April 26, 2000 00-17RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Oatmeal Raisin Cookies, in clear-rigid plastic container with a clear-rigid plastic snap on lid, 4 cookies per container. Recall #F-287-0. CODE All product on the market at time of recall initiation. MANUFACTURER Kollar Cookies, Long Branch, New Jersey. RECALLED BY Manufacturer, by telephone on December 7, 1999. Firm-initiated recall complete. DISTRIBUTION New York, New Jersey. QUANTITY 240 cookies were distributed. REASON Product contained undeclared walnuts. ________ PRODUCT Weinberger's Nova Lox Salad, in 7-ounce plastic containers. Recall #F-288-0. CODE 2/30. MANUFACTURER Weinberger Appetizing, Brooklyn, New York. RECALLED BY Manufacturer, by visit on February 28, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Approximately 50 containers were distributed. REASON Product was contaminated with Listeria monocytogenes. ________ PRODUCT Wonka Chewy Runts Fun Chewy Fruit Shaped Candy, in 7-ounce flexible plastic bag. Recall #F-291-0. CODE All product in 7-ounce bags on market at time of recall initiation. MANUFACTURER Nestle USA, Inc., (also known as Willy Wonka Factory), Itasca, Illinois. RECALLED BY Nestle USA, Inc., Glendale, California, by telephone, fax, and letter on March 15, 2000, and by press release on March 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 20,630 cases (12 bags per case) were distributed. REASON Product contains undeclared egg albumen. ________ PRODUCT Perry's Ice Cream brand Vanilla Ice Cream Sandwiches, in 12-sandwich carton. Recall #F-292-0. CODE Carton codes: 2007 009178 13:58 to 2007 009230 14:14 All cartons have a "BEST USED BY DEC. 00" MANUFACTURER Perry's Ice Cream Company, Inc., Akron, New York. RECALLED BY Manufacturer, by telephone and visit between March 8 and 13, 2000, and by press release March 7, 2000. Firm-initiated recall complete. DISTRIBUTION New York and Pennsylvania. QUANTITY 24 12-packs were distributed. REASON Some packages actually contain vanilla/peanut butter swirl ice cream bars.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT a) Jiabo brand Preserved Mandarin Peel, packaged in 32 gram flexible plastic bags; b) Jiabo brand Preserved Red Bayberry, packaged in 80 gram flexible plastic bags. Recall #F-289/290-0. CODE None. MANUFACTURER Jiawei Foodstuffs Factory, Guangdong, China. RECALLED BY Wicsun Trading, Inc., Brooklyn, New York, by letter on February 1, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION a) New York, Massachusetts, Pennsylvania, New Jersey; b) New York, New Jersey, Pennsylvania, Maryland, Virginia. QUANTITY a) 95 cases (120 packages per case); b) 20 cases (120 packages per case) were distributed. REASON The products contain sodium saccharin which is regulated for use in food under 21 CFR 180.37. This regulation does not allow for the use of sodium saccharin in these preserved fruit products. Therefore, the safety of sodium saccharin in these products has not been established.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Platelets. Recall #B-534-0. CODE Unit Numbers: 3455102, 3455105, 3456479, 3456480, 3456495 3480733, 3480737, 3480740, 3485781, 3456519, 3456477, 3456486, 3456494, 3485778, 3485779, 3456497, 3456498, 3456499, 3456502, 3456505, 3456506, 3456511, 3456515, 3456525, 3485800. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by fax on November 16, 1998. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 25 units were distributed. REASON Blood products were labeled with extended expiration dates, were distributed. ________ PRODUCT Source Plasma. Recall #B-539-0. CODE 99,405 units collected between 7/21/97 and 12/28/99. MANUFACTURER Centeon Bio Services, Inc., Des Moines, Iowa. RECALLED BY Aventis Bio-Services, Inc., King of Prussia, Pennsylvania, by letter dated February 24, 2000, or by telephone on or about February 10, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina, Illinois, Switzerland, Germany. QUANTITY 99,405 units were distributed. REASON Blood products were