January 16, 2002 02-02
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
______________________ PRODUCT US Label: Solgar's Digestive Aid, Dietary Supplement UK Label: Solgar's Digestive Enzymes Israeli Label: Solgar's Digestive Aid French Label: Solgar's Digestive Enzymes Tablets packaged in plastic bottles of 100's. Recall # F-114-2. CODE Lot 31993 and 30957 RECALLING FIRM/MANUFACTURER Solgar Vitamin and Herb Leonia, NJ, by letter 4/25/01, FDA issued a press release on 4/27/01. Firm initiated recall complete. REASON The product was manufactured using pepsin that American Laboratories, Inc. recalled due to Salmonella contamination. VOLUME OF PRODUCT IN COMMERCE 754 bottles DISTRIBUTION Nationwide and UK, South Africa, France, Ireland, and Israel. _______________________ PRODUCT 1) Nature's Plus(R) brand Nature Cleanse(R) BotaniCleanse(R) Natural Cleansing Supplement Botanical Concentrates, Green Foods & Vitamin C, 90 tablets per bottle, Product No. 1138. Recall # F-115-2; 2) Nature's Plus(R) brand Complete Digestive Aid Digestive Enzyme Supplement, 90 tablets per bottle, Product No. 4450. Recall # F-116-2; 3) Nature's Plus(R) brand Maximum Strength Ultra-Zyme(R) Digestive Enzyme Supplement The Ultimate Digestive Aid a) 90 tablets per bottle, Product No. 4452. b) 180 tablets per bottle, Product No. 4453. c) Italian label Nature's Plus(R) brand Enzimi Alimentari Ultra-Zyme(R)Bioalimento 90 Tavolette Peso netto 75g Prodotto Numero E0 4452 01. Recall # F-117-2; 4) Nature's Plus(R) brand Dietary Supplement Betaine Hydrochloride 600 mg, 90 tablets per bottle, Product No. 4370. Recall # F-118-2. CODE Firm on labels - Manufactured with LOVE by Natural Organics Laboratories, Inc., makers of Nature's Plus Amityville, New York U.S.A. NATURAL ORGANICS, Inc.(TM)Codes: Product Name Product # Lot #s Nature Cleanse 1138 008597 BotaniCleanse Betaine Hydrochloride 4370 1006874 Digestive Enzyme 4450 1008884 Ultra-Zyme 90 tabs 4452 1007110 1005942 1009520 1007562 Ultra-Zyme 180 tabs 4453 1005943 1007116 1009596 1006906 Ultra-Zyme 4452 01 1009034 Bioalimento RECALLING FIRM/MANUFACTURER Recalling Firm: Natural Organics, Inc. Melville, NY, by press release and letter on May 8, 2001, Manufacturer: Natural Organics Laboratories, Inc. Amityville, NY. FDA initiated recall is ongoing. REASON The products were manufactured using pepsin that American Laboratories, Inc., recalled due to Salmonella contamination. VOLUME OF PRODUCT IN COMMERCE BotaniCleanse: 1802 bottles; Digestive Enzyme:1461 bottles; Betaine HCl: 1771 bottles; Ultra-Zyme: 9626 bottles (90 tabs), 7446 (180 tabs), & 150 bottles (product to Italy). DISTRIBUTION Nationwide and International. The Ultra-Zyme Italian labeled product was sold to a sole distributor account in Italy _______________________ PRODUCT "Margaret" brand Korean Cookies, imported from Korea, 8.04 ounce foil packages, containing ca. 12 cookies per package, and packed in papercard boxes/12 boxes per case. Product labeled in English and Korean, Recall # F-121-2. CODE 09828K. RECALLING FIRM/MANUFACTURER Recalling Firm: Rhee Brothers, Inc. Columbia, MD, by letter on Oct. 23, 2001, and by press release on Nov. 13, 2001. Manufacturer: Lotte Confectionery Co., Ltd. Seoul, South Korea.State initiated recall is complete. REASON Product contains undeclared eggs and peanuts. VOLUME OF PRODUCT IN COMMERCE 205 cases. DISTRIBUTION Nationwide _______________________ PRODUCT 17 varieties of Islands Bakery brand bread and 1 variety of Trader Joe brand bread. Island's Bakery brand: F-122-2 Wheat bread; F-123-2 Cracked Wheat bread; F-124-2 Oat & Wheat Berry bread; F-125-2 Multi Grain bread; F-126-2 7-Grain bread; F-127-2 Honey-Wheat bread; F-128-2 Wheat Berry bread; F-129-2 Health bread; F-130-2 Old Fashioned Oat bread; F-131-2 Honey Spelt bread; F-132-2 Seed bread; F-133-2 Sunflower Barley bread; F-134-2 Caraway Rye bread; F-135-2 Apricot Walnut bread; F-136-2 Sourdough French bread;F-137-2 White bread; F-138-2 Jalapeno Cheese bread. Trader Joe's brand: F-139-2 Multi Seed bread. CODE All loaf breads' labels are dated "10 31" or before. RECALLING FIRM/MANUFACTURER Newman Foods, Inc. Arlington, WA , by press release on Oct. 26, and on site visit on Oct. 26 and 27 and by telephone on Oct. 27, 2001. Firm initiated recall is complete. REASON Loaf breads contain undeclared eggs. VOLUME OF PRODUCT IN COMMERCE Undetermined. DISTRIBUTION Western Washington State. _______________________ PRODUCT Recall Number(s): F-141-2/F-143-2 1. Colts Chocolate Dipped Animal Crackers, 2 oz., plastic package. Recall #F-141-2; 2. Roy Rogers Happy Trails Chocolate Peanut Butter & Trail Mix, 12/19 gram pieces, individually wrapped in plastic and sold in 6 and 12 unit boxes. Recall # F-142-2; 3. Colts Bolts Chocolate peanut Butter & Almonds, 2 oz, plastic package; Treasure Island at the Mirage Chocolate Peanut Butter & Almonds,2 oz; Mirage Las Vegas Chocolate Peanut Butter & Almonds, 2 oz; Bellagio Chocolate Peanut Butter & Almond, 2 oz; Golden Nugget Chocolate Peanut Butter & Almonds, 2 oz. Recall # F-143-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Colt, Inc. Nashville, TN, by letter dated September 5, 2001. Firm initiated recall ongoing. REASON Milk Chocolate-Coated products contain undeclared milk. VOLUME OF PRODUCT IN COMMERCE Approximately 1220 cases of product DISTRIBUTION Nationwide _______________________ PRODUCT Recall Number(s): F-148-2/F-154-2 Products are labeled with "INLAND CATERING Expando-O-Systems" brand. 1. Rueben Sandwich - undeclared egg yolk, and FD&C Yellow #5. Recall # F-148-2; 2. Turkey Wrap Sandwich - Undeclared egg yolk. Recall # F-149-2; 3. Ham Wrap Sandwich - Undeclared egg yolk. Recall # F-150-2; 4. Roast Beef and Cheese Sandwich - undeclared egg. Recall # F-151-2; 5. Tuna Salad Sandwich - undeclared crustacea (clam broth) and fails to list the subingredients of mayonnaise. Recall # F-152-2; 6. Meatball Sandwich - undeclared soy flour. Recall # F-153-2; 7. BBQ Beef Sandwich - undeclared soy flour. Recall # F-154-2. CODE Products with a pull date of 23-Jul-01 or before. RECALLING FIRM/MANUFACTURER Expand O Systems LLC, Boise, ID, route manager and drivers were notified on 7/17/01. FDA initiated recall complete. REASON Products contain undeclared ingredients that can elict reactions in sensitive individuals(see product list for specific ingredients). VOLUME OF PRODUCT IN COMMERCE Unknown DISTRIBUTION IDRECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
_______________________ PRODUCT Tortillas labeled: "6" YELLOW CORN FLOUR 6/10 DZ. Packaged as 120 count per plastic bag, 6 bags to a shipping case, Recall # F-119-2. CODE Product not coded. RECALLING FIRM/MANUFACTURER Super Lopez Tortilla Factory Houston, TX , by letter and telephone on 10/19/00. Firm initiated recall is complete. REASON The product was manufactured using an ingredient which appeared to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspies tolworthi. The pesticide is not allowed for use in foods for human consumption. VOLUME OF PRODUCT IN COMMERCE 8 cases. DISTRIBUTION TX _______________________ PRODUCT Sunflower Enriched Degerminated Self-Rising Yellow Corn Meal Mix in 5 lb. Bags (8 bags/bale). Recall # F-140-2. CODE Lot Code #112215 RECALLING FIRM/MANUFACTURER Hopkinsville Milling Company, Hopkinsville, KY, by telephone on 11/20/2001 and by fax and mail on 11/29/2001. FDA initiated recall ongoing. REASON The product was manufactured using an ingredient which appeared to contain the genetic material (DNA) necessary for the production in corn (trade name: Starlink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspies tolworthi. The pesticide is not allowed for use in foods for human consumption. VOLUME OF PRODUCT IN COMMERCE 912 bales (36,480 LBS) DISTRIBUTION AL, TN, MS, and AR. _______________________ PRODUCT Recall Number(s): F-155-2/F-163-2 Products are labeled with "INLAND CATERING Expando-O-Systems" brand. 1. Egg Salad Sandwich - does not list the subingredients of mayonnaise. Recall # F-155-2; 2. Chicken Salad Sandwich - does not list the subingredients of mayonnaise. Recall # F-156-2; 3. Ham Salad Sandwich - does not list the subingredients of mayonnaise. Recall # F-157-2; 4. Vanilla Oreo Pudding Pie - undeclared wheat flour, FD&C Yellow #5, and FD&C Yellow #6. Recall # F-158-2; 5. Banana Cream Pudding Pie - undeclared wheat flour, FD&C Yellow #5, and FD&C Yellow #6. Recall # F-159-2; 6. Coconut Cream Pudding Pie - undeclared wheat flour, FD&C Yellow #5 and FD&C Yellow #6. Recall # F-160-2; 7. Cherry Cheesecake - undeclared wheat flour, FD&C Yellow #5, and FD&C Yellow #6. Recall # F-161-2; 8. Blueberry Cheesecake - undeclared wheat flour, FD&C Yellow #5, and FD&C Yellow #6. Recall # F-162-2; 9. Chocolate Chip Pudding Pie - undeclared wheat flour, FD&C Yellow #5, and FD&C Blue #1. Recall # F-163-2. CODE Products with a pull date of 23-Jul-01 or before. RECALLING FIRM/MANUFACTURER Expand O Systems LLC Boise, ID, route manager and drivers were notified on 7/17/01. FDA initiated recall complete. REASON Products contain undeclared ingreients (see product list for specifics). VOLUME OF PRODUCT IN COMMERCE Unknown DISTRIBUTION ID
_______________________ PRODUCT Ferrous Sulfate Tablets, 325 mg. (Dietary Supplement) under the Eckerd, H.E.B., Longs, Nature's Valley, Sav-on Osco by Albertson's and Ultima labels. The product is packed in 60 and 100 tablet blister strips in a carton, Recall # F-120-2. CODE Lot Numbers OD01649, OF02547, OMB0627, OM02553, OM03538, OD01649, OF02547, OH02400, 1CA2142, OH02400, OMB0628, OF02546, OMB1226, OKB1115, OMB0629. RECALLING FIRM/MANUFACTURER Recalling Firm: Leiner Health Products, Inc. Carson, CA, by letter on May 16, 2001. Manufacturer: Leiner Health Products, Inc. Fort Mill, SC. Firm initiated recall is complete. REASON The product is misbranded since it lists an incorrect tablet strength on the inner blister packs. VOLUME OF PRODUCT IN COMMERCE 130,380 cartons. DISTRIBUTION Nationwide. _______________________ PRODUCT Golden Boy Dried Mushrooms packaged in rigid plastic trays, net wt. 2 oz., 50 - 2 oz. pkgs. per case. Recall # F-164-2. CODE None RECALLING FIRM/MANUFACTURER Recalling Firm: Strong America Limited Brooklyn, NY, by letter dated 10/2/00. Manufacturer: Xiamen Da Chang Hua Imp. & Exp. Co. Ltd. Xiamen, Fujian, China. State initiated recall complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 21 cases (50 - 2 oz. packages per case) DISTRIBUTION NY, FL and TNRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT CVS brand Infants' gas relief drops (simethicone/antiflatulent) 0.3 mL contains 20 mg of Simethicone, 1 oz bottle, Recall # D-059-2. CODE Lot 1251 Exp. 4/2003. RECALLING FIRM/MANUFACTURER Accumed Inc., Lawrenceville, NJ, by letter on 10/26/2001. Firm initiated recall is ongoing. REASON Microbial test specification failure - Pseudomonas aeruginosa. VOLUME OF PRODUCT IN COMMERCE 12,210 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Carbamazepine Tablets, Tegretol brand, 200 mg, in bottles of 100 Tablets (NDC 0083-0027-30) and 1000 Tablets (NDC 0083-0027-40), Recall # D-066-2. CODE Lot/code/expiration date: 124B0093 (bottles of 100s), NDC 0083-0027-30, APR 2002; 174D4344 (bottles of 1000s), NDC 0083-0027-40, FEB 2003; 234E9126 (bottles of 1000s), NDC 0083-0027-40, MAR 2004. RECALLING FIRM/MANUFACTURER Novartis Pharmaceuticals Corp., Suffern, NY, by letter on 11/12/01. Firm initiated recall is ongoing. REASON Dissolution failure (at stability testing). VOLUME OF PRODUCT IN COMMERCE 44, 212 bottles: lot 124B0093 - 36,665 bottles; lot 174D4344 - 3717 bottles; lot 234E9126 - 3830 bottles. