May 29, 2002 02-21
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Green Cedar brand All Natural Ackawi Cheese in 1 lb. Packages. Recall # F-454-2. CODE Sell by date: August 7, 2002. RECALLING FIRM/MANUFACTURER Green Cedar Dairy, Dearborn, MI, by visit on February 27, 2002. State initiated recall is complete. REASON Michigan Department of Agriculture found Listeria monocytogenes in a sample of All Natural Ackawi cheese. VOLUME OF PRODUCT IN COMMERCE 220 pkgs. DISTRIBUTION MI. _______________________ PRODUCT Apple Cinnamon Quakes Crispy Mini Rice Snacks, 3.52 oz. laminated bag, 12 bags per case, UPC #30000-16921. Recall # F-455-2. CODE Product code 16921 lot/Best Before code: AUG 1202/CZ 1 "XX", where XX may be 01 thru 07 Case code: MFG. DATE: FEB-13-02 CZ 1 0 "TT:TT" 12/3.52 OZ. PKGS QUAKER Mini Rice Snacks Apple Cinnamon 1 00 30000 16921 3 (case count bar code) TT:TT = military time. RECALLING FIRM/MANUFACTURER Recalling Firm: The Quaker Oats Company, Chicago, IL, by fax and e-mail on March 29, 2002. Manufacturer: The Quaker Oats Company Columbia, MO. Firm initiated recall is complete. REASON The product contains milk ingredients, which are not declared on the label. VOLUME OF PRODUCT IN COMMERCE 7,251 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Raisin Pound Cake, NET WT. 14 OZ.(369 g) and NET WT. 2 LBS. (907 g). Recall # F456-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Golden Chocolate International Inc., Brooklyn, NY, by visit, letter and telephone beginning November 30, 2001. State initiated recall is complete. REASON The product contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE Firm produces approximately 200 / 2 lbs. loaves & 120 / 14 oz. loaves per week. DISTRIBUTION NY.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Reinecker's Cheese Cake, Net Wt. 23 ounces. The product is a square- shaped cheesecake on a flat styrofoam holder, placed into a plastic bag, and tied at the end. Recall # F-438-2. CODE All Cheese Cakes on the market at the time the recall was initiated - the product was not coded. RECALLING FIRM/MANUFACTURER Reinecker's Bakery, Macedonia, OH, by visit beginning on April 5, 2002. FDA initiated recall is complete. REASON The product contained undeclared FD&C Yellow No. 5. VOLUME OF PRODUCT IN COMMERCE 22. DISTRIBUTION OH _______________________ PRODUCT Goldenrod brand 50% Orange Juice Drink, pasteurized, in 8 fl. oz. plastic pouches, 70 units per case. Recall # F-439-2. The cases are labeled in part, "Goldenrod 50% Orange Juice Drink Contains 50% Fruit Juice *** Ingredients: Water, Corn Sweetened, Orange Juice Concentrate, *** 70-8 Fluid oz containers (560 FL.OZ. - 4.38 GAL.) INSTITUTIONAL USE ONLY *** NOT FOR RETAIL SALES PROCESSED AND PACKAGED BY PLANT NO. 21-41." The individual pouches are coded, with no labels. CODE All Use-By Dates of April 12 or earlier. RECALLING FIRM/MANUFACTURER U. C. Milk Company, LLC., Madisonville, KY, by telephone and mail on March 4, 2002. FDA initiated recall is complete. REASON Product contained undeclared FD&C Yellow No. 6. VOLUME OF PRODUCT IN COMMERCE 36,680 units. DISTRIBUTION KY. _______________________ PRODUCT F. K. Sweetland brand Gummy Mellos Peach packed in flexible plastic packages, net wt. 1.5 or 1.75 oz. Recall # F-440-2. CODE Barcode # 41340 03602 and no other coding. RECALLING FIRM/MANUFACTURER Fatin Sweetland, Inc. (dba F. K. Sweetland), Brooklyn, NY, by letters on August 8, 2001. State initiated recall is complete. REASON The product contained undeclared FD&C Yellow No. 5, Yellow No.6 and Red No. 40. VOLUME OF PRODUCT IN COMMERCE Approximately 360 cases (12 packages per case). DISTRIBUTION Actual distribution pattern and dates are unknown. The firm has a total of 88 retail accounts within the New York City area. _______________________ PRODUCT Cholesterol Free (K) RAINBOW COOKIES, NET WT. 8 oz. Recall # F-441-2. CODE Barcode # 45957 20150 and no other