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From: TSS (wt-d6-140.wt.net)
Subject: BLOOD PRODUCTS RECALL DUE TO vCJD THREAT USA October 20, 2004
Date: October 20, 2004 at 12:48 pm PST

-------- Original Message --------
Subject: BLOOD PRODUCTS RECALL DUE TO vCJD THREAT USA
Date: Wed, 20 Oct 2004 14:53:41 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE


##################### Bovine Spongiform Encephalopathy #####################

PRODUCT
Source Plasma. Recall # B-0004-5.
CODE
Units BY0081013, BY0081234, BY0081539, BY0081749, BY0082116, BY0082324,
BY0082909, BY0082977.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Bryan, LLC, Bryan, TX, by facsimile dated November 6,
2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in western Europe, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
NY.

___________________________________

PRODUCT
Source Plasma. Recall # B-0038-5.
CODE
Units CS0179785, CS0195693.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, LLC, College Station, TX, by letter dated January
2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.

_______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0041-5.
CODE
Unit 2372493 (split unit).
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
March 7, 20, and 27, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for
Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # 0044-5;
b) Fresh Frozen Plasma. Recall # B-0045-5.
CODE
a) and b) Unit 2374447.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
January 22, and February 21, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was at risk for
Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0049-5;
b) Recovered Plasma. Recall # B-0050-5.
CODE
a) and b) Unit 2368943.
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile dated
February 13, 2003, and April 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in western Europe, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Vienna, Austria, and TX.
_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0056-5;
b) Cryoprecipitated AHF. Recall # B-0057-5;
c) Recovered Plasma. Recall # B-0058-5.
CODE
a), b), and c) Unit number 2372945.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
February 25, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX, and Switzerland.

_______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0059-5;
Recovered Plasma. Recall # B-0060-5.
CODE
a) and b) Unit number 2348391.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
February 12, and 19, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of
residing in an area considered at increased risk of exposure to variant
Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Austria.

_______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0080-5;
b) Fresh Frozen Plasma. Recall # B-0081-5.
CODE
a) and b) Unit 2356608.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
March 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for
Creuztfeldt Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________

END OF ENFORCEMENT REPORT FOR October 20, 2004

http://www.fda.gov/TSS

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