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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 57787
Product Type Biologics
Status Terminated
Recalling Firm Talecris Plasma Resources, Inc.
City Research Triangle Park
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-12-28
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern NC

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Source Plasma 3340071032; 3340070642; 3340044324; 3340081726; 3340081366; 3340080719; 3340080104; 3340086530; 3340086069; 3340084877; 3340083843; 3340092284; 3340090982; 3340090228; 3340088666; 3340088012; 3340087273; 3340082485; 3340070129, 3340069731, 3340067853, 3340067544 , 3340066891, 3340066603, 3340065983, 3340065723, 3340065086 , 3340064810, 3340064234, 3340063955, 3340063394, 3340063120, 3340062623 , 3340062177 , 3340061767, 3340061288, 3340060867, 3340058732 , 3340057797, 3340056897, 3340056423, 3340055934, 3340055465, 3340054968, 3340054612, 3340053991, 3340053539, 3340053011, 3340052581. Class III Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. 49 units B-0659-13
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