August 1, 2001 01-30RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-443-1, Muszelki Chocolate Filled Candy Walnut Flavor packed in flexible plastic packages, net wt. 8 oz., product of Poland. There are 48 - 8 oz. packages per case. (Note: This product was distributed in 1997.) The product was not coded but can be identified by barcode # 0 76841 01273 1. REASON: New York State Department of Agriculture and Marketsí analysis found that the product contained undeclared peanuts. MANUFACTURER: Unknown RECALLED BY: Adamba Imports International Inc., Brooklyn, NY via press release and telephone beginning on 4/28/00. The firm additionally sent recall letters on 5/19/00. STATE INITIATED RECALL: Complete DISTRIBUTION: NY, CA, WA, PA, CT, MA, MD, NJ QUANTITY: 823.5 cases (48 - 8 oz. packages per case) of productRECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: a) F-440-1 Yellow Tortillas b) F-441-1 Green Tortillas TORTILLAS PACKED 60 DOZEN PER CORRUGATED CASE. CASE LABELED IN PART "DEL RIO QUALITY MEXICAN PRODUCTS SABOR DEMEXICO INGREDIENTS Stoneground Corn Masa Flour, Water, Calcium Propionate, Citric acid and a trace of Lime 7 OZ. CORN 60 DOZ. ***". PRODUCT IS NOT CODED REASON: a) The yellow tortillas contain undeclared FD&C Yellow No. 5, FD&C Red No. 40, and propylparaben. b) The green tortillas contain undeclared FD&C Yellow No. 5, FD&C Blue No. 1, and propylparaben. MANUFACTURER/RECALLING FIRM/: DEL RIO PROCESSING COMPANY, SEATTLE, WA RECALLED BY: THE RECALLING FIRM VISITED CUSTOMERS 2/12 THRU 14/01. THE PRODUCT WAS RELABELED. A LETTER WAS PROVIDED TO EACH CUSTOMER STATING THE PRODUCTS DID NOT CONTAIN THE PROPER INGREDIENT STATEMENT. THE LETTER PROVIDED THE UNDECLARED INGREDIENTS FOR EACH COLOR OF TORTILLA. FIRM INITIATED RECALL: Complete DISTRIBUTION: Seattle, WA QUANTITY: 2,819 cases of yellow 15 cases of green _______________________________ RECALL NUMBER, PRODUCT AND CODE: Recall number F-439-1 is assigned to both brands of cherry pie. a. Hostess Fruit Pie,Cherry, net wt. 4.5 oz., packaged in a paper wrapper. The responsible firm on the label is Interstate Brands Corp., Kansas City, MO. b. Countrys' Delight Cherry Pie, net wt. 4.5 oz., packaged in a paper wrapper. The responsible firm on the label is Certified Grocers Midwest, Inc., Hodgkins, IL. REASON: The product was contaminated with glass. MANUFACTURER: Interstate Brands Corp., Schiller Park, IL RECALLED BY: Interstate Brands Companies, Kansas City, MO, sent a letter on 11/28/00, to the vending machine customers informing them the product may contain a foreign substance and was being withdrawn. The product was removed from the retail shelves by company route sales personnel beginning on 11/28/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Chicago, IL, Indianapolis, IN, Columbus, OH, Columbus, IN, and Davenport, IA QUANTITY: 54,240 pies (53,040 under the Hostess label; 1,200 under the Country Delight label) _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-438-1, Diet Pepsi in 20 oz. plastic bottles with a Grand Slam Game promotional label, UPC #121300 Bottles were coded 1230QY042512. REASON: The bottles actually contain Wild Cherry Pepsi sweetened with high fructose corn syrup or sugar. MANUFACTURER: Wis-Pak of Quincy, Quincy, IL RECALLED BY: Wis-Pak , Watertown, WI, by telephone on 5/16/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL and northern MO QUANTITY: 408 bottles _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-446-1, Hood Light Chocolate Cookie Dough Ice Cream, Half-Gallon. Code Date located on end flap: "04/24/02". REASON: The product contains undeclared almonds. MANUFACTURER/RECALLING FIRM: H.P. HOOD INC, SUFFIELD, CT RECALLED BY: H.P. HOOD INC., CHELSEA, MA FIRM INITIATED RECALL: Complete DISTRIBUTION: New England States and NY QUANTITY: 49 packages RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-442-1 Red Tortillas , TORTILLAS PACKED 60 DOZEN PER CORRUGATED CASE. CASE LABELED IN PART "DEL RIO QUALITY MEXICAN PRODUCTS SABOR DEMEXICO INGREDIENTS Stoneground Corn Masa Flour, Water, Calcium Propionate, Citric acid and a trace