, Exp Date 2/25/2014; Lot # 120213-101, Exp Date 3/2/2014; Lot # 121 113-106, Exp Date 3/11/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix JD 6-4, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot # 100313-103. Exp Date 1/3/2014, Lot # 112013-105, Exp Date 2/20/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix ACNC, in 45 lbs bags intended to be used in the manufacture of cheese dip Lot# 121213-101 Class II Undeclared wheat Custom Ingredients LLC
Food Chipotle Cheese Pre-mix DA 15-1, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 101613-108, Exp Date 1/16/2014; Lot# 110413-106, V 2/4/2014; Lot# 011314-108, Exp Date 4/13/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Monterey Jack Pre-mix EI 20-3, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 082913-102, Exp Date 11/29/2013; Lot# 091713-101, Exp Date 12/17/2014 Class II Undeclared wheat Custom Ingredients LLC
Food All Natural Cheese Pre-mix IA 9-4, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 101613-104 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix DRWC, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 082013-101, 2/20/2014; Lot# 080813-102, 2/8/2014; Lot# 090413-102, 3/4/2014; Lot# 092413-101, 3/24/2014; Lot# 092513-106, 3/25/2014; Lot# 093013-104, 3/30/2014; Lot# 100813-107, 4/8/2014; Lot# 103013-101, 4/30/2014; Lot# 120413-103, 6/4/2014; Lot# 011314-101, 7/13/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix JG 9-1, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 072913-104, Exp Date 10/29/2013; Lot# 082213-101, Exp Date 11/22/2013; Lot# 082113-101, Exp Date 11/21/2013; Lot# 091713-103, Exp Date 12/17/2013; Lot# 101613-107, Exp Date 1/16/2014; Lot# 121913-101, Exp Date 3/19/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix JC 9-3, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 121713-102 Class II Undeclared wheat Custom Ingredients LLC
Food All Natural Cheese Pre-mix JF 12-1, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 100813-109, Exp Date 1/8/2014; Lot# 121013-101, Exp Date 3/10/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix ME 14-1, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 100813-108, Exp Date 4/8/2014; Lot# 112113-102, Exp Date 5/21/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix EF 18-1, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 091913-102 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix DRNC, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 073113-103/104, Exp Date 1/31/2014; Lot# 091913-105/106, Exp Date 3/19/2014; Lot# 102813-104/105, Exp Date 4/28/2014; Lot# 121013-103, Exp Date 6/10/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Monterey Jack Pre-mix HI 10-3, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 073113-101/102 Class II Undeclared wheat Custom Ingredients LLC
Food Spinach Pre-mix HG 25-3, in 50 lbs bags intended to be used in the manufacture of dip Lot# 092513-108, Exp Date 12/25/2013; Lot# 010814-103, Exp Date 4/8/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix JC 6-1, in 50 lbs bags intended to be used in the manufacture of dip Lot# 080113-101/102, Exp Date 2/1/2014; Lot# 092413-104/105, Exp Date 3/24/2014; Lot# 102513-103, Exp Date 4/25/2014; Lot# 120513-102/103/104/105, Exp Date 6/5/2014; Lot# 010814-104/105, Exp Date 7/8/2014 Class II Undeclared wheat Custom Ingredients LLC
Food Cheese Pre-mix JE 4-2, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 082813-103/104/105/106, Exp Date 11/28/2013;  ...
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Class II Undeclared wheat Custom Ingredients LLC
Food Natural Cheese Pre-mix DRWC DJ 6-2, in 50 lbs bags intended to be used in the manufacture of cheese dip Lot# 080813-102, Exp Date 2/8/2014; Lot# 090413-102, Exp Date 3/4/2014; Lot# 092413-101, Exp Date 3/24/2014; Lot# 093013-104, Exp Date 3/30/2014; Lot# 120413-103, Exp Date 6/4/2014 Class II Undeclared wheat Custom Ingredients LLC
Food DOS PADRES BRAND; SOUTHWEST QUESO; NET WT. 15.6 oz. (442g); Distributed by; Cyclone ENTERPRISES; Houston, Texas 77060 UPC: 64258 20110 Lot # 03614 A DPSQ Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm. Consolidated Mills, Inc
Food DOS PADRES BRAND; CHIPOTLE QUESO; NET WT. 15.6 oz. (442g); Distributed by; CYCLONE ENTERPRISES; Houston, Texas 77060 UPC: 64258 20120 Lot # 29513 C DPSQ Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm. Consolidated Mills, Inc
Food TRULY TEXAS; CHIPOTLE CON QUESO; Queso With Chipotles; NET WT.; 16 OZ. (453g) and NET WT. 8 OZ. (226g); Distributed by: Double T Gourmet Foods, Inc.; PO Box 1582 Montgomery, TX 77356; Phone 936-582-6798; ww.trulytexasfoods.com UPC: 90191 00105 (16 oz.) and UPC: 90191 00129 (8 oz.) 16 OZ: Lot # 30913 B TTCQ Exp Date 11/5/2014; Lot # 00814 B TTCQ Exp Date 1/8/2015 8 OZ: Lot # 29413G TTCQ, Exp Date 10/21/2014; 02114A TTCQ, Exp Date 1/21/2015; 30913 A TTCQ E, Exp Date 11/5/2014 Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm. Consolidated Mills, Inc
Food SILVER STAR; TEX-MEX QUESO; CHIPOTLE QUESO; Medium Dip; NET WT. 16 OZ; (453g); Brought To You By: Silver Star Salsas; Box 50583; Austin, TX 78763 Lot # 310afv3A Exp date 11/15/2015; Lot # 022afv4A Exp Date 1/22/2015 Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm. Creative Foodworks, Inc
Food NATIVE TEXAN QUESO; NACHO; Medium; NATIVE TEXAN FOOD Co.; NET WT 16oz 453g 1LB.; NATIVE TEXAN FOOD CO. box 50583, Austin TX 78763 www.NativeTexan1836.com Lot # 290afs3A Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm. Creative Foodworks, Inc
Food Central Market HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 454g; DISTRIBUTED BY H-E-B CENTRAL MARKET, AUSTIN, TX 78735 Lot # 218afd3A, Exp Date 8/6/2015; 218afd3B,, Exp  ...
