BEUDAMED
    FDA Recall Terminated

    CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

    Recall: Z-2246-2021 · Initiated June 25, 2021

    Recall

    Recall Number
    Z-2246-2021
    Event Number
    88249
    Firm
    Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany
    FEI Number
    3002808001
    Product Code
    FJL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 25, 2021
    Terminated
    January 5, 2024

    Description

    CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

    Reason

    Product labeled as Cutting Electrode may contain BIVAP electrode.

    Action

    The firm notified its importer 06/25/2021 and subsequently initiated the recall by letter (titled URGENT SAFETY INFORMATION) to its consignees on 06/29/2021. The letter explained the issue and the hazard, and requested consignees and user facilities scrap the affected device.

    Distribution

    US Nationwide Distribution in the states of CA, CO, IN, MA, NH

    Quantity

    20 boxes