May 09, 2001 01-18RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT: a) Marshallís Best Smoked Whitefish Salad. Recall #F-364-1; b) Marshallís Best Smoked Kippered Salmon Salad. Recall #F-365-1. The products are sold in 8oz and 5lb containers. CODE: a) Marshall's Best Smoked Whitefish Salad 8 oz containers: code date 1/19/01 batch #11891 and code date 1/26/01 batch # 11923. Marshall's Best Smoked Whitefish Salad 5 lb containers: code date 1/12/01 batch #11891 and code date 1/12/01 batch #11784. b) Marshall's Best Smoked Kippered Salmon Salad 8 oz containers: code date 1/12/01 batch #11844 and code date 1/19/01 batch #01901. Marshall's Best Smoked Kippered Salmon Salad 5 lb containers: code date 1/12/01 batch #11790. MANUFACTURER: Premier Smoked Fish Inc, dba Homarus/Marshall Smoked Fish Co., Inc., Bensalem, PA. RECALLED BY: Manufacturer, by press relase on 1/4/01 and by fax 1/9/01. Completed frecall resulted form sample analysis conducted by the New York State Department of Agriculture and Markets. DISTRIBUTION: NY QUANTITY: Whitefish: 480 cases of 8 oz and 4500 lb of 5 lb; salmon: 60 cases of 8 oz and 1500 lbs of 5 lb. REASON: Products were contaminated with Listeria monocytogenes. __________ PRODUCT: Marshalls Best Smoked Nova Salmon Spread. Recall #F-362-1. CODE: Batch #12146 5 lb use by 3/16/01 8 oz use by 4/16/01 MANUFACTURER: Premier Smoked Fish Inc., dba Homarus/MarshallSmoked Fish Co., Inc. Bensalem, PA. RECALLED BY: Manufacturer, by press release on 2/1/01 and by fax 2/2/01. Firm initiated recall completed. DISTRIBUTION: NY QUANTITY: 20 cases of 8 oz containers and 47 containers of 5 lb containers. REASON: Product contaminated with Listeria Monocytogenes..RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT: Blue Luna Cafe Nachos 'n' Cheese Dip Combo Snack Tray. Recall #F-387-1. CODE: All lots. MANUFACTURER: M.A. Gedney Co., Chaska, MN. RECALLED BY: Manufacturer, by telephone and letter dated February 6, 2001. Firm initiated recall completed. DISTRIBUTION: FL and NY. QUANTITY: About 6000 cases (24 packages per case) were distributed. REASON: The product contained undeclared FD&C Yellow No. 5. __________ PRODUCT: Cravin Asian Oriental Mix. The product is sold in 3 oz, 5 oz, 6 oz, 14 oz, 24 oz, 10 lb, and 20 lb containers. Recall #F-380-1. CODE: Item Numbers 1053 (10 lb bulk), 2053 (20 lb bulk), 3253 (24 oz), 1653 (14 oz), 6053 (6 oz), 8053 (5 oz), and 3053 (3 oz). MANUFACTURER: Society Hill Snacks,Philadelphia, PA. RECALLED BY: Manufacturer, by letter on 3/19/01. Firm-initiated recall completed. DISTRIBUTION: Nationwide. QUANTITY: 2994 units were distributed. REASON: The product contained undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Blue No. 1. ___________ PRODUCT: a) Silver Creek Fresh Prep Vanilla Pudding with Cream, 7 oz.. Recall #F-384-1; b) Silver Creek Fresh Prep Pudding Swirl, 7 oz. Recall #F-385-1; c) Silver Creek Fresh prep Fresh Strawberry Shortberry Shortcake, 10 oz. Recall #F-386-1. CODE: a) Vanilla Pudding with Cream - "use by 3 23" or earlier; b) Pudding Swirl - "use by 3 23" or earlier; c) Strawberry Shortcade - "use by 3 20" or earlier. MANUFACTURER: Silver Creek Fresh Prep, Rupert ID. RECALLED BY: Manufacturer, by letter on 3/14/01. Firm initiated recall complete. DISTRIBUTION: Idaho and Utah. QUANTITY: Vanilla Pudding - 1 case/12/7 oz. Pudding Swirl - 12 cs/12/7 oz. Combo (3 units each of choc pudding, tapioc, pudding swirl, vanilla w/cream) - 60 cs/12/7 oz. 98 cs/6/10 oz. REASON: a)and b)The products contain undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. C) The product contains undeclared FD&C Yellow No.5, FD&C yellow No. 6 and FD&C Red no. 40.