October 10, 2001 01-40
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-631-1, Country Farms Honey Bran Bread, net wt. 24-oz. The responsible firm on the label shows the product is distributed by Albertson's Inc., Boise, ID., Codes: Not coded. The new bags have a plastic band around the front half of the plastic bag advertising a NASCAR sweepstakes, as well as the listing of soy fiber in the ingredient statement. REASON: The product contained undeclared soy fiber MANUFACTURER: Interstate Brands Corp. Pomona, CA RECALLED BY: Interstate Brands Companies, Kansas City, MO, and Interstate Brands Corp. Pomona, CA, via phone on 8/30/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA and NV QUANTITY: 4,979 loaves _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-633-1, Healthy Times brand of Cabana Banana baby food (banana puree) in 4 oz. glass jars, Codes: 35303J08 REASON: Product may be contaminated with glass. MANUFACTURER/RECALLING FIRM: Glacier Foods Sanger, CA RECALLED BY: Glacier Foods, by fax and letter beginning on 7/19/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA QUANTITY: 346 casesRECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-632-1, Canada Dry Club Soda Sodium Free packaged in 12-fl. oz. cans, 6- packs, Codes: NOV 1201 SLB2 and JUL 0901 SLB3 REASON: Regular Club Soda was packaged in cans labeled as “sodium free.” MANUFACTURER: Central States Coca Cola Bottling Co., Div. of Coca Cola Enterprises, Maryland Heights, MO RECALLED BY: Central States Coca Cola Bottling Co., Div. of Coca Cola Enterprises, St. Charles, MO, by visit and letter dated 3/22/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: MO. QUANTITY: 2,332 casesRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-130-1, Red Blood Cells, unit number 20H26216 B-131-1, Platelets, unit number 20H26216 B-132-1, Fresh Frozen Plasma, unit number 20H26216 REASON: Blood products, collected from a donor that subsequently provided a history of a positive test for hepatitis, were distributed. MANUFACTURER: The American National Red Cross, Salt Lake City, UT RECALLED BY: American Red Cross Blood Services, Boise, ID, by telephone on January 21, 2000, and by letter dated January 25, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: California and Utah QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-133-1, Red Blood Cells, unit number 20M06695 B-134-1, Recovered Plasma, unit number 20M06695 REASON: Blood products, collected from a donor that subsequently provided a history of positive tests for hepatitis B, were distributed MANUFACTURER: The American National Red Cross, Salt Lake City, UT RECALLED BY: American Red Cross Blood Services, Boise, ID, by letter dated September 9, 1999, and facsimile on October 5, 1999 FIRM INITIATED RECALL: Complete DISTRIBUTION: California QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-135-1, Red Blood Cells, unit number 20M06828 B-136-1, Recovered Plasma, unit number 20M06828 REASON: Blood products, collected from a donor that subsequently provided a history of a positive test for hepatitis, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Salt Lake City, UT RECALLED BY: American Red Cross Blood Services, Boise, ID, by letter dated September 20, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: California QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-137-1, Red Blood Cells, unit number 040LR05579 B-138-1, Recovered Plasma, unit number 040LR05579 REASON: Blood products, that tested negative for the antibodies to the human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Peoria, IL RECALLED BY: The recalling firm by letters June 28, 2001, and July 10, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NE and CA QUANTITY: 2 units ______________________________ RECALL NUMBER,PRODUCT AND CODE: B-139-1, Source Plasma, unit number 38647758 REASON: Blood product, that was collected from a donor that previously tested repeatedly reactive for the antibody to hepatitis C virus (anti-HCV), was distributed. MANUFACTURER/RECALLING FIRM: Nabi, Corpus Christi, TX, RECALLED BY: The recalling firm, by facsimile on November 16, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: California QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-414-1, Platelet, Pheresis, Leukoreudced, Unit 16354-1741(split units) REASON: Blood products, which were labeled as leukoreduced, but that failed the quality control specification for white blood cell count, were distributed. MANUFACTURER: United Blood Services, Meridian, MS RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on September 18, 2000, and by letter dated October 10, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: