November 28, 2001 01-47
**CORRECTION** An incorrect date appeared in the June 20, 2001 Enforcement Report for Recalls F-419-1 to F-425-1. The sentence should have read: “Manufacturer, by telephone and visit beginning on 12/1/00.”RECALLS AND FIELD CORRECTIONS: FOODS CLASS I
_______________________ PRODUCT Bulk Pepsin 1:10,000 NF XII Powder in 110-lb. drums or varying sizes per customer need, For Manufacturing Use Only, Recall # F-056-2. CODE Lot #50200986 and Lot #50200958. RECALLING FIRM/MANUFACTURER American Laboratories Incorporated Omaha, NE, by telephone on 4/18/01 and followed by letter on 4/19/01. Firm initiated recall is complete. REASON The product was contaminated with Salmonella. VOLUME OF PRODUCT IN COMMERCE Approximately 2,400.40 lbs. DISTRIBUTION NJ, WY, WI, TX, NY, MN and France and Germany. _______________________ PRODUCT Bulk pepsin in polyethylene-lined fiber drums of varying sizes as follows: a) Pepsin 1:10,000 BP 59 Powder, Recall # F-057-2; b) Pepsin 1:3000 NF XII Powder, Recall # F-058-2; c) Pepsin 1:2500 NF XII Powder, Recall # F-059-2. CODE This product is for manufacturing use only. The responsible firm on the label is American Laboratories Incorporated, Omaha, NE. a) Lot 42000838 (Pepsin 1:10,000 BP 59 Powder); b) Lot 54710053 (Pepsin 1:3000 NF XII Powder); c) Lot 22210106 (Pepsin 1:2500 NF XII Powder mfrd. from Lot 54710053). RECALLING FIRM/MANUFACTURER American Laboratories Incorporated Omaha, NE, by telephone on 5/9/01 followed by letter on 5/12/01 and 5/14/01. Firm initiated recall is complete. REASON The products were contaminated with Salmonella. VOLUME OF PRODUCT IN COMMERCE Approximately 2401 lbs. DISTRIBUTION OH, CA, OR, UT, TX, SC, and NV and Egypt and Australia. _______________________ PRODUCT City Nut and Candy Co. "California Mix" 8 oz. plastic bag with label, Recall # F-060-2. CODE Product is uncoded. RECALLING FIRM/MANUFACTURER City Nut and Candy, Inc. Hollywood, FL , by onsite visit on 6/21/01. Firm initiated recall is complete. REASON California Mix (trail mix) contained undeclared sulfites (140 ppm). VOLUME OF PRODUCT IN COMMERCE 36 bags. DISTRIBUTION FL. _______________________ PRODUCT Lightlife Smart Cutlets Seasoned Chick'N, labeled in part: Lightlife Meatless Low Fat Baked, Ready to Use! Smart Cutlets Rich in Soy Seasoned Chick'n Two Breaded Cutlets*** NET WT. 8 OZ.***"UPC code #43454-10101, Recall # F-061-2. CODE Lot # "Best By Date" 10120106956 10/12/01 10140106984 10/14/01 RECALLING FIRM/MANUFACTURER Lightlife Foods, Inc., Turner Falls, MA, by letter on 8/17/01. Firm initiated recall is complete. REASON The poultry substitute product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 10,000 cases. DISTRIBUTION Nationwide and worldwide.RECALLS AND FIELD CORRECTIONS: FOODS CLASS II
_______________________ PRODUCT Lightlife Smart Cutlets Seasoned Chick'N, labeled in part: Lightlife Meatless Low Fat baked ready to use! Smart Cutlets Rich in Soy Seasoned Chick'n Two Breaded Cutlets*** NET WT. 8 OZ.***"UPC code #43454-10101, Recall # F-062-2. CODE Lot # "Best By Date" 08170106544 08/17/01 08230106580 08/23/01 08240106580 08/24/01 08310106644 08/31/01 09010106660 09/01/01 09070106697 09/07/01 09140106796 09/14/01 09200106796 09/20/01 09280106908 09/28/01 10050106908 10/05/01 10060106908 10/06/01 10190107012 10/19/01 10200107012 10/20/01 10260107062 10/26/01 RECALLING FIRM/MANUFACTURER Lightlife Foods, Inc., Turner Falls, MA, by letter on 8/17/01. Firm initiated recall is complete. REASON The poultry substitute product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE Approximately 10,000 cases. DISTRIBUTION Nationwide and worldwide.RECALLS AND FIELD CORRECTIONS: FOODS CLASS III
_______________________ PRODUCT DeConna Big Daddy Brand Reduced Fat Ice Cream 12 Ounce cardboard cups, 12 cups to a sleeve. Vanilla, Recall # F-051-2; Strawberry, Recall # F-052-2; Chocolate, Recall # F-053-2; Cookies N Cream, Recall #F-054-2. CODE All product with serving size of 12 oz listed on label. RECALLING FIRM/MANUFACTURER Recalling Firm: DeConna Ice Cream Orange Lake, FL, by telephone on 6/18/01 followed by visit to apply corrected labels. Manufacturer: Highland Roberts Dairy Norfolk, NE. Firm initiated recall is complete. REASON The product label incorrectly stated the serving size as 12 oz. when it actually should have stated 4 oz. VOLUME OF PRODUCT IN COMMERCE Approx. 