BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1365-2022 · Initiated May 20, 2022

    Recall

    Recall Number
    Z-1365-2022
    Event Number
    90423
    Firm
    Draeger Medical Systems, Inc.
    FEI Number
    2510954
    Product Code
    FPL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 20, 2022
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    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.

    Action

    On May 20, 2022, the firm began to send Important Field Safety Notice letters to affected customers. Customers were instructed to avoid using the ventilator portion of the system due to the potential for enriched ambient air rising beyond safe levels until a replacement part can be installed and tested. The firm will send customers a replacement kit and testing which will be completed at no charge to the customer. Draeger Service Representatives will call customers and schedule a service visit to update affected systems.

    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)