Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | Cornea |
|---|---|
| Recall Number | B-0388-13 |
| Classification | Class III |
| Code Info | 120349100; 120349200 |
| Product Distributed Qty | 2 |
| Reason For Recall | Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
Event Detail
| Event Id | 63678 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | East Tennessee Lions Eye Bank |
| City | Knoxville |
| State | TN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-18 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Tennessee |
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