BEUDAMED
    FDA Enforcement Class III Terminated

    Pneupac paraPac plus 300 ventilator kit, REF P300NGB

    Recall: Z-0163-2022 · Reported November 3, 2021

    Enforcement

    Recall Number
    Z-0163-2022
    Event ID
    88675
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 3, 2021
    Initiation Date
    July 15, 2021
    Classification Date
    October 22, 2021
    Termination Date
    August 11, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    Pneupac paraPac plus 300 ventilator kit, REF P300NGB

    Reason

    Two devices were labeled with the same serial number

    Code Info

    SN RF70121

    Distribution

    UK

    Quantity

    2 units