December 19, 2001 01-50
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Hot Smoked Salmon under Pacific Shellfish brand and San Diego Seafood brand. Recall # F-100-2. These are vacuum packaged in clear plastic; Approximately 6 oz. The individual packages are further packed in cardboard boxes, 10 pounds each. CODE The product was not coded. All salmon portions produced on 7/19/01 were being recalled. RECALLING FIRM/MANUFACTURER Anthony's Fish Grotto dba Ghio Seafoods, San Diego, CA., by telephone and Fax on 8/29/01. Firm-initiated recall complete. strong>REASON Listeria monocytogenes VOLUME OF PRODUCT IN COMMERCE 124 pounds in 6 ounce packages. DISTRIBUTION CA. _______________________ PRODUCT 8-10 oz. packages of Cheese Cubes, packed under the Biery Cheese label in vacuum sealed clear bags, 19-21 packages per case. a) Cheddar & Horseradish Cubes Recall # F-101-02; b) Colored American Cubes Recall # F-102-2; c) White American Cubes Recall # F-103-2; d) Colored Colby Cubes Recall # F-104-2. CODE The code for all these products is Sell-by Date: 12-3-01. This date appears at the top of the packages. RECALLING FIRM/MANUFACTURER Biery Cheese Company Louisville, OH., by telephone letter and press release on 8/13/01. Firm-initiated recall complete. REASON The cheese cube products are contaiminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE 624 cases (156 cases of each product). 6,200 lbs. DISTRIBUTION MD and PA _______________________ PRODUCT Meatball Sub, 6 oz. Recall # F-105-2; Super Meatball Sub, 8.25 oz. Recall # F-106-2; Both sandwiches are individually wrapped in clear cellophane, under the Deck Vend Services brand label. CODE FRESH THRU: 10/26/02 and 10/27/02 RECALLING FIRM/MANUFACTURER Deck Vend Services, Inc. Conneaut, OH., by memo on 10/22/01. Firm-initiated recall is complete. REASON Undeclared egg whites, milk, and other ingredients. VOLUME OF PRODUCT IN COMMERCE 358 sandwiches DISTRIBUTION OH and PA _______________________ PRODUCT Carrot Sheet Cake 40 Cut (Nut Free), net wt. 3.75 lbs., in a corrugated tray that is wrapped in a poly film. Recall # F-107-02. CODE Lot 015801 RECALLING FIRM/MANUFACTURER Awrey Bakeries, Inc. Livonia, MI., by press release on 10/15/01. Firm-initiated recall is complete. REASON Undeclared walnuts. VOLUME OF PRODUCT IN COMMERCE 26 cakes DISTRIBUTION MI ____________________ PRODUCT a) Vital Nutrients Joint Ease, Capsules 60 and 120 count. Recall # F-108-2. b) F-109-2 Verified Quality Brand Joint Comfort Complex, Capsules 60 and 120 count. Recall # F-109-2. CODES a) Vital Nutrients Joint Ease, Capsules 60 and 120 count b) Verified Quality Brand Joint Comfort Complex, Capsules 60 and 120 count All lots Hypoallergenic Dietary Supplement RECALLING FIRM/MANUFACTURER VITAL Nutrients, Middletown, CT, by letter via First Class Mail on 5/22/01. and a Press Release to AP on 5/21/01. Firm Initiated recall is complete. REASON Products contain aristolochic acid, a potent carcinogen and nephrotoxin. VOLUME OF PRODUCT IN COMMERCE 60 Count=454 Bottles; 120 count =238 bottles DISTRIBUTION NationwideRECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
______________________ PRODUCT Mrs. Prindables Chocolate Covered Caramel Apples with or without Pecans packaged with either a Santa, snowman or winged girl angel ornament. Pecan Caramel Apple, Net Wt. 1 lb. 8 oz., Recall # F-089-2; Triple Chocolate Caramel Apple, Net Wt. 1 lb. 7.5 oz, Recall # F-090-2. CODE UPC #34986-17001. There are no production codes on the apples. RECALLING FIRM/MANUFACTURER Affy Tapple Inc. Chicago, IL, via e-mail on 12/19/00. Firm initiated recall is complete. REASON Off odor and taste from styrene plastic. VOLUME OF PRODUCT IN COMMERCE 14,530 apples. DISTRIBUTION Nationwide _______________________ PRODUCT Lowery's brand coffee - whole beans and ground coffee. Four flavors include: Toasty Creamy Almond, Recall # F-091-2; Koffee Almond Fudge, Recall # F-092-2; Swiss Chocolate Almond, Recall # F-093-2; Decaffeinated Swiss Chocolate Almond, Recall # F-094-2. CODE All products on the market at the time the recall was initiated. Products were not coded. RECALLING FIRM/MANUFACTURER Lowery's Specialty Foods Company Monroe, WA, by letter and store visit on 10/16/01. FDA initiated recall is complete. REASON Undeclared almonds. VOLUME OF PRODUCT IN COMMERCE 200 lbs. DISTRIBUTION WA, ID, OR, and MT. _______________________ PRODUCT Product is in a translucent plastic bottle with shrink wrapped safety seal around the twist cap. The labeling is multicolored print on plastic wrapper. Product is labeled in part: "Good Neighbor Pharmacy*Pediatric Electrolyte Oral Maintenance Solution*Compare to Pedialyte*1 Liter (33.8 FL OZ) Unflavored* Ingredients.