BEUDAMED
    FDA Enforcement Class II Ongoing

    Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

    Recall: Z-1352-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1352-2023
    Event ID
    91852
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2023
    Initiation Date
    February 15, 2023
    Classification Date
    April 7, 2023
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

    Reason

    Product that was built for design verification testing was inadvertently distributed to customers.

    Code Info

    Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496

    Distribution

    U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A

    Quantity

    17 devices