BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.

    Recall: Z-1956-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1956-2020
    Event ID
    85342
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 20, 2020
    Initiation Date
    September 12, 2019
    Classification Date
    May 11, 2020
    Termination Date
    May 27, 2022
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.

    Reason

    labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.

    Code Info

    Catalog Number: K21-00031, Lot Number: H1583914, UDI: 00884450426357

    Distribution

    US Nationwide distribution in the state of MI.

    Quantity

    15 kits