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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea 2009227C; 2009228C; Class III 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. 2 corneas B-2558-13
Sclera 2009227SB; 2009227SC Class III 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. 2 sclera B-2559-13
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