August 14, 2002 02-32
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Drake's Sunny Doodles (creme filled golden cakes) packaged in a 12-oz. Family Pack containing 12 individually-wrapped cakes or a 3-oz. snack pack containing 3 cakes within the same wrapping. Recall # F-724-2. CODE BEST BEFORE DATES OR PULL DATES: JUL 22 JUL 24 JUL 26 JUL 30 AUG 02. RECALLING FIRM/MANUFACTURER Recalling Firm: Interstate Brands Corp., Kansas City, MO, by press release on July 12, 2002. Manufacturer: Interstate Brands Corp., Wayne, NJ. Firm initiated recall is complete. REASON Drake's Sunny Doodles snack cakes contain undeclared soy flour. VOLUME OF PRODUCT IN COMMERCE 29,042 family packs and 185,248 snack packs. DISTRIBUTION NY, CT, MA, NH, VT, NJ, PA, GA, AL and FL. _______________________ PRODUCT SF brand DRIED SWEET POTATO, NET WT. 7 oz. INGREDIENT: POTATO. PRODUCT OF CHINA. Recall # F-725-2. CODE Bar Code #923153 500545 and no other coding. RECALLING FIRM/MANUFACTURER Recalling Firm: Allied Imports Inc., Brooklyn, NY, by food safety alert on January 17, 2002. Manufacturer: Zhong Shan Carlos Health Drinks Co. Ltd., Shaxi Town, Zhongshan, Guangdo. State initiated recall is complete. REASON The PRODUCT contained undeclared sulfites (653 ppm). VOLUME OF PRODUCT IN COMMERCE 2 cases (100 - 7 oz. packages per case). DISTRIBUTION NY. _______________________ PRODUCT "Susie" cantaloupes sizes 9, 12, 15, and 18 which also indicates the number of cantaloupes in each box. Box labeled as Susie brand cantaloupes. Recall # F- 726-2. CODE Only "Susie" brand cantaloupes distributed between May 1, 2002 and May 10, 2002 were affected. RECALLING FIRM/MANUFACTURER Recalling Firm: I. Kunik, McAllen, TX, by press release, telephone and fax on May 11, 2002. Manufacturer: PRODUCTora Melonera Tres Hermanos S.A. De C.V. Firm initiated recall is complete. REASON The cantaloupes were associated with an outbreak of Salmonella Poona infection, which took place between March 31, 2002 and April 24, 2002. VOLUME OF PRODUCT IN COMMERCE 23,309 cases domestically; 1,792 cases Canada (25,101 total). DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT LA TAPATIA brand TELERAS, Net Wt. 18 oz., 6 count in clear plastic packages with UPC: 43209-50865. Recall # F-727-2. CODE Expiration Code dates - Jun 28 Jun 20 Jun 27 Jun 19 Jun 26 Jun 18 Jun 25 Jun 17 Jun 24 Jun 16 Jun 23 Jun 15 Jun 22 Jun 14 Jun 21 Jun 13 (Codes are on stick-on labels). RECALLING FIRM/MANUFACTURER La Tapatia Tortilleria, Inc., Fresno, CA, by letter and press release on June 20, 2002. Firm initiated recall is complete. REASON Teleras contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE 114 pkgs. DISTRIBUTION CA.
_______________________ PRODUCT Berthelet brand NATURALLY FLAVORED CRYSTALS, 15 1/2 OZ. PRODUCT OF CANADA. Papaya flavor: undeclared sunset yellow FCF (certifiable as FD&C Yellow No. 6) and allura red AC (certifiable as FD&C Red No. 40). Recall # F-722-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Southeastern Food Specialties, Margate, FL, by telephone and fax on November 15, 2001. Manufacturer: Berthelet Foods products, Inc., Laval (Quebec), Canada. State initiated recall is complete. REASON Undeclared certifiable colors. VOLUME OF PRODUCT IN COMMERCE 576 cases (12X15.43oz). DISTRIBUTION FL.
_______________________ PRODUCT Berthelet brand NATURALLY FLAVORED CRYSTALS, 15 1/2 OZ. PRODUCT OF CANADA. Watermelon flavor: undeclared allura red AC (certifiable as FD&C Red No. 40). Recall # F-723-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Southeastern Food Specialties, Margate, FL, by telephone and fax on November 15, 2001. Manufacturer: Berthelet Foods products, Inc., Laval (Quebec), Canada. State initiated recall is complete. REASON Undeclared certifiable colors. VOLUME OF PRODUCT IN COMMERCE 480 cases (12X15.43 oz). DISTRIBUTION FL.
_______________________
PRODUCT
a) Clonazepam Tablets, USP 1 mg, 100, 500, and 1,000 count bottles, Rx
only. Recall # D-372-2;
b) Clonazepam Tablets, USP 2 mg, 100 and 500 count bottles, Rx only. Recall
# D-373-2.
CODE
a) Lot numbers for 1 mg strength:
356546 exp. 11/30/03, 356547 exp. 11/30/03, 356548 exp. 11/30/03, 356549 exp.
