October 17, 2001 01-41
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-523-1, Mrs. Gerry's Kitchen Inc. Supreme Seafood Salad, net weight 4 lbs. Codes: All lots distributed prior to the recall were mislabeled. The lots in distribution, which are within expiration, have use-by dates of 04/14/01 to 05/10/01. REASON: The product contained undeclared eggs, pollack, snow crabmeat, soy protein and wheat starch. MANUFACTURER/RECALLING FIRM: Mrs. Gerry's Kitchen, Inc., Albert Lea, MN RECALLED BY: Manufacturer, by letter on April 12, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: IA, IL, MI, MN, MO, ND, WI QUANTITY: 1,024 cases (two-4 pound packages per case) ______________________________ RECALL NUMBER, PRODUCT AND CODE: F-001-2, Double Chocolate Fudge Bar: a) In clear wrap sold as bulk candy without any labeling and b) Sold individually with stick-on label stating in part "THE CANDY BASKET DOUBLE CHOCOLATE FUDGE BAR NET WT. 1 1/2 OZ. CANDY BASKET, INC. PORTLAND, OREGON 97230***". REASON: The product contained undeclared egg whites. MANUFACTURER/RECALLING FIRM: The Candy Basket, Inc. Portland, OR RECALLED BY: The recalling firm, by telephone on 7/12/01 and by faxed letter on 7/13/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: OR QUANTITY: Approximately 50 lbs _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-002-2, Golden Lion Trade Mark Dried Lotus Roots in flexible plastic bags, net wt. 7 oz. (200 g), product of China. Codes: None REASON: The product contained undeclared sulfites. MANUFACTURER: Hang Tai Marine Products Co. West Hong Kong RECALLED BY: Hong Won Trading Co., Inc. Brooklyn, NY, by press release on 8/22/00 followed by letter 8/23/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY QUANTITY: 3 cases (100-7 oz. packages per case) _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-004-2, Hydrozyme, tablets, a dietary supplement sold in bottles of 90 and 250. F-005-2, HCl Plus, tablets, a dietary supplement sold in bottles of 90. Codes: Product HCl Plus, lot 21150 Product Hydrozyme, lot 21173, 21245, 21280 REASON: The products were manufactured using pepsin that American Laboratories, Inc., Omaha, NE recalled due to Salmonella contamination. MANUFACTURER/RECALLING FIRM: Biotics Research Corporation Rosenberg, TX RECALLED BY: Recalling firm, by letter on 4/26/01 and by press release on August 7, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 1,133,560 tablets _______________________________ RECALL NUMBER, PRODUCT AND CODE: Treasure of the East brand Chinese herbal products, sold in powder form in 3.5 oz. bottle and/or capsules, 100 per bottle. F-006-2, Guan Mu Tong, 3.5 oz bottle (powder) Item # 100176-0. Product was listed in catalog as Mu Tong (Akebia caulis). Product was actually Guan Mu Tong which contains aristolochia. Product labels identified item as Guan Mu Tong. This product was sold as a single ingredient powder and was also used as an ingredient to manufacture 11 combination formulas. F-007-2, Ma Dou Ling , 3.5 oz bottle (powder), Item #100644-2. This product contains aristolochia spp. and was only sold as a single ingredient product. It was not used to manufacture combination products. F-008-2, Ba Zheng San , 3.5 oz bottle (powder) & 100 capsule bottle, Item #B015. Recalled product contained 8 ingredients including 13% Guan Mu Tong (aristolochia). F-009-2, Dang Gui Si Ni Tang, 3.5 oz bottle (powder) & 100 capsule bottle, Item #D060. Recalled product contained 8 ingredients including 12% Guan Mu Tong (aristolochia). F-010-2, Dao Chi San, 3.5 oz bottle (powder) & 100 capsule bottles, Item #D075. Recalled product contained 4 ingredients including 25% Guan Mu Tong. F-011-2, Fu Fang Di Hu Tang, 3.5 oz bottle (powder) & 100 capsule bottles, Item #F050. Recalled product contained 9 ingredients including 8% Guan Mu Tong (aristolochia). F-012-2, Gan Lu Xiao Du Dan, 3.5 oz bottle (powder) & 100 capsule bottles, Item #G005. Recalled product contained 12 ingredients including 7% Guan Mu Tong (aristolochia). F-013-2, Kou Yan Ning, 3.5 oz bottle (powder) & 100 capsule bottles, Item #K030. Recalled product contained 8 ingredients including 6% Guan Mu Tong (aristolochia). F-014-2, Long Dan Xie Gan Tang, 3.5 oz bottle (powder) & 100 capsule bottles, Item #L070. Recalled product contained 9 ingredients including 12% Guan Mu Tong (aristolochia). F-015-2, Pai