BEUDAMED
    FDA Enforcement Class II Terminated

    CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

    Recall: Z-2246-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2246-2021
    Event ID
    88249
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard Wolf GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    June 25, 2021
    Classification Date
    August 11, 2021
    Termination Date
    January 5, 2024
    Address
    Pforzheimer Str. 32, N/A, Knittlingen, N/A, N/A, Germany

    Description

    CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

    Reason

    Product labeled as Cutting Electrode may contain BIVAP electrode.

    Code Info

    Lot Number 21002858

    Distribution

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

    Quantity

    20 boxes