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 Allograft, Heart valve.

FDA Recall Z-0719-03 · Posted 2003-04-10

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-02-24
Date Terminated2004-07-23
Product Quantity2 individual heart valve allografts.

Reason for Recall

Pre-processing cultures detected certain microorganisms in donor tissue.

Firm Action

Consignees were first notified by telephone on 2/24/2003 with follow up letter on March 6, 2003 and were advised, if the tissue had not yet been implanted, to remove tissue from implantable inventory and place it into quarantine. CryoLife will provide specific instructions for returning the tissue. A stamped, self-addressed postcard was provided to confirm receipt of the notice and to provide information regarding the disposition of the tissue.

Root Cause

Other

Distribution Pattern

Heart allografts were distributed to two hospitals in OH and Quebec, Canada.

Official Source

View FDA Recall →

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

↑