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Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm. Creative Foodworks, Inc
Food Native Texan HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 453g; DISTRIBUTED BY Native Texan Food Co. Box 50583, Austin 78763 www.NATIVETEXAN1836.com Lot # 225afd3A, Exp Date 8/13/2015; 225afd3B, Exp Date 8/13/2015; 262afd3A, Exp Date 9/19/2015; 262afd3B,Exp Date 9/19/2015; 290afd3A,Exp Date 10/17/2015; 006afd4A, Exp Date 1/6/2016 Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm. Creative Foodworks, Inc
Food CRAZY JERRY"S DA BIG CHEESE; NET WT. 16 OZ. ( 1 LB.) 454g; Prepared for Crazy Jerry's Inc. P.O. Box 891 Roswell, GA 30077 Lot # 289mf3A Class II Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm. Creative Foodworks, Inc
Drugs VIVITROL (naltrexone for extended-release injectable suspension); 380 mg vial NDC 65757-300-01; RX Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451. Batch Number: 412-3732AA; expiration date 07/2016 (NDC# 65757-302-02; Kit Pacaging Lot Number: 2013-021; expiration date 07/2016 (NDC# 65757-300-01. Class II Customer complaints for failure to deliver the dose. Alkermes, Inc.
Drugs Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68. Lot #: E21294K3C Exp Date: 6/29/2014 Class I Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Pharmakon Pharmaceuticals
Drugs Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48. A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014 Class I Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Pharmakon Pharmaceuticals
Drugs Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70. Lot #: E131210.212 Exp: 07/14/2014 Class II Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Pharmakon Pharmaceuticals
Drugs Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78. Lot #: E0333282R; Exp: 7/13/2014 Class I Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Pharmakon Pharmaceuticals
Devices Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes. Paradigm: MMT-523NAB, MMT-723KNB, MMT-523NAH, MMT-723KNH, MMT -523NAL, MMT-723KNL, MMT-523NAP, MMT-723KNP, MMT-523NAS, MMT-723KNS, MMT-723NAB, MMT-723NAH, MMT-723NAL, MMT-723NAP, MMT-723NAS, MMT-523KNB, MMT-523KNH, MMT-523KNL, MMT-523KNP, MMT-523KNS. MiniMed 530G: MMT-551NAM, MMT-551NAH, MMT-551NAL, MMT-551NAP, MMT-551NAS, MMT-751NAB, MMT-751NAH, MMT-751NAL, MMT-751NAP, MMT-751NAS. Class II Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount. Medtronic MiniMed Inc.
Food ORGANIC TRADITIONS SPROUTED CHIA SEED POWDER NET WT. 8 oz. and 16 oz., UPC 854260006162, item number AHM616 and UPC 854260005462, item number AHM546 All codes starting with BIO13 and ending with 269 up to and including 365; All codes starting with BIO14 and ending with 001 up to and including 156 Class I HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella Contamination. Health Matters America Inc.
Food ORGANIC TRADITIONS SPROUTED CHIA & FLAX SEED POWDER; NET WT. 8 oz., 16 oz and 50 lbs, UPC 854260006216, item AHM621, UPC 854260005479, item number AHM547 and item number BLK622 For 8 oz. & 16 oz., all codes starting with BIO13 and ending with 269 up to and including 365 and all codes starting with BIO14 and ending with 001 up to and including 156. For bulk 50 lb., all lot codes Class I HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella contamination Health Matters America Inc.
Food ORGANIC SPROUTED DARK SPROUTED CHIA SEED POWDER BULK; NET WT. 50 lb; item number BLK548 All lot codes Class I HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella contamination Health Matters America Inc.
Food ORGANIC TRADITIONS CHIA SEEDS; NET WT. 8 oz., 16 oz. and 50 lb., UPC 854260006131, UPC 854260006148, no UPC for 50 lb. For 8 oz. & 16 oz., all codes starting with ASCBO13. For 50 lb., all lot codes. Class I HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella contamination Health Matters America Inc.
Food ORGANIC TRADITIONS ULTIMATE SUPERFOOD TRAILMIX; NET WT. 3.5 oz UPC 854260010701 All lots ending in 003-13 to 005-14. Class I HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder, Sprouted Chia & Flax Seed Powder and Chia Seeds due to possible Salmonella contamination Health Matters America Inc.
Drugs PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Lot # 13-920741-0-1 EXP 21 JUN 2014 Class I Non Sterility; microbial contamination identified as Aspergillus species Central Admixture Pharmacy Services, Inc.
Drugs del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Lot# 13-920742-0-1 EXP 21 JUN 2014 and Lot# 13-920452-0-1 through 13-920452-0-30, EXP 21 JUN 2014 Class I Non Sterility; microbial contamination identified as Aspergillus species Central Admixture Pharmacy Services, Inc.
Drugs adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Lot# 13-920757-0-1 through Lot# 13-920757-0-5 (5 total doses) EXP 06 JUL 2014 Class I Non Sterility; microbial contamination identified as Aspergillus species Central Admixture Pharmacy Services, Inc.