***”, Recall # F-095-2. CODE Lot Number 1183U 0817 Expiration 7/03 and 1183U 0900 Expiration 7/03. RECALLING FIRM/MANUFACTURER Unico Holdings, Inc. Lake Worth, FL., by telephone and fax on 8/31/01. Firm initiated recall complete. REASON FDA sample assayed sub-potent for sodium (78.2% and 76.9%) VOLUME OF PRODUCT IN COMMERCE 363 cases of 8-1 liter containers. DISTRIBUTION CO, CA, and MS. _______________________ PRODUCT Paskesz Frootee Ice brand Freezer Pops, Ready to Freeze and Eat, in cases of 110 - 30ml sealed plastic tubes. Recall # F-097-02. CODE Lots 050803 and 050703, Best by 05/08/03. RECALLING FIRM/MANUFACTURER Pack’em Enterprises, Inc., Detroit, MI., by telephone and letter on 10/25/01. State-initiated recall ongoing. REASON Undeclared FD&C colors Yellow #5, Yellow #6, Red #40, Blue #1 VOLUME OF PRODUCT IN COMMERCE 1440 cases DISTRIBUTION NY _______________________ PRODUCT Kings Canyon brand Poppycots apricots packaged in variety of sizes. Recall # F-098-2; California Fresh Fruit brand apricots packaged in variety of sizes. Recall # F-099-2. CODE 810512 430A01; 810511 430A01; 810514 430A01; and 810516 430A01. RECALLING FIRM/MANUFACTURER Manufacturer: GROWER: Bernard Tevelde, B&R Tevelde Farms Visalia, CA Recalling Firm: Kings Canyon Corrin, LLC. Reedley, CA., by telephone and fax on 6/29/01. FDA-initiated recall complete. REASON Over tolerance level of Chlorothalnil (herbercide) in apricots. VOLUME OF PRODUCT IN COMMERCE 1,436 cases DISTRIBUTION CA, PA and CanadaRECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT a) “Mrs Baird's Chocolate Cups Creme Filled" Cupcakes, Recall # F-072-2; b) “Mrs Baird's Butter Cups Creme Filled “ Cupcakes, Recall # F-073-2. CODE a) UPC 708754; b) UPC 708774. Date code on affected packages: Apr 24 through May 10. RECALLING FIRM/MANUFACTURER Recalling Firm: Mrs Bairds Bakeries, Fort Worth, TX, by letter on 4/26/01. Manufacturer: Grupo Bimbo S.A. de C.V. Colonia Pena Guerra, Mexico. Firm initiated recall is complete. REASON Small particles of aluminum have been found on the icing on some of the cakes. VOLUME OF PRODUCT IN COMMERCE 50,000. DISTRIBUTION TX, OK, and AR. _______________________ PRODUCT Good Day Artificially Flavored Blue Raspberry Drink packaged in 1-gal. plastic jugs, Recall # F-096-2. CODE 31-22 205 RECALLING FIRM/MANUFACTURER Meadow Gold Dairy Lincoln, NE, via telephone on 9/13/01 and fax on 9/14/01. FDA initiated recall is complete. REASON Mold and yeast contamination. VOLUME OF PRODUCT IN COMMERCE 240 gallons. DISTRIBUTION KS and NE.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Cortisporin Ointment (neomycin and polymyxin B sulfates, bactracin zinc, and hydrocortisone ointment, USP), Rx, ½ ounce tube, NDC 61570-0031-50. Recall # D-049-2. CODE MK10/8899, EXP June 2004. RECALLING FIRM/MANUFACTURER King Pharmaceuticals, Inc., Bristol, TN., by letter dated 11/26/01. Firm-initiated recall ongoing. REASON Subpotent for Polymycin B Sulfate component (Stability 28-month test point). VOLUME OF PRODUCT IN COMMERCE 38,481 units DISTRIBUTION Nationwide _______________________ PRODUCT Cardiolite (kit for the preparation of technetium Tc99m Sestamibi for injection), 5ml vial packaged in a 5 vial kit. Recall # D-050-2. CODE Lot Number 3749; Exp. 1 Apr ‘03 RECALLING FIRM/MANUFACTURER Ben Venue Laboratories, Inc., Bedford, OH., by fax on 11/9/01. Firm- initiated recall ongoing. REASON Lack of assurance of sterility (Vial seal integrity) VOLUME OF PRODUCT IN COMMERCE 3,543 kits (5-vial kits) DISTRIBUTION Nationwide, Aman, Guam _______________________ PRODUCT a. Pangestyme Capsules (Ethex brand) UL12 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 12,000 USP units lipase, 39,000 USP units amylase, and 39,000 USP units protease, packaged in 12-capsule bottles, NDC #58177-048-10, and 100-capsule bottles, NDC #58177-048-04, RX. Recall # D-052-2; b. Pangestyme Capsules (ETHEX brand) UL18 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 18,000 USP units lipase, 58,500 USP units amylase, and 58,500 USP units protease, packaged in 100-capsule bottles, NDC #58177-049-04, RX only. Recall # D-053-2; c. Pangestyme Capsules (ETHEX brand) UL20 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 20,000 USP units lipase, 65,000 USP units amylase, and 65,000 USP units protease, packaged in 100-capsule bottles, NDC #58177-050-04, RX only. Recall # D-054-2. d. Pangestyme Capsules (Ethex brand) MT16 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 16,000 USP units lipase, 48,000 USP units amylase and 48,000 USP units protease, packaged in 100-capsule bottles, NDC #58177-028-04, RX only. Recall # D-055-2; e. Pangestyme Capsules (ETHEX brand) EC Pancrelipase Enteric Coated Microspheres Contained in Capsules, each dye-free capsule contains 4,500 USP units lipase, 20,000 USP units amylase, and 25,000 USP units protease, packaged in 12-, 100-, and 250-capsule bottles, NDC #58177-031- 10 (12's), #58177-031-04 (100's) and #58177-031-06 (250's), RX only. Recall # D-056-2. All bottles are labeled as Manufactured by KV Pharmaceutical Co. for ETHEX Corporation, St. Louis, MO. CODES: a. Pangestyme UL12 Lot 28462, Exp. 04/02 Lot 28463, Exp. 04/02 Lot 32515, Exp. 11/02 b. Pangestyme UL18 Lot 28465, Exp.04/02 Lot 28466, Exp. 06/02 Lot 28467, Exp. 06/02 Lot 29888, Exp. 06/02 c. Pangestyme UL20 Lot 28642, Exp. 04/02 Lot 28643, Exp. 06/02 Lot 28653, Exp. 06/02 Lot 29930, Exp. 06/02 Lot 29931, Exp. 06/02 Lot 29932, Exp. 06/02 d. Pangestyme MT16 Lot 27478, Exp. 03/02 Lot 27479, Exp. 03/02 Lot 27480, Exp. 03/02 Lot 28639, Exp. 04/02 Lot 28640, Exp. 04/02 Lot 28641, Exp. 05/02 Lot 30245, Exp. 04/02 e. Pangestyme EC Lot 27487, Exp. 05/02 Lot 27488, Exp. 05/02 Lot 27489 (250-ct.), Exp. 05/02 Lot 27777, Exp. 06/02 Lot 27778, Exp. 07/02 Lot 27779 (250-ct.), Exp. 07/02 Lot 27780 (250-ct.), Exp. 08/02 Lot 30882, Exp. 07/02 Lot 30883, Exp. 07/02 Lot 30934, Exp. 07/02 RECALLING FIRM/MANUFACTURER