Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CryoValve Pulmonary Valve & Conduit.

FDA Recall Z-0939-03 · Posted 2003-06-17

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-05-23
Date Terminated2003-12-10
Product Quantity2 individual heart valve allografts.

Reason for Recall

Microorganisms detected in associated allografts.

Firm Action

The medical facility was notified by letter on May 23, 2003. The implanting physician was notified by letter on May 28, 2003.

Root Cause

Other

Distribution Pattern

The tissues were distributed to one medical facility in CT and to one physician in MT.

Official Source

View FDA Recall →

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

↑