Enforcement Report - Week of November 21, 2012
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Product Detail
| Product Description | Cornea |
|---|---|
| Recall Number | B-0196-13 |
| Classification | Class III |
| Code Info | 1106057COS; 1101093CODG1; 1101093CODG2; 1101093COSG1; 1101093COSG2; 1103009COD; 1103009COSG1; 1103009COSG2; 1103042CODG1; 1103042CODG2; 1103042COS; 1104100COD; 1104100COS; 1105042COD; 1105042COSGW; 1105052COD; 1105052COS; 1106005COD; 1106005COS; 1106057COD; 1107047COD; 1107047COS; 1109010COD; 1109010COS; 1110020CODG1; 1110020CODG2; 1110020COSG1; 1110020COSG2; 1203082COD; 1203082COS; 1204060COD; 1204060COS; 1206025COD; 1206025COS; 1105073-COD; 05073COS |
| Product Distributed Qty | 36 |
| Reason For Recall | Human Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. |
Event Detail
| Event Id | 63332 |
|---|---|
| Product Type | Biologics |
| Status | Terminated |
| Recalling Firm | Florida Lions Eye Bank, Inc. |
| City | Miami |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-01 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Florida; Dominican Republic |
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