BEUDAMED
    FDA Recall 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 · Initiated December 6, 2013

    Recall

    Recall Number
    Z-0614-2014
    Event Number
    67128
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 6, 2013
    Posted
    December 31, 2013
    Terminated
    January 27, 2014
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    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.

    Action

    Merit Medical Systems sent an Urgent Product Recall Notice dated December 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of the Maestro Microcatheters identified and isolate them in a quarantined area until the product is over-labeled by their Merit Sales Representative Customers were instructed to ensure that all personnel to whom the devices were distributed were made aware of the field action. Customers with questions were instructed to contact their sales representative or call 1-801-826-4062. For questions regarding this recall call 801-253-1600.

    Distribution

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

    Quantity

    59