BEUDAMED
    FDA Enforcement Class I Ongoing

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;

    Recall: Z-2591-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2591-2024
    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: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;

    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

    a) UDI/DI 15021312005691, Product Code/List Number/Item Code 60N030, Serial Numbers: 3853477, 3868292, 3877665, 3884248, 3904659, 3930047, 3949025, 3952381, 3955770, 3965339, 3965340, 4006289, 4051641, 4066298, 4080798, 4089297, 4110464, 4128036, 4138992, 4159934, 4171560, 4196292, 4204824, 4206834, 4212788, 4233976, 4254268, 4286813, 4331629, 4335053, 4348776, 4353055, 4358515, 4381032, 4388201, 4389921; b) UDI/DI 15021312005707, Product Code/List Number/Item Code 60N035, Serial Numbers: 3880712, 3904683, 3911437, 3946267, 3949046, 3952351, 4006291, 4023792, 4048023, 4056228, 4077083, 4086032, 4096829, 4107578, 4119113, 4136144, 4151019, 4161994, 4171561, 4180455, 4212789, 4237394, 4260075, 4279346, 4331630, 4335054, 4348749, 4348780, 4348781, 4388202, 4389922; c) UDI/DI 15021312005714, Product Code/List Number/Item Code 60N040, Serial Numbers: 3868302, 3884255, 3907990, 3931153, 3949023, 3952346, 3962603, 3982698, 3988169, 4015574, 4051633, 4089296, 4107569, 4128033, 4142419, 4156652, 4176206, 4209580, 4221355, 4233978, 4238778, 4286814, 4345040, 4362872

    Distribution

    Worldwide distribution.