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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65280
Product Type Biologics
Status Terminated
Recalling Firm DCI Donor Services dba Sierra Donor Services
City Sacramento
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-20
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Tennessee

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea SDS130600OSCN; SDS130600ODCN Class II Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. 2 units B-2025-13
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