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Terminated

CryoValve Pulmonary Valve and Conduit

FDA Recall Z-1057-04 · Posted 2004-07-20

Recalling FirmCryolife Inc
Recall StatusTerminated
Product CodeMIE
Date Initiated2004-06-17
Date Terminated2005-03-07
Product Quantity3 unit

Reason for Recall

The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070).

Firm Action

Consignees were notified by letter on 06/17/2004 and 06/18/2004.

Root Cause

Other

Distribution Pattern

CA, OH, OR, PA.

Official Source

View FDA Recall →

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

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