BEUDAMED
    FDA Enforcement Class II Terminated

    smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

    Recall: Z-0102-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0102-2022
    Event ID
    88667
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    March 10, 2020
    Classification Date
    October 13, 2021
    Termination Date
    September 22, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

    Reason

    Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

    Code Info

    All codes

    Distribution

    Austria, France, Germany, Great Britain, and Saudi Arabia

    Quantity

    13620 units