July 3, 2002 02-26
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Stewartís brand beverages in assorted flavors as follows: a) ORIGINAL Stewart'S BIRCH-BEER, COLD-BREWED DRAFT, STEWART'S SINCE 1924, 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, WHITE PLAINS, NY. Barcode # 98794 29401. Bottled in clear glass bottles with red and yellow lettering. Recall # F-545-2 b) ORIGINAL Stewart'S GINGER-BEER, OLD-FASHIONED, SPICY GINGER ALE, 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC. DENVER, CO 80202 (applied ceramic label) or BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP., DENVER, CO. (pressure sensitive label). Barcode # 98794 70300. Bottled in amber glass bottles with yellow and green lettering. Recall # F-546-2. c) ORIGINAL Stewart'S ROOT-BEER, COLD-BREWED DRAFT SINCE 1924., 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC. DENVER, CO 80202 (applied ceramic label) or BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP., DENVER, CO. (pressure sensitive label). Barcode # 98794 30300. Bottled in amber glass bottles with orange and white lettering. Recall # F-547-2. ORIGINAL Stewart'S ROOT-BEER, 16 FL.OZ., 473 mL, COLD-BREWED DRAFT SINCE 1924. Bottled under authority of Stewart's Beverages, Inc., Denver, CO. Barcode # 98794 30316. Bottled In barrel-shaped, amber bottles with orange and white lettering. ORIGINAL Stewart'S ROOT-BEER, COLD-BREWED DRAFT SINCE 1924, 32 FL.OZ., 947 mL. Bottled under authority of Cable Car Beverage Corp., Denver, CO. Barcode # 98794 30700. Bottled in amber glass bottles with orange and white lettering. d) DIET Stewart'S ROOT-BEER, COLD-BREWED DRAFT SINCE 1924. 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC., DENVER, CO. (applied ceramic label and pressure sensitive label). Barcode # 98794 50500. Bottled in amber glass bottles with orange and white lettering. Recall # F-548-2. DIET Stewart'S ROOT-BEER, 16 FL.OZ., 473 mL, COLD-BREWED DRAFT SINCE 1924. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, WHITE PLAINS, NY. Barcode # 98794 50516. Bottled in amber glass, barrel-shaped bottles with orange and white lettering. DIET Stewart'S ROOT-BEER, COLD-BREWED DRAFT SINCE 1924., 32 FL. OZ., 947 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC., DENVER, CO. Barcode # 98794 50700. Bottled in amber glass bottles with orange and white lettering. e) Stewart'S WISHNIAK BLACK-CHERRY, STEWART'S SINCE 1924, 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, WHITE PLAINS, NY. Barcode # 98794 29301. Bottled in clear glass bottles with purple, red and white lettering. Recall # F-549-2; f) Stewart'S GRAPE-SODA, 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC., DENVER, CO. (applied ceramic label) or BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP DENVER., CO. (pressure sensitive label). Barcode # 98794 01212. Bottled in clear glass bottles with purple, green, and white lettering. Recall # F-550-2. Stewart'S GRAPE-SODA, 16 FL.OZ., 473 mL. Bottled under authority of Cable Car Beverage Corp. Denver, CO. Barcode #98794 01216. Bottled in clear glass, barrel-shaped bottles with purple, green, and white lettering. g) Stewart'S KEY LIME, 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC., DENVER, CO. (applied ceramic label) or BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP DENVER, CO. (pressure sensitive label). Barcode # 98794 90112. Bottled in clear glass bottles with green and white lettering. Stewart'S KEY LIME, 16 FL.OZ., 473 mL. Bottled under authority of Cable Car Corp Denver, CO. Barcode # 98794 90016. Bottled in clear glass, barrel-shaped bottles with green and white lettering. Stewart'S Classic KEY LIME, 32 FL.OZ., 947 mL. BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP., DENVER, CO. Barcode # 98794 90132. Bottled in clear glass bottles with green and white lettering. Recall # F-551-2; h) ORIGINAL Stewart'S PEACH-SODA, JUICY, PEACH FLAVOR! 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC., DENVER, CO. (applied ceramic label and pressure sensitive label). Barcode # 98794 71512. Bottled in clear glass bottles with peach and white lettering. Recall # F-552-2; i) ORIGINAL Stewart'S CREAM-SODA, GREAT OLD-FASHIONED TASTE, 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP., DENVER, CO. Barcode # 98794 20300. Bottled in clear glass bottles with red and white lettering. ORIGINAL Stewart'S CREAM-SODA, 16 FL.OZ., 473 mL, GREAT OLD- FASHIONED TASTE! Bottled under authority of Stewart's Beverages, Inc. Denver, CO. Barcode # 98794 20316. Bottled in clear glass, barrel- shaped bottles with red and white lettering. ORIGINAL Stewart'S CREAM-SODA, GREAT OLD-FASHIONED TASTE! 