BEUDAMED
    FDA Enforcement Class II Terminated

    Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.

    Recall: Z-2946-2020 · Reported September 16, 2020

    Enforcement

    Recall Number
    Z-2946-2020
    Event ID
    86345
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 16, 2020
    Initiation Date
    August 28, 2020
    Classification Date
    September 9, 2020
    Termination Date
    May 13, 2021
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States

    Description

    Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.

    Reason

    Label has the incorrect size for the tracheotomy tube.

    Code Info

    Lot# 3952216

    Distribution

    US Distribution to state of: CT

    Quantity

    3 units