of Lime 7 OZ. CORN 60 DOZ. ***". NO CODE REASON: The red tortillas contain undeclared red No. 40 and propy MANUFACTURER/RECALLING FIRM: DEL RIO PROCESSING COMPANY, SEATTLE, WA RECALLED BY: The product was relabeled during customer visits conducted by the recalling firm on 2/12 - 14/01. A LETTER WAS PROVIDED TO EACH CUSTOMER STATING THE PRODUCTS DID NOT CONTAIN THE PROPER INGREDIENT STATEMENT. FIRM INITIATED RECALL: Complete DISTRIBUTION: Seattle, WA QUANTITY: 22 CS _______________________________ RECALL NUMBER, PRODUCT AND CODE: a) F-444-1, Re/Neph HP/HC, Vanilla Flavored Renal Supplement. CODE: #692726L01, exp date 9/29/01, Stock Code 60020 b) F-445-1, Re/Neph FREE, HP/HC, No Sugar Added Lactose Free, Vanilla Flavored Renal Supplement. ) CODE: #730186L02, exp date 2/1/02, Stock Code 60011. Both products are packaged under the NutraBalance label, in 4 oz cardboard cartons, and sold frozen. REASON: a) The cartons actually contain Re/Neph Free HP/HC product. b) The cartons actually contain Re/Neph HP/HC product. MANUFACTURER/RECALLING FIRM: Prairie Farms Dairy, Inc., Anderson, IN RECALLED BY: Ross Products Division, Abbott Laboratories, Inc., Columbus, OH FIRM INITIATED RECALL: Ongoing DISTRIBUTION: PA, TN, MN, KY, MI, TX, NY, OH, FL, NJ, MO, IN, and SC. QUANTITY: 939 CasesRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-265-1, ECO DENT ULTIMATE NATURAL DAILY RINSE, Tangy Orange-Clove,labeled in part,"ECO-DENT***PREMIUM ORAL CARE PRODUCTS***Tangy Orange-Clove Ultimate Essential MouthCare Natural Daily Rinse***Mer- flu-an*** 8 fl. oz/237 ml** CODE: Lots 9431, 0002, 0376. REASON: BACTERIA CONTAMINATION; Pseudomonas alcaligenes & Pseudomonas baleurica MANUFACTURER/RECALLING FIRM: TRUETT LABORATORIES, INC., CA RECALLED BY: The firm issued a recall letter dated July 9, 2001 to all distributors. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AR, AZ, CA, CO, FL, IA, IN, NH, NJ, NY, OH, OR, TX, VT, WI AND INTERNATIONALLY TO CANADA AND AUSTRALIA QUANTITY: 14,209 8 oz bottlesRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
______________________________ RECALL NUMBER,PRODUCT AND CODE: B-1613-1 Crushed Cancellous Chips Tissue ID #s 990078-003, 990078-004, 990078-005, 990078-006, 990078-007, 990078-008, 990078-009, 990078-012, 990078-014, 990078-019, 990078-021, 990078- 022, 990078-023 Fascia Lata Tissue ID #990078-024, 990078-025 Achilles Tendon Tissue ID #990078-027 Cortical Cancelleous, unprocessed Tissue ID #990078-028 Unprocessed Cartilage Tissue ID #990078-002 REASON: Tissues for transplant, that were contaminated with E.coli, or corresponded to a donor whose tissue was implicated in the transmission of E-coli, were distributed. MANUFACTURER/RECALLING FIRM: South Texas Blood and Tissue Center, San Antonio, Texas RECALLED BY: Telephone on October 10, 2000 and letters between May 14 and June 1, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: TX and CA QUANTITY: 18RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1725-1, Source Plasma, units G-53071-009, G-53091-009 REASON: Blood products, collected in manner that compromised the sterility of the units, were distributed. MANUFACTURER: Alpha Therapeutic Corporation, Tacoma, WA RECALLED BY: Alpha Therapeutic Corporation, Los Angeles, CA, notified consignees located in California by fax dated February 6, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1726-1, Red Blood Cells, unit H68034 B-1727-1, Platelets, unit H68034 B-1728-1, Frozen Recovered Plasma, unit H68034 REASON: Blood products, which tested negative for antibody to hepatitis C virus (anti- HCV), but collected from a donor that previously tested repeatedly reactive, were distributed. MANUFACTURER/RECALLING FIRM: Nueces County Medical Society Community, Corpus Christi, TX RECALLED BY: The recalling firm notified consignees located in Texas and California by letter or fax dated September 29,2000 or October 9, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX and CA QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1729-1, Source Plasma Units 31608961, 28487654, 27826591, 27627884, 27460436, 27458808, 