September 3, 2003
03-36
PRODUCT
PSP brand Round Salted Herring in 225 lb. (100 kilos) barrels. Imported from Norway. Recall # F-502-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Brooklyn Imports, Inc., Brooklyn, NY, by press release on April 24, 2003, and letters, dated April 24, 2003. New York State initiated recall is complete.
REASON
Uneviscerated processed fish - product had the potential to be contaminated with Clostridium Botulinum spores, which can cause botulism.
VOLUME OF PRODUCT IN COMMERCE
9 - 225 lb. barrels.
DISTRIBUTION
NY, NJ, CT, PA, MI, and IL
PRODUCT
Hearty Hero Cheeseburger Sandwiches (UPC 051000 04350). Recall # F-503-3.
CODE
MAR2004 122902.
RECALLING FIRM/MANUFACTURER
Pinnacle Food Corp., Mountain Lakes, NJ, by press release on July 9, 2003. Firm initiated recall is ongoing.
REASON
The packages actually contained a different product, Hearty Hero Meatball Sandwiches. These meatballs contained egg whites that were not listed on the label of the Hearty Hero Cheeseburger Sandwiches.
VOLUME OF PRODUCT IN COMMERCE
2,600 sandwiches.
DISTRIBUTION
PA, DE, MD, VA, and WV.
PRODUCT
Leslie DeeAnn Jet Black Mascara, 10 gold colored tubes packaged in paper box. Recall # F-504-3.
CODE
Lots 3401, 1302, 1562, 1572, 2142, and 0732.
RECALLING FIRM/MANUFACTURER
Cosmeceutical Creations, Auckland, NZ, by letter on April 23-24, 2003. Firm initiated recall is complete.
REASON
The firm's analysis discovered that the product may be contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
12,571 units.
DISTRIBUTION
Nationwide, and Internationally.
PRODUCT
INFANT 4.2% Sodium Bicarbonate Injection, USP, 5 mEq (0.5 mEq/mL), 10 mL unit of use syringe, LifeShield, Glass Abboject, Rx only. Recall D-297-3.
CODE
Lot number 95-257-DK, Expiration date December 1, 2004.
RECALLING FIRM/MANUFACTURER
Abbott Labs, North Chicago, IL, by letters on July 11, 2003. Firm initiated recall is ongoing.
REASON
Mispacked; A correctly labeled vial of 10% Calcium Chloride Injection, USP was incorrectly packed in a carton labeled as Infant 4.2% Sodium Bicarbonate Injection, USP.
VOLUME OF PRODUCT IN COMMERCE
45,800 syringes.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
Pain Relieving Rub, (Menthol 10% and Methyl salicylate 15%), Greaseless/Stainless Analgesic Cream, Net Wt. 4 oz (114 g) tubes, Manufactured by G & W Laboratories, Inc., South Plainfield, NJ. Also sold under other brand names as
---- Greaseless Pain Relieving Rub, Greaseless/Stainless
Analgesic Cream, Distributed by: Happy Harry's, Inc.,
Newark, DE.
---- Muscle Rub, Greaseless Pain Relieving Cream,
Distributed by Drug Guild Distributors, Inc., Glen
Rock, NJ.
---- Pain Relieving Rub, Greaseless/Stainless Analgesic
Cream, Distributed by Ingles, Asheville, NC.
---- Pain Relieving Cream, Greaseless, Distributed by
Navarro Distribution Center, Inc., Miami, FL.
---- Muscle Rub, Distributed By: Kerr Drug Inc., Durham, NC
---- Muscle Rub, Greaseless, Stainless, Pain Relieving Rub,
Distributed by: Select Brand Distributors, Pine Bluff,
AR. Recall # D-318-3.
CODE
Lot No/Exp. Date:
2087-2 Exp. 04/2004;
2139-9 Exp. 05/2004;
2140-2 Exp. 06/2004;
2159-2 Exp. 06/2004;
2204-1 Exp. 08/2004;
2220-1 Exp. 08/2004;
2270-3 Exp. 10/2004.
RECALLING FIRM/MANUFACTURER
G & W Labs, Inc., South Plainfield, NJ, by letters on July 24, 2003. Firm initiated recall is ongoing.
