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Terminated

CryoValve, Pulmonary Valve & Conduit SG

FDA Recall Z-1591-05 · Posted 2005-09-28

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-04-19
Date Terminated2008-01-07
Product Quantity1 tissue

Reason for Recall

This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection.

Firm Action

Consignees were notified by telephone and letter on 04/19/2004.

Root Cause

Other

Distribution Pattern

MO, TX and Sidney Australia

Official Source

View FDA Recall →

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

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