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Anti-Aging Wrap solution, 8 oz., 32 oz. and 36 oz. plastic bottles. (conditioned water plus a proprietary blend of sodium magnesium and potassium salts, boron and other naturally occurring trace elements and herbal essences), Recall # D-070-2. CODE All Codes labeled as "Anti-Aging Wrap" that were distributed from 10/1/00 through 10/1/01 including lot #'s AA439090500 and AA110101CS. RECALLING FIRM/MANUFACTURER Recalling Firm: VMM Enterprises, Inc. Clearwater, FL , by letter on Oct. 8, 2001. Manufacturer: Pyramid Consulting and Investiment Co., Inc. Clearwater, FL. FDA initiated recall is ongoing. REASON Microbial Contamination; product is contaminated with Pseudomonas aeruginosa. VOLUME OF PRODUCT IN COMMERCE Unknown DISTRIBUTION Nationwide _______________________ PRODUCT Tazicef (Ceftazidime for Injection) 1 gram 15,20 & 100 mL vial; Tazicef (Ceftazidime for Injection) 2 gram 21,60 & 100 mL vial; Tazicef (Ceftazidime for Injection) 6 gram 100 mL vial. Recall Nos. D-071-02/D-073-02. Tazidime (Ceftazidime for Injection,USP) 1 gram 15,20 & 100 mL vial; Tazidime (Ceftazidime for Injection,USP) 2 gram 21,60 & 100 mL vial; Tazidime (Ceftazidime for Injection,USP) 6 gram 100 mL vial. Recall Nos. D-074-02/D-076-02. CODE Tazicef & Tazidime: Abbott Product Numbers: K5082-16, K5083-11, K5084-11, K5085-11, and K-5086-11 and Eli Lilly Product Numbers: VL72310, VL72340, VL72380, VL72390, and VL72410 Tazicef ADD-Vantage & Tazidime: Abbott Product Numbers: K5090-16 and K5091-11 Eli Lilly Product Numbers: VL72900 and VL72910 Abbott Product #K5082-04-16, NDC#0007-5082-16 Lots: 59004DA exp. Nov-01, 59011DA exp. Nov-01, 59012DA exp. Nov-01, 59016DA exp. Nov-01, 61017DA exp. Jan-02, 61018DA exp. Jan-02, 62001DA exp. Feb-02, 68012DA exp. Aug-02, 69007DA exp. Sep-02, 71010DA exp. Nov-02, 72001DA exp. Dec-02, and 72006DA exp. Dec-02. Abbott Product #K5083-04-01, NDC#0007-5083-11 Lots: 61008DA exp. Jan-02 and 70003DA exp. Oct-02. Abbott Product #K5084-04-01, NDC#0007-5084-11 Lots: 59013DA exp. Nov-01, 59014DA exp. Nov-01, 59015DA exp. Nov-01, 61005DA exp. Jan-02, 64005DA exp. Apr-02, 71011DA exp. Nov-02, and 76029DA exp. Apr-03. Abbott Product #K5085-04-01, NDC#0007-5085-11 Lot: 61009DA exp. Jan-02 Abbott Product #K5086-04-01, NDC#0007-5086-11 Lots: 58008DA exp. Oct-01, 60002DA exp. Dec-01, 60003DA exp. Dec-01, 71009DA exp. Nov-02, 72007DA exp. Dec-02, 73020DA exp. Jan-03, and 77007DA exp. May-03. Abbott Product #K5090-04-01, NDC#0007-5090-16 Lots: 58005DA exp. Oct-01, 58006DA exp. Oct-01, 72003DA exp. Dec-02, and 75020DA exp. Mar-03. Abbott Product #K5091-04-11, NDC#0007-5091-16 Lots: 58007DA exp. Oct-01, 61003DA exp. Jan-02, and 61004DA exp. Jan-02. Eli Lilly NDC#0002-7290-25 Lots: 8010T90 exp. 3/31/02, 8020T90 exp. 4/30/02, 8029T90 exp. 9/30/01, 8030T90 exp. 4/30/02, 8039T90 exp. 9/30/01, 8040T90 exp. 5/31/02, 8049T90 exp. 9/30/01, 8050T90 exp. 5/31/02, 8059T90 exp. 10/31/01, 8069T90 exp. 10/31/01, 8079T90 exp. 10/31/01, 8089T90 exp. 10/31/01, 8099T90 exp. 10/31/01, 8109T90 exp. 11/30/01, 8129T90 exp. 12/31/01, and 8139T90 exp. 12/31/01. Eli Lilly NDC#0002-7238-10 Lot: 4019T83 exp. 12/31/01 Eli Lilly NDC#0002-7231-25 Lots: 1010T82 exp. 2/28/02, 1011T82 exp. 1/31/03, 1020T82 exp. 2/28/02, 1029T82 exp. 11/30/01, 1030T82 exp. 2/28/02, 1039T82 exp. 11/30/01, 1040T82 exp. 4/30/02, 1050T82 exp. 7/31/02, 1060T82 exp. 11/30/02, 1070T82 exp. 11/30/02, and 1080T82 exp. 12/31/02. Eli Lilly NDC#0002-7291-10 Lots: 9010T91 exp. 3/31/02, 9019T91 exp. 10/31/01, 9020T91 exp. 3/31/02, 9029T91 exp. 11/30/01, 9030T91 exp. 4/30/02, 9039T91 exp. 11/30/01, and 9040T91 exp. 4/30/02. Eli Lilly NDC#0002-7239-10 Lot:5019T85 exp. 12/31/01 Eli Lilly NDC#0002-7234-10 Lots: 2010T84 exp. 2/28/02, 2019T84 exp. 11/30/01, 2020T84 exp. 3/31/02, 2030T84 exp. 4/30/02, 2040T84 exp. 5/31/02, and 2050T84 exp. 11/30/02. Eli Lilly NDC#0002-7241-16 Lots: 6010T86 exp. 2/28/02, 6011T86 exp. 1/31/03, 6020T86 exp. 4/30/02, 6029T86 exp. 10/31/01, 6039T86 exp. 10/31/01, 6049T86 exp. 11/30/01, 6059T86 exp. 11/30/01, and 6069T86 exp. 11/30/01. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories Abbott Park, IL, (Abbott, Eli Lilly and GlaxoSmithKline) jointly issued a recall letter dated 10/29/01 via certified mail. Manufacturer: GlaxoSmithKline Conshohocken, PA. Firm initiated recall ongoing. REASON Lack of assurance of sterility VOLUME OF PRODUCT IN COMMERCE 1124637 units DISTRIBUTION Nationwide ________________________ PRODUCT Poly-Tussin Syrup Sugar Free/Alcohol Free Sorbitol Free/Sodium Free 16 oz bottles, Rx Only Each 5 mL (one teaspoonful)for oral administration contains: Hydrocodone Bitartrate 5 mg, Phenylephrine Hydrochloride 5 mg, and Chlorpheniramine Maleate 2 mg. Recall # D-079-2. CODE Lot # 1E04, exp 05/03 RECALLING FIRM/MANUFACTURER Pharmacon Labs, Inc. Tampa, FL , by telephone and letters on 7/17/01. Firm initiated recall is ongoing. REASON Superpotentcy : Hydrocodone Bitartrate and Phenylephrine HCl. VOLUME OF PRODUCT IN COMMERCE 1,313 16 oz bottles. DISTRIBUTION KY _______________________ PRODUCT Triple Paste, Medicated Oinment, Zinc Oxide 11.6%, 2 oz (56.7g) - NDC # 11086-0020-01; 1 lb. (454 g) - NDC # 11086-0020-02; and Physician samples (11.5 g) - NDC# 11086-0020-03. Recall # D-082-2. CODE 2 oz size Lots: 102101 exp. 10/04 and 107011 exp. 11/04 1 lb size Lots: 102101 exp. 10/04, 107011 exp. 11/04, and 106011 exp. 11/04 sample size Lots: 102101 exp. 10/04 RECALLING FIRM/MANUFACTURER Recalling Firm: Summer Laboratories Inc Collegeville, PA, via certified mail on 12/5/01. Manufacturer: EMS Fort Washington, PA. Firm Initiated recall ongoing. REASON Misbranding : Product used as labeled may cause skin irritations VOLUME OF PRODUCT IN COMMERCE 25687 units - 7230 of 2oz, 2857 of 1lb, & 15600 sample tubes DISTRIBUTION Nationwide (except Alaska) _______________________ PRODUCT Levothroid Tablets, Forest Brand (levothyroxine sodium tablets, USP), 25 mcg., packaged in 100-tablet bottles, NDC #0456-0320-01, Rx only. Recall # D-083-2. CODE Lot #120011, Exp. 12/02 Lot #120013, Exp. 12/02 RECALLING FIRM/MANUFACTURER Recalling Firm: Forest Pharmaceuticals, Inc., St. Louis, MO, by letter dated 11/16/01. Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, OH. FDA initiated recall ongoing. REASON Subpotent- prior to labeled expiration date VOLUME OF PRODUCT IN COMMERCE Lot 120011 - 14,447/100-tab. btls; Lot 120013 - 14,607/100-tab. btls DISTRIBUTION NationwideRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
______________________ PRODUCT a) Respond First Aid Antiseptic Spray, 3 fl. oz, Lidocaine 2.5%, Benzalkonium Chloride 0.14%, Recall # D-060-2; b) Respond Burn Relief with Aloe Vera Antiseptic/Anesthetic Spray, 3 oz., Benzocaine 5% and Benzalkonium chloride 0.14%, Recall # D-061-2. CODE Respond Burn Spray, Lot # 0011037; Respond Antiseptic Spray, Lot # 0003065. RECALLING FIRM/MANUFACTURER Recalling Firm: Respond Industries, Inc., Arvada, CO., by letter on 9/10/2001. Manufacturer: York Pharmaceuticals, Kansas City, KS. Firm initiated recall is ongoing. REASON Potency: Super-potent Benzocaine in burn spray, Sub-potent Lidocaine in antiseptic spray. VOLUME OF PRODUCT IN COMMERCE 244 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Generlac Solution, (Lactulose Solution, USP), 10 g/15 mL, 16 oz., bottles, product code 8038, packaged under the MGP label, NDC 60432-038-16, Rx only, Recall # D-062-2; b) Hydroxyzine Hydrochloride Syrup, USP, 10 mg/5 mL, 4 oz. & 16 oz. bottles, product code 8150, Rx only, Recall # D-063-2; Packaged under the following labels: i) MGP label, NDC 60432-150-04 - 4 oz. & NDC 60432-150-16 - 16 oz., ii) Major Pharmaceuticals label, NDC 0904-0379-16 - 16 oz., iii) URL label, NDC 0677-1421-33 - 16 oz., c) Metoclopramide Oral Solution, USP, 5 mg/5 mL, 16 oz. bottles, product code 7622, packaged under the MGP label, NDC 60432- 622-16 Recall # D-064-2; d) Clindamycin Phosphate Topical Solution, USP 1%, 1 oz. & 2 oz. bottles, product code 8693, Rx Only, packaged under the MGP label, NDC #60432-693-30 - 1 oz. and 60432-693-60 - 2 oz. Recall # D-065-2. CODE a) Generlac Solution - lot 23562; b) Hydroxyzine HCl Syrup - lot 23413A, 23413F; c) Metoclopramide Oral Solution - lot 23576; d) Clindamycin Phosphate Topical Solution - lot 23408A, 23408C, 23408E. RECALLING FIRM/MANUFACTURER Morton Grove Pharmaceuticals, Inc. Morton Grove, IL, by letters dated 10/31/01 and 11/6/01. Firm initiated recall is ongoing. REASON Subpotency for Generlac, Hydroxyzine HCL, and Metoclopramide; Degradent failure for Clindamycin. VOLUME OF PRODUCT IN COMMERCE a) 15120 btls; b) 6912-4 oz & 36238-16 oz btls; c) 38588 btls; d) 6123-1 oz & 5700-2 oz btls. DISTRIBUTION Nationwide. _______________________ PRODUCT AK-CIDE brand of Prednisolone Acetate, USP and Sulfacetamide Sodium, USP, Ophthalmic Ointment-Sterile, 3.5 g tube. Each gram of ointment contains 100 mg/g of Sulfacetamide sodium USP and 5 mg/g of Prednisolone acetate USP. NDC 17478-276-35, Recall # D-067-2. CODE Lot 9-AH-1, exp. date March 2002; Lot 9-AH-2, exp. date March 2002. RECALLING FIRM/MANUFACTURER Schering-Plough Products, Inc., Manati, Puerto Rico, by letter dated 11/6/01. Firm initiated recall is ongoing. REASON Subpotency for Sodium Sulfacetamide component (stability). VOLUME OF PRODUCT IN COMMERCE 48,000 units. DISTRIBUTION IL. _______________________ PRODUCT Infants' Simethicone Drops, Simethicone, 20 mg in each 0.3 mL, 1 fluid ounce(30mL) bottles. This product was distributed under 52 brand labels, Recall # D-068-2. 