BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-1667-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1667-2013
    Event ID
    65449
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bryan Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 17, 2013
    Initiation Date
    April 17, 2013
    Classification Date
    July 8, 2013
    Termination Date
    October 29, 2013
    Address
    6811 Mount Vernon Ave, N/A, Cincinnati, OH, 45227, United States

    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.

    Code Info

    The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752

    Distribution

    Distributed in KY and AL.

    Quantity

    5 units