BEUDAMED
    FDA Enforcement Class II Terminated

    HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.

    Recall: Z-1479-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1479-2021
    Event ID
    87647
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 28, 2021
    Initiation Date
    March 31, 2021
    Classification Date
    April 21, 2021
    Termination Date
    March 20, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.

    Reason

    Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

    Code Info

    a. Model Number MX496HP, Lot Numbers: 3952480, 3974771 b. Model Number MX497HP, Lot Numbers: 3949391, 3971003

    Distribution

    Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.

    Quantity

    8150 units