BEUDAMED
    FDA Enforcement Class II Terminated

    Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.

    Recall: Z-0614-2014 · Reported January 8, 2014

    Enforcement

    Recall Number
    Z-0614-2014
    Event ID
    67128
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 8, 2014
    Initiation Date
    December 6, 2013
    Classification Date
    December 31, 2013
    Termination Date
    January 27, 2014
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095, United States

    Description

    Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.

    Reason

    Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.

    Code Info

    Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada.

    Quantity

    59