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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Cornea
Recall Number B-2274-13
Classification Class II
Code Info 130051100; 130051200
Product Distributed Qty 2 allografts
Reason For Recall Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that 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 65633
Product Type Biologics
Status Terminated
Recalling Firm Midsouth Eye Bank for Sight Restoration Inc
City Memphis
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-21
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Venezuela
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