REASON
Subpotent (methyl salicylate) 12 month stability.
VOLUME OF PRODUCT IN COMMERCE
24,315 tubes.
DISTRIBUTION
Nationwide.
PRODUCT
Platelets. Recall # B-1202-3.
CODE
Unit 2866330.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 17, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had the oral typhoid immunization, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
a) Red Blood Cells. Recall # B-1511-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1512-3;
c) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-1513-3;
d) Platelets. Recall # B-1514-3;
e) Cryoprecipitated AHF. Recall # B-1515-3.
CODE
a) Unit 1401448;
b) Units 1638433, 1697679;
c) Unit 1360055;
d) Unit 1638433;
e) Unit 1360055.
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile dated June 14, 19, and July 10, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received Human Chorionic Gonadatropin (HCG), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
FL and TX.
PRODUCT
Red Blood Cells, Deglyercolized. Recall # B-1516-3.
CODE
Unit 1855781.
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile dated May 13, 2002. Firm initiated recall is complete.
REASON
Red Cells, which exceeded the firm's specifications for free hemoglobin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall B-1536-3;
b) Fresh Frozen Plasma. Recall # B-1537-3.
CODE
a) and b) Unit 04V99092.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by letter dated May 9, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA.
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall B-1540-3.
CODE
Unit 004M02161.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by letter dated March 5, 2003. 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
MA.
PRODUCT
Source Plasma. Recall # B-1542-3.
CODE
Unit BFBKCY.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Fort Worth, TX, by letter dated July 23, 2001. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
a) Red Blood Cells, Leucocytes Removed, Irradiated.
Recall # B-1562-3;
b) Platelets. Recall # B-1563-3.
CODE
a) and b) Unit 9063837.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated March 30, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who disclosed travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Platelets, Pheresis, Leukoreduced. Recall # B-1564-3.
CODE
Units 8003897A, 1267316A, 8001723A, 8001723B.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by facsimile on February 14, 2003. Firm initiated recall is complete.
REASON
Platelets, with inadequate plasma volume to support the platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA.
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall B-1565-3;
b) Platelets, Leukoreduced, Irradiated. Recall # B-1566-3;
c) Recovered Plasma. Recall # B-1567-3.
CODE
a), b), and c) Unit 1858633.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on April 9, 2002 and June 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who resided in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX and FL.
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1568-3;
b) Recovered Plasma. Recall # B-1569-3.
CODE
a) and b) Unit 2330487.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 14, 2002, and June 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who resided in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and FL.
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1570-3.
CODE
Unit N36145.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on October 10, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an unacceptably low hemoglobin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Platelets. Recall # B-1575-3.
CODE
Unit N30268.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on September 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Arthrotec, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1576-3;
b) Recovered Plasma. Recall # B-1577-3.
CODE
a) and b) Unit N06278.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on October 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN and NY.
PRODUCT
Fresh Frozen Plasma. Recall # B-1578-3.
CODE
Unit 2913812.
RECALLING FIRM/MANUFACTURER
Carter Blood Care, Bedford, TX, by telephone on July 18, 2002, and by letter dated July 26, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight Whole Blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1579-3.
CODE
Unit 8003918A, 8003918B.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by facsimile dated February 13, 2003. Firm initiated recall is complete.
REASON
Platelets, which had a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1580-3.
CODE
Unit 20P17647.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Boise, ID, by telephone on December 16, 2002.
Manufacturer: American Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Platelets, which were labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
a) Platelets. Recall # B-1581-3;
b) Platelets, Leukocytes Reduced. Recall # B-1582-3;
c) Fresh Frozen Plasma. Recall # B-1583-3;
d) Cryoprecipitated AHF. Recall # B-1584-3.
