BEUDAMED
    FDA Enforcement Class II Terminated

    RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

    Recall: Z-1851-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1851-2014
    Event ID
    68387
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    May 23, 2014
    Classification Date
    June 23, 2014
    Termination Date
    January 13, 2016
    Address
    2917 Weck Dr., N/A, Research Triangle Park, NC, 27709, United States

    Description

    RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

    Reason

    Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label.

    Code Info

    Product Code: 102004040, Lot #13371, 13381, 13291, 13281, 13251 & 13231; Product Code: 102004050, Lot #13461, 13441, 13401, 13431, 13421, 13381, 13371, 1329, 13301, 13311, 13361, 13261, 13231, 13251 & 13241; Product Code: 102004060, Lot #13441, 13451, 13431, 13411, 13381, 13361, 13311, 13301, 13281, 13271, 13261, 13241 & 13231; Product Code: 102004070, Lot #13441, 13421, 13381, 13351, 13291, 13311, 13271 & 13261; Product Code: 102004070, Lot #13251 & 13241; and Product Code: 102004080, Lot #13371, 13301 & 13251.

    Distribution

    Nationwide Distribution and the country of Colombia.

    Quantity

    1658 ea