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Terminated

CryoValve, Pulmonary Valve and Conduit

FDA Recall Z-0747-04 · Posted 2004-07-20

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-02-18
Date Terminated2004-03-30
Product Quantity1 unit

Reason for Recall

CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995.

Firm Action

Consignees were notified by telephone on 02/18/2004.

Root Cause

Other

Distribution Pattern

DC, TX

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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