BEUDAMED
    FDA Enforcement Class I Terminated

    MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. 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-1008-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1008-2015
    Event ID
    70127
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    December 4, 2014
    Classification Date
    February 6, 2015
    Termination Date
    March 21, 2017
    Address
    550 E Swedesford Rd Ste 400, N/A, Wayne, PA, 19087-1601, United States

    Description

    MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. 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

    Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.

    Code Info

    Batch Numbers: 201321, 201323, and 201324.

    Distribution

    Distributed in the states of FL, MI, WV, and KS.

    Quantity

    18