Shi Tang, 3.5 oz bottle (powder) & 100 capsule bottles, Item #P005. Recalled product contained 9 ingredients including 9% Guan Mu Tong (aristolochia). F-016-2, Xiao Ji Yin Zi, 3.5 oz bottle (powder) & 100 capsule bottles, Item #X072. Recalled product contained 10 ingredients including 7% Guan Mu Tong (aristolochia). F-017-2, Xin Yi San, 3.5 oz bottle (powder) & 100 capsule bottles, Item #X125. Recalled product contained 10 ingredients including 10% Guan Mu Tong (aristolochia). F-018-2, Yang Yin Xiao Yan Tang, 3.5 oz bottle (powder) & 100 capsule bottles, Item #Y020. Recalled product contained 8 ingredients including 21% Guan Mu Tong (aristolochia). Codes: Products with "MFG NO." of 2000 08 (=August 2000) and lower are subject to recall. Both the single ingredient products and the combination products are identified with the year and month of production (i.e. "2001 03") and a use by date which is three years from the date of manufacture (i.e. 03 2004). NOTE: Products with a lot number of 2000 09 or greater are NOT under recall. REASON: Products contain aristolochic acid, a potent carcinogen and nephrotoxin. MANUFACTURER: F-006/007-2: Tianjiang Pharmaceutical Co. Ltd., China F-008/018-2: Blue Light, Inc. Ithaca, NY RECALLED BY: Blue Light, Inc., Ithaca, NY by letters issued in March 2001 and June 19, 2001. FDA issued a Press Release on 6/20/01 regarding this recall. FIRM INITIATED RECALL: Completed DISTRIBUTION: Nationwide QUANTITY: Approximate quantities distributed are: Guan Mu Tong: 193 x 3.5 oz bottles Ma Dou Ling: 35 x 3.5 oz bottles Ba Zheng San: 60 x 3.5 oz btls & 51 x 100-capsule bottles Dang Gui Si Ni Tang: 56 x 3.5 oz btls, 84 x 100-capsule bottles Dao Chi San: 8 x 3.5 oz bottles & 10 x 100-capsule bottles Fu Fang Di Hu Tang: 88 x 3.5 oz bottles & 113 x 100-capsule bottles Gan Lu Xiao Du Dan: 7 x 3.5 oz bottles & 12 x 100-capsule bottles Kou Yan Ning: 28 x 3.5 oz bottles & 24 x 100- capsule bottles Long Dan Xie Gan Tang: 159 x 3.5 oz bottles & 346 x 100-capsule bottles Pai Shi Tang: 8 x 3.5 oz bottles & 1 x 100-capsule bottle Xiao Ji Yin Zi: 5 x 3.5 oz bottles Xin Yi San: 15 x 3.5 oz bottles & 22 x 100-capsule bottles Yang Yin Xiao Yan Tang: 8 x 3.5 oz bottles & 27 x 100-capsule bottlesRECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-003-2, Fleischmann's Unsalted Margarine in 1 lb. packages with 4 - 1/4 lb. sticks per package Codes: Fleischmann's Unsalted Stick Margarine, Best if used by "JAN 31 02 ON" REASON: Some cartons contained sticks of Fleischmann's Original Margarine. The Original Margarine contains whey, which is not listed as an ingredient on the unsalted margarine label. MANUFACTURER/RECALLING FIRM: ConAgra Dairy Foods Indianapolis, IN RECALLED BY: The recalling firm, by press release, telephone and letter on September 21, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide. QUANTITY: 3,000 poundsRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-305-1, Pulmolite, a kit for the preparation of Technetium Tc99m Albumin Aggregated for Injection, labeled as sterile and non-pyrogenic, Rx, for diagnostic use. Codes: Lot Number 127254; Expiration Date 01 AUG 02. REASON: Lack of assurance of sterility (crimp seal problems). MANUFACTURER: Ben Venue Laboratories, Inc. Bedford, OH. RECALLED BY: CIS-US, Inc., Bedford, MA, by letter on 7/27/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 33,475 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-308-1, Etrafon Tablets,USP, brand of perphenazine and amitriptyline hydrochloride, each tablet contains perphenazine, USP 2 mg, and amitriptyline hydrochloride, USP 25mg,100 tablet bottles and 100 tablets packaged unit dose, Rx only. Codes: Lot No: 9-ANC-1, Exp. Date September 2001 REASON: Dissolution Failure (18 Month Stability) MANUFACTURER/RECALLING FIRM: Schering Corp Kenilworth, NJ RECALLED BY: Manufacturer, by first class letters mailed 8/22/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 15,477 bottles of 100 and 2,220 unit dose blisters in boxes of 100 _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-309-1, Nitro Tab (Nitroglycerin Tablets, USP) 0.3mg (1/200 gr), Rx Only, 100 Sublingual tablets, Lot 021002, bottles of 100's. Codes: Lot 012002, Exp. 12/2002. REASON: Mislabeled: 0.3 MG Product Labeling (Exterior Carton ) incorrectly declares bottles to contain 0.4 MG. tablets. MANUFACTURER/RECALLING