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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description Skin
Recall Number B-0379-13
Classification Class III
Code Info 20111263BL16; 20111263BL26; 20111263BL36; 20111263BL46; 20111263BL56; 20111263BL66; 20111263FL15; 20111263FL25; 20111263FL35; 20111263FL45; 20111263FL55
Product Distributed Qty 11
Reason For Recall Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.

Event Detail

Event Id 63562
Product Type Biologics
Status Terminated
Recalling Firm Transplant Services Center UT Southwestern Medical Center
City Dallas
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Texas
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