BEUDAMED
    FDA Enforcement Class II Terminated

    Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

    Recall: Z-1408-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1408-2013
    Event ID
    65150
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    May 2, 2013
    Classification Date
    May 25, 2013
    Termination Date
    July 22, 2013
    Address
    1600 West Merit Parkway, N/A, South Jordan, UT, 84095, United States

    Description

    Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

    Reason

    Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.

    Code Info

    Lot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391

    Distribution

    USA Nationwide Distribution.

    Quantity

    1,465