Mississippi and Texas QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-529-1, Source Plasma (26 units), unit numbers 0051876, 0053560, 0055603, 0057150, 0060264, 0065912, 0051240, 0054176, 0055878, 0057556, 0061959, 0052577, 0054471, 0056282, 0057707, 0062682, 0052752, 0054807, 0056519, 0058447, 0062719, 0053278, 0055185, 0056914, 0058675, and 0065381 REASON: Blood products, that tested negative for viral markers, but were collected from a donor that subsequently providing disqualifying information concerning a history of: 1) incarceration; and 2) tattoos, were distributed. MANUFACTURER/RECALLING FIRM: Westgate Biologicals, Inc., College Station, TX RECALLED BY: Diagnostic Chemistries, Inc., Mount Kisco, NY, by letter on June 1, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: New York QUANTITY: 26 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-769-1, Red Blood Cells Unit 5361624 B-770-1, Cryoprecipitate Unit 5361624 B-771-1, Recovered Plasma, Unit 5361624 REASON: Blood product, collected from a donor with a history of having tested positive for hepatitis, was distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, Texas RECALLED BY: The recalling firm, by telephone on May 16, 2001, and by letters dated May 30, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Texas and Switzerland QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-772-1, Red Blood Cells Unit 4878852 B-773-1, Recovered Plasma Unit 4878852 REASON: Blood products, collected from a donor with a history of having tested positive for anti-HCV, with a negative RIBA, were distributed. MANUFACTURER/RECALLING FIRM: Our Lady of the Lake Hospital, Inc., Baton Rouge, LA RECALLED BY: The recalling firm, by facsimiles on September 26, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: LA and FL QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-774-1, Fresh Frozen Plasma, Unit 10709-7376 B-775-1, Platelets, Unit 10709-7376 REASON: Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed. MANUFACTURER: United Blood Services, Scottsdale, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 18, 2001, and letters dated June 1, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1246-1, Red Blood Cells, Unit 5327406 REASON: Blood product, collected from a donor who was participating in an experimental drug study, was distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: The recalling firm notified the Texas consignee by telephone on February 3, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1341-1, Red Blood Cells, unit number 20LM75309 B-1342-1, Recovered Plasma, unit number 20LM75309 REASON: Blood products,which tested negative for anti-HCV, but were collected from a donor who had previously tested reactive for anti-HCV, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Boise, ID RECALLED BY: The recalling firm notified the consignee, located in Idaho by letter dated November 15, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: ID QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1583-1, Platelets, Pheresis, Leukoreduced, Irradiated, Unit 40FP12993 REASON: Blood product, labeled as irradiated but did not meet the requirements for irradiation, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Peoria, IL RECALLED BY: The recalling firm, by telephone on July 12, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1584-1, Source Plasma for Manufacturing Use Only, Unit 00MMNB8076 REASON: Blood product, collected from a donor who had not completed the CJD/nvCJD increased risk questions, was distributed MANUFACTURER: Community Bio-Resources, Inc., Mankato, MN RECALLED BY: Community Bio-Resources, Inc., Hoover, AL, by fax dated June 14, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Austria QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1893-1, Red Blood Cells, Units 2166658, 1281004 B-1894-1, Red Blood Cells, Leukoreduced, Unit 4118199 B-1895-1, Platelets, Unit 2166658 B-1896-1, Fresh Frozen Plasma, Units 2166658, 4118199 REASON: Blood products, collected from a donor who had received a dura mater graft, thirty years prior to donation, were distributed MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas City, Kansas City, MO RECALLED BY: The firm notified consignees, located in by letters dated January 21, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Missouri, Kansas and Ohio QUANTITY: 6 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1917-1, Red Blood Cells, Leukoreduced, Unit 10631-4160 REASON: Blood product, that was not quarantined after receiving information concerning a post donation illness, was distributed. MANUFACTURER/Manufacturer: United Blood