1) Guardian brand Infant's Wind Relief With Simethicone, NDC: N/A. 2) Albertson's brand, NDC: 41163-119-10. Discontinued. 3) Sav-on Osco by Albertson's brand Infants' Simethicone Drops, NDC: 41163-119-10. 4) Sav-on Osco by Albertson's brand Infants' Simethicone Drops, Non-Staining Formula, NDC: 41163-882-10. 5) American Fare brand Infants' Gas Symptom Relief Simethicone Drops, NDC: 49738-119-10. 6) Ameripharm brand Infants' Baby Gaz Simethicone Anti-Gas Drops, NDC: N/A. 7) Brite-Life brand Infants' Gas Relief Drops Simethicone Anti-Gas, NDC: 24385-785-30. 7) Dominick's brand Infants' Simethicone Drops, NDC:38694-119-10. 9) Drug Emporium brand Infants' Simethicone Drops, NDC: 62865-119-10. 10) Elect Health brand Infants' Gas Relief Drops Simethicone, Non-Staining Formula, NDC: 37012-882-10. 11) Equate brand Infants' Gas Relief Drops Simethicone, Non-Staining Formula, NDC: 0113-1882-10. 12) Finast brand Infants' Gas Relief Drops Simethicone, Non-Staining Formula, NDC: 41520-882-10. 13) Food Lion brand Infants' Simethicone Drops, NDC:55316-119-10. 14) Full Value brand NDC: 52297-299-10. 15) Giant Eagle brand Infants' Gas Relief Drops Simethicone, NDC: 56194-119-10. 16) Good Neighbor Pharmacy brand Infants' Gas Relief Drops, Simethicone, NDC: 24385-785-30. 17) Good Sense brand Infants' Simethicone Drops, Perrigo. NDC: 0113-0119-10. 18) Good Sense brand Infants' Simethicone Drops, Non-Staining Formula, Perrigo. NDC: 0113-0882-10. 19) H.E.B. Pharmacy brand Infants' Simethicone Drops, NDC: 37808-119-10. 20) Health Mart Pharmacies brand Simethicone Gas Relief Infants' Drops, NDC: 52297-664-10. 21) Kaiser Permanente brand Infants' Simethicone Drops, Kaiser Foundation Hospitals, Livermore, CA. NDC: 0179-0119-10. 22) Kn'K Preferred brand Infants' Simethicone Drops, Dist. by Kash n' Karry, Tampa, FL. NDC: 46279-119-10. 23) Kerr Drug brand Infants' Simethicone Drops, NDC: 55166-119-10. 24) Kroger brand Infants' Simethicone Drops, Non-Staining Formula, NDC: 30142-882-10. 25) Leader brand Infants' Simethicone Drops, Dist. by Cardinal Health, Inc., Dublin, OH. NDC: 37205-119-10. 26) Longs brand Infants' Simethicone Drops, Dist. by Longs Drug Stores, Walnut Creek, CA. NDC: 12333-9972-1. 27) Longs brand Infants' Simethicone Drops Non-Staining Formula, NDC: 12333-9879-1. 28) Marquee brand Infants' Simethicone Drops, NDC: 11205-119-10. 29) May's Drug brand Infants' Simethicone Drops Non-Staining Formula, NDC: 56017-882-10. 30) Meijer brand Infants' Simethicone Drops Non-Staining Formula, NDC: 41250-882-10. 31) Osco brand NDC: 12810-119-10. Discontinued. 32) Osco brand NDC: 12810-882-10. Discontinued. 33) Perfect Choice brand Infants' Simethicone Drops, NDC: 41226- 119-10. 34) Perfect Choice brand Infants' Simethicone Drops Non-Staining Formula, Cincinnati, OH. NDC: 41226-882-10. 35) Phar Mor brand Infants' Simethicone Drops, NDC: 60362-119-10. 36) Phar Mor brand Infants' Simethicone Drops Non-Staining Formula, NDC: 60362-882-10. 37) Safeway brand Infants' Simethicone Drops, NDC: 21130-119-10. 38) Sav-On brand NDC: 37097-119-10. Discontinued. 39) Sav-On brand NDC: 37097-882-10. Discontinued. 40) Shop Rite brand Infants' Simethicone Drops, NDC: 41190-119-10. 41) Shopko brand NDC: 37012-882-65. Discontinued. 42) Stater Bros. Markets brand Infants' Simethicone Drops, NDC: 38985-119-10. 43) Stop & Shop brand Infants' Gas Relief Drops Non-Staining Formula, NDC: 21120-882-10. 44) Swan brand Infants' Simethicone Drops, Perrigo. NDC: 0113-0119-10. 45) Target brand Infants' Gas Relief Non-Staining Formula, NDC: 11673-882-10. 46) Today's Health brand Infants' Simethicone Drops, NDC: 38309-119-10. 47) Top Care Infants' Simethicone Drops, NDC: 36800-119-10. 48) Valu Rite brand Simethicone Gas Relief Infants' Drops, NDC: 49348-577-34. 49) Valu Rite brand Simethicone Gas Relief Infants' Drops Non-Staining Formula, NDC: 49348-376-27. 50) Vons brand Infants' Simethicone Drops, NDC: 58828-119-10. 51) Walgreens brand Infants' Gas Relief Drops, NDC: 0363-0119-10. 52) Walgreens brand Infants' Gas Relief Drops Non-Staining Formula, NDC: 0363-0882-10. 53) Western Family brand Simethicone Infants' Gas Relief Drops, NDC: 55312-119-10. 54) Medic brand Infants' Simethicone Drops, NDC: 56039-119-10. CODE All lots within expiry. RECALLING FIRM/MANUFACTURER Perrigo, Allegan, MI, by letter on 11/28/01. Firm initiated recall is ongoing. REASON Subpotent for simethicone. VOLUME OF PRODUCT IN COMMERCE 234,473 bottles DISTRIBUTION Nationwide, Vietnam and the Philippines. _______________________ PRODUCT Premarin tablets, 1.25mg (Conjugated Estrogens Tablets, USP), Rx, 100 count tablets, Recall # D-069-2. CODE Lot #03138, Exp 09/03, NDC# 00046-0866-81. RECALLING FIRM/MANUFACTURER Recalling Firm: Rx Pak, Division of McKesson HBOC Memphis, TN, by letter on 8/13/01. Manufacturer: Ayerst Laboratories, Rouses Point, NY. Firm initiated recall is ongoing. REASON Dissolution failure by manufacturer. VOLUME OF PRODUCT IN COMMERCE 41, 545 100 count bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Ketoprofen Extended-Release Capsules, 200 mg., 100 capsules bottles labeled as Mfd. for: Schein Pharmaceutical, Inc., Mfd by: Elan Pharma Ltd. The product is an Rx only, Recall # D-077-2. CODE Lot P0K0252. RECALLING FIRM/MANUFACTURER Recalling Firm: Elan Pharmaceuticals Research Corp. Gainesville, GA, by letter on Oct. 19, 2001. Manufacturer: Elan Pharma Ltd. County Westmeath, Ireland, Firm initiated recall is complete. REASON Dissolution failure (at stability testing). VOLUME OF PRODUCT IN COMMERCE 8,646 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Risperdal (Risperidone)Tablets, 0.25mg, bottles of 60 and 500 tablets. Rx only Risperdal tablets, 0.25mg, are a prescription benzisoxazole antipsychotic agent in a solid dosage form intended for the management of the manifestations of psychotic disorders, Recall # D-078-2. CODE Lot Number -- Expiration Date NDC number 50458-301-04 and 50458-301-50 500'S 90P0550 -- 3/31/02 90P0739 -- 3/31/02 90P0775 -- 9/30/02 91P0112E -- 9/30/02 91P0003 -- 10/31/02 91P0161 -- 12/31/02 91P0223 -- 1/31/03 91P0372 -- 1/31/03 91P0471 -- 3/31/03 91P0415 -- 3/31/03 91P0582 -- 3/31/02 91P0640E -- 3/31/03 91P1011 -- 5/31/03 91P1053E -- 5/31/03 91P0883 -- 5/31/03 60'S 90P0746E -- 9/30/02 90P0795E -- 9/30/02 91P0113 -- 10/31/02 91P0002 -- 10/31/02 91P0206E -- 12/31/02 91P0369 -- 1/31/03 91P0468E -- 1/31/03 91P0414 -- 3/31/03 91P0575E -- 3/31/03 91P0614E -- 3/31/03 91P0661E -- 3/31/03 91P0898 -- 5/31/03 91P0840 -- 5/31/03 91P1009 -- 5/31/03 91P1067E -- 6/30/03. RECALLING FIRM/MANUFACTURER Recalling Firm: Pharmaceutical Sourcing Group Americas (Janssen ) Titusville, NJ , by letter on 11/30/2001. Manufacturer: Janssen-Cilag S.P.A Latina, Italy. Firm initiated recall is ongoing. REASON Dissolution failure. VOLUME OF PRODUCT IN COMMERCE 496370 bottles of 60's; 40925 bottles of 500. DISTRIBUTION Nationwide _______________________ PRODUCT a) Derma-Smoothe/FS (Scalp Oil)Fluocinolone Acetonide 0.01% Topical Oil, Rx only, 4 fl. oz. Recall # D-080-2; b) Derma-Smoothe/FS, Atopic Pak, Fluocinolone Acetonide 0.01%, For Topical Use Only, 4 fl. ounce bottles, Rx only. Recall # D-081-2. CODE a) Lots L000099, M000110, B010020, B010026, C010038 and D010045 b) Lots A010004 and C010030. RECALLING FIRM/MANUFACTURER Hill Dermaceuticals, Inc. Sanford, FL, by letter on Aug. 30, 2001. Firm initiated recall is complete. REASON Subpotency for Flucinolone Acetonide. VOLUME OF PRODUCT IN COMMERCE 226,659 bottles. DISTRIBUTION Nationwide and Canada.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Platelets, Recall # B-0137-2. CODE Units 90204, 90207, 90208, 90209, 90212. RECALLING FIRM/MANUFACTURER Lane Memorial Blood Bank, Eugene, OR, by letter dated May 24, 2001. Firm initiated recall is complete. REASON Platelets, prepared with short rest times, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION OR _______________________ PRODUCT Red Blood Cells, Irradiated, Recall # B-0304-2. CODE Unit GL30657 RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated June 13, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to anarea designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0397-2; b) Red Blood Cells, Leukoreduced, Recall # B-0398-2; c) Platelets, Recall # B-0399-2; d) Fresh Frozen Plasma, Recall # B-0400-2. CODE a), c) and d) Unit 0475883; b), c) and d) Unit 0452175 RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH, by letter dated Feb. 21, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION OH, KY and FL. _______________________ PRODUCT a) Whole Blood, Recall # B-0407-2; b) Red Blood Cells, Recall # B-0408-2; c) Recovered Plasma, Recall # B-0409-2. CODE a) 0674137; b) and c) 0464795. RECALLING FIRM/MANUFACTURER Recalling Firm: Central Kentucky Blood Center, Lexington, KY, by letter on May 25, 2001. Firm initiated recall complete. REASON Blood products, collected from a donor with a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION KY and PA _______________________ PRODUCT Counterfeit Neupogen (Filgrastim), labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single use vials per carton; quantity distributed unknown, Recall # B-0410-2. CODE Lot Number P000890, Expiration Date 12/02 Lot Number P000992, Expiration Date 06/03 Lot Number P000948, Expiration Date 0503 RECALLING FIRM/MANUFACTURER First Choice Pharmaceutical Wholesalers, Inc., Davie, FL, by fax on June 8, 2001. Firm initiated recall ongoing. REASON Counterfeit Neupogen was distributed. VOLUME OF PRODUCT IN COMMERCE Quantity distributed unknown DISTRIBUTION CT, FL, MD, MS, NY, NJ and CA. _______________________ PRODUCT Source Plasma, Recall # B-0411-2. CODE Unit G-06924-035. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, City of Industry, CA, by fax dated Oct. 6, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor at increased risk for nvCJD due to having lived in the United Kingdom, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________ PRODUCT Platelets, Recall # B-0413-2. CODE Unit L18480. RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, by fax on July 26, 2001. Firm initiated recall is complete. REASON Platelets, which were prepared from a Whole Blood unit collected from a donor who had taken aspirin within thirty six hours of donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT a)Red Blood Cells, Recall # B-0419-2; b)Platelets, Recall # B-0420-2; c)Cryoprecipitated AHF, Recall # B-0421-2;; d)Recovered Plasma, Recall # B-0422-2. CODE a) and d) Units FX11976, FX12047, FX12460, FX12482; b) Unit FX11976; c) Unit FX12047. RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, by letter on July 27, 2001. Firm initiated recall is complete. REASON Blood products, collected from donor's who had not been properly screened, were distributed. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION Illinois and Switzerland. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0425-2. CODE Unit 011GN28095. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO, by letter dated June 22, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MO. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0426-2. CODE Unit 011GG05960. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO, by letter dated December 15, 1999. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MO. _______________________ PRODUCT a) Red Blood Cells, Irradiated, Recall # B-0427-2; b) Platelets, Pheresis, Irradiated, Recall # B-0428-2. CODE a) Units 6232418, 3598452; b) Units 4203391, 2621939. RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL, by telephone on May 20, 2001. Firm initiated recall is complete. REASON Blood products, for which documentation of irradiation was incomplete, were distributed VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-0429-2. CODE Units 00YARB2710, 00YARB3056, 00YARB2539, 00YARB1483, 00YARB2338, 00YARB2567. RECALLING FIRM/MANUFACTURER Community Bio-Resources, Inc., Fayetteville, AR, by fax on July 27, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION Austria. _______________________ PRODUCT Platelets, Pheresis, Recall # B-0430-2. CODE Unit 1425342. RECALLING FIRM/MANUFACTURER New York Blood Center, New York, NY, by letter dated Oct. 12, 2000. Firm initiated recall is complete. REASON Blood product, which had an unacceptable platelet count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0460-2; b) Platelets, Recall # B-0461-2; c) Fresh Frozen Plasma, Recall # B-0462-2; d) Recovered Plasma, Recall # B-0463-2. CODE a), b) and c) Unit 011M59982; a) and d) Unit 011M45914. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO, by letter date May 26, 2000. Firm initiated recall is complete. REASON Blood products, were collected from a donor who provided post donation information regarding having tested positive for hepatitis, and engaging in high risk behavior. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION MO and AL. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0464-2; b) Recovered Plasma, Recall # B-0465-2. CODE a) and b) Unit 011LX74127 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO, by letters dated July 21 and Aug. 1, 2000. Firm initiated recall is complete. REASON Donor, who had been deferred at another donor center, was allowed to donate. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MO. _______________________ PRODUCT a) Red Blood Cells Recall # B-0466-2; b) Fresh Frozen Plasma, Recall # B-0467-2. CODE a) and b) Unit 011N18566. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO, by letter dated January 20, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who had received blood products while in a country at increased risk for HIV Group O, and who had also engaged in high risk behaviors, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MO. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0468-2. CODE Unit 21KL28446. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR by letter dated March 2, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Irradiated, Recall # B-0469-2. CODE Unit 21GE20086. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by letter dated March 27, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0470-2; b) Fresh Frozen Plasma, Recall # B-0471-2. CODE a) and b) Unit 11FN86287. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, St. Louis, MO, by letters dated Feb. 11 and 22, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who had engaged in high risk behaviors, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MO and NJ. _______________________ PRODUCT Human Tissue for Transplant (3 tissues): a) Descending Thoracic Aorta; b) Pulmonary Hemi-artery; c) Pulmonary Trunk Patch, Recall # B-0472-2. CODE a) Model No. A020 - Serial No. 6489451; b) Model No. PH00 - Serial No. 6489478; c) Model No. P010 - Serial No. 6489486. RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA, by letter dated Nov. 1, 2001. Firm initiated recall ongoing. _____ REASON Tissues for transplant were collected from a donor who had not been properly evaluated. VOLUME OF PRODUCT IN COMMERCE 3 tissues. DISTRIBUTION MN, FL and PA _______________________ PRODUCT Source Plasma Units, Recall # B-0473-2. CODE T-16183-051, T-16000-051, T-16149-051, T-15936-051, T-16109-051, T-15911-051, T-16072-051, T-15858-051, T-16036-051, T-15831-051, T-15768-051, T-15740-051, T-15674-051, T-15631-051, T-15567-051, T-15529-051, T-15477-051, T-15435-051, T-15375-051, T-15302-051, T-15254-051, T-15145-051, T-15104-051, T-15020-051, T-14987-051, T-14925-051, T-14872-051 RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile on July 13, 2000. Manufacturer: Alpha Therapeutic Corporation, Fontana, CA. Firm initiated recall complete. REASON Blood products, collected from a donor who subsequently Provided information involving high-risk behaviors, were distributed. VOLUME OF PRODUCT IN COMMERCE 27 units DISTRIBUTION Spain ______________________ PRODUCT Red Blood Cells, Recall # B-0475-2. CODE Unit 7014073. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Anchorage, AK, by letter dated May 22, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of jaundice, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AK. _______________________ PRODUCT Various Human Freeze Dried Bone and/or Frozen Human Tissue, grafts including: Cancellous Chips, 40cc; Cancellous Chips,30cc; Cancellous Chips, 60cc; Cancellous Chips, 90cc Cancellous Cubes, 40cc; Corticocancellous Chips, 40cc; Frozen Achilles Tendon with Bone Block; Frozen Bisected Femoral Shaft; Frozen Bisected Patella Ligament; Frozen Femoral Head; Frozen Humeral Head; Fascia Lata Medium(Freeze Dried); Fascia Lata, Regular (Freeze Dried); Fascia Lata Small(Freeze Dried); Iliac Crest Wedge Size 5cm. Recall# B-0476-2. CODE Graft Identificaiton Numbers (45 grafts); 98-1302-022, 98-1302-023, 99-0893-004, 99-0893-005, 99-0893-007, 99-0893-009, 98-1302-015, 99-0893-008, 99-0893-008, 98-1302-010, 98-1302-001, 98-1302-004, 98-1302-024, 98-1302-025, 98-1302-026, 98-1302-027, 98-1302-028, 98-1302-029, 98-1302-030, 98-1302-031, 98-1302-032, 98-1302-033, 98-1302-034, 98-1302-035, 99-0893-013, 98-1302-014, 98-1302-007, 98-1302-005, 98-1302-006, 98-1302-008, 98-1302-016, 98-1302-017, 98-1302-009, 99-0893-010, 99-0893-015, 98-1302-002, 99-0893-002, 99-0893-003, 98-1302-011, 98-1302-012, 98-1302-018, 98-1302-019, 98-1302-020, 98-1302-021, 98-1302-036, 98-1302-003. RECALLING FIRM/MANUFACTURER New England Organ Bank, Newton, MA., by letter dated November 19, 2001. Firm initiated recall complete. REASON Various tissues for transplant which were collected from donors who had not been properly evaluated. VOLUME OF PRODUCT IN COMMERCE 45 grafts DISTRIBUTION Massachusetts, Main, Rhode Island, Louisiana, and Minnesota _______________________ PRODUCT a) Red Blood Cells, Recall # B-0477-2; b) Cryoprecipitated AHF, Recall # B-0478-2; c) Recovered Plasma, Recall # B-0479-2. CODE a) and c) Units 21GG61180, 21GK50548, 21GH47812, 21GJ30559, 21GG25081, 21GM14995, 21GK10418; b) Unit 21GK10418. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by letter on January 22, 2001, or fax on April 5, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 15 units. DISTRIBUTION OR, CA, MI and PA. _______________________ PRODUCT a) Red Blood Cells, Recall 3 B-0480-2; b) Platelets, Recall # B-0481-2. CODE a) and b) Unit 53GE49324. RECALLING FIRM/MANUFACTURER American Red Cross, Baltimore, MD, by letter dated April 4, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MD and DC. ___________________ PRODUCT a) Red Blood Cells, Recall # B-0482-2; b) Platelets, Recall # B-0483-2. CODE a) and b) Unit W19112. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter dated July 23, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA. ______________ PRODUCT Red Blood Cells, Recall # B-0484-2. CODE Unit 29KY05839. RECALLING FIRM/MANUFACTURER American Red Cross, Norfolk, VA, by letter dated February 26, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0485-2. CODE Unit 53H81155. RECALLING FIRM/MANUFACTURER American Red Cross, Baltimore, MD, by letter dated March 20, 2001. Firm initiated recall complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MD. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0486-2. CODE Unit 53G42454. RECALLING FIRM/MANUFACTURER American Red Cross, Baltimore, MD, by letter dated Feb. 27, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MD. _______________________ PRODUCT Red Blood Cells, Recall # B-0487-2. CODE Unit 53M94621. RECALLING FIRM/MANUFACTURER American Red Cross, Baltimore, MD, by letter dated March 22, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0488-2; b) Platelets, Recall # B-0489-2; c) Plasma, Frozen, Recall # B-0490-2. CODE a), b) and c) Unit 53J67564. RECALLING FIRM/MANUFACTURER American Red Cross, Baltimore, MD, by telephone on March 29, and by letter dated March 29, 2001. Firm initiated recall complete. REASON Blood products, collected from a donor taking the drug Evista, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MD and DC. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0491-2; b) Fresh Frozen Plasma, Recall # B-0492-2. CODE a) and b) Unit0738502. RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, San Francisco, CA, by letter dated March 19, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who took the drug Accutane, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0493-2; b) Red Blood Cells, Leukoreduced, Recall # B-0494-2; c) Frozen Plasma; Recall # B-0495-2; CODE a) Units 29GL58513, 29GP55604; b) Unit 29GL58012; c) Unit 29GL58513; RECALLING FIRM/MANUFACTURER American Red Cross, Norfolk, VA, by letter dated March 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Arava, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION VA and NC. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0497-2. CODE Unit 35GG97881. RECALLING FIRM/MANUFACTURER American Red Cross, Roanoke, VA, by telephone on April 30, and by letter dated May 11, 2001. Firm initiated recall is complete. REASON Blood products, prepared from an overweight whole blood unit, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WV.
