MARCH 6, 2002 02-09
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Crystal Lake brand Diced Egg Topping, (I.Q.F.) Frozen, 4/5 lb. bags in 20 lb. cartons (institutional pack). Recall # F-301-2 CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Crystal Lake LLC, Warsaw, IN., by telephone on August 1, 2001. State initiated recall complete. REASON Product contained undeclared milk. VOLUME OF PRODUCT IN COMMERCE Undetermined. DISTRIBUTION IA, PA and WI.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Crystal Lake brand Frozen Cooked Egg Omelets with Cheese, 72/3.5 oz. omelets in 15.75 lb. cartons institutional pack). Recall # F-302-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Crystal Lake LLC, Warsaw, IN, by telephone on August 1, 2001. State initiated recall is complete. REASON The product contained undeclared ingredients, including FD&C Yellow No. 6. VOLUME OF PRODUCT IN COMMERCE 200 cases. DISTRIBUTION IA, PA and WI.RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
_______________________ PRODUCT Rejuvenating Mist, Manufactured for Soroko Blade Laboratories, Made in Canada. Recall # F-298-2. CODE All products on the market at the time the recall was initiated (the product was not coded). RECALLING FIRM/MANUFACTURER Recalling Firm: Soroko Inc., Clifton, NJ, by letters on Jan. 9, 2001. Manufacturer: Undetermined. Firm initiated recall is complete. REASON Rejuvenating Mist was contaminated with Pseudomonas sp. VOLUME OF PRODUCT IN COMMERCE 250 x 3.3 ounce spray bottles and an undetermined number of 2 oz. bottles. DISTRIBUTION NY, NJ, TX, Mexico, Scotland and Canada.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT SPES capsules, Herbal Dietary Supplement, Immune System Formula, 30 capsules per bottle, 300 mg each, containing 15 different herbs. Recall # D-196-2. CODE Lot 5311214 distributed from 8/9/2001 to 1/8/2002; Lot 5431249 distributed from 10/25/2001 to 1/8/2002. RECALLING FIRM/MANUFACTURER Botanic Lab Brea, CA, by letters on January 28, 2002. Firm initiated recall is ongoing. REASON Product contains the undeclared prescription drug alprozolam. VOLUME OF PRODUCT IN COMMERCE Undetermined DISTRIBUTION Nationwide and internationally. _______________________ PRODUCT Liquid Oxygen, USP, Medical, Refrigerated, transfilled into Cryogenic Home Units (models PB-31 and PB-41; 70-80 lbs. per unit) and Cryogenic Dewars (models Dura 5200/375 lbs. and 5500/450 lbs per unit). Recall # D-197-2. CODE All units transfilled and distributed from 1/22/02 through 1/30/02. RECALLING FIRM/MANUFACTURER Medico Medical Equipment & Supplies Inc., Berea, OH, by visits beginning January 31, 2002. FDA initiated recall is complete. REASON The firm failed to perform identity and potency testing prior to distribution. VOLUME OF PRODUCT IN COMMERCE 140 home units and 11 dewars. DISTRIBUTION OH. ______________________ PRODUCT Gemzar (Gemcitabine HCl for Injection)1 gram, single use vial, For I.V. use only, Rx Only. Recall # D-200-2. CODE Lot 5MR98M. Exp. 8/1/03. RECALLING FIRM/MANUFACTURER Eli Lilly & Co., Indianapolis, IN, by letters dated February 4, 2002. Firm initiated recall is ongoing. REASON Vial incorrectly has a vacuum and the product cannot be removed for use. VOLUME OF PRODUCT IN COMMERCE 5,644 vials. DISTRIBUTION Nationwide, Jamaica and Qatar. _______________________ PRODUCT Sodium Chloride Injection, USP, 0.45%, 2mL, Rx only. Recall # D-201-2. CODE Lot number 6001 Exp. 05/2003. RECALLING FIRM/MANUFACTURER Hollister-Stier Laboratories LLC, Spokane, WA, by letter dated January 30, 2002. Firm initiated recall is ongoing. REASON pH failure. VOLUME OF PRODUCT IN COMMERCE 39,500 vials. DISTRIBUTION CO. _______________________ PRODUCT Oxygen, USP, Compressed D size cylinders. Recall # D-202-2. CODE All lots RECALLING FIRM/MANUFACTURER William Burke LTD dba Main at Locust Pharmacy, Davenport, IA, by telephone on February 13, 2002. FDA initiated recall is complete. REASON Product was manufactured in the absence of Good Manufacturing Practice Regulations (GMP's) including, but not limited to, the lack of potency testing. VOLUME OF PRODUCT IN COMMERCE 9 cylinders. DISTRIBUTION IA. _______________________ PRODUCT Trihexyphenidyl Hydrochloride Tablets, USP, 5 mg., Rx only, bottles of 100 and 1000 tablets. Recall # D-203-2. CODE 07419A, 074019B, 074019C, 074019D, 074019E. RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals Inc., Charlotte, NC, by letter on February 8, 2000. Firm initiated recall is complete. REASON Mispackaging; 2mg. tablets mixed in bottles of 5 mg. tablets bearing 5mg labeling. VOLUME OF PRODUCT IN COMMERCE 1,457 bottles. DISTRIBUTION AL.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Microgestin Fe 1/20 Tablets, (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 28-day regimen, 6 tablet dispensers, 28 tablets each. Rx only. Each white tablet (21) contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each brown tablet (7) contains 75 mg ferrous fumarate. Recall # D-199-2. CODE Lot 63002H01, Exp 6/2003. Cartons are with 6 tablet dispensers x 28 tablets each. RECALLING FIRM/MANUFACTURER Recalling Firm: Watson Pharmaceuticals Inc., Corona, CA, by letters on February 6, 2002. Firm initiated recall is ongoing. REASON Impurity specification failure (stability). VOLUME OF PRODUCT IN COMMERCE 21,372 cartons. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT a) Red Blood Cells, Recall # B-0821-2; b) Platelets, Pooled, Recall # B-0822-2; c) Fresh Frozen Plasma, Recall # B-0823-2; d) Source Leukocytes, Recall # B-0824-2. CODE a) and c) Unit 8524588, 8690328, 0484764; b) Units 0073682, 8690328; d) Unit 8524588. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH, by letter on November 28, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having tested positive for Hepatitis B, were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION KY and FL. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0829-2. CODE Units 32KP21617, 32KP21618 (split into 2 units), 32KP21619, 32KP21620, 32KP21621. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by letter dated July 26, 2001. Firm initiated recall is complete. REASON Blood products, labeled with extended expiration dates, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION IL, IA, MI and WI. _______________________ PRODUCT Various Tissues for Transplant, Recall # B-0848-2. CODE Saphenous Vein Allograft- Model Number V010, Serial Numbers 6549977 and 6549985; Femoral Vein with Valve Allograft - Model Number V061, Serial Number 6549616; Tibialis Tendon Allograft - Model Number T080, Serial Numbers 4248244, 4248279 and 4248287. RECALLING FIRM/MANUFACTURER CryoLife Inc., Kennesaw, GA, by letter dated January 4, 2002. Firm initiated recall is complete. REASON Various tissues for transplant were collected from a donor who had not been properly evaluated. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION AZ, FL, IN, MA and UT. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0851-2. CODE Unit 12GS29844. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Carolinas Region, Charlotte, NC, by letter dated October 24, 2001. Manufacturer: American Red Cross Blood Services, Carolinas Region, Durham, NC. 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 NC. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0852-2. CODE Unit 12KE67714. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Carolinas Region, Charlotte, NC, by letter dated November 21, 2001. Manufacturer: American Red Cross Blood Services, Carolinas Region - Wilmington, Wilmington, NC. 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 SC. _______________________ PRODUCT Human Cornea Tissue, Recall # B-0857-2. CODE Units (Group A, Corneas 1-14) 99-3485 99-4225 99-4703 2000-06-2499 2000-01-0175 99-3486 99-4226 99-4704 2000-06-2500 2000-01-0176 2000-05-2235 2000-05-2115 2000-05-2236 2000-05-2116 (Group B, Corneas 15 & 16)) 2000-06-2493 2000-06-2494 (Group C, Corneas 17-22) 2000-06-2774 2000-06-2765 2000-06-2776 2000-06-2777 2000-06-2766 2000-06-2778 (Group D, Corneas 23-30) 2000-06-2541 2000-06-2619 2000-07-3043 2000-07-2895 2000-06-2542 2000-06-2620 2000-07-3044 2000-07-2896 RECALLING FIRM/MANUFACTURER Recalling Firm: Central Florida Lions Eye and Tissue Bank Inc., Tampa, FL, by letters dated August 7 through 28, 2000. Responsible Firm: (Contract lab that performed suspect testing), Bryce Clinical Labs, Tampa, FL. Firm initiated recall ongoing. REASON Human corneas, not tested or improperly tested for Hepatitis B surface antigen (HBsAg), were distributed. VOLUME OF PRODUCT IN COMMERCE 30 units. DISTRIBUTION Nationwide and internationally. _______________________ PRODUCT Source Plasma, Recall # B-0867-2. CODE Unit G33730051. RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, City of Industry, CA, by fax on May 4, 2001. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who admitted to recently experiencing an unexplained 10-lb weight loss, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Switzerland. _______________________ PRODUCT Source Plasma, Recall # B-0868-2. CODE Units 0370412903, 0370412916, 0370413071, 0370413015, 0370413023, 0370413049, 0370413074, 0140982030, 7020148146, 0420861591, and 0420861598. RECALLING FIRM/MANUFACTURER NABI, Miami, FL, by letters dated October 18 and November 4, 1999. Firm initiated recall is complete. REASON Blood products, which were untested for the antibodies to the hepatitis B surface antigen (anti-HBsAg), the antibodies to the human immunodeficiency virus 1/2 (anti-HIV-1/2), the antibodies to the hepatitis C encoded virus (anti-HCV), and the HIV-1 Antigen, were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION NC, NY and internationally. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0870-2. CODE Unit numbers 01GW50865 and 01GQ51041. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letter on May 31, 2001. Manufacturer: American Red Cross Blood Services, Albany, NY. Firm initiated recall 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 a) Platelets, Leukocytes Reduced, Recall # B-0872-2; b) Fresh Frozen Plasma, Recall # B-0873-2. CODE a) and b) Unit number 42X47994. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on November 30 and by letter dated December 11, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MI and OH. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0874-2; b) Platelets, Irradiated, Recall # B-0875-2. CODE a) and b) Unit number 50H06499. RECALLING FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie Region,Toledo, OH, by letter dated September 27, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT Red Blood Cells, Recall # B-0876-2. CODE Unit numbers 0438914 and 0597590. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by recall letters on February 22 and July 11, 2001. Firm initiated recall is complete. REASON Blood products, that were not properly quarantined after the donors of the products reported post donation illnesses, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH and KY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0877-2; b) Fresh Frozen Plasma, Recall # B-0878-2. CODE a) and b) Unit 24GQ22679. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, River Valley Region, Louisville, KY, by letter dated July 20, 2001. Firm initiated recall is complete. REASON Blood products, which were manufactured from an overweight whole blood unit, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IN. _______________________ PRODUCT Source Plasma, Recall # B-0879-2. CODE Unit A02973520. RECALLING FIRM/MANUFACTURER Community Bio-Resources Inc., Hoover, AL, by fax dated July 1, 1999. Firm initiated recall is complete. REASON Blood product, which was collected from a donor who had received the MMR vaccine within 2 weeks of the donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria. _______________________ PRODUCT Platelets, recall # B-0880-2. CODE Unit 2107987. RECALLING FIRM/MANUFACTURER LifeShare Inc., Elyria, OH, by letter dated August 8, 2001. Firm initiated recall is complete. REASON Blood product, which was collected in a manner that compromised the sterility of the product, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT a) Red Blood Cells, B-0881-2; b) Red Blood Cells, Leukocytes Reduced, B-0882-2; c) Platelets, B-0883-2; d) Fresh Frozen Plasma, B-0884-2; CODE a)Units 26164-1236, 26164-1237, 26164-1238, 26164-1240, 26164-1242, 26164-1243, 6164 1244, 26164-1247, 26164-1250, 26164-1251, 26164-1253, 26164-1256, 26164-1258, 26164-1300, 26164-1366, 26164-1367, 26164-1368, 26164-1369, 26164-1371, 26164-1372, 26164-1374, 26164-1375, 26164-1387, 26164-1389, 26164-1396, 26164-1398, 26164-1401, 26164-1403, 26164-1405, 26164-1409, 26164-1414, 26164-1416, 26164-1419, 26164-1422, 26164-1424, 26164-1436, 26164-1438, 26164-1444, 26164-1446, 26164-1448, 26164-1450, 26164-1452, 26164-1454, 26164-1456, 26164-1460, 26164-1470, 26164-1472, 26164-1474, 26164-1475, 26164-1476, 26164-1498, 26164-1499, 26164-1501, 26164-1502, 26164-1504, 26164-1505, 26164-1507, 26164-1508, 26164-1509, 26164-1522, 26164-1566, 26164-1570, 26164-1630, 26164-1634, 26164-1722, 26164-1835, 26164-1843, 26164-3937, 26164-3939, 26164-3942, 26164-3944, 26164-3946, 26164-3950, 26164-3959, 26164-3966, 26164-3969, 26164-3970, 26164-3972, 26164-3985, 26164-3995, 26164-3997, 26164-3998, 26164-4003, 26164-4004, 26164-4014, 26164-4016, 26164-4018, 26164-4020, 26164-4022, 26164-4026, 26164-4027, 26164-4029, 26164-4040, 26164-4042, 26164-4051, 26164-4053, 26164-4062, 26164-4064, 26164-4069, 26164-4071, 26164-4077, 26164-4079, 26164-4081, and 26164-4090; b) Units 26164-1279, 26164-1280, 26164-1281, 26164-1282, 26164-1283, 26164-1284, 26164- 1286, 26164-1290, 26164-1293, 26164-1295, 26164-1298, 26164-1378, 26164-1381, 26164-1385, 26164-1393, 26164-1477, 26164-1478, 26164-1479, 26164-1484, 26164-1485, 26164-1506, 26164-1530, 26164-1535, 26164-1539, 26164-1541, 26164-1543, 26164-1545, 26164-1551, 26164-1552, 26164-1553, 26164-1554, 26164-1555, 26164-1557, 26164-1558, 26164-1560, 26164-1561, 26164-1562, 26164-1564, 26164-1569, 26164-1576, 26164-1581, 26164-1583, 26164-1587, 26164-1592, 26164-1597, 26164-1601, 26164-1604, 26164-1605, 26164-1609, 26164-1612, 26164-1613, 26164-1615, 26164-1616, 26164-1641, 26164-1644, 26164-1651, 26164-1654, 26164-1680, 26164-1725, 26164-1730, 26164-1731, 26164-1732, 26164-1740, 26164-1741, 26164-1744, 26164-1745, 26164-1746, 26164-1747, 26164-1787, 26164-1811, 26164-1870, 26164-6694, 26164-1727, 26164-1836-01, and 26164-1836-02; c) Units 26164-1507, 26164-1508, 26164-1509, 26164-1566, 26164-1567, 26164-1570, 26164-1572, 26164-1574, 26164-1634, 26164-1835, 26164-1843, 26164-3939, 26164-3942, 26164-3946, 26164-3950, 26164-3959, 26164-3966, 26164-3969, 26164-3970, 26164-3972, 26164-3985, 26164-4014, 26164-4016, 26164-4022, 26164-4027, 26164-4029, and 26164-4042; d) Units 26164-1237, 26164-1238, 26164-1242, 26164-1243, 26164-1244, 26164-1253, 26164-1256, 26164-1405, 26164-1409, 26164-1414, 26164-1475, 26164-1520, 26164-1522, 26164-1567, 26164-1583, 26164-1597, 26164-1730, 26164-1740, 26164-1744, 26164-3959, 26164-3966, 26164-3970, 26164-3985, 26164-3992, 26164-3995, 26164-3998, 26164-4014, 26164-4018, 26164-4020, 26164-4026, 26164-4029, and 26164-4040. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Hot Springs, AR, by telephone between August 8 through December 21, 2000. Firm initiated recall is complete. REASON Blood products that were collected from donors in which donor suitability was not adequately determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 238 units. DISTRIBUTION AR, TX, VA and LA. _______________________ PRODUCT Cryoprecipitated AHF, Recall B-0886-2. CODE Unit number E23417. RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, by letters on October 22 and 30, 2001. Firm initiated recall is complete. REASON Blood products, that contained antibodies to the red blood cell antigens C and D (anti-C and anti-D), but were incorrectly labeled as negative for unexpected antibodies, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0888-2 CODE Units C16886, C16897, C16898, C16900, C16904, C16920, C17340, C17353, C17354, C17356, C17361, C17362, C17368, C17380, C17384, C17388, C32051, C32068, C32070, C32091, C51060, C51061, C51282, C68742, C71150, C94686, C94688, C94692, C96749, W78089, X46968, X46974, X46976, X46977, X48503, X48506, Y15177, Y15212, Y15213, Y15218, Y15762, Y15763, Y15765, Y21675, Y77939, Y83868, Y84995, Y91280, Y91316, Y93144, Y93145, Y93146, Y93156, Y93157, Y93158, Y93235, Y93939, Y93941, Y93942, Y93974, Y94181, Y94182, Y95173, and Y95185. RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, by letters dated November 20 and December 18, 2001. Firm initiated recall is complete. REASON Blood product, which was manufactured in a manner that compromised the sterility of the units, was distributed. VOLUME OF PRODUCT IN COMMERCE 64 units. DISTRIBUTION IL and IN.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0767-2. CODE Units 03C05600, 03C05601, 03C05602, 03C05607, 03C05610, 03C05612, 03C05613, 03C05615, 03C05622, 03C05624, 03C05625, 03C05627, 03C05628, 03F06223, 03F06225, 03KC07809, 03KC07810, 03KC07814, 03KC07817, 03KC07818, 03KC07819, 03KE09750, 03KE09752, 03KE09756, 03KE09758, 03KM08197, 03KM08205, 03KM08207, 03KM08210, 03KM08212, 03KM08213, 03KM08538, 03KM08540, 03KR04395, 03KR04396, 03KR04398, 03R03082, 03R03083, 03R03084, 03R03085. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Southern Region, Atlanta, GA, by telephone on February 11, and by letter on February 24, 1998. Manufacturer: American Red Cross, Miami, FL. Firm initiated recall is complete. REASON Fresh Frozen Plasma products, that may not have been separated and frozen within eight hours of phlebotomy, were distributed. VOLUME OF PRODUCT IN COMMERCE 40 units. DISTRIBUTION FL. _______________________ PRODUCT Corneas for Transplant, Recall # B-0854-2. CODE Unit numbers 01-1975 and 01-1976. RECALLING FIRM/MANUFACTURER Minnesota Lions Eye Bank, Minneapolis, MN, by telephone on January 14 and by letter dated January 18, 2002. Firm initiated recall is complete. REASON Corneas for transplant that were collected from a donor who tested repeatedly reactive for HIV-1 p24 antigen, but was not neutralized, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MN. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0855-2. CODE Units FR30007-2, FR30007-3, FR30036-1, FR30036-2, FR30183-1, FR30183-2, FR30183-3, FR30206-1, FR30206-2, FR30887-1, FR30887-2, FR30914-1, FR30914-3, FR31094-1, FR31094-2, FR31094-3, FR31126-1, FR31126-2, FR31131-1, FR31131-2, FR31144-2, FR31144-3, FR31177-1, FR31177-2, FR31244-1, FR31244-2, FR31270-1, FR31270-2, FR31270-3, FR31356-1, FR31356-2, FR31356-3, FR31358-1, FR31358-2, FR31358-3, FR31383-1, FR31383-2, FR31383-3, FR31388-1, FR31388-2, FR31388-3, FR31439-1, FR31439-2, FR31439-3, FR31474-1, FR31474-2, FR31497-1, FR31497-2, FR31497-3, FR31518-1, FR31518-2, FR31633-1, FR31633-2, FR31633-3, FR31649-1, FR31649-2, FR31649-3, FR31656-1, FR31656-2, FR31656-3, FR31735-1, FR31735-2, FR31735-3, FR31761-1, FR31761-2, FR31761-3, FR31801-1, FR31801-2, FR31801-3, FR31814-1, FR31814-2, FR31814-3, FR31823-1, FR31823-2, FR31823-3, FR31840-1, FR31840-2, FR31840-3, FR31867-1, FR31867-2, FR31867-3, FR31869-1, FR31869-2, FR31869-3, FR31916-1, FR31916-2, FR31916-3, FR31981-1, FR31981-2, FR31981-3, FR31999-1, FR31999-2, FR31999-3, FR32152-1, FR32152-2, FR32152-3, FR32274-1, FR32274-2, FR32336-1, FR32336-2, FR32394-1, FR32394-2, FR32394-3, FR32397-1, FR32397-2, FR32397-3, FR32428-1, FR32428-2, FR32435-1, FR32435-2, FR32454-1, FR32454-2, FR32454-3, FR32462-2, FR32462-3, FR32488-1, FR32488-2, FR32488-3, FR32510-1, FR32510-2, FR32511-1, FR32511-2, FR32614-1, FR32614-2, FR32614-3, FR32624-1, FR32624-2, FR32624-3, FR32698-1, FR32698-2, FR32706-1, FR32706-2, FR32706-3, FR32715-1, FR32715-2, FR32769-1, FR32769-2, FR32769-3, FR32782-1, FR32825-1, FR32825-2, FR32851-1, FR32851-2, FR32876-1, FR32876-2, FR32942-1, FR32942-2, FR32957-2, FR32957-3, FR33049-1, FR33049-2, FR33049-3, FR33215-1, FR33215-2, FR33434-1, FR33481-1, FR33481-3, FR33552-1, FR33552-2, FR33628-1, FR33628-2, FR33693-1, FR33693-2, FR33693-3, FR33722-1, FR33722-2, FR33775-1, FR33775-2, FR33775-3, FR33801-1, FR33801-2, FR33801-3, FR34086-1, FR34086-2, FR34086-3, FR34198-1, FR34198-2, FR34198-3, FR34216-1, FR34216-2, FR34216-3, FR34273-1, FR34273-2, FR34273-3, FR34323-1, FR34323-2, FR34402-1, FR34402-2, FR34415-1, FR34415-2, FR34415-3, FR34438-1, FR34438-2, FR34438-3, FR34470-1, FR34470-2, FR34560-1, FR34560-2, FR34664-1, FR34664-2, FR34672-1, FR34672-2, FR34688-1, FR34688-2, FR34688-3, FR34690-1, FR34690-2, FR34698-2, FR34698-3, FR34719-1, FR34719-2, FR34738-1, FR34738-2, FR34806-1, FR34806-2, FR34812-1, FR34857-1, FR34857-2, FR34857-3, FR34858-1, FR34858-2, FR34858-3, FR34878-1, FR34878-2, FR34878-3, FR34976-1, FR34976-2, FR34976-3, FR35084-1, FR35084-2, FR35128-1, FR35128-2, FR35219-1, FR35219-2, FR35337-1, FR35337-2, FR35337-3, FR35344-1, FR35344-2, FR35344-3, FR35397-1, FR35397-2, FR35418-1, FR35418-2, FR35436-1, FR35436-2, FR35462-1, FR35462-2, FR35492-1, FR35492-2, FR35510-1, FR35510-2, FR35530-1, FR35530-2, FR35572-1, FR35592-1, FR35592-2, FR35682-1, FR35682-2, FR35695-1, FR35695-2, FR35760-1, FR35760-2, FR35760-3, FR35784-2, FR35934-1, FR35934-2, FR35986-1, FR35986-2, FR35986-3, FR36173-1, FR36173-2, FR36220-1, FR36220-2, FR36228-1, FR36228-2, FR36249-1, FR36249-2, FR36340-1, FR36349-1, FR36349-2, FR36372-1, FR36372-2, FR36428-1, FR36428-2, FR36428-3, FR36479-1, FR36479-2, FR36587-1, FR36587-2, FR36681-1, FR36681-2, FR36681-3, FR36685-1, FR36685-2, FR36707-1, FR36707-2, FR36713-1, FR36715-1, FR36715-2, FR36791-1, FR36791-2, FR36792-1, FR36792-2, FR36890-1, FR36912-1, FR36917-1, FR36924-1, FR36924-2, FR36933-1, FR36933-2, FR36951-1, FR36978-1, FR37002-1, FR37008-1, FR37008-2, FR37014-1, FR37014-2, FR37073-1, FR37081-1, FR37088-1, FR37088-2, FR37088-3, FR37090-1, FR37090-2, FR37110-1, FR37110-2, FR37119-1, FR37148-1, FR37203-1, FR37228-1, FR37261-1, FR37359-1, FR37359-2, FR37426-1, FR37508-1, FR37510-1, FR37510-2, FR37586-1, FR37590-1, FR37593-1, FR37613-1, FR37613-2, FR37615-1, FR37615-2, FR37630-1, FR37655-1, FR37655-2, FR37669-1, FR37669-2, FR37674-1, FR37674-2, FR37763-1, FR37763-2, FR37782-1, FR37782-2, FR37794-1, FR37794-2, FR37867-1, FR37867-2, FR37902-1, FR37970-1, FR37996-1, FR37996-2, FR38006-1, FR38047-1, FR38051-1, FR38066-1, FR38094-1, FR38134-1, FR38134-2, FR38172-1, FR38181-1, FR38222-1, FR38268-1, FR38297-1, FR38348-1, FR38355-1, FR38441-1, FR38447-1, FR38617-1, FR38740-1, FR38740-2, FR38746-1, FR38746-2, FR38767-1, FR38827-1, FR38994-1, FR38994-2, FR39133-1, FR39133-2, FR39287-1, FR39287-2, FR39441-1, FR39441-2, KZ51586-1, KZ51586-2, KZ51590-1, KZ51590-2, KZ51590-3, KZ51613-1, KZ51613-2, KZ51642-1, KZ52207-1, KZ52207-2, KZ52209-1, KZ52209-2, KZ52339-1, KZ52339-2, KZ52339-3, KZ52387-1, KZ52387-2, KZ52468-1, KZ52468-2, KZ52485-1, KZ52485-2, KZ52655-1, KZ52655-2, KZ52675-1, KZ52675-2, KZ52693-1, KZ52693-2, KZ52693-3, KZ52711-2, KZ52713-1, KZ52713-2, KZ52753-1, KZ52753-2, KZ52753-3, KZ52767-1, KZ52767-2, KZ52767-3, KZ52776-1, KZ52776-2, KZ52776-3, KZ52791-1, KZ52791-2, KZ52951-1, KZ52951-2, KZ52951-3, KZ52965-1, KZ52965-2, KZ52969-1, KZ52969-2, KZ52969-3, KZ52974-1, KZ52974-2, KZ52974-3, KZ52985-1, KZ52985-2, KZ52990-1, KZ52990-2, KZ53005-1, KZ53005-2, KZ53162-1, KZ53162-2, KZ53164-1, KZ53164-2, KZ53186-1, KZ53186-2, KZ53186-3, KZ53190-1, KZ53190-2, KZ53260-1, KZ53260-2, KZ53260-3, KZ53283-1, KZ53283-2, KZ53283-3, KZ53360-1, KZ53360-2, KZ53360-3, KZ53389-1, KZ53389-2, KZ53389-3, KZ53467-1, KZ53467-2, KZ53467-3, KZ53524-1, KZ53524-2, KZ53524-3, KZ53570-1, KZ53570-2, KZ53625-1, KZ53625-2, KZ53625-3, KZ53639-1, KZ53639-2, KZ53639-3, KZ53657-1, KZ53657-2, KZ53700-1, KZ53700-2, KZ53700-3, KZ53747-1, KZ53747-2, KZ53747-3, KZ53763-1, KZ53763-2, KZ53777-1, KZ53777-2, KZ53847-1, KZ53847-2, KZ53946-1, KZ53946-2, KZ53950-1, KZ53950-2, KZ53965-1, KZ53965-2, KZ53980-1, KZ53980-2, KZ53983-1, KZ53983-2, KZ54014-2, KZ54033-1, KZ54033-2, KZ54033-3, KZ54056-1, KZ54056-2, KZ54061-1, KZ54061-2, KZ54061-3, KZ54074-1, KZ54074-2, KZ54113-1, KZ54113-2, KZ54113-3, KZ54144-1, KZ54144-2, KZ54144-3, KZ54162-1, KZ54162-2, KZ54162-3, KZ54226-1, KZ54226-2, KZ54265-1, KZ54265-2, KZ54285-1, KZ54285-2, KZ54307-1, KZ54307-2, KZ54338-1, KZ54338-2, KZ54355-1, KZ54355-2, KZ54355-3, KZ54371-1, KZ54371-2, KZ54371-3, KZ54418-1, KZ54421-1, KZ54421-2, KZ54435-1, KZ54435-2, KZ54435-3, KZ54467-1, KZ54467-2, KZ54467-3, KZ54818-1, KZ54818-2, KZ54818-3, KZ54824-1, KZ54824-2, KZ54824-3, KZ54831-1, KZ54831-2, KZ54831-3, KZ54903-1, KZ54903-2, KZ54903-3, KZ54966-1, KZ54966-2, KZ55041-1, KZ55041-2, KZ55041-3, KZ55058-1, KZ55058-2, KZ55058-3, KZ55087-1, KZ55087-2, KZ55087-3, KZ55147-1, KZ55147-2, KZ55204-1, KZ55204-2, KZ55204-3, KZ55227-1, KZ55227-2, KZ55236-1, KZ55236-2, KZ55236-3, KZ55243-1, KZ55243-2, KZ55277-1, KZ55277-3, KZ55317-1, KZ55317-2, KZ55317-3, KZ55324-1, KZ55324-2, KZ55370-1, KZ55370-2, KZ55493-1, KZ55493-2, KZ55493-3, KZ55628-1, KZ55628-2, KZ55628-3, KZ55666-1, KZ55666-2, KZ55666-3, KZ55668-1, KZ55668-2, KZ55668-3, KZ55685-1, KZ55685-2, KZ55685-3, KZ55708-1, KZ55708-2, KZ55755-1, KZ55755-2, KZ55759-1, KZ55759-2, KZ55776-1, KZ55776-2, KZ55864-1, KZ55864-2, KZ55870-1, KZ55870-2, KZ55911-1, KZ55911-2, KZ55983-1, KZ55983-2, KZ55988-1, KZ55988-2, KZ55997-1, KZ55997-2, KZ56002-1, KZ56002-2, KZ56084-1, KZ56084-2, KZ56084-3, KZ56132-1, KZ56132-2, KZ56132-3, KZ56136-1, KZ56136-2, KZ56136-3, KZ56221-1, KZ56221-2, KZ56290-1, KZ56290-2, KZ56290-3, KZ56302-1, KZ56302-2, KZ56339-1, KZ56339-2, KZ56365-1, KZ56365-2, KZ56398-1, KZ56398-2, KZ56398-3, KZ56456-1, KZ56456-2, KZ56456-3, KZ56475-1, KZ56475-2, KZ56499-1, KZ56499-2, KZ56499-3, KZ56514-1, KZ56514-2, KZ56514-3, KZ56611-1, KZ56611-2, KZ56633-1, KZ56633-2, KZ56687-1, KZ56687-2, KZ56687-3, KZ56703-1, KZ56703-2, KZ56735-1, KZ56735-2, KZ56744-1, KZ56744-2, KZ56744-3, KZ56775-1, KZ56775-2, KZ56779-1, KZ56779-2, KZ56779-3, KZ56793-1, KZ56793-2, KZ56796-1, KZ56796-2, KZ56818-1, KZ56818-1, KZ56854-1, KZ56854-2, KZ56854-3, KZ57006-1, KZ57006-2, KZ57006-3, KZ57020-1, KZ57020-2, KZ57020-3, KZ57089-1, KZ57089-2, KZ57089-3, KZ57106-1, KZ57106-2, KZ57106-3, KZ57126-1, KZ57126-2, KZ57186-1, KZ57186-2, KZ57197-1, KZ57197-2, KZ57197-3, KZ57206-1, KZ57206-2, KZ57206-3, KZ57227-1, KZ57227-2, KZ57227-3, KZ57237-1, KZ57237-2, KZ57358-1, KZ57358-2, KZ57427-1, KZ57427-2, KZ57427-3, KZ57473-1, KZ57473-2, KZ57476-1, KZ57476-2, KZ57476-3, KZ57493-1, KZ57493-2, KZ57497-1, KZ57497-2, KZ57524-1, KZ57524-2, KZ57681-1, KZ57681-2, KZ57834-1, KZ57834-2, KZ57834-3, KZ57947-1, KZ57947-2, KZ57