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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description Cornea
Recall Number B-1495-13
Classification Class III
Code Info 1302059; 1302060;
Product Distributed Qty 2 corneas
Reason For Recall Human Cornea, recovered from a donor whose donor eligibility was not determined in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, was distributed.

Event Detail

Event Id 64864
Product Type Biologics
Status Terminated
Recalling Firm Arkansas Lions Eye Bank & Laboratory
City Little Rock
State AR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Arkansas