January 29, 1997 97-05 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Parisian French Bread Stuffing, in 12 ounce cartons. Recall #F-205-7. CODE Lot #09597. MANUFACTURER San Francisco French Bread Products Company, Oakland, California. RECALLED BY Manufacturer, by visit on December 2, 1996, followed by letter. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 212 cases (12 units per case) were distributed. REASON Product is contaminated with small pieces of glass. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Menko Egg Kichel, in 7 ounce cellophane bags. Recall #F-128-7. CODE None. MANUFACTURER Lee Avenue Food Products, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by visit on October 7 and 10, 1996. Completed recall resulted from inspection and followup by the New York State Department of Agriculture and markets. DISTRIBUTION New York. QUANTITY 56.5 dozen bags were distributed. REASON The product is misbranded as follows: 1) Product does not qualify for the "No Cholesterol" claim based on a finding of 55 mg of cholesterol per 30 g serving. 2) The label fails to declare the ingredients in the enriched flour. 3) The nutrition information does not comply with the format requirements. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-245/247-7. CODE Unit #40GT44463. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on June 7, 1996, followed by letters dated June 11 and 13, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), and were subjected to additional retesting. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-255/257-7. CODE Unit numbers: (a) 40GN11464, 40GW08142, 40GV43592; (b) 40GW08142, 40GV43592; (c) 40GN11464, 40GW08142, 40GV43592. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on June 7, 1996, followed by letters dated June 11, 13, and 18, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois, California. QUANTITY (a) 3 units; (b) 2 units; (c) 3 units were distributed. REASON Blood products tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), and were subjected to additional retesting, or were collected from a donor who previously tested repeatedly reactive for anti-HIV-1. -2-_______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-263/264-7. CODE Unit numbers: (a) 814366, V25076, F06913; (b) F06913. MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg, South Carolina. RECALLED BY Manufacturer, by letters between the dates of December 8, 1995 through January 2, 1996. Firm-initiated recall complete. DISTRIBUTION South Carolina, Florida, California, Tennessee. QUANTITY (a) 3 units; (b) 1 unit was distributed. REASON Blood products were collected from a donor who reported a history of cancer. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-266/268-7. CODE Unit #KT66899. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by letter dated February 2, 1996. Firm-initiated recall complete. DISTRIBUTION Iowa, Pennsylvania, California. QUANTITY 1 unit of each component. REASON Blood products were collected from a donor whose spouse had a history of intravenous (IV) drug use. _______________ PRODUCT Red Blood Cells. Recall #B-269-7. CODE Unit #G09463. MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg, South Carolina. RECALLED BY Manufacturer, by letter dated February 20, 1996. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had a history of ear piercing within one year of donation. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-271/273-7. CODE Unit #M26418. MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg, South Carolina. RECALLED BY Manufacturer, by letter dated March 4, 1996. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit of each component was distributed. -3-REASON Blood products were collected from a donor who had a history of ear piercing within one year of donation. _______________ PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma. Recall #B-274/275-7. CODE Unit #M27100. MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg, South Carolina. RECALLED BY Manufacturer, by letter dated February 20, 1996. Firm-initiated recall complete. DISTRIBUTION South Carolina and North Carolina. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had a history of ear piercing within one year of donation. _______________ PRODUCT Red Blood Cells. Recall #B-276-7. CODE Unit #47C46545. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on June 18, 1996, followed by letter dated June 24, 1996. Firm- initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product tested initially reactive for the antibody to the hepatitis B core antigen (anti-HBc), and was not retested in duplicate. _______________ PRODUCT Red Blood Cells. Recall #B-277-7. CODE Unit #47C47811. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on June 18, 1996, followed by letter dated June 24, 1996. Firm- initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product tested initially reactive for the antibody to the hepatitis B core antigen (anti-HBc), and was not retested in duplicate. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-282/284-7. CODE Unit #29135-8563. MANUFACTURER United Blood Services, Chicago, Illinois. -4-RECALLED BY Manufacturer, by telephone on July 19, 1996, and by letter dated August 6, 1996. Firm- initiated recall complete. DISTRIBUTION Illinois and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of hepatitis A. _______________ PRODUCT (a) Platelets; (b) Recovered Plasma. Recall #B-288/289-7. CODE Unit #0561598. MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas. RECALLED BY Manufacturer, by letters dated April 8, 1996 and May 15, 1996. Firm-initiated recall complete. DISTRIBUTION Texas and California. QUANTITY 1 unit of each component was distributed. REASON Blood products, with confirmed weaker than expected Rh testing results when performing D antigen testing, were distributed. _______________ PRODUCT Red Blood Cells. Recall #B-290-7. CODE Unit #3A28118. MANUFACTURER W.E. & Lela I. Stewart Blood Center, Inc., Tyler, Texas. RECALLED BY Manufacturer, by telephone on April 22, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a previous history of hepatitis. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-251/252-7. CODE Unit #40GS47369. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on May 23, 1996, followed by letter dated June 3, 1996. Firm- initiated recall complete. DISTRIBUTION Illinois and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested repeatedly reactive for the hepatitis B surface antigen (HBsAg), but were subjected to additional retesting. The donor has since met reentry. -5-_______________ PRODUCT Red Blood Cells. Recall #B-260-7. CODE Unit numbers: 29134-2563 and 29134-9427. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on June 21, 1996. Firm-initiated recall complete. DISTRIBUTION North Dakota. QUANTITY 2 units were distributed. REASON Red Blood Cells had no quality control testing performed after deglycerolization. _______________ PRODUCT Cryoprecipitated AHF. Recall #B-261-7. CODE Unit #53GQ51195. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated August 18, 1996. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with an extended collection time. _______________ PRODUCT Red Blood Cells. Recall #B-262-7. CODE Unit #02H46945. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on January 23, 1996. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product may have been shipped at an unacceptable temperature. _______________ PRODUCT Recovered Plasma. Recall #B-265-7. CODE Unit numbers 814366 and F06913. MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg, South Carolina. RECALLED BY Manufacturer, by letters dated December 8, 1995, and January 2, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 2 units were distributed. REASON Blood product was collected from a donor who reported a history of cancer. _______________ PRODUCT Red Blood Cells. Recall #B-270-7. CODE Unit #42FJ53189. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. -6-RECALLED BY Manufacturer, by telephone on August 6, 1996, followed by letter dated August 8, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT HYATE:C, Antihemophilic Factor (Porcine), Factor VIII. Recall #B-281-7. CODE Lot #559. MANUFACTURER Speywood Biopharm Limited, Wrexham, Wales, UK. RECALLED BY Speywood Pharmaceuticals, Inc., Milford, Massachusetts (distributor), by telephone on December 4, 1996, and by letter dated December 5, 1996. Firm-initiated recall complete. DISTRIBUTION Alabama, California, Louisiana, Iowa, Rhode Island, Maine, Missouri, New Mexico, Pennsylvania, Florida, New York, Texas. QUANTITY 1,019 vials were distributed. REASON Factor VIII product was positive (adulterated) for porcine parvovirus (PPV). _______________ PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Recovered Plasma. Recall #B-285/287-7. CODE Unit numbers: (b&c) 9711351; (a) 9658388. MANUFACTURER Hoxworth Blood Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated May 7, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio and Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected in expired blood collection bags. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Kangaroo Entriflush Enteral Feeding Pump, Rx device used to regulate the flow of enteral feedings: (a) Catalog #8884-352405 (new); (b) Catalog #8884-352413 (refurbished). Recall #Z-208/209-7. CODE All pumps. MANUFACTURER Sherwood Davis & Geck, Watertown, New York. RECALLED BY Sherwood Davis & Geck, St. Louis, Missouri, by letter dated December 4, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,954 units were distributed. REASON The pumps may deliver formula at rates up to twice the programmed feeding rate. -7-_______________ PRODUCT Abiomed (R) BVS 5000i Bi-Ventricular Support System, temporary artificial heart system consoles. Recall #Z-221-7. CODE Serial Numbers: 1500-1523. MANUFACTURER Abiomed, Inc., Danvers, Massachusetts. RECALLED BY Manufacturer, by letter on