August 13, 2003
03-33
_______________________________
PRODUCT
Sundown Fish Oil 1000 MG Dietary Supplement 120 Softgels Omega-3 Fatty Acids EPA/DHA Concentrate, packed in plastic bottles with screw on plastic caps. Recall # F-483-3.
CODE
Lot Number 357849.
RECALLING FIRM/MANUFACTURER
Rexall Sundown, Boca Raton, FL, by letter on April 8, 2002. Firm initiated recall is complete.
REASON
Product labeled as Fish Oil Capsules consists in whole or in part of Vitamin E capsules.
VOLUME OF PRODUCT IN COMMERCE
35,000 120 capsule bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0860-3.
CODE
Unit 210005.
RECALLING FIRM/MANUFACTURER
Aultman Hospital Association Blood Center, Canton, OH, by letter dated May 6, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Source Plasma. Recall # B-1079-3.
CODE
0090617980, 0090617953, 0090617855, 0090617819, 0090617708, 0090617650, 0090617549, 0090617504, 0090617340, 0090617282, 0090617149, 0090617060, 0090616974, 0090616896, 0090616817, 0090616727, 0090616648, 0090616547, 0090616475, 0090616361, 0090616280, 0090616160, 0090616086, 0090615984, 0090615911, 0090615813, 0090615729, 0090615606, 0090615525, 0090615395, 0090615314, 0090615169, 0090615086, 0090614848, 0090614719, 0090614628, 0090614511, 0090614413, 0090614276, 0090614123, 0090612941, 0090612774, 0090612705, 0090612012, 0090611964
37238674, 37236595, 37233150, 37231446, 37230098, 37229016, 37227135, 37210229, 37209469, 37205553, 37204242, 37203030, 37202101, 37200633, 37199500, 37198244, 37196486, 37195182, 37194260, 37192785, 37191672, 37190514, 37188528, 37187293, 37185756, 37183714, 37181079, 37180027, 37175634, 37174361, 37173166
RECALLING FIRM/MANUFACTURER
NABI Biomedical Center, Scranton, PA, by letters dated April 12 and April 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
76 units.
DISTRIBUTION
PA, CA, Israel, and Scotland.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1290-3;
b) Red Blood Cells, Irradiated. Recall # B-1291-3;
c) Platelets. Recall # B-1292-3;
d) Platelets, Leukocytes Reduced. Recall # B-1293-3.
e) Platelets, Pheresis, Leukocytes Reduced.
Recall # B-1294-3;
f) Platelets, Pheresis, Irradiated. Recall # B-1295-3;
g) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
Recall #B-1296-3;
h) Fresh Frozen Plasma. Recall # B-1297-3;
i) Cryoprecipitated AHF. Recall # B-1298-3;
j) Plasma. B-1299-3.
CODE
a) FH29405, FH29406, FH29407, FH29408, FH29409, FH29410,
FH29411, FH29412, FH29413, FH29414, FH29415, FH29416, FH29417, FH29418, FH29420, FH29421, FH29422, FH29423, FH29424, FH29425, FH29426, FT99923, FT99924, FT99925, FT99926, FT99928, FT99929, FT99930, FT99931, FT99932, FT99933, FT99934, FT99935, FT99936, FT99937, FT99939, FT99940, FT99942, FT99943, FT99944, FT99945, FT99946, FT99947, FT99949, FT99950, FT99951, FT99952, FT99953, FT99955, FT99956, FT99957, FT99958, FT99959, FT99962, FT99963, FT99964, FT99966, FT99967, FT99968, FT99969, FT99970, FT99971, KS09091, KS09092, KS09093, KS09094, KS09095, KS09096, KS09097, KS09098, KS09099, KS09101, KS09102, KS09103, KS09104, KS09105, KS09106, KS09107, KS09108, KS09109, KS09110, KS09111, KS09112, KS09113, KS09114, KS09115, KS09116, KS09118, KS09119, KS09120, KS09121, KS09122, KS09123, KS09124, KS09125, KS09126, KS09127, KS09128, KS09129, KS09130, KS09131, KS09132, KS09133, KS09135, KS09137, KS09138, KS09139, KS09140, KS09141, KS09142, KS09143, KS09144, KS09145, KS09146, KS09147, KS09148, KS09149, KS09151, KS09154, KS09155, KS09156, KS09157, KS09158, KS09160, KS09161, KS09162, KS09163, KS09164, KS09166, KS09167, KS09168, KS09169, KS09170, KS09171, KS09172, KS09174, KS09175, KS09176, KS09177, KS09178, KS09179, KS09180, KS09181, KS09182, KS09183, KS09184, KS09185, KS09186, KS09187, KS09188, KS09189, LC20654, LC20655, LC20656, LC20658, LC20659, LC20660, LC20661, LC20662, LC20663, LC20664, LC20665, LC20666, LC20667, LC20668, LC20669, LC20670, LC20672, LC20673, LC20674, LC20675, LC20676, LC20677, LC20678, LC20679, LC20680, FT99925, FT99930, FT99932, FT99933, FT99934, FT99935, T99937, FT99942, FT99943, FT99944, FT99945, FT99949, FT99951;
b) KS09153;
c) FT99925, FT99930, FT99932, FT99933, FT99934, FT99935,
FT99937, FT99942, FT99943, FT99944, FT99945, FT99949,
FT99951;
d) FT99921 (2 splits), FT99922, FT99926, FT99938;
e) FT99963, LC20671 (3 splits);
f) FT99922, FT99926, FT99938, FT99954;
g) FT99920;
h) FH29406, FH29412, FH29414, FH29416, FH29424, FT99923,
FT99932, FT99933, FT99935, FT99942, FT99943, FT99951,
FT99952, FT99953 (split units), FT99956, FT99959,
FT99964, FT99966, FT99971, KS09091 (split units),
KS09113, KS09116, KS09123(split units), KS09128,
KS09129, KS09137, KS09140(split units), KS09143,
KS09154, KS09157, KS09160, KS09163, KS09164, KS09166,
KS09167, KS09168, KS09171, KS09172, KS09174, KS09177,
KS09179, KS09180, KS09181, KS09189
