BEUDAMED
    FDA Recall Terminated

    Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.

    Recall: Z-1667-2013 · Initiated April 17, 2013

    Recall

    Recall Number
    Z-1667-2013
    Event Number
    65449
    Firm
    Bryan Medical Inc
    FEI Number
    3005803389
    Product Code
    BTO
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    April 17, 2013
    Posted
    July 8, 2013
    Terminated
    October 29, 2013
    Address
    6811 Mount Vernon Ave, Cincinnati, OH, 45227

    Description

    Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.

    Reason

    The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

    Action

    The consignees were contacted by telephone and asked to return the recalled product.

    Distribution

    Distributed in KY and AL.

    Quantity

    5 units