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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 64462
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Svs. Indiana-Ohio Region
City Fort Wayne
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-10
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern California; Indiana

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Blood and Blood Products for Reprocessing 038GZ69902; 038Y79139; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 2 units B-1468-13
Red Blood Cells Leukocytes Reduced 038GZ69902; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. 1 B-1467-13
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