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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64268
Product Type Biologics
Status Terminated
Recalling Firm Indiana Lions Eye and Tissue Transplant Bank
City Indianapolis
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern Saudi Arabia; Indiana

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea CN100033OS; CN100033OD Class II Human Corneas, recovered from a donor whose donor screening was performed in a manner that did not determine the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. 2 B-0967-13