March 21, 2001 01-11RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT: Recall #F-294-1. Colby and Monterey Jack Cheese in chunks, loaves, longhorn style, shredded, or cubed): 1) ALBERTSON'S 1 lb. (chunk) Colby Jack Cheese; 2) ALBERTSON'S 8 oz. (chunk) Colby Jack Cheese; 3) ALBERTSON'S 9 to 15 oz. (chunk) Colby and Monterey Jack Cheese; 4) ALBERTSON'S 2 lb. (loaf) Colby Jack Cheese; 5) AMERICAN HERITAGE 26 to 32 oz. (chunk) Colby/Jack Cheese; 6) AMERICAN HERITAGE 1 lb. (chunk) Colby/Jack Cheese; 7) AMERICAN HERITAGE 2 lb. (loaf) Colby/Jack Cheese; 8) AMERICAN HERITAGE 8 oz. (chunk) Colby/Jack Cheese; 9) BEST CHOICE 9 to 15 oz. (chunk) Colby/Jack Cheese; 10) BEST CHOICE 8 oz. (longhorn) Colby/Jack Cheese; 11) BEST CHOICE 1 ½ lb. (chunk) Colby/Jack Cheese; l2) BEST CHOICE 10 oz. (chunk) Colby/Jack Cheese; 13) BEST CHOICE 1 lb. (chunk) Colby/Jack Cheese; 14) COOPER 10 oz. (chunk) Colby/Jack Cheese; 15) COOPER 7 oz. (chunk) Colby/Jack Cheese; 16) COOPER 2 lb. (loaf) Colby/Jack Cheese; 17) COOPER 2 1/2 lb. (loaf) Colby/Jack Cheese; 18) COUNTRY CROSSING 8 oz. (chunk) Natural Colby/Jack Cheese; 19) CUB FOODS 9 to 15 oz. (chunk) Colby Jack Cheese; 20) FLAVORITE 9 to 15 oz. Longhorn Style Colby/Jack Cheese; 21) FLAVORITE 1 lb. (chunk) Colby/Jack Cheese; 22) FLAVORITE 8 oz. (chunk) Colby/Jack Cheese; 23) FLAVORITE 26 to 32 oz. (chunk) Colby/Jack Cheese; 24) GREAT VALUE 2 lb. Feather Shredded Colby and Monterey Jack Cheese; 25) GREAT VALUE 8 oz. Fancy Shredded Colby and Monterey Jack Cheese; 26) GREAT VALUE 8 oz. Cubed Colby and Monterey Jack Cheese; 27) GREAT VALUE 1 lb. (chunk) Colby and Monterey Jack Cheese; 28) HEINEN’S 8 oz. (chunk) Colby/Jack Cheese; 29) HILL COUNTRY FARE 8 oz Cheese Bites Colby & Monterey Jack Cheeses; 30) HOME HARVEST 26 to 32 oz. (chunk) Colby/Jack Cheese; 31) HY-TOP 9 to 15 oz. (chunk) Colby/Jack Cheese; 32) HY-TOP 9 to 15 oz. Longhorn Style Colby/Jack Cheese; 33) HY-TOP 2 lb. Feather Shredded Colby/Jack Cheese; 34) HY-TOP 1 lb. (chunk) Colby/Jack Cheese; 35) HY-TOP 2 lb. Fancy Shredded Colby/Jack Cheese; 36) IGA 8 oz. Fancy Shredded Colby & Monterey Jack Cheese; 37) OUR FAMILY 1 lb. (chunk) Natural Colby & Monterey Jack Cheese; 38) OUR FAMILY 8 oz. (chunk) Natural Colby & Monterey Jack Cheese; 39) OUR FAMILY 9 to 15 oz. (chunk) Natural Colby and Monterey Jack; 40) OUR FAMILY 8 oz. Fancy Shredded Colby & Monterey Jack Cheese; 41) PARADE 1 lb. (chunk) Colby/Jack Cheese; 42) PARADE 2 lb. Feather Shredded Colby/Jack Cheese; 43) PARADE 2 lb. (loaf) Colby/Jack Cheese; 44) PARADE 8 oz. Fancy Shredded Colby/Jack Cheese; 45) PIGGLY WIGGLY 8 oz. (chunk) Colby/Jack Cheese; 46) REDNERS 9 to 15 oz. (chunk) Colby/Jack Cheese; 47) REDNERS 26 to 32 oz. (chunk) Colby/Jack Cheese; 48) REMARKABLE 9 to 15 oz. Natural Longhorn Style Colby/Jack Cheese; 49) SHOP'n SAVE 26 to 32 oz.(chunk) Natural Colby/Jack Cheese; 50) SHURFINE 1 lb. (chunk) Colby and Monterey Jack Cheese; 51) SPARTAN 9 to 15 oz. (chunk) Natural Colby/Jack Cheese; Recall #F-295-1. Shredded Four Cheese Blend (Mexican Blend, Fiesta Blend, Taco Cheese) consisting of Monterey Jack, Cheddar, Queso Quesadilla, and Asadero Cheeses: 52) ALBERTSON'S 8 oz. Fancy Shredded 4 Cheese Mexican Blend; 53) BEST CHOICE 8 oz. Shredded 4 Cheese Mexican Blend Cheese; 54) COOPER 8 oz. Fancy Shredded 4 Cheese Mexican Blend; 55) COOPER 8 oz. Fancy Shredded Colby/Jack Cheese; 56) COUNTRY CROSSING 12 oz. Fancy Shredded Mexican 4 Cheese Blend; 57) FLAVORITE 