BEUDAMED
    FDA Enforcement Class I Terminated

    MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

    Recall: Z-1051-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1051-2015
    Event ID
    70257
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    January 12, 2015
    Classification Date
    February 6, 2015
    Termination Date
    May 10, 2016
    Address
    4024 Stirrup Creek Dr, N/A, Durham, NC, 27703-9000, United States

    Description

    MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

    Reason

    Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.

    Code Info

    Lot numbers: 201413, 201414, 201415, 201417, 201419 and 201422.

    Distribution

    Distributed to FL, KS, MI and WV.

    Quantity

    100 units