July 04, 2001 01-26
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-435-1 Product labeled as: "Nature's Wealth brand Chelated Potassium 99 mg Dietary Supplement", 100-tablets bottles. Firm identified on the label: "Natural Welath Nutrition Corp Bohemia, Ny". REASON: Bottles labeled as "Chelated Potassium 99 mg" actually contained a different product, "Ultra Vita-Min Ultra Potency Vitamin & Mineral Formula". MANUFACTURER: NBTY, Inc., Bohemia, NY RECALLED BY: The firm sent a recall letter, dated 12/01/00. FIRM INITIATED RECALL: Complete. DISTRIBUTION: Nationwide QUANTITY: 1086 - 100 tablet bottlesRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________________________________ RECALL NUMBER, PRODUCT AND CODE: D-240-1, ADAGEN (pegademase bovine injection) 250 units per mL. Intramuscular use only 1.5 mL single-dose vials (units of 4) Rx only. NDC 57665-001-01 NDA 19-818 REASON: Cross contamination with FOMEPIZOLE (4-METHYL-PYRAZOLE) MANUFACTURER/RECALLING FIRM: Enzon, Inc, Piscataway, NJ RECALLED BY: Manufacturer, on March 23, 2001, by telephone. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: CA, FL, IL, LA, MD, MA, NY, NC, OH, OK, TN, TX, UT and including Japan, Australia, Canada, Denmark, Croatia, France, Germany, Italy, Switzerland, and Spain QUANTITY 792 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-241-1, Serostim, 6 mg. vials (somatropin rDNA origin for injection), 7 vials per carton with 7 vials of sterile diluent. Lot Number MNH605A, Exp. 4/02 REASON: COUNTERFEIT MANUFACTURER: Unknown RECALLED BY: Distributor or recalling firm, issued recall notice via letter on 5/15/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: GA, SC and SC QUANTITY: 4 cartons, 7 x 6 mg. vials per cartonRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-887-1, Red Blood Cells, unit 4056710 B-888-1, Platelets, unit 4056710 REASON: Blood products, collected from a donor with Crohn’s disease, were distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center, Dayton, OH RECALLED BY: The recalling firm, by letters dated September 28, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: 2 units _______________________________ RECALL NUMBER,PRODUCT AND CODE: B-1130-1, Red Blood Cells Leukoreduced, unit 12GR03564 REASON: Blood product, which was collected from a donor with active post- poliomyelitis muscular atrophy, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Carolinas Region, Charlotte, NC RECALLED BY: The recalling firm, by telephone on February 18, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1449-1, Red Blood Cells, unit 1727888. REASON: Blood products, collected from a donor with a history of Hodgkin’s Disease, were distributed. MANUFACTURER/RECALLING FIRM: Central Indiana Regional Blood Center, Indianapolis, Indiana RECALLED BY: The recalling firm, by letter dated September 8, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN and Switzerland QUANTITY 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1461-1, Red Blood Cells, unit number 04R64529 REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, New England Region, Dedham, MA RECALLED BY: The recalling firm, by letter dated January 22, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1462-1, Red Blood Cells (2 units), unit number 04GJ02418 (split unit) REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, New England Region, Dedham, MA RECALLED BY: The recalling firm, by letter dated January 23, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA QUANTITY 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1463-1, Red Blood Cells, unit number 04FC79460 REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, New England Region, Dedham, MA RECALLED BY: The recalling firm notified the consignee, by letter dated January 24, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MA QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1464-1, Red Blood Cells, unit number 53H77398 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD RECALLED BY: The recalling firm, by letters dated December 8, 2000, and December 14, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MD QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1465-1, Red Blood Cells, Leukocytes Reduced, unit number 29GX12243 REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Mid-Atlantic Region, Norfolk, VA RECALLED BY: The recalling firm, by letter dated January 29, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1466-1, Red Blood Cells, unit number 29FW40076 REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Mid-Atlantic Region, Norfolk, VA RECALLED BY: The recalling firm, by letter dated November 16, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: VA QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1467-1, Red Blood Cells, Leukocytes Reduced, unit number 49GN04187 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Southwest Region, Ponca City, OK RECALLED BY: The recalling firm, by letter dated January 8, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OK QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1497-1, Red Blood Cells, units 12FQ48437, 12FP34499, 12FP34084, and 12FR52236 B-1498-1, Fresh Frozen Plasma, unit 12FP34084 B-1499-1, Cryoprecipitated AHF, unit 12FQ48437 B-1500-1, Recovered Plasma, units 12FQ48437, 12FP34499, 12FQ44113, and 12FR52236 REASON: Blood products, which were collected from a donor with a history of Behcet’s Syndrome, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Charlotte, NC RECALLED BY: The recalling firm, by telephone on June 4, 1999 or by letter dated June 8, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC and Switzerland QUANTITY 10 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1506-1, Red Blood Cells, units 1233721, 1242026, 1246035, 1256941 B-1507-1, Platelets, units 1233721, 1246035 B-1508-1. Plasma, unit 1242026 B-1509-1, Fresh Frozen Plasma, unit 1246035 B-1510-1, Red Blood Cells, Leukocytes Reduced, unit 1274972 B-1511-1, Recovered Plasma, unit 1256941 REASON: Blood products, collected from an unsuitable donor due to previously testing positive for HIV, were distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas City, Kansas City, MO RECALLED BY: The recalling firm, by letters dated December 6, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: MO, KS, CA QUANTITY 10 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1523-1, Red Blood Cells (6 units), unit numbers 2201304, 8071111, 5032285, 5025214, 5016026, and 5005762 B-1524-1, Platelets (2 units), unit numbers 2201304 and 5032285 B-1525-1. Cryoprecipitated AHF (2 units), unit numbers 8071111 and 5025214 B-1526-1, Fresh Frozen Plasma (3 units), unit numbers 2201304, 5016026, and 5005762 B-1527-1, Plasma, Cryoprecipitate Removed (1unit), unit number 8071111 B-1528-1, Recovered Plasma (2 units), unit numbers 5032285 and 5025214 REASON: Blood products, that tested negative for hepatitis, but were collected from an unsuitable donor based on previous reactive hepatitis testing, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare, Inc., Elyria, OH RECALLED BY: The recalling firm notified consignees in Ohio, Florida, and Tennessee. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH, FL, TN QUANTITY 16 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1513-1, Red Blood Cells, Leukocytes Reduced, units 0344150, 0345460, 0347722, 0347726, 0347733, 0347738 REASON: Blood products, which were labeled as leukoreduced but did not undergo leukoreduction, were distributed. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas City, Kansas City, MO RECALLED BY: The recalling firm, by telephone on October 13, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: KA QUANTITY 6 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1514-1, Platelets Pheresis, Leukocytes Reduced (2 units), unit number 0079513 (split unit - 2 aliquots distributed) B-1515-1, Platelets Pheresis, Leukocytes Reduced Irradiated (3 units), unit numbers 0079516 (split unit - 1 aliquot distributed) and 0079518 (split unit - 2 aliquots distributed) REASON: Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed. MANUFACTURER/RECALLING FIRM: Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI RECALLED BY: The recalling firm, by letter on January 2, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1529-1, Platelet, Pheresis, Leukoreduced , unit 3872596 REASON: Blood product, with a low platelet count, was distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, Texas RECALLED BY: The recalling firm, by fax dated June 30, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1537-1, Red Blood Cells, unit number 3809631 B-1538-1, Cryoprecipitated AHF, unit number 3809631 B-1539-1, Plasma, Cryoprecipitate Removed, unit number 3809631 REASON: Blood products, collected from a donor who should have been deferred due to use of the medication Arthrotec, were distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, Texas RECALLED BY: The recalling firm, by letter on July 7, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1540-1, Red Blood Cells, unit numbers 42W06650 and 42M97944 B-1541-1, Red Blood Cells, Leukocytes Reduced, unit number 42FH96660 B-1542-1, Platelets, unit number 42FH96660 REASON: Blood products, that tested negative for antibody to hepatitis B core antigen (anti-HBc), but were