coding. RECALLING FIRM/MANUFACTURER Luna Rossa Bakery Inc., Staten Island, NY, by letter dated May 31, 2001. State initiated recall is complete. REASON The product contained undeclared FD&C Yellow No. 5, FD&C Red No. 40 and FD&C Blue No. 1. VOLUME OF PRODUCT IN COMMERCE 100 - 8 oz. packages were distributed. DISTRIBUTION NY. _______________________ PRODUCT Lulu's Desert brand CARAMEL FLAN Vanilla Flavored, 4.5 oz. individual units. UPC code 52839 82795. Recall # F-442-2. CODE 5 Lot numbers: 121801-07 103 cases mfd 12/18/01 122801-06 111 cases mfd 12/28/01 012302-07 110 cases mfd 1/23/01 020602-07 109 cases mfd 2/6/02 020702-02 115 cases mfd 2/7/02 RECALLING FIRM/MANUFACTURER Lulu's Desert Factory, Inc., Vernon, CA, by telephone on February 14, 2002. Firm initiated recall is complete. REASON The product contained undeclared FD&C Yellow No. 5. VOLUME OF PRODUCT IN COMMERCE 438 cases, 24 units per case. DISTRIBUTION CA and IL. _______________________ PRODUCT Hana Brand Japanese Cookies (Shoga Toh) in 4.5 ounce plastic visual packages, 20 packages per case, and labeled in part ***starch, sugar, ginger***, Product of Japan. Recall # F-443-2. CODE 09126J. RECALLING FIRM/MANUFACTURER Recalling Firm: Rhee Brothers, Inc., Columbia, MD, by letter, telephone and fax on December 3, 2001. Manufacturer: New Japan Food Group, Kitanagusa-Dori, Chou-Ku. State initiated recall is complete. REASON The product contained undeclared FD&C Yellow No. 5, FD&C Red No. 3, and FD&C Blue No. 1. VOLUME OF PRODUCT IN COMMERCE 12 cases. DISTRIBUTION MD, VA, KS, MI, NC and TN. _______________________ PRODUCT SP Natural Peanut Butter Standard Bar, Multi-Vitamin Whole Food Health Bar, Net Wt 1.75 ounces. Recall # F-444-2. CODE “Best Before Jul 26, 02,” “Best By Jul 31, 02” or “Best By Nov 20, 02” on the bar wrappers. The recalled 18-bar boxes have batch numbers of 1299, 1304, 0r 2051 on the bottom of the boxes. RECALLING FIRM/MANUFACTURER Recalling Firm: Standard Process, Inc., Palmyra, WI, by letter on April 19, 2002. Manufacturer: Elan Nutrition (Formerly Five Star Brands) Grand Rapids, MI. Firm initiated recall is ongoing. REASON The labels do not list sesame seeds or extra virgin olive oil, which are contained in the product. VOLUME OF PRODUCT IN COMMERCE 3362 boxes (18 bars each). DISTRIBUTION Nationwide. _______________________ PRODUCT Jelly Belly brand Goelitz Confections Assorted Jelly Belly Mix, Net Wt. 10 LBS in bulk boxes. Recall # F-446-2. CODE All product on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Ferris Coffee and Nut Co., Grand Rapids, MI, by letter on March 1, 2002. Manufacturer: Goelitz Confection, Jelly Belly Candy Co., Fairfield, CA. FDA initiated recall is complete. REASON The product contained undeclared FD&C Yellow No. 5, Yellow No. 6 and Red No. 40. VOLUME OF PRODUCT IN COMMERCE Undetermined. DISTRIBUTION MI. _______________________ PRODUCT Lenah Game Meats of Tasmania brand Frozen Whole Opossum, Skin-on (vacuum packed clear). Each carcass weighs about 4 pounds. Recall # F-449-2. CODE Pack date 6/8-21/9/01 (Aug 6- Sept 21, 2001). RECALLING FIRM/MANUFACTURER Recalling Firm: Broadleaf Game Meats, Vernon, CA, by telephone on January 4, 2002. Manufacturer: Lenah Game Meats of Tasmania, Mowbray, Austrailia. Firm initiated recall is complete. REASON FDA found Salmonella in a sample of frozen opossum. VOLUME OF PRODUCT IN COMMERCE 90 cases. DISTRIBUTION CA. _______________________ PRODUCT Diet Coke, packaged in a 3-liter plastic PET bottle. Recall # F-450-2. CODE JUL0802MBA2_ _ _ _ (dashes indicate a time stamp). RECALLING FIRM/MANUFACTURER Recalling Firm: Coca-Cola Consolidated, Charlotte, NC, by telephone on May 6, 2002. Manufacturer: Coca-Cola Bottling Company, Mobile, AL. Firm initiated recall is ongoing. REASON The bottles actually contained Coca-Cola Classic sweetened with a nutritive sweetener. VOLUME OF PRODUCT IN COMMERCE 1539 cases (9234 units). DISTRIBUTION