February 13, 2002 02-06
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Hana Brand Agar-agar (Kanten -Red-) is an unflavored dry powder gelatin for food use, imported from Japan, packaged in 0.5 ounce clear plastic packages, 50 packages per case. Recall # F-289-2. CODE 07383J. RECALLING FIRM/MANUFACTURER Recalling Firm: Rhee Brother, Inc., Columbia, MD, by letter, telephone and fax on Dec. 3, 2001. Manufacturer: New Japan Food Group Chuo-ku, Japan. State initiated recall is ongoing. REASON The product contained Ponceau 4R, an unapproved color additive. VOLUME OF PRODUCT IN COMMERCE 10 cases. DISTRIBUTION MD, NY, MO, GA, FL and Guam. _______________________ PRODUCT Hamburger Buns: 1) Aunt Millie’s Hamburger Buns, 8-ct. 2) 5 Star Hamburger Buns, 8-ct. 3) Fresh & Soft Hamburger Buns, 8-ct. 4) Kleen Maid hamburger Buns, 8-ct. 5) Meijer Hamburger Buns, 8-ct. 6) Prevo Hamburger Buns, 8-ct. 7) Such Crust hamburger Buns, 8-ct. 8) Sunkist Hamburger Buns, 8-ct. 9) Flavorite Hamburger Buns, 8-ct. Recall # F-290-2; Hot Dog Buns: 1) Aunt Millie’s Hot Dog Buns, 8-ct. 2) Aunt Millie’s Hot Dog Buns, 16-ct. 3) 5 Star Hot Dog Buns, 8-ct. 4) Flavorite Hot Dog Buns, 8-ct. 5) Fresh & Soft Hot Dog Buns, 8-ct. 6) Kleen Maid Hot Dog Buns, 8-ct. 7) Meijer Hot Dog Buns, 8-ct. 8) Prevo Hot Dog Buns, 8-ct. 9) Such Crust Hot Dog Buns, 8-ct. 10) Sunkist Hot Dog Buns, 8-ct. Recall # F-291-2; Fat Free Potato Hamburger Buns: 1) Aunt Millie’s healthy Goodness 98% Fat Free Potato Hamburger Buns, 8-ct., Recall # F-292-2; Fat Free Potato Hot Dog Buns: 1) Aunt Millie’s Healthy Goodness 98% Fat Free Potato Hot Dog Buns, 8-ct., Recall # F-293-2; Honey Hamburger Buns: 1) Aunt Millie’s Homestyle Honey Hamburger Buns, 8-ct., Recall # F-294-2; Honey Hot Dog Buns: 1) Aunt Millie’s Homestyle Honey Hot Dog Buns, 8-ct., Recall # F-295-2; Buttermilk Hamburger Buns: 1) Aunt Millie’s Homestyle Buttermilk Hamburger Buns, 8-ct., Recall # F-296-2; Buttermilk Hot Dog Buns: 1) Aunt Millie’s Homestyle Buttermilk Hot Dog Buns, 8-ct., Recall # F-297-2. CODE 1. Hamburger Buns with an ink jet code starting with D1 or D2 with a sell by date of 6/23 and 6/24 (brand names included under "Products") 2. Hot dog buns with an ink jet code starting with D1 or D2 with a sell by date of 6/24 (brand names included under "Products") RECALLING FIRM/MANUFACTURER Recalling Firm: Perfection Bakeries, Inc. Fort Wayne, IN, by press releases and E-mails on June 21, 2001. Manufacturer: Gase Bakery, Saginaw, MI. Firm initiated recall is complete. REASON Product is adulterated. VOLUME OF PRODUCT IN COMMERCE 149,244 units. DISTRIBUTION IN, MI and OH.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Various tablet and capsule dosage form drug products, repackaged into plastic amber pharmacy vials and unit dose blister packs of varying sizes/counts, labeled with brand or generic names, strength, lot number, expiration date, manufacturer, National Drug Codes (NDC) and name of repacker of the products (PDS), Recall # D-107-2/D-190-2. PRODUCT RECALL NUMBER ACETAMINOPHEN 325 mg tablets-----------------------------D-107-2 AMOXICILLIN 500 mg capsules------------------------------D-108-2 ALLEGRA-D (FEXOFENADINE/PSEUDOEPHEDRINE HCL) 60mg/120mg tablets---------------------------------------D-109-2 ASPIRIN EC 325 mg tablets--------------------------------D-110-2 ASPIRIN EC 81 mg tablets---------------------------------D-111-2 ATENOLOL 50 mg tablets-----------------------------------D-112-2 BAYCOL (CERIVASTATIN SOD) 0.3 mg tablets-----------------D-113-2 BAYCOL (CERIVASTATIN SODIUM) 0.4 mg tablets--------------D-114-2 BENZONATATE 100mg capsules-------------------------------D-115-2 CALCIUM 500 mg (OYSCO) tablets---------------------------D-116-2 CALCIUM 500 mg (OYST-CAL) tablets------------------------D-117-2 CARDURA (DOXAZOSIN MESYLATE) 2 mg tablets----------------D-118-2 CELEXA (CITALOPRAM HBr) 20 mg tablets--------------------D-119-2 CEPHALEXIN 250 mg capsules-------------------------------D-120-2 CIPROFLOXACIN HCL 500 mg tablets-------------------------D-121-2 CLARITIN (Loratidine) 10 mg tablets----------------------D-122-2 CYCLOBENZAPRINE HCL 10 mg tablets------------------------D-123-2 DE-CONGESTINE (CHLORPHEN. MALEATE 8 mg/PSEUDOEPHEDRINE 120mg) capsules-------------------------------------------------D-124-2 DECONSAL II (PSEUDOEPHEDRINE AND GUAIFENESIN) 60 mg/600mg tablets--------------------------------------D-125-2 DIPHENHYDRAMINE HCL 25 mg