8 oz. Fancy Shredded 4 Cheese Mexican Blend; 58) GREAT VALUE 8 oz. Fancy Shredded Fiesta Blend Cheese; 59) HY-TOP 8 oz. Fancy Shredded 4 Cheese Mexican Blend; 60) IGA 8 oz. Fancy Shredded 4 Cheese Mexican Blend; 61) OUR FAMILY 8 oz. Fancy Shredded 4 Cheese Mexican Blend; 62) PRICE CHOPPER 8 oz. Coyote Joe's Taco Cheese; 63) PRICE CHOPPER 1 lb. Coyote Joe's Taco Cheese. CODE: 1) coded 18 Dec 00 - 18 Mar 01; 2) coded 15 Dec 00 - 17 Mar 01; 3) coded 16 Dec 00 -18 Mar 01; 4) coded 21 Nov 00 - 27 Jan 01; 5) coded 02 Dec 00 - 19 Mar 01; 6) coded 21 Nov 00; 7) coded 03 Dec 00 - 24 Mar 01; 8) coded 05 Dec 00; 9) coded 07 Dec 00 - 03 Mar 01; 10) coded 08 Feb 01; 11) coded 21 Nov 00 - 11 Feb 01; l2) coded 08 Dec 00 - 08 Mar 01; 13) coded 18 Mar 01; 14) coded 23 Feb 01 - 06 Jun 01; 15) coded 07 Dec 00 - 29 Jan 01; 16) coded 24 Nov 00 - 17 Mar 01; 17) coded 03 Dec 00 - 09 Mar 01; 18) coded 24 Nov 00 - 03 Mar 01; 19) coded 14 Jan 01 - 03 Mar 01; 20) coded 30 Dec 00 - 05 Mar 01; 21) coded 18 Mar 01; 22) coded 28 Nov 00 - 05 Mar 01; 23) coded 21 Nov 00 - 03 Mar 01; 24) coded 26 Nov 00 - 24 Mar 01; 25) coded 24 Nov 00 - 22 Mar 01; 26) coded 14 Nov 00 - 25 Jan 01; 27) coded 15 Dec 00 - 25 Feb 01; 28) coded 05 Dec 00 - 04 Feb 01; 29) code 02 Dec 00 - 20 Jan 01; 30) coded 02 Dec 00 - 21 Dec 00; 31) coded 09 Feb 01 - 03 Mar 01; 32) coded 04 Dec 00; 33) coded 06 Dec 00 - 18 Mar 01; 34) coded 16 Dec 00 - 11 Feb 01; 35) coded 08 Mar 01; 36) coded 02 Feb 01; 37) coded 05 Dec 00 - 18 Mar 01; 38) coded 27 Nov 00 - 18 Mar 01; 39) coded 02 Dec 00 - 18 Mar 01; 40) coded 08 Jan 01 - 22 Mar 01; 41) coded 16 Dec 00 - 30 Dec 00; 42) coded 06 Dec 00 - 18 Mar 01; 43) coded 03 Dec 00 - 27 Jan 01; 44) coded 25 Nov 00 - 09 Mar 01; 45) coded 25 Nov 00 - 10 Mar 01; 46) coded 02 Dec 00 - 29 Jan 01; 47) coded 02 Dec 00 - 29 Jan 01; 48) coded 28 Jan 01; 49) coded 02 Feb 01; 50) coded 16 Dec 00 - 07 Jan 01 with UPC # 15400-83308; 51) coded 14 Dec 00 - 18 Mar 01; Recall #F-295-1: 52) coded 17 Jan 01 - 04 Apr 01; 53) coded 06 Mar 01 - 08 Apr 01; 54) coded 14 Apr 01; 55) coded 29 Mar 01 - 20 Jun 01; 56) coded 13 Jan 01 - 12 Feb 01; 57) coded 24 Feb 01 - 06 Mar 01; 58) coded 23 Dec 00 - 09 Apr 01; 59) coded 27 Dec 00 - 02 Apr 01; 60) coded 08 Apr 01; 61) coded 27 Dec 00 - 07 Apr 01; 62) coded 23 Dec 00 - 07 Apr 01; 63) coded 02 Apr 01. MANUFACTURER OF BULK CHEESE: Hill & Valley Cheese, Inc., Cashton, WI. RECALLED BY: Schreiber Foods, Inc., Green Bay, WI., by press release on 11/6/00 and letter dated 11/2/00. Completed recall resulted from sample analysis and follow-up by the Wisconsin Department of Agriculture. DISTRIBUTION: Nationwide. QUANTITY: 1,431,539 pounds. REASON: The cheese products were manufactured using bulk cheese that Hill & Valley Cheese, Inc., Cashton, WI recalled due to potential Listeria monocytogenes contamination. ________ PRODUCT: Kellogg Eggo Nutrigrain Whole Wheat Waffles - 12.3 oz. (10 waffles per carton/ 12 cartons per case). Recall #F-296-1. CODE: Manufacturing code date beginning with 06300EJB. MANUFACTURER: Kellogg Company, San Jose, CA. RECALLED BY: Kellogg Company, Battle Creek, MI., by press release on October 10, 2000, followed by letter October 11, 2000. Firm-initiated recall complete. DISTRIBUTION: California, Montana, Nevada, Washington, Utah, Texas, Arizona and Hawaii. QUANTITY: 4,800 cases (10 waffles/carton/ 12 cartons/case). REASON: The cartons labeled as "Eggo Nutri-Grain Whole Wheat Waffles" actually