AL, GA, MS, and FL.RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT a) Kroger Sliced Pickled Beets, Net Weight 15 Oz. in cans; b) S & W Sliced Pickled Beets, Net Weight 15 Oz. in cans,; c) Lakeside Sliced Pickled Beets, Net Weight 15 Oz. in cans; Recall # F-445-2. CODE a) BPXCE/1A170, BPYCE/1A170, BPXAE/1A260, BPXAE/1A270, BPYAE/1A270, BPXAE/2A260, and BPYAE/2A260; b) BPXCE/1A220; c) BPXCE/2A220. RECALLING FIRM/MANUFACTURER Recalling Firm: Lakeside Foods, Inc., Manitowoc, WI, by letters on March 18 and March 20, 2002. Manufacturer: Lakeside Foods, Inc., Belgium, WI. Firm initiated recall is complete. REASON The product is unfit for food because of swollen and leaking cans. VOLUME OF PRODUCT IN COMMERCE 9585 cases (24 cans per case). DISTRIBUTION GA, KS, KY, OH, TN and VA. _______________________ PRODUCT Vitasoy brand Vanilla Delite Soy Milk in one-quart size 32 fl oz (1 QT) 946ml; 12 packages/case in Tetra Paper cartons. Recall # F-448-2. CODE "BEST BEFORE JUN 19, 2002". RECALLING FIRM/MANUFACTURER Recalling Firm: Vitasoy USA, Inc., South San Francisco, CA, by fax and letters on August 13, 2001. Firm initiated recall is complete. REASON The product is unfit for food due to sour taste and curdling/lumpy appearance. VOLUME OF PRODUCT IN COMMERCE 5,871 cases (12 packages/case). DISTRIBUTION Nationwide. _______________________ PRODUCT a) "Wolfgang Puck's Chicken Parmesan with Pasta Hearty Sout NET WT. 14.5OZ. (411g)***Ingredients: Chicken Stock*** Recall # F-451-2; b) "Wolfgang Puck's Hearty Vegetable Beef Hearty Soup NET WT. 14.5OZ. (411g)***INGREDIENTS: BEEF STOCK*** Recall # F-452-2; c) "S&W Kidney Beans Premium Dark Red" Net wt 15 1/4OZ (432G)***Ingredients: Prepared Dark Red Kidney Beans*** Recall # F-453-2. CODE a) W65P6C306A, W65P6C306B, W65P6C306C; b) W63P6C313A, W63P6C313B, W63P6C313C, W63P6C313D; c) 961P8C313. RECALLING FIRM/MANUFACTURER Chiquita Processed Foods, LLC, Payette, ID, by letter on January 24, 2001. Firm initiated recall is complete. REASON a) Cans actually contain garbanzo beans; b) Cans actually contain dark red kidney beans; c) Cans actually contain French onion soup; VOLUME OF PRODUCT IN COMMERCE a) 181,936 cans; b) 230,976 cans; c) 2156 cans. DISTRIBUTION CA, WA, AZ, CO, UT and OR.RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
_______________________ PRODUCT Royal Jelly Milk Balm Moisture Lotion, 1 oz. and 1.7 oz. For Dry to Normal Skin. Recall # F-447-2. CODE Lots: UU1295B, UU1295A, UU1285A, UU1198B, UU1198A. RECALLING FIRM/MANUFACTURER Recalling Firm: Jafra Cosmetics International, Westlake Village, CA, by letters on March 1, 2002. Manufacturer: Universal Packaging Systems, Inc. Chino, CA. Firm initiated recall is complete. REASON The product was contaminated with Burkholderia cepacia. VOLUME OF PRODUCT IN COMMERCE 33,389. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT MAXAIR Inhaler With Oral Adapter (pirbuterol acetate) 0.2 mg per actuation, 25.6g Inhalation Aerosol, 300 metered inhalations, Rx only. Recall # D-264-2. CODE Lot Numbers Expiration Date 000644 August ’03 000756 August ’03 000947 October ’03 001009 Nov. ’03 001110 Dec. ’03 001111 Dec. ’03 010025 Jan. ’04 010195 March ’04 010413 April ’04 010283 March ’04 010482 May ’04 010580 June ’04 010708 July ’04 010709 July ’04 010414 May ’04 011210 Dec. ’04 RECALLING FIRM/MANUFACTURER Recalling Firm: 3M Pharmaceuticals, Inc., St. Paul, MN, by letters dated May 6, 2002. Manufacturer: 3M Pharmaceuticals, Inc., Northridge, CA. Firm initiated recall is ongoing. REASON Defective container; inhaler may stick intermittantly and patients may not receive the expected puff of medication. VOLUME OF PRODUCT IN COMMERCE 737,975 inhalers. DISTRIBUTION Nationwide. _______________________ PRODUCT Adriamycin PFS, (doxorubicin hydrochloride) Injection USP, 150mg/75mL (2mg/mL), 75 mL Multidose Cytosafe Vial, Rx only, Recall # D-268-2; Adriamycin PFS, (doxorubicin