BEUDAMED
    FDA Recall Terminated

    Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.

    Recall: Z-1748-2013 · Initiated May 28, 2013

    Recall

    Recall Number
    Z-1748-2013
    Event Number
    65303
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    OOY
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    May 28, 2013
    Posted
    July 17, 2013
    Terminated
    August 28, 2013
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.

    Reason

    Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label.

    Action

    The firm, Boston Scientific, sent a letter dated May 28, 2013, via express mail to all its direct consignees. The letter described the product, problem and actions to be taken. The customers were informed that you can continue to use the device until the expiration date on the outer box lablel, 2014-04; No product is being recalled and the you are not required to return product to Boston Scientific. The customers were instructed to read the enclosed information carefully and post the information in a conspicuous location near the affected product and/or take such other steps, consistent with your internal policies and procedures, to ensure that the information is easily accessible to all users of this device; and to complete and return the Customer Acknowledgment Form even if you no longer have any units from the affected lot/batch via email: [email protected] or Fax to: Field Action Center - 1866-213-1806. If you have any questions, call 763-494-1133 or email: [email protected] .

    Distribution

    Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.

    Quantity

    35 units