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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea 1302059; 1302060; Class III 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. 2 corneas B-1495-13
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