BEUDAMED
    FDA Recall Terminated

    Merit Inflation Syringe Kit. Catalog Number KOS-02857

    Recall: Z-0002-2017 · Initiated August 25, 2016

    Recall

    Recall Number
    Z-0002-2017
    Event Number
    75127
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    MAV
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    August 25, 2016
    Terminated
    December 1, 2016
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    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.

    Action

    Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units. The returned units will be re-labeled. For further questions, please call (801) 316-3690.

    Distribution

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

    Quantity

    1,297 total units