30,000 sleeves, various flavors (12/12 oz. cups per sleeve). DISTRIBUTION GA, AL, SC and FL. _______________________ PRODUCT Hokan brand Whole Oysters, 8 oz. cans, Responsible firm on the label: Packed Specially for Hokan, Tuxedo, NY 10987-0186 *** Product of China, Recall # F-055-2. CODE H32 990503 5, H32 990506, H32 990521 50, H32 990605, H32 990605 50. RECALLING FIRM/MANUFACTURER Recalling Firm: Novalia Ltd., Tuxedo, NY, by letter dated 9/6/00. Manufacturer: Qingdao Dani-Foodstuffs Co., Ltd., China. Firm initiated recall is complete. REASON The product does not meet the requirement of 21 CFR 161.145 in that the drained weight of the oysters was less than 59% of the water capacity of the container. VOLUME OF PRODUCT IN COMMERCE 600 cases (12-8oz. cans per case). DISTRIBUTION FL.RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS II
_______________________ PRODUCT a) Red Blood Cells, Recall # B-0259-2; b) Red Blood Cells, Leukoreduced, Recall # B-0260-2; c) Platelets, Unit, Recall # B-0261-2; d) Fresh Frozen Plasma, Recall # B-0262-2. CODE a) Unit 07FK18764; b) Unit 07FG66060; c) Unit 07FG52378; d) Units 07FG66060, 07FG52378. RECALLING FIRM/MANUFACTURER American National Red Cross, Tucson, AZ, by letter dated May 11, 2001. Firm initiated recall is complete. REASON Blood products prepared from overweight units of whole blood, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION AZ. _______________________ PRODUCT Platelets, Pheresis, Recall # B-0263-2. CODE Units KT23552P1, KT23552P2. RECALLING FIRM/MANUFACTURER Southern California Permanente Medical Group, Los Angeles, CA, by letter on June 27, 2001. Firm initiated recall is complete. REASON Blood products, which had unacceptable platelet counts, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT a) Platelets, Pheresis, Leukocytes Reduced, Recall # B-0264-2; b) Platelets, Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0265-2. CODE a) Units 8787307, 6243364; b) Units 2265360, 6243364. RECALLING FIRM/MANUFACTURER New York Blood Center (Center West), A Division of New York Blood Center, Inc., New York, NY, by letter dated May 21, 2001. Firm initiated recall is complete. REASON Blood products, which had unacceptable platelet counts, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION NY. _______________________ PRODUCT Platelets, Pheresis, Leukocytes Reduced, Recall # B-0268-2. CODE Units (7 units) 6243124 (bags 1 and 2), 6243128 (bags 1 and 2), 2265125 (bags 1 and 2), 8788344 (bag 2). RECALLING FIRM/MANUFACTURER Recalling Firm: New York Blood Center (Center West), A Division of New York Blood Center, Inc., New York, NY, by letter dated May 21, 2001. Manufacturer: New York Blood Center/Hudson Valley Blood Services, A Division of New York Blood Center, Inc., Elmsford, NY. Firm initiated recall is complete. REASON Blood products, which had unacceptable platelet counts, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION NY. _______________________ PRODUCT Counterfeit Neupogen (Filgrastim), Recall # B-0269-2. CODE Labeled as containing 300 mcg/1.0 ml, packaged 10/1.0 ml. single use vials per box. Lot Number P000890, Expiration Date 12/02, Lot Number P000992, Expiration Date 06/03, Lot Number P000948, Expiration Date 05/03, Lot Number P000954, Expiration Date 05/03. Quantity of counterfeit units distributed can not be determined. RECALLING FIRM AmeriSourceBergen, AmeriSource, Inc., Paducah, KY, by letter dated July 24, 2001. Firm initiated recall is ongoing. REASON Counterfeit Neupogen was distributed. VOLUME OF PRODUCT IN COMMERCE Quantity of counterfeit units distributed can not be determined. DISTRIBUTION IN, KY, AR, LA, TN, MS, AL, MO. _______________________ PRODUCT Platelets, Irradiated, Recall # B-0270-2. CODE Unit 03GZ26906. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Atlanta, GA, by telephone on February 12, 2001, and by letter dated February 19, 2001. Firm initiated recall is complete. REASON Blood product, for which documentation of irradiation was incomplete, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT Platelets, Pheresis, Recall # B-0271-2. CODE Unit 01FP12102. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by telephone on January 26, 2000. Manufacturer: American Red Cross Blood Services, Albany, NY. Firm initiated recall is complete. REASON Blood products, which were labeled as leukoreduced, but failed the quality control specification for white blood cell count, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY. _______________________ PRODUCT Platelets, Irradiated , Recall # B-0272-2. CODE Units 03E21742, 03GG75545. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Atlanta, GA, by telephone on February 20, 2001, and by letter dated March 2, 2001. Firm initiated recall is complete. REASON Blood products, for which documentation of irradiation was incomplete, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION GA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0274-2; b) Red Blood Cells, Leukoreduced, Recall # B-0275-2; c) Platelets, Recall # B-0276-2; d) Fresh Frozen Plasma, Recall # B-0277-2. CODE a) Unit L20561; b) Unit L24918; c) Unit L24918; d) Unit L20561, L24918. RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, by letter dated June 8, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Nardil, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION IL and VA. _______________________ PRODUCT Red Blood Cells, Recall # B-0278-2. CODE Unit 1127467. RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH, by letter dated April 19, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor taking the drug Agrylin, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced , Recall # B-291-2; b) Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B- 292-2; c) Platelets, Recall # B-293-2. CODE a) Unit number 01FF36700; b) Unit number 01E46286; c) Unit number 01E46286. RECALLING FIRM/MANUFACTURER The American National Red Cross, West Henrietta, NY, by letter dated May 4, 2001. Firm initiated recall is 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 3 units DISTRIBUTION NY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0294-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0295-2; c) Platelets, Recall # B-0296-2. CODE a) Unit 01KH31923; b) Unit 01KH44532 and 01KH37026; c) Unit 01KH31923. RECALLING FIRM/MANUFACTURER The American National Red Cross, West Henrietta, NY, recall by letter dated June 7, 2001. Firm initiated recall is 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 NY and PA. _______________________ PRODUCT Cornea (1 tissue), Recall # B-0306-2. CODE ID number NE-01-07-037-R-1. RECALLING FIRM/MANUFACTURER New England Eye and Tissue Transplant Bank, Boston, MA, by letter on September 11, 2001. Firm initiated recall is complete. REASON Human tissue for transplantation was distributed untested by licensed donor screening tests for human immunodeficiency virus, types 1 and 2 (HIV-1/2), hepatitis B virus (HBV), and hepatitis C virus (HCV). VOLUME OF PRODUCT IN COMMERCE 1 tissue. DISTRIBUTION MA. _______________________ PRODUCT Red Blood Cells , Recall # B-0312-2. CODE Unit 04L613416. RECALLING FIRM/MANUFACTURER Civitan Regional Blood Center, Inc., Gainesville, FL, by telephone on or about February 4, 1999. Firm initiated recall is complete. REASON Blood product, that tested initially reactive for the antibody to hepatitis B core antigen (anti-HBc), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0314-2. CODE Unit 12GM69795. RECALLING FIRM/MANUFACTURER The American National Red Cross, Charlotte, NC, by telephone and letter on August 8, 2001. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to a history of hepatitis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC.RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS III
_______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall B-0098-2; b) Frozen Plasma, Recall B-0099-2. CODE a) Unit 29KN24189; b) Unit 29KN24189. RECALLING FIRM/MANUFACTURER American Red Cross , Norfolk, VA, by letter dated April 16, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had undergone a splenectomy, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA and MD. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0284-2; b) Platelets, Recall # B-0285-2; c) Fresh Frozen Plasma, Recall # B-0286-2; d) Recovered Plasma, Recall # B-0287-2. CODE a) Units 18FW18046, 18FC52069, 18E52918, and 18Z54170; b) Units 18FC52069 and 18E52918; c) Unit 18FC52069; d) Units 18FW18046 and 18E52918. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Lansing, MI, by letters on March 20 and 23, 2001, and April 6, 2001. Manufacturer: American Red Cross Blood Services, Muskegon, MI Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with the drug Tamoxifen, were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION MI, MA, TN and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0288-2; b) Recovered Plasma, Recall # B-0289-2. CODE a) Unit 18GN04983, 18GN04984, 18GN04985, 18GN04989, 18GN04990, 18GN04995, 18GN04996, 18GN04997, 18GN04998 and 18GN04999; b) Unit 18FJ40541, 18GN04983, 18GN04984, 18GN04985, 18GN04986, 18GN04989, 18GN04990, 18GN04995, 18GN04997 and 18GN04999. RECALLING FIRM/MANUFACTURER The American National Red Cross, Lansing, MI, recall by telephone on March 2, 2001, and by letters on March 6, 2001. Firm initiated recall is complete. REASON Blood products, manufactured in a centrifuge that failed to maintain proper temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 20 units. DISTRIBUTION MI, IN and Switzerland. _______________________ PRODUCT Red Blood Cells, Recall # B-0290-2. CODE Unit FR06851 (two split units distributed). RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA, by telephone on September 7, 2000. Firm initiated recall is complete. REASON Blood products, labeled with the incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0307-2; b) Recovered Plasma, Recall # B-0308-2. CODE a) Red Blood Cells, Unit 04L572282; b) Recovered Plasma, Unit 04L572282. RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL, by telephone and letter on and about January 18, 2000. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who had an elevated body temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION GA and CA. _______________________ PRODUCT Recovered Plasma, Recall # B-0309-2. CODE Unit 22411-4126. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Las Vegas, NV, by facsimile on February 24, 2000. Firm initiated recall is complete. REASON Blood product, which was collected in a manner that possibly compromised the sterility of the collection system, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NV. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0310-2; b) Recovered Plasma, Recall # B-0311-2. CODE a) Unit FM88429; b) Unit FM88429. RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA, by letter dated January 7, 1999. Firm initiated recall is complete. REASON Blood products, which were collected from donor whose health history was not adequately performed, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Recall # B-0313-2. CODE Unit 04L703004. RECALLING FIRM/MANUFACTURER Civitan Regional Blood Center, Inc., Gainesville, FL, by telephone on or about February 4, 1999. Firm initiated recall is complete. REASON Blood product, that tested initially reactive for