capsules-----------------------D-126-2 DOCUSATE SODIUM 100 mg capsules--------------------------D-127-2 DOCUSATE SODIUM 100 mg gel capsules----------------------D-128-2 DOXYCYCLINE 100 mg capsules------------------------------D-129-2 ERYTHROMYCIN 250 mg tablets------------------------------D-130-2 FOLIC ACID 1 mg tablets----------------------------------D-131-2 FUROSEMIDE 20 mg tablets---------------------------------D-132-2 FUROSEMIDE 40 mg tablets---------------------------------D-133-2 GLUCOPHAGE (METFORMIN HCL) 500 mg tablets----------------D-134-2 GUAIFENESIN LA 600 mg capsules---------------------------D-135-2 GUAIFENEX PSE 600 mg/60mg capsules-----------------------D-136-2 HYDROCHLOROTHIAZIDE 25 mg capsules-----------------------D-137-2 HYDROXYZINE HCL 25 mg tablets----------------------------D-138-2 HYTRIN (TERAZOCIN) 2 mg capsules-------------------------D-139-2 HYTRIN (TERAZOCIN) 5 mg capsules-------------------------D-140-2 IBUPROFEN 400 mg tablets---------------------------------D-141-2 IBUPROFEN (MOTRIN) 800 mg tablets------------------------D-142-2 ISONIAZID 300 mg tablets---------------------------------D-143-2 K-DUR (KCl) 20 mEq tablets-------------------------------D-144-2 CEPHALEXIN (KEFLEX) 250 mg capsules----------------------D-145-2 KLOR-CON (KCl) 10mEq (750 mg) tablets--------------------D-146-2 LEVAQUIN (LEVOFLOXACIN) 500 mg tablets-------------------D-147-2 LEVOTHROID .1 mg tablets---------------------------------D-148-2 MACROBID (NITROFURANTOIN) 100 mg capsules----------------D-149-2 METHOCARBAMOL 500 mg tablets-----------------------------D-150-2 METRONIDAZOLE 250 mg tablets-----------------------------D-151-2 MOTRIN (IBUPROFEN) 600 mg tablets------------------------D-152-2 MULTI-VITAMINS Tablets-----------------------------------D-153-2 NAPROSYN 500 mg tablets----------------------------------D-154-2 NAPROXEN 500 mg tablets----------------------------------D-155-2 NORVASC (Amlodipine Besylate) 5 mg tablets---------------D-156-2 NORVASC (Amlodipine Besylate) 10mg tablets---------------D-157-2 PHENAZOPYRIDINE HCL 100 mg tablets-----------------------D-158-2 PLENDIL (FELODIPINE) 5 mg tablets------------------------D-159-2 POTASSIUM CHLORIDE 10mEq capsules------------------------D-160-2 PREMARIN .3 mg tablets-----------------------------------D-161-2 PREMARIN .625 mg tablets---------------------------------D-162-2 PRILOSEC (OMEPRAZOLE) 20 mg capsules---------------------D-163-2 PROMETHAZINE 25 mg tablets-------------------------------D-164-2 PROVERA 2.5 mg tablets-----------------------------------D-165-2 PROZAC (FLUOXETINE) 20 mg capsules-----------------------D-166-2 PSEUDOEPHEDRINE HCL 30 mg tablets------------------------D-167-2 PSEUDOEPHEDRINE HCL 60 mg tablets------------------------D-168-2 Q-BID LA (GUAIFENESIN LA) 600 mg tablets-----------------D-169-2 RANITIDINE 150 mg tablets--------------------------------D-170-2 SULFAMETHOXAZOLE/TRIMETHOPRIM 800/160 MG tablets--------------------------------------------------D-171-2 SYNTHROID (LEVOTHYROXINE) 0.05 mg tablets----------------D-172-2 SYNTHROID (LEVOTHYROXINE) 0.075 mg tablets---------------D-173-2 SYNTHROID (LEVOTHYROXINE) 0.1 mg tablets-----------------D-174-2 SYNTHROID (LEVOTHYROXINE) 0.125 mg tablets---------------D-175-2 TRIAMTERENE AND HYDRO-CHLORTHIAZIDE(MAXIDE) 75 mg/50 mg tablets--------------------------------------D-176-2 TRIMOX (AMOXICILLIN) 250 mg tablets----------------------D-177-2 TYLENOL 325 mg tablets-----------------------------------D-178-2 VIAGRA 100 mg tablets------------------------------------D-179-2 VITAMIN E 400 mg SOFTGEL capsules------------------------D-180-2 VERAPAMIL 240 mg tablets---------------------------------D-181-2 ZESTRIL (LISINOPRIL) 5 mg tablets------------------------D-182-2 ZESTRIL (LISINOPRIL) 10 mg tablets-----------------------D-183-2 ZESTRIL (LISINOPRIL) 20 mg tablets-----------------------D-184-2 ZESTRIL (LISINOPRIL) 40 mg tablets-----------------------D-185-2 ZOCOR (SIMVASTATIN) 10 mg tablets------------------------D-186-2 Z0COR (SIMVASTATIN) 20 mg tablets------------------------D-187-2 ZOCOR (SIMVASTATIN) 40 mg tablets-----------------------D-188-2 ZOLOFT (SERTRALINE) 100 mg tablets-----------------------D-189-2 ZYRTEC 10 mg tablets-------------------------------------D-190-2. CODE All expiration dates for the products distributed by the repacker since startup of firm's operations in Aug 2000 through exp. date Nov 2002. Expiration dates are printed on the label applied to vials and blister packs and determined by the repacker based on one year from date of repack. RECALLING FIRM/MANUFACTURER Pharmaceutical Distribution Services, Laurel, MD, by telephone and letter on Dec. 5, 2001. Firm initiated recall is ongoing. REASON Contamination: Failure to test for penicillin in non-penicillin products due to potential cross-contamination operations VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION MD, DC and VA.