BEUDAMED
    FDA Enforcement Class II Terminated

    Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

    Recall: Z-0045-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0045-2014
    Event ID
    66400
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2013
    Initiation Date
    September 13, 2013
    Classification Date
    October 22, 2013
    Termination Date
    January 3, 2014
    Address
    1600 West Merit Parkway, N/A, South Jordan, UT, 84095, United States

    Description

    Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.

    Reason

    4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.

    Code Info

    Part Number/Lot Number: 7560-43/I663860, 7560-43/I663861, 7560-G3/I664519 and 7560-G3/I666388.

    Distribution

    US Distribution including the states of CO, VA, and MS.

    Quantity

    200