collected from donors who were not properly screened. ________ PRODUCT Human Tissue for Transplant: Various Musculoskeletal Tissues, Skin, and Blood Vessels. Recall #B-541-0. CODE Each graft is uniquely identified with a nine or ten digit graft number. MANUFACTURER LifeNet, Virginia Beach, Virginia. RECALLED BY Manufacturer, by letter dated January 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Puerto Rico, Israel. QUANTITY 1,434 allografts. REASON Various tissues for transplant were collected from twenty donors who had not been properly evaluated. ________ PRODUCT Red Blood Cells. Recall #B-549-0. CODE Unit #21373-0196. MANUFACTURER Blood Systems, Inc., Fargo, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated September 15, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Source Plasma. Recall #B-551-0. CODE Unit Numbers: 99-EWIA-4754 and 99-EWIA-5416. MANUFACTURER Community Bio-Resources, Inc., Eau Claire, Wisconsin. RECALLED BY Manufacturer, by fax dated April 8, 1999. Firm-initiated recall complete. DISTRIBUTION Austria. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT Source Plasma. Recall #B-553-0. CODE Unit Numbers: Units 99-SMNC-1358, 99-SMNC-1690, 99-SMNC-2371, 99-SMNC-3875, 99-SMNC-4143. MANUFACTURER Community Bio-Resources, Inc., St. Cloud, Minnesota. RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama, by fax dated September 1, 1999. Firm-initiated recall complete. DISTRIBUTION Austria. QUANTITY 5 units were distributed. REASON Blood products were collected from a donor who had received an MMR vaccination within four weeks of donation. ________ PRODUCT Source Plasma. Recall #B-555-0. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER Interstate Blood & Plasma, Inc., Madison, Wisconsin. RECALLED BY Interstate Blood Bank, Inc., Memphis, Tennessee, by letter dated October 15, 1997. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 44 units were distributed. REASON Blood products were collected from a donor who had body piercing within twelve months of donation. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-556-0. CODE Unit Numbers: 24KS29226, 24GK15680, 24KN07785. MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated January 26, 2000. Firm-initiated recall complete. DISTRIBUTION Indiana and Kentucky. QUANTITY 2 units were distributed. REASON Blood products were collected from donors whose hemoglobin had not been documented. ________ PRODUCT Platelets, Pheresis. Recall #B-570-0. CODE Unit #18219-9392. MANUFACTURER United Blood Services, Cheyenne, Wyoming. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 18, 1999, and by letter dated September 17, 1999. Firm-initiated recall complete. DISTRIBUTED Wyoming. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. ________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-571-0. CODE Unit Numbers: 24204-3038-01 and 24204-3038-02. MANUFACTURER Blood Systems, Inc., Rapid City, South Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 4, 1999, and by letter dated August 16, 1999. DISTRIBUTION Nevada. QUANTITY 2 units were distributed. REASON Blood products had unacceptable platelet counts. ________ PRODUCT Pulmozyme R, (dornase alfa), Inhalation Solution, each carton contains 5 foil pouches each containing 6 single use 2.5 mL ampules, a recombinant inhalation solution. Recall #B-587-0. CODE Lot Numbers: H9706A, H9708A, H9709A, H9710A, H9711A, H9715A, H9716A, H97120A, H9721A, H9727A, H9730A, H9731A, H9732A, K9702A, K9703A, K9704A, K9707A, K9708A, K9712A, K9714A, K9715A, K9718A, K9719A. MANUFACTURER Genentech, Inc., South San Francisco, California. RECALLED BY Manufacturer, by fax, e-mail, letter and/or visit, on March 13, 2000, and by press release issued on March 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 4,729,950 ampules were distributed. REASON Single-use ampule may have a minuscule puncture at the tip of the ampule thus compromising the integrity of the container closure and allowing product leakage.