BEUDAMED
    FDA Enforcement Class I Ongoing

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60

    Recall: Z-2597-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2597-2024
    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: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60

    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 15021312516821, Product Code/List Number/Item Code 60PFP60, Serial Numbers: 3853449, 3880705, 3887741, 3894904, 3897853, 3918010, 3920943, 3926956, 3942473, 3942474, 3962604, 3982663, 3982664, 3991153, 4015523, 4026688, 4033722, 4035735, 4043946, 4048020, 4056241, 4075244, 4092639, 4100894, 4113112, 4125821, 4138978, 4153591, 4159946, 4173734, 4179355, 4201374, 4212776, 4240147, 4331605, 4334997, 4345009, 4348463, 4374433, 4374434, 4374435, 4389897, 4399173

    Distribution

    Worldwide distribution.