hydrochloride) Injection, USP, 20mg/10mL (2mg/mL), 10 mL Single dose Cytosafe Vial. Recall # D-269-2; Adriamycin PFS, (doxorubicin hydrochloride) Injection USP, 200mg/100mL (2mg/mL), 100 mL Multidose Cytosafe Vial, Rx only. Recall # D-270-2; Ellence, (epirubicin hydrochloride) Injection, 200mg/100mL (2mg/mL), Single use 100 mL Vial, Rx only; Recall # D-271-2; Ellence, (epirubicin hydrochloride) Injection, 50mg/25mL (2mg/mL), Single use 25 mL Vial, Rx only. Recall # D-272-2; Idamycin PFS, (idarubicin hydrochloride) Injection, 10mg/10mL (1mg/mL), 10 mL Single dose Cytosafe Vial, Rx only. Recall # D-273-2; Idamycin PFS, (idarubicin hydrochloride) Injection, 20mg/20mL (1mg/mL), 20 mL Single dose Cytosafe Vial, Rx only. Recall # D-274-2; Idamycin PFS, (idarubicin hydrochloride) Injection, 5mg/5mL (1mg/mL), 5 mL Single dose Cytosafe Vial, Rx only. Recall # D-275-2. CODE a) Adriamycin PFS 1. Lot R945, Exp 02/03. 2. Lot R944, Exp 02/03. 3. Lots R871 and R910, Exp 02/03 and 02/03. b) Ellence 1. Lot R870, Exp 03/03. 2. Lot T079, Exp 04/03. c) Idamycin PFS 1. Lot R993, Exp 03/03. 2. Lot T021, Exp 03/03. 3. Lot T060, Exp 03/03. RECALLING FIRM/MANUFACTURER Recalling Firm: Pharmacia Corp., Kalamazoo, MI, by letter on May 10, 2002. Manufacturer: Pharmacia (Perth) Pty Limited, Bentley, WA, 6102, Austrailia. Firm initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 57,580 units. DISTRIBUTION United States and Puerto Rico.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Claforan Sterile (cefotaxime) for injection, USP (formerly sterile cefotaxime sodium), 500 mg IM/IV, Vial, Rx only. Recall # D-265-2.; Claforan Sterile (cefotaxime) for injection, USP (formerly sterile cefotaxime sodium), 1 gram IM/IV, Vial, Rx only. Recall # D-266-2; Claforan Sterile (cefotaxime) for injection, USP (formerly sterile cefotaxime sodium), 2 grams IM/IV, Vial, Rx only. Recall # D-267-2. CODE 500-mg. x 10 Lot No. Exp. Date 100632 Oct-02 120416 Dec-02 120469 Dec-02 021969 Feb-03 051739 May-03 091877 Sep-03 1-gram x 50 Lot No. Exp. Date 090668 Sep-02 090686 Sep-02 090688 Sep-02 110558 Nov-02 110565 Nov-02 110567 Nov-02 120421 Dec-02 120452 Dec-02 021912 Feb-03 021910 Feb-03 021914 Feb-03 021913 Feb-03 021911 Feb-03 031902 Mar-03 031903 Mar-03 041786 Apr-03 041829 Apr-03 041858 Apr-03 061704 Jun-03 091881 Sep-03 2-gram x 10 Lot No. Exp. Date 090683 Sep-02 110551 Nov-02 041729 Apr-03 071840 Jul-03 101894 Oct-03 2-gram x 25 Lot No. Exp. Date 110627 Nov-02 031947 Mar-03 041778 Apr-03 071839 Jul-03 2-gram x 50 Lot No. Exp. Date 090679 Sep-02 110554 Nov-02 021948 Feb-03 041730 Apr-03 041791 Apr-03 041821 Apr-03 071838 Jul-03. RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Pharmaceuticals, Inc., Kansas City, MO, by letter dated February 22, 2002. Manufacturer: Patheon UK Limited, Swindon, Wiltshire SN35BZ, England. Firm initiated recall is ongoing. REASON Labeling; product label declares inactive ingredients that are not contained in the product (Dextrose Hydrous, USP, Sodium Citrate Hydrous, USP and Hydrochloric Acid) VOLUME OF PRODUCT IN COMMERCE 500-mg. - 418,200 vials; 1-gram - 1,635,450 vials; 2-gm. - 647,574 vials. DISTRIBUTION Nationwide. _______________________ PRODUCT Q-Bid DM Sustained Release Tablet (Guaifenesin 600mg/ Dextromethorphan 30mg), 100 tablet bottles, Rx only. Recall # D-279-2. CODE Lot No. 005F1F. RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville, AL, by letter on February 21, 2002. Firm initiated recall is ongoing. REASON Tablet mix-up; Q-Bid LA tablet containing the active ingredient guaifenesin was found in a bottle of Q-Bid DM. VOLUME OF PRODUCT IN COMMERCE 14,150 bottles of 100 tablets. DISTRIBUTION Nationwide. _______________________ PRODUCT Ortho Micronor Oral Contraceptive Tablets (norethindrone) 0.35 mg, 28 tablets in a ring-shaped blister pack, Rx only. Recall # D-280-2. CODE Trade: NDC 0062-1411-16 Lot 11M001 Exp. 11/04 Lot 11M002 Exp. 11/04 Lot 12C003 Exp. 01/05 