11/30/03, 356550 exp. 11/30/03, 356551 exp. 11/30/03, 356552 exp. 11/30/03,
356553 exp. 11/30/03, 356554 exp. 11/30/03, 356555 exp. 11/30/03, 356556 exp.
11/30/03, 356557 exp. 11/30/03, 356558 exp. 11/30/03, 356559 exp. 11/30/03,
356560 exp. 11/30/03, 356561 exp. 11/30/03, 356562 exp. 11/30/03, 356563 exp.
11/30/03, 356564 exp. 11/30/03, and 356565 exp. 11/30/03.
b) Lot numbers for 2 mg strength:
355108 exp. 11/30/03, 355109 exp. 11/30/03, and
355110 exp. 11/30/03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Sellersville, PA, by letters on June
10, 2002.
Manufacturer: Teva Pharmaceuticals, Jerusalem, Israel.
Firm initiated recall is ongoing.
REASON
Tablet mix up: 2 mg tablets may be in bottles labeled as containing 1 mg tablets
and/or 1 mg tablets may be in bottles labeled as containing 2mg tablets.
VOLUME OF PRODUCT IN COMMERCE
160,391 bottles.
DISTRIBUTION
Nationwide.
_______________________
PRODUCT
a) Levothroid Tablets (levothyroxine sodium tablets, USP),
100-mcg, 100-count and 5,000-count bottles. Recall # D-377-2.
b) Levothroid Tablets (levothyroxine sodium tablets,
USP), 125-mcg, 100-count bottles. Recall # D-378-2.
CODE
a) 125 mcg. - Lot 70035, Exp. 07/2002, 100-count
Lot 70038, Exp. 07/2002, 100-count
Lot 80033, Exp. 08/2002, 100-count
Lot 80034, Exp. 08/2002, 100 count
b) 100 mcg. - Lot 80017, Exp. 08/2002, 5,000 count
Lot 80019, Exp. 08/2002, 5,000 count
Lot 90014, Exp. 09/2002, 5,000 count
Lot 120028, Exp. 01/2003, 100 count.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals, Inc., St. Louis, MO, by letters dated
May 30, 2002.
Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, OH.
Firm initiated recall is ongoing.
REASON
Subpotent prior to expiration date.
VOLUME OF PRODUCT IN COMMERCE
790/5,000-tab. btls; 64,637/100-tab. btls.
DISTRIBUTION
Nationwide.
_______________________ PRODUCT Lariam (mefloquine HCl) Tablets, 250mg, 25 carton count. Recall # D-337-2. CODE B1023-50 exp. 12/2003 B1024, exp. 12/2003 B1025, exp. 12/2003. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Laboratories, Nutley, NJ, by letters on April 19, 2002. Manufacturer: F. Hoffmann-La Roche, Basel, Switzerland. Firm initiated recall is ongoing. REASON Potential cross contamination with active ingredients which could include levodopa/benserazide, and/or sulfamethoxazole. VOLUME OF PRODUCT IN COMMERCE 69,447 bottles. DISTRIBUTION Nationwide _______________________ PRODUCT Imodium Advanced Chewable Tablets (Loperamide HCL/Simethicone), single pack for display hanger, 2 tablets per pack. Packaged in the clear pouch of the display hanger card is a viewable single packet labeled Imodium A-D ANTI-DIARRHEAL (Loperamide HCl) Caplets, 2 CAPLETS Each caplet contains 2 mg loperamide HCl. Recall # D-374-2. CODE Lot Numbers DFC049 and DEC051. RECALLING FIRM/MANUFACTURER Recalling Firm: Navajo Manufacturing Company, Inc., Denver, CO, by telephone and letter on May 22, 2002. Manufacturer: McNeil Consumer products, Fort Washington, PA. Firm initiated recall is ongoing. REASON Mispackaging by repacking firm; Imodium A-D Caplets containing Loperamide HCl were mislabeled as Imodium Advanced chewable tablets containing Loperamide and Simethicone. VOLUME OF PRODUCT IN COMMERCE 51 / 2500 ct. cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Cortizone 10 Anti-Itch Ointment, 1% Hydrocortisone, 30% Bonus Size, 1.3 oz tube. Recall # D-375-2. CODE Open Stock -- Lot 2499604. Floor Display -- Lot 1899031 (this lot identifies the display lot where Lot 2499604 is packaged within). RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer Consumer Healthcare, Morris Plains, NJ, by letters on May 21, 2002. Manufacturer: Pfizer Inc., Parsippany, NJ. Firm initiated recall is ongoing. REASON Superpotency (24 month stability test point). VOLUME OF PRODUCT IN COMMERCE Open stock -- 28,956; part of display -- 81,672. DISTRIBUTION Nationwide _______________________ PRODUCT North Burn Jel Topical Analgesic: Contains Lidocaine HCL (2.0%) Six-Packets 1/8 oz. (3.5 g). Recall # D-376-2. CODE Lot Number: M1G0407 Expiration Date: 01/04. RECALLING FIRM/MANUFACTURER Recalling Firm: North Safety products, Cranston, RI, by telephone on July 22, 2002. Manufacturer: North Safety products, Mexacli, BC. Firm initiated recall is ongoing. REASON Misbranding: Six unit holding carton mislabeled as Burn Jel (Lidocaine HCl) but actually contains individual non-medicated packages of the PRODUCT Cool Jel. VOLUME OF PRODUCT IN COMMERCE 1,200 units. DISTRIBUTION AZ, CA, CO, IL, OH, PA, FL, SC, MT, NV, WY and TX. _______________________ PRODUCT a) Hydrocortisone Cream 1%, 0.9 gram and 1 gram packets. Recall # D-379-2; b) Hydrocortisone Cream .5%, 0.9 gram and 1 gram packets. Recall # D-380-2. These over-the-counter drugs are sold under the following private labels: Hydrocortisone Cream USP 1%, 0.9 gram Manufactured for Just American Safety, Osceola, IN 1% Hydrocortisone Anti-Itch Cream, 0.9 gram Manufactured for First Aid Direct, Sunrise, FL Hydrocortisone