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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Event Detail

Event ID 62305
Product Type Biologics
Status Terminated
Recalling Firm SightLife
City Seattle
State WA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-01
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern One cornea was shipped to each of 2 physicians in Japan.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Corneas AAG744ODCN; AAG744OSCN Class II Human Corneas, recovered from a donor with evidence of infection due to a communicable disease agent, were distributed. 2 corneas, (1 right, 1 left) B-2312-12