the antibody to hepatitis B core antigen (anti-HBc), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL.RECALLS AND FIELD CORRECTIONS: DEVICES CLASS II
_______________________ PRODUCT Radiation Treatment Planning Decision Support System (DSS), Recall # Z-0213-2. CODE All versions. RECALLING FIRM/MANUFACTURER Multidata Systems International Corp., St. Louis, MO, by letter on 6/22/01. Firm initiated recall is ongoing. REASON The software calculates radiation overdoses that require human intervention to detect and prevent injury to radiation therapy patients. VOLUME OF PRODUCT IN COMMERCE 320. DISTRIBUTION Nationwide and worldwide. _______________________ PRODUCT Replace (brand), Easy Abutment, 5.5mmH, 0.5mm MARGIN, 4.3mm SERIES (SELECT), Recall # Z-0295-2. CODE Part Number: 61641; Lot Number: 320130, 320150, 320151, 320403, 320404, 320405, 320926. Part Number: 61642; Lot Number: 320161, 320162, 320406, 320407, 320482. Part Number: 61643; Lot Number: 320163, 320408, 321748. Part Number: 61644; Lot Number: 320164, 320409, 321749. Part Number: 61645; Lot Number: 320172, 320174, 320927, 320928, 322079, 322664. Part Number: 61646; Lot Number: 320179, 320929, 320930, 322080, 322668. Part Number: 61647; Lot Number: 320180, 320931, 321750, 322081, 322669. Part Number: 61648; Lot Number: 320181, 321752, 333082, 322672. Part Number: 61649; Lot Number: 320182, 321440, 322083. Part Number: 61650; Lot Number: 320183, 321325, 322084. Part Number: 61651; Lot Number: 320184, 321441. Part Number: 61652; Lot Number: 320185, 321442. Part Number: 61656; Lot Number: 321679, 326218. Part Number: 61657; Lot Number: 321680, 324398, 326342. Part Number: 61658; Lot Number: 321681. RECALLING FIRM/MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, CA, by letter dated July 13, 2001. Firm initiated recall is ongoing. REASON Poor rework instructions caused mix of sterile and nonsterile components. VOLUME OF PRODUCT IN COMMERCE 2,952 DISTRIBUTION Nationwide and worldwide. _______________________ PRODUCT a) LifeSite Hemodialysis Access System; b) LifeSite Hemodialysis Cannula Exchange Kit, Recall Number(s): Z-0296-2. CODES a) LifeSite Hemodialysis Access System, Catalog # LHAS14120, Lot Numbers: ADH0013, ADH0015, ADH0020, ADI001, ADI002, ADI0007, ADI0008,ADJ0009, ADJ0016, ADJ0017, ADJ0018, ADJ0019, ADJ0020, ADJ0021, ADK0017, ADK0018; 83, 85 TO 91; 258 TO 261; 11057 AND 11058. b) LifeSite Hemodialysis Cannula Exchange Kit, Model LHCEK0000, Lot Numbers: 99;100;406;407;408 and 409. RECALLING FIRM/MANUFACTURER Vasca Inc., Tewksbury, MA, by letter on 8/2/01. Firm initiated recall is ongoing. REASON Labeling Change to Instructions for use in Heparin Lock Concentration. VOLUME OF PRODUCT IN COMMERCE a) 2,262 units; b) 658 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Storz Opthalmics Concentrix Phaco Pack Sterile, Recall # Z-0297-2. CODE Lot number S7831. RECALLING FIRM/MANUFACTURER Recalling Firm: Bausch & Lomb St. Louis, MO., by letter on 10/5/01. Manufacturer: Bausch & Lomb Surgical Clearwater, FL . Firm initiated recall is ongoing. REASON The irrigated line tubing may not properly adhere to the product's cassette. VOLUME OF PRODUCT IN COMMERCE 870 units (145 boxes of 6 units per box). DISTRIBUTION Nationwide and Bausch & Lomb facilities in China; Australia, Canada, Japan, and Mexico. _______________________ PRODUCT CryoValve Allograft (Heart Valve): a) Recall # Z-0299-2; b) Recall # Z-0300-2. CODE a) Model No. AV00 - Serial Number 6170625; b) Model No. PV00 - Serial Number 6173071. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by letter on 10/25/01. Firm initiated recall is complete. REASON Donor does not meet current guidelines regarding serodilution of plasma. VOLUME OF PRODUCT IN COMMERCE 2 valves. DISTRIBUTION MD and CA. _______________________ PRODUCT CryoValve Allograft, Recall # Z-0301-2. CODE Model PV10 - Serial Number 6132081. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by letter on 10/31/01. Firm initiated recall is complete. REASON Donor does not meet current guidelines regarding serodilution of plasma. VOLUME OF PRODUCT IN COMMERCE 1 valve. DISTRIBUTION WI. _______________________ PRODUCT CryoValve Allograft, Recall # Z-0302-2. CODE Model AV00 - Serial Number 6173837. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA by letter on 10/31/01. Firm initiated recall is complete. REASON Donor does not meet current guidelines regarding serodilution of plasma VOLUME OF PRODUCT IN COMMERCE 1 valve. DISTRIBUTION NC. _______________________ PRODUCT CryoValve Allograft, Recall # Z-0303-2. CODE Model Number PV00 - Serial Number 6173845. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by letter on 10/31/01. Firm initiated recall is complete. REASON Donor does not meet current guidelines regarding serodilution of plasma VOLUME OF PRODUCT IN COMMERCE 1 valve. DISTRIBUTION PA. _______________________ PRODUCT CryoValve Allograft, Recall # Z-0304-2. CODE Model Number AV00 - Serial Number 6132073. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, Ga, by telephone on 10/29/01. REASON Donor does not meet current guidelines regarding serodilution of plasma VOLUME OF PRODUCT IN COMMERCE 1 valve. DISTRIBUTION CA. _______________________ PRODUCT Arcoskop Ceiling Mounted Image Intensifier System, Recall # Z-0305-2. CODE Model Number 4774019, Serial Numbers 01019, 01017, 01015, 01002. RECALLING FIRM/MANUFACTURER Manufacturer: Siemens AG D-91025 Erlangen, Germany, Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, via telephone on 4/30/2001. Firm initiated recall is complete. REASON The C-arm separated from the swivel arm and fell. VOLUME OF PRODUCT IN COMMERCE 4 devices. DISTRIBUTION FL, NJ, TX, WI, and Germany. _______________________ PRODUCT The Abbott AxSYM System is a fully automated Immunoassay analyzer designed to perform Microparticle Enzyme Immunoassay (MEIA), Fluorescence Polarization Immunoassay (FPIA), Radiative Energy Attenuation (REA) Assay Technology, and Ion Capture (IC) Immunoassay Technologies. The AxSYM System performs random access, continuous access, and STAT processing of both large and small molecular weight analytes, Recall # Z-306-2 to Z- 311-2. CODE Software versions 3.00, 3.01, 3.03, 3.04a, 3.60, 4.00. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by letter dated 9/26/01. Firm initiated recall is ongoing. REASON The system may report sample results from the incorrect sample tube. VOLUME OF PRODUCT IN COMMERCE 17,508. DISTRIBUTION Nationwide and world wide.RECALLS AND FIELD CORRECTIONS: DEVICES CLASS III
_______________________ PRODUCT Remel Mueller Hinton Agar, Recall # Z-0298-2. CODE Product No. 01620 packaged 10 plates/pkg, Lot No. 189356. RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa, KS, Recall letters dated 10/8/01 were issued via certified mail requesting the customer to discard the affected units. Recall is ongoing. REASON Some plates in the lot were contaminated with Staphylococcus aureus. VOLUME OF PRODUCT IN COMMERCE 2,420 plates. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
_______________________ PRODUCT Gentadip (Gentamicin Sulfate Solution), Ellsworth and Med-Pharmex brands in 80 ml bottles; 50 mg per ml of gentamicin sulfate; OTC drug labeled for use in dipping turkey eggs, Recall # V-007-2. CODE Stock # 1450-8. Lot #s: 8097, F7949, F7461, F7117, F9678, F6984, F6110, F6778, F6714. RECALLING FIRM/MANUFACTURER Veterinary Pharmaceuticals, Inc. (VPI), Hanford, California, by letters on December 17, 1999. FDA initiated recall is complete. REASON The product is labeled as gentamicin for use in dipping turkey eggs, but the firm intended it for use as an injectable in cattle. Gentamicin is not allowed in cattle. VOLUME OF PRODUCT IN COMMERCE 40,639 bottles. DISTRIBUTION CA, ID, KS, OR.END OF ENFORCEMENT REPORT FOR November 28, 2001 ####
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