Lot 12C004 Exp. 02/05 Physician Samples: NDC#0062-1411-29 Lot 11M019 Exp. 11/04 Refills: NDC# 0062-1411-23 Veridate 12A029 Exp. 01/05 12C030 Exp. 01/05. RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Mcneil Pharmaceutical, Inc., Raritan, NJ, by letters on April 3, 2002. Manufacturer: Ortho-Mcneil Pharmaceutical Inc., Manati, Puerto Rico. Firm initiated recall is ongoing. REASON Mislabeling; labeling incorrectly informs user that missing any pills 22- 28 will still leave them protected. VOLUME OF PRODUCT IN COMMERCE Trade -- 339,336 blisters; Veridate -- 40,320 blisters; Samples -- 124,704. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Ziox Ointment (papain-urea-chlorophyllin copper complex sodium) 30 gram tube, Rx only. Recall # D-276-2; b) Kovia Ointment (papain-urea), 30 gram tube, Rx only. Recall # D-277-2; c) Nuquin HP 4% Gel (hydroquinone USP, 4%), 1/2 oz and 1 oz tubes, Rx only. Recall # D-278-2. CODE a) Lot #5075 Exp. 6/2003; b) Lot #5041 Exp. 6/2002; c) Lot #5015 Exp. 9/2002. RECALLING FIRM/MANUFACTURER Sonar Products Inc., Carlstadt, NJ, by letter on March 6, 2002. Firm initiated recall is complete. REASON Subpotent: Ziox and Kovia Ointment for papain and Nuquin 4% for padimate- o and dioxybenzone. VOLUME OF PRODUCT IN COMMERCE a) 9,648 x 30g tubes; b) 51,201 x 30g tubes; c) 4,731 x 30g tubes, 2,537 x 15 g tubes. DISTRIBUTION FL.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1292-2. CODE Unit number C46225. RECALLING FIRM/MANUFACTURER South Bend Medical Foundation, Inc., Central Blood Bank, South Bend, IN, by telephone on November 30, 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 IN. _______________________ PRODUCT Platelet, Pheresis, Recall # B-1297-2. CODE Unit K20252. RECALLING FIRM/MANUFACTURER Recalling Firm: Mississippi Valley Regional Blood Center, Davenport, IA, by fax on July 16, 2001 and by letter on July 30, 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 IL. _______________________ PRODUCT Red Blood Cells, Recall # B-1301-2. CODE Units S11408, S11410, S11411, S11412, S11413, S11414, S11420, S11421, S11425, S11428, S11429, S11430, S11432, S11436, S11442, S11444, S11445, S11446, S11447, S11448, S11449, S11451, S11452, S11456, S11458, S11462, S11463, S11465, S11466, S11467, S11468, S11470, S11474, S11476, S11478, S11480, S11482, S11483, S11485, S11487, S11490, S11493, S11497, S11499, S11506, S11508, S11510, S11514. RECALLING FIRM/MANUFACTURER Recalling Firm: Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI, by fax on February 18, 2002. Manufacturer: Michigan Community Blood Centers, Saginaw, MI. Firm initiated recall is complete. REASON Blood products, collected from a donor whose hemoglobin was unacceptable, were distributed. VOLUME OF PRODUCT IN COMMERCE 48 units. DISTRIBUTION MI. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1302-2. CODE Unit number 01GK19138 (distributed as two split units). RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letter dated August 15, 2001. Manufacturer: The American National Red Cross, New York-Penn Region, Syracuse, NY. 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 NY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1303-2. CODE Unit number 17195-0076. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX, by letter dated November 8, 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 TX. _______________________ PRODUCT Red Blood Cells, Recall # B-1304-2. CODE Unit number 6401476. RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL, by telephone on January 23, 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 IL. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1305-2. CODE Unit number H62115. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by letter dated January 18, 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 IA. _______________________ PRODUCT Red Blood Cells, Recall # B-1306-2. CODE Unit number V95530. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by letter dated August 29, 2000. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TN. _______________________ PRODUCT Red Blood Cells, Recall # B-1307-2. CODE Unit number N52125. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by letter dated March 12, 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 IL. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1308-2; b) Platelets, Recall # B-1309-2; c) Fresh Frozen Plasma, Recall # B-1310-2. CODE a); b) and c) Unit number 2448450. RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL, by telephone on January 27 and 28, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who should have been deferred due to use of the medication Arthrotec, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IL. _______________________ PRODUCT Source Plasma, Recall # B-1311-2. CODE Unit number N-51595-072. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., Long Beach, CA, by fax on July 5, 2001. Firm initiated recall is complete. REASON Blood product, that tested negative for viral markers, but was collected from a donor that previously tested reactive for a viral marker, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Spain. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1313-2. CODE Unit numbers 15387-2445, 15389-4681, 15011-6796, 15011-7710, 15011-7851, 15011-7931, 15011-8269, 15012-2838, 15012-4682, 15012-4888, 15012-5269, 15012-6900, 15012-6923, 15013-0059, 15386-4194, 15386-4666, 15387-5270, 15387-6874, 15388-2342, 15388-6031, 15388-8240, 15388-9162, 15389-1057, 15389-3858, 15389-6179, and 15390-0496. RECALLING FIRM/MANUFACTURER Blood Systems Inc., Lubbock, TX, by letter dated January 11, 2002. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 26 units. DISTRIBUTION TX. _______________________ PRODUCT Platelet, Pheresis, Leukoreduced, Recall # B-1316-2. CODE Unit K21759. RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, IA, by letter dated January 18, 2002. Firm initiated recall is complete. REASON Blood product, labeled as leukoreduced but did not have white blood cell count determination, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MO. _______________________ PRODUCT Platelet, Pheresis, Leukoreduced, Recall # B-1317-2. CODE Unit 17196-3292. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX, by letter dated November 3, 2001. Firm initiated recall is complete. REASON Blood product, incorrectly labeled as leukoreduced, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MO.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Red Blood Cells, Recall # B-1312-2. CODE Unit number T61875. RECALLING FIRM/MANUFACTURER Recalling Firm: Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI, by fax on February 18, 2002. Manufacturer: Michigan Community Blood Centers, Traverse City, MI. 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 MI. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1314-2. CODE Unit number 17196-0442. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX, by telephone on September 17, 2001. Firm initiated recall is complete. REASON Blood product, labeled with the incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1315-2. CODE Unit numbers 11325-4060, 11325-4059, 11325-4058, 11325-4057, 11325-4056, 11325-4055, 11325-4054, 11325-4053, 11325-4052, and 11325-4051. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX, by telephone on May 25, 2000. Firm initiated recall is complete. REASON Unlicensed blood products were distributed interstate. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION NM.