May 15, 2002 02-19
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT a) Truffle Babies, a chocolate, peanut butter and almond confection individually wrapped, one ounce pieces. Recall # F-388-2; b) Mighty Marshmallows, a chocolate dipped marshmallow, individually wrapped in clear cellophane with no ingredient statement. Recall # F-389-2. CODE Products are not coded. RECALLING FIRM/MANUFACTURER Colt, Inc., Nashville, TN, by press release on January 15, 2002. Firm initiated recall is complete. REASON The products contained undeclared milk ingredients. VOLUME OF PRODUCT IN COMMERCE a) 19,680 pieces; b) 12,240 pieces. DISTRIBUTION Nationwide. _______________________ PRODUCT GFS (Gordon Food Service) brand 12-inch Turtle Elegance Torte, Reorder NO. 610151, each case contains two torte cakes, Net Wt. 4lbs 3oz. Sold as frozen product. Recall # F-390-2. CODE All lots on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Arnie's Bakery, Grand Rapids, MI, by telephone on December 26, 2001. Firm initiated recall is terminated. REASON The product contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION IN, IL, KY, MI, OH, PA and WV. _______________________ PRODUCT a) Masa Real Coconut various weights, packed in 9 count clear plastic trays. Recall # F-391-2; b) Masa Real Guava various weights, packed in 9 count clear plastic trays. Recall # F-392-2; c) Croissants, various weights, packed in two, four or six pack clear trays. Recall # F-393-2. CODE "Sell By" dates before February 3, 2002. RECALLING FIRM/MANUFACTURER Winn Dixie Stores, Inc., Jacksonville, FL, by e-mail on February 1, 2002. State initiated recall is complete. REASON The products contained undeclared egg ingredients. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION FL. _______________________ PRODUCT Ingles Best Banana Split Ice Cream in half-gallon oval cartons. Recall # F-394-2. CODE Code: 5 13 02. RECALLING FIRM/MANUFACTURER Dairy Fresh, Inc., LLC Winston-Salem, NC, by letter and press release on October 5, 2001. Firm initiated recall is complete. REASON The product contained undeclared almonds. VOLUME OF PRODUCT IN COMMERCE 5,298 half gallons. DISTRIBUTION AL, GA, NC, SC, TN and VA. _______________________ PRODUCT Stella D'Oro Coffee Treats Anisette Toast Cookies, item #194, Net Wt. 6.5 oz., UPC 73510-00194. Recall # F-395-2. Some of the almond toast product was packaged in Stella D'Oro Anisette Toast, item #194,, and the mislabeled packages were then placed in correctly labeled cases of Stella D'Oro Almond Toast, 12 packages per case. CODE Lot 2163 AB101. RECALLING FIRM/MANUFACTURER Recalling Firm: Kraft Foods Inc., Northfield, IL, by notification to sales force on January 31, 2002, and by press release on February 1, 2002. Manufacturer: Stella D'Oro, Bronx, NY. Firm initiated recall is complete. REASON Some packages actually contain a second product, almond toast cookies. Almonds are not listed as an ingredient on the label of the anisette toast cookies. VOLUME OF PRODUCT IN COMMERCE 2,688 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Badia Ground Oregano, 1 3/4 oz. bottle. Recall # F-396-2. CODE Lot # 0104602 with expiration 092006 or 102006. RECALLING FIRM/MANUFACTURER Badia Spices, Inc., Miami, FL, by visits and letters on January 24, 2002, and by press release on February 1, 2002. State initiated recall is complete. REASON The product with 102006 expiration was contaminated with salmonella. The product with the 092006 expiration was manufactured from the same bulk lot. VOLUME OF PRODUCT IN COMMERCE 16,296/1.75 oz. Bottles. DISTRIBUTION FL, NY, MD, GA, MA, Puerto Rico and Guatemala, Bahamas and the West Indies.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________ PRODUCT Ultra Slim-Fast brand with Soy Protein Ready to Drink Liquid Shakes in 11.5 fl. oz. sizes: (a) Orange-Pineapple. Recall # F-397-2; (b) Apple-Cranberry-Raspberry. Recall # F-398-2; (c) Orange-Strawberry-Banana. Recall # F-399-2. CODE “BEST BY” dates affected: JANUARY 2002 FEBRUARY 2002 MARCH 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Slim-Fast Foods Co, (a Unilever Co.), West Palm Beach, FL, by telephone, e-mail and fax beginning on February 13, 2001 and by letters on February 14, 2001. Manufacturer: Kagome, Inc., Slim-Fast Foods Co., Los Banos, CA. Firm initiated recall is complete. REASON Products are contaminated with butyric acid anaerobes, resulting in sour taste and swollen cans. VOLUME OF PRODUCT IN COMMERCE 13,896,864 cans. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Recall Extension for the following products: a) Pangestyme Capsules (ETHEX brand) UL20 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 20,000 USP units lipase, 65,000 USP units amylase, and 65,000 USP units protease, packaged in 100-capsule bottles, NDC #58177-050-04, RX only. Recall # D-054-2; b) Pangestyme Capsules (Ethex brand) MT16 Pancrelipase Enteric Coated Microtablets Contained in a Capsule, each capsule contains 16,000 USP units lipase, 48,000 USP units amylase and 48,000 USP units protease, packaged in 100-capsule bottles, NDC #58177-028-04, RX only. Recall # D-055-2; c. Pangestyme Capsules (ETHEX brand) EC Pancrelipase Enteric Coated Microspheres Contained in Capsules, each dye-free capsule contains 4,500 USP units lipase, 20,000 USP units amylase, and 25,000 USP units protease, packaged in 12-, 100-, and 250-capsule bottles, NDC #58177-031-10 (12's), #58177-031-04 (100's) and #58177-031-06 (250's), RX only. Recall # D-056-2. CODE a) Pangestyme UL20 Lot 28642, Exp. 04/02 Lot 28643, Exp. 06/02 Lot 28653, Exp. 06/02 Lot 29930, Exp. 06/02 Lot 29931, Exp. 06/02 Lot 29932, Exp. 06/02 Recall extension lot: Lot 34846, Exp 02/03 b) Pangestyme MT16 Lot 27478, Exp. 03/02 Lot 27479, Exp. 03/02 Lot 27480, Exp. 03/02 Lot 28639, Exp. 04/02 Lot 28640, Exp. 04/02 Lot 28641, Exp. 05/02 Lot 30245, Exp. 04/02 Recall extension lot: Lot 35703, Exp. 03/03 c) Pangestyme EC Lot 27487, Exp. 05/02 Lot 27488, Exp. 05/02 Lot 27489 (250-ct.), Exp. 05/02 Lot 27777, Exp. 06/02 Lot 27778, Exp. 07/02 Lot 27779 (250-ct.), Exp. 07/02 Lot 27780 (250-ct.), Exp. 08/02 Lot 30882, Exp. 07/02 Lot 30883, Exp. 07/02 Lot 