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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description Cornea
Recall Number B-2025-13
Classification Class II
Code Info SDS130600OSCN; SDS130600ODCN
Product Distributed Qty 2 units
Reason For Recall 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.

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