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Terminated

CryoValve, Pulmonary Valve

FDA Recall Z-0216-06 · Posted 2005-11-30

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-11-19
Date Terminated2009-07-02
Product Quantity1 unit

Reason for Recall

Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms.

Firm Action

Consignees were notified by letter starting 11/17/2003.

Root Cause

Other

Distribution Pattern

AR, AZ, CA, CT, DC, FL, IL, LA, MN, NC, NH, NV, NY, TN, TX, UT, and Germany.

Official Source

View FDA Recall →

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

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