Drugs LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150 Lot # 13-920739-01 through Lot # 13-920739-04 (4 total doses) EXP 21 Jun 2014 Class I Non Sterility; microbial contamination identified as Aspergillus species Central Admixture Pharmacy Services, Inc.
Food La Finquita Quesito Fresco Campesino / Fresh Farmers Cheese. The product is packaged in a 14.11oz. plastic container, UPC Code: 0 94922 76809 4 Use by 6/28/14. Class II The milk used to manufacture the cheese may be contaminated with peanuts and tree nuts (pistachios). La Finquita
Drugs Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05. Lot 3040063 Exp. 07/14 Class III Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. Mylan Pharmaceuticals Inc.
Devices Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test. (Catalog No. 20-005-019) Kit Numbers (US Distribution): 051013019-9, 6288-1, 6547-1, 6420-1, 5478-1, 5802-1, 6190-1, 7360-3, 5452-2, 6499-1, 6414-1, 7183-1, 7511-1, 5225-1, 5225-2, 6495-1, 5760-1, 5779-1, 7259-1, 6783-1, 7435-1 Kit Numbers (Foreign Distribution): 7300-4, 5500-1, 5908-3, 5970-3, 6402-1, 6402-2, 6105-1, 6123-1, 6793-1, 6827-1, 6224-1 Class III Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing. Nanosphere, Inc.
Biologics Red Blood Cells W050911079673; Class II Blood products, collected from donors whose health history screening was not adequately performed, were distributed. HCSC-Blood Center
Biologics Red Blood Cells W050911076204 Class III Blood products, collected from donors whose health history screening was not adequately performed, were distributed. HCSC-Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W050911081096; Class II Blood products, collected from donors whose health history screening was not adequately performed, were distributed. HCSC-Blood Center
Drugs Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11. Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016. Class III Failed Impurity/Degradation Specification; 12-month stability time point Novel Laboratories, Inc.
Devices BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells. A) REF #362753, 8 mL,16 x 125 mm, Lot #'s 4063409, 4063413 and 4063414 with expiry 03/15, Lot  ...
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Class II BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells. Becton Dickinson & Company
Devices 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit Lot Numbers: 2470635, 2453453, 2443370, 2438608, 2412131, 2394050, 2380339, 2380338, 2376475, 2361590, 2352067, 2322810, 2271334, 2260548, 2223901, 2208177, 2202236, 2191909, 2161059, 2077168, 2042400, 12050 Class I The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. Smiths Medical ASD, Inc.
Devices H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit Lot Numbers: 2470637, 2470636, 2457747, 2448649, 2443371, 2438610, 2438609, 2428204, 2428203, 2423483, 2412132, 2405733, 2405732, 2394049, 2394048, 2394047, 2389237, 2389236, 2385647, 2380340, 2376638, 2376473, 2371941, 2365534, 2361589, 2357817, 2357816, 2353342, 2347040, 2343290, 2339700, 2335460, 2326892, 2322812, 2309462, 2298736, 2298735, 2286584, 2278061, 2263550, 2260549, 2250041, 2233738, 2228354, 2219206, 2211922, 2208179, 2191911,  ...
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Class I The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. Smiths Medical ASD, Inc.
Devices H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit Lot Numbers: 2474641, 2470638, 2453454, 2448650, 2438611, 2433436, 2428205, 2412133, 2400804, 2347041, 2343292, 2326893, 2298737, 2271338, 2260550, 2211923, 2188448, 2175049, 2135974, 2099500, 2068120, 2042404, 11872, 11861 Class I The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. Smiths Medical ASD, Inc.
Devices H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit Lot Numbers: 2481849, 2474643, 2470640, 2470639, 2465819, 2462292, 2462291, 2457748, 2453455, 2448671, 2443372, 2438612, 2428206, 2420088, 2412135, 2394046, 2394045, 2394044, 2385648, 2380341, 2376618, 2376489, 2365439, 2361588, 2343298, 2329576, 2326894, 2322814, 2317088, 2309465, 2309464, 2298739, 2298738, 2286586, 2278062, 2271339, 2188449, 2179222, 2164289, 2146292, 2142175, 2137959, 2128629, 2119945, 2109011, 2099501, 2090215, 2068121,  ...
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Class I The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. Smiths Medical ASD, Inc.
Devices H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit Lot Numbers: 2597332, 2585074, 2580798, 2576365, 2564404, 2564403, 2563088, 2549367, 2519413, 2500170, 2488207, 2474646, 2465828, 2453473, 2443378, 2438615, 2433450, 2412145, 2380351, 2376498, 2365494, 2365493, 2361580, 2357823, 2353347, 2343313, 2329583, 2326899, 2322825, 2298752, 2286594, 2278069, 2271358, 2263553, 2260562, 2260561, 2250053, 2250052, 2250050, 2250049, 2244749, 2228363, 2219213, 2211929, 2208194, 2191930, 2179229, 2175056,  ...
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Class I The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. Smiths Medical ASD, Inc.
Devices H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit Lot Numbers: 2602399, 2588625, 2580799, 2576366, 2523679, 2513119, 2492246, 2481855, 2474647, 2465829, 2457754, 2443379, 2438616, 2433451, 2428215, 2412146, 2394061, 2380352, 2376566, 2365454, 2361579, 2357822, 2347642, 2343312, 2343311, 2329584, 2322827, 2309473, 2298755, 2298754, 2286596, 2271359, 2250054, 2244752, 2244751, 2228364, 2211930, 2208196, 2191931, 2188460, 2179231, 2175057, 2154535, 2152054, 2146301, 2142179, 2135984, 2128636,  ...
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Class I The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter. Smiths Medical ASD, Inc.
