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Terminated

Pulmonary heart valve allograft, human tissue for transplantation.

FDA Recall Z-0525-03 · Posted 2003-02-01

Recalling FirmLifeNet
Recall StatusTerminated
Product CodeMIE
Date Initiated2002-12-19
Date Terminated2003-01-27
Product Quantity1 valve

Reason for Recall

Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.

Firm Action

Firm notified consignee by phone and letter 12/19/02 and requested valve to be returned.

Root Cause

Other

Distribution Pattern

Product was shipped to one hospital in NY

Official Source

View FDA Recall →

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

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