32 FL.OZ. 947 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC., DENVER, CO. Barcode # 98794 20700. Bottled in clear glass bottles with red and white lettering. Recall # F-553-2; j) ORIGINAL Stewart'S CREAM-SODA Soda mousse, 355 mL, GREAT OLD-FASHIONED TASTE! Stewart's Beverages, Inc.,Denver, CO. (applied ceramic label). Barcode # 98794 20309. Bottled in clear glass bottles with red and white lettering. Recall # F-554-2; k) Stewart'S CHERRIES N'CREAM, 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP DENVER, CO 80202 (pressure sensitive label) or BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC., DENVER, CO. (applied ceramic label). Barcode # 98794 90212. Bottled in clear glass bottles with red and white lettering. Stewart'S CHERRIES N'CREAM, 16 FL.OZ., 473 mL. Bottled under authority of Cable Car Beverage Corp., Denver, CO. Barcode # 98794 90216. Bottled in clear glass, barrel-shaped bottles with red and white lettering. Stewart'S Old-Fashioned CHERRIES N'CREAM, 32 FL.OZ., 947 mL. BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP DENVER, CO. Barcode # 98794 90232. Bottled in clear glass bottles with red, beige and white lettering. Recall # F-555-2; l) Stewart'S ORANGE N'CREAM since 1924., 12 FL. OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC. DENVER, CO 80202 (applied ceramic label) or BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP., DENVER, CO. (pressure sensitive label). Barcode # 98794 80300. Bottled in clear glass bottles with green and white lettering. Stewart'S ORANGE N'CREAM since 1924., 16 FL.OZ. 473 mL. Bottled under authority of Cable Car Beverage Corp., Denver, CO. Barcode # 98794 80316. Bottled in clear glass, barrel-shaped bottles with green and white lettering. ORIGINAL Stewart'S Country ORANGE N'CREAM since 1924., 32 FL.OZ., 947 mL. BOTTLED UNDER AUTHORITY OF CABLE CAR BEVERAGE CORP DENVER, CO. Barcode # 98794 80700. Bottled in clear glass bottles with green and white lettering. Recall # F-556-2; n) DIET Stewart'S (and Diet Stewart'S Country) ORANGE N'CREAM since 1924, 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, INC., DENVER, CO. (applied ceramic label and pressure sensitive label). Barcode # 98794. Bottled in clear glass bottles with green and white lettering. Recall # F-557-2; o) Stewart'S STRAWBERRIES N'CREAM, 12 FL.OZ., 355 mL. BOTTLED UNDER AUTHORITY OF STEWART'S BEVERAGES, WHITE PLAINS, NY. (applied ceramic label). Barcode # 98794 29501. Bottled in clear glass bottles with red, green and white lettering. Recall # F-558-2. CODE All bottling codes on the market at the time of the initiation of the recall, 12/18/01, bearing plant code "CT 571" which were distributed from August 2001 through December 18, 2001. This code usually appears on the shoulder of the bottle on the 12-oz. and 32-oz. glass bottles and near the seam of the 16-oz. barrel bottle. Dark bottles should be tipped and held towards the light for easier viewing. Continue to turn the bottle until black ink jet code is visible. Barcode Numbers: 12 oz. Birch Beer - 98794 29401 12 oz. Ginger Beer - 98794 70300 12 oz. Root Beer - 98794 30300 16 oz. Root Beer - 98794 30316 32 oz. Root Beer - 98794 30700 12 oz. Diet Root Beer - 98794 50500 16 oz. Diet Root Beer - 98794 50516 32 oz. Diet Root Beer - 98795 50700 12 oz. Black Cherry - 98794 29301 12 oz. Grape Soda - 98794 01212 16 oz. Grape Soda - 98794 01216 12 oz. Key Lime - 98794 90112 16 oz. Key Lime - 98794 90116 32 oz. Key Lime - 98794 90132 12 oz. Peach Soda -98794 71512 12 oz. Cream Soda - 98794 20300 16 oz. Cream Soda - 98794 20316 32 oz. Cream Soda - 98794 20700 12 oz. Cream Soda Soda Mousse - 98794 20309 12 oz. Cherries N'Cream - 98794 90212 16 oz. Cherries N Cream - 98794 90216 32 oz. Cherries N'Cream - 98794 90232 12 oz. Orange N'Cream - 98794 80300 16 oz. Orange N'Cream - 98794 80316 32 oz. Orange N'Cream - 98794 80700 12 oz. Diet Orange N'Cream - 98794 80500 12 oz. Strawberries N'Cream - 98794 29501. RECALLING FIRM/MANUFACTURER Recalling Firm: Stewartís Beverages, Inc., White Plains, NY, by telephone beginning on December 14, 2001 and by letters on December 18 and 26, 2001. Manufacturer: Hillside Bottling Corp., Hillside, NJ. Firm initiated recall is complete. REASON The products may be contaminated with ammonia. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Nationwide. _______________________ PRODUCT Mistic SPARKLING brand beverages in the following flavors: a) Lime Kiwi NATURAL FLAVORED BEVERAGE Mistic(R) SPARKLING, 16 FL.OZ. (473 mL), CONTAINS NO JUICE, DISTRIBUTED UNDER THE AUTHORITY OF MISTIC BRANDS, INC. WHITE PLAINS, NY. MADE IN USA. Barcode # 89396 15632. Bottled in clear, light blue glass bottles, with white, fuschia and purple lettering. Recall # F-559-2; b) Mango Passion Lime Kiwi NATURAL FLAVORED BEVERAGE Mistic (R)SPARKLING, 16 FL.OZ. (473 mL), CONTAINS NO JUICE, DISTRIBUTED UNDER THE AUTHORITY OF MISTIC BRANDS, INC., WHITE PLAINS, NY. MADE IN USA. Barcode # 89396 15633. Bottled in clear, light blue glass bottles, with white and fuschia lettering. Recall # F-560-2; c) Peach NATURAL FLAVORED BEVERAGE Mistic(R) SPARKLING, 16 FL.OZ. (473 mL), CONTAINS NO JUICE, DISTRIBUTED UNDER THE AUTHORITY OF MISTIC BRANDS, INC., WHITE PLAINS, NY. MADE IN USA. Barcode # 89396 15637. Bottled in clear, light blue glass bottles, with white and fuschia lettering. Recall # F-561-2; d) Raspberry Boysenberry NATURAL FLAVORED BEVERAGE Mistic (R) SPARKLING, 16 FL.OZ. (473 mL), CONTAINS NO JUICE, DISTRIBUTED UNDER THE AUTHORITY OF MISTIC BRANDS, INC., WHITE PLAINS, NY. MADE IN USA. Barcode # 89396 15631. Bottled