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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 50328
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Dedham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-09-13
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern CA, MA, NH, VT

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced 004KM33220;004KM61922;004KM69676;004KQ32543;004KT69103 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 5 units B-0574-13
Blood and Blood Products for Reprocessing 004KM69676 Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0575-13
Plasma Frozen 004KT69103 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0576-13
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