BEUDAMED
    FDA Recall Terminated

    Manifold Kit. Catalog Number K09-11867AP

    Recall: Z-0632-2017 · Initiated September 23, 2016

    Recall

    Recall Number
    Z-0632-2017
    Event Number
    75367
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    OJV
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 23, 2016
    Posted
    November 19, 2016
    Terminated
    March 27, 2017
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    Manifold Kit. Catalog Number K09-11867AP

    Reason

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

    Action

    Consignees notified via letter on 09/23/16 to quarantine any devices and discontinue use, ensure all personnel to whom the devices were distributed are made aware of the field action, and return affected devices to Merit Medical.

    Distribution

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

    Quantity

    40 units