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U.S. Department of Health and Human Services

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