BEUDAMED
    FDA Enforcement Class II Terminated

    Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.

    Recall: Z-0795-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0795-2020
    Event ID
    84528
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Riverpoint Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2020
    Initiation Date
    February 8, 2019
    Classification Date
    January 10, 2020
    Termination Date
    April 28, 2021
    Address
    825 NE 25th Ave, Portland, OR, 97232-2304, United States

    Description

    Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.

    Reason

    The integrity of the sterile grid packaging is potentially compromised.

    Code Info

    Lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705; UDI number 00812444028638.

    Distribution

    Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution.

    Quantity

    3,234 devices