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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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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
Distribution Pattern Florida; Dominican Republic

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea 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 Class III 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. 36 B-0196-13