i) FT99931, KS09093, KS09096, KS09097, KS09098, KS09099,
KS09101, KS09102, KS09105, KS09106, KS09107, KS09110,
KS09111, KS09115, KS09118, KS09119, KS09120, KS09131, KS09122, KS09124, KS09125, KS09127, KS09136, KS09139, KS09141, KS09145, KS09146, KS09147, KS09148, KS09149, KS09151, KS09153, LC20658, LC20659, LC20661, LC20662, LC20663, LC20664, LC20665, LC20666, LC20667, LC20669, LC20670, LC20673, LC20674, LC20676, LC20678, LC20679;
j) KS09093, KS09105, KS09118, KS09139.
RECALLING FIRM/MANUFACTURER
Inova Health System, Blood Donor Services, Annandale, VA, by facsimile dated August 19, 2002, and by letter dated August 20, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 176 units;
b) 1 unit;
c) 13 units;
d) 5 units;
e) 4 units;
f) 4 units;
g) 1 unit;
h) 49 units;
i) 48 units;
j) 4 units.
DISTRIBUTION
VA, MD, and D.C.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1341-3.
CODE
Unit 6556662.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on March 4, 2003. Firm initiated recall is complete.
REASON
Blood product, mislabeled as having been tested by NAT for HIV and HCV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1415-3;
b) Platelets. Recall # B-1416-3.
CODE
a) Unit J69016;
b) Units J69016, J69412.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw Valley Blood, Saginaw, MI, by fax on March 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI.
______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1417-3;
b) Recovered Plasma. Recall # B-1418-3.
CODE
a), and b) Units 38FK24368, 38FK23499.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter or fax dated March 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
IN, and NC.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1433-3;
Red Blood Cells, Leukocytes Reduced. Recall # B-1434-3.
CODE
a) Unit numbers 11005909, 11006938, 11007822, 11008816,
11020399, 11021067, 11021753, 11022707, 11023533;
b) Unit number 11019730.
RECALLING FIRM/MANUFACTURER
W.E. and Lela I. Stewart Blood Center, Tyler, TX, by letter on June 8, 2001. 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
a) 9 units;
b) 1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
Platelets. Recall # B-1435-3.
CODE
Unit number 91-86411.
RECALLING FIRM/MANUFACTURER
Medic, Inc, Knoxville, TN, by letter on July 25, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1436-3.
CODE
Unit number 9065066 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on March 20, 2001, and by letter on March 26, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1437-3;
b) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1438-3.
CODE
a) Unit numbers 90-55646, 90-61262, 90-61898, 90-67011,
90-55965, 90-67231, and 90-70748;
b) Unit number 9065066 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on October 24, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 1 unit;
b) 7 units.
DISTRIBUTION
TN, and KY.
________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1439-3;
b) Platelets. Recall # B-1440-3.
CODE
a) Unit numbers 90-65239 and 94-81988;
b) Unit number 90-65239.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on December 19, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TN.
________________________________
PRODUCT
a) Red Blood Cells. Recall # B-1441-3;
b) Platelets. Recall # B-1442-3.
CODE
a) Unit 34027138;
b) Unit 34028850.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by telephone and by letter dated January 5, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
________________________________
PRODUCT
Red Blood Cells. Recall # B-1443-3.
CODE
Unit 34027009.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by letter dated February 1, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
Red Blood Cells. Recall # B-1444-3.
CODE
Unit 10021325.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by letter dated November 16, 1999. 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
TX.
________________________________
PRODUCT
Platelets, Pheresis. Recall # B-1446-3.
CODE
Unit 10022651.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by telephone on August 9, 1999. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have affected the sensitivity of viral marker test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
________________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1447-3.
CODE
Unit 12011400.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by letter dated October 10, 2000. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
Source Plasma. Recall # B-1450-3.
CODE
Units GP54665, GP64415, GP64203.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN, by facsimile transmission dated November 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA, Vienna, and Austria.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1454-3;
b) Platelets. Recall # B-1455-3.