Services, Scottsdale, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on October 10, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1919-1, Fresh Frozen Plasma, Unit 10708-6547 REASON: Blood product, corresponding to a unit of clotted Red Blood Cells, was distributed. MANUFACTURER: United Blood Services, Scottsdale, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 28, 2001 and by letter dated April 24, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1918-1, Fresh Frozen Plasma, Unit 10704-7955 REASON: Blood product, corresponding to a unit that was observed to have clots, was distributed. MANUFACTURER: United Blood Services, Scottsdale, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 25, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1924-1, Source Plasma, Units 8MW086B, 9J9631B, 9J9719B, 9NS107B, 9NS829B, 9SW795B, 814206B, 814307B REASON: Blood products, collected from a donor who had a history of drug use, were distributed. MANUFACTURER/RECALLING FIRM: Aventis Bio-Services, Inc., Oklahoma City, OK RECALLED BY: The recalling firm, by letter dated January 16, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 8 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1928-1, Corneas, Units MSN-2000-0507, MSN-2000-0508 REASON: Corneas, collected from a donor who tested repeatedly reactive for the HTLV I/II antibody, with an indeterminate HTLV Western Blot, were distributed. MANUFACTURER/RECALLING FIRM: Lions Eye Bank of Wisconsin, Inc., Madison, WI RECALLED BY: The recalling firm by letter dated August 31, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: WI QUANTITY: 2 unitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1156-1/Z-1168-1, Patient Restraints, with locks. Codes: Cat. No. Name 1070 Keylock Buckle 1334 Posey Keylock Belt 1337 Swedish Belt 2320 Series Connecting Straps 2350 Series Connecting Straps 2792 Locking TAT Cuffs 2793 Locking TAT Cuffs 2794 Wrist, Bed Set 2795 Ankle, Bed Set 2798 Locking TAT Cuffs 2799 Locking TAT Cuffs 2800 TAT Ambulatory Belt 2801 TAT Hobble REASON: Locks break open at 50 pounds pressure, specification is 100 pounds. MANUFACTURER/RECALLING FIRM: J. T. Posey Co. Arcada, CA RECALLED BY: The firm sent recall letters dated July 26, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 20,031 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1169-1, Medtronic Single Chamber Temporary Pacemaker, Model 5348, Codes:Serial Numbers PEP016687P - PEP016696P, PEP016698P - PEP016744P, PEP016746P - PEP016763P, PEP016765P - PEP016780P, PEP016782P - PEP016797P, PEP016799P - PEP016809P, PEP016831P, PEP016922P, PEP016952P, PEP016953P, and PEP016955P. Use before date of December 31, 2039 according to Medtronic's C/R report. REASON: Possibility of device shutdown if the non conforming component fails. The device would not complete the self-test routine prior to the shutdown. Another possible condition is that the battery life may not last the intended 7 days at nominal settings. MANUFACTURER/RECALLING FIRM: MedTronic, Inc. Minneapolis, MN. RECALLED BY: Manufacturer, by letter dated June 28, 2001. Ongoing DISTRIBUTION: Nationwide and Canada, Netherlands and Japan QUANTITY: 42 pacemakers _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1203-1/Z-1204-1, Split Tissue Protection Sleeve Codes: Product Number 393.745 Lot number 4041562 and Product Number 393-746 Lot number 4044728. REASON: Mislabeled protection sleeves MANUFACTURER: Synthes (USA) West Chester, PA RECALLED BY: Synthes (USA) Paoli, PA., by telephone on 7/25/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 24 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1205-1, Save-A-Tooth Emergency Tooth Preserving System. The product is shipped in cases of 24 units. A unit is a complete preserving system. The unit is a plastic jar filled with preserving solution. Codes: catalog number Z-12488-1, part number 32-393, lot number 512844 REASON: Product leaking, compromising sterility. MANUFACTURER: Polysciences, Inc. Warrington, PA RECALLED BY: Save-A-Tooth, Inc. Pottstown, PA, by telephone (date unknown). FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ QUANTITY: 417 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1207-1 Examination gloves contained in the following Products: Product name 1) Central Line DRSG Valve 2) Dry Prep Tray 3) Peripheral Vascular Tray 4) Sterile O.R. Prep Tray 5) LTC/Laparoscopy Tracepak 6) Dr. Calhoun Lap Chole 7) Exit Site Care Kit 8) Pgy-Bk Peritonitis Kit 9) Patient Prep Tray 10) Diag. Gyn. Lapar Tracepak 11) Dr. Danielson ACF Tracepak 12) Cath Lab Pacemaker 13) Dr. Pridjian Heart Tracepak 14) Exploratory Lap Tracepak 15) Prostatectomy Tracepak Codes: Product