Class 2 Device Recall

• Date Initiated by Firm: April 22, 2004
• Date Posted: September 29, 2004
• Recall Status: Terminated on January 12, 2005
• Recall Number: Z-1487-04
• Recall Event ID: 29886
• Product Classification: Prosthesis, Larynx (Stents And Keels) - Product Code FWN
• Product: Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202
• Code Information: Size 12x40, Part #90129-20, Lot #AC0406; Size 14x40, Part #90129-21, Lot #AC0409; Size 16x40, Part #90129-22, Lot #AA0411; Size 16x60, Part #90129-23, Lot #A0413; Size 12x20, Part #90129-24, Lot #AA0404; Size 14x40, Part #90129-25, Lot 3AA0409; Size 14x40, Part #90129-26, Lot #AC0409; Size 16x60, Part #90129-27, Lot #AA0413
• Recalling Firm/ Manufacturer: Alveolus, Inc.; 401 N Tryon St Fl 10th; Charlotte NC 28202-2108
• For Additional Information Contact: David R. Hamilton; 704-998-6014
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: Consignees were notified by telephone on 4/22/2004.
• Distribution: FL, SC, TX
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.