BEUDAMED
    FDA Enforcement Class II Terminated

    PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

    Recall: Z-0726-2021 · Reported January 6, 2021

    Enforcement

    Recall Number
    Z-0726-2021
    Event ID
    86954
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 6, 2021
    Initiation Date
    December 15, 2020
    Classification Date
    December 28, 2020
    Termination Date
    December 20, 2022
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

    Reason

    A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

    Code Info

    Lot Number 3991195

    Distribution

    US nationwide distribution.

    Quantity

    238 devices