Manufacturer: KV Pharmaceutical Co. St. Louis, MO Recalling Firm: ETHEX Corporation St. Louis, MO, by Fax and letter on 10/3/01. Firm-initiated recall ongoing. REASON: Subpotency (Stability) VOLUME OF PRODUCT IN COMMERCE a) UL12 - 4,581 btls; b) b) UL18 - 3,474 btls; c) c) MT16 - 9,016 btls; d) d) UL20 - 6,462 btls; e) e) EC - 22,723 btls DISTRIBUTION NationwideRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Dipyridamole Injection, 50 mg/10 mL (5 mg/mL), 10 mL fill in 10 mL, Flint Tubing single dose vial; NDC #63323-613-10, Rx only. Recall # D-051-2. CODE Lot 110632, Exp. April 2002 RECALLING FIRM/MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, IL., by letter dated 11/14/01. Firm-initiated recall ongoing. REASON Specification failure in impurities testing. VOLUME OF PRODUCT IN COMMERCE 20,130 vials DISTRIBUTION NationwideRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells (2 units). Recall #B-0164-2 CODE Units 7489992, 7413238 RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, by letters dated June 5, 2000 or June 11, 2000. Firm-initiated recall complete. REASON Blood products, collected from donors whose hemoglobin counts had not been documented, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 Units DISTRIBUTION TX _______________________ PRODUCT Source Plasma, Recall # B-0300-2. CODE Unit G-66580-77. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., Los Angeles, CA, by fax dated August 24, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who had skin piercing performed within twelve months of donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________ PRODUCT a) Red blood Cells, Recall B-0301-2; b) Fresh Frozen Plasma, Recall B-0302-2. CODE a) Unit FR03243; b) Unit FR06851. RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA, by telephone on September 18, 2000 and by letter dated September 19, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of hepatitis A, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-0303-2. CODE Unit G-54290-051. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by fax dated June 28, 2000. Manufacturer: Alpha Therapeutic Corporation, Fontana, CA 92335 Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of hepatitis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-0318-2. CODE Unit S90062. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA, by telephone on or about October 5, 2000. Firm initiated recall is complete. REASON Blood product, that was labeled leukoreduced but had an elevated white blood cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall B-0320-2. CODE Units T-20466-097, T-20408-097, T-20305-097, T-20082-097, T-20005-097, T-19838-097, T-19768-097, T-19691-097, T-19625-097, T-19475-097, T-19440-097, T-19301-097, T-19266-097, T-19038-097, T-18764-097, T-17876-097, T-17733-097, T-17411-097, T-16703-097, T-16558-097, T-13952-097, T-13828-097, T-13661-097, T-13503-097, T-13319-097, T-13138-097, T-12952-097, T-12798-097, T-12571-097, T-12279-097, G-96207-097, G-95761-097, G-94757-097. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by fax dated August 3, 2000. Manufacturer: Alpha Therapeutic Corporation, San Diego, CA. Firm initiated recall is complete. REASON Blood products, which tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested reactive to anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 33 units. DISTRIBUTION Spain ____________________ PRODUCT Source Plasma. Recall # B-0336-2. CODE Unit 43278527 RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN, by facsimile dated October 30, 2000. Firm-initiated recall complete. REASON Source Plasma, with an elevated alanine aminotransferase (ALT), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION California ____________________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall # B-0362-2 CODE Unit number 8245160 RECALLING FIRM South Florida Blood Banks, Inc., West Palm Beach, FL, by letter dated May 16, 2001. Firm-initiated recall complete. REASON Blood product, that tested negative for syphilis, but was collected from an ineligible donor based on previous reactive testing for syphilis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Georgia _______________________ PRODUCT a) Red Blood Cells, Recall B-0386-2; b) Recovered Plasma, Recall B-0387-2. CODE a) Units 49GR03327, 49LH18661, and 49LH27047; b) Unit 49GR03327. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK by letters dated July 14, 1998, August 19, 1998, and April 20, 2001. Firm initiated recall is ongoing. