BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

    Recall: Z-0027-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0027-2020
    Event ID
    83738
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 9, 2019
    Initiation Date
    October 26, 2018
    Classification Date
    October 1, 2019
    Termination Date
    June 12, 2020
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

    Reason

    Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

    Code Info

    Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05

    Distribution

    U.S.: VA, IL

    Quantity

    24 kits