CODE
a) Units 24GK13407, 24KQ26976, 24KQ26978, 24KJ44023,
24KL30738, 24KS27745, 24KY31103, 24KE29214, 24KY33832,
24KS34740, 24GZ10305, 24GL25817, 24KJ34429, 24KQ19933,
24KE22085, 24KG27452, 24KH34007, 24KM42179, 24KS25419,
24KH34392, 24KY25938, 24KG27554, 24KY26030, 24KG26589,
24KM47096, 24GQ24082, 24KE24358, 24KM48129, 24GQ25221,
24KK86791, 24KY30020, 24GY10853, 24KG29766, 24KY31075,
24KY31076, 24KE27597, 24KY31463, 24KL33842, 24KK92631,
24KJ49506, 24KY39209, 24GQ37865, 24GQ42475, 24GQ42579,
24GL25814, 24GJ49366, 24KH70077, 24KJ57494, 24KJ37014;
b) Units 24GQ52000, 24KH73191, 24KJ59638, 24GK25666,
24KL33103, 24KY51366, 24KL53937, 24FC02265, 24FC03714,
24KH76541, 24KQ47756, 24KH79761, 24KG49355, 24KH82735,
24GL29661, 24KH92226, 24KH71063;
c) Units 24KM35258, 24KQ27943, 24KF03555, 24KH46347,
24KY33049, 24KH46457, 24KK95086, 24KM72095, 24KH72519,
24KY51366, 24KH18011, 24KH19224, 24KG19956, 24KG21919,
24KF02308, 24KE22085, 24KS24784, 24KS25419, 24KG27452,
24KY25067, 24KH34007, 24KM42179, 24KH34392, 24KY25938,
24KG27554, 24KQ25150, 24KE23865, 24KM47096, 24KJ43570,
24KS26194, 24KM48129, 24KK86791, 24KJ44023, 24KL30738,
24KS27745, 24KS28563, 24KY31075, 24KY31076, 24KE27597,
24KY31103, 24KY31463, 24KM52449, 24KE29214, 24KE29463,
24KH42908, 24KL34756, 24KH61351, 24KH61493, 24KH67155,
24FC03714, 24KH72189, 24KJ59298, 24KH73191, 24KJ59638,
24KH76541, 24KL33103, 24KH76982, 24KL53235, 24KQ47756,
24KH79761, 24KG49355, 24KL56631, 24KH92226, 24KH82735,
24KJ35682, 24KQ19933, 24KH20767;
d) Units 24KL22612, 24FK02148, 24KJ57913, 24KM71032,
24KL52096, 24KC26307, 24KH75236, 24KJ60683, 4KX08815.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by letter dated April 11, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of clotted Red Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 49 units;
b) 17 units;
c) 67 units;
d) 9 units.
DISTRIBUTION
KY, IN, GA, PA, VA, AK, AL, NY and Puerto Rico.
PRODUCT
Plasma. Recall # B-1586-3.
CODE
Unit 03FV82722.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Atlanta, GA, by telephone on February 11, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of clotted Red Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1587-3.
CODE
Unit 03F14795.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Atlanta, GA, by telephone on Feburary 18, 2003, and by letter dated March 13, 2003. Firm initiated recall is complete.
REASON
Platelets, which contained aggregates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.
PRODUCT
a) Platelets, Pheresis, Leukocytes Reduced.
Recall # B-1588-3;
b) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1589-3.
CODE
a) Unit 01FP24683 (part 2);
b) Unit 01FP24683 (part 1).
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letter dated December 4, 2002.
Manufacturer:American Red Cross Blood Services, Albany, NY. Firm initiated recall is complete.
REASON
Blood products, tested using sample tubes that may have been diluted with saline, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.
PRODUCT
Red Blood Cells. B-1590-3;
Red Blood Cells, Leukocytes Reduced. Recall # B-1591-3;
Platelets. Recall # B-1592-3;
Recovered Plasma. Recall # B-1593-3.
CODE
a) Units 7923116, 3582022;
b) Unit 9553569;
c) Unit 7923116;
d) Units 7923116, 3582022, 9553569.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on April 11, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but were collected from a donor that was subsequently determined to have a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
IL.
PRODUCT
a) Red Blood Cells. Recall # B-1594-3;
b) Fresh Frozen Plasma. Recall # B-1595-3;
c) Cryoprecipitated AHF. Recall # B-1596-3;
d) Recovered Plasma. Recall # B-1597-3.
CODE
a) Units 9822891, 9053018, 9052141;
b) Unit 9822891;
c) Units 9053018, 9052141;
d) Unit 9052141.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on March 7, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of having tested positive for hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 Units.