collected from a donor that previously tested repeatedly reactive for anti-HBc on more than one occasion, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Northern Ohio Region, Cleveland, OH RECALLED BY: The recalling firm, by letter dated February 26, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY 4 units. _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1543-1, Red Blood Cells, Leukocytes Reduced, unit number 18GG34166 REASON: Blood product, that tested negative for antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor that previously tested repeatedly reactive for anti-HBc on more than one occasion, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Great Lakes Region, Lansing, MI RECALLED BY: The recalling firm, by letter dated July 25, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1544-1, Red Blood Cells, Leukocytes Reduced, unit numbers 18FX26150 and 18FX26162 B-1545-1, Platelets, unit numbers 18FX26150, 18FX26158, 18FX26161, and 18FX26162 REASON: Blood products, collected from donors whose donor suitability determinations were inadequately performed, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Great Lakes Region, Lansing, MI. RECALLED BY: The recalling firm, by telephone on January 18, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI and MN QUANTITY 6 _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1585-1, Red Blood Cells, Leukocytes Reduced, unit number 13GQ40747 B-1586-1, Platelets, unit number 13GQ40747 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Southeastern Michigan Region, Detroit, MI RECALLED BY: The recalling firm, by letter dated February 2, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1587-1, Platelets, unit number C24942 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL RECALLED BY: The recalling firm, by letter dated March 19, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1588-1, Red Blood Cells (4 units), unit numbers 3879151 and 3758915 (split units) B-1589-1 Platelets Pheresis (1 unit), unit number 3850090 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, TX RECALLED BY: The recalling firm, by letters on October 20, 2000, and November 1, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY 5 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1590-1, Red Blood Cells, unit number S60865 B-1591-1, Platelets, unit number S60865 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids,MI RECALLED BY: The recalling firm, letter on November 29, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1597-1, Red Blood Cells, Leukocytes Reduced, unit number 3824411 B-1598-1, Platelets, unit number 3824411 B-1599-1, Source Leukocytes, unit number 3824411 B-1600-1, Recovered Plasma, unit number 3824411 REASON: Blood products, collected from an unsuitable donor due to a history of residing in the United Kingdom for more than 6 months, were distributed. MANUFACTURER/RECALLING FIRM: Gulf Coast Regional Blood Center, Houston, TX RECALLED BY: The recalling firm, by letters on August 2, 2000, and April 23, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX, NJ and NY QUANTITY 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1601-1, Red Blood Cells, units 6241118, 6144105 B-1602-1, Recovered Plasma, units 6241118, 6144105 REASON: Blood products, collected from a donor with a history of having tested positive for anti-HCV, 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, Michigan, by letters on or about September 19, 2000 and a Swiss consignee by fax on September 21, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: MI and Switzerland QUANTITY 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1606-1, Source Plasma, units 0420888166, 0420888436, 0420890211, 420890474, 0420891296, 0420891501, 0420892022, 0420892407, 0420893055, 0420893454 REASON: Blood products, collected from a donor who engaged in high-risk behavior, were distributed. MANUFACTURER North American Biologicals, Inc., Lansing, MI RECALLED BY: North American Biologicals, Inc., Boca Raton, FL, by fax dated September 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NC QUANTITY 10 _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1607-1, Red Blood Cells, units 5068746, 5021652, 5006567, 4917781, 4865822, 4809574, 4750536 B-1608-1, Platelets, units 5068746, 4089574 B-1609-1, Plasma, unit 5021652 B-1610-1, Cryoprecipitate, units 5021652, 5006567 B-1611-1, Recovered Plasma, units 5068746, 4917781, 4089574, 4750536 REASON: Blood products, collected from a donor with a history of hepatitis, were distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Dallas, TX RECALLED BY: The recalling firm, by letters dated January 15, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY 16 units _______ RECALL NUMBER, PRODUCT AND CODE: B-1617-1, Hormodendrum cladosporioides, lot 202032000 REASON: Allergenic extract, which failed initial bulk sterility testing, was distributed. MANUFACTURER/RECALLING FIRM: Allergy Laboratories, Inc., Oklahoma City, OK RECALLED BY: The recalling firm, by letter dated February 13, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: OK QUANTITY 1 lotRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-533-1, Red Blood Cells, unit 18FT32301 REASON: Blood product, which was determined to have a hematocrit value greater than 80%, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Great Lakes Region, Lansing, MI RECALLED BY: The recalling firm, by telephone and letter on April 25, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1517-1, Red Blood Cells Units 38L44237, 38FE33563, 38FE33278, 38K59003, 38E70908, 38K59036, 38E70946, 38E77059, 38FE35349, 38FE33509, 38FE32769, 38L43220. B-1518-1, Red blood cells, Leukoreduced, Unit 38FC36671 B-1519-1, Platelets, Units 38FC36671, 38E70946 B-1520-1, Fresh Frozen Plasma, Units 38E70946, 38FE32769 B-1521-1, Recovered Plasma, Units 38L44550, 38FE33563, 38K59003, 38K59036,38L43220 REASON: Blood products, collected from donors who were not asked the question regarding the use of the drug Propecia, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Fort Wayne, IN RECALLED BY: The recalling firm, by letters or fax dated February 16, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA, IN, MI, NY, OH and Switzerland QUANTITY 22 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1530-1, Whole Blood (1 unit), unit number 0276103 B-1531-1, Red Blood Cells (4 units), unit numbers 0249088, 2145854, 4102609, and 4112519 B-1532-1, Red Blood Cells, Leukocytes Reduced (4 units), unit numbers 0269990, 2166487, 0306783, and 2178914 B-1533-1, Platelets (3 units), unit numbers 0249088, 2145854, and 4102609 B-1534-1, Cryoprecipitated AHF (1 unit), unit number 2178914 B-1535-1, Plasma (1 unit), unit number 2178914 B-1536-1, Fresh Frozen Plasma (4 units), unit numbers 0249088, 2145854, 4102609, and 0269990 REASON: Blood products tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-1, were distributed.. MANUFACTURER/RECALLING FIRM: Community Blood Center of Greater Kansas City, Kansas City, MO RECALLED BY: The recalling firm, by letter dated July 11, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MO, KS, NE QUANTITY 18 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1450-1, Recovered Plasma for use in Manufacturing Injectable products, unit 1727888 REASON: Blood product, collected from a donor with a history of Hodgkin’s Disease, were distributed. MANUFACTURER/RECALLING FIRM: Central Indiana Regional Blood Center, Inc., Indianapolis, IN RECALLED BY: The recalling firm, by letters, dated September 8, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Switzerland QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1472-1, Limulus Amebocyte Lysate (LAL) Reagent Water, lot numbers 8L5410 and 9L3690 REASON: LAL Reagent Water, that may cause inhibition of the LAL assay, was distributed. MANUFACTURER/RECALLING FIRM: BioWhittaker, Inc., Walkersville, MD RECALLED BY: The recalling firm, by telephone or facsimile on August 4, 2000 and November 1, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Mexico, Brazil, South Africa, Italy, Belgium, Sweden, Canada, and Pakistan QUANTITY 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1505-1, Platelets, unit 01KX48677 REASON: Blood product, prepared from a unit of Whole Blood with an extended collection time, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY RECALLED BY: The recalling firm notified the consignee by letters dated December 22, 2000 and February 20, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY QUANTITY 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1512-1, Red Blood Cells, unit 53FL89870 REASON: Blood product, which was determined to have a hematocrit value greater than 80%, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD RECALLED BY: The recalling firm, by telephone on December 16, 2000 and by letter dated December 27, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MD QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1522-1, Red Blood Cells, unit number 13FY56324 REASON: Blood product, incorrectly tested for the Kell antigen, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Southeastern Michigan Region, Detroit, MI RECALLED BY: The recalling firm, of the recall by letter on July 11, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 1 