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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description Source Plasma
Recall Number B-1016-13
Classification Class III
Code Info 12GINB4552;
Product Distributed Qty 1
Reason For Recall Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

Event Detail

Event Id 64098
Product Type Biologics
Status Terminated
Recalling Firm Bio-Blood Components, Inc.
City Gary
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-30
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Tennessee
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