BEUDAMED
    FDA Enforcement Class II Ongoing

    Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

    Recall: Z-1365-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1365-2022
    Event ID
    90423
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2022
    Initiation Date
    May 20, 2022
    Classification Date
    July 11, 2022
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

    Reason

    The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.

    Code Info

    Model, country, and serial number: MS20508: El Salvador DSPN-0003 Mexico DSPM-0003, DSPH-0002 Chile DSPL-0003 Saudi Arabia DSPJ-0003, DSPL-0004, DSPL-0005, DSPL-0006, DSPL-0007, DSPM-0001, DSPM-0002, DSPL-0008, DSPK-0002, DSPH-0003, DSPJ-0004, DSRA-0001 Kuwait DSPJ-0002, DSPK-0001 India DSPN-0001, DSPN-0002, DSRA-0002 Taiwan DSPL-0001, SPL-0002, DSPJ-0001 MS20509: Germany DSPH-0003 Qatar DSPL-0007, DSRB-0001 Spain DSPK-0002, DSPJ-0006, DSPJ-0003, DSPH-0001, DSPJ-0004, DSPK-0001, DSPL-0008 Hungary DSPF-0003 Belarus DSPJ-0005 United Kingdom DSPF-0002 Italy DSPJ-0002

    Distribution

    No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW.

    Quantity

    38 OUS (no US distribution)