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible due to a reported history of previous reactive testing for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION MA, TX, CA, OK. _________________ PRODUCT Platelet, Pheresis (Split). Recall # B-0392-2. CODE Unit 42KF05882 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, Ohio, by telephone on August 15, 2001 and letter dated August 17, 2001. Firm- initiated recall complete. REASON Blood products, which were labeled as leukoreduced but did not undergo leukoreduction, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION Ohio ______________________ PRODUCT a) Red Blood Cells, Leukocytes Removed. Recall # B-0393-2; b) Platelets Pheresis, Irradiated. Recall # B-0394-2; c) Platelets Pheresis, Leukocytes Removed. Recall # B-0395.2. d) Platelets Pheresis, Irradiated, Leukocytes Removed. Recall # B-0396-2. CODE a) Unit (1 unit) 03FT57071; b) Unit (1 unit) 03P27096 (part 1) c) Units (15 units) 03P26308 (parts 1 and 2), 03P25910 (parts 1 and 2), 03P25244 (parts 1 and 2), 03P24729 (parts 1 and 2), 03P24437 (parts 1 and 2), 03P24154 (part 2), 03P23553 (parts 1 and 2), 03P23222 (parts 1 and 2) d) Unit (1 unit) 03P27096 (part 2) RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Southern Region, Atlanta, Georgia, by letter dated Feburary 22, 2001 or March 28, 2001. Firm-initiated recall complete. REASON Blood products, collected from a donor who was taking Ridaura for rheumatoid arthritis, were distributed. VOLUME OF PRODUCT IN COMMERCE 18 units DISTRIBUTION Georgia ________________ PRODUCT Red Blood Cells. Recall # B-0445-2. b) Fresh Frozen Plasma. Recall B-0446-2 CODE a) Unit (1 unit) 5345710; b) Unit (1 unit) 5345710. RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX, by telephone on August 7, 2001 and by letter dated August 21, 2001. REASON Blood products, collected from a donor with a previous false positive test result, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION Texas _______________________ PRODUCT a) Red Blood Cells, Recall # B-0450-2; b) Platelets, Recall # B-0451-2; c) Fresh Frozen Plasma , Recall # B-0452-2. CODE a) Unit M06614; b) Unit M06614; c) Unit M06614. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter dated March 12, 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 VA. _______________________ PRODUCT Source Plasma (29 units), Recall # B-0456-2. CODES unit numbers 0450600364, 0450599949, 0450599290, 0450598802, 0450598419, 0450606264, 0450605972, 0450605050, 0450604608, 0450604235, 0450603828, 0450603529, 0450602773, 0450602503, 0450602084, 0450601729, 0450601368, 0450601094, 0450597482, 0450597045, 0450596820, 0450596130, 0450595521, 0450595060, 0450594817, 0450594334, 0450594147, 0450593683, and 0450593459 RECALLING FIRM/MANUFACTURER Recalling Firm: Nabi, Boca Raton, FL , by facsimile on January 23, 2001. Firm-initiated recall complete. Manufacturer: Nabi, Youngstown, OH. REASON Blood products, collected from an ineligible donor due to previous incarceration, were distributed. VOLUME OF PRODUCT IN COMMERCE 29 units. DISTRIBUTION South Korea and the United Kingdom. _______________________ PRODUCT Source Plasma, Recall # B-0459-2. CODE Unit G-93925-044 RECALLING FIRM/MANUFACTURER Recalling Firm: Pyramid Biological CorporationVan Nuys, CA, by letter dated April 11, 2000. Manufacturer: Pyramid Biological Corporation, San Diego, CA. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to the presence of unexplained needle marks, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 Unit DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced (1 unit). Recall # B-501-2. CODE Unit 12FW95875 RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Region, Charlotte, NC, by letter dated October 5, 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 North Carolina _______________________ PRODUCT a) Red Blood Cells (1 unit). Recall # B-0502-2; b) Platelets, Pheresis Leukocytes Removed (1 unit). Recall # B-0503-2. CODE a) and b) unit W66927 RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter dated July 18, 2001. Firm-initiated recall 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 Virginia _______________________ PRODUCT Red Blood Cells, Leukocytes Removed (1 unit). Recall # B-0504-2. CODE Unit GL80645 RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by telephone on July 27, 2001. Firm-initiated recall complete. REASON Blood product, collected from a donor who previously lived in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION California _______________________ PRODUCT Red Blood Cells (1 unit). Recall # B-0505-2. CODE Unit 53FM44312 RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated January 23, 2001. Firm-initiated recall complete. REASON Blood product, collected from a donor who previously lived in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Maryland _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced (1 unit), Recall # B-0508-2; b) Cryoprecipitated AHF (1 unit), Recall # B-0509-2; c) Recovered Plasma (1 unit), Recall # b-0510-2. CODE a), b), and c) unit number FJ72754 RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI., of the recall by telephone and facsimile on July 18, 2001. Firm-initiated recall complete. REASON Blood products, collected from an unsuitable donor based on a medical history of the disease Polycythemia, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION Florida, Rhode Island, and Switzerland, _______________________ PRODUCT a) Red Blood Cells (2 units). Recall # B-0516-2; b) Platelets, Pooled (1 unit). Recall # B-0517-2; c) Cryoprecipitated AHF (1 unit). Recall # B-0518-2; d) Fresh Frozen Plasma (1 unit). Recall # B-0519-2. CODE a) Units 0476135, 0461226; b) Unit 0461226 (pool number - 0070014); c) unit 0461226; d) unit 0476135 RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated February 1, 2001. Firm-initiated recall complete. REASON Blood products, collected from a donor who received a human bite within the last 12 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units DISTRIBUTION Ohio, Florida, and