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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012
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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea 20111263; 20111264 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 2 B-0378-13
Skin 20111263BL16; 20111263BL26; 20111263BL36; 20111263BL46; 20111263BL56; 20111263BL66; 20111263FL15; 20111263FL25; 20111263FL35; 20111263FL45; 20111263FL55 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 11 B-0379-13
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