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT: VALENCIA brand DICED ITALIAN STYLE PLUM TOMATOES, NET WT. 14.5 OZ. Recall #F-379-1. CODE: Any product with the CAN Code beginning with "CXIT", OR "DJI". MANUFACTURER: Sun Garden-Gangi Canning, Atwater, CA. RECALLED BY: Tree of Life Inc, St. Augustine, Fl., by e-mail on 2/2/01. Firm initiated recall ongoing. DISTRIBUTION: WI, TX, CA. QUANTITY: 27,432 cans. REASON: The cans actually contains a second tomato product which itself contains sugar and spices not listed on the plum tomato label. _________ PRODUCT: Finest Grated Parmesan Cheese 8 oz containers. Recall #F-371-1. CODE: a) Lot number 12CB8 and sell by date 7 7 01; b) Lot number 12CB2 and sell by date 7 28 01. MANUFACTURER: Colonna Brothers, North Bergen, NJ. RECALLED BY: Giant Food Stores Inc., Carlisle, PA, by press release on 3/15/01 and by voice mail 3/13/01. Firm-initiated complete. DISTRIBUTION: PA and NY. QUANTITY: 612 cases. REASON: The product was contaminated with mold. ________ PRODUCT: Minute Maid Fruit Punch in 16-oz. PET Bottles. Recall #F-381-1. CODE: NOV0501HFB. MANUFACTURER: The Minute Maid Company of Coca-Cola USA at Hi Country Foods, Selah, WA. RECALLED BY: Coca-Cola USA Operations, Atlanta, GA, by email on 2/15/01. Firm-initiated recall completed. DISTRIBUTION: IL, IN, IA, MI, MN, MO, MT, NB, ND, OH, WA, WI & WY. QUANTITY: 9,840 cases. REASON: The product was contaminated with mold. ___________ PRODUCT: a) Minute Maid 100% Orange Juice. Recall #F-382-1; b) Minute Maid 100% Orange Juice plus Calcium. Recall #F-383-1. CODE: a) Minute Maid OJ - JUN1101CCB, JUN1101CCC,JUN1101CCD, JUN1101CCE, JUN1801CCB, JUN1801CCC, JUN1801CCD and JUN1801CCE; b) Minute Maid OJ plus Calcium - JUN1101CCD and JUN1101CCE. MANUFACTURER: The Minute Maid Company of Coca-Cola at United Packers, Chattanooga, TN. RECALLED BY: Coca-cola USA Operations, Atlanta, GA., on February 1, 2001 by email. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 153,784 cases. REASON: The product was fermented.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT: Keftab (Cephalexin Hydrochloride) 500mg. NDC 5147-9034-02, 6445-034-02, 64455- 034-01 and 64455-034-10. Keftab tablets are sold in bottles of 100 and 60 count blisters. Recall #D-191-1. CODE: Lot # Expiration date 3AP73A 10/1/01 3AR48A 1/1/02 3AS36A 2/1/02 3AS37A 8/1/02 3AD93A 4/1/01 3AD94A 4/1/01 3AD96B 4/1/01 3AE63B 4/1/01 3AG03A 5/1/01 3AG38A 4/1/01 3AG40A 10/1/00 3AG73A 5/1/01 3AH64A 8/1/01 3AH65A 2/1/01 3AM54A 10/1/01 3AM55A 10/1/01 3AP74A 10/1/01 3AR46A 12/1/01 3AR47A 6/1/01 3AR49A 1/1/02 3AR50A 1/1/02 3AS34A 2/1/02 3AS35A 2/1/02 3AS36A 2/1/02 3AS37A 2/1/02 3AS38A 2/1/02 3AS39B 8/1/01 4AA77A 2/1/02 4AA78A 8/1/02 4AD08A 5/1/02 4AD09A 11/101 4AD10M 12/1/01 4AE21A 6/1/02 4AE22A 12/1/01 4AE23M 1/1/02 4AE24M 2/1/02 4AE25B 2/1/02 4AE26B 8/1/02 4AF21D 8/1/02 4AF22A 8/1/02 4AF23A 8/1/02 4AF24A 8/1/02 4AG82A 3/1/02 4AG83D 9/1/02 4AG84M 3/1/02 4AK36C 3/1/02 4AK37A 9/1/02 4AK38B 9/1/02 4AK39A 9/1/02 4AK40A 10/1/02 4AK41B 10/1/02 4AK42B 4/1/02 4AK44C 4/1/02 4AL40A 8/1/02 4AM60A 9/1/02 4AN34B 11/1/02 4AN35A 11/1/02 MANUFACTURER: Lilly del Caribe, Carolina, PR. RECALLED BY: Eli Lilly and CO., Indianapolis, IN, by letters dated 3/27/0. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 45,189,243 units. REASON: Problems with dissolution properties. ________ PRODUCT: P.G. Walker Compressed Oxygen USP in M-6 aluminum cylinders with a Sherwood valve. Recall #D-193-1. CODES: Lot 513-1710-37. MANUFACTURER: P. G. Walker, Div. of Air Products and Chemicals Joplin, MO. RECALLED BY: Lincare, Inc. called customers by telephone on 7/9/00. Firm-initiated recall complete. DISTRIBUTION: Southwest Missouri. QUANTITY: 23 cylinders. REASON: Strong chlorine odor emitted from the oxygen cylinder. _______ PRODUCT: Tetrahydrozine HCI Nasal Spray 0.1% and Pediatric Nasal Drops 0.05%. Brand name-Tyzine. Both 15 ml (1/2 Fl oz) units NDC numbers 0482-4770-15 and 0482-4760-15. Recall #D-195-1; Recall#D-196-1. CODE: 0.1% -- Lot 6234 exp.8/2002; 0.05% -- lot 6235 exp. 8/2004. MANUFACTURER: Denison Pharmaceuticals, Inc., Pawtucket, RI. RECALLED BY: Kenwood Therapeutics,by letter on March 24, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: Lot 6235--25,397 units; Lot 6234 -- 11,595 units. REASON: High counts of microbiological contamination.