30934, Exp. 07/02 Recall extension lots: Lot 30884, Exp 12/02 Lot 31558, Exp 12/02 Lot 32562, Exp 01/03 Lot 34399, Exp 01/03 Lot 34796, Exp 01/03 Lot 34835, Exp 03/03 Lot 35986, Exp 04/03 Lot 35987, Exp 04/03 Lot 36499, Exp 05/03. RECALLING FIRM/MANUFACTURER Recalling Firm: ETHEX Corp., St. Louis, MO, by fax and letter on October 3, 2001 and by letter dated March 4, 2002. Manufacturer: KV Pharmaceutical Co., St. Louis, MO. Firm initiated recall is ongoing. REASON Subpotency (Stability). VOLUME OF PRODUCT IN COMMERCE UL12 - 4,581 btls; UL18 - 3,474 btls; MT16 - 10,899 btls; UL20 - 8,728 btls; EC - 50,070 btls. DISTRIBUTION Nationwide. _______________________ PRODUCT Bactroban Ointment, brand of mupirocin, 2% Ointment, 22 gram tubes, Rx only, distributed under the SmithKline Beecham Pharmaceuticals, Philadelphia, PA label. Recall # D-241-2. CODE Lot No. Exp. date: 50-1B25 11/30/2002 29-1B25 9/30/2002 62-1B25 11/30/2002 84-1B25 2/28/2003 94-1B25 3/31/2003 106-1B25 4/30/2003. RECALLING FIRM/MANUFACTURER Glaxo SB Pharmco Puerto Rico, Inc., Cidra, Puerto Rico by letter. FDA initiated recall is ongoing. REASON Microbial Contamination; presence of Pseudomona fluorescens, Burkholderia pickettii or Ralstonia paucula. VOLUME OF PRODUCT IN COMMERCE 194, 580 units (Tubes 22 grams). DISTRIBUTION Nationwide. _______________________ PRODUCT a) Mivacron Injection (mivacurium chloride), Equivalent to 20 mg/10 mL (2 mg/mL) mivacurium, 10 mL Single-dose Fliptop Vial, Rx only. Recall # D-253-2; b) Nimbex Injection (cisatracurium besylate), Equivalent to 10mg/5mL (2 mg/mL) cisatracurium, 5 mL Single-dose Vial, Rx only. Recall # D-254-2; c) Nimbex Injection (cisatracurium besylate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple-dose Vial, Rx only. Recall # D-255-2. CODE a) NDC #0074-4365-10, lot 0H2493, exp. 05/02; b) NDC #0074-4378-05, lot 0E2030, exp. 12/01 c) NDC #0074-4380-10, lot 0E2033, exp. 01/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Inc., Hospital Products Division, Abbott Park, IL, by letters dated December 7, 2001. Manufacturer: DSM Catalytica Pharmaceuticals, Inc., Greenville, NC. Firm initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE a) 107,360 vials; b) 52,610 - 5 ml vials; c) 102,690 - 10 ml vials. DISTRIBUTION Nationwide. _______________________ PRODUCT Diflucan (Fluconazole) Injection, 200 mg (2mg/mL), Iso-Osmotic Sodium Chloride Diluent, 100 mL saline bag, Viaflex Plus single dose, sterile, nonpyrogenic, Rx only, Roerig, a div of Pfizer brand. Recall # D-256-2. CODE Lot no. PS109439 Exp. date 5/03 RECALLING FIRM/MANUFACTURER: Recalling Firm: Pfizer, Inc., New York, NY, by letters dated April 2, 2002. Manufacturer: Baxter Health Corp. Jayuya, PR. Firm initiated recall ongoing. REASON Lack of assurance of sterility; the port tube may be leaking. VOLUME OF PRODUCT IN COMMERCE 17,243 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Red Blood Cells, Recall # B-1228-2; b) Recovered Plasma, Recall # B-1229-2. CODE a)and b)Unit number 06LV79979. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern California Region, Los Angeles, CA, by letters on July 5, 2001 and August 9, 2001. Firm initiated recall i s complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a disclosure of previous positive hepatitis testing, were distributed VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1230-2; b) Platelets, Recall # B-1231-2. CODE a)and b) Unit numbers 22LP16785 and 22KR03384 RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated August 7, 2000. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION PA and NJ. _______________________ PRODUCT Source Plasma, Recall # B-1232-2. CODE Unit numbers BRQNSW and BPQPSL. RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by fax on February 28, 2002. Manufacturer: Aventis Bio-Services, Inc., Akron, OH. Firm initiated recall is complete. REASON Blood products, collected from a donor that was not tested for syphilis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL. _______________________ PRODUCT Platelets, Recall # B-1233-2. CODE Unit numbers G21944 and G21949. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI, by fax on January 16, 2002. Firm initiated recall is complete. REASON Blood products, manufactured in a way that resulted in a lower than appropriate product volume, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MI. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1234-2. CODE Unit number 22LY73810. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated October 10, 2000. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NJ. _______________________ PRODUCT Platelets, Leukocytes Reduced, Recall # B-1236-2. CODE Unit number 6938331 (distributed as two split units). RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on March 27, 2002. Firm initiated recall is complete. REASON Platelets with a lower platelet count than the labeled platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IN. _______________________ PRODUCT Source Plasma, Recall # B-1240-2. CODE Unit numbers BMDJZG, BMDKJB, BMDGVK, BMDGZM, BMDJGC, BMDJPF, BMDKXN, BMDLLJ, BMDLWQ, BMDGCF, BMDFMK, BMDGHW, BMBWDW, BMBWHK and BMBXBP. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, West Lafayette, IN, by letter on October 18, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for human immunodeficiency virus (HIV), but were collected from an ineligible donor due to behavior known to increase risk of infection with HIV, were distributed. VOLUME OF PRODUCT IN COMMERCE 15 units. DISTRIBUTION Switzerland. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1263-2. CODE Unit numbers 02FC82677, 02FC78761, and 02FC74564. RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Plains Region, Wichita, KS, by letters on December 14, 2000 and January 17, 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 KS and NJ. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1264-2. CODE Unit number 02FH98629. RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Plains Region, Wichita, KS, by letters dated October 29 and December 1, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OFPRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1265-2. CODE Unit number 02FH92079. RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Plains Region, Wichita, KS, by telephone on March 9, 2001 and by letter dated March 14, 2001. Firm initiated recall complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE Unit number 02FH92079. DISTRIBUTION KS. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1266-2; b) Recovered Plasma, Recall # B-1267-2. CODE a)and b) Unit number 02LG08428. RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Plains Region, Wichita, KS, by letter on February 21, 2001. Firm initiated is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION KS and NY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1268-2; b) Platelets Pheresis, Recall # B-1269-2; c) Fresh Frozen Plasma, Recall # B-1270-2; d) Recovered Plasma, Recall # B-1271-2. CODE a) and d) Unit number 09K88895; b) and c) Unit numbers 09P61434 and 09P62865. RECALLING FIRM/MANUFACTURER The American National Red Cross, Midwest Region, Omaha, NE, by letters on May 3, 1999 and June 7, 1999 and by fax on May 4, 1999. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION CA, NE and IA. _______________________ PRODUCT Cornea, Human Tissue for Transplantation, Recall # B-1273-2. CODE Tissue numbers OB-02-01-033-R-1 and OB-02-01-033-L-1. RECALLING FIRM/MANUFACTURER Medical Eye Bank of Maryland, Baltimore, MD, by letter on February 22, 2002. Firm initiated recall is complete. REASON Corneas, that tested negative for the antibody to hepatitis C virus (anti-HCV), but tested inconclusive for HCV using the polymerase chain reaction (PCR) assay, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 corneas. DISTRIBUTION MD and CA. _______________________ PRODUCT Red Blood Cells, Recall # B-1275-2. CODE Units 1220275, 7742293 RECALLING FIRM/MANUFACTURER Suncoast Communities Blood Bank, Inc., Sarasota, FL, by telephone on December 26, 2000. Firm initiated recall is complete. REASON Blood products, which were determined to have a low hematocrit value, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION FL.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Recovered Plasma, Recall # B-1226-2. CODE Unit number 16GW01365. RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Ohio Region, Columbus, OH, by fax on February 12, 2002 and March 14, 2002. Firm initiated recall is complete. REASON Blood product, that tested negative for viral markers, but was collected from a donor whose health history was inadequately determined, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1227-2. CODE Unit numbers 1879146, 1866189, 1822498, 1866195, 1874833, 1879083, 1866189, 1871642, 1874807, 1874840, 1847922, 1859969, 1878351, 1875068, 1875109, 1875629, 1878201, 1879021, 1871639, 1875100, 1871623, 1871622, 1879091, 1863335, 1861939, 1873542, 1874704, 1874706, 1871513, 1877323, 1876417, 1870377, 1878358, and 1873445. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY, by fax or telephone on February 28, 2002 and March 11, 2002. Firm initiated recall is complete. REASON Blood products, subjected to incorrect storage temperatures, were distributed. VOLUME OFPRODUCT IN COMMERCE 34 units. DISTRIBUTION KY and NY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1235-2. CODE Unit numbers 38J46049 and 38J46113. RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on February 19, 2002. Firm initiated recall is complete. REASON Blood products, that were leukoreduced using expired filters, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IN. _______________________ PRODUCT Recovered Plasma, Recall # B-1237-2. CODE Unit number G27748. RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI, by fax and letter on October 26, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Switzerland. _______________________ PRODUCT Source Leukocytes, Recall # B-1238-2. CODE Unit number 4150255. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on October 24, 2002. Firm initiated recall is complete. REASON Blood product, that tested reactive for human immunodeficiency virus (HIV) p24 antigen, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NJ. _______________________ PRODUCT Platelets, Recall # B-1239-2 CODE Unit number 4114060. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on September 28, 2001. Firm initiated recall is complete. REASON Blood product, prepared from a unit of Whole Blood whose collection time could not be determined, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Recall # B-1272-2. CODE Unit numbers LF02982, LF02986, LF02989, LF02985, and LF02991. RECALLING FIRM/MANUFACTURER Gateway Blood Association, Gateway Community Blood Program, St. Louis, MO, by telephone on April 8, 2001 and by letter on April 9, 2001. Firm initiated recall is complete. REASON Blood product, labeled with the incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION MO. _______________________ PRODUCT Source Plasma, Recall # B-1274-2. CODE Unit numbers XJ53514, XJ58871, XJ54704, XJ62079, XJ73559, XJ74086, and XJ74868. RECALLING FIRM/MANUFACTURE Community Bio-Resources, Inc., Joplin, MO, by fax on June 21, 2000. Firm initiated recall is complete. REASON Source Plasma, collected from an ineligible donor due to a case of active tuberculosis, was distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION MI and Austria.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT AeroVent II Collapsible Holding Chamber (CHC) - for use in the administration of metered dose inhaler medications into a ventilator breathing circuit. Recall # Z-0992-2/Z-0994-2. CODE The following Part Numbers/Lot Numbers represent all products ever shipped. Part Number 85750: Lot numbers: 2127-01 2127-02 2142-01 2142-02 2142-03 2179-01 2179-02 2225-01 Part #85750A; Lot numbers: 2147-01 2147-02 Part Number 58750; Lot numbers: 2145-01 2160-01 2188-01. RECALLING FIRM/MANUFACTURER Monaghan Medical Corp., Plattsburgh, NY, by letters dated March 20, 2002. Firm initiated recall is ongoing. REASON Collapsable Holding Chamber inadvertently opening. VOLUME OFPRODUCT IN COMMERCE 957 cases/50 per case. DISTRIBUTION Nationwide. _______________________ PRODUCT Amira AtLast brand Blood Glucose Test System. Recall # Z-0999-2. CODE All units/lots. RECALLING FIRM MANUFACTURE Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by addendum to labeling beginning December 17, 2001. Manufacturer: Amira Medical, Scotts Valley, CA. Firm initiated recall is ongoing. REASON Alternate site results not reliable when patient blood glucose level is low. VOLUME OF PRODUCT IN COMMERCE 250,000 meters. DISTRIBUTION Nationwide and Japan. _______________________ PRODUCT Baxter Interlink Solution Sets and Baxter Interlink Secondary Medication Sets which contain the BD Interlink Lever Lock Cannula; these sterile fluid paths are used for the administration of fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. 