BEUDAMED
    FDA Enforcement Class III Terminated

    RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.

    Recall: Z-0777-2019 · Reported February 6, 2019

    Enforcement

    Recall Number
    Z-0777-2019
    Event ID
    81935
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Riverpoint Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 6, 2019
    Initiation Date
    January 9, 2018
    Classification Date
    January 28, 2019
    Termination Date
    April 15, 2019
    Address
    825 NE 25th Ave, N/A, Portland, OR, 97232-2304, United States

    Description

    RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement.

    Reason

    Product is labeled with "CE", but is not yet approved in the European Union.

    Code Info

    Lot Numbers: 18061816, 18101521

    Distribution

    US Nationwide Distribution in the states of IL, WA, and FL

    Quantity

    443 devices