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______ PRODUCT: Heart-Trex Tablets. Recall #D-197-1. CODE: a) Safety Pack Boxes (250 Packets of 2); b) C577 Unit boxes of 8X2 Packets All lots. MANUFACTURER: Otis Clapp & Son, Inc., Canton, MA. RECALLED BY: Manufacturer, via fax and overnight mail on 4/18/01. Firm-initiated recall ongoing. DISTRIBUTION: AL,FL,GA,IN,KY,MA,NC,NJ,NY,NV,OH,OR,PA,TN,TX,WA QUANTITY: Safety Pack: 320 boxes C577 Units: 297 boxes. REASON: Product distributed without an approved new drug application for the cardiovascular related uses represented in the labeling and because it bears no dosage direction for use in pain and fever relief. _______ PRODUCT: Armour Thyroid (thyroid tablets, USP) 2 Grain (120 mg), each tablet provides 76 mcg levothyroxine (T4) and 18 mcg liothyronine (T3), 100 tablets, (10) 2x5 unit dose strips, individually blister-sealed tablets, NDC#0456-0461-63, RX indicated as a replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transiet hypothyroidism during the recover phase of subacute thyroiditis. Recall #D-194-1. CODE: Lot 30012, Exp.12/01. MANUFACTURER: Forest Pharmaceuticals, Inc., Cincinnati, Ohio. RECALLED BY: Manufacturer, by letters dated 2/16/01. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 553/10/10 tablet strip boxes. REASON: The incorrect NDC number is printed on the blister cards. _______ PRODUCT: Cimetidine Tablets, USP, 800 mg. In bottles of 100 tablets, NDC #60505-0021-2, ANDA 74-890. Recall #D-189-1. CODE: Lot 90570A and Lot 00197A. MANUFACTURER: TorPharm, A Division of Apotex, Etobiocoke, Ontario, Canada. RECALLED BY: Manufacturer, by letters dated 4/10/01. Firm-initiated recall ongoing. DISTRIBUTION: FL, MI, CA, IN, TN, NY, IL, TX, WI, MN and KY. QUANTITY: 2013 bottles of 100 tablets. REASON: Lot 90570A failed the 12 month test station dissolution test at room temperature conditions. Lot 00197A went to S3 testing during followup testing of 35 lots of the same age range. ______ PRODUCT: Pin-Rid Soft Gel Capsules, Each Capsules contains 180 Mg Pyrantel. Recall #D-188-1. CODE: Lot 5085H. MANUFACTURER: Apothecary products, Inc., Burnsville, MN. RECALLED BY: Manufacturer, by facsimile on June 30,2000. Firm-initiated recall complete. DISTRIBUTION: AK, CA, FL, IL, MN, NJ, OH, OK, OR, TX. QUANTITY: 600 bottles. REASON: All the bottles in the recalled lot each contained 12 instead of 24 capsules as labeled.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______ PRODUCT: Red Blood Cells. Recall #B-908-1. CODES: Unit 1711389 MANUFACTURER: Mississippi Blood Services Jackson, MS RECALLED BY: Manufacturer, by telephone on August 19,1998. Firm-initiated recall complete. DISTRIBUTION: Mississippi. QUANTITY: One unit. REASON: Blood product, collected from a donor who was ineligible to donate due to receiving a tattoo, was distributed. ___________ PRODUCT: Source Plasma. Recall #B-958-1. CODE: Units FT59033669, FT59033701. MANUFACTURER: Seramed, Inc Canton, OH. RECALLED BY: Manufacturer, by fax on December 5, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: Two units. REASON: Blood products, which were not tested for Anti-HCV, were distributed. ___________ PRODUCT: a) Red Blood Cells. Recall #B-1038-1. b) Platelets. Recall #: B-1039-1 CODE: a) Unit 65-49796; b) Unit 65-49796. MANUFACTURER: Michigan Community Blood Center Grand Rapids, MI. RECALLED BY: Manufacturer, by facsimile dated June 27, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: Two units. REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. ________ PRODUCT: Whole Blood. Recall #B-1061-1 CODE: Unit C27892 MANUFACTURER: Community Blood Center of Greater Kansas Kansas City, MO. RECALLED BY: Manufacturer, by letter on 2/10/98. Firm-initiated recall