959-1, KZ57959-2, KZ58110-1, KZ58110-2, KZ58120-1, KZ58120-2, KZ58163-1, KZ58163-2, KZ58219-1, KZ58219-2, KZ58268-2, KZ58268-3, KZ58306-1, KZ58306-2, KZ58321-1, KZ58321-2, KZ58321-3, KZ58395-1, KZ58395-2, KZ58395-3, KZ58457-1, KZ58457-2, KZ58472-1, KZ58472-2, KZ58503-1, KZ58503-2, KZ58524-1, KZ58524-2, KZ58541-1, KZ58541-2, KZ58555-1, KZ58555-2, KZ58555-3, KZ58687-1, KZ58687-2, KZ58721-1, KZ58721-2, KZ58765-1, KZ58765-2, KZ58906-2, KZ58906-3, KZ58910-1, KZ58910-2, KZ58910-3, KZ58981-1, KZ58981-2, KZ59068-1, KZ59068-2, KZ59068-3, KZ59129-2, KZ59129-3, KZ59153-1, KZ59153-2, KZ59153-3, KZ59172-1, KZ59172-2, KZ59288-1, KZ59288-2, KZ59370-1, KZ59377-1, KZ59377-2, KZ59377-3, KZ59406-1, KZ59406-2, KZ59406-3, KZ59426-1, KZ59432-1, KZ59432-2, KZ59485-1, KZ59563-1, KZ59563-2, KZ59587-1, KZ59587-2, KZ59587-3, KZ59629-1, KZ59634-1, KZ59660-1, KZ59706-1, KZ59719-1, KZ59793-1, KZ59807-1, KZ59838-1, KZ59842-1, KZ59842-2, KZ59860-1, KZ59860-2, KZ59860-3, KZ59865-1, KZ59878-1, KZ59878-2, KZ59878-3, KZ59949-1, KZ59949-2, KZ59949-3, KZ59954-1, KZ60104-1, KZ60104-2, KZ60124-1, KZ60151-1, KZ60172-1, KZ60250-1, KZ60250-2, KZ60256-1, KZ60276-1, KZ60319-1, KZ60319-2, KZ60356-1, KZ60356-2, KZ60377-1, KZ60382-1, KZ60444-1, KZ60460-1, KZ60460-3, KZ60485-1, KZ60485-2, KZ60489-1, KZ60489-2, KZ60634-1, KZ60634-2, KZ60644-1, KZ60644-2, KZ60681-1, KZ60688-2, KZ60747-1, KZ60747-2, KZ60750-1, KZ60760-2, KZ60760-3, KZ60796-3, KZ60817-1, KZ60825-1, KZ60854-1, KZ60854-2, KZ60854-3, KZ60866-1, KZ60900-1, KZ60956-1, KZ60956-2, KZ60980-1, KZ61032-1, KZ61083-1, KZ61123-1, KZ61145-1, KZ61148-1, KZ61269-1, KZ61307-1, KZ61318-1, KZ61450-1, KZ61450-2, KZ61514-2, KZ61517-1, KZ61590-1, KZ61687-1, KZ61687-2, KZ61735-1, KZ61735-2, KZ61759-1, KZ61759-2. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin Inc., Milwaukee, WI, by telephone on September 25 and 26, 2001, and by follow-up letters on September 26 and October 5, 2001. Firm initiated recall is complete. REASON Fresh Frozen Plasma, labeled with the incorrect anticoagulant, were distributed. VOLUME OF PRODUCT IN COMMERCE 907 units. DISTRIBUTION WI _______________________ PRODUCT Human Cornea for Transplantation, Recall # B-0869-2. CODE Units 2001052145 and 2001052146. RECALLING FIRM/MANUFACTURER Central Florida Lions Eye and Tissue Bank, Inc., Tampa, FL, by telephone and letter on July 19, 2001. Firm initiated recall is complete. REASON Human tissue, which was collected from a donor who tested repeatedly reactive for the antibody for hepatitis C encoded virus (anti-HCV) and negative by RIBA, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION FL. _______________________ PRODUCT Leukoreduced Red Blood Cells, Recall # B-0871-2. CODE Units 49FJ83113, 49FJ83117, and 49FJ83122. RECALLING FIRM/MANUFACTURER American National Red Cross, Southwest Region, Tulsa, OK, by telephone on May 31, 2001. Firm initiated recall is complete. REASON Blood products, which were not prepared within the appropriate time frame after collection, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OK. _______________________ PRODUCT Recovered Plasma, B-0885-2. CODE Units 26164-1240, 26164-1247, 26164-1250, 26164-1251, 26164-1258, 26164- 1290, 26164-1293, 26164-1294, 26164-1296, 26164-1298, 26164-1300, 26164- 1375, 26164-1378, 26164-1381, 26164-1383, 26164-1385, 26164-1387, 26164- 1389, 26164-1393, 26164-1396, 26164-1401, 26164-1403, 26164-1416, 26164- 1424, 26164-1474, 26164-1476, 26164-1498, 26164-1502, 26164-1507, 26164- 1509, 26164-1562, 26164-1581, 26164-1592, 26164-1741, 26164-1745, 26164- 3939, 26164-3942, 26164-3944, 26164-3946, 26164-3950, 26164-3969, 26164- 3972, 26164-3997, 26164-4003, 26164-4004, 26164-4016, 26164-4022, 26164- 4027, 26164-4042, 26164-4051, 26164-4053, 26164-4062, 26164-4064, 26164- 4069, 26164-4071, 26164-4081, 26164-4085, 26164-1280, 26164-1281, 26164- 1283, 26164-1284, 26164-1286, 26164-1366, 26164-1367, 26164-1368, 26164- 1371, 26164-1372, 26164-1374, 26164-1412, 26164-1436, 26164-1438, 26164- 1444, 26164-1446, 26164-1448, 26164-1450, 26164-1454, 26164-1456, 26164- 1460, 26164-1478, 26164-1485, 26164-1499, 26164-1501, 26164-1504, 26164- 1506, 26164-1526, 26164-1527, 26164-1530, 26164-1532, 26164-1535, 26164- 1539, 26164-1541, 26164-1543, 26164-1545, 26164-1547, 26164-1548, 26164- 1551, 26164-1552, 26164-1553, 26164-1554, 26164-1555, 26164-1557, 26164- 1558, 26164-1560, 26164-1561, 26164-1722, 26164-1725, 26164-1732, 26164- 3937, and 26164-4024. RECALLING FIRM/MANUFACTURER Blood Systems Inc., Hot Springs, AR, by telephone between August 9 through December 21 or by fax on August 28, 29, 2000 and/or by letter dated January 8, 2001. Firm initiated recall is complete. REASON Blood products that were collected from donors in which donor suitability was not adequately determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 109 units. DISTRIBUTION AR, TX, VA and LA. _______________________ PRODUCT Red Blood Cells, Recall # B-0887-2. CODE Unit number E23417. RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, by letters on October 22 and 30, 2001. Firm initiated recall is complete. REASON Blood products, that contained antibodies to the red blood cell antigens C and D (anti-C and anti-D), but were incorrectly labeled as negative for unexpected antibodies, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT FlexiLab Laboratory Information System, Version 5.2, 5.23, and 5.3, Recall # Z-0531-02. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Sunquest Information Systems Inc., Tucson, AZ, by mail on November 26, 2001. Firm initiated recall is ongoing. REASON Software glitch can cause results to be filed under an incorrect accession number under certain conditions. VOLUME OF PRODUCT IN COMMERCE 573. DISTRIBUTION Nationwide and United Kingdom, Ireland, Canada, Denmark, and Bermuda. _______________________ PRODUCT Thumper Cardiopulmonary Resuscitator. Model 1007; catalog # 14000 and 15000, Recall # Z-0532-2. CODE Units manufactured prior to October 2000. RECALLING FIRM/MANUFACTURER Michigan Instruments Inc., Grand Rapids, MI, by field correction beginning in October 2000. Firm initiated recall is complete. REASON Compressions may vary from 5:1 compression-ventilation ratio. VOLUME OF PRODUCT IN COMMERCE 619. DISTRIBUTION Nationwide and Canada, Japan, Korea, Spain, Taiwan and Turkey. _______________________ PRODUCT Valleylab CUSA EXcel Manifold Tubing 36kHz, Sterile, Made in Mexico. Packaged 6 per case. Recall # Z-0533-2. CODE Catalog No. C3601, Lot No. U12632. RECALLING FIRM/MANUFACTURER Recalling Firm: Valleylab Inc., Boulder, CO, by letter or E-mail on February 8, 2002. Manufacturer: Nellcor, Div. of Tyco Healthcare Group LP, Tijuana, MX. Firm initiated recall is ongoing. REASON Sterilization can not be assured for entire lot. VOLUME OF PRODUCT IN COMMERCE 312 cases (6 per case). DISTRIBUTION Nationwide and Australia, Canada, France, Japan and South Africa. _______________________ PRODUCT Surgimate (tm) brand, Sterile Instrument Pouches, aka "surgical drapes", packed in surgical grade white paper pouches, 100 pouches per case. Pouches are labeled with item #31-283, sterility exp. date "2006- 11". Recall # Z-0534-2. CODE Lots 249729, 250788, 251361, 252476, 253250, 253798, and 253842, sterility exp. date "2006-11". RECALLING FIRM/MANUFACTURER Deroyal Surgical, Rose Hill, VA, by mail on December 10, 2001. Firm initiated recall is ongoing. REASON Surgical drapes labeled as sterile may contain non-sterile product. VOLUME OF PRODUCT IN COMMERCE 1300 drapes. DISTRIBUTION TN and SC. _______________________ PRODUCT Dermabond Topical Skin Adhesive, Model No. BD12. Recall # Z-0535-2. CODE Lot Number 061057, 061058, 061059. RECALLING FIRM/MANUFACTURER Closure Medical Corp., Raleigh, NC, by letter dated November 27, 2001. Firm initiated recall is ongoing. REASON Inadequate seal in the blister packaging. VOLUME OF PRODUCT IN COMMERCE 130,116 units. DISTRIBUTION Nationwide. _______________________ PRODUCT 35cm J-Hook Electrode. Recall # Z-0536-2. CODE Catalog ES3510B, Lots FI,FJ,FK,GA,GB,GC,GE,GI. RECALLING FIRM/MANUFACTURER Encision Inc., Boulder, CO, by phone or visit beginning October 25, 2001. Firm initiated recall is ongoing. REASON J-hook, fixed-tip electrode may break off during electrosurgical use. VOLUME OF PRODUCT IN COMMERCE 219 units. DISTRIBUTION GA, PA, WA, IA and MS. _______________________ PRODUCT Infant Apnea Monitors as follows: a) AMI 9700 Apnea Monitor, Recall # Z-0537-2; b) AMI 9700A Apnea Monitor, Recall # Z-0538-2; c) AMI Plus 9700B Infant Central Apnea/Heart Rate Monitor, Recall # Z-0539-2. CODE a) AMI 9700 Apnea Monitor; b) AMI 9700A Apnea Monitor; c) AMI Plus 9700B Infant Central Apnea/Heart Rate Monitor. RECALLING FIRM/MANUFACTURER Cas Medical Systems Inc., Branford, CT, by letter on December 17, 2001. Firm initiated recall is ongoing. REASON Infant Apnea Monitor may shut down and the audible alarm may fail to sound. VOLUME OF PRODUCT IN COMMERCE 5282. DISTRIBUTION Nationwide and Canada, Brazil, Argentina and Nellcor PB the Netherlands. _______________________ PRODUCT Dual Stage Venous Return Cannula with Bullet Tip intended for use as a single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open-heart surgery. The product is labled in part: "Dual Stage Venous Return Cannulae Chase Medical, Inc., Richardson, TX", packaged individually, sterile and 10 to a case. Recall # Z-0540-2/0545-2. CODE All codes are recalled. RECALLING FIRM/MANUFACTURER Chase Medical Inc., Athens, TX, by letter dated November 28, 2001. Firm initiated recall is ongoing. REASON Venous Return Cannula Tip may separate in use. VOLUME OF PRODUCT IN COMMERCE 3,715. DISTRIBUTION Internationally. _______________________ PRODUCT Rx Multi Link Penta Coronary Stent Systems, U.S. and Rx Multi Link Penta Coronary Stent Systems, CE. Common Name for this device is Rapid Exchange Coronary Stent System. Classification Name is Coronary Stent. Recall # Z-0546-2. CODE Batch Numbers: 1112232 1112231 1111933 1112331 1111932 1112031 1111931 1112131 1111931 1112032 RECALLING FIRM/MANUFACTURER Guidant Corp., Temecula, CA, by letter beginning Dec. 22, 2001. Firm initiated recall is ongoing. REASON Potential compromise of sterility. VOLUME OF PRODUCT IN COMMERCE 1,000. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Supreme Blood Glucose Test Strips, Product Number 880050, 50-count bottles and Select GT Blood Glucose Test Strips, Product Number 660100, 100-count (a carton containing two 50-count bottles). Recall # Z-0547-2. CODE Select GT test strips: Lot 12290A; Supreme test strips: Lots 12150B, 12220B, 12280B, 12290B, and 01031B. RECALLING FIRM/MANUFACTURER Hypoguard (USA) Inc., formerly Chronimed Inc. Edina, MN, by letters on Jan. 4, 2002. Firm initiated recall is ongoing. REASON The product gives abnormally low readings when samples have high glucose levels. VOLUME OF PRODUCT IN COMMERCE 11,625 bottles of 50 strips. DISTRIBUTION Nationwide. _______________________ PRODUCT Colleague Infusion Pumps: a) Colleague Single Channel Volumetric Infusion Pumps, Recall # Z-0548-2; b) Colleague 3 Triple Channel Volumetric Infusion Pumps, Recall # Z-0549-2. Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL. Made in Singapore. CODE Codes: all serial numbers prior to 1201XXXXYY (XXXX = sequential number and YY represents a product code) of the following pumps: a) Colleague Infusion Pump - Single Channel product code 2M8151 - U.S. Distribution 2M8151R - Refurbished, U.S. Distribution 2M8151K - CE Marked, English language FKM8151 - English language CNM8151 - Swedish language DNM8151 - French language GNM8151 - Danish language HNM8151 - German language PNM8151 - Spanish language WNM8151 - Dutch language; b) Colleague 3 Infusion Pump - Triple Channel product code 2M8153 - U.S. distribution 2M8153R - Refurbished, U.S. distribution 2M8153K - CE Marked, English language CNM8153 - Swedish language DNM8153 - French language GNM8153 - Danish language HNM8153 - German language PNM8153 - Spanish language WNM8153 - Dutch language. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated November 11, 2002. Manufacturer: Baxter Healthcare Corp., Singapore, SN. Firm initiated recall is ongoing. REASON Malfunction of on/off circuit. VOLUME OF PRODUCT IN COMMERCE 126,800 units. DISTRIBUTION Internationally. _______________________ PRODUCT CD HORIZON Spinal System Laminar Hook. REF/Catalog # 84101H. Non- sterile. The product is distributed in individual packages. Recall # Z-0550-2. CODE Lots 16352, 17659, 22752, 33841, 40131 and 40132. RECALLING FIRM/MANUFACTURER Medtronic Sofamor Danek Manufacturing, Warsaw, IN, by letters dated Oct. 19, 2001. Firm initiated recall is complete. REASON Reduced tensile strength. VOLUME OF PRODUCT IN COMMERCE 269. DISTRIBUTION DE, FL, MI, MS, NY, PA, TX and Argentina, Australia, Austria, Belgium, France, Italy, Morocco, Norway, South Africa and Spain. _______________________ PRODUCT Sterile upper extremity drape surgical kits containing an "S" hook component, The "S" hook is used to attach the rope to the stockinette to hold the arm in position for the surgery. Recall # Z-0553-2/0555-2. CODE Catalog #IN 9300 CLF, lots 0P133, 1B007, 1B064, 1C057, 1D136, 1E016, 1F061, 1F085, 1F091, 1F194, 1G077; Catalog #IN 9300 E, lot 1E152; Catalog #SD-199, lots 1A129, 1D120, 1E116. RECALLING FIRM/MANUFACTURER Medikmark Inc., Waukegan, IL, by letters on August 16, 17 and 20, 2001. Firm initiated recall ongoing. REASON S-hook may fail during use in surgery. VOLUME OF PRODUCT IN COMMERCE 19,356 kits. DISTRIBUTION MI and FL.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Monopolar Foot Control Electrosurgical Pencils, as follows: a) Foot Switch Pencil with Standard Electrode, single use, sterile. Catalog # PEN05. Recall # Z-0529-2; b) Foot Switch Pencil with Coated Electrode, single use, non- sterile. Catalog # CK205. Recall # Z-0530-2. CODE a) Catalog # PEN05. Lot # 0346; b) Catalog # CK205. Lot # 0354. RECALLING FIRM/MANUFACTURER New Deantronics Taiwan LTD., Hsin Tien City, by letter on October 30, 2001. Firm initiated recall is ongoing. REASON Terminal may pull out of pencil body while the blade is being changed. VOLUME OF PRODUCT IN COMMERCE 1,300 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Magnetom Harmony, Symphony, Sonata, and Allegra Nuclear Resonance Magnetic Imaging System, Diagnostic Imaging. Magnetom Harmony, Magnetom Symphony, Magnetom Sonata and Magnetom Allegra Nuclear Resonance Magnetic Imaging Systems, Diagnostic Imaging. Brand Label: "SIEMENS MAGNETOM Harmony MAGNETOM Symphony*** Whole Body Magnetic Resonance System*** Siemens Aktiengesellschaft*** Medical Engineering Group*** Henkestrasse 127, D-91052 Erlangen*** Order No. A91001-M2235-G800-2-7600" "SIEMENS MAGNETOM*** Harmony Perfect your performance*** Siemens Aktiengesellschaft, Medical Engineering Group, Henkestrasse 127, D-91052 Erlangen*** aOrder No. A91100-M2220-E866-1-7600" "SIEMENS MAGNETOM Symphony Master excellence in MR*** Siemens Aktiengesellschaft, Medical Engineering Group, Henkestrasse 127, D-9105 Erlangen*** Order No. A91100-M2220-E927-1-7600" "SIEMENS MAGNETOM Sonata*** The Dedicated Cardiovascular MR System*** Siemens Aktiengesellschaft, Medical Engineering Group, Henkestrasse 127, D-91052 Erlangen*** Order No. A91004-M2220-E850-1-4A00" "SIEMENS Preliminary Data Sheet*** MAGNETOM Allegra*** 3 Tesla Dedicated MR System*** version 4.5*** August 29, 2001". Recall # Z-0552-2. CODE Model Numbers: Serial No.: Magnetom Harmony 47 59 309 K2200 10001-10429 Magnetom Symphony 47 60 265 K2200 13001-13580 Magnetom Sonata 57 54 655 K2240 21001-21036 Magnetom Allegra 71 05 658 K2183 20001-20012. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems Inc., Iselin, NJ, by letter on April 6, 2001. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing. REASON Image reconstruction errors. VOLUME OF PRODUCT IN COMMERCE 1057. DISTRIBUTION Nationwide.END OF ENFORCEMENT REPORT FOR MARCH 6, 2002 ####
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