CODE
a) and b) Unit number K90576.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letters on March 25, and 26, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to body piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1456-3;
b) Platelets. Recall # B-1457-3;
c) Recovered Plasma. Recall # B-1458-3.
CODE
a), b), and c) Unit number R20297.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letters on March 17, and 18, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL, and CA.
________________________________
PRODUCT
a) Red Blood Cells. Recall # B-1459-3;
b) Recovered Plasma. Recall # B-1460-3.
CODE
a) and b) Unit 30025565.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by telephone and letter on or about October 8, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and CA.
________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1461-3.
CODE
Unit numbers 6835898, 6835900, 6835903, and 6835904.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by telephone on June 10, 2002. Firm initiated recall is complete.
REASON
Blood products, collected using a phlebotomy method that may have compromised the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX.
________________________________
PRODUCT
Red Blood Cells. Recall # B-1463-3.
CODE
Unit number 33019935.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by letter on September 19, 2001. Firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
Platelets, Pheresis, Leukoreduced Irradiated. Recall # B-1465-3.
CODE
Unit 9067395 (A&B).
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated June 7, 2001. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1466-3;
b) Fresh Frozen Plasma. Recall # B-1467-3.
CODE
a) and b) Unit 6704359.
RECALLING FIRM/MANUFACTURER
LifeShare, Inc., Elyria, OH, by letter dated May 12, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.
______________________________
PRODUCT
Source Plasma. Recall # B-1469-3.
CODE
Unit 92194526.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN, by fax dated April 28, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had body piercing within twelve months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
______________________________
PRODUCT
Allergenic Extract, Mite (D, pteronyssinus), scratch vials. Recall # B-1470-3.
CODE
Lot number 326042299.
RECALLING FIRM/MANUFACTURER
Allergy Laboratories, Inc., Oklahoma City, OK, by telephone on June 17, 2002, and by letter on June 20, 2002. Firm initiated recall is complete.
REASON
Allergenic extract, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 vials of 1 lot.
DISTRIBUTION
VA, TX, OK, KN, and MA.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1474-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1475-3.
CODE
a) Unit numbers 042FN11160 and 042Y34192;
b) Unit numbers 042FJ12443 and 042S94980.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on February 6, 2003, and by letters on February 7, 2003, and March 13, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose body temperature was not properly determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OH.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1476-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1477-3;
c) Platelets. Recall # B-1478-3;
d) Recovered Plasma. Recall # B-1479-3.
CODE
a) Unit number 01GG40727;
b) Unit number 01GG49030;
c), and d) Unit numbers 01GG40727 and 01GG49030.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by facsimile on November 20 and 21, 2002.
Manufacturer: American Red Cross Blood Services, Syracuse, NY. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NY, and CA.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1204-3.
CODE
Units 6814988, 8246928, 4031556, 82337732, 2733153, 8414722, 2898803, 7807747,
8235476, 8247304.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., by telephone on April 8, 2003,
and May 9, 2003. Firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
IN.
________________________
PRODUCT
Platelets. Recall # B-1315-3.
CODE
Unit 7917032.
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL, by facsimile dated February
19, 2001. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Red Blood Cells that was implicated
in a transfusion reaction and contaminated with Propionibacterium acnes, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1448-3.
CODE
Unit 15002456.
RECALLING FIRM/MANUFACTURER
W. E. & Lela I. Stewart Blood Center, Inc., Tyler, TX, by letter dated July
27, 1998. Firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
Source Plasma. Recall # B-1451-3.
CODE
Unit GP56843.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN, by facsimile transmission dated November
5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to behavior associated
with an increased risk of infection with the human immunodeficiency virus (HIV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA, Vienna, and Austria.
______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1452-3.
CODE
Unit number 91602298.
RECALLING FIRM/MANUFACTURER
Vermont Blood Center, Williston, VT, by telephone and letter on November 12,
2002. Firm initiated recall is complete.
REASON
Blood product, prepared more than eight hours after collection of the corresponding
unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.
______________________________
PRODUCT
Platelets. Recall # B-1453-3.
CODE
Unit number F68743.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on
April 14, 2003, and by letter on April 15, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had extended collection
time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1462-3.
CODE
Unit numbers 6801456 and 6801459.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by telephone on October 16,
2001. Firm initiated recall is complete.
REASON
Blood products possibly exposed to unacceptable storage temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Irradiated. Recall # B-1468-3.
CODE
Units 231471951, 231471949.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT, by telephone on October 1, 2002. Firm initiated
recall is complete.
REASON
Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MT.
______________________________
PRODUCT
Source Plasma. Recall # B-1473-3.
CODE
Unit numbers 0270736 and 0271056.
RECALLING FIRM/MANUFACTURER
Bowling Green Biologicals, LLC, Bowling Green, KY, by facsimile on January 7
and 16, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV),
but were not properly quarantined after the receipt of subsequent repeatedly
reactive anti-HCV results for the donor of the unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
END OF ENFORCEMENT REPORT FOR AUGUST 13, 2003
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Hypertext created by clb 2003-AUG-13.