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT a) Marinol (Dronabinol) Capsules, 2.5 mg, bottles of 60, Rx only, Recall # D-105-2; b) Marinol (Dronabinol) Capsules, 10 mg, bottles of 60, Rx only, Recall # D-106-2. CODE a) 2.5 mg. capsules, NDC #0051-0021-21 Lots 11110010A and 11110011A, both expire 10/03; b) 10 mg. capsules, NDC #0051-0023-21 Lot 11110012A, expires 10/03. RECALLING FIRM/MANUFACTURER Recalling Firm: Unimed Pharmaceuticals, Inc. Deerfield, IL, by fax on Jan. 15, 2002. Manufacturer: Banner Pharmacaps, Inc. Chatsworth, CA. Firm initiated recall is ongoing. REASON Container defects-some bottles are missing their inner foam seal. VOLUME OF PRODUCT IN COMMERCE 8,240 bottles of 2.5 mg, 456 bottles of 10 mg. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells, Recall # B-0500-2. CODE Unit GK48567. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated June 12, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced Units, Recall # B-0657-2. CODE 21KC25927, 21KC25975, 21KC25984, 21KC25993, 21KC25911, 21KC26059, 21KC25904, 21KC25910, 21KC25979, 21KC25981, 21KC26068, 21KC26071, 21KC26000, 21KC26002, 21KC26003, 21KJ59739, 21KJ59743, 21KJ59749, 21KJ59750, 21KJ59751, 21KC26049, 21KC26064, 21KC26045, 21KC26069, 21KJ59717, 21KJ59718, 21KJ59721, 21KJ59732, 21KJ59736, 21KJ59747, 21KC26065, 21KC26073, 21FM71818, 21FM71823, 21FM71829, 21FM71855, 21FT36620, 21GY73884, 21KC25885, 21KC25890, 21KC25892, 21KJ59715, 21KJ59716, 21KJ59728, 21KJ59729, 21KW07539, 21KZ03873, 21KJ59663, 21KM28345, 21KC25943, 21KC25974, 21FM71825, 21FM71837, 21FM71851, 21FZ06573, 21GW33220, 21FM71777, 21GL65904, 21GY73846, 21GY73853, 21GY73879, 21KH59551, 21KL39407, 21Y67612, 21KC25833, 21KC25849, 21KJ59696, 21KR18255, 21KW07524, 21KW07526, 21KW07535, 21KW07538, 21KZ03859, 21KZ03864, 21KZ03866, 21KZ03874, 21KZ03876, 21KZ03877, 21KZ03882 RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by telephone on July 26, 2001. Firm initiated recall is complete. REASON Blood products, stored at incorrect temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 79 units. DISTRIBUTION WA and OR. _______________________ PRODUCT Safetrace, TX, Recall # B-0664-2. CODE Versions 1.2.1, 2.0.0, 2.1.0, information systems. RECALLING FIRM/MANUFACTURER Global Med Technologies, Inc., El Dorado Hills, CA, by letter dated Sept. 13, 2001. Firm initiated recall is complete. REASON Software performance tests conducted by the manufacturer found that under certain circumstances, compatibility test results may be posted to another patient’s record. VOLUME OF PRODUCT IN COMMERCE 3 versions. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Platelet, Pheresis, Leukoreduced, Recall # B-0665-2. CODE Units A213449-1, A213449-2, B205254 RECALLING FIRM/MANUFACTURER Puget Sound Blood Center & Program, Seattle, WA, by letter dated April 16, 2001. Firm initiated recall is complete. REASON Blood products, incorrectly labeled as leukoreduced, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WA. _______________________ PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0709-2. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 13, 2001. Firm initiated recall is complete. REASON Blood bank computer system, which had a software glitch or defect, was distributed. VOLUME OF PRODUCT IN COMMERCE 3 versions. DISTRIBUTION Nationwide and Saudi Arabia and the United Kingdom. _______________________ PRODUCT FlexiLab? Laboratory Information System, Recall # B-0710-2. CODE Versions 5.23 and 5.3 with RBR module. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated March 19, 2001. Firm initiated recall is complete. REASON Blood bank computer system, which had a software glitch or defect, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 versions. DISTRIBUTION Nationwide and Denmark. _______________________ PRODUCT FlexiLab? Blood Bank and Blood Donor Software, Recall # B-0711-2. CODE Versions 5.2 and 5.23. RECALLING FIRM/MANUFACTURER Sunquest Information Systems, Inc., Tucson, AZ, by letter dated June 22, 2000. Firm initiated recall is complete. REASON Blood bank computer system, which had a software glitch or defect, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Nationwide and Saudi Arabia, Canada, Ireland and the United Kingdom. _______________________ PRODUCT Recovered Plasma, Recall # B-0721-2. CODE Unit 4001. RECALLING FIRM/MANUFACTURER Community Hospital of Lancaster Blood Bank, Lancaster, PA, by telephone Sept. 19, 1997 and by letter on Sept. 22, 1997. REASON Blood product, collected from a donor who had previously been deferred for failure to complete the confidential unit exclusion, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Rabies Vaccine, RabAvert, Recall # B-0729-2. CODE Lot 261011, expires 09.2001 and 09.2003; Lot 273011, expires 01.2001. RECALLING FIRM/MANUFACTURER Chiron Corporation, Emeryville, CA.,by letter dated March 16, 2001. Firm initiated recall is complete. REASON Drug products, for which sterility cannot be assured due to evidence of broken or cracked vials, were distributed. VOLUME OF PRODUCT IN COMMERCE 52,745 vials. DISTRIBUTION Nationwide. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B0735-2. CODE Unit LH58241-1. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on May 22, 2001. Firm initiated recall is complete. REASON Blood product, which was labeled as leukoreduced but had a white cell count that exceeded the specifications for a leukoreduced product, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Platelets, Pooled, Iradiated, Recall # B-0736-2. CODE UnitPool Id. P26393 RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone and letter on Aug. 22, 2001. Firm initiated recall is complete. REASON Pooled unit of Platelets, pooled from five units, was labeled as having been pooled from six units. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0737-2. CODE Unit LN49196. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on July 19, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who had traveled to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0738-2; b) Platelets, Pooled, Recall # B-0739-2. CODE a) Unit FW22414; b) Unit P22751. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on Sept. 20, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who had been incarcerated, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION PA and WI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0751-2; b) Platelets, Recall # B-0752-2; c) Recovered Plasma, Recall # B-0753-2. CODE a), b) and c) Unit 32R 83404. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Madison, WI, by letter dated Aug. 13, 1999. Manufacturer: American Red Cross Blood Services, Waterloo, IA. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for Hepatitis C, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WI. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Irradiated, Recall # B-0759-2. CODE Unit KM27909-1. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc.,Milwaukee, WI, by telephone on July 28, 2000 and by letter dated Aug. 22, 2001 Firm initiated recall is complete. REASON Blood product, which had a low platelet count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0760-2. CODE Units LX92840-1, LH54884-2. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on July 28, 2000 and by letter dated Aug. 22, 2001. Firm initiated recall is complete. REASON Blood products, which had a low platelet counts, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0763-2. CODE Unit GR11438. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on May 11, 2000 and by letter dated Aug. 22, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of jaundice, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0768-2. CODE Unit 32LP02560. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Madison, WI, by telephone on April 24 and a letter dated May 4, 2001. Firm initiated recall is complete. REASON Blood product, that was labeled as having been leukoreduced, did not have a white blood cell count performed prior to distribution. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Recall # B-0769-2. CODE Unit 32KE42114. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Madison, WI, by letter dated Aug. 7, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0772-2; b) Platelets, Pooled Unit. Recall # B-0773-2. CODE a) KZ56941 and b) P11161. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by letter dated Aug. 22, 2001 and by telephone on Aug. 23, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION WI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0779-2; b) Platelets, Recall # B-0780-2. CODE a) and b) Unit 17KC09962. RECALLING FIRM/MANUFACTURER American Red Cross North Central Blood Services, St. Paul, MN, by letter dated May 17, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MN. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0783-2; b) Recovered Plasma, Recall # B-0784-2. CODE a) and b) Unit T71772. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by fax on April 27, 2000, by telephone on May 11, 2000 and by letter on Aug. 22, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor receiving Lupron injections, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Wisconsin and Switzerland. _______________________ PRODUCT a) Red Ant Extract; b) Red Ant Extract, Recall # B-0799-2. CODE a) Lot 5V18, Expiration: August, 2001; b) Lot 7S12, Expiration: May, 2003. RECALLING FIRM/MANUFACTURER ALK-Abello, Round Rock, TX, by firm representative after January 28, 1999. Firm initiated recall is complete. REASON Customers were informed that two different Ant species were from the same source material. VOLUME OF PRODUCT IN COMMERCE 42 viles. DISTRIBUTION Nationwide _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0807-2; b) Platelets, Leukocytes Reduced, Recall # B-0808-2. CODE a) and b) Unit number 17KP84688. RECALLING FIRM/MANUFACTURER The American National Red Cross, St. Paul, MN, by letter on June 20, 2000. 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 MN. _______________________ PRODUCT Red Blood Cells, Recall # B-0809-2. CODE Unit number 17KR76040. RECALLING FIRM/MANUFACTURER The American National Red Cross, St. Paul, MN, by letter on Sept. 22, 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 MI. _______________________ PRODUCT Red Blood Cells, Recall # B-0810-2. CODE Unit number 19244-9069. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on July 25, 2001. Manufacturer: Blood Systems, Inc., Reno, NV. 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 NV. _______________________ PRODUCT Red Blood Cells, Recall # B-0811-2. CODE Unit number LP34860. RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by telephone on Feb. 12, 2001 and by letter dated February 16, 2001. Firm initiated recall is complete. REASON Blood product, that tested reactive for the antibody to hepatitis B core antigen (anti-HBc), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0812; b) Platelets, Leukocytes Reduced, Recall # B-0813-2. CODE a) and b) Unit number 17KT51541. RECALLING FIRM/MANUFACTURER The American National Red Cross, St. Paul, MN, by telephone on Feb. 14, 2001 and by letter dated February 22, 2001. Firm initiated recall is complete. REASON Blood products, collected in a manner that may have compromised the sterility of the products, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MN. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0814-2. CODE Unit numbers 17KY44958 and 17KT52490. RECALLING FIRM/MANUFACTURER The American National Red Cross, St. Paul, MN, by telephone on March 6, 2001. Firm initiated recall is complete. REASON Blood products, corresponding to units of Platelets that were pooled and may have been bacterially contaminated with Staphylococcus epidermidis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION SD and WI. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0815-2. CODE Unit numbers 17KX77106, 17KX77121, 17KX77083, 17KX77072, and 17KX77105. RECALLING FIRM/MANUFACTURER The American National Red Cross, St. Paul, MN, by telephone on May 8, 2001. Firm initiated recall is complete. REASON Blood products, corresponding to units of Platelets that were pooled and may have been bacterially contaminated with Bacillus cereus, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION SD and MN. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0819-2. CODE Units 24208-7626. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Sept. 5 and 6, 2000. Manufacturer: United Blood Services, Rapid City, SD. Firm initiated recall is complete. REASON Blood product, which went through leukoreduction twice, was distributed. VOLUME OF PRODUCT IN COMMERCE One unit DISTRIBUTION SD. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0835-2; b) Cryoprecipitated AHF, Recall # B-0836-2; c) Recovered Plasma, Recall # B-0837-2. CODE a), b) and c) Unit number 18FJ35193. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Lansing, MI, by telephone on April 13, 2001 and by letters dated April 16 and 17, 2001, and September 6, 2001. Manufacturer: American Red Cross Blood Services, Muskegon, MI. Firm initiated recall is complete. REASON Blood products, collected from a donor whose health history screening was inadequately performed, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA, PA and Switzerland.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Platelets Pheresis Leukocytes Reduced, Recall # B-0454-2. CODE Reduced Units 15387-5375, 15387-6038 (split unit) RECALLING FIRM/MANUFACTURER United Blood Services (Blood Systems, Inc.), Lubbock, TX, by telephone on April 27 or May 2, 2001. Firm initiated recall is complete. REASON Blood products, contaminated with gram positive rods, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX. _______________________ PRODUCT White Pine Allergenic Extract, Recall # B-0455-2. CODE Lot B608302A. RECALLING FIRM/MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, OH, by fax dated Sept. 4, 2001. Firm initiated recall is complete. REASON Allergenic extract, labeled with an incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 vial. DISTRIBUTION OH. _______________________ PRODUCT a) Reagent Red Blood Cells, Panocell-10, Recall # B-0645-2; b) Reagent Red Blood Cells, Ficin Panocell-10, Recall # B-0646-2. CODE a) Lot # 32189; b) Lot # 32189E. RECALLING FIRM/MANUFACTURER Immucor, Norcross, GA., by letter dated Aug. 30, 2001. Firm initiated recall is complete. REASON Reagent Red Blood Cells, which contained the same phenotype of red cells in vial #4 and vial #5, were distributed. VOLUME OF PRODUCT IN COMMERCE 712 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Gamma Panel TWENTY?, Reagent Red Blood Cells, Recall # B-0709-2. CODE Lot 0704/20. RECALLING FIRM/MANUFACTURER Gamma Biologicals, Inc., Houston, TX, by letters dated July 11 and 31, 2000. Firm initiated recall is complete. REASON Reagent red blood cells, which were not tested for the f-antigen but were incorrectly labeled as f-antigen negative, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Red Blood Cells, Washed, Irradiated, Recall # B-0728-2. CODE Unit 21379-9966. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Dec. 11, 2000. Manufacturer: United Blood Services, Fargo, ND. Firm initiated recall is complete. REASON Blood product, labeled with an extended expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION ND. ________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0740-2; b) Red Blood Cells, Leukoreduced, Irradiated, Recall # B-0741-2. CODE a) Unit 21380-4380; b) Unit 21380-5352. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Jan. 31, 2001 and by letter dated March 1, 2001. Manufacturer: United Blood Services, Fargo, ND. Firm initiated recall is complete. REASON Blood products, which may have been stored at unacceptable temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION ND. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0742-2. CODE Unit 21382-0148. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 8, 2001. Manufacturer: United Blood Services, Fargo, ND. Firm initiated recall is complete. REASON Blood product, which may have been stored at unacceptable temperatures, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION ND. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Irradiated, Recall # B-0743-2. CODE Units 21383-4269, 21383-4707. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Aug. 3, 2001. Manufacturer: United Blood Services, Fargo, ND. Firm initiated recall is complete. REASON Blood products, which were stored at unacceptable temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION ND. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0744-2. CODE Unit LC03932. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on Aug. 1, 2001 and by letter dated August 6, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of Crohn’s disease, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, for Autologous Use, Recall # B-0764-2 CODE Unit 32LG04641. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by letter dated June 7, 2001. Firm initiated recall is complete. REASON Blood product, collected from an autologous donor who had an elevated body temperature, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Platelets, Recall # B-0765-2. CODE Unit 32KF98906. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Madison, WI, by letter dated Aug. 30, 2001. REASON Blood product, prepared from a unit of Whole Blood with an extended collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0770-2 CODE Units GR17474, GR17489, GR17493, LE31634, LE31660, LE31689, LP28976 RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on Aug. 21, 23 and 24 and by letter dated Aug. 22, 2001. Firm initiated recall is complete. REASON Unlicensed blood products were distributed in interstate commerce. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION MO. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-0775-2; b) Cryoprecipitated AHF, Pooled,Recall # B-0776-2; c) Recovered Plasma, Recall # B-0777-2. CODE a) and c) Unit LX92249; b) Unit PO7572. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by letters on July 27 and Aug. 10 and 29, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who received a cornea transplants within a year of donation were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WI and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0816-2; b) Fresh Frozen Plasma, Recall # B-0817-2; (1 unit), c) Recovered Plasma, Recall # B-0818-2. CODE a) Unit numbers 17KZ14795, 17KN74130, 17KN74147, and 17KE04189; b) Unit number 17KN74130; c) Unit numbers 17KZ14795, 17KN74147, and 17KE04189. RECALLING FIRM/MANUFACTURER The American National Red Cross, St. Paul, MN, by telephone on June 11 and by letter on June 27, 2000. Firm initiated recall is complete. REASON Blood products, corresponding to units of Platelets that were pooled and may have been bacterially contaminated with Propionibacterium acnes, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units. DISTRIBUTION MI, WI and NY.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______________________ PRODUCT Solar 9500 Physiological ECG monitor, Recall # Z-0429-02. CODE Serial Numbers: C1MU1460G, D1MU1469G, D1MU1470G, D1MU1471G, D1MU1474G, D1MU1475G, D1MU1476G, D1MU1477G, D1MU1478G, D1MU1480G, D1MU1487G, D1MU1489G, D1MU1492G, D1MU1494G, D1MU1498G, D1MU1499G, D1MU1503G D1MU1506G, D1MU1508G, D1MU1509G, D1MU1510G, D1MU1516G, D1MU1518G, D1MU1519G, D1MU1520G, D1MU1523G, E1MU1525G, E1MU1526G, E1MU1527G, E1MU1529G, E1MU1530G, E1MU1535G, E1MU1538G, E1MU1539G, E1MU1541G, E1MU1544G, E1MU1547G, E1MU1548G, E1MU1564G, F1MU1566G, F1MU1569G, F1MU1571G, F1MU1572G, F1MU1577G, F1MU1580G, F1MU1583G, F1MU1588G, F1MU1589G, F1MU1591G, F1MU1594G, G1MU1596G, G1MU1597G, G1MU1598G, G1MU1601GMU, G1MU1602GMU, NB1643428, NB1664094, NB1664099, NB1664109, NB1664113, NB1664117, NB1672800, NB1672802, NB1672823, NB1672832, NB1672840, NB1734988, NB1734990, NB1734997, NB1743637, B1743638, NB1743639, NB1743640 - NB1743666, NB1786821, NB1786822, NB1786826, NB1786827, NB1786828, NB1786832, NB1786838, and NB1807559. RECALLING FIRM/MANUFACTURER GE Medical Systems, Information Technologies Milwaukee, WI, by letter dated July 20, 2001. Firm initiated recall is complete. REASON The installation of incorrect chips could result in device failure. VOLUME OF PRODUCT IN COMMERCE 73 monitors. DISTRIBUTION CO, IA, IL, MS, OH, TN, TX, WI and Belgium, Denmark, France and the Netherlands.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT Vitros 950 and 950AT Chemistry Systems Responsible firm on the label: Made in U.S.A. Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626 Recall # Z-0073/0075. CODE Vitros 950: s/n less than 09501559 Vitros 950AT: s/n less than 09600129 RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester, NY, by letters on Feb. 28, 2000. Firm initiated recall is complete. REASON Positive outliers for Potassium. VOLUME OF PRODUCT IN COMMERCE VITROS 950 - 1,420; VITROS 950AT - 30 DISTRIBUTION Nationwide. _______________________ PRODUCT Vitros ECi Immunodiagnostic System. Recall # Z-0165-01. CODE s/n 30000054 thru 30001160. RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Inc. Rochester, NY, by letters dated 4/8/1998, 2/2/1999 and 5/7/1999. Firm initiated recall ongoing. REASON Biased results due to inadequate delivery of reagent fluids to the reaction well. VOLUME OF PRODUCT IN COMMERCE 1,157 DISTRIBUTION Worldwide. _______________________ PRODUCT Polarus Broach. Instrument belongs to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumention. The broach is reusable and provided non-sterile. Recall # Z-0501-02. CODE Lot #W03397. RECALLING FIRM/MANUFACTURER Acumed, Inc., Beaverton, OR, by fax or E-mail