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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

Product Description Cornea
Recall Number B-2526-12
Classification Class II
Code Info 2010063945; 2010063946
Product Distributed Qty 2
Reason For Recall Human corneas, recovered from a donor whose donor eligibility may have been been determined with inaccurate and/or incomplete donor records, were distributed.

Event Detail

Event Id 63052
Product Type Biologics
Status Terminated
Recalling Firm Lions Eye Institute for Transplant & Research, Inc.
City Tampa
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern California; Florida