Biologics Platelets Pooled Leukocytes Reduced W051714804850 Class III Blood product, collected from an ineligible donor, was distributed. Rhode Island Blood Center
Biologics Fresh Frozen Plasma W036514012312; Class III Blood product, collected from a donor who had unsuitable test results, was distributed. LifeShare Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W036513143356; Class II Blood products, which was collected from a donor who traveled to a malarial endemic area, were distributed. LifeShare Blood Centers
Devices Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made. Item Number 42509900400, Lot Number: 62313324, 62415340, 62561031, 62668655, 62313326, 62430425, 62580270, 62695918, 62341561, 62442314, 62590506, 62702686, 62358628, 62473246, 62594059, 62715932, 62368700, 62507846, 62611157, 62728374, 62376588, 62522771, 62624943, 62742362, 62396348, 62530133, 62637095, 62749057, 62401156, 62534170, 62641120, 62757397, 62407514, 62538842, 62662172, 62766074, 62410673, 62542958, & 62668654. Class II Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position. Zimmer, Inc.
Devices Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM Item Numbers 00579104100, 00579104200, 00598304048, 00598304148 Exp Date Prior to 2023-11 Class II Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. Zimmer, Inc.
Devices Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM DIA ENDO FEMORAL HEAD 50MM DIA ENDO FEMORAL HEAD 51MM DIA ENDO FEMORAL HEAD 52MM DIA ENDO FEMORAL HEAD 53MM DIA ENDO FEMORAL HEAD 54MM DIA ENDO FEMORAL HEAD 55MM DIA ENDO FEMORAL HEAD 57MM DIA ENDO FEMORAL HEAD 60MM DIA ENDO FEMORAL HEAD 63MM DIA ENDO FEM HEAD 41MM ENDO FEM HEAD 42MM ENDO FEM HEAD 43MM ENDO PROS HEAD 44MM ENDO FEM HEAD 45MM ENDO FEM HEAD 46MM ENDO FEM HEAD 47MM ENDO FEM HEAD 48MM ENDO FEM HEAD 49MM ENDO FEM HEAD 50MM ENDO FEM HEAD 51MM ENDO FEM HEAD 52MM ENDO FEM HEAD 53MM ENDO FEM HEAD 54MM ENDO FEM HEAD 55MM ENDO FEM HEAD 57MM ENDO FEM HEAD 60MM ENDO FEM HEAD 63MM UNIPOLAR COMPONENT, 41MM UNIPOLAR COMPONENT, 42MM UNIPOLAR COMPONENT, 43MM UNIPOLAR COMPONENT, 44MM UNIPOLAR COMPONENT, 45MM UNIPOLAR COMPONENT, 46MM UNIPOLAR COMPONENT, 47MM UNIPOLAR COMPONENT, 48MM UNIPOLAR COMPONENT, 49MM UNIPOLAR COMPONENT, 50MM UNIPOLAR COMPONENT, 51MM UNIPOLAR COMPONENT, 52MM UNIPOLAR COMPONENT, 53MM UNIPOLAR COMPONENT, 54MM UNIPOLAR COMPONENT, 55MM UNIPOLAR COMPONENT, 56MM UNIPOLAR COMPONENT, 57MM UNIPOLAR COMPONENT, 58MM UNIPOLAR COMPONENT, 59MM UNIPOLAR COMPONENT, 60MM Item Numbers 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500, 00781805700, 00781806000, 00781806300, 00902604101, 00902604201, 00902604301, 00902604401, 00902604501, 00902604601, 00902604701, 00902604801, 00902604901, 00902605001, 00902605101, 00902605201, 00902605301, 00902605401, 00902605501, 00902605701, 00902606001, 00902606301, 451000041, 451000042, 451000043, 451000044, 451000045, 451000046, 451000047, 451000048, 451000049, 451000050, 451000051, 451000052,  ...
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Class II Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. Zimmer, Inc.
Devices Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 44MM DIA, ENDO FEMORAL HEAD 45MM DIA, ENDO FEMORAL HEAD 46MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 49MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 51MM DIA, ENDO FEMORAL HEAD 52MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 55MM DIA Item Numbers : 00781804300, 00781805300, 00781804700, 00781805000, 00781804200, 00781805400, 00781804800, 00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500 Lot Numbers: 37210958, 37210967, 37211180, 37211183, 37211311, 37211316, 37211320, 37211379, 37211482, 62561484, 37211643, 37211645, 37211646, 37211647, 37211653, 37211655, 37211657, 37211658, 37211661, 37211801, 37211804, 37211805, 37211806, 37211811,  ...
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Class II Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. Zimmer, Inc.
