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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Detail

Product Description Red Blood Cells (Apheresis) Leukocytes Reduced
Recall Number B-2511-13
Classification Class II
Code Info W040713692503; W040713692503; W040713443772; W040713211379; W040713443792; W040713614024; W040713444328; W040713444328; W040713211403; W040713211403; W040713462890; W040713462917; W040713462926; W040713602263; W040713211672; W040713693099; W040713213007; W040713463015; W040713456715; W040713456715; W040713602387; W040713211251; W040713614094; W040713692560; W040713692560;
Product Distributed Qty 25
Reason For Recall Blood products, with disparate weights between the two units collected during the apheresis procedure, were distributed.

Event Detail

Event Id 65725
Product Type Biologics
Status Terminated
Recalling Firm Indiana Blood Center
City Indianapolis
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-25
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Indiana