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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 52254
Product Type Biologics
Status Terminated
Recalling Firm New York Blood Center, Inc.
City New York
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-03-09
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern NY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) Irradiated W047008155090B; W047008155091A; W047008155089B Class II Blood products, which did not meet the acceptable product specifications, were distributed. 3 units B-0865-13
Red Blood Cells (Apheresis) W047008155090A; 047008155046A; W047008155046B; W047008155053A; W047008155053B; W047008155085A; W047008155085B; W047008155087A; W047008155087B; W047008155088A; W047008155089A; W047008155091B; W047008155093A; W047008155093B; W047008155094A; W047008155094B; W047008155118B; W047008155120B; W047008155121B; W047008155122B; W047008155118A; W047008155120A; W047008155121A; W047008155122A; W047008155123A; W047008155123B; W047008155124B; W047008155125B; W047008161334B; W047008161341B; W047008184441B; W047008184422B; W047008184435B; W047008184441B; W047008155124A; W047008155125A; W047008161334A; W047008161341A; W047008184441A; W047008184422A; W047008184435A; W047008184441A Class II Blood products, which did not meet the acceptable product specifications, were distributed. 42 units B-0866-13
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