BEUDAMED
    FDA Enforcement Class II Ongoing

    smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

    Recall: Z-0146-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0146-2025
    Event ID
    95181
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2024
    Initiation Date
    July 18, 2024
    Classification Date
    October 23, 2024
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000

    Reason

    Uncertainty in the seal integrity of the sterile packaging.

    Code Info

    UDI/DI 35019315022405, Lot Numbers: 4122013, 4130776, 4130777

    Distribution

    Worldwide distribution.

    Quantity

    27,971 units