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-0673-03 · Posted 2003-03-21

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2003-02-18
Date Terminated2003-07-21
Product QuantityThere were six (6) individual heart valve allografts.

Reason for Recall

Microorganisms were detected in distributed donor tissue.

Firm Action

Medical facilities were contacted by CryoLife Technical Representatives via letter on/about 2/20/2003 to alert the facility of the removal and to determine the disposition of the allografts. Firms were advised, if the tissue has not been implanted, not to implant or distribute the tissue and to place it into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department-Field Assurance, and a representative would issue a Return Materials Authorization number and will provide specific instructions for returning the tissue. There is a stamped, self addressed postcard attached to affirm receipt of the notification.

Root Cause

Other

Distribution Pattern

Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or government accounts.

Official Source

View FDA Recall →

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

↑