27453704, 27451076, 27375105, 27372883, 23366787, 23364462, 23198203, 23195417, 23498259, 23495678, 23108882, 23106291, 23101180, 22294265, 22291639, 26087191, 23520394, 23514430, 23511798, 23793279, 23790773, 23693180, 19870236, 43802562 REASON: Blood products, which tested negative for antibody to hepatitis C virus (anti- HCV), but collected from a donor that previously tested repeatedly reactive, were distributed. MANUFACTURER/RECALLING FIRM: Sera-Tec Biologicals Limited Partnership, Toledo, Ohio RECALLED BY: The recalling firm notified consignees located in California and New York by fax dated March 30, 2001 or April 11, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA and NY QUANTITY: 30 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1730-1, Red Blood Cells, units 42FW79310, 42Y10050 B-1731-1, Platelets, unit 42Y10050 B-1732-1, Recovered Plasma, unit 42Y10050 REASON: Blood products, collected from a donor taking the drug Purinethol for Crohnís disease, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH RECALLED BY: The recalling firm notified consignees located in Ohio and California by telephone, letter or fax on March 26, 2001, April 3, 2001 or April 4, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH and CA QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1735-1, Recovered Plasma, Frozen, Unit 12FK28839 REASON: Blood product, collected from an unsuitable donor based on a history of hepatitis, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Carolinas Region, Charlotte, NC RECALLED BY: The recalling firm notified a California consignee by letter dated April 30, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1758-1, Source Plasma, units 38624582, 38653087 REASON: Blood product, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed MANUFACTURER/RECALLING FIRM: Nabi BioMedical Center, Corpus Christi, TX RECALLED BY: The recalling firm notified the California consignee by fax on September 13, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1759-1, Platelets, unit 2105657 REASON: Blood product, collected from an ineligible donor, was distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria, OH RECALLED BY: The recalling firm notified the Ohio consignee by letter dated March 16, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1761-1, Red Blood Cells, unit 4168875 B-1762-1, Fresh Frozen Plasma, unit 4168875 REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis B core antigen (anti-HBc), were distributed. MANUFACTURER/RECALLING FIRM: Blood Center of New Jersey, East Orange, NJ RECALLED BY: The recalling firm notified consignees located in New Jersey by letter dated February 24, 2000 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NJ QUANTITY: 2 unitsRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1640-1, Red Blood Cells, unit 3567383 B-1641-1, Platelets, unit 3567383 B-1642-1, Source Leukocytes, unit 3567383 REASON: Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, TX RECALLED BY: The recalling firm notified consignees, located in Texas and New Jersey, by facsimiles dated September 11, 2001. FIRM INITIATED RECALL: ONGOING DISTRIBUTION: TX and NJ QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1685-1, Red Blood Cells, unit M30637 B-1686-1, Platelets, unit M30637 B-1687-1, Recovered Plasma, unit M30637 REASON: Blood products, collected from a donor who lived in an HIV Group O risk area, were distributed. MANUFACTURER: Michigan Community Blood Center, Saginaw Valley Blood Program, Saginaw, Michigan RECALLED BY: Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI, notified consignees located in Michigan and Switzerland by fax dated November 28, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI and Switzerland QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1689-1, Red Blood Cells, units 04C03680, 04C12090 B-1690-1, Platelets, unit 04C12090 B-1691-1, Recovered Plasma, units 04C03680, 04C12090 REASON: Blood products, collected from a donor who engaged in high-risk behaviors, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, New England Region, Dedham, MA