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Platelets, Pheresis, Leukocytes Reduced. Recall #B-536-0. CODE Unit #26159-6817-02. MANUFACTURER United Blood Services, Fort Smith, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 19, 1999, and by letter dated July 28, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was shipped at an unacceptable temperature. ________ PRODUCT Red Blood Cells, Irradiated. Recall #B-550-0. CODE Unit Numbers: T36089 and T36092. MANUFACTURER Blood Centers of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin. RECALLED BY Manufacturer, by telephone on July 2, 1999. Firm-initiated recall complete. DISTRIBUTION Wisconsin. QUANTITY 2 units were distributed. REASON Unlicensed blood products were distributed without obliteration of the firm's license number. ________ PRODUCT Fresh Frozen Plasma. Recall #B-552-0. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled MANUFACTURER Marathon County Blood Bank, Inc., Wausau, Washington state. RECALLED BY Manufacturer, by letter dated October 5, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan, Indiana, North Carolina, New York, California, Texas. QUANTITY 241 units were distributed. REASON Unlicensed blood products were distributed in interstate commerce. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-554-0. CODE Unit #30171-6914. MANUFACTURER Blood Systems, Inc., Bismark, North Dakota. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated July 20, 1999. Firm-initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Navane. ________ PRODUCT Red Blood Cells. Recall #B-563-0. CODE Unit number 18219-1198. MANUFACTURER United Blood Services, Inc., Cheyenne, Wyoming. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on August 31, 1999. Firm-initiated recall complete. DISTRIBUTION Wyoming. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Platelets. Recall #B-601-0. CODE Unit #50LG11374. MANUFACTURER American Red Cross Blood Services, Toledo, Ohio. RECALLED BY Manufacturer, by letter dated February 2, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
________ PRODUCT ProCide NS Reusable Activated Dialdehyde Sterilizing and Disinfecting Solution, in 2.5-gallon, 1-gallon and 1-quart units, a re-usable activated dialdehyde sterilizing and disinfecting solution. Recall #Z-283-0. CODE All lots. Expiration dates range from September 2000 through December 2001. MANUFACTURER Metrex Research Corporation, Parker, Colorado. RECALLED BY Sybron Dental Specialties, Inc., Orange, California, by letter dated March 17, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,057 cases (1-quart size), 143,409 (1-gallon size), and 356 cases (2.5-gallon size) were distributed. REASON Failure of the product to achieve sterilization or high level disinfection may result in patients being exposed to the risk of infection.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Rascal and Chauffeur Heavy Duty Scooters: a) Rascal and Chauffeur Heavy Duty 3-Wheel Scooters (Models 205,235, and 245); b) Rascal and Chauffeur Heavy Duty Indoor 4-Wheel Scooters (Models 255 and 275); c) Rascal and Chauffeur Heavy Duty Outdoor 4-Wheel Scooters (Models 215, 305, and 315). Recall #Z-529/531-0. CODE The prefixes to the serial numbers affected by the recall are: UR; RO; RU; RUF; RUU; RDEM; CVU MANUFACTURER Electric Mobility Corporation, Sewell, New Jersey. RECALLED BY Manufacturer, by letters sent on January 26. 2000, and February 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 10,778 scooters were affected. REASON The drive train gears fail (sheer) allowing the scooters to coast (free-wheel) without control for stopping. ________ PRODUCT Pacesetter Trilogy Pulse Generator, indicated for the treatment of bradycardia: a) Trilogy(tm) SR 2250L Pulse Generator; b) Trilogy(r)SR+ 2260L Pulse Generator; c) Trilogy(r) SR+ 2264L Pulse Generator; d) Trilogy(tm) DC 2308L Pulse Generator; e) Trilogy(r) DC+ 2318L Pulse Generator; f) Trilogy(tm) DR 2350L Pulse Generator; g) Trilogy(tm) DR+ 2360L Pulse Generator; h) Trilogy(tm) DR+ 2364L Pulse