BEUDAMED
    FDA Enforcement Class II Terminated

    Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.

    Recall: Z-2757-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2757-2016
    Event ID
    74934
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 14, 2016
    Initiation Date
    August 12, 2016
    Classification Date
    September 8, 2016
    Termination Date
    March 27, 2017
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503, United States

    Description

    Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.

    Reason

    The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.

    Code Info

    Lot Numbers: 1425900137, 1433900079, 1433900080, 1435300088.

    Distribution

    Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.

    Quantity

    1205 units worldwide