BEUDAMED
    FDA Enforcement Class II Ongoing

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    Recall: Z-0529-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0529-2025
    Event ID
    95605
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 28, 2024
    Classification Date
    November 25, 2024
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States

    Description

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    Reason

    Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

    Code Info

    UDI/DI 35021239002593, Lot Numbers: 0003373, 0003456, 0003621, 0003374, 0003376, 0003375, 0003459, 0003391, 0003480, 0003549, 0003301, 0003124, 0003130, 0003139, 0003140, 0003144, 0003148, 0003152, 0003161, 0003169, 0003185, 0003205, 0003210, 0003222, 0003232, 0003236, 0003255, 0003276, 0003277, 0003315, 0003329, 0003339, 0003367, 0003370, 0003371, 0003372, 0003381, 0003395, 0003399, 0003403, 0003414, 0003449, 0003457, 0003469, 0003476, 0003477, 0003489, 0003492, 0003500, 0003573, 0003484, 0003619, 0003557, 0003510, 0003522, 0003597, 0003511, 0003622, 0003553, 0003581, 0003605, 0003529,

    Distribution

    Worldwide distribution.

    Quantity

    12282 units