BEUDAMED
    FDA Recall Terminated

    Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    Recall: Z-1470-2010 · Initiated April 13, 2010

    Recall

    Recall Number
    Z-1470-2010
    Event Number
    55354
    Firm
    Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
    FEI Number
    2936999
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 13, 2010
    Posted
    May 6, 2010
    Terminated
    January 18, 2012
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214

    Description

    Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

    Reason

    Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

    Action

    Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm. For further Information, contact Covidien at 1-800-635-5267.

    Distribution

    Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay.

    Quantity

    3,759 units