BEUDAMED
    FDA Enforcement Class II Terminated

    Merit Inflation Syringe Kit. Catalog Number KOS-02857

    Recall: Z-0002-2017 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-0002-2017
    Event ID
    75127
    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 12, 2016
    Initiation Date
    August 25, 2016
    Classification Date
    October 3, 2016
    Termination Date
    December 1, 2016
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Merit Inflation Syringe Kit. Catalog Number KOS-02857

    Reason

    Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.

    Code Info

    Lot Numbers: H959038, H970334, H984351.

    Distribution

    One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.

    Quantity

    1,297 total units