code Lot number 1) 50-13363 501105 2) 50-10751 500067 3) 50-3052 485681 4) 50-750 494735 5) 90-0185 509809 6) 90-0224 505813 7) 50-9246 492900, 503238 8) 50-9248 503239 9) 50-002 500644 10) 90-1342 502793, 511059 11) 90-1031 507203 12) 90-1742 510730 13) 90-1972 505551, 505473 14) 90-0731 508799 15) 90-2229 505715 REASON: Examination gloves in surgical kits fail leak test due to defects and holes MANUFACTURER: DeRoyal Orthopedic Fabrication, Maynardville, TN RECALLED BY: The DeRoyal Industries, Inc Powell, TN, by letter dated 8/15/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: LA, PA, TN, NY, OK, CA, MN, MS and NC QUANTITY: 358 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1208-1/Z-1209-1, Allograft Heart Valve, Codes: Serial No. - 6226337 - Model No. AV05 Serial No. - 6226345 - Model No. PV05 Serial No. - 6289924 - Model No. AV00 Serial No. - 6289932 - Model No. PV00 REASON: Donor does not meet current guidelines for serodilution of plasma MANUFACTURER/RECALLING FIRM: CryoLife, Inc. Kennesaw, GA RECALLED BY: Firm issued recall letters on 5/12/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ, MT, MO and GA. QUANTITY: 4 valves _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1210-1, MacConkey Agar w/ Sorbitol, Product No. 01-556, packaged 10 plates per sleeve, Codes: MacConkey Agar w/ Sorbital, Catalog No. 01-556, Lot No. 057184, Exp. Date 02-12-01 REASON: Product is mislabeled as MacConkey Agar w/ Sorbital. MANUFACTURER/RECALLING FIRM: Remel Inc. Lenexa, KS RECALLED BY: Manufacturer via letter dated 1/2/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 2,730 plates ______________________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1211-1, 18" Flat Panel Color LCD Monitor with touch screen, Codes: Part Number: 0160-00-0059, Serial Number: 01-9694, 01-9698, 01- 9682, 01-9683, 01-9688, 01-9696, 01-9700, 01-9703, 01-9699. Distributed in France: 01-9685, 01-9686, 01-9690, 01-9695, 01-9704, 01-9901 REASON: In attempting to incline the monitor, the montior may tip over MANUFACTURER/RECALLING FIRM: DataScope Corp.,Mahwah, NJ RECALLED BY: Customer notification of the field correction was initiated by certified mail on 6/28/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and International QUANTITY: 15 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1214-1/Z-1215-1, Allograft Heart Valve, Model Numbers AV00 and PV00, Codes: Model Number AV00 - Serial Number 3861457 Model Number PV00 - Serial Number 3861465 REASON: Donor does not meet current guidelines regarding serodilution of plasma MANUFACTURER/RECALLING FIRM: Cryolife, Inc. Kennesaw, GA RECALLED BY: Firm issued letter on 8/6/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: OH QUANTITY: 2 valves _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1216-1/Z-1217-1, Allograft Heart Valve, Model Numbers AV00 and PV00, Codes:Model AV00 - Serial Number 3789357 Model PV00 - Serial Number 3789349 REASON: Donor does not meet current guidelines regarding serodilution of plasma MANUFACTURER/RECALLING FIRM: Cryolife, Inc. Kennesaw, GA RECALLED BY: Firm issued letters on 7/27/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: TN and WA QUANTITY: 2 valves _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1218-1/Z-1219-1, Allograft Heart Valve, Model Number AV00 and PV00, Codes: Model No. AV00 - Serial Number 3896536 Model No. PV00 - Serial Number 3896528 REASON: Donor does not meet current guidelines regarding serodilution of plasma MANUFACTURER/RECALLING FIRM: Cryolife, Inc. Kennesaw, GA RECALLED BY: Firm issued a letter on 8/6/01 . FIRM INITIATED RECALL: Ongoing DISTRIBUTION: IN QUANTITY: 2 valves _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1220-1, Allograft Heart Valve, Model Number PV00 Codes: Model No. PV00 - Serial Number 6335756 REASON: Donor does not meet current guidelines regarding serodilution of plasma MANUFACTURER/RECALLING FIRM: Cryolife, Inc. Kennesaw, GA RECALLED BY: Firm issued a letter on 8/9/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: New York, NY QUANTITY: 1 valve _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1221-1, Monticelli Spinelli Single Action Wire Tensioner Wire Tensioner Orthopedic Manual Surgical Instrument Codes: Product: Monticelli-Spinelli Single Action Wire Tensioner Catalog No: 5119-0-850 Lot: All manufacturing lot codes REASON: The internal mechanism may experience wear that eventually hinders its function MANUFACTURER: Stryker Trauma Geneva, Switzerland, RECALLED BY: Howmedica Osteonics Corp., Rutherford, NJ, by letter on 4/20/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Australia QUANTITY: 128 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1222-1, Baxter