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Terminated

CryoValve, Pulmonary Valve & Conduit

FDA Recall Z-0165-05 · Posted 2004-11-03

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-05-06
Date Terminated2010-06-29
Product Quantity17 units

Reason for Recall

CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.

Firm Action

Consignees were notified by letter on/about May 6, 2004.

Root Cause

Other

Distribution Pattern

Nationwide, Austria, Canada, Germany

Official Source

View FDA Recall →

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

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