BEUDAMED
    FDA Enforcement Class II Terminated

    Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A

    Recall: Z-0635-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0635-2017
    Event ID
    75367
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 30, 2016
    Initiation Date
    September 23, 2016
    Classification Date
    November 19, 2016
    Termination Date
    March 27, 2017
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A

    Reason

    Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

    Code Info

    Lot Numbers: H992344 and H996476

    Distribution

    Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.

    Quantity

    53 units