DISTRIBUTION
WI. and IL.
PRODUCT
a) Red Blood Cells. Recall # B-1599-3;
b) Platelets. Recall # B-1600-3;
c) Recovered Plasma. Recall # B-1601-3.
CODE
a), b), and c) Units 2370458, 2365850.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on February 10, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-(HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IL and WI.
PRODUCT
Source Plasma. Recall # B-1602-3.
CODE
BFFSPH, BFFRBY, BFFNCX, BFFMNK, BFFKXS, BFFKJP,BFFJQM, BFFJDZ, BFFGXN.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Fort Worth, TX, by letter dated November 27, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
IL.
PRODUCT
Source Plasma. Recall # B-1603-3.
CODE
Units 7YK689, 7YK417, 7YK201, 7YJ182, 7YJ007.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Fort Worth, TX, by letter dated October 29, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
Il.
PRODUCT
Source Plasma. Recall # B-1604-3.
CODE
Units BFFQML, BFFQKJ, BFFQFM, BFFPYC, BFFPPY, BFFPRH, BFFNYV, BFDBVJ, BFDBMV, BFDBKF, BFCXYW, BCXWZ, BFCWMJ, BFCWJZ, BFCVVV, BFBLNP, BFBLFX, BFBKQL, 98B140, 98B116, 435250, 435201, 435123, 435093.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Fort Worth, TX, by facsimile dated November 26, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of cocaine addiction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
IL.
PRODUCT
Source Plasma. Recall # B-1605-3.
CODE
Unit BFGQCS.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Fort Worth, TX, by letter dated May 15, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had a tattoo within twelve months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1607-3;
b) Fresh Frozen Plasma. Recall # B-1608-3.
CODE
a) Units 0929865, 0930998, 0929168, 0930997, 0929864;
b) Unit 0947221.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, UC Medical Center, Cincinnati, OH, by telephone on March 18, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to Platelets that were implicated in a transfusion reaction and contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
OH and KY.
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1611-3.
CODE
Unit 0951054.
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, UC Medical Center, Cincinnati, OH, by telephone on May 6, 2003. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1612-3.
CODE
Unit T49967.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on July 31, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had multiple high-risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Source Plasma. Recall # B-1613-3.
CODE
Units F01160036, F01350036, F01842036.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Cincinnati, OH, by fax on February 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who admitted to engaging in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
PRODUCT
Platelets. Recall # B-1614-3.
CODE
Unit M84822.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on January 28, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1626-3;
b) Platelets. Recall # B-1627-3;
c) Fresh Frozen Plasma. Recall # B-1628-3.
CODE
a), b), and c) Unit 0152938.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 16, 2002. Firm initiated recall is complete.
REASON
Blood products collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1632-3.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on April 23, 2002. 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
1 unit.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1634-3;
b) Cryoprecipitated AHG. Recall # B-1635-3.
CODE
a) and b) Unit 22FK96155.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on April 3, 2003, and by letters dated April 4, 2003, April 8, 2003 and May 2, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1639-3.
CODE
Unit numbers 22GX86790, 22LJ61279, 22GX88251, 22KK53847, 22GL02181, 22GX88249, 22GL03432, 22KQ77905, 22KY68185, 22KQ80251, 22KN39879, 22GW84320, 22LY89558, 22LY89559, 22FC02366, 22KJ86705, 22KV49324, 22LJ63898, 22LJ61407, 22FJ79499, 22KP83903, 22FW91671, 22LJ61403, 22GW85331, 22KT50613, 22FQ06113, 22FQ06053, 22LW65828, 22FS13608, 22FC02795, 22LY91168, 22FC05447, 22GW87669, 22KK49767, 22LJ61398, 22LJ61410, 22GL02180, 22LY90436, 22LJ61404, 22LJ61411, 22KC45332, 22LY91166, 22LJ61414, 22FJ76871, and 22LY91663.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letters on February 6, 2003, and March 6, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
45 units.
DISTRIBUTION
PA, NJ, MD, NY, and VA.
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1641-3.
CODE
Unit numbers 27LG42571, 27LG42573, 27LG42572, 27LG42574, and 27LG42568.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letter on April 11, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
PA, WV, and MD.
