BEUDAMED
    FDA Enforcement Class I Ongoing

    NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

    Recall: Z-1138-2023 · Reported March 1, 2023

    Enforcement

    Recall Number
    Z-1138-2023
    Event ID
    91538
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2023
    Initiation Date
    January 23, 2023
    Classification Date
    February 23, 2023
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

    Reason

    The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

    Code Info

    All Lot numbers. UDI-DI: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581)

    Distribution

    US Nationwide Distribution

    Quantity

    893 units