in clear, light blue glass bottles, with white and fuschia lettering. Recall # F-562-2; e) Wild Cherry NATURAL FLAVORED BEVERAGE Mistic (R) SPARKLING, 16 FL.OZ. (473 mL), CONTAINS NO JUICE, DISTRIBUTED UNDER THE AUTHORITY OF MISTIC BRANDS, INC., WHITE PLAINS, NY. MADE IN USA. Barcode # 89396 15636. Bottled in clear, light blue glass bottles, with white and fuschia lettering. Recall # F-563-2; f) 0 Calorie Lime Kiwi NATURAL FLAVORED BEVERAGE Mistic(R) SPARKLING, 16 FL.OZ. (473 mL), *PHENYLKETONURICS: CONTAINS PHENYLALANINE, DISTRIBUTED UNDER THE AUTHORITY OF MISTIC BRANDS, INC., WHITE PLAINS, NY. MADE IN USA. Barcode # 89396 15118. Bottled in clear, glass bottles, with white, fuschia and purple lettering. Recall # F-564-2; g) 0 Calorie Raspberry Boysenberry NATURAL FLAVORED BEVERAGE Mistic (R) SPARKLING, 16 FL.OZ. (473 mL), PHENYLKETONURICS: CONTAINS PHENYLALANINE, DISTRIBUTED UNDER THE AUTHORITY OF MISTIC BRANDS, INC., WHITE PLAINS, NY. MADE IN USA. Barcode # 89396 15119.Bottled in clear, glass bottles, with white, fuschia and purple lettering. Recall # F-565-2; h) 0 Calorie Wild Cherry NATURAL FLAVORED BEVERAGE Mistic (R) SPARKLING, 16 FL.OZ. (473 mL), *PHENYLKETONURICS: CONTAINS PHENYLALANINE, DISTRIBUTED UNDER THE AUTHORITY OF MISTIC BRANDS, INC., WHITE PLAINS, NY. MADE IN USA. Barcode # 89396 15123. Bottled in clear, glass bottles, with white, fuschia and purple lettering. Recall # F-566-2; CODE All bottling codes with plant code "CT571" on the bottle. This code usually appears on the widest part of the bottle at the base of the taper. RECALLING FIRM/MANUFACTURER Recalling Firm: Mistic Brands, Inc., White Plains, NY, by telephone beginning on December 14, 2001 and by letters on December 18 and 26, 2001. Firm initiated recall is complete. REASON The products may be contaminated with ammonia. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION NY, CT, NJ and PA. _______________________ PRODUCT a) Don's Salads Macaroni Salad 10 lbs. Recall # F-567-2; b) Don's Salads Creamed Cabbage 10 lbs. Recall # F-568-2. CODE Use by 6/29/02. RECALLING FIRM/MANUFACTURER Shernoff's Salads, Philadelphia, PA, by telephone on May 20, 2002. FDA initiated recall is ongoing. REASON a) Fails to list subingredients of mayonnaise and macaroni; b) Fails to list subingredients of mayonnaise. VOLUME OF PRODUCT IN COMMERCE a) 3900 containers; b) 20 containers. DISTRIBUTION PA and NJ. _______________________ PRODUCT Assis brand Grape Drink Concentrate.Recall # F-570-2. CODE Catalog No. 910-41-867 (For Passover holiday sales) Lot No's: 0 018 15 and 0 334 14 43 Catalog No. 110-41-867 (for year round sales) Lot Numbers: 0 018 15 and 0 334 14 43 RECALLING FIRM/MANUFACTURER Recalling Firm: Osem USA, Inc., Englewood Cliffs, NJ, by letters on May 9, 2002. Manufacturer: Beit Hashita Assis Food Industries R.A. Israel, State initiated recall is complete. REASON The product contained the unapproved color additive Ext. Red No. 10 and contained brilliant blue FCF (certifiable as FD&C Blue No. 1). VOLUME OF PRODUCT IN COMMERCE 780 boxes/12 bottles DISTRIBUTION Nationwide. _______________________ PRODUCT a) GELLWE(R) TERAZ POLSKA brand galaretka o smaku owocow lesnych z witamina C (in Polish), FOREST-FRUITS JELLY, in flexible foil packaging, net wt. 3.52 oz. (Masa netto 100 g). Recall # F-571-2; b) GELLWE(R) TERAZ POLSKA brand KISIEL smak truskawkowy z WIT. C (in Polish), STRAWBERRY JELLY, in flexible foil packaging, net wt. 40 grams (Masa netto 40 g). Recall # F-572-2 c) GELLWE(R) TERAZ POLSKA brand galaretka o smaku malinowym z witamina C (in Polish), RASPBERRY JELLY, in flexible foil packaging, net wt. 100 g on foil label, sticker label declares net weight as 3.17 oz. (Masa netto 90 g). Recall # F-573-2; d) GELLWE(R) TERAZ POLSKA brand galaretka o smaku agrestowym z witamina C (in Polish), GOOSEBERRY JELLY in flexible foil packaging, net wt. 100 g on foil label, net wt. 3.17 oz. (90 grams) o on sticker label. Recall # F-574-2; CODE Barcode Numbers on product labels: a) Forest Fruit Jelly: 900552 000129 b) Strawberry Jelly: 900552 000617 c) Raspberry Jelly: 900552 000051 d) Gooseberry Jelly: 900552 000044. RECALLING FIRM/MANUFACTURER Recalling Firm: Polonica, Inc., Brooklyn, NY, by telephone on September 14, 2001. Manufacturer: Gellwe Sp. z.o.o. Krakow, Zabierz, Poland. State initiated recall is complete. REASON The products contained unapproved color additives. VOLUME OF PRODUCT IN COMMERCE 50 cases (20 bags per case) DISTRIBUTION NY, NJ, PA, CT. _______________________ PRODUCT China Noodle Brand Noodles in 1-lb. plastic packages described as: a) Wan Ton Wrap. Recall # F-576-2; b) Sue Gow Skin, Recall # F-577-2; c) Pot Sticker Skin. Recall # F-578-2; d) Su My Skin. Recall # F-579-2; e) Fried Wan Ton Wrap. Recall # F-580-2; f) Chinese Mein (Steamed Noodle). Recall # F-581-2; g) Chinese Mein (Wonton Noodle). Recall # F-582-2; h) Chinese Mein (Fresh Noodle). Recall # F-583-2; i) Chinese Mein (Whole Egg Noodle). Recall # F-584-2; j) Egg Roll Wrap. Recall # F-585-2. CODE There are no production codes on the products. RECALLING FIRM/MANUFACTURER China Noodle