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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 64122
Product Type Biologics
Status Terminated
Recalling Firm Beth Israel Medical Center, The Ralph Gore Blood Bank
City New York
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern New York

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Irradiated W139312000229; Class II Blood product, labeled as leukoreduced, but which had not undergone leukoreduction, was distributed. 1 B-0990-13