BEUDAMED
    FDA Recall 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 · Initiated February 8, 2019

    Recall

    Recall Number
    Z-0795-2020
    Event Number
    84528
    Firm
    Riverpoint Medical, LLC
    FEI Number
    3006981798
    Product Code
    IWJ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 8, 2019
    Posted
    January 10, 2020
    Terminated
    April 28, 2021
    Address
    825 NE 25th Ave, Portland, OR, 97232-2304

    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.

    Action

    Recall notifications dated 2/8/2019 were issued via email and overnight mail on 2/8/2019.

    Distribution

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

    Quantity

    3,234 devices