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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Event Detail

Event ID 39175
Product Type Biologics
Status Terminated
Recalling Firm Southern California Permanente Medical Group Blood Donor Center
City Irvine
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-04-04
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern CA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plasma Frozen KK15215; KK15186; KK13926; KK13907; KK13906; KK13867; KK13868; KJ42191; KK13869 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 9 units B-1681-13
Red Blood Cells KK15215; KK15213; KK15186 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 3 units B-1680-13
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