contain a second product, Eggo Nut & Honey Waffles. The Nut & Honey Waffles contain peanuts that are not listed on the label of the Whole Wheat Waffles. ________ PRODUCT: The First brand Dried Persimmon packed in flexible plastic packages, net wt. 14-oz. (396g). CODE: None. MANUFACTURER: Soon Foong Company, West Hong Kong, China. RECALLED BY: Strong America Limited, Importer and distributor, Brooklyn, NY., by Recall Notice, dated 10/02/00. Completed recall resulted from follow-up by the New York State Dept. of Agriculture and Markets. DISTRIBUTION: NY, MA and IL. QUANTITY: 120 cases (50 - 14 oz. Packages per case). REASON: The product contains undeclared sulfites. ________ PRODUCT: a) Recall #F-300-1. Shredded Monterey Jack Cheese: 1) Sysco Imperial Shredded Monterey Jack Cheese, Net Wt. 5 lbs; 2) Darlington Shredded Monterey Jack Cheese, Net Wt. 5 lbs; 3) Glenview Farms Fancy Shredded Monterey Jack Cheese, Net Wt. 10 lbs.; 4) Glenview Farms Feather Shredded Monterey Jack Cheese, Net Wt. 5 lbs.; 5) Sargento Deep V Shredded Monterey Jack Cheese, Pack/Size 6/5 LB, Net Wt 30#. b) Recall #F-301-1. Shredded Cheddar/Monterey Jack Cheese: 1) Shullsburg Wisconsin Cheese Fancy Shredded 50% Cheddar/50% Monterey Jack Cheese, Net Wt. 5 Lbs. 2) Glenview Farms Fancy Shredded Mild Cheddar/Monterey Jack Cheese, Net Wt. 10 Lbs. c) Recall #F-302-1. Shredded Colby/Monterey Jack Cheese: Schreiber Ready-Cut Select Cheese, A Blend of Feather Shredded 50% Colby and 50% Monterey Jack Cheese, Net Wt. 5 Lbs. CODE: a) 1) labeled as packed 08 17 00; 2) coded 231 0; 3) coded 08M18AL0 or 09M01AL0; 4) coded 08M19AL0 5) dated NOV 14 00 b) 1) labeled with sell by date May 15 01; 2) coded 08M15AL0. c) coded 228 0 or 232 0. MANUFACTURER OF BULK CHEESE: Hill and Valley Cheese, Cashton, WI. RECALLED BY: Marathon Cheese Corporation, Marathon, WI., by letter dated 10/27/00. Completed recall resulted from sample analysis and follow-up by the Wisconsin Department of Agriculture. DISTRIBUTION: Nationwide. QUANTITY: 1609 twenty pound cases and 1000 thirty pound cases. REASON: The cheese products were manufactured using bulk cheese that Hill & Valley Cheese, Inc., Cashton, WI recalled due to potential Listeria monocytogenes contamination. ________ PRODUCT: STR brand Dried Vegetable (Lily Flower) in 6 oz. (170g) plastic bags. Recall #F-303-1. CODE: None. MANUFACTURER: Xiamen Da Chang Hua Imp. & Exp. Co., Ltd., Xiamen, Fujian, China. RECALLED BY: Strong America Limited, Brooklyn, NY., by an Allergen Alert to Associated Press on 6/30/00 and letter dated 10/2/00. Completed recall resulted from follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York. QUANTITY: 10 cases (100 - 6 oz bags per case). REASON: The product contained undeclared sulfites. ________ PRODUCT: Norpaco Imported Sun Dried Tomatoes, 32 oz. Size. Recall #F-304-1. CODE: All codes on the market at the time the recall was initiated. MANUFACTURER: Norpaco Gourmet Foods, Bristol, CT RECALLED BY: Manufacturer, by press release January 2002, followed by fax on 1/24/01. The New York State Department of Agriculture and Markets initiated recall complete. DISTRIBUTION: New York. QUANTITY: 144 cases (12/32 oz case). REASON: The product contained undeclared sulfites. ________ PRODUCT: Husty brand Dried Lily Flower in 6 oz. (170g) plastic bags. Recall #F-305-1. CODE: None. MANUFACTURER: Fouzhou Golden Banyan Foodstuffs Co., Ltd., Fujian, China. RECALLED BY: Well Luck Co., Jersey City, NJ., by two versions of the recall letter dated 12/12/00, (one version in Chinese and one in English) and by press release on January 18, 2001. The New York State Department of Agriculture and Markets initiated recall complete. DISTRIBUTION: VA, PA, NC, NY, MA, MO, DE, FL, OH, NJ, IL, MD. QUANTITY: 386 cases X 50 - 6 oz bags. REASON: The product contained undeclared sulfites.