Generator. Recall #Z-536/543-0. CODE 2250 ALL SERIAL NOS 2260 ALL SERIAL NOS. EXCEPT 184500 THRU 223346 2264 ALL SERIAL NOS. EXCEPT 182800 THRU 196114 2308 ALL SERIAL NOS. 2318 ALL SERIAL NOS. EXCEPT 184500 THRU 202821 2350 ALL SERIAL NOS. 2360 ALL SERIAL NOS. EXCEPT 194956 THRU 200821 2364 ALL SERIAL NOS. EXCEPT 212662 THRU 213771; 214271 THRU 215421; 216422 THRU 217346; 217847 THRU 218946; 219222 THRU 219721; AND, 219947 THRU 220545 AND 50000-159000. MANUFACTURER St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California. RECALLED BY Manufacturer, by letter on July 19, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Approximately 163,000 affected pulse generators have been implanted since their introduction to commerce in 1995. the firm states that there are about 3200 affected devices in field inventories. REASON The devices may exhibit premature battery depletion caused by a current leakage path that could be created during the laser welding process to attach the battery to the device hybrid. ________ PRODUCT Pacesetter Affinity Dual Chamber Pulse Generators, also known as cardiac pacemaker: a) Model No. 5130L; b) Model No. 5130R; c) Model No. 5230R; d) Model No. 5330R; e) Model No. 5330L. Recall #Z-544/548-0. CODE Affected products all have a "use before" date of December 2000. They were produced in June 1999. MANUFACTURER St. Jude, Inc., Cardiac Rhythm Management Division, Sylmar, California. RECALLED BY Manufacturer, by notification material distributed on February 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Sweden. QUANTITY 850 were implanted 41 have been explanted plus 18 non-implanted units were returned. REASON Decreased reliability has been observed in a limited, very specific, and well-defined group of Affinity pulse generators. Testing has revealed that conductive material used to secure a resistor to the hybrid circuitry may not provide continuous and proper electrical connection to the underlying circuitry. This resistor is used to measure the battery operating current of the pulse generator and is reported to the clinician through the programmer. The battery itself is not affected. ________ PRODUCT Outbound Disposable Syringe Infuser and Kits, indiated for intravenous, intra-arterial and subcutaneous delivery of antibiotics, analgesics, or chemotherapeutic agents and other medication or fluids requiring continuous delivery at controlled infusion rates: a) Outbound Disposable Syringe Infuser, Sterile, Catalog No. OB1N00; b) Outbound Surgical Application Continuous Postoperative Pain Control System, Catalog No. 500-120; c) Stryker Pain Pump Disposable Syringe Infuser Surgical Application, Catalog No. 500-110. Recall#Z-549/551-0. CODE Catalog Numbers: OB1N00 (infuser) 500-120 (kit) 500-110 (kit) Infuser Lot Numbers: D990322-H, D990324-D, D990326-A, D990412-B, D990412-F, D990415-B, D990419-B, D990419-E, D990422-G, D990426-A, D990426-B, D990426-F, D990427-A, and D990428-E. MANUFACTURER McKinley Medical LLLP, Wheat Ridge, Colorado. RECALLED BY Manufacturer, by telephone or fax beginning June 14, 1999. Firm-initiated recall complete. DISTRIBUTION California, Colorado, Florida, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, Nevada, Oklahoma, Tennessee, Texas, Washington state, and Italy QUANTITY 24,174 infusers. REASON The pumps would not infuse, prime, or experienced backflow. ________ PRODUCT Sarns 8K Safety Monitor and 9K Perfusion System, indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures: a) 8000 Perfusion System Safety Monitor, Part No. 98-0702-06606; b) Reconditioned 8K Safety Monitor, Part No. 78-8067-7278-2; c) Trial 8K Safety Monitor, Part No. 78-8067-6878-0; d) Loaner 8K Safety Monitor, Part No. 78-8067-6053-0; e) 9000 Perfusion System 110V, Part No. 98-0702-0270-4; f) 9000 Perfusion System 220V, Part No. 98-0702-0269-6; g) 9000 Perfusion System 100V, Part No. 98-0702-0268-8; h) Reconditioned 9K Perfusion System, Part No. 78-8066-6922-8; i) Trial 9K Perfusion System, Part No. 78-8066-8934-1. Recall #Z-552/560-0. CODE See above. MANUFACTURER Terumo Cardiovascular Systems Corporation, Ann Arbor, Michigan. RECALLED BY Manufacturer, by mail or E-mail starting on February 16, 2000, followed by telephone and fax. