BEUDAMED
    FDA Enforcement Class II Terminated

    ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.

    Recall: Z-1516-2021 · Reported May 5, 2021

    Enforcement

    Recall Number
    Z-1516-2021
    Event ID
    87642
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    May 5, 2021
    Initiation Date
    March 31, 2021
    Classification Date
    April 29, 2021
    Termination Date
    January 31, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.

    Reason

    The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

    Code Info

    Device Model Number: 11-1122; Lot Number: 3809856

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of PA and MN. The countries of Columbia, Germany, Greece, Hong Kong, Qatar, Thailand, and United Arab Emirates.

    Quantity

    250 units