BEUDAMED
    FDA Enforcement Class II Terminated

    CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.

    Recall: Z-2763-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2763-2015
    Event ID
    71935
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Med Tec Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 23, 2015
    Initiation Date
    August 19, 2015
    Classification Date
    September 14, 2015
    Termination Date
    October 7, 2016
    Address
    1401 8th St SE, PO Box 320, Orange City, IA, 51041-7463, United States

    Description

    CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.

    Reason

    The wrist straps used for positioning the patient are too long

    Code Info

    Lot numbers M765570 and M784310.

    Distribution

    Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong

    Quantity

    18 sets