BEUDAMED
    FDA Enforcement Class I Ongoing

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040

    Recall: Z-2607-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2607-2024
    Event ID
    94852
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2024
    Initiation Date
    May 29, 2024
    Classification Date
    August 23, 2024
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States

    Description

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040

    Reason

    Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

    Code Info

    UDI/DI 15021312006230, Product Code/List Number/Item Code 67N040, Serial Numbers: 3877658, 3901313, 3923737, 3936563, 3942521, 3965334, 4016051, 4331550, 4334880, 4352757, 4362870, 4369535, 4380068

    Distribution

    Worldwide distribution.