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Terminated

Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202

FDA Recall Z-1487-04 · Posted 2004-09-29

Recalling FirmAlveolus, Inc.
Recall StatusTerminated
Product CodeFWN
Date Initiated2004-04-22
Date Terminated2005-01-12

Reason for Recall

The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.

Firm Action

Consignees were notified by telephone on 4/22/2004.

Root Cause

Other

Distribution Pattern

FL, SC, TX

Official Source

View FDA Recall →

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

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