48 units per case. Recall # Z-1000-2/Z-1007-2. CODE a) Product code 1C8476, lot GR169524; b) Product code 1C8591, lots GR169987, GR169979, GR169961; c) Product code 2C6401, lot range SI366112R through SI376533R; d) Product code 2C6402, lot range SI366484R through SI377192R; e) Product code 2H6490, R01K28305, R01K28313, R01K28321; f) Product code 2C7451, lot ranges R215186 through R221010, R01H17212 through R01K30087, and SI365791R through SI376699R; g) Product code 2C7452, lot ranges R215087 through R222604 and R01H14284 through R01K30111; h) Product code 2H7451, lot ranges R217364 through R223099 and R01H22170 through R01K12176. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February 13, 2002. Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing. REASON Fluid leaks associated with BD Lever Lock cannulas. VOLUME OF PRODUCT IN COMMERCE 14,295,103 sets. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Somatom Esprit, Esprit+, Balance, Emotion, Emotion Due, Volume Zoom, and Volume Access. Recall # Z-1010-2. CODE Siemens part: Somatom: Computed Tomography System, Diagnostic Imaging Esprit: 3810079 Esprit+: 3810137 Balance: 3810152 Emotion: 3812160 Emotion Duo: 3812950 Volume Zoom: 4806118 Volume Access: 7114023. All serial numbers under these models. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter on May 14, 2001. Manufacturer: Siemens Medical Solutions, Erlangan,Germany. Firm initiated recall is ongoing. REASON Errors occurring while using graphics tools. VOLUME OF PRODUCT IN COMMERCE 400. DISTRIBUTION Nationwide. _______________________ PRODUCT Steri-Oss Replace Select TiUnite Implant. Recall # Z-1011-2. CODE Catalog Number 62004; Lot number 338849. RECALLING FIRM/MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, CA, by telephone on March 12, 2002 and by letters on March 26, 2002. Firm initiated recall is ongoing. REASON Labeling mix-up. VOLUME OF PRODUCT IN COMMERCE 124. DISTRIBUTION Nationwide. _______________________ PRODUCT Pressure Regulator Assembly (Cat. No. 85). Recall # Z-1012-2. This is a component part used in Infant and Child models of the Laerdal Silicone Resuscitator (LSR). It is also distributed in replacement patient valve assemblies, and as individual spare parts. CODE Identification of the recalled part: Molded-in number "4" on the top of the Regulator Cap identifies the affected parts. (Caps with numbers "2", "3", and "5" are NOT affected.) RECALLING FIRM/MANUFACTURER Recalling Firm: Laerdal Medical Corp., Wappingers Falls, NY, by letters on March 29, 2002. Manufacturer: Laerdal Medical, Stavanger, Norway. Firm initiated recall is ongoing. REASON Molding irregularity in Pressure Regulator Cap which could impede free movement of valve stem. VOLUME OF PRODUCT IN COMMERCE 2,250 (approximately 25% of these are mold #4). DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Hill-Rom brand Resident low bed, model 872. Recall # Z-1014-2. CODE All beds distributed prior to May 4, 2001. RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN, by notification on April 26, 2002. Firm initiated recall is ongoing. REASON Pinched cables may cause arcing/shock hazard. VOLUME OF PRODUCT IN COMMERCE 3031 beds. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT a) Model No. 105-5060 1.5 French FlowRider Micro Catheter. Recall # Z-1016-2; b) Model No. 105-5063 1.8 French FlowRider Micro Catheter. Recall # Z-1017-2; c) Model No. 105-5067 1.5 French FlowRider Plus Micro Catheter. Recall # Z-1018-2; d) Model No. 105-5068 1.8 French FlowRider Plus Micro Catheter. Recall # Z-1019-2. The difference between a FlowRider and FlowRider Plus is the presence of a silicone lubricant in the lumen of the FlowRider which is absent in the Plus. CODE All lots all codes. RECALLING FIRM/MANUFACTURER Micro Therapeutics, Inc., Irvine, CA, by fax and e-mail on April 2, 2002. Firm initiated recall is ongoing. REASON Catheter rupture. VOLUME OF PRODUCT IN COMMERCE 8505. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Misys Laboratory Information System, Versions 5.23 and 5.3. Recall # Z-1020-2. CODE Versions 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by a workaround issued on April 1, 2002. Firm initiated recall is ongoing. REASON No QA Checking Performed on Differential Results. VOLUME OF PRODUCT IN COMMERCE 450. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT HP InkJet Printers connected as an accessory to a Beckman Coulter. Recall # Z-1022-2. CODE All printer power cords manufactured by Longwell. RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter, Inc., Brea, CA, by product safety alert dated April 18, 2002. Manufacturer: Longwell Electronics, Inc., Brea, CA. Firm initiated recall is ongoing. REASON Printer Power Cord may cause shock to lab personnel. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Medtronic Intersept Custom Tubing Packs. Recall # Z-1023-2/Z-1029-2. The packs are custom assembled for hospitals and each is identified with a product number. The product numbers and hospitals or distributors, for which the packs were assembled, are identified below: Product number 0V67R10. Recall # Z-1023-2; Made for: MERCY HOSPITAL, Des Moines, IA Product number 1H22R2. Recall # Z-1024-2; Made for: EXTRACORPOREAL ALLIANCE, Port Huron, MI Product number 1H23R5. Recall # Z-1025-2; Made for: EXTRACORPOREAL ALLIANCE, Pontiac, MI Product number 1P82R3. Recall # Z-1026-2; Made for: EXTRACORPOREAL ALLIANCE, Dearborn, MI Product number 2D68R2. Recall # Z-1027-2; Made for: PROVIDENCE MEDICAL CENTER, Kansas City, KS Product number 2D81R. Recall # Z-1028-2; Made for: COMPREHENSIVE PREFERRED CARE SVR, Buffalo, NY Product number 5778R19. Recall # Z-1029-2. Made for: HEALTH MIDWEST, Kansas City, MO CODE PRODUCT # LOT 0V67R10 0201000908 0V67R10 0202000147 0V67R10 0202000406 0V67R10 0202000408 0V67R10 0202004036 1H22R2 0202002131 1H23R5 0202004031 1P82R3 0202003516 1P82R3 0202003520 2D68R2 0203000095 2D68R2 0203001683 2D81R 0201002670 2D81R 0201002671 5778R19 0202000164 5778R19 0203001047 5778R19 0203001045 5778R19 0203001046. RECALLING FIRM/MANUFACTURER Recalling Firm: Medtronic Perfusion Systems, Minneapolis, MN, by, Urgent field action notice dated April 10, 2002. Manufacturer: Medtronic Mexico, S. Del R.L. de C.V. Tijuana, BB. Firm initiated recall is ongoing. REASON The vent valves in the recalled tubing packs may leak blood during cardiopulmonary bypass surgery, or the parts of the valves may separate, due to inadequate glue application. VOLUME OF PRODUCT IN COMMERCE 856 tubing packs. DISTRIBUTION IA, KS, MI, MO and NY. _______________________ PRODUCT Gambro Phoenix Hemodialysis System. Recall # Z-1030-2. CODE Catalog Number: 6022933700 Serial Numbers in the range PH0165-PH1769. RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Healthcare, Lakewood, CO, by telephone and fax on April 9, 2000. Manufacturer: Gambro Dasco S.p.A. 41036, Medolla, Italy. Firm initiated recall is ongoing. REASON Incorrect measurement of dialysate conductivity due to electronic comp. failure. VOLUME OF PRODUCT IN COMMERCE 827 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT BD MST Accessory Kit. Recall # Z-0997-2. CODE Catalog 384820, Lot 106458. RECALLING FIRM/MANUFACTURER Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT, by telephone on September 20, 2001. Firm initiated recall is complete. REASON Kits labeled as containing 16 GA introducer actually contained 20 GA introducer. VOLUME OF PRODUCT IN COMMERCE 410 units. DISTRIBUTION Nationwide. _______________________ PRODUCT CryoValve Allograft, Recall # Z-1008-2. CODE Serial No. 6281362, Model Number MV 10. RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA, by visit on March 6, 2002. Firm initiated recall is complete. REASON Donor did not meet current guidelines regarding behavioral/social history. VOLUME OF PRODUCT IN COMMERCE One valve. DISTRIBUTION UT. _______________________ PRODUCT CryoValve Allograft, Recall # Z-1009-2. CODE Serial Number 6281354, Model Number AV40. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by letter on March 8, 2002. Firm initiated recall is complete. REASON Donor did not meet current guidelines regarding behavioral/social history. VOLUME OF PRODUCT IN COMMERCE One valve. DISTRIBUTION WA. _______________________ PRODUCT Vitros Immunodiagnostics CEA (carcinoembryonic antigen) Calibrators. Recall # Z-1013-2. CODE Lot 210, Exp. 28 March 2002 Lot 220, Exp. 25 April 2002 Lot 230, Exp. 11 June 2002 Lot 240, Exp. 11 June 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY, by letters on March 15, 2002, and via email and/or fax on March 17, 2002. Manufacturer: Ortho-Clinical Diagnostics, Inc., Cardiff. Firm initiated recall is ongoing. REASON Calibration failures/shift in QC results. VOLUME OF PRODUCT IN COMMERCE 279 domestic / 495 international. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT LAP Band Sterile, Lap-Band Adjustable Banding System, 9.75cm and 10.0cm sizes. PMA# P000008 dated 6/5/01. Recall # Z-1015-2. The Lap-Band System is an inflatable silicone band that is laparoscopically placed around the upper part of the stomach to restrict how much food can be eaten at one time. It is indicated for use in weight reduction of severely obese patients. CODE Catalog numbers B-20210 LAP-BAND System II (9.75cm) and B-20220 LAP-BAND System II (10.0cm) are located on the primary and the box labels. Serial numbers S01LB186-89, S01LB186-90, S01LB199-11, S01LB199-12, S01LB199-13, S01LB210-56, S01LB210-57, S01LB210-58, S01LB210-59, S01LB210-60, S01LB196-151, S01LB196-152, S01LB196-153, S01LB195-154, S01LB201-153, and S01LB196-155 are located on the primary and the box labels. Serial number code breakdown is as follows: S = Sterile 01= 2001 LB= Lap-Band Next three/four numbers are sequentially assigned. RECALLING FIRM/MANUFACTURER Bioenterics Corp., Carpinteria, CA, by telephone on March 29, 2002 and by letters dated April 1, 2002. Firm initiated recall is complete. REASON Does not conform to PMA re: labeling. VOLUME OF PRODUCT IN COMMERCE 16. DISTRIBUTION NY, OR, CA and NV. _______________________ PRODUCT 2-K AC-2409-D acid concentrate and bicarbonate dialysate, 55 Gallons, calcium 2.50 meq/l, etc. Recall # Z-1021-2. CODE Lot Number G9D051. RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Healthcare, Deland, FL, by telephone on May 26 and 27, 1999, and letter dated June 1, 1999. Manufacturer: Di-Chem Concentrates, Inc., Lewisberry, PA. Firm initiated recall is complete. REASON Calcium Concentrate was higher than the specified range. VOLUME OF PRODUCT IN COMMERCE 119/55 gallon. DISTRIBUTION NJ, IL, PA, OH, MD, WASH DC, MI and NY. _______________________ PRODUCT Aeroset Cholesterol Reagent. Recall # Z-1031-2. CODE Lot 82099HW00 Firm's List No. 7D62-01. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., South Pasadena, CA, by letters on April 17, 2002. Firm initiated recall is ongoing. REASON Stability may be compromised over time, product currently OK. VOLUME OF PRODUCT IN COMMERCE 715 DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT Carbosan N.D (non-dispersible) single mineral products: Carbosan Copper N.D. (Pentadydrated Copper Sulfate), copper 12.7%, 127 grams of Copper/1000 grams, 25 Kg. net weight in bags, Product Code 2571 for export to Europe. Recall # V-034-2 SQM single mineral products: SQM Copper 12.7%, 25 Kg. (55.12 pounds) net weight in bags, Product Code 5719. Recall # V-036-2 (SQM) Copper 10%, 50 pounds, or 25 Kg. net weight in bags, Product Code 5737. Recall # V-037-2 SQM Iron 14.6%, 25 Kg. net weight in bags, Product Code 5720A, imported by Primo, 8200 Brugge, Belgium. Recall # V-038-2 (SQM) Iron 10%, 50 pounds, or 25 Kg. net weight in bags, Product Code 5736. Recall # V-039-2 SQM Magnesium 10%, 25 Kg. (55.12 pounds) net weight in bags, Product Code 5731. Recall # V-040-2 SQM Magnesium 5.4%, 25 Kg. (55.12 pounds) net weight in bags, Product Code 5721. Recall # V-041-2 Carbosan D (dispersible) single mineral products: Carbosan Copper 12.7%, 25 Kg. (55.11 pounds) net weight in bags, Product Codes 2534. Recall # V-049-2 Carbosan Iron 12.0%, 25 Kg. (55 pounds) net weight in bags, Product Code 2533. Recall # V-051-2 Carbosan Magnesium 5%, 25 Kg. (55 pounds) net weight in bags,Product Code 2532A. Recall # V-053-2 SQM combination premixes: SQM 4 Dairy, Zinc 7.05%, Manganese 4.233%, Copper 2.116%, Cobalt 0.141%, 50 pounds net weight in bags, Product Code 6923. Recall # V-055-2 SQM 4 Dairy, Zinc 70,500 mg/kg, Manganese 42,330 mg/kg, Copper 21,160 mg/kg, Cobalt 1,410 mg/kg, Iodine 400 mg/kg, Product Code 6923X. Recall # V-056-2 SQM 4 Beef, Zinc 7.05%, Manganese 4.233%, Copper 2.116%, Cobalt 0.141%, 50 pounds net weight in bags, Product Code 6921. Recall # V-057-2 SQM 4 Beef, Zinc 70,500 mg/kg, Manganese 42,330 mg/kg, Copper 21,160 mg/kg, Cobalt 1,410 mg/kg, Iodine 400 mg/kg, 25 Kg. (55.11 pounds) net weight in bags, Product Code 6921X. Recall # V-058-2 SQM 4 Swine, Zinc 10.00%, Manganese 1.50%, Iron 5.00%, Copper 0.75%, 25 Kg. (55.11 pounds) net weight in bags, Product Code 5715. Recall # V-059- 2 SQM-Dairy, Zinc 7.00%, Iron 3.50%, Manganese 7.00%, Copper 0.75%, Cobalt 0.03%, 25 Kg. (55.1 pounds) net weight in bags, Product Code 5726. Recall # V-060-2 SQM Ruminant, Zinc 8.50%, Iron 4.50%, Manganese 3.50%, Copper 0.75%, Cobalt 0.15%, 50 pounds, or 25 Kg. net weight in bags, Product Code 5711. Recall # V-061-2 SQM Non-Ruminant Trace Mineral, Zinc 9.00%, Manganese 6.00%, Iron 3.00%, Copper 0.25%, 25 Kg. (55.11 pounds) net weight in bags, Product Code 5705. Recall # V-062-2 SQM 4 Equine, Zinc 4.650%, Manganese 3.570%, Copper 3.220%, Cobalt 0.014%, 25 pounds and also 25 Kg. (55.11 pounds) net weight in bags, Product Code 6925. Recall # V-063-2 SQM Mineral Premix for Swine Feeds, Iron 91,500 mg/kg, Zinc 50,000 mg/kg, Manganese 20,000 mg/kg, Copper 2,500 mg/kg, 25 Kg. (55.12 pounds) net weight in bags, Product Code 6918. Recall # V-065-2 SQM Mineral Premix for Swine Feeds, Iron 100,000 mg/kg, Zinc 70,000 mg/kg, Manganese 50,000 mg/kg, Copper 25,000 mg/kg, Cobalt 1000 mg/kg, Iodine 1000 mg/kg, Selenium 200 mg/kg, 25 Kg. (55.12 pounds) net weight in bags, Product Code 6919. Recall # V-066-2 SQM Canine, Zinc 6.000%, Iron 4.000%, Copper 0.365%, Manganese 0.250%, 25 Kg. (55.11 pounds) net weight in bags, Product Code 6922. Recall # V-067- 2 Private label SQM Combination premixes (in alphabetical order by distributors' names): Animal Medic Dairy Breeder Pack, Calcium 7.00%, Zinc 44,090 ppm, Manganese 26,454 ppm, Copper 17,636 ppm, Magnesium 8,818 ppm, Iron 8,818 ppm, Cobalt 2,204 ppm, Iodine 480.58 ppm, and Selenium 110.22 ppm, 5 pounds net weight, Product Code 9409A, Manufactured for Animal Medic, Inc., Manchester, PA. Recall # V-068-2 (Agri-Nutrition Services, Inc.) ANS Swine SQM Trace Minerals, Zinc 10%, 25 Kg (55.11 pounds) net weight in bags, Product Code 6875, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V-069-2 ANS Pig Starter L-F-S-C, L-Lysine 31.36% and Copper 5.08%, 50 pounds net weight in bags, Product Code 6841F, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V-070-2 Cargill SQM Dairy Add-Pack, Cobalt 475 ppm, Copper 4,354 ppm, Iron 7,265 ppm, Manganese 31,965 ppm, Zinc 31,965 ppm, Iodine 475 ppm, 50 pounds net weight in bags, Product Code 8233. Recall # V-071-2 (Cattleman's Choice) Loomix ORE-BAC Organic TM Premix, 50 pounds net weight in bags, Product Code 9790A, Manufactured for Cattleman's Choice Loomix, Johnstown, CO. Recall # V-072-2 CLP Bull Premix, Zinc 2.00%, Manganese 2.00%, Iron 3.00%, Copper 0.40%, Cobalt 0.004%, Iodine 0.020%, 50 pounds net weight in bags, Product Code 9930, Manufactured for CLP Feeds, Fort Collins, CO. Recall # V-073-2 Custom Mix SQM Concentrate, Zinc 4.00%, Manganese 4.00%, Iron 5.00%, Copper 1.010%, Cobalt 0.010%, 50 pounds net weight in bags, Manufactured for Consolidated Nutrition, Omaha, NB, Product Code 8560B. Recall # V- 074-2 Ewing #707 Trace Mineral Premix, Zinc 5.0%, Iron 7.5%, Manganese 3.0%, Copper 0.75%, 50 pounds net weight, Product Code 9808, manufactured for John Ewing Co., La Salle, CO. Recall # V-075-2 Heims Feeds and Concentrates Trace Mineral Ruminant, Zinc 6.00%, Manganese 6.00%, Iron 1.50%, Copper 1.50%, Cobalt 0.05%, Iodine 0.08%, Selenium 0.036%, Calcium 2.3%, 50 pounds net weight in bags, Product Code 7344P, Manufactured for Heim Milling Company, St Cloud, MN. Recall # V- 076-2 Hi-Plains Nutrition Trace Mineral Premix, contains Per Pound: Zinc 45,400 mg, Manganese 22,700 mg, Copper 4,540 mg, Cobalt 454 mg, 50 pounds net weight in bags, Product Code 9457, Manufactured for Hi-Plains Nutrition, Whitewood, SD. Recall # V-077-2 Mc Cauley Custom SQM Premix, Zinc 6.80%, Manganese 2.80%, Iron 3.60%, Copper 3.14%, Cobalt 0.012%, 50 pounds net weight in bags, Product Code 9933, Manufactured for Mc Cauley Brothers, Versailles, KY. Recall # V-078-2 NCS SQM 4 Equine - Iron Premix, Zinc 3.00%, Manganese 2.302%, Copper 2.077%, Cobalt 0.009%, Iron 5.183%, 50 pounds net weight in bags, Product Code 9828, Manufactured for Nutrition Consulting Service, Pawnee, OK. Recall # V-079-2 PM Ag TM Premix SQM + Sulfates + Selenium, Copper 1.93%, Manganese 7.71%, Zinc 5.79%, Iron 9.44%, Cobalt 89 mg/lb, Iodine 2.26 g/lb, Selenium 440 mg/lb, 50 pounds net weight in bags, Product Code 9944, Manufactured for PM Ag Products, Houston, TX. Recall # V-080-2 Pro-Tech Inman Custom Premix, Manganese 22,222 ppm, Zinc 35,250 ppm, Iron 10,000 ppm, Copper 11,111 ppm, Cobalt 707 ppm, 50 pounds net weight in bags, Product Code 9981, Manufactured for Pro-Tech Services, Inc., Rock Valley, IA (contains SQM premixes Mn, Zn, Fe, Cu). Recall # V-081-2 Pro-Tech Sow Pro, Manganese 28,400 ppm, Zinc 30,000 ppm, Iron 31,200 ppm, Copper 400 ppm, Iodine 394 ppm, and Selenium 30 ppm, 50 pounds net weight, Product Code 9978, Manufactured for Pro-Tech Services, Inc., Rock Valley, IA. Recall # V-082-2 Purina Lab/Zoo SQM Mix, Zinc 9.60%, Manganese 6.00%, Copper 2.00%, Cobalt 0.025%, Iodine 0.15%, 50 pounds net weight in bags, Product Code 9702, Manufactured for Purina Mills, Inc., St Louis, MO. Recall # V-083-2 Standard SQM Ruminant Premix, Zinc 8.5%, Manganese 8.5%, Copper 1.0%, 25 Kg. (55.12 pounds) net weight in bags, Product Code 9577, Manufactured for Standard Manufacturing Co., Omaha, NE. Recall # V-084-2 Sunshine SQM Custom Premix, Copper 8826 ppm, Iron 70,810 ppm, Manganese 7,040 ppm, Zinc 88,330 ppm, 50 pounds net weight in bags, Product Code 9957, Manufactured for Sunshine Mills, Red Bay, AL. Recall # V-085-2 Suther 842 Premix, Cobalt 0.14%, Copper 2.00%, Manganese 4.00%, Zinc 8.00%, 50 pounds net weight in bags, Product Code 9964, Manufactured for Suther Feeds, Frankfurt, KS. Recall # V-086-2 U.S. Feeds Organic 5, contains Per Pound: Zinc 25,600 mg, Manganese 12,800 mg, Copper 6,400 mg, Magnesium 5,670 mg, Cobalt 639 mg, 50 pounds net weight in bags, Product Code 9983, Manufactured for United Suppliers, Eldora, IA. Recall # V-087-2 Vitamin-Mineral Premixes (in alphabetical order by distributors' names): (Agri-King, Inc.) Foley Custom "S" Mix, 50 pounds net weight in bags, Product Code 9936, Manufactured for Agri-King, Inc., Fulton, IL. Recall # V-089-2 (Agri-Nutrition Services) ANS Swine G-F Premix-2.5XT, 50 pounds net weight in bags, Product Code 6810, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V-090-2 ANS Swine Breeder Premix-EB, 50 pounds net weight in bags, Product Code 6802, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V-091-2 ANS Swine Breeder Premix-EB, 50 pounds net weight in bags, Product Code 6844C, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V-092-2 ANS Dairy Premix, 50 pounds net weight in bags, Product Code 6848D, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall #V- 093-2 ANS Swine Breeder Premix-EB, 50 pounds net weight in bags, Product Code 6844C, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V-094-2 ANS Swine G-F Premix, 50 pounds net weight in bags, Product Code 6837C, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V- 095-2 ANS Layer Premix, 50 pounds net weight in bags, Product Code 6835D, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V- 096-2 ANS Dairy Rumen Balancer Premix (40X), 50 pounds net weight in bags, Product Code 6825G, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V-097-2 ANS Swine Breeder Premix, 50 pounds net weight in bags, Product Code 6819D, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V-098-2 (Agri-Nutrition Services, Inc.) Winner's Edge, 8 pounds net weight, Product Code 6850D, Manufactured for Agri-Nutrition Services, Inc., Shakopee, MN. Recall # V-099-2 Baby Doll Premix #3, 50 pounds net weight in bags, Product Code 9667A, Manufactured for Baby Doll Nutrition, Ltd., Lake St Louis, MO (ingredients are not specified on the label). Recall # V-101-2 Baby Doll Premix #4, 50 pounds net weight in bags, Product Code 9673A, Manufactured for Baby Doll Nutrition, Ltd., Lake St Louis, MO (ingredients are not specified on the label). Recall # V-102-2 Baby Doll Premix #5, 50 pounds net weight in bags, Product Code 9816, Manufactured for Baby Doll Nutrition, Ltd., Lake St Louis, MO (ingredients are not specified on the label). Recall # V-103-2 Baby Doll Premix # 10003, 50 pounds net weight in bags, Product Code 9818, Manufactured for Baby Doll Nutrition, Ltd., Lake St Louis, MO (ingredients are not specified on the label). Recall # V-104-2 Baby Doll Premix #15003, 50 pounds net weight in bags, Product Code 9819, Manufactured for Baby Doll Nutrition, Ltd., Lake St Louis, MO (ingredients are not specified on the label). Recall # V-105-2 (Consolidated Nutrition) Prosponse Trace Plus 8708, 50 pounds net weight in bags, Product Code 9962, Manufactured for Consolidated Nutrition, Omaha, NE. Recall # V-108-2 Duncan's Udder Food Premix, 60 pounds net weight in bags, Product Code 9451A, Manufactured for Duncan Premixes, Inc., Lake City, MN. Recall # V- 109-2 EAGLE Beowulf Vitamin/TM Premix, 30 pounds net weight in bags, Product Code 9854, Manufactured for Eagle Products, Inc., Mishawaka, IN. Recall # V-110-2 Eagle Cat Food Premix 2X, 10 pounds net weight, Product Code 9693, Manufactured for Eagle Products, Inc., Mishawaka, IN. Recall # V-111-2 Eagle Dog Food Extra, 50 pounds net weight in bags, Product Code 8290T, Manufactured for Eagle Products, Inc., Mishawaka, IN. Recall # V-112-2 Freedom SQM Booster No. 1, 50 pounds net weight in bags, Product Code 9786, Manufactured for Freedom Feed Mill, Inc., Kaukauna, WI. Recall # V- 113-2 G & J Beef Premix, 50 pounds net weight in bags, Product Code 9118, Manufactured for G & J Midwest AG, Inc., New Richmond, WI. Recall # V- 114-2 J & R 100 Premix, 50 pounds net weight in bags, Product Code 9861, Manufactured for J & R Feed Service, Cullman, AL. Recall # V-115-2 Kammes Konsulting Dairy Premix NPDA 85 KK P50, 50 pounds net weight in bags, Product Code 9960, Manufactured for Kammes Konsulting, Hazel Green, WI. Recall # V-117-2 KOW VTM Pak For Dairy Cattle, 50 pounds net weight in bags, Product Code 9866, Manufactured for Kow Consulting Association, Blanchardville, WI. Recall # V-118-2 Lake's Premix, 60 pounds net weight in bags, Product Code 8782l, Manufactured for Lake's Minnesota Macaws, Inc., St. Paul, MN. Recall # V- 119-2 Lake's Premix, 60 pounds net weight in bags, Product Code 9782l, Manufactured for Lake's Minnesota Macaws, Inc., St. Paul, MN. Recall # V- 120-2 Larson Nutrition Research Premix LN-RD-01 Premix #1, 50 pounds net weight in bags, Product Code 9965 (ingredients not listed on the label). Recall # V-121-2 Larson Nutrition Research Premix LN-RD-03 Premix #3, 50 pounds net weight in bags, Product Code 9966, (ingredients not listed on the label). Recall # V-122-2 (Milk Specialties Company) Buckeye Mare Milk Premix, 50 pounds net weight in bags, Product Code 9424, Manufactured for Milk Specialties Co., Dundee, IL. Recall # V-123-2 Owl Livestock Premix For Milk, 50 pounds net weight in bags, Product Code 9830, Manufactured for Owl Livestock, Grandview, TX (ingredients not specified by label). Recall # V-124-2 Pro-Tech Beef Pro, 50 pounds net weight in bags, Product Code 9971, Manufactured for Pro-Tech Services, Inc., Rock Valley, IA. Recall # V- 125-2 Pro-Tech Custom Mix, 50 pounds net weight in bags, Product Code 9973, Manufactured for Pro-Tech Services, Inc., Rock Valley, IA. Recall # V- 126-2 Pro-Tech Dairy Pro, A nutritional supplement for dairy cattle, 50 pounds net weight in bags, Product Code 9975, Manufactured for Pro-Tech Services, Inc., Rock Valley, IA. Recall # V-127-2 Pro-Tech Pig Pro, 50 pounds net weight in bags, Product Code 9972, Manufactured for Pro-Tech Services, Inc., Rock Valley, IA. Recall # V- 128-2 Pro-Tech Sow Pro, 50 pounds net weight in bags, Product Code 9978, Manufactured for Pro-Tech Services, Inc., Rock Valley, IA. Recall # V- 129-2 Sweet Pro Vitamin TM Premix 2000, 50 pounds net weight in bags, Product Code 9833, Manufactured for Sweet Pro Feeds, Walhalla, ND. Recall # V- 130-2 U of M Dairy Trial Premix #2, 50 pounds net weight in bags, Product Code 6932 (ingredients are not specified on the label) V-131-2 U of M Dairy Trial Premix #3, 50 pounds net weight in bags, Product Code 6933 (ingredients are not specified on the label). Recall # V-132-2 VIP A to Z -- SQ-2, 50 pounds net weight in bags, Product Code 9356B, Manufactured for Veterinarian Indorsed Products, Inc., Menomonie, WI. Recall # V-133-2 VIP BON-AP'PETIT, 10 pounds net weight in bags, Product Code 8237D, Manufactured for Veterinarian Indorsed Products, Inc., Menomonie, WI. Recall # V-136-2 VIP EXCEL, 5 pounds net weight, Product Code 8680, Manufactured for Veterinarian Indorsed Products, Inc., Menomonie, WI. Recall # V-137-2 WA JA Vital-Supp, 25 pounds net weight in bags, Product Code 9487, Manufactured for WA JA Farms, Inc., New Albany, PA. Recall # V-138-2 Willard Goat Feed Premix, 50 pounds net weight in bags, Product Code 9934, Manufactured for Willard Milling Company, Inc., Willard, KY. Recall # V-139-2 CODE Lot 5101 (made on 2/9/01) to lot 8999 (made just prior to the start of the recall). The lot numbers are consecutive. RECALLING FIRM/MANUFACTURER Quali-Tech, Inc., Chaska, MN, by letter dated February 27, 2002. Firm initiated recall is ongoing. REASON High dioxin levels VOLUME OF PRODUCT IN COMMERCE Distribution of recalled lots 5101 to 8999 of the products: 1,847,289 pounds of SQM products (some labeled as Carbosan ND for European distribution), 88,845 pounds of Carbosan D products, and 2,590,619 lbs of vitamin-mineral premixes. DISTRIBUTION Nationwide and Argentina, Australia, Belgium, Costa Rica, Korea, France, and Taiwan.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III
_______________________ PRODUCT Carbosan N.D (non-dispersible) single mineral products: Carbosan Zinc N.D, Zinc 22%, 220 grams of Zinc/1000 grams, 25 Kg. net weight in bags, Product Code 2575 for export to Europe. Recall # V-035-2 SQM single mineral products: SQM Manganese 16%, 25 Kg. net weight in bags, Product Code 5722, imported by Primo, 8200 Brugge, Belgium. Recall # V-042-2 (SQM) Manganese 10%, 50 pounds, or 25 Kg. net weight in bags, Product Code 5735. Recall # V-043-2 SQM Zinc 22%, 25 Kg. net weight in bags, Product Code 5723, imported by Primo, 8200 Brugge, Belgium. Recall # V-044-2 (SQM) Zinc 18%, 50 pounds, or 25 Kg. net weight in bags, Product Code 5733. Recall # V-045-2 (SQM) Zinc 10%, 50 pounds, or 25 Kg. net weight in bags, Product Code 5734. Recall # V-046-2 (SQM) Zinc 4%, 50 pounds, or 25 Kg. net weight in bags, Product Code 5732. Recall # V-047-2 Site Release Zinc, Zinc 4.5%, 5 pounds net weight, Product Code 9279. Recall # V-048-2 Carbosan D (dispersible) single mineral products: Carbosan Zinc 14.4%, 25 Kg. (55 pounds) net weight in bags, Product Codes 2536. Recall # V-050-2 Carbosan Manganese 11.5%, 25 Kg. (55 pounds) net weight in bags, Product Code 2535. Recall # V-052-2 Carbosan Cobalt 13.2%, 25 Kg. (55 pounds) net weight in bags, Product Code 2531. Recall # V-054-2 SQM combination premixes: SQM 4 Small Ruminants, Zinc 8.00%, Manganese 7.00%, Cobalt 0.04%, 25 Kg. (55.11 pounds) net weight in bags, Product Code 6924. Recall # V-064-2 Carbosan (dispersible) Premix: Carbosan Veal, Zinc 9.0%, Manganese 4.5%, Copper 0.63%, 25 Kg. (55.11 pounds) net weight in bags, Product Code 2530. Recall # V-088- 2 Vitamin-Mineral Premixes (in alphabetical order by distributors' names): Baby Doll Milk Replacer Premix, 50 pounds net weight in bags, Product Code 9662A, Manufactured for Baby Doll Nutrition, Ltd., Lake St Louis, MO. Recall # V-100-2 (Buckeye Equine Nutrition} Foal-Aide, 25 pounds net weight in bags, Product Code 9278C, Manufactured for Buckeye Equine Nutrition, Dalton, OH. Recall # V-106-2 Buckeye Veal Services Veal Premix, Product Code 8579E, 40 pounds net weight in bags, Buckeye Veal Services, Wooster, OH. Recall # V-107-2 Kaeco Biotin 800 Z with Zinc Nutritional Supplement for Horses, 6 pounds net weight, Product Code 9953, Manufactured for Kaeco Group, Inc., Savannah, MO. Recall # V-116-2 VIP B +, 50 pounds net weight in bags, Product Code 9228, Manufactured for Veterinarian Indorsed Products, Inc., Menomonie, WI. Recall # V-134-2 VIP Blood Builder, 10 pounds net weight in bags, Product Code 7627E, Manufactured for Veterinarian Indorsed Products, Inc., Menomonie, WI. Recall # V-135-2 CODE Lot 5101 (made on 2/9/01) to lot 8999 (made just prior to the start of the recall). The lot numbers are consecutive. RECALLING FIRM/MANUFACTURER Quali-Tech, Inc., Chaska, MN, by letter dated February 27, 2002. Firm initiated recall is ongoing. REASON High dioxin levels VOLUME OF PRODUCT IN COMMERCE Distribution of recalled lots 5101 to 8999 of the products: 1,847,289 pounds of SQM products (some labeled as Carbosan ND for European distribution), 88,845 pounds of Carbosan D products, and 2,590,619 lbs. of vitamin-mineral premixes. DISTRIBUTION Nationwide and Argentina, Australia, Belgium, Costa Rica, Korea, France, and Taiwan.END OF ENFORCEMENT REPORT FOR MAY 15, 2002 ####
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