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT: a) Meijer brand Newborn Gentle Real Fabric Cloths baby wipes. 80 per package. Distributed by Meijer Distribution, Inc., Grand Rapids, MI. b) Target brand Sensitive Skin cloth Baby Wipes. 2-80 ct tubs per package. Distributed by Target Corporation, Minneapolis, MN. c) White Cloud brand Newborn Gentle fabric cloth baby wipes. 80 per package. Recall #F-297-1. CODE: All lots on the market at the time the recall was initiated. MANUFACTURER: Nice-Pak Products, Inc., Mooresville, IN. RECALLED BY: Manufacturer, by telephone and e-mail on 8/8/00 and by telephone and letter on 8/10/00. Firm-initiated recall complete. DISTRIBUTION: Nationwide (Meijer, Target and Wal-Mart outlets). QUANTITY: Approximately 20,000 cases. REASON: The product may be contaminated with Burkholderia cepacia.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT: (Rx) Trecator®-SC Sugar-Coated Tablets (Ethionamide), 250mg, 100 count. Recall #D-145-1. CODE: LOT NO. 3990893, Exp. 11/04. MANUFACTURER: Wyeth-Ayerst Laboratories, Rouses Point, NY. RECALLED BY: Wyeth-Ayerst Laboratories, Richmond, VA., by letters dated 2/12/01. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and Sweden, New Zealand, and Czech Republic. QUANTITY: 2,005 bottles. REASON: Dissolution failure. ________ PRODUCT: (Rx) Leukeran® tablets (Chlorambucil), 2 mg, 50 count. Recall #D-146-1 (an extension to Recall #D-459-0). CODE: LOT NO. 0E2036. MANUFACTURER: GlaxoSmithKline, Inc., Research Triangle Park, NC. RECALLED BY: Manufacturer, by letter on 1/22/01. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and to GlaxoSmithKline Canada. QUANTITY: 25,808 bottles, 7,200 (bulk) tablets were shipped to Canada. REASON: Impurity specification failure (stability). "Correction: The Enforcement Report for March 14, 2001 (Recall Number D-140/141-1) incorrectly listed the recall Class as Class II. The recall is a Class III".RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT: a) Red Blood Cells. Recall #B-451-1; b) Recovered Plasma. Recall #B-452-1. CODE: a) and b) unit 12K35228. MANUFACTURER: American National Red Cross, Carolina Region, Charlotte, NC. RECALLED BY: Manufacturer, by letter dated February 14, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: Two units. REASON: Blood products, collected from donor who had engaged in multiple high-risk behaviors, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-542-1; b) Recovered Plasma. Recall B-543-1. CODE: a) and b) Unit 2270350. MANUFACTURER: Central Texas Regional Blood and Tissue Center, Austin, TX. RECALLED BY: Manufacturer, by letter dated August 13, 1999 and by fax on February 16, 2001. Firm-initiated recall complete. DISTRIBUTION: Texas and Florida. QUANTITY: Two units. REASON: Blood products, collected from a donor who had sexual contact with an individual who lived in an HIV Group O risk area, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-635-1; b) Platelets. Recall #B-636-1; c) Fresh Frozen Plasma. Recall #B-637-1. CODE: a), b) and c) Unit 1552893. MANUFACTURER: South Texas Blood and Tissue Center, San Antonio, Texas. RECALLED BY: Manufacturer, by telephone on January 22, 1999 and by letter dated December 3, 1999. Firm-initiated recall complete. DISTRIBUTION: Texas. QUANTITY: Three units. REASON: Blood products, collected from donor with a history of exposure to hepatitis, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-858-1. CODE: unit numbers 0540486 and 5651070. MANUFACTURER: Blood Center of New Jersey, Inc., East Orange, NJ. RECALLED BY: Manufacturer, by letters dated November 19, 1998, and November 20, 1998. Firm-initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: Two units. REASON: Blood products, collected from unsuitable donors based on living in areas considered endemic for malaria, were distributed. ________ PRODUCT: Platelets Pheresis, Leukocytes Reduced. Recall #B-861-1. CODE: Unit number 22417-9517. MANUFACTURER: Blood Systems, Inc., Las Vegas, NV. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on November 2, 2000. Firm-initiated recall complete. DISTRIBUTION: Nevada. QUANTITY: One unit. REASON: Platelets, labeled with the incorrect expiration date, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-862-1; b) Platelets. Recall # B-863-1. CODE: a) and b) unit number 42FZ95782. MANUFACTURER: The American National Red Cross, Northern Ohio Region, Cleveland, OH. RECALLED BY: Manufacturer, by letter dated July 19, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Two units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-864-1. CODE: Unit number 16LR36528. MANUFACTURER: The American National Red Cross, Central Ohio Region, Columbus, OH. RECALLED BY: Manufacturer, by telephone on September 11, 2000, and by letter dated September 15, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-865-1. CODE: Unit 2203976. MANUFACTURER: LifeShare, Inc. Elyria, OH. RECALLED BY: Manufacturer, by letter dated December 12, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCT: Platelets, Pheresis. Recall #B-866-1. CODE: Unit numbers 6616471, 6616656, and 6617016. MANUFACTURER: Blood Center of New Jersey, Inc., East Orange, NJ. RECALLED BY: Manufacturer, by letter dated February 27, 1998. Firm-initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: 3 units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. ________ PRODUCT: Platelets. Recall #B-867-1. CODE: Unit numbers 2211259 and 2211195. MANUFACTURER: LifeShare, Inc., Elyria, OH. RECALLED BY: Manufacturer, by letter dated December 12, 2000. DISTRIBUTION: Ohio. QUANTITY: Two units. REASON: Platelets, collected from a donor that had ingested aspirin in the previous 72 hours, were distributed. ________ PRODUCT: Recovered Plasma. Recall #B-868-1. CODE: Unit number 182679. MANUFACTURER: Aultman Hospital Association Blood Bank, Canton, OH. RECALLED BY: Manufacturer, by letter dated December 22, 2000. Firm-initiated recall complete. DISTRIBUTION: Maryland. QUANTITY: One unit. REASON: Blood product, that tested repeatedly reactive for the antibody to hepatitis C virus (anti-HCV), was distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-859-1. CODE: Unit numbers 40GR52224, 40GR52228, 40GR52230, 40GR52232, and 40GR52233. MANUFACTURER: The American National Red Cross, Heart of America Region, Peoria, IL. RECALLED BY: Manufacturer, by telephone on November 18, 2000. Firm-initiated recall complete. DISTRIBUTION: Illinois and California. QUANTITY: Five units. REASON: Blood products, labeled