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1642-3.
CODE
Unit 27GM66969.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letter on February 3, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Cryoprecipitated AHF. Recall # B-1646-3;
Fresh Frozen Plasma. Recall # B-1647-3;
Plasma. Recall # B-1648-3.
CODE
a) Unit numbers 40FE63121, 40GC36624, 40GC44003,
40GE49395, and 40GR53922;
b) Unit numbers 40FQ32204, 40FR19351, 40FT13405, 40FT13496,
40GC74563, 40GH48138, and 40LR20977;
c) Unit numbers 40FC13332, 40FH25228, 40FR19045, 40FR19213,
40FT14459, 40FV09348, 40GC36624, 40GC44003, 40GE45027,
40GJ45926, 40GK28674, 40GR53922, 40LV01273, and
40LV01653.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on April 2, 2003, and by letter on April 8, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 5 units;
b) 7 units;
c) 14 units.
DISTRIBUTION
IL, CA, GA, AL, NY, KY, MD, and Puerto Rico.
PRODUCT
a) Platelets. Recall # B-1649-3;
b) Fresh Frozen Plasma. Recall # B-1650-3;
c) Plasma. Recall # B-1651-3.
CODE
a) Unit numbers 004E31856, 004E36041, 004F47692, 004F47781,
004J06720, 004L28769, 004L29186, 004L33969, 004LE21609,
004LE28881, 004LE31793, 004M00843, 004N00608, 004N95851,
and 004R50766;
b) Unit numbers 004E31856, 004E48034, 004E54457, 004F94378,
004F99311, 004G32054, 004G33078, 004H13290, 004H14175,
004H16904, 004H22123, 004H23228, 004J06720, 004J40881,
004J41904, 004J43925, 004J93385, 004KF33157, 004KF33164,
004KF33167, 004KL55198, 004L28769, 004L29186, 004L33969,
004L37935, 004LE31793, 004LE34404, 004LE35484,
004M13291, 004N00608, 004N02880, 004N08177, 004N09303,
004N15283, 004N15605, 004N95851, 004R50766, and
004V93648;
c) Unit numbers 004C48321, 004C50132, 004E38244,
004FJ53043, 004FS34672, 004FS52923, 004J49423,
004KT27924, 004KT30330, 004KW50764, 004KW94327,
004R97281, and 004V00362.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on April 3, 2003, and by letters on April 9, 2003, and July 18, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 15 units;
b) 38 units;
c) 13 units.
DISTRIBUTION
AR, NH, NY, MA, ME, VT, and Puerto Rico.
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-1652-3.
CODE
Unit number E41298.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on February 17, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells. Recall #B-1653-3.
CODE
Unit numbers 3944106, 3944192, 3944141, 3944198, 3944200, 3944210, 3944217, 3944216, 3944219, 3944226, and 3944180
RECALLING FIRM/MANUFACTURER
Dept. of the Army, U.S. Army Blood Bank, Center Fort Hood, TX, by facsimile on June 29, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from ineligible donors due to decreased hemoglobin values, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
TX, FL, WA, and VA.
PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-1660-3.
CODE
Tissue numbers 2003-07-6045 and 2003-07-6046.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Lions Eye Banks, Columbia, MO, by telephone on July 23, 2003, and by facsimile and letter on July 25, 2003.
Manufacturer: Heartland Lions Eye Banks, Kansas City, MO. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
FL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated.
Recall # B-1665-3.
CODE
Unit number 8760522.
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by telephone on March 6, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for the antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor that had been previously deferred for reactive testing for anti-HBc, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1666-3.
CODE
Unit number 8755082.
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter on January 8, 2003. 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
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells. Recall # B-1200-3.
CODE
Units LX08481, LX08482, LX08484, LX08486, LX08488.
RECALLING FIRM/MANUFACTURER
Inova Health System, Blood Donor Services, Annandale, VA, by letter dated December 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected without daily quality control being performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
VA.
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1201-3.
CODE
Units 21GW35433, 21GW35434, 21GW35436, 21GW35437, 21GW35438, 21GW35439, 21GW35440, 21GW35441, 21GW35442, 21GW35443, 21GW35444, 21GW35445, 21GW35446, 21GW35447, 21GW35448.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on July 18, 2002, and by letter dated July 31, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured using equipment that had not been quality controlled, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
WA and OR.