Devices Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0MMX115MMLG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0X120LG CANN BONE SCREW 7.0MMX120MMLG CANN BONE SCREW 7.0X125LG CANN BONE SCREW 7.0MMX125MMLG CANN BONE SCREW 7.0X130LG CANN BONE SCREW 7.0MMX130MMLG RECON SCR LGE 5.5MMDX105MM RECON SCR LGE 5.5MMDX110MM RECON SCR LGE 5.5MMDX115MM RECON SCR LGE 5.5MMDX120MM RECON SCR LGE 5.5MMDX125MM RECON SCR LGE 5.5MMDX130MM ITST ANTI-ROT SCR 6.5MMDX105MM ITST ANTI-ROT SCR 6.5MMDX110MM PERI. SCR 3.5MM X105MML PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 140MM L PERI SCR. 6.5MM X 100MM L PERI SCR. 6.5MM X 100MM L 3.5MM CORT SCR X 105MM SELFTAP 3.5MM CORT SCR X 110MM SELFTAP 5.5MM X 100MM CANN LKNG SCREW Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115 CANC SCREW FA Z NAIL 6.0 X 120 CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA Z NAIL 6.0 X 105 CANC SCREW PT Z NAIL 6.0 X 110 CANC SCREW PT Z NAIL 6.0 X 115 CANC SCREW PT Z NAIL 6.0 X 120 CANC SCREW PT Z NAIL 6.0 X 125 CANC SCREW PT Z NAIL 6.0 X 130 CANC SCREW PT Z NAIL 6.0 X 135 CANC SCREW PT Z NAIL 6.0 X 140 CANC SCREW PT Z NAIL 6.0 X 105 CANC SCREW FA Z NAIL 6.0 X 110 CANC SCREW FA Z NAIL 6.0 X 115CANC SCREW FA Z NAIL 6.0 X 120CANC SCREW FA Z NAIL 6.0 X 125 CANC SCREW FA Z NAIL 6.0 X 130 CANC SCREW FA Z NAIL 6.0 X 135 CANC SCREW FA Z NAIL 6.0 X 140 CANC SCREW FA 3.5X105 CORT SCR 3.5 X 105 CORT SCR SELF TAP 3.5X110 CORT SCR 3.5 X 110 CORT SCR SELF TAP 3.5X115 CORT SCR 3.5 X 115 CORT SCR SELF TAP 3.5X120 CORT SCR 3.5 X 120 CORT SCR SELF TAP 3.5X125 CORT SCR 3.5X130 CORT SCR 3.5X135 CORT SCR 3.5X140 CORT SCR 3.5X145 CORT SCR 3.5X150 CORT SCR 4.5 X 105 CORT SCR SELF TAP 4.5 X 110 CORT SCR SELF TAP 4.5 X 120 CORT SCR SELF TAP 6.5X105 CANC SCR, FULLY THDED 6.5X105 CANC SCR, 16MM THD 6.5X105 CANC SCR, 32MM THD 6.5X110 CANC SCR, FULLY THDED 6.5X110 CANC SCR, 16MM THD 6.5X110 CANC SCR, 32MM THD 6.5X115 CANC SCR, 32MM THD 6.5X120 CANC SCR, 32MM THD Item Numbers 00114610099, 00114610500, 00114610532, 00114610599, 00114611000, 00114611032, 00114611099, 00114611500, 00114611532, 00114611599, 00114612000, 00114612032, 00114612099, 00114612500, 00114612599, 00114613000, 00114613099, 00225210555, 00225211055, 00225211555, 00225212055, 00225212555, 00225213055, 00225710565, 00225711065, 47234712005, 47234712400, 47234712440, 47234712500, 47234712600, 47234810535, 47234811035, 47235910055, 47248310560, 47248311060, 47248311560, 47248312060, 47248312560, 47248313060, 47248313560, 47248314060, 47248410560, 47248411060, 47248411560, 47248412060, 47248412560, 47248413060, 47248413560,  ...
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Class II Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. Zimmer, Inc.
Devices Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SCP PLT 135DX8H TUBE&SCP PLT 135DX10H TUBE&SCP PLT 135DX12H TUBE&SCP PLT 135DX14H TUBE&SCP PLT 140DX8H TUBE&SCP PLT 140DX10H TUBE&SCP PLT 140DX12H TUBE&SCP PLT 140DX14H TUBE&SCP PLT 145DX8H TUBE&SCP PLT 145DX10H TUBE&SCP PLT 145DX12H TUBE&SCP PLT 145DX14H TUBE&SCP PLT 150DX6H TUBE&SCP PLT 150DX8H TUBE&SCP PLT 150DX10H TUBE&SCP PLT 150DX12H TUBE&SCP PLT 150DX14H VERSA-FX II SC TUBE PLT 90DX6H VERSA-FX II SC TUBE PLT 90DX8H VERSA-FXII SC TUBE PLT 90DX10H VERSA-FXII SC TUBE PLT 90DX12H VERSA-FXII SC TUBE PLT 90DX14H VERSA-FXII SC TUBE PLT 95DX6H VERSA-FXII SC TUBE PLT 95DX8H VERSA-FXII SC TUBE PLT 95DX10H VERSA-FXII SC TUBE PLT 95DX12H VERSA-FXII SC TUBE PLT 95DX14H VERSA-FX KEYLESS 90D X 8HOLE VERSA-FX KEYLESS 90D X 11HOLE VERSA-FX KEYLESS 95D X 8HOLE VERSA-FX KEYLESS 95D X 11HOLE VERSA-FX KEYLESS 95D X 14HOLE VERSA-FX II STD TUBE 130DX8H VERSA-FX II STD TUBE 130DX10H VERSA-FX II STD TUBE 130DX12H VERSA-FX II STD TUBE 130DX14H VERSA-FX II STD TUBE 135DX8H VERSA-FX II STD TUBE 135DX10H VERSA-FX II STD TUBE 135DX12H VERSA-FX II STD TUBE 135DX14H VERSA-FX II STD TUBE 140DX8H VERSA-FX II STD TUBE 140DX10H VERSA-FX II STD TUBE 140DX12H VERSA-FX II STD TUBE 140DX14H VERSA-FX II STD TUBE 145DX8H VERSA-FX II STD TUBE 145DX10H VERSA-FX II STD TUBE 145DX12H VERSA-FX II STD TUBE 145DX14H VERSA-FX II STD TUBE 150DX8H VERSA-FX II STD TUBE 150DX10H VERSA-FX II STD TUBE 150DX12H VERSA-FX II STD TUBE 150DX14H VERSA-FX II KEYLESS TB 130DX8H VERSA-FX II KEYLESS TB 135DX8H VERSA-FX II KEYLESS TB 140DX8H VERSA-FX II KEYLESS TB 145DX8H VERSA-FX II KEYLESS TB 150DX8H VERSA-FX KEYLESS 90D X 8HOLE VERSA-FX KEYLESS 90D X 11HOLE VERSA-FX KEYLESS 95D X 8HOLE VERSA-FX KEYLESS 95D X 11HOLE VERSA-FX KEYLESS 95D X 14HOLE Item Numbers: 00118109006, 00118109008, 00118109010, 00118109506, 00118109508, 00118109510, 00118113008, 00118113010, 00118113012, 00118113014, 00118113508, 00118113510, 00118113512, 00118113514, 00118114008, 00118114010, 00118114012, 00118114014, 00118114508, 00118114510, 00118114512, 00118114514, 00118115006, 00118115008, 00118115010, 00118115012, 00118115014, 00119309006, 00119309008, 00119309010, 00119309012, 00119309014, 00119309506, 00119309508, 00119309510, 00119309512, 00119309514, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514, 00119313008, 00119313010, 00119313012, 00119313014, 00119313508, 00119313510, 00119313512,  ...