Interlink System Micro-Infusion Manifold with 4-Way Stopcock and Extension Set, product code 2N3411; Baxter Healthcare Corporation, Deerfield, IL, Codes: Product code 2N3411, lot U557207R REASON: Pinholes in packaging compromise the sterility of the product MANUFACTURER: Baxter Healthcare Corp. of Puerto Rico Aibonito, PR. RECALLED BY: Baxter Healthcare Corp., Round Lake, IL, by letter dated 7/10/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN and Japan QUANTITY: 2150 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1224-1/Z-1226-1 Codes: A) Bivona Flextend Plus pediatric cuffless tracheostomy tube. All catalog numbers beginning with 60PFP. All lots. B) Bivona Flextend Standard pediatric cuffless tracheostomy tube. All catalog numbers beginning with 60PFS. All lots. C) Bivona obturators labeled for use with Bivona Flextend Plus or Flextend Standard tracheostomy tubes. All catalog numbers beginning with the letters OBT and ending with the numbers –009-3. All lots. REASON: Obdurator tip may not be bonded to the shaft MANUFACTURER/RECALLING FIRM: Bivona Medical Technologies, Inc. Gary, IN. RECALLED BY: The firm, by telephone on 8/15/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Belgium, England, France and Germany QUANTITY: 548RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1155-1, Steris Quick Connect, Model C1665, is designed to process the Olympus 20D Series and BF-XT20 Bronchoscopes in STERIS SYSTEM I Sterile Processing System, with C1160 Universal Processing Tray. Codes: Lot Number: CA22900, Catalogue Number: #QC 1665. REASON: The tubing in the kits are labeled with an incorrect endoscope model number. MANUFACTURER/RECALLING FIRM: Steris Corp. Mentor, OH RECALLED BY: The firm, by telephone on 9/15/2000. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: GA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1213-1, BD Vacutainer Plus Plasma Separator Tube (PST) 4.5.ml 13 x 100, Codes: Catalog Number: 367962, Lot Number: 1008353 REASON: Some tubes did not have required amount of Lithium Heparin MANUFACTURER: Becton Dickinson & Co., Broken Bow, NE RECALLED BY: Becton Dickinson & Co. Franklin Lakes, NJ. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 1,017,000 tubes _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1223-1, Software versions AE through AL (except AI) for the Bayer Advia Centaur Automated Chemiluminescence Immunoassay System. The affected software was distributed as a component of the Advia Centaur Automated Chemiluminescence Immunoassay system. Codes: Software versions AE through AL, except version AI. Catalog Number: 120535 REASON: Software defect. MANUFACTURER/RECALLING FIRM: Bayer Corporation Tarrytown, NY RECALLED BY: Manufacturer, by letter on 1/29/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and France, Canada, Belgium, Australia, Sweden and Germany. QUANTITY: 57 units contain the affected softwareRECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Ruminant Custom Mix Feeds: V-388-1 "Beef Feed" manufactured with Buckeye 40% Beef Finisher Pellets, Item 40950. V-389-1 "Rita's Goat Feed" manufactured with Buckeye 39% Lamb Conc. Pellets, Item 41250. V-390-1 "Calf-Beef/Dairy Feed" manufactured with Buckeye 32% Golden Expectation Pellets, Item 42150 V-391-1 "Feed with Vitamin A" manufactured with Buckeye Vitamin A-30, Item 1614 V-392-1 "Feed/A-D-E Premix" manufactured with Buckeye A-D-E Mix, Item 152850 V-409-1 "Calf Feed" manufactured with Buckeye 32% Calf Grower Concentrate, Item 42350 Non-Ruminant Custom Mix Feeds: V-393-1 "40% Poultry Feed" manufactured with Buckeye 40% Poultry Concentrate Crumbles, Item 12100 V-394-1 "40% Hog Feed" manufactured with Buckeye 40% Gro'Em Lean, Item 20550 V-395-1 "Horse Premium Mixer" manufactured with Buckeye 32% Premium Mixer Pellets, Item 38000 Code: All bulk custom mix feeds manufactured prior to April 20, 2001. The customer invoices indicate the type of Buckeye supplement used in the bulk feed. REASON: The bulk custom mix feeds were prepared with ruminant feed supplements recalled by Buckeye Nutrition due to contamination with protein derived from mammalian tissues. The non-ruminant bulk custom mix feeds were not labeled with the required BSE caution statement "Do Not Feed to Cattle or Other Ruminants." MANUFACTURER/RECALLING FIRM: Ferrin Cooperative Equity Exchange, Inc., Carlyle, Illinois RECALLED BY: The firm , by letter beginning on June 28, 2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: IL QUANTITY: 169 tons of ruminant feeds and 27 tons of non-ruminant feedsEND OF ENFORCEMENT REPORT FOR October 10, 2001. ####
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