Cream 1% Manufactured for Textilease Medique, Skokie, IL Hydro-Max 1% Hydrocortisone Acetate Cream, 0.9 gm Manufactured for: AFFIRMED MEDICAL INC., Dallas, TX Hydrocortisone 1%, 0.9 gm Manufactured for: ESAFETYCO, Salinas, CA SWIFT Hydrocortisone Cream USP 1% packets, 1 gm Dist. by Swift FIRST AID, INC., Valencia, CA Hydrocortisone Cream, 1/2% and 1%, 1 gm Distributed by: Moore Medical Corp., New Britian, CT 1/2% NDC #0839-8019-72 and 1% NDC #0839-8020-72 Hydrocortisone 1%, 0.9 gm Mfg. for American First Aid, Hanover, MD Hydrocortisone Cream 1%, 1 gm Dist. by Green Guard First Aid and Safety Service, St. Louis, MO Respond Hydrocortisone 1% Cream Itch Relief, 1 gm Manufactured for: Respond Ind., Denver, CO. CODE 1/2% cream lot numbers: 2238, Exp. 10/02 K-2380, Exp. 6/03 A-K-2445, Exp. 10/03 1% cream lot numbers: A-K-2331, EXP. 9/02 A-K-2237, EXP. 10/02 A-K-2247, EXP. 11/02 A-K-2251, EXP. 12/02 A-K-2253, EXP. 12/02 A-K-2299, EXP. 1/03 A-K-2318, EXP. 2/03 A-K-2322, EXP. 3/03 A-K-2377, EXP. 5/03 A-K-2380, EXP. 6/03 A-K-2411, EXP. 7/03 A-K-2426, EXP. 9/03 A-K-2468, EXP. 11/03 A-K-2481, EXP. 12/03 A-K-2536, EXP. 2/04 A-K-2578, Exp. 2/04 K-2237, EXP. 10/02 K-2238, EXP. 10/02 K-2247, EXP. 11/02 K-2251, EXP. 12/02 K-2299, EXP. 1/03 K-2322, EXP. 3/03 K-2380, EXP. 6/03 K-2419, EXP. 8/03 247, EXP. 11/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Ultraseal Corp., New Paltz, NY, by letters beginning July 5, 2002. Manufacturer: Ultratab Laboratories, Inc., Highland, NY. Firm initiated recall is ongoing. REASON Subpotent. VOLUME OF PRODUCT IN COMMERCE 1/2% - 622,944 packets; 1 % - 786,416 packets. DISTRIBUTION CA, CO, FL, IL, KS, MD, and MO.
_______________________ PRODUCT Platelets, Pheresis, Leukocytes Reduced, Recall # B-1743-2. CODE Units 12469-8003, 12469-9377. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 15, 2001 and by letter dated October 25, 2001. Manufacturer: United Blood Services, Albuquerque, NM. Firm initiated recall is complete. REASON Blood products, which were labeled as leukoreduced, but did not meet the requirements for a leukoreduced PRODUCT, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NM. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1744-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1745-2. CODE a) Unit 12449-9367; b) Unit 12451-7894. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated October 18, 2001. Manufacturer: United Blood Services, Albuquerque, NM. Firm initiated recall is ongoing. REASON Blood products, collected from a donor who had traveled to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MD and NM. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1746-2. CODE Unit 18223-8780. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated March 28, 2001. Manufacturer: United Blood Services, Cheyenne, WY. Firm initiated recall is ongoing. REASON Blood PRODUCT, collected from a donor who traveled to a malarial endemic area, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MS. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1747-2. CODE Unit 12472-1680. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone and fax on May 29, 2002. Manufacturer: United Blood Services, Albuquerque, NM. Firm initiated recall is ongoing. REASON Blood PRODUCT, collected from a donor who traveled to a malarial endemic area, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NM. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1748-2. CODE Unit number 36264-6036. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 2, 2002 and by letter on May 31, 2002. Manufacturer: Blood Systems, Inc., Ventura, CA. Firm initiated recall is complete. REASON Blood PRODUCT, manufactured in a manner that may have compromised the sterility of the unit, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1753-2. CODE Unit number 41FP32037. RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL, by letters dated October 2, 2000 and November 3, 2000. Firm initiated recall is complete. REASON Platelets Pheresis with an elevated platelet count based on volume of PRODUCT collected were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AL. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1754-2. CODE Unit number 041FP31572. RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on May 5, 2000 and by letter dated May 11, 2000. Firm initiated recall is complete. REASON Platelets Pheresis with an elevated platelet count based on volume of PRODUCT collected were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AL. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1755-2. CODE Unit numbers 041GP47502 and 041GP47503 (distributed as two split units). RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL, by letter dated April 13, 2000. Firm initiated recall is complete. REASON Platelets Pheresis with an elevated platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION AL. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-1756-2. CODE Unit numbers 41FP31994, 41GP48203, 41GP48632 (distributed as two split units), 41GP31997, 41FP30974, 41FP32115, 41FP31607 (distributed as two split units), and 41FP31664 (distributed as two split units). RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL, by letters dated August 21, 2000 and September 29, 2000. Firm initiated recall is complete. REASON Platelets Pheresis with unacceptable platelet counts were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION AL. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1757-2; b) Platelets, Recall # B-1758-2; c) Fresh Frozen Plasma, Recall # B-1759-2. CODE a); b) and c) Unit 22LY49320. RECALLING FIRM/MANUFACTURER American Red Cross, Penn Jersey Region, Philadelphia, PA, by letter dated September 7, 2001. Firm initiated recall is ongoing. REASON Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION PA. _______________________ PRODUCT Source Plasma, Recall # B-1760-2 CODE Units 60225252, 60227225, 60228840, 58492246, 58493748, 58496800, 58497753, 58499993, 61620988, 61623477, 61625846, 61627611, 61670891, 62632263, 62635240, 62637503, 62639521, 62902298, 62904520, 62907200, 62909167. RECALLING FIRM/MANUFACTURER SeraCare, Inc., SerCare Acquisitions, Inc., Everett, WA, by letter dated December 24, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor who had previously been deferred due to high risk behaviors associated with increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 21 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1761-2; b) Platelets, Recall # B-1762-2; c) Plasma, Frozen, Recall # B-1763-2. CODE a); b) and c) Unit 21GH93947. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by letter dated October 23, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor who subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OK. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1764-2; b) Platelets, Recall # B-1765-2. CODE a) and b) Unit 22KR71901. RECALLING FIRM/MANUFACTURER American Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on June 13, 2001 and by letter dated June 19, 2001. Firm initiated recall is ongoing. REASON Blood products, collected from a donor with a history of having tested positive for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION PA. _______________________ PRODUCT Source Plasma, Recall # B-1766-2. CODE Units 58518540, 58681473, 58684177, 58685433. RECALLING FIRM/MANUFACTURER Recalling Firm: SeraCare, Inc., Colorado Springs, CO, by letter dated October 8, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who tested positive for syphilis, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1767-2. CODE Units IN0010564, IN0010483. RECALLING FIRM/MANUFACTURER Recalling Firm: SeraCare, Inc., Colorado Springs, CO, by letter dated July 12, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who was not tested for syphilis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Spain. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1768-2. CODE Unit 21KL46102. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by telephone on February 26, 2002 and by letter dated March 6, 2002. Firm initiated recall is complete. REASON Blood PRODUCT, collected from a donor whose temperature was not accurately determined, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1769-2; b) Frozen Plasma, Recall # B-1770-2; c) Recovered Plasma, Recall # B-1771-2. CODE a) Units 21FL53241, 21FS22716; b) Unit 21FL53241; c) Unit 21FS22716. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Blood Services, Portland, OR, by letters dated August 31, 2001 and October 10,2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION OR, Washington, DC and Switzerland.
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1331-2. CODE Unit numbers 41FP31181 and 41FP31188. RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL, by letter dated June 23, 2000. Firm initiated recall is complete. REASON Blood products, that were not leukoreduced within the appropriate time period from collection, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AL. _______________________ PRODUCT Source Plasma, Recall # B-1742-2. CODE Units 9M5023, 9M4309, 9M3666, 9L4278, 9L3371, 9L2830, 9L2451, 9L1933, 9L1193, 9L0881, 9HI935, 9HI484, 9HH808, 9HH547, 9GU857, 9GU611, 9GT956, 9GT720, 9FW104, 9FV502, 9FV053, 9EJ683, 9EJ537. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Kansas City, MO, by fax dated August 15, 2001. Firm initiated recall is complete. REASON Source Plasma, collected from a donor taking anti-depressant drugs, were distributed. VOLUME OF PRODUCT IN COMMERCE 23 units. DISTRIBUTION IL and Germany. _______________________ PRODUCT Frozen Plasma, Recall # B-1780-2. CODE Unit 21KE15405. RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, OR, by telephone on April 3, 2002 and by letter dated April 8, 2002. Firm initiated recall is complete. REASON Blood PRODUCT, collected from a donor who developed a hematoma, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR.
