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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 22, 2004
Date Posted September 29, 2004
Recall Status1 Terminated 3 on January 12, 2005
Recall Number Z-1487-04
Recall Event ID 29886
510(K)Number K040523  
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 2		 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.
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