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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Product Detail

Product Description Cornea
Recall Number B-2275-13
Classification Class III
Code Info 20130076OD; 20130076OS
Product Distributed Qty 2 corneas
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 65525
Product Type Biologics
Status Terminated
Recalling Firm International Sight Restoration, Inc.
City Tampa
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-05
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Egypt; Florida
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