on Nov. 9, 2001. REASON The word “lateral” is marked on the medial side of the broach. VOLUME OF PRODUCT IN COMMERCE 27 DISTRIBUTION United Kingdom, Finland, Spain and The Netherlands. _______________________ PRODUCT Datascope's Profile 8 French Intra-Aortic Balloon Catheter. Recall # Z-0518/Z-0519-02. CODE 0684-00-0297-01, Lot #1095, expiry date 10/17/2003 0684-00-0299-01, Lot #1097, expiry date 10/27/2003 0884-00-3441-01, Lot #1097, expiry date 10/27/2003 0884-00-3441-02, Lot #1097, expiry date 10/27/2003. RECALLING FIRM/MANUFACTURER Datascope Corp., Cardiac Assist Division Fairfield, NJ, by letter on Nov. 19, 2001. Firm initiated recall is ongoing. REASON Catheters may have a misalignment in the inner lumen path. VOLUME OF PRODUCT IN COMMERCE Lot #1095 -- 89 units; Lot #1097 -- 746 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Accu-Chek HQ System, Meter Cradle with Scanner. Recall # Z-0522-02/Z- 0523-02. CODE Catalog numbers 2138026 and 2139260. All units. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN, by letters dated Jan. 9, 2002. Firm initiated recall is ongoing. REASON Patient/sample mismatch. VOLUME OF PRODUCT IN COMMERCE 5,000. DISTRIBUTION Nationwide. _______________________ PRODUCT ADAC brand Pinnacle Radiation Therapy Planning System Radiation Therapy Treatment Software version 5.2g, Recall # Z-0524-02. CODE Model: 9200-0579A. RECALLING FIRM/MANUFACTURER ADAC Laboratories, Milpitas, CA, by letters on Sept. 26, 2000. Firm initiated recall is complete. REASON A Software problem that could result in incorrect radiation dosage being applied. VOLUME OF PRODUCT IN COMMERCE 373 units. DISTRIBUTION Nationwide and internationally. _______________________ PRODUCT Troponin I Reagent Pack - for In Vitro Diagnostic Use Only Cat 194 9882, 100 Test Units Responsible firm on the label: Ortho-Clinical Diagnostics, Amersham, UK. Recall # Z-0525-02. CODE Lot Numbers: 503, Exp. 23 January 2002 504, Exp. 26 January 2002 510, Exp. 16 January 2002 521, Exp. 19 February 2002 531, Exp. 25 March 2002. RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Inc. Rochester, by, by letter dated Dec. 26, 2001. Firm initiated recall is ongoing. REASON False positive results on some serum & EDTA plasma samples. VOLUME OF PRODUCT IN COMMERCE 6,436. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT CryoValve Allograft, Recall # Z-0528-02. CODE Model No. PV00 - Serial Number 7162707. RECALLING FIRM/MANUFACTURER Cryolife, Inc. Kennesaw, GA, by letter on Dec. 12, 2001. Firm initiated recall is complete. REASON Donor kidney was positive for cancer. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MN.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Digene brand, Hybrid Capture (tm) System Automated Plate Washer I, Recall # Z-0526-02. CODE Serial numbers 232928, 232947, 232907, 232960, 232903, 232959, 232920, 232905 and 232904 RECALLING FIRM/MANUFACTURER Recalling Firm: Digene Corp. Gaithersburg, MD, by phone and fax on Dec. 10 and 12, 2001. Manufacturer: TriContinent Grass Valley, CA. Firm initiated recall is ongoing. REASON IVD microwell plate washer malfunctioned. VOLUME OF PRODUCT IN COMMERCE 9 DISTRIBUTION CA, NY, OH, TX, VA and Germany. _______________________ PRODUCT Soft Cell (tm), PVA Foam Surgical Spears, Quantity: 10 Spears per package, 150 Spears per case/carton, Recall # Z-0527-02. CODE All Lots, Manufacturing Date Sept 2001; Expiry date October 2004. RECALLING FIRM/MANUFACTURER Recalling Firm: Oasis Medical, Inc., Glendora, CA, by fax on Nov. 26, 2001. Manufacturer: M-Pact Corporation Eudora, KS. Firm initiated recall is ongoing. REASON Increase in reports of kerratitis attributed to PVA Foam Spears from lot 1220C. VOLUME OF PRODUCT IN COMMERCE 3,247. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT Custom mixed poultry feed, packed in 100 pound bags, unlabeled. Recall # V-029-2. CODE The bags are uncoded. RECALLING FIRM/MANUFACTURER Valley Feed Mill, Inc., Orwell, OH, by onsite visit on April 20, 2001. Firm initiated recall is complete. REASON The animal feed contains protein derived from mammalian tissues and must bear the statement “Do not feed to cattle or other ruminants” on the label to prevent the establishment and amplification of BSE through feed. This statement does not appear on the label. VOLUME OF PRODUCT IN COMMERCE 2000 pounds. DISTRIBUTION OHEND OF ENFORCEMENT REPORT FOR FEBRUARY 13, 2002
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