PRODUCT
Fresh Frozen Plasma. Recall # B-1640-3.
CODE
Unit numbers 22GE68914, 22GW83714, 22KN39474, 22KQ77666, 22KV52853, 22KQ77745, 22KX49083, 22LQ93652, 22FJ79499, 22GE69423, 22GE70152, 22GX88251, 22KF40584, 22KN39879, 22KP83074, 22KQ77667, 22KQ77905, 22KT50613, 22KX53099, 22LY91574, 22FW91671, 22KP83853, 22KT51070, 22LY92464, 22FW90686, 22LQ97205, 22GK97803, 22KQ77739, 22KT51803, and 22FV99166.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letters on February 6, 2003, and March 6, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
PA, NJ, MD, NY, and VA.
PRODUCT
a) Platelets. Recall B-1643-3;
b) Platelets Pheresis. Recall # B-1644-3.
CODE
a) Unit numbers 27GV65689, 27GV65690, 27GT85267, 27GV65698,
27GV65701, 27GV65705, 27GV65707, 27GV65710, 27GV65712,
27GV65715, 27GX62779, 27GX62785, 27GX62786, 27GX62789,
27GX62796, and 27LF54256;
b) Unit numbers 27P62933 and 27P62931.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies, Region, Johnstown, PA, by telephone on April 6, 2003, and by letter on April 14, 2003. Firm initiated recall is complete.
REASON
Platelets, not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 16 units;
b) 2 units.
DISTRIBUTION
PA.
PRODUCT
Source Plasma. Recall # B-1645-3.
CODE
Unit numbers 0082503, 0082651, 0083204, 0083346, 0083896, 0084129, 0084267, 0084653, 0084848, 0086061, 0086201, 0086752, 0086843, 0087509, 0087643, 0088328, 0088483, 0088722, 0088899, 0089206, 0089395, 0089709, 0089968, 0090161, 0090361, 0090553, 0090824, 0091145, 0091632, 0091920, 0092191, 0092415, 0093968, 0094202, 0095281, 0095802, 0097697, 0097766, 0098241, 0098468, 0098929, 0099114, 0099373, 0099615, 0100065, 0100384, 0100562, 0100887, 0101095, 0101399, 0101580, CD0102028, CD0102378, CD0102605, CD0102705, CD0102926, CD0103059, CD0103245, CD0103453, CD0103570, CD0104697, CD0104840, CD0105054, CD0105202, CD0105448, CD0105633, CD0105864, CD0105962, CD0106906, CD0107285, CD0107753, CD0108080, CD0109071, CD0109588, CD0109724, CD0110047, CD0111004, CD0111498, CD0111670, CD0112048, CD0113149, CD0113577, CD0114177, CD0114485, CD0114862, CD0117743, CD0118132, CD0118444, CD0118831, CD0119171, CD0119202, CD0119435, CD0119530, CD0119913, CD0120074, CD0120469, CD0120771, CD0120955, CD0121251, CD0121475, CD0121766, CD0121952, CD0122352, CD9122518, CD0122789, and CD0122942.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Carbondale, Inc., Carbondale, IL, by facsimile on May 29, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of a chronic ulcerative condition, were distributed.
VOLUME OF PRODUCT IN COMMERCE
106 units.
DISTRIBUTION
NC and NY.
PRODUCT
Products: Platelets Pheresis, Leukocytes Reduced. Recall # B-1661-3.
CODE
Unit numbers 040P93047, 40FP17029, 40FP17030, 40FP17033, 40FP17034, 40P93034, 40P93035, 40P93041, 40P93038, 40P93042, 40P93044, 40P93050, and 40FP17027; and the following units were distributed as two split products: unit numbers 40FP17028, 40P93047, 40P93045, and 40FP17032.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America Region, Peoria, IL, by telephone on April 14, 2003, and by letter on April 18, 2003. Firm initiated recall is complete.
REASON
Platelets Pheresis incorrectly tested for platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
AL, TX and AZ.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 3, 2003
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