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Terminated

CryoValve, Pulmonary Valve & Conduit SG

FDA Recall Z-0479-06 · Posted 2006-02-04

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-05-06
Date Terminated2010-06-28
Product Quantity3 units

Reason for Recall

During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.

Firm Action

Consignees were notified by letter dated May 6, May 11, or May 12, 2004.

Root Cause

Other

Distribution Pattern

FL, NC , NE, NV, NY, TN, TX, UT, WA, and Canada

Official Source

View FDA Recall →

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

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