FIRM: Able Laboratories, South Plainfield, NJ RECALLED BY: Manufacturer, by letter dated 8/27/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: OH QUANTITY: 1260/100 tablet bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-311-1, Levoxyl(Levothyroxine Sodium Tablets,USP) 25 mcg (0.025 mg)100 and 1000 tablet bottles, Rx only D-312-1, Levoxyl(Levothyroxine Sodium Tablets,USP) 150 mcg (0.15 mg)100 tablet bottles, Rx only Codes: 25mcg: Lot number 6413, Exp 12/2001 150mcg: Lot number 6294, Exp 11/2001 REASON: Subpotency (During Stablity) MANUFACTURER: King Pharmaceuticals, St. Petersburg, Fl. (formerly Daniels Pharmaceuticals), St. Petersburg, FL RECALLED BY: King Pharmaceuticals, Inc. Bristol, TN, by certified mail on 9/19/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 19,390 units of lot 6413 and 37,882 units of lot 6294 _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-314-1, Oxygen USP, compressed, sold in high pressure cylinders of size E. Codes:297 cylinders were involved in the recall to two consignees. The lot numbers are: 016ORL1018A 016ORL1018D 022ORL1018F 357ORL0018C. REASON: Misbranded: Cylinders were shipped empty or partially filled. MANUFACTURER: Air Liquide America Orlando, FL RECALLED BY: Air Liquide America Corp Houston, TX , by letter on 3/5/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: FL QUANTITY: 297 _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-316-1, Motion Sickness (Meclizine HCl 25 mg) Tablets, 8 Tablet cartons, Non-prescription(OTC). Codes: PL Developments lots: 2193, J1931, J1932, exp. 4/2002 PDK bulk lot: 00D388. Longs NDC: 12333-9831-1 Eckerd NDC: 19458-039-51 Discount Drug Mart-Food Fair barcode #: 933351 10978 Valu-Rite NDC: 49348-363-67 REASON: Dissolution Failure MANUFACTURER/RECALLING FIRM: PL Developments, Farmingdale, NY RECALLED BY: Manufacturer, by letter on 9/7/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, FL and OH QUANTITY: 34,782 blistered units (8 tablets per blister)RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-310-1, Etodolac Capsules, USP, 200 mg, Rx only, 100 Capsule bottles, NDC 51672-4016-1, Codes: Lot 014430, expiration date 5/2003, NDC 51672-4016-1, ANDA #75-078. REASON: Misbranded: Product label incorrectly declares product as tablets. MANUFACTURER: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel, RECALLED BY: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY, via letter on 9/13/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: PA and KY QUANTITY: 1582 bottles (100s) _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-313-1, Women's Tylenol Menstrual Relief Caplets. The OTC Product is 500 mg acetaminophen and 25 mg pamabron film coated caplets. The product is sold in 40 count bottles. Codes: Lot DJM099 exp. 9/02 REASON: Dissolution Failure - Acetaminophen component (STABILITY) MANUFACTURER: McNeil Consumer Healthcare Guelph, Ontario, Canada RECALLED BY: McNeil Consumer Healthcare, Fort Washington, PA, via letter on 8/24/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 133,296 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-315-1, Sentry Simethicone Emulsion USP, (30% Active) in 40 pound pails and 425 pound drums,Bulk pharmaceutical, OTC Codes: Batches 248450, 248451, 248453, 248454, 248455, all expire 10/2002 REASON: Failed USP Defoaming Test. MANUFACTURER/RECALLING FIRM: Crompton Corporation/OSI Specialties Friendly, WV RECALLED BY: Manufacturer, via e-mail and telephone on 6/19/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY, OH, NJ, MO, Fl QUANTITY: 13,085 lbsRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1247-1, Platelets Unit 7751352 REASON: Unit of red blood cells, implicated in a transfusion reaction, was found contaminated with Staphylococcus aureus. Corresponding blood products were distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, Texas RECALLED BY: The recalling firm, by letter dated October 3, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1368-1, Source Plasma, unit number 99GMIE6807 REASON: Source Plasma, which was collected from a donor who was accepted for donation within four weeks of receipt of an MMR immunization, was distributed. MANUFACTURER/RECALLING FIRM: Community Bio-Resources, Inc., Grand Rapids, MI RECALLED BY: The recalling firm, by letter dated July 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1579-1, Whole