_______________________ PRODUCT Recovered Plasma; Recall # B-0496-2 CODE Unit 29GL58012, 29GP55604 RECALLING FIRM/MANUFACTURER American Red Cross, Norfolk, VA, by letter dated March 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Arava, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION CARECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
___________________ PRODUCT Recall #'s Z-0414-02/Z-0420-02 A.NextStitch Cardiovascular Valve Suture, Sterile. Labeled in part: "NEXTSTITCH Cardiovascular Valve Suture TEVDEK II Braided PTFE Impregnated Polyester STERILE***" (6-Pack and 9-Pack Configurations) See Code Section for Product Codes and Lot Numbers B.Sutures:Deklene, Polydek, Polyene, Silk, Tevdek; and Pledgets Sutures in various Combination of numbers of sutures and needles. 74 Product Codes- Refer to Code Section CODE NextStitch Cardiovascular Valve Suture 6-Pack and 9-Pack Configurations NextStitch(tm) Cardiovascular Valve Suture Product Code Lot Number Product Code Lot Number EG79-105C6 416480 EH7-100C9 442014 EG79-105C6 436937 EH7-100C9 447758 EG79-105C6 436962 EH7-100C9 463186 EG79-105C6 436963 EH7-100C9 474139 EG79-105C6 438589 EH79-100C6 454675 EG79-105C6 443688 EH79-100C6 472308 EG79-105C6 451644 EH79-100C6 475397 EG79-105C6 456236 EH79-100C9 454672 EG79-105C6 457722 EH79-100C9 475394 EG79-105C6 463191 E7-103C9 474142 EG79-105C6 466017 E79-104C9 413242V EG79-105C6 474591 E79-104C9 416440 EG79-105C9 438590 E79-104C9 451648 EG79-105C9 443683 E79-104C9 458929 EG79-105C9 460297 E79-104C9 458930 EG79-105C9 471540 E79-104C9 463696 EG79-105C9 474143 E79-104C9 467259 EG79-105C9 474592 E79-105C9 413243V EG79-107C9 463188 E79-105C9 416442 EG79-108C9 442018 E79-105C9 454673 EG79-108C9 457684 E79-105C9 461993 EG79-112C9 456241 E79-105C9 461994 EG79-112C9 456253 E79-105C9 463184 EG79-114C6 464187 E79-105C9 463185 EG79-114C6 470165 E79-108C9 474141 EG79-114C9 464188 EB79-105C6 413274V EG79-114C9 470166 EB79-105C6 416441 EH7-100C6 454674 EB79-105C6 447787 EH7-100C6 461995 EB79-105C6 461996 EH7-100C6 467260 EB79-105C6 475398 79-104C9K 492361 EG7-113C9 463190 EB79-100C6 411366V E79-111C9 411384V EB79-100C6 416438 E79-111C9 416439 EB79-100C6 447779 E79-111C9 451647 EB79-100C6 451641 E79-111C9 460295 EB79-100C6 460298 E79-111C9 463695 EB79-100C6 463694 E79-111C9 467258 EB79-100C6 466014 E79-111C9 472319 EC7-100C9 420296 E79-111C9 477209 EC7-100C9 423250 E79-111C9 479026 EC79-100C9 416479 EG79-104C9 442017 EC79-100C9 458925 EG79-104C9 458931 EG7-106C6 464768 EG79-104C9 460296 EG7-106C6 464769 EG79-104C9 474823 EG7-106C6 466012 7-106C9K 483498 EG7-106C6 471542 7-106C9K 496851 EG7-106C9 442015 7-113C6K 478430 EG7-106C9 447772 7-113C9K 492359 EG7-106C9 474140 G79-114C6K 483454 EG7-113C6 472312 G79-114C6K 488454 EG7-113C6 479025 G79-114C6K 506534 EG79-100C6 416478 G79-114C9K 483455 EG79-100C6 436936 G79-114C9K 488455 EG79-100C6 442019 G79-114C9K 497925 EG79-100C9 438039 G79-114C9K 506535 EG79-100C9 442016 G79-114C9K 507773 EG79-100C9 456252 79-100C9K 492360 EG79-104C6 447786 H7-100C6K 486084 EG79-104C6 451642 H7-100C6K 488457 EG79-104C6 458932 H7-100C6K 495410 EG79-104C6 458934 79-104C6K 489810 EG79-104C6 464770 79-104C6K 507949 EG79-104C6 466015 H7-100C9K 486098 EG79-104C6 474821 H7-100C9K 492350 G79-107C6K 478431 H79-100C6K 482103 H79-100C9K 483459 G7-113C9K 483449 H79-100C9K 496850 G7-113C9K 484917 79-105C9K 486093 G7-113C9K 486745 79-112C9K 475324 G7-113C9K 493391 N7-100C6K07 503849 G7-113C6K 483448 N7-100C9K07 503844 G7-113C6K 486742 N7-106C6K07 503852 G7-113C6K 499198 N7-106C9K07 503848 G7-106C9K 480494 N7-113C6K07 503850 G7-106C9K 486744 N7-113C9K 503695 G7-106C9K 493390 N7-113C9K07 503845 G7-106C9K 496845 N7-113C9K07 503846 G7-106C9K 496846 N79-105C6K 488458 G7-106C6K 486741 N79-114C6K07 503851 G7-100C6K 490444 N79-114C9K07 503847 G7-100C6K 496847 6-100C9K 497408 G7-100C9K 486095 6-113C9K 497409 G79-105C9K 480496 6-113C9K 505585 G79-105C9K 488450 7-103C6K 497932 G79-104C6K 486750 7-103C9K 486091R G79-100C9K 482104 7-103C9K 492358 G79-100C6K 482102 7-106C6K 483500 G79-105C9K 508232 G79-105C6K 480495 G79-105C6K 488448 G79-105C6K 488449 G79-105C6K 497924 G79-104C9K 482106 G79-104C9K 493388 G79-104C9K 496848 G79-104C9K 496849 Sutures:Deklene, Polydek, Polyene, Silk, Tevdek;and Pledgets Extended Recall:Sutures in various Combination of numbers of sutures and needles. Suture Type/Part number Lot Number Description Deklene ED-7063M2A 277502 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 281786 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 290167 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 295887 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 309343 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 313321 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 315685 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 317033 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 320992 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 340434 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 344296 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 348331 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 352014 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 362412 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 366010 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 374313 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 377544 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene 392445 DEK BL MF 7-0 XT-6 2N 2X75CM Deklene ED-7070M1A 277505 DEK BL MF 6-0 XT-6 2N 75CM Deklene 283635 DEK BL MF 6-0 XT-6 2N 75CM Deklene 290745 DEK BL MF 6-0 XT-6 2N 75CM Deklene 297336 DEK BL MF 6-0 XT-6 2N 75CM Deklene 484819 DEK BL MF 6-0 XT-6 2N 75CM Deklene 323464 DEK BL MF 6-0 XT-6 2N 4X75CM Deklene 433205 DEK BL MF 6-0 XT-6 2N 4X75CM Deklene 277503 DEK BL MF 6-0 XT-1 2N 75CM Deklene 281379 DEK BL MF 6-0 XT-1 2N 75CM Deklene 288846 DEK BL MF 6-0 XT-1 2N 75CM Deklene 290168 DEK BL MF 6-0 XT-1 2N 75CM Deklene 297337 DEK BL MF 6-0 XT-1 2N 75CM Deklene 316605 DEK BL MF 6-0 XT-1 2N 75CM Deklene 320994 DEK BL MF 6-0 XT-1 2N 75CM Deklene 333969 DEK BL MF 6-0 XT-1 2N 75CM Deklene 335795 DEK BL MF 6-0 XT-1 2N 75CM Deklene 337253 DEK BL MF 6-0 XT-1 2N 75CM Deklene 337705 DEK BL MF 6-0 XT-1 2N 75CM Deklene 369664 DEK BL MF 6-0 XT-1 2N 75CM Deklene 396715 DEK BL MF 6-0 XT-1 2N 75CM Deklene ED-7310M2 347964 DEK BL MF 7-0 ST6 2N 2X60CM Deklene 437199 DEK BL MF 7-0 ST6 2N 2X60CM Deklene ED-7414M1B 415958 DEK BL MF 6-0 EZ-1 2N 1X75CM Deklene 451756 DEK BL MF 6-0 EZ-1 2N 1X75CM Deklene 474291 DEK BL MF 6-0 EZ-1 2N 1X75CM Deklene 491919 DEK BL MF 6-0 EZ-1 2N 1X75CM Deklene 499273 DEK BL MF 6-0 EZ-1 2N 1X75CM Deklene 501459 DEK BL MF 6-0 EZ-1 2N 1X75CM Deklene ED-7414M4 308522 DEK BL MF 6-0 EZ-1 2N 4X75CM Deklene 363857 DEK BL MF 6-0 EZ-1 2N 4X75CM Deklene 387280 DEK BL MF 6-0 EZ-1 2N 4X75CM Deklene 419202 DEK BL MF 6-0 EZ-1 2N 4X75CM Deklene 451757 DEK BL MF 6-0 EZ-1 2N 4X75CM Deklene 462610R DEK BL MF 6-0 EZ-1 2N 4X75CM Deklene 480039 DEK BL MF 6-0 EZ-1 2N 4X75CM Deklene ED-7505M1A 289233 DEK BL MF 8-0 XT-6.5 2N 1X24" Deklene 303625 DEK BL MF 8-0 XT-6.5 2N 1X24" Deklene 317320 DEK BL MF 8-0 XT-6.5 2N 1X24" Deklene 321002 DEK BL MF 8-0 XT-6.5 2N 1X24" Deklene ED-7505M1B 421084 DEK BL MF 8-0 XT-6.5 2N 1X24" Deklene ED-7506M4 273190 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 287109 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 290720 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 304412 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 317321 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 321003 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 323300 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 325291 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 330579 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 358503 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 363943 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 369267 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 380045 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 386639 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 399098 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 407444 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 410885 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 414654 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 452182 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 455711 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 460590R DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 469042 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene 504286 DEK BL MF 7-0 XT-6.5 2N 4X60CM Deklene ED-7507M2 377613 DEK BL MF 7-0 XT-6.5 2N 2X75CM Deklene 387281 DEK BL MF 7-0 XT-6.5 2N 2X75CM Deklene 476888 DEK BL MF 7-0 XT-6.5 2N 2X75CM Deklene ED-5007M1B 438883 DEK BL MF 6-0 XT-6 2N 1X60CM Deklene ED-5007M4A 303626 DEK BL MF 6-0 XT6 2N 4X60CM Deklene 328421 DEK BL MF 6-0 XT6 2N 4X60CM Deklene 351660 DEK BL MF 6-0 XT6 2N 4X60CM Deklene 376473 DEK BL MF 6-0 XT6 2N 4X60CM Deklene 456231 DEK BL MF 6-0 XT6 2N 4X60CM Deklene 501396 DEK BL MF 6-0 XT6 2N 4X60CM Deklene ED-6263M1 285411 DEK BL MF 8-0 XT-7 2N 1X75CM Deklene 311890 DEK BL MF 8-0 XT-7 2N 1X75CM Deklene 476885 DEK BL MF 8-0 XT-7 2N 1X75CM Deklene ED-6290M1 291536 DEK BL MF 8-0 XT-6.5 2N 1X75CM Deklene ED-6456M1B 415954 DEK BL MF 7-0 EZ-6 2N 1X75CM Deklene 419207 DEK BL MF 6-0 EZ-6 2N 1X75CM Deklene ED-6459M1 380613 DEK BL MF 6-0 EZ-6 2N 1X75CM Deklene ED-7004M1A 391473 DEK BL MF 7-0 XT-6 2N 1X60CM Deklene 434408 DEK BL MF 7-0 XT-6 2N 1X60CM Deklene ED-7004M1B 415955 DEK BL MF 7-0 XT-6 2N 1X60CM Deklene 451755 DEK BL MF 7-0 XT-6 2N 1X60CM Deklene 499272 DEK BL MF 7-0 XT-6 2N 1X60CM Deklene 501397 DEK BL MF 7-0 XT-6 2N 1X60CM Deklene ED-7004M4A 296300 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 324313 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 337252 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 346462 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 358051 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 384707 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 390461 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 401973 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 409651 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 415981 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 421896 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 427862 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 441825 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 444637 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 444971 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 447320 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 474305 DEK BL MF 7-0 XT6 2N 4X60CM Deklene 476428 DEK BL MF 7-0 XT6 2N 4X60CM Deklene ED-7015M4A 309603 DEK BL MF 7-0 XT-1 2N 4X60CM Deklene 329833 DEK BL MF 7-0 XT-1 2N 4X60CM Deklene 377609 DEK BL MF 7-0 XT-1 2N 4X60CM Deklene ED-7018M1A 377656 DEK BL MF 5-0 XT-1 2N 1X75CM Deklene ED-7018M1B 415956 DEK BL MF 5-0 XT-1 2N 1X75CM Deklene ED-7018M2A 336143 DEK BL MF 5-0 XT-1 2N 2X75CM Deklene 347981 DEK BL MF 5-0 XT-1 2N 2X75CM Deklene 349538 DEK BL MF 5-0 XT-1 2N 2X75CM Deklene 387279 DEK BL MF 5-0 XT-1 2N 2X75CM Deklene 403685 