Kentucky _______________________ PRODUCT Platelet, Pheresis, Leukoreduced (Split), Recall # B-0520-2. CODE Unit 10715-4536. RECALLING FIRM/MANUFACTURER United Blood Services, Scottsdale, AZ, by telephone on September 1, 2001 and by letter dated October 8, 2001. Firm initiated recall is complete. REASON Blood products, which were labeled as leukoreduced but did not meet the standard for a leukoreduced product, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _______________________ PRODUCT Platelet, Pheresis, Leukoreduced, Recall # B-0522-2. CODE Unit 53P82401. RECALLING FIRM/MANUFACTURER American Red Cross, Baltimore, MD, by telephone on February 22, 2001. Firm initiated recall is complete. REASON Blood product, labeled with extended expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT a) Red Blood Cells (1 unit). Recall # B-0532-2; b) Platelets, Irradiated (1 unit). Recall # B-0533-2; c) Platelets Pheresis (1 unit). Recall # B-0534-2; d) Platelets Pheresis, Irradiated (1 unit). Recall # B-0535-2. CODE a)and b) unit number M88417; c) and d) unit number W65868. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter dated July 23, 2001. Firm-initiated recall complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units DISTRIBUTION Virginia _______________________ PRODUCT a) Red Blood Cells (2 units), B-0536-2; b) Platelets (2 units), B-0537-2 CODE a) and b) unit numbers M87464 and C44135. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letters dated July 18, 2001, and August 14, 2001. Firm-initiated recall complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units DISTRIBUTION Virginia _______________________ PRODUCT Red Blood Cells. Recall # B-0538-2. CODE Unit number W17169 RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by telephone on January 9, 2001, and by letter dated May 7, 2001. Firm-initiated recall complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Virginia _______________________ PRODUCT Red Blood Cells. Recall # B-0539-2. CODE Unit number 53L31073 RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD , by letter dated April 20, 2001. Firm-initiated recall complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Maryland _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0540-2. CODE Unit number 13GC93156 RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated September 26, 2001. Firm-initiated recall complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Michigan _____________________ PRODUCT a) Red Blood Cells (1 unit). Recall # B-0541-2; b) Recovered Plasma (1 unit). Recall # B-0542-2 . CODE a) and b) unit number 084FT13238 RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern California Region, Oakland, CA , by letter dated May 19, 2000. Firm-initiated recall complete. REASON Blood products, collected from an ineligible donor due to a history of medication with human growth hormone, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 Units DISTRIBUTION California and MarylandRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT a) Red Blood Cells, Leukocytes Removed, Recall # B-192-2 b)Recovered Plasma, Recall # B-193-2. CODE a)Unit 10709-3995 b)Unit 10709-3995 RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated Aug. 10. 2001. Manufacturer: United Blood Services, Scottsdale, AZ Firm initiated recall is complete. REASON Blood products, collected from a donor whose skin disease status had not been accurately documented, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _______________________ PRODUCT Red Blood Cells, Recall # B-194-2. CODE Unit 13FF27987. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Southeastern Region, Detroit, MI, by letter dated June 6, 2001. Firm initiated recall is complete. REASON Red Blood Cells, incorrectly phenotyped for the Fy(a) antigen, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _______________________ PRODUCT Plasma CryoReduced, Recall # B-0234-2. CODE Units 11FF68858, 11GL31717, 11GZ21406, 11GL31753, GL31726,11GQ28023, 11GV26567 11GQ28013, 11GQ28020, 11GL31759, 11GN35708, 11FM61901, 11GQ28021, 11GN35740, 11GN35449, 11GN35737. RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA, by telephone on March 5, 2001 and by letter dated March 12, 2001. Firm initiated recall is complete. REASON Blood products, lacking assurance of proper temperature storage during shipment, were distributed. VOLUME OF PRODUCT IN COMMERCE 16 Units. DISTRIBUTION GA. _______________________ PRODUCT a) Platelet Pheresis, Recall # B-0236-2; b) Platelet Pheresis, Leukoreduced, Recall # B-0237-2. CODE a) Unit 0430100; b) Unit 0430101. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio, by letter dated March 27, 2001. Firm initiated recall is complete. REASON Platelet pheresis products, lacking platelet count determinations, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT Platelets Pheresis, Leukocyte Reduced, Recall # B-0239-2. CODE Units 03P21270, 03FG16013, 03FL84241, 03FL84249, 03FL84267, 03FZ08125, 03KR06923, 03LL12267, 12GP28143, 12KG50372, 03FG16098, 03F09811, 03KR06985, 03LL12324, 03F10115, 03FK19610, 03FL84186. RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA, by letter dated March 2, 2000. Firm initiated recall is complete. REASON Blood products, exposed to unacceptable storage temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 17 Units DISTRIBUTION GA. _______________________ PRODUCT Red Blood Cells, Recall # B-0297-2. CODE Units 04Q988444, 04Q986186, 04Q988143, 04Q988223, 04Q988272, 04Q981990, 04Q96382X, 04Q985245. RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL, by telephone on or about May 3, 2001. Collection/Processing site: Civitan Regional Blood Center, Ocala, FL. Firm initiated recall is complete. REASON Blood products, labeled with extended expiration dates, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units DISTRIBUTION FL and AL. _______________________ PRODUCT Source Plasma, Recall # B-0499-2. CODE Unit LA-51839. RECALLING FIRM/MANUFACTURER Recalling Firm: Pyramid Biological Corporation, Van Nuys, CA, by letter dated May 24, 2000. Manufacturer: Pyramid Biological Corporation, Las Vegas, NV, Firm initiated recall is complete. REASON Blood product, collected from a donor whose arm inspection was incorrectly performed, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Leukocytes Removed (1 unit). Recall #B-0506-2. CODE Unit 12GY36547 RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Region, Charlotte, NC, by letter dated October 2, 2001. Firm-initiated recall complete. REASON Red Blood Cells, incorrectly tested for Jsa and labeled Jsa negative, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION North Carolina _______________________ PRODUCT Platelets (1 unit), Recall # B-0507-2. CODE Unit number 12453-4695 RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ., by telephone on June 7, 2001, and by letter dated June 19, 2001. Firm-initiated recall complete. Manufacturer: Blood Systems, Inc., Albuquerque, NM. REASON Blood product, exposed to unacceptable temperatures, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION New Mexico _______________________ PRODUCT a) Red Blood Cells (1 unit), Recall # B-0511-2; b) Red Blood Cells, Leukocytes Reduced (15 units). Recall # B-0512-2; c) Cryoprecipitated AHF (7 units). Recall # B-0513-2; d) Cryoprecipitated AHF, Pooled (3 pools). Recall # B-0514-2; e) Recovered Plasma (19 units). Recall # B-0515-2. CODE a) unit number 21GS09406; b) unit numbers 21GS09407, 21GS09408, 21GS09409, 21GS09410, 21GS09411, 21GS09412, 21GS09413, 21GS09414, 21GS09415, 21GS09416, 21GS09419, 21GS09421, 21GS09422, 21KE09671, and 21KE09673 c) unit numbers 21GS09406, 21GS09408, 21GS09409, 21GS09412, 21GS09413, 21GS09419, and 21GS09421 d) pool numbers 4185 (contained recalled units 21GS09407, 21GS09410, 21GS09411, 21GS09415, and 21GS09416), 4158 (contained recalled unit 21GS09414), and 4160 (contained recalled unit 21GS09422) e) unit numbers 21GS09406, 21GS09407, 21GS09408, 21GS09409, 21GS09410, 21GS09411, 21GS09412, 21GS09413, 21GS09414, 21GS09415, 21GS09416, 21GS09417, 21GS09418, 21GS09419, 21GS09421, 21GS09422, 21KE09671, 21KE09673, 21KE09674 RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on October 4, 2000, and by letters dated October 19, 2000, and November 28, 2000. Firm-initiated recall complete. REASON Blood products, manufactured from units of Whole Blood shipped at incorrect temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 45 units DISTRIBUTION Alaska, Washington, Oregon, California, and SwitzerlandRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT a) TDx/TDxFlx Ethanol Reagent, Recall # Z-0289-2; b) ADx Ethanol Reagent, Recall # Z-0290-2. CODE a) List no. 9545-60 Lot nos. Exp. Date 72250Q100 7/30/01; 75440Q100 10/5/01; 75528Q100 10/17/01; 76478Q100 11/22/01. b) List No. 9545-55 Lot no. Exp. Date 72259Q100 7/23/01; 72727Q100 9/9/01; 75532Q100 10/12/01; 76474Q100 11/11/01. RECALLING FIRM/MANUFACTURER Abbott Health Products, Inc. Barceloneta, Puerto Rico, by letter dated 10/12/01. Firm-initiated recall is ongoing. REASON Calibration curve failure. VOLUME OF PRODUCT IN COMMERCE 5,600 units. DISTRIBUTION Worldwide. _______________________ PRODUCT A sterile dressing, labeled in part: "SURGIPAD* Combine Dressing DRESSING 8 in x 7.5 in. Recall # Z-0337-2. CODE Product Code is 2144 and can be found in the lower right corner of the front label face as "REORDER 2144". Lot Numbers (found in the upper right corner of front of the package): 2001 07 1 01; 2001 07 2 01; 2001 07 3 01; 2001 08 1 01; 2001 08 2 01; 2001 08 3 01. RECALLING FIRM/MANUFACTURER Recalling Firm: Johnson & Johnson Medical, Div. of Ethicon, Inc. Arlington, TX, by letters dated 9/12/01. Manufacturer: Johnson & Johnson Medical, Div. of Ethicon, Inc. Sherman, TX. Firm initiated recall is ongoing. REASON Seal Integrity - possibly non-sterile device. VOLUME OF PRODUCT IN COMMERCE 751,680. DISTRIBUTION Nationwide. _______________________ PRODUCT Medi-tech TSK Surecut Biopsy Needle (Sterile) as follows: Recall #’s Z-0341-02/ Z-0349-02. CODE Catalog # Product UPN/Material# Lot# EXP.Date 40-812 SURECUT/15/70 M001408120 6157 04/2001 40-815 SURECUT/15/120 M001408150 6167 04/2001 40-823 SURECUT/16/90 M001408230 6118 03/2001 40-823 SURECUT/16/90 M001408230 6157 04/2001 40-834 SURECUT/17/100 M001408340 6167 04/2001 40-834 SURECUT/17/100 M001408340 6234 05/2001 40-843 SURECUT/18/90 M001408430 6157 04/2001 40-843 SURECUT/18/90 M001408430 6234 05/2001 40-855 SURECUT/19/120 M001408550 6118 03/2001 40-865 SURECUT/21/120 M001408650 6118 03/2001 40-865 SURECUT/21/120 M001408650 6167 04/2001 40-873 