Blood ,unit M53886 B-1580-1, Platelets, Pheresis ,units K14465 and K13687 B-1581-1, Platelets ,units T57068, T55284, and T045922 B-1582-1, Fresh Frozen Plasma units, T75696, T65873, T57068, T045922, and T030337 REASON: Blood products, which contained anti-Fya and anti-Bg but were labeled as negative for unexpected antibodies, were distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas City, Topeka, KS RECALLED BY: The recalling firm, by letters, dated October 9 or October 16, 1998, and by telephone on October 12, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: KA, MI, FL, NY, IN, KY, AL, GA QUANTITY: 10 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1922-1, Red Blood Cells, Leukoreduced, Irradiated, Unit 10708-1375 REASON: Blood product, for which documentation of irradiation was incomplete, was distributed. MANUFACTURER: United Blood Services, Scottsdale, AZ RECALLED BY: The recalling firm, by telephone on March 16, 2001 and by letter dated March 28, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Arizona QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1923-1, Red Blood Cells, Leukoreduced Units 33GS09579, 33GS09580, 33LL89335 REASON: A unit of Pooled Platelets, Leukoreduced, implicated in a transfusion reaction, was found contaminated with Staphloccus aureus. Corresponding blood products were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Connecticut Region, Farmington, CT RECALLED BY: The recalling firm, by letters dated April 12, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CT QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1929-1, Corneas, Units MSN-2000-0965, MSN-2000-0966 REASON: Corneas, collected from a donor who tested repeatedly reactive for the HTLV I/II antibody, with a negative HTLV Western Blot, were distributed. MANUFACTURER/RECALLING FIRM: Lions Eye Bank of Wisconsin, Inc., Madison, WI RECALLED BY: The recalling firm, by letters dated September 22, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: WI QUANTITY: 2 units ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1930-1, Red Blood Cells, Unit 55C29521 B-1931-1, Platelets, Unit 55C29521 B-1932-1, Fresh Frozen Plasma, Unit 55C29521 REASON: Blood products collected from a donor with a history of having tested positive for HCV was distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross, Little Rock, AR RECALLED BY: The recalling firm, by letters dated December 15, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1933-1, Source Plasma, Units FN0004446, FN0004481, FG0032236, FG0032392, FG0032913 REASON: Blood products, collected from a donor who had been permanently deferred at another donor center for having had a reactive viral marker test, were distributed. MANUFACTURER/RECALLING FIRM: Sera-Care Fort Smith/BHM Labs, Fort Smith, AR RECALLED BY: The recalling firm, by facsimile on January 21, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Spain QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1935-1, Source Plasma, Units 4WG262A, 4WG558A, 4WF974A REASON: Blood Products, collected from a donor who had engaged in high risk behaviors, were distributed. MANUFACTURER/RECALLING FIRM: Centeon (Aventis) Bio-Services, Inc., Tulsa, OK RECALLED BY: The recalling firm, by facsimiles on 6/3/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL and TN QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1936-1, Red Blood Cells, Unit 5331819 REASON: Blood product, collected from a donor with a history of jaundice, was distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, Tx. RECALLED BY: The recalling firm, by telephone on March 8, 2001 and by letter dated April 18, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1937-1, Red Blood Cells, Unit LR44461 B-1938-1, Recovered Plasma, Unit LR44461 REASON: Blood products, collected from a donor with a history of Hepatitis A, were distributed. MANUFACTURER/RECALLING FIRM: The Blood Center of Central Iowa, Des Moines IA RECALLED BY: The recalling firm, by letter dated December 14, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL and Switzerland QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1939-1, Platelet, Pheresis, Leukoreduced (Split #3), Unit 107-7-2502 REASON: Blood product, which had a high platelet count, was distributed. MANUFACTURER: United Blood Services, Scottsdale, AZ RECALLED BY: Blood Systems Inc., Scottsdale, AZ, by telephone on May 4, 2001 and by letter dated June 1, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1941-1, Platelet, Pheresis, Leukoreduced (Split units) Units 15386-9795 15386-9890 15386-9896 15387-0353 15387-0363 15387-0382 15387-0425 15387-0490 15387-2325 15387-2333 15387-2439 15387-2443 15387-2456 REASON: Blood products, which had a high platelet count, were distributed MANUFACTURER/RECALLING FIRM: United Blood Systems, Inc., Lubbock, Texas RECALLED BY: The recalling firm, by telephone on February 27, 2001 and by letter dated March 20, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: TX QUANTITY: 26 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1957-1, Red Blood Cells, Unit number L27547 REASON: Blood product, that tested positive for the c antigen, but was labeled c antigen negative, was distributed. MANUFACTURER/RECALLING FIRM: Central Illinois Community Blood Bank, Springfield, IL 62703 RECALLED BY: The recalling firm, by telephone on May 15, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1960-1, Red Blood Cells, unit number 42FS65173 B-1961-1, Recovered Plasma, unit number 42FS65173 REASON: Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that reported previously tested reactive for anti-HIV, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Cleveland, OH RECALLED BY: The recalling firm, by telephone and facsimile on January 18, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH and CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1962-1, Platelets, unit number 7260139 B-1963-1, Recovered Plasma, unit number 7260139 REASON: Blood products, that tested negative for the antibody to human immunodeficiency virus, type 1 (anti-HIV-1), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-1, were distributed. MANUFACTURER/RECALLING FIRM: New York Blood Center, Inc., New York, NY RECALLED BY: The recalling firm, by letter dated May 18, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1964-1, Red Blood Cells (11 units), unit numbers 2391722, 2349976, 2288525, 2271728, 2963378, 2878216, 2790053, 2593211, 2489919, 2461890, and 2383187 B-1965-1, Platelets (5 units), unit numbers 2391722, 2349976, 2288525, 2271728, and 2461890 B-1966-1, Cryoprecipitated AHF (2 units), unit numbers 2878216 and 2790053 B-1967-1, Fresh Frozen Plasma (1 unit), unit number 2271728 B-1968-1, Source Leukocytes (1 unit), unit number 2391722 B-1969-1, Recovered Plasma (10 units), unit numbers 2391722, 2349976, 2288525, 2963378, 2593211, 2489919, 2461890, 2383187, 2878216, and 2790053 REASON: Blood products, that tested negative for the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from donors that previously tested repeatedly reactive for anti-HIV-1/2, were distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, TX RECALLED BY: Recalling firm, by facsimile on March 24, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX, CA, Fl, and NJ QUANTITY: 30 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1970-1, Red Blood Cells, Leukocytes Reduced, unit number 36FF06361 REASON: Blood product collected in a manner that may have compromised sterility was distributed. MANUFACTURER: The American National Red Cross, Charleston, SC RECALLED BY: The American National Red Cross, Columbia, SC, by telephone on July 24, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: SC QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1972-1, Red Blood Cells, Units 26164-0085, 26164-0086 REASON: Blood products, collected from donors who reported travel to an area designated as endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Fort Smith, AR RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter dated April 18, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AR QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1973-1, Red Blood Cells, Leukoreduced, Unit 15012-8539 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER: United Blood Services, Lubbock, TX RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter dated May 1, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1974-1, Red Blood Cells, Unit 352-9407 B-1975-1, Recovered Plasma, Unit 352-9407 REASON: Blood products, collected from a donor who was exposed to a needle stick while in a Group O HIV risk area, were distributed. MANUFACTURER/RECALLING FIRM: United Blood Services, Meridian, MS RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 12, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MS QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1976-1, Red Blood Cells, Leukoreduced, Unit 49GR50852 REASON: Blood product, collected from a donor taking the drug Methotrexate, was distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross, Tulsa, OK RECALLED BY: The recalling firm, by telephone on May 10, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OK QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1995-1, Source Plasma, Units 0200233074, 0200232869, 0200232623, 0200232198, 0200231997, 0200231741, 0200231589, 0200232458, 0200231341, 0200231159, 0200230484, 0200230300, 0200230026, 0200229859, 0200229550, 0200229375, 0200223481, 0200245976, 0200245675, 0200245326, 0200245132, 0200244925, 0200244180, 0200243993, 0200243512, 0200243053, 0200242740, 0200242540, 0200242179, 0200241021, 0200235293, 0200234180, 0200233965, 0200233466 REASON: Blood products, collected from a donor who had a tattoo within twelve months of donation, were distributed. MANUFACTURER/RECALLING FIRM: Nabi, Norman, Ok RECALLED BY: The recalling firm, by facsimile on March 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY and Korea, United Kingdom QUANTITY 34 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-2005-1, Red Blood Cells (Split unit), Unit 7586815 REASON: Blood product, collected from a donor with a history of jaundice, was distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, Texas RECALLED BY: The recalling firm, by letter dated May 30, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-2006-1, Units 947214, 947361, 947551, 949508, 949894, 95A180 95N605, 95N968, 9VY339, 9VY495 REASON: Blood products, collected from a donor who engaged in high-risk behavior, were distributed. MANUFACTURER/RECALLING FIRM: Aventis Bio-Services, Inc., Oklahoma City, OK RECALLED BY: The recalling firm, by fax dated March 8, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY 10 unitsRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-767-1, Red Blood Cells, Leukocytes Reduced, Unit number C46657 REASON: Blood product that was out of controlled storage for more than 30 minutes was distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Aurora, IL RECALLED BY: The recalling firm, by letter dated August 1, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-768-1, Platelets Pheresis, Leukocytes Reduced, unit number H97216 REASON: Blood product, untested for the antibody to hepatitis C virus (anti-HCV), was distributed. MANUFACTURER/RECALLING FIRM: Regional Health Resource Center, Urbana, IL RECALLED BY: The recalling firm, by telephone on June 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit ______________________________ RECALL NUMBER, PRODUCT AND CODE: B-776-1, Red Blood Cells, Irradiated, Unit 42FH05199 REASON: Blood product, labeled with an extended expiration date, was distributed. MANUFACTURER/RECALLING FIRM: St. Elizabeth Health Center, Youngstown, OH RECALLED BY: The recalling firm, by telephone and facsimile on June 13, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1248-1, Recovered Plasma, unit 7751352 REASON: Unit of recovered plasma, implicated in a transfusion reaction. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, Texas RECALLED BY: The recalling firm, by letter dated October 3, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Switzerland QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1369-1, Source Plasma, unit number 99GMIE8596 REASON: Source Plasma, which was collected from a donor who was accepted for donation within four weeks of receipt of an MMR immunization, were distributed. MANUFACTURER/RECALLING FIRM: Community Bio-Resources, Inc., Grand Rapids, MI RECALLED BY: The recalling firm, by letter dated July 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1577-1, Red Blood Cells, units K10480, S00147, K01880, T94445, T92792, T79231, T75696, T67833, T65873, T62360, T58570, T57068, T55284, T047839, T045922, T039722, T002195, and T030337 B-1578-1, Red Blood Cells, Leukoreduced, unit T99018 REASON: Blood products, which contained anti-Fya and anti-Bg but were labeled as negative for unexpected antibodies, were distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas City, Topeka, KS RECALLED BY: The recalling firm, by