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT EBI XFIX DFS OptiROM Elbow Fixator. Recall # Z-1035-2. The product is sold non-sterile and is packaged either in an inner foam liner aluminum metal casing or in plastic bag. CODE DC09575 or 09575 will be etched on the unit and the following lot numbers: 40994, 44782, 206883, 204881, 204882, 271159, 288313, 316281, 355170, 393638, 422625, 439685, 456129, 493368, 500176, 504015, 522720, 516609. RECALLING FIRM/MANUFACTURER EBI, l.p., Parsippany, NJ, by voluntary recall on March 6, 2002. Firm initiated recall is ongoing. REASON Pin migration at the connection of OptiROM central body and fixator. VOLUME OF PRODUCT IN COMMERCE 339. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Seprapack-Unilateral Application, sterile. (Bioresorbable nasal packing and sinus stent). Recall # Z-1038-2. CODE Product Code: 7089-0807 Lot Number: 51579V. RECALLING FIRM/MANUFACTURER Genzyme Biosurgery, a division of Genzyme Corp., Fall River, MA, by letter dated April 3, 2002. Firm initiated recall is ongoing. REASON Product packaging may have voids in the seal compromising sterility of device. VOLUME OF PRODUCT IN COMMERCE 348 units. DISTRIBUTION TN. _______________________ PRODUCT Bayer Immuno 1(R) Troponin I Method. Recall # Z-1039-2. Common Name: Immuno 1(R) Troponin I Method. CODE Product No. T01-3887-51, Lot V60275. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corp., Business Group Diagnostics, Tarrytown, NY, by Support Bulletin IM-050 and a Customer Bulletin on 4/24/02. Manufacturer: Fisher Diagnostics Middletown, VA. Firm initiated recall is ongoing. REASON Complaints received of low recoveries on Immuno 1 Troponin I Reagent Lot V60275. VOLUME OF PRODUCT IN COMMERCE 6488 units. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Puritan Bennett-840 Ventilator System with optional compressor. Recall # Z-1040-2. CODE Ventilators with Rev. E BD CPU boards with Serial numbers 3510000007 through 3510012304. RECALLING FIRM/MANUFACTURER Recalling Firm: TYCO Healthcare, Nellcor Puritan Pennett, Pelasanton, CA, by letter dated October 22, 2001. Manufacturer: Nellcor Puritan Bennett Ireland, ltd. Mervue, Galway, Ireland. Firm initiated recall is ongoing. REASON Failure of optional compressor on ventilator. VOLUME OF PRODUCT IN COMMERCE 2,599 ventilators systems and 299 field replacement units with Rev. E BD CPU boards DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT a) Lightcycler microchemistry analyzer, catalog number 2011468, printers. Recall # Z-1041-2; b) Lightcycler microchemistry analyzer, catalog number 2043912, printers. Recall # Z-1042-2; c) Lumi Imager microchemistry analyzer, catalog number 2012847, printers. Recall # Z-1043-2. CODE All Hewlett Packard Deskjet 800 and 900 series and PhotoSmart 1000, 1100, 1200 and 1300 series printers shipped between April 2001 and January 2002 with a Longwell "LS-7C" gray two-prong power cord. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated May 7, 2002. Manufacturer: Hewlett Packard Company, Loveland, CO. Firm initiated recall is ongoing. REASON Printer power cord poses a shock hazard. VOLUME OF PRODUCT IN COMMERCE 220. DISTRIBUTION Nationwide. _______________________ PRODUCT Linvatec brand Double-Armed, Straight, Trocar Point 13” (33cm) Suture Needle Polyester, Green Braided, 36” (91.4cm) 2-0 U.S.P 3.0. metric. Recall # Z-1044-2. CODE 432188 430382 432189 432190 434760 456391 465144 469384 466961 473349 480470 486004. RECALLING FIRM/MANUFACTURER ReGen Biologics, Inc., Redwood City, CA, by letters on April 16, 2002. Firm initiated recall is ongoing. REASON Sterility may be compromised. VOLUME OF PRODUCT IN COMMERCE 10,760 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Synapse Image and Information Management System. Recall # Z-1045-2. CODE Synapse Image and Information Management System with software versions 2.0.2 and 2.1.1. RECALLING FIRM/MANUFACTURER Fujifilm Medical Systems U.S.A., Inc., Stamford, CT, by letter dated April 11, 2002. Firm initiated recall is ongoing. REASON Rotated/flipped Images not viewed on the screen may not rotate but left / right markers will be flipped. VOLUME OF PRODUCT IN COMMERCE 70. DISTRIBUTION Nationwide. _______________________ PRODUCT