unit. _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1546-1, Red Blood Cells, unit numbers 38FC69047 and 38FC69035 REASON: Blood products, labeled with a volume that was below the firm’s minimum specification, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN RECALLED BY: The recalling firm, by telephone on January 16, 2001, and by letter dated February 5, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IN QUANTITY 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1615-1, American Elm Allergenic Extract, lot B710241A B-1616-1, White Ash Allergenic Extract, lot B712022A REASON: Allergenic extracts, which were labeled with incorrect expiration dates, were distributed. MANUFACTURER/RECALLING FIRM: Allergy Laboratories of Ohio, Inc., Columbus, OH RECALLED BY: The recalling firm, by facsimile on February 9, 2001, and by letter dated February 8, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: MD QUANTITY 2 lotsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-327-1, X-Ray Table, XRT 600 REASON: The units were found defective under 21 CFR 1003.2, in that they fail to comply with performance standards with regards to: importation, establishing and maintaining manufacturing records and finished device records, no product report submitted and an inadequate certification program. MANUFACTURER: Imago Radiology, Abbiategrosso, Italy. RECALLED BY: Wuestec Medical, Mobile AL, telephoned the firm on June 7, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0631-1 Linear MC150-C Manual Collimator, catalog #70-631xx Z-0632-1 Linear MC150 Manual Collimator, catalog #70-630xx Z-0633-1 Linear II Automatic Collimator, catalog #70-4300x Z-0634-1 Linear III Automatic Collimator, catalog #70-53xxx Z-0635-1 Linear IV Automatic Continuous SID Collimator, catalog #70-750xx REASON: Collimator housing may separate from the tube mounting plate MANUFACTURER/RECALLING FIRM: PROGENY, INC. Buffalo Grove, IL RECALLED BY: Recalling Firm, by letters dated 1/24/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, Canada, Turkey QUANTITY 224 collimators ________________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0636-1, Osmo 23G series reverse osmosis machine with the Permeate Divert Option. These are intended to purify the water for use in hemodialysis applications. REASON: Potential failure of Permeate valve could allow feed water into permeate stream MANUFACTURER/RECALLING FIRM: OSMONICS, INC. Minnetonka, MN RECALLED BY: OSMONICS, INC. KENT, WA, on 3/2&5/01 by letters, and by telephone on 3/6/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Canada QUANTITY 386 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0637-01 thru Z-0638-01 Intra-Ocular Lens. Silicone based. These lens are sterile and foldable. The affected lens come in two styles - plated haptics and a modified C loop haptic. Various models and diopters are involved. Each IOL is contained inside a small cardboard box that is labeled in part, “STAAR IOL FOLDABLE INTRAOCULAR LENS *** FOR SINGLE USE ONLY *** STERILE *** *** MODEL *** DIOPTER”. 510K/PMA PMA P910059 for models AA; and P910060 for models AQ Only model numbers with a prefix of "AA" (plate haptic) or "AQ" (loop haptic) may be affected. Serial numbers are too numerous to list as they are not consecutive. REASON: Increased tear rate of lens upon insertion into the eye. MANUFACTURER/RECALLING FIRM: STAAR SURGICAL CO., MONROVIA, CA RECALLED BY: Recalling Firm by First Class letter dated 4/5/2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide. Internationally to Canada, Newfoundland, Puerto Rico, Nova Scotia. QUANTITY 25,000 lensesRECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: V-351-1, Veterinary Device - Anesco brand Mapleson C breathing circuits, Ref #A1003. REASON: Potential occlusion due to excess plastic in the fresh gas inlet of the elbow MANUFACTURER/RECALLING FIRM: King Systems Corportion, Noblesville, Indiana RECALLED BY: Recalling Firm, by letters on January 30, 2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide, Canada, Japan and Mexico QUANTITY: 21,680 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: V-352-1, Bulk Lamb Meal, All lots of bulk lamb meal shipped by the recalling firm REASON: The product is not labeled with the required caution statement “Do not feed to Cattle or other Ruminants.” MANUFACTURER/RECALLING FIRM: International Proteins Corporations (IPC), St. Paul MN RECALLED BY: Recalling Firm, Revised labeling by letter on April 17, 2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: MN, IL, MO, AR and TX QUANTITY 3,094 tons END OF ENFORCEMENT REPORT FOR July 04, 2001.####
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