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Terminated

One heart and pericardium from donor 12144.

FDA Recall Z-0677-03 · Posted 2003-03-26

Recall StatusTerminated
Product CodeMIE
Date Initiated2002-08-20
Date Terminated2003-04-08
Product QuantityOne heart and pericardium.

Reason for Recall

Human tissue was procured from donor using non-sterile instruments.

Firm Action

Consignee was notified by memorandum on 8/20/2002.

Root Cause

Other

Distribution Pattern

GA

Official Source

View FDA Recall →

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

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