letters, dated October 9, October 16, 1998, and by telephone on October 12, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: KS, MO, FL, NY, IN, KY, AL, GA QUANTITY: 19 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1605-1, Whole Blood for further manufacture, unit number VF-07553 REASON: Blood product, that tested negative for viral markers, but was collected from a donor whose health history was inadequately determined, was distributed. MANUFACTURER/RECALLING FIRM: Pyramid Biological Corporation, Van Nuys, CA RECALLED BY: The recalling firm, by letters dated November 3, 2000, and June 12, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1740-1, Fresh Frozen Plasma, Unit 084FT15792 REASON: Blood product, prepared from a unit of Whole Blood that should have been designated as a slow bleed, was distributed. MANUFACTURER/RECALLING FIRM: The American Red Cross, San Jose, CA RECALLED BY: The recalling firm by letter dated October 13, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1775-1, Platelets, Unit 5300696 REASON: Blood product, prepared from a Whole Blood unit that had discrepant start and end times documented, was distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: The recalling firm, by facsimile dated February 23, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1777-1, Red Blood Cells, Leukoreduced, Unit 17195-9179 REASON: Red Blood Cells, that failed the red cell recovery ratio, were distributed. MANUFACTURER: Blood Systems, Inc., McAllen, TX RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 16, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1913-1, Red Blood Cells, Leukoreduced, Unit 10625-8071 B-1914-1, Recovered Plasma, Unit 10625-8071 REASON: Blood products, collected from a donor who received a tissue transplant within a year of donation, were distributed MANUFACTURER/RECALLING FIRM: United Blood Services, Scottsdale, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter dated December 22, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ and VA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1916-1, Red Blood Cells, Unit 08FR19156 REASON: Blood product, collected from donor who exceeded the donor acceptance criteria for body temperature, was distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross, San Jose, CA RECALLED BY: The recalling firm, by letter dated August 14, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1920-1, Red Blood Cells, Pheresis, Units 10004-0270 (bag 1 and 2) B-1921-1, Platelets, Pheresis, Unit 10619-9328 REASON: Blood products, collected in a manner that cannot assure that the units are sterile, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc, Tucson, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letters dated June 2, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1925-1, Red Blood Cells, Unit M66735 REASON: Blood product, which was not refrigerated within 8 hours of Whole Blood collection, was distributed. MANUFACTURER/RECALLING FIRM: Lane Memorial Blood Bank, Eugene, OR. RECALLED BY: The recalling firm, by letter dated March 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OR QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1927-1, Platelets, Pheresis, Unit 6756762 REASON: Blood product, collected from a donor taking Ancef, was distributed. MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers, Lake Charles, LA RECALLED BY: The recalling firm, by telephone on December 10, 1999, and by letter dated January 3, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: LA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1934-1, Red Blood Cells, Leukoreduced, Autologous, Unit 10708-2602 REASON: Blood product, collected from a donor who was taking Ciprofloxacin for a sinus infection, was distributed. MANUFACTURER/RECALLING FIRM: United Blood Services, Scottsdale, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on February 28, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1958-1, Red Blood Cells, Irradiated, unit number C51185 REASON: Blood product that was possibly out of controlled storage for more than 30 minutes was distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL RECALLED BY: The recalling firm, by letter dated July 20, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1959-1, Red Blood Cells, Leukocytes Reduced, unit numbers 10706-5254, 