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Class II Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. Zimmer, Inc.
Devices Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST FNSTRD HIP 52HDX152ST FNSTRD HIP 53HDX152ST FNSTRD HIP 54HDX152ST FNSTRD HIP 55HDX152ST FNSTRD HIP 57HDX152ST FNSTRD HIP 60HDX152ST FNSTRD HIP 63HDX152ST FNSTRD HIP 38HDX140ST FNSTRD HIP 40HDX140ST FNSTRD HIP 41HDX140ST FNSTRD HIP 42HDX140ST FNSTRD HIP 43HDX140ST FNSTRD HIP 44HDX140ST FNSTRD HIP 45HDX152ST FNSTRD HIP 46HDX152ST FNSTRD HIP 47HDX152ST FNSTRD HIP 48HDX152ST FNSTRD HIP 49HDX152ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST HIP PROS 38HDX105ST HIP PROS 40HDX105ST HIP PROS 41HDX105ST HIP PROS 42HDX105ST HIP PROS 43HDX105ST HIP PROS 44HDX105ST HIP PROS 45HDX105ST HIP PROS 46HDX105ST HIP PROS 47HDX105ST HIP PROS 48HDX105ST HIP PROS 49HDX105ST HIP PROS 50HDX105ST HIP PROS 51HDX105ST HIP PROS 52HDX105ST HIP PROS 53HDX105ST HIP PROS 54HDX105ST HIP PROS 55HDX105ST HIP PROS 57HDX105ST HIP PROS 60HDX105ST HIP PROS 63HDX105ST FNSTRD HIP 38HDX165ST FNSTRD HIP 40DX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 42HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 45HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 47HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 50HDX191ST FNSTRD HIP 51HDX191ST FNSTRD HIP 52HDX191ST FNSTRD HIP 53HDX191ST FNSTRD HIP 54HDX191ST FNSTRD HIP 55HDX191ST FNSTRD HIP 57HDX191ST FNSTRD HIP 60HDX191ST FNSTRD HIP 63HDX191ST FNSTRD HIP 38HDX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 51HDX165ST HIP PROS 38HDX127ST HIP PROS 40HDX127ST HIP PROS 41HDX127ST HIP PROS 42HDX127ST HIP PROS 43HDX127ST HIP PROS 44HDX127ST HIP PROS 45HDX140ST HIP PROS 46HDX140ST HIP PROS 47HDX140ST HIP PROS 48HDX140ST HIP PROS 49HDX140ST HIP PROS 50HDX152ST HIP PROS 51HDX152ST HIP PROS 52HDX152ST HIP PROS 53HDX152ST HIP PROS 54HDX152ST HIP PROS 55HDX152ST HIP PROS 57HDX152ST HIP PROS 60HDX152ST HIP PROS 63HDX152ST HIP PROS 38HDX165ST HIP PROS 40HDX165ST HIP PROS 41HDX165ST HIP PROS 42HDX165ST HIP PROS 43HDX165ST HIP PROS 44HDX165ST HIP PROS 45HDX165ST HIP PROS 46HDX165ST HIP PROS 47HDX165ST HIP PROS 48HDX165ST HIP PROS 49HDX165ST HIP PROS 50HDX191ST HIP PROS 51HDX191ST HIP PROS 52HDX191ST HIP PROS 53HDX191ST HIP PROS 54HDX191ST HIP PROS 55HDX191ST HIP PROS 57HDX191ST HIP PROS 60HDX191ST HIP PROS 63HDX191ST Item Numbers:00400500038, 00400500040, 00400500041, 00400500042, 00400500043, 00400500044, 00400500045, 00400500046, 00400500047, 00400500048, 00400500049, 00400500050, 00400500051, 00400500052, 00400500053, 00400500054, 00400500055, 00400500057, 00400500060, 00400500063, 00400600038, 00400600040, 00400600041, 00400600042, 00400600043, 00400600044, 00400600045, 00400600046, 00400600047, 00400600048, 00400600049, 00400600050, 00400600051, 00401000038, 00401000040, 00401000041, 00401000042, 00401000043, 00401000044, 00401000045, 00401000046, 00401000047, 00401000048, 00401000049, 00401000050, 00401000051, 00401000052, 00401000053, 00401000054, 00401000055,, 00401000057, 00401000060, 00401000063, 00402200038, 00402200040, 00402200041, 00402200042, 00402200043, 00402200044, 00402200045,  ...
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Class II Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. Zimmer, Inc.