Company, Inc., Oakland, CA, by letter sent July 2001. Firm initiated recall is ongoing. REASON All the labels of the products did not declare FD&C Yellow #6 in the ingredient list. In addition, labels for the Chinese Mein (Whole Egg Noodle, Fresh Noodle, Steamed Noodle), distributed in 1-lb. packages, did not declare FD&C Yellow #5. VOLUME OF PRODUCT IN COMMERCE 2,000 lbs. DISTRIBUTION CA. _______________________ PRODUCT Forge Mountain Green Tomato Relish Net 16 fl. oz. The product is packed in glass jars under two different labels (Forge Mountain and Dana Fancy Foods). Recall # F-586-2. CODE Green Tomato Relish--Lot 461351. RECALLING FIRM/MANUFACTURER Dana Fancy Foods, Dana, NC, by visit on September 27, 2001. Firm initiated recall is complete. REASON The product may have been insufficiently acidified to prevent growth of microrganisms of public health concern. VOLUME OF PRODUCT IN COMMERCE 206/16 oz. jars. DISTRIBUTION NC.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________ PRODUCT Shernoff's Macaroni Salad 5 lbs. and 30 lbs. Recall # F-569-2. CODE Use by 6/29/02. RECALLING FIRM/MANUFACTURER Shernoff's Salads, Philadelphia, PA, by telephone on May 30, 2002. FDA initiated recall is ongoing. REASON Fails to list subingredients of macaroni. VOLUME OF PRODUCT IN COMMERCE 400 containers of the 5 lb. macaroni and 1100 containers of the 30 lb. macaroni. DISTRIBUTION PA and NJ.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Opalescence Xtra Boost, chemically activated whitening gel (38% hydrogen peroxide) for in office tooth whitening kit. Recall # 342-2. CODE Lot Numbers 4192 and 4LQ0. RECALLING FIRM/MANUFACTURER Ultradent Products, Inc., South Jordan, UT, by telephone on March 25 and 26, 2002. Firm initiated recall is ongoing. REASON Cracks in syringe causing misapplication of hydrogen peroxide. VOLUME OF PRODUCT IN COMMERCE 260 kits. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Xylocaine 2% Jelly (lidocaine HCL), For Topical Use Only, 20 mL syringe, Rx only, Sterile, Single Use Syringe, NDC 0186-0336-53. Recall # D-340-2. CODE Lot Numbers: CB652 Exp 8/02; DA725 EXP 7/03. RECALLING FIRM/MANUFACTURER Recalling Firm: Astrazeneca Pharmacuetical LP., Wilmington, DE, by letter on June 10, 2002. Manufacturer: Astrazeneca Lquid production [LPS] Karlskoga. Firm initiated recall is ongoing. REASON Stability-super potency/low fill: Product may have low syringe fill volume and high lidocaine assay. VOLUME OF PRODUCT IN COMMERCE 51,740. DISTRIBUTION Nationwide. _______________________ PRODUCT Methotrexate For Injection USP, 1 g, lyophilized, preservative free 1 g Single Dose Vial, Sterile, Rx only, NDC #63323-122-50. Recall # D-341-2 CODE Lot numbers: 210275-1, 210305-1, 210315-1, 210276-1, 210306-1, 210303-1, 210308-1, 210326-1, 210323-1. RECALLING FIRM/MANUFACTURER Recalling Firm: American Pharmaceutical Partners, Inc., Melrose Park, IL, by letter dated June 11, 2002. Manufacturer: Bigmar Pharmaceuticals, Bargengo, Switzerland. Firm initiated recall is ongoing. REASON Misbranding; The product is labeled with the wrong NDC # and has a misspelled name. VOLUME OF PRODUCT IN COMMERCE 29,361 vials. DISTRIBUTION Nationwide. _______________________ PRODUCT Doxycycline Hyclate Capsules, 100mg, 500-count bottles, Rx Only. Recall # D-344-2. CODE Lot No. Exp. Date 2985-103511 12/00/04 RECALLING FIRM/MANUFACTURER Recalling Firm: Ivax Pharmaceuticals, Inc., Miami, FL, by letter March 5, 2002. Manufacturer: Ivax Pharmaceuticals Caribe, Inc., Cidra, Puerto Rico. Firm initiated recall is ongoing. REASON Active ingredient fails to meet test specification for related compounds. VOLUME OF PRODUCT IN COMMERCE 3,601, 500-count bottles. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
_______________________ PRODUCT a) Human Tissue for Transplantation of the following types: b) Femoral-Politeal Artery SG c) Right Medial Femoral Condyle d) Left Lateral Femoral Condyle e) Semitendinosis/Gracilis Tendon f) Tibialis Tendon g) Pulmonary Monocusp Hemi-Artery h) Right Lateral Femoral Condyle. Recall # B-1453-2. CODE a) Numbers 7718049 and 7718051 b) Number 7707487 c) Number 7707494 d) Number 7707372 e) Number 7707539 f) Number 7706651 g) Number 7707477 RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by telephone on or about April 5, 2002 and by letter on April 5, 2002. Firm initiated recall is complete. REASON Human tissue for transplantation, associated with tissue that was implanted in a recipient that subsequently developed a bacterial infection with Clostridium bifermentans, was distributed. VOLUME OF PRODUCT IN COMMERCE 7 tissues. DISTRIBUTION TX, FL, TN, WI, OH and GA. _______________________ PRODUCT Corneas, Human Tissue for Transplantation, Recall # B-1454-2. CODE Numbers 02-0597 and 02-0598. RECALLING FIRM/MANUFACTURER Georgia Eye Bank, Inc., Atlanta, GA, by telephone and letter on April 22, 2002. Firm initiated recall is complete. REASON Human tissue for transplantation was procured from a donor that tested positive for human immunodeficiency virus (HIV) by the polymerase chain reaction (PCR) assay. VOLUME OF PRODUCT IN COMMERCE 2 