SURECUT/22/90 M001408730 6118 03/2001 40-873 SURECUT/22/90 M001408730 6167 04/2001 40-894 SURECUT/25/100 M001408940 6054 02/2001 RECALLING FIRM/MANUFACTURER Recalling Firm: Med I-Tec, a division of Boston Scientific Corp., Watertown, MA., via certified letter on 10,3,01. Manufacturer: TSK Laboratory Japan, Tochigi-Ken, Japan. Firm-initiated recall ongoing. REASON Expired sterile product was distributed. VOLUME OF PRODUCT IN COMMERCE 167 Units. DISTRIBUTION Nationwide _______________________ PRODUCT Allegiance Custom Sterile Procedure Kits; labeled as containing either one or two size 7.5 powdered synthetic surgical gloves and may or may not have a warning labeled "Caution: This product contains natural rubber latex which may cause allergic reactions. Recall Number(s) Z-0350-02/Z-0358-02. CODE a) Cat. SAN31ANELA, lot/order #497768, exp. 3/01/03 b) Cat. SMA31VGWLG, lot/order #501204, exp. 12/01/01 c) Cat. SER33OBCDC, lot/order #498994, exp. 5/01/03 d) Cat. SCV32AVMDC, lot/order #496157 e) Cat. SBA34BAMGA, lot/order #499993 f) Cat. SOP34ARMGG, lot/order #496681 g) Cat. SLC34LPMGF, lot/order #506220, exp. 6/01/03 h) Cat. SOP34KNBMM, lot/order #499947, exp. 3/31/03 i) Cat. SBA40ABPLF, lot/order #493477, exp. 3/01/03 RECALLING FIRM/MANUFACTURER Recalling Firm: Allegiance Healthcare Corporation McGaw Park, IL by letter on 9/28/01. Manufacturer: Allegiance Healthcare Corporation, Custom Sterile Division McGaw Park, IL. Firm-initiated recall ongoing. REASON Custom Sterile Kits contain Latex Gloves not declared on label. VOLUME OF PRODUCT IN COMMERCE 897 kits DISTRIBUTION OH, MN, IL, MI, and Canada _______________________ PRODUCT a) Gravity and Infusion Pump Intravascular (IV) Sets including brand names: Primary ADDitIV IV Sets, Horizon Pump Primary ADDitIV IV Sets, Safsite Horizon Pump IV Sets, SafeLine Horizon Pump IV Sets, Clave Horizon Pump IV Sets, Intelligent Pump Primary ADDitIV IV Sets, Clave Intelligent Pump IV Sets, Baxter Compatible Pump IV Sets with SafeLine, Baxter Compatible Pump IV Sets with Clave, Baxter Compatible Pump Primary ADDitIV IV Sets, SafeLine Primary ADDitIV IV Sets, and Clave Primary ADDitIV IV Sets. Common Name: Intravascular Administration Set. Recall # Z-0359-02. b) Gravity and Infusion Pump Intravascular (IV) Sets including brand names: Primary ADDitIV IV Sets, Horizon Pump Primary ADDitIV IV Sets, Ultrasite Horizon Pump IV Sets, Safsite Horizon Pump IV Sets, SafeLine Horizon Pump IV Sets, Clave Horizon Pump IV Sets, Vista Pump IV Sets, Ultrasite Vista Pump IV Sets, Ultrasite IV Sets, Clave IV Sets, and Clave Primary ADDitIV IV Sets. Common Name: Intravascular Administration Set. Recall # Z-0360-02. CODES a) Catalog numbers CC1270, CC1271, CC1290, CC3130, CC3130-SP0, CC3230, CC6413, NF1250, NF3140, NF3140-10, NF3140D, NF3160, NF6413, SS3140, SS3160, SS6413, US3131, V1443, V1444-12, V1445, V1445-24, V1445-30, V1445-44, V1446, V1447, V1449-12, V1452, V1453, V1464, V1484, V1485, V1785, V6410, V6413, V6430, V7210, V7410, and V7410-10. The following Lot numbers are involved in the recall: 60053136, 60060573, 60060596, 60060607, 60060614, 60060630, 60060632, 60063756, 60063769, 60064892, 60067686, 60068313, 60070114, 60070183, 60070503, 60070903, 60070921, 60071429, 60071430, 60072370, 60073185, 60074375, 60074376, 60075886, 60075964, 60075965, 60076494, 60076554, 60076560, 60076562, 60076652, 60076655, 60076659, 60076740, 60076746, 60076757, 60078427, 60078438, 60078439, 60078445, 60078452, 60078455, 60078853, 60078918, 60079388, 60081052, 60082545, 60082630, 60083490, 60083977, 60083979, 60083980, 60083981, 60083983, 60083984, 60084051, 60084058, 60084074, 60085504, 60088341, 60088485, 60088577, 60088695, 60088855, 60088858, 60088866, 60088867, 60088868, 60088872, 60088873, 60088876, 60088928, 60089309, 60089313, 60089328, 60089432, 60090779, 60090783, 60090805, 60091132, 60091137, 60091140, 60091148, 60091149, 60091150, 60091162, 60091458, 60091459, 60091460, 60091463, 60091467, 60091470, 60091474, 60092542, 60092686, 60092733, 60093306, 60093307, 60093309, 60093313, 60093314, 60093573, 60093600, 60093605, 60093609, 60093619, 60093881, 60094452, 60095083, 60095252, 60095789, 60095792, 60095813, 60095830, 60095835, 60095843, 60095845, 60095846, 60095847, 60095848, 60095850, 60095851, 60096116, 60096176, 60096199, 60096206, 60096218, 60096231, 60096485, 60097397, 60097407, 60097416, 60097686, 60097687, 60097688, 60097691, 60097695, 60097697, 60097699, 60097703, 60097711, 60097723, 60097725, 60097727, 60098003, 60098007, 60098066, 60098085, 60098092, 60098098, 60098141, 60098218, 60099589, 60099692, 60099903, 60100061, 60100320, 60100321, 60100327, 60100328, 60100332, 60100610, 60100615, 60100624, 60100627, 60100639, 60101312, 60101701, 60101702, 60101703, 60101728, 60101733, 60101932, 60102181, 60102300, 60102320, 60102330, 60102560, 60102647, 60102652, 60102654, 60102656, 60102657, 60102720, 60102722, 60102744, 60103171, 60103174, 60103910, 60104238, 60104240, 60104246, 60104249, 60104250, 60104261, 60104267, 60104269, 60104272, 60104883, 60104929, 60105356, 60105370, 60105372, 60105816, 60106045, 60106053, 60106064, 60106066, 60106289, 60106310, 60106314, 60106412, 60106772, 60107539, 60107540, 60107573, 60107610, 60107690, 60107937, 60107938, 60109024, 60109986, 60111419, 60111420, 60111422, 60111430, 