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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 Sclera
Recall Number B-2559-13
Classification Class III
Code Info 2009227SB; 2009227SC
Product Distributed Qty 2 sclera
Reason For Recall Human tissue allografts, 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 65991
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; Venezuela
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