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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Cornea
Recall Number B-0967-13
Classification Class II
Code Info CN100033OS; CN100033OD
Product Distributed Qty 2
Reason For Recall 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.

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 E-Mail
Distribution Pattern Saudi Arabia; Indiana