BEUDAMED
    FDA Enforcement Class II Terminated

    Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

    Recall: Z-1845-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1845-2015
    Event ID
    71537
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Volcano Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2015
    Initiation Date
    June 4, 2015
    Classification Date
    June 25, 2015
    Termination Date
    October 27, 2015
    Address
    2870 Kilgore Rd, Rancho Cordova, CA, 95670-6133, United States

    Description

    Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

    Reason

    During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture

    Code Info

    Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.

    Distribution

    US Nationwide Distribution and one account in Canada.

    Quantity

    162 total (both devices)