complete. DISTRIBUTION: Missouri. QUANTITY: One unit. REASON: Blood product, collected from a donor with a history of jaundice, was distributed. _________ PRODUCT: Red Blood Cells Leukoreduced. Recall #B-1062-1. CODE: Unit 29FW39053. MANUFACTURER: American Red Cross Norfolk, VA. RECALLED BY: Manufacturer, by letters dated November 2, 2000 and December 4, 2000. Firm- initiated recall complete. DISTRIBUTION: Maryland. QUANTITY: One unit. REASON: Blood product, collected from a donor who reported having lived in an area designated as endemic for malaria, was distributed. ________ PRODUCT: Platelets, Pheresis. Recall #B-1070-1. CODE: Unit 12FM05887. MANUFACTURER: American Red Cross Blood Services Charlotte, NC. RECALLED BY: Manufacturer, by telephone on October 26, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, which was mislabeled as CMV antibody negative, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-1095-1; b) Platelets. Recall #B-1096-1; c) Recovered Plasma. Recall #B-1097-1. CODE: a), b) and c) Unit 29FW31723; MANUFACTURER: American Red Cross Norfolk, VA. RECALLED BY: Manufacturer, by letters dated October 12, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina, and South Carolina. QUANTITY: Three units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis B, were distributed. ________ PRODUCT: Source Plasma. Recall #B-1131-1. CODE: Units G85894117, G07405117, G07807117, and G08618117. MANUFACTURER: Alpha Therapeutic Corporation Lubbock, TX. RECALLED BY: Manufacturer, by letter dated April 12, 2000. Firm-initiated recall complete. DISTRIBUTION: Spain, and Germany. QUANTITY: Four units. REASON: Blood products, which were collected from a donor with a history of hepatitis, were distributed. _______ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-1132-1. CODE: Unit number 12GY34863. MANUFACTURER: The American National Red Cross Charlotte, NC. RECALLED BY: Manufacturer, by letter dated December 14, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _______ PRODUCT: Platelets, Pheresis. Recall #B-1133-1. CODE: Unit number 12FM03536. MANUFACTURER: The American National Red Cross Charlotte, NC. RECALLED BY: Manufacturer, by letter dated October 17, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _______ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-1134-1. CODE: Unit number 12GM63197. MANUFACTURER: The American National Red Cross, Asheville, NC. RECALLED BY: The American National Red Cross Charlotte, NC, by letter dated December 21, 2000. Firm-initiated recall complete. DISTRIBUTION: Tennessee. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-1135-1. CODE: Unit number 04KK34574. MANUFACTURER: The American National Red Cross, Dedham, MA. RECALLED BY: Manufacturer, by letter dated December 21, 2000. Firm-initiated recall complete. DISTRIBUTION: New Hampshire. QUANTITY: One Unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _______ PRODUCT: Red Blood Cells. Recall #B-1136-1. CODE: Unit number 04GK41538. MANUFACTURER: The American National Red Cross Dedham, MA. RECALLED BY: Manufacturer, by letter dated December 18, 2000. Firm-initiated recall complete. DISTRIBUTION: New York. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _______ PRODUCT: Red Blood Cells. Recall #B-1139-1. CODE: Unit number 04GC03583. MANUFACTURER: The American National Red Cross, Dedham, MA. RECALLED BY: Manufacturer, by letter dated November 17, 2000. Firm-initiated recall complete. DISTRIBUTION: Massachusetts. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _______ PRODUCT: Red Blood Cells, Leukocytes. Reduced. Recall #B-1140-1. CODE: Unit number 19GK44686. MANUFACTURER: The American National Red Cross Nashville, TN. RECALLED BY: Manufacturer, by letter dated October 27, 2000. Firm-initiated recall complete. DISTRIBUTION: Tennessee. 