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,688 units were distributed. REASON The level sensor system malfunctions. The malfunctions have been related to false alarms when there was an adequate fluid level in the reservoir and failure to alarm when the blood level fell below the position of the sensor. ________ PRODUCT Puritan-Bennett Reusable Coupling Temperature Probe, component of the Reusable Volume Ventilator Circuits: a) Reusable Coupling Temperature Probe (Coupler), Catalog No. 4-007897-00; b) Patient Tubing Circuit with Nebulizer, Catalog No. 4-018062-00; c) Simplified Circuit with Vial, Catalog No. 4-018744-00; d) Simplified Circuit without Collector Vial and Adapter, Catalog No. 4-020740-00; e) Simplified Circuit with Traps, Catalog No. 4-015254-00; f) Simplified Circuit with Nebulizer, Catalog No. 4-018052-00; g) Simplified Patient Circuit, Catalog No. 4-018011-00; h) Patient Tubing Circuit - Conventional, Catalog No. 4-019348-00; i) Simplified Patient Circuit, Catalog No. 4-007170-00; ii) Simplified Circuit w/o Vial, Catalog No. 4-018743-00. Recall #Z-561/569-0. CODE All product with lot numbers K00902 or lower, and all lots with a numeric lot number only (no letter "K" prefix). MANUFACTURER Avenida Reforma S/N, Local A-3, Tijuana B.C., Mexico. RECALLED BY Puritan Bennett Corporation, a subsidiary of Mallinckrodt, Inc., Carlsbad, California, by letter dated February 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 4,381 couplers domestically, and 8,170 couplers internationally were distributed. REASON The flashing in the area of the temperature probe port was not removed. ________ PRODUCT Percutaneous Catheter Introducer Kits containing recalled Clinipad products. Recall #Z-572-0. CODE Abbott Kits: Part #KIT-015-00 Lots F53699 and F40968 Part #KIT-016-00 Lot F40958 Becton Dickinson Kits: Part #KIT-012-00 Lot F52529 Part #KIT-009-01 Lot F51169 Part #KIT-010-00 Lot F51209 Part #KIT-012-01 Lot F52539 Part #KIT-009-00 Lot F51159. MANUFACTURER Thomas Medical Products, Inc., Malvern, Pennsylvania. RECALLED BY Manufacturer, by letter dated March 15, 2000. Firm-initiated recall ongoing. End users were instructed to remove and destroy the Clinipad products included in the kits. COMPONENT MANUFACTURER Clinipad Corporation, Charlotte, North Carolina. DISTRIBUTION California and Utah QUANTITY 3,090 kits. REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. ________ PRODUCT Trinity IV Start Kits containing recalled Clinipad Products. Recall #Z-574-0. CODE Item #1067-01-03-R1, Lot Numbers: 99236, 99247, 99248. MANUFACTURER Trinity Laboratories, Inc., Salisbury, Maryland. RECALLED BY Manufacturer, by telephone on March 16, 2000. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION New York. QUANTITY 432 cases (50 pads per case) were distributed. REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______ UPDATES ALYCON Sample Syringe, 50uL, List #05D49-02, recalled by Abbott Laboratories, Inc., Diagnostics Division, Irving, Texas, which appeared in the April 12, 2000 Enforcement Report should read Recall #Z-534-0. Roche Reagent for AST, Catalog #42381, recalled by Roche Diagnostics Corp., Indianapolis, Indiana, which appeared in the April 12, 2000 Enforcement Report should read Recall #Z-535-0.RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
________ PRODUCT Recall #V-067/068-0, DVM Nutri-Balance High Protein Dog Food, product code 52GP, 50 lb bags manufactured for Tri-State Veterinary Supply, Sioux City, IA and Golden Sun Feeds Hi-Pro Hunter Dog Food, product code 52GY, 50 lb bags manufactured for Golden Sun Feeds, Inc., Estherville, IA, which appeared in the April 19, 2000 Enforcement Report is a completed recall. END OF ENFORCEMENT REPORT FOR APRIL 26, 2000.####
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