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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Cornea
Recall Number B-2353-13
Classification Class II
Code Info 201062C
Product Distributed Qty 1 cornea
Reason For Recall Human cornea, 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, was distributed.

Event Detail

Event Id 65945
Product Type Biologics
Status Terminated
Recalling Firm Lions Eye Bank For Long Island
City Valley Stream
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern New York
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