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-1141-1. CODE: Unit numbers 3749849 and 3809907. MANUFACTURER: United Blood Services Lubbock, TX. RECALLED BY: United Blood Systems, Inc. Scottsdale, AZ , by letter dated November 10, 1999. Firm-initiated recall complete. DISTRIBUTION: Texas. QUANTITY: Two units REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ___________ PRODUCT: a) Red Blood Cells, Leukocytes Reduced. Recall #B-1142-1; b) Platelets, Pheresis, Leukocytes Reduced. Recall #B-1143-1. CODE: a) Unit number 17190-8816; b) Unit number 17192-7810. MANUFACTURER: Blood Systems, Inc. McAllen, TX. RECALLED BY: Blood Systems, Inc. Scottsdale, AZ, by letter dated December 6, 2000. Firm-initiated recall complete. DISTRIBUTION: Texas. 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-1144-1. CODE: Unit number 3807881. MANUFACTURER: United Blood Services, Lubbock, TX. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter dated November 22, 2000. Firm-initiated recall complete. DISTRIBUTION: Texas. QUANTITY: One unit REASON: Blood product, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but was collected from a donor that previously tested repeatedly reactive for anti-HIV-1/2, was distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
__________ PRODUCT: Pooled Plasma, Solvent/Detergent Treated, PLAS+?SD (3 lots). Recall #B-712-1. CODE: Lot numbers GZ90602, FZ90610 and FZ90614. MANUFACTURER: American Red Cross Plasma Services Arlington, VA. RECALLED BY: Manufacturer, by letter dated March 16, 2001. Firm-initiated recall complete. DISTRIBUTION: Nationwide, Quebec and Virgin Islands. QUANTITY: Three lots. REASON: Blood products, stored to unacceptable storage temperatures, were distributed. ___________ PRODUCT: Platelet Pheresis, Leukocytes Reduced, Irradiated. Recall # B-1054-1; CODE: Units 19GL33940,19GL33925, 19GL33926 (Split unit). MANUFACTURER: American Red Cross Blood Services Nashville, TN. RECALLED BY: Manufacturer, by telephone on October 23, 2000 and by letters dated October 27, 2000 or October 30, 2000. Firm-initiated recall complete. DISTRIBUTION: Tennessee. QUANTITY: Three units. REASON: Blood products which were exposed to an unacceptable temperature during preparation were distributed. ________ PRODUCT: Platelets Unit. Recall #B-1064-1. CODE: 13FH78418. MANUFACTURER: American Red Cross Blood Services Detroit, MI. RECALLED BY: Manufacturer, by letter on January 9, 2001. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: One unit. REASON: Blood product, prepared from a unit of Whole Blood with an extended collection time, was distributed. ________ PRODUCT: Fresh Frozen Plasma. Recall #B-1129-1. CODE: Unit 49Y71539. MANUFACTURER: American Red Cross Blood Services Tulsa, OK. RECALLED BY: Manufacturer, by telephone on September 28, 2000. Firm-initiated recall complete. DISTRIBUTION: Texas. QUANTITY: One unit. REASON: Blood Blood product, which was prepared from whole blood with an extended collection time, was distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
___________ PRODUCT: ISS 2001 X-Ray Imaging System. Recall # Z-246-1. CODE: ISS 2001 X-Ray Imaging Systems. MANUFACTURER: Fischer Imaging Corporation,Denver, Colorado. RECALLED BY: Manufacturer, to supply new version (1.4) of software by May 1, 2002. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 27 units. REASON: The systems fail to conform to design specifications relating to the emission of electronic product radiation. ________ PRODUCT: GE OEC Laser Aimer. Recall #Z-247-1. CODE: Case Number: I1-1888. MANUFACTURER: GE OEC Medical Systems, UT. RECALLED BY: The manufacturer will effect a modification to device and labeling by February 28, 2002. Firm-initiated recall ongoing. DISTRIBUTION: Worldwide. QUANTITY: 1699 units. (1452 units in the United States) REASON: The laser aimer became disengaged from the image intensifier. ________ PRODUCT: MobileArt Mobile X-Ray System. Recall # Z-523-1. CODE: Model MUX-100. MANUFACTURER: Shimadzu, Kyoto, Japan. RECALLED