BEUDAMED
    FDA Enforcement Class II Terminated

    Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

    Recall: Z-0512-2019 · Reported December 5, 2018

    Enforcement

    Recall Number
    Z-0512-2019
    Event ID
    81599
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 5, 2018
    Initiation Date
    November 19, 2018
    Classification Date
    November 28, 2018
    Termination Date
    June 5, 2020
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.

    Reason

    Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924

    Code Info

    Model Number (Lot Number): MX4301L (3538569), MX4331L (3562377, 3546826), MX4331R (3546924)

    Distribution

    The potentially affected products were shipped to customers in the US, Canada, and Mexico.

    Quantity

    2,425 devices