corneas. DISTRIBUTION GA. _______________________ PRODUCT a) Patella Tendon, Bisected, Fresh Frozen, Irradiated In addition, the following products were procured from the same donor and not included in the recall notification: b) Achilles Tendon c) Fascia d) Femoral Head e) Lumbar f) Skin g) Crushed Cancellous Chips. Recall # B-1455-2. CODE a) Numbers 99126-008 and 99126-009; In addition, the following products were procured from the same donor and not included in the recall notification: b) Numbers 99126-004 and 99126-005; c) Number 99126-003; d) Numbers 99126-010 and 99126-011; e) Number 99126-034; f) Numbers 99126-001 and 99126-002; g) Numbers 99126-012, 99126-013, 99126-014, 99126-015, 99126-016, 99126- 017, 99126-018, 99126-019, 99126-020, 99126-021, 99126-022, 99126-023, 99126-024, 99126-025, 99126-027, 99126-028, 99126-030, 99126-031, 99126- 032, and 99126-033. RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, TX, by telephone in early June 2000. Firm initiated recall is ongoing. REASON Human tissue for transplantation, associated with tissue that was implanted in recipients that subsequently developed bacterial infections, was distributed. VOLUME OF PRODUCT IN COMMERCE 30 tissues. DISTRIBUTION SC and TX.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1256-2. CODE Unit 53FH89968. RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated September 14, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who was taking the drug Evista, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MD. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1276-2; b) Platelets, Recall # B-1277-2; c) Fresh Frozen Plasma, Recall # B-1278-2. d) Recovered Plasma, Recall # B-1279-2; e) Source Leukocytes, Recall # B-1280-2. CODE a) Units 22LR41265, 22LM28239, 22FX24558 b) Units 22LM28239, 22FX24558 c) Units 22LM28239, 22FX24558, 22FX20504 d) Unit 22LR41265 e) Unit 22 FX20504 RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region, Philadelphia, PA, by letters dated September 15 and October 13, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of IV drug use, were distributed. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION PA, NY and NJ. _______________________ PRODUCT Source Plasma, Recall # B-1283-2. CODE Units G-65858-032, G-65739-032, G66974-032. RECALLING FIRM/MANUFACTURER Alpha Therapeutics Corp., City of Industry, CA, by fax dated January 3, 2001. Firm initiated recall is complete. REASON Source Plasma, collected from donors who had tattoos applied within the past 12 months, was distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION Spain. _______________________ PRODUCT Platelets, Pheresis, Leukocytes Reduced, Recall # B-1323-2. CODE Units 35Z11343, 35Z11347, 35Z11351, 35Z11353 and 35Z11348. RECALLING FIRM/MANUFACTURER American Red Cross, Appalachian Region, Roanoke, VA, by letter dated September 17, 2001. Firm initiated recall is complete. REASON Blood products, collected on an instrument that was not validated for leukoreduction, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION VA. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Irradiated, Recall # B-1354-2. CODE Unit W49129. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter dated August 28, 2001. Firm initiated recall is complete. REASON Blood product, which was labeled leukoreduced but had an elevated white blood cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Source Plasma, Recall # B-1382-2. CODE Unit 57185057. RECALLING FIRM/MANUFACTURER SeraCare, Inc., Topeka, KS, by fax on or about February 20, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor whose health history screening was not adequately performed, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1419-2. b) Fresh Frozen Plasma, Recall # B-1420-2. CODE a) Units R11410, W20111; b) Unit W20111. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by letter dated June 19 or July 17, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION VA and MD. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1421-2; b) Recovered Plasma, Recall # B-1422-2. CODE a) and b) Unit 53J64496. RECALLING FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by fax on August 6, 2001 and by letter dated August 21, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MD. _______________________ PRODUCT Red Blood Cells, Recall # B-1459-2. CODE Unit number 36261-2229. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on November 6, 2001. Manufacturer: Blood Systems, Inc., Ventura, CA. 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 CA. _______________________ PRODUCT Source Plasma, Recall # B-1464-2. CODE Units 76F336, 76G590, 76G081, 76G206, 76G453, 76F636, 76H090, 76H269, 76H491, 76H696, 76H897, 76I140, 76I305, 76I560, 76I739, 9Q4619, 9Q4904, 9Q5033, 9Q5269, 9A5448, 9Q5709, 9Q5877, 9SY532, CKCTGT, CKCTMF, CKCVBC, CKCVGD, CKCVRW, CKCWBY, CKCXLZ, CKCXYX, CKCYYK RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated November 26, 2001 and by e-mail dated March 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of cocaine use, were distributed. VOLUME OF PRODUCT IN COMMERCE 32 units. DISTRIBUTION IL. And Germany _______________________ PRODUCT Source Plasma, Recall # B-1465-2. CODE Units 73G189, 73G287, 73G504, 73G589, 73G810, 73G922. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated October 16, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of cocaine use, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1466-2. CODE Units 9ZU248, 9ZU316, CKCMSM, CKCWZL, CKCXMD RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated October 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of crystal meth use, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1467-2. CODE Units 9XT460, 9ZS909, CKBPWH, SKBSFC, SKBSMB, CKBSWC. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated November 20, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of cocaine and crystal meth use, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1468-2. CODE Units 73J676, 73J787, 73K237, 73K799, 73M059, CFFLVM, CFFMHD, CFFNCY, CFFNSF, CFFPKL, CFFQDP, CFFRMZ, CFFSNY, CFFSZZ, CFFWLM, CFFXXJ, CFFYXJ, CFFZGR, CFGBDJ, CFGBVH, CFGCHN, CFGCWP, CFGDMN, CFGDWQ, CFGRSV, CFGSPH, CFGSYN RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated November 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of cocaine use, were distributed. VOLUME OF PRODUCT IN COMMERCE 27 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1469-2. CODE Units 73N653, 73N731, 73P056, 73P207, 73P432, 73P569, 73P887, 73Q004, 73Q400, 73Q526, 73Q837, 73R064, 73R401, 73R645, 73R956, 73S082, 73S612, 73S780, 73U044, 73U804, 73U921, 73V375, 73V695, 73V792, 74A192, 74A283, 74A670, 74B147, 74B248, 74B601, 74B731, 74C049, 74C220, 74C521, 74D818, 76A255, 76A461, 76A751, 76A881, 76B497, 76B638, 76B819, 76B987, 76C293, 76D030. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated November 26, 2001 and by e-mail dated March 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of crystal meth use, were distributed. VOLUME OF PRODUCT IN COMMERCE 45 units. DISTRIBUTION IL and Germany. _______________________ PRODUCT Source Plasma, Recall # B-1470-2. CODE Units 9ZS767, 9ZS845, 9ZT117, 9ZT1027, 9ZT302, 9XT318, CKBBSG. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated November 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of cocaine use, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1471-2; CODE Units 73A181, 73A296, 73A516. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated November 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of crystal meth use, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1472-2. CODE Units 74B749, 74C018, 74C331. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated October 16, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of cocaine use, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1473-2. CODE Units CKCRZZ, CKCSFX, CKCSVD, CKCTGP, CKCTMK, CKCVDW, CKCMNK, CKCNVB, CKCNWW, CKCPBZ, CKCPDS, CKCPKD, CKCPNB, CKCPPR, CKCPSR, CKCPVG, CKDHSK, CKDHWG. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letters dated November 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of using hard drugs, were distributed. VOLUME OF PRODUCT IN COMMERCE 18 units. DISTRIBUTION IL and Germany. _______________________ PRODUCT Source Plasma, Recall # B-1474-2. CODE Units 73Q441, 73Q678, 73R131, 73R201, 73R526, 73S055, 73S268, 73T232, 73T379, 73T673, 73U579, 73U705, 73V035, 73V204, 73V814, 73V988, 74A317, 74A480, 74B149, 74B290, 74B776, 74B945. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letter dated November 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of cocaine use, were distributed. VOLUME OF PRODUCT IN COMMERCE 22 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1475-2. CODE Units CFCRWG, CFCSDY, CFCSVQ, CFCTDW, CFCTTN, CFCVCY, CFCVSS, CFCWRP, CFDCVR, CFDCWY, CFDCZP, CFDDFD, CFDBSR RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Tucson, AZ, by letters dated November 26, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of cocaine use, were distributed. VOLUME OF PRODUCT IN COMMERCE 13 units. DISTRIBUTION IL and Germany. _______________________ PRODUCT Corneas, Recall # B-1514-2. CODE Tissue numbers 2002-05-2023 and 2002-05-2024. RECALLING FIRM/MANUFACTURER Heartland Lions Eye Banks, Columbia, MO, by telephone on May 31, 2002. Firm initiated recall is complete. REASON Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 tissues. DISTRIBUTION NY. _______________________ PRODUCT a) Cryoprecipitated AHF, Recall # B-1515-2; b) Plasma, Recall # B-1516-2. CODE a) and b) Unit number S11205. RECALLING FIRM/MANUFACTURER Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, by fax on February 11, 2002. Manufacturer: Michigan Community Blood Centers, Saginaw, MI. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to use of the medication Lipitor, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MI and NV. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-1518-2. CODE Unit KZ62978-1. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on July 26, 2001 and by letter dated July 27, 2001. Firm initiated recall is complete. REASON Blood product, which had a low platelet count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Recall # B-1522-2. CODE Unit number LX05804. RECALLING FIRM/MANUFACTURER Inova Health Care Services, Annandale, VA, by fax on February 1, 2001. Firm initiated recall is complete. REASON Blood product, that tested negative for viral markers, but was collected from a donor who disclosed a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1525-2. CODE Unit number 32KE53743. RECALLING FIRM/MANUFACTURER The American National Red Cross, Badger-Hawkeye Region, Madison, WI, by telephone on November 8, 2001. Firm initiated recall is complete. REASON Blood product, manufactured from a unit of Whole Blood that was stored at room temperature for more than 8 hours after collection, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Recall # B-1533-2. CODE Unit number FS99623. RECALLING FIRM/MANUFACTURER Inova Health Care Services, Annandale, VA, by fax on February 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 OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _______________________ PRODUCT Red Blood Cells, Recall # B-1534-2. CODE Unit number LN52627. RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by telephone on January 5, 2002 and by letter dated January 7, 2002. 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 WI. DISTRIBUTION 1 unit. _______________________ PRODUCT Red Blood Cells, Recall # B-1535-2. CODE Unit number 29FF47588. RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on February 20, 2002 and by letter on February 22, 2002. 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 VA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1536-2. CODE Unit numbers 29KL26170 and 29KN26855. RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter on February 21, 2002. 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 2 units. DISTRIBUTION VA and NC. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1537-2; b) Platelets, Recall # B-1538-2. CODE a) Unit numbers 53FE70174, 53FE68916, and 53FE66885 b) Unit number 53FE70174 RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated April 4, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION MD and Washington DC. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1539-2 b) Platelets Pheresis, Recall # B-1540-2; c) Platelets Pheresis, Leukocytes Reduced, Recall # B-1541-2; d) Platelets Pheresis, Irradiated, Recall # B-1542-2. CODE a) Unit number 07FK60316; b) Unit number 07FR11875 (distributed as two split units); c) and d) Unit number 07FP11052. RECALLING FIRM/MANUFACTURER The American National Red Cross, Arizona Region, Tucson, AZ, by letter dated December 19, 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 5 units. DISTRIBUTION AZ. _______________________ PRODUCT Collagenase Santyl? Ointment (1 lot), 250 units per gram, 15 gram tubes, Recall # B-1543-2. CODE Lot number 01SO151053. RECALLING FIRM/MANUFACTURER Advance Biofactures Corporation, Lynbrook, NY, by letter dated April 3, 2002. Firm initiated recall is ongoing. REASON Product was manufactured during a period when leaking container tubes were encountered due to a problem on the manufacturing line. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION FL.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Source Plasma, Recall # B-1381-2 CODE Unit 57185859. RECALLING FIRM/MANUFACTURER SeraCare, Inc., Topeka, KS, by fax on or about December 28, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor whose health history screening was not adequately performed, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-1385-2. CODE Units FQ12572. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on June 13, 2000 and by letter dated August 22, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of treatment for Lyme disease was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Platelets, Recall # B-1497-2. CODE Unit 22FK86721. RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on September 30, 2000 and by letter dated October 13, 2000. Firm initiated recall is complete. REASON Blood product, which may have contained the additive solution Adsol, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1523-2; b) Recovered Plasma, Recall # B-1524-2. CODE a) and b) Unit number 29KF14979. RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region,Norfolk, VA, by telephone on March 1, 2002 and by letters on March 4 and 6, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NC and CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1526-2. CODE Unit number LW16913. RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA, by letter on April 10, 2002. Firm initiated recall is complete. REASON Blood product, that was leukoreduced using an expired filter, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-1527-2. CODE Unit numbers 5118528, 5116574, 5117854, 5117850, 5117851, 5116449, and 5119939 RECALLING FIRM/MANUFACTURER Department of the Navy, Naval Medical Center Portsmouth Blood Bank, Portsmouth, VA, by letter and fax on January 16 and 17, 2002. Firm initiated recall is complete. REASON Blood products, that were not frozen within 8 hours of collection, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION NJ, VA, CA, Germany, Cuba and Washington, DC. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1528-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1529-2; c) Recovered Plasma, Recall # B-1530-2. CODE a) Unit number 07GX01562; b) and c) Unit numbers 07FG83774 and 07FJ50079. RECALLING FIRM/MANUFACTURER The American National Red Cross, Arizona Region, Tucson, AZ, by letters on December 7, 2001. Firm initiated recall is complete. REASON Blood products, collected from donors whose arm inspection were not documented, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION AZ and CA. _______________________ PRODUCT Source Plasma, Recall # B-1531-2. CODE Unit number VP-29652. RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA, by letter on June 1, 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 Austria. _______________________ PRODUCT Source Plasma, Recall # B-1532-2. CODE Unit number G-87181-046. RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA, by letter on August 23, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor whose arm inspection was not acceptable, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Platelets, Irradiated, Recall # B-1544-2. CODE Units 32KN01500, 32KN01524 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Madison, WI, by telephone on October 5, 2001 and by letter on October 25, 2001. Firm initiated recall is complete. REASON Blood products, which were irradiated twice, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION WI.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT Axiom Artis Angiographic X-Ray. Recall # Z-1108-2. CODE Siemens part #:5904433. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letters on January 8, 2002. Manufacturer: Siemens AG, Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing. REASON System Database damage, last and future images not saved. VOLUME OF PRODUCT IN COMMERCE 15 units. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Varian Medical System's Eclipse VERSION 6.5 software, a proprietary application for Varian Vision (tm) imaging systems. Recall # Z-1109-2. CODE Eclipse software, version 6.5, Serial Numbers: 0016 0018 0022 0034 0044 0045 0051 0052 0053 0054 0055 0056 0057 0058 0059 0060 0061 0062 0068 0069 0107 0108 0119 0133 0134 0135 0138 0139 0148 0149 0150 0181 0187 0188 0189 0210 0212 0213 0243 0248 0249. RECALLING FIRM/MANUFACTURER Recalling Firm: Varian Medical Systems, Inc., Palo Alto, CA, by letter, telephone and fax on February 14, 2002. Manufacturer: Varian Medical Systems, Inc., Charlottesville, VA. Firm initiated recall is ongoing. REASON Radiation treatment planning software malfunction could result in incorrect treatment regimen. VOLUME OF PRODUCT IN COMMERCE 37 units. DISTRIBUTION AL, GA, IN, KY, MS, MI, and NY and Japan. _______________________ PRODUCT Information Center System and Upgrades as follows: a) M3150A Agilent or Virida Information center. Recall # Z-1119-2; b) M3151A Agilent or Virida Information Center Client. Recall # Z-1120-2; c) M3153A Agilent or Virida Surveillance Center. Recall # Z-1121-2; d) M3150AU#A01 Agilent or Virida Information Center Upgrade. Recall # Z-1122-2. CODE Systems distributed with a Hewlett Packard Vectra VL400 Personal Computer(PC),HP Part# P3715W with the following serial numbers: US10204040 through US10710329 US10811665 through US10811789 US10902444 US10902817 through US10902887 US11304210 US11304576 through US11304670 US11307358 US11307974 through US11500994 US11608246 US11608393 through US11703817 US11704443 US11709038 through US11709052 US11800005 US11800291 through US11904733 US12104028 US12104584 through US12104621 US12106958 US12107167 through US12107365 US12203988 US12203996 through US12204354 US12210341 US12210494 through US12210535 US12210537 US12210539 through US12210575 US12210579 US12210581 US12210583 through US12210622 US12403504 US12403528 through US12408065 US12408067 US12408070 through US12408085 US12608928 US12609515 through US12609752 US12609757 through US12609883 US12618799 US12618806 through US12618807 RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems, formerly Agilent Technologies, Andover, MA, by letter on April 2, 2002. Manufacturer: Philips Medical Systems, Andover, MA. Firm initiated recall is ongoing. REASON Central Station Monitor may have a premature hard drive failure causing the unit to shut down. VOLUME OF PRODUCT IN COMMERCE 2,296. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Syncor PharmaSeed BT-125-1, radioactive iodine-125 brachytherapy source. Recall # Z-1107-2. CODE Model BT-125-1, Lot Numbers I125G-0567, I125G-0568, I125G-0583, I125G- 0584, I125G-0585. RECALLING FIRM/MANUFACTURER Syncor Pharmaceuticals, Inc., Golden, CO, by verbal notification on February 14, 2002. Firm initiated recall is complete. REASON Seeds may not meet established internal criteria for radial dose uniformity. VOLUME OF PRODUCT IN COMMERCE 5 lots. DISTRIBUTION GA and MD.END OF ENFORCEMENT REPORT FOR JULY 3, 2002 ####
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2002-JUL-02.