BEUDAMED
    FDA Enforcement Class II Terminated

    PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.

    Recall: Z-1993-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1993-2021
    Event ID
    87983
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 7, 2021
    Initiation Date
    May 14, 2021
    Classification Date
    July 1, 2021
    Termination Date
    June 9, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.

    Reason

    One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.

    Code Info

    Lot Number 4072715

    Distribution

    US Nationwide distribution in the states of PA, MI, MD, FL.

    Quantity

    40 units