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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 38800
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Cleveland
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-03-28
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern OH

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced 042K90931 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-1958-13
Platelets Pooled Leukocytes Reduced 042K90931 (pool 1997) Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-1959-13
Plasma Frozen 042K90931 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. 1 unit B-1960-13
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