Recall Z-1487-04 ยท FWN Prosthesis, Larynx (Stents And Keels)
Alveolus, Inc.
Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202
| Date | Sep 29, 2004 (initiated Apr 22, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Consignees were notified by telephone on 4/22/2004. |
| Distribution | FL, SC, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.