DEK BL MF 5-0 XT-1 2N 2X75CM Deklene 447324 DEK BL MF 5-0 XT-1 2N 2X75CM Deklene 473023 DEK BL MF 5-0 XT-1 2N 2X75CM Deklene 501398 DEK BL MF 5-0 XT-1 2N 2X75CM Deklene ED-7018M4A 288420 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 317032 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 340432 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 344290 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 358912 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 364669 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 371494 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 389636 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 405891 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 414652 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 424803 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 478236 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene 482530 DEK BL MF 5-0 XT-1 2N 30"X4 Deklene ED-7060M4A 293520 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 304220 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 308791 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 310760 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 318572 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 342990 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 346461 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 369264 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 406110 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 455246 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 462609 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene 504211 DEK BL MF 5-0 XT-1 2N 4X60CM Deklene ED-7061M1A 391476 DEK BL MF 5-0 XT-1 2N 1X90CM Deklene 466250 DEK BL MF 5-0 XT-1 2N 1X90CM Deklene ED-7063M1A 275051 DEK BL MF 7-0 XT-6 2N 75CM Deklene 281785 DEK BL MF 7-0 XT-6 2N 75CM Deklene 288421 DEK BL MF 7-0 XT-6 2N 75CM Deklene 290744 DEK BL MF 7-0 XT-6 2N 75CM Deklene 297335 DEK BL MF 7-0 XT-6 2N 75CM Deklene 323297 DEK BL MF 7-0 XT-6 2N 75CM Deklene 330260 DEK BL MF 7-0 XT-6 2N 75CM Deklene 335793 DEK BL MF 7-0 XT-6 2N 75CM Deklene 337704 DEK BL MF 7-0 XT-6 2N 75CM Deklene 344294 DEK BL MF 7-0 XT-6 2N 75CM Deklene 346463 DEK BL MF 7-0 XT-6 2N 75CM Deklene 351194 DEK BL MF 7-0 XT-6 2N 75CM Deklene 354695 DEK BL MF 7-0 XT-6 2N 75CM Deklene ED-7076M2A 277504 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 281787 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 295888 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 297338 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 318997 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 322208 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 328422 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 333970 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 340442 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 353738 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 364670 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 368399 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 378521 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 385873 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 387347 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 390956 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 397344 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene 401000 DEK BL MF 6-0 XT-1 2N 2X75CM Deklene ED-7076M4A 273413 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 288187 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 298545 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 304213 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 310772 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 315686 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 317319 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 320995 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 328424 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 341346 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 348332 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 355793 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 366025 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 374315 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 378522 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 382100 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 406084 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 413262 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 418224 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 424805 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 444638 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene 472534 DEK BL MF 6-0 XT-1 2N 4X75CM Deklene ED-7504M2 271469 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 278091 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 287108 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 290401 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 304215 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 306920 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 309925 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 330578 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 333972 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 337706 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 342991 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 351195 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 355795 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 358053 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 366758 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 374217 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 376767 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 424792 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 427767 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 429860 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 435885 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 450904 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 460589 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 469041 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 471414 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 475309 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 480098 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 481011 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 486065 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene 488853 DEK BL MF 8-0 XT-7 2N 2X60CM Deklene ED-7505M2A 290735 DEK BL MF 8-0 XT-6.5 2N 2X60CM Deklene 380641 DEK BL MF 8-0 XT-6.5 2N 2X60CM Deklene ED-7506M2 271442 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 278079 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 288847 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 293523 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 295532 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 303636 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 307950 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 321721 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 326141 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 331663 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 337588 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 357710 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 365654 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 369266 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 380044 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 386638 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 401164 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 480099 DEK BL MF 7-0 XT-6.5 2N 2X60CM Deklene 488854 DEK BL MF 7-0 XT-6.5 2N 2X60CM Polydek EXRN6-5089M4 276419 POL GN BR 3-0 DLX30 1RN 4X45CM Polydek 347980 POL GN BR 3-0 DLX30 1RN 4X45CM Polydek 377649 POL GN BR 3-0 DLX30 1RN 4X45CM Polydek 387230 POL GN BR 3-0 DLX30 1RN 4X45CM Polydek 435381 POL GN BR 3-0 DLX30 1RN 4X45CM Polydek 440105 POL GN BR 3-0 DLX30 1RN 4X45CM Polydek 463493 POL GN BR 3-0 DLX30 1RN 4X45CM Polydek 493463 POL GN BR 3-0 DLX30 1RN 4X45CM Polydek 499274 POL GN BR 3-0 DLX30 1RN 4X45CM Polydek EXRN6-5184M6 276422 POL GN BR 0 DS30 1RN 6X45CM Polydek 298546 POL GN BR 0 DS30 1RN 6X45CM Polydek 304212 POL GN BR 0 DS30 1RN 6X45CM Polydek 358931 POL GN BR 0 DS30 1RN 6X45CM Polydek 364559 POL GN BR 0 DS30 1RN 6X45CM Polydek 366030 POL GN BR 0 DS30 1RN 6X45CM Polydek 385878 POL GN BR 0 DS30 1RN 6X45CM Polydek 391531 POL GN BR 0 DS30 1RN 6X45CM Polydek 395822 POL GN BR 0 DS30 1RN 6X45CM Polydek 399085 POL GN BR 0 DS30 1RN 6X45CM Polydek 399787 POL GN BR 0 DS30 1RN 6X45CM Polydek 474310 POL GN BR 0 DS30 1RN 6X45CM Polydek 482301 POL GN BR 0 DS30 1RN 6X45CM Polydek 486054 POL GN BR 0 DS30 1RN 6X45CM Polydek 500443 POL GN BR 0 DS30 1RN 6X45CM Polydek EXRN6-5088M4 275411 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 297216 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 327656 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 353178 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 358065 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 380437 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 402174 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 406977 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 408449 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 439705 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 463492 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 473752 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 478046 POL GN BR 2-0 DLX30 1RN 4X45CM Polydek 494933R POL GN BR 2-0 DLX30 1RN 4X45CM Polydek ERN6-6493M8 377633 POL GN BR 3-0 DLX30 1RN 8X45CM Polydek 398642 POL GN BR 3-0 DLX30 1RN 8X45CM Polydek E6-5146M6 275240 POL GN BR 0 DS30 1N 6X45CM Polydek 285083 POL GN BR 0 DS30 1N 6X45CM Polydek 290177 POL GN BR 0 DS30 1N 6X45CM Polydek 297218 POL GN BR 0 DS30 1N 6X45CM Polydek 308246 POL GN BR 0 DS30 1N 6X45CM Polydek 310188 POL GN BR 0 DS30 1N 6X45CM Polydek 316206 POL GN BR 0 DS30 1N 6X45CM Polydek 320677 POL GN BR 0 DS30 1N 6X45CM Polydek 321783 POL GN BR 0 DS30 1N 6X45CM Polydek 327577 POL GN BR 0 DS30 1N 6X45CM Polydek 336904 POL GN BR 0 DS30 1N 6X45CM Polydek 344400 POL GN BR 0 DS30 1N 6X45CM Polydek 353364 POL GN BR 0 DS30 1N 6X45CM Polydek 354732 POL GN BR 0 DS30 1N 6X45CM Polydek 360477 POL GN BR 0 DS30 1N 6X45CM Polydek 400021 POL GN BR 0 DS30 1N 6X45CM Polydek 410606 POL GN BR 0 DS30 1N 6X45CM Polydek 414650 POL GN BR 0 DS30 1N 6X45CM Polydek 421778 POL GN BR 0 DS30 1N 6X45CM Polydek 424800 POL GN BR 0 DS30 1N 6X45CM Polydek 434521 POL GN BR 0 DS30 1N 6X45CM Polydek 438024 POL GN BR 0 DS30 1N 6X45CM Polydek 448347 POL GN BR 0 DS30 1N 6X45CM Polydek 460585 POL GN BR 0 DS30 1N 6X45CM Polydek 463030 POL GN BR 0 DS30 1N 6X45CM Polydek 465949 POL GN BR 0 DS30 1N 6X45CM Polydek 481242 POL GN BR 0 DS30 1N 6X45CM Polydek 493665 POL GN BR 0 DS30 1N 6X45CM Polydek 499673 POL GN BR 0 DS30 1N 6X45CM Polydek 502393 POL GN BR 0 DS30 1N 6X45CM Polydek 504681 POL GN BR 0 DS30 1N 6X45CM Polylene E13-5524M4 295873 PLENE GN 2-0 HR22+1RN4X45CM Polylene E13-6492M4 377639 PLENE GN 3-0 DS18 1RN 4X45CM Polylene E13-6835M8 309583 PLENE