RECALLED BY: The recalling firm notified consignees located in Massachusetts by letter dated February 27, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA QUANTITY: 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1723-1, Red Blood Cells, unit FK23676 B-1724-1, Cryoprecipitate, unit FK23676 REASON: Blood products, collected from a donor who was taking the drug Amantadine for Parkinsonís disease, was distributed. MANUFACTURER/RECALLING FIRM: Healthcare Provider Services Inc., Rhode Island Blood Center, Providence, RI RECALLED BY: The recalling firm notified consignees located in Rhode Island and Mississippi by telephone on January 4, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: RI and MS QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1733-1, Source Plasma, units S0020R, S0021R, S0022R, S0023R, S0024R, S0021B, S0022, S0023, S0024 REASON: Blood products, which were exposed to an unacceptable storage temperature and not relabeled as Source Plasma, Salvaged, were distributed. MANUFACTURER/RECALLING FIRM: Indianapolis Blood Plasma, Inc., Indianapolis, IN RECALLED BY: Indianapolis Blood Plasma, Inc., Cincinnati, OH, notified consignee located in North Carolina by letter dated March 6, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY: 9 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1734-1, Platelet Pheresis, Leukoreduced, unit 12LT50607 REASON: Unlicensed blood product was distributed in interstate commerce. MANUFACTURER/RECALLING FIRM: American Red Cross, Carolina Region, Charlotte, NC RECALLED BY: The recalling firm notified consignee located in South Carolina by telephone on June 19, 2000 and by letter dated December 22, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: SC QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-639-1 - Castle Model GCL 500 Surgical Light; Z-640-1 - Castle Model GCL 550 Surgical Light; Z-641-1 - Castle Model GCL 750 Surgical Light; Z-642-1 - 500 Series Lamp Head, Serial #GL 9911017 - GL 0003051. REASON: Excessive force on the surgical lamp head may cause one of the welded joints in the suspension yoke to fail. MANUFACTURER/RECALLING FIRM: Getinge/Castle, Inc., North Charleston, SC RECALLED BY: Field correction notice sent to manufacturer dated March 27, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada, Sweden, South Africa, Egypt, Malaysia and Mexico QUANTITY: 182 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-709-1, H-TRONplusV100 Insulin Infusion Pump REASON: Labeling claims insulin pump is waterproof but some pumps malfunctioned when exposed to water. MANUFACTURER/RECALLING FIRM: Disetronic Medical Systems, St. Paul, MN RECALLED BY: An ìImportant Safety Informationî letter dated March 14, 2001 was sent to all patients using the pump and to physicians, educators and distributors. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 30,000 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0665-2, Medtronic Membrane Oxygenator with Integral Heat Exchangers Model Number I-4500-2A Z-0666-1, Medtronic Membrane Oxygenator with Integral Heat Exchangers Model Number I-3500-2A. CODE: The firm distributed 7 units from lot 0103002433 (Model I-4500-2A) for clinical use, and 46 units of lot 0103002707(Model I-3500-2A) for non-clinical use. REASON: Shorter than specified forced aeration has resulted in higher EtO levels. MANUFACTURER/RECALLING FIRM: MEDTRONIC, INC., MINNEAPOLIS, MN 55432 RECALLED BY: Sales representatives contacted hospital customers on May 11, 2001, and informed them not to use the product. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: MI, MO, NC and CA QUANTITY: 53 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0717-1, Silhouette Five-Sided Nut Driver (part 7010-0021-00) for the Sulzer Spine-Tech Silhouette Spinal Fixation System. The Five-Sided Nut Driver is distributed in a case of instruments labeled "SILHOUETTE SCREW INSTRUMENT GENERIC CASE COMPLETE SET: 7050-0000-00". CODE: ALL LOTS. REASON: The socket of a tool used for locking nuts for a spinal fixation device can slip. MANUFACTURER: Beere Precision, Racine, WI; Metal Craft Machine & Engineering, Inc., Elk River, MN; and Houck Machine Company, Minneapolis, MN. RECALLED BY: SULZER SPINE-TECH , MINNEAPOLIS, MN, sent a September 15, 2000 "Confidential Memorandum", which gave the reason for the recall and requested that the Five- Sided Nut Drivers be removed from the instrument kits in distribution and returned to the firm. FIRM INITIATED RECALL: Complete DISTRIBUTION: 1 to U.S. and 53 distributed to Australia, China, Japan, South Korea and Switzerland. QUANTITY: 304 tools (Estimated 240 in possession of company representatives). _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0720-1, ZOmega IV Angiographic Table, (angiographic x-ray system), Model: 2120637; Z-0721-1, ZOmega IV Angiographic Table, (angiographic x-ray system), Model: 2219154; Z-0722-1, ZOmega IV Angiographic Table, (angiographic x-ray system), Model: 2154474; Z-0723-1, ZOmega IV Angiographic Table, (angiographic x-ray system), Model: 2219155; Z-0724-1, ZOmega IV Angiographic Table, (angiographic x-ray system), Model: 2252036; Z-0725-1, ZOmega IV Angiographic Table, (angiographic x-ray system), Model: 2252037 Code Information: Model Numbers: 2120637, 2219154, 2154474, 2219155 - All units manufactured are to be corrected. Model Numbers 2252036, 2252037 - All units manufactured prior to May, 2001 are to be corrected. REASON: Cable that controls table movement could break resulting in uncontrolled motion MANUFACTURER: GE MEDICAL SYSTEMS EUROPE, FRANCE RECALLED BY: GENERAL ELECTRIC MEDICAL, WAUKESHA, WI issued field modification instructions on 05/01/2001 to GE's field engineers. Two control cables on each unit are to be replaced by better cables. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada, Europe, Latin America and Asia QUANTITY: 512 nationwide and 700 worldwide _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0726-1, Medtronic Micro Jewel II Implantable Cardioverter Defibrillator, Model 7223Cx CODE: There are about 8000 mostly non-consecutive serial numbers which are not in one or a few ranges. The devices were made and distributed in the last month of 1996 and the first half of 1997. REASON: Extended Charge times, which can delay the delivery of cardioversion and defibrillation therapies, and allow the extension of ventricular fibrillation or other tachyarrhythmia event. MANUFACTURER/RECALLING FIRM: Medtronic, Inc., Minneapolis, MN 55432-3576 Medtronic Med Rel, Inc. Rd, Puerto Rico 00791 Medtronic, B.V. European Service and Technology Center, The Netherlands RECALLED BY: MEDTRONIC, INC., MINNEAPOLIS, MN, sent an ìImportant Update on Micro Jewel II (7223Cx) ICD Charge timeî letter, dated November 10, 2000. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and worldwide QUANTITY: 8000 defibrillatorsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-687-1, X-100 Suspension System for Carl Zeiss Dental Surgical Microscope, Catalog Numbers: 000000-1080-347, 000000-1080-344, 000000-1080-324. Serial Numbers: 346526,346422,346522,346517,346505,346501,346518,349893, 351941,351972,351932,351971,346418,346518,349893,351941,351972,351932,351971,346 418,350201,346558,350308,350373,351921, and 351924 REASON: A tertiary screw in the microscope-to-stand coupling may not secure the coupling of two components. MANUFACTURER/RECALLING FIRM: Carl Zeiss, Inc., Thornwood, N.Y. 10594 RECALLED BY: On 5/8/01, Carl Zewiss sent ìNotice of Field Corrective Actionî letters. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 19 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-707-1, Roche HbAlc Calibrator, Code: Catalog No. 0755664/47110 REASON: A negative bias of up to 10% may be observed in patient results. MANUFACTURER/RECALLING FIRM: Roche Diagnostics Corps, Indianapolis, IN RECALLED BY: The firm sent an Urgent Product Removal letter dated 06/22/01 to customers. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada QUANTITY: 1320 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-712-1, Havel's brand 5-0 Plain Gut Sterile Absorbable Surgical Suture, U.S.P., with CC-77 Needle or C-3 Needle. One needle with suture is packaged in a sterile pouch, 12 pouches per carton. CODE: Lot Numbers: #MG02540 and #MG03830. REASON: The sterile suture needles may be defective with rust-like corrosion. MANUFACTURER/RECALLING FIRM: SURGICAL SPECIALTIES CORP. 100 DENNIS DRIVE READING, PA RECALLED BY: HAVEL'S INC. 3726 LONSDALE STREET CINCINNATI, OH, mailed a recall letter on 11/7/2000. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 154 cartons _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0713-1 Architect Anti-HBS Reagent Kitlist 7C18-30 This is an in vitro diagnostic Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of antibody to Hepatitis B surface antigen (anti-HBs) in human serum and plasma used to monitor the success of Hepatitis B vaccination and to monitor the convalescence and recovery of Hepatitis B infected individuals. CODE: List 07C18-30, lot 71120M300 REASON: Microbial growth MANUFACTURER/RECALLING FIRM: ABBOTT LABORATORIES, INC. ABBOTT PARK, IL 60064 RECALLED BY: Abbott's Japanese subsidiary sent recall letters dated 3/1/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Japan QUANTITY: 62 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0718-1, Scanlan Diethrich-Potts Scissors, Micro Fine Tips, Super Cut and Ultra Sharp. CODES: O94, P91, P92, P93, P94, Q91, Q92, Q93, Q94, R91, and R92 REASON: Scissors blades could break in high stress situations (e.g. sterilization). MANUFACTURER/RECALLING FIRM: SCANLAN INTL., INC. ST PAUL, MN 55107 RECALLED BY: On 10/13/00, recalling firm sent a recall letter to consignees. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and worldwide QUANTITY: 1505 scissors _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0719-1, Focus Dailies Spherical Contact Lenses, Lot No. 1096004 REASON: The primary label indicated Focus Dailies Spherical, while the secondary label indicates Focus Dailies Progressive. MANUFACTURER/RECALLING FIRM: Ciba Vision Corp., Duluth, GA RECALLED BY: Recalling firm sent letter on 5/10/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: AZ, FL, MA, MO, NM, NC, PA QUANTITY: 10/15 packs were shippedRECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: V-385-1 - Rock-N-Rooster Competition Blend, lots: K01611 K01719 K01912 K01916 K02012 K02015 K02214 K02310 K02314 K02318 K02519 K02615 K02917 K03018 K03114 K03215 K03316 K03413 K10116 K10119 K10219 K10313 K10417 K10610 K10714 K10914 K11115 K11214 K11412 K11512 K02019 K02813 K03516 K10616 K11515 V-386-1 - Rock-N-Rooster Premium Five-Grain Scratch, lots: K01611 K01715 K01718 K01812 K01912 K01916 K02012 K02015 K02019 K02117 K02214 K02310 K02318 K02513 K02518 K02710 K02719 K02813 K02910 K02917 K03011 K03018 K03114 K03215 K03413 K03418 K03516 K03517 K10012 K10013 K10115 K10119 K10219 K10310 K10312 K10410 K10611 K10614 K10616 K10713 K10810 K10812 K10914 K10919 K11012 K11114 K11115 K11216 K11213 K11214 K11315 K11412 K11419 K11512 K01918 K02314 K02814 K03316 K101121 K10510 K10819 K11211 K11515 V-387-1 - Rock-N-Rooster Maintainer, lots: K01611 K01719 K01812 K01912 K01916 K01918 K02015 K02117 K02314 K02318 K02513 K02519 K02813 K02814 K02917 K03011 K03018 K03114 K03316 K03413 K03418 K03514 K03516 K03517 K10116 K10119 K10219 K10312 K10417 K10512 K10617 K10714 K10810 K11012 K11115 K11211 K11315 K11512 K11515 K02012 K02615 K03215 K10012 K10616 K11214 REASON: The product contained prohibited material; however, the bags were not labeled with the required BSE cautionary statement. MANUFACTURER/RECALLING FIRM: Southern States Cooperative, Inc., Richmond, Virginia RECALLED BY: The recalling firm ceased distribution on June 6, 2001, and notified feed mill distributors and distribution points by e-mail on June 6 and 7, 2001, to stop sale and notify their retail customers of the stop sale and provide further instructions for relabeling of any of the affected inventory. The firm sent labels with the cautionary statement to their consignees. FIRM INITIATED RECALL: ONGOING DISTRIBUTION: KY, VA, MD, WV, NC, SC, GA, AL, DE, FL, MS and TN QUANTITY: 962 tonsEND OF ENFORCEMENT REPORT FOR August 1, 2001. ####
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2001-AUG-02.