Liebel-Flarsheim Angiomat Illumena Media Power Injectors, P/N 900001, using Version 8.0 software with new console. Recall # Z-1046-2. CODE Serial Numbers: 0202-5000 to 0402-5126. RECALLING FIRM/MANUFACTURER Recalling Firm: Mallinckrodt, Inc. / Liebel-Flarsheim Business, Cincinnati, OH, by telephone beginning April 22 and by letter on April 23, 2002. Manufacturer: Liebel-Flarsheim Co., Cincinnati, OH. Firm initiated recall is ongoing. REASON Pushing the scoll button repeatedly / rapidly results in erroneous protocol ID. VOLUME OF PRODUCT IN COMMERCE 62. DISTRIBUTION Nationwide and Canada, Taiwan, China, So. Africa and Australia. _______________________ PRODUCT Stryker Secure II hospital beds with an optional 110V outlet box assembly. Recall # Z-1055-2. CODE All beds manufactured between June 1, 2001 and February 19, 2002 that has the optional 110V outlet assembly box. RECALLING FIRM/MANUFACTURER Stryker Corp., Kalamazoo, MI, by letter dated April 26, 2002. Firm initiated recall is ongoing. REASON Shock hazard. VOLUME OF PRODUCT IN COMMERCE 1,4460 beds. DISTRIBUTION United States and Canada. _______________________ PRODUCT Duoflo, Applicator Dispenser Kit, with Tisseal VH, Fibrin Sealant. Recall # Z-1053-2. CODE Product Code 921023; lot number 03130001 in USA. Lot 05290106 in foreign distribution. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corporation Glendale, CA, by notice on March 18, 2002. Manufacturer: Hemaedics, Inc., Brentwood, CA. Firm initiated recall is ongoing. REASON Tip breakage into surgical site. VOLUME OF PRODUCT IN COMMERCE 11,624. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT a) 3T vent valves for perfusion circuits; sterile. Recall # Z-1036-2; b) 3T vent valves for perfusion circuits; non-sterile. Recall # Z-1037-2. CODE a) CATALOG # 030 (STERILE)- all lots bearing a sterilization date prior to April 5, 2002. b) CATALOG #030NS (NON-STERILE)- all lots sold to manufacturers prior to initiation of the recall. RECALLING FIRM/MANUFACTURER Recalling Firm: 3T Medical Systems, LLC, Dearborn, MI, by letter dated April 5, 2002. Manufacturer: MPC/Geneva Medical Products, Prairie Du Chien, WI. Firm initiated recall is complete. REASON Inadequate bond allows blood leakage or separation during use. VOLUME OF PRODUCT IN COMMERCE 7,200. DISTRIBUTION Nationwide. _______________________ PRODUCT EB-250S and EB-450S bronchoscope. Recall # Z-1051-2/Z-1052-2. CODE Model/Catalog No. EB-250S: Serial Numbers: 2B027C002; 2B027C051, 2B027C061, 2B027C003, 2B027C067, 2B027C005, 2B027C001, 2B027C004, 2B027C017, 1B027C016, and 1B027C017 Model/Catalog No. EB-450S: Serial Numbers: 1B028C048, 1B028C011, 1B028B040, 1B028C004, 1B028C013, 2B028C007, 2B028C008, 2B028C070, 2B028C076, 2B028C023, 2B028C001, 2B028C013, 2B028C015, 2B028C048, 2B028C002, 2B028C009, 2B028C010, 2B028C003, 2B028C033, 2B028C017, and HB028A038. RECALLING FIRM/MANUFACTURER Recalling Firm: Fujinon, Inc., Wayne, NJ, by letter dated January 31, 2002. Manufacturer: Fuji Photo Optical Co. Ltd., Omiya, Saitama, 300-0036, Japan. Firm initiated recall is complete. REASON During brochoscopy, suction valve stuck in active position. VOLUME OF PRODUCT IN COMMERCE 32. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Padgett Instruments, Inc. roller cylinder for the Mesh Skin Graft Expander, Model P-170, for use in producing a honeycomb pattern on the graft so it will expand. Recall # Z-1054-2. CODE Not coded. RECALLING FIRM/MANUFACTURER Recalling Firm: Padgett Instruments, Inc., Kansas City, MO, by letters dated March 21, 2002. Manufacturer: Dadson Mfg. Corp., Grain Valley, MO. Firm initiated recall is ongoing. REASON The roller assembly might be defective. VOLUME OF PRODUCT IN COMMERCE 39 P-170 units as of 4/24/02. DISTRIBUTION FL, WV, NY and TX and Brazil, Portugal, Chile, Finland, England, Spain and Ireland.END OF ENFORCEMENT REPORT FOR MAY 29, 2002 ####
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