BEUDAMED
    FDA Enforcement Class II Terminated

    MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.

    Recall: Z-2683-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2683-2016
    Event ID
    74793
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2016
    Initiation Date
    December 3, 2015
    Classification Date
    August 29, 2016
    Termination Date
    January 24, 2017
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.

    Reason

    Cracking may occur at the 15mm and 22mm ISO female connector.

    Code Info

    Model number: 01-06-8125-8, Product code: XKC01-06-8125-8, Lot numbers: 201450, 201451, 201452 and 201504.

    Distribution

    US Distribution to the states of : FL, KS, and WV.

    Quantity

    2,700 units