_______________________ PRODUCT CAPTIA Syphilis G ELISA Test Kit For in vitro diagnostic use. Packed in kits of 96 determinations and kits of 960 determinations. Recall # Z-1186-2. CODE Lot numbers: K00841, Exp. 14 JAN 03 K00842, Exp. 14 JAN 03 K00839, Exp. 14 JAN 03 K00838, Exp. 14 JAN 03 (these may be suffixed by a letter) PRODUCT CODEs: 800-925, 96 tests per kit 801-030, 960 tests per kit 801-032, 96 tests per kit 801-033, 960 tests per kit. RECALLING FIRM/MANUFACTURER Trinity Biotech plc Co., Wicklow, Ireland, by letters dated July 22, 2002. Firm initiated recall is ongoing. REASON Potential false negative results. VOLUME OF PRODUCT IN COMMERCE 292 units. DISTRIBUTION CA, FL, MN, NJ, and PA.
_______________________ PRODUCT a)Calcium reagent for Hitachi Modular P analyzer, catalog no. 1730240. Recall # Z-1124-2; b)Calcium reagent for Hitachi Modular P and D analyzers, catalog nos. 1929780 and 1929798. Recall # Z-1125-2; c)Calcium reagent for Hitachi Modular D analyzer, catalog nos. 1929801 and 1929828. Recall # Z-1126-2; d)Calcium reagent for Hitachi Model 704, 717, 902, 904, 911, 912 and 914 analyzers, catalog no. 1489216. Recall # Z-1127-2; e)Calcium reagent for Hitachi Model 717, 904, 911, 912 and 914 analyzers, catalog no. 1125621. Recall # Z-1128-2; f)Calcium reagent for Hitachi Model 736, 737 and 747 analyzers, catalog nos. 1127551 and 1127560. Recall # Z-1129-2; g)Calcium reagent for Hitachi Model 747-400 analyzers, catalog nos. 1554352 and 1554352. Recall # Z-1130-2; h)Cobas INTEGRA 400, 700, and 800 calcium reagent, Art 0763128; catalog no. 2055716. Recall # Z-1131-2. CODE All lots. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 10, 2002. Firm initiated recall is complete. REASON MRI contrast media interferes with calcium test results. VOLUME OF PRODUCT IN COMMERCE 2,867 analyzers. DISTRIBUTION Nationwide. _______________________ PRODUCT e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations. Recall # Z-1189-2. CODE e.soft software version 2.0 installed on e.soft A and e.soft A/P workstations. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters and CD on July 12, 2002. Firm initiated recall is ongoing. REASON Incorrect image time stored for static images resulting in incorrect results. VOLUME OF PRODUCT IN COMMERCE 346 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT OEC MiniView 6800 Mobile C-arm X-ray system. Recall # Z-1190-2. CODE OEC MiniView 6800 Mobile C-arm. 369 units within the Serial Number range 86-0009 thru 86-0798. RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on May 6, 2002. Firm initiated recall is ongoing. REASON Unit may become unbalanced and tip when the C-arm assembly is extended. VOLUME OF PRODUCT IN COMMERCE 369. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT CODE BLUE, PEDI BLUE, and BABY BLUE line of manual resuscitators, Recall # Z- 1191-2. CODE Model Numbers: 72054, 7500, 7500JACK, 7500K, 75045, 7505, 7505E, 7505EK, 7505EK9, 7505K, 7550, 7550A, 7550E, 7550EK, 7550K, 7550K9, 7550T9, 7552, 7552K, 7800, 7800JACK, 7800R, 7800R79, 7803, 7803R, 7830, 7830R, 7830T9, 7834, 7834A, 7840, 7868R, 78689, 7900, 7900JACK, 7900R, 7900R79, 7900T, 7902, 7902R, 7910, 7910A, 7910R, 7920, 7920C, 7920P9, 7920R, 7920S, 7920T, 7921, 7921AT9, 7921CNPT, 7921CP, 7921OSHU, 7921R, 7921S, 7921T, 79249. Lot Numbers: All lot CODEs beginning with "D" and "E" 001 through 365 and those beginning with "F" and "H" 001 through 106. RECALLING FIRM/MANUFACTURER Vital Signs, Inc., Totowa, NJ, by letter dated May 13, 2002. Firm initiated recall is ongoing. REASON Failures due to air/oxygen leakage. VOLUME OF PRODUCT IN COMMERCE 227,580. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Disposable Bipolar Cable, sterile, 12 foot, packaged in pouch, under the Q2 MEDICAL label, 10 pouches per case. Recall # Z-1193-2. CODE Lot Number 108932 Part Number 20-1102. RECALLING FIRM/MANUFACTURER Olsen Medical, Louisville, KY, by telephone on June 25, 2002 and by letter on July 2, 2002. Firm initiated recall is complete. REASON Device may not be sterile due to packaging defect. VOLUME OF PRODUCT IN COMMERCE 2,650 units. DISTRIBUTION NM, WA, VA, MI, NY, PA, TX, OK and TN. _______________________ PRODUCT MedComp Custom Dialysis Trays/Kits. The trays/kits are prep trays that do not contain a catheter. The trays/kits contain Wyeth's Heparin 1000 units/ml 1 ml dosette vial. Recall # Z-1197-2. CODE Catalog Number Tray #614JR Lot Number M001070; Catalog Number Tray #322 Lot Number M001520; Catalog Number Tray #500 Lot Number M002000; Catalog Number Tray #119 Lot Number M002370; Catalog Number Tray #273 Lot Number M005780; Catalog Number Tray #328 Lot Number M008600; Catalog Number Tray #119 Lot Number M010740; Catalog Number Tray #163 Lot Number M012680; Catalog Number Tray #119 Lot Number M013230; Catalog Number Tray #322 Lot Number M015930; Catalog Number Tray #119 Lot Number M016860; Catalog Number Tray #293 Lot Number M017120; Catalog Number Tray #163 Lot Number M017520; Catalog Number Tray #614JR Lot Number M017980; Catalog Number Tray #163 Lot Number M018350; Catalog Number Tray #328 Lot Number M020250; Catalog Number Tray #163 Lot Number M020260; Catalog Number Tray #498 Lot Number M021920; Catalog Number Tray #163 Lot Number M024150; Catalog Number Tray #163 Lot Number M029170; Catalog Number Tray #500 Lot Number M032740; Catalog Number Tray #273 Lot Number M033590; Catalog Number Tray #163 Lot Number M034030; Catalog Number Tray #328 Lot Number M034060; Catalog Number Tray #163 Lot Number M034250; Catalog Number Tray #3 Lot Number M036190; Catalog Number Tray #293 Lot Number M038260; Catalog Number Tray #293 Lot Number M040950; Catalog Number Tray #273 Lot Number M041850; Catalog Number Tray #322 Lot Number M043130; Catalog Number Tray #328 Lot Number M043250; Catalog Number Tray #119 Lot Number M043290; Catalog Number Tray #163 Lot Number M048640; Catalog Number Tray #163 Lot Number M048920; Catalog Number Tray #328 Lot Number M050000; Catalog Number Tray #322 Lot Number M102130; Catalog Number Tray #614JR Lot Number M102410; Catalog Number Tray #498 Lot Number M103380; Catalog Number Tray #163 Lot Number M103970; Catalog Number Tray #273 Lot Number M104390; Catalog Number Tray #163 Lot Number M104830; Catalog Number Tray #328 Lot Number M104860; Catalog Number Tray #614JR Lot Number M106730; Catalog Number Tray #163 Lot Number M106990; Catalog Number Tray #273 Lot Number M107000; Catalog Number Tray #119 Lot Number M109850; Catalog Number Tray #163 Lot Number M110040; Catalog Number Tray #498 Lot Number M112450; Catalog Number Tray #328 Lot Number M112540; Catalog Number Tray #328A Lot Number M112550; Catalog Number Tray #163 Lot Number M113410; Catalog Number Tray #163 Lot Number M114760; Catalog Number Tray #293 Lot Number M115060; Catalog Number Tray #328 Lot Number M115280; Catalog Number Tray #163 Lot Number M116370; Catalog Number Tray #163 Lot Number M117960; Catalog Number Tray #614JR Lot Number M118960; Catalog Number Tray #163 Lot Number M119060; Catalog Number Tray #500 Lot Number M121830; Catalog Number Tray #163 Lot Number M123930; Catalog Number Tray #163 Lot Number M124410; Catalog Number Tray #119 Lot Number M130080; Catalog Number Tray #273 Lot Number M134880; Catalog Number Tray #163 Lot Number M136380; Catalog Number Tray #293 Lot Number M137480; Catalog Number Tray #273 Lot Number M138600; Catalog Number Tray #498 Lot Number M138610; Catalog Number Tray #328 Lot Number M140100; Catalog Number Tray #322 Lot Number M140110; Catalog Number Tray #322 Lot Number M142350; Catalog Number Tray #119 Lot Number M142720; Catalog Number Tray #328 Lot Number M143950; Catalog Number Tray #273 Lot Number M147330; Catalog Number Tray #328 Lot Number M200500; Catalog Number Tray #163 Lot Number M201940; Catalog Number Tray #293 Lot Number M203590; Catalog Number Tray #163 Lot Number M203760; Catalog Number Tray #328B Lot Number M209330; Catalog Number Tray #273 Lot Number M209420; Catalog Number Tray #273 Lot Number M210220; Catalog Number Tray #163 Lot Number M215100; Catalog Number Tray #163 Lot Number M920280; Catalog Number Tray #500 Lot Number M920290; Catalog Number Tray #163 Lot Number M921220; Catalog Number Tray #119 Lot Number M923420; Catalog Number Tray #163 Lot Number M927630; Catalog Number Tray #273 Lot Number M928300; Catalog Number Tray #322 Lot Number M928900; Catalog Number Tray #163 Lot Number M929440; Catalog Number Tray #119 Lot Number M929460; Catalog Number Tray #328 Lot Number M929480; Catalog Number Tray #163 Lot Number M931940; Catalog Number Tray #163 Lot Number M935350; Catalog Number Tray #163 Lot Number M935590; Catalog Number Tray #498 Lot Number M937630; Catalog Number Tray #163 Lot Number M940560; Catalog Number Tray #328 Lot Number M940570; Catalog Number Tray #163 Lot Number M941880; Catalog Number Tray #163 Lot Number M944170 and Catalog Number Tray #163 Lot Number M944180. RECALLING FIRM/MANUFACTURER Medical Components, Inc., Harleysville, PA, by letters May 6, 2002. Firm initiated recall is ongoing. REASON Kits contain recalled Heparin. VOLUME OF PRODUCT IN COMMERCE 8603 kits. DISTRIBUTION Nationwide. _______________________ PRODUCT Terumo(tm) Hypodermic Syringes, sterile, bulk packed in plastic thermo-formed "Pharmacy Trays", heat sealed with Tyvek lidstock. 10 syringes per tray, 12 trays per case. Recall # Z-1201-2. CODE Catalog #SS30LT, Lot #CE15. exp 2007-03. RECALLING FIRM/MANUFACTURER Terumo Medical Corp., Elkton, MD, by telephone and fax on June 6, 2002. Firm initiated recall is complete. REASON Hypodermic Syringe packaging defect could compromise sterility. VOLUME OF PRODUCT IN COMMERCE 2040 syringes. DISTRIBUTION MO and Canada. _______________________ PRODUCT CrossSail (brand) Coronary Dilatation Catheter, 3.0 x 20 mm. Recall # Z-1202-2. Common name: Coronary Dilatation Catheter CODE Part number 1005270-20 Lot number 2010952. RECALLING FIRM/MANUFACTURER Guidant Corp., Temecula, CA, by notice on June 3, 2002. Firm initiated recall is ongoing. REASON Inadequate bond joint. VOLUME OF PRODUCT IN COMMERCE 145. DISTRIBUTION Nationwide. _______________________ PRODUCT Logix-CM Compounder Software. Recall # Z-1203-2. CODE Catalog #2M8400, Logix-CM software version 1.0.2. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL, by telephone on June 18, 2002. Firm initiated recall is ongoing. REASON Software allows ingredient concentration errors during compounding. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION NC, UT, AZ and WI. _______________________ PRODUCT Kimberly-Clark Ballard TRACH CARE* Closed Suction System for Pediatrics. Tracheobronchial suction catheter. Recall # Z-1204-2. CODE Catalog No. 1910, Lot 159541. RECALLING FIRM/MANUFACTURER Ballard Medical products, Draper, UT, by letter on March 19, 2002. Firm initiated recall is complete. REASON PRODUCT is unusable as assembled due to an incorrect component (elbow). VOLUME OF PRODUCT IN COMMERCE 61 cases (1220 units). DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT a) AxSYM B12 Reagent Pack (Dual Pack), list 3C79-20. Recall # Z-1205-2; b) IMx B12 Reagent Pack, list 2200-20. Recall # Z-1206-2. 100 test kits CODE a) Lots 84411M100, 89273M300, 89274M300, 89275M300, 89470M200; b) Lots 75782M200, 75998M200. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL, by letter dated July 18, 2002. Firm initiated recall is ongoing. REASON Precision problem - controls out of range. VOLUME OF PRODUCT IN COMMERCE 5,826 kits. DISTRIBUTION Internationally. _______________________ PRODUCT a) LifeScan brand ONETOUCH Ultra Blood Glucose Meter. Recall # Z-1210-2; b) LifeScan Brand InDuo Blood Glucose Meter. Recall # Z-1211-2. CODE All serial numbers. RECALLING FIRM/MANUFACTURER Recalling Firm: LifeScan, Inc., Milpitas, CA, by letters on May 13, 2002. Manufacturer: Inverness Medical Ltd., United Kingdom. Firm initiated recall is ongoing. REASON products may encounter display problem: "Er 4" message. VOLUME OF PRODUCT IN COMMERCE 2,080,000 units. DISTRIBUTION Nationwide and Internationally.
