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 |
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