GN 4-0 HR17+1RN 8X45CM Polylene 319813 PLENE GN 4-0 HR17+1RN 8X45CM Silk ERN-5689M4 309580 SLK BK BR 4-0 HR12+1RN 4X45CM Silk ES-9028M5 287111 SLK BK BR 3 5X45CM Silk 290710 SLK BK BR 3 5X45CM Silk EXRNS-5721M8A 276411 SLK BK BR 0 HR30 1RN 8X45CM Silk 280553 SLK BK BR 0 HR30 1RN 8X45CM Silk 297217 SLK BK BR 0 HR30 1RN 8X45CM Silk 308820 SLK BK BR 0 HR30 1RN 8X45CM Silk 313290 SLK BK BR 0 HR30 1RN 8X45CM Silk 321001R SLK BK BR 0 HR30 1RN 8X45CM Silk 327652 SLK BK BR 0 HR30 1RN 8X45CM Silk 333975 SLK BK BR 0 HR30 1RN 8X45CM Silk 364548 SLK BK BR 0 HR30 1RN 8X45CM Silk EXS-9028M5 276423 SLK BK BR 3 5X45CM Silk 293548 SLK BK BR 3 5X45CM Silk EXRNS-6131M8 276410 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 284753 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 300018 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 317038 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 327654 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 328425 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 341378 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 344354 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 356951 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 366029 SLK BK BR 3-0 HR22 1RN 8X45CM Silk 374304 SLK BK BR 3-0 HR22 1RN 8X45CM Tevdek E7975-0052 493374 TEV GN BR 5-0 KT-1 1N 18" Tevdek E7975-0054 493375 TEV GN BR 5-0 KT-2 1N 18" Tevdek 497630 TEV GN BR 5-0 KT-2 1N 18" Tevdek 505055 TEV GN BR 5-0 KT-2 1N 18" Tevdek 508759 TEV GN BR 5-0 KT-2 1N 18" Tevdek E7975-0056 489615 TEV GN BR 6-0 KT-1 1N 18" Tevdek E7975-0063 491831 TEV GN BR 4-0 KT-1/KT-2 2N 36" Tevdek E7975-0065 491978 TEV GN BR 5-0 KT-1/KT-2 2N 36" Tevdek 497683 TEV GN BR 5-0 KT-1/KT-2 2N 36" Tevdek E7RN-6384M4 333486 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek 385284 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek 389787 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek 399284 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek 401241 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek 443808 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek 447318 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek 489777 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek 491133 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek 504217 TEV GN BR 2-0 HR22+ 1RN 4X45CM Tevdek E7RN-4834M8 310962 TEV GN 4-0 HR12+ 1RN 8X45CM Tevdek 393040 TEV GN 4-0 HR12+ 1RN 8X45CM Tevdek 401091 TEV GN 4-0 HR12+ 1RN 8X45CM Tevdek 411813 TEV GN 4-0 HR12+ 1RN 8X45CM Tevdek 423561 TEV GN 4-0 HR12+ 1RN 8X45CM Tevdek 424453 TEV GN 4-0 HR12+ 1RN 8X45CM Tevdek 463499 TEV GN 4-0 HR12+ 1RN 8X45CM Tevdek 480658 TEV GN 4-0 HR12+ 1RN 8X45CM Tevdek 494520 TEV GN 4-0 HR12+ 1RN 8X45CM Tevdek E7RN-5336M8 303180 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 303371 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 306328 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 308823 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 310804 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 311616 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 318978 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 324307 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 330254 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 427772 TEV GN 4-0 HR17 1RN 8X45CM Tevdek 491345 TEV GN 4-0 HR17 1RN 8X45CM Tevdek E7RN-5697M8 293539 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 297332 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 306112 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 308824 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 328432 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 333985 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 343187 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 369304 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 385299 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 388520 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 398011 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 448350 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 463036 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 466513 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 472819 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 491346 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek 500442 TEV GN 2-0 HR26+ 1RN 8X45CM Tevdek E7RN-5698M8 326927 TEV GN BR 0 HR26+ 1N 8X45CM Tevdek 366591 TEV GN BR 0 HR26+ 1N 8X45CM Tevdek 385280 TEV GN BR 0 HR26+ 1N 8X45CM Tevdek 467352 TEV GN BR 0 HR26+ 1N 8X45CM Tevdek 480037 TEV GN BR 0 HR26+ 1N 8X45CM Tevdek ERN7-6071M8 306123 TEV GN BR 3-0 HR17+ 1RN 8X45CM Tevdek 308819 TEV GN BR 3-0 HR17+ 1RN 8X45CM Tevdek 309933 TEV GN BR 3-0 HR17+ 1RN 8X45CM Tevdek 320998 TEV GN BR 3-0 HR17+ 1RN 8X45CM Tevdek 323303 TEV GN BR 3-0 HR17+ 1RN 8X45CM Tevdek ERN7-6486M8 503470 TEV GN BR 3-0 HR12 1RN 8X45CM Tevdek ERN7-6518M4 402724 TEV GN BR 3-0 HR22+ 1RN 4X45CM Tevdek 451322 TEV GN BR 3-0 HR22+ 1RN 4X45CM Tevdek 462605 TEV GN BR 3-0 HR22+ 1RN 4X45CM Tevdek 463039 TEV GN BR 3-0 HR22+ 1RN 4X45CM Tevdek 470160 TEV GN BR 3-0 HR22+ 1RN 4X45CM Tevdek E7-5793M4 346866 TEV GN 4-0 DSM19(RE2)1N 4X45CM Tevdek 415959 TEV GN 4-0 DSM19(RE2)1N 4X45CM Tevdek ERN7-5113M8 278094 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 284407 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 296304 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 303386 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 311618 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 315283 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 318986 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 328054 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 337550 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 344333 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 351674 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 354415 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 360171 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 371477 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 374986 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 390473 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 401975 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 409141 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 410602 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 412850 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 422128 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 479594 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 488259 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 494524 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek 505975 TEV GN BR 3-0 HR22+ 1RN 8X45CM Tevdek E7-6344GWM8 326022 TEV G/W 2-0 DR23 2N 8X75CM Tevdek 312431 TEV G/W 2-0 DR23 2N 8X75CM Tevdek 319570 TEV G/W 2-0 DR23 2N 8X75CM Tevdek EV7-6471GWM10 500448 TEV G/W 2-0 KC2 2N 10X75CM PSM Tevdek EV7-1271GWM10 298188 EXH USE EV7-1271GWM10 Tevdek EG7-5649GWM16 311297 TEV G/W2-0 HRT17 2N16X75CMPFM Tevdek 319569 TEV G/W2-0 HRT17 2N16X75CMPFM Tevdek ERN7-5741M8 275395 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 276400 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 300016 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 321444 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 321731 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 329851 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 333169 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 336513 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 337551 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 347551 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 353174 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 357960 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 361316 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 371478 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 384714 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 394868 TEV GN BR 2-0 HRT20 1RN 8X45CM Tvdek 399598 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevek 410601 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevek 414645 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdk 462269 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevde 472537 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 478045 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 486067 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 493122 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 499658 TEV GN BR 2-0 HRT20 1RN 8X45CM Tevdek 503038 TEV GN BR 2-0 HRT20 1RN 8X45CM Pledget Part Number Lot Number Description Pledget EX-5145 322561 PLED SFT 6"X5/16"X1/16" X2 Pledget 352280 PLED SFT 6"X5/16"X1/16" X2 Pledget 401350 PLED SFT 6"X5/16"X1/16" X2 Pledget 443799 PLED SFT 6"X5/16"X1/16" X2 Pledget EX-6499 388061 PLED INT 1/2" X4" X1/16" X1 Pledget 409461 PLED INT 1/2" X4" X1/16" X1 Pledget 486051 PLED INT 1/2" X4" X1/16" X1 Pledget 494480 PLED INT 1/2" X4" X1/16" X1 Pledget EX-6500 399607 PLED INT 1/2"X6"1/16"X1 Pledget 409462 PLED INT 1/2"X6"1/16"X1 Pledget 429359 PLED INT 1/2"X6"1/16"X1 Pledget 455247 PLED INT 1/2"X6"1/16"X1 Pledget 467353 PLED INT 1/2"X6"1/16"X1 Pledget 480040 PLED INT 1/2"X6"1/16"X1 Pledget 493452 PLED INT 1/2"X6"1/16"X1 RECALLING FIRM/MANUFACTURER Genzyme Biosurgery a div. of Genzyme Corporation Fall River, MA, by letter on 11/21/01. Firm initiated recall is ongoing. REASON Sterility of the device may be compromised due to breach in the pouch seal. VOLUME OF PRODUCT IN COMMERCE 14,179 pieces DISTRIBUTION Nationwide and International _______________________ PRODUCT Optetrak 3-Peg Patella, Size 29mm and Optetrak 3-Peg Patella, Size 32 mm, Recall # Z-0422-02. CODE Catalog Number 200-02-29, serial numbers 240816 through 0240870 and catalog number 200-02-32, serial numbers 0240761 through 0240815. RECALLING FIRM/MANUFACTURER Exactech, Inc. Gainesville, FL, by telephone and by letter faxed and mailed on 6/8/2001. Firm initiated recall is ongoing. REASON Mislabled with incorrect device size. VOLUME OF PRODUCT IN COMMERCE 69 DISTRIBUTION Nationwide. _______________________ PRODUCT Straumann Endosseous Dental Implant Esthetic Plus Solid Screw labeled as: Strauman Solid Screw Implant 0.48 mm, 6.0 mm PLUS (endosseous length 7.0 mm), Ti. Sterile. Recall # Z-0423-02. CODE Catalog Number: 043.240S Lot Number: 1007 Exp. Date: 2005-03 RECALLING FIRM/MANUFACTURER Recalling Firm: The Straumann Co. Waltham, MA , by letters on 10/11/01. Manufacturer: Institut Strauman AG Waldenburg, SWITZERLAND, Firm initiated recall is ongoing. REASON Some Dental Implants mislabeled as Wide Neck Implant on the back of the outside packaging VOLUME OF PRODUCT IN COMMERCE 191 implants. DISTRIBUTION Nationwide _______________________ PRODUCT E.CAM Ball Screws, a component of the ball screw yoke assemblies of the E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; The ball screws were used to make the following assemblies a) part 5208587 - Right for Upper Yoke Assembly (Pivot Side) b) part 5208892 - Right for Lower Yoke Assembly (Clutch Side) c) part 5208884 - Left for Uppper Yoke Assembly (Clutch Side) d) part 5208900 - Left for Lower Yoke Assembly (Pivot Side) Recall # Z-0424-02 CODE Ball screw assemblies, part numbers 5208587, 5208892, 5208884 and 5208900 are components in the following cameras: Model 4380221 - E.CAM Gantry Dual Head Variable, serial numbers 0005 to 1215 Model 5242826 - E.CAM Gantry Dual Head Variable, serial numbers 1001 to 3141, 4001 to 4111 Model 5977066 - E.CAM Gantry Dual Head Variable, serial numbers 4100 to 4178 Model 4380213 - E.CAM Gantry Single Head, serial numbers 0001 to 4016 Model 5977074 - E.CAM Gantry Single Head, serial numbers 4001 to 4031 RECALLING FIRM/MANUFACTURER Siemens Medical Systems, Inc., Hoffman Estates, IL. There was no end user notification. Service Bulletin NM011/00/R issued on 4/27/00. Firm initiated recall is complete. REASON E.Cam radial drive ball screw may fail VOLUME OF PRODUCT IN COMMERCE 764 cameras. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT E.CAM PHS beds used with the E.CAM Emission Imaging Computed TOmography Systems used for all common nuclear medicine procedures. Recall # Z-0425-2/0426-02. CODE Model 4366618, serial numbers 0006 through 2034 Model 4381088, serial numbers 0002 through 2029 RECALLING FIRM/MANUFACTURER Siemens Medical Systems, INC. Hoffman Estates, IL , There was no end user notification. Service Bulletin FMI-274 issued on 11/20/98. Firm initiated recall is complete. REASON Acme screw may fail and cause front or rear of bed to fall during use VOLUME OF PRODUCT IN COMMERCE 181 units. DISTRIBUTION Nationwide and International. _______________________ PRODUCT Bulb Irrigation Trays, 20 trays per case; labeled under the following labels: a) Gent-L-Kare Irrigation Tray with 60 cc Bulb Syringe, catalog 4092 Premium Plastics Inc., Chicago, IL b) Bulb Irrigation Tray, catalog 750170, Distributed by C.R. Bard, Inc., Covington, GA 30014 c) Bardia Bulb Irrigation Tray, catalog 802050, Distributed by C.R. Bard, Inc., Covington, GA 30014, Recall # Z-0430-02 CODE catalog #4092, lots beginning with "MF", "MH","N", "P", "R", "S", "T" and "U". catalog #750170 and 802050 - all lots RECALLING FIRM/MANUFACTURER Premium Plastics, INC. Chicago, IL , via telephone on 11/14/01 and by letters on 11/16/01. Firm initiated recall is ongoing. REASON Holes may develop in the trays, compromising the sterility of the kits VOLUME OF PRODUCT IN COMMERCE 829,960 trays DISTRIBUTION Nationwide, Canada, and Saudi Arabia _______________________ PRODUCT Procedural Trays, and Kits containing Procedural Trays, Recall # Z-0431-02. 1) Johnson & Johnson Medical Procedural Trays for BIOVUE Peripherally Inserted Family of Catheters; and 2) Kits consisting of: (a) Johnson & Johnson BIOVUE Peripherally Inserted Central Catheter (PICC), or Midline Catheter, both with OCRILON II Polyurethane; (b) PROTECTIV Safety Introducer System; and (c) Procedural Tray. KITS with Peripherally Inserted Central Catheter (PICC): Product Description #97901 PICC - Dual Lumen Procedure Kit 16 G /5 Fr #97907 PICC - Dual Lumen Procedure Kit 18 G /4 Fr #97910 PICC - Single Lumen Procedure Kit 18 G /4 Fr #97913 PICC - Single Lumen Procedure Kit 20 G /3 Fr #97916 PICC - Single Lumen Procedure Kit 24 G /2 Fr KITS with Peripherally Inserted Midline Catheter: Product Description #97919 Midline - Dual Lumen Procedure Kit 18 G/ 4 Fr #97922 Midline - Single Lumen Procedure Kit 18 G/ 4 Fr #97925 Midline - Single Lumen Procedure Kit 20 G/ 3 Fr, PROCEDURE TRAYS: Product Description #97993 Procedure tray for use with BIOVUE PICC's and Midlines 'Latex-Free'. #97994 Procedure tray for use with BIOVUE PICC's and Midlines. CODE All packaging lot numbers, still within their expiry period, are affected by this recall. RECALLING FIRM/MANUFACTURER Recalling Firm: ETHICON ENDO-SURGERY, INC. CINCINNATI, OH, by letters on 11/6/01. Manufacturer: Johnson & Johnson Medical, Cincinnati, OH. Firm initiated recall is ongoing. REASON Sterility of the device may be compromised as evidenced by a loss of package integrity. VOLUME OF PRODUCT IN COMMERCE 12,305 DISTRIBUTION Nationwide. _______________________ PRODUCT MediSense Precision PCx Blood Glucose Test Strips for use with the Precision G, Precision PCx or i-STAT 1 Analyzer Blood Glucose Systems. Recall # Z-0446-2/Z-0448-2. CODE Medisense Precision PCx Blood Glucose Test Strips Part Number: 98849-12 (100 count)Europe, Middle East Dist. Part Number: 98757-12 (100 count)USA, Canada, Australia, New Zealand, Southeast Asia Part Number: 99565-01 (100 count) USA Distribution Lot No. 126425 127595 127715 127745 127775 127785 127875 127885 127965 127975 127995 128155 128175 128345 128355 128455 128545 128565 128575 128615 128625 128635 128695 128845 128925 128935 129085 129095 129115 129135 129145 129155 129265 129295 129365 129455 129525 129535 129565 128675 128465 129555 129565 127145 127575 129055 129555 128675 RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories Medisense Products Bedford, MA, by letter on 8/24/01. Manufacturer: Medisense United Kingdom, Limited, Abingdon, United Kingdom. Firm initiated recall is ongoing. REASON Blood Glucose Test Strips Control Solution ranges are incorrectly assigned VOLUME OF PRODUCT IN COMMERCE 235,905. DISTRIBUTION Nationwide and worldwide. _______________________ PRODUCT Integris Monitor Arm, Product P997, Recall # Z-0454-2. CODE Integris Monitor Arm, Product number P997. RECALLING FIRM/MANUFACTURER Hill-Rom CO. Batesville, IN. Hill-Rom Field Service technicians to repair products beginning 12/03/2001. Firm initiated recall is ongoing. REASON Monitor arm may loosen and fall or drop the monitor VOLUME OF PRODUCT IN COMMERCE 2,970. DISTRIBUTION Nationwide. _______________________ PRODUCT Insight Technologies Instruments Keratome Blade, Disposable and Sterile. For use with the Becton Dickinson Model BD K-3000 Microkeratome System, Recall # Z-0455-2. CODE Insight Technologies Instruments Disposable Keratome Blade, Sterile Reference: 300300 Lot numbers: M20186 M20198 M20219 M20223 M20240 M20527 M20282 M21009 RECALLING FIRM/MANUFACTURER Recalling Firm: BD [Becton Dickinson] Ophthalmic Systems Waltham, MA, by telephone on July 18, 2001. Manufacturer: Micro Specialties, Inc. Milford, CT. Firm initiated recall is complete. REASON Kerotome Blade may fail to oscillate properly and cause corneal abrasion VOLUME OF PRODUCT IN COMMERCE 3270 DISTRIBUTION AK, CA, IL, NY, PA, WA. _______________________ PRODUCT Prisma Dialysis System Control Unit, Catalog No. 018080101, Serial Numbers 963111 thru 963143, and 963194 thru 963530, Recall # Z-0456-2. CODE Prisma Control Unit, Catalog No. 018080101, Serial numbers 963111 to 963143, 963194 to 963530. RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Renal Products Lakewood, CO, by letter on Oct. 2, 2001. Manufacturer: GAMBRO Dasco S.p.A. I-41036 Medolla (MO), IT Firm initiated recall is ongoing. REASON Displayed value of "actual patient fluid removal" can be incorrect VOLUME OF PRODUCT IN COMMERCE 161 DISTRIBUTION Nationwide. _______________________ PRODUCT 2.17 mm Coronary TEC Catheter. Model C102165. Recall # Z-0457-02 CODE Lot F0122702 RECALLING FIRM/MANUFACTURER Interventional Technologies, INC., San Diego, CA., by telephone and letter dated 11/6/2001. Firm initiated recall ongoing. REASON Mislabeled with smaller size. VOLUME OF PRODUCT IN COMMERCE 19 DISTRIBUTION CA, OH, PA, NY, IL, MO, NC, FL. ________________ PRODUCT Human Heart Valves, processed and frozen, for transplantation, Recall # Z-0458-2. CODES: 99-1311HV-02 98-1532HV-02 98-0476HV-01 98-0476HV-02 98-1532HV-01 98-0132HV-01 98-0132HV-02 98-1302HV-01 99-1311HV-01 RECALLING FIRM/MANUFACTURER Lifenet, Virginia Beach, VA , by letter on Oct. 9, 2001. Firm initiated recall is ongoing. REASON Donor of tissues for transplantation was not properly assessed for suitability. VOLUME OF PRODUCT IN COMMERCE 9 heart valves DISTRIBUTION MA, VA, GA, PA, ME and TX. ________________ PRODUCT Dissecting Tools, a round, fluted dissecting accessory tool to the Midas Rex III System and the Midas Rex Classic System, which are both pneumatic drill systems for use in surgery, Recall # Z-0459-2. CODE Product code G8-340 Dissecting Tool, Lot number Q6400. RECALLING FIRM/MANUFACTURER Midas Rex, L.P. Fort Worth, TX, by letter on Aug. 7, 2001. Firm initiated recall is complete. REASON Product mix-up. VOLUME OF PRODUCT IN COMMERCE 50 DISTRIBUTION Nationwide and South AfricaRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Architect Total T4 calibrators, list 6C49-01; for the calibration of the Architect i System when used for the quantitative determination of thyroxine (Total T4) in human serum and plasma; Abbott Laboratories, Abbott Park, IL 60064, Recall # Z-0421-02. CODE list 6C49-01, lot 71756Q100 RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, INC. Abbott Park, IL, by letters dated 8/20/01. Manufacturer: Abbott Health Products, INC. Barceloneta, Puerto Rico. Firm initiated recall is ongoing. REASON 9% negative bias in patient results VOLUME OF PRODUCT IN COMMERCE 212 kits. DISTRIBUTION Nationwide and International _______________________ PRODUCT Autoperfusion Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0427-02. CODE Autoperfusion Software, versions 1.0 and 1.1 installed on ICON P and ICON AP workstations RECALLING FIRM/MANUFACTURER Siemens Medical Systems, Inc., Hoffman Estates, IL, by letters dated 11/24/98 and 3/18/99, and software upgrades issued 1/29/99 and 11/5/99. Firm initiated recall is complete. REASON The software did not save oblique data correctly VOLUME OF PRODUCT IN COMMERCE 211 DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Autoperfusion Software, which includes The Cardiac Review (Profile Review) application, used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0428-02. CODE Autoperfusion Software, version 1.2 installed on ICON P and ICON AP workstations. RECALLING FIRM/MANUFACTURER Siemens Medical Systems, INC. Hoffman Estates, IL, by letter on 2/23/00. Firm initiated recall is ongoing. REASON Rest/stress datasets are mislabeled; summed or non-gated data not saved VOLUME OF PRODUCT IN COMMERCE 2520 units DISTRIBUTION NationwideRECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
________________ PRODUCT Optimin Water Soluble Selenium Powder, elemental Selenium 0.5%, in 25 kg paper bags and 1 kg foil pouches. Recall # V-017-2. CODE Product code 09611411 - 25 kg. bag Product code 09611402 - 1 kg. Bag All lots of both sizes RECALLING FIRM/MANUFACTURER Recalling Firm: Trouw Nutrition USA, L.L.C. Highland, IL, by telephone call on 11/6/01. Manufacturer: Trouw Nutrition USA, L.L.C. Willmar, MN. Firm Initiated recall complete. REASON Selenium is unapproved for use in animal drinking water VOLUME OF PRODUCT IN COMMERCE 204 - 25 kg bags DISTRIBUTION Minnesota, Florida, North Dakota and New Zealand ________________ PRODUCT Consolidated Nutrition Metabalance 15/25 10484AQC Medicated, Type A Category II medicated article, containing carbadox 0.0055%, packaged in 50-lb. bags, used as the sole ration for starter pigs from 15-25 lbs. Recall #V-018-2. CODE Lot #AB13601 RECALLING FIRM/MANUFACTURER Consolidated Nutrition, L.C. Abilene, KS, by telephone on 8/9/01. FDA initiated recall complete. REASON Cross-contaminated with monensin VOLUME OF PRODUCT IN COMMERCE 64/50-lb. bags DISTRIBUTION KSEND OF ENFORCEMENT REPORT FOR JANUARY 16, 2002
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