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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description Source Plasma
Recall Number B-0218-14
Classification Class III
Code Info HS0301473; HS0301715; HS0307866; HS0335910; HS0336124; HS0308613
Product Distributed Qty 6 units
Reason For Recall Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.

Event Detail

Event Id 66781
Product Type Biologics
Status Terminated
Recalling Firm DCI Biologicals Hot Springs, Inc
City Hot Springs National Park
State AR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-27
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern United Kingdom