with the incorrect expiration date, were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced Irradiated. Recall #B-860-1. CODE: Unit numbers 4126206, and 8212298. MANUFACTURER: Central Indiana Regional Blood Center, Inc., Indianapolis, IN. RECALLED BY: Manufacturer, by telephone on August 29, 2000 and by letter dated September 15, 2000. Firm-initiated recall complete. DISTRIBUTION: Indiana. QUANTITY: Two units. REASON: Blood products, labeled with the incorrect expiration date, were distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
________ PRODUCT: Puritan-Bennett® 840 Series™ Ventilator System. Recall # Z-272-1. CODE: All Serial Numbers with Revision E Level Software. MANUFACTURER: Puritan Bennett Corp., Carlsbad, CA. RECALLED BY: Manufacturer, by letter on December 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and International. QUANTITY: 656 units. REASON; A malfunction may result in overpressure and barotrauma that could lead to serious injury or death in patients whose body weight is less than 20 kg.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: a) Model No. XGS dual gas spring portable mobile stand. Recall #Z-397-1. b) Model No. XGS Mark II dual gas spring portable mobile stand. Recall #Z-398-1. CODE: Model numbers XGS and XGS Mark II. MANUFACTURER: Royal Enterprises, Helmet, CA. RECALLED BY: MinXray, Inc., Northbrook, IL, by letter on December 2000. Field correction Ongoing. DISTRIBUTION: Nationwide. QUANTITY: 292 units. REASON: Failure of the device’s mounting stud may allow the trunnion of the xray unit to unintentionally separate from the tube arm and allow the xray unit to fall. ________ PRODUCT: InterOp Acetabular Shell: a) Hemispherical, Catalog No. 4360-00-039/065. Recall #Z-404-1; b) Revision, Catalog No. 4361-00043/081. Recall #Z-405-1; c) Rim Flare, Catalog No. 4361-00-039/071, Recall #Z-406-1; d) Protrusion, Catalog No. 4363-00-053/081. Recall #Z-407-1 CODE: a) Lot Nos. 1307848 and Higher; b) All Lot Numbers; c) Lot Nos. 1398234 and Higher; d) Lot Nos. 1397531 and Higher. MANUFACTURER: Sulzer Orthopedics, Inc., Austin, TX. RECALLED BY: Manufacturer, by letter on December 7 and 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and International. QUANTITY: 10,114 devices. REASON: The device contains a manufacturing residue, machining oil. ________ PRODUCT: Safety Seals, Catalog No. SS. Recall #Z-408-1. CODE: Lot Nos. 5031 through 5341. MANUFACTURER: Midas Rex, L.P., Fort Worth, TX. RECALLED BY: Manufacturer, by letter on January 18, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and International. QUANTITY: 100,548 units. REASON: The safety seals may swell during autoclaving which can cause the migration of the seals to an incorrect position within the motor- attachment assembly resulting in an increased chance of oil leaks and seal disintegration during surgery.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT: Immolate brand of Valproic Acid Test Kit. Recall ##Z-385-1. CODE: Lot No. 105, Model No. LKVAI. MANUFACTURER: Diagnostic Products Corp, Los Angeles, CA. RECALLED BY: Manufacturer, by letter on September 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Arizona and International. QUANTITY: 14 kits. REASON: The barcode used to label the adjustor kit component had an error that caused the system to reject it. The printing error prevents the barcode from being read and the instruments will not process the assay and patient