_______________________ PRODUCT ENDOPATH Non-Bladed Obturator Trocar with Smooth Sleeve, size 5mm, length 100mm, handled. The handled obturator trocar and the smooth sleeve components are packaged, dissasembled, as a set in a single labeled package. The devices are packaged as 6 sets per unit box. Each of the components can also be purchased separately by end-users. Recall # Z-1192-2. CODE Packaging Lot number: P4PP4J The catalog number: 35HL. RECALLING FIRM/MANUFACTURER Recalling Firm: Ethicon Endo-Surgery, Inc., Cincinnati, OH, by e-mail on February 27, 2002. Manufacturer: Ethicon Endo-Surgery, Inc., Ciudad Juarez Chihuahua, Mexico. Firm initiated recall is complete. REASON The packaged device is missing the trocar sleeve component. VOLUME OF PRODUCT IN COMMERCE 171 units (1026 components). DISTRIBUTION Nationwide. _______________________ PRODUCT Gambro Renal products Acid Concentrate for Bicarbonate Dialysate AC-2412-4 Date of Mfg. DEC 01 EXP DATE: DEC 03. Recall # Z-1194-2. CODE Lot G1L034. RECALLING FIRM/MANUFACTURER Recalling Firm: Gambro Renal products, Daytona Beach, FL, by telephone and letter on December 21, 2001. Manufacturer: Di-Chem Concentrates, Inc., Lewisberry, PA. Firm initiated recall is complete. REASON Incorrect ingredient concentrations on labeling. VOLUME OF PRODUCT IN COMMERCE 41/ 4 gallon cases. DISTRIBUTION VI, PA, MA and NYK. _______________________ PRODUCT PW-41 Microplate Washer. Recall # Z-1196-2. Washer automatically washes microtiter plates. PRODUCT is labeled in part "***Bio-Rad, Redmond, WA***". CODE Serial #s KBOL001 - KBOL005, KBOL011 - KBOL020. RECALLING FIRM/MANUFACTURER Recalling Firm: Bio-Rad Laboratories, Redmond, WA, by telephone on April 13, 2002. Manufacturer: Adil Instruments, SA Strasbourh Schiltigheim, France. Firm initiated recall is complete. REASON FIRMWARE ERROR - time base rate for calculating soaking time & method interval. VOLUME OF PRODUCT IN COMMERCE 9. DISTRIBUTION FL, KS, OH, PA, PR, SC, TX, and WI. _______________________ PRODUCT Multiplace Hyperbaric Chamber Systems. Recall # Z-1198-2. CODE The following Multiplace Chamber Serial Numbers are involved: 97028C, 98091B, 98091A, 99005A, 99005B, 97028C, 97028B, 95068. RECALLING FIRM/MANUFACTURER Tampa Hyperbaric Enterprise Inc., Tampa, FL, by letters on March 12, 2002. Firm initiated recall is ongoing. REASON Various potential chamber component failures. VOLUME OF PRODUCT IN COMMERCE 8. DISTRIBUTION AZ, MA, WV, FL, CA, AND VA. _______________________ PRODUCT Kallestad Hep-2 12 well, 48 Test Kit Kallestad Hep-2 12 well, 60 Test Kit PRODUCT is for the detection and semi-quantitation of human autoantibodies. PRODUCT is labeled in part "***Bio-Rad Laboratories Diagnostics Group ** Redmond, WA***" or "Sanofi Diagnostics Pasteur". (Bio-Rad was previously Sanofi Diagnostics Pasteur). Recall # Z-1199-2/Z-1200-2. CODE Lot #s 908849, 908866. RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories, Redmond, WA, by letter dated March 2, 2002. Firm initiated recall is complete. REASON Incorrect temperature storage information provided on outer label. VOLUME OF PRODUCT IN COMMERCE Lot #908849 - 214; lot #908866 - 139. DISTRIBUTION Nationwide. _______________________ PRODUCT CT-SMAC Agar Plates, Catalog number G129. Recall # Z-1209-2. CODE Lot 2175. RECALLING FIRM/MANUFACTURER Hardy Diagnostics, Santa Maria, CA, by telephone on July 15, 2002. Firm initiated recall is complete. REASON Fails to grow bacteria according to specifications and labeling. VOLUME OF PRODUCT IN COMMERCE 620. DISTRIBUTION AR, CA, IL and WY. _______________________ PRODUCT IRISpec1 Microscopic Calibrator/Control for Flow and Focus Determination. Catalog Number 475-0001. Recall # Z-1212-2. PRODUCT is used in IRIS Urinalysis Workstations adn Models 900/939UDx Urine Pathology Systems. CODE Lot No. 126-2002-001. Exp Date 11/2002. RECALLING FIRM/MANUFACTURER Intl. Remote Imaging Systems, Chatsworth, CA, by telephone between May 28 and 30, 2002. Firm initiated recall is ongoing. REASON Does not meet labeled specification. VOLUME OF PRODUCT IN COMMERCE 319. DISTRIBUTION Nationwide and England. _______________________ PRODUCT VITROS Immunodiagnostics products: Anemia Controls. In vitro diagnostic use. CAT #161 9360. Recall # Z-1213-2. CODE Lot Numbers: 90, Exp. 26 June 2002** 100, Exp. 19 August 2002 110, Exp. 7 November 2002 **Although Lot 90 appears to be stable, its formulation was similar to Lots 100 and 110. Without understanding the root cause of the problem, Lot 90 was included in this action. RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY, by letters dated May 28, 2002. Manufacturer: Ortho-Clinical Diagnostics, Inc., Cardiff. Firm initiated recall is ongoing. REASON Folate is not stable resulting in negatively biased QC results. VOLUME OF PRODUCT IN COMMERCE Domestic - 694 units / International - 586 units. DISTRIBUTION Nationwide and Internationally.
_______________________ PRODUCT Homestead Poultry Starter Grower Medicated 55 lb. bags. Recall # V-154-2. CODE Not coded. RECALLING FIRM/MANUFACTURER Recalling Firm: Shur-Gain USA Inc., Elma, NY, by visit on June 24, 2002. Manufacturer: Shur-Gain, St. Marys, Ontario, Canada. FDA initiated recall is complete. REASON Contains ruminant proteins but lacks caution statement. VOLUME OF PRODUCT IN COMMERCE 31 bags. DISTRIBUTION NY.END OF ENFORCEMENT REPORT FOR AUGUST 14, 2002 ####
Enforcement Report Index | FDA News Page | FDA Home Page
Office of Public Affairs
Hypertext uploaded by tg 2002-AUG-14.