Devices Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1 Item Numbers:00598801020, 00598801022, 00598801024, 00598801520, 00598801522, 00598801524, 00598801620, 00598801622, 00598801624, 00598801913, 31810604200, 32598801212, 32598801213, 32598801214, 32598801215, 32598801216, 32598801217, 32598801218, 32598801220, 32598801222, 621519095, 621519115, 621519135, 621519155, 621519175, 621520105, 621520125, 621520145, 621520165, 621520185, 621525105, 621525125, 621525145, 621525165, 681515125, 681515145, 681515165, 681515185, 681515205, 681517125, 681517145, 681517165, 681517185, 681517205, 681517225, 681519105, 681519115, 681519125, 681519135, 681519145, 681519165, 681519185 EXPIRATION DATE PRIOR TO 2024-07 Class II Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost. Zimmer, Inc.
Biologics Blood and Blood Products for Reprocessing 4324143; 1778709; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Indiana Blood Center
Biologics Red Blood Cells Leukocytes Reduced W0352130159273; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Platelets Irradiated W0352130159273; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W0352130159273; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Red Blood Cells Leukocytes Reduced W041014084117W; Class III Blood product, in which an antibody identified was labeled and distributed without antibody documented on final label, was distributed. United Blood Services
Biologics Red Blood Cells Leukocytes Reduced W116514736867Z; Class III Blood product, collected from a donor that was missing or incorrectly identified on deferral list who should have been deferred due to history, was distributed. Central Shared Services, LLC.
Biologics Red Blood Cells Leukocytes Reduced W044413308634; Class II Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed. Northern Illinois Blood Bank dba Rock River Valley BC
Devices Cordis EMPIRA NC RX PTCA Dilatation Catheter 63 Catalog numbers: 75R06200N, 75R06225N, 75R06250N, 75R06275N, 75R06300N, 75R06325N, 75R06350N, 75R06375N, 75R06400N, 75R10200N, 75R10225N, 75R10250N, 75R10275N, 75R10300N, 75R10325N, 75R10350N, 75R10375N, 75R10400N, 75R12200N, 75R12225N, 75R12250N, 75R12275N, 75R12300N, 75R12325N, 75R12350N, 75R12375N, 75R12400N, 75R15200N, 75R15225N, 75R15250N, 75R15275N, 75R15300N, 75R15325N, 75R15350N, 75R15375N, 75R15400N, 75R20200N, 75R20225N, 75R20250N, 75R20275N, 75R20300N, 75R20325N, 75R20350N, 75R20375N, 75R20400N, 75R25200N, 75R25225N,  ...
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Class II The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery. Cordis Corporation
Devices Cordis EMPIRA RX PTCA Dilatation Catheter 70 Catalog numbers: 85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S, 85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S, 85R10225S,85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S, 85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S, 85R12275S, 85R12300S, 85R12325S, 85R12350S, 85R12375S, 85R12400S, 85R15150S, 85R15200S, 85R15225S, 85R15250S, 85R15275S, 85R15300S, 85R15325S, 85R15350S, 85R15375S, 85R15400S, 85R20150S, 85R20200S, 85R20225S, 85R20250S, 85R20275S, 85R20300S, 85R20325S, 85R20350S, 85R20375S, 85R20400S, 85R25150S, 85R25200S, 85R25225S, 85R25250S, 85R25275S, 85R25300S,  ...
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Class II The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery. Cordis Corporation
Biologics Red Blood Cells Leukocytes Reduced W224314502250; Class III Blood product, collected from a donor with a reported post donation illness, was distributed. Houchin Community Blood bank
Devices Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338 Class II Siemens Healthcare Diagnostics, Inc.
Food Shoprite Spring Water Net 1 GAL (120 Fl Oz.) 3.78L Distributed by Wakefern Food Corp Elizabeth, NJ Made in USA UPC 041190007196 Code Date: 060514 Exp 060515 Code Date: 060714 Exp 060715 Class II Spring Water was found to be positive for E. Coli bacteria. Readington Farms Inc.
Food PriceRite Spring Water Net 1 GAL (3.78 L) Distributed by P.R.R.C. Inc. 5000 Riverside Drive Keasby, NJ 00832 UPC 041190755189 0849 060514 EXP 06/05/15 and 0839 060714 EXP 06/07/15 Class II Spring Water was found to be positive for E. Coli bacteria. Readington Farms Inc.
Biologics Red Blood Cells Leukocytes Reduced W04101407700600; Class III Misbranded Red Blood Cell was distributed. United Blood Services
Biologics Source Plasma 9140152016; 9140156096; 9140180695; Class III Source Plasma, collected from an ineligible donor, was distributed. Cangene Plasma Resources, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W038114057623; W038114053700; W038114022752; W038114024500; Class II Misbranded Red Blood Cells were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W051714803732; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. Rhode Island Blood Center
Food Rising Moon Organics Butternut Squash Ravioli, Organic, Vegetarian & Delicious; Keep Frozen; Net Wt. 8 oz. UPC: 7-85030-55557-6. Manufactured for Rising Moon Organics. Manufactured by: Carmel Food Group, Hayward, CA Sell by APR 09 2015; Product code 55557. Class II Consumer complaint alerted firm that one date code of Butternut Squash Ravioli, may actually contain Spinach Florentine Ravioli that contains milk, egg and soy ingredients that are not listed as ingredients of the package. Carmel Food Group, Inc.
Devices CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire guides, coils, balloons, catheters, and filters. Model Number(s): VRS-6.0-9.0 Lot numbers: 3583416, 3583418, 3583422, 3583424, 3583426, 3583428, 3583430, 3583432, 3583434, 3583436, 3583440, 3583442, 3583452, 3583456, 3583458, 3583462, 3583464, 3583466, 3583468, 3583470, 3583472, 3583474, 3583476, 3583478, 3583480, 3583482, 3583484, 3583486, 3583488, 3583490, 3583492, 3583494, 3583496, 3583498, 3583500, 3583502, 3583504, 4293921, 4293923, 4293925, 4293927, 4319573, 4319575, 4319577, 4319579, 4319581,  ...