60111434, 60111436, 60111464, 60111466, 60111467, 60111468, 60111472, 60112240, 60112241, 60113258, 60113263, 60113266, 60113268, 60113272, 60113281, 60113285, 60113371, 60113389, 60113391, 60113394, 60113396, 60113397, 60113478, 60113512, 60113514, 60113517, 60113764, 60114081, 60115239, 60115378, 60115379, 60115465, 60115493, 60115657, 60116531, 60116541, 60116542, 60116563, 60116599, 60116601, 60116658, 60116897, and 60118838. b) Catalog numbers CC1270, CC1271, CC1290, CC3130, CC3130- SP0, CC3230, CC6413, NF1250, NF3140, NF3140-10, NF3140D, NF3160, NF6413, SS3140, SS3160, SS6413, US3131, V1443, V1444-12, V1445, V1445-24, V1445-30, V1445-44, V1446, V1447, V1449-12, V1452, V1453, V1464, V1484, V1485, V1785, V6410, V6413, V6430, V7210, V7410, and V7410-10. The following Lot numbers are involved in this recall: 60202057, 60202059, 60204396, 60204399, 60204563, 60206655, 60206671, 60211413, 60211414, 60213590, 60213594, 60215815, 60218346, 60218349, 60218373, 60218607, 60219461, 60219481, 60221910, 60223949, 60223965, 60223973, 60223976, 60224952, 60225296, 60228002, 60229236, 60230334, 60230342, 60234884, 60234884, 60235982, 60236759, 60236775, 60242007, 60242010, 60243129, 60243130, 60243132, 60243135, 60243136, 60243138, 60243583, 60243586, 60243588, 60243599, 60244153, 60244154, 60244155, 60244180, 60244209, 60244210, 60244211, 60244214, 60244217, 60244219, 60244370, 60245338, 60245340, 60245341, 60245342, 60245360, 60245362, 60245364, 60245369, 60246702, 60246971, 60246972, 60246973, 60246975, 60246976, 60246977, 60246978, 60246978, 60246979, 60246980, 60247404, 60247429, 60248250, 60248250, 60248313, 60248315, 60248318, 60248322, 60248329, 60249590, 60249732, 60250052, 60250053, 60250054, 60250055, 60250057, 60250065, 60250261, 60251486, 60251488, 60253762, 60253770, 60253776, 60254072, 60254073, 60254074, 60254075, 60254077, 60254078, 60254080, 60254081, 60254086, 60255310, 60255311, 60255312, 60255317, 60255318, 60255321, 60256117, 60256123, 60256147, 60256148, 60256157, 60256160, 60256162, 60257354, 60257373, 60258119, 60258158, 60258159, 60258161, 60258163, 60258167, 60258168, 60259837, 60259868, 60260586, 60260587, 60260592, 60260594, 60260607, 60261925, 60261937, 60261961, 60261976, 60261977, 60262821, 60262823, 60262839, 60262848, 60262849, 60263719, 60263724, 60263725, 60263752, 60263859, 60264549, 60264606, 60264609, 60264613, 60264614, 60264620, 60265844, and 60265845. RECALLING FIRM/MANUFACTURER Braun Medical, Inc. Allentown, PA, via letters on 10/10/01. Firm- initiated recall ongoing. REASON a) Inadequate bonding of tube to bottom cap of the drip chamber may cause leaking; b) tubing may disconnect from Universal Drip Chamber VOLUME OF PRODUCT IN COMMERCE a) 53,864 cases; b) 44521 cases DISTRIBUTION Nationwide and Canada _______________________ PRODUCT SCIMED UltraFuse Coronary Infusion/Guide Wire Exchange Catheter. Recall #Z-0361-02. CODE Catalog number H74908251041: 4174749, 4181061, 4190629, 4200473, 4200474, 4200475 and 4282946; Catalog number H74908251081: 4181059, 4184618, 4187511 and 4203048 RECALLING FIRM/MANUFACTURER Boston Scientific Scimed Maple Grove, MN, bv letter on October 29, 2001. Firm-initiated recall ongoing. REASON Some of the recalled Coronary Infusion Catheters have side holes which are partially or completely blocked. VOLUME OF PRODUCT IN COMMERCE 55 catheters. DISTRIBUTION Nationwide and Japan. _______________________ PRODUCT Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL or Baxter Healthcare Corporation, McGaw Park, IL. Recall # Z-0362-02. CODE All System 1000 instruments are affected, and include the following serial number ranges, 1001S to 1142S, 50001 to 52109, and 01001 to 19250. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp. Round Lake, IL, by letter dated 11/12/01. Manufacturer: Baxter/Althin Medical, Inc. Miami Lakes, FL. Firm-initiated recall ongoing. REASON Spontaneous Dialysate Proportioning Ratio change. VOLUME OF PRODUCT IN COMMERCE Approximately 20,500 units. DISTRIBUTION Nationwide and International.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III
_______________________ PRODUCT Vedco Hydrogen Peroxide 3% Solution Topical Antiseptic-Cleansing Agent packaged in 1 – gal. Containers, 4 gal./case. Recall # V-015-1 CODE L030611 RECALLING FIRM/MANUFACTURER Ameri-Pac, Inc., Leavenworth, KS., via telephone on 3/22/01 and Fax letter on 3/23/01. Firm-initiated recall complete. REASON Subpotent VOLUME OF PRODUCT IN COMMERCE 83 4/1-gal. Container cases. DISTRIBUTION MO. _______________________ PRODUCT Fort Dodge Hetacin-K Hetacillin Potassium, For Intramammary Infusion for Lactating Cows Only, Equivalent to 62.5 mg. Ampicillin, each 10-ml. syringe contains 62.5 mg. of ampicillin activity as hetacillin potassium, 12 syringes/box, RX, NADA 55- 054. Recall # V-016-1. CODE Lot H8020, Exp. 1May-03. RECALLING FIRM/MANUFACTURER Recalling Firm: Fort Dodge Animal Health, Fort Dodge, IA, Manufacturer: G.C. Hanford Manufacturing Co., Syracuse, NY., via telephone on 5/14/01. Firm-initiated recall complete. REASON Manufactured using an unapproved source of hetacillin potassium. VOLUME OF PRODUCT IN COMMERCE 52,128 syringes (4,344 boxes DISTRIBUTION PA. and KY.END OF ENFORCEMENT REPORT FOR DECEMBER 19, 2001 ####
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