10707-1267, and 10708-5608 REASON: Blood products that were possibly out of controlled storage for more than 30 minutes were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Scottsdale, AZ RECALLED BY: The recalling firm, by telephone on April 5, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 3 unitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0001-2, Integra Neurosciences True Tech REF NL960-V Ventricular Tunneling Pressure Monitoring Kit Ventrix® True Tech Codes: Lot numbers: a) VTT0024 Carries an Expiration Date of August 2001 b) VTT0025 Carries an Expiration Date of August 2001 c) VTT0026 Carries an Expiration Date of October 2001 REASON: The "lock/unlock" label was reversed on the catheter connector. MANUFACTURER/RECALLING FIRM: Integra Neurocare LLC, San Diego, CA RECALLED BY: The Recalling firm, via FedEx letter on August 10, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: a) 24 units; b) 48 units; and c) 36 units. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0002-2, Western OPC-830 Portable Oxygen Conserving Regulator. The OPC- 830 is a regulator and conserving device combined within one unit. The user can switch between the Continuous Mode (delivers a constant flow, regardless of breathing patterns) and Conserve Mode (delivers flow only during inhalation) without disconnecting the unit. Codes: All Serial Numbers. REASON: Defective demand valve does not function as intended in the 'Conservative Mode'. MANUFACTURER/RECALLING FIRM: Western Medica Westlake, OH. RECALLED BY: The Recalling firm, on 10/23/2000 by telephone and letter. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 1,846 units. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0003-2, Babytherm 8004/8010 with Phototherapy Option. The device is an infant warming system. Codes: Catalog Numbers FR00104, FR00105, FR00114, FR00120, FR00098, 2M30404. REASON: Breakage MANUFACTURER: Drager Medizintechnik GmbH Lubeck, Germany, RECALLED BY: North American Drager,Telford, PA, by letter, no date indicated. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 140 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0004-2, MediVators brand Rapicide High-Level Disinfectant and Sterilant. Active ingredient: Glutaldehyde. CODE: Lots L020711, L021211 and L021411. REASON: Bottles may leak. MANUFACTURER/RECALLING FIRM: Ecolab Inc. Huntington, IN RECALLED BY: Manufacturer, by letter on 8/14/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: MN QUANTITY: 2,956 cases of 4 units each _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0008-2, COBAS Integra 400 laboratory clinical chemistry analyzer, Model 400, Catalog number 1045199. All serial numbers of analyzers lower than 38-2606. Serial numbers of 38-2606 or higher have already been updated with software revision upgrade 4. REASON: If the operator fails to position the diluent on the instrument, the instrument may not detect that the reagent is missing an aspirate air instead of diluent. MANUFACTURER: Tegimenta, AB Switzerland, RECALLED BY: Roche Diagnostics Corp. Indianapolis, IN, by letter dated August 17, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 161 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0009-2/Z-0010-2, Heartport brand StillSite II Stabilizer, Straight Arm, A beating Heart Stabilization System Codes: 505021F; 515011B; 515011A Catalog Numbers: PO-S2S, P0-S2C REASON: Sterility may be compromised MANUFACTURER: MedSource - Newton Newton, Ma RECALLED BY: Heartport, Inc. Redwood City, CA, by telephone and letter on 8/31/2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 466 devices _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0011-2, Dual Stage Venous Return Cannulae, labeled in part: "PRODUCT CODE: DNF-3651S DUAL STAGE VENOUS RETURN CANNULA, NON-WIRE REINFORCED, 36/51 FR. BULLET TIP STERILE EO CHASE Medical, Inc. Richardson, TX 75081", packaged individually, 10 units per shipping box. DNF-3651S Lot Numbers: C008135, C008159, C009180, C010120, C010206 REASON: Tip may separate in use MANUFACTURER/RECALLING FIRM: Chase Medical, Inc. Athens, TX RECALLED BY: Recalling firm, by letter dated 12/8/00 FIRM INITIATED RECALL: Complete DISTRIBUTION: Scotland and Portugal QUANTITY: 280 unitsEND OF ENFORCEMENT REPORT FOR OCTOBER 17, 2001. ####
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Hypertext uploaded by tg 2001-OCT-17.