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From: TSS (216-119-144-71.ipset24.wt.net)
Subject: CJD AND VCJD PLASMA RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II October 27, 2004
Date: October 27, 2004 at 1:53 pm PST
-------- Original Message --------
Subject: CJD AND VCJD PLASMA RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II October 27, 2004
Date: Wed, 27 Oct 2004 15:56:10 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy #####################
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II _______________________________
PRODUCT
Source Plasma. Recall # B-0039-5.
CODE
Units 86888165, 86886536, 86881807, 86891257, 86884730, 86882774,
86831673, 86828680, 86814492, 86892100, 86885843, 86883184, 86876278,
86872171, 86860963, 86859790, 86889131, 86855549, 86850490, 86880909,
86876766, 86874625, 86890724, 86887571, 86885379, 86882255, 86879811,
86877329, 86874694, 86871198, 86866941, 86864428, 86876599, 86874182,
86870924, 86868730, 86865524, 86863216, 86859608, 86856508, 86854252,
86851305, 86849630, 86846301, 86840118, 86838979, 86834674, 86832922,
86829595, 86826440, 86822190, 86820066, 86814935, 86812351, 86808422,
86806572, 86804257, 86802390, 69746536, 69743252, 69739309, 69736865,
69732409, 69730054, 86821070, 86817615, 86890878, 86888103, 86867023,
86865937, 86859936, 86857659, 86854641, 86850551, 86847742, 86845700,
86842174, 86840255, 86836951, 86834803, 86831147, 86828765, 86959216,
86816755, 86843911.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX, by letter dated June 12, 2003.
Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history screenings
did not include questioning regarding risk factors for Creutzfeldt-Jakob
Disease (CJD) and variant Creutzfeldt-Jakob Disease (nvCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE
85 units.
DISTRIBUTION
IL. _______________________________ October 27, 2004 http://www.fda.gov/ TSS ################# BSE-L-subscribe-request@uni-karlsruhe.de #################
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