BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0045-2014 · Initiated September 13, 2013

    Recall

    Recall Number
    Z-0045-2014
    Event Number
    66400
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 13, 2013
    Posted
    October 22, 2013
    Terminated
    January 3, 2014
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    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.

    Action

    Consignees were notified on 9/13/13 via Urgent Product Recall Notice, email, and product retrieval forms. Actions required of customers: 1. Please immediately determine if any of the devices are within your facility, quarantine them and discontinue use. 2. Ensure that all personnel to whom the devices were distributed are made aware of this field action. 3. Contact your Merit Sales Representative in order to arrange product return and replacement or credit. 4. If you have any questions concerning this communication, please don't hesitate to contact Guido Sandulli at 1-801-826-4046.

    Distribution

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

    Quantity

    200