BEUDAMED
    FDA Enforcement Class I Terminated

    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

    Recall: Z-0951-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-0951-2014
    Event ID
    67266
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    January 6, 2014
    Classification Date
    February 21, 2014
    Termination Date
    June 17, 2016
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709, United States

    Description

    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.

    Reason

    The tracheal tube can kink during patient use.

    Code Info

    Product Code: 5-13013, Lot numbers: 01A1000316, 01B1000255, 01J1000392, 01A1100209, 01M1000286, 01C1100125, 01D1100298, 01F1100648, 01H1100367, 01L1100147, 01J1100232, 01L1100371, 01M1100176, 01C1200083, 01E1200461, 01E1200545, 01H1200156, 01F1200171, 01A1300637, 01F1300055 and 01F1300297.

    Distribution

    Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.

    Quantity

    190,871 each (148, 275 US)