BEUDAMED
    FDA Recall Terminated

    Pneupac paraPac plus 300 ventilator kit, REF P300NGB

    Recall: Z-0163-2022 · Initiated July 15, 2021

    Recall

    Recall Number
    Z-0163-2022
    Event Number
    88675
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    BTL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 15, 2021
    Terminated
    August 11, 2023
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Pneupac paraPac plus 300 ventilator kit, REF P300NGB

    Reason

    Two devices were labeled with the same serial number

    Action

    The firm notified the consignee by email on 07/15/2020 and requested the return of the units.

    Distribution

    UK

    Quantity

    2 units