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Class I This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire. Cook Inc.
Biologics Source Plasma 3770200847; 3770200549; 3770199963; 3770199790; Class II Source Plasma, collected from an ineligible donor, was distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 3770200579; 3770200319; Class II Blood product, for which donor eligibility was not complete, was distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced W038513350781; W038513343287; Class II Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. Walter L. Shepeard Community Blood Center, Inc.
Biologics Plasma Frozen W038513350781; W038513343287; Class II Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed. Walter L. Shepeard Community Blood Center, Inc.
Devices Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis. 00-5926-014-01; Lot 62455332 Class II Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging. Zimmer, Inc.
Food Organic Raw Carob Powder is shipped in original twenty pound case from supplier or re-packaged and sold in five pound plastic bags. Five pound bags are labeled in part "OG RAW CAROB POWDER*** C110-5# Lot: *** 5 lbs***Distributed by Hummingbird Wholesale Eugene, OR 97401 Certified Organic by Oregon Dept. of Agriculture***", with the lot number applied with a stick-on label. The twenty pound supplier case is labeled in part, "***Sunfood SUPERFOODS RAW ORGANIC CAROB POWDER***NET WT. 9 kg (19.8lb)***Distributed by Sunfood 1830 Gillespie Way, Suite 101 El Cajon, CA 92020 USA***". UPC code 803813-04429 8. 5lb bags coded with lot #: 14142, 14156, 14177, and 14189. 20lb case coded lot # 140509 and 140609; Exp Date 6/5/2015 or 11/2015. Class I Hummingbird Wholesale was notified by their Organic Carob Powder supplier of the voluntary recall of this product due to potential Salmonella contamination. Honey Heaven Wholesale, Inc.
Devices CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery. Lot numbers: M431760, M431710, M426580, M430200, M423010 Class II A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product. Civco Medical Instruments Inc
Devices CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm. Lot 0414 Class II The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function. Curbell Medical, Inc.
Food RegeneSlim Appetite Control, 2 capsules/ packet, Dietary Supplement 11414RE5516, EX0616R15814, 823230415, EX0616R15813 Class II RegeneSlim was found to contain DMAA by FDA analysis. Regeneca, Inc
Devices The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant. Model P4000 Serial numbers affected: 20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005 Class II A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded. Thermedx LLC
Food Tiny Isle Chocolate Truffles: Gluten Free, Raw, Vegan; Sold in 4 pack box - 4 oz: Flavors: Sea Salt, Coconut, Macadamia Nut, Mint Crunch Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 4 pack box UPC 011386711558 No lot codes or expiry dates All individual truffles have the same UPC number so I made them one product.. Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Chocolate Truffles: Gluten-Free, Raw, Vegan, Flavor varieties: Kauai Coconut, Mac Nut, Sea Salt, Mint Crunch, Spicy Lava. 1-oz Tiny Isle 4504 Kukui St, 20A Kapaa, HI 96746 No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Original Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil. agave nectar, carob powder, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC 011386071157No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Coconut Fudge, 2-oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,coconut, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC 011386711909; No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Mac Nut Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,mac nuts, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC 011386071188; No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Mint Crunch Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder cacao nibs, mint, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC 011386071164; No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Lava Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder, nioi chili's, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC 011386071164; No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Chocolate Truffles Kauai Coconut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC for single truffles: 11386711886 No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Chocolate Truffles Spicy Lava: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC for single truffles: 11386711886 No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Chocolate Truffles Macadamia Nut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC for single truffles: 11386711886 No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Chocolate Truffles Mint Crunch: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC for single truffles: 11386711886 No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Chocolate Truffles Hawaiian Sea Salt: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746 UPC for single truffles: 11386711886 No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Fudge Mix Organic, Organic-Raw- Gluten Free; Cacao powder, carob powder, Hawaiian sea salt. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746 UPC for single truffles: 11386711886 No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Food Tiny Isle Fudge Pack, Organic-Raw- Gluten Free: Mint Crunch, Mac Nut Fudge, Lava Fudge, 5-oz. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746 UPC for Fudge Pack: 11386071195 No lot codes or expiry dates Class I Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination. Florimont, Inc.
Drugs Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. Perrigo, 502 Eastern Ave, Plant #6, Allegan, MI 49010. Labeled: A) CareOne, 81 and 108 Ct Cartons, Distributed by: Foodhold U.S.A., LLD, Landover, MD 20785, NDC: 41520-734-02, 41520-734-03, B) CVS Pharmacy, 81 Ct Cartons, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC: 59779-734-02, C) equate, 27, 108, and 135 Ct Cartons, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-734-01, 49035-734-03, 49035-734-04, D) Kroger, 81 Ct Cartons, Distributed by: The Kroger Co., Cincinnati, Ohio 45202, NDC: 30142-734-02, E) Rite Aid, 81 and 108 Ct Cartons, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC: 11822-0734-3, 11822-0734-2, F) TopCare, 81 Ct Cartons, Distributed by Topco Associates LLC., Elk Grove Villiage, IL 60007, NDC: 36800-734-60 G) Walgreens, 81 and 135 Ct Cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC: 0363-0734-02, 0363-0374-04, H) 20 Ct Stretchcard, Target Corporation, Minneapolis, MN 55403. NDC: 11673-734-02. Cartons of 27 ct Tubes: Lot #: 2MV1074, Expiry: 09/14;  ...
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Class III Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges. Perrigo Holland Inc
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