BY: Shimadzu, Torrance, CA, by letter on March 6, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 27 units U.S. distributed. REASON: A failure of a semi-conductor module in the motor drive could result in the out of control movement of the system and the emergency off button may not be effective in removing power to the motorized drive. ________ PRODUCT: MobileArt Mobile X-ray System, Recall #Z-524-1. CODE: Model MUX-100. MANUFACTURER: Shimadzu, Kyoto, Japan. RECALLED BY: Shimadzu, Torrance, CA, by letter on March 6, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 21 units U.S. Distributed. 2 units in Inventory REASON: A bolt securing a chain inside the third section of the telescoping arm could come out resulting in the unit not being able to be positioned for clinical use.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
___________ PRODUCT: Laparoscopic Clip Applier; Recall #Z-522-1. CODE: Lot 00M150. MANUFACTURER: Applied Medical Resources, Laguna Hills, CA. RECALLED BY: Manufacturer, by Federal Express letter dated February 1, 2000. Firm initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 87 REASON: The handle maynot allow proper engagement of the clip applier cartridge, rendering the unit unusable. ___________ PRODUCT: GE Senographe 2000D Mammographic X-Ray System. Model Number 2228448. Recall # Z-525-1. CODE: All serial numbers. MANUFACTURER: GE Medical Systems Europe, Buc Cedex, France. RECALLED BY: GE Medical Systems, Waukesha, WI, by letter, dated march 19, 2001. Firm initiated recall ongoing. DISTRIBUTION: Worldwide. QUANTITY: 30 units in U.S. 33 units in Foreign distribution. REASON: The spot compression paddle extended beyond the detector front by more than one percent of the source to image distance.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDS -- CLASS II
___________ PRODUCT: Buckeye 26% Hi Fat Swine Mix, Sandy Lake 40% Hog Supplement, 100 lb. containers, flexible plastic burlap bags. Recall #V-026-1. CODE: None are used. MANUFACTURER: Sandy Lake Mills, Sandy Lake, PA. RECALLED BY: Manufacturer, by telephone and visit. Firm initiated recall complete. DISTRIBUTION: Pennsylvania. QUANTITY: Seven containers, each weighing 100 pounds. REASON: The product contains prohibited material (ruminant animal proteins) used as an ingredient in the finished product swine feed. The product is not labeled with the required caution statement "Do Not Feed to Cattle or Other Ruminants." ________ PRODUCT: Custom Vaquero Supplement for Cattle identified by Purina Mills. Recall #V-027- 1. CODE: 7V87. MANUFACTURER: Purina Mills, Inc., Gonzalez, Texas. RECALLED BY: Manufacturer, contacted the one consignee on January 17, 2001. DISTRIBUTION: Texas. QUANTITY: 44,355 pounds. REASON: The ruminant feed product contains meat and bone meal (MBM) of bovine origin.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDS -- CLASS III
___________ PRODUCT: Dionne Gentle Iodine Topical antiseptic, OTC, for use on horses, cattle and swine. Recall #V-031-1. CODES: Lot: OG24B. MANUFACTURER: Qualis, Inc., Des Moines, Iowa. RECALLED BY: Manufacturer, by telephone on October 3, 2000. Firm-initiated recall complete. DISTRIBUTION: Colorado, Missouri and Iowa. QUANTITY: Seventy-Two containers. REASON: Shipping cartons and bottle labels of Dionne Tincture Iodine 7% were incorrectly labeled with the Dionne Gentle Iodine label. ________ PRODUCT: Safeguard 10% Suspension Gallons. Recall #V-031-1. CODES: NDC Number 12799-097-93. Product Code: 809781. Lot Numbers: NEDL Expiration Date 4/2003. NHEK Expiration Date 7/2003. MANUFACTURER: Hoechst Roussel Vet, Hampton, NJ. RECALLED BY: Manufacturer, via certified letter mailed on March 1, 2000. DISTRIBUTION: QUANTITY: Units 742, 282 quarantined. REASON: Labels were missing or flagging from the bottles. END OF ENFORCEMENT REPORT FOR MAY 9, 2001.
Office of Public Affairs
Hypertext uploaded by clb 2001-MAY-10.