BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1487-04 · Initiated April 22, 2004

    Recall

    Recall Number
    Z-1487-04
    Event Number
    29886
    Firm
    Alveolus, Inc.
    FEI Number
    3004039296
    Product Code
    FWN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 22, 2004
    Posted
    September 29, 2004
    Terminated
    January 12, 2005
    Address
    401 N Tryon St, Fl 10th, Charlotte, NC, 28202-2108

    Description

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

    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.

    Action

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

    Distribution

    FL, SC, TX