October 8, 1996. Firm-initiated recall ongoing. DISTRIBUTION California, Connecticut, District of Columbia, Florida, Illinois, Kentucky, Massachusetts, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, West Virginia. QUANTITY 24 consoles (2 valves each) were distributed. REASON The transducers may malfunction and result in several types of device failures. If the transducer fails during power-up, the BVS System may fail the self-test. If the transducer malfunctions during use, the BVS System may produce erratic or reduced blood flow. _______________ PRODUCT Fresenius Hemodialysis Delivery Systems: (a) Model 2008H/3008; (b) Model 2008E; (c) Model 2008C/D; (d) Model 2008BSS. Recall #Z-224/227-7. CODE All lots. MANUFACTURER Fresenius USA, Inc., Walnut Creek, California. RECALLED BY Manufacturer, by visit November 22, 1996. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Canada, Mexico. QUANTITY 5,172 modules were distributed. REASON Certain solenoids used in the level detector module line clamp contain a rubber bumper that may become gummy, causing the line clamp to stick open after a blood alarm. _______________ PRODUCT Xanar Surgical CO2 Lasers, for general surgery and dermatology: (a) Model No. XL40; (b) Model No. XL60 (c) Model No. XL55; (d) Model No. XA50. Recall #Z-228/231-7. CODE Serial numbers: (a) 207, 111, 189; (b) 60151, 60172, 60150, 60155, 60194; (c) 221, 161; (d) 334, 233. MANUFACTURER Coherent, Palo Alto, California. RECALLED BY Manufacturer, by fax on May 17, 1996. Firm- initiated field correction complete. DISTRIBUTION Nationwide. QUANTITY 12 units were distributed. -8-REASON Devices failed to comply with 21 CFR 1040.11(a)(1) in that they may deliver twice the power requested by the user and displayed on the terminal. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Richard Allen brand Disposable Endoscopic Clip Applier, Reflex-ELC with Titanium Clips, Product No. 530, used in Reflex Brand Cholecystectomy Kit No. 37001. Recall #Z-218-7. CODE Custom Kit Nos. C37200 and C37201, All lots with Lot No./Expiration Date of 25JAN99 or earlier. MANUFACTURER Richard-Allan Medical, Richland, Michigan. RECALLED BY Manufacturer, by sending technical bulletin dated February 21, 1994, and by letter dated March 1, 1994. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Clip applier jaw are subject to opening too far and not being able to contain an unformed clip, allowing the clip to fall during use. _______________ PRODUCT Bio-Tek Software Microplate Readers, in-vitro diagnostic medical device: (a) Product #ELx800; (b) ELx808. Recall #Z-219/220-7. CODE All serial numbers. MANUFACTURER Bio-Tek Instruments, Inc., Winooski, Vermont. RECALLED BY Manufacturer, by letter on November 19, 1996. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,328 units were distributed. REASON An error in the device's data reduction software could produce erroneous results. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II =========== _______________ PRODUCT Pro Lean 18/95 CSP Medicated Starter/Grower (pelleted swine feed medicated with chlortetracycline, sulfathiazole and penicillin). Recall #V-024-7. CODE Lot numbers: 1N2576 and 1N2616. MANUFACTURER Growmark, Inc., Nashville, Illinois. RECALLED BY Manufacturer, by telephone on November 8, 1996. Firm-initiated recall complete. -9-DISTRIBUTION Illinois. QUANTITY 5 tons were distributed; firm estimates none remains on the market. REASON Subpotency of chlortetracycline and penicillin ingredients. RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ========= _______________ PRODUCT Baytril (enrofloxacin) Antibiotic Tablets No. 20 and No. 60, for the treatment of bacterial pathogens in dogs and cats. Recall #V-025-7. CODE Lot #142139; Product Codes: Baytril No. 60 - 1882 Baytril No. 20 - 1881. MANUFACTURER Bayer Corporation, Shawnee, Kansas. RECALLED BY Manufacturer, by telephone on October 28, 1996, followed by letter on November 11, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 2,556 bottles of Baytril No. 60 and 3,041 bottles of Baytril No. 20 were distributed. REASON A single lot failed content uniformity. MEDICAL DEVICE SAFETY ALERTS: ============================== _______________ PRODUCT Picker Prism Nuclear Medicine Imaging Systems, used for diagnostic purposes for SPECT and body imaging performed in a hospital or clinic setting: (a) Model No. 1000S/215003, Model No. 1000XP/210337 and Model No. 1500XP/210502; (b) Model Nos. 2000S/215000, 2000XP/210336; (c) N-006-7 - Model No. 3000S/210060 and Model No. 3000XP/210335. Safety Alert #N-004/006-7. CODE All models and all serial numbers. MANUFACTURER Picker International, Inc., Highland Heights, Ohio. ALERTED BY Manufacturer, by letter dated November 16, 1996. DISTRIBUTION Nationwide and international. -10-QUANTITY 1,112 units were distributed. REASON Objects should not be placed in the path of the equipment. -11- END OF ENFORCEMENT REPORT FOR JANUARY 29, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for