results will not be obtained. ________ PRODUCT: a) Vitros 250 and Vitros 250 AT Chemistry Systems Software version below 7.0.; Recall #Z-386-1. b) Vitros 950 and Vitros 950AT Chemistry Systems with software version below 3.07. Recall #Z-387-1. CODE: a) Model No. 3332, Catalog No. 8132086 (Vitros 250); Model No. 3391, Catalog No. 1558143 (Vitros 250AT); b) Model No. 3360, Catalog No. 8748790 (Vitros 950); Model No. 3361, Catalog No. 1735356 (Vitros 950AT). MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by letter on June 28 and October 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and International. QUANTITY: a) 279 devices; b) 18 devices. REASON: The Bilirubin (Unconjugated Bilirubin) results may be reported as 0.0 mg/dL or Bc (Conjugated Bilirubin) result may not be flagged with a potential interferent code when a spectral interferent is present in a patient sample. ________ PRODUCT: Vitros Clinical Chemistry - Performance Verifier I. Kodatrol I and II Control and Diluent Set, Model and Catalog Numbers Performance Verifier I, Catalog No. 806 7324. Recall #Z-388-1. CODE: Lot No. X1815, Exp. 30 Jun 02. MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by e-mail and fax, on November 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and International. QUANTITY: 8,928 kits. REASON: Sodium QC results may run above the published Range-of-Means (ROM) on some analyzers with this lot of Performance Verifier control fluid. ________ PRODUCT: VITROS Immunodiagnostic Product: a) Ferritin Reagent Pack, Catalog No. 835 6636. Recall #Z-389-1; b) Total B-hCG Reagent Pack. Recall # Z-390-1. CODE: a) Lot No. 134; b) Lot No. 144. MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by letter on January 26, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and International. QUANTITY: a) 983 kits; b) 1,033 kits. REASON: Incorrect placement of reagent bottles in the reagent pack. The incorrect configuration will cause very low light signal, which will result in either failure to calibrate, an error code, or signal results of 0 ng/mL. ________ PRODUCT: Vitros Immunodiagnostic Products CA 15-3™ Reagent Packs, Catalog No. 6800039. Recall #Z-391-1. CODE: Lot No. 80. MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by letter on December 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and International. QUANTITY: a) 22 kits; b) 173 kits. REASON: Reagent bottles are incorrectly positioned in these products and using them would produce CA 15-3 results of less than 1U/ml. ________ PRODUCT: Rifton Chairs: a) Small, low back, Recall #Z-392-1. b) Medium, low back. Recall #Z-393-1 c) Medium, high back. Recall #Z-394-1 d) Medium, low back. Recall #Z-395-1 e) Large, high back. Recall #Z-396-1 CODE: All Serial Numbers: a) Model No. R501; b) Model No. R502; c) Model No. R503; d) Model No. R504; e) Model No. R505. MANUFACTURER: Community Products LLC/Community Playthings, Rifton, NY RECALLED BY: Manufacturer, by letter on January 8, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and International. QUANTITY: 3,567 chairs. REASON: The plastic housing, into which the brackets that hold the seat is inserted have broken. "Correction: The Enforcement Report for February 14, 2001, (Recall Number Z-200-1) and January 31, 